Target species
Chickens and embryonated chicken eggs
Indications for use, specifying the target species
For active immunisation of 18-day-old embryonated chicken eggs or one-day-old chicks to reduce mortality, clinical signs and lesions caused by mild and virulent strains of Marek’s disease virus.
Onset of immunity: 9 days after the vaccination.
Duration of immunity: A single vaccination is sufficient to provide protection during the risk period of infection with Marek’s disease.
Contraindications
None.
Special warnings for each target species
Vaccinate healthy animals only.
Special precautions for use
Special precautions for use in animals
The vaccine strain was shown to be excreted by chickens for 46 days. The excreted vaccine strain was not harmful in turkeys in safety trials; however, special precautions should be taken to avoid spreading of the vaccine strain to turkeys. A ten-fold overdose was safe for turkeys, ducks, quails, guinea fowls, pheasants and pigeons.
No spread was demonstrated between chickens.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Liquid nitrogen containers and vaccine ampoules should be handled by properly trained personnel only.
Personal protective equipment consisting of protective gloves, spectacles and boots should be worn when handling the veterinary medicinal product, before withdrawing from liquid nitrogen, during the ampoule thawing and opening operations.
Frozen glass ampoules may explode during sudden temperature changes.
Store and use liquid nitrogen only in a dry and well-ventilated place. Inhalation of the liquid nitrogen is dangerous.
Personnel involved in the treatment of vaccinated birds should follow hygiene principles and take particular care in handling litter from vaccinated chickens.
Adverse reactions (frequency and seriousness)
None known.
Use during pregnancy, lactation or lay
Do not use in birds in lay or within 4 weeks before the onset of the laying period.
Interaction with other medicinal products and other forms of interaction
No information is available on the safety and efficacy of this immunological veterinary medicinal product 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.
Amounts to be administered and administration route
In ovo or subcutaneous use:
In ovo:
One single injection of 0.05 ml is injected into each 18-day-old embryonated chicken egg. For in ovo application an automatic in ovo egg injector can be used. In ovo equipment should be calibrated to ensure that a 0.05 ml dose is applied to each egg.
Subcutaneous use (preferably under the skin of the neck):
One single injection of 0.2 ml per chick is applied at one day of age.
The vaccine may be injected by automatic syringe. The 500 dose presentation is recommended for manual injection.
Overview table for recommended dilution possibilities of different presentations:
For in ovo administration:
Frozen suspension presentation No. of ampoules x doses (D) | Solvent presentation (ml) | Volume of one dose (ml) |
8 * 500 D | 200 | 0.05 |
8 * 1000 D | 400 |
4 * 2000 D | 400 |
2 * 4000 D | 400 |
4 * 4000 D | 800 |
5 * 4000 D | 1000 |
6 * 4000 D | 1200 |
8 * 4000 D | 1600 |
The speed of automatic injection is at least 2500 eggs per hour. Solvent presentation of at least or more than 400 ml is recommended to prime the machine and inject for longer than 10 minutes. The 200 ml solvent presentation may be used for manual in ovo equipment.
For subcutaneous administration:
Frozen suspension presentation No. of ampoules x doses (D) | Solvent presentation (ml) | Volume of one dose (ml) |
2 * 500 D | 200 | 0.20 |
1 * 1000 D | 200 |
1 * 2000 D | 400 |
2 * 2000 D | 800 |
1 * 4000 D | 800 |
3 * 2000 D | 1200 |
2 * 4000 D | 1600 |
The usual aseptic precautions should be applied to all administration procedures.
Be familiar with all safety and precautionary measures for handling liquid nitrogen in order to prevent personal injury.
Reconstitution of the vaccine:
1After matching the dose size of the ampoules with the solvent size, quickly remove the exact number of ampoules needed from the liquid nitrogen container.
2Draw up 2 ml of solvent into a 5 ml syringe. Use minimum 18 gauge needle.
3Thaw rapidly the contents of the ampoules by gentle agitation in water at 27-39°C.
4As soon as they are completely thawed, open ampoules holding them at arm length in order to prevent any risk of injury should the ampoule break.
5Once the ampoule is open, slowly draw up the content into the 5-ml sterile syringe prepared as in point 2.
6Transfer the thawed suspension into the solvent bag. The reconstituted vaccine prepared as described is mixed by gentle agitation.
7Withdraw a portion of the diluted vaccine from the solvent bag into the syringe and use it to rinse the ampoule. Inject it gently back into the solvent bag. Repeat once or twice.
8The reconstituted vaccine prepared as described is mixed by gentle agitation so as to be ready for use.
Repeat the operations in point 2-7 for the appropriate number of ampoules to be thawed.
Use the reconstituted vaccine immediately, slowly mix regularly to ensure uniform suspension of cells and use within a period not exceeding 2 hours.
It should be ensured that the diluted vaccine is mixed regularly in a gentle way during the vaccination session to guarantee that the vaccine remains homogenous and that the correct virus titer is administered (e.g. when automatic in ovo injection machines are used or during long vaccination sessions).
Overdose (symptoms, emergency procedures, antidotes), if necessary
No symptoms were observed after the administration of a 10-fold dose of vaccine.
Withdrawal period(s)
Zero days.