País: Nueva Zelanda
Idioma: inglés
Fuente: Medsafe (Medicines Safety Authority)
Ceftazidime pentahydrate 2.328 g equivalent to 2g ceftazidime; ;
Viatris Limited
Ceftazidime pentahydrate 2.328 g (equivalent to 2g ceftazidime)
2 g
Powder for injection
Active: Ceftazidime pentahydrate 2.328 g equivalent to 2g ceftazidime Excipient: Sodium carbonate
Vial, Type II glass with chlorobutyl rubber (EP) (1 vial pack) (not marketed), 2 g
Prescription
Prescription
Orchid Chemicals and Pharmaceuticals Limited
Indicated for the treatment of single and mixed infections caused by susceptible organisms. May be used alone as first choice medicine before the results of sensitivity tests are available. May be used in combination with an aminoglycoside or most other ?- lactam antibiotics. May be used with an antibiotic against anaerobes when the presence of Bacteroides fragilis is suspected. Susceptibility to ceftazidime will vary with geography and time and local susceptibility data should be consulted where available. Indications include: Severe infections: for example: - 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)
Package - Contents - Shelf Life: Vial, Type II or Type III glass with chlorobutyl rubber (EP) or bromobutyl (EP) - 1 dose units - 24 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, Type II or Type III glass with chlorobutyl rubber (EP) or bromobutyl (EP) - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)
2007-05-07
Page 1 of 12 NEW ZEALAND DATA SHEET CEFTAZIDIME MYLAN 1. PRODUCT NAME Ceftazidime Mylan, 250 mg, 500 mg, 1 g & 2 g, powder for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 250 mg, 500 mg, 1 g or 2 g of ceftazidime (as pentahydrate). For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Ceftazidime Mylan Powder for Injection is supplied as a white or almost white, crystalline powder, containing 116.4 mg sodium carbonate per gram of ceftazidime. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS _ Treatment of single or multiple infections caused by susceptible organisms. May be used alone as first choice medicine before the results of sensitivity tests are available. May be used in combination with an aminoglycoside or most other β- lactam antibiotics. May be used with an antibiotic against anaerobes when the presence of _ Bacteroides fragilis_ is suspected. Susceptibility to ceftazidime will vary with geography and time and local susceptibility data should be consulted where available (see section 5.1). INDICATIONS INCLUDE: • Severe infections e.g. - Septicaemia, bacteraemia, peritonitis, meningitis - Infections of 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). Page 2 of 12 _4.2 _ _DOSE AND METHOD OF ADMINISTRATION _ DOSE Dosage depends upon the severity, sensitivity, site and type of infection and upon the age and renal function of the patient. _ADULTS _ 1-6 g/day in 2 or 3 divided doses by IV or IM injection. URINARY TRACT AND LESS SEVERE INFECTIONS - 500 mg or 1g every 12 hours._ _ MOST INFECTIONS - 1 g every 8 hours or 2 g every 12 ho Leer el documento completo