Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
OXYTETRACYCLINE (AS OXYTETRACYCLINE DIHYDRATE PH. EUR.)
Eurovet Animal Health B.V.
QJ01AA06
OXYTETRACYCLINE (AS OXYTETRACYCLINE DIHYDRATE PH. EUR.)
200 Mg/Ml
Solution for Injection
POM
Bovine, Porcine
Oxytetracycline
Antibacterial
Authorised
1988-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Cyclosol LA 200mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance: Oxytetracycline (as dihydrate) 200 mg Excipients: Sodium formaldehyde sulphoxylate dihydrate 5 mg For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for injection. A clear yellow to reddish-brown solution for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Cyclosol LA is indicated for the treatment of infections caused by oxytetracycline sensitive microorganisms. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use by intravenous route. Do not use in animals with serious kidney and liver disturbances. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES In case of a serious anaphylactic reaction the administration of epinephrine, antihistamines and/or corticosteroids should be considered. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 23/12/2016_ _CRN 7025269_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals It is strongly recommended to divide the intramuscular dosages over two or more injection sites (see posology). 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. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant t Läs hela dokumentet