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Advasure
Adjuvanted vaccine against classical swine fever

15/20

authorised

no

Medicinal


Medicinal Product no longer authorised

PACKAGE LEAFLET


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


    Marketing authorisation holder:

    Pfizer Ltd. Sandwich

    Kent, CT13 9NJ

    United Kingdom


    Manufacturer responsible for batch release:

    Bayer AG

    Business Group Animal Health Osterather Strasse 1a

    D-50739 Köln

    Germany


  2. NAME OF THE VETERINARY MEDICINAL PRODUCT


    Advasure


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


    Per dose of 2 ml:


    Active substance


    E2 glycoprotein of Classical Swine Fever (CSF) virus minimum 32 µg


    Adjuvant


    Adjuvant composition - Double oil emulsion:

    Mineral oil 0.64 ml

    Emulsifiers 0.064 ml

    Phosphate buffered saline 0.63 ml


    Preservative:

    Thiomersal maximum 1:10,000


  4. INDICATION(S)


    Active immunisation of pigs, over the age of 2 weeks, against Classical Swine Fever (CSF), to prevent mortality, reduce clinical signs of the disease and the excretion of field virus.

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


  5. CONTRAINDICATIONS


    None

    Medicinal Product no longer authorised

  6. ADVERSE REACTIONS


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


  7. TARGET SPECIES


    Pigs


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


    The dosage for pigs, over 2 weeks, is 2 ml of the vaccine Intramuscular injection


  9. ADVICE ON CORRECT ADMINISTRATION


    The vaccine is to be administered aseptically by intramuscular injection closely behind the ear of the pig.

    The pigs should be vaccinated in time before the expected exposure to the field virus, preferably prior to housing (crowding) or transfer to new groups. It is strongly recommended to vaccinate all pigs in the herd.


    The dosage for pigs, over the age of 2 weeks, is 2 ml of the vaccine.


    In emergency situations the basic immunisation consists of one intramuscular injection with one dose (2 ml) for all pigs over the age of 2 weeks, irrespective of the level of maternal antibodies.

    Depending on the infection pressure and the disease situation sows and piglets over the age of 2 weeks (irrespective of the level of maternal antibodies) may be vaccinated twice with one dose (2 ml), 4–6 weeks apart. For fattening pigs over the age of 10 weeks, however, one intramuscular injection with one dose is administered.


    Re-vaccination:

    one dose (2 ml) at 6 months intervals.


    Can be used during pregnancy. The vaccine has been shown to prevent transplacental transmission of low virulence strains after two vaccinations of the sow. However it may not prevent transplacental transmission of highly virulent strains from the sow to the foetuses.


  10. WITHDRAWAL PERIOD


    Zero days


  11. SPECIAL STORAGE PRECAUTIONS


    Store out of reach and sight of children.

    Store at 2°C – 8°C Do not freeze. Protect from light. Do not use after the expiry date stated on the label.

    Medicinal Product no longer authorised

  12. SPECIAL WARNING(S)


    The use of immunosuppressive veterinary medicinal products (e.g. corticosteroids) or modified live Porcine Reproductive and Respiratory Syndrome (PRRS) vaccines within 7 days before and 7 days after application of Advasure may interfere with the induction of immunity and should therefore be avoided.

    Do not mix with any other vaccine/immunological product. 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. 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 insert 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 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


    13-02-2006


  15. OTHER INFORMATION


The Classical Swine Fever (CSF, Hog Cholera) virus, a member of the Pestivirus genus, carries a number of structural and non-structural glycoproteins, e.g. E2, E1, Erns, gp54, gp80. The E2 glycoprotein is considered to be the main immunogen of the CSF virus against which the neutralising antibodies are directed. The gene coding for the E2 glycoprotein (E2 gene) is a rather conserved region. The E2 glycoprotein is considered to be immunologically cross-reactive with all field strains.

Medicinal Product no longer authorised

Immunological properties:

The vaccine, as formulated with the mineral oil and the emulsifiers, induces protection in pigs against clinical signs caused by the Classical Swine Fever (CSF) virus. As a consequence of the subunit nature of the vaccine, vaccination does not induce production of antibodies against CSF virus antigens, other than E2.


For any information about this veterinary medicinal product, please contact the local representative of the Marketing Authorisation Holder.


België/Belgique/Belgien


Tel./Tél.: +32 (0)2 554 62 11

Luxembourg/Luxemburg


Tél.: + 32 (0)2 554 62 11


Danmark


Tlf: +45 49 12 76 65

Nederland


Tel: +31 (0)10 4064 600


Deutschland


Tel: +49 (0)721 6101 438

Österreich


Tel: +43 (0)1 52 11 57 20


Greece


Tel: +30 210 7517981

Portugal


Telefone: +351 21 2278200


España


Teléfono: +34 91 4909900

Suomi/Finland


Telephone: +358 (0)9 4300 40


France


Téléphone: +33 (0)1 58 07 46 00

Sverige


Tel: +46 (0)8 623 64 40


Ireland


Telephone: +353 (0)1 408 9700

United Kingdom


Telephone: +44 (0)1304 616161


Italia


Telefono: +39 06 3318 2933

Czech Republic


Tel: +420 283 004 111


Hungary


Tel: +361 488 3695

Malta


Tel: +356 21 465 797


Eesti


Tel: +370 5 269 17 96

Polska


Tel: +48 22 550 42 32

Medicinal Product no longer authorised

Slovenija


Tel: +386 (0) 1 52 11 670

Slovenská republika


Tel: +420 283 004 111


Cyprus


Tel: +30 210 7517981

Latvija


Tel: +370 5 269 17 96


Lietuva


Tel: +370 5 269 17 96