Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
canine distemper virus, strain CDV Bio 11/A, canine adenovirus type 2, strain CAV-2 Bio 13, canine parvovirus type 2b, strain CPV-2b Bio 12/B, canine parainfluenza type 2 virus, strain CPiV-2 Bio 15 (all live attenuated), Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 1088, L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, strain MSLB 1089, L. interrogans serogroup Canicola serovar Canicola, strain MSLB 1090, L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091...
Zoetis Belgium SA
QI07AI02
live, attenuated Canine distemper virus, canine adenovirus, canine parvovirus, canine parainfluenza virus inactivated
Dogs
live canine distemper virus + live canine adenovirus + live canine parainfluenza virus + live canine parvovirus + inactivated leptospira, Immunologicals for canidae
Active immunisation of dogs from 6 weeks of age:to prevent mortality and clinical signs caused by canine distemper virus,to prevent mortality and clinical signs caused by canine adenovirus type 1,to prevent clinical signs and reduce viral excretion caused by canine adenovirus type 2,to prevent clinical signs, leucopoenia and viral excretion caused by canine parvovirus,to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus,to prevent clinical signs, infection and urinary excretion caused by L. interrogans serogroup Australis serovar Bratislava,to prevent clinical signs and urinary excretion and reduce infection caused by L. interrogans serogroup Canicola serovar Canicola and L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae and to prevent clinical signs and reduce infection and urinary excretion caused by L. interrogans serogroup Grippotyphosa serovar Grippotyphosa.
Revision: 6
Authorised
2014-05-06
17 B. PACKAGE LEAFLET 18 PACKAGE LEAFLET: VERSICAN PLUS DHPPI/L4 LYOPHILISATE AND SUSPENSION FOR SUSPENSION FOR INJECTION FOR DOGS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM Manufacturer responsible for batch release: Bioveta, a.s., Komenského 212, 683 23 Ivanovice na Hané, CZECH REPUBLIC 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi/L4 lyophilisate and suspension for suspension for injection for dogs 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of 1 ml contains: ACTIVE SUBSTANCES: LYOPHILISATE (LIVE ATTENUATED): MINIMUM MAXIMUM Canine distemper virus, strain CDV Bio 11/A 10 3.1 TCID 50 * 10 5.1 TCID 50 Canine adenovirus Type 2, strain CAV-2 Bio 13 10 3.6 TCID 50 * 10 5.3 TCID 50 Canine parvovirus Type 2b, strain CPV-2b Bio 12/B 10 4.3 TCID 50 * 10 6.6 TCID 50 Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15 10 3.1 TCID 50 * 10 5.1 TCID 50 SUSPENSION (INACTIVATED): _Leptospira interrogans_ serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae strain MSLB 1089 ALR** titre ≥ 1:51 _Leptospira interrogans _ serogroup Canicola _ _ serovar Canicola, strain MSLB 1090 ALR** titre ≥ 1:51 _Leptospira kirschneri _ serogroup Grippotyphosa _ _ serovar Grippotyphosa _,_ strain MSLB 1091 ALR** titre ≥ 1:40 _Leptospira interrogans _ serogroup Australis serovar Bratislava _,_ strain MSLB 1088 ALR** titre ≥ 1:51 ADJUVANT: Aluminium hydroxide 1.8–2.2 mg. * Tissue culture infectious dose 50%. 19 ** Antibody micro agglutination-lytic reaction. Lyophilisate: spongy matter of white colour. Suspension: whitish colour with fine sediment. 4. INDICATION(S) Active immunisation of dogs from 6 weeks of age: − to prevent mortality and clinical signs caused by canine distemper virus, − to prevent mortality and clinical signs caused by canine adenovirus type 1, − to prev Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi/L4 lyophilisate and suspension for suspension for injection for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains: ACTIVE SUBSTANCES: LYOPHILISATE (LIVE ATTENUATED):_ _ MINIMUM MAXIMUM_ _ Canine distemper virus, strain CDV Bio 11/A 10 3.1 TCID 50 * 10 5.1 TCID 50 Canine adenovirus Type 2, strain CAV-2 Bio 13 10 3.6 TCID 50 * 10 5.3 TCID 50 Canine parvovirus Type 2b, strain CPV-2b Bio 12/B 10 4.3 TCID 50 * 10 6.6 TCID 50 Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15 10 3.1 TCID 50 * 10 5.1 TCID 50 SUSPENSION (INACTIVATED): _Leptospira interrogans_ serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae strain MSLB 1089 ALR** titre ≥ 1:51 _Leptospira interrogans _ serogroup Canicola serovar Canicola, strain MSLB 1090 ALR** titre ≥ 1:51 _Leptospira kirschneri _ serogroup Grippotyphosa serovar Grippotyphosa _,_ strain MSLB 1091 ALR** titre ≥ 1:40 _Leptospira interrogans_ serogroup Australis _ _ serovar Bratislava _,_ strain MSLB 1088 ALR** titre ≥ 1:51 * Tissue culture infectious dose 50%. ** Antibody micro agglutination-lytic reaction. ADJUVANT: Aluminium hydroxide 1.8–2.2 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and suspension for suspension for injection. The visual appearance is as follows: Lyophilisate: spongy matter of white colour. Suspension: whitish colour with fine sediment. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 3 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of dogs from 6 weeks of age: − to prevent mortality and clinical signs caused by canine distemper virus, − to prevent mortality and clinical signs caused by canine adenovirus type 1, − to prevent clinical signs and reduce viral excretion caused by canine adenovirus type 2, − to prevent clinical signs, leucopoenia and viral excretion caused by canine parvovirus, − to prevent clinical signs (nasal and Aqra d-dokument sħiħ