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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/281953/2007

EMEA/V/C/000038

EPAR summary for the public

Suvaxyn Aujeszky 783 + O/W

Live attenuated Aujeszky's Disease Virus

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 Suvaxyn Aujeszky 783 + O/W?

Suvaxyn Aujeszky 783 + O/W is a vaccine that contains a live attenuated (weakened) form of Aujeszky's disease virus strain NIA3-783. Suvaxyn Aujeszky 783 + O/W is a powder and solvent that are made up into an emulsion (a mixture of oil- and water-based liquids) for injection.

What is Suvaxyn Aujeszky 783 + O/W used for?

Suvaxyn Aujeszky 783 + O/W is used to vaccinate pigs from the age of 10 weeks against Aujeszky's disease, an illness similar to rabies that is caused by a herpesvirus. It prevents death and symptoms of the disease and reduces the shedding of the virus. Vaccination of gilts (female pigs that have not yet had piglets) and sows (female pigs that have had piglets before) with Suvaxyn Aujeszky 783 + O/W can also result in immunity in the pig's offspring.

Suvaxyn Aujeszky 783 + O/W is given as two 2 ml injections into the muscle of the neck behind the ear, three to four weeks apart. Immunity starts after three weeks and lasts for three months. Female breeding pigs should be revaccinated before their first mating or during each pregnancy, three to six weeks before giving birth. Breeding boars (male pigs) should be revaccinated every six months. To vaccinate a whole herd, one dose should be given to every male and female breeding pig every four months.

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© European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.

Suvaxyn Aujeszky 783 + O/W is a vaccine. Vaccines work by 'teaching' the immune system (the body's natural defences) how to defend itself against a diseases. Suvaxyn Aujeszky 783 + O/W contains small amounts of a weakened form of the virus that causes Aujeszky's disease. The virus has been genetically modified: it has had one of its gene deleted (the gene that makes it able to produce an enzyme called thymidine kinase) and this is what makes it weaker. The vaccine also contains 'adjuvants' (a compound containing aluminium as well as mineral oil, an emulsifier and a detergent) to stimulate a better response.

When a pig is given the vaccine, the immune system recognises the weakened viruses as 'foreign' and makes antibodies against them. In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses. This protects the pigs against the disease. The antibodies are also passed on from mother to piglet through the colostrums (first milk) and milk. This enables the piglets of vaccinated pigs to be protected against the disease.

How has Suvaxyn Aujeszky 783 + O/W been studied?

The effectiveness of Suvaxyn Aujeszky 783 + O/W has been studied in a large number of pigs in several farms in studies lasting around two years. The herds of pigs were monitored for signs of infection with the type of Aujeszky's disease virus that is can be caught in the field. The studies compared the levels of infection in vaccinated and unvaccinated pigs.

What benefit has Suvaxyn Aujeszky 783 + O/W shown during the studies?

Suvaxyn Aujeszky 783 + O/W was effective at preventing infection with the virus. After vaccination, the number of pig herds with signs of infection fell significantly, as did the number of infected pigs within the herds. There was no change in the infection rates in the pigs that were not vaccinated.

What is the risk associated with Suvaxyn Aujeszky 783 + O/W?

In up to a half of pigs being vaccinated, a slight temporary reaction can occur at the site of injection. This can be up to 2 cm in diameter after first injection and up to 5 cm after the second, but they usually disappear within three weeks. An increase in body temperature up to about 40.5°C can occur in a small number of pigs, lasting for up to two days.

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

Wash and disinfect hands and equipment after use. Accidental injection can cause severe pain and swelling, particularly if the vaccine is injected into a joint or finger. In case of accidental injection, seek prompt medical advice and show the Package Leaflet to the doctor. If pain persists for more than 12 hours after examination, seek medical advice again.

What is the withdrawal period?

The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or eggs or milk used for human consumption. The withdrawal period for Suvaxyn Aujeszky 783 + O/W is zero days.

Suvaxyn Aujeszky 783 + O/W EMA/281953/2007

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Suvaxyn Aujeszky 783 + O/W exceed the risks for the treatment of active immunisation of pigs from the age of 10 weeks to prevent the mortality and clinical signs of Aujeszky's Disease and to reduce the excretion of Aujeszky's Disease field virus. Passive immunisation of the progeny of vaccinated gilts and sows to reduce mortality and clinical signs of Aujeszky's Disease and to reduce the excretion of Aujeszky's Disease field virus, and recommended that Suvaxyn Aujeszky 783 + O/W be given a marketing authorisation. The benefit/risk balance may be found in the scientific discussion module of this EPAR.

Other information about Suvaxyn Aujeszky 783 + O/W:

The European Commission granted a marketing authorisation valid throughout the European Union, for Suvaxyn Aujeszky 783 + O/W on 7 August 1998. Information on the prescription status of this product may be found on the label/outer package.

This summary was last updated in: 04-2013.

Suvaxyn Aujeszky 783 + O/W EMA/281953/2007

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