Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LEPTOSPIRA CANICOLA INACTIVATED, LEPTOSPIRA ICTEROHAEMORRHAGIAE INACTIVATED
Merial Animal Health Limited
QI07AB01
LEPTOSPIRA CANICOLA INACTIVATED, LEPTOSPIRA ICTEROHAEMORRHAGIAE INACTIVATED
%v/v
Suspension for Injection
POM
Canine
Leptospira vaccine
Immunological - Inactivated vaccine
Authorised
2004-11-05
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Eurican L 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Inactivated_ Leptospira canicola................................._ } > 80% protection* Inactivated_ Leptospira icterohaemorrhagiae............._ } Excipient..................................................................... qs 1 dose of 1 ml *According to Ph. Eur. hamster potency test For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs from 8 weeks of age. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In dogs: Active immunisation against _Leptospira canicola_ and_ Leptospira icterohaemorrhagiae_ to prevent mortality and to reduce clinical symptoms of Leptospira infections caused by these agents. Onset of immunity: 14 days after primary vaccination. The duration of immunity is one year. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE (I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS: Vaccinate only healthy animals (II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL PRODUCT TO THE ANIMALS: In the case of accidental self-injection, wash the area immediately with water. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _3_ _1_ _/_ _0_ _3_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _4_ _0_ _6_ _4_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.6 ADVERSE REACTIONS Read the complete document