Etoposid Ebewe

Etoposid Ebewe Caution For Usage

etoposide

Manufacturer:

EBEWE Pharma

Distributor:

Maxxcare

Marketer:

Mega Lifesciences
Full Prescribing Info
Caution For Usage
Special precautions for disposal and other handling: Procedures for proper handling and disposal of anti-cancer medicinal products should be followed.
Care must be taken whenever handling cytostatic products. Always take steps to prevent exposure. As with other potentially toxic compounds, caution should be exercised in handling and preparing etoposide solutions. Skin reactions associated with accidental exposure to etoposide may occur. The use of gloves is recommended. If etoposide should contact the skin or mucosa, immediately wash the skin with soap and water and flush the mucosa with water.
Etoposide solutions must be prepared under aseptic conditions.
Preparation of etoposide 100 mg powder for solution for infusion: Before use the content of each vial must be reconstituted with 5 ml or 10 ml of: water for injections or, 5% glucose solution or, 0.9 % sodium chloride solution.
This will yield a reconstituted stock solution containing 20 mg/ml or 10 mg/ml etoposide.
After reconstitution, the solution can be administered without further dilution or it can be further diluted with 5% glucose solution or 0.9% sodium chloride solution to obtain concentrations as low as 0.1 mg/ml etoposide.
The products administered by parenteral route must be visually examined to check for any particulates or discoloration prior to administration. If any discolouration or particulate matter is observed, the reconstituted solution must be discarded.
Etoposide is for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
[Etoposide 1000 mg powder for solution for infusion]: Preparation of etoposide 1000 mg powder for solution for infusion: Etoposide 1000 mg is intended to be handled by pharmaceutical staff in central hospital units for the preparation of cytostatics. All steps of preparation must be carried out under Laminar Air Flow conditions. Solutions should be prepared under aseptic conditions. The stopper of the vial should be pierced only once and a sterile transfusion set or any other auxiliary device should be used for withdrawal for the solution. If spikes are used they should be equipped with particle filters or other measures should be taken (e.g. inline-filters) to ensure that only particle free solutions are administered.
The content of each injection vial of etoposide 1000 mg has to be diluted in 100 ml of: water for injections or, 5% glucose solution or, 0.9% sodium chloride solution.
This will yield a reconstituted stock solution containing 10 mg/ml etoposide.
The resulting stock solution may be administered without further dilution or can be further diluted with 5% glucose solution or 0.9% sodium chloride solution to a final concentration of 0.1 mg/ml etoposide.
The stock solution should be withdrawn under aseptic conditions according to the physician's prescription and transferred to the infusion bottles and/or syringes for the individual patients. Exact measuring must be ensured for withdrawal. The stock solution should be used as soon as possible (see Shelf-life under Storage).
Products administered by parenteral route must be visually examined to check for any particulates or discolouration prior to administration. If any discolouration or particulate matter is observed, the reconstituted solution must be discarded.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Etoposide must not be diluted with buffered solutions with a pH value 8, as it precipitates in this milieu.
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