Cardisure Pimobendan
Pimobendan
plus added benefits
Cardisure Pimobendan
Pimobendan plus added benefits Cardisure is bioequivalent to the leading brand while also offering added benefits. The flavoured, divisible, blister-packed tablets are available in four strengths and enable accurate and flexible dosing.
Treatment with pimobendan at the onset of clinical signs of congestive heart failure is recommended in guidelines published by the American College of Veterinary Internal Medicine.1
Its dual actions are: •
Positive inotropy (mediated by sensitisation of myocardial fibres to intracellular calcium and by phosphodiesterase III inhibition) for improved contractility without increasing myocardial oxygen demand
•
Vasodilation (mediated by phosphodiesterase III inhibition) for reduced preload and afterload, easing the workload of the failing heart
With the further plus of competitive pricing, why not contact us today and discover how using Cardisure can add up for your practice.
Divisible tablets Divisible tablets
imobendan at the onset of congestive heart failure d in guidelines published College of Veterinary Cardisure’s easily divisible tablets Cardisure’s easily divisible tablets e.1
enable accurate and flexible dosing. enable accurate and flexible dosing.
mediated by erase III inhibition) for ad and afterload, easing of the failing heart
contact us today ur practice.
Flavoured tabletsFlavoured tab
Cardisure tablets have a naturalCardisure meat tablets have a flavouring to encourage acceptance. flavouring to encourage a
Blister packs
Blister packs
Cardisure comes in blister packsCardisure which comes in blister packs which are quick and easy to dispense.are quick and easy to dispense. Each box holds 10 strips of 10 tablets and dividedEach tablets boxcan holds 10 strips of 10 tablets and divided tablets can be used up to three days after first opening the blister be used pack. up to three days after first opening the blister pack.
4 strengths
1.25 mg
1.25 mg
2.5 mg
2.5 mg
4 strengths 5 mg
5 mg
ng for dogs of all sizes. Flexible dosing for dogs of all sizes. 10 mg
10 mg
Dosage Dosage Chart Chart Recommended dosageRecommended based on the dogs dosage body based weight, on the dogs body weight, to be taken twice daily and to beattaken least twice one hour dailybefore and atfeeding. least one hour before feeding.
Body Weight
Daily Body dose at 0.5Weight mg/kg
Daily B.I.D.dose at 0.5 Dose mg/kg
Morning B.I.D. Tablet Dose
5 kg
2.55mg kg
2.5 1.25 mgmg
1.25 mg
10 kg
5 mg 10 kg
52.5 mgmg
2.5 mg
15 kg
7.515 mgkg
7.5 3.75 mgmg
3.75 mg
20 kg
10 20 mgkg
10 5 mg mg
5 mg
25 kg
12.5 25mg kg
12.5 6.25mg mg
6.25 mg
30 kg
15 30 mgkg
15 7.5mg mg
7.5 mg
35 kg
17.5 35mg kg
17.5 8.75mg mg
8.75 mg
40 kg
20 40 mgkg
20 10mg mg
10 mg
50 kg
25 50 mgkg
25 12.5 mgmg
12.5 mg
60 kg
30 60 mgkg
30 15mg mg
15 mg
The dose range is 0.2-0.6 mg/kg Thebody doseweight rangeper is 0.2-0.6 day with mg/kg the preferable body weight per day with the preferable 1.25two mg doses. 2.5 mg dose being 0.5 mg/kg body weight doseper being day0.5 divided mg/kg into body twoweight doses.per day divided into
Evening Morning TabletTablet
E T
5 mg 1.25 mg10 mg 2.5 mg
5
sure Cardisure
dan Pimobendan
CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS
CINAL PRODUCT 1. NAME OF THE VETERINARY MEDICINAL PRODUCT blets for dogs. Cardisure Flavoured 1.25 / 2.5 / 5 / 10 mg tablets for dogs.
COMPOSITION
mobendan.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Pimobendan Each tablet contains 1.25 / 2.5 / 5 / 10 mg pimobendan. Excipients: For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM Tablet and plain on the other Light sidebrown round tablets, scored on one side and plain on the other side al parts. The 1.25 mg tablets can be divided into 2 equal parts. o 4 equal parts. The 2.5 / 5 / 10 mg tablets can be divided into 4 equal parts. 4.
CLINICAL PARTICULARS
4.1 Target species Dogs.
5. PHARMACOLOGICAL PROPERTIES 5. PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: Cardiac stimulant (phosphodiesterasePharmacotherapeutic inhibitor) group: Cardiac stimulant (phosphodiesterase inhibitor) ATCvet code: QC01CE90 ATCvet code: QC01CE90 5.1 Pharmacodynamic properties 5.1 Pharmacodynamic properties Pimobendan, a benzimidazole-pyridazinone derivative, is a non-sympathomimetic, Pimobendan, a benzimidazole-pyridazinone non-glycoside inotropic substance derivative, with is apotent non-sympathomimetic, non-glycoside inotropic substance with potent vasodilatative properties. vasodilatative properties. Pimobendan exerts its stimulatory myocardial effect by a dual mode Pimobendan of action: itexerts increases its stimulatory calcium sensitivity myocardial of cardiac effect bymyofilaments a dual modeand of action: it increases calcium sensitivity of cardiac myofilaments and inhibits phosphodiesterase (type III). It also exhibits a vasodilatoryinhibits action phosphodiesterase through inhibition of(type phosphodiesterase III). It also exhibits III activity. a vasodilatory action through inhibition of phosphodiesterase III activity. When used in cases of valvular insufficiency in conjunction with furosemide, When usedthe in cases product of valvular has beeninsufficiency shown to improve in conjunction the quality withoffurosemide, life and the product has been shown to improve the quality of life and extend life expectancy in treated dogs. extend life expectancy in treated dogs. When used in a limited number of cases of dilated cardiomyopathyWhen in conjunction used in a limited with furosemide, number ofenalapril cases of dilated and digoxin cardiomyopathy the productinhasconjunction with furosemide, enalapril and digoxin the product has been shown to improve the quality of life and to extend life expectancy been shown in treated to improve dogs. the quality of life and to extend life expectancy in treated dogs. 5.2 Pharmacokinetic particulars 5.2 Pharmacokinetic particulars Absorption: Absorption: Following oral administration of this veterinary medicinal product Following the absolute oralbio-availability administrationofofthe thisactive veterinary principle medicinal is 60 - product 63%. Since the absolute bio-availability of the active principle is 60 - 63%. Since this bio-availability is considerably reduced when pimobendan is administered this bio-availability with food is considerably or shortly thereafter, reduced when it is recommended pimobendan istoadministered treat with food or shortly thereafter, it is recommended to treat animals approximately 1 hour before feeding. animals approximately 1 hour before feeding.
Distribution Distribution e target species 4.2 Indications for use, specifying the target species The volume of distribution is 2.6 l/kg, indicating that pimobendanThe is distributed volume ofreadily distribution into the is 2.6 tissues. l/kg,The indicating mean plasma that pimobendan protein binding is distributed readily into the tissues. The mean plasma protein binding ailure originating from Forvalvular the treatment insufficiency of canine (mitral congestive and/or heart tricuspid failure regurgitation) originating orfrom dilated valvular insufficiency is 93%.(mitral and/or tricuspid regurgitation) or dilated is 93%. cardiomyopathy. Metabolism Metabolism 4.3 Contraindications The compound is oxidatively demethylated to its major active metabolite The compound (UD-CG is212). oxidatively Furtherdemethylated metabolic pathways to its major are phase activeIImetabolite conjugates(UD-CG 212). Further metabolic pathways are phase II conjugates opathies or clinical conditions Do not usewhere in cases an augmentation of hypertrophicofcardiomyopathies cardiac output is not or clinical possibleconditions for where anof augmentation cardiacglucuronides output is notand possible for UD-CG-212, inofessence sulphates. of UD-CG-212, in essence glucuronides and sulphates. tenosis). functional or anatomical reasons (e.g. aortic stenosis). Elimination Elimination See also section 4.7. The plasma elimination half-life of pimobendan is 1.1 ± 0.7 hours.The plasma elimination half-life of pimobendan is 1.1 ± 0.7 hours. 4.4 Special warnings The main active metabolite is eliminated with a plasma eliminationThehalf-life main active of 1.5metabolite ± 0.2 hours.is eliminated Almost thewith entirea plasma dose is eliminated eliminationvia half-life of 1.5 ± 0.2 hours. Almost the entire dose is eliminated via mpty stomach at leastThe oneproduct hour before should meals, be administered as absorptiononisanreduced emptywhen stomach given at least with feed. one hour beforefaeces. meals, as absorption is reduced when given with feed. faeces. 4.5 Special precautions for use 6. PHARMACEUTICAL PARTICULARS 6. PHARMACEUTICAL PARTICULARS (i) Special precautions for use in animals 6.1 List of excipients 6.1 List of excipients ngestion the tablets should The product be stored is flavoured. out of reach To avoid of dogs. accidental An in vitro ingestion study the in rattablets tissueshould be stored out of reachmicrocrystalline of dogs. An in (E460) vitro study in rat tissue Cellulose, Cellulose, microcrystalline (E460) cose-induced insulindemonstrated release from pancreatic that pimobendan ß-cells inincreased a dose dependent glucose-induced manner.insulin If therelease from pancreatic ß-cells sodium in a dose dependent manner. If the Croscarmellose Croscarmellose sodium d glucose levels should product be carefully is administered monitored. to diabetic As pimobendan dogs, blood is metabolised glucose levels in the should liver,be carefully monitored. As pimobendan is metabolised in the liver, Magnesium stearate Magnesium stearate tering the product toparticular dogs withcare severe should hepatic be taken insufficiency. when administering the product to dogs with severeNatural hepaticmeat insufficiency. flavour Natural meat flavour son administering the(ii)veterinary Special precautions medicinal product to be taken to animals by the person administering the veterinary medicinal to animals 6.2 product Incompatibilities 6.2 Incompatibilities Noneleaflet known.or the label to the physician. None known. dvice immediately and In case showofthe accidental packageingestion, leaflet or seek the label medical to the advice physician. immediately and show the package Wash hands after use. 6.3 Shelf life 6.3 Shelf life ally by a child, may lead Advice to the to doctors: occurrence accidental of tachycardia, ingestion,orthostatic especiallyhypotension, by a child, may flushing lead toofthe occurrence orthostatic hypotension, of for sale :Shelf Shelf of lifetachycardia, of the veterinary medicinal product asflushing packaged 30 months. life of the veterinary medicinal product as packaged for sale : 30 months. the face and headaches. Shelf life of divided tablets after first opening the blister: 3 daysShelf life of divided tablets after first opening the blister: 3 days d seriousness) 4.6 Adverse reactions (frequency and seriousness) 6.4. Special precautions for storage 6.4. Special precautions for storage omiting may occur inArare moderate cases. positive However,chronotropic these effectseffect are dose-dependent and vomiting mayandoccur mayin rare cases. However, effects are dose-dependent mayand use within 3 days. Returnthese any divided tablet to the openedand blister Return any divided tablet to the opened blister and use within 3 days. s. In rare cases transient be avoided diarrhoea, by reducing anorexia or thelethargy dose in have thesebeen cases.observed. In rare cases Although transient a diarrhoea, anorexia or lethargy have been observed. Although a Do not store above 30°C Do not store above 30°C learly established, inrelationship very rare cases, withsigns pimobendan of effectshas on primary not beenhaemostasis clearly established, (petechiae in very rare cases, signs of effects on primary haemostasis (petechiae 6.5 Nature anddisappear composition orrhages) may be observed on mucous during membranes, treatment.subcutaneous These signs disappear haemorrhages) when the may treatment be observed is during treatment. These signs whenof theimmediate treatment ispackaging 6.5 Nature and composition of immediate packaging – PVC/PE/PVDC blister: Aluminium – PVC/PE/PVDC blister: valve regurgitation has withdrawn. been observed In rare during cases, an chronic increase pimobendan in mitral valve treatment regurgitation in dogs has withbeen observedAluminium during chronic pimobendan treatment in dogs with 10 tablets per blister: 5, 10 or 25 blisters per carton. 10 tablets per blister: 2, 5, 10 or 25 blisters per carton. ction and morphology mitral is recommended valve disease. inMonitoring animals treated of cardiac withfunction pimobendan. and morphology is recommended in animals treated 2,with pimobendan.
Aluminium – Aluminium blister: Aluminium – Aluminium blister: or lay 4.7 Use during pregnancy, lactation or lay per blister: 5, 10 or 25 blisters perhave carton. 10 tablets per blister: 2, 5, 10 or 25 blisters per carton. t produced any evidence Laboratory of teratogenic studies or in foetotoxic rats and rabbits effects.have However, not produced these studies any evidence have of teratogenic10ortablets foetotoxic effects.2,However, these studies toxic effects at high doses, shownand evidence have also of maternotoxic shown that pimobendan and embryotoxic is excreted effectsinto at high milk.doses, and have also shown that pimobendan is excreted into milk. presentations be marketed. Not all presentations may be marketed. ed in pregnant or nursing The safety bitches. of the Useproduct only according has nottobeen the assessed benefit/risk in pregnant assessment or nursing by the bitches. UseNot onlyallaccording to themay benefit/risk assessment by the responsible veterinarian. 6.6 Special precautions for the disposal of unused veterinary 6.6 Special medicinal precautions product or forwaste the disposal of unused veterinary medicinal product or waste materials derived from the use of such products materials derived from the use of such products l products and other 4.8forms Interaction of interaction with other medicinal products and other forms of interaction ween the cardiac glycoside In pharmacological ouabain and studies pimobendan no interaction was detected. between The the pimobendan-induced cardiac glycoside ouabain and was detected. Theproduct pimobendan-induced Anypimobendan unused veterinary medicinal or waste materials derived Anyfrom unused suchveterinary veterinarymedicinal medicinalproduct productsorshould waste materials be disposed derived of in from such veterinary medicinal products should be disposed of in ted in the presence ofincrease the calcium in contractility antagonistofverapamil the heart and is attenuated the β-antagonist in the presence propranolol. of the calcium antagonist verapamil andrequirements. the β-antagonist propranolol. accordance with local accordance with local requirements. dministration route 4.9 Amounts to be administered and administration route 7. MARKETING AUTHORISATION HOLDER 7. MARKETING AUTHORISATION HOLDER an/kg body weight. The preferable daily dose is 0.5 mg pimobendan/kg body weight. Eurovet Animal Health BV Eurovet Animal Health BV Do not exceed the recommended dosage. Handelsweg 25, 5531 AE Bladel, The Netherlands Handelsweg 25, 5531 AE Bladel, The Netherlands reatment to ensure correct Determine dosage. the bodyweight accurately before treatment to ensure correct dosage. Tel: + 31 497 544300, Fax: + 31 497 544302 Tel: + 31 497 544300, Fax: + 31 497 544302 dose range of 0.2 mgTheto tablets 0.6 mgshould pimobendan/kg be administered body weight orally atpera dose day. The range dose of should 0.2 mgbe to 0.6 mg pimobendan/kg body weight per day. The doseNUMBER(S) should be 8. MARKETING AUTHORISATION 8. MARKETING AUTHORISATION NUMBER(S) body weight each),divided one halfinto of the twodose administrations in the morning (0.25 andmg/kg the other bodyhalf weight approximately each), one12half of the dose in the1.25 morning and the half approximately 12 Cardisure mg tablet Vmother 16849/4026 Cardisure 1.25 mg tablet Vm 16849/4026 ndividually adjusted hours by thelater. responsible The maintenance veterinarian dose according should be to the individually severity ofadjusted the disease. by the responsible veterinarian according to the severity of the disease. Cardisure 2.5 mg tablet Vm 16849/4027 Cardisure 2.5 mg tablet Vm 16849/4027 Cardisure 5 mg tablet Vm 16849/4028 Cardisure 5 mg tablet Vm 16849/4028 treatment e.g. furosemide. The product may be combined with a diuretic treatment e.g. furosemide. Cardisure 10 mg tablet Vm 16849/4029 Cardisure 10 mg tablet Vm 16849/4029 blet on an even surface To break with the a tablet scoredinto sidetwo up,halves, hold one place halftheof tablet the tablet on anand even press surface downwith on the scored side up, hold one half of the tablet and press down on into quarters, place the tablet other half. on anToeven breaksurface a double withscored the scored tabletside into up quarters, and apply placepressure the tablet on an even the scored side up and apply pressure OF THE AUTHORISATION 9. surface DATEwith OF FIRST AUTHORISATION/RENEWAL 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION ould be given approximately on the middle one hour withbefore your thumb. feeding.Each dose should be given approximately one hour9before Augustfeeding. 2011 9 August 2011 y procedures, antidotes), 4.10 Overdose if necessary (symptoms, emergency procedures, antidotes), if necessary 10 DATE OF REVISION OF THE TEXT 10 DATE OF REVISION OF THE TEXT c effect and vomitingInmay the occur. case ofInoverdose, this situation, a positive the dosage chronotropic shouldeffect be reduced and vomiting and may occur. In this situation, August 2011 the dosage should be reduced and August 2011 e initiated. appropriate symptomatic treatment should be initiated. 4.11 Withdrawal period(s) Not applicable.
Cardisure is a UK: POM-V IE: POM Cardisure is a UK: POM-V IE: POM Use medicines responsibly: www.noah.co.uk/responsible Use medicines responsibly: www.noah.co.uk/responsible
nsus statement:1Atkins guidelines et al (2009) for theACVIM diagnosis consensus and treatment statement: of chronic guidelines valvular for the heart diagnosis disease.and Journal treatment of Veterinary of chronic Internal valvular Medicine heart disease. 23: 1142-1150 Journal of Veterinary Internal Medicine 23: 1142-1150
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