Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Canine parainfluenza type 2 virus, strain CPiV-2 Bio 15 (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 and L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091 (all inactivated)
Zoetis Belgium SA.
QI07AI08
canine parainfluenza virus and Leptospira
Dogs
Immunologicals for canidae, Live viral and inactivated bacterial vaccines
Active immunisation of dogs from six weeks of age. - to prevent clinical signs and reduce viral excretion caused by canine parainfluenza virus, - to prevent clinical signs, infection and urinary excretion caused by Leptospira serovars bratislava, canicola, grippotyphosa and icterohaemorrhagiae. Onset of immunity: Immunity has been demonstrated from 3 weeks after completion of the primary course for CPiV and from 4 weeks after completion of the primary course for Leptospira components. Duration of immunity: At least one year following the primary vaccination course for all components of Versican Plus Pi/L4.
Revision: 4
Authorised
2014-07-30
16 B. PACKAGE LEAFLET 17 PACKAGE LEAFLET: VERSICAN PLUS PI/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 Pi/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 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%. ** Antibody micro agglutination-lytic reaction. 18 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 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 Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi/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 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 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of dogs from 6 weeks of age: 3 − 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. kirschneri_ serogroup Grippotyphosa serovar Grip Lestu allt skjalið