Target species
Chickens and embryonated chicken eggs.
Indications for use for each target species
For active immunisation of one day old chickens and 18-19 day old embryonated chicken eggs to
- reduce mortality, clinical signs and lesions caused by Marek’s disease (MD) virus and
- prevent mortality and clinical signs and reduce lesions caused by infectious bursal disease (IBD) virus.
Onset of immunity: | MD: 7 days post vaccination for in ovo and 9 days for subcutaneous use IBD: 15 days post vaccination for in ovo and 14 days for subcutaneous use |
Duration of immunity: | MD: a single vaccination is sufficient to provide protection for the entire risk period IBD: 64 days of age |
Contraindications
None.
Special warnings
Vaccinate healthy animals only.
Special precautions for use
Special precautions for safe use in the target species:
The vaccine strain may be excreted by vaccinated chickens for a maximum of 6 weeks post-vaccination and has the potential to spread to turkeys and to a very limited extent to chickens. Safety trials (including reversion to virulence studies in chickens) have shown that the strain is safe for turkeys and chickens. However, precautionary measures including following general hygiene principles and taking particular care in handling animal waste and bedding materials from recently vaccinated chickens should be taken to avoid spreading of the vaccine strain.
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.
Store and use liquid nitrogen only in a dry and well-ventilated place.
Special precautions for the protection of the environment:
Not applicable.
Other precautions:
Not applicable.
Adverse events
Chickens and embryonated chicken eggs:
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
The safety of the veterinary medicinal product has not been established during lay.
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.
Administration routes and dosage
The vaccine is administered to chickens by subcutaneous injection in the neck or by in ovo injection.
One single injection of 0.2 ml per chicken at day of hatch, by subcutaneous use.
One single injection of 0.05 ml per chicken egg at 18-19 days of embryonation, by in ovo route.
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 mix-ups of ampoules with different number of doses is avoided and the correct volume of solvent (Poulvac Solvent) is used.
For subcutaneous use, reconstitute each 2,000 doses with 400 ml of Poulvac Solvent and each 4,000 doses with 800 ml of Poulvac Solvent. For in ovo use, reconstitute each 2,000 doses with 100 ml of Poulvac Solvent and 4,000 doses with 200 ml of Poulvac Solvent. The solvent must be at room temperature (15 °C – 25 °C) at the time of mixing with the vaccine.
Overview tables for the dilution examples for the different dose presentations for both subcutaneous and in ovo administration are provided:
Poulvac Solvent bag | Number of vaccine ampoules for subcutaneous use |
Bag of 400 ml solvent | 1 ampoule containing 2,000 doses |
Bag of 800 ml solvent | 2 ampoules containing 2,000 doses |
Bag of 800 ml solvent | 1 ampoule containing 4,000 doses |
Poulvac Solvent bag | Number of vaccine ampoules for in ovo use |
Bag of 200 ml solvent | 2 ampoules containing 2,000 doses |
Bag of 400 ml solvent | 4 ampoules containing 2,000 doses |
Bag of 400 ml solvent | 2 ampoules containing 4,000 doses |
Bag of 800 ml solvent | 4 ampoules containing 4,000 doses |
Bag of 1,000 ml solvent | 5 ampoules containing 4,000 doses |
Reconstitution should be done under aseptic conditions. Before withdrawing the ampoules from the liquid nitrogen container, protect the hands with gloves, wear long sleeves and use a face shield or goggles.
It is recommended to handle a maximum of 5 ampoules at a time. After removing the ampoule(s), the remaining ampoules should be put back immediately into the canister in the liquid nitrogen container.
Take the ampoule(s) of vaccine out of the liquid nitrogen container and thaw the vaccine by immersing in water at 25 ºC – 30 ºC, while gently swirling the ampoule(s) to disperse the content. As soon as vaccine in the ampoule is completely thawed, remove from the water, dry the ampoule and break the ampoules at its neck.
Once opened, slowly withdraw the total contents of the ampoule carefully into a 10 ml sterile disposable syringe with an 18-gauge needle. Slowly draw about 8 ml of Poulvac Solvent into the syringe. Turn the syringe 5-10 times to mix the contents well. Slowly transfer a small volume of the mixture into the empty vaccine ampoule in order to rinse the ampoule and withdraw this small amount back into the syringe.
Carefully transfer the entire content of the syringe into the Poulvac Solvent container. Remove the syringe and invert the solvent bag about 10 times to mix the vaccine. The vaccine is now ready for use.
The ready to use vaccine is a red, slightly opalescent liquid.
In case automated equipment is used for in ovo or subcutaneous administration, the equipment should be calibrated to ensure that the correct dose is applied to each egg or chicken. The instructions for use of this device should be followed.
The bag of vaccine should be gently swirled frequently during vaccination to guarantee that the vaccine suspension remains homogenous and that the correct vaccine virus titre is administered.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
No symptoms were observed after the administration of a 10-fold dose of the vaccine.
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.