Summary of medicine characteristics - Vectormune FP ILT
SUMMARY OF PRODUCT CHARACTERISTICS
Vectormune FP ILT 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*
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* 50% Tissue Culture Infective Dose
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: pink or beige.
Solvent: clear, blue liquid.
4. CLINICAL PARTICULARS4.1 Target species
Chickens
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4.2 Indications for use, specifying the target species
For active immunisation of chickens from 8 weeks of age in order to reduce the skin lesions due to fowlpox and to reduce the clinical signs and tracheal lesions due to avian infectious laryngotracheitis.
Onset of immunity:
Fowlpox and avian infectious laryngotracheitis: 3 weeks after vaccination
Duration of immunity:
Fowlpox: 34 weeks after vaccination.
Avian infectious laryngotracheitis: 57 weeks after vaccination.
4.3 Contraindications
None.
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4.4 Special warnings for each target species
Vaccinate healthy animals only.
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4.5 Special precautions for use
Special precautions for use in animals
None.
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.
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4.6 Adverse reactions (frequency and seriousness)
Small swelling/scabs typical of fowlpox vaccine take are very common and should disappear within 14 days after vaccination.
The frequency of adverse reactions is defined using the following convention:
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– very common (more than 1 in 10 animals treated displaying adverse reaction(s))
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
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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.
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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:
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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.
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2. Draw up all the reconstituted vaccine suspension into the syringe and inject into the solvent vial.
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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.
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4.11 Withdrawal period(s)
Zero days.
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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. The vaccine induces active immunity against fowlpox and avian infectious laryngotracheitis.
For fowlpox, 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).
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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.
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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/2/20/266/001–006
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 09/12/2020