Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Oxytetracycline dihydrate
Eurovet Animal Health B.V.
QJ01AA06
Oxytetracycline dihydrate
200 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Pigs
oxytetracycline
Antibacterial
Authorised
1988-10-01
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cyclosol LA 200 mg/ml solution for injection for cattle and pigs. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Oxytetracycline (as dihydrate) 200 mg EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS QUANTITATIVE COMPOSITION IF THAT INFORMATION IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE VETERINARY MEDICINAL PRODUC t _ _ Sodium formaldehyde sulphoxylate dihydrate 5.0 mg Povidone K17 50.0 mg N-methyl pyrrolidone 380.0 mg Magnesium oxide, light Ethanolamine Water for injections A clear yellow to reddish-brown solution for injection. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Cattle and pigs. 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES The veterinary medicinal product is indicated for the treatment of infections caused by oxytetracycline sensitive microorganisms. 3.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance, or to any of the excipients. Do not use in animals with serious liver and/or kidney disturbances. Do not use by intravenous route. 3.4 SPECIAL WARNINGS In case of a serious anaphylactic reaction the administration of epinephrine, antihistamines and/or corticosteroids should be considered. 3.5 SPECIAL PRECAUTIONS FOR USE Special precautions for safe use in the target species: It is strongly recommended to divide the intramuscular dosages over two or more injection sites (see posology). Use of the veterinary medicinal 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 veterinary medicinal 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 tetracyclines, due to the potential for cross resistance. Special precautions to be taken by the person Preberite celoten dokument