国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
OXYTETRACYCLINE DIHYDRATE
Univet Limited
QJ01AA06
OXYTETRACYCLINE DIHYDRATE
200 Mg/Ml
Solution for Injection
POM
Bovine, Ovine, Porcine
Oxytetracycline
Antibacterial
Authorised
1988-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Duocycline LA 200mg/ml 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 LA _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 administer by the intravenous route. Do not use in horses, dogs and cats. Do not use in animals with known hypersensitivity to the active ingredient. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Each ml contains: ACTIVE SUBSTANCE Oxytetracycline (as dihydrate) 200.0 mg EXCIPIENTS Sodium formaldehyde sulfoxylate 3.0 mg For a full list of excipients, see section 6.1 IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 23/10/2012_ _CRN 7011590_ _page number: 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 BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS This product contains dimethylacetamide (DMAC) and care should be taken to prevent absorption through the skin. Wash hands after use. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Transient local reacti 阅读完整的文件