Nobilis Rismavac+CA126 Data Sheet

Presentation 

Nobilis® Rismavac+CA126 consists of a suspension of living, cultured avian cells containing at least 3.0 log₁₀ pfu Marek’s Disease virus (strain CVI 998) and at least 3.0 log₁₀ pfu Turkey Herpesvirus (strain FC 126) per dose.

Nobilis Rismavac+ CA126 is supplied in frozen ampoules held in metal canes stored in a liquid nitrogen canister. Nobilis Diluent CA is supplied for reconstitution of the vaccine prior to use.

Uses 

To reduce mortality, clinical signs and lesions after infection with Marek’s disease virus (MDV).

Dosage and administration   

Reconstitution: 

The actual volume of diluent per dose needed for reconstitution of the vaccine may depend on the number of doses per ampoule, the route of administration and for in-ovo on the settings of the vaccination equipment.   In the table below the volume of diluent per ampoule for the various dose-presentations, routes of administration and settings of the in-ovo equipment are given.

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.   Fill the sterilised repeating syringe/ automatic vaccinator according to the manufacturer’s instructions.   The vial of reconstituted vaccine should be kept in an ice bath when not being used.

Administration:

Day-old vaccination:

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 appropriate 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. The recommended age for vaccination is day-old.

In-ovo vaccination:

Inject one dose of the reconstituted vaccine to each 18-day embryonated egg with an appropriate automatic in-ovo  vaccinator.   The actual volume per dose may depend on the settings of the in-ovo  vaccination equipment. This should not be less that 50µl or more than 100µl.   Depending on the volume to be administered the vaccine should be reconstituted according to the instructions below”.   The egg should be in an upright position with the blunt side up.

Contra-indications, warnings, etc. 

1.   Only healthy birds should be vaccinated.

2.   With the exception of Nobilis Rismavac and Nobilis Marexine CA126 which can be co-administered (although the combination vaccine, Nobilis Rismavac+ CA126, is available), no information is available on the effects of concurrent use of these vaccines with any other poultry vaccines.   It is therefore recommended that no other vaccine should be administered within 14 days before or after vaccination with these products.

3.   There is evidence that some antibiotics may cause interference with the performance of Marek's vaccine if mixed for administration.   Nobilis Marek's vaccines should not be mixed with any other product.

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

Occasional microscopic lesions might be seen after in-ovo vaccination.

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 thermal 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 + 1°C 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   

Marek's cell associated vaccines must be stored frozen in liquid nitrogen at a temperature below 
-150°C.   Thawed ampoules must not be refrozen.  

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

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

Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant, in accordance with the national requirements.

Legal category
POM-VPS                   To be supplied only on veterinary prescription.

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

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 

Vm 01708/4354   Nobilis Rismavac+ CA126

Vm 01708/4270   Nobilis Diluent CA

UK authorised veterinary medicinal products.

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 

26/07/06