Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ceftazidime (ceftazidime pentahydrate)
GlaxoSmithKline Manufacturing SpA
J01DD02
ceftazidime (ceftazidime pentahydrate)
500mg
powder for solution for injection/infusion
(1) glass vial
Prescription
Registered
2018-08-31
FORTUM™ CEFTAZIDIME QUALITATIVE AND QUANTITATIVE COMPOSITION _FORTUM_ injection contains 250 mg, 500 mg, 1 g, 2 g or 3 g of ceftazidime (as pentahydrate). _FORTUM MONOVIAL_ ™ contains 1 g or 2 g of ceftazidime (as pentahydrate). Ceftazidime pentahydrate is formulated in a mixture with sodium carbonate. When constituted, this mixture provides a solution of ceftazidime sodium. PHARMACEUTICAL FORM Powder for injection/infusion CLINICAL PARTICULARS INDICATIONS Treatment of single or multiple infections caused by susceptible organisms. May be used alone as first choice drug before the results of sensitivity tests are available. May be used in combination with an aminoglycoside or most other beta-lactam antibiotics. May be used with an antibiotic against anaerobes when the presence of _Bacteroides fragilis_ is suspected. Susceptibility to _FORTUM _will vary with geography and time and local susceptibility data should be consulted where available (_see Pharmacological properties, Pharmacodynamic effects_). Indications include: - severe infections e.g. - septicaemia, bacteraemia, peritonitis, meningitis - infections in immunosuppressed patients - infections in patients in intensive care, e.g. infected burns - respiratory tract infections including lung infections in cystic fibrosis - ear, nose and throat infections - urinary tract infections - skin and soft tissue infections - gastrointestinal, biliary and abdominal infections - bone and joint infections - infections associated with haemo- and peritoneal dialysis and with continuous ambulatory peritoneal dialysis (CAPD) - prophylaxis: prostatic surgery (transurethral resection). DOSAGE AND ADMINISTRATION Dosage depends upon the severity, sensitivity, site and type of infection and upon the age and renal function of the patient. Use _FORTUM_ injection by intravenous (i.v.) or deep intramuscular (i.m.) injection. Recommended i.m. injection sites are the upper outer quadrant of the gluteus maximus or lateral part of the thigh. _FORTUM_ solutions may be given directly in Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT FORTUM ™, CEFTAZIDIME 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _FORTUM_ injection contains 250 mg, 500 mg, 1 g, 2 g or 3 g of ceftazidime (as pentahydrate). _FORTUM_ _MONOVIAL_™ contains 1 g or 2 g of ceftazidime (as pentahydrate). Cetftazidime pentahydrate is formulated in a mixture with sodium carbonate. When constituted, this mixture provides a solution of ceftazidime sodium. 3. PHARMACEUTICAL FORM Powder for injection/infusion 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of single or multiple infections caused by susceptible organisms. May be used alone as first choice drug before the results of sensitivity tests are available. May be used in combination with an aminoglycoside or most other beta-lactam antibiotics. May be used with an antibiotic against anaerobes when the presence of _Bacteroides _ _fragilis_ is suspected. Susceptibility to _FORTUM _will vary with geography and time and local susceptibility data should be consulted where available (_see Pharmacological properties, _ _Pharmacodynamic effects_). Indications include: - severe infections e.g. - septicaemia, bacteraemia, peritonitis, meningitis - infections in immunosuppressed patients - infections in patients in intensive care, e.g. infected burns - respiratory tract infections including lung infections in cystic fibrosis - ear, nose and throat infections - urinary tract infections - skin and soft tissue infections - gastrointestinal, biliary and abdominal infections - bone and joint infections - infections associated with haemo- and peritoneal dialysis and with continuous ambulatory peritoneal dialysis (CAPD) - prophylaxis: prostatic surgery (transurethral resection). 4.2 DOSAGE AND ADMINISTRATION Dosage depends upon the severity, sensitivity, site and type of infection and upon the age and renal function of the patient. Use _FORTUM_ injection by intravenous (i.v.) or deep intramuscular (i.m.) injection. Recommended i.m. injection sites are the upper oute Прочитать полный документ