Država: Cipar
Jezik: grčki
Izvor: Κυπριακή Δημοκρατία, Υπουργείο Γεωργίας, Αγροτικής Ανάπτυξης και Περιβάλλοντος, Κτηνιατρικές Υπηρεσίες
GRANTED
QJ01GB03
GENTAMICIN 50 MG/ML (EQUIVALENT TO GENTAMYCIN SULPHATE)
GRANTED
FATRO SpA ITALY
SOLUTION FOR INJECTION
N. A. CHANCE TRADING CO
Withdrawal period: CALVES PIGLETS (FIRST MONTH); Distributor: ANTIINFECTIVES FOR SYSTEMIC USE
ΠΑΡΑΡΤΗΜΑ 1: ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ 1. NAME OF THE VETERINARY MEDICINAL PRODUCT AAGENT, 50 mg/ml, solution for injection for calves and piglets up to one month old. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCE: gentamicin 50 mg equivalent to gentamicin sulphate 82 mg EXCIPIENTS: sodium methyl parahydroxybenzoate (E219) 1.8 mg sodium propyl parahydroxybenzoate (E217) 0.2 mg Sodium metabisulphite (E 223) 1.6 mg Other excipients q.s. to 1 ml For a complete list of the excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES Calves and piglets up to one month old. 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES AAGENT is indicated for the treatment of infectious diseases due to Gram-positive and, principally, Gram-negative bacteria, also secondary to viral infections, caused in particular by _Enterobacter_ spp., _E. coli_, _Klebsiella_ spp., _Proteus_ spp., _Pseudomonas_ spp., _Salmonella_ spp., _Shigella_ spp., _Treponema_ spp., staphylococci and certain streptococci, in the pathologies of: - digestive system (bacterial enteritis, neonatal colibacillosis); - respiratory system (bronchopneumonia, pneumonia); - integumentary system (pyoderma, abscesses and septic wounds); - septicemia. 4.3. CONTRAINDICATIONS Do not administer to animals with known hypersensitivity to gentamicin. The use of AAGENT is contraindicated in subjects with severely compromised renal function. 1 / 13 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES To be used exclusively in calves and piglets up to one month old. 4.5. SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Owing to possible variations (over time or geographical) in the sensitivity of the target microbial species to gentamicin, a sensitivity test should be performed. Improper use of the product may increase the incidence of bacteria resistant to gentamicin and reduce the efficacy of treatments with other Pročitajte cijeli dokument