Porcilis Porcoli Diluvac Forte (previously Porcilis Porcoli)

F4ab (K88ab) fimbrial adhesin / F4ac (K88ac) fimbrial adhesin / F5 (K99) fimbrial adhesin / F6 (987P) fimbrial adhesin / LT toxoid

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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 Porcilis Porcoli Diluvac Forte?

Porcilis Porcoli Diluvac Forte is a vaccine for use in pigs. It is a suspension for injection and contains the active substances F4ab, F4ac, F5, F6 and LT toxoid.

What is Porcilis Porcoli Diluvac Forte used for?

Porcilis Porcoli Diluvac Forte is used to reduce death and clinical signs of enterotoxicosis caused by E. coli bacteria in piglets during the first days of their life. Enterotoxicosis is a reaction in the intestines to toxins produced by some bacteria. Porcilis Porcoli Diluvac Forte is used to immunise against E. coli which have the adhesins (surface components) F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P). The vaccine is given to sows (female pigs) only. Their piglets then become immunised when they drink the colostrum (first milk).

Porcilis Porcoli Diluvac Forte is given as a dose of 2 ml by intramuscular (into a muscle) injection to female pigs. The vaccine is given in the neck in the area behind the ear. Female pigs that have not been vaccinated should be given two injections with an interval of six weeks between them. To maintain the immunity, a single injection should be given before each subsequent farrowing (giving birth to the piglets). It is preferable to vaccinate female pigs during the second half of their pregnancy, but not within two weeks before the expected date of farrowing.

How does Porcilis Porcoli Diluvac Forte work?

Porcilis Porcoli Diluvac Forte contains adhesins that are found on the surface of E. coli bacteria. When the sow is injected, this small exposure helps the pig’s immune system to recognise and attack the E. coli bacteria. When exposed to any of these bacteria later in life, the pig will either not become infected or have a much less serious infection. This immunity is passed onto the sow’s piglets through her colostrum.

How has the effectiveness of Porcilis Porcoli Diluvac Forte been studied?

The vaccine (or parts of the vaccine) has been studied in several trials in pregnant pigs of various breeds. These pigs were given two injections of the vaccine and then the litters of these pigs, as well as litters where the mother had not been vaccinated (controls), were exposed to E. coli containing the adhesins or LT toxin present in the vaccine. The main measure of effectiveness was the percentage cumulative mortality (overall death rate) of the piglets.

What benefit has Porcilis Porcoli Diluvac Forte shown during the studies?

Porcilis Porcoli Diluvac Forte reduced the death rate in all the studies when compared with the control piglets.

What are the side effects of Porcilis Porcoli Diluvac Forte?

Porcilis Porcoli Diluvac Forte can cause mild, temporary clinical reactions (fever, lethargy, reduced food intake) during the first 24 hours after vaccination. There may be redness and / or a swelling at the injection site for up to two weeks after vaccination.

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

If someone is accidentally injected with this product, they should seek immediate medical advice immediately. The package leaflet should be taken to the doctor.

Why has Porcilis Porcoli Diluvac Forte been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Porcilis Porcoli Diluvac Forte, to reduce death and clinical signs of enterotoxicosis caused by E. coli bacteria, are greater than any risks. They recommended that Porcilis Porcoli Diluvac Forte should be given a marketing authorisation. The benefit-risk balance may be found in the scientific-discussion document available under the 'assessment history' tab.

Other information about Porcilis Porcoli Diluvac Forte

The European Commission granted a marketing authorisation valid throughout the European Union for Porcilis Porcoli Diluvac Forte to Intervet International B.V. on 2 May 2002. Information on the prescription status of this product may be found on the outer package.

Name Language First published Last updated
Porcilis Porcoli Diluvac Forte: EPAR - summary for the public BG = bălgarski 2006-09-14 2013-02-28
Porcilis Porcoli Diluvac Forte: EPAR - summary for the public ES = español 2006-09-14 2013-02-28
Porcilis Porcoli Diluvac Forte: EPAR - summary for the public CS = čeština 2006-09-14 2013-02-28
Porcilis Porcoli Diluvac Forte: EPAR - summary for the public DA = dansk 2006-09-14 2013-02-28
Porcilis Porcoli Diluvac Forte: EPAR - summary for the public DE = Deutsch 2006-09-14 2013-02-28
Porcilis Porcoli Diluvac Forte: EPAR - summary for the public ET = eesti keel 2006-09-14 2013-02-28
Porcilis Porcoli Diluvac Forte: EPAR - summary for the public EL = elliniká 2006-09-14 2013-02-28
Porcilis Porcoli Diluvac Forte: EPAR - summary for the public EN = English 2006-09-14 2013-02-28
Porcilis Porcoli Diluvac Forte: EPAR - summary for the public FR = français 2006-09-14 2013-02-28
Porcilis Porcoli Diluvac Forte: EPAR - summary for the public IT = italiano 2006-09-14 2013-02-28
Porcilis Porcoli Diluvac Forte: EPAR - summary for the public LV = latviešu valoda 2006-09-14 2013-02-28
Porcilis Porcoli Diluvac Forte: EPAR - summary for the public LT = lietuvių kalba 2006-09-14 2013-02-28
Porcilis Porcoli Diluvac Forte: EPAR - summary for the public HU = magyar 2006-09-14 2013-02-28
Porcilis Porcoli Diluvac Forte: EPAR - summary for the public MT = Malti 2006-09-14 2013-02-28
Porcilis Porcoli Diluvac Forte: EPAR - summary for the public NL = Nederlands 2006-09-14 2013-02-28
Porcilis Porcoli Diluvac Forte: EPAR - summary for the public PL = polski 2006-09-14 2013-02-28
Porcilis Porcoli Diluvac Forte: EPAR - summary for the public PT = português 2006-09-14 2013-02-28
Porcilis Porcoli Diluvac Forte: EPAR - summary for the public RO = română 2006-09-14 2013-02-28
Porcilis Porcoli Diluvac Forte: EPAR - summary for the public SK = slovenčina 2006-09-14 2013-02-28
Porcilis Porcoli Diluvac Forte: EPAR - summary for the public SL = slovenščina 2006-09-14 2013-02-28
Porcilis Porcoli Diluvac Forte: EPAR - summary for the public FI = suomi 2006-09-14 2013-02-28
Porcilis Porcoli Diluvac Forte: EPAR - summary for the public SV = svenska 2006-09-14 2013-02-28

This EPAR was last updated on 14/04/2014 .

Authorisation details

Product details

Product details for Porcilis Porcoli Diluvac Forte (previously Porcilis Porcoli)
NamePorcilis Porcoli Diluvac Forte (previously Porcilis Porcoli)
Agency product numberEMEA/V/C/000024
Active substance

F4ab (K88ab) fimbrial adhesin / F4ac (K88ac) fimbrial adhesin / F5 (K99) fimbrial adhesin / F6 (987P) fimbrial adhesin / LT toxoid

International non-proprietary name (INN) or common name

vaccine to provide passive immunity to the progeny against E. coli in pigs

Species Pigs (gilts and sows)
Anatomical therapeutic chemical veterinary (ATCvet) codeQI09AB02

Publication details

Publication details for Porcilis Porcoli Diluvac Forte (previously Porcilis Porcoli)
Marketing-authorisation holder

Intervet International BV

Revision7
Date of issue of marketing authorisation valid throughout the European Union29/02/1996

Contact address:

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

Product information

Product information

04/04/2014  Porcilis Porcoli Diluvac Forte (previously Porcilis Porcoli) -EMEA/V/C/000024 -IG/0420

Name Language First published Last updated
Porcilis Porcoli : EPAR - Product Information SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - Product Information SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - Product Information SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - Product Information SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - Product Information SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - Product Information SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - Product Information SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - Product Information SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - Product Information SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - Product Information SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - Product Information SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - Product Information SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - Product Information SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - Product Information SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - Product Information SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - Product Information SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - Product Information SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - Product Information SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - Product Information SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - Product Information SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - Product Information SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - Product Information SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - Product Information SV = svenska 2006-09-14 2011-07-21

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
Porcilis Porcoli : EPAR - All Authorised presentations SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - All Authorised presentations SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - All Authorised presentations SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - All Authorised presentations SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - All Authorised presentations SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - All Authorised presentations SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - All Authorised presentations SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - All Authorised presentations SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - All Authorised presentations SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - All Authorised presentations SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - All Authorised presentations SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - All Authorised presentations SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - All Authorised presentations SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - All Authorised presentations SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - All Authorised presentations SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - All Authorised presentations SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - All Authorised presentations SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - All Authorised presentations SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - All Authorised presentations SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - All Authorised presentations SV = svenska 2006-09-14 2011-07-21
Porcilis Porcoli : EPAR - All Authorised presentations SV = svenska 2006-09-14 2011-07-21

Pharmacotherapeutic group

Immunologicals

Therapeutic indication

For the passive immunisation of piglets by active immunisation of sows / gilts to reduce mortality and clinical signs such as diarrhoea due to neonatal enterotoxicosis during the first days of life, caused by those E.coli strains which express the fimbrial adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Porcilis Porcoli Diluvac Forte: EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2006-09-14 2014-04-14

Initial marketing-authorisation documents

Name Language First published Last updated
Porcilis Porcoli : EPAR - Scientific Discussion SV = svenska 2008-10-01 2011-07-21
Porcilis Porcoli : EPAR - Procedural steps taken before authorisation SV = svenska 2006-09-14