Respiporc FLUpan H1N1

inactivated influenza A virus/human

strain: A/Jena/VI5258/2009(H1N1)pdm09

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This is a summary of the European public assessment report (EPAR) for Respiporc FLUpan H1N1. It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Respiporc FLUpan H1N1.

For practical information about using Respiporc FLUpan H1N1, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

What is Respiporc FLUpan H1N1 and what is it used for?

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

How is Respiporc FLUpan H1N1 used?

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 further information, see the package leaflet.

How does Respiporc FLUpan H1N1 work?

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.

What benefits of Respiporc FLUpan H1N1 have been shown in studies?

The effectiveness of Respiporc FLUpan H1N1 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 of virus in the lung and excreted from the nose.

What are the risks associated with Respiporc FLUpan H1N1?

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.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

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

What is the withdrawal period in food-producing animals?

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

Why is Respiporc FLUpan H1N1 approved?

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Respiporc FLUpan H1N1’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Other information about Respiporc FLUpan H1N1:

The European Commission granted a marketing authorisation valid throughout the EU for Respiporc FLUpan H1N1 on 17 May 2017.

For more information about treatment with Respiporc FLUpan H1N1, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

Name Language First published Last updated
Respiporc FLUpan H1N1 : EPAR - Summary for the public BG = bălgarski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Summary for the public ES = español 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Summary for the public CS = čeština 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Summary for the public DA = dansk 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Summary for the public DE = Deutsch 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Summary for the public ET = eesti keel 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Summary for the public EL = elliniká 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Summary for the public EN = English 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Summary for the public FR = français 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Summary for the public IT = italiano 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Summary for the public LV = latviešu valoda 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Summary for the public LT = lietuvių kalba 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Summary for the public HU = magyar 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Summary for the public MT = Malti 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Summary for the public NL = Nederlands 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Summary for the public PL = polski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Summary for the public PT = português 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Summary for the public RO = română 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Summary for the public SK = slovenčina 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Summary for the public SL = slovenščina 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Summary for the public FI = suomi 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Summary for the public SV = svenska 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Summary for the public HR = Hrvatski 2017-06-20  

This EPAR was last updated on 20/06/2017 .

Authorisation details

Product details

Product details for Respiporc FLUpan H1N1
NameRespiporc FLUpan H1N1
Agency product numberEMEA/V/C/003993
Active substance

inactivated influenza A virus/human

strain: A/Jena/VI5258/2009(H1N1)pdm09

International non-proprietary name (INN) or common name

inactivated influenza A virus/human

strain: A/Jena/VI5258/2009(H1N1)pdm09

Species Pigs
Anatomical therapeutic chemical veterinary (ATCvet) codes QI09AA03


Publication details

Publication details for Respiporc FLUpan H1N1
Marketing-authorisation holder

IDT Biologika GmbH

Revision0
Date of issue of marketing authorisation valid throughout the European Union17/05/2017

Contact address:

IDT Biologika GmbH
Am Pharmapark
06861 Dessau-Rosslau
Germany

Product information

Product information

17/05/2017  Respiporc FLUpan H1N1 -EMEA/V/C/003993

Name Language First published Last updated
Respiporc FLUpan H1N1 : EPAR - Product Information HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Product Information HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Product Information HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Product Information HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Product Information HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Product Information HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Product Information HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Product Information HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Product Information HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Product Information HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Product Information HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Product Information HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Product Information HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Product Information HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Product Information HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Product Information HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Product Information HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Product Information HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Product Information HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Product Information HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Product Information HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Product Information HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Product Information HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Product Information HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - Product Information HR = Hrvatski 2017-06-20  

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Respiporc FLUpan H1N1 : EPAR - All Authorised presentations HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - All Authorised presentations HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - All Authorised presentations HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - All Authorised presentations HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - All Authorised presentations HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - All Authorised presentations HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - All Authorised presentations HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - All Authorised presentations HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - All Authorised presentations HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - All Authorised presentations HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - All Authorised presentations HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - All Authorised presentations HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - All Authorised presentations HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - All Authorised presentations HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - All Authorised presentations HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - All Authorised presentations HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - All Authorised presentations HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - All Authorised presentations HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - All Authorised presentations HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - All Authorised presentations HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - All Authorised presentations HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - All Authorised presentations HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - All Authorised presentations HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - All Authorised presentations HR = Hrvatski 2017-06-20  
Respiporc FLUpan H1N1 : EPAR - All Authorised presentations HR = Hrvatski 2017-06-20  

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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Respiporc FLUpan H1N1 : EPAR - Public assessment report HR = Hrvatski 2017-06-20  
CVMP summary of positive opinion for RESPIPORC FLUpan H1N1 HR = Hrvatski 2017-03-17  
CVMP post-authorisation summary of negative opinion for Respiporc FLUpan H1N1 HR = Hrvatski 2016-12-09