* Concentrate for solution for infusion. Intravenous route in infusion.
* Method and route of administration:
& & – Intravenous route in a 2 to 6-hour infusion.
& & – DO NOT INJECT WITHOUT PRIOR DILUTION.
* Prescription only medicine – List I. Keep to the prescribed doses.
& & Medicinal product reserved to hospital prescription. Prescription reserved to
& & specialists in oncology or hematology or to doctors qualified in cancerology.
& & Close monitoring is necessary during treatment by this medicinal product.
* Handling and destruction:
& & Oxaliplatin must not be handled by pregnant women.
& & Compliance must be ensured with procedures for appropriate handling and destruction.
& & These procedures must comply with current recommendations for cytotoxic drugs.
& & Special precautions for disposal of unused medicinal products or waste materials derived from
& & such medicinal products, if appropriate. Any fractions or unused product must be incinerated.
* Special precautions for storage:
& & – In the original package: the product before reconstitution should be stored below 30 degrees C
& & and protected from light in its outer carton.
& & DO NOT FREEZE.
& & – Following dilution in 5% dextrose solution, the physicochemical stability of the diluted solution
& & has been demonstrated or 24 hours at 2 degrees C to 8 degrees C or 6 hours at 25 degrees C.
& & However, from a microbiological point of view, the infusion preparation should be used immediately,
& & If not used immediately, the conditions and duration of storage after dilution and prior to use are
& & the responsibility of the user and should not be longer than 24 hours at 2 degrees C to 8 degrees C,
& & unless dilution was performed under controlled and validated aseptic conditions.
* Read the package leaflet carefully before use.
* Manufacturer: Aventis Pharma – UNITED KINGDOM (UK).
& & sanofi-aventis france – France. استيراد: رامكو
الوزن | 100 كيلوجرام |
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