Quốc gia: New Zealand
Ngôn ngữ: Tiếng Anh
Nguồn: Medsafe (Medicines Safety Authority)
Etoposide phosphate 579.4mg equivalent to 500 mg etoposide (includes 2% overage);
Link Pharmaceuticals Ltd
Etoposide phosphate 579.4 mg (equivalent to 500 mg etoposide; includes 2% overage)
500 mg
Powder for injection
Active: Etoposide phosphate 579.4mg equivalent to 500 mg etoposide (includes 2% overage) Excipient: Dextran 40 Nitrogen Sodium citrate dihydrate
Vial, glass, single dose, 500 mg
Prescription
Prescription
Nippon Kayaku Co Ltd
In combination with other approved chemotherapeutic agents as first-line treatment in patients with small cell lung cancer.
Package - Contents - Shelf Life: Vial, glass, single dose, - 500 mg - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 7 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours reconstituted stored at or below 25°C
1999-12-16
ETOPOPHOS V12 1 DATA SHEET 1 PRODUCT NAME ETOPOPHOS 100 mg powder for injection. ETOPOPHOS 500 mg powder for Injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ETOPOPHOS 100 MG Each single use vial contains 113.6 mg of etoposide phosphate (equivalent to 100 mg etoposide) as a lyophilised powder for injection. Excipients with known effect: Each 100 mg vial of ETOPOPHOS contains 7.7 mg of sodium. ETOPOPHOS 500 MG Each pharmacy bulk vial contains 568 mg of etoposide phosphate (equivalent to 500mg etoposide) as a lyophilised powder for injection Excipients with known effect: Each 500 mg vial of ETOPOPHOS contains 38.3 mg of sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lyophilised powder for injection. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ETOPOPHOS is indicated in the treatment of: SMALL CELL LUNG CANCER - ETOPOPHOS Injection in combination with other approved chemotherapeutic agents as first-line treatment in patients with small cell lung cancer. HODGKIN'S DISEASE MALIGNANT (NON-HODGKIN'S) LYMPHOMAS, especially of the histiocytic variety. ACUTE NON-LYMPHOCYTIC LEUKAEMIA TESTICULAR TUMOURS both as first-line combination regimens and for the treatment of refractory testicular tumours. ETOPOPHOS V12 2 4.2 DOSE AND METHOD OF ADMINISTRATION ETOPOPHOS is administered by slow intravenous infusion. ETOPOPHOS SHOULD NOT BE GIVEN BY RAPID INTRAVENOUS INJECTION. The usual dose for etoposide is 50 to 100 mg/m 2 /day, days 1 to 5 or 100 mg/m 2 /day, days 1, 3 and 5 every 3 to 4 weeks in combination with other agents approved for use in the disease to be treated. Dosage should be modified to take into account the myelosuppressive effects of other medications in the combination or the effects of prior X-ray therapy or chemotherapy which may have compromised bone marrow reserve. ETOPOPHOS may be infused over 5-210 minutes. Prior to use, the contents of each vial must be reconstituted with Sterile Water for Injection, 5% Dextrose Injection, 0.9% Sodium Chloride Injection, Ba Đọc toàn bộ tài liệu