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Q1629_cardisure_flavou.1_9.tp

Dechra Veterinary Products
Limited
(A business unit of Dechra
Pharmaceuticals PLC)
Sansaw Business Park
Hadnall, Shrewsbury
Shropshire SY4 4AS
Tel: 01939 211200
CARDISURE® FLAVOURED 1.25 MG, 2.5 MG, 5
glucose levels should be carefully monitored. As MG AND 10 MG TABLETS FOR DOGS
pimobendan is metabolised in the liver, particularcare should be taken when administering the product Qualitative and quantitative composition Active
to dogs with severe hepatic insufficiency.
Each 1.25 mg tablet contains 1.25 mg pimobendan.
Special precautions to be taken by the person admin- Each 2.5 mg tablet contains 2.5 mg pimobendan.
istering the veterinary medicinal product to ani- Each 5 mg tablet contains 5 mg pimobendan.
In case of accidental ingestion, seek medical Each 10 mg tablet contains 10 mg pimobendan.
advice immediately and show the package leaflet or Excipients: For a full list of excipients, see Excipi- Wash hands after use.
Advice to doctors: Accidental ingestion, especially Pharmaceutical form
by a child, may lead to the occurrence of tachycardia, scored on one side and plain on the other side.
orthostatic hypotension, flushing of the face and The 1.25 mg tablets can be divided into 2 equal The 2.5 mg, 5 mg and 10 mg tablets can be divided tropic effect and vomiting may occur in rare cases.
Clinical particulars
However, these effects are dose-dependent and may be avoided by reducing the dose in these cases. Inrare cases transient diarrhoea, anorexia or lethargy have been observed. Although a relationship with congestive heart failure originating from valvular pimobendan has not been clearly established, in very insufficiency (mitral and/or tricuspid regurgitation) or rare cases, signs of effects on primary haemostasis (petechiae on mucous membranes, subcutaneoushaemorrhages) may be observed during treatment.
These signs disappear when the treatment is with- phic cardiomyopathies or clinical conditions where drawn. In rare cases, an increase in mitral valve an augmentation of cardiac output is not possible for regurgitation has been observed during chronic pi- functional or anatomical reasons (e.g. aortic steno- mobendan treatment in dogs with mitral valve dis- ease. Monitoring of cardiac function and morphology See also Use during pregnancy and lactation.
is recommended in animals treated with pimoben- Special warnings for each target species: The prod- uct should be administered on an empty stomach at Use during pregnancy and lactation: Laboratory least one hour before meals, as absorption is reduced studies in rats and rabbits have not produced any evidence of teratogenic or foetotoxic effects. How- Special precautions for use in animals: The product ever, these studies have shown evidence of materno- is flavoured. To avoid accidental ingestion the tablets toxic and embryotoxic effects at high doses, and have should be stored out of reach of dogs. An in vitro also shown that pimobendan is excreted into milk.
study in rat tissue demonstrated that pimobendan The safety of the product has not been assessed in increased glucose-induced insulin release from pan- pregnant or nursing bitches. Use only according to creatic beta-cells in a dose dependent manner. If the the benefit/risk assessment by the responsible veteri- product is administered to diabetic dogs, blood phodiesterase (type III). It also exhibits a vasodilatory tion between the cardiac glycoside ouabain and action through inhibition of phosphodiesterase III pimobendan was detected. The pimobendan-induced increase in contractility of the heart is attenuated in When used in cases of valvular insufficiency in the presence of the calcium antagonist verapamil and conjunction with furosemide, the product has been shown to improve the quality of life and extend lifeexpectancy in treated dogs. When used in a limited Amounts to be administered and administration number of cases of dilated cardiomyopathy in con- The preferable daily dose is 0.5 mg pimoben- junction with furosemide, enalapril and digoxin the product has been shown to improve the quality of life Do not exceed the recommended dosage.
and to extend life expectancy in treated dogs.
Determine the body weight accurately before treat- ment to ensure correct dosage. The tablets should be Pharmacokinetic properties: Absorption: Following administered orally at a dose range of 0.2 mg to 0.6 oral administration of this veterinary medicinal prod- mg pimobendan/kg body weight per day. The dose uct the absolute bioavailability of the active principle should be divided into two administrations (0.25 mg/ is 60-63%. Since this bio-availability is considerably kg body weight each), one half of the dose in the reduced when pimobendan is administered with food morning and the other half approximately 12 hours or shortly thereafter, it is recommended to treat later. The maintenance dose should be individually animals approximately 1 hour before feeding.
adjusted by the responsible veterinarian according to Distribution: The volume of distribution is 2.6 l/kg, indicating that pimobendan is distributed readily into The product may be combined with a diuretic the tissues. The mean plasma protein binding is 93%.
Metabolism: The compound is oxidatively deme- 1.25 mg tablets: To break a tablet into two halves, thylated to its major active metabolite (UD-CG 212).
place the tablet on an even surface with the scored Further metabolic pathways are phase II conjugates side up, hold one half of the tablet and press down of UD-CG-212, in essence glucuronides and sulpha- 2.5 mg, 5 mg and 10 mg tablets: To break a double Elimination: The plasma elimination half-life of scored tablet into quarters, place the tablet on an even surface with the scored side up and apply The main active metabolite is eliminated with a pressure on the middle with your thumb.
plasma elimination half-life of 1.5 ± 0.2 hours. Almost Each dose should be given approximately one hour the entire dose is eliminated via faeces.
Pharmaceutical particulars
Cellulose (microcrystalline (E460)), cros- No. of tablets per administra-
carmellose sodium, magnesium stearate, natural tion (morning and evening)
Incompatibilities: None known.
product as packaged for sale: 30 months.
Shelf life of divided tablets after first opening the tablet to the opened blister and use within 3 days. Do not store above 30˚C. Keep out of the reach and sight blister: 10 tablets per blister. 2, 5, 10 or 25 blisters percarton.
In the case of overdose, a positive chron- 1.25 mg and 2.5 mg tablets: 10 tablets per blister. 2, otropic effect and vomiting may occur. In this situa- tion, the dosage should be reduced and appropriate 5 mg and 10 mg tablets: 5 tablets per blister. 4, 10, symptomatic treatment should be initiated.
Withdrawal period: Not applicable.
Pharmacological
particulars
or waste materials derived from such veterinary group: Cardiac stimulant (phosphodiesterase inhibi- medicinal products should be disposed of in accor- Marketing authorisation holder (if different from
distributor)
zimidazole-pyridazinone derivative, is a non-sympa- 25, 5531 AE Bladel, The Netherlands.
thomimetic, non-glycoside inotropic substance withpotent vasodilatative properties.
Marketing authorisation number
Pimobendan exerts its stimulatory myocardial ef- fect by a dual mode of action: it increases calcium sensitivity of cardiac myofilaments and inhibits phos- GTIN (Global Trade Item No)
Cardisure Flavoured 1.25 mg Tablets for Dogs 100
authorisation
renewal 09.08.2011
Cardisure Flavoured 2.5 mg Tablets for Dogs 100 Date of revision of the text August 2011
tablets: 08714225153121Cardisure Flavoured 5 mg Tablets for Dogs 100 Any other information
To be supplied only on veterinary prescription.
Cardisure Flavoured 10 mg Tablets for Dogs 100 Legal category POM-V
Requested by: kate.gittins@dechra.com
Approved datasheets found: 1
Creation date: 10/10/2012 14:24:37 (UK)
Approved for book but not on website: 0
Datasheets marked as draft (ignored): 0
Cardisure Flavoured 1.25 mg, 2.5 mg, 5 mg and Directory of participants
Dechra Veterinary Products
Limited
(A business unit of Dechra
Pharmaceuticals PLC)
Sansaw Business Park
Hadnall, Shrewsbury
Shropshire SY4 4AS
Tel: 01939 211200Fax: 01939 211201email: info.uk@dechra.comwww.dechra.com LIST OF PRODUCTS BY THERAPEUTIC INDICATION List of Products by Therapeutic Indication
PHARMACEUTICALS
Cardiovascular and respiratory preparations
Cardisure Flavoured 1.25 mg, 2.5 mg, 5 mg and List of Products by Species
Please note that a species in brackets after a product name may not necessarily be a part of that product namebut is intended to make the index easier to use.
Dogs
Cardisure Flavoured 1.25 mg, 2.5 mg, 5 mg and 10
List of Products by Active Ingredients
This index of non-proprietary names (active ingredients) is provided to enable users of the Compendium toidentify the brand names of relevant products when only the non-proprietary names are known.
It should be noted that although different products may contain the same active ingredient this does not implythat they are equivalent in regard to bioavailability or therapeutic activity.
Some products contain a number of ingredients and it has not been possible in every instance to identify suchproducts by a reference in this index to each ingredient.
Non-proprietary name in bold type. Proprietary name in ordinary type.
Pimobendan
Cardisure Flavoured 1.25 mg, 2.5 mg, 5 mg and 10 GRED
IN
E
IV

Alphabetical Index of Products

Source: http://www.dechra.be/files/dechra/Downloads/Pharma/Datasheets/Cardisure_Flavoured_1_25_mg-10-10-12.pdf

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