Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Oxytetracycline hydrochloride
Univet Limited
QJ01AA06
Oxytetracycline hydrochloride
10 percent weight/volume
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Pigs, Sheep
oxytetracycline
Antibacterial
Authorised
1988-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Duocycline 10% Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for injection. A clear amber solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, sheep and pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES _Duocycline 10_ is recommended in the treatment of a wide range of common systemic, respiratory and local infections caused by, or associated with, organisms sensitive to Oxytetracycline. 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active ingredient. Do not use in sheep producing milk for human consumption. Do not administer intravenously. Do not use in horses, dogs and cats. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Each ml contains: ACTIVE SUBSTANCE Oxytetracycline Hydrochloride 100.0 mg EXCIPIENTS Sodium formaldehyde sulfoxylate 1.0 mg For a full list of excipients, see section 6.1 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_ _2_ _/_ _2_ _0_ _1_ _1_ _C_ _R_ _N_ _ _ _7_ _0_ _1_ _0_ _2_ _1_ _0_ _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. SPECIAL PRECAUTIONS TO BE TAKEN Olvassa el a teljes dokumentumot