Dogs and cats.

∙ 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.

∙ 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.

None.

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 Cerenia solution for injection against vomiting due to motion sickness is not recommended.

Although Cerenia 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.

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

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.

Cerenia 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.

Not applicable.

Dogs and cats:

Very common (>1 animal / 10 animals treated):	Injection site pain1,2
Very rare (<1 animal / 10,000 animals treated, including isolated reports):	Anaphylactic-type reaction (e.g. allergic oedema, urticaria, erythema, collapse NOS, dyspnoea, pale mucous membranes) Lethargy Neurological disorder (e.g. ataxia, convulsion, seizure, muscle tremor)

1 When injected subcutaneously.

2 A moderate to severe response can be observed in approximately one third of cats.

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 16 of the package leaflet for respective contact details.

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.

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 medicines.

For subcutaneous or intravenous use in dogs and cats.

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

In dogs, Cerenia can be used to treat or prevent vomiting either as tablets or as solution for injection administered once daily. Cerenia solution for injection may be administered for up to five days and Cerenia tablets for up to fourteen days.

To prevent vomiting, Cerenia solution for injection should be administered more than 1 hour in advance. The effect duration is approximately 24 h 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.

Apart from transient reactions at the injection site following subcutaneous administration, Cerenia solution for injection 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.

Not applicable.