AVINEW
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
08-08-2015
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Senda beiðni.
Senda beiðni.
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:
Unknown
Lyfjaform:
Lyophilisate for suspension
Gerð lyfseðils:
POM
Meðferðarhópur:
Fowl - Chicken
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 consid
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