Introduction

Company name: Boehringer Ingelheim Limited

Address: Ellesfield Avenue

Bracknell

Berkshire RG12 8YS

Telephone: Sales & Marketing Enquiries 01344 746959

Telephone: Technical Enquiries 01344 746957

Fax: 01344 741349

Presentation

Vetmedin Flavour Tablets, containing 1.25 mg or 5 mg pimobendan per tablet.

Uses

For the treatment of canine congestive heart failure originating from dilated cardiomyopathy or valvular insufficiency (mitral and/or tricuspid regurgitation). When used in cases of valvular insufficiency in conjunction with frusemide the product has been shown to improve the quality of life and extend life expectancy in treated dogs. When used in a limited number of cases of dilated cardiomyopathy in conjunction with frusemide, enalapril and digoxin, the product has been shown to improve the quality of life and to extend life expectancy in treated dogs.

Dosage and administration

See dosing table below.

Vetmedin 1.25 mg and 5 mg Tablets Dosage Guide
Bodyweight	Daily Dosage	Morning			Evening
(kg)	(mg)	1.25 mg	5.0 mg	5.0 mg	1.25 mg	5.0 mg	5.0 mg
< 5	1.25	½	-	-	½
5 - 10	2.5	1	-	-	1	-	-
11 – 20	5	-	½	-	-	½	-
21 – 40	10	-	-	1	-	-	1
41 – 60	20	-	-	2	-	-	2
> 60	30	-	-	3	-	-	3

Vetmedin Flavour Tablets should be administered orally at a dose of 0.2 mg to 0.6 mg pimobendan/kg body weight per day. The preferable daily dose is 0.5 mg pimobendan/kg bodyweight. The daily dose should be divided into two equal administrations, one half of the dose given in the morning and the other half approximately 12 hours later. Each dose should be given approximately one hour before feeding. The tablet is flavoured and may be given as a treat. The large size of 5 mg can be readily divided into two halves, using the scored line on the tablet to give a dose that contains 2.5 mg. Do not exceed the recommended dosage.

Determine the bodyweight accurately before prescribing to ensure administration of the correct dosage.

Vetmedin Flavour Tablets may be combined with a diuretic treatment such as frusemide.

Contra-indications, warnings, etc

Vetmedin Tablets should not be used in cases of hypertrophic cardiomyopathies or clinical conditions where an augmentation of cardiac output is not possible for functional or anatomical reasons (e.g. aortic stenosis). The product should only be used in dogs with cardiac insufficiency.

A moderate positive chronotropic effect and vomiting may occur in rare cases. However, these cases are dose-dependent and may be avoided by reducing the dose.

In studies with rats and rabbits, pimobendan had no effect on fertility and embryotoxic effects occurred only at maternotoxic doses. In experiments with rats it has been shown that pimobendan is excreted into milk. No information is available on the safety of Vetmedin in pregnant and lactating bitches.

The pimobendan-induced increase in contractility of the heart is attenuated in the presence of the calcium antagonist verapamil and the β-antagonist propranolol. In pharmacological studies no interaction between the cardiac glycoside ouabain and pimobendan was detected. Do not exceed the recommended dosage.

In the case of overdose, symptomatic treatment should be initiated.

Dispose of used packaging in the household refuse. Unused product should be returned to the Veterinary Surgeon.

For animal treatment only.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Pharmaceutical precautions

Keep the container tightly closed.

Keep out of reach and sight of children.

Legal category

POM-V

Packaging Quantities

50 tablets of 1.25mg or 5 mg tablets packed in white child-resistant polypropylene bottles.

Further information

Pimobendan, a benzimidazole-pyridazinone derivative, is a non-sympathomimetic, non-glycoside inotropic substance with potent vasodilatative properties. It increases calcium sensitivity of cardiac myofilaments and inhibits phosphodiesterase (type III). It also exhibits a vasodilatory action through inhibition of phosphodiesterase III activity.

As the bioavailability of pimobendan is considerably reduced when administered with or shortly after food, it is recommended that animals are treated approximately 1 hour before feeding.

Marketing authorisation number

Vm 00015/4077 Vetmedin 1.25mg Flavour Tablets.

Vm 00015/4076 Vetmedin 5 mg Flavour Tablets.