PACKAGE LEAFLET FOR

PORCILIS PORCOLI DILUVAC FORTE

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT

   
   

   Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer

   The Netherlands

   
   

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

   
   

   Porcilis Porcoli Diluvac Forte suspension for injection

   
   

3. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)

   
   

   Each dose of two ml contains the F4ab (K88ab) fimbrial adhesin, the F4ac (K88ac) fimbrial adhesin, the F5 (K99) fimbrial adhesin, the F6 (987P) fimbrial adhesin and of LT toxoid, which induce a mean antibody titre of respectively ≥ 9.0 log2 Ab titre, ≥ 5.4 log2 Ab titre, ≥ 6.8 log2 Ab titre, ≥ 7.1 log2 Ab titre, and 6.8 log2 Ab titre after vaccination of mice with a 1/20 sow dose. The antigens are adjuvanted with 150 mg dl-α-tocopherol acetate per dose.

   
   

4. INDICATION(S)

   
   

   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).

   
   

5. CONTRA-INDICATIONS

   
   

   None

   
   

6. ADVERSE REACTIONS

   
   

   A mean transient increase in body temperature of about 1°C, in some pigs up to 3 oC, may occur in the first 24 hours after vaccination. Reduced feed intake and listlessness may occur in approximately 10% of the animals on the day of vaccination, but returns to normal within 1-3 days. A transient swelling and redness at the injection site may be observed in approximately 5% of the animals. The diameter of the swelling is in general below 5 cm, but in some cases a larger size swelling may occur. Swelling and redness at the injection site may occasionally last for at least 14 days.

   
   

   If you notice any other side effects, please inform your veterinary surgeon.

   
   

7. TARGET SPECIES

   
   

   Pigs (sows/gilts)

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

   
   

   Intramuscular injection in sows/gilts of 2 ml of the vaccine per animal in the neck in the area behind the ear.

   
   

   Vaccination scheme:

   
   

   Basic vaccination: Sows/gilts which have not yet been vaccinated with the product shall be given an injection preferably 6 to 8 weeks before the expected date of farrowing followed by a second injection 4 weeks later.

   
   

   Revaccination: A single revaccination shall be carried out during the second half of each subsequent pregnancy, preferably 2 to 4 weeks before the expected date of farrowing.

   
   

9. ADVICE ON CORRECT ADMINISTRATION

   
   

   • Before using the vaccine allow it to reach room temperature.

   • Shake well before use.

   • Use sterile syringes and needles.

   • Avoid introduction of contamination.

   • Vaccinate only healthy animals.

   
   

10. WITHDRAWAL PERIOD

    
    

    Zero days

    
    

11. SPECIAL STORAGE PRECAUTIONS

    
    

    Store in a refrigerator (+2°C to +8°C). Do not freeze.

    Shelf-life after first opening: 3 hours.

    
    

12. SPECIAL WARNING(S)

    
    

    No information is available on the safety and efficacy from concurrent use of this vaccine with any other. It is therefore recommended that no other vaccine should be administered within 14 days before or after vaccination with this product.

    
    

    In the absence of incompatibility studies this vaccine must not be mixed with other veterinary medical products.

    
    

    In the case of accidental self-injection, seek medical advice immediately and show the package insert or label to the physician.

    
    

    Keep out of the reach and sight of children.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

    
    

    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

    
    

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

    
    

15. OTHER INFORMATION

Not all pack sizes may be marketed.

The fimbrial adhesins F4ab, F4ac, F5 and F6 are responsible for the adhesion and the virulence of E. coli strains, which cause neonatal enterotoxicosis in piglets. These immunogens are incorporated in an adjuvant in order to enhance a prolonged stimulation of immunity. Neonatal piglets derive passive immunity via ingestion of colostrum from vaccinated sows/gilts.

For animal treatment only.