Vetmedin Chew 2.5 mg Chewable Tablets for Dogs

Composition

Each chewable tablet contains:

Active substance:

Pimobendan: 2.5 mg

Excipients:

For the full list of excipients, see section 6.1.

6.1 List of excipients

Lactose monohydrate

Microcrystalline cellulose

Starch, Pregelatinised

Sodium starch glycolate (Type A)

Macrogol 6000

Stearoyl macrogolglycerides

Dried yeast

Liver powder flavour

Talc

Magnesium stearate

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Pharmaceutical form

Brownish, oval, divisible tablet, scored on both sides.

The chewable tablet can be divided into two equal parts.

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Pharmacological properties

Pharmacotherapeutic group: Cardiac stimulants excl. cardiac glycosides, phosphodiesterase inhibitors

ATCvet code: QC01CE90

5.1 Pharmacodynamic properties

Pimobendan, a benzimadazole-pyridazinone derivative has a positively inotropic action and possesses pronounced vasodilator properties.

The positive inotropic effect of pimobendan is mediated by a dual mechanism of action: increase in calcium sensitivity of cardiac myofilaments and inhibition of phosphodiesterase III. Thus the positive inotropism is triggered neither by an action similar to that of the cardiac glycosides nor sympathomimetically. The vasodilator effect arises from inhibition of phosphodiesterase III.

When used in cases of symptomatic valvular insufficiency in conjunction with furosemide the veterinary medicinal 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 symptomatic dilated cardiomyopathy in conjunction with furosemide, enalapril and digoxin, the veterinary medicinal product has been shown to improve the quality of life and to extend life expectancy in treated dogs.

In a randomized and placebo controlled study in 363 dogs with preclinical myxomatous mitral valve disease, all dogs met the following inclusion criteria: age ≥ 6 years, bodyweight ≥ 4.1 and ≤ 15 kg, characteristic systolic heart murmur of moderate to high intensity (≥ grade 3/6) with maximal intensity over the mitral area; echocardiographic evidence of advanced myxomatous mitral valve disease (MMVD) defined as characteristic valvular lesions of the mitral valve apparatus, echocardiographic evidence of left atrial and left ventricular dilatation and radiographic evidence of cardiomegaly (vertebral heart sum (VHS) > 10.5. The median time to onset of clinical signs of heart failure or cardiac death/euthanasia was extended in these dogs by approximately 15 months. Additionally, there was a reduction in the heart size of dogs treated with pimobendan in the preclinical stage of myxomatous mitral valve disease. Furthermore, overall survival time was prolonged by approximately 170 days in all dogs receiving pimobendan independent of their cause of death (cardiac death/ euthanasia and non-cardiac death/euthanasia). Cardiac related death or euthanasia occurred in 15 dogs in the pimobendan group and 12 dogs in the placebo group prior to the onset of CHF. Dogs in the pimobendan group spent a longer time in the study (347.4 patient years) than those in the placebo group (267.7 patient years) resulting in a lower rate of occurrence.

In a randomized and placebo controlled study including Doberman Pinschers with preclinical dilated cardiomyopathy (asymptomatic with an increase in left ventricular end-systolic and end-diastolic diameter following echocardiographic diagnosis), the time to onset of congestive heart failure or sudden death was extended and survival time was prolonged among dogs administered pimobendan.

Additionally, there was a reduction in the heart size of dogs treated with pimobendan in the preclinical stage of dilated cardiomyopathy. Efficacy evaluation is based on data from 19 (of 39) and 25 (of 37) dogs that reached the primary efficacy endpoint in the pimobendan and the placebo group, respectively.

5.2 Pharmacokinetic particulars

Absorption:

After oral administration of this veterinary medicinal product the absolute bioavailability of its active substance is 60 - 63%. Since simultaneous or previous food intake reduces the bioavailability, pimobendan should be administered about 1 hour before feeding.

Distribution:

The volume of distribution is 2.6 l/kg, indicating that pimobendan is distributed readily into the tissues. The mean plasma protein binding is 93%.

Metabolism:

The compound is demethylated by oxidation to the major active metabolite (UD-CG212). Further metabolic steps are phase II conjugates of UD-CG212, such as glucuronides and sulphates.

Elimination:

The plasma elimination half-life of pimobendan is 0.4 ± 0.1 hours, which corresponds to the high clearance of 90 ± 19 ml/min/kg and the short mean residence of 0.5 ± 0.1 hours.

The most significant active metabolite is eliminated with a plasma elimination half-life of 2.0 ± 0.3 hours. Almost the entire dose is eliminated in the faeces.

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Target species

Dogs.

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Indications

For the treatment of canine congestive heart failure originating from dilated cardiomyopathy or valvular insufficiency (mitral and/or tricuspid valve regurgitation).

For the treatment of dilated cardiomyopathy in the preclinical stage (asymptomatic with an increase in left ventricular end-systolic and end-diastolic diameter) in Doberman Pinschers following echocardiographic diagnosis of cardiac disease.

For the treatment of dogs with myxomatous mitral valve disease (MMVD) in the preclinical stage (asymptomatic with a systolic mitral murmur and evidence of increased heart size) to delay the onset of clinical symptoms of heart failure.

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Dosage

Oral use.

To ensure a correct dosage, body weight should be determined as accurately as possible.

A dosage range of 0.2 mg to 0.6 mg pimobendan/kg body weight, divided into two daily doses, should be respected.

The preferable daily dose is 0.5 mg pimobendan/kg body weight, divided into two daily doses (0.25 mg/kg bodyweight each) approximately 12 hours apart.

For a body weight of 10 kg, this corresponds to one 2.5 mg chewable tablet in the morning and one 2.5 mg chewable tablet in the evening.

Do not exceed the recommended dosage.

Administration of pimobendan should take place approximately one hour before feeding.

Pimobendan may also be used in combination with a diuretic, e.g. furosemide or torasemide.

To allow accurate dosing according to body weight, the chewable tablet can be halved along the designated score line.

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Contraindications

Do not use pimobendan in hypertrophic cardiomyopathies or in diseases in which an improvement in cardiac output cannot be achieved for functional or anatomical reasons (e.g. aortic stenosis).

Since pimobendan is metabolised mainly via the liver, it should not be used in dogs with severe impairment of liver function.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

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Adverse reactions

Dogs:

Rare (1 to 10 animals / 10,000 animals treated): Vomiting1, diarrhoea2; Anorexia2, lethargy2; Increased heart rate1,3, increase in mitral valve regurgitation4

Very rare (< 1 animal / 10,000 animals treated, including isolated reports): Mucosa petechiae5, haemorrhage5 (subcutaneous)

1 These effects are dose-dependent and can be avoided by reducing the dose.

2 Transient

3 Due to a slight positively chronotropic effect.

4 Observed during chronic pimobendan treatment in dogs with mitral valve disease.

5 A relationship with pimobendan has not been clearly established, signs disappear when the treatment is withdrawn.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for use in animals:

The blood glucose should be tested regularly during treatment in dogs with existing diabetes mellitus.

For use in the preclinical stage of dilated cardiomyopathy (asymptomatic with an increase in left ventricular end-systolic and end-diastolic diameter), a diagnosis should be made by means of a comprehensive cardiac examination (incl. echocardiographic examination and possibly Holter monitoring).

For use in the preclinical stage of myxomatous mitral valve disease (stage B2, according to ACVIM consensus: asymptomatic with mitral murmur ≥ 3/6 and cardiomegaly due to myxomatous mitral valve disease), a diagnosis should be made by means of a comprehensive physical and cardiac examination which should include echocardiography or radiography where appropriate.

Monitoring of cardiac function and morphology is recommended in animals treated with pimobendan.

The chewable tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of animals.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

Wash hands after use.

To avoid accidental ingestion of the veterinary medicinal product by a child, divided or unused tablets should be returned to the open blister pocket and placed back in the cardboard box.

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

Advice to doctors: accidental ingestion, especially by a child, may lead to the occurrence of tachycardia, orthostatic hypotension, flushing of the face and headaches.

Special precautions for the protection of the environment:

Not applicable.

Other precautions:

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy and lactation:

Laboratory studies in rats and rabbits have not produced any evidence of teratogenic or foetotoxic effects. However, these studies have shown evidence of maternotoxic and embryotoxic effects at high doses, and have also shown that pimobendan is excreted into milk. The safety of the veterinary medicinal product has not been established during pregnancy and lactation in bitches. Use only according to the benefitrisk assessment by the responsible veterinarian.

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Interactions

In pharmacological studies no interaction between the cardiac glycoside ouabain (strophanthin) and pimobendan was observed. The pimobendan-induced increase in cardiac contractility is attenuated by the calcium antagonists verapamil and diltiazem and by the β-antagonist propranolol.

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Overdose

An overdose may cause a positive chronotropic effect, vomiting, apathy, ataxia, heart murmurs or hypotension. In this situation, the dosage should be reduced and appropriate symptomatic treatment should be initiated.

In prolonged exposure (6 months) of healthy beagle dogs at 3 and 5 times the recommended dose, mitral valve thickening and left ventricular hypertrophy were observed in some dogs. These changes are of pharmacodynamic origin.

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Special warnings

The veterinary medicinal product has not been tested in cases of asymptomatic DCM in Dobermans with atrial fibrillation or sustained ventricular tachycardia. The veterinary medicinal product has not been tested in cases of asymptomatic myxomatous mitral valve disease in dogs with significant supraventricular and/or ventricular tachyarrhythmia.

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Withdrawal period

Not applicable.

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Immediate packaging

Heat sealed Aluminium// PVC/ Aluminium/ Polyamide blister containing 10 tablets.

Cardboard box with 2 blisters of 10 tablets (20 tablets)

Cardboard box with 5 blisters of 10 tablets (50 tablets)

Cardboard box with 10 blisters of 10 tablets (100 tablets)

Not all pack sizes may be marketed.

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Storage

Do not store above 25°C.

Divided tablets should be returned to the open blister pocket and placed back in the cardboard box.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life of the divided (halved) tablets: 3 days.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

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Additional information

Vm 08327/5032

9 DATE OF FIRST AUTHORISATION

08 April 2015

10 DATE OF REVISION OF THE TEXT

March 2024

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

11 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ or ‘PID’ on www.gov.uk.

Gavin Hall Approved: 30 October 2024

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Registration holder

Boehringer Ingelheim Animal Health UK Limited

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

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