מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
OXYTETRACYCLINE
Kela n.v.
QJ01AA06
OXYTETRACYCLINE
20 %w/v
Solution for Injection
POM
Bovine
Oxytetracycline
Antibacterial
Authorised
1988-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Oxytetracycline 20% w/v L.A. Solution for Injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for injection. A clear, pale yellow to brown solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment and prophylaxis of susceptible bacterial infections. Some specific indications are: respiratory infections such as pasteurellosis, bronchopneumonia, bovine respiratory disease complex. 4.3 CONTRAINDICATIONS Do not use in animals with severe renal insufficiency. Do not use in animals with known hypersensitivity to tetracyclines. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Each ml contains: Active substance Oxytetracycline 200 mg as Oxytetracycline hydrochloride Excipients Sodium formaldehyde sulfoxylate 5 mg For a full list of excipients see section 6.1. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 10/02/2014_ _CRN 7013325_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Warm the solution to body temperature before use. 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 PRODUCT TO ANIMALS In order to prevent any possible reaction, direct contact with the drug must be avoided. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Transient swelling at the injection site. During the period of tooth development, including late pregnancy, th קרא את המסמך השלם