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Pharmaceutical precautions
Special precautions for use
i) Special precautions for use in animals:
The safety of the veterinary medicinal product 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 veterinary medicinal product at refrigerated temperature may reduce pain at injection.
ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Maropitant is a neurokinin-1 (NK1) receptor antagonist that acts in the central nervous system. The veterinary medicinal product may therefore cause nausea, dizziness and drowsiness in case of accidental self-injection. If accidental self-injection occurs, seek medical advice immediately and show the package leaflet or the label to the physician.
Due to the content of benzyl alcohol the veterinary medicinal product may cause mild local irritation. Skin contact should therefore be avoided. In case of accidental exposure, wash affected skin area with plenty of water.
The veterinary medicinal product may cause skin sensitisation. People with known hypersensitivity to maropitant or to any of the excipients should administer the veterinary medicinal product with caution. If you develop symptoms such as a skin rash after accidental exposure, seek medical advice and show the physician this warning.
The veterinary medicinal product may cause eye irritation. Eye contact should be avoided. In case of accidental eye exposure, flush the eyes with plenty of water and seek medical attention.
Wash hands after use.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 60 days.
Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
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.