Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
INACTIVATED LEPTOSPIRA INTERROGANS SEROGROUP CANICOLA STRAIN 16070, INACTIVATED LEPTOSPIRA INTERROGANS SEROGROUP ICTEROHAEMORRHAGIAE STRAIN 16069, INACTIVATED LEPTOSPIRA INTERROGANS SEROGROUP GRIPPOTYPHOSA STRAIN MAL 1540
Merial Animal Health Limited
QI07AB01
INACTIVATED LEPTOSPIRA INTERROGANS SEROGROUP CANICOLA STRAIN 16070, INACTIVATED LEPTOSPIRA INTERROGANS SEROGROUP ICTEROHAEMORRHA
Unknown
Suspension for Injection
POM
Canine
Leptospira vaccine
Immunological - Inactivated vaccine
Authorised
2015-11-27
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Eurican Lmulti Suspension for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (1 ml) of suspension contains: ACTIVE SUBSTANCES: Inactivated_ Leptospira interrogans_ serogroup and serovar Canicola strain 16070 ................................................................................ Activity acc. to Ph. Eur.447* Inactivated_ Leptospira interrogans_ serogroup and serovar Icterohaemorrhagiae strain16069 ................................................................................. Activity acc. to Ph. Eur.447* Inactivated_ Leptospira interrogans_ serogroup and serovar Grippotyphosa strain Grippo Mal 1540............................................................... Activity acc. to Ph. Eur.447* * 80 % protection in hamsters EXCIPIENTS: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection. Opalescent and homogenous suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of dogs to : - prevent mortality, clinical signs, infection, bacterial excretion, renal carriage and renal lesions caused by _Leptospira_ interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae - prevent mortality* and clinical signs, reduce infection, bacterial excretion, renal carriage and renal lesions caused by_ Leptospira_ interrogans serogroup Canicola serovar Canicola. - prevent mortality*, and reduce clinical signs, infection, bacterial excretion renal carriage and renal lesions caused by_ Leptospira_ kirschneri serogroup Grippotyphosa serovar Grippotyphosa. Onset of immunity : 2 weeks for all strains Duration of immunity: at least one year after the second injection of the primary vaccination course for all strains. * For_ Leptospira_ Canicola and Grippotyphosa, no mortality occurred during the duration of immunity challenge. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ _ Citiți documentul complet