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AstraZeneca

Zulvac 8 Bovis
inactivated bluetongue virus, serotype 8

Medicinal product no longer authorised


Medicinal product no longer authorised

PACKAGE LEAFLET FOR:

ZULVAC 8 Bovis suspension for injection for cattle


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


    Marketing authorisation holder: Zoetis Belgium SA

    Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM


    Manufac turer responsible for batc h releas e: Zoetis Manufacturing & Research Spain, S.L. Ctra. Camprodon s/n "la Riba"

    17813 Vall de Bianya

    Girona SPAIN


  2. NAME OF THE VETERINARY MEDICINAL PRODUCT


    ZULVAC 8 Bovis suspension for injection for cattle


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


    One dose of 2 ml of vaccine contains:

    Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02 RP* ≥ 1


    *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in cattle.


    Adjuvants:

    Aluminium hydroxide (Al3+) 4 mg

    Saponin 0.4 mg


    Excipient:

    Thiomersal 0.2 mg


  4. INDICATION(S)


    Active immunisation of cattle from 3 months of age for the prevention* of viraemia caused by bluetongue virus, serotype 8.

    *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome) Onset of immunity: 25 days after administration of the second dose.

    The duration of immunity is at least 1 year after the primary vaccination course.

    Medicinal product no longer authorised

  5. CONTRAINDICATIONS


    None.


  6. ADVERSE REACTIONS


    In one laboratory safety study, no adverse reactions were observed after the first injection of a single dose of vaccine to calves.

    After the second injection of a single dose, a slight and transient but significant increase in the mean rectal temperature of 0.4ºC was very commonly recorded in the vaccinated calves during the first 24 hours. On day 2 after vaccination, rectal temperatures had returned to normal values. This clinical sign has been reported very rarely from the field.


    The frequency of adverse reactions is defined using the following convention:

    • very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one

      treatment)

    • common (more than 1 but less than 10 animals in 100 animals)

    • uncommon (more than 1 but less than 10 animals in 1,000 animals)

    • rare (more than 1 but less than 10 animals in 10,000 animals)

    • very rare (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


    Cattle


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


    Intramuscular use.

    Apply usual aseptic procedures.

    Shake gently immediately before use. Avoid bubble formation, as this can be irritating at the site of injection. The entire content of the bottle should be used immediately after broaching and during the same procedure. Avoid multiple vial broaching.


    Primary vaccination:

    Administer one dose of 2 ml according to the following vaccination scheme:

    1st injection: from 3 months of age. 2nd injection: after 3 weeks.


    Revaccination:

    Any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.


  9. ADVICE ON CORRECT ADMINISTRATION


    In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multi- injection type vaccination system when larger dose presentations are used.

    Medicinal product no longer authorised

  10. WITHDRAWAL PERIOD


    Zero days


  11. SPECIAL STORAGE PRECAUTIONS


    Keep out of the sight and reach of children. Store and transport refrigerated (2 °C – 8 °C). Protect from light.

    Do not freeze

    Once broached use immediately.

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


  12. SPECIAL WARNING(S)


    Spec ial w arnings for eac h target species :

    Use in other domestic and wild ruminant species that are considered at risk of infection should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination. The level of efficacy for other species may differ from that observed in cattle.


    No information is available on the use of the vaccine in animals with maternally derived antibodies however the vaccine has been shown safe and efficacious in seropositive cattle.


    Spec ial prec autions for use in animals: Only use in healthy animals


    Pregnanc y:

    Can be used during pregnancy.


    Fertilit y:

    The safety and the efficacy of the vaccine have not been established in breeding males. In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or national Competent Authorities on the current vaccination policies against BTV.


    Interac tion w ith other medic inal produc ts and other forms of interac tion:

    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.


    Inc ompatib ilit ies:

    Do not mix with any other veterinary medicinal product.


    Overdose:

    After administration of a double dose, a slight and transient but significant increase in the mean rectal temperature of 0.7 ºC was recorded in the vaccinated calves during the first 24 hours. On day 2 after vaccination, rectal temperatures had returned to normal values. Local reactions of more than 2 cm are common after 2 fold overdose while reactions of up to 5 cm may occasionally occur after overdose administration, these resolve within a maximum of 57 days.

    Medicinal product no longer authorised

  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. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help 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 (https://w w w.ema. europa. eu/).


  15. OTHER INFORMATION


Pack sizes

Pack of 1 bottle of 10 doses (20 ml).

Pack of 1 bottle of 50 doses (100 ml).

Not all pack sizes may be marketed.


The manufacture, import, possession, sale, supply and/or use of ZULVAC 8 Bovis may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation. Any person intending to manufacture, import, possess, sell, supply and use ZULVAC 8 Bovis must consult the relevant Member State’s competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.


For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.


België/Belgique/Belgien Zoetis Belgium SA Tél/Tel.: +32 (0) 800 99 189

Lietuva

Oriola Vilnius UAB

Tel: +370 610 05088


Република България

Zoetis Belgium SA

Teл: +359 2 4775791

Luxembourg/Luxemburg Zoetis Belgium SA Tél/Tel.: +352 8002 4026


Česká republika

Zoetis Česká republika, s.r.o.

Tel: +420 257 101 111

Magyarország Zoetis Hungary Kft. Tel: +361 224 5222


Danmark

Zoetis Finland Oy

Tlf: +358 (0)9 4300 40

Malta

Agrimed Limited

Tel: +356 21 465 797


Deutschland

Zoetis Deutschland GmbH Tel: +49 30 330063 0

Nederland

Zoetis B.V.

Tel: +31 (0)10 714 0900


Eesti

Oriola Vilnius UAB

Tel: +370 610 05088

Norge

Zoetis Finland Oy

Tlf: +358 (0)9 4300 40

Medicinal product no longer authorised

Ελλάδα

Zoetis Hellas S.A.

Τηλ.: +30 210 6791900

Österreich

Zoetis Österreich GmbH Tel: +43 1 2701100 110


España

Zoetis Spain, S.L. Tel: +34 91 4191900

Polska

Zoetis Polska Sp. z o.o. Tel: +48 22 2234800


France

Zoetis France

Tél: +33 (0)810 734 937

Portugal

Zoetis Portugal, Lda. Tel: + 351 21 042 72 00


Hrvatsk a

Zoetis B.V., Podružnica Zagreb za promidžbu Tel: +385 1 644 1460

România

Zoetis România S.R.L Tel : +40 21 202 3083


Ireland

Zoetis Belgium SA

Tel: +353 (0) 1 256 9800

Slovenija

Zoetis B.V., Podružnica Zagreb za promidžbu Tel: +385 1 644 1460


Ìsland

Zoetis Finland Oy

Sími: +358 (0)9 4300 40

Slovenská republika

Zoetis Česká republika, s.r.o.

Tel: +420 257 101 111


Italia

Zoetis Italia S.r.l.

Tel: +39 06 3366 8133

Suomi/Finland

Zoetis Finland Oy

Puh/Tel: +358 (0)9 4300 40


Kύπρος

Zoetis Hellas S.A.

Τηλ.: +30 210 6791900

Sverige

Zoetis Finland Oy

Tel: +358 (0)9 4300 40


Latvija

Oriola Vilnius UAB

Tel: +370 610 05088

United Kingdom

Zoetis UK Limited

Tel: +44 (0) 845 300 8034