Cevac MD HVT Suspension and Solvent for Suspension for Injection for Chickens

Summary of Product characteristics

                                Revised: September 2022
AN: 01480/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cevac MD HVT suspension and solvent for suspension for injection for
chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (0.05 ml _in ovo_ or 0.2 ml subcutaneous) contains:
ACTIVE SUBSTANCE:
Cell-associated live turkey herpes virus (HVT, Marek’s disease
virus),
serotype 3, strain FC-126
2000-8000 PFU


PFU: plaque forming unit
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension and solvent for suspension for injection.
Vaccine: yellowish-brownish, dense, frozen virus suspension.
Solvent: clear, orange to red solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens and embryonated chicken eggs
4.2
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.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Revised: September 2022
AN: 01480/2022
Page 2 of 6
4.5
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
                                
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