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PACKAGE LEAFLET

B.

Medicinal product no longer authorised

PACKAGE LEAFLET

authorised

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

   
   

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

   The Netherlands

   
   

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

   
   

   Porcilis Pesti emulsion for injection for pigs

   
   

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

   
   

   Each dose of 2 ml contains:

   120 Elisa Units Classical Swine Fever Virus-E2 subunit antigen Liquid paraffin as adjuvant: 941.4 mg

   
   

4. INDICATION(S)

   
   

   no

   Active immunisation of pigs from the age of 5 weeks onwards to prevent mortality and to reduce clinical signs of Classical Swine Fever, as well as to reduce infection with and excretion of CSF field virus.

   The onset of protection is 2 weeks. The duration of protection is 6 months.

   
   

5. CONTRAINDICATIONS

   
   

   None

   
   

6. ADVERSE REACTIONS

   
   

   Medicinal

   A local and in most cases transient swelling at the injection site may occur up to 4 weeks after administration of each dose of the vaccine. Transient hyperthermia may occur post the second dose.

   Abscesses may be observed at the injection site. Since safety after giving both inoculations at the same site has not been examined, it is advised to carry out the second vaccination at a different site than the first vaccination.

   
   

   If you notice any serious side effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

   
   

7. TARGET SPECIES

   
   

   Pigs

8. DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION

   
   

   authorised

   Administer one dose (2 ml) by deep intramuscular injection in the neck area behind the ear. Vaccination scheme:

   Basic vaccination: Inject one dose per pig followed by a second injection 4 weeks after the first injection. Re-vaccination: Every 6 months, using a single dose.

   
   

9. ADVICE ON CORRECT ADMINISTRATION

   
   

   Shake well before use.

   Before use, allow the vaccine to reach room temperature. Use sterile syringes and needles.

   It is recommended to use a closed multiject vaccination system.

   
   

10. WITHDRAWAL PERIOD

    
    

    Zero days

    
    

11. SPECIAL STORAGE PRECAUTIONS

    
    

    Keep out of the reach and sight of children. Store in a refrigerator (2°C to 8°C).

    no

    Do not freeze.

    Shelf-life after first broaching the bottle: 3 hours.

    Do not use after the expiry date which is stated on the label.

    
    

12. SPECIAL WARNINGS

    Vaccinate only healthy animals. To the user:

    This product contains mineral oil. Accidental injection/self injection may result in severe pain and

    swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.

    Medicinal

    If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.

    If pain persists for more than 12 hours after medical examination, seek medical advice again.

    
    

    To the physician:

    This product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.

    
    

    The product can be used during pregnancy but may not prevent transplacental transmission of Classical swine fever field virus from the sow to foetuses.

    
    

    No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.

    authorised

    After administration of an overdose, local reactions at the injection site may be more pronounced. Do not mix with any other veterinary medicinal product.

    The import, sale, supply and/or use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of CSF (Council Directive 80/217/EEC, as amended). Any person intending to import, sell, supply and/or use the veterinary medicinal product must be authorised by the competent authority of the Member State.

    
    

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

    
    

    Detailed information on this product is available on the website of the European Medicines Agency (EMA)

    .

    
    

15. OTHER INFORMATION

no

As a consequence of the subunit nature of the vaccine, vaccination does not induce production of antibodies against CSF virus antigen, other than E2.

50 ml/100 ml/250 ml multidose glass bottle 50 ml/100 ml/250 ml multidose PET bottle

Medicinal

Not all pack sizes may be marketed.