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AstraZeneca

Gripovac 3
inactivated influenza-A virus, swine

16

Medicinal product no longer authorised


PACKAGE LEAFLET FOR:


Gripovac 3 Suspension for injection for pigs


authorised

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


    Marketingauthorisationholder: MERIAL

    29 avenue Tony Garnier 69007 Lyon,

    France


    Manufacturerresponsibleforbatchrelease: IDT Biologika GmbH

    Am Pharmapark

    06861 Dessau-Rosslau Germany


  2. NAME OF THE VETERINARY MEDICINAL PRODUCT


    Gripovac 3 suspension for injection for pigs


    no

  3. STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS


    Clear, yellowish orange to pink colored suspension for injection. Each dose of 2 ml contains:


    Active substances:

    Strains of inactivated Influenza A virus/swine/

    Bakum/IDT1769/2003 (H3N2) ≥ 10.53 log2 GMNU1

    Haselünne/IDT2617/2003 (H1N1) ≥ 10.22 log2 GMNU1

    Bakum/1832/2000 (H1N2) ≥ 12.34 log2 GMNU1


    Medicinal

    1 GMNU = Geometric mean of neutralizing units induced in Guinea pigs after twice immunisation with 0.5 ml of this vaccine.


    Adjuvant:

    Carbomer 971 P NF 2.0 mg


    Excipient:

    Thiomersal 0.21 mg


  4. INDICATION(S)


    Active immunisation of pigs from the age of 56 days onwards including pregnant sows against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection.


    Onset of immunity: 7 days after primary vaccination

    Duration of immunity: 4 months in pigs vaccinated between the age of 56 and 96 days and 6 months in pigs vaccinated for the first time at 96 days and above.

    Active immunisation of pregnant sows after finished primary immunisation by administration of a single dose 14 days prior to farrowing to develop high colostral immunity which provides clinical protection of piglets for at least 33 days after birth.


    authorised

  5. CONTRAINDICATIONS


    None.


  6. ADVERSE REACTIONS


    A transient slight swelling may occur on very rare occasions after vaccination at the site of injection, regressing within 2 days. On very rare occasions, a slight transient rectal temperature increase might occur after vaccination (“very rare” corresponds to a frequency of adverse reactions less than 1 animal in 10,000 animals, including isolated reports).

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


  7. TARGET SPECIES


    Pigs


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

    no

    For intramuscular use. Piglets:

    Primary vaccination: 2 injections of one dose (2 ml)

    • From the age of 96 days, with an interval of 3 weeks between injections to achieve duration of immunity over 6 months.

      or

    • Between the age of 56 and 96 days, with an interval of 3 weeks between injections to achieve duration of immunity over 4 months.


    Gilts and sows:

    Medicinal

    Primary vaccination: see above

    A booster is possible at each stage of pregnancy and lactation. When vaccination is performed 14 days prior to farrowing with one dose (2 ml), it provides maternally-derived immunity to the piglets which

    protects them from clinical signs of influenza at least until day 33 after birth.


    Maternally-derived immunity in the piglets interacts with antibody induction. Generally, maternally- derived antibodies induced by vaccination last for approx. 5-8 weeks after birth. In particular cases of multiple contacts of the sows with antigens (field infections + vaccination) the antibodies transmitted to the piglets may last until week 12 of life. In the latter case piglets should be vaccinated after the age of 96 days.


  9. ADVICE ON CORRECT ADMINISTRATION


    None.

  10. WITHDRAWAL PERIOD


    Zero days


    authorised

  11. SPECIAL STORAGE PRECAUTIONS


    Keep out of the sight and reach of children.

    Store in a refrigerator (2 ºC − 8 ºC). Do not freeze.

    Keep the vial in the outer carton in order to protect from light. Shelf-life after first opening the container: 10 hours.

    Do not use this veterinary medicinal product after the expiry date which is stated on the label and

    carton after EXP.


  12. SPECIAL WARNINGS


    Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto animals:

    In case of accidental self-injection only a minor injection site reaction is expected.


    Pregnancyandlactation:

    The vaccine can be used during pregnancy and lactation.


    Interactionwithothermedicinalproductsandotherformsofinteraction:

    no

    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.


    Incompatibilities:

    Do not mix with any other medicinal product.


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


    Medicines should not be disposed of via wastewater or household waste.

    Medicinal

    Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required. These measures should help to protect the environment.


  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

    .

  15. OTHER INFORMATION


authorised

The vaccine stimulates an active immunity against Swine Influenza A virus subtypes H1N1, H3N2 and H1N2. It induces neutralizing and haemagglutination inhibiting antibodies against each of the three subtypes. When a single dose of the vaccine is administered 14 days prior to farrowing as a booster to previously vaccinated sows, the vaccine stimulates active immunity in order to provide maternally-derived immunity to the progeny against Swine Influenza A virus subtypes H1N1, H3N2 and H1N2.


Package sizes:

Cardboard box with 1 glass or PET vial of 10 doses (20 ml), 25 doses (50 ml) or 50 doses (100 ml) with a rubber stopper and flanged cap.


Medicinal

no

Not all pack sizes may be marketed.