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Poulvac Marek CVI, Frozen virus-infected cell suspension, after thawing to be diluted in Poulvac Marek Diluent for Chickens.

Description

Active Ingredients:Per 0.2 ml dose
Live Marek's disease virus, strain CVI 988, cell associated >103.0 TCID50
Poulvac Marek Diluent:Dose volume
0.2 ml0.5 ml
Sucrose 10.25 mg 25.62 mg
Potassium dihydrogen phosphate 0.10 mg 0.26 mg
Potassium monohydrogen phosphate 0.25 mg 0.63 mg
Peptone (NZ amine) 3.00 mg 7.50 mg
Amaranth* (E123) 4.00 mg 10.00 mg
Aqua ad injectabilia ad 0.20 mg 0.50 mg
*In case Phenol Red is used 2.00 μg 5.00 μg

INDICATIONS

For the active immunisation of chickens to reduce mortality and lesions caused by Marek's Disease.
The onset of immunity is from 3 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.

CONTRAINDICATIONS

Do not vaccinate unhealthy chickens.

ADVERSE REACTIONS

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.

TARGET SPECIES

Chickens from one day of age.

DOSAGE, ROUTE AND METHOD OF ADMINISTRATION

One 0.2 ml dose per chicken.
The vaccine is to be administered by intramuscular injection in the thigh muscle or by subcutaneous injection in the neck.
Dilution of vaccine: Reconstitute each 1,000 doses with 200 ml of diluent. 2,000 dose ampoules should be reconstituted in 400 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 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.
Administration: 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.

WITHDRAWAL PERIOD

Zero days

SHELF LIFE

Shelf-life of the veterinary medicinal product as packaged for sale:

Poulvac Marek CVI:30 months
Poulvac Marek Diluent:24 months
Following reconstitution, the vaccine should be stored at +2°C to +8°C and used within 2 hours.

SPECIAL STORAGE PRECAUTIONS

The vaccine is to be stored at -196oC in a container with liquid nitrogen. Store the diluent at room temperature or at +2oC to +8oC in the dark. Avoid exposure to heat and/or direct sunlight. Once thawed, the vaccine cannot be refrozen.

SPECIAL WARNINGS

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.
Special precautions for use in animals

Special precautions to be taken by the person administering the veterinary medicinal product to animals
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 + 1oC 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.
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.
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.

OTHER INFORMATION

ATCvet code: QI01AD03
Nature: glass ampoule
Contents: 2 ml (1000 or 2000 dose)
Poulvac Marek Diluent
Glass bottles
Nature: Type II hydrolytic glass bottles (Ph.Eur.) with rubber stoppers (Ph.Eur.) and aluminium overseal
Contents: 200 ml, 400 ml or 500 ml
Collapsible plastic bag

Nature: Pouch body:Draka 3250, 3256 or NM80
Filling tube:Draka 3260
Sep port:Draka 3286
Needle guide:Draka 3244
Stopper:Burnet stopper
Additive port:Draka 3286
Contents:200 ml, 400 ml, 500 ml or 1 litre
Not all pack sizes may be marketed.

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