Respiporc FLUpan H1N1

1 x 25 dose

Suspension for injection

Active substance

Swine influenza A virus / human (H1N1) (strain A/Jena/VI5258/2009) (attenuated)

ATC code

QI09AA03 Porcine influenza virus

QI09AA Inactivated viral vaccines

QI09A Immunologicals for pig

QI09 Immunologicals for suidae

QI Immunologicals

Species

Pigs.

Indications

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.

Dose to be administered and administration route

For intramuscular use.

Piglets:

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.

Gilts and sows:

Primary vaccination: 2 injections of one dose (1 ml) with an interval of 3 weeks between injections and up to 3 weeks before expected farrowing or during lactation.

The efficacy of single dose revaccination has not been investigated and therefore no single dose revaccination schedule is proposed for further pregnancies.

Adverse reactions

Common

(1 to 10 animals / 100 animals treated):

Injection site swelling¹ Hyperthermia².

¹ transient swelling up to 2 cm³, resolves within 5 days.

² transient increase in rectal temperature not exceeding 2°C, does not persist for more than one day.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See also section 16 of the package leaflet for contact details.