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Contra-indications, warnings, etc
Cerenia tablets have been shown to be effective in the treatment of emesis, however where the frequency of vomiting is high, orally administered Cerenia may not be absorbed before the next vomiting event occurs. It is therefore recommended to initiate the treatment of emesis with Cerenia solution for injection.
Vomiting can be associated with serious, severely debilitating conditions including gastrointestinal obstructions; therefore, appropriate diagnostic evaluations should be employed.
The safety of the veterinary medicinal product has not been established in dogs less than 16 weeks of age for the 8 mg/kg dose (motion sickness), and in dogs less than 8 weeks of age for the 2 mg/kg dose (vomiting) as well as in pregnant or lactating bitches. Use only according to the benefit-risk assessment by the responsible veterinarian.
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 cause of the vomiting. The safety of maropitant during treatment beyond 5 days has not been explored in the target population (i.e. young dogs suffering from viral enteritis). In case treatment for a longer period than 5 days is regarded as necessary, careful monitoring of potential adverse events should be implemented.
Cerenia tablets were well tolerated when administered for 15 days at dosages up to 10 mg/kg bodyweight per day. Clinical signs including vomiting on first administration, excess salivation and watery faeces have been observed when the product has been administered at doses in excess of 20 mg/kg.
Maropitant is metabolised in the liver and therefore should be used with caution in dogs 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 in addition to any adverse events should be implemented during long term treatment.
Cerenia should be used with caution in animals suffering from or with a 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.
Cerenia 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 drugs.
Maropitant is non-sedative and should not be used as a sedative in motion sickness.
(1 to 10 animals / 100 animals treated):
Very rare
(<1 animal / 10,000 animals treated, including isolated reports):
Neurological disorder (e.g. ataxia, convulsion, seizure, muscle tremor)
1 Observed pre-travel, usually within two hours of dosing.
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.
User warnings:
People with known hypersensitivity to maropitant should administer the veterinary medicinal product with caution.
Wash hands after use. In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician.