国家: 欧盟
语言: 英文
来源: EMA (European Medicines Agency)
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 (all inactivated)
Zoetis Belgium S.A.
QI07AB01
Canine leptospirosis vaccine (inactivated)
Dogs
Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia), Immunologicals for canidae
Active immunisation of dogs from six weeks of age 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 4 weeks after completion of the primary course. Duration of immunity: At least one year following the primary vaccination course.
Revision: 4
Authorised
2014-07-30
15 B. PACKAGE LEAFLET 16 PACKAGE LEAFLET: VERSICAN PLUS L4 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 L4 suspension for injection for dogs 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of 1 ml contains: ACTIVE SUBSTANCES: 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. * Antibody micro agglutination-lytic reaction. Appearance: whitish liquid with fine sediment. 17 4. INDICATION(S) Active immunisation of dogs from 6 weeks of age: − 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 Grippotyphosa. Onset of immunity: 4 weeks after the completion of primary course. Duration of immunity: At least one year following the primary vaccination course for all components of Versican Plus L4. 5. CONTRAINDICATIONS N 阅读完整的文件
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus L4 suspension for injection for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains: ACTIVE SUBSTANCES: 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 * 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 Suspension for injection. The visual appearance is as follows: Whitish liquid 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: − 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 3 − to prevent clinical signs and reduce infection and urinary excretion caused by _L. kirschneri_ serogroup Grippotyphosa serovar Grippotyphosa _._ Onset of immunity: 4 weeks after completion of the primary course. Duration of immunity: At least one year following the primary vaccination course for all components of Versican Plus L4. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES A good immune response is reliant on a fully competent immune system. Immunocompetence of the animal may be compromised by a variety of factors including poor hea 阅读完整的文件