Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
OXYTETRACYCLINE (AS OXYTETRACYCLINE DIHYDRATE PH. EUR.)
Laboratorios Hipra S.A.
QJ01AA06
OXYTETRACYCLINE (AS OXYTETRACYCLINE DIHYDRATE PH. EUR.)
200 Mg/Ml
Solution for Injection
POM
Bovine, Ovine, Porcine
Oxytetracycline
Antibacterial
Authorised
2006-04-03
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Oxipra 20 L.A. Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, sheep and swine. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Indicated for the treatment of infections caused by sensitive germs in cattle, sheep and swine: anaplasmosis, respiratory infection, keratoconjunctivitis and metritis, mastitis and aglactia (MMA) syndrome. 4.3 CONTRAINDICATIONS - Do not use in animals which are sensitive to tetracyclines. - Do not use in animals which have liver or kidney disorders. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Each ml contains: ACTIVE SUBSTANCE Oxytetracycline (as oxytetracycline dihydrate) 200 mg EXCIPIENTS Sodium Formaldehyde Sulfoxylate 10 mg N,N-Dimethylacetamide 467 mg For a full list of excipients, see section 6.1 HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 27/10/2016_ _CRN 7025110_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Do not administer more than 10 ml at the injection site. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS None. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Intramuscular injection may be painful, producing swelling at the injection site. In sensitive animals anaphylaxis-like reactions can be observed. 4.7 USE DURING PREGNANCY, LACTATION OR LAY The product can be used during these periods. 4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION The product should not be administered together with bactericide antibiotics. 4.9 AMOUNTS T Izlasiet visu dokumentu