Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

Poulvac Marek CVI is a live cell-associated virus vaccine based on the Rispens CVI 988 strain cultivated on tissue culture, ≥103.0 TCID50/dose.

Contains trace amounts of residual gentamicin.

Excipients of Poulvac Marek Diluent: potassium dihydrogen phosphate, potassium monohydrogen phosphate and colourant: Phenylsulphonophthalein (phenol red).

Uses

For the vaccination of healthy susceptible, immune-competent day-old chicks against Marek's disease.

Dosage and administration

Dosage: One dose of 0.2 ml of the diluted vaccine per day-old chick by intramuscular injection into the thigh muscle. MD Vac Lyo (PL 1598/4027) or MD Vac (Frozen Wet) PL 1598/4026 may be mixed and administered in the same diluent as Poulvac Marek CVI.

Dilution of vaccine: Reconstitute each 1,000 dose vial with 200 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. Take the ampoule of vaccine out of the container of liquid nitrogen into a bowl containing clean tepid water (temperature 80°F and not higher than 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 10 ml sterile disposable syringe, using an 18G x 1 and a half 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 vaccine is now ready for use.

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

Administration: Poulvac Marek CVI may be administered either manually preferably by using a multi-dose syringe dose and fitted with a 21G x 1 inch (0.8 x 2.5 cm) needle or by a vaccination machine.

Administer the vaccine intramuscularly into the thigh muscle.

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

Contra-indications, warnings, etc

For Animal Treatment Only.

Withdrawal period - zero days.

Only healthy birds should be vaccinated.

The vaccine should be administered to day-old chicks.

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

Avoid stress in chickens before and after vaccination.

Avoid injection into or near joints and tendons.

No information is available on the compatibility of this vaccine when used at one day of age with any other except Poulvac IBH120, Poulvac NDW, Poulvac TRT and MD Vac. Therefore the safety and efficacy of this product when used with any other than those named above (either when used on the same day or at different times) has not been demonstrated.

Operator Warnings

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.†

Environmental Warning: To protect the environment, all empty or part-used vials should be burnt or immersed in an approved disinfectant.†

† Schedule 1 to the Diseases of Animals (Approved Disinfectants) Order 1978 (as amended).

Pharmaceutical precautions

Vaccine should be stored in liquid nitrogen at -196.5°C until just before use. Always ensure that the level of liquid nitrogen in the container is topped up regularly.

The diluent should be stored in a cool place.

Reconstituted vaccine should be used immediately and not stored.

Reconstitute the vaccine only with the diluent provided.

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

Do not expose reconstituted vaccine to direct sunlight or heat.

Once thawed, the vaccine concentrate CANNOT BE REFROZEN.

Do not vigorously shake the ampoule or reconstituted vaccine. The reconstituted vaccine must be handled and mixed gently and administered through wide gauge needles to avoid damaging the cells containing the vaccine virus.

Keep out of the reach and sight of children.

Legal category

POM-VPS

Packaging Quantities

The sealed glass ampoules of frozen vaccine contain 1,000 and 2,000 doses. The vials are supplied in containers filled with liquid nitrogen. Diluent is presented in glass bottles containing 200ml, 400ml, 500ml and 1 litre.

Not all pack sizes may be marketed.

Further information

Rispens vaccine (Poulvac Marek CVI) in combination with either of the Fort Dodge Animal Health licensed HVT vaccines has been demonstrated to be effective against current Marek's Disease outbreaks in the field in the UK.

In any animal population there will be a small number of individuals which fail to respond fully to vaccination. Successful vaccination depends upon correct storage and administration of the vaccine and the animal's ability to respond. Immune competence can be influenced by genetic factors, intercurrent infection, age, nutritional status, concurrent drug therapy, stress, etc.

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.

Marketing authorisation number

Vm 01596/4339