NOBILIS ND C2

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LIVE ATTENUATED NEWCASTLE DISEASE VIRUS (NDV) STRAIN C2

Available from:

Intervet Ireland Limited

ATC code:

QI01AD06

INN (International Name):

LIVE ATTENUATED NEWCASTLE DISEASE VIRUS (NDV) STRAIN C2

Dosage:

Unknown

Pharmaceutical form:

Lyophilisate for suspension for oculonasal or spray app

Prescription type:

POM

Therapeutic group:

Fowl - Chicken

Therapeutic area:

Newcastle disease virus / paramyxovirus vaccine

Therapeutic indications:

Immunological - Live Vaccine

Authorization status:

Authorised

Authorization date:

2005-06-03

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis ND C2.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
Live attenuated Newcastle disease virus (NDV) strain C2: 5.7 - 7.5 log
10
EID
50
* per dose.
*EID
50
= 50% Embryo infective dose: the virus titre required to produce
infection in 50% of the embryos inoculated
EXCIPIENTS:
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Lyophilisate for suspension for oculonasal or spray application.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of chickens against Newcastle disease virus to
reduce clinical signs and mortality.
Onset and duration of immunity: 2 and 5 weeks after vaccination of
seronegative animals, respectively.
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.
4.3 CONTRAINDICATIONS
Do not vaccinate clinically ill (especially respiratory disease) or
stressed birds.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The vaccine virus may spread to unvaccinated birds up to 10 days post
vaccination. Thi