DESCRIPTION: Each dose of 1 ml contains: Active substances: -Inactivated Influenza A virus/human -Strain: A/Jena/VI5258/2009(H1N1)pdm09 16-64 HU1 1HU - haemagglutinating units in the vaccine

Adjuvant: -Carbomer 971 P NF 2.0 mg Excipient: -Thiomersal 0.1 mg -Clear to slightly turbid, reddish to pale-pink coloured suspension. Indication; -Active immunisation of pigs from the age of 8 weeks onwards against pandemic H1N1 porcine influenza virus to reduce viral lung load and virus excretion. Onset of immunity: 7 days after primary vaccination

Duration of immunity: 3 months after primary vaccination Contraindications None. Adverse reactions A transient increase in rectal temperature, not exceeding 2 °C, is common after vaccination and this does not persist for more than one day. A transient swelling up to 2 cm3 may occur at the site of injection, these reactions are common but resolve within 5 days. If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon. Target species Pigs Dosage for each species, route(s) and method of administration For intramuscular use Vaccination: 2 injections of one dose (1 ml) from the age of 56 days, with an interval of 3 weeks between injections. The efficacy of revaccination has not been investigated and therefore no revaccination schedule is proposed. Maternally-derived antibodies in piglets interfere with the RESPIPORC FLUpan H1N1 mediated immunity. Generally, maternally-derived antibodies induced by vaccination last for approximately 5-8 weeks after birth. In case of exposure of sows with antigens (field infections and/or vaccination) the antibodies transmitted to the piglets can interfere with active vaccination at 12 weeks of age. In this case piglets should be vaccinated after the age of 12 weeks.

Advice on correct administration None. Withdrawal period Zero days

Special storage precautions Keep out of the sight and reach of children. Store in a refrigerator (2 °C - 8 °C). Do not freeze. Keep the vial in the outer carton in order to protect from light. Shelf life after first opening the bottle: 10 hours.

Special warnings Special precautions to be taken by the person administering the veterinary medicinal product to animals Pregnancy and lactation: The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

Interaction with other medicinal products and other forms of interaction: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.

Incompatibilities: Do not mix with any other veterinary medicinal product.