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1. NAME OF THE MEDICINAL PRODUCT
ETOPOPHOS INJECTION
Etopophos 100mg Powder for Solution for Injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 113.6 mg etoposide phosphate (equivalent to 100 mg etoposide).
Each vial also contains 7.64 mg (0.33mmol) sodium
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Lyophilised pPowder for solution for injection.
White to off-white lyophilised powder.
6.3 Shelf Life
18 months.
Chemical and physical in-use stability has been demonstrated for 7 days at 2-8°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 7 days at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
When reconstituted as directed, Etopophos solutions can be stored in glass or plastic containers under refrigeration (2-8°C) for 7 days; at controlled room temperature 20-25°C for 24 hours following reconstitution with Sterile Water for Injection, USP, 5% Dextrose Injection, USP, or 0.9% Sodium Chloride Injection, USP; or at controlled room temperature 20-25°C for 48 hours following reconstitution with Bacteriostatic Water for Injection with Benzyl Alcohol or Bacteriostatic Sodium Chloride for Injection with Benzyl Alcohol. Etopophos solutions further diluted as directed can be stored under refrigeration (2-8°C) or at controlled room temperature 20-25°C for 24 hours.
6.6 Instructions For Use/Handling
Immediately prior to administration, the content of each vial must be reconstituted with either 5 ml or 10 ml Water for Injection B.P. , 5% Glucose Intravenous Infusion B.P. or 0.9% Sodium Chloride Intravenous Infusion BP to a concentration equivalent to 20 mg/ml or 10 mg/ml etoposide (22.7 mg/ml or 11.4 mg/ml etoposide phosphate), respectively. Following reconstitution the solution may be administered without further dilution or it can be further diluted to concentrations as low as 0.1 mg/mL etoposide (0.14 mg/ml etoposide phosphate) with either 5% Glucose Intravenous Infusion BP or 0.9% Sodium Chloride Intravenous Infusion BP.
When reconstituted and/or diluted as directed Etopophos solutions are chemically and physically stable for 48 hours at 37°C, 96 hours at 25°C and 7 days under refrigeration (2-8°C) under normal room fluorescent light in both glass and plastic containers. For microbiological reasons, the product should be stored for not more than 8 hours at room temperature or 24 hours in a refrigerator. Solutions of Etopophos should be prepared in an aseptic manner.
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