Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
OXYTETRACYCLINE (AS DIHYDRATE)
Interchem Ireland Ltd
QJ01AA06
OXYTETRACYCLINE (AS DIHYDRATE)
200 Mg/Ml
Solution for Injection
POM
Bovine, Ovine, Porcine
Oxytetracycline
Antibacterial
Authorised
2012-11-16
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Procycline LA 200 mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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 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 _Procycline 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. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/11/2012_ _CRN 7011596_ _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 r Izlasiet visu dokumentu