Dogs.

∙ For the prevention of nausea induced by chemotherapy.

∙ For the prevention of vomiting induced by motion sickness.

∙ For the prevention and treatment of vomiting, in conjunction with Cerenia solution for injection and 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.

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.

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 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.

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.

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 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 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.

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.

Not applicable.

Dogs:

Common (1 to 10 animals / 100 animals treated):	Vomiting1
Very rare (<1 animal / 10,000 animals treated, including isolated reports):	Neurological disorder (e.g. ataxia, convulsion, seizure, muscle tremor) Lethargy

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.

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 drugs.

For oral use.

For motion sickness, a light meal or snack before dosing is recommended; prolonged fasting before administration should be avoided. However, Cerenia tablets should not be administered wrapped or encapsulated in food as this may delay dissolution of the tablet and consequently the onset of efficacy.

Dogs should be carefully observed following administration to ensure that each tablet is swallowed.

To treat or prevent vomiting, Cerenia tablets should be administered once daily, at a dose of 2 mg maropitant per kg bodyweight, using the number of tablets given in the table below. Tablets are breakable along the score line on the tablet.

To prevent vomiting, tablets should be given more than 1 hour in advance. The duration of the effect is approximately 24 hours and, therefore, tablets can be given the night before administration of an agent that may cause emesis (e.g. chemotherapy).

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.

Prevention of nausea induced by chemotherapy Treatment and prevention of vomiting (except motion sickness)
Dog body weight (kg)	Number of tablets
	16 mg	24 mg	60 mg
3.0–4.0*	½
4.1–8.0	1
8.1–12.0		1
12.1–24.0		2
24.1–30.0			1
30.1–60.0			2

To prevent vomiting induced by motion sickness, Cerenia tablets should be administered once daily, at a dose of 8 mg maropitant per kg bodyweight, using the numbers of tablets given in the table below. Tablets are breakable along the score line on the tablet.

Tablets should be administered at least one hour before starting the journey. The anti-emetic effect persists for at least 12 hours, which for convenience may allow administration the night before early morning travel. Treatment may be repeated for a maximum of two consecutive days.

Prevention of motion sickness
Dog body weight (kg)	Number of tablets
	16 mg	24 mg	60 mg	160 mg
1.0–1.5		½
1.6–2.0	1
2.1–3.0		1
3.1–4.0	2
4.1–6.0		2
6.1–7.5			1
7.6–10.0				½
10.1–15.0			2
15.1–20.0				1
20.1–30.0				1½
30.1–40.0				2
40.1–60.0				3

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.

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.

Not applicable.