Gallimune 302 ND + IB + EDS
Country: Ireland
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
21-08-2013
Summary of Product characteristics
(SPC)
21-08-2013
Active ingredient:
EDSV strain 127 162 HI, IBV strain Mass41 10 HI, NDV strain Ulster 2c 10 HI
Available from:
Merial
ATC code:
QI01AA
Pharmaceutical form:
Emulsion for injection
Therapeutic group:
Inactivated viral vaccines
Therapeutic area:
Chicken Layers
Authorization date:
2010-11-23
Patient Information leaflet
February 2009
SUMMARY OF PRODUCT CHARACTERISTICS
February 2009
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
GALLIMUNE 302 ND+IB+EDS*
*
for all countries except Austria, Belgium, Denmark and Sweden.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.3-ml dose of vaccine contains:
ACTIVE SUBSTANCES:
Inactivated Newcastle Disease virus, Ulster 2C strain,
at least ................................................ 50PD
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
(culture substrate: hen eggs, duck embryo cells)*
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.
(culture substrate: hen eggs , duck embryo cells)*: for Germany only
ADJUVANT(S):
Paraffin
oil ........................................................................................................................170
to 186 mg
EXCIPIENT(S):
Thiomersal,
at most ...................................................................................................................... 30
μg
Formaldehyde, at most ...............................................................................................................43.2 µg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Water-in oil emulsion for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens (breeder and layer pullet
Read the complete document
Summary of Product characteristics
February 2009
SUMMARY OF PRODUCT CHARACTERISTICS
February 2009
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
GALLIMUNE 302 ND+IB+EDS*
*
for all countries except Austria, Belgium, Denmark and Sweden.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.3-ml dose of vaccine contains:
ACTIVE SUBSTANCES:
Inactivated Newcastle Disease virus, Ulster 2C strain,
at least ................................................ 50PD
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
(culture substrate: hen eggs, duck embryo cells)*
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.
(culture substrate: hen eggs , duck embryo cells)*: for Germany only
ADJUVANT(S):
Paraffin
oil ........................................................................................................................170
to 186 mg
EXCIPIENT(S):
Thiomersal,
at most ...................................................................................................................... 30
μg
Formaldehyde, at most ...............................................................................................................43.2 µg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Water-in oil emulsion for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens (breeder and layer pullet
Read the complete document
