Nobilis Rismavac Data Sheet

Presentation 

Nobilis^® Rismavac^® consists of a suspension of living cultured avian cells containing at least 3.0 log₁₀ TCID₅₀ of attenuated Marek's Disease virus (strain CVI 998) per dose.  

The vaccine is supplied in frozen ampoules held in metal canes stored in a liquid nitrogen canister.   Diluent Cell Associated Marek's vaccine is supplied for reconstitution of the vaccine prior to use.

Uses

For the active immunisation of chickens against Marek's disease.

Dosage and administration   

Reconstitution: 

Reconstitute the vaccine in Nobilis Diluent CA (Vm 01708/4270), allowing 1000 doses of vaccine to each 200 ml. Prior to reconstitution the vaccine is thawed.   Great care should be taken - see operator warnings. Remove one ampoule from the cane and immediately replace the cane in the liquid nitrogen canister.   Thaw the contents of the ampoule rapidly by immersing in water at room temperature.   Do not thaw in hot or ice-cold water.   Dry the ampoule and shake to disperse contents.   After thawing open the ampoule immediately and draw the entire contents into a sterile 5 - 10 ml syringe using an 18 gauge needle to avoid rupturing the cells.   Insert the needle through the stopper of the diluent vial (which should be at room temperature) and draw up slowly a portion of the diluent.   Add the contents of the syringe to the remaining diluent.   It is important that this is done slowly, allowing the vaccine to run down the side of the bottle.   Gently shake the bottle as the vaccine is being mixed.   Withdraw a portion of the vaccine and use to rinse the ampoule.    Inject the washing back in to the diluent vial.    The reconstituted vaccine must be handled gently and administered through wide gauge needles to avoid rupturing the cells.

Care should be taken to ensure that the vaccine virus does not spread to unvaccinated birds.

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 x 1/2" should be used to inject the birds.     Equipment used for vaccination should be sterile and contain no traces of detergents or disinfectants.

For further information on use of a vaccine in specific circumstances or in conjunction with other Intervet vaccines consult Intervet technical staff.

Contra-indications, warnings, etc. 

1.         Only healthy birds should be vaccinated. Sick or weak birds will not develop adequate immunity following vaccination.

2.          Do not co-administer with vaccines other than Nobilis Marexine^® CA126. 

3.          Do not mix with unapproved products.

Operator warning

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

First aid treatment of frost bite injuries:Warm affected part by immersion in water at 29 + 10ºC or use body heat. There will be considerable pain during warming, but this is normal. Do not rub affected area, seek medical advice.

Withdrawal period:  Zero days

FOR ANIMAL TREATMENT ONLY.    KEEP OUT OF REACH AND SIGHT OF CHILDREN.

Pharmaceutical precautions

Nobilis^® Rismavac must be stored frozen in liquid nitrogen at a temperature below - 150ºC.   Thawed ampoules must not be refrozen.  

The diluent may be stored at room temperature (below 25°C).

Once diluted the vaccine should be kept between +2°and + 8 °C and used within 2 hours.   Do not expose reconstituted vaccine to direct sunlight or heat. 

Disposal advice

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

Legal category

POM-VP                                     

Package quantities

Ampoules containing 1000, 2000, 4000 or 5000 doses supplied together with Nobilis Diluent CA (Vm 01708/4270). Not all presentations may be marketed.

Further information

Nobilis^® Rismavac in combination with Turkey Herpes Virus vaccine has been demonstrated to be effective against Marek's Disease outbreaks in the field in the UK.

A good immune response is reliant on the reaction of an immunogenic agent and a fully competent immune system.   Immunogenicity of the vaccine antigen will be reduced by poor storage or inappropriate administration.   Immuno-competence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress.   Under certain conditions, for example extreme disease pressure and variant challenge, fully immune birds may succumb to disease.   Therefore, successful vaccination may not be synonymous with full protection in the face of a disease challenge.

Marketing Authorisation numbers   

Nobilis Rismavac                      Vm 01708/4294

Nobilis Diluent CA                    Vm 01708/4270

Marketing Authorisation holder

Intervet UK Ltd

Walton Manor

Walton

Milton Keynes

Bucks. MK7 7AJ

Distributed in Northern Ireland by:

Intervet Ireland Ltd.

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

Date of text preparation

02/08/06