Respiporc Flu3

inactivated influenza-A virus / swine

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This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

What is Respiporc Flu3?

Respiporc Flu3 is a vaccine that contains three different strains of swine influenza-A virus which have been inactivated (killed). Respiporc Flu3 is a suspension for injection.

What is Respiporc Flu3 used for?

Respiporc Flu3 is used to vaccinate pigs, including pregnant sows, over the age of 56 days against swine influenza in order to help them clinically but also to reduce the amount of virus present in the lungs. Respiporc Flu3 is also used to vaccinate pregnant sows following their first immunisation by giving them one dose 14 days prior to farrowing in order that the sows milk contains enough antibodies to help protect the piglets against swine influenza for at least 33 days after birth.

How does Respiporc Flu3 work?

Respiporc Flu3 is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Respiporc Flu3 contains small amounts of a modified and then killed form of the pig's influenza virus that causes lesions and illness. The vaccine also contains ‘adjuvants’ to stimulate a better response. When a pig is given the vaccine, the immune system recognises the killed viruses as ‘foreign’ and makes antibodies against them. In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses. This protects the pigs against the disease.

How has Respiporc Flu3 been studied?

The effectiveness of Respiporc Flu3 has been studied in animals 56 days of age and older and in sows before and during pregnancy and these studies document that the vaccine protects against swine influenza.

What benefit has Respiporc Flu3 shown during the studies?

Use of the Respiporc Flu3 in pigs reduces clinical signs and reduces the amount of virus in the lungs after infection caused by swine influenza-A virus.

What is the risk associated with Respiporc Flu3?

A slight swelling may occur after vaccination at the site of injection in a small number of pigs but this goes down within two days. Sometimes, a slight increase in the rectal temperature might occur after vaccination.

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

In case of accidental self-injection, only a minor injection-site reaction is expected.

What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?

Zero days.

Why has Respiporc Flu3 been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Respiporc Flu3 exceed the risks for the vaccination of pigs from the age of 56 days onwards, including pregnant sows, against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection and recommended that Respiporc Flu3 be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

Other information about Respiporc Flu3

The European Commission granted a marketing authorisation valid throughout the European Union, for Respiporc Flu3 to IDT Biologika GmbH on 14 January 2010. Information on the prescription status of this product may be found on the label / outer package.

Name Language First published Last updated
Respiporc Flu3 : EPAR - Summary for the public BG = bălgarski 2010-01-19  
Respiporc Flu3 : EPAR - Summary for the public ES = español 2010-01-19  
Respiporc Flu3 : EPAR - Summary for the public CS = čeština 2010-01-19  
Respiporc Flu3 : EPAR - Summary for the public DA = dansk 2010-01-19  
Respiporc Flu3 : EPAR - Summary for the public DE = Deutsch 2010-01-19  
Respiporc Flu3 : EPAR - Summary for the public ET = eesti keel 2010-01-19  
Respiporc Flu3 : EPAR - Summary for the public EL = elliniká 2010-01-19  
Respiporc Flu3 : EPAR - Summary for the public EN = English 2010-01-19  
Respiporc Flu3 : EPAR - Summary for the public FR = français 2010-01-19  
Respiporc Flu3 : EPAR - Summary for the public IT = italiano 2010-01-19  
Respiporc Flu3 : EPAR - Summary for the public LV = latviešu valoda 2010-01-19  
Respiporc Flu3 : EPAR - Summary for the public LT = lietuvių kalba 2010-01-19  
Respiporc Flu3 : EPAR - Summary for the public HU = magyar 2010-01-19  
Respiporc Flu3 : EPAR - Summary for the public MT = Malti 2010-01-19  
Respiporc Flu3 : EPAR - Summary for the public NL = Nederlands 2010-01-19  
Respiporc Flu3 : EPAR - Summary for the public PL = polski 2010-01-19  
Respiporc Flu3 : EPAR - Summary for the public PT = português 2010-01-19  
Respiporc Flu3 : EPAR - Summary for the public RO = română 2010-01-19  
Respiporc Flu3 : EPAR - Summary for the public SK = slovenčina 2010-01-19  
Respiporc Flu3 : EPAR - Summary for the public SL = slovenščina 2010-01-19  
Respiporc Flu3 : EPAR - Summary for the public FI = suomi 2010-01-19  
Respiporc Flu3 : EPAR - Summary for the public SV = svenska 2010-01-19  

This EPAR was last updated on 25/09/2017 .

Authorisation details

Product details

Product details for Respiporc Flu3
NameRespiporc Flu3
Agency product numberEMEA/V/C/000153
Active substance

inactivated influenza-A virus / swine

International non-proprietary name (INN) or common name

inactivated influenza-A virus / swine

Species Pigs
Anatomical therapeutic chemical veterinary (ATCvet) codes QI09AA03




Publication details

Publication details for Respiporc Flu3
Marketing-authorisation holder

IDT Biologika GmbH
 

Revision2
Date of issue of marketing authorisation valid throughout the European Union14/01/2010

Contact address:

IDT Biologika GmbH
Am Pharmapark
PO Box 400 214
06861 Dessau-Rosslau
Germany

Product information

Product information

07/09/2017  Respiporc Flu3 -EMEA/V/C/000153 -II/0014

Name Language First published Last updated
Respiporc Flu3 : EPAR - Product Information SV = svenska 2010-01-19 2017-09-25
Respiporc Flu3 : EPAR - Product Information SV = svenska 2010-01-19 2017-09-25
Respiporc Flu3 : EPAR - Product Information SV = svenska 2010-01-19 2017-09-25
Respiporc Flu3 : EPAR - Product Information SV = svenska 2010-01-19 2017-09-25
Respiporc Flu3 : EPAR - Product Information SV = svenska 2010-01-19 2017-09-25
Respiporc Flu3 : EPAR - Product Information SV = svenska 2010-01-19 2017-09-25
Respiporc Flu3 : EPAR - Product Information SV = svenska 2010-01-19 2017-09-25
Respiporc Flu3 : EPAR - Product Information SV = svenska 2010-01-19 2017-09-25
Respiporc Flu3 : EPAR - Product Information SV = svenska 2010-01-19 2017-09-25
Respiporc Flu3 : EPAR - Product Information SV = svenska 2010-01-19 2017-09-25
Respiporc Flu3 : EPAR - Product Information SV = svenska 2010-01-19 2017-09-25
Respiporc Flu3 : EPAR - Product Information SV = svenska 2010-01-19 2017-09-25
Respiporc Flu3 : EPAR - Product Information SV = svenska 2010-01-19 2017-09-25
Respiporc Flu3 : EPAR - Product Information SV = svenska 2010-01-19 2017-09-25
Respiporc Flu3 : EPAR - Product Information SV = svenska 2010-01-19 2017-09-25
Respiporc Flu3 : EPAR - Product Information SV = svenska 2010-01-19 2017-09-25
Respiporc Flu3 : EPAR - Product Information SV = svenska 2010-01-19 2017-09-25
Respiporc Flu3 : EPAR - Product Information SV = svenska 2010-01-19 2017-09-25
Respiporc Flu3 : EPAR - Product Information SV = svenska 2010-01-19 2017-09-25
Respiporc Flu3 : EPAR - Product Information SV = svenska 2010-01-19 2017-09-25
Respiporc Flu3 : EPAR - Product Information SV = svenska 2010-01-19 2017-09-25
Respiporc Flu3 : EPAR - Product Information SV = svenska 2010-01-19 2017-09-25
Respiporc Flu3 : EPAR - Product Information SV = svenska 2010-01-19 2017-09-25
Respiporc Flu3 : EPAR - Product Information SV = svenska 2010-01-19 2017-09-25
Respiporc Flu3 : EPAR - Product Information SV = svenska 2010-01-19 2017-09-25

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 Flu3 : EPAR - All Authorised presentations SV = svenska 2010-01-19  
Respiporc Flu3 : EPAR - All Authorised presentations SV = svenska 2010-01-19  
Respiporc Flu3 : EPAR - All Authorised presentations SV = svenska 2010-01-19  
Respiporc Flu3 : EPAR - All Authorised presentations SV = svenska 2010-01-19  
Respiporc Flu3 : EPAR - All Authorised presentations SV = svenska 2010-01-19  
Respiporc Flu3 : EPAR - All Authorised presentations SV = svenska 2010-01-19  
Respiporc Flu3 : EPAR - All Authorised presentations SV = svenska 2010-01-19  
Respiporc Flu3 : EPAR - All Authorised presentations SV = svenska 2010-01-19  
Respiporc Flu3 : EPAR - All Authorised presentations SV = svenska 2010-01-19  
Respiporc Flu3 : EPAR - All Authorised presentations SV = svenska 2010-01-19  
Respiporc Flu3 : EPAR - All Authorised presentations SV = svenska 2010-01-19  
Respiporc Flu3 : EPAR - All Authorised presentations SV = svenska 2010-01-19  
Respiporc Flu3 : EPAR - All Authorised presentations SV = svenska 2010-01-19  
Respiporc Flu3 : EPAR - All Authorised presentations SV = svenska 2010-01-19  
Respiporc Flu3 : EPAR - All Authorised presentations SV = svenska 2010-01-19  
Respiporc Flu3 : EPAR - All Authorised presentations SV = svenska 2010-01-19  
Respiporc Flu3 : EPAR - All Authorised presentations SV = svenska 2010-01-19  
Respiporc Flu3 : EPAR - All Authorised presentations SV = svenska 2010-01-19  
Respiporc Flu3 : EPAR - All Authorised presentations SV = svenska 2010-01-19  
Respiporc Flu3 : EPAR - All Authorised presentations SV = svenska 2010-01-19  
Respiporc Flu3 : EPAR - All Authorised presentations SV = svenska 2010-01-19  
Respiporc Flu3 : EPAR - All Authorised presentations SV = svenska 2010-01-19  
Respiporc Flu3 : EPAR - All Authorised presentations SV = svenska 2010-01-19  
Respiporc Flu3 : EPAR - All Authorised presentations SV = svenska 2010-01-19  
Respiporc Flu3 : EPAR - All Authorised presentations SV = svenska 2010-01-19  

Pharmacotherapeutic group

Immunologicals

Therapeutic indication

Active immunisation of pigs from the age of 56 days onwards, including pregnant sows, against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection.

Onset of immunity: 7 days after primary vaccination

Duration of immunity: 4 months in pigs vaccinated between the age of 56 and 96 days and 6 months in pigs vaccinated for the first time at 96 days and above.

Active immunisation of pregnant sows after finished primary immunisation by administration of a single dose 14 days prior to farrowing to develop high colostral immunity, which provides clinical protection of piglets for at least 33 days after birth.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Respiporc Flu3 : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2015-01-21 2017-09-25

Initial marketing-authorisation documents