Krajina: Rakúsko
Jazyk: angličtina
Zdroj: HMA (Heads of Medicines Agencies)
canine adenovirus 4.9 GKID50, canine distemper virus 4.7 GKID50, canine parainfluenza virus 4.6 GKID50, canine parvovirus 6.1 GKID50, leptospira interrogans serogroup canicola 32 MALR, leptospira interrogans serogroup icterohaemorragiae 32 MALR, Rabies virus, inactivated 2 IU
Pfizer Limited
QI07AJ06
Suspension for injection
live canine distemper virus + live canine adenovirus + live parainfl.virus + live canine parvovirus + inactivated rabies + inact
Dogs Non Food
2011-12-21
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Versican DHPPi/L3R, lyophilisate and solvent for suspension for injection for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Composition per 1 ml dose: ACTIVE SUBSTANCES: Freeze-dried fraction (live attenuated)_ _ Minimum Maximum_ _ Canine Distemper virus, strain CDVU 39 10 3.0 TCID 50 * 10 4.7 TCID 50 Canine Adenovirus Type 2, strain CAV2-Bio 13 10 3.5 TCID 50 * 10 4.9 TCID 50 Canine Parvovirus, strain CPV-Bio 12 10 4.5 TCID 50 * 10 6.1 TCID 50 Canine Parainfluenza Type 2 virus, strain CPiV-2-Bio 15 10 3.0 TCID 50 * 10 4..6 TCID 50 Liquid fraction (inactivated) _Leptospira interrogans_ serovar Icterohaemorrhagiae_,_ strain MSLB 1008 ARL** titre ≥ 1:32 _Leptospira interrogans _serovar Canicola, strain MSLB 1010 ARL** titre ≥ 1:32 _Leptospira kirschneri _serovar Grippotyphosa_,_ strain MSLB 1009 ARL** titre ≥ 1:64 Inactivated rabies virus, strain SAD Vnukovo-32 ≥2.0 IU*** * Tissue culture infectious dose-50 % ** Antibody micro agglutination -lytic reaction *** International units ADJUVANT: Aluminium hydroxide gel 1.8 - 2.2 mg EXCIPIENT: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent, for suspension for injection The visual appearance is as follows: Lyophilisate: Lyophilised vaccine is spongy matter, cream and white colour Solvent: Pink colour with fine sediment Reconstituted vaccine: Pink/red, or yellowish colour with light opalescence 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 3 Prečítajte si celý dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Versican DHPPi/L3R, lyophilisate and solvent for suspension for injection for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Composition per 1 ml dose: ACTIVE SUBSTANCES: Freeze-dried fraction (live attenuated)_ _ Minimum Maximum_ _ Canine Distemper virus, strain CDVU 39 10 3.0 TCID 50 * 10 4.7 TCID 50 Canine Adenovirus Type 2, strain CAV2-Bio 13 10 3.5 TCID 50 * 10 4.9 TCID 50 Canine Parvovirus, strain CPV-Bio 12 10 4.5 TCID 50 * 10 6.1 TCID 50 Canine Parainfluenza Type 2 virus, strain CPiV-2-Bio 15 10 3.0 TCID 50 * 10 4..6 TCID 50 Liquid fraction (inactivated) _Leptospira interrogans_ serovar Icterohaemorrhagiae_,_ strain MSLB 1008 ARL** titre ≥ 1:32 _Leptospira interrogans _serovar Canicola, strain MSLB 1010 ARL** titre ≥ 1:32 _Leptospira kirschneri _serovar Grippotyphosa_,_ strain MSLB 1009 ARL** titre ≥ 1:64 Inactivated rabies virus, strain SAD Vnukovo-32 ≥2.0 IU*** * Tissue culture infectious dose-50 % ** Antibody micro agglutination -lytic reaction *** International units ADJUVANT: Aluminium hydroxide gel 1.8 - 2.2 mg EXCIPIENT: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent, for suspension for injection The visual appearance is as follows: Lyophilisate: Lyophilised vaccine is spongy matter, cream and white colour Solvent: Pink colour with fine sediment Reconstituted vaccine: Pink/red, or yellowish colour with light opalescence 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 3 Prečítajte si celý dokument