Nobilis Rismavac Data Sheet
Qualitative and quantitative composition
Active ingredients per dose: live cell associated Marek’s Disease virus strain CVI988 ≥ 3.0 log10 TCID50.
For a list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Deep frozen suspension for injection after dilution and diluent.
Clinical particulars
Target species
Chickens.
Indications for use
For the vaccination of chickens against Marek’s disease.
Contra-indications
None.
Special warnings for each target species
None.
Special precautions for use
Only healthy birds should be vaccinated. The vaccine virus spreads; care should be taken to prevent such spread in multi-age sites.
Operator warnings: 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 ± 1ºC 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.
Adverse reactions
None.
Use during pregnancy, lactation or lay
Not to be used for birds in lay. Interactions 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.
Amounts to be administered and administration route
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 diluent 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 diluent provided. Injection should be made using an approved repeating syringe or automatic vaccinator. A needle of 20 g x ½” should be used to inject the birds. Equipment used for vaccination should be sterile and contain no traces of detergents or disinfectants.
Overdose
No specific treatment or antidote recommended.
Withdrawal periods
Zero days.
Pharmacological particulars
Immunological properties: ATC vet code: QI01AD03
Pharmacotherapeutic group: Immunologicals for aves, Domestic fowl, live viral vaccine. The vaccine contains live, cell-associated Marek's Disease virus for parenteral administration to chickens to stimulate active immunity against the disease.
Pharmaceutical particulars
Excipients
Vaccine: Calf serum and DMSO
Diluent: Sucrose, Pancreatic digest of casein, Potassium dihydrogen phosphate, Phenolsulfonphthalein and Water for injections.
Major incompatibilities
Do not mix with any other veterinary medicinal products.
Shelf life
Vaccine: Shelf life of the veterinary medicinal product as packaged for sale: 5 years.
Shelf life after dilution or reconstitution according to directions: 2 hours when kept at +2°C to +8°C.
Diluent Shelf life as packaged for sale: 3 years in glass bottles or polyethylene bags and 2 years in multilayer plastic bags.
Special precautions for storage
Store and transport frozen in liquid nitrogen at a temperature below – 150°C. Thawed ampoules must not be refrozen. Do not expose reconstituted vaccine to direct sunlight or heat.
Immediate packaging
Vaccine 1000, 2000, 4000 and 5000 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.
Diluent (the diluent is licensed separately – Vm 01708/4270) 200, 400 and 500 ml in type II glass vials closed with a halogenobutyl rubber stopper and an aluminium crimp cap. 200, 400, 500, 600, 800, 1000, 1200 ml in polyethylene bags. 200, 400, 500, 600, 800, 1000 ml in multilayer plastic bags.
Not all presentations may be marketed.
Disposal
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant, approved for use by the competent authorities.
Marketing Authorisation Holder (if different from distributor)
-
Marketing authorisation number
Vm 01708/4294.
Date of the first authorisation or date of renewal
19 August 2008.
Date of revision of the text
15 June 2011.
Any other information
Nil
Legal category
POM-VPS
