Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
CLOSANTEL SODIUM DIHYDRATE
Elanco Animal Health, Eli Lilly and Company Limited
QP52AG09
CLOSANTEL SODIUM DIHYDRATE
50 Mg/Ml
Solution for Injection
LM: Licensed Merchant as defined in relevant national legislation
Cattle
closantel
Endoparasiticide
Authorised
2012-10-12
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT FLUKIVER BOVIS 50 mg/ml Solution for Injection for cattle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for injection. Clear yellow to amber solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment and control of liver fluke, gastro-intestinal nematodes and arthropods. TREMATODES _Fasciola hepatica_ _Fasciola gigantica_ NEMATODES _Haemonchus placei_ _Bunostomum phlebotomum_ _Oesophagostomum radiatum_ ARTHROPODS _Hypoderma bovis_ _Hypoderma lineatum_ Each ml contains: ACTIVE SUBSTANCE: Closantel 50 mg (equivalent to closantel sodium dihydrate 54.375 mg) EXCIPIENTS: Propylene glycol 414.4 mg For the full list of excipients, see section 6.1. 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_ _7_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _0_ _1_ _2_ _4_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.3 CONTRAINDICATIONS See section 4.11. Do not administer to animals with known hypersensitivity to the active ingredient. Not for i.v. or i.m. use. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy: • Too frequent and repeated use of anthelmintics from the same class, over an extended period of time. • Underdosing, which ma Lue koko asiakirja