Frozen suspension of cells infected with live Marek's disease virus, strain CVI 988 (not less than 102.9 CCID50/ds) and live Marek HVT strain F#126 (not less than 1000 PFU/ds), for intramuscular or subcutaneous injection after resuspension in Poulvac Marek Diluent.

For the vaccination of healthy one-day-old chickens to reduce mortality and lesions caused by Marek’s disease.

One dose (0.2 intramuscularly or 0.5 subcutaneously) per chicken. The vaccine is to be administered intramuscularly in one of the leg muscles or subcutaneously into the neck.

Use within 2 hours of reconstitution.

Reconstitute each 1,000 doses with 200ml of diluent. 2,000 dose vials should be reconstituted in 400mls of diluent. To administer subcutaneously, dilute 1,000 doses in 500ml 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.

Break the ampoule and withdraw the total contents carefully into a 10ml sterile disposable syringe, using an 18G x 1.5 inch (1.2 x 40mm) or larger gauge needle. Slowly withdraw about 8ml 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.

Poulvac Marek CVI + HVT may be administered either manually preferably by using a multi-dose syringe dose and fitted with a 23G x 1 inch (0.60 x 25mm) 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. Use within 2 hours of reconstitution.

Do not vaccinate unhealthy chickens.

Avoid early exposure of chicks to Marek’s disease to allow for development of protection.

No more than one single dose of vaccine should be administered to one day old chicks only.

No information is available on the safety and efficacy from the concurrent use of this vaccine with any other except Poulvac IB Primer and Poulvac NDW. It is therefore recommended that no other vaccines than these should be administered within 14 days before or after vaccination with the product.

Do not mix with any other vaccine/immunological product except Poulvac Marek Diluent.

The vaccine has shown to be safe in ten-fold times the recommended dose. No emergency procedure has been described.

The vaccine viruses have the potential to spread. All chickens on a site should be vaccinated. In a study in highly susceptible Rhode Island Red birds, vaccine virus was shown to increase in virulence after 10 passages.

Exposure to heat and direct sunlight must be avoided.

Contact with disinfectants makes the vaccine ineffective.

Use clean materials for vaccination.

Avoid vaccination of stressed animals.

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+HVT:

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.

Following reconstitution, the vaccine should be stored at +2°C to +8°C and used within 2 hours.

For animal treatment only.

Keep out of the sight and reach of children.

Poulvac Marek CVI + HVT is packed in glass ampoules containing 1000 or 2000 doses. The ampoules are stored in liquid nitrogen containers in a 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.