Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Ivermectin
Chanelle Pharmaceuticals Manufacturing Limited
QP54AA01
Ivermectin
0.8 milligram(s)/millilitre
Oral solution
POM: Prescription Only Medicine as defined in relevant national legislation
Sheep
ivermectin
Endectoparasiticides
Authorised
2009-05-29
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Animec 0.8 mg/ml Oral Solution for Sheep. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Each ml contains: Ivermectin 0.8mg EXCIPIENT(S): Benzyl Alcohol (E1519) 28.6mg Butylhydroxyanisole (E320) 0.10 mg Propyl Gallate (E310) 0.10 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral Solution. A transparent, yellow coloured solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Sheep. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of infections with the following parasites: NEMATODES GASTROINTESTINAL ROUNDWORMS (adult and fourth larval stage) _Haemonchus contortus_ _Teladorsagia circumcincta_ _Trichostrongylus_ spp. _Cooperia_ spp. _Nematodirus_ spp. Including_ N. battus_ _Strongyloides papillosus_ _Chabertia ovina_ LUNGWORMS(adult and fourth larval stage) _Dictyocaulus filaria_ ARTHROPODS NASAL BOT (all larval stages) _Oestrus ovis_ 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active ingredient or any of the excipients. 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_ _ _ _1_ _2_ _/_ _0_ _5_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _0_ _6_ _6_ _9_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 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: Read the complete document