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

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Newcastle disease virus, live

から入手可能:

GENERA Inc

ATCコード:

QI01AD06

INN（国際名）:

Newcastle disease virus, live

投薬量:

.

医薬品形態:

Lyophilisate for oculonasal suspension/use in drinking water

処方タイプ:

POM: Prescription Only Medicine as defined in relevant national legislation

治療群:

Chickens

治療領域:

newcastle disease virus / paramyxovirus

適応症:

Immunological - Live Vaccine

認証ステータス:

Authorised

承認日:

2018-05-18

製品の特徴

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