Nobilis ND C2 lyophilisate for oculonasal suspension for chickens

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Live attenuated newcastle disease virus (ndv) strain c2

Доступно од:

Intervet Ireland Limited

АТЦ код:

QI01AD06

INN (Међународно име):

Live attenuated newcastle disease virus (ndv) strain c2

Дозирање:

.

Фармацеутски облик:

Lyophilisate for oculonasal suspension

Тип рецептора:

POM: Prescription Only Medicine as defined in relevant national legislation

Терапеутска група:

Fowl - Chicken

Терапеутска област:

newcastle disease virus / paramyxovirus

Терапеутске индикације:

Immunological - Live Vaccine

Статус ауторизације:

Authorised

Датум одобрења:

2005-06-03

Карактеристике производа

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis ND C2 lyophilisate for oculonasal suspension for chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of reconstituted vaccine:
ACTIVE SUBSTANCE:
Live attenuated Newcastle disease virus (NDV) strain C2: 5.7 - 7.5 log
10
EID
50
* .
*EID
50
= 50% Embryo infective dose: the virus titre required to produce
infection in 50% of the embryos
inoculated
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
Sorbitol
Hydrolysed gelatine
Pancreatic digest of casein
Disodium phosphate dihydrate
Purified water
Lyophilisate.:
Vials: white/off-white coloured pellet.
Cups: white/off-white, predominantly sphere shaped.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Chickens.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Active immunisation of chickens against Newcastle disease virus to
reduce clinical signs and
mortality.
Onset of immunity: 2 weeks after vaccination of seronegative animals.
Duration of immunity: 5 weeks after vaccination of seronegative
animals.
Onset of protection is demonstrated at 2 weeks after vaccination of
animals with maternally derived
antibodies.
Duration of immunity is in accordance with the vaccination programme.
3.3
CONTRAINDICATIONS
Do not vaccinate clinically ill (especially respiratory disease) or
stressed birds.
3.4
SPECIAL WARNINGS
Vaccinate healthy animals only.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
The vaccine virus may spread to unvaccinated birds up to 10 days post
vaccination. This spread does
not induce clinical signs but may lead to seroconversion in
unvaccinated chickens.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals:
The vaccine can be pathogenic for humans. Since this vaccine has been
prepared with live, attenuated
viruses, appropriate measures should be taken to prevent contamination
of the handler and other
people that collaborate in the process.
In case of spray administration, personal protective equi