البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
DORAMECTIN
Elanco Animal Health, Eli Lilly and Company Limited
QP54AA03
DORAMECTIN
10 Mg/Ml
Solution for Injection
LM: Licensed Merchant as defined in relevant national legislation
Porcine
doramectin
Endectoparasiticides
Authorised
2011-12-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Zearl 10 mg/ml Solution for Injection for Pigs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml Zearl 10 mg/ml Solution for Injection contains the following: ACTIVE SUBSTANCE: Doramectin 10 mg (1) EXCIPIENT(S): Butylhydroxyanisole (E320) 0.1 mg (1) Contains no overage and assumes a potency of 100 percent. The actual amount of doramectin added will depend on the potency of the ingoing drug substance. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Colourless to pale yellow sterile oily solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs. I R I S H M E D I C I N E S B O A R D ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _0_ _/_ _0_ _1_ _/_ _2_ _0_ _1_ _4_ _C_ _R_ _N_ _ _ _7_ _0_ _1_ _6_ _3_ _1_ _2_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For treatment of mange mites, gastrointestinal roundworms, lungworms, kidney worms and sucking lice in pigs. Gastrointestinal nematodes (adults and fourth stage larvae) _Hyostrongylus rubidus_ _Ascaris suum_ _Strongyloides ransomi (adults only)_ _Oesophagostomum dentatum_ _Oesophagostomum quadrispinulatum_ Lungworms _Metastrongylus spp. (adults only)_ Kidney worms _Stephanurus dentatus (adults only)_ Sucking Lice _Haematopinus suis_ Mange Mites _Sarcoptes scabiei_ Zearl injection for pigs protects pigs against infection or reinfection with_ Sarcoptes scabiei_ for 18 days. 4.3 CONTRAINDICATIONS The product has be اقرأ الوثيقة كاملة