Gallimune 302 ND + IB + EDS

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Egg drop syndrome virus, Infectious bronchitis virus, Newcastle disease virus

Available from:

Boehringer Ingelheim Animal Health UK Ltd

ATC code:

QI01AA13

INN (International Name):

Egg drop syndrome virus, Infectious bronchitis virus, Newcastle disease virus

Pharmaceutical form:

Emulsion for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Chickens

Therapeutic area:

Inactivated Viral Vaccine

Authorization status:

Authorized

Authorization date:

2004-10-15

Summary of Product characteristics

Revised November 2023
AN: 03221/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
GALLIMUNE 302 ND+IB+EDS emulsion for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.3 ml dose of vaccine contains:
ACTIVE SUBSTANCES:
Inactivated Newcastle disease virus, Ulster 2C strain, at
least.................................50 PD
50
1
Inactivated infectious bronchitis virus, Mass41 strain, at least
...................................18 HI.U
Inactivated egg drop syndrome virus (EDS76), V127 strain, at least
.......................180 HI.U
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
1
Minimum protective dose according to monograph 0870 of Ph. Eur.
ADJUVANT:
Paraffin oil
........................................................................................................170
to 186 mg
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS
AND OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT
INFORMATION IS ESSENTIAL FOR PROPER
ADMINISTRATION OF THE VETERINARY
MEDICINAL PRODUCT
Thiomersal
30 μg
Formaldehyde
at most 43.2 µg
Ester of fatty acids and of polyols
Ester of fatty acids and of ethoxylated
polyols
Water for injections
Whitish homogeneous emulsion.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Chickens (breeder and layer pullets).
3.2
INDICATIONS FOR USE FOR EACH 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,
Revised November 2023
AN: 03221/2022
Page 2 of 5
-
Infectious bronchitis virus in order to reduce egg drop linked to
infectious bronchitis
infection caused by the Mass41 strain,
Active immunisation of breeder and layer pullets in order to reduce
egg drop linked to
infection with egg drop syndrome virus (EDS76) without priming.
Onset of immunity: 4 weeks after vaccination.
Durati