Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
OXYTETRACYCLINE HYDROCHLORIDE (EQUIVALENT TO OXYTETRACYCLINE PH.EUR.)
Intervet Ireland Limited
QD06AA03
OXYTETRACYCLINE HYDROCHLORIDE (EQUIVALENT TO OXYTETRACYCLINE PH.EUR.)
25 Mg/Ml
Cutaneous Spray, suspension
POM
Bovine, Ovine, Porcine
Oxytetracycline
Antibacterial
Authorised
2009-10-02
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Engemycin Spray, 25 mg/mL, cutaneous spray, suspension for cattle, sheep and pigs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains: 3 PHARMACEUTICAL FORM Cutaneous spray, suspension. Green to green-blue suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, sheep and pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of the following infections caused by, or associated with, organisms sensitive to oxytetracycline in cattle, sheep and pigs: Treatment of foot infections caused in particular by:_ Dichelobacter nodosus_,_ Fusobacterium necrophorum_ and other _Fusobacterium_ spp., and_ Bacteroides_ spp. Supporting treatment of superficial wound infections following surgery or physical injuries, e.g., tail biting in pigs, scratches and abrasions. 4.3 CONTRAINDICATIONS Do not use for treatment of teats in order to prevent the product from getting into milk. Do not use in animals in cases of hypersensitivity to oxytetracycline or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. ACTIVE SUBSTANCE: Oxytetracycline Hydrochloride 25.00 mg (equivalent to Oxytetracycline 23.15 mg) EXCIPIENTS: Patent Blue V (E131) 1.25 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_ _ _ _1_ _8_ _/_ _0_ _1_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _5_ _3_ _9_ _4_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ Leggi il documento completo