Summary of Product Characteristics

1. Name of the veterinay medicinal product

Nobilis Rismavac

2. Qualitative and quantitative composition of product

Active ingredients per dose

Live cell associated Marek’s disease virus strain CVI988 3.0 log₁₀TCID₅₀

Excipients

For a list of excipients, see section 6.1

3. Pharmaceutical form

Deep frozen suspension for injection after dilution and solvent.

4. Clinical particulars

4.1 Target species

Chickens

4.2 Indications for use specifying the target species

For the vaccination of chickens against Marek’s disease.

4.3 Contra-indications

None.

4.4 Special warnings for each target species

None

4.5 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.

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.

4.6 Adverse reactions (frequency and seriousness)

None

4.7 Use during pregnancy, lactation or lay

Not to be used for birds in lay.

4.8 Interaction with other medicinal products and other forms of interaction

Nobilis Rismavac can be co-administered with Nobilis Marexine CA 126 if the combination vaccine Nobilis Rismavac + CA 126 is unavailable.

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.

4.9 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 20G * ½” should be used to inject the birds.

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

4.10 Overdose (symptoms, emergency procedures, antidotes) (if necessary)

No specific treatment or antidote recommended.

4.11 Withdrawal periods

Zero days

5. Pharmacological properties

ATCvet 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.

6 Pharmaceutical particulars

6.1 List of excipients

Vaccine

Calf serum

DMSO

Solvent

Sucrose

Pancreatic digest of casein

Potassium dihydrogen phosphate

Phenolsulfonphthalein

Water for injections

6.2 Incompatibilities

Do not mix with any other veterinary medicinal products.

6.3 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 at +2 C to +8 C.

Solvent

Shelf life as packaged for sale: 3 years in glass bottles or polyethylene bags.

2 years in multilayer plastic bags.

6.4 Special precautions for storage

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

Thawed ampoules must not be refrozen.

Do not expose reconstituted vaccine to direct sunlight or heat.

6.5 Nature and composition of immediate packaging

Vaccine

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 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, 1,000, 1,200 ml in polyethylene bags

200, 400, 500, 600, 1,000 ml in multilayer plastic bags.

Not all presentations may be marketed.

6.6 Special precautions for disposal of unused veterinary medicinal product or waste material derived from the use of such product

Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant, approved for use by the competent authorities.

7. marketing authorisation holder

Intervet UK Ltd.

Walton Manor

Walton

Milton Keynes

Buckinhamshire

MK7 7AJ

8. MARKETING AUTHORISATION NUMBER

Vm01708/4294

9. Date of first authoriations

24 February 1994

10. Date of revision of the text

May 2016

PROHIBITION OF SALE, SUPPLY AND /OR USE

Not applicable

03 May 2016