Live cell associated Marek’s disease virus strain CVI988 ≥ 3.0 log10 TCID50

For the full list of excipients, see section 6.1.

Deep frozen suspension for injection after dilution and diluent.

Chickens.

For the vaccination of chickens against Marek’s disease.

None.

None.

Only healthy birds should be vaccinated.

The vaccine virus spreads; care should be taken to prevent such spread in multi-age sites.

The operator should be aware of the general precautions to be taken when handling liquid nitrogen and/or material at very low temperature. Ampoules may explode on sudden temperature changes; therefore the operator should protect himself with gloves and a visor. When removing an ampoule from a cane hold the palm of a gloved hand away from body and face.

First aid treatment of frost bite injuries: Warm affected part by immersion in water at 29 ± 1 ºC or use body heat. There will be considerable pain during warming, but this is normal. Do not rub affected area, seek medical advice.

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

None.

Not to be used for birds in lay.

Safety and efficacy data are available which demonstrate that Nobilis Rismavac can be mixed in the same solvent and administered by the subcutaneous route either with Innovax-ILT or Innovax-ND-IBD or Innovax-ND-ILT. For this mixed use, an onset of immunity of 5 days has been demonstrated for MD.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 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.

Preparation:

For use the ampoule of vaccine is thawed, by placing in water at room temperature (not hot or icy cold). When the vaccine has thawed the ampoule is opened immediately and diluted in the solvent using a sterile syringe allowing 1000 doses of vaccine to each 200 ml of fluid.

Administration:

Administer by a single injection of 0.2 ml subcutaneously in the neck or intramuscularly in the leg, after reconstitution in the solvent provided. Injection should be made using an approved repeating syringe or automatic vaccinator.

A needle of 20G * ½” should be used to inject the birds.

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

No specific treatment or antidote recommended.

Zero days.

ATC Vet Code: QI01AD03.

Immunologicals for aves, Domestic fowl, Live viral vaccines.

The vaccine contains live, cell-associated Marek's disease virus for parenteral administration to chickens to stimulate active immunity against the disease.

Bovine serum

Veggie medium

Dimethyl sulfoxide

Sucrose

Sodium Chloride

Disodium hydrogen phosphate dihydrate

Phenolsulfonphtalein (Phenol red)

Potassium dihydrogen phosphate Water for injections

Do not mix with any other veterinary medicinal product except Innovax-ILT or Innovax-ND-IBD or Innovax-ND-ILT and the solvent supplied for use with this medicinal product.

Shelf life of the cell concentrate as packed for sale: 5 years.

Shelf life after dilution or reconstitution according to directions: 2 hours at +2ºC to +8 ºC.

Shelf life of the solvent (multilayer plastic bags) as packaged for sale: 3 years.

Cell concentrate:

Store and transport frozen in liquid nitrogen at a temperature below ≤ -150oC.

Thawed ampoules must not be refrozen.

Do not expose reconstituted vaccine to direct sunlight or heat.

Solvent:

Store below 30°C.

Container:

Store liquid nitrogen container securely in an upright position in a clean, dry and well-ventilated room separated from the hatching/chicken room

Cell concentrate:

1,000, 2,000, 4,000 and 5,000 dose ampoules of hydrolytical class type I (Ph. Eur.) glass containing the cell suspension. The ampoules are heat sealed.

The ampoules are inserted in metal canes and shipped and stored in a liquid nitrogen container.

Solvent:

- One 200 ml multilayer plastic bag.

- One 400 ml multilayer plastic bag.

- One 500 ml multilayer plastic bag.

- One 600 ml multilayer plastic bag.

- One 800 ml multilayer plastic bag.

- One 1000 ml multilayer plastic bag.

- One 1200 ml multilayer plastic bag.

- One 1600 ml multilayer plastic bag.

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.

19 August 2008.

July 2022.

For animal treatment only. Keep out of the sight and reach of children.