Vectormune FP ILT + AE - summary of medicine characteristics

Summary of medicine characteristics - Vectormune FP ILT + AE

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

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

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

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

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Lyophilisate and solvent for suspension for injection.

Lyophilisate: whitish-brownish.

Solvent: clear, blue liquid.

4. CLINICAL PARTICULARS4.1 Target species

Chickens

4.2 Indications for use, specifying the target species

For active immunisation of chickens of 8 to 13 weeks of age in order to reduce the 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.

4.3 Contraindications

None.

4.4 Special warnings for each target species

Vaccinate healthy animals only.

4.5 Special precautions for use

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.

4.6 Adverse reactions (frequency and seriousness)

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).

4.7 Use during pregnancy, lactation or lay

Laying birds:

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

4.8 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.

4.9 Amounts to be administered and administration route

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 (10^l).

The vaccine is delivered by transfixion of inner side of the wing web using the two pronged-applicator supplied with the product. 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.

Recommended 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

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 all 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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Ten times the maximum dose was shown to be safe.

4.11 Withdrawal period(s)

Zero days.

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: immunologicals for aves, live viral vaccines for domestic fowls.

ATCvet code: {not yet assigned}

The vaccine is a live recombinant fowlpox virus expressing the membrane fusion protein and the encapsidation protein of avian infectious laryngotracheitis virus and a live avian encephalomyelitis virus. The vaccine induces active immunity against fowlpox, avian infectious laryngotracheitis and avian encephalomyelitis viruses.

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 fowl pox, increased speed of cicatrisation is observed until 49 weeks after vaccination.

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Lyophilisate

Dipotassium phosphate

Gelatin

Lactose

Potassium dihydrogen phosphate

Sorbitol

Sucrose

Tryptose Phosphate Broth

Water for injections

Solvent

Glycerol

Patent blue V (E131)

Water for injections

6.2 Major incompatibilities

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

6.3 Shelf life

Shelf life of the lyophilisate as packaged for sale: 21 months

Shelf life of the solvent as packaged for sale: 3 years.

Shelf life after reconstitution according to directions: 2 hours.

6.4. Special precautions for storage

Store and transport refrigerated (2 °C – 8 °C).

6.5 Nature and composition of immediate packaging

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.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

7. MARKETING AUTHORISATION HOLDER

Ceva-Phylaxia Co. Ltd.

1107 Budapest, Szallas u. 5.

Hungary

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/20/250/001–006

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 24/04/2020.