देश: न्यूज़ीलैंड
भाषा: अंग्रेज़ी
स्रोत: Medsafe (Medicines Safety Authority)
Etoposide 20 mg/mL; ;
Pfizer New Zealand Limited
Etoposide 20 mg/mL
100 mg/5mL
Solution for injection
Active: Etoposide 20 mg/mL Excipient: Citric acid Ethanol Macrogol 300 Polysorbate 80
Ampoule, glass, 1 x 5 mL, 5 mL
Prescription
Prescription
Sicor (Societa Italiana Corticosteroidi) Srl
Package - Contents - Shelf Life: Ampoule, glass, - 5 mL - 24 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, - 5 mL - 24 months from date of manufacture stored at or below 25°C
1989-11-20
Version 4.0 Page 1 of 11 NEW ZEALAND DATA SHEET 1. PRODUCT NAME _ _ DBL ® Etoposide Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Etoposide is a semi-synthetic derivative of podophyllotoxin. DBL ® Etoposide Injection contains Etoposide, citric acid, polysorbate 80, Macrogol 300, and ethanol. EXCIPIENT(S) WITH KNOWN EFFECT Macrogol 300 Ethanol For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM DBL® Etoposide Injection is available as a clear, colourless to pale yellow viscous liquid, in clear glass vials. Solution for injection 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DBL ® Etoposide Injection is indicated for use in the treatment of: 1. Small cell carcinoma of the lung. 2. Acute monocytic and myelomonocytic leukaemia. 3. Hodgkin's disease. 4. Non-Hodgkin's lymphoma. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE Biological activity appears to be schedule dependent with multiple dosage over 3 or 5 days showing superiority over single dose administration. Version 4.0 Page 2 of 11 ADULT : _Intravenous_: Intravenously, 50-60 mg/m 2 /day for 5 days followed by a treatment-free interval of 2-4 weeks. Total dose should not exceed 400 mg/m 2 per course. DBL ® Etoposide Injection must be diluted prior to use with either Sodium Chloride Intravenous Infusion (0.9%) or 5% Glucose Injection to give a final concentration of 0.2 to 0.4 mg/mL. More concentrated solutions show crystal formation upon stirring or seeding within 5 minutes and should not be given intravenously. Note: Hard plastic devices made of acrylic or ABS (a polymer composed of acrylonitrile, butadiene, and styrene) have been reported to crack and leak when used with UNDILUTED Etoposide Injection. Hypotension following rapid intravenous administration has been reported, hence, the diluted DBL ® Etoposide Injection solution should be administered over a period of 30 to 60 minutes. More prolonged infusion lessens the risk of a hypotensive reaction. DBL ® ETOPOSIDE INJECTION SHOULD NOT BE GIVEN BY A RAPID INTRAVEN पूरा दस्तावेज़ पढ़ें