देश: हंगरी
भाषा: अंग्रेज़ी
स्रोत: HMA (Heads of Medicines Agencies)
IBV strain Mass41 10 HI, NDV strain Ulster 2c 10 HI, turkey rhinotracheitis virus 60 IP
Merial
QI01AA21
Emulsion for injection
Avian infectious bronchitis virus vaccine + Newcastle disease virus / paramyxovirus vaccine + Avian rhinotracheitis virus vaccin
Chicken Layers
2009-07-13
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 पूरा दस्तावेज़ पढ़ें
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 पूरा दस्तावेज़ पढ़ें