Nobilis ND C2 Lyophilisate for Oculonasal Suspension for Chickens

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Newcastle disease virus

Available from:

MSD Animal Health UK Limited

ATC code:

QI01AD06

INN (International Name):

Newcastle disease virus

Pharmaceutical form:

Lyophilisate for suspension for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Chickens

Therapeutic area:

Live Viral Vaccine

Authorization status:

Authorized

Authorization date:

2005-04-25

Summary of Product characteristics

Revised: April 2024
AN: 00160/2023
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
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
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate.
Vials: white/off-white coloured pellet.
Cups: white/off-white, predominantly sphere shaped.
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 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.
Revised: April 2024
AN: 00160/2023
Page 2 of 7
4.3
CONTRAINDICATIONS
Do not vaccinate clinically ill (especially respiratory disease) or
stressed
birds.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
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. 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 ad