Avinew

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Newcastle disease virus VG/GA AVINEW strain live

Fáanlegur frá:

Merial Animal Health Limited

ATC númer:

QI01AD

INN (Alþjóðlegt nafn):

Newcastle disease virus VG/GA AVINEW strain live

Skammtar:

5.5-7.0 log 10 50% embryo infective dose/dose

Lyfjaform:

Lyophilisate for suspension

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Meðferðarhópur:

Chickens

Lækningarsvæði:

Live viral vaccines

Ábendingar:

Immunological - Live Vaccine

Leyfisstaða:

Authorised

Leyfisdagur:

2002-11-28

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Avinew.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of reconstituted vaccine contains:
ACTIVE SUBSTANCE:
Live Newcastle disease virus, VG/GA-AVINEW strain, at least
5.5 log
10
EID
50
EID50: Egg Infective Dose 50 per cent.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate for suspension for oral and ocular administration and for
spraying.
Pale, homogeneous lyophilisate.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens (broiler, future layer and future breeder pullets).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In broiler chickens from the age of one day:
Active immunisation against Newcastle disease to reduce mortality and
clinical signs associated with the disease.
Onset of immunity: 14 days after primary vaccination.
Duration of immunity induced by the vaccination scheme described under
4.9: protection until the age of 6 weeks.
In future layer and future breeder pullets from the age of 4 weeks:
Priming for active immunisation against egg drop caused by Newcastle
disease before vaccination with an inactivated
vaccine (strain Ulster 2C) prior to the beginning of lay.
For duration of immunity of full schedule, see SPC of the inactivated
booster vaccine
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccine virus can spread to unvaccinated birds. Infection of
unvaccinated birds with the vaccine virus from vaccinated
birds does not
induce any sign of disease.
Moreover,
a reversion to virulence trial
carried out
in the laboratory has
shown that the vaccine virus does not acquire any pathogenic
characteristic after 10 passages in chickens.
Therefore,
spread to unvaccinated birds, in the present state of knowledge, can
be considered as safe.
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