Lg product list june03 2016

Page 1

Leading Global Life Sciences

LGLS is contributing to improve human health and quality of life, striving to reach global prominence.


Electronics Sector will continue to evolve as a trusted company.

Since 1958, when the company name was Goldstar Co., LG has led Korea's electronics industry with innovative technology. Through aggressive research and development, global marketing, and innovation, LG has secured market leadership, exploring new possibilities in the global electronics industry.

LG Electronics

LG Corp.

LG Display

LG Siltron

LG Innotek

LUSEM

Chemicals Sector Launched as Lucky Chemicals Industries Co.in 1947, the company espoused the management philosophy of "being committed to making products essential to people's lives". LG promises to provide distinguished values in the lives of customers.

Since its inception in 2003 as holdings company, LG has gone on to broaden its portfolio in electronics, chemicals, telecommunications, and service sectors while strengthening its expertise in each field and working to create customer values.

LG Chem

LG Household & Health Care

LG Life Sciences

LG Hausys

LG MMA

Telecommunications and Services Sector This sector provides customers with better access to information anytime anywhere. The key goal is to create a world transcending communication networks.

LG U+

LG N-Sys

LG CNS

LG Sports

LG International

SERVEONE


Contents 001 Corporate Profile 004 Global Network 006 Pipeline

Biologics 009 EspogenⓇ / EpotivⓇ 010 EutropinⓇ / Eutropin PenⓇ

Corporate Profile

011 EutropinPlus / DeclageⓇ

HA Based Products 012 HyruanⓇ Series 013 ProtescalTM / HyalⓇ Series 014 YVOIREⓇ Series

Fertility Treatments 016 FollitropeⓇ / IVF-M HPTM 017 IVF-MTM / IVF-CTM

Vaccine 018 Euvax BTM / EuhibTM 019 EupentaTM / Euforvac-HibTM

Chemicals 020 FactiveⓇ 021 ZemigloⓇ / ZemimetⓇ SR 022 RovatitanⓇ / LevacalmⓇ 023 Generics

Veterinary Medicine 024 BoostinⓇ

In August 2002, LG Life Sciences Ltd., (LGLS) spun off from LG Chem Investment as 025 Locations

a full-fledged LG affiliate with a mission to be a specialty company and to maximize shareholder value. LG Life Sciences Ltd., corporate vision is to grow into a world-class life science company with top-tier pharmaceutical products. With this vision in mind, LG Life Sciences Ltd., has been focusing all of its resources on building strategic alliances and capabilities to develop new drugs and to strengthen its marketing competency. LG Life Sciences Ltd., has made a significant investment in life sciences; a field expected to be a major growth engine for LG. As a result of these initiatives, LG Life Sciences Ltd., is already in possession of state-of-the-art technologies to develop new drugs that make our lives more rewarding and enjoyable.


LG Life Sciences Ltd., is a leading pharmaceutical company with global sales & marketing network over 80 countries around the world.

Global Network LG Life Sciences Poland

LG LG Life Sciences China

LG

LG Headquarter

LG

LG Life Sciences Thailand

LG Life Sciences MENA Office

LG

LG

LG Life Sciences India

Global Standard PRODUCT

ACTIVITIES

FACTIVE

US FDA Post-Approval Inspection for API('06), US FDA Approval ('03, 4), US FDA Pre-Approval Inspection for API ('00)

TM

TM

WHO Pre-Qualification (Euvax BTM: '96, '99, '01, '04, '07/ Euforvac-HibTM: '12/ EupentaTM: ’16), EU Inspection & Approval ('05)

TM

Euvax B , Euforvac-Hib , Eupenta We, LG Life Sciences Ltd., invest more than 20% of our revenue on R&D, hence, maintaining the dominant position in Korean Ⓡ

pharmaceutical industry. We have established world-class manufacturing facilities and we are committed to meet the global standard set by the US FDA, EMEA, the WHO and other international organizations. With our innovative R&D and world class

US FDA Approval ('07,4), German Authority(RPDA) Inspection for hGH DS ('01,'03)and SR-hGH DP ('03), Import License from RPDA FOR hGH DS ('02)/Review of LB03002 at US FDA ongoing, LB03002 approval by EMA ('13)

Eutropin /Valtropin LB03002 Ⓡ

facilities, LG Life Sciences Ltd., has been presenting the highest quality products to the world.

Espogen

German Authority(RPDA)'s Inspection and Import License

Hyruan /Hyruan Plus /Hyruan One Ⓡ

Hyal 2000 /Hyal Plus Ⓡ

YVOIRE classic s /YVOIRE volume s Ⓡ

Global network 004

005

YVOIRE contour

CE marking on Hyruan PlusⓇ ('07) and Hyruan OneⓇ ('14)

CE marking on YVOIREⓇ classic(’13), YVORIEⓇ volume s(’13), YVOIREⓇ contour(’13)


Category

Vaccine

Biologics

Biosimilar

Pipeline

NME

Product

Type

LBVC

Polio virus vaccine

Poliomyelitis prevention

LBVD

Hexavalent vaccine

DTP/HepB/Hib/Polio prevention

LBVE

Pneumococcal Conjugate Vaccine

Pneumococcus prevention

SR-hGH

Weekly hGH

Eutropin Pen

Daily hGH

GHD, TS, CRI, SGA, ISS

Espogen

BEPO albumin

Anemia of CRF

LBEC0101

Etanercept biosimilar

Rheumatoid Arthritis

LBAL

Adalimumab biosimilar

Rheumatoid Arthritis

LBDE

Darbepoetin-α biosimilar

Anemia of CRF

Besifovir

DNA Pol. inhibitor

Hepatitis B

LC280126

Necrosis inhibitor

Myocardial Infarction

LC54AID3

GPR120 agonist

Type 2 Diabetes

CAR T-cell

IMD

Medical Device

LG Life Sciences Ltd.,

has initiated genetic engineering research since 1984,

long before its spin off from LG Chemistry in 2002. The innovative R&D history for the past 30 years has contributed to establishing strong pipeline both in biopharmaceuticals and new chemical entities.

Pipeline 006

007

Indication

DS PC

Clinical Trial PⅠ

PⅡ

PⅢ

Adult GHD Pediatric GHD

Immune cell therapy

ZemiMet

DPP IV inhibitor/Metformin

Type 2 Diabetes

ZemiSU

DPP IV inhibitor/SU

Type 2 Diabetes

ZemiStatin

DPP IV inhibitor/Statin

Diabetes / Hyperlipidemia

ZemiARB

DPP IV inhibitor/ARB

Diabetes / Hypertension

YVOIRE soft plus

Cross-linked HA/lidocaine

Facial augmentation

YVOIRE intensive plus

Cross-linked HA/lidocaine

Facial augmentation

DS : Discovery PC : Preclinical Studies NME : New molecular entity IMD : Incrementally modified drug GHD : Growth Hormone Deficiency TS : Turner Syndrome CRI : Chronic Renel Insufficiency SGA : Small for Gestational Age ISS : Idiopathic Short Stature BEPO : Bioreactor EPO DPP : Dipeptidyl Pepidase SU : sulfonylurea ARB : Angiotensin Receptor Blocker HA : Hyaluronic acid

NDA


Erythropoietin injection Biologics

Free from human serum albumin, manufactured by bioreactor process

COMPOSITION

EspogenⓇ is a recombinant human erythropoietin for the treatment of anemia induced by chronic renal failure in patients with or without dialysis. It is manufactured by a bioreactor process which does not use animal-derived material, is free from human serum albumin.

ach pre-filled syringe contains 1,000, 2,000, 3,000, 4,000, E 6,000, 8,000 or 10,000 IU of rhEPO Each vial contains 4,000, 10,000 or 20,000 IU of rhEPO

INDICATION Treatment of anemia of chronic renal failure(CRF) patients DOSAGE & ADMINISTRATION

猬 猬

Recombinant human erythropoietin using CHO cells Manufactured by bioreactor process capable of covering high capacity Devoid of additives derived from animal origin in the manufacture process Safe and effective treatment for renal anemia associated with chronic renal failure (CRF) Newly developed for global market

Initial dose : Administer 50 IU/kg 3 times a week or 150 IU/kg once a week by S.C. or I.V. injection over 1~2 minutes Maintenance dose : If 30~35% of Hct level is achieved, administer 20~50 IU/kg 2~3 times a week, in any case, maximum dose should not exceed 200IU/kg in a single day 3 times per week. HOW SUPPLIED Vial : 10 vials / box PFS : 6 syringe / box 5 syringe / box (10000IU) STORAGE CONDITION Store in hermetic container at 2-8℃. Do not freeze or shake SHELF LIFE

Products

24 months

Recombinant human erythropoietin suspension for injection, vial or pre-filled syringe A recombinant human erythropoietin manufactured by recombinant DNA technology, EspogenⓇ has the identical amino acid sequence and analogous carbohydrate structures to naturally occuring erythropoietin. Erythropoietin is thought to be an ideal treatment for renal anemia of CRF patients with good efficacy and safety. 猬 猬 猬 猬

Products 008

009

Recombinant human erythropoietin using CHO cells Manufactured by roller-bottle process 10,000 IU of once-weekly dosage for patients' compliance Safe and effective treatment for renal anemia associated with chronic renal failure(CRF)

Biologics

Espogen / Epotiv


Eutropin / Eutropin Pen

Biologics

EutropinPlus Somatropin injection

Somatropin injection Biologics

LGLS is Committed to Leadership and Innovation in GHD Therapy. 猬

Proven quality : Proven efficacy and safety, 20 years of patient

Short stature due to an inadequate secretion of endogenous growth hormone in children (Pediatric Growth Hormone Deficiency, PGHD) Short stature caused by Turner Syndrome (TS) Short stature caused by Chronic Renal Insufficiency (CRI) Short stature in children born Small for Gestational Age (SGA) Short stature associated with Idiopathic Short Stature (ISS) Replacement therapy in adults with GH deficiency of either childhood- or adult-onset etiology

experience

DOSAGE & ADMINISTRATION

M anufactured using LGLS’advanced technology : Drug substance approved by US FDA

U niquely produced in yeast (Saccharomyces cerevisiae) : GRAS by FDA hence, non pathogenic and non pyrogenic

INDICATION

Eutropin

®Injection 4IU

COMPOSITION Each vial contains 4IU of recombinant human growth hormone

Biologics

The FIRST once-a-week hGH product with proven efficacy and safety comparable to daily products. Satisfies needs of patient groups requiring reduced frequency of injections.

COMPOSITION Each vial contains 24 mg of recombinant human growth hormone INDICATION Short stature due to an inadequate secretion of endogenous growth hormone in children (Pediatric Growth Hormone Deficiency, PGHD) DOSAGE & ADMINISTRATION The recommended dosage is 0.5 mg per Kg of body weight per week

1. PGHD : 0.5~0.6 IU/kg/week or 12 IU/m2 body surface area/ weak is recommended. The weekly dose should be divided into 3 to 6 SC injections. 2. TS : 1 IU/kg/week is given by SC or IM injection. The weekly dosage is divided into 6~7 injections. 3. CRI : 0.15 IU/kg/day is given by SC injection. 4. SGA : 0.48 mg/kg/week is given divided into 6~7 SC injections. 5. ISS : 0.37 mg/kg/week is given divided into 6 SC injections. 6. Replacement therapy in adult GHD : The recommended dosage at the start of therapy is 0.125 IU (0.04 mg)/kg/ week, divided into 6~7 injections. The dose may be increased according to individual patient requirements to a maximum of 0.25 IU (0.08 mg)/kg/week.

HOW SUPPLIED 24 mg/vial with accompanying solvent in a pre-filled syringe/unit STORAGE CONDITION Store at 2~8℃. Do not freeze. Protect from light. Keep out of reach of children. SHELF LIFE 36 months

HOW SUPPLIED 4 IU/vial x 1, 5, 10 vials/pack (with solvent) 15 IU/vial x 1 vial/pack (with solvent) 36 IU/pen/pack STORAGE CONDITION

Declage

Somatropin injection Biologics

Store in hermetic container at 2~8℃ SHELF LIFE

Eutropin Pen ®Injection 36 IU Ⓡ

4 IU : 36 months 15 IU : 36 months 36 IU : 18 months

Once weekly hGH product for AGHD (Adult Growth Hormone Deficiency) patients

COMPOSITION Each vial contains 3 mg of recombinant human growth hormone INDICATION

COMPOSITION

Replacement therapy in adults with GH deficiency of either childhood- or adult-onset etiology

Each pen contains 36 IU of recombinant human growth hormone

DOSAGE & ADMINISTRATION The recommended dosage at the start of therapy is 2 mg/ week. The dose may be increased according to individual patient requirements to a maximum of 4 mg/week. HOW SUPPLIED 3 mg/vial with accompanying solvent in a pre-filled syringe/unit STORAGE CONDITION Store at 2~8℃. Do not freeze. Protect from light. SHELF LIFE 36 months

Biologics 010

011


Hyruan ®Series Intra-articular injection for osteoarthritis treatment Ⓡ

Protescal Medical device for anti-adhesion barrier Hyal Series Injection for ophthalmic surgery TM

HA Based Products

LG’s sodium hyaluronate is microbially fermented using Streptococcus zooepidemicus, with high purity and consistency. To pursue the global standard, our hyaluronate gained Certificate of Suitability from European Directorate for the Quality of Medicines (EDQM), and Hyruan Plus and Hyruan ONE are CE marked.

Post-operation anti-adhesion barrier It is a biodegradable and resorbable adhesion barrier composed of sodium hyaluronate, carboxymethylcellulose (CMC) and sodium alginate. It effectively prevents the formation of adhesions between tissues after intrauterine surgery and degrades safely in our body.

Protescal ® TM

Hyruan ONE ®Injection Ⓡ

Novel single injection preparation

LG’s sodium hyaluronate products utilize microbially fermented hyaluronate of European Pharmacopoeia grade. Our hyaluronate is certified by European Directorate for the Quality of Medicines (EDQM) for quality.

DESCRIPTION This is a viscous sol type product presented in a prefilled syringe filled with 1.5 mL, 5.0 mL of colorless, clear and viscous liquid.

COMPOSITION Each mL contains 20 mg of cross-linked sodium hyaluronate INDICATION For use as a symptomatic treatment for osteoarthritis of weight bearing joints including knee, shoulder, hip and ankle.

Hyruan Plus ®Injection Ⓡ

DOSAGE & ADMINISTRATION 3.0 mL at once by intra-articular injeciton

INDICATION To prevent or reduce post-surgical adhesion formation of below operations: - Endoscopic sinus surgery - Hysteroscopy

HOW SUPPLIED 3.0 mL in a prefilled syringe/pack

HOW SUPPLIED 1.5 mL, 5.0 mL in a prefilled syringe/pack.

STORAGE CONDITION Store in light-resistant hermetic container at 1~30℃

STORAGE CONDITION 2~25℃

SHELF LIFE 24 months

SHELF LIFE 24 months

COMPOSITION Each mL contains 10 mg of sodium hyaluronate INDICATION For use as a symptomatic treatment for osteoarthritis of weight bearing joints including knee, shoulder, hip and ankle.

Hyal 2000

COMPOSITION Each mL contains 15 mg of sodium hyaluronate

COMPOSITION Each mL contains 10 mg of sodium hyaluronate

INDICATION Used in surgical interventions involving the anterior chamber, such as cataracts (crystalline lens transplants), corneal transplants and glaucoma operations

INDICATION Used in surgical interventions involving the anterior chamber, such as cataracts (crystalline lens transplants), corneal transplants and glaucoma operations

DOSAGE & ADMINISTRATION Injection volume is adjusted according to the type of eye surgery: - Cataract Surgery and Intraocular Lens Implantation - Keratoplasty - Glaucoma Filtration Surgery

DOSAGE & ADMINISTRATION Injection volume is adjusted according to the type of eye surgery: - Cataract Surgery and Intraocular Lens Implantation - Keratoplasty - Glaucoma Filtration Surgery

HOW SUPPLIED 0.85mL in a prefilled syringe/pack

HOW SUPPLIED 0.85 mL in a prefilled syringe/pack

HOW SUPPLIED 2.5 mL in a prefilled syringe X 1, 5/pack

STORAGE CONDITION Store in light-resistant hermetic container at 2~8℃ in the refrigerator

STORAGE CONDITION Store in light-resistant hermetic container at 2~8℃ in the refrigerator

STORAGE CONDITION Store in light-resistant hermetic container at 2~8℃ in the refrigerator

SHELF LIFE 36 months

SHELF LIFE 36 months

HOW SUPPLIED 2.0 mL in a prefilled syringe X 1, 3/pack STORAGE CONDITION Store in light-resistant hermetic container at 2~25℃

Hyruan ®Injection

SHELF LIFE 36 months

COMPOSITION Each mL contains 10 mg of sodium hyaluronate INDICATION Osteoarthritis of the knees and periarthritis of the shoulder DOSAGE & ADMINISTRATION 2.5 mL once a week for 5 weeks by intra-articular injection

SHELF LIFE 36 months HA Based Products 012

013

Hyal 2000 and Hyal Plus are sodium hyaluronate, which are sterile non-pyrogenic high molecular weight viscoelastic substances for intraocular surgeries. They protect the endothelium from injury, enhance endogenous endothelial regeneration and allow safe manipulation during ophthalmic surgeries.

Hyal Plus

DOSAGE & ADMINISTRATION 2.0 mL once a week for 3 weeks by intra-articular injection

Ophthalmic surgery, Prefilled syringe

HA Based Products

Treatment of degenerative joint diseases, Prefilled syringe Hyaluronic acid is a natural polysaccharide which moisturizes and lubricates the body's soft tissue. It protects injured chondrocyte by building proteoglycan aggregates and suppressing degenerative change of cartilage. It is the major macromolecule species in synovial fluid and is responsible for the fluid's viscoelastic properties.

HA Based Products


YVOIRE

YVOIRE

Dermal Filler

Dermal Filler

HA Based Products

HA Based Products

HA Based Products

Tissue augmentation and wrinkle correction Based on the original technology for manufacturing high-quality sodium hyaluronate, LG Life Sciences Ltd., developed a biomaterial for tissue augmentation using the cross-linked sodium hyaluronate. It is injected into the facial skin layer in the face using separate needles supplied with YVOIRE series use HICE(High Concentration Equalized) crosslinking technology which effectively stabilizes high concentration, high molecular weight HA.

YVOIRE contour®

YVOIRE contour plus®

COMPOSITION Cross-linked sodium hyaluronate 22mg/mL (2.2%)

COMPOSITION Cross-linked sodium hyaluronate 20mg/mL (2.0%) Lidocaine 0.3%

YVOIRE classic s

YVOIRE classic plus®

COMPOSITION Cross-linked sodium hyaluronate 22mg/mL(2.2%)

COMPOSITION Cross-linked sodium hyaluronate 20mg/mL (2.0%) Lidocaine 0.3%

INDICATION Facial tissue augmentation by injection into areas in which restoration is required. Typically used for treatment of facial wrinkles and folds, and also for augmentation of lips. HOW SUPPLIED 1.0mL in a prefilled syringe/box with 27G & 30G needles STORAGE CONDITION 2~25℃ free from light, in a hermetic container

INDICATION Facial tissue augmentation by injection into areas in which restoration is required. Typically used for treatment of facial wrinkles and folds, and also for augmentation of lips. The addition of lidocaine provides a pain relieving effect during treatment. HOW SUPPLIED 1.0mL in a prefilled syringe/box with 27G & 30G needles STORAGE CONDITION 2~25℃ free from light, in a hermetic container

SHELF LIFE 24 months

INDICATION Facial tissue augmentation typically used for treatment of extreme facial wrinkles and folds, and also replacement of volume defects, facial lipoatrophy and improvement of facial contour deformities by injection in the facial subcutaneous and supraperiosteal facial layers. HOW SUPPLIED 2.0mL in a prefilled syringe/box with 21G & 23G needles STORAGE CONDITION 2~25℃ free from light, in a hermetic container SHELF LIFE 24 months

* YVOIRE plus products contain 0.3% lidocaine reducing pain during the injection procedure.

COMPOSITION Cross-linked sodium hyaluronate 22mg/mL(2.2%)

COMPOSITION Cross-linked sodium hyaluronate 20mg/mL (2.0%) Lidocaine 0.3%

COMPOSITION Sodium hyaluronate 20mg/mL (2.0%)

STORAGE CONDITION 2~25℃ free from light, in a hermetic container SHELF LIFE 24 months

INDICATION Facial tissue augmentation by injection into areas in which restoration is required. Typically used for treatment of severe facial wrinkles and folds into the deep dermis layer and/or subcutaneous layer, and also for augmentation of lips. The addition of lidocaine provides a pain relieving effect during treatment. HOW SUPPLIED 1.0mL in a prefilled syringe/box with two 27G needles STORAGE CONDITION 2~25℃ free from light, in a hermetic container SHELF LIFE 24 months * YVOIRE plus products contain 0.3% lidocaine reducing pain during the injection procedure.

HA Based Products 014

015

STORAGE CONDITION 2~25℃ free from light, in a hermetic container

* YVOIRE plus products contain 0.3% lidocaine reducing pain during the injection procedure.

YVOIRE hydro®

HOW SUPPLIED 1.0mL in a prefilled syringe/box with two 27G needles

HOW SUPPLIED 1.0mL in a prefilled syringe/box with two 23G Cannula needle

SHELF LIFE 24 months

YVOIRE volume plus

INDICATION Facial tissue augmentation by injection into areas in which restoration is required. Typically used for treatment of severe facial wrinkles and folds into the deep dermis layer and/or subcutaneous layer, and also for augmentation of lips.

INDICATION Facial tissue augmentation typically used for treatment of extreme facial wrinkles and folds, and also replacement of volume defects, facial lipoatrophy and improvement of facial contour deformities by injection in the facial subcutaneous and supraperiosteal facial layers. The addition of lidocaine provides a pain relieving effect during treatment.

SHELF LIFE 24 months

YVOIRE volume s® Ⓡ

INDICATION Temporary relief of wrinkles by injection into the skin layer around the facial wrinkle area HOW SUPPLIED 1.0mL in a prefilled syringe/box with two 30G needles STORAGE CONDITION 2~8℃ SHELF LIFE 24months


Follitrope

IVF-MTM Injection 75,150 IU

Injection 75, 150, 225, 300 IU Fertility Treatments

Recombinant Human Follitropin (FSH) lyophilized powder in vial and liquid formulation in prefilled syringe for injection. COMPOSITION Each vial contains 75 or 150 IU of recombinant follitropin (FSH). Each prefilled syringe contains 75,150, 225 or 300 IU of recombinant follitropin (FSH).

Fertility Treatments

STORAGE CONDITION FollitropeⓇ Inj. vial: Store below 25℃ in hermetic container protected from light. FollitropeⓇ Inj. prefilled syringe: Store between 2-8℃ in hermetic container protected from light. Avoid freezing.

IVF-MTM Injection is a preparation of human

SHELF LIFE 36 months

luteinizing hormone (LH) activity in the ratio of

INDICATION Female: F or stimulation of the development of multiple follicles (superovulation) in women undergoing Assisted Reproductive Techniques (ART), For ovulatory disorder - Ovulation induction

approximately 1.

Male: Hypogonadotropic hypogonadism

menopausal gonadotropin (Menotropin) extracted from the urine of postmenopausal women, which contains follicle stimulating hormone (FSH) and

COMPOSITION Each vial contains 75 or 150 IU of FSH and 75 or 150 IU of LH

INDICATION Controlled ovarian hyperstimulation (COH) to induce the development of multiple follicles in medically assisted reproduction program (e.g. in vitro fertilization/embryo transfer; IVF/ET, gamete intra-fallopian transfer; GIFT, zygote intrafallopian transfer; ZIFT, intracytoplasmic sperm injection; ICSI). Anovulation in clomiphene-resistant anovulatory infertility women (WHO Group II, including polycystic ovarian disease (PCOD)).

ADMINISTRATION Subcutaneous or intramuscular injection

ADMINISTRATION Subcutaneous or intramuscular injection

SHELF LIFE 24 months

HOW SUPPLIED 75 IU/vial X 1 vial/pack (with solvent) 150 IU/vial X 1, 5 vials/pack (with solvent)

HOW SUPPLIED - FollitropeⓇ Inj. vial: 75 IU 1 vial per pack (with its accompanying solvent in vial) 150 IU 1, 5 vials per pack (with its accompanying solvent in vial) - FollitropeⓇ Inj. prefilled syringe: 75, 150, 225, 300 IU 1 prefilled syringe/pack

IVF-M HP

IVF-C

TM

TM

Injection 75 IU

Injection 1000, 5000 IU

Fertility Treatments

IVF-M HPTM Injection is a preparation of highly purified human menopausal gonadotropin (Menotropin HP) extracted from the urine of postmenopausal women, which contains follicle stimulating hormone (FSH) and luteinizing hormone (LH) activity in the ratio of approximately 1.

ADMINISTRATION Subcutaneous injection HOW SUPPLIED 75 IU/vial X 1 vial/pack (with solvent) STORAGE CONDITION Store in the light-resistant place at RT (1~30℃) SHELF LIFE 36 months

Fertility Treatments

IVF-CTM Injection is a preparation of human chorionic gonadotropin (hCG) extracted from the urine of pregnant women.

COMPOSITION Each vial contains 1,000 or 5,000 IU of hCG INDICATION Female: O vulation induction in women undergoing Assisted Reproductive Techniques (ART), Anovulatory infertility, Inadequate luteal phase, Habitual abortion & Threatened abortion Male: Hypogonadotropic hypogonadism

COMPOSITION Each vial contains 75 IU of FSH and 75 IU of LH

ADMINISTRATION Intramuscular injection

INDICATION Female: For stimulation of the development of multiple follicles(superovulation) in women undergoing Assisted Reproductive Techniques (ART), For ovulatory disorder - Ovulation induction

HOW SUPPLIED 1,000 IU/vial X 1 vial/pack (with solvent) 5,000 IU/vial X 1, 3 vials/pack (with solvent) STORAGE CONDITION Store in the light-resistant cool place (below 15℃) SHELF LIFE 24 months

Fertility Treatments 016

017

Fertility Treatments

STORAGE CONDITION Store in the light-resistant place at RT (1~30℃)


Euvax B

Eupenta

TM

TM

Injection

Injection

Hep B Vaccine

Recombinant hepatitis B vaccine Suspension for injection Highly qualified, safe and effective 猬 Prequalified by WHO (first in Korea) & Certified as EU GMP 猬 Major supplier of UN Agencies 猬 Produced by recombinant DNA technology expressed in yeast cell (Saccharomyces cerevisiae) 猬 Free from components of human origin 猬 Over 600 million doses have been used worldwide 猬 Effective protection in all age groups with a variety of vaccination schedules 猬 Preservative free composition

CLASS Monovalent Vaccine

DTwP - Hep B-Hib Vaccine

Adsorbed Diphtheria, Tetanus, whole-cell Pertussis, Hepatitis B (r-DNA) and Hib vaccine Suspension for injection

COMPOSITION Each ml of Euvax BTM Inj. contains Active ingredient: Purified HBsAg (rDNA)

20 ㎍

Adjuvant: Aluminum hydroxide gel (as Al)

0.5 mg

INDICATION Immunization against infection caused by all known subtypes of hepatitis B virus

Effective, safe and convenient 猬 Highly immunogenic and well tolerable to the healthy infants 猬 Improved compliance 猬 Long shelf life 猬 Manufactured under world-class GMP standards

DOSAGE & ADMINISTRATION 0.5 ml (10 ㎍ HBsAg) is administered to neonates, infants and children aged up to 15 years and 1.0 ml (20 ㎍ HBsAg) is administered to adult aged from 16 years, by intramuscular injection Basic immunization schedule: 0-1-6 months Alternate immunization schedule: 0-1-2 months

Diphtheria toxoid

15 Lf

Tetanus toxoid

10 Lf

Inactivated pertussis suspension

≥ 4 IU

Purified HBsAg (r-DNA)

10 ㎍

Purified capsular polysaccharide (PRP) of Hib conjugated to tetanus toxoid

30~50 ㎍ (as PRP 10 ㎍)

DOSAGE & ADMINISTRATION 3 doses (1 dose = 0.5 ml) at 6, 10 and 14 weeks of age, by intramuscular injection The same when hepatitis B vaccine was already administered at birth

STORAGE CONDITION Store at 2~8℃. Do not freeze.

Vaccine

COMPOSITION Each single dose of 0.5 mL contains

INDICATION Active primary immunization against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b disease

STORAGE CONDITION Store at 2~8℃. Do not freeze.

SHELF LIFE 36 months

Euhib

CLASS Monovalent Vaccine

SHELF LIFE 36 months

Euforvac-Hib

TM

TM

Injection

Injection

Haemophilus influenzae type b (Hib) vaccine Lyophilized powder with a diluent in pre-filled syringe for injection

CLASS Monovalent Vaccine

High-tech, effective and safe 猬 The first Hib tetanus toxoid conjugate vaccine to be developed with second-generation conjugate technology in Korea 猬 One of the Korea’s 10 Best New Technologies of 2011 猬 Awarded a prize from Minister of Knowledge Economy 猬 Highly immunogenic and well tolerable to the healthy infants 猬 Preservative free composition

Lyophilized powder:

COMPOSITION Each single dose of 0.5 ml contains - Purified capsular polysaccharide (PRP) of Hib conjugated to tetanus toxoid

30~50 ㎍ (as PRP 10 ㎍)

- Lactose

10.08 ㎎

Diluent: - Sodium chloride

0.9% (w/v)

- Water for injection

q.s.

INDICATION Active immunization of infants and toddlers from the age of 2 months for prevention of invasive disease caused by Haemophilus influenzae type b DOSAGE & ADMINISTRATION 3 doses (1 dose = 0.5 ml) at 2, 4 and 6 months of age and a booster dose of 0.5 ml at 12~15 months of age, by intramuscular injection STORAGE CONDITION Store at 2~8℃. Do not freeze. SHELF LIFE 36 months Vaccine 018

019

DTwP - Hep B / Hib Vaccine

Adsorbed Diphtheria, Tetanus, whole-cell Pertussis, Hepatitis B (r-DNA) and Hib vaccine Suspension and lyophilized powder for injection

CLASS Combined Vaccine

Highly qualified, safe and effective 猬 Prequalified by WHO and supplied to UN Agencies 猬 The first pentavalent vaccine in Korea 猬 Long shelf life 猬 Manufactured under world-class GMP standards 猬 Highly immunogenic and well tolerable to the healthy infants

Active ingredients:

DTwP-HepB vaccine (liquid) DTwP-HepB vaccine contains purified diphtheria toxoid (DT), tetanus toxoid (TT), inactivated whole cell pertussis (wP) and recombinant hepatitis B surface antigen (HBsAg) as active ingredients, absorbed on aluminum salts as an adjuvant and preserved with thimerosal. Hib vaccine (lyophilized powder) Hib vaccine consists of the Haemophilus influenzae type b capsular polysaccharide (polyribosyl-ribitol-phosphate, often called as PRP) covalently bound to tetanus toxoid.

COMPOSITION After reconstitution, each single dose of 0.5 ml contains Diphtheria toxoid

15 Lf

Tetanus toxoid

10 Lf

Inactivated pertussis suspension

≥ 4 IU

Purified HBsAg (r-DNA)

10 ㎍

Purified capsular polysaccharide (PRP) of Hib conjugated to tetanus toxoid

30~50 ㎍ (as PRP 10 ㎍)

INDICATION Active primary immunization against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b disease DOSAGE & ADMINISTRATION 3 doses (1 dose = 0.5 ml) of reconstituted vaccine is recommended at 6, 10 and 14 weeks of age, by intramuscular injection STORAGE CONDITION Store at 2~8℃. Do not freeze. SHELF LIFE 36 months

Vaccine

Hib Vaccine


Factive

Zemiglo / Zemimet SR Tablet

Tablet / Injection

Chemicals

FDA approved respiratory fluoroquinolone antibiotic, gemifloxacin Dual targeting quinolone with broad spectrum Marketed more than 30 countries including US New intravenous formulation has been approved by MFDS COMPOSITION FactiveⓇ Tablet : Each tablet contains gemifloxacin mesylate equivalent to 320 mg of gemifloxacin FactiveⓇ Injection : Each vial contains gemifloxacin mesylate equivalent to 200 mg of gemifloxacin

INDICATION, DOSAGE & ADMINISTRATION Indication : Dose and duration of therapy depending on the type of indications are described in the following Table. The dose of Factive is 320mg (orally) or 200mg (as an intravenous injection) once every 24 hours. Indication

Dose every 24 hours

Duration (days)

Acute bacterial exacerbation of chronic bronchitis

320 mg(oral), 200mg(IV) +

Community-acquired pneumonia

320 mg(oral), 200 mg(IV) + 5*, 7

Chemicals

Zemiglo ®Tablet Ⓡ

Superior DPP-4 inhibition compared to Sitagliptin Highly selective DPP-4 inhibitor No dose adjustment in renal impaired patients

5

Acute bacterial sinusitis

320 mg(oral), 200 mg(IV) + 5

Uncomplicated urinary tract infections

320 mg(oral)

Otitis media

320 mg(oral), 200 mg(IV) + 7+

* Approved in U.S., Mexico and Brazil § Approved in S. Africa and Mexico + Approved in Korea

HOW SUPPLIED FactiveⓇ tablet : white to off-white, oval, film-coated tablet.

COMPOSITION Each tablet contains 68.9 mg gemigliptin tartrate sesquihydrate equivalent to 50 mg of gemigilptin INDICATION 1. As monotherapy or 2. In combination with - metformin as initial therapy in treatment naive patients inadequately controlled by diet and exercise alone. - metformin in patients with inadequate glycemic control with the maximal tolerated dose of metformin alone. - metformin and sulfonylurea in patients with inadequate glycemic control with the maximal tolerated dose of metformin and sulfonylurea dual therapy DOSAGE & ADMINISTRATION The recommended daily dose of ZemigloⓇ is 50mg. ZemigloⓇ can be taken with or without food.

Factive injection : white to light brown-coloured lyophilized powder in a brown-coloured glass vial Ⓡ

HOW SUPPLIED ZemigloⓇ is available as Clear blisters (PVC/PVDC and aluminum). Pack of 28 or 56 film-coated tablets in unit dose blisters.

STORAGE CONDITION Factive tablet : Store at 1~30℃ in tight container, Protect from light Factive injection : Store at 1~30℃, Protect from light

STORAGE CONDITION Store at room temperature (1~30℃) in airtight container

SHELF LIFE FactiveⓇ tablet : 48 months FactiveⓇ injection : 36 months Chemicals

SHELF LIFE 48 months

Zemimet SR®Tablet Ⓡ

Once daily DPP-IV Inhibitor and Metformin SR combination product

INDICATION ZemimetⓇ SR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ZemimetⓇ SR can be administered 1) As initial therapy for treatment naive patients with inadequate glycemic control by diet and exercise alone. 2) In patients with inadequate glycemic control with the maximal tolerated dose of metformin alone. 3) In combination with sulphonylurea in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. 4) In patients already receiving an identical combination of gemigliptin and metformin as separate tablets. Chemicals 020

021

HOW SUPPLIED 50/500 : Zemimet® SR 50/500 mg is oval shaped, orange colored, film-coated tablet 50/1000 : Zemimet® SR 50/1000mg is oblong shaped, brown colored, film-coated tablet Opaque blisters (PVC/PVDC and aluminum). A pack of 28 or 56 film-coated tablets in unit dose blisters. ●

STORAGE CONDITION Store at room temperature (1~30°C ) in airtight container SHELF LIFE 25/500mg : 36months 50/1000mg : 36months 50/500mg : 18 months

Chemicals

COMPOSITION Three-dosage tablets contain active ingredients respectively; 25/500mg : gemigliptin 25mg and metformin 500mg 50/1000mg : gemigliptin 50mg and metformin 1000mg 50/500mg : gemigliptin 50mg and metformin 500mg

DOSAGE & ADMINISTRATION The recommended dose of ZemimetⓇ SR is once daily. ZemimetⓇ SR should be generally administered once daily with a meal in the evening. The maximum recommended daily dose is 50 mg gemigliptin and 2000 mg metformin extended-release.


Rovatitan / LevaCalm Ⓡ

Generics

Tablet Chemicals

Amlovalsa V ®Tablet Ⓡ

Rovatitan ®Tablet Ⓡ

Once daily ARB and Statin FDC drug for simultaneous management of hypertension and dyslipidemia COMPOSITION Six-dosage tablets contain active ingredients respectively; 5/80 mg: rosuvastatin calcium 5 mg and valsartan 80 mg 5/160 mg: rosuvastatin calcium 5 mg and valsartan 160 mg 10/80 mg: rosuvastatin calcium 10 mg and valsartan 80 mg 10/160 mg: rosuvastatin calcium 10 mg and valsartan 160 mg 20/80 mg: rosuvastatin calcium 20 mg and valsartan 80 mg 20/160 mg: rosuvastatin calcium 20 mg and valsartan 160 mg ●

Chemicals

INDICATION ROVATITANⓇ is indicated for the treatment of patients who must administer both rosuvastatin and valsartan. DOSAGE & ADMINISTRATION Once-daily. Dosage must be individualized on the basis of both effectiveness and tolerance of valsartan and rosuvastatin. HOW SUPPLIED 5/80 mg: light-orange colored, circular film-coated tablet 5/160 mg: light-orange colored, oval film-coated tablet 10/80 mg: pink colored, circular film-coated tablet 10/160 mg: pink colored, oval film-coated tablet 20/80 mg: brown colored, circular film-coated tablet 20/160 mg: brown colored, oval film-coated tablet ●

Amlovalsa V is the combination tablet of amlodipine besylate, a calcium channel blocker (CCB), and valsartan, an angiotensin II receptor blocker (ARB). COMPOSITION Three-dosage tablets contain active ingredients respectively; 5/80 mg: amlodipine besylate 5 mg and valsartan 80 mg 5/160 mg: amlodipine besylate 5 mg and valsartan 160 mg 10/160 mg: amlodipine besylate 10 mg and valsartan 160 mg ●

INDICATION Amlovalsa VⓇ is indicated for the treatment of hypertension in patients not adequately controlled on mono-therapy

DOSAGE & ADMINISTRATION Once-daily HOW SUPPLIED 28 tablets in alu-alu foil /box STORAGE CONDITION Store at room temperature (1~30°C) in a tight container SHELF LIFE 36 months OTHER INFORMATION BE study against Exforge has been conducted in Korea

STORAGE CONDITION Store at room temperature (1~30°C) in light-resistant airtight container

Injectable

SHELF LIFE 36 months

Anti-infective

LevaCalm ®Tablet

MOLECULE

BRAND NAME

STRENGTH

Ceftriaxone

Elcefrin inj.

250, 500, 1000, 2000 mg (under registration)

Cefotaxime

Cefatam inj.

250, 500, 1000, 2000 mg (under registration)

Ceftazidime

Tarocef inj.

1000 mg

FORM

Vial

NOTE

Broad spectrum anti-biotic agent (Gram +/- bacteria)

PACK

10V

Once daily fixed-dose combination drug of lercanidipine and valsartan for hypertension

HOW SUPPLIED 10/80 mg: light yellowish brown colored, circular film-coated tablet 10/160 mg: light yellowish brown colored, oval film-coated tablet 20/160 mg: pink colored, oval film-coated tablet

Anti-cancer Agent MOLECULE

BRAND NAME

Docetaxel

LG Docetaxel inj.

20, 80 mg

STORAGE CONDITION Store at room temperature (1~30°C) in airtight container

Oxaliplatin

Eliplatin inj.

50, 100 mg

SHELF LIFE 36 months

Gemcitabine

Elcitabine inj.

200, 1000 mg

STRENGTH

FORM

Chemicals

Vial

INDICATION LevaCalmⓇ is indicated for the treatment of essential hypertensive patient whose blood pressure is not adequately controlled with lercanidipine HCl alone. DOSAGE & ADMINISTRATION Once-daily

Chemicals 022

023

PACK

NSCL, Ovarian, Prostate, Breast, Gastric, Head & Neck cancer

COMPOSITION Three-dosage tablets contain active ingredients respectively; 10/80 mg: lercanidipine hydrochloride 10 mg and valsartan 80 mg 10/160 mg: lercanidipine hydrochloride 10 mg and valsartan 160 mg 20/160 mg: lercanidipine hydrochloride 20 mg and valsartan 160 mg

NOTE

Colorectal, Stomach cancer

1V

NSCL, Ovarian, Bladder, Breast, Pancreatic, Biliary tract cancer

X-Ray Contrast Media MOLECULE

BRAND NAME

STRENGTH

Iopromide

Prosure inj.

623.4 mg/mL 768.86 mg/mL

Iohexol

Hexosure inj.

647 mg/mL 755 mg/mL

Ioversol

Optisure inj.

678 mg/mL 741 mg/mL

FORM

Vial

NOTE

X-ray Contrast Media (50, 100 mL)

PACK

10V


Boostin

Injection Veterinary Medicine

Recombinant bovine growth hormone (somatotropin) liquid formulation in pre-filled syringe for injection

Boostin -S®Injection

Boostin -250®Injection

BOOSTINⓇ-S is a milk production stimulant in a sustained release formulation that contains bovine somatotropin (bST). It was exclusively developed with inhouse technology by LG Life Sciences Ltd. The Korean Ministry of Commerce, Industry and Energy designated BOOSTINⓇ-S as a "world-leading product," and since being launched commercially, it has become the best-selling milk production stimulant in markets outside the US. Healthy cows supplemented with BOOSTINⓇ-S injections will consume 8% more feed while producing some 20% more milk. Administration is easy, as a single injection will remain effective for two weeks.

BOOSTINⓇ-250 is designed for increasing the production of milk in both dairy and beef cows. In the latter case, the greater milk supply will help calves grow faster. Bovine somatotropin (bST) is a protein hormone that consists of 191 amino acids and is produced in and secreted from the pituitary gland of healthy cows. The bST hormone breaks down excess fat in the body and is used as an energy source for synthesizing milk. It promotes the secretion of IGF-1 in the liver and generation of mammary gland cells.

he effects are fast and definite. T Milk production will increase within 2-3 days after the first BOOSTINⓇ-S injection; the amount of increase will average around 20%. he drug is safe. T The milk quality will not be affected in any way; the safety to both humans and dairy cows is internationally recognized. dministration is easy. A The effects of one injection last for two weeks

INDICATION Increase of milk production Improvement of feed efficiency

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION

猬 猬

猬 猬

猬 猬 猬

猬 猬

MANUFACTURING SITES IN KOREA Iksan Plant 129, Seogam-ro, Iksan-si, Jeollabuk-do 54588, Korea Tel: 82-63-830-4777 / Fax: 82-63-830-4204 Osong Plant 151, Osongsaengmyeong 1-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do 28162, Korea Tel: 82-43-710-6003 / Fax: 82-43-710-6009

Vitamin E is included. Each syringe also contains vitamin E, promoting the health of the lactating cow.

INDICATION Increase of milk production Improvement of feed efficiency

RESEARCH & DEVELOPMENT CENTER LG Life Sciences R&D 188, Munji-ro, Yuseong-gu, Daejeon 34122, Korea Tel: 82-42-866-2114 / Fax: 82-42-862-0332

GLOBAL MARKETING SUBSIDIARIES LG Life Sciences India Ltd. LG House, Plot No.11, Sector-44 Gurgaon (Haryana)-122001, India Tel: 91-124-4830000

Target animal : dairy and beef cows in lactation Recommended dosage : 1 syringe (250 mg) every 2 weeks Optimum period for administration : From just after lactation peak throughout late stage Ending Time : 1 month before dry period Administration route : subcutaneous (SC) injection at the ischiorectal fossa or subscapular area in a regular alternating manner(right and left)

HOW SUPPLIED 5 syringes/Box 25 syringes/Box

HOW SUPPLIED 5 syringes/Box 25 syringes/Box

STORAGE CONDITION Store between 2℃ and 8℃ (in a refrigerator). Do not freeze.

STORAGE CONDITION Store between 2℃ and 8℃ (in a refrigerator). Do not freeze.

SHELF LIFE 36 months

SHELF LIFE 24 months

LG Life Sciences (Beijing) Ltd. Room No.1103, West Tower, LG Twin Towers No.B-12 Jianguomenwai Avenue, Chaoyang District Beijing, China Tel: 86-10-6563-2300 / Fax: 86-10-6563-2304 LG Life Sciences (Thailand) Ltd. 19th floor, CRC Tower, All seasons place, 87 wireless Road, Phatumwan Bangkok 10330, Thailand Tel: 66-2-654-2323 LG Life Sciences, MENA Office 403- Al Hijaz Towers 158 Makkah Street P.O. Box 485 Amman 11821 - Jordan Tel: 962-6-554-8708 / Fax: 962-6-554-8737

www,lgls.com Veterinary Medicine 024

HEADQUARTER LG Gwanghwamun Bldg., 58, Saemunan-ro, Jongno-gu, Seoul 03184, Korea overseas@lgls.com

Use is worry-free Such prestigious bodies as the FDA and JECFA have already recognized the safety and effectiveness of bST.

COMPOSITION Each pre-filled syringe contains 250 mg of Recombinant bovine Somatotropin (rBST) with Vitamin E

Target animal : dairy and beef cows in lactation Recommended dosage : 1 syringe (500 mg) every 2 weeks Optimum period for administration : From just after lactation peak throughout late stage Ending Time : 1 month before dry period Administration route : subcutaneous (SC) injection at the ischiorectal fossa or subscapular area in a regular alternating manner(right and left)

Locations

Calves are heavier and more resistant to disease. Mother cows supplemented with BOOSTINⓇ-250 will produce more colostrum upon giving birth, ensuring the baby calf gets plenty of antibodies and nutrition that will aid in the fortification of immune system. In addition, the milk supply is increased and the calf will get a sufficient amount during its first stages of life. Weight gain will improve as a result.

COMPOSITION Each pre-filled syringe contains 500 mg of Recombinant bovine Somatotropin (rBST) with Vitamin E

LG Life Sciences Ltd.

LG Life Sciences Poland Sp.z.o.o ul, Grzybowska 80/82 00-844 Warsaw, Poland Tel: 48-781-111-100 / Fax: 48-781-111-000


LG Gwanghwamun Bldg., 58, Saemunan-ro, Jongno-gu, Seoul 03184, Korea overseas@lgls.com www.lgls.com Printed in Apr. 2016


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