Eurican Herpes 205

Summary

European Medicines Agency

EMEA/V/C/059

EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) EURICAN HERPES 205 EPAR summary for the public

This document is a summary of the European Public Assessment Report. 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 document 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 Eurican Herpes 205?

Eurican Herpes 205 is a powder and solvent that is made into an emulsion for injection. Eurican Herpes 205 contains the active substance canine herpes virus (F205 strain) antigens in a dose of 0.3 to 1.75 pg.

What is Eurican Herpes 205 used for?

Eurican Herpes 205 is used to immunise pregnant bitches to prevent mortality, clinical signs and lesions in puppies caused by canine herpes virus infections acquired in the first few days of life. Eurican Herpes 205 is given as two 1 ml subcutaneous (under the skin) doses. The first injection is given either when the bitch is on heat or 7 -10 days after the date of mating. The second injection is given 1 to 2 weeks before the expected date of whelping. The bitch should be revaccinated in the same way during each pregnancy.

How does Eurican Herpes 205 work?

Eurican Herpes 205 contains small amounts of canine herpes virus antigens. When injected, this small exposure helps the dog’s immune system to synthesize antibodies against the canine herpes virus and to neutralize it. Once vaccinated, bitches will, through colostrum, give those antibodies to puppies. When exposed to canine herpes virus later in life, the puppies will either not become infected or have a much less serious infection. Eurican Herpes 205 is intended to protect the puppies from this infection during the first few days of life.

How has the effectiveness of Eurican Herpes 205 been studied?

Eurican Herpes 205 has been studied in three laboratory studies and two field trials. In one field trial the serological response (antibody production) was measured. In the other, a study was made of the effect of vaccination on the ability of bitches to breed in an infected kennel. The first laboratory study tested the dose needed to provide protection. The second study was carried out to show the protection of puppies from vaccinated bitches from canine herpe svirus. Here Eurican Herpes 205 was compared with no vaccination (controls). The last one has demonstrating that induction of antibodies is equivalent when bitches are vaccinated the day of heat or 7-10 days after mating.

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What benefit has Eurican Herpes 205 shown during the studies?

Eurican Herpes 205 showed good protection from canine herpes virus. In the study to show the protection of puppies (from vaccinated bitches) from canine herpes virus, over 80% of the pups from the vaccinated bitches survived..

What are the side effects of Eurican Herpes 205?

The injection of Eurican Herpes 205 may cause temporary oedema (fluid under the skin) at the injection site in up to 10% of animals. This side effect usually disappears within one week. Rarely, hypersensitivity (allergic) reactions may occur, which require treatment.

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

Eurican Herpes 205 contains mineral oil. Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger - rarely causing the loss of a finger. If someone is accidentally injected with this product, they must seek immediate medical advice even if only a very small amount is injected. The Package Leaflet should be taken to the doctor. If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.

Why has Eurican Herpes 205 been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Eurican Herpes 205 are greater than any risks to immunise healthy bitches against canine herpes virus. They recommended that Eurican Herpes 205 should be given a marketing authorisation. The benefitrisk balance may be found in module 6 of this EPAR.

Other information about Eurican Herpes 205:

The European Commission granted a marketing authorisation valid throughout the European Union, for Eurican Herpes 205 to Merial on 26 March 2001. Information on the prescription status of this product may be found on the labelling.

This summary was last updated in 11-2006.