Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Oxytetracycline hydrochloride
Interchem Ireland Ltd
QJ01AA06
Oxytetracycline hydrochloride
15 percent weight/volume
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Pigs, Sheep
oxytetracycline
Antibacterial
Authorised
2008-03-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Interject 15% Injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE Oxytetracycline Hydrochloride Ph. Eur. 150 mg EXCIPIENTS Dimethylacetamide q.s to 1 ml (Approx. 48 %) For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, sheep and pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES _Interject 15%_ 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 sheep producing milk for human consumption. Do not use in animals with known hypersensitivity to the active ingredient. Do not administer intravenously. Do not use in horses, dogs and cats. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS None. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Wash hands after use. This product contains dimethylacetamide (DMAC) and care should be taken to prevent absorption through the skin. 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. I R I S H M E D I C I N E S B O A R D ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ Aqra d-dokument sħiħ