Maa: Uusi-Seelanti
Kieli: englanti
Lähde: Medsafe (Medicines Safety Authority)
Fluconazole 2 mg/mL
Baxter Healthcare Ltd
Fluconazole 2 mg/mL
0.2% w/v
Solution for infusion
Active: Fluconazole 2 mg/mL Excipient: Hydrochloric acid Sodium chloride Water for injection
Bottle, glass, Clear, colourless Type I with bromobutyl stopper 50 mL, 50 mL
Prescription
Prescription
Mylan Laboratories Limited
Cryptococcosis, including cryptococcal meningitis and infections of other sites (e.g. pulmonary, cutaneous). Normal hosts, and patients with AIDS, organ transplants or other causes of immunosuppression may be treated. Fluconazole-Claris can be used as maintenance therapy to prevent relapse of cryptococcal disease in patients with AIDS.
Package - Contents - Shelf Life: Bottle, glass, Clear, colourless Type I with bromobutyl stopper 50 mL - 50 mL - 36 months from date of manufacture stored at or below 30°C protect from light. Do not refrigerate - Bottle, glass, Clear, colourless Type I with bromobutyl stopper 100 mL - 100 mL - 36 months from date of manufacture stored at or below 30°C protect from light. Do not refrigerate - Bottle, glass, Clear, colourless Type I with bromobutyl stopper 200 mL - 200 mL - 36 months from date of manufacture stored at or below 30°C protect from light. Do not refrigerate
2006-05-19
NEW ZEALAND DATA SHEET Fluconazole‐Baxter Data Sheet 22 February 2022 Page 1 of 23 Baxter Healthcare Ltd 1 FLUCONAZOLE‐BAXTER (0.2% w/v, solution for infusion) FLUCONAZOLE‐BAXTER 0.2% w/v (2mg/mL) solution for infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION FLUCONAZOLE‐BAXTER, solution for infusion contains 2mg fluconazole per mL. Each 50mL vial of solution for infusion contains 100mg fluconazole. Each 100mL vial of solution for infusion contains 200mg fluconazole. Each 200mL vial of solution for infusion contains 400mg fluconazole. _Excipient(s) with known effect _ Each mL contains 9mg sodium chloride (equivalent to 0.154 mmol sodium) (see section 4.4). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. FLUCONAZOLE‐BAXTER is a colourless solution. The pH of the solution is 4.0 ‐ 8.0 4 CLINICAL PARTICULARS 4.1 Therapeutic indications FLUCONAZOLE‐BAXTER intravenous solution for infusion should be used only when fluconazole cannot be administered orally. FLUCONAZOLE‐BAXTER is indicated for the treatment of the following conditions: • Cryptococcosis, including cryptococcal meningitis and infections of other sites (e.g., pulmonary, cutaneous). Normal hosts, and patients with AIDS, organ transplants or other causes of immunosuppression may be treated. FLUCONAZOLE‐BAXTER can be used as maintenance therapy to prevent relapse of cryptococcal disease in patients with AIDS. • Systemic candidiasis including candidaemia, disseminated candidiasis and other forms of invasive candidal infection including infections of the peritoneum, endocardium and pulmonary and urinary tracts. Patients with malignancy, in intensive care units, receiving cytotoxic or immunosuppressive therapy, or with other factors predisposing to candidal infection may be treated. • Mucosal candidiasis. These include oropharyngeal, oesophageal, non‐invasive bronchopulmonary infections, candiduria, mucocutaneous and chronic oral atrophic candidiasis (denture sore mouth). Normal hosts an Lue koko asiakirja