Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Adverse reactions (frequency and seriousness)
Dogs and Cats
Very common (>1 animal / 10 animals treated): | Injection site pain* |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Anaphylactic-type reaction, allergic oedema, urticaria, erythema, collapse, dyspnoea, pale mucous membrane; Lethargy; Neurological disorders (e.g. ataxia, convulsion/seizure, muscle tremor) |
*May occur when injected subcutaneously. In approximately one third of cats
moderate to severe response to injection is observed.
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 also section ‘contact details’ of the package leaflet for respective contact details.
Special warnings
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 antiemetic 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).
Special precautions for use
Special precautions for safe use in the target species:
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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
This product may cause skin sensitisation. People with known hypersensitivity to maropitant should administer the veterinary medicinal product with caution. Wash the exposed skin immediately after exposure with large amounts of water. If you develop symptoms such as a rash after accidental exposure, seek medical advice and show the physician this warning.
This veterinary medicinal product may be irritant to the eyes. Avoid eye contact. In case of accidental contact of the product with eyes rinse abundantly with fresh water. If symptoms occur, seek the advice of a physician.
Maropitant is a neurokinin-1 (NK1) receptor antagonist that acts in the central nervous system. Accidental self-injection or ingestion may result in nausea, dizziness and somnolence. Care should be taken to avoid accidental self-injection. In case of accidental oral intake or self-injection seek medical advice immediately and show the package leaflet or the label to the physician.
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
Use during pregnancy, lactation or lay
Use only accordingly to the benefit-risk assessment by the responsible veterinarian because conclusive reproductive toxicity studies have not been conducted in any animal species.
Interaction with other medicinal products and other forms of interaction
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.