Nobilis ND Clone 30 live lyophilisate for oculonasal suspension/use in drinking water for chickens and turkeys.

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Live newcastle disease virus clone 30

Fáanlegur frá:

Intervet Ireland Limited

ATC númer:

QI01AD06

INN (Alþjóðlegt nafn):

Live newcastle disease virus clone 30

Skammtar:

.

Lyfjaform:

Lyophilisate for oculonasal suspension/use in drinking water

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Meðferðarhópur:

Chickens, Turkeys

Lækningarsvæði:

newcastle disease virus / paramyxovirus

Ábendingar:

Immunological - Live Vaccine

Leyfisstaða:

Authorised

Leyfisdagur:

2004-08-31

Vara einkenni

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis ND Clone 30 live lyophilisate for oculonasal suspension/use in
drinking water for chickens
and turkeys.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
PER DOSE
Live Newcastle disease virus, strain Clone 30
≥ 6.0 log
10
ELD
50
*
For a full list of excipients, see section 6.1.
* ELD
50
= 50 % Egg Lethal Dose
3.
PHARMACEUTICAL FORM
Lyophilisate for oculonasal suspension/use in drinking water.
Vials: white/off-white coloured pellet.
Cups: white/off white, predominantly sphere shaped.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens and turkeys.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of chickens and turkeys to reduce
mortality and clinical signs resulting
from infection with Newcastle Disease (but for use in turkeys, see
comments in section 4.9).
Onset of immunity: 2 weeks.
Duration of immunity: 6 weeks in chickens, 4 weeks in turkeys.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
A good immune response is reliant on the reaction of an immunogenic
agent and a fully competent
immune system.
Immunogenicity of the vaccine antigen will be reduced by poor storage
or inappropriate
administration.
Immunocompetence of the animal may be compromised by a variety of
factors including poor health,
nutritional status, genetic factors, concurrent drug therapy and
stress. Under certain conditions, for
example extreme disease pressure, fully immune birds may succumb to
disease. Therefore successful
vaccination may not be synonymous with full protection in the face of
a disease challenge.
Do not vaccinate unhealthy birds. Sick or weak birds will not develop
adequate immunity following
vaccination. The vaccine virus may spread to susceptible, unvaccinated
birds.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
MEDICINAL PRODUCT TO ANIMALS
The vaccine virus can ca