Avinew

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Newcastle disease virus VG/GA AVINEW strain live

Prieinama:

Boehringer Ingelheim Vetmedica GmbH

ATC kodas:

QI01AD

INN (Tarptautinis Pavadinimas):

Newcastle disease virus VG/GA AVINEW strain live

Dozė:

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

Vaisto forma:

Lyophilisate for suspension

Recepto tipas:

POM: Prescription Only Medicine as defined in relevant national legislation

Gydymo sritis:

Live viral vaccines

Autorizacija statusas:

Authorised

Leidimo data:

2002-11-28

Prekės savybės

Health Products Regulatory Authority
07 December 2018
CRN008MP1
Page 1 of 6
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.
Health Products Regulatory Authority
07 December 2018
CRN008MP1
Page 2 of 6
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.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
V