Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
CLOXACILLIN (AS CLOXACILLIN BENZATHINE BP (VET))
Zoetis Belgium S.A.
QJ51CF02
CLOXACILLIN (AS CLOXACILLIN BENZATHINE BP (VET))
500 mg/syringe
intramammary Suspension
POM
Bovine
Cloxacillin
Antibacterial
Authorised
2017-03-10
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Orbenin Dry Cow 500 mg Intramammary Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 3g dose unit contains: Active Substance Cloxacillin (as cloxacillin benzathine) 500mg Excipients Mineral oil base to 3g For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Sterile off-white hydrophobic intramammary suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the infusion of cows at drying off, to treat mastitis infections and to provide protection against further infections during the dry period. 4.3 CONTRAINDICATIONS Do not use in the lactating cow. If lactating cows are accidentally infused, milk should be withheld from the bulk supply for 35 days or less time if testing shows it to be free from antibiotic residues. In common with other penicillins, cloxicillin should not be used orally or parenterally in rabbits, guinea-pigs, hamsters or gerbils. Caution is advised in its use in other very small herbivores. Do not use in animals with known sensitivity to the active ingredient. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 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_ _0_ _/_ _0_ _3_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _5_ _3_ _7_ _2_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTION(S) FOR USE IN ANIMALS None. SPECIAL PRECAUTIONS TO BE T Baca dokumen lengkap