A clear, colourless solution for injection. Each ml contains 0.75 mg pimobendan.

Target species: Dog.

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

For single intravenous use.

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

The recommended dosage is 0.15 mg pimobendan/kg body weight (i.e. 2 ml/10 kg body weight).

A 5 ml and a 10 ml vial can treat up to a 25 kg and 50 kg body weight dog, respectively.

Each vial is for single use only.

Vetmedin chewable tablets or Vetmedin capsules for dogs may be used for continuation of treatment at the recommended dosage, to be started 12 hours after administration of the injection.

In the case of overdose symptomatic treatment should be initiated.

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

Do not use 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).

None.

In case of accidental subcutaneous injection temporary swelling and mild to slight resorptive inflammatory reactions can occur at or below the injection site.

For single administration only.

The veterinary medicinal product should be used for the initiation of treatment of congestive heart failure in dogs, following a risk:benefit assessment by the responsible veterinarian, taking into account the overall health status of the dog. Before treatment, diagnosis should be made by the means of a comprehensive physical and cardiac examination which should include echocardiography or radiography where appropriate.

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

Wash hands after use.

Not applicable.

Not applicable.

Dogs:

Rare

(1 to 10 animals / 10,000 animals treated):

- Vomiting, diarrhoea1

- Anorexia1, lethargy1

- Increased heart rate2

1 Transient

2 Due to a moderate chronotropic effect

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.

Embryotoxic effects only occurred at maternotoxic doses. In rat experiments it has been shown that pimobendan is excreted into milk. Therefore, the veterinary medicinal product should only be administered to pregnant and lactating bitches if the expected therapeutic benefits outweigh the potential risk.

In studies with rats and rabbits pimobendan had no effect on fertility.

In pharmacological studies no interaction between the cardiac glycoside ouabain and pimobendan was detected. The pimobendan-induced increase in contractility of the heart is attenuated in the presence of the calcium antagonist verapamil and the ß-antagonist propranolol.

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf life after first opening the immediate packaging: use immediately.

This veterinary medicinal product does not require any special storage conditions.

This veterinary medicinal product does not contain an antimicrobial preservative. This veterinary medicinal product is intended for single use only. Any veterinary medicinal product remaining in the bottle after withdrawal of the required dose should be discarded.

Keep out of the sight and reach of children. For animal treatment only.

To be supplied only on veterinary prescription.

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

Medicines should not be disposed of via wastewater. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Single-use 5 ml or 10 ml colourless injection Type 1 glass vial with a FluroTec coated butyl rubber stopper and sealed with an aluminium cap, packed singly in a cardboard box. Not all pack sizes may be marketed.

Pimobendan, a benzimidazole-pyridazinone derivative, is a non-sympathomimetic, non-glycoside inotropic substance with potent vasodilatative properties. Pimobendan exerts its stimulatory myocardial effect by a dual mechanism of action: increase in calcium sensitivity of cardiac myofilaments and inhibition of phosphodiesterase (type III). It also exhibits a vasodilating action through an inhibitory action on phosphodiesterase III activity.

Absorption: Due to the intravenous administration, the bioavailability is 100 %.

Distribution: After intravenous administration 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 oxidatively demethylated to its major active metabolite (UD-CG 212). Further metabolic pathways are phase II conjugates of UD-CG 212, in essence glucuronides and sulfates.

Elimination: Following intravenous administration, the plasma elimination half-life of pimobendan is 0.4 + 0.1 hours, consistent with the high clearance of 90 + 19 ml/min/kg and a short mean residence time of 0.5 + 0.1 hours. The main active metabolite is eliminated with plasma elimination half-life of 2.0 ± 0.3 hours. Almost the entire dose is eliminated via faeces.