PREVOMAX 10 MG/ML MAROPITANT / CERENIA ANALOGUE / 20 ML

Prevomax 10 mg/ml Maropitant 20 ml   Target species Dogs and cats. Indications for use 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. 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 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). Special precautions for use in animals 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. Special precautions to be taken by the person administering the veterinary medicinal product to animals 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. Adverse reactions Pain at injection site may occur when injected subcutaneously. In cats, moderate to severe response to injection is very commonly observed (in approximately one third of cats). In very rare cases, anaphylactic type reactions (allergic oedema, urticaria, erythema, collapse, dyspnoea, pale mucous membranes) may occur. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals, including isolated reports). Use during pregnancy and lactation 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. Interactions 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. Amounts to be administered and administration route 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. Overdose 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 has been presented on overdoses in adult cats.