AVINEW
Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Tabia za bidhaa
(SPC)
08-08-2015
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Tuma ombi.
Viambatanisho vya kazi:
NEWCASTLE DISEASE VIRUS VG/GA AVINEW STRAIN LIVE
Inapatikana kutoka:
Merial Animal Health Limited
ATC kanuni:
QI01AD
INN (Jina la Kimataifa):
NEWCASTLE DISEASE VIRUS VG/GA AVINEW STRAIN LIVE
Kipimo:
Unknown
Dawa fomu:
Lyophilisate for suspension
Dawa ya aina:
POM
Kundi la matibabu:
Fowl - Chicken
Eneo la matibabu:
Live viral vaccines
Matibabu dalili:
Immunological - Live Vaccine
Idhini hali ya:
Authorised
Idhini ya tarehe:
2002-11-28
Tabia za bidhaa
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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