DNA Healthcare Advertising Portfolio by adam gay

DNA Portfolio

ÂŠ DNA Healthcare Advertising Ltd. DNA Portfolio.

Brands: C DS, HHS, Neurology, Cardiology, Breast Cancer Client: GE Healthcare GE Healthcare

GE Healthcare

Clinical Department Solutions

Let us complete the picture.

Diagnostic Imaging

Neonatal ICU/ICU

GE CV portfolio

Web buttons

GE imagination at work

CDS adverts

GE Healthcare

Clinical Department Solutions

Mr. Bob Smith V.P. Environmental Controls ABC Company 123 AnyStreet Anycity, NY, 10001

Title or tagline

Dear

ical ent Clinpartm De tions Solu . ork Artw

Artwork.

GE imagination at work

tion

gina

ima

At lant moditatur remperi buscim vellanis mi, suntis alit et aut acimolorem veliquiscia volorae voloribusa di to vel etur, cusci tenit est, coremperum as dolorem nos expelessit init, vendesse sequiaesti quodis aut odi aliquia desequam, il eate doluptamus molenia simo voluptati ut mincti ne dolupta sam iliqui ipsa deribus dolorrum et doluptio. Et am, a doluptat adi culparu mquiatiur?

GSF logo

ealth

H NA

9SS

27 12. , SE d. 20 London g Lt , tisin Place n dver re A Paxto 43. lthca 6 - 8 04 47 Hea d. NA ing Lt ) 20 30 D (0 © tis dver t +44 re A

GE Healthcare

Clinical Department Solutions

ork

at w

CD sleeve and sleeve

Let us complete the picture. Sincerely,

Name Title

GE imagination at work

Neurology web page

Letter template

Let us complete the picture for you. If you have a great vision of what your hospital development should be, we’ll help you realize it. Our CDS (Clinical Department Solutions) teams have completed over 200 internationally successful projects already. Their knowledge and ability to access to everything your project will need are second to none. CDS teams add significant value throughout the life of projects. Effectively coordinating with all stakeholders, to ensure you get exactly what you envisiged - on time and on budget. Click here for more information, or come see us at stand xxx

GE imagination at work

A5 leave piece DNA Portfolio. © DNA Healthcare Advertising Ltd.

Email flyer

Neurology web page illustrations

MRI

ECG

Technology stickers - 148mm diameter

Echo FF

Care Pathway: Coronary Artery Disease

ECG

History / Examination

MRI

Discharge

x5 Stress Test

ECG

logy st

Low Risk

History / Examination

Pre-op Monitoring

Noninvasive Imaging

Home

Physician’s Office

Ambulance

Stress

Emergency Department/ Outpatient Department

Noninvasive Imaging

Rest

STEMI

PCI

Non-invasive Diagnostics

or obligation.

GE Healthcare

GE Healthcare, a division of General Electric Company. * Trademark of General Electric Company

About GE Healthcare GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems. Our “healthymagination” vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality around the world. Headquartered in the United Kingdom, GE Healthcare is a unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employees are committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com GE Healthcare, Levent Ofis – Esentepe Mah, Talatpasa Cd. Harman Sk. No 8 Levent. 34394 Istanbul

MRI

Patient

PCP/GP

x x5 5

xx55

Let us complete the picture.

Biomarker

Outpatient Clinic

Home

Rehab Facility

Blank x 10

Physician’s Office

Out of Hospital

Technology stickers - 148mm diameter Paramedics

Nurse

care pathway poster P/GP

Patient

Echo ECG FFR

Nurse

Paramedics

50 mm ickers - 90 x

st Blank spare x 5x 5 xx 55

ED x5

PET-CT General Cardiologist

MRI

Sonographer

Pathway xx55examples xx 55poster sticker

xxx555

Contrast

Biomarker Stress

Rest

CDS icons

Pathway: Coronary Artery Disease AN EVENT BYCare COMMERCIAL WOMENx 5

Nurse

Paramedics

General Patient Cardiologist

x 5x 5

x 5 Blank x 10 x 5

Sonographer CAKP LogoNurse Radiologist PCP/GP x 5x 5

x 5x 5

FACT 2

Moderated by Maxine Benson MBE, co-founder everywoman.

Frontiers on Advising Cardiovascular Technologies Five successful business women from across industry will share their thoughts Blank spare stickers - 90 x 50 mm and stories on how they have led business growth, developed people and Medical Advisory Board challenged leadership stereotypes, to become highly respected, authentic female for Coronary Artery Disease leaders. You will be able to ask them for insight on any of your own personal Care Pathway: Coronary Artery Disease challenges or observations. Cardiology Appointment

Discharge

Maxine Benson Stress Test

Low Risk

Karen Gill

Risk Assessment

Cardiology Appointment

x 10

Cardiology Department

Data Transfer

Discharge Stress Test

Chest Pain

Data Transfer

Physician

Data Transfer

ECG / Stress Test

x 10

ECG / Stress Test Holter Monitoring

Monitoring

Founder and CEO of Alexander Mann Solutions NSTEMI

Data Transfer

History / Examination

ECG

Stable Angina

Data Transfer

Monitoring

Diagnostic Angiography

Pre-op Monitoring

Blood Tests

Rosaleen Blair

ECG

Physician’s Appointment

Discharge

Co-founder of everywoman History / Examination

Physician

ECG / Stress Test

History / Examination

High Risk ECG

Chest Pain

Data Transfer

Holter Monitoring

Monitoring

Co-founder of everywoman

ECG

Data Transfer

Monitoring

Diagnostic Angiography

History / Examination

Blank spare stickers - 90 x 50 mm

Physician’s Appointment

Cardiology Department

Blood Tests

ECG / Stress Test

Monitoring Low Risk

Post-op Monitoring

High Risk

Risk Assessment

Pre-op Monitoring

Discharge

History / Examination

Data Transfer

Monitoring

ACS

Blood Tests

Hester Larkin

STEMI

PCI

CABG

Stable Angina Post-op Monitoring

NSTEMI

ECG

Founder Hester Larkin Associates Noninvasive Imaging

Noninvasive Imaging

ACS STEMI

Blood Tests

PCI

CABG

Catheterisation Lab

Operating Room

Noninvasive Imaging

Melanie Eusebe

Managing Consultant, Ernst & Young Home

Home

Physician’s Office

Out of Hospital For internal GE use only.

Ambulance

Emergency Department/ Outpatient Department

Pathology Department

Non-invasive Diagnostics

Physician’s Office

Ambulance

Catheterisation Lab

Date: 27th June 2012 Out of Hospital Hospital Location: The Ark, Hammersmith Time: 5 - 7.30 pm 1

Emergency Department/ Outpatient Department

Operating Room

Pathology Department

Coronary Intensive Care Unit

For internal GE use only.

Spaces are limited so please register by selecting http://sc.ge.com/*RegisterforRosaleenBlairEvent

GE imagination at work

For further information contact Gabrielle Silver or Rachel Stracey.

Non-invasive Diagnostics

Ward

Outpatient Clinic

Hospital

Coronary Intensive Care Unit

Home

Ward

Outpatient Clinic

Rehab Facility

Home

Rehab Facility

Physician’s Office

Out of Hospital

SMO-Cardiovascular®

SMO-Cardiovascular

Cardiology adboard A4 workbook

Visit us online sc.ge.com/*WNUKIRE

Banner 1 x 2m

xxx555

Hosted by GE Leaders, Mark Elborne, Pascale Witz and Sandy Lucas.

ECG

Radiologi

Information owner stickers - 148mm diameter

CDS Brand Guidelines

Patient PCP/GP THE AUTHENTIC FEMALE LEADER

History / Examination

OCT

Sub-technology stickers - 100mm diameter

x 10

Information owner stickers - 148mm diameter

CDS DL leave piece

Clinical Department Solutions

ECG / Stress Test

GE imagination at work

GE Healthcare

Data Transfer

5t Contrxas

er 8mm diamet

Ward

Rest

Cardiology DL leave piece

Coronary Intensive Care Unit

3D x5

Contrast

stickers - 14 x5

Stress

x 10

www.gehealthcare.com

GE imagination at work

Operating Room

Brand Sub-technologyBlank stickers - 100mm spare stickers diameter - 90 x 50 mm Guidelines.

A new vision for Cardiology

althcare

SMO-Cardiovascular®

ECG

Clinical Department Solutions

Physician

ECG / Stress Test

Data Transfer

Hospital

Technology stickers - 148mm diameter Information owner stickers - 148mm diameter Coronary artery disease

Clinical Department Solutions

GE and GE Monogram are trademarks of General Electric Company.

3D ation owner x5

Catheterisation Lab

Physician’s Appointment

Data Transfer

Post-op Monitoring

CABG

For internal GE use only.

A5 adboard info booklet

General Electric Company reserves the right to make changes in specification and GE Healthcare features shown herein, or discontinue the product described at any time without notice

x 5Inform

Pathology Department

Out of Hospital

NSTEMI

ACS

Data Transfer

Monitoring

Discharge

Stable Angina

Blood Tests

PET-CT

Data Transfer

Holter Monitoring

Rest

Stress

ECG

Monitoring

High Risk

Sub-technology stickers - 100mm diameter

Cardiology Department

Monitoring

Risk Assessment

Chest Pain

m diamet ickers - 100m

Sub-techno x5 Diagnostic Angiography

History / Examination

Echo FFR Cardiology Appointment

ECG

Blood Tests

Women in commercial poster © DNA Healthcare Advertising Ltd. DNA Portfolio.

Paramed IC

x x55

Brand: Tomudex Client: Hospira Logo design

Detail aid

A5 leave piece

Press advert - A4 portrait - mesothelioma (MPM)

A positive choice for your 5â&#x20AC;&#x201C;FU intolerant patients Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard Adverse events should also be reported to Hospira UK Ltd. Telephone Medical Information: +44 (0) 1926 834400

Prescribing information is available on this stand. UK/12/003. Date of preparation: March 2012.

Press advert - landscape - colorectal cancer (CRC) DNA Portfolio. ÂŠ DNA Healthcare Advertising Ltd.

Exhibition stand panel

Detail aid slide set

Conference Stand Design

Conference speaker support and printed assets

Prescrib ing Informat ion Tomude x Abbrevi ated before of Product Characteris tics (SmPC) Please refer to full Summary prescribing . in each vial. powder for solution for injection where Presentation: 2 mg raltitrexed of advanced colorectal cancer Indications: The palliative treatment regimens are either not tolerated or based 5-Fluorouracil and folinic acid inappropriate. 2 treatment may ly. In the absence of toxicity, s are Dosage: 3 mg/m intravenous modification interval Dose and dosage inal or be repeated every 3 weeks. impairment and those with gastrointest required in patients with renal ml of either haematological toxicities. over 15 minutes in 50 to 250 Administration: Intravenous infusion solution. glucose 5% or should be 0.9% sodium chloride solution and breastfeeding. Pregnancy Contraindications: Pregnancycommenced. Severe renal impairment. excluded before treatment is not be given folic acid preparations must Interactions: Folinic acid or administration. immediately prior to, or during of physicians only be used under supervision Monitor Warnings and Precautions: Should conditions. treated the of patients with creatinine experienced in management es, serum bilirubin and serum full blood count, liver transaminas is necessary in patients with depressed y, elderly prior to each treatment. Caution general condition, prior radiotherap ed bone marrow function, poor impairment. Not recommend hepatic moderate to mild in for at least patients or Pregnancy should be avoided in severe hepatic impairment. of either partner. 6 months after cessation of treatment vomiting, anorexia, gastrointestinal anaemia, Adverse effects: Nausea, diarrhoea, , leucopenia, neutropenia, asthenia, bleeding, dyspepsia, constipation rash, ALT, increases in AST and The SmPC thrombocytopenia, reversible infections, cellulitis and sepsis. fever, abdominal pain, headache, of other undesirable effects. should be consulted for details . Legal category: POM ck/Basic NHS Price PL 04515/0225 Marketing Authorisation Number/Pa ÂŁ175. 2mg. raltitrexed , Royal Single vial containing Hospira UK Limited, Queensway Marketing Authorisation Holder:CV31 3RW. United Kingdom. Leamington Spa, Warwickshire, UK Ltd. Hospira from request on Further information is available (UK/12/013). Date of preparation: March 2012 Reporting forms and information Adverse events should be reported. wcard. Adverse events should can be found at www.mhra.gov.uk/yello Ltd. Telephone Medical Information: also be reported to Hospira UK1926 834400. +44 (0)

Tomud ex Hospir a UK Ltd. Queen sway Spa, Royal Leamin gton Warwi ckshire CV31 3RW, UK www.h ospira. com UK/13/027. February 2013.

Brand guidelines manual and CD

abou t Tomu dex Your ques tions

in patient s Tomud ex usage for which A discus sion of , colorec tal cancer either not with advanc ed regime ns are 5-fluorouracil -based priate. tolerate d or inappro 24. n can be found on page Prescribin g informatio

Q&A document

RPC mailer ÂŠ DNA Healthcare Advertising Ltd. DNA Portfolio.

Brand: Xifaxanta Client: Norgine Pharmaceuticals Ltd Practice Nursing News

21/12/2011 13:02

Xifaxanta. BMJ (GP) Whole/full page advert. 280 x 210mm. 3mm bleed.

NEW rhoea

T For

Don’t let travellers’ diarrhoea spoil your holiday or business trip

rav i ellers’ D

Xifaxanta™ gets to work here ...and only here1,2

Get travellers’ diarrhoea advice BEFORE you leave.

The first and only virtually non-absorbed antibiotic licensed for the treatment of non invasive Travellers’ Diarrhoea3

Travellers’ diarrhoea (TD) is the most common infectious disease in those travelling abroad from the UK. Every year, 5 million UK holiday and business travellers will suffer from a bout of TD. Up to 40% of travellers to high risk regions (such as Latin America, Africa and Southern Asia) suffer with TD

XIFAXANTA™ Prescribing Information REFER TO FULL SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) BEFORE PRESCRIBING. Presentation: Film-coated tablet containing rifaximin 200 mg. Uses: Xifaxanta is indicated for the treatment of travellers’ diarrhoea that is not associated with fever, bloody diarrhoea, eight or more unformed stools in the previous 24 h, occult blood or leucocytes in the stool. Dosage and administration: Adults over 18 years of age: 200 mg every 8 hours for three days (total 9 doses). Rifaximin must not be used for more than 3 days even if symptoms continue and a second course of treatment must not be taken. Not recommended in children under 18 years of age. Contraindications: Hypersensitivity to the active substance, to any rifamycin (e.g. rifampicin or rifabutin) or to any of the excipients. Warnings and precautions for use: Not recommended for the treatment of travellers’ diarrhoea caused by invasive enteric pathogens. If symptoms worsen, treatment with rifaximin should be interrupted. If symptoms have not resolved after 3 days of treatment, or recur shortly afterwards, a second course is not recommended. The potential association of rifaximin treatment with Clostridium difficile associated diarrhoea and pseudomembranous colitis

cannot be ruled out. Interactions: Due to the negligible gastrointestinal absorption of orally administered rifaximin (less than 1%), the systemic drug interaction potential is low. Rifaximin should not be administered concomitantly with other rifamycins and the tablets should not be administered for at least two hours after the administration of charcoal. Pregnancy and lactation: Rifaximin is not recommended during pregnancy and in women of childbearing potential not using contraception. The benefits of rifaximin treatment should be assessed against the need to continue breastfeeding. Undesirable effects: Common effects reported in clinical trials are dizziness, headache, abdominal pain, constipation, defecation urgency, diarrhoea, flatulence, bloating, distension, nausea, vomiting, rectal tenesmus and pyrexia. Other effects that have been reported are candidiasis, herpes simplex infections, clostridial infections, palpitations, increased blood pressure, liver function test abnormalities, blood disorders (e.g. thrombocytopenia) and anaphylactic reactions, (e.g. angioedemas,hypersensitivity and skin reactions). Licensing and legal category: Legal category: POM. Cost: Basic NHS price £15.15 (9 tablets). MA number: PL 20011/0021. For further

However, you don’t need to go to a developing or an ‘exotic’ country to be at risk

information contact: Norgine Pharmaceuticals Limited, Norgine House, Moorhall Road, Harefield, Middlesex, UB9 6NS. 01895 826606. E-mail: medinfo@norgine.com. Date of preparation/revision: XIF/2553/AUG/11.

Bacteria are the most common cause of TD, around 80% of cases are thought to be caused by a form of E. coli

Adverse events should be reported. Reporting forms and information can be found at http://yellowcard.mhra.gov.uk. Adverse events should also be reported to Medical Information at Norgine Pharmaceuticals Ltd on 01895 826606.

You may be confined to your room and unable to continue fully with your plans. This could be a disaster for your holiday or business trip and prove to have been a waste of time and money.

References 1. Jiang ZD et al. Antimicrob Agents Chemother 2000;44 (8):2205-2206. 2. Descombe JJ et al. Int J Clin Pharmacol Res 1994;14 (2):51-56. 3. Xifaxanta™ Summary of Product Characteristics. XIFAXANTA is a trademark of AlfaWassermann Hungary KFT, exclusively licensed in the UK to the Norgine group of companies. XIF/2563/AUG/11.

Although it is usually a short illness, TD can sometimes last many weeks - some people may even develop long term bowel troubles

Date of preparation: August 2011.

A4 UK advert

A5 leave piece

Clinic leaflet

Every year approximately 80 million people travel from developed to developing countries, and it is estimated that nearly half contract travellers’ diarrhoea (TD); making it the most common illness affecting travellers.1,2 Aside from the physical cost, there are high costs in terms of time, money and distress. One third of TD sufferers are forced to abandon their travel plans altogether.5 TD is caused by the ingestion of pathogens through consumption of contaminated food and drink. Bacteria are the commonest cause of this problem with the enterotoxigenic (ETEC) strain of E.Coli being the most implicated.3 Even when a pathogenic cause can not be identified, antibiotic therapy is still effective.4

Xifaxanta The Travel Show. Bench poster. 450 x 450mm. CMYK

The medical consequences of TD are far from trivial: research shows that longer term complications may also occur – a small of

lth ea 05 l H P1 ve A k ra nd As he T Sta t e at on Z

Where would you rather spend your holiday?

travellers with TD have long-term bowel problems. Some research shows that up to 10% of TD sufferers may go on to develop Post-Infectious Irritable Bowel Syndrome. However, this is a topic of ongoing debate. Yet despite the physical and financial cost of TD, only half of travellers to high-risk countries are seeking advice from their GP or travel clinic before they travel.1 Travellers returning from most European countries and the United States had very low rates of infection, but the rates are drastically higher in those returning from popular tourist destinations like Egypt (up to 40% risk) followed by Turkey, India, Thailand, Morocco, Kenya and Tunisia.5 Xifaxanta™ - ‘Zi-fax-anta’ - is the first oral antibiotic for the treatment of non-invasive TD which remains almost entirely inside the gut (<99%) and is active against enterotoxigenic E.Coli (ETEC):6 as such, the potential for resistance is low, despite Xifaxanta™’s use in many countries over several years.7,8 In addition, the risk of systemic side effects and/or drug-drug interactions is reduced. Xifaxanta™ presents prescribers with an opportunity to treat TD efficiently, but without the concerns of inducing systemic bacterial resistance. Importantly, over the last 10 years there has been increasing global resistance with commonly first-line used antibiotics like ciprofloxacin9 (resistance among Campylobacter strains to flouroquinolones in Southern Europe and Thailand6). Xifaxanta™ has not been associated with clinically significant cross-resistance to other members of the rifamycin class, in particular rifampicin. Xifaxanta™ has been available in the USA and other European countries since 2004, but can now be prescribed by UK general practitioners and travel clinics to patients travelling to high risk destinations as a ‘stand by treatment’.10 Administration is via a course of tablets - one to be taken three times a day for three days - with or without food.10 The course should be started as soon as symptoms arise. The following patients in particular could benefit from taking Xifaxanta™: Those visiting high risk regions

Get travellers’ diarrhoea advice BEFORE you leave. Every year, 5 million UK holiday and business travellers will suffer from a bout of travellers’ diarrhoea (TD). And it’s not just those who travel to developing or exotic countries.

Wherever you’re travelling, get advice from your doctor or practice nurse first - before you go.

Those for whom an episode of TD would adversely disrupt their planned activities Those returning from travel with uncomplicated TD

EFFICACY: COMPARISON WITH CIPROFLOXACIN AND LOPERAMIDE A clinical trial has found no significant difference between the efficacy of Xifaxanta™ and ciprofloxacin in TREATING

For more information visit www.travellersdiarrhoea.co.uk A patient information service from Norgine. Norgine Pharmaceuticals Limited, Moorhall Road, Harefield, Middlesex, UB9 6NS. Email: medinfo@norgine.com. Tel: 01895 826606

XIF/3126/OCT/12. Date of preparation: November 2012.

Detail aid interactive PDF

Those with increased susceptibility to infection (eg immunocompromised)

non-invasive TD.11,12 The median time from taking Xifaxanta™ until the last unformed stool is between 32 and 32½ hours.10 Clinical ‘wellness’ was achieved significantly faster with Xifaxanta™-containing regimens compared with loperamide alone.13

CONTRAINDICATIONS & SIDE EFFECTS

Destinations Travel Show, bench poster FRONT COVER

Xifaxanta™ is generally well-tolerated, and is associated with a low incidence of adverse events14 which are generally mild to moderate in severity.15 The most commonly-reported events are gastrointestinal in nature, such as flatulence and abdominal pain, and distinction from the condition can be difficult.

Detail Aid

Where would you rather spend your holiday? XIFAXANTA™ (rifaximin- )

FORMULARY INFORMATION

Wherever you’re travelling, get advice from your doctor or practice nurse first - before you go.

For more information please ask at this clinic, read the travellers’ diarrhoea leaflets available here, or visit www.travellersdiarrhoea.co.uk XIF/2873/APR/12. Date of preparation: April 2012.

A patient information service from Norgine. Norgine Pharmaceuticals Limited, Moorhall Road, Harefield, Middlesex, UB9 6NS. Email: medinfo@norgine.com. Tel: 01895 826606

References:

Prescribing Information:

1. Wang M, Szecs TD, Steffen R. Economic aspects of travellers’ diarrhoea. J Travel Med. 2008; 15(2): 110-118 2. Du Pont HL. Systematic review : prevention of travellers’ diarrhoea. Aliment Pharmacol Ther 2008;27:741-751 3. Shah N et al. Global Etiology of Travelers’ Diarrhea: Systematic Review from 1973 to the Present. Am J Trop Med Hyg 2009;80(4):609–614 4. DuPont HL, Haake R, Taylor DN, et al. Rifaximin Treatment of Pathogen-Negative Travelers’ Diarrhea. International Society of Travel Medicine 2007;14:1195-1982. 5. Steffen R. Epidemiology of Traveler’s Diarrhea. CID 2005: 41 (Suppl 8): S536-40 6. Robbins GW et al. Drugs 2005:65(12)1697-1713 7. Ericsson CD. Drug Saf 2006; 29 (£):201207 8. Dupont HL et al. Clin Micro Infect 2004 ;10:1006-1035 9. Ouyang-Latimer J et al. In Vitro Antimicrobial Susceptibility of Bacterial Enteropathogens Isolated from International Travelers to Mexico, Guatemala, and India from 2006 to 2008. Antimicrob Agents Chemother 2011;55:874–8. 10. XIFAXANTA™ SMPC 11. Layer P, et al. Aliment Pharmacol Ther 2010;31:1155-1164 12. DuPont et al. Clin Infect Dis 2011;33:18071815 13. DuPont et al. Clin Gastroenterol Hepatol 2007;5(4):451-456 14. Koo HL, DuPont HL. Rifaximin: a unique gastrointestinal-selective antibiotic for enteric diseases. Current Opinion in Gastroenterology. 2010; 26: 17-25 15. Ericsson CD. Safety and tolerability of the antibacterial rifaximin in the treatment of travellers' diarrhoea. Drug Saf. 2006;29(3):201-7.

REFER TO FULL SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) BEFORE PRESCRIBING. Presentation: Film-coated tablet containing rifaximin 200 mg. Uses: Xifaxanta is indicated for the treatment of travellers' diarrhoea that is not associated with fever, bloody diarrhoea, eight or more unformed stools in the previous 24 h, occult blood or leucocytes in the stool. Dosage and administration: Adults over 18 years of age: 200 mg every 8 hours for three days (total 9 doses). Rifaximin must not be used for more than 3 days even if symptoms continue and a second course of treatment must not be taken. Not recommended in children under 18 years of age. Contraindications: Hypersensitivity to the active substance, to any rifamycin (e.g. rifampicin or rifabutin) or to any of the excipients. Warnings and precautions for use: Not recommended for the treatment of travellers' diarrhoea caused by invasive enteric pathogens. If symptoms worsen, treatment with rifaximin should be interrupted. If symptoms have not resolved after 3 days of treatment, or recur shortly afterwards, a second course is not recommended. The potential association of rifaximin treatment with Clostridium difficile associated diarrhoea and pseudomembranous colitis cannot be ruled out. Interactions: Due to the negligible gastrointestinal absorption of orally administered rifaximin (less than 1%), the systemic drug interaction potential is low. Rifaximin should not be administered concomitantly with other rifamycins and the tablets should not be administered for at least two hours after the administration of charcoal. Pregnancy and lactation: Rifaximin is not recommended during pregnancy and in women of childbearing potential not using contraception.The benefits of rifaximin treatment should be assessed against the need to continue breastfeeding. Undesirable effects: Common effects reported in clinical trials are dizziness, headache, abdominal pain, constipation, defecation urgency, diarrhoea, flatulence, bloating, distension, nausea, vomiting, rectal tenesmus and pyrexia. Other effects that have been reported are candidiasis, herpes simplex infections, clostridial infections, palpitations, increased blood pressure, liver function test abnormalities, blood disorders (e.g. thrombocytopenia) and anaphylactic reactions, (e.g. angioedemas, hypersensitivity and skin reactions). Licensing and legal category: Legal category: POM. Cost: Basic NHS price £15.15 (9 tablets). MA number: PL 20011/0021. For further information contact: Norgine Pharmaceuticals Limited, Norgine House, Moorhall Road, Harefield, Middlesex, UB9 6NS. 01895 826606. E-mail: medinfo@norgine.com. Date of preparation/revision: XIF/2553/AUG/11. Adverse events should be reported. Reporting forms and information can be found at http://yellowcard.mhra.gov.uk. Adverse events should also be reported to Medical Information at Norgine Pharmaceuticals Ltd on 01895 826606.

The only virtually non-absorbed antibiotic for the treatment of non invasive Travellers’ Diarrhoea XIFAXANTA is a trademark of Alfa-Wassermann Hungary KFT, exclusively licensed in the UK to the Norgine group of companies.

Prescribing information can be found on page 24. 1

XIF/2496/JUN/11. Date of preparation: August 2011.

file:///Users/Kee/Desktop/Kee/Job%20and%20project/2011/DNA/xifaxanta_newsletter/xifaxnata_html/xifaxanta_211211.html

Web card DNA Portfolio. © DNA Healthcare Advertising Ltd.

Waiting room poster

Formulary pack

eNewsletter

Page 1 of 1

T For

rhoe a

NEW

Global Relative Risk of Travellers’ Diarrhoea

rav i ellers’ D

Risk level: n Low – diarrhoea rates <4% n Intermediate – diarrhoea rates 8-15% n High – diarrhoea rates ~40%

Xifaxanta™ gets to work here ...and only here1,2

High and intermediate risk countries by continent Latin America Anguilla Antigua & Barbuda Argentina Aruba Bahamas Barbados Bermuda Bolivia Brazil British Virgin Islands Cayman Islands Chile Colombia Costa Rica Cuba Dominica

Asia Dominican Republic Ecuador French Guiana (Fr.) Grenada Guadeloupe Guatemala Guyana Haiti Honduras Jamaica Martinique Mexico Montserrat Netherlands Antilles Nicaragua Panama

Afghanistan Armenia Azerbaijan Bahrain Bangladesh Bhutan Brunei Burma Cambodia East Timor Eastern Russia Georgia India Indonesia Iran Iraq

Paraguay Peru Puerto Rico South Georgia and the South Sandwich Islands (UK) St. Kitts & Nevis St. Lucia St. Vincent & the Grenadines Suriname Trinidad & Tobago Turks & Caicos Islands Uraguay U.S. Virgin Islands Venezuela

Africa Israel Jordan Kazakhstan Kuwait Lebanon Malaysia Maldives Mongolia Nepal North Korea Oman Pakistan Papua New Guinea People’s Republic of China Philippines

Europe

Qatar Russia

Algeria

Saudi Arabia

Benin

Singapore

Botswana

Sri Lanka

Burkina Faso

Syria

Burundi

Tajikistan

Cameroon

Angola

Thailand

Cape Verde

Turkey

Central African Republic

Turkmenistan United Arab Emirates Uzbekistan Vietnam Yemen

Chad Comoros Côte d’Ivoire Democratic Republic of the Congo Djibouti

Egypt Equatorial Guinea Eritrea Ethiopia Gabon Gambia Ghana Guinea Guinea-Bissau Kenya Lesotho Liberia Libya Madagascar Malawi Mali

Mauritania

Sierra Leone

Mauritius

Somalia

Mayotte (Fr.)

Sudan

Morocco (excluding Western Sahara) Mozambique

South Africa South Sudan Swaziland

Namibia

Tanzania

Niger

Togo

Nigeria

Tunisia

Réunion (Fr.)

Uganda

Rwanda Saint Helena, Ascension & Tristan da Cunha (UK) São Tomé & Príncipe Senegal Seychelles

Western Sahara Zambia Zimbabwe

Belarus Slovenia Ukraine Montenegro Moldova Romania Greece Bulgaria Hungary Serbia Austria Czech Republic Croatia Bosnia and Herzegovina Slovakia Albania Macedonia XIF/2557/AUG/11.

Date of preparation: August 2011.

st the mo g hoea is ellers visitin rs’ Diarr trav Travellent illness fories3 freque ping countr lion develo r 14 mil isk -r ade ove or high dents m UK resi interme4diate trips tos in 2010 region ainst )5, the tive ag ta™ is ac coli (ETEC 6 Xifaxantoxigenic E .n invasive TD entero cause of no major

A2 poster

Online banner advert Patient Information

Collecting your Xifaxanta™

Key facts about Travellers’ Diarrhoea (TD)

You can present your private prescription at any pharmacy. However, although the drug costs will be the same, different pharmacies may charge different fees for dispensing your medication. It may be worth shopping around for the best price.

Travellers’ Diarrhoea is the most common medical condition in those who venture abroad from the UK Around 5 million people from the UK will suffer from a bout of TD every year Bacteria are the most common cause of TD; around 80% of cases are thought to be caused by a harmful form of E. coli Travellers’ diarrhoea infections can be passed from person to person by touching contaminated surfaces or objects, or by eating or drinking contaminated food or water High-risk foods include: – Raw or undercooked meat – Poultry – Seafood – Unwashed raw fruits and vegetables – Tap water (including ice!) – Unpasteurised milk and dairy products

Alternatively, you may wish to use a service called Pharmacy2U. This service can dispense and deliver your medication discreetly and securely to an address that is convenient to you (e.g. your home or work address). Pharmacy2U will charge for your private prescription:

Private Prescription

References 1. Descombe JJ et al. Int J Clin Pharmacol Res 1994;14(2):51-56. 2. Jiang ZD et al. Antimicrob Agents Chemother 2000;44(8):2205-2206. 3. Health Protection Agency UK - Foreign travel-associated illness: A focus on travellers’ diarrhoea: 2010 Report: National Travel Health Network & Centre; 2010. 4. Norgine Pharmaceuticals Ltd. Data on file: N124. Contains public sector information licensed under the Open Government Licence v1.0. 5. Robins GW et al. Drugs 2005;65(12):1697-1713. 6. Shah N et al. Am J Trop Med Hyg 2009;80(4):609-614. Prescribing information is available on this stand. XIFAXANTA is a trademark of Alfa-Wassermann Hungary KFT, exclusively licensed in the UK to the Norgine group of companies. XIF/2527/JUL/11.

Patient details

The only virtually non-absorbed antibiotic for the treatment of non invasive Travellers’ Diarrhoea

Date of preparation: July 2011.

NAME DATE OF BIRTH ADDRESS

Exhibition stand and rep stand panel

POSTCODE

Doctor details SIGNATURE OF DOCTOR NAME OF DOCTOR GMC NUMBER

DATE

Prescription for:

1 course of Xifaxanta™ treatment (9 tablets)

£18.95

NAME OF MEDICINE NO. OF ORIGINAL PACKS OF DOSE STRENGTH (mg)

Details about the Pharmacy2U service are available overleaf, including an order form.

Dear Pharmacist,

DOSING INSTRUCTIONS

New Xifaxanta™ for travellers’ diarrhoea (TD)

Surgery Stamp

Norgine are pleased to announce the launch of Xifaxanta™ (rifaximin-α) - the first and only virtually non-absorbed antibiotic for the treatment of non-invasive travellers’ diarrhoea in adults.1 FOR ASSISTANCE WITH ORDERING CONTACT:

Travellers’ diarrhoea is the most common illness affecting travellers from industrialised countries to high-risk destinations such as Latin America, Africa and Southern Asia. 2

0845 803 9033

A4 private patient presciption pad

UK residents made over 14 million trips to intermediate or high-risk regions in 20103 making appropriate (pre-travel) preparation an essential element of any trip.

Clinic support items RPC mailer for Envelope

iler, 162

A5 RPC ma

New Xifaxanta™: CMYK x 229mm.

Is active against non-invasive E coli4, the major cause of travellers’ diarrhoea5

Resolves the symptoms of travellers’ diarrhoea in just under half the time of Loperamide6 (32.5 ± 4.14hr vs. 69 ± 4.11hr, p = 0.0019) Has demonstrated comparable efficacy to ciprofloxacin in treating non-invasive travellers’ diarrhoea7 (32.0hr vs. 28.8hr, p = 0.35) When you next see a patient planning a trip to an “at risk” region, please discuss the impact travellers’ diarrhoea could have and recommend they seek advice from their GP or a local travel clinic who will be able to determine if a prescription for Xifaxanta™ is appropriate. If you would like further information about Xifaxanta™, please contact your local Norgine representative or call 01895 826 606.

Yours faithfully,

Norgine

6pp RPC mailer

Pharmaceu

ticals Lim

ited, Nor

gine Hou

se, Moorhal

l Road, Har

efield,

UB9 6NS Middlesex,

, UK

Andrew Middleton Group Brand Manager Norgine Pharmaceuticals Limited

Letter mailer and envelope © DNA Healthcare Advertising Ltd. DNA Portfolio.

Brand: Moviprep (UK assets adapted from global material) Client: Norgine Pharmaceuticals Ltd Moviprep UK A4 advert

Moviprep. 3x3 (Conference) stand. 3440 x 2300mm. CMYK.

CONFIDENCE THROUGH CLARITY

PROVEN EFFICACY IN BOWEL CLEANSING1,2,3 PROVEN EFFICACY IN BOWEL CLEANSING1,2,3

MOVIPREP® and MOVIPREP® Orange Abbreviated Prescribing Information. REFER TO THE SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) BEFORE PRESCRIBING Presentation: A box containing two transparent bags, each containing two separate sachets, A and B. Sachet A contains macrogol 3350 100g; sodium sulphate anhydrous 7.5g; sodium chloride 2.691g and potassium chloride 1.015g as white to yellow powder. Sachet B contains ascorbic acid 4.7g and sodium ascorbate 5.9g as white to light brown powder. MOVIPREP also contains aspartame (E951), acesulfame potassium (E950) and a lemon or orange flavour. Uses: Bowel cleansing prior to any clinical procedure requiring a clean bowel. Dosage and administration: Adults and elderly: A course of treatment consists of two litres of MOVIPREP. A further litre of clear fluid is recommended during the course of treatment. A litre of MOVIPREP consists of one Sachet A and one Sachet B dissolved in water. This reconstituted solution should be drunk over a period of one to two hours. This should be repeated with a second litre of MOVIPREP. The two litres of MOVIPREP may be consumed either as a divided dose, 1L the evening before the procedure and 1L in the early morning of the procedure, or as a single dose the evening before the procedure. There should be at least one hour between the end of intake and the start of the procedure. No solid food should be taken from the start of the treatment and until after the procedure. Children: Not recommended in children below 18 years of age. Contraindications, warnings etc: Contra-indications: Known or suspected gastrointestinal obstruction or perforation; disorders of gastric emptying; ileus; phenylketonuria; glucose-6-phosphodehydrogenase deficiency; toxic megacolon complicating severe inflammatory conditions of the GI tract or hypersensitivity to any of the ingredients.

Do not use in unconscious patients. Warnings: Diarrhoea is an expected effect. Administer with caution in fragile patients in poor health or serious clinical impairment such as severe renal insufficiency, cardiac impairment (NYHA grade III or IV), severe acute inflammatory disease or dehydration and those with an impaired gag reflex or impaired consciousness. Dehydration, if present, should be corrected before using MOVIPREP. Patients prone to aspiration should be closely monitored during administration, particularly if this is via a naso-gastric tube. If symptoms indicating shifts of fluid or electrolytes occur, plasma electrolytes should be measured and any abnormality treated appropriately. In debilitated fragile patients, patients with poor health, those with clinically significant renal impairment and those at risk of electrolyte imbalance, the physician should consider performing baseline and post-treatment electrolyte and renal function test. If patients experience symptoms which make it difficult to continue the preparation, they may slow down or temporarily stop consuming the solution and should consult their doctor. MOVIPREP containing orange flavour is not recommended for patients with glucose and galactose malabsorption. Interactions: Oral medication should not be taken within one hour of administration as it may be flushed from the GI tract and not absorbed. Pregnancy and lactation: There is no experience of use in pregnancy or lactation so it should only be used if judged essential by the physician. Side effects: Very common or common: abdominal pain, nausea, abdominal distension, anal discomfort, malaise, vomiting, dyspepsia, hunger, thirst, sleep disorder, headache, dizziness, and rigors. Uncommon or unknown: Dysphagia, discomfort, abnormal liver function tests, allergic reactions including rash, urticaria, angioedema and anaphylaxis, electrolyte disturbances which are more common in patients taking concomitant medication affecting the kidneys, convulsions associated with severe hyponatraemia, transient increase in blood

pressure, flatulence and retching. Refer to the Summary of Product Characteristics (SmPC) for full list and frequency of adverse events. Overdose: In case of gross accidental overdosage, conservative measures are usually sufficient. In the rare event of severe metabolic derangement, intravenous rehydration may be used. Pharmaceutical Particulars: Sachets: Store in the original package below 25oC. Reconstituted solution: Keep covered. May be stored for up to 24 hours below 25oC or in a refrigerator. Legal Category: P Packs: One pack of MOVIPREP or MOVIPREP Orange contains a single treatment. Basic NHS Price: UK £9.87 Marketing Authorisation Number: PL 20142/0005 (MOVIPREP). PL 20011/0006 (MOVIPREP Orange). For further information contact: Norgine Pharmaceuticals Ltd, Moorhall Road, Harefield, Middlesex, UB9 6NS. Tel: 01895 826606. E-mail: medinfo@norgine.com MOVIPREP® is a registered trademark of the NORGINE® group of companies. Date of preparation/revision: MP/3001/JUL/12. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Medical Informationat Norgine Pharmaceuticals Ltd on 01895 826 606.

References: 1. Worthington J et al. Curr Med Res Opin 2008;24(2):481–488. 2. Bitoun A et al. Aliment Pharmacol Ther 2006;24:1631–42. 3. Ell C et al. Am J Gastroenterol 2007;102:1–11.

UK:

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Medical Information at Norgine Pharmaceuticals Ltd on 01895 826 606.

Prescribing Information is available from the stand. Date of preparation: March 2013

MP/3344/MAR/13

A4 Advert

Date of preparation: March 2013. MP/3343/MAR/13.

Postcard item request RPC mailer

Ireland: Adverse events should be reported to Medical Information at Norgine Pharmaceuticals Ltd on 0044 1895 826606.

Conference stand panels

CONFIDENCE THROUGH CLARITY

13. can be found on page Prescribing Information

ORANGE

A5 6pp leave piece

Detail aid

AM and PM 6pp DL dosing leave pieces DNA Portfolio. © DNA Healthcare Advertising Ltd.

Moviprep. Reps desk top panel. 1000 x 850mm. CMYK

CONFIDENCE THROUGH CLARITY

PROVEN EFFICACY IN BOWEL CLEANSING1,2,3

UK: Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Medical Information at Norgine Pharmaceuticals Ltd on 01895 826 606.

References: 1. Worthington J et al. Curr Med Res Opin 2008;24(2):481–488. 2. Bitoun A et al. Aliment Pharmacol Ther 2006;24:1631–42. 3. Ell C et al. Am J Gastroenterol 2007;102:1–11. Prescribing Information is available from the stand.

Harefield Cleansing Scale A5 4pp leave piece Top edge binding

Ireland: Adverse events should be reported to Medical Information at Norgine Pharmaceuticals Ltd on 0044 1895 826606.

Date of preparation: March 2013. MP/3342/MAR/13.

Reps desk top stand panel

Front Cover

Prescribing Information can be found on page 16.

A3 desktop presenter

Hints and advice 12pp booklet CONFIDENCE THROUGH CLARITY

BOWEL CANCER PATIENT INFORMATION MATERIALS F.A.O. Norgine Pharmaceuticals Ltd FREE POST (HA 4696) Uxbridge Middlesex UB9 6BR

REQUEST CARD

1. 2. 1. 2. 2. 3.

XIF/3159/DEC/12. Date of preparation: December 2012.

Bowel cancer patient info materials request RPC card

2. 3. Produced by Norgine Pharmaceuticals as a service to medicine in association with Beating Bowel Cancer. Date of preparation: April 2013.

CONFIDENCE THROUGH CLARITY

CONFIDENCE THROUGH CLARITY PROVEN EFFICACY IN BOWEL CLEANSING1,2,3 CONFIDENCE THROUGH CLARITY PROVEN EFFICACY IN BOWEL CLEANSING1,2,3

PROVEN EFFICACY IN BOWEL CLEANSING1,2,3

Code: MP/XXXX/APR/13.

3. 4.

CLICK HERE FOR PRESCRIBING INFORMATION MP/3347/APR/13

PROVEN EFFICACY IN BOWEL CLEANSING1,2,3

CLICK HERE FOR PRESCRIBING INFORMATION MP/3347/APR/13

3. 4.

CLICK HERE FOR PRESCRIBING INFORMATION MP/3347/APR/13

Banner animated online advert

Brand: Targaxan (UK assets adapted from global material) Client: Norgine Pharmaceuticals Ltd A4 Advert master. 297 x 210mm. CMYK. Targaxan 3x3 stand. 3440 x 2300mm. CMYK

Effective protection against recurrent episodes of hepatic encephalopathy1

NE W

Effective protection against recurrent episodes of hepatic encephalopathy1

NE W

728px x 90px

Prescribing Information can be found on the back cover. TARGAXAN 550 mg film-coated tablets. REFER TO FULL SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) BEFORE PRESCRIBING Presentation: Film-coated tablet containing rifaximin 550 mg. Uses: Targaxan is indicated for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥ 18 years of age. Dosage and administration: Adults 18 years of age and over: 550 mg twice daily, with a glass or water, for up to 6 months. Treatment beyond 6 months should be based on risk benefit balance including those associated with the progression of the patients hepatic dysfunction. No dosage changes are necessary in the elderly or those with hepatic impairment. Use with caution in patients with renal impairment. Contraindications: Contraindicated in hypersensitivity to rifaximin, rifamycin-derivatives or to any of the excipients and in cases of intestinal obstruction. Warnings and precautions for use: The potential association of rifaximin treatment with Clostridium difficile associated diarrhoea and pseudomembranous colitis cannot be ruled out. The administration of rifaximin

TARGAXAN® is indicated for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥ 18 years of age.2

with other rifamycins is not recommended. Use with caution in patients with severe (Child-Pugh C) hepatic impairment and in patients with MELD (Model for EndStage Liver Disease) score > 25. The effectiveness of oral oestrogenic contraceptives could be decreased after Rifaximycin administration. It is recommended to take additional contraceptive precautions, in particular if the oestrogen content of oral contraceptives is less than 50 μg.

Cost: Basic NHS price £259.23 for 56 tablets.

Pregnancy and lactation: Rifaximin is not recommended during pregnancy. The benefits of rifaximin treatment should be assessed against the need to continue breastfeeding.

Side effects: Common effects reported in clinical trials are dizziness, headache, depression, dyspnoea, upper abdominal pain, abdominal distension, diarrhoea, nausea, vomiting, ascites, rashes, pruritus, muscle spasms, arthralgia and peripheral oedema. Other effects that have been reported include: Clostridial infections, urinary tract infections, candidiasis and pneumonia. Blood disorders e.g. anaemia, thrombocytopenia. Anaphylactic reactions, angioedemas, hypersensitivity. Hypo and hypertension. Pyrexia. Liver function abnormalities. Licensing and legal category: Legal category: POM.

Prescribing Information is available on this stand.

Product under licence from Alfa Wassermann S.p.A. TARGAXAN® is a registered trademark of Alfa Wassermann Hungary KFT, licensed to the Norgine group of companies.

Reference: 1. Bass NM et al. N Engl J Med 2010;362:1071-81.

TA/3181/DEC/12.

Date of preparation: December 2012.

MA number: PL 20011/0020. For further information contact: Norgine Pharmaceuticals Limited, Norgine House, Moorhall Road, Harefield, Middlesex, UB9 6NS. 01895 826606 E-mail: medinfo@norgine.com Date of preparation/revision: TA/3206/JAN/13.

3 x 3 exhibition stand and rep stand panels

Reference: 1. Bass NM et al. N Engl J Med 2010;362:1071-81. Product under licence from Alfa Wassermann S.p.A. TARGAXAN® is a registered trademark of Alfa Wassermann Hungary KFT, licensed to the Norgine group of companies.

TA/3189/DEC/12. Date of preparation: December 2012.

A4 print advert

Online banner advert

A5 Abbreviated Advert master. 210 x 148mm. 5mm bleed CMYK.

Effective protection against recurrent episodes of hepatic encephalopathy

NE W

PRESCRIBING INFORMATION

Dr. A Medic A Hospital, Invented Road, Sometown, Someplace, ABC DEF, UK 12th December 2012

References: 1. Bass NM et al. N Engl J Med 2010;362:1071-81.

Formulary Pack to support the use ® of TARGAXAN 550Rifaximin mgisbd (rifaximin-a) 6lactation: Pregnancy and not recommended

Dear Doctor X, Norgine are pleased to announce the launch of new TARGAXAN® 550 mg (rifaximin-aα) for the reduction in recurrence of episodes of overt Hepatic Encephalopathy (HE) in patients ≥ 18 years of age.1

during pregnancy. The benefits of rifaximin treatment should be assessed against the need to continue breastfeeding.

Licensed in the reduction in recurrence of episodes of overt Side effects: Commonin effects reported in clinical hepatic encephalopathy patients ≥ 18trials years of age1

Contraindications: Contraindicated in hypersensitivity to rifaximin, rifamycin-derivatives or to any of the excipients and in cases of intestinal obstruction.

Product under licence from Alfa Wassermann S.p.A. TARGAXAN® is a registered trademark of Alfa Wassermann Hungary KFT, licensed to the Norgine group of companies. TA/3190/DEC/12.

NE W

Product under licence from Alfa Wassermann S.p.A. TARGAXAN® is a registered trademark of Alfa Wassermann Hungary KFT, licensed to the Norgine group of companies. Prescribing Information can be found on the back cover.

A5 abbreviated advert DNA Portfolio. © DNA Healthcare Advertising Ltd.

Licensing and legal category: Legal category: POM. Cost: Basic NHS price £259.23 for 56 tablets. MA number: PL 20011/0020

For further information contact: Norgine Pharmaceuticals Limited, Norgine House, Moorhall Road, Harefield, Middlesex, UB9 6NS. 01895 826606 Warnings and precautions for use: The potential medinfo@norgine.com information can be foundE-mail: at the end of this document. association of rifaximin treatment withPrescribing Clostridium difficile Date of preparation/revision: TA/3206/JAN/13 associated diarrhoea and pseudomembranous colitis cannot be ruled out. The administration of rifaximin with other rifamycins is not recommended. Use with caution in patients with severe (Child-Pugh C) hepatic impairment and in patients with MELD (Model for End-Stage Liver Adverse events should be reported. Reporting forms Disease) score > 25. The effectiveness of oral oestrogenic and information can be found at contraceptives could be decreased after Rifaximycin www.mhra.gov.uk/yellowcard. Adverse events should administration. It is recommended to take additional also be reported to Medical Information at Norgine TA/3155/NOV/12. Date of preparation: Januarycontraceptive 2013. precautions, in particular if the oestrogen Pharmaceuticals Ltd on 01895 826606. content of oral contraceptives is less than 50 μg.

Letterhead and digital Word template

Formulary pack Product under licence from Alfa Wassermann S.p.A. TARGAXAN® is a registered trademark of Alfa Wassermann Hungary KFT, licensed to the Norgine group of companies. TA/3191/DEC/12. Date of preparation: January 2013.

Overt HE occurs in 30-45% of patients with cirrhosis.3

TARGAXAN® 550 mg bd significantly reduces the risk of an episode of HE. 4 • TARGAXAN® 550 mg bd plus lactulose significantly reduced (p<0.001) the relative risk of recurrence of overt HE episodes by 58% (absolute risk reduction 23.8%) vs. placebo plus lactulose over 6 months4

TARGAXAN® 550 mg bd significantly reduces the risk of hospitalisation.4 • TARGAXAN® 550 mg bd plus lactulose significantly reduced (p=0.01) the relative risk of hospitalisation involving HE by 50% (absolute risk reduction 9%) vs. placebo plus lactulose over 6 months4

TARGAXAN® 550 mg bd is a new convenient option for reducing the recurrence of episodes in patients with hepatic encephalopathy.1 If you would like further information about TARGAXAN®, please contact your local Norgine representative or call 01895 826 606. Yours faithfully,

Neil Smith UK and Ireland Marketing Manager Norgine Pharmaceuticals Limited

NE W

Dosage and administration: Adults 18 years of age and over: 550 mg twice daily, with a glass or water, for up to 6 months. Treatment beyond 6 months should be based on risk benefit balance including those associated with the progression of the patients hepatic dysfunction. No dosage changes are necessary in the elderly or those with hepatic impairment. Use with caution in patients with renal impairment.

HE is the occurrence of confusion, altered level of consciousness and potentially coma, due to the influence on the brain of toxic compounds that accumulate in the blood due to the inability of the cirrhotic liver to remove them from the blood, as would occur in healthy individuals.2

NE W

Uses: Targaxan is indicated for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥ 18 years of age.

are dizziness, headache, depression, dyspnoea, upper abdominal pain, abdominal distension, diarrhoea, nausea, vomiting, ascites, rashes, pruritus, muscle spasms, arthralgia and peripheral oedema. Other effects that have been reported include: Clostridial infections, urinary tract infections, candidiasis and pneumonia. Blood disorders e.g. anaemia, thrombocytopenia. Anaphylactic reactions, angioedemas, hypersensitivity. Hypo and hypertension. Pyrexia. Liver function abnormalities.

TA/3186/DEC/12.

NE W

Presentation: Film-coated tablet containing rifaximin 550 mg.

Prescribing Information can be found on the back.

Retail and hospital pharmacy letter mailers and envelopes NE W

TARGAXAN6 550 mg film-coated tablets. REFER TO FULL SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) BEFORE PRESCRIBING

Uses: Targaxan is indicated for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥ 18 years of age. Legal category: POM. Please consult Summary of Product Characteristics before prescribing, particularly in relation to side effects, precautions and contra-indications. Information about this product, including adverse reactions, precautions, contraindications and method for use can be found at http://www.medicines.org.uk. Further information is available on request from Norgine pharmaceuticals Limited, Moorhall Road, Harefield, Middlesex, UB9 5NS.

Norgine Pharmaceuticals Limited Norgine House, Widewater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK

Home Hepatic encephalopathy

Effective protection against recurrent episodes of hepatic encephalopathy1

HE & QoL Introducing TARGAXAN® Study Design

NE W

Efficacy: breakthrough data 1 Efficacy: breakthrough data 2 Efficacy: hospitalisation data 1 Efficacy: hospitalisation data 2

A5, 6pp Hepatology, Gastroenterology and Nurses RPC mailers and envelopes

Health-related QoL Safety & Tolerability Resitance & Dosing Summary

TARGAXAN® is indicated for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥ 18 years of age.2 Prescribing information can be found by selecting the Prescribing Info & References tab.

NE W

Prescribing Info & References

D O

TA/3182/DEC/12. Date of preparation: December 2012.

S IN G

ifaximin is not recommended its of rifaximin treatment the need to continue

TARGAXAN® 550 mg bd: Simple dosing regimen1

ts reported in clinical trials ression,dyspnoea, upper distension, diarrhoea, nausea, scle spasms, arthralgia and ects that have been reported , urinary tract infections, Blood disorders e.g. anaemia ctic reactions, angioedemas, ypertension. Pyrexia. Liver

Detail aid Interactive PDF for iPad

NE W

ory: Legal category: POM.

ntact: Norgine

orgine House, Moorhall Road, NS. 01895 826606 om

on: TAR/XXX/XXX. Draft 26

NE W

d be reported. Reporting tion can be found at owcard. Adverse events d to Medical Information cals Ltd on 01895 826606.

Prescribing Information can be found on the back cover.

TARGAXAN® is indicated for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥ 18 years of age.1

FOLD

Dosing, (plus MoA and Efficacy) leave pieces

macist as quickly as possible.

Outside front A4 Patient Medication Record. CMYK. Front.

Patient Medication Record for TARGAXAN® 550 (Rifaximin-a) Your doctor has diagnosed you with a condition called Hepatic Encephalopathy (often referred to as HE) and has prescribed a medicine called TARGAXAN® 550 (rifaximin-a) for you to take twice every day. Hepatic Encephalopathy is a condition which can lead to the impairment of brain function as toxins accumulate in the blood. Normally these toxins are removed from the body by your liver, but your liver is not performing this function as effectively as it used to, which means that you may suffer from breakthrough episodes of HE, which may require hospitalisation and may lead to more serious complications.

TARGAXAN® and Hepatic Encephalopathy Patient Compliance Aid

Symptoms of HE include forgetfulness, confusion, personality changes and some problems with muscles and movement of the limbs. In more severe cases this may result in coma. As part of your management, your doctor or nurse will discuss possible changes to your lifestyle, such as your diet, exercise levels and also other things that may contribute to you having an episode of HE. You have also been advised to take a medicine called TARGAXAN® 550 every day. Your medication is an antibiotic that works by killing the bacteria in your gut and it has been shown to reduce the recurrence of HE episodes. To help you manage your medicine, it may help to keep a record.

Week 1 Date

Morning tablet taken?

Evening tablet taken?

Weeks 2, 3 and 4 on reverse.

Provided as a service to medicine by Norgine Pharmaceuticals Limited TA/3156/DEC/12. Date of preparation: December 2012.

DL patient compliance aid

TA/3157/DEC/12. Date of preparation: December 2012.

Provided as a service to medicine by Norgine Pharmaceuticals Limited

Patient medication record

Trail making test app © DNA Healthcare Advertising Ltd. DNA Portfolio.

Brand: Movicol / Movicol Orange / Movicol Liquid (Assets adapted from global material) Client: Norgine Pharmaceuticals Ltd Home Tips on

125ml

UK & Ireland nursing home mini detail aid / 6pp leave piece Movicol Irish Abbreviated Advert: 188 x 82mm. 3mm bleed. CMYK

For the treatment of chronic constipation

Blends proven efficacy with fast-mix convenience

UK & Ireland DL leave piece Movicol (Norgine) 10x4 advert (205 x 130mm). 5mm bleed. CMYK. Irish Medical News

macrogol 3350, sodium hydrogen carbonate, sodium chloride, potassium chloride A systematic review of RCTs concluded that overall, macrogol was superior to lactulose in the management of chronic constipation1

If your patients prefer a liquid laxative …

Please consult Summary of Product Characteristics before prescribing, particularly in relation to side effects, precautions and contra-indications. Further information is available on request from: Norgine Pharmaceuticals Limited, Moorhall Road, Harefield, Middlesex UB9 6NS. Legal category: POM. MO/3061/SEP/12.

Adverse events should be reported to Medical Information at Norgine Pharmaceuticals Ltd on +44 1895 826606.

www.MOVICOL.co.uk

Established MOVICOL® efficacy1

Tailor to individual patient’s needs2

... move to

favourite cordial) (add to

® ICOL Pla MOV Unflavoured in

MOV ICO L ®Ha lf

Lem Adol on esce & nts lim , ad 2-6 sa e ult che ts/d s& ay th in 16 sach e div el ets o de id ver 2-4 sa ed 6 che do ts f h fo or r ex up te nd to 20 s ed a 30 s chet ach s £ ets 2. £4 92 .3

ys da e us

1 ac ses ed do y s– 2s ivid ar – /da in d achets ye rs 6 ea ets by 2 s . 2- 1 y s ch 1 sa sing 7 day day 7– 4 rea to ets/ rs inc up sach 38 , or 12 £4. f . ets ax ach s 30

(

Plain tric dia ae oured cordial) ® P L Unflfaavvourite n CO add to Childre sachehte/dtas/yday

ren ay ild et/d ay Ch ach ts/d 1 s ache ses ed do s– 2s ivid ets/day ar – nd ch ye rs ts i 2 sa 6 ea he g by ys. 2- 1 y c 1 sa sin 7 da day 7– 4 rea to ets/ rs inc up sach 4.38 , or 12 s£ f . t e ax ach s 30 (

L CO add to

Ch ro ni cc o

MOV ICO L ®Ha lf

r fl Un avou f

ay et/d ay C ach ts/d 1 s ache ses ed do y s– 2s ivid ar – /da in d achets ye rs 6 ea ets by 2 s . 2- 1 y s ch 1 sa sing 7 day day 74 a – re to ets/ rs inc up sach 38 . 4 , or 12 £ f . ets ax ach s 30 dd (a

in ic Pla iatr ed Pa avourieted cordial) ®

MOV ICO L ®Ha lf

Lem Adol on esce & nts lim , ad 2-6 sa e ult che ts/d s& ay th in 16 sach e div el ets o de id ver 2-4 sa ed 6h che do ts f or for u ex p te nd to 20 s ed ach 30 s ach ets £ ets 2. £4 92 .3

s, adults & the eld lescent erly Ado day in divided d achets/ o 1-3 s chets/day for long term ses use) sa (1-2 s over 6h for up to 3 d chet ays 8 sa

5 ov -11 er ye 12 a h M

r fl Un avou n f dre to hil

30 sachets £6.68 chets £11.13 50 sa

Plain

Fa ec al

® ICOL Plain MOV

es e) os us ys m da

ic iatr ed Pa avourieted cordial)

Lem Adol on esce & nts lim , ad 2-6 sa e ult che ts/d s ay C & t h in h 16 sach dirvo e e ets o ld idni v e e 2-4 sa edc r6 che dcoo ts f h fFoae or r ex ucpal te nd toi 20 s ed a 30 s chet ach s £ ets 2N. H £4 92 .3

Unflavoured favourite cordial) (add to

M OV I

rly

L CO

s, adults & the eld lescent erly Ado day in divided d achets/ o 1-3 s chets/day for long term ses use) sa (1-2 s over 6h for up to 3 d chet ays 8 sa

5 ov -11 er ye 12 a h M

rly

Dosing wheel (new PI)

s se

500ml £4.45

® OVICOL Plain

MOVICOL

formulation and dosage guide

rly

M OV I

MOVI C O L ®C ho co la

formulation and dosage guide to

L ICO OV M

M OV I

DNA Portfolio. © DNA Healthcare Advertising Ltd.

Irish A4 advert

Ch Adol oco esce n l t a s , ad te 1-3 s ult (1-2 ache s& s a c het ts/day th s/d ay in d 8 sach e ets o el for iv de ver lon ide 6h g dd fo te ru r p to

A2 poster

www.MOVICOL.co.uk

MOVICOL

30 s ach ets £6 .6 8

MO/3066/SEP/12

www.MOVICOL.co.uk

Presentation: MOVICOL Sachet of The maximum dose needed does not white powder which dissolves in about 125ml normally exceed 4 sachets a day. Treatment (approximately ½ glassful) water to make a lemon/r of children with chronic constipation needs to be u for a prolonged period (at least 6-12 months). Faecal lime flavoured drink. Each sachet contains: 13.125g vo macrogol 3350, 178.5mg sodium hydrogen carbonate, rImpaction: Escalating dose regimen starting with 4 sachets la 350.7mg sodium chloride and 46.6mg potassium Fchloride. fo per day for children aged 5-11 years. Refer to Summary of MOVICOL Plain Sachet of white powder which dissolves in about Characteristics (SmPC) for full dosing recommendations. ho oProduct 125ml (approximately ½ glassful) water. Each sachet contains: iForn patients of 12 years and older it is recommended that MOVICOL W t a 13.125g macrogol 3350, 178.6mg sodium hydrogen carbonate,p is used. Not recommended in children with cardiovascular impairment ti or renaln insufficiency. Doses for prevention of re-impaction should be as 350.8mg sodium chloride and 50.2mg potassium chloride. Does snot n o contain flavourings or sweeteners. MOVICOL Chocolate Sachet of white fortipatients with chronic constipation. Contraindications: Intestinal c to light brown powder which dissolves in about 125ml (approximately ½ or obstruction due to structural or functional disorders of the aperforation glassful) water to make a chocolate flavoured drink. Each sachet contains: p gut wall, ileus and severe inflammatory conditions of the intestinal tract, 13.125g macrogol 3350, 178.5mg sodium hydrogen carbonate, 350.7mgm such as Crohn’s disease, ulcerative colitis and toxic megacolon. Hypersensitivity u sodium chloride and 31.7mg potassium chloride. MOVICOL-Half Sachet of to macrogol, or any of the excipients. Warnings and precautions for e ic ice of impaction should be confirmed. If patients develop any white powder which dissolves in about 62.5ml (approximately ¼ glassful) of use: Diagnosis pr prindicating shifts of fluids/electrolytes the product should be stopped water to make a lemon and lime flavoured drink. Each sachet contains: 6.563g symptoms S S macrogol 3350, 89.3mg sodium hydrogen carbonate, 175.4mg sodium chloride immediately. When using MOVICOL Paediatric Plain to treat faecal impaction, use 50 3 8 and 23.3mg potassium chloride. MOVICOL Paediatric Plain Sachet of white powder, with caution in patients with impaired gag reflex, reflux oesophagitis or diminished which dissolves in about 62.5 ml (approximately ¼ glassful) of water. Each sachet levels of consciousness. Interactions: There is a possibility that the absorption of contains: 6.563g macrogol 3350, 89.3mg sodium hydrogen carbonate, 175.4mg concomitantly administered medication could be transiently reduced. Pregnancy sodium chloride and 25.1mg potassium chloride. Does not contain flavourings or and lactation: There is insufficient data on use in pregnancy and lactation, and should sweeteners. Uses: MOVICOL, MOVICOL Plain, MOVICOL Chocolate and MOVICOLonly be used if considered essential. Undesirable effects: Reactions related to the Half: Treatment of chronic constipation and faecal impaction in adults, adolescents and gastrointestinal tract are the most common and include: abdominal pain, abdominal the elderly. MOVICOL Paediatric Plain: Treatment of chronic constipation in children distension, nausea, vomiting, diarrhoea, flatulence, borborygmi and anal discomfort. aged 2-11 years. For the treatment of faecal impaction in children from the age of Allergic reactions, including anaphylactic reaction, angioedema, dyspnoea and skin 5 years. Dosage and administration: MOVICOL, MOVICOL Plain and MOVICOL reactions can occur. Other effects can include electrolyte disturbances, headache and Chocolate Chronic Constipation: Adults, adolescents and the elderly: 1-3 sachets peripheral oedema. Pharmaceutical particulars: Do not store sachet above 25°C. daily in divided doses, according to individual response. For extended use: adjust dose MOVICOL, MOVICOL Plain, MOVICOL Chocolate and MOVICOL-Half: Reconstituted down to 1 or 2 sachets. Children (below 12 years): not recommended. See MOVICOL solution should be stored covered in a refrigerator (2-8°C) for up to 6 hours. MOVICOL Paediatric Plain. Extended use may be necessary in patients with severe chronic or Paediatric Plain: Reconstituted solution should be stored covered in a refrigerator (2-8°C) resistant constipation, secondary to multiple sclerosis or Parkinson’s Disease, or induced for up to 24 hours. Licensing and legal category: MOVICOL Legal category: P. Cost: by regular constipating medicine, in particular opioids and antimuscarinics. A course of 20 sachets £4.45, 30 sachets £6.68, 50 sachets £11.13. MA number: PL 00322/0070. ® MOVICOL, MOVICOL Plain or MOVICOL Chocolate treatment does not normally exceed MOVICOL Plain Legal Category: P. Cost: 30 sachets £6.68,® 50 sachets £11.13. 2 weeks, but can be repeated if required. Faecal Impaction: Adults, adolescents MA number: PL 20142/0004. MOVICOL Chocolate Legal Category: P. Cost: 30 sachets and the elderly: 8 sachets per day. A course of treatment for faecal impaction does £6.68. MA number: PL 00322/0086. MOVICOL-Half Legal Category: P. Cost: 20 not normally exceed 3 days. The 8 sachets should be taken over 6 hours (2 sachets sachets £2.92, 30 sachets £4.38. MA number: Number PL 00322/0080. MOVICOL macrogol 3350, sodium bicarbonate, sodium chloride, potassium chloride potassium chloride, sodium bicarbonate, sodium macrogol per hour maximum in cardiovascular impairment). The 8 sachets may be dissolved 3350, Paediatric Plain Legal Category: POM; Cost: 30 sachets £4.38; MA number: Number chloride in 1 litre of water. Children (below 12 years): Not recommended. See MOVICOL PL 20011/0005. For further information contact: Norgine Pharmaceuticals Paediatric Plain. MOVICOL-Half Chronic Constipation: Adults, adolescents and the Limited, Norgine House, Moorhall Road, Harefield, Middlesex, UB9 6NS 01895 elderly: 2-6 sachets daily in divided doses, according to individual response. For 826606 E-mail: medinfo@norgine.com MOVICOL® is a registered trademark of extended use: adjust dose down to 2 or 4 sachets. Children (below 12 years): Not the NORGINE® group of companies. See MOVICOL Paediatric Plain. Extended use may be necessary Date of preparation/revision: MO/2812/MAR/12 help you choose from the whole MOVICOL® family of products including recommended. choose from the whole MOVICOL® family of products including help toyou tosecondary in patients with severe chronic or resistant constipation, multiple sclerosis or Parkinson’s Disease, or induced by regular constipating medicine, in Adverse events should be reported. Reporting forms and particular opioids and antimuscarinics. A course of MOVICOL-Half treatment information can be found at www.mhra.gov.uk/yellowcard. does not normally exceed 2 weeks, but can be repeated if required. Faecal Impaction: Adults, adolescents and the elderly: 16 sachets per day. A Adverse events should also be reported to Medical course of treatment for faecal impaction does not normally exceed 3 Information at Norgine Pharmaceuticals Ltd days. The 16 sachets should be taken over 6 hours (4 sachets per on 01895 826606. hour maximum in cardiovascular impairment). The 16 sachets may be dissolved in 1 litre of water. Children (below 12 years): Not recommended. See MOVICOL Paediatric Plain. MOVICOL Paediatric Plain Chronic Constipation: The usual starting macrogol 3350, sodium hydrogen carbonate, macrogol 3350, sodium hydrogen carbonate, dose is 1 sachet daily for children aged 2-6 years, and sodium chloride, potassium chloride 2 sachets daily for children aged 7-11 years. The sodium chloride, potassium chloride dose should be adjusted up or down as required to produce regular soft stools. If the dose Prescribing Information appears overleaf www.MOVICOL.co.uk Prescribing Information appears overleaf needs increasing this is best done every second day. MO/3064/SEP/12

ur in 100ml of water 1-3 tim vo uted e y for extende r l dil times a da d us s daily Fla fo e) 25m (1-2 ho on Not indicated W ti Ad rly tipa (1 1-3 n -2 nsses o i 8s s ctys ac he pada 0ml £4.45 0 5 m 3 se

e rly lim elde n& the ses mo s& d do use) Le ult ide d ad div tende s, in x nt ays ay or e ce o3d s/d y f es up t et da ol for ch ts/ 6h sa he in ac ith w ts 45 £4. 8 ets 6.6 3 ch ts £ 1 sa che £11. 20 sa hets 0 ac s

when administered to patients on a controlled sodium diet. MOVICOL

References: 1. Lee-Robichaud H, et al. Lactulose versus Polyethylene Glycol for Chronic Constipation. Cochrane Database of Systematic Reviews 2010, Issue 7. Art. No.: CD007570. DOI:10.1002/14651858.CD007570.pub2. 2. Nurse Prescribers Formulary. Available at: http://www.medicinescomplete.com/mc/bnf/current/119717. htm. Accessed Mar 2012. 3. Taylor RR, Guest JF. Aliment Pharmacol Ther 2009; 31: 302-312. 4. MOVICOL® Liquid Summary of Product Characteristics.

Adverse events should be reported to Medical Information at Norgine Pharmaceuticals Ltd on +44 1895 826606. MO/3062/SEP/12

MOVI CO ® L Ch oc ol a

Ch Ado l o e s c cen ola ts, te 1-3 a d s u (1-2 sa achets lts che /da & t th s / day y in 8 sach e ets o el for div de ver lon ide 6h g dd fo te ru r p to

contact: Norgine Pharmaceuticals Limited, Norgine House, Moorhall Road, Harefield, Middlesex UB9 6NS. Telephone: 01895 826606. E-mail: medinfo@norgine.com MOVICOL® is a registered trademark of the NORGINE® group of companies. Date of preparation/ revision: MO/3011/AUG/12. United Kingdom

30 s ach ets £6 .6 8

macrogol 3350, sodium hydrogen carbonate, sodium chloride, potassium chloride

of the intestinal tract, such as Crohn’s disease, ulcerative colitis and toxic megacolon. Hypersensitivity to the active substances or any of the excipients. Warnings and precautions for use: If patients develop any symptoms indicating shifts of fluids/electrolytes MOVICOL Liquid should be stopped immediately. MOVICOL Liquid contains 8.125 mmol of sodium in each diluted dose of 125 ml and should be considered when administered to patients on a controlled sodium diet. MOVICOL Liquid contains benzyl alcohol. Do not exceed the maximum recommended daily dose. Interactions: There is a possibility that the absorption of concomitantly administered medication could be transiently reduced. Pregnancy and lactation: There is insufficient data on use in pregnancy and lactation, and should only be used if considered essential. Undesirable effects: Reactions related to the gastrointestinal tract are the most common and include: abdominal pain, abdominal distension, nausea, dyspepsia, vomiting, diarrhoea, flatulence, borborygmi and anal discomfort. Allergic reactions, including anaphylactic reaction, angioedema, dyspnoea and skin reactions can occur. Other effects can include electrolyte disturbances, headache and peripheral oedema. Licensing and legal category: Legal Category: UK P, IE Prescription-only Cost: 500ml UK £4.45, IE€ €10.81 (Trade price). MA numbers: PL20011/0007, PA 1336/2/4 For further information

e rly lim elde n& the ses mo s& d do use) Le ult ide d ad div tende s, in x nt ays ay or e ce o3d s/d y f es up t et da ol for ch ts/ 6h sa che in a ith w ts 45 £4. 8 ets 6.6 3 ch ts £ 1 sa che £11. 20 sa hets 0 ac s

macrogol 3350, sodium hydrogen carbonate, sodium chloride, potassium chloride

- Tailor to individual patient’s needs across a spectrum of severity4

Orange

s, adults & the eld lescent erly Ado in 100ml of water 1-3 tim uted e y for extende l dil times a da d us e 25m (1-2 Not indicated

s, adults & the eld lescent erly Ado

L ICO OV M

- Treat chronic constipation with various causes in children, adults and elderly4

adults & dose the eneeded nts, maximum Presentation: MOVICOL Sachet of The maximum dose needed does not ceThe Presentation: MOVICOL Sachet olof lder does not d es normally white powder which dissolves in about 125ml normally exceed 4 sachets a day. Treatment white powder which dissolves in aboutA125ml exceed 4 sachets a lyday. Treatment (approximately ½ glassful) water to make a lemon/ of children with chronic constipation needs to be watchronic 0ml ofwith er 1-3constipation needs to be (approximately ½ glassful) water to make a lemon/ in of 10children tleast imes6-12 months). Faecal lime flavoured drink. Each sachet contains: 13.125g for a prolonged period (at least 6-12 months). Faecal ted lime flavoured drink. Each sachet contains: 13.125g ay for experiod tend(at a adprolonged dilu timesfor edregimen lcarbonate, macrogol 3350, 178.5mg sodium hydrogen carbonate, Impaction: Escalating dose regimen starting with 4 sachets aily with 4 sachets macrogol 3350, 178.5mg sodium hydrogen Impaction: Escalating dose use) dstarting 25m chloride. 350.7mg sodium chloride and 46.6mg potassium chloride. per day for children aged 5-11 years. Refer to Summary of (1-2 350.7mg sodium chloride and 46.6mg potassium per dayinfor 5-11 years. Refer to Summary of dicchildren ated aged Not Characteristics MOVICOL Plain Sachet of white powder which dissolves in about Product Characteristics (SmPC) for full dosing recommendations. MOVICOL Plain Sachet of white powder which dissolves in about Product (SmPC) for full dosing recommendations. Ad 125ml (approximately ½ glassful) water. Each sachet contains: For patients of 12 years and older it is recommended that MOVICOL 125ml (approximately ½ glassful) y water. Each sachet contains: For patients of 12 years and older it is recommended that MOVICOL l r 13.125g macrogol 3350, 178.6mg sodium hydrogen carbonate, is used. Not recommended in children with cardiovascular impairment 13.125g macrogol 3350, 178.6mg sodium hydrogen carbonate, is used. Not recommended in children with cardiovascular (1 1-3impairment 350.8mg sodium chloride and 50.2mg potassium chloride. Does not or renal insufficiency. Doses for prevention of re-impaction should be as espotassium chloride. Does not or renal insufficiency. Doses for prevention of8 re-impaction -2 should be as 350.8mg sodium chloride and 50.2mg s contain flavourings or sweeteners. MOVICOL Chocolate Sachet of white for patients with chronic constipation. Contraindications: Intestinal s sa contain flavourings or sweeteners. MOVICOL Chocolate Intestinal ys Sachet of white for patients with chronic constipation. Contraindications: ch to light brown powder which dissolves in about 125ml (approximately ½ perforation or obstruction due to structural or functional disorders of the to light brown powder which dissolves in about 125ml due to structural or functional disorders of the da (approximately ½ perforation 45 500ml £or4.obstruction e glassful) water to make a chocolate flavoured drink. Each sachet contains: gut wall, ileus and severe inflammatory conditions of the intestinal tract, 3 glassful) water to make a chocolate flavoured drink. Each se sachet contains: gut wall, ileus and severe inflammatory conditions of the intestinal tract, 13.125g macrogol 3350, 178.5mg sodium hydrogen carbonate, 350.7mg such as Crohn’s disease, ulcerative colitis and toxic megacolon. Hypersensitivity 13.125g macrogol 3350, 178.5mg sodium hydrogenu carbonate, 350.7mg such as Crohn’s disease, ulcerative colitis and toxic megacolon. Hypersensitivity sodium chloride and 31.7mg potassium chloride. MOVICOL-Half Sachet of to macrogol, or any of the excipients. Warnings and precautions for sodium chloride and 31.7mg potassium chloride. MOVICOL-Half Sachet of to macrogol, or any of the excipients. Warnings and precautions for white powder which dissolves in about 62.5ml (approximately ¼ glassful) of use: Diagnosis of impaction should be confirmed. If patients develop any white powder which dissolves in about 62.5ml (approximately ¼ glassful) of use: Diagnosis of impaction should be confirmed. If patients develop any water to make a lemon and lime flavoured drink. Each sachet contains: 6.563g symptoms indicating shifts of fluids/electrolytes the product should be stopped water to make a lemon and lime flavoured drink. Each sachet contains: 6.563g symptoms indicating shifts of fluids/electrolytes the product should be stopped 3 macrogol 3350, 89.3mg sodium hydrogen carbonate, 175.4mg sodium chloride immediately. When using MOVICOL Paediatric Plain to treat faecal impaction, use macrogol 3350, 89.3mg sodium hydrogen carbonate, 175.4mg sodium Plain to treat faecal impaction, use 50 Paediatric 8 chloride immediately. When using MOVICOL and 23.3mg potassium chloride. MOVICOL Paediatric Plain Sachet of white powder, with caution in patients with impaired gag reflex, reflux oesophagitis or diminished and 23.3mg potassium chloride. MOVICOL Paediatric Plain Sachet of white powder, with caution in patients with impaired gag reflex, reflux oesophagitis or diminished which dissolves in about 62.5 ml (approximately ¼ glassful) of water. Each sachet levels of consciousness. Interactions: There is a possibility that the absorption of which dissolves in about 62.5 ml (approximately ¼ glassful) of water. Each sachet levels of consciousness. Interactions: There is a possibility that the absorption of contains: 6.563g macrogol 3350, 89.3mg sodium hydrogen carbonate, 175.4mg ® Liquid, concomitantly administered medication could be transiently MOVICOL Orange Flavour, concentrate forreduced. oral Pregnancy Liquid contains benzylcontains: alcohol. Domacrogol not exceed the sodium maximum 6.563g 3350, 89.3mg hydrogen carbonate, 175.4mg concomitantly administered medication could be transiently reduced. Pregnancy sodium chloride and 25.1mg potassium chloride. Does not contain flavourings or and lactation: There is insufficient data on use in pregnancy and lactation, and should sodium chloride and 25.1mg chloride. Does not contain flavourings or and lactation: There is insufficient data on use in pregnancy and lactation, and should recommended daily dose. Interactions: There potassium is a possibility that the solution. Prescribing Information. REFER TO related sweeteners. Uses: MOVICOL, MOVICOL Plain, MOVICOL Chocolate and MOVICOL- Abbreviated only be used if considered essential. Undesirable effects: Reactions to the sweeteners. Uses: MOVICOL, MOVICOL Plain, MOVICOL Chocolate and MOVICOLonly be used if considered essential. Undesirable effects: Reactions related to the Half: Treatment of chronic constipation and faecal impaction in adults, adolescents and gastrointestinal tract areCHARACTERISTICS the most common and include: pain, abdominal absorption of concomitantly administered medication could bein adults, adolescents and gastrointestinal tract are the most common and include: abdominal pain, abdominal FULL SUMMARY OF PRODUCT (SMPC)abdominal BEFORE Half: Treatment of chronic constipation and faecal impaction the elderly. MOVICOL Paediatric Plain: Treatment of chronic constipation in children distension, nausea, vomiting, diarrhoea, flatulence, borborygmi and anal discomfort. the elderly. MOVICOL Paediatric Plain: Treatment of chronic constipation in children distension, nausea, vomiting, diarrhoea, flatulence, borborygmi and anal discomfort. and lactation: There is insufficient PRESCRIBING. Presentation: A clear, concentrated which is transiently aged 2-11 years. For the treatment of faecal impaction in children from the age of Allergic reactions, including anaphylactic reaction, liquid, angioedema, dyspnoea and skin reduced. Pregnancy aged 2-11 years. For the treatment of faecal impaction in children from the age of Allergic reactions, including anaphylactic reaction, angioedema, dyspnoea and skin data and on use in pregnancy lactation, and should only be used if Plain and MOVICOL reactions can occur. Other effects can include electrolyte disturbances, headache and 5 years. Dosage and administration: MOVICOL, MOVICOL Plain and MOVICOL reactions can occur. Other effects can include electrolyte diluted in water to make an orange flavoured drink. Eachdisturbances, 25 ml of headache 5 years.and Dosage and administration: MOVICOL, MOVICOL Chocolate Chronic Constipation: Adults, adolescents and the elderly: 1-3 sachets peripheral oedema. Pharmaceutical particulars: Do not store sachet above 25°C. Chocolate Chronic Constipation: Adults, related adolescents effects: Reactions to and the the elderly: 1-3 sachets peripheral oedema. Pharmaceutical particulars: Do not store sachet above 25°C. essential. Undesirable MOVICOL Liquid is diluted in 100 ml of water before use and contains considered daily in divided doses, according to individual response. For extended use: adjust dose MOVICOL, MOVICOL Plain, MOVICOL Chocolate and MOVICOL-Half: Reconstituted daily in divided doses, according to individual response. For extended use: adjust dose MOVICOL, MOVICOL Plain, MOVICOL Chocolate and MOVICOL-Half: Reconstituted gastrointestinal tract are the most common and include: abdominal the following active ingredients: 13.125 g macrogol (polyethylene down to 1 or 2 sachets. Children (below 12 years): not recommended. See MOVICOL solution should be stored covered in a refrigerator (2-8°C) for up to 6 hours. MOVICOL down to 1 or 2 sachets. Children (below 12 years): not recommended. See MOVICOL solution should be stored covered in a refrigerator (2-8°C) for up to 6 hours. MOVICOL Paediatric Plain. Extended use may be necessary in patients with severe chronic or 178.5 Paediatric Reconstituted solution should be stored in a refrigerator (2-8°C) Paediatricnausea, Plain. Extended use mayvomiting, be necessary in patients with severe chronic or Paediatric Plain: Reconstituted solution should be stored covered in a refrigerator (2-8°C) pain, abdominal distension, dyspepsia, diarrhoea, glycol) 3350, mgPlain: sodium hydrogen carbonate, 350.7covered mg sodium resistant constipation, secondary to multiple sclerosis or Parkinson’s Disease, or induced for up to 24 hours. Licensing and legal category: MOVICOL Legal category: P. Cost: resistant constipation, secondary to multiple sclerosis or Parkinson’s Disease, or induced for up to 24 hours. Licensing and legal category: MOVICOL Legal category: P. Cost: flatulence, borborygmi by and anal discomfort. Allergic reactions, including chloride chloride. Treatment chronic by regular constipating medicine, in particular opioids and antimuscarinics. A courseand of 46.6mg 20 sachetspotassium £4.45, 30 sachets £6.68,Uses: 50 sachets £11.13. MAofnumber: PL 00322/0070. regular constipating medicine, in particular opioids and antimuscarinics. A course of 20 sachets £4.45, 30 sachets £6.68, 50 sachets £11.13. MA number: PL 00322/0070. MOVICOL, MOVICOL Plain or MOVICOL Chocolate treatment does not normally exceed MOVICOL Plain Legal Category: P. Cost: 30 sachets £6.68, 50 sachets £11.13. angioedema, dyspnoea and skin reactions candoes not normally exceed MOVICOL Plain Legal Category: P. Cost: 30 sachets £6.68, 50 sachets £11.13. constipation. Dosage and administration: Adults, adolescents and anaphylactic reaction, MOVICOL, MOVICOL Plain or MOVICOL Chocolate treatment 2 weeks, but can be repeated if required. Faecal Impaction: Adults, adolescents MA number: PL 20142/0004. MOVICOL Chocolate Legal Category: P. Cost: 30 sachets 2include weeks, but can be repeated if required. Faecal Impaction: Adults, adolescents MA number: PL 20142/0004. MOVICOL Chocolate Legal Category: P. Cost: 30 sachets electrolyte disturbances, headache and the elderly: ml diluted in 100PLml00322/0086. of water 1-3 times daily in Category: divided P. occur. and the elderly: 8 sachets per day. A course of treatment for faecal impaction does 25 £6.68. MA number: MOVICOL-Half Legal Cost: 20Other effects can and the elderly: 8 sachets per day. A course of treatment for faecal impaction does £6.68. MA number: PL 00322/0086. MOVICOL-Half Legal Category: P. Cost: 20 peripheral oedema. Licensing andexceed legal category: Legal Category: not normally exceed 3 days. The 8 sachets should be taken over 6 hours (2 sachets sachets £2.92, 30 sachets £4.38.For MAextended number: Number PL 00322/0080. doses, according to individual response. use, the dose can MOVICOL not normally 3 days. The 8 sachets should be taken over 6 hours (2 sachets sachets £2.92, 30 sachets £4.38. MA number: Number PL 00322/0080. MOVICOL per hour maximum in cardiovascular impairment). The 8 sachets may be dissolved Paediatric Plain Legal Category: POM; Cost: 30 sachets £4.38; MA number: Number per hour maximum in cardiovascular impairment). The 8 sachets may be dissolved Paediatric Plain Legal Category: POM; Cost: 30 sachets £4.38; MA number: Number be adjusted down to 1 or 2 doses per day, each consisting of 25 ml Prescription medicine. MA number: PA 1336/2/4. For further in 1 litre of water. Children (below 12 years): Not recommended. See MOVICOL PL 20011/0005. For further information contact: Norgine Pharmaceuticals 1 litre of water. Children (below 12 years): Not recommended. See MOVICOL PL 20011/0005. For further information contact: Norgine Pharmaceuticals information contact:inPaediatric Norgine Pharmaceuticals Limited, Norgine diluted 100 Limited, ml of water. use may necessary in patients Paediatric Plain. MOVICOL-Half Chronic Constipation: Adults, adolescents andinthe NorgineExtended House, Moorhall Road,beHarefield, Middlesex, UB9 6NS 01895 Plain. MOVICOL-Half Chronic Constipation: Adults, adolescents and the Limited, Norgine House, Moorhall Road, Harefield, Middlesex, UB9 6NS 01895 ® elderly: 2-6 sachets daily in divided doses, according to individual with response. For chronic 826606 or E-mail: medinfo@norgine.com is a registered trademark of elderly: 2-6 sachets daily in UB9 divided6NS. doses,Telephone: according to individual response. For 826606 E-mail: medinfo@norgine.com MOVICOL® is a registered trademark of House, Moorhall Road, Harefield, Middlesex severe resistant constipation,MOVICOL secondary to multiple extended use: adjust dose down to 2 or 4 sachets. Children (below 12 years): Not the NORGINE® group of companies. ® Children (below 12 years): Not extended use: adjust dose down to 2 or 4 sachets. the NORGINE® group of companies. MOVICOL is a or Parkinson’s Disease, or induced by regular constipating 01895 826606. E-mail: medinfo@norgine.com. recommended. See MOVICOL Paediatric Plain. Extended use maysclerosis be necessary Date of preparation/revision: MO/2812/MAR/12 recommended. See MOVICOL Paediatric Plain. Extended use may be necessary Date of preparation/revision: MO/2812/MAR/12 ® in patients with severe chronic or resistant constipation, secondary to multiplein particular opioids and antimuscarinics. A course of group companies. Date of secondary to multiple registered trademark of the NORGINE medicine, in patients with severeof chronic or resistant constipation, sclerosis or Parkinson’s Disease, or induced by regular constipating medicine, in sclerosis or Parkinson’s Disease, or induced by regular constipating medicine, in MOVICOL does not normally exceed 2 weeks, butand can preparation/revision: MO/3085/SEP/12. Adverse events should be reported. Reporting forms Adverse events should be reported. Reporting forms and particular opioids and antimuscarinics. A course of MOVICOL-Half treatmentLiquid treatment particular opioids and antimuscarinics. A course of MOVICOL-Half treatment information can be(below found at12 www.mhra.gov.uk/yellowcard. does not normally exceed 2 weeks, but can be repeated if required. Faecal if required. be repeated Children years): not recommended. information can be found at www.mhra.gov.uk/yellowcard. does not normally exceed 2 weeks, but can be repeated if required. Faecal Impaction: Adults, adolescents and the elderly: 16 sachets per day. A Adverse events should also be reported to Medical Impaction: Adults, adolescents and the elderly: 16 sachets per day. A Adverse events should also be reported to Medical See MOVICOL Paediatric Plain. Contra-indications: Intestinal course of treatment for faecal impaction does not normally exceed 3 course to of treatment faecal impaction Adverse events should be reported Medicalfor Information at does not normally exceed 3 Information at Norgine Pharmaceuticals Ltd Information at Norgine Pharmaceuticals Ltd days. The 16 sachets should be taken over 6 hours perforation (4 sachets per or obstruction due to structural or functional disorders of days. The 16 sachets should be taken over 6 hours (4 sachets per on 01895 826606. on 01895 826606. Norgine Pharmaceuticals Ltd on +44 1895 826606. hour maximum in cardiovascular impairment). The 16 may ileus and severe inflammatory conditions of the intestinal hour maximum in cardiovascular impairment). The 16 sachets may thesachets gut wall, be dissolved in 1 litre of water. Children (below 12 years): Not be dissolved in 1 litre of water. Children (below 12 years): Not tract, such as Crohn’s disease, ulcerative colitis and toxic megacolon. recommended. See MOVICOL Paediatric Plain. MOVICOL recommended. See MOVICOL Paediatric Plain. MOVICOL Paediatric Plain Chronic Constipation: TheHypersensitivity usual starting to the active substances or any of the excipients. References: Paediatric Plain Chronic Constipation: The usual starting dose is 1 sachet daily for children aged 2-6 years, and dose is 1 sachet daily for children aged 2-6 years, and Warnings 1. Attar A et al. Gut 1999; 44: 226-230. 2 sachets daily for children aged 7-11 years. The and precautions for use: If patients develop any 2 sachets daily for children aged 7-11 years. The dose should be adjusted up or down as required indicating shifts of fluids/electrolytes MOVICOL Liquid ® symptoms dose should be adjusted up or down as required 2. MOVICOL Liquid Orange flavour, to produce regular soft stools. If the dose to produce regular soft stools. If the dose www.MOVICOL.co.uk should be stopped immediately. MOVICOL Liquid contains 8.125 mmol www.MOVICOL.co.uk Summary of Product Characteristics. needs increasing this is best done needs increasing this is best done sodium diluted dose of 125 ml and should be considered every of second day.in each MO/3064/SEP/12 every second day. MO/3064/SEP/12

® ICOL Liquid MOV

MOVICOL®, MOVICOL® Plain, MOVICOL® Chocolate, MOVICOL®-Half and MOVICOL® Paediatric Plain Abbreviated Prescribing Information REFER TO FULL SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) BEFORE PRESCRIBING

Orange

30 sachets £6.68 chets £11.13 50 sa

Flexible

® ICOL Liquid MOV

MOVICOL®, MOVICOL® Plain, MOVICOL® Chocolate, MOVICOL®-Half and MOVICOL® Paediatric Plain Abbreviated PrescribingOInformation range REFER TO FULL SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) BEFORE PRESCRIBING

NHS cost comparable to lactulose3

es e) os us ys m da

Unflavoured favourite cordial) (add to s, adults & the eld lescent erly Ado day in divided d achets/ o 1-3 s chets/day for long term ses use) -2 sa r 6h for up to 3 da ets ove ys sach

® ICOL Liquid MOV

MOVICOL , MOVICOL® Plain, MOVICOL® Chocolate, MOVICOL®-Half and MOVICOL® Paediatric Plain Abbreviated Prescribing Information REFER TO FULL SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) BEFORE PRESCRIBING

Now included in the Nurse Prescribers’ Formulary2

5 ov -11 er ye 12 a h M

Orange-flavoured

30 sachets £6.68 chets £11.13 50 sa

The first liquid macrogol

MOVICOL® Liquid, Orange Flavour, concentrate for oral solution. Abbreviated Prescribing Information. REFER TO FULL SUMMARY OF PRODUCT CHARACTERISTICS (SMPC) BEFORE PRESCRIBING. Presentation: A clear, concentrated liquid, which is diluted in water to make an orange flavoured drink. Each 25 ml of MOVICOL Liquid is diluted in 100 ml of water before use and contains the following active ingredients: 13.125 g macrogol (polyethylene glycol) 3350, 178.5 mg sodium hydrogen carbonate, 350.7 mg sodium chloride and 46.6mg potassium chloride. Uses: Treatment of chronic constipation. Dosage and administration: Adults, adolescents and the elderly: 25 ml diluted in 100 ml of water 1-3 times daily in divided doses, according to individual response. For extended use, the dose can be adjusted down to 1 or 2 doses per day, each consisting of 25 ml diluted in 100 ml of water. Extended use may be necessary in patients with severe chronic or resistant constipation, secondary to multiple sclerosis or Parkinson’s Disease, or induced by regular constipating medicine, in particular opioids and antimuscarinics. A course of MOVICOL Liquid treatment does not normally exceed 2 weeks, but can be repeated if required.Children (below 12 years): not recommended. See MOVICOL Paediatric Plain.Contra-indications: Intestinal perforation or obstruction due to structural or functional disorders of the gut wall, ileus and severe inflammatory conditions

UK & Ireland A5 abbreviated advert

Convenient liquid formulation

MOVICOL®Liquid and the original powder formulation of MOVICOL®(macrogol 3350, sodium bicarbonate, sodium chloride, potassium chloride) produce the same active solution once reconstituted.

Client: Norgine Pharmaceuticals Ltd Various projects

Norgine book service mailer

South Africa conference slide template

ÂŠ DNA Healthcare Advertising Ltd. DNA Portfolio.

Brand: Imotech Medical Client: United Drug Imotech Medical OO7 day trial offer

A6 medical request card flyer

DL Leave Piece

Brand Guidelines

Advert

Exhibition Stand Design DNA Portfolio. ÂŠ DNA Healthcare Advertising Ltd.

Brand: Napp Respiratory & Corporate Client: Napp Pharmaceuticals Logo design

Napp Respiratory. BMJ (GP) Whole/full page advert. 280 x 210mm. 3mm bleed.

A breath of fresh air in respiratory medicine

Delivering Innovation in Pain Management WORLD 1st

bi-phasic delivery mechanism for an opioid analgesic (OxyContin® tablets) Napp registered in the UK.

1923

1970

1980

1990

2000

2009

WORLD 1st

prolonged release Morphine Sulphate tablets (MST® Continus® tablets)

WORLD 1st

once daily Morphine Sulphate capsules (MXL® capsules)

WORLD 1st

7-day analgesic patch (Butrans® patches)

UK 1st

opioid agonist / antagonist combination (Targinact® tablets)

We have built our business around the concept of putting known, trusted and effective molecules into innovative delivery mechanisms so that patients can benefit from improved effectiveness through reduced or improved dosing methods. In recent years, we have started to branch out into other areas of expertise, including oncology and respiratory medicine, with the same innovative spirit that we have applied to our analgesics business.

Corporate Prix Galien A4 advert Napp corporate ad BMJ (CR) whole page advert. 280 x 210mm. Type Area 248 x 186mm. 3mm Bleed. CMYK.

Code: UK/RES-11007a. Date of preparation: February 2011.

Continuing Commitment

to deliver Innovation

Second stage adverts Napp Respiratory. C&D half page horizontal page advert. 210 x 143mm. 3mm bleed.

A breath of fresh air in respiratory medicine

We have built our business around the concept of putting known, trusted and effective molecules into innovative delivery mechanisms so that patients can benefit from reduced dosage frequency and improved dosing methods. In recent years, we have started to branch out into other areas of expertise, including oncology and respiratory medicine, with the same innovative spirit that we have applied to our analgesics business. Code: UK/UNA-10210c. Date of preparation: October 2010.

Napp_BMJ_CR_211010.indd 1

Code: UK/RES-11007k. Date of preparation: February 2011.

21/10/2010 14:25:17

Corporate A4 advert © DNA Healthcare Advertising Ltd. DNA Portfolio.

Brand: OxyNorm, OxyContin Client: Napp Pharmaceuticals British Journal of Nursing. Whole page. Type: 255 x 195mm. Trim: 297 x 230mm with 3mm bleed. Outside back cover.

OxyContin. Whole page advert. 297 x 210mm (A4). 3mm Bleed. CMYK.

OxyContin® prolonged release analgesia – flexibility of dosing with reduced pill burden

OxyContin

NEW STRENGTHS AVAILABLE

Prolonged release oxycodone hydrochloride tablets

Tablets are not shown at actual size

OxyNorm 5 mg

10 mg

15 mg

20 mg

NEW

30 mg NEW

40 mg

60 mg

80 mg

120 mg NEW

NEW

Prescribe by brand to reduce possible errors1,2 A leading London teaching hospital demonstrated an error rate in the prescribing of opioids of 27%.

Reduce the risk of dispensing errors: prescribe by brand name

OxyContin Prolonged release oxycodone hydrochloride tablets For prolonged release oxycodone write OxyContin.

4% of the errors being potentially fatal.3

10 mg

5 mg

15 mg

20 mg 5 mg/2.5 mg 5 mg

OxyNorm

Help release your patients from the pain of cancer OxyContin tablets contain an opioid analgesic

presenting with severe pain uncontrolled by weaker opioids: 10 mg, 12-hourly. Some patients may benefit from a starting dose of 5 mg to minimise the incidence of side effects. Opioid naïve patients with mild to moderate renal and/or mild hepatic impairment may be started on 5 mg, 12-hourly and titrated to pain relief. Any dose increases should be made, where possible, in 25% – 50% increments. When transferring from morphine, the following ratio should be used as guidance: 10 mg oral oxycodone is equivalent to 20 mg oral morphine. Opioids are not first-line therapy in non-malignant pain, nor are they recommended as the only treatment. The need for continued treatment in non-malignant pain should be assessed at regular intervals.

OxyContin® (oxycodone hydrochloride) 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 120 mg prolonged release tablets.

Prescribing Information, United Kingdom. Please read the Summary of Product Characteristics (SmPC) before prescribing. Indications Moderate to severe pain in patients with cancer or post-operative pain. Severe pain requiring the use of a strong opioid. Dosage and administration Tablets must be swallowed whole, and not broken, chewed or crushed. Elderly and adults over 18 years: Take tablets at 12-hourly intervals. Dosage is dependent on the severity of pain and the patient’s previous history of analgesic requirements. Not intended for use as a prn analgesic. Usual starting dose for opioid naïve patients, or patients

Children under 18 years: Not recommended. Contra-indications Respiratory depression, head injury, paralytic ileus, acute abdomen, delayed gastric emptying, chronic obstructive airways disease, cor pulmonale, severe bronchial asthma, hypercarbia, known sensitivity to

oxycodone or any of the constituents, moderate to severe hepatic impairment, severe renal impairment, chronic constipation, concurrent administration of monoamine oxidase inhibitors or within two weeks of discontinuation of their use, galactose intolerance, lactase deficiency, glucosegalactose malabsorption, any situation where opioids are contraindicated, pre-operative use or use during the first 24 hours post-operatively, pregnancy. Precautions and warnings Hypothyroidism, opioid dependent patients, raised intracranial pressure, hypotension, hypovolaemia, toxic psychosis, diseases of the biliary tract, pancreatitis, inflammatory bowel disorders, prostatic hypertrophy, adrenocortical insufficiency, alcoholism, delirium tremens, chronic renal and hepatic disease, severe pulmonary disease, debilitated patients, elderly and infirm patients, history of alcohol and/or drug abuse. Do not use where there is a possibility of paralytic ileus occurring and if this is suspected or occurs during use discontinue immediately. Prescribing Information continues inside back cover

60 mg

80 mg

120 mg

10 mg in 1 ml

20 mg in 2 ml

50 mg in 1 ml

Prolonged release

OxyContin® (oxycodone hydrochloride) 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 120 mg prolonged release tablets Prescribing Information, United Kingdom. Please read the Summary of Product Characteristics (SmPC) before prescribing. Indications Moderate to severe pain in patients with cancer or post-operative pain. Severe pain requiring the use of a strong opioid. Dosage and administration Tablets must be swallowed whole, and not broken, chewed or crushed. Elderly and adults over 18 years: Take tablets at 12-hourly intervals. Dosage is dependent on the severity of pain and the patient’s previous history of analgesic requirements. Not intended for use as a prn analgesic. Usual starting dose for opioid naïve patients, or patients presenting with severe pain uncontrolled by weaker opioids: 10 mg, 12-hourly. Some patients may benefit from a starting dose of 5 mg to minimise the incidence of side-effects. Opioid naïve patients with mild to moderate renal and/or mild hepatic impairment may be started on 5 mg, 12-hourly and titrated to pain relief. Any dose increases should be made, where possible, in 25% – 50% increments. When transferring from morphine, the following ratio should be used as guidance: 10 mg oral oxycodone is equivalent to 20 mg oral morphine. Opioids are not firstline therapy in non malignant pain, nor are they recommended as the only treatment. The need for continued treatment in non-malignant pain should be assessed at regular intervals. Children under 18 years: Not recommended. Contra-indications Respiratory depression, head injury, paralytic ileus, acute abdomen, delayed gastric emptying, chronic obstructive airways disease, cor pulmonale, severe bronchial asthma, hypercarbia, known sensitivity to oxycodone or any of the constituents, moderate to severe hepatic impairment, severe renal impairment, chronic constipation, concurrent administration of monoamine oxidase inhibitors or within two weeks of discontinuation of their use, galactose intolerance, lactase deficiency, glucose-galactose malabsorption, any situation where opioids are contraindicated, pre-operative use or use during the first 24 hours post operatively, pregnancy. Precautions and warnings Hypothyroidism, opioid dependent patients, raised intracranial pressure, hypotension, hypovolaemia, toxic psychosis, diseases of the biliary tract, pancreatitis, inflammatory bowel disorders, prostatic hypertrophy, adrenocortical insufficiency, alcoholism, delirium tremens, chronic renal and hepatic disease, severe pulmonary

disease, debilitated patients, elderly and infirm patients, history of alcohol and/ or drug abuse. Do not use where there is a possibility of paralytic ileus occurring and if this is suspected or occurs during use discontinue immediately. Patients about to undergo additional pain relieving procedures (e.g. surgery, plexus blockade) should not receive OxyContin tablets for 12 hours prior to the intervention. OxyContin 60 mg, 80 mg and 120 mg tablets should not be used in opioid naïve patients. OxyContin tablets should be used with caution following abdominal surgery, and not used until normal bowel function returns. OxyContin tablets have a similar abuse profile to other strong opioids. OxyContin tablets must be swallowed whole and not broken, chewed or crushed which leads to a rapid release and absorption of a potentially fatal dose of oxycodone. Concomitant use of alcohol and OxyContin tablets may increase the undesirable effects of OxyContin tablets; concomitant use should be avoided. Interactions OxyContin tablets, like other opioids, potentiate the effects of transquilisers, anaesthetics, hypnotics, antidepressants, sedatives, phenothiazines, neuroleptic drugs, other opioids, muscle relaxants and antihypertensives. Monoamine oxidase inhibitors are known to interact with narcotic analgesics, producing CNS excitation or depression with hypertensive or hypotensive crisis. Inhibitors of CYP3A4 or CYP2D6 may inhibit the metabolism of oxycodone. Alcohol may enhance the pharmacodynamic effects of OxyContin tablets; concomitant use should be avoided. Pregnancy and lactation Not recommended. Side effects Common (≥ 1%): constipation, nausea, vomiting, dry mouth, anorexia, dyspepsia, abdominal pain, diarrhoea, headache, confusional state, asthenic conditions, dizziness, sedation, anxiety, abnormal dreams, nervousness, insomnia, thinking abnormal, somnolence, bronchospasm, dyspnoea, cough decreased, rash, pruritus, hyperhidrosis, chills. Uncommon (≤ 1%): but potentially serious: anaphylactic reaction, anaphylactoid reaction, hypersensitivity, biliary colic, cholestasis, ileus, gastritis, dysphagia, dental caries, hallucinations, depression, dysphoria, affect lability, mood altered, restlessness, agitation, euphoria, disorientation, amnesia, vision abnormal, vertigo, drug tolerance, drug dependence, drug withdrawal syndrome, paraesthesia, speech disorder, convulsions, urinary retention, ureteral spasm, libido decreased, supraventricular tachycardia, hypotension, orthostatic hypotension, respiratory depression, syncope, oedema, oedema peripheral, increased hepatic enzymes, exfoliative dermatitis, urticaria, amenorrhoea, erectile dysfunction. Overdose may produce respiratory depression, pin-point pupils, hypotension and hallucinations. Circulatory failure and somnolence progressing to stupor or deepening coma, skeletal muscle flaccidity, bradycardia and death may occur in more severe cases. The effects of overdosage will be potentiated by the simultaneous ingestion of alcohol or

5 mg/5 ml

10 mg

10 mg/5 mg

20 mg/10 mg

40 mg/20 mg

20 mg

10 mg/ml

Immediate release

Prolonged release

Prescribe 4 – 6 hourly

Prescribe 12-hourly

OxyContin other psychotropic drugs. Please refer to the SmPC for a full list of side effects. Tolerance and dependence may occur. It may be advisable to taper the dose when stopping treatment to prevent withdrawal symptoms. Legal category CD (Sch2) POM. Package quantities and price 5 mg – £12.50 (28 tablets). 10 mg – £24.99 (56 tablets). 15 mg – £37.41 (56 tablets). 20 mg – £49.98 (56 tablets). 30 mg – £74.81 (56 tablets). 40 mg – £99.98 (56 tablets). 60 mg – £149.66 (56 tablets). 80 mg – £199.97 (56 tablets). 120 mg – £299.31 (56 tablets). Marketing Authorisation number PL 16950/0097-0100, 0123, 0139-0141, 0150 Marketing Authorisation holder Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge CB4 0GW, UK. Tel: 01223 424444. Member of the Napp Pharmaceutical Group. For medical information enquiries, please contact medicalinformationuk@napp.co.uk Date effective January 2012 (UK/OXYC-11026).

Prolonged release oxycodone hydrochloride tablets

OxyContin tablets contain an opioid analgesic

OxyNorm

For the treatment of moderate to severe pain in patients with cancer and post-operative pain. Severe pain requiring the use of a strong opioid.

The OxyNorm range contains an opioid analgesic

Targinact tablets contain an opioid analgesic

For the treatment of moderate to severe pain in patients with cancer and postoperative pain, and severe pain requiring the use of a strong opioid.

® OxyContin and the NAPP device are Registered Trade Marks. © 2011 – 2012 Napp Pharmaceuticals Limited. European Patent (UK) 0 253 104. European Patent (UK) 0 576 643. European Patent Application No. 96102992.3 Adverse events should be reported. Reporting forms and information can be found at use www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Napp Pharmaceuticals Limited on 01223 424444. 1. Department of Health. Building a safer NHS for patients: Improving medication safety. 2004. 2. Dickman A. Branded prescribing of strong opioids should be adopted as good practice. The Pharmaceutical Journal 2005; 275: 546. 3. Davies ED et al. A prevalence study of errors in opioid prescribing in a large teaching hospital. International Journal of Clinical Practice 2011; 65(9): 923-929.

OxyContin

For the treatment of severe pain, which can be adequately managed only with opioid analgesics. Naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut.

‘‘Including the brand name on the prescription and dispensing label will aid in the identification of the correct formulation to be dispensed or administered.” Department of Health1 Images are not shown to scale.

Prescribing information can be found on the reverse.

Prolonged release oxycodone hydrochloride tablets Code: UK/OXYC-12001. Date of preparation: Mar 2012.

OxyNorm

Prescribe by brand A2 poster

OxyContin A4 OxyContin advert - follow-on stage

OxyContin A4 advert

OxyContin

OxyNorm OxyNorm

OxyNorm injection contains an opioid analgesic ®

OxyNorm® 10 mg/ml and 50 mg/ml, solution for injection or infusion Prescribing Information United Kingdom Presentation Solution for injection or infusion containing oxycodone hydrochloride 10 mg/ml or 50 mg/ml. Indications For the treatment of moderate to severe pain in patients with cancer and postoperative pain, and severe pain requiring the use of a strong opioid. Dosage and administration For subcutaneous or intravenous injection or infusion. For adults over 18 years: A gradual increase in dose may be required if analgesia is inadequate or if pain severity increases. NB. Where dilutions are recommended, use 0.9% saline, 5% dextrose or water for injections. i.v. (Bolus): Dilute as required. Administer a bolus dose of 1 - 10 mg, slowly, over 1-2 minutes not more frequently than every 4 hours. i.v. (Infusion): Dilute as required. A starting dose of 2 mg/hour is recommended. i.v. (PCA): Dilute as required. Administer bolus doses of 0.03 mg/kg with a minimum lock-out time of 5 minutes. s.c. (Bolus): use the 10 mg/ml concentration or dilute the 50 mg/ml as required. A starting dose of 5 mg is recommended, repeated at 4 hourly intervals as required. s.c. (Infusion): dilute if required. A starting dose of 7.5 mg/day is recommended in opioid naïve patients. Cancer patients transferring from oral oxycodone may require higher doses. Patients transferring between oral and parenteral oxycodone: The dose should be based on the following guide ratio: 2 mg of oral oxycodone is equivalent to 1 mg of parenteral oxycodone and each patient is to be titrated to the appropriate dose. Elderly patients and patients with mild to moderate renal and/or mild hepatic impairment: Treat with caution, the lowest dose should be given with careful titration to pain control. Children under 18 years: Not recommended. Opioids are not first-line therapy in non-malignant pain, nor are they recommended as the only treatment. The need for continued treatment in non-malignant pain should be assessed at regular intervals. Contra-indications Respiratory depression; head injury; paralytic ileus; acute abdomen; chronic obstructive airways disease; cor pulmonale; chronic bronchial asthma; hypercarbia; known hypersensitivity to oxycodone or any of the constituents or in any situation where opioids are contraindicated, moderate to severe hepatic impairment; severe renal impairment; chronic constipation; concurrent administration of monoamine oxidase inhibitors or within 2 weeks of discontinuation of their use; pregnancy. Precautions and warnings Hypothyroidism, respiratory depression, opioid dependent patients, raised intracranial pressure, hypotension, hypovolaemia, toxic psychosis, diseases of the biliary tract, inflammatory bowel disorders, prostatic hypertrophy,

40 mg

Prescribe 12-hourly

OxyContin® tablets contain an opioid analgesic

30 mg

adrenocortical insufficiency, acute alcoholism, delirium tremens, pancreatitis, chronic renal and hepatic disease or severe pulmonary disease, debilitated and elderly patients, history of alcohol and/or drug abuse. Do not use where there is a possibility of paralytic ileus occurring and if this is suspected or occurs during use discontinue immediately. Oxycodone has an abuse profile similar to other strong opioids. Infants born to dependent mothers may exhibit withdrawal symptoms and may have respiratory depression at birth. Interactions As with other opioids, OxyNorm injection interacts with tranquillisers, anaesthetics, hypnotics, anti-depressants, sedatives, phenothiazines, neuroleptic drugs, alcohol, other opioids, muscle relaxants and antihypertensives. Pregnancy and Lactation Not recommended. Side-effects Common side-effects seen during therapy are constipation, nausea, vomiting, dry mouth, anorexia, dyspepsia, abdominal pain, diarrhoea, headache, confusional state, asthenia, faintness, dizziness, sedation, anxiety, abnormal dreams, nervousness, insomnia, thinking disturbances, somnolence, twitching, orthostatic hypotension, bronchospasm, dyspnoea, decreased cough reflex, rash, pruritus, hyperhidrosis, chills. Some side-effects which are uncommon but could be serious are biliary colic, ileus, gastritis, hallucinations, hypertonia, depression, drug withdrawal syndrome, paraesthesia, convulsions, urinary retention, ureteral spasm, libido decreased, supraventricular tachycardia, hypotension, syncope, oedema, increased hepatic enzymes, respiratory depression, exfoliative dermatitis, hypersensitivity, anaphylactic and anaphylactoid reaction. Please refer to the SPC for further details of other uncommon side-effects. Tolerance and dependence may occur. It may be advisable to taper the dose when stopping treatment to prevent withdrawal symptoms. Legal category CD (Sch2) POM Package quantities and price 10 mg/ml 1 ml ampoule - £8.00 (5 ampoules) 2 ml ampoule - £16.00 (5 ampoules) 50 mg/ml 1 ml ampoule - £70.10 (5 ampoules) Marketing Authorisation number PL 16950/0128 PL 16950/0155 Marketing Authorisation holder Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge CB4 0GW, UK Tel: 01223 424444 Member of the Napp Pharmaceutical Group Further information is available from Napp Pharmaceuticals Limited. Date of preparation May 2011. ® OxyNorm, NAPP and the NAPP device (logo) are Registered Trade Marks. © 2009 Napp Pharmaceuticals Limited.

You asked... we delivered

Our latest release

for severe cancer pain

Introducing a 50 mg/ml ampoule, addressing your dosing needs

Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk. Adverse events should also be reported to Napp Pharmaceuticals Limited on 01223 424444. For medical information enquiries, please contact medicalinformationuk@napp.co.uk References: 1. Summary of Product Characteristics. OxyNorm® 10 mg/ml, solution for injection or infusion. September 2008. Summary of Product Characteristics. OxyNorm® 50 mg/ml, solution for injection or infusion. Jan 2009. 2. Twycross R and Wilcock A.Oxycodone Palliative Carehydrochloride Formulary, Thirdsolution Edition. 2008. Page 471.or infusion for injection 3. British National Formulary. Edition 61, March 2011. Page 24. 4. Gardiner PR. Compatibility of an injectable oxycodone formulation with typical diluents, syringes, tubings, infusion bags and drugs for potential co-administration. Hosp Pharm 2003;10:354-61. Please consult the Summary of Product Characteristics before prescribing, particularly in relation to side-effects, precautions and 5. Hines Pleasance S. Compatibility of an injectable high strength oxycodone formulation typical diluent, syringes, infusion contra-indications. Legal category: CDS,(Sch 2) POM. Further information is available on request from the Marketingwith Authorisation bags and drugs for Science potentialPark, co-administration. PracticeCB4 2009;15:32-8. holder: Napp Pharmaceuticals Limited, Cambridge Milton Road, EJHP Cambridge, 0GW, UK. Code: UK/OXNO-10007 Date of preparation: June 2010.

OxyNorm A5 advert

Oxycodone hydrochloride solution for injection or infusion

Using OxyNorm® 10 mg/ml and 50 mg/ml injections in a syringe driver OxyNorm injection 10 mg/ml and 50 mg/ml are solutions of oxycodone hydrochloride for injection or infusion. The 10 mg/ml solution is available in 1 ml and 2 ml ampoules. The 50 mg/ml solution is available in 1 ml ampoules. OxyNorm injection is licensed for the treatment of moderate to severe pain in patients with cancer and post-operative pain and for severe pain requiring the use of a strong opioid.

Oxy range 6pp mini sales aid

Dosing recommendations for s.c. infusion Dilute in 0.9% saline, 5% dextrose or water for injections, if required. Diluted solutions should be used immediately or within 24 hours, unless diluted under controlled and validated aseptic conditions.1

Help release your patients from the pain of cancer

Conversion ratio from oral to subcutaneous oxycodone1 = 2:1 e.g. for a patient receiving 30 mg prolonged release oxycodone tablets 12-hourly (i.e. 60 mg/day), 30 mg/day OxyNorm injection may represent a suitable starting dose. Conversion ratio from subcutaneous morphine to subcutaneous oxycodone2 = 1:1 Conversion ratio from subcutaneous diamorphine to subcutaneous oxycodone = 1:1 (there are no available data providing direct conversion ratios between these two drugs, therefore when converting from subcutaneous diamorphine to subcutaneous oxycodone an initial 1:1 ratio is suggested, based on the recommended morphine:diamorphine equivalence listed in the BNF).3 Please note that caution is always necessary during conversions between different opioids or routes of administration. Conversion ratios can never be more than an approximate guide. Careful monitoring during conversion is mandatory to avoid both underdosing and excessive dosing. It is often appropriate to use a lower dose than the suggested equivalence above. This is particularly the case during switching at high doses, or if there has been a recent rapid escalation in dose of the first opioid.

OxyNorm A5 leave piece

OxyContin

OxyContin Product monograph OxyContin Prolonged release oxycodone hydrochloride tablets

Online banner advert

DNA Portfolio. © DNA Healthcare Advertising Ltd.

OxyNorm dosing leave piece

OxyNorm

OxyContin

OxyNorm OxyNorm

OxyNorm Immediate release oxycodone hydrochloride capsules, liquid & concentrate

Oxycodone hydrochloride solution for injection or infusion

Prescribing information can be found on Pages 28 – 29

Oxy range product monograph

Brand: Opioid 10 Client: Napp Pharmaceuticals Opioid10. BMJ (GP) Whole/full page advert. 280 x 210mm. 3mm bleed.

Napp. OPIOID10 RCGP exhibition booth panel. W: 1168.4mm x H: 2336.8mm. CMYK.

OPIOID 10 BRAND GUIDELINES

VI VII VI VII

COLOUR

FULL-COLOUR LOGO

BLACK & WHITE LOGO

REVERSE COLOUR LOGO

REVERSE BLACK & WHITE LOGO

www.opioid10.co.uk

COLOUR PALETTE

R 193 G 70 B 45 C 0 M 82 Y 80 K 0

R 153 G 56 B 34 C 8 M 92 Y 100 K 33

R 187 G 212 B 214 C 23 M0 Y 10 K 0

R 88 G 135 B 160 C 96 M9 Y 32 K 29

R 51 G 88 B 111 C 89 M 22 Y 34 K 65

www.opioid10.co.uk www.opioid10.co.uk

10-Minute Modules to support the 10-minute consultation. OPIOID-10 is supplied as an educational resource developed by Napp Pharmaceuticals Limited in association with an expert task force panel. © 2011 Napp Pharmaceuticals Limited. October 2011. UK/PAIN-11088c.

TYPE

HEADLINE TYPOGRAPHY

BODY COPY TYPOGRAPHY

TAHOMA BOLD CAPS

10-Minute modules to support the 10-Minute consultation. A practical GP resource on the appropriate use of opioids for non-malignant pain.

A4 advert

Brand guidelines

XII I XII XII I X

II IIIII III IIII IIIIV V

EARN 5.5 CPD CREDITS A practical GP resource on the appropriate use of opioids for non-malignant pain.

LOGO

IX IX VIII VIII

IX IXX X VIII VIII

II IIIII III IIII IIIIV V

XII I XII XII I X

VI VI VI VIII

Logo design www.opioid10.co.uk

www.opioid10.co.uk

Online MPU animated advert

EARN 5.5 CPD CREDITS A practical GP resource on the appropriate use of opioids for non-malignant pain. 10-Minute Modules to support the 10-minute consultation. OPIOID-10 is supplied as an educational resource developed by Napp Pharmaceuticals Limited in association with an expert task force panel. © 2011 Napp Pharmaceuticals Limited. October 2011. UK/PAIN-11083c.

Exhibition stand panel © DNA Healthcare Advertising Ltd. DNA Portfolio.

Brand: Targinact Client: Napp Pharmaceuticals A4 advert master 297 x 210mm. Bleed 5mm. CMYK.

y ud ST TS w uL Ne ReS

Enhanced recovery

is a priority for the NHS

Better Pain Relief

Superior GI Tolerability

Improved Quality of Life

MORE GOOD DAYS

Compared to previous treatment in a clinical practice study (n=7836)1,2 Targinact ® tablets contain an opioid analgesic Targinact® 5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg and 40 mg /20 mg prolonged release tablets Prescribing Information United Kingdom Presentation Film-coated, oblong, prolonged release tablets containing oxycodone hydrochloride and naloxone hydrochloride, marked OXN on one side and the oxycodone strength on the other. Colours: Blue - 5 mg (oxycodone hydrochloride) /2.5 mg (naloxone hydrochloride), white - 10 mg (oxycodone hydrochloride)/5 mg (naloxone hydrochloride), pink - 20 mg (oxycodone hydrochloride) /10 mg (naloxone hydrochloride) and yellow - 40 mg (oxycodone hydrochloride)/20 mg (naloxone hydrochloride). Indications Severe pain, which can be adequately managed only with opioid analgesics. The opioid antagonist naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut. Dosage and administration Adults over 18 years: Usual starting dose for opioid naïve patients is Targinact 10 mg/5 mg, taken orally at 12-hourly intervals.Targinact 5 mg/2.5 mg is intended for dose titration when initiating opioid therapy and individual dose adjustment. The dosage is dependent on the severity of the pain and the patient’s previous history of analgesic requirements. Patients already receiving opioids may be started on higher doses of Targinact depending on their previous opioid experience. The maximum daily dose of Targinact is 80 mg oxycodone hydrochloride and 40 mg naloxone hydrochloride. Targinact tablets are not intended for the treatment of breakthrough pain. For the treatment of breakthrough pain, a single dose of “rescue medication” should amount to one sixth of the equivalent daily dose of oxycodone hydrochloride. Please refer to the SmPC for further details on dose titration. Targinact tablets must be swallowed whole and not be broken, chewed or crushed which leads to a rapid release and absorption of a potentially fatal dose of oxycodone.

References: 1. Schutter U et al. Innovative pain therapy with a fixed combination of prolonged-release oxycodone/naloxone: a large observational study under conditions of daily practice. Curr Med Res Opin 2010; 26:1377–1387. 2. Napp Pharmaceuticals Limited. Data on file. Study codes: OXN9002a and OXN9002b.

Children under 18 years: Not recommended Contra-indications Hypersensitivity to the active substances or excipients, any situation where opioids are contra-indicated, severe respiratory depression with hypoxia and/or hypercapnia; severe chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma, non-opioid induced paralytic ileus, moderate to severe hepatic impairment. Precautions and warnings Respiratory depression, elderly or infirm, opioid-induced paralytic ileus, severely impaired pulmonary function, hypothyroidism, adrenocortical insufficiency, toxic psychosis, cholelithiasis, prostate hypertrophy, alcoholism, delirium tremens, history of alcohol and drug abuse, pancreatitis, hypotension, hypertension, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, pre-existing cardiovascular diseases, head injury (due to risk of raised intracranial pressure), epileptic disorder or predisposition to convulsions, patients taking MAO inhibitors, renal impairment, mild hepatic impairment, preoperative use or within the first 12 - 24 hours post-operatively. Not suitable for the treatment of withdrawal symptoms. Not recommended in cancer associated with peritoneal carcinomatosis or sub-occlusive syndrome in advanced stages of digestive and pelvic cancers. Interactions Substances having a CNS-depressant effect (e.g. alcohol, other opioids, sedatives, hypnotics, anti-depressants, sleeping aids, phenothiazines, neuroleptics, anti-histamines and anti-emetics) may enhance the CNS-depressant effect of Targinact (e.g. respiratory depression). Interaction with coumarin anti-coagulants may increase or decrease INR. Pregnancy and lactation Not recommended. Side-effects Common adverse drug reactions are decreased/loss of appetite, restlessness, headache, vertigo, decrease in blood pressure, abdominal pain, diarrhoea, dry mouth, constipation, flatulence, vomiting, nausea, dyspepsia, increased hepatic enzymes, hiccups, altered mood, decreased activity, psychomotor hyperactivity, agitation, dysuria, pruritus, skin reactions, hyperhidrosis, dizziness, drug withdrawal syndrome, feeling hot and cold, chills, asthenic conditions. Some side-effects which are uncommon but could be serious are hypersensitivity, confusion, depression, hallucinations,

disturbance in attention, somnolence, speech disorder, convulsions, syncope, visual disturbances, palpitations, angina pectoris, tachycardia, increase in blood pressure, dyspnoea, respiratory depression, biliary colic, erectile dysfunction, urinary retention, peripheral oedema, abdominal distension and chest pain. Please refer to the SmPC for further details of other uncommon side-effects and oxycodone class-effects. Tolerance and dependence may occur. It may be advisable to taper the dose when stopping treatment to prevent withdrawal symptoms. Legal category CD (Sch2) POM. Package quantities & price Blisters of 28 tablets 5 mg/2.5 mg - £17.56 Blisters of 56 tablets 10 mg/5 mg - £35.11; 20 mg/10 mg - £70.22; 40 mg/20 mg - £ 140.44 Marketing Authorisation numbers PL 16950/0157-158, PL16950/0161-162. Marketing Authorisation holder Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0GW, UK. Tel: 01223 424444. Member of the Napp Pharmaceutical Group. For medical information enquiries, please contact medicalinformationuk@napp.co.uk date of preparation March 2010. ® Targinact, NAPP and the NAPP device (logo) are Registered Trade Marks. © 2009 - 2010 Napp Pharmaceuticals Limited.

Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk. Adverse events should also be reported to Napp Pharmaceuticals Limited on 01223 424444.

Code: UK/TARG-10129. date of preparation: August 2010.

When suffering from cancer, don’t let severe pain be the difference between existing and living Targinact ® tablets contain an opioid analgesic Targinact® 5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg and 40 mg /20 mg prolonged release tablets Prescribing Information United Kingdom Presentation Film-coated, oblong, prolonged release tablets containing oxycodone hydrochloride and naloxone hydrochloride, marked OXN on one side and the oxycodone strength on the other. Colours: Blue - 5 mg (oxycodone hydrochloride) /2.5 mg (naloxone hydrochloride), white - 10 mg (oxycodone hydrochloride)/5 mg (naloxone hydrochloride), pink - 20 mg (oxycodone hydrochloride)/10 mg (naloxone hydrochloride) and yellow - 40 mg (oxycodone hydrochloride)/20 mg (naloxone hydrochloride). Indications Severe pain, which can be adequately managed only with opioid analgesics. The opioid antagonist naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut. Dosage and administration Adults over 18 years: Usual starting dose for opioid naïve patients is Targinact 10 mg/5 mg, taken orally at 12-hourly intervals.Targinact 5 mg/2.5 mg is intended for dose titration when initiating opioid therapy and individual dose adjustment. The dosage is dependent on the severity of the pain and the patient’s previous history of analgesic requirements. Patients already receiving opioids may be started on higher doses of Targinact depending on their previous opioid experience. The maximum daily dose of Targinact is 80 mg oxycodone hydrochloride and 40 mg naloxone hydrochloride. Targinact tablets are not intended for the treatment of breakthrough pain. For the treatment of breakthrough pain, a single dose of “rescue medication” should amount to one sixth of the equivalent daily dose of oxycodone hydrochloride. Please refer to the SmPC for further details on dose titration.Targinact tablets must be swallowed whole and not be broken, chewed or crushed which leads to a rapid release and absorption of a potentially fatal dose of oxycodone. Children under 18 years: Not recommended Contra-indications Hypersensitivity to the active substances or excipients, any situation where opioids are contra-indicated, severe

respiratory depression with hypoxia and/or hypercapnia; severe chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma, non-opioid induced paralytic ileus, moderate to severe hepatic impairment. Precautions and warnings Respiratory depression, elderly or infirm, opioid-induced paralytic ileus, severely impaired pulmonary function, hypothyroidism, adrenocortical insufficiency, toxic psychosis, cholelithiasis, prostate hypertrophy, alcoholism, delirium tremens, history of alcohol and drug abuse, pancreatitis, hypotension, hypertension, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, pre-existing cardiovascular diseases, head injury (due to risk of raised intracranial pressure), epileptic disorder or predisposition to convulsions, patients taking MAO inhibitors, renal impairment, mild hepatic impairment, preoperative use or within the first 12 - 24 hours post-operatively. Not suitable for the treatment of withdrawal symptoms. Not recommended in cancer associated with peritoneal carcinomatosis or sub-occlusive syndrome in advanced stages of digestive and pelvic cancers. Interactions Substances having a CNS-depressant effect (e.g. alcohol, other opioids, sedatives, hypnotics, anti-depressants, sleeping aids, phenothiazines, neuroleptics, anti-histamines and anti-emetics) may enhance the CNS-depressant effect of Targinact (e.g. respiratory depression). Interaction with coumarin anti-coagulants may increase or decrease INR. Pregnancy and lactation Not recommended. Side-effects Common adverse drug reactions are decreased/loss of appetite, restlessness, headache, vertigo, decrease in blood pressure, abdominal pain, diarrhoea, dry mouth, constipation, flatulence, vomiting, nausea, dyspepsia, increased hepatic enzymes, hiccups, altered mood, decreased activity, psychomotor hyperactivity, agitation, dysuria, pruritus, skin reactions, hyperhidrosis, dizziness, drug withdrawal syndrome, feeling hot and cold, chills, asthenic conditions. Some side-effects which are uncommon but could be serious are hypersensitivity, confusion, depression, hallucinations, disturbance in attention, somnolence, speech disorder, convulsions,

syncope, visual disturbances, palpitations, angina pectoris, tachycardia, increase in blood pressure, dyspnoea, respiratory depression, biliary colic, erectile dysfunction, urinary retention, peripheral oedema, abdominal distension and chest pain. Please refer to the SmPC for further details of other uncommon side-effects and oxycodone class-effects. Tolerance and dependence may occur. It may be advisable to taper the dose when stopping treatment to prevent withdrawal symptoms. Legal category CD (Sch2) POM. Package quantities & price Blisters of 28 tablets 5 mg/2.5 mg - £17.56 Blisters of 56 tablets 10 mg/5 mg - £35.11; 20 mg/10 mg - £70.22; 40 mg/20 mg - £ 140.44 Marketing Authorisation numbers PL 16950/0157-158, PL16950/0161-162. Marketing Authorisation holder Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0GW, UK. Tel: 01223 424444. Member of the Napp Pharmaceutical Group. For medical information enquiries, please contact medicalinformationuk@napp.co.uk Date of preparation March 2010. ® Targinact, NAPP and the NAPP device (logo) are Registered Trade Marks. © 2009 - 2010 Napp Pharmaceuticals Limited.

It is essential that the patient has the best possible management during and after his/her operation to reduce pain, gut dysfunction

and immobilisation

NHS ENHANCED RECOVERY PARTNERSHIP

Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk. Adverse events should also be reported to Napp Pharmaceuticals Limited on 01223 424444.

Code: UK/TARG-XXXXX. Date of preparation: November 2010.

Targinact ® is the UK’s first and only prolonged release analgesic that combines an opioid agonist with an antagonist. Targinact ® is licensed for the treatment of severe pain.

Targinact ® is the UK’s rst and only prolonged release analgesic that combines an opioid agonist with an antagonist. Targinact ® is licensed for the treatment of severe pain.

A4 UK advert back pain

A4 UK advert palliative care

Prescribing information can be found on the final page.

Post-op slide kit

Post-Op detail aid

Targinact ® tablets contain an opioid analgesic Targinact® ▼ (oxycodone hydrochloride/naloxone hydrochloride) 5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg and 40 mg/20 mg prolonged release tablets. Prescribing Information United Kingdom. Please read the Summary of Product Characteristics (SmPC) before prescribing.

Why prescribe

Targinact for patients with severe

back pain?

Indications Severe pain, which can be adequately managed only with opioid analgesics. Naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut. Dosage and administration Adults over 18 years: Usual starting dose for opioid naïve patients: 10 mg/5 mg taken orally at12-hourly intervals. Patients already receiving opioids may be started on higher doses depending on their previous opioid experience.Targinact 5 mg/2.5 mg is intended for dose titration when initiating opioid therapy and individual dose adjustment. The dosage is dependent on the severity of the pain and the patient’s previous history of analgesic requirements. Maximum daily dose of Targinact is 80 mg oxycodone hydrochloride and 40 mg naloxone hydrochloride. Targinact is not intended for the treatment of breakthrough pain. Please refer to SmPC for further details. Targinact must be swallowed whole and not be broken, chewed or crushed. Children under 18 years: Not recommended. Contra-indications Hypersensitivity to active substances or excipients, any situation where opioids are contra-indicated, severe respiratory depression with hypoxia and/or hypercapnoea; severe COPD, cor pulmonale, severe bronchial asthma, non-opioid induced paralytic ileus, moderate to severe hepatic impairment. Precautions and warnings Respiratory depression, elderly or infirm, opioid-induced paralytic ileus, severely impaired pulmonary function, myxoedema, hypothyroidism, adrenocortical insufficiency, toxic psychosis, cholelithiasis, prostate hypertrophy, alcoholism, delirium tremens, pancreatitis, hypo- or hyper-tension, pre-existing cardiovascular diseases, head injury, epileptic disorder, predisposition to convulsions, patients taking MAO inhibitors, history of alcohol/drug abuse, galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, renal impairment, mild hepatic impairment, pre-operative use or within the first 12 - 24 hours post-operatively. Not suitable for treatment of withdrawal symptoms. Not recommended in cancer associated with peritoneal carcinomatosis or sub-occlusive syndrome in advanced stages of digestive and pelvic cancers. Concomitant use of alcohol and Targinact may increase the undesirable effects of Targinact and should be avoided. Tolerance and dependence may occur. It may be advisable to taper dose when stopping treatment to prevent withdrawal symptoms. Interactions Substances having a CNS-depressant effect (e.g. other opioids, sedatives, hypnotics, anti-depressants,

sleeping aids, phenothiazines, neuroleptics, anti-histamines and anti-emetics) may enhance CNS-depressant effect of Targinact (e.g. respiratory depression). Alcohol may enhance the pharmacodynamic effects of Targinact; concomitant use should be avoided. Interaction with coumarin anticoagulants may increase/decrease INR. Pregnancy and lactation Not recommended. Side-effects Common: decreased/loss of appetite, restlessness, dizziness, headache, vertigo, decrease in blood pressure, abdominal pain, diarrhoea, dry mouth, constipation, flatulence, vomiting, nausea, dyspepsia, increased hepatic enzymes, hiccups, altered mood, personality change, decreased activity, psychomotor hyperactivity, agitation, dysuria, pruritus, skin reactions, hyperhidrosis, drug withdrawal syndrome, feeling hot and cold, chills, asthenic conditions. Uncommon but potentially serious: hypersensitivity, confusion, depression, euphoric mood, hallucinations, paraesthesia, speech disorder, convulsions, sedation, syncope, visual disturbances, palpitations, angina pectoris, tachycardia, increase in blood pressure, dyspnoea, respiratory depression, biliary colic, erectile dysfunction, urinary retention, peripheral oedema, tooth disorder, chest pain and injuries from accidents. Refer to SmPC for further details of other uncommon side-effects and oxycodone class-effects. Legal category CD (Sch2) POM Package quantities and price Blisters of 28 tablets 5 mg/2.5 mg - £ 17.56. Blisters of 56 tablets 10 mg/5 mg - £35.11. 20 mg/10 mg - £70.22. 40 mg/20 mg - £ 140.44 Marketing Authorisation numbers PL 16950/0157-158, PL16950/0161-162. Marketing Authorisation holder Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0GW, UK. Tel: 01223 424444. Member of the Napp Pharmaceutical Group. For medical information enquiries, please contact medicalinformationuk@napp.co.uk. Date effective March 2012 ® Targinact, NAPP and the NAPP device (logo) are Registered Trade Marks. © 2011 - 2012 Napp Pharmaceuticals Limited. PI Code UK/TARG-12031. PI Approved March 2012. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Napp Pharmaceuticals Limited on 01223 424444.

References:

The British Pain Society. Opioids for persistent pain: Good practice. London: British Pain Society; 2010.

Vondrackova D, Leyendecker P, Meissner W, et al. Analgesic efficacy and safety of oxycodone in combination with naloxone as prolonged release tablets in patients with moderate to severe chronic pain. J Pain 2008;9:1144-54.

Simpson K, Leyendecker P, Hopp M, et al. Fixed-ratio combination oxycodone/naloxone compared with oxycodone alone for the relief of opioid-induced constipation in moderate-to-severe noncancer pain. Curr Med Res Opin 2008;24(12):3503-12.

Löwenstein O, Leyendecker P, Hopp M, et al. Combined prolonged-release oxycodone and naloxone improves bowel function in patients receiving opioids for moderate-to-severe non-malignant chronic pain: a randomised controlled trial. Expert Opin Pharmacother 2009;10:531-43.

Napp Pharmaceuticals Limited. Data on file. OXN3001 PAC-SYM analysis.

Dunlop W, Uhl R, Khan I, et al. Quality of life benefits and cost impact of prolonged release oxycodone/naloxone versus prolonged release oxycodone in patients with moderate-to-severe non-malignant pain and opioid-induced constipation: a UK cost-utility analysis. J Med Econ. 2012;15(3):564-75.

Scottish Intercollegiate Guidelines Network (SIGN). SIGN 106; Control of pain in adults with cancer. Edinburgh: SIGN 2001-2009; November 2008 [accessed August 2011]. Available from http://www.sign.ac.uk/pdf/SIGN106.pdf

Foley KM. The treatment of cancer pain. N Engl J Med 1985;313(2):84-95.

Twycross R, Wilcock A. Palliative Care Formulary. 3rd ed. palliativedrugs.com Ltd 2007; p.269.

10. Summary of product characteristics. OxyContin® tablets. May 2011. 11. British National Formulary, 61st Edition, March 2011.

Prescribing information can be found on the back cover.

Code: UK/TARG-12048. Date of preparation: April 2012.

Prescribing information can be found on the final page.

A5 leave piece - back pain

Back pain detail aid

Post-op detail aid briefing notes

Targinact stand panel. 25%: 440mm x 193mm. 3mm Bleed. CMYK.

delivers effective pain relief1,2

counteracts opioid-induced constipation2,3

OBJECTION HANDLER

Targinact is licensed for the treatment of severe pain, which can be adequately managed only with opioid analgesics. The opioid antagonist naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut.4

FOR INTERNAL USE ONLY

Prescribing information is available on this stand.

Objection handler

Dose card leave piece

Code: UK/TARG-11059. Date of preparation: November 2011.

References: 1. Vondrackova D, Leyendecker P, Meissner W, et al. Analgesic efficacy and safety of oxycodone in combination with naloxone as prolonged release tablets in patients with moderate to severe chronic pain. J Pain 2008;9:1144-54.

2. Sandner-Kiesling A, Leyendecker P, Hopp M, et al. Long-term efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of non-cancer chronic pain. Int J Clin Pract 2010;64 (6):763-74.

3. Simpson K, Leyendecker P, Hopp M, et al. Fixed-ratio combination oxycodone/naloxone compared with oxycodone alone for the relief of opioid-induced constipation in moderate-to-severe noncancer pain. Curr Med Res Opin 2008;24(12):3503-12. 4. Targinact® 5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg, 40 mg/20 mg prolonged release tablets. Summary of Product Characteristics. Revised August 2011.

Targinact® tablets contain an opioid analgesic. Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk. Adverse events should also be reported to Napp Pharmaceuticals Limited on 01223 424444.

Exhibition stand panel

Targinact BPS stand panel. 1000mm x 2000mm Targinact BPS stand. CMYK. 100% to scale.

A5 leave piece - post-op A4 (297 x 210mm). CMYK.

“Sometimes it seems to take over your life”

“Don’t feel normal” “Cannot sleep”

“Part of your mind is on your pain, and another part of your brain is taken up with constipation”

delivers effective pain relief1,2

“I know I have to take my pain meds but it’s awful to always feel constipated”

“Makes one feel isolated”

counteracts opioid-induced constipation2,3

“It is a constant discomfort and makes me unhappy”

“It dominates everything I can do” “Constantly worrying or upset”

Real patient quotes taken from a survey commissioned by Napp Pharmaceuticals of 2,000 UK opioid treated patients.

When was the last time you asked them about it? 59% of patients taking opioids suffer from constipation.1 They might not tell you unless you ask.

Prescribing information is available on this stand. References: 1. Vondrackova D, Leyendecker P, Meissner W, et al. Analgesic efficacy and safety of oxycodone in combination with naloxone as prolonged release tablets in patients with moderate to severe chronic pain. J Pain 2008;9:1144-54. 2. Sandner-Kiesling A, Leyendecker P, Hopp M, et al. Long-term efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of non-cancer chronic pain. Int J Clin Pract 2010;64 (6):763-74. Code: UK/PAIN-12019f. Date of preparation: April 2012.

1. Napp Pharmaceuticals Limited. Constipation survey of 2,000 UK adults taking opioids. July 2012. Data on file.

Targinact® tablets contain an opioid analgesic. Adverse events should be reported. Reporting forms and information can be found at use www.mhra.gov.uk/yellowcard Adverse events should also be reported to Napp Pharmaceuticals Limited on 01223 424444.

UK/PAIN-12272. Nov 2012.

UK pain advert

Back pain detail aid briefing notes

Mode of action bookmark leave piece

Brand: Osvaren & Venofer (Assets adapted from global material) Client: Fresenius Medical Care

mation escribing Infor Abbreviated Pr

d) and Information (Irelan ibing. D preparations ® /235mg Prescribing (SPC) before prescr particularly if used with vitamin rm administration Osvaren 435mg Characteristics and long-te performed, in ary of Product . cs. High doses usually asymptomatic, but Refer to the Summ thiazide diureti a scored oral tablets emia,

ts with film-coated associated with may result in hypermagnesa be seen. Patien Presentation: yellowent of hyperphosphataemia ic effects may ic episodes, oing dialysis some cases systemciency may develop hypercalcaem Indications: Treatm ciency in patients underg of n of metabolites insuffi chronic renal insuffi s). chronicrenal the administratio symptoms peritoneal dialysi e Adults: 3 to 10 film-coated especially in combination with of the possible (haemodialysis, ts should be warnedtherapy with this medicine, istration: Dosag hate level. The Patien Admin phosp D. and rm serum Dosing the number of vitamin alcaemia. During long-te ssion or the appearance of depending on according to the of hyperc progre tablets per day, ses by be subdivided recommended be paid to the The risk decrea daily dose should day (usually three a day). The dosage may attention must tissue calcifications. t to <4.5mmol2/L2. In the soft the over and ary, ar taken necess produc If meals To achieve vascul g the calcium phosphate ne should only three tablets daily. tablets per® day. ides, this medici lowerin starting dose is ally 12 film-coated should be taken patients receiving digitalis glycos l and monitoring of the serum be raised to maxim hate binding effect, Osvaren d or chewed. under ECG contro calcium salts may result in of the maximum phosp meal and should not be crushe iately before be administered l advice the Increased intake d to seek medica only together with broken along the score line immedtion of other calcium level. should be advise or magnesium salts. In be ation. Patients extent of absorp calcium The tablets may be reduced. rently with constiptaking antacids containing e the rate and/or should concur Becaus ne used wing. medici . swallo of this vary when be taken before ea the dosage contains sodium products may nal products should istration case of diarrho oral medicinal e. This medicine on a controlled admin other oral medici contains sucros by patients this medicine no hours before and 3 hours after dose should This medicine into consideration 2 taken next be to the period has the dose, This within risks with In case of a missed t should be made to make nce. Balance of this medicine. attemp 18. sodium diet. ion: No experie normal time (no d for patients under or Pregnancy and Lactat be taken at the Not recommende ia with Soft stools, on; dose). alcaem Comm missed hyperc s. a, benefit disorders: up for the of Hypophosphataemi ia, sensation an overdose of Side effects: Gastrointestinal nausea, anorex Contra-indications: oms, e.g. as a result of olism and ma, breast irritation like l sympt diarrhoea. Metab tomatic gastrointestinal me (bronchial carcino without clinica asymp metastases, g and constipation, oplastic syndro cytoma), bone fullness, belchin Common: Hypercalcaemia either Uncommon: vitamin D, a parane carcinoma, plasma orosis. Elevated serum n disorders: agnesaemia. osteop cancer, renal cell oms of nutritio omatic, asymptomatic hyperm alcaemia, symptomatic immobilisation l/L, and/or sympt sympt sarcoidosis or symptomatic hyperc a, magnesium-induced more than 2mmo gravis; hypersensitivity or of severe to levels enia Moderate magnesium Hyperkalaemi AV-block III°, myasth emia. Very rare: hypermagnesa hypermagnesaemia,nces or to any of the excipients. disturbances. g one pack of kind of dialysis diet and the osteal mineralisation Price: Osvaren® 435mg/235m to the active substa ® should only be Basic Precautions: Review Pack size and ent. Osvaren Warnings and €35.45 monitoring of initiating treatm film-coated tablets treatment before caution (only with continuous of severe 180 Category: POM. 0/4/1. hate) in case administered with sium and phosp more than Legal ting Authorisation number: PA135 of Medical Care magne , ius roduct hate-p : Fresen Marke serum calcium v.d.H., isation holder with a calcium-phosprefractory hyperkalaemia; Bad Homburg Marketing Author hyperphosphataemia therapy; GmbH 61346 if; refractory to with bradycardia. Nephrologica Deutschland 5.3mmol2/ L2; September 2012 or AV-block II° magnesium, of preparation: t bradycardia phosphate, serum should be Germany. Date clinical relevan ring of serum found at be can Continuous monito the calcium-phosphate-product and and information serum calcium fmc-ag.com Repor ting forms nline- Forms.aspx ted. fo-ie@ repor medin lity/O --Qua s should be 550 166 or Adverse eventhttp://www.imb.ie/EN/Safety depar tment on 1800 drug safety ted to Fresenius s should be repor Adverse event

ers OsvaRen deliv • • •

binding Dual phosphate 4 ate levels of serum phosph Effective reduction 4 profile Good tolerability

get 1 control your bud t will help you …at a cost tha 1 comparison* Monthly cost €14.06 starting dose 4 upper dose €56.2

OsvaRen

upper €430.57 dose

starting €86.11 dose

sevelamer

0 10 20

100

150

200

250

300

400

350

y. 28 days’ therap * Costs based on November 2012. in MIMs Ireland, Based on prices

trol Phosphate con

hate control in carbonate for phosp M, et al. Magnesium –201. 3. Osvaren Summary of Referencebers:2012. 2. Tzanakis IP, PapadakiIntAN,UrolWeiNeph ate as a rol 2008; 40:193 e/magnesium carbon

upper €333.95 dose

starting €112.56 dose

lanthanum carbon ate hydrate

450

in harmony

trial. AG , Novem tion of calcium acetat lled randomized study (CALM 1. MIMS Ireland mized controlled ALM et al. Evalua dialysis. A rando 3/ndt/ a contro patients on hemo ics, Januar y 2011. 4. de Francisco dialysis patients: 7, 2010; DOI: 10.109 ation hloride in haemo s published on June calcific Product Characterist red with sevelamer hydroc Advanced Acces presence of peripheral vascular compa Tsomi A, ol Dial Transplant phosphate binder ation between the 22-227. 6. Tzanakis I, Virvidakis K, tolerability. Nephr and associ y ant efficac i K, et al. Signific rch 2004; 17(2): 2007; 68(4):2 study) assessing ra E, Okuno S, Kitatanialysis patients. Clinical Nephrology dialysis patients Magnesium Resea -, Phosphat- und gfq292. 5. Ishimu magnesium in hemod levels and atheromatosis in haemoders Kalziumacetat-Mg 2+Im Kalzium safety of an and lower serum y and ellular magnesium erten Phosphatbin Deuber HJ. Long-term efficac Nieren-und 8. et al. Intra- and extrac A. Stellenwert des kalziumreduzi dialysis patients. 2008 S. 6:260–78. fner 102-108. 7. Hümp Nieren- und Hochdruckkrankheiten and magnesium carbonate in haemo . e ement acetat Manag sHPTboth calcium Huthwaite, binder containing Nunn Brook Road, ghamshire, 03–8. oral phosphate Nottin ten 2004; 33(8):4 Sutton-in-Ashfield, 2HU Hochdruckkrankhei

ation appears on

Prescribing inform

back cover.

Date of preparation:

NP-1012-254. November 2012.

NG17

6pp A5 leave piece

OsvaRen JRN whole page ad. 280 x 210mm with 5mm bleed. CMYK. 750mm w x 1500mm h. Venofer BRS stand. CMYK. 100% scale.

Phosphate control

in harmony

Irish detail aid on iPad OSVAREN® CORE CLAIMS DOCUMENT (Claims in black were derived from refs used in UK sales aid and have been reference checked – claims in some other colours came from elsewhere – see reference list for notes on source of claims and references and to what extent they have been verified).

Need for the product Almost 40% of haemodialysis patients and 30% of peritoneal dialysis patients may not achieve K/DOQI serum phosphorus target levels.1

OsvaRen® delivers

• Dual phosphate binding • Effective reduction of serum phosphate levels • Good tolerability profile

Indication

Treatment of hyperphosphatemia associated with chronic renal insufficiency in patients undergoing dialysis (haemodialysis, peritoneal dialysis).

Patients who may be likely to benefit • •

OsvaRen delivers

…at a cost that will help you control your budget1 Osvaren® 435mg/235mg Prescribing Information (UK) Refer to the Summary of Product Characteristics (SPC) before prescribing.

Presentation: Yellow film-coated scored oral tablets. Indications: Treatment of hyperphosphataemia associated with chronic renal insufficiency in patients undergoing dialysis (haemodialysis, peritoneal dialysis). Dosing and Administration: Dosage Adults: 3 to 10 film-coated tablets per day, depending on the serum phosphate level. The daily dose should be subdivided according to the number of meals taken over the day (usually three a day). The recommended starting dose is three tablets daily. If necessary, the dosage may be raised to maximally 12 film-coated tablets per day. To achieve the maximum phosphate binding effect, Osvaren® should be taken only together with the meal and should not be crushed or chewed. The tablets may be broken along the score line immediately before swallowing. Because the rate and/or extent of absorption of other oral medicinal products may vary when used concurrently with this medicine no other oral medicinal products should be taken within the period 2 hours before and 3 hours after administration of this medicine. In case of a missed dose, the next dose should be taken at the normal time (no attempt should be made to make up for the missed dose). Not recommended for patients under 18. Contra-indications: Hypophosphataemia, Hypercalcaemia with or without clinical symptoms, e.g. as a result of an overdose of vitamin D, a paraneoplastic syndrome (bronchial carcinoma, breast cancer, renal cell carcinoma, plasmacytoma), bone metastases, sarcoidosis or immobilisation osteoporosis Elevated serum magnesium levels of more than 2mmol/l, and/or symptoms of hypermagnesaemia, AV-block III°, Myasthenia gravis; hypersensitivity to the active substances or to any of the excipients. Warnings and Precautions: Review diet and the kind of dialysis treatment before initiating treatment. Osvaren® should only be administered with caution (only with continuous monitoring of serum calcium, magnesium and phosphate) in case of severe hyperphosphataemia with a calcium-phosphate-product of more than 5.3mmol2/L2; if; refractory to therapy; refractory hyperkalaemia; clinical relevant bradycardia or AV-block II° with bradycardia. Continuous monitoring of serum phosphate, serum magnesium, serum calcium and the calcium-phosphate-product should be performed, particularly if used with vitamin D preparations and thiazide diuretics. High doses and long-term administration may result in hypermagnesaemia, usually asymptomatic, but in some cases systemic effects may be seen. Patients with a chronic renal insufficiency may develop hypercalcaemic episodes, especially in combination with the administration of metabolites of vitamin D. Patients should be warned of the possible symptoms of hypercalcaemia. During long-term therapy with this medicine, attention must be paid to the progression or the appearance of vascular and soft

tissue calcifications. The risk decreases by lowering the calcium-phosphate-product to <4.5mmol2/L2. In patients receiving digitalis glycosides, this medicine should only be administered under ECG control and monitoring of the serum calcium level. Increased intake of calcium salts may result in constipation. Patients should be advised to seek medical advice before taking antacids containing calcium or magnesium salts. In case of diarrhoea the dosage of this medicine should be reduced. This medicine contains sucrose. This medicine contains sodium. This has to be taken into consideration by patients on a controlled sodium diet. Pregnancy and Lactation: No experience. Balance risks with benefits. Side-effects: Gastrointestinal disorders: Common; Soft stools, gastrointestinal irritation like nausea, anorexia, sensation of fullness, belching and constipation, diarrhoea. Metabolism and nutrition disorders: Common: Hypercalcaemia either asymptomatic or symptomatic, asymptomatic hypermagnesaemia Uncommon: Moderate to severe symptomatic hypercalcaemia, symptomatic hypermagnesaemia. Very rare: Hyperkalaemia, magnesium-induced osteal mineralisation disturbances. Pack size and Basic NHS Price: Osvaren® 435mg/235mg one pack of 180 film-coated tablets £24.00. Legal Category: POM. Marketing Authorisation number: PL29386/0005. Marketing Authorisation holder: Fresenius Medical Care Nephrologica Deutschland GmbH 61346 Bad Homburg v.d.H., Germany. Date of preparation: May 2011. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Fresenius drug safety department on 0844 5027 200. medinfo-uk@fmc-ag.com References 1. MIMS online, May 2012. [Accessed May 2012]. 2. de Francisco ALM et al. Evaluation of calcium acetate/magnesium carbonate as a phosphate binder compared with sevelamer hydrochloride in haemodialysis patients: a controlled randomized study (CALMAG study) assessing efficacy and tolerability. Nephrol Dial Transplant. Advanced Access published on June 7, 2010; DOI: 10.1093/ ndt/gfq292. Nunn Brook Road, Huthwaite, Sutton-in-Ashfield, Nottinghamshire, NG17 2HU

• •

Key efficacy claims

Dual phosphate binding

•

svaRen provides a dual phosphate-binding effect from calcium acetate and magnesium O carbonate2,3 OsvaRen is the only phosphate binder that contains a combination of a magnesium salt and a calcium salt (in the UK – checked in BNF)

Effective reduction of serum phosphate levels 1

•

Good tolerability profile 1

OsvaRen delivers:

…at a cost that will help you control your budget 2

• • • • •

Effective reduction of serum phosphorus levels2,12 Serum calcium levels maintained within K/DOQI guideline range2 Serum magnesium levels mildly elevated2,12 which may have potential benefits4,5 Lowers serum iPTH (intact parathyroid hormone) levels2 Good tolerability profile2,20

OsvaRen delivers phosphate control in harmony Abbreviated Prescribing Information is available on this stand. References:

The benefits of the combination

de Francisco ALM et al. Evaluation of calcium acetate/magnesium carbonate as a phosphate binder compared with sevelamer hydrochloride in haemodialysis patients: a controlled randomized study (CALMAG study) assessing efficacy and tolerability. Nephrol Dial Transplant Advanced Access published on June 7, 2010; DOI: 10.1093/ndt/gfq292.

•

MIMS, January 2012.

For full prescribing information refer to the Summary of Product Characteristics. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Fresenius drug safety department on 0844 5027 200. medinfo-uk@fmc-ag.com



NP-0712-236. Date of preparation: July 2012.

Date of preparation: March 2012. NP-0312-186.

Press advert

Patients with phosphate levels not controlled on current therapy (from sales aid) Patients with hyperphosphataemia insufficiently controlled by calcium-containing phosphate binders alone or for whom there are concerns about calcification with calcium-containing phosphate binders; (positioning submitted to) SMC Patients with raised parathyroid hormone levels Patients with low magnesium levels

Exhibition panel

•

svaRen provides a dual phosphate-binding effect from calcium acetate and magnesium O carbonate and delivers: – The additional phosphate binding effect of magnesium carbonate3 – Reduction in calcium content per tablet compared with pure calcium salts,12 based on a theoretical argument not on a comparative dose ranging study – Lower calcium uptake and reduced risk of hypercalcaemia compared to calcium acetate and calcium carbonate20 – Mildly elevated serum magnesium levels2 which may provide potential benefits: – In some circumstances, preventative effect in relation to calcification20 – No evidence of symptomatic hypermagnesaemia2 – Comparable efficacy to sevelamer hydrochloride (HCl)2 OsvaRen is the only phosphate binder that contains a combination of a magnesium salt and a calcium salt (in the UK – checked in BNF)

Core claims document

750mm w x 1500mm h. Venofer BRS stand. CMYK. 100% scale.

6pp A5 leave piece

Well recognised for the treatment of iron deficiency

Venofer® is the most frequently prescribed IV iron therapy in the UK1

Tried and tested anaemia management

Well recognised for the treatment of iron deficiency The most frequently prescribed IV iron therapy in the UK1 Effective IV iron replacement for haemodialysis patients2,3 Optimises ESA therapy2,3

Tried and tested anaemia management

Abbreviated Prescribing Information is available on this stand. References:

Date of Preparation: September 2012. NP-0912-247.

Prescribing information can be found on last page.

1. Data on file, Nephropharm 2010. 2. Richardson D, et al. Amer J Kidney Dis 2001; 38(1):109-17. 3. Shiesser D, et al. Nephrol Dial Transplant 2006; 21:2841-2845.

Detail aid on iPad For full prescribing information refer to the Summary of Product Characteristics. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard Adverse events should also be reported to Vifor Pharma UK Ltd. Tel: +44 1276 853633. Venofer ® is a registered trademark.

Date of preparation: April 2012. NP-0312-187.

Brand: Inovelon Client: Eisai Logo design ABBREVIATED PRESCRIBING INFORMATION Inovelon®6(rufinamide) Please refer to the SPC before prescribing. Presentation: Film coated tablets containing 100 mg, 200 mg or 400 mg rufinamide. Indication: Adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome in patients 4 years and older. Dose and administration: Children 4 years and older: (see SmPC). For oral use - Children weighing < 30 kg not receiving valproate; Initial daily dose is 200 mg in two divided doses and may be increased by 200 mg/day increments, as frequently as every two days, up to a maximum dose of 1000 mg/day. Children weighing < 30 kg receiving valproate; Initial daily dose is 200 mg in two divided doses and may be increased by 200 mg/day after a minimum of 2 days, up to a maximum dose of 400 mg/day. Adults and children 4 years or older of m 30kg; Initial daily dose is 400 mg in two divided doses and may be increased by 400 mg/day increments, as frequently as every two days, up to a maximum of 3200 mg/day based on patient’s weight (see SPC). Inovelon should be administered twice daily with water and preferably with food in the morning and in the evening. Inovelon can be crushed and administered with half a glass of water. Elderly and patients with renal or hepatic impairment: No dosage adjustment required in elderly and renal impairment. Not recommended in severe hepatic impairment. Contra-Indications: Hypersensitivity to rufinamide, triazole derivatives or any excipients. Pregnancy: Inovelon should not be used during pregnancy unless clearly necessary. Lactation: Excretion into human breast milk unknown. Lactation should be avoided during maternal treatment with Inovelon. Warnings and Precautions: Cases of status epilepticus have been observed during clinical studies, which led to discontinuation in 20% of the cases. The benefit risk ratio of the therapy should be reassessed if patients develop new seizure types and/or experience an increased frequency of status epilepticus. Withdraw gradually to reduce possibility of seizures on withdrawal and reduce dose by approximately 25% every two days. Inovelon has been associated with dizziness, somnolence, ataxia and gait abnormalities which could increase the occurrence of accidental falls in this population, therefore patients and carers should exercise caution. Serious antiepileptic drug hypersensitivity syndrome has occurred with rufinamide, e.g. fever and rash associated with other organ system involvement, lymphadenopathy, liver function tests abnormalities, haematuria. If this reaction is suspected, rufinamide should be discontinued and alternative treatment started. Closely monitor patients on rufinamide with unexplained rash. Women of childbearing potential must use contraceptive measures during treatment with Inovelon. Inovelon tablets contain lactose, therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Inovelon. Drug Interactions: Rufinamide concentration may be decreased by co-administration with carbamazepine, phenobarbital, phenytoin, vigabatrin or primidone. Significant increases in rufinamide plasma concentrations possible when co-administered with valproate. Consideration should be given to a dose reduction in patients < 30 kg who are on valproate therapy. No significant changes in rufinamide concentration when co-administered with lamotrigine, topiramate or benzodiazepines. Rufinamide has no clinically relevant effect on carbamazepine, lamotrigine, phenobarbital, topiramate or valproate steady state concentrations. Rufinamide may decrease phenytoin clearance and increase concentrations of co-administered phenytoin, therefore reducing the dose of phenytoin should be considered. Rufinamide decreases the AUC of a combined oral contraceptive (ethinyloestradiol 35 μg and norethindrone 1 mg). Women of child-bearing potential should use an additional safe and effective contraceptive method. Rufinamide does not inhibit the activity of cytochrome P450 enzymes. Rufinamide has been shown to induce the CYP3A4 enzyme. Carefully monitor patients on drugs metabolised by the CYP3A enzyme for two weeks at start of, or after the end of treatment with Inovelon. Dose adjustments should be considered when Inovelon is co-administered with drugs with narrow therapeutic window such as warfarin and digoxin. No effects on the pharmacokinetics of olanzapine. No interaction data with alcohol. Side effects: The most common adverse reactions in clinical development program were headache, dizziness, fatigue, and somnolence. Adverse reactions associated with Inovelon in clinical studies: Very common effects (>1/10): somnolence, headache, dizziness, nausea, vomiting, fatigue. Common effects (>1/100, <1/10): pneumonia, influenza, nasopharyngitis, ear infection, sinusitis, rhinitis, anorexia, eating disorder, decreased appetite, anxiety, insomnia, status epilepticus, convulsion, coordination abnormal, nystagmus, psychomotor hyperactivity, tremor, diplopia, vision blurred, vertigo, epistaxis, abdominal pain upper, constipation, dyspepsia, diarrhoea, rash, acne, back pain, oligomenorrhoea, gait disturbance, weight decrease, head injury, contusion. Uncommon (>1/1000<1/100): hypersensitivity and hepatic enzyme increase. Legal Category: POM Presentation: Aluminium/aluminium blisters. Basic UK NHS cost: Inovelon 100 mg: packs of 10 £8.58, Inovelon 200 mg: packs of 60 £51.48, Inovelon 400 mg: packs of 60 £85.80. Basic Irish cost: Inovelon 100 mg: packs of 10 €12.68, Inovelon 200 mg: packs of 60 €76.15, Inovelon 400 mg: packs of 60 €126.91. Marketing authorisation numbers: Inovelon 100 mg: packs of 10 EU/1/06/378/001, Inovelon 200 mg: packs of 60 EU/1/06/378/009, Inovelon 400 mg: packs of 60 EU/1/06/378/014. Marketing authorisation holder: Eisai Ltd. Further Information from/Marketed by: Eisai Ltd, Hammersmith International Centre, 3 Shortlands, London, W6 8EE, UK Date of preparation: July 2007 Information about adverse event reporting can be found at www.yellowcard.gov.uk Adverse events should also be reported to Eisai Ltd on 0208 600 1400 or Lmedinfo@eisai.net

A 42.5% reduction in drop attacks isn’t something...

...unless you’re the one falling

A new way forward in Lennox-Gastaut Syndrome

Eisai code: INO 1002. Date of preparation: August 2007.

A5 patient information booklet

A4 advert

A4 folder

Information about adverse event reporting can be found at www.yellowcard.gov.uk Adverse events should also be reported to Eisai Ltd. on 0208 600 1400 or Lmedinfo@eisai.net

Banner stand poster for conferences

Detail aid slides on CD

Dose card

Product monograph

Packaging

MON TUE WED THU 1

FRI 2

SAT

SUN MON TUE WED THU

FRI 9

SAT

SUN MON TUE WED THU

FRI

SAT

SUN MON TUE WED THU 19

FRI

SAT

SUN MON TUE WED THU 26

FRI

SAT

SUN MON

TUE

JAN

FEB

MAR

MAR 1

APR

APR 29

MAY

MAY 1

JUN

JUL

JUL 29

AUG

AUG 1

SEP

OCT

OCT 29

NOV

NOV 1

DEC

Walll planner

Leave piece

Detail aid

Formulary pack

Training manual

SmPC

BRAND IDENTITY Detail aid GUIDELINES

Launch letter / RPC mailer

Brand: Prialt Client: Eisai

A5 patient information booklet

A4 UK advert

A4 EU advert

Banner stand poster for conferences

Product monograph

Case studies

Abstract poster book DNA Portfolio. ÂŠ DNA Healthcare Advertising Ltd.

Formulary pack

Medical request card

Conference signage & flyers

Abstracts in folder for conference

Brand guidelines Exhibition stand posters

Website

Detail aid ÂŠ DNA Healthcare Advertising Ltd. DNA Portfolio.

Brand: Linx Client: Torax Medical Inc. Size is 105 x 145mm plus 3mm bleed

W NE

RETHINK

REFLUX THE TREATMENT OF

A NEW TREATMENT FOR CHRONIC REFLUX DISEASE

RETHINK

THE TREATMENT OF

REFLUX

D E AN C O M US O N S EE D G2

STAN

3197 Rev 27-Jan-11

Email: sfreedman@toraxmedical.com

Linx A5 advert insert for exhibition

FOLD

Linx detail aid (produced in 4 languages for EU and US markets)

Torax Medical, Inc. and the LINX Reflux Management System are trademarks of Torax Medical, Incorporated.

ÜBERDENKEN SIE DIE BEHANDLUNG DER

REFLUX-KRANKHEIT

PREISLISTE

LINX™ REFLUX MANAGEMENT SYSTEM Folgende Hinweise sollen es Ihnen erleichtern, das Linx™ Reflux Management System zu bestellen: • Geben Sie bitte die Grösse und Anzahl der benötigten Implantate an • Faxen Sie Ihren Auftrag bitte an folgende Nr. +1 651-361-8910 att. Brian Mower

North 55126, USA medical.com

EN N FREU WIR UF IHRE A N S UN SUCH A BE EREM UNS NR 103 D STAN

Torax™ Medical, Inc. und das LINX ™ Reflux-Managementsystem sind Marken der Torax Medical, Inc.

Email: glandwehr@toraxmedical.com

Dok. Nr. 3198-2. Datum der Veröffentlichung: 11. MAI

FOLD

k. Nr.Doc. 3223 - 2 Rev 1. Veröffentlichung: 11. MAI.

4pp A5 Linx German price list

Linx online video/animation

Linx A4 German advert

LINX Centre Promotional Guide French

NX® REFLUX AGEMENT SYSTEM EST-IL PTÉ À MON CAS ?

MYRIAD ROMAN

PANTONE 5425

PANTONE BLACK (70%)

44c / 15m / 7y / 22k

0c / 0m / 0y / 70k

(FOR REFERNCE ONLY – DO NOT RESET) DESIGNER: Kurt Mueller/Dan Hannon

RECONSIDÉREZ VOTRE

REFLUX

z-vous toujours les symptômes du reflux, a prise régulière de médicaments ? Êtes-vous uant aux effets secondaires à long terme édicaments ? Le LINX® Reflux Management st peut-être une solution adaptée à votre cas. s d’informations, consultez votre médecin ou otre site à l’adresse www.toraxmedical.com.

CURA DEL PAZIENTE

COLOR LOGO

NEL POSTOPERATORIO

edical, Inc. ngton Avenue North w, Minnesota 55126, États-Unis fo-ous@toraxmedical.com

B&W LOGO

Actual size

REVERSED LOGO

A Medical, NEWInc.TREATMENT FOR Torax et LINX Reflux Management System sont des marques CHRONIC REFLUX DISEASE commerciales de Torax Medical, Incorporated. ®

N. doc 3218-3 Rev 1 Data di emissione APR 11

UN NOUVEAU TRAITEMENT POUR LE REFLUX PATHOLOGIQUE CHRONIQUE

Doc. N° 3208-4 Rév. 1. Date of issue Oct 12.

Linx 6pp DL post-op patient leave piece (Italian)

Linx 6pp DL brochure (French)

LAPAROSCOPIC SPHINCTER AUGMENTATION DEVICE ELIMINATES REFLUX SYMPTOMS AND NORMALISES ESOPHAGEAL ACID EXPOSURE: ONE AND TWO YEAR RESULTS OF A FEASIBILITY TRIAL

UN NOUVEAU TRAITEMENT

POUR

REVERSED LOGO WITH T R A N S PA R E N C Y

LE REFLUX

CHRONIQUE

The LINX™ Reflux Management System offers a new treatment for patients with GERD, who have incomplete symptom relief from PPI therapy. Comprising a string of interlinked titanium beads with magnetic cores, the LINX™device is implanted laparoscopically around the gastro-esophageal junction, forming a flexible ring that rests around the Lower Esophageal Sphincter (LES). The magnetic bond between adjacent beads allows a weak LES to resist gastric distension, effectively stopping reflux at its source. The beads temporarily separate to accommodate a swallowed bolus and reapproximate to augment the LES in the closed position. The one and two year results of a feasibility trial, show the LINX™ device provides excellent relief from GERD symptoms without creating new side effects. 50

Figure 1a – The LINX ™ device in the closed position, 1b - the closed position showing no compression of the esophageal wall, and 1c - the LINX device in the open position.

METHODS The LINX™ device was implanted at the gastro-esophageal junction, in 44 patients in a multi-centre, prospective clinical study carried out between February 2007 and October 2008. There were 26 (59%) males and 18 (41%) females with a mean age of 42.3 years (range 19-72 years) and a BMI range from 19.0 to 38.4 (mean 25.7). Heartburn was the primary symptom in all patients and all were taking proton-pump inhibitors at standard or double dose. Eighteen patients had no hernia and twenty-six of the 44 patients (59.1%) had a <3cm sliding hiatal hernia based on radiologic and/or endoscopic criteria. Each patient was evaluated before surgery with a symptom questionnaire, upper gastrointestinal endoscopy, barium swallow,

Torax ® Medical, esophagealInc. manometry, and 24-hour esophageal pH monitoring. The Gastro-Esophageal 4188 Lexington Avenue Reflux NorthDisease Health-Related Quality of Life (GERD-HRQL) questionnaire was administered preoperatively “off” Shoreview, Minnesota 55126, États-Unis PPI therapy before any diagnostic test. All tests were repeated postsurgery at 3, 12 and 24 months apart from esophageal manometry Email: info-ous@toraxmedical.com which was carried out at 3 and 12 months. Exclusion criteria:

symptoms of dysphagia, previous upper abdominal surgery, previous endoluminal antireflux procedures, >3 cm sliding hiatal hernia, greater than grade A esophagitis, and/or the presence of histologically documented Barrett’s esophagus. ®

Torax ® Medical, Inc. et LINX Reflux RESULTS All devices were implanted without complications with a Management System sont des marques median operative time of 40 minutes (range: 19 – 104) and all but 1 commerciales Medical, Incorporated. patient de wasTorax discharged within 48 hours. A free diet was allowed after

radiological assessment of esophageal transit on postoperative day one. The total mean GERD-HRQL symptom scores improved from a mean baseline value of 25.7 to 3.8 and 2.4 at 1- and 2-year follow-up, representing an 85% and 90% reduction, respectively (P < 0.0001).

40 35 30 25

25.7

20 15 10 5 0

Pre-implant n = 44

4.6

3.8

2.4

3 months

12 1 2 months

24 months 2

n = 37

n = 39

n = 28

Follow-up Time Point

Pre- and postoperative mean total score from the GERD-HRQL questionnaire (p<.0001).

Complete cessation of PPI use was reported by 90% of patients at 1 year and by 86% of patients at 2 years. Early dysphagia occurred in 43% of the patients and self-resolved by 90 days. At 1 and 2 years, 77% and 90% of patients had a normal esophageal acid exposure. The mean percentage time pH was less than 4 decreased from a baseline of 11.9% to 3.1% (P < 0.0001) at 1 year and to 2.4% (P < 0.0001) at 2 years. The average DeMeester score was reduced from 42.3 to 9.4 after 2 years. Patient satisfaction was 87% at 1 year and 86% at 2 years. One device was laparoscopically explanted for persistent dysphagia without disruption of the anatomy or function of the cardia. There were no device migrations, erosions, or induced mucosal injuries and all patients preserved the ability to belch after surgery. Four patients experienced the need to vomit and were able to do so.

www.toraxmedical.co.uk Normalised Normalis

90% 70%

% Patients

Total Score TotalGERD-HRQL GORD-HRQL Score

76%

77%

60% 50% 40%

Doc No 3393-3 Rév 1. Date of issue: Oct 2012

30% 20% 10% 0%

3 months n = 38

12 months 1 n = 39

24 months 2 n = 20

Foll Follow-up Tim Time Point

Percentage of patients who had their esophageal acid exposure normalised after surgery.

CONCLUSION This study shows that augmentation of the LES barrier using the LINX™ Reflux Management System is an effective treatment for patients with uncomplicated GERD who are dissatisfied with acid suppression therapy. It is a reversible procedure, with minimal surgical dissection and preservation of normal anatomy. Furthermore, with a short operating time and the ability to resume a normal diet the day after implantation, the LINX™ Reflux Management System is likely to offer a consistent and less variable outcome in the treatment of reflux.

A5 Linx post-consultation booklet (French)

Bonavina, et al. (2010) Laparoscopic Sphincter Augmentation Device Eliminates Reflux Symptoms and Normalises Oesophageal Acid Exposure. Annals of Surgery 252:857-862

EMEA – 3225-1 Rev 2 Date of preparation: September 2011.

Brands: Novo Nordisk, Mirena (Bayer Schering) & MSD Client: Cohn & Wolfe MEDIA ROUNDTABLE

Caring for Women: Engage in Conversations

Fitters’ Passport for Mirena (Bayer Schering)

Monday 18th May 2009, 14.00 – 15.00 North Gallery Room 4, ExCeL London One Western Gateway, Royal Victoria Dock, London E16 1XL Novo Nordisk FemCare AG, the European Menopause and Andropause Society (EMAS), and the British Menopause Society (BMS), are pleased to invite you to a media roundtable entitled ‘Caring for Women: Engage in Conversations’ and a satellite symposium entitled ‘Vaginal atrophy: Are we lost in translation?’ The media roundtable will provide you with exclusive presentations from Professor David Barlow, President of EMAS, on the role of EMAS in raising the issue of menopausal conditions and problems and its educational programmes for healthcare professionals in this area, and Dr. Tim Hillard, Chairman of BMS, on the confusion and complications around the menopause that currently exist and the challenge of menopause management, from a UK perspective. In addition there will be an in-depth briefing on the findings from an international survey of women on communication issues associated with post-menopausal vaginal atrophy. The details for both events are as follows:

Satellite Symposium: 12.15-13.45 Venue: Hall A, ExCeL London Media Roundtable: 14.00-15.00 Venue: North Gallery Room 4, ExCeL London (North Gallery Room 4 is a short walk from Hall A) Agenda/speakers Introduction. Prof. Henry Burger and Prof. David Barlow The European Menopause and Andropause Society – How we can ensure problems and solutions to menopausal issues are shared. Prof. David Barlow The challenges of menopause management – Experiences from the British Menopause Society. Dr. Tim Hillard Women’s voices: International survey findings in context – Highlighting international trends and variations. Dr. Rossella Nappi From our experience – expert viewpoints •

Italy

Dr. Rossella Nappi

•

United Kingdom

Dr. Heather Currie

Start the conversation: Practical recommendations. Prof. Henry Burger Open moderated Q&A with media. Media / panel

Spokespersons available for interviews/one-to-ones following the media roundtable •

Prof. David Barlow

•

Dr. Tim Hillard

President of EMAS Chairman of BMS

•

Prof. Serge Rozenberg

Secretary General & President-Elect of EMAS

•

Prof. Henry Burger

Jean Hailes Foundation for Women’s Health, Australia

•

Dr. Rossella Nappi

University of Pavia, Italy

•

Dr. Heather Currie

Dumfries and Galloway Royal Infirmary, United Kingdom Light refreshments will be served prior to the media roundtable.

To register attendance, and to set up interviews / one-to-ones, please contact Jonathan Kearney at Cohn & Wolfe London, who will be facilitating the meeting: Email: jonathan.kearney@cohnwolfe.com Telephone: +44 20 7331 2364

Press invite for Novo Nordisk

DIZZINESS, DROWSINESS, FAST HEARTBEAT, FEELING JITTERY, HEADACHE, HUNGER, IRRITABILITY, SWEATING, WEAKNESS TYPE 2 DIABETES HYPOGLYCAEMIA

DIZZINESS, DROWSINESS, FAST HEARTBEAT, FEELING JITTERY, HEADACHE, HUNGER, IRRITABILITY, SWEATING, WEAKNESS TY

MEDIA INVITATION EASD 2010 The Type 2 Diabetes Dilemma: Exploring Hypoglycaemia WHEN:

Thursday 23rd September 9.00am – 10.30am

WHERE: EASD press conference room Stockholmsmässan Stockholm

A5 invitation

The Type 2 Diabetes Dilemma: Exploring Hypoglycaemia

Thursday 23rd September, 9.00am – 10.30am EASD press conference room Stockholmsmässan, Stockholm The Type 2 Diabetes Dilemma: Exploring Hypoglycaemia

A1_poster_070910.indd 1

A1 poster

07/09/2010 16:18:34

Press Kit

A4 press kit folder

DNA Portfolio

Brand: Alux Client: Torben Hersborg Logo design

Website

A1 poster DNA Portfolio. ÂŠ DNA Healthcare Advertising Ltd.

Leaflet

Brand: Comply Services Client: Katrin Spaepen Logo design

Brochure

Slide set

Business card

ÂŠ DNA Healthcare Advertising Ltd. DNA Portfolio.

DNA Healthcare Advertising Ltd. 6 - 8 Paxton Place, London, SE27 9SS. t +44 (0) 20 3004 4743.

DNA Portfolio. ÂŠ DNA Healthcare Advertising Ltd.