PACKAGE LEAFLET:

Neocolipor

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

   
   

   MARKETING AUTHORISATION HOLDER

   Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein

   GERMANY

   
   

   MANUFACTURER FOR THE BATCH RELEASE

   Boehringer Ingelheim Animal Health France SCS Laboratoire Porte des Alpes

   Rue de l’Aviation

   F-69800 SAINT PRIEST FRANCE

   
   

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

   
   

   Neocolipor suspension for injection

   
   

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

   
   

   Per dose of 2 ml:

   E. coli adhesin F4 (F4ab, F4ac, F4ad), at least….2.1 SA.U*

   E. coli adhesin F5, at least………………………1.7 SA.U*

   E. coli adhesin F6, at least………………………1.4 SA.U*

   E. coli adhesin F41, at least…………………….1.7 SA.U*

   *: 1 SA.U: quantity sufficient to obtain an agglutinating antibody titre of 1 log10 in the guinea pig.

   Adjuvant:

   Aluminium (as hydroxide) ............................................................................................................. 1.4 mg

   
   

4. INDICATION(S)

   
   

   Adjuvanted inactivated vaccine for the reduction of neonatal enterotoxicosis of piglets, caused by E. coli strains, expressing the adhesins F4ab, F4ac, F4ad, F5, F6 and F41.

   
   

5. CONTRAINDICATIONS

   
   

   None.

   
   

6. ADVERSE REACTIONS

   Vaccination may cause a slight hyperthermia (less than 1.5°C during a maximum period of 24 hours). If you notice any serious effects or other effects not mentioned in this leaflet, please inform your

   veterinary surgeon.

7. TARGET SPECIES

   
   

   Pigs (sows and gilts)

   
   

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

   
   

   One 2 ml dose according to the following schedule: Primary vaccination:

   First injection: 5 to 7 weeks before farrowing Second injection: 2 weeks before farrowing.

   
   

   Revaccination:

   
   

   1 injection 2 weeks before each subsequent farrowing.

   
   

9. ADVICE ON CORRECT ADMINISTRATION

   Intramuscular injection in the neck in the area behind the ear. Shake the vial vigorously before use.

   Use sterile syringe and needles. Administer using aseptic procedures.

   
   

10. WITHDRAWAL PERIOD(S)

    
    

    Zero days.

    
    

11. SPECIAL STORAGE PRECAUTIONS

    
    

    Store and transport at 2°C - 8°C, protected from light. Do not freeze. Shelf life of broached vial: 3 hours.

    
    

12. SPECIAL WARNING(S)

    
    

    • Since the protection of piglets is ensured by colostrum intake, each piglet should ingest a sufficient quantity of colostrum within 6 hours of birth.

    • Vaccinate only healthy animals.

    • Do not administer in conjunction with other medicinal products.

    
    

    No information is available on the compatibility of this vaccine with any other. Therefore the safety and efficacy of this product when used with any other (either when used on the same day or at different times) has not been demonstrated.

    
    

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

    
    

    Wash and disinfect hands after use.

    
    

    No undesirable effects have been observed after the administration of twice the recommended dosage. Do not mix with any other vaccine.

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 the local requirements

    
    

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

    
    

    
    

15. OTHER INFORMATION

The vaccine contains the inactivated strains of E. coli expressing the adhesins F4ab, F4ac, F4ad, F5, F6 and F41, which cause neonatal enterotoxicosis in piglets, in aluminium hydroxide adjuvant. In sows and gilts, the vaccine induces the specific seroconversion of vaccinated animals; piglets are passively immunised by intake of colostrum and milk containing adhesin-specific antibodies.

Box of 5-dose 10 ml vial (glass type I vial with butyl rubber stopper). Box of 10-dose 20 ml vial (glass type I vial with butyl rubber stopper). Box of 25-dose 50 ml vial (glass type I vial with butyl rubber stopper). Box of 50-dose 100 ml vial (glass type I vial with butyl rubber stopper). Not all pack sizes may be marketed.

Veterinary medicinal product subject to prescription.