Maa: Singapore
Kieli: englanti
Lähde: HSA (Health Sciences Authority)
ETOPOSIDE
PFIZER PRIVATE LIMITED
L01CB01
100 mg/5 ml
INJECTION
ETOPOSIDE 100 mg/5 ml
INTRAVENOUS
Prescription Only
PFIZER (PERTH) PTY LTD
ACTIVE
1993-02-11
PRODUCT INFORMATION – ETOPOSIDE (ETOPOSIDE) 1. NAME OF THE MEDICINE Etoposide 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Etoposide Injection is a sterile solution containing etoposide 20 mg/mL in an organic solvent base. Excipient with known effect: Ethanol For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Concentrate for Solution for Infusion Etoposide is a white or almost white, crystalline powder, practically insoluble in water, sparingly soluble in methanol, slightly soluble in alcohol and in methylene chloride. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Small cell carcinoma of the lung. • Acute monocytic and myelomonocytic leukaemia. • Hodgkin’s disease. • Non-Hodgkin’s lymphoma. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE The usual dose of etoposide must be based on the clinical and haematological response and tolerance of the patient. A repeat course of etoposide should not be administered until the patient’s haematological function is within acceptable limits (see section 4.4 Special warnings and precautions for use). _ADULT _ The dosage for Etoposide Injection is 50-60 mg/m 2 /day intravenously for 5 consecutive days followed by a treatment free interval of 2-3 weeks. Total dose should not usually exceed 400 mg/m 2 per course. In any case, repeat courses should not be given until the haematological parameters have been checked for evidence of myelosuppression and found to be satisfactory. METHOD OF ADMINISTRATION Plastic devices made of acrylic or ABS (a polymer of acrylonitrile, butadiene and styrene) have been reported to crack or leak when used with undiluted Etoposide injection. Etoposide should only be given by slow intravenous infusion (see section 4.4 Special warnings and precautions for use, section 4.8 Adverse effects (undesirable effects)). Etoposide should not be administered by intrapleural or intraperitoneal injection. Etoposide must be diluted before administration. Resultant concentrations should not be greater than 0.4 Lue koko asiakirja