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

Description

Active Ingredients:Per dose
Live Marek's disease virus, strain CVI 988, cell associated: > 102.9 TCID50
Live Marek HVT strain F#126, cell associated:> 1000 PFU
Constituents:
Dimethylsulphoxide 0.21 μl
Foetal calf serum 0.21 μl
Freezing medium ad 2.05 μl*

*Consisting of tryptose phosphate broth, Medium 199, amino acids, vitamins, salts, glutamine, nitric acids, dextrose and phenol red per 1,000 dose - pro rata for 2,000 dose.

Active Ingredients:Dose volume
 0.2 ml0.5 ml
Sucrose10.25 mg25.62 mg
Potassium dihydrogen phosphate0.10 mg0.26 mg
Potassium monohydrogen phosphate0.25 mg0.63 mg
Peptone (NZ amine)3.00 mg7.50 mg
Amaranth* (E123)4.00 µg10.00 µg
Aqua ad injectabilia ad0.20 ml0.50 ml
*In case Phenol Red is used2.00 µg5.00 µg

INDICATIONS

Vaccination of healthy chickens to reduce mortality and lesions caused by Marek's Disease.

CONTRAINDICATIONS

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.

ADVERSE REACTIONS

None (if vaccinated according to recommended methods).

TARGET SPECIES

Chickens from one day of age.

DOSAGE, ROUTE AND METHOD OF ADMINISTRATION

One dose per chicken to be administered 0.2 intramuscularly or 0.5 subcutaneously. The vaccine is to be administered intramuscularly in one of the leg muscles or subcutaneously in the neck.
Use within 2 hours of reconstitution.
Dilution of vaccine: Reconstitute each 1,000 doses with 200 ml of diluent. 2,000 dose vials should be reconstituted in 400 ml of diluent. To administer subcutaneously, dilute 1,000 doses in 500 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.
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 bottle of diluent should be kept closed throughout the procedure.
The vaccine is now ready for use.
Administration
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 25 mm) needle, or by a vaccination machine.
Administer the vaccine intramuscularly into the thigh muscle or subcutaneously in the neck.
NB During vaccination procedure, rotate the bottle of reconstituted vaccine solution every 5 minutes to prevent the cells from sedimenting.
Use within 2 hours of reconstitution.
The vaccine has shown to be safe in ten-fold times the recommended dose. No emergency procedure has been described.

WITHDRAWAL PERIOD

Zero days

SHELF LIFE

Shelf-life of the veterinary medicinal product as packaged for sale:
Poulvac Marek CVI + HVT: 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 -196°C in a container with liquid nitrogen. Store the diluent at room temperature or at +2°C to +8°C in the dark. Avoid exposure to heat and/or direct sunlight. Once thawed, the vaccine cannot be refrozen.

SPECIAL WARNINGS

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.
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 frostbite 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.
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.
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 and composition of immediate packaging
Poulvac Marek CVI + HVT
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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