Syvazul BTV
Authorised
This medicine is authorised for use in the European Union
Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 3)
MedicineVeterinaryAuthorised
Overview
Syvazul BTV is a vaccine used in sheep and cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
The vaccine contains inactivated (killed) bluetongue viruses. The variety (serotype) of the virus in the vaccine is selected depending on which serotypes are circulating and causing disease at the time of manufacture, so it may contain serotype 1, 4 or 8 or a combination of any two of these.
The vaccine is available as an injection and can only be obtained with a prescription.
Sheep
The vaccine is given as a single injection under the skin to sheep from 3 months of age. Revaccination is required after 1 year. The vaccine starts to be effective 39 days after vaccination and protection lasts for 1 year.
Cattle
The vaccine is given as two injections into a muscle to calves from 2 months of age if the calves have no immunity to bluetongue virus or from 3 months of age in calves born to mothers already immune to the disease. The second injection is given 3 weeks after the first. Revaccination with one injection is required after 1 year. The vaccine starts to be effective 21 days after completion of the initial vaccination course and protection lasts one year.
For more information about using Syvazul BTV, see the package leaflet or contact your veterinarian or pharmacist.
Syvazul BTV is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Syvazul BTV contains bluetongue viruses that have been inactivated so that they cannot cause the disease. When it is given to sheep and cattle, the animals’ immune systems recognise the viruses as ‘foreign’ and make antibodies against them. In the future, if the animals are exposed to the bluetongue virus, their immune system will be able to produce antibodies more quickly. This will help to protect them against the disease.
Syvazul BTV contains bluetongue virus of one or two types selected from serotypes 1, 4 and 8. The vaccine also contains ‘adjuvants’ (aluminium hydroxide and saponin) that enhance the response of the immune system.
Laboratory studies were conducted in which sheep and cattle vaccinated with Syvazul BTV were exposed to BTV serotype 1, 4 or 8. The main measure of effectiveness was the presence of virus in the blood and the studies have shown that the vaccine is effective in producing protective antibodies in sheep and cattle.
Sheep
Laboratory studies showed that in sheep the vaccine starts to be effective 39 days after vaccination and protection lasts for 1 year. In a field study, 3 groups of 35 lambs from 3 months of age (with no antibodies to bluetongue virus) received vaccination with vaccines containing BTV-1, BTV-8 and BTV 1+8. Effectiveness was measured by comparing antibody levels to the virus at days 35 and 63 after vaccination with levels from laboratory studies. The data showed that antibody levels at day 63 after vaccination for each group remained at levels similar to day 35 after vaccination and above levels from the laboratory studies.
Cattle
Laboratory studies showed that in cattle the vaccine starts to be effective 21 days after completion of the initial vaccination course and protection lasts one year. Groups of 25 calves from 2 months of age (with no antibodies to bluetongue virus) were vaccinated with vaccines containing BTV-1, BTV-8 and BTV 1+8 in a field study. Effectiveness was measured by comparing antibody levels at 21 and 42 days after completing the initial vaccination course with levels from laboratory studies. The data showed that antibody levels at day 42 after vaccination for each group remained at levels similar to day 21 after vaccination and above levels from the laboratory studies.
No field studies were provided with BTV-4 in sheep or cattle, however, the laboratory studies were considered sufficient to show effectiveness of the BTV-4 vaccine.
The most common side effects with Syvazul BTV (which may affect more than 1 in 10 animals) are local injection site reactions, erythema (reddening of the skin) with mild to moderate swelling 1 to 6 days after vaccination, a painless nodule (up to 3.8 cm diameter in sheep and 7 cm diameter in cattle) 2 to 6 days after vaccination and a short-lived increase in body temperature of no more than 2.3?C in the 48 hours after vaccination.
For the full list of side effects and restrictions of Syvazul BTV, see the package leaflet.
Safety information has been included in the summary of product characteristics and the package leaflet for Syvazul BTV, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
People who are hypersensitive (allergic) to aluminium hydroxide, thiomersal or saponins should avoid contact with Syvazul BTV.
In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption. It is also the time required after administration of a medicine before milk may be used for human consumption.
The withdrawal period for meat and milk from sheep and cattle treated with Syvazul BRV is ‘zero’ days, which means that there is no mandatory waiting time.
The European Medicines Agency decided that Syvazul BTV’s benefits are greater than its risks and it can be authorised for use in the EU.
Syvazul BTV received a marketing authorisation valid throughout the EU on 9 January 2019.
Product information
Latest procedure affecting product information: IAIN/0004
20/01/2022
Product details
- Name of medicine
- Syvazul BTV
- Active substance
- Inactivated bluetongue virus, serotype 1, strain ALG2006/01 E1
- Inactivated bluetongue virus, serotype 4, strain BTV-4/SPA-1/2004
- Inactivated bluetongue virus, serotype 8, strain BEL2006/01
- International non-proprietary name (INN) or common name
- Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 3)
- Species
- Cattle
- Sheep
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QI04AA02
Pharmacotherapeutic group
Inactivated viral vaccinesTherapeutic indication
For active immunisation of sheep to prevent viraemia and reduce clinical signs and lesions caused by bluetongue virus serotypes 1 and/or 8 and/or to reduce viraemia* and clinical signs and lesions caused by bluetongue virus serotype 4
For active immunisation of cattle to prevent viraemia caused by bluetongue virus serotypes 1 and/or 8 and/or to reduce viraemia* caused by bluetongue virus serotype 4.
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