Country: ইস্রায়েল
ভাষা: ইংরেজি
সূত্র: Ministry of Health
GENTAMICIN AS SULFATE
LAPIDOT MEDICAL IMPORT AND MARKETING LTD
S01AA11
SOLUTION FOR INFUSION
GENTAMICIN AS SULFATE 0.3 G / 100 ML
I.V
Required
B.BRAUN MELSUNGEN AG, GERMANY
GENTAMICIN
GENTAMICIN
Treatment of serious infections caused by susceptible microorganisms
2017-11-30
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Gentamicin B. Braun 1 mg/ml Gentamicin B. Braun 3 mg/ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Gentamicin B. Braun 1 mg/ml, solution for infusion: _ 1 ml of solution for infusion contains gentamicin sulphate equivalent to 1 mg gentamicin. 1 bottle of 80 ml contains 80 mg of gentamicin. Excipients with known effect: 283 mg (12 mmol) of sodium (as chloride) per 80 ml bottle Water for injections _Gentamicin B. Braun 3 mg/ml, solution for infusion: _ 1 ml of solution for infusion contains gentamicin sulphate equivalent to 3 mg gentamicin. 1 bottle of 80 ml contains 240 mg of gentamicin. 1 bottle of 120 ml contains 360 mg of gentamicin. Excipients: 283 mg (12 mmol) of sodium (as chloride) per 80 ml bottle. 425 mg (18 mmol) of sodium (as chloride) per 120 ml bottle. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion. A clear colourless aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of serious infections caused by susceptible microorganisms. Gentamicin B. Braun 1 mg/ml and Gentamicin B. Braun 3 mg/ml should for all indications, except complicated urinary tract infections, only be used in combination with other relevant antibiotics (predominantly together with a beta-lactam antibiotic or with an antibiotic effective against anaerobic bacteria). Under these conditions, Gentamicin B. Braun 1 mg/ml and Gentamicin B. Braun 3 mg/ml may be used in: ● Complicated and recurrent urinary tract infections ● Nosocomial lower respiratory tract infections including severe pneumonia ● Intraabdominal infections including peritonitis ● Skin and soft tissue infections including severe burns ● Septicaemia including bacteraemia ● Treatment of bacterial endocarditis ● Treatment of surgical infections Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY DOSAGE IN PATIENTS WITH সম্পূর্ণ নথি পড়ুন