Avinew

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Newcastle disease virus

Available from:

Boehringer Ingelheim Animal Health UK Ltd

ATC code:

QI01AD06

INN (International Name):

Newcastle disease virus

Pharmaceutical form:

Oral lyophilisate

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Chickens

Therapeutic area:

Live Viral Vaccine

Authorization status:

Expired

Authorization date:

2003-07-23

Summary of Product characteristics

Revised: November 2018
AN: 01034/2018
Page 1 of 5
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, 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
Revised: November 2018
AN: 01034/2018
Page 2 of 5
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
Vaccinate healthy birds only.
Apply the usual aseptic procedures.
SPECIAL PRECAU