দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Oxytetracycline hydrochloride
Intervet Ireland Limited
QJ01AA06
Oxytetracycline hydrochloride
10 percent weight/volume
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cats, Cattle, Dogs, Horses, Pigs, Sheep
oxytetracycline
Antibacterial
Authorised
1988-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Engemycin 10 % DD Solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE Oxytetracycline (as oxytetracycline hydrochloride) 100 mg EXCIPIENTS Sodium formaldehyde sulphoxylate 5 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. A clear yellow aqueous solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, sheep, pigs, horses, dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of infections caused by organisms sensitive to oxytetracycline in horses, cattle, sheep, pigs, dogs and cats. _In vitro_, oxytetracycline is active against a range of both Gram-positive and Gram-negative microorganisms including: _Streptococcus_ spp.,_ Staphylococcus_ spp.,_ Listeria monocytogenes_,_ Mannheimia haemolytica_,_ Haemophilus_ _parahaemolyticus_ and_ Bordetella bronchiseptica_, and against_ Chlamydophila abortus_, the causative organism of enzootic abortion in sheep. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in horses during concomitant corticosteroid therapy. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Exercise caution when treating stressed horses with tetracyclines. 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_ _ _ _2_ _3_ _/_ _1_ _1_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _4_ _6_ _1_ _4_ _p_ _a_ সম্পূর্ণ নথি পড়ুন