Dogs and cats.

Dogs: For the treatment and prevention of nausea induced by chemotherapy.

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

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

For the prevention of perioperative nausea and vomiting and improvement in recovery from general anaesthesia after use of the μ-opiate receptor agonist morphine.

Cats: For the prevention of vomiting and the reduction of nausea, except that induced by motion sickness.

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

Vomiting can be associated with serious, severely debilitating conditions including gastrointestinal obstructions; therefore, appropriate diagnostic evaluations should be employed.

Good veterinary practice indicates that antiemetics should be used in conjunction with other veterinary and supportive measures such as dietary control and fluid replacement therapy while addressing the underlying causes of the vomiting.

The use of the veterinary medicinal product against vomiting due to motion sickness is not recommended.

Dogs: Although maropitant has been demonstrated to be effective in both the treatment and prevention of emesis induced by chemotherapy, it was found more efficacious if used preventively. Therefore, it is recommended to administer the veterinary medicinal product prior to administration of the chemotherapeutic agent.

Cats: The efficacy of maropitant in reduction of nausea was demonstrated in studies using a model (xylazine-induced nausea).

The safety of maropitant has not been established in dogs less than 8 weeks of age, or in cats less than 16 weeks of age, and in pregnant or lactating dogs and cats. Use only according to the benefit/risk assessment by the responsible veterinarian.

Maropitant is metabolised in the liver and therefore should be used with caution in patients with hepatic disease. As maropitant is accumulated in the body during a 14 day treatment period due to metabolic saturation, careful monitoring of liver function and any adverse events should be implemented during long term treatment.

The veterinary medicinal product should be used with caution in animals suffering from or with predisposition for cardiac diseases as maropitant has affinity to Ca- and K-ion channels. Increases of approximately 10% in the QT interval of the ECG were observed in a study on healthy Beagle dogs administered 8 mg/kg orally; however, such an increase is unlikely to be of clinical significance.

Due to the frequent occurrence of transient pain during subcutaneous injection, appropriate animal restraining measures may have to be applied. Injecting the product at refrigerated temperature may reduce pain at injection.

People with known hypersensitivity to maropitant should administer the veterinary medicinal product with caution.

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 laboratory studies, maropitant has been shown to be a potential eye irritant. In the case of accidental eye exposure, flush the eyes with plenty of water and seek medical attention.

Target species: Dog, cat

a in cats - moderate to severe (in approximately one third of cats) when injected subcutaneously.

b in dogs - when injected subcutaneously.

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 the national competent authority via the national reporting system. See section `Contact details´ of the package leaflet.

Use only according to the benefit/risk assessment by the responsible veterinarian, because conclusive reproductive toxicity studies have not been conducted in any animal species.

The veterinary medicinal product should not be used concomitantly with Ca-channel antagonists as maropitant has affinity to Ca-channels.

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

For subcutaneous or intravenous use in dogs and cats.

The veterinary medicinal product solution for injection should be injected subcutaneously or intravenously, once daily, at a dose of 1 mg of maropitant/kg body weight (1 ml/10 kg body weight) for up to 5 consecutive days. Intravenous administration of the veterinary medicinal product should be given as a single bolus without mixing the product with any other fluids.

To prevent vomiting, the veterinary medicinal product 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.

As the pharmacokinetic variation is large and maropitant accumulates in the body after once daily repeated administration, lower doses than recommended might be sufficient in some individuals and when repeating the dose.

For administration by subcutaneous injection, see also Special precautions for use in animals.

Apart from transient reactions at the injection site following subcutaneous administration, maropitant was well tolerated in dogs and young cats injected daily with up to 5 mg/kg (5 times the recommended dose) for 15 consecutive days (3 times the recommended duration of administration). No data have been presented on overdoses in adult cats.