Target species
Chickens (one day-old chicks).
Indications for use for each target species
For the active immunisation of one day old chickens to reduce mortality and lesions caused by Marek’s disease virus.
Onset of immunity: 9 days after vaccination.
Duration of immunity: not known but has been shown by challenge to be at least 4 weeks.
Vaccine virus and antibodies to Marek’s disease virus have been shown to persist in vaccinated chickens for up to 2 years.
Contraindications
None.
Special warnings
Vaccinate healthy animals only.
Special precautions for use
Special precautions for safe use in the target species:
Vaccine virus spreads from bird to bird. In a study in highly susceptible Rhode Island Red birds, vaccine virus was shown to increase in virulence after ten passages.
Maternally derived antibodies (MDA) can interfere with the development of active immunity. Where it is likely that recent field infection or vaccination of the parent flock has stimulated a high antibody titre and consequently a high level of MDA, the timing of the vaccination programme should be planned accordingly.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Liquid nitrogen can cause serious freeze burns and thawing ampoules may occasionally explode as result of sudden temperature changes. Therefore, liquid nitrogen containers and vaccine ampoules should be handled by properly trained personnel only.
Personal protective equipment consisting of gloves, facial protection or safety goggles and skin-covering clothing should be worn when handling the veterinary medicinal product starting when withdrawing from liquid nitrogen.
General hygiene principles including cleaning and disinfecting of hands should be followed.
Store and use liquid nitrogen only in a dry and well-ventilated place.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Chickens (one day-old chicks):
None known.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Laying birds:
The safety of the veterinary medicinal product has not been established during lay.
Interaction with other medicinal products and other forms of interaction
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Poulvac MD Vac. Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Poulvac IB H120, Poulvac NDW and Poulvac TRT. In the case of products administered parenterally on the same day, the products should be given at different sites.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above. 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.
Administration routes and dosage
Intramuscular or subcutaneous use.
Administer a single dose (0.2 ml) to day-old-chicks by intramuscular injection in one of the leg muscles or by subcutaneous injection in the neck.
Preparation of the vaccine:
Preparation of the vaccine shall be planned before the ampoules are taken from the liquid nitrogen and the exact amount of vaccine ampoules and amount of solvent needed shall be calculated first. There is no information available on the number of doses on the ampoules once they are removed from the cane. Special care has to be taken to ensure that the mix-ups of ampoules with different number of doses is avoided and the correct volume of solvent (Poulvac Solvent) is used.
Dilute each 2,000 doses with 400 ml of Poulvac Solvent, 4,000 doses with 800 ml of Poulvac Solvent and the 5,000 doses with 1,000 ml of Poulvac Solvent.
Take the ampoule(s) of vaccine concentrate out of the liquid nitrogen container and thaw the vaccine concentrate by carefully immersing in water at 25 °C – 30 °C, while gently swirling the ampoule(s) to disperse the content. Then remove the ampoule from the water and dry it. The thawed vaccine concentrate must be used immediately.
Break the ampoule and withdraw the total contents carefully into a 10 ml sterile disposable syringe, using an 18G x 1.5 inch (1.2 x 40 mm) or larger gauge needle. Slowly draw about 8 ml of Poulvac Solvent into the syringe. Turn the syringe 5-10 times to mix the content well. Slowly transfer a small volume of the mixture into the empty ampoule in order to remove the last remnants of the vaccine concentrate and withdraw this small amount back into the syringe.
Carefully transfer the entire contents of the syringe into the Poulvac Solvent container. Rotate the container about 10 times to mix the contents well. The vaccine is now ready for use and should be used within 2 hours of reconstitution.
Once reconstituted the vaccine is a light red, slightly opalescent liquid.
NB During the vaccination procedure, rotate the bottle of reconstituted vaccine solution every 5 minutes to prevent the cells from sedimenting.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
No local or systemic reactions have been observed after the administration of a 10-fold overdose.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Zero days.