Avishield ND B1, lyophilisate for oculonasal suspension/use in drinking water for chickens.

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Newcastle disease virus, live

Dostopno od:

GENERA Inc

Koda artikla:

QI01AD06

INN (mednarodno ime):

Newcastle disease virus, live

Odmerek:

.

Farmacevtska oblika:

Lyophilisate for oculonasal suspension/use in drinking water

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtska skupina:

Chickens

Terapevtsko območje:

newcastle disease virus / paramyxovirus

Terapevtske indikacije:

Immunological - Live Vaccine

Status dovoljenje:

Authorised

Datum dovoljenje:

2018-05-18

Lastnosti izdelka

Health Products Regulatory Authority
18 May 2018
CRN000V9G
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Avishield ND B1, lyophilisate for oculonasal suspension/use in
drinking water for
chickens
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose contains
ACTIVE SUBSTANCE:
Live, lentogenic virus of Newcastle disease, strain Hitchner B1 10
6.0
to 10
7.0
TCID
50
TCID
50
= 50% Tissue Culture Infective Dose
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate for oculonasal suspension/use in drinking water
Cream coloured lyophilisate
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens (broilers and future layers/breeders)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of chickens (broilers and future
layers/breeders) to reduce
mortality and clinical signs due to infection with Newcastle disease
virus.
Onset of immunity: 3 weeks post vaccination.
Duration of immunity: 5 weeks post vaccination.
4.3 CONTRAINDICATIONS
None.
Health Products Regulatory Authority
18 May 2018
CRN000V9G
Page 2 of 6
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Maternally Derived Antibodies (MDA) can interfere with the development
of active
immunity. In flocks where high levels of MDAs are expected,
vaccination programme
should be planned accordingly.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
All the birds in the flock should be vaccinated at the same time. The
vaccine strain
can spread to susceptible, unvaccinated birds for at least 10 days
following
vaccination. The spread does not induce clinical signs. The vaccine
strain can spread
to non-target susceptible species. Appropriate veterinary and
husbandry measures
should be taken to avoid spread of the vaccine strain to susceptible
species.
The vaccine virus can disseminate to the trachea, spleen, kidneys,
lung, caecal tonsils,
duodenum and brains of chickens without inducing pathological changes
to these
organs.
S