Summary of Product Characteristics

1. Name of the veterinary medicinal product

Nobilis Marexine CA 126

2. Qualitative and quantitative composition of product

Active ingredients per dose

Live Turkey Herpes virus strain FC126 >3.0 log₁₀PFU

Excipients:

For a full 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 active immunisation of chickens to prevent mortality, clinical signs and/or lesions after Marek’s disease.

4.3 Contra-indications

None

4.4 Special warnings for each target species

None

4.5 Special precautions for use

i. Special precautions of use in animals

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

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. Immunocompetence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress.

ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals

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 1ºC or use body heat. There will be considerable pain during warming, but this is normal.

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

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

Use the contents of one ampoule of vaccine per bottle of diluent for the indicated number of chickens. Inject 0.2 ml reconstituted vaccine to each bird subcutaneously in the neck or intramuscularly in the leg using a 20g x ½" needle with an approved repeating syringe or automatic vaccinator. Equipment used for vaccination should be sterile and contain no traces of detergents or disinfectants.

The recommended age for injection is day-old but Nobilis Marexine CA126 can be effectively administered to birds up to three weeks of age.

Reconstitution:

Reconstitute the vaccine in Nobilis Diluent CA, 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. 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.

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

No adverse effects anticipated.

4.11 Withdrawal periods

Zero days

5. Immunological properties

ATC code: QI01AD03

Pharmacotherapeutic group:Immunologicals for aves, Domestic fowl, Live viral vaccines.

Vaccine contains cell associated live Turkey Herpes virus to stimulate active immunity against Marek's disease in chickens

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 Major incompatibilities

Do not mix with other veterinary medicinal products.

6.3 Shelf life

Vaccine

Shelf life of the veterinary medicinal product as packaged for sale: 51 months

Shelf life after dilution or reconstitution according to directions:

2 hours when kept 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

Vaccine

Store 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.

6.5 Nature and composition of immediate packaging

Vaccine

1000 and 2000 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 (the solvent 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.

6.6 Special precautions for disposal of unused 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.

Intervet UK Ltd.

Walton Manor

Walton

Milton Keynes

Bucks MK7 7AJ

8. MArketing authorisation Number

Vm01708/4289

9. Date of first authoristion/renewal of authorisation

Date:30^thJanuary 1996 / 30^thJanuary 2006

10. Date of revision of the text

Date:October 2012