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.
This EPAR was last updated on 14/04/2014 .
04/04/2014 Porcilis Porcoli Diluvac Forte (previously Porcilis Porcoli) -EMEA/V/C/000024 -IG/0420
- 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.
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).
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||14/09/2006||14/04/2014|
Initial marketing-authorisation documents
|Name||Language||First published||Last updated|
|Porcilis Porcoli : EPAR - Scientific Discussion||SV = svenska||01/10/2008||21/07/2011|
|Porcilis Porcoli : EPAR - Procedural steps taken before authorisation||SV = svenska||14/09/2006|
This medicine is approved for use in the European Union