GALLIMUNE 303 ND+IB+ART Emulsion for injection

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Inactivated newcastle disease virus, ulster 2c strain, Inactivated infectious bronchitis virus, mass41 strain, Inactivated avian rhinotracheitis virus (swollen head syndrome), vco3 strain

Disponible desde:

Merial Animal Health Limited

Código ATC:

QI01AA21

Designación común internacional (DCI):

Inactivated newcastle disease virus, ulster 2c strain, Inactivated infectious bronchitis virus, mass41 strain, Inactivated avian

Dosis:

.

formulario farmacéutico:

Emulsion for injection

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapéutico:

Chickens

Área terapéutica:

avian infectious bronchitis virus + newcastle disease virus / paramyxovirus + avian rhinotracheitis virus

indicaciones terapéuticas:

Immunological - Inactivated Vaccine

Estado de Autorización:

Authorised

Fecha de autorización:

2005-11-25

Ficha técnica

Health Products Regulatory Authority
30 May 2018
CRN000WPS
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
GALLIMUNE 303 ND+IB+ART Emulsion for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.3-ml dose contains:
ACTIVE SUBSTANCE(S):
Inactivated Newcastle Disease virus, Ulster 2C strain, at least
50PD
50
1
Inactivated Infectious Bronchitis virus, Mass41 strain, at least
18 HI.U
Inactivated Avian Rhinotracheitis virus (Swollen Head Syndrome),
VCO3 strain, at least
0.76 ODD
The concentrations are expressed by the antibody titre obtained
during the potency test. One unit (U) corresponding to an antibody
titre of 1.
HI: haemagglutination inhibiting
ODD: Optical Density Difference
(1): Minimum protective dose according to monograph 0870 of Ph.
Eur.
ADJUVANT(S):
Paraffin oil
170 to 186 mg
EXCIPIENT(S):
Thiomersal, at most
30 μg
Formaldehyde, at most
45 µg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Whitish homogeneous emulsion for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens (breeder and layer pullets).
Health Products Regulatory Authority
30 May 2018
CRN000WPS
Page 2 of 5
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Booster immunisation of breeder and layer pullets after vaccination
with live vaccines against:
- Newcastle Disease virus in order to reduce egg drop linked to
Newcastle Disease infection,
- Infectious Bronchitis virus in order to reduce egg drop linked to
Infectious Bronchitis
infection caused by the Mass 41 strain,
- Avian pneumovirus in order to reduce respiratory signs linked to
avian pneumovirus
infection (Avian Rhinotracheitis).
Newcastle Disease and Infectious Bronchitis components:
- onset of immunity: 4 weeks after vaccination,
- duration of immunity: one laying period.
Avian Rhinotracheitis component:
- onset of immunity: 14 weeks after vaccination
- duration of immunity: one laying period.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals