Χώρα: Κύπρος
Γλώσσα: Ελληνικά
Πηγή: Κυπριακή Δημοκρατία, Υπουργείο Γεωργίας, Αγροτικής Ανάπτυξης και Περιβάλλοντος, Κτηνιατρικές Υπηρεσίες
GRANTED
QJ01AA06
OXYTETRACYCLINE HYDROCHLORIDE 100 MG/ML (92.7 MG/ML OXYTETRACYCLINE)
GRANTED
FATRO SpA ITALY
SOLUTION FOR INJECTION
N. A. CHANCE TRADING CO
Withdrawal period: HORSES CATTLE SHEEP PIGS; Distributor: ANTIBACTERIALS FOR SYSTEMIC USE
ΠΑΡΑΡΤΗΜΑ 1: ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ 1. NAME OF THE VETERINARY MEDICINAL PRODUCT OXTRA10%, 92.7mg/ml, solution for injection for cattle, horses, swine, sheep. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCE: oxytetracycline……………………………………92.7 mg (equivalent to oxytetracycline hydrochloride……100 mg) EXCIPIENTS: sodium formaldehyde sulphoxylate………….……….4 mg For a full list of the excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES Cattle, horses, swine, sheep. 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In cattle, horses, swine and sheep ,infections caused by Gram-positive bacteria (_Actinomyces_ spp., _Arcanobacterium _ _pyogenes,Bacillus_ _anthracis, Clostridium _spp,_Corynebacterium_ spp., _Staphylococcus_ spp., _Streptococcus_ spp., ) Gram-negative bacteria (_Aerobacter aerogenes,_ _Bortedella spp, Brucella spp. , E.coli, Haemophilus spp., Klebsiella spp.,_ _Pasteurella spp., Proteus spp., Pseudomonas spp., Salmonella spp.,_ _Shigella spp., )_ _ _Spirochetes, Chlamydiae,Mycoplasmas, Rickettsiae, Protozoa and Leptospirae sensitive to oxytetracycline_. _ More specifically: bronchopulmonary infections (bronchitis, bronchopneumonia); gastro-intestinal infections (enteritis, gastroenteritis); mammary infections (acute parenchymatous mastitis); 1/15 traumatic reticuloperitonitis, metritis and metroperitonitis, phlegmons, infected wounds, purulent lesions. 4.3. CONTRAINDICATIONS Do not use in case of known hypersensitivity to oxytetracycline or any of the excipients. Do not use if resistance to the tetracyclines has been found in the breeding establishment, owing to potential cross-resistance. 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES Use is not permitted in horses producing milk for human consumption. Owing to possible variations, over time and geographically, in the sensitivity of Διαβάστε το πλήρες έγγραφο