Nobilis IB Ma5

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Live attenuated IB virus strain Ma5

Disponível em:

Intervet Ireland Limited

Código ATC:

QI01AD07

DCI (Denominação Comum Internacional):

Live attenuated IB virus strain Ma5

Dosagem:

.

Forma farmacêutica:

Lyophilisate for suspension for oculonasal or spray app

Tipo de prescrição:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapêutico:

Chickens

Área terapêutica:

avian infectious bronchitis virus

Indicações terapêuticas:

Immunological - Live Vaccine

Status de autorização:

Authorised

Data de autorização:

2003-02-19

Características técnicas

2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis IB Ma5
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE(S)
PER DOSE
Live avian infectious bronchitis virus, strain Ma5
≥ 10
3.5
EID
50
*
*EID
50
= 50 % Embryonic Infective Dose
EXCIPIENTS
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for suspension.
Vials: off-white/cream-coloured pellet.
Cups: off-white predominantly sphere shaped.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
To reduce mortality and clinical signs of Massachusetts or
serologically related types of infectious
bronchitis. A single vaccination gives protective immunity that lasts
at least through the normal broiler
rearing period (5 – 7 weeks). Where appropriate, e.g. in layers and
breeders, revaccination at
approximately 6 week intervals is advised.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The vaccine virus may spread from vaccinates to non-vaccinated birds
and appropriate care should be
taken to separate vaccinates from non-vaccinates.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Only healthy chickens should be vaccinated.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
Wash and disinfect hands after use.
When spraying the vaccine, to avoid hay-fever like reactions in some
individuals, operators should
wear respiratory and eye protection conforming to current European
Standards.
3
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Mild, respiratory signs may occur from 1 to 3 weeks after vaccination.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Not recommended for use during lay.
Emergency vaccination during lay may result in a transient drop in egg
production.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Safety and efficacy data are available which demonstrate that this
vaccine can be mixed and
administered with Nobilis IB 4-91 or Nobi