Vectormune FP ILT + AE - Patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

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, Szallas 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 (10pl). 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 × 1000 doses	10 ml	0.01 ml
1 × 2000 doses	20 ml	0.01 ml

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.

Zero days.

11. 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.

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.

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

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED