البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Spectinomycin
Ceva Animal Health Limited
QJ01XX04
Spectinomycin
50 milligram(s)/millilitre
Oral solution
POM: Prescription Only Medicine as defined in relevant national legislation
Pigs, Sheep
spectinomycin
Antibacterial
Authorised
1988-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Spectam Scour Halt Oral Solution 50 mg/ml. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Oral solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (piglets). Sheep (lambs). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES a) For the treatment of enteritis caused by strains of Escherichia coli sensitive to spectinomycin in piglets. b) For the prevention of bacterial neonatal disease (e.g. watery mouth disease) in lambs which are at risk of colostrum deprivation. 4.3 CONTRAINDICATIONS Known hypersensitivity to the active ingredient. Do not use in pigs over 4 weeks of age or over 7kg bodyweight. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None known. Per ml: ACTIVE SUBSTANCE: Spectinomycin (as spectinomycin dihydrochloride pentahydrate) 50.0 mg EXCIPIENTS: Tartrazine (E102) 0.60 mg For a 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_ _ _ _0_ _7_ _/_ _0_ _1_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _2_ _6_ _2_ _7_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. Ensure that the pump and plastic extension tu اقرأ الوثيقة كاملة