Each dose of 1 ml contains:

Inactivated influenza A virus/human

Strain: A/Jena/VI5258/2009(H1N1)pdm09 ≥ 16 HU1

1HU – haemagglutinating units.

Carbomer 971P NF 2 mg

Thiomersal 0.1 mg

For the full list of excipients, see Pharmaceutical particulars.

Suspension for injection. Clear to slightly turbid, reddish to pale-pink coloured suspension.

Pigs.

Active immunisation of pigs from the age of 8 weeks onwards against pandemic H1N1 porcine influenza virus to reduce viral lung load and viral excretion.

Onset of immunity: 7 days after primary vaccination.

Duration of immunity: 3 months after primary vaccination.

None

Vaccinate healthy animals only.

Not applicable.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

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.

Can be used during pregnancy and lactation.

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.

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 cases of exposure of the sows to antigens (from either field infections and/or vaccination) the antibodies transmitted to the piglets can interfere with active immunisation at 12 weeks of age. In such cases the piglets should be vaccinated after the age of 12 weeks.

None known.

Zero days.

Pharmacotherapeutic group: Immunologicals, inactivated viral vaccines for pigs, porcine influenza virus. ATCvet code: QI09AA03.

The vaccine stimulates an active immunity against pandemic porcine influenza A/Jena/VI5258/2009 (H1N1)pandemic09-like virus. It induces neutralising and haemagglutination-inhibiting antibodies against this subtype. The antibody responses mentioned in the following have been documented in pigs without maternally-derived immunity. Neutralising antibodies in serum have been detected in more than 75% of the immunised pigs on day 7 after primary immunisation lasting in more than 75% of the pigs for over 3 months. Haemagglutination-inhibiting antibodies have been detected in 15–100% of the immunised pigs on day 7 after primary immunisation which disappeared in the majority of animals within 1 to 4 weeks thereafter.

Efficacy of the vaccine was examined in laboratory challenge studies in pigs without maternally-derived antibodies and was demonstrated against the following strains:

FLUAV/Hamburg/NY1580/2009(H1N1)pdm09 (human origin),

FLUAV/swine/Schallern/IDT19989/2014 (H1N1)pdm09 (swine origin) and

FLUAV/sw/Teo(Spain)/AR641/2016 (H1N1)pdm09 (swine origin).

Carbomer 971P NF, Thiomersal, Sodium chloride solution (0.9%).

Do not mix with any other veterinary medicinal product.

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the vial: 10 hours.

Store in a refrigerator (2 ºC−8 ºC). Do not freeze.

Keep the vial in the outer carton in order to protect from light.

PET vials:

25 ml polyethylene terephthalate (PET) vials

50 ml PET vials

Stoppers: Bromobutyl rubber stoppers

Caps: Aluminium flanged caps

Package sizes: Cardboard box with 1 vial of 25 doses (25 ml) or 50 doses (50 ml) with a rubber stopper and flanged cap.

Not all pack sizes may be marketed.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements

Ceva Santé Animale, 10 av. de La Ballastière, 33500 Libourne, France

UK(GB):Vm 15052/5017

UK(NI): EU/2/17/209/001–002

Date of first authorisation: 16/05/2017

October 2022.

Nil