Gallimune 302 ND + IB + EDS
Krajina: Portugalsko
Jazyk: angličtina
Zdroj: HMA (Heads of Medicines Agencies)
Príbalový leták
(PIL)
21-08-2013
Súhrn charakteristických
(SPC)
21-08-2013
Aktívna zložka:
EDSV strain 127 162 HI, IBV strain Mass41 10 HI, NDV strain Ulster 2c 10 HI
Dostupné z:
Merial
ATC kód:
QI01AA
Forma lieku:
Emulsion for injection
Terapeutické skupiny:
Inactivated viral vaccines
Terapeutické oblasti:
Chicken Layers
Dátum Autorizácia:
2010-11-23
Príbalový leták
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
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Súhrn charakteristických
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
Prečítajte si celý dokument
