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AstraZeneca

Vectormune FP ILT + AE
fowlpox, avian infectious laryngotracheitis vaccine (live, recombinant) and avian encephalomyelitis vaccine (live)


PACKAGE LEAFLET:

Vectormune FP ILT + AE

Lyophilisate and solvent for suspension for injection for chickens


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


    Marketing authorisation holder and manufacturer responsible for batch release:


    Ceva-Phylaxia Co. Ltd. 1107 Budapest, Szállás u. 5. Hungary


  2. NAME OF THE VETERINARY MEDICINAL PRODUCT


    Vectormune FP ILT + AE lyophilisate and solvent for suspension for injection for chickens


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


    Each dose (0.01 ml) contains:


    Active substances:

    Live recombinant fowlpox virus expressing the membrane fusion protein and the encapsidation protein of avian infectious laryngotracheitis virus (rFP-LT) 2.7 to 4.5 log10 TCID50*


    Avian encephalomyelitis virus, strain Calnek 1143 (AE) 2.7 to 4.5 log10 EID50**


    * 50% Tissue Culture Infective Dose

    ** 50% Egg Infective Dose


    Lyophilisate: whitish-brownish. Solvent: clear, blue liquid.


  4. INDICATION(S)


    For active immunisation of chickens of 8 to 13 weeks of age in order to reduce the clinical signs (skin lesions) due to fowlpox, to reduce the clinical signs and tracheal lesions due to avian infectious laryngotracheitis and to prevent egg production losses due to avian encephalomyelitis.


    Onset of immunity

    Fowlpox and avian infectious laryngotracheitis: 3 weeks after vaccination Avian encephalomyelitis: 20 weeks after vaccination


    Duration of immunity:

    Fowlpox: 34 weeks after vaccination

    Avian infectious laryngotracheitis and avian encephalomyelitis: 57 weeks after vaccination.


  5. CONTRAINDICATIONS


    None.

  6. ADVERSE REACTIONS


    Small swelling/scabs typical of folwpox vaccine take are very common and should disappear within 14 days after vaccination.


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

    • very common (more than 1 in 10 animals treated displaying adverse reaction(s))

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

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

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

    • very rare (less than 1 animal in 10,000 animals treated, including isolated reports).


    If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.


  7. TARGET SPECIES


    Chickens


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


    Wing web-stab use

    The vaccine is to be administered once from 8 weeks of age and not later than 4 weeks before the onset of lay. The injection volume is 0.01 ml (10µl). The vaccine is delivered by transfixion of the inner side of the wing web with the help of a pronged-applicator. The applicator is inserted from beneath through the wing web and care should be taken to push the feathers aside so as to avoid damaging the blood vessels.

    The wing web should be slightly stretched.


    Proposed dilutions for administration:


    Number of vaccine ampoules

    Volume of solvent to be used

    Volume of one dose

    1 x 1000 doses

    10 ml

    0.01 ml

    1 x 2000 doses

    20 ml

    0.01 ml


  9. ADVICE ON CORRECT ADMINISTRATION


Preparation of vaccine suspension for injection:

  1. Using a sterile syringe fitted with at least a 20-18 gauge needle, withdraw 4 to 5 ml of solvent from the solvent vial and inject into the vial containing the lyophilisate (freeze-dried vaccine). Swirl gently until the lyophilisate has dissolved.

  2. Draw up the reconstituted vaccine suspension into the syringe and inject into the solvent vial.

  3. Then take 4-5 ml of the diluted vaccine suspension from the solvent vial, use it to rinse the vaccine vial and transfer it back into the solvent vial.


  1. WITHDRAWAL PERIOD(S)


    Zero days.


  2. SPECIAL STORAGE PRECAUTIONS

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

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

    Shelf life after reconstitution according to directions: 2 hours.


  3. SPECIAL WARNING(S)


    Special warnings for each target species: Vaccinate healthy birds only.


    Special precautions for use in animals:

    The avian encephalomyelitis virus vaccine strain can spread to unvaccinated chickens. Special precautions should be taken to avoid spreading of the vaccine strain to unvaccinated chickens.


    Special precautions to be taken by the person administering the veterinary medicinal product to animals:

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


    Lay:

    Do not use in birds in lay or within 4 weeks before the start of the laying period.


    Interaction with other medicinal products and other forms of interaction:

    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.


    Overdose (symptoms, emergency procedures, antidotes): Ten times the maximum dose was shown to be safe.


    Major incompatibilities:

    Do not mix with any other veterinary medicinal product except the solvent supplied for use with the veterinary medicinal product.


  4. 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 product should be disposed of in accordance with local requirements.


  5. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED


    ).


  6. OTHER INFORMATION


For avian encephalomyelitis, serological data suggest that the maximum seroconversion rate is reached between 4 and 7 weeks after vaccination and is maintained until 57 weeks after vaccination.


For fowlpox, increased speed of cicatrisation is observed until 49 weeks after vaccination.

Lyophilisate: Type I glass vial containing, 1000 or 2000 doses of vaccine.

Solvent (Cevac Solvent Wingweb): Type I glass vial containing 10 ml (1000 doses) or 20 ml (2000 doses) of solvent

Presentations:

Cardboard box of 1 vial of 1000 doses of vaccine, 1 vial of 10 ml of solvent and 1 pronged applicator. Cardboard box of 1 vial of 2000 doses of vaccine, 1 vial of 20 ml of solvent and 1 pronged applicator. Cardboard box of 5 vials of 1000 doses of vaccine. + Cardboard box of 5 vials of 10 ml of solvent and 5 pronged applicators.

Cardboard box of 5 vials of 2000 doses of vaccine. + Cardboard box of 5 vials of 20 ml of solvent and 5 pronged applicators.

Cardboard box of 10 vials of 1000 doses of vaccine. + Cardboard box of 10 vials of 10 ml of solvent and 10 pronged applicators.

Cardboard box of 10 vials of 2000 doses of vaccine. + Cardboard box of 10 vials of 20 ml of solvent and 10 pronged applicators.


Not all pack sizes may be marketed.