Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Leptospira interrogans serogroup Australis, Leptospira interrogans serogroup Canicola, Leptospira interrogans serogroup Grippotyphosa, Leptospira interrogans serogroup Icterohaemorrhagiae
Boehringer Ingelheim Vetmedica GmbH
Leptospira interrogans serogroup Australis, Leptospira interrogans serogroup Canicola, Leptospira interrogans serogroup Grippotyphosa, Leptospira interrogans serogroup Icterohaemorrhagiae
Suspension for injection
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Inactivated Bacterial Vaccine
Authorized
2023-06-02
Amended Pages: August 2023 AN: 01518/2021 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Eurican L4 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 strain 16069 .................................................................Activity acc. to Ph. Eur.447* (*) Inactivated _Leptospira interrogans _serogroup and serovar_ _Grippotyphosa strain Grippo Mal 1540 ....................................................Activity acc. to Ph. Eur.447* (*) Inactivated _Leptospira interrogans _serogroup Australis and serovar_ _Bratislava strain 16785......................................................................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 from 7 weeks of age to prevent or reduce mortality, clinical signs, infection, bacterial excretion, renal carriage and renal lesions caused by: - Leptospira interrogans serogroup Canicola serovar Canicola, - Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, - Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa, and - Leptospira interrogans serogroup Australis serovar Bratislava. Amended Pages: August 2023 AN: 01518/2021 Page 2 of 5 INDICATION SEROGROUP / SEROVAR MORTALITY CLINICAL SIGNS INFECTION BACTERIAL EXCRETION RENAL CARRIAGE RENAL LESIONS Canicola / Canicola Prevention* Prevention* Reduction Reduction Reduction Reduction Icterohaemorrhagiae / Ictero Read the complete document