Respiporc Flu3
Authorised
This medicine is authorised for use in the European Union
inactivated influenza-A virus / swine
MedicineVeterinaryAuthorised
- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
Respiporc FLU3 is a vaccine that contains 3 different strains of swine influenza A virus which have been inactivated (killed). Respiporc FLU3 is a suspension for injection.
Respiporc FLU3 is used to vaccinate pigs including pregnant sows over the age of 56 days against swine influenza in order to help them clinically but also to reduce the amount of virus present in the lungs. Respiporc FLU3 is also used to vaccinate pregnant sows following their first immunisation by giving them one dose 14 days prior to farrowing in order that the sows milk contains enough antibodies to help protect the piglets against swine influenza for at least 33 days after birth.
The medicine can only be obtained with a prescription. For primary vaccination, piglets, gilts and sows are given 2 injections of one dose. A booster is possible at each stage of pregnancy and lactation. For more information about using Respiporc FLU3, see the package leaflet or contact your veterinarian or pharmacist.
Respiporc FLU3 is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Respiporc FLU3 contains small amounts of a modified and then killed form of the pig’s influenza virus that causes lesions and illness. The vaccine also contains ‘adjuvants’ to stimulate a better response. When a pig is given the vaccine, the immune system recognises the killed 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 effectiveness of Respiporc FLU3 has been studied in animals 56 days of age and older and in sows before and during pregnancy, and these studies document that the vaccine protects against swine influenza.
Use of the Respiporc FLU3 in pigs reduces clinical signs and reduces the amount of virus in the lungs after infection caused by swine influenza A virus.
A slight swelling may occur after vaccination at the site of injection in a small number of pigs but this goes down within 2 days. Sometimes, a slight increase in the rectal temperature might occur after vaccination.
For the full list of side effects and restrictions of Respiporc FLU3, see the package leaflet.
In case of accidental self-injection only a minor injection site reaction is expected. Safety information has been included in the summary of product characteristics and the package leaflet for Respiporc FLU3, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
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. The withdrawal period for meat from pigs treated with Respiporc FLU3 is ‘zero’ days, which means that there is no mandatory waiting time.
The European Medicines Agency decided that Respiporc FLU3’s benefits are greater than its risks and it can be authorised for use in the EU.
Respiporc FLU3 received a marketing authorisation valid throughout the EU on 14 January 2010.
Product information
Latest procedure affecting product information:
IG/1256/G
15/09/2020
Product details
- Name of medicine
- Respiporc Flu3
- Active substance
- inactivated influenza-A virus / swine
- International non-proprietary name (INN) or common name
- inactivated influenza-A virus
- swine
- Species
- Pigs
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QI09AA03
Pharmacotherapeutic group
ImmunologicalsTherapeutic indication
Active immunisation of pigs from the age of 56 days onwards, including pregnant sows, against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection.
Onset of immunity: 7 days after primary vaccination
Duration of immunity: 4 months in pigs vaccinated between the age of 56 and 96 days and 6 months in pigs vaccinated for the first time at 96 days and above.
Active immunisation of pregnant sows after finished primary immunisation by administration of a single dose 14 days prior to farrowing to develop high colostral immunity, which provides clinical protection of piglets for at least 33 days after birth.
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