Quốc gia: New Zealand
Ngôn ngữ: Tiếng Anh
Nguồn: Medsafe (Medicines Safety Authority)
Flucloxacillin sodium monohydrate 1.05 g Equivalent to 1 g flucloxicillin.;
Pfizer New Zealand Limited
Flucloxacillin sodium monohydrate 1.05 g (Equivalent to 1 g flucloxicillin.)
1 g
Powder for injection
Active: Flucloxacillin sodium monohydrate 1.05 g Equivalent to 1 g flucloxicillin.
Vial, glass, 5x1g, 5 g
Prescription
Prescription
Fresenius Kabi Anti-Infectives S.r.l.
For the treatment of confirmed or suspected staphylococcal and other Gram-positive coccal infections.
Package - Contents - Shelf Life: Vial, glass, 1g - 5 dose units - 36 months from date of manufacture stored at or below 25°C - Vial, glass, 1g - 10 dose units - 36 months from date of manufacture stored at or below 25°C
1993-10-07
Version pfdflucv10519 Supersedes: Version 6.0 Page 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME DBL™ Flucloxacillin Sodium 1g Powder for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DBL Flucloxacillin Sodium Powder for Injection is the sodium salt of flucloxacillin. DBL Flucloxacillin Sodium Powder for Injection contains 1 g of flucloxacillin as flucloxacillin sodium. It should be recognised that each 1 gram of flucloxacillin sodium monohydrate contains 2.2 mmol of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for injection. Flucloxacillin sodium is a white or almost white, crystalline powder, hygroscopic, freely soluble in water and in methanol, soluble in alcohol. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications For the treatment of confirmed or suspected staphylococcal and other Gram-positive coccal infections. Indications include pneumonia, osteomyelitis and skin and skin structure infections, such as wound infections, infected burns and cellulitis. 4.2 Dose and method of administration Dose Usual adult dosage Intramuscular 250 mg 6 hourly Intravenous 250 mg to 1 g 6 hourly Intrapleural 250 mg once daily Intra-articular 250 mg to 500 mg once daily Note: Systemic doses may be doubled where necessary in severe infections. Special populations Renal impairment As flucloxacillin is excreted to a large extent by the kidney, the dose or dose interval may need modification in patients with renal failure, as the half life in patients with renal failure is increased. However dosage recommendations for various plasma creatinine levels for patients with impaired renal function are not available. Flucloxacillin is not significantly removed by haemodialysis. Version pfdflucv10519 Supersedes: Version 6.0 Page 2 Hepatic impairment Adjustment of dosage may not be necessary as flucloxacillin is not metabolised in the liver to any appreciable extent. However, during prolonged treatment it is advisable to check periodically for hepatic dysfunction. Paediatric population 2 to 10 Đọc toàn bộ tài liệu