Name of the Immunological Veterinary Medicinal Product
Avian Influenza Fowlpox Vaccine Live Fowl Pox Vector, Subtype H5, TROVAC AIV H5

Qualitative And Quantitative Composition

PHARMACEUTIC FORM

Lyophilized Immunological properties
Live recombinant fowl pox virus against avian influenza subtype H5.
The vaccine strain is an attenuated live fowl ox virus expressing the hemagglutinin gene of the avian influenza A/turkey /Ireland/ H5N8 virus.
The vaccine stimulates an active immune response that may be quantitated serologically with the avian influenza HI test and an AGPT for pox.

Clinical Particulars

Target species: chickens one day of age or older. Indications fore use, specifying target
For active immunization of chickens: - To prevent morbidity and mortality due to infection with avian influenza subtype H5. The onset of protection is evident by 0ne week of age and extends 20 weeks.
- To prevent the clinical signs of fowl pox disease. The onset of protection is one week and persists for 12 weeks.

Contraindications: Vaccinate only health birds - Immunity may be less than expected in birds previously inoculated with a live fowl pox vaccine or wild type virus.

Undesirable effects: None known

Special Precautions for Use: Do not inject intramuscularly. Not intended for in ovo use.

Interaction with other veterinary medicinal products and other forms of interaction: This product may be mixed and injected subcutaneously in one day old chickens with Merial Live Marek's and Marek's- Bursal Disease vaccines.

Posology and Method of administration

Reconstitution of the vaccine
- Remove the aluminum cap and rubber stopper
- Draw up 1 mi of sterile diluent into a sterile 5 ml syringe
- Let the vaccine dissolve in the liquid diluent. Transfer the vaccine solution into the diluent container at a rate of 1 vial to 200 ml of diluent.
- Rinse the ampoule again with diluent and add the solution back into the container of diluent and vaccine.
- Gently mix the diluted vaccine by rocking the container back and forth several times. Al of the mixed vaccine should be used within one hour. Keep cool while in use. Posology:
One single subcutaneous injection of 0.2ml in the nape of the neck at one day of age is recommended.

Overdose:
No adverse signs have been reported with an overdose of the target species.

Special warnings for each target species: None

Withdrawal period: 21days before slaughter

Special handling precautions for the person administering the product to animals: Use caution

Pharmaceutical Particulars

Incompatibilities: None known

Shelf life:
- Shelf life of the non reconstituted vaccine - 24 months
- Shelf life of the reconstituted vaccine: up to two hours stored at a temperature lower than 25°C.

Special storage conditions:
- Store refrigerated between 4-7°C
- Do not freeze or keep unused vaccine overnight

Nature and contents of containers:
2 ml volume of fowl pox virus and stabilizer in a 3.0 ml glass vial closed with a butyl stopper and aluminum seal cap.

For veterinary use only