Target Species
Chickens.
Indications for use
To reduce mortality, clinical signs and lesions after infection with Marek’s disease virus (MDV).
For the vaccination of one-day old chickens against Marek’s disease.
Contraindications
None.
Special warnings for each target species
The vaccine virus spreads; care should be taken to prevent such spread in multi-age sites.
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. 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.
Special precautions for use
Not applicable.
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 °C ± 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.
CAUTION: The ampoules have been known to explode on exposure to sudden temperature changes. Do not thaw in hot water or ice-cold water. Thaw the ampoules in clean water at 25 °C – 27 °C.
Adverse Reactions
Chickens:
None known.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also the last section of the package leaflet for contact details.
Use during pregnancy or lactation
The safety of the veterinary medicinal product has not been established during lay.
Interactions
Safety and efficacy data are available which demonstrate that this vaccine can be mixed in the same solvent and administered by the subcutaneous route with Innovax-ILT or Innovax-ND-IBD or Innovax-ND-ILT. For this mixed use, an onset of immunity of 5 days has been demonstrated for MD. The product information of the other product should also be consulted in case of mixed use.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above. 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
Subcutaneous or intramuscular use.
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 solvent using a sterile syringe allowing 1 000 doses of vaccine to each 200 ml of fluid.
Administration:
The recommended age for vaccination is day-old.
Administer by a single injection of 0.2 ml subcutaneously in the neck or intramuscularly in the leg, after reconstitution in the solvent provided. Injection should be made using an approved repeating syringe or automatic vaccinator.
A needle of 20G 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
Following the administration of a 10-fold dose, no adverse events other than those described in section 3.6 have been observed.
Withdrawal periods
Zero days.