Country: Germany
Language: English
Source: HMA (Heads of Medicines Agencies)
EDSV strain 127 162 HI, IBV strain Mass41 10 HI, NDV strain Ulster 2c 10 HI
Merial
QI01AA
Emulsion for injection
Inactivated viral vaccines
Chicken Layers
2010-11-23
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
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