Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Oxytetracycline hydrochloride
FATRO S.p.A.
QJ01AA06
Oxytetracycline hydrochloride
100 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
oxytetracycline
Authorised
2020-09-18
Health Products Regulatory Authority 09 October 2020 CRN009Z3P Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT OXTRA DD 100 mg/ml solution for injection for cattle, sheep, pigs, horses, dogs and cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Oxytetracycline (as oxytetracycline hydrochloride) 100 mg EXCIPIENTS: Sodium formaldehyde sulfoxylate 5 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear yellow to brown-yellow 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 susceptible to oxytetracycline in horses, cattle, sheep, pigs, dogs and cats. 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 None. 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. Official and local antimicrobial policies should be taken into account when the product is used. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to oxytetracycline and may decrease the effectiveness of treatment with other tetracyclines due to the potential for cross-resistance. The product should be used cautiously in animals with hepatic or renal impairment. Use with caution in horses with gastro-intestinal disturbances or under stress. See 4.7 before use in male animals. Do not dilute the product. If concurre Les hele dokumentet