Cerenia 10 mg/ml Solution for Injection for dogs

Introduction

Company name: Pfizer Limited

Address: Ramsgate Road

Sandwich

Kent CT13 9NJ

Telephone: 0845 300 8034 (Out of hours: 01304 616161)

Fax: 01737 332521

Email: UKVetLine@pfizer.com

Website: www.only4vets.co.uk

Presentation

Cerenia Solution for Injection contains 10 mg maropitant per ml as maropitant citrate monohydrate as a clear, colourless to light yellow solution and metacresol as preservative.

Uses

Cerenia Solution for Injection is indicated for the following:

For the prevention of vomiting except that induced by motion sickness.

For the treatment of vomiting, in combination with other supportive measures.

Dosage and administration

For subcutaneous use in dogs.

Cerenia Solution for Injection should be injected subcutaneously once daily at a dose of 1 mg/kg bodyweight (1 ml/10 kg bodyweight). Treatment may be repeated for up to five consecutive days to treat vomiting.

Cerenia can be used to treat or prevent vomiting either as tablets or as Solution for Injection once daily for up to 5 days.

Although Cerenia is effective in the treatment and prevention of vomiting induced by chemotherapy, it is more efficacious if used preventatively. Therefore it is recommended to administer Cerenia prior to the administration of the chemotherapeutic agent.

To prevent vomiting, Cerenia Solution for Injection should be administered more than 1 hour in advance. The duration of effect is approximately 24 hours and therefore treatment can be given the night before administration of an agent that may cause emesis e.g. chemotherapy.

In some individual dogs, and when repeating the treatment, lower doses than recommended might be sufficient.

Contra-indications, warnings, etc

Vomiting can be associated with serious, severely debilitating conditions and the cause should be investigated. Cerenia Solution for Injection should be used with other supportive measures as appropriate.

The safety of Cerenia has not been established in dogs less than 16 weeks of age and in pregnant or lactating bitches. Use only according to a risk benefit assessment by the responsible veterinary surgeon.

Cerenia Solution for Injection was well tolerated in dogs injected daily with up to 5 times the recommended dose for up to 15 days. Cerenia should be used with caution in animals suffering from or with a predisposition for heart diseases. Cerenia should not be used concomitantly with Ca-channel antagonists as maropitant has affinity to Ca-channels. Maropitant is metabolised in the liver and therefore should be used with caution in dogs with liver disease.

Maropitant is highly bound to plasma proteins and may compete with other highly bound drugs.

The use of Cerenia Solution for Injection against vomiting due to motion sickness is not recommended.

User warnings:

Wash hands after use. In case of accidental self injection seek medical advice immediately and show the package leaflet or the label to the physician. In the case of accidental eye exposure, flush the eyes with plenty of water and seek medical attention.

Pharmaceutical precautions

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

Once opened, the vial should be used within 28 days.

In the absence of compatibility studies, Cerenia Solution for Injection must not be mixed with other veterinary medicinal products in the same syringe.

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

Keep out of the reach and sight of children.

For animal treatment only.

Legal category

POM-V

Packaging Quantities

Cerenia Solution for Injection is available in 20 ml amber glass vials.

Further information

Nil.

Marketing authorisation number

EU/2/06/062/005.

Significant Changes

Cerenia 10 mg/ml Solution for Injection for dogs

Pfizer Limited

New data sheet

10/04/2007