Cerenia

maropitant

This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

What is Cerenia?

Cerenia contains the active substance maropitant. It is available as tablets (16 mg, 24 mg, 60 mg and 160 mg) for dogs and as a solution for injection for dogs and cats.

What is Cerenia used for?

Cerenia is an antiemetic medicine, which means that it is used to prevent or, in combination with other supportive measures, to treat vomiting in dogs (tablets and solution for injection) and cats (solution for injection). For these purposes, Cerenia can be given for up to five days.

It is also used to prevent (dogs) or to reduce (cats) nausea, except nausea due to motion (travel) sickness (e.g. when a dog tends to vomit when travelling by car). However, Cerenia tablets can be used in dogs at a higher dose for a maximum of two days to prevent vomiting due to motion sickness.

How does Cerenia work?

Cerenia blocks a neurokinin 1 (NK1) receptor, which acts in the central nervous system. It prevents a peptide (‘substance P’) from binding to the NK1 receptors, which is involved in causing vomiting. By stopping substance P, Cerenia acts as an antiemetic.

How has Cerenia been studied?

A large number of studies with Cerenia were carried out either in laboratory dogs and cats or in animal patients at veterinary practises in several European countries and in the United States.

Dogs:

For the prevention of vomiting, Cerenia was studied in dogs which received either Cerenia or a placebo (a dummy tablet or injection without any active ingredient) before another substance known to trigger vomiting (such as those used in chemotherapy) was given to them. For the treatment of vomiting, the effect of Cerenia (or a placebo) was examined in sick dogs that were vomiting for various reasons, for example because of a gastrointestinal infection. Most of these dogs also received additional treatment. Dogs were treated with either 1 mg/kg (injection) or 2 mg/kg (tablet) once daily up to five days.

In order to study the effect of Cerenia in motion sickness, dogs known to vomit when travelling were taken on car journeys lasting several hours for up to two days. The animals received either Cerenia tablets at a dose of 8 mg/kg bodyweight or a placebo of up to two days.

Cats:

For the prevention of vomiting, Cerenia was studied in cats which received either Cerenia or placebo before another substance known to trigger vomiting was given to them. For the treatment of vomiting the effect of Cerenia (or placebo) was examined in sick cats that were vomiting for various reasons. Cats were treated with 1 mg/kg (injection) once daily up to five days.

What benefit has Cerenia shown during the studies?

The results of the studies showed that Cerenia was more effective than placebo: less vomiting was seen in dogs and cats that received the medicine than in animals that received placebo, both in the treatment or in the prevention of vomiting. For dogs, the treatment of vomiting should be started with the injection, since vomiting animals might throw the intact tablet up again. For follow-up treatment, the animal owner can administer the tablets to the dog. In cats, treatment of vomiting is with the injection only. Also, the treatment of vomiting should only be together with other supportive measures or other veterinary therapy while addressing the underlying causes of the vomiting.

What is the risk associated with Cerenia?

Cerenia was generally well tolerated.

A common side effect of the tablets when used at a high dose of 8 mg/kg in dogs (for motion sickness) was vomiting before the car journey started. Since this was mainly observed in dogs with an empty stomach, it is recommended to feed a light meal or snack a while before the tablets are given. Other reported side effects were decreased activity levels and tiredness.

A very common side effect in cats was a painful response to the injection and this may be reduced by injection of the product at refrigerated temperature.

The active substance in Cerenia, maropitant, is broken down via the liver and it is, therefore, recommended to use it with caution in animals with liver disease. Since maropitant could affect the heart activity, Cerenia should be used with caution in animals with certain heart conditions.

Since Cerenia has not been studied in very young dogs or cats, or pregnant or lactating bitches or queens, any use of Cerenia in these animals should be discussed with your veterinarian.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

Cerenia does not represent a particular risk for people.

However, maropitant can produce acute eye irritation and in the case of accidental eye exposure, flush the eyes with plenty of water and seek medical attention. In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician.

As the injection causes pain in cats, the animal will need to be restrained when treated.

Why has Cerenia been approved?

The CVMP concluded that the benefits of Cerenia exceed its risks and recommended that Cerenia be given a marketing authorisation. The benefit-risk balance can be found in module 6 of this EPAR.

Other information about Cerenia

The European Commission granted a marketing authorisation valid throughout the European Union, for Cerenia on 29/09/2006. Information on the prescription status of this product can be found on the label / outer package.

This EPAR was last updated on 11/05/2012 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

13/04/2012  Cerenia -EMEA/V/C/000106 -II/0013

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic Group

Antiemetics and antinauseants

Therapeutic indication

Tablets (dogs):

• For the prevention of nausea induced by chemotherapy.
• For the prevention of vomiting including that induced by motion sickness.
• For the treatment of vomiting, in conjunction with Cerenia Solution For Injection and in combination with other supportive measures.

Solution for injection:

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.

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.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents