Gallimune 302 ND + IB + EDS
Land: Ungarn
Sprog: engelsk
Kilde: HMA (Heads of Medicines Agencies)
Indlægsseddel
(PIL)
21-08-2013
Produktets egenskaber
(SPC)
21-08-2013
Aktiv bestanddel:
EDSV strain 127 162 HI, IBV strain Mass41 10 HI, NDV strain Ulster 2c 10 HI
Tilgængelig fra:
Merial
ATC-kode:
QI01AA
Lægemiddelform:
Emulsion for injection
Terapeutisk gruppe:
Inactivated viral vaccines
Terapeutisk område:
Chicken Layers
Autorisation dato:
2010-11-23
Indlægsseddel
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
Læs hele dokumentet
Produktets egenskaber
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
Læs hele dokumentet
