Frozen suspension of cells infected with live Marek's disease virus, strain CVI 988, cell associated (not less than 250 CCID50*/ds) for intramuscular or subcutaneous injection after resuspension in Poulvac Marek Diluent.

*CCID50 = 50% cell culture infective dose

For the active immunisation of one-day-old chickens to reduce mortality and lesions caused by Marek's disease.

The onset of immunity is from 9 days of vaccination and the duration of immunity is 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.

One 0.2ml dose per chicken.

The vaccine is to be administered by intramuscular injection in the thigh muscle or by subcutaneous injection in the neck.

Reconstitute the 2000 dose presentation with 400ml of diluent and the 5000 dose presentation with 1000 ml of diluent. Dilution should be done under sterile conditions with diluent at room temperature. An ampoule may occasionally explode after it has been taken out of liquid nitrogen so goggles should be worn.

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 diluent 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 diluent is used.

Take the ampoule of vaccine out of the container of liquid nitrogen into a bowl containing clean tepid water (temperature 27°C (80°F) and not higher than 37°C (98°F)). Thaw the vaccine concentrate by carefully turning the ampoule, then remove from the water and dry the ampoule. The thawed vaccine concentrate must be used immediately and cannot be refrozen.

All equipment used for vaccination should be sterile and contain no traces of detergents or disinfectants.

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 withdraw about 8 ml of diluent 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 remove the last remnants of the vaccine and withdraw this small amount back into the syringe, and carefully transfer the entire contents of the syringe into the diluent bottle. Rotate the bottle about 10 times to mix the contents well.

The bottle of diluent should be kept closed throughout the procedure.

The vaccine is now ready for use and should be used within 2 hours of reconstitution.

Poulvac Marek CVI may be administered either manually, preferably by using a multi-dose syringe dose and fitted with a 23G x 1 inch (0.60 x 25 mm) needle, or by a vaccination machine.

Administer the vaccine intramuscularly into the thigh muscle or subcutaneously in the neck.

NB During the vaccination procedure, rotate the bottle of reconstituted vaccine solution every 5 minutes to prevent the cells from sedimenting.

Do not use in sick chickens.

Do not use in birds in lay.

No local or systemic reactions have been observed following the administration of the vaccine during safety studies. However, and in common with other immunological products, it is expected that local or systemic reactions may occur in a very small proportion of vaccinated birds.

No local or systemic reactions have been observed after the administration of a tenfold overdose.

Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Poulvac Marek Diluent or Poulvac MD Vac. Do not mix with any other veterinary medicinal product.

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, Poulvac TRT and Poulvac MD Vac. In the case of products administered parenterally, 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.

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 antibody (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.

Avoid stress in chickens before and after vaccination.

Avoid injection into or near joints and tendons.

To avoid all possible risks of working with liquid nitrogen and/or explosion of glass ampoules, the following precautions must be taken.

- Use of gloves

- Use of facial protection or safety goggles.

- Use of skin- covering clothing.

Liquid nitrogen causes serious freeze burns and thawing ampoules may occasionally explode after removal from the liquid nitrogen. Operators must protect their face with a visor or goggles and hands with gloves, when handling liquid nitrogen containers and when thawing ampoules.

If liquid nitrogen is spilt and comes into contact with skin causing frost bite injuries immediately:

Warm affected area by immersion in water at 29 ± 1°C or by the use of body heat. Considerable pain will be experienced during warming but this is normal. Do not rub the affected area. Seek medical advice if full function and feeling are not rapidly restored.

After handling vaccine, operators should wash and disinfect their hands with an approved disinfectant.

Zero days.

Poulvac Marek CVI:

Store and transport at -196°C in a container with liquid nitrogen. Once thawed, the vaccine concentrate CANNOT BE REFROZEN.

Poulvac Marek Diluent:

Store and transport at room temperature at +2°C to +8°C in the dark.

Avoid exposure to heat and/or direct sunlight. Do not freeze.

Keep out of the sight and reach of children.

Poulvac Marek CVI is packed in glass ampoules containing 2000 or 5000 doses. The ampoules are stored in liquid nitrogen containers in a cane (5 ampoules per cane). The dose presentation is presented on the extremity of each cane.

Diluent is presented in glass bottles containing 200ml, 400ml or 500ml and in plastic bags containing 200ml, 400ml, 500ml or 1 litre.

Not all pack sizes may be marketed.

Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.

Vm 42058/4107