Overview

Respiporc FLUpan H1N1 is a vaccine used to protect pigs from eight weeks of age against swine influenza caused by pandemic subtype H1N1. Swine influenza or swine flu is a disease of the lungs and airways in pigs. Signs can include fever, depression, coughing, sneezing, difficulty breathing and loss of appetite. The vaccine can also be used during pregnancy up to three weeks before expected farrowing and during lactation.

The vaccine contains inactivated (killed) influenza A virus/Jena/VI5258/2009(H1N1)pdm09, a strain of the virus that causes swine influenza.

Respiporc FLUpan H1N1 is available as a suspension for injection and can only be obtained with a prescription. It is given as two injections into the muscle, three weeks apart. The vaccine starts to be effective one week after the second injection and protection lasts for three months.

For more information about using Respiporc FLUpan H1N1, see the package leaflet or contact your veterinarian or pharmacist.

Respiporc FLUpan H1N1 is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Respiporc FLUpan H1N1 contains influenza A virus (Pan H1N1) which has been inactivated so it cannot cause the disease. When a pig is given the vaccine, the pig’s immune system recognises the virus as ‘foreign’ and reacts by building up an active immune response. In the future, the immune system will be able to react against the virus more quickly when it is exposed to the virus. This active immune response will help to protect the pig against the disease caused by this virus.

Respiporc FLUpan H1N1 contains an adjuvant (carbomer) to enhance the immune response.

The effectiveness of Respiporc FLUpan H1N1 in pigs from eight weeks of age was shown in three laboratory studies and one combined field/laboratory study. The studies showed that pigs vaccinated with Respiporc FLUpan H1N1 had a reduction in the amount of virus in the lung and excreted from the nose. Two laboratory studies and a field study showed that vaccination during pregnancy and lactation was well-tolerated and no negative effects on reproduction were seen.

The most common side effects with Respiporc FLUpan H1N1 (which may affect up to 1 in 10 animals) are a short-lived increase in rectal temperature, not exceeding 2°C, which does not last for more than one day and a transient swelling up to 2 cm3 at the site of injection which usually resolves within 5 days.

No special precautions are required. In case of accidental self-injection, only a minor injection site reaction is expected.

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 vaccinated with Respiporc FLUpan H1N1 is ‘zero’ days, which means that there is no mandatory waiting time.

The European Medicines Agency decided that Respiporc FLUpan H1N1’s benefits are greater than its risks and it can be authorised for use in the EU.

Respiporc FLUpan H1N1 received a marketing authorisation valid throughout the EU on 17 May 2017.

 

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Latest procedure affecting product information: II/0013

04/11/2021

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Product details

Name of medicine
Respiporc FLUpan H1N1
Active substance
Influenza A virus/human strain: A/Jena/VI5258/2009 (H1N1)pdm09, inactivated
International non-proprietary name (INN) or common name
Porcine influenza vaccine (inactivated)
Species
Pigs
Anatomical therapeutic chemical veterinary (ATCvet) code
QI09AA03

Pharmacotherapeutic group

Immunologicals, inactivated viral vaccines for pigs, porcine influenza virus

Therapeutic indication

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.

The vaccine can be used during pregnancy up to three weeks before expected farrowing and during lactation lactation.

Authorisation details

EMA product number
EMEA/V/C/003993
Marketing authorisation holder
CEVA Santé Animale

10 avenue de La Ballastière
33500 Libourne
France

Opinion adopted
07/12/2016
Marketing authorisation issued
17/05/2017
Revision
6

Assessment history

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