Gallimune 303 ND+IB+ART
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:
IBV strain Mass41 10 HI, NDV strain Ulster 2c 10 HI, turkey rhinotracheitis virus 60 IP
Available from:
Merial
ATC code:
QI01AA21
Pharmaceutical form:
Emulsion for injection
Therapeutic group:
Avian infectious bronchitis virus vaccine + Newcastle disease virus / paramyxovirus vaccine + Avian rhinotracheitis virus vaccin
Therapeutic area:
Chicken Layers
Authorization date:
2009-07-13
Patient Information leaflet
February 2009
SUMMARY OF PRODUCT CHARACTERISTICS
February 2009
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
GALLIMUNE 303 ND+IB+ART*
*
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 Avian Rhinotracheitis virus (Swollen Head Syndrome),
VCO3 strain, at least... 60 IP.U
(culture substrate: hen eggs, Vero 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 - IP: interference percentage
(1): Minimum protective dose according to monograph 0870 of Ph. Eur.
(culture substrate: hen eggs, Vero cells )*: for Germany only
ADJUVANT(S):
Paraffin
oil ..................................................................................................................... 170
to 186 mg
EXCIPIENT(S):
Thiomersal, at most ....................................................................................................................30
μg
Formaldehyde, at most ............................................................................................................... 45 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 pullets).
4
Read the complete document
Summary of Product characteristics
February 2009
SUMMARY OF PRODUCT CHARACTERISTICS
February 2009
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
GALLIMUNE 303 ND+IB+ART*
*
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 Avian Rhinotracheitis virus (Swollen Head Syndrome),
VCO3 strain, at least... 60 IP.U
(culture substrate: hen eggs, Vero 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 - IP: interference percentage
(1): Minimum protective dose according to monograph 0870 of Ph. Eur.
(culture substrate: hen eggs, Vero cells )*: for Germany only
ADJUVANT(S):
Paraffin
oil ..................................................................................................................... 170
to 186 mg
EXCIPIENT(S):
Thiomersal, at most ....................................................................................................................30
μg
Formaldehyde, at most ............................................................................................................... 45 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 pullets).
4
Read the complete document
