Oxaliplatin Ebewe Caution For Usage

Instructions for use/handling: As with other potentially toxic compounds, caution should be exercised when handling and preparing oxaliplatin solutions.
Instructions for Handling: The handling of this cytotoxic agent by nursing or medical personnel requires every precaution to guarantee the protection of the handler and his surroundings.
The preparation of injectable solutions of cytotoxic agents must be carried out by trained specialist personnel with knowledge of the medicines used, in conditions that guarantee the protection of the environment and in particular the protection of the personnel handling the medicines. It requires a preparation area reserved for this purpose. It is forbidden to smoke, eat or drink in this area.
Personnel must be provided with appropriate handling materials, notably long sleeved gowns, protection, masks, caps, protective googles, sterile single-use gloves, protective covers for the work area, containers and collection bags for waste.
Excreta and vomit must be handled with care.
Pregnant women must be warned to avoid handling cytotoxic agents.
Any broken container must be treated with the same precautions and considered as contaminated waste. Contaminated waste should be incinerated in suitably labelled rigid container. See Disposal as follows.
If oxaliplatin concentrate, reconstituted solution or infusion solution, should come into contact with skin, wash immediately and thoroughly with water.
If oxaliplatin concentrate, premix solution or infusion solution, should come into contact with mucous membranes, wash immediately and thoroughly with water.
Special precautions for administration: DO NOT use injection material containing aluminium.
DO NOT administer undiluted.
DO NOT reconstitute or dilute for infusion with saline solution.
DO NOT mix with any other medication in the same infusion bag or administer simultaneously by the same infusion line (in particular 5-fluorouracil, basic solutions, trometamol and folinic acid products containing trometamol as an excipient).
Oxaliplatin can be co-administered with folinic acid infusion using a Y-line placed immediately before the site of injection. The drugs should not be combined in the same infusion bag. Folinic acid must be diluted using isotonic infusion solutions such as 5% glucose solution but NOT sodium chloride solutions or alkaline solutions.
Flush the line after oxaliplatin administration.
USE ONLY the recommended solvents (see as follows).
Any reconstituted solution that shows evidence of precipitation should not be used and should be destroyed with due regard to legal requirements for disposal of hazardous waste (see as follows).
Reconstitution of the solution: Water for injections or 5% glucose solution should be used to reconstitute the solution.
For a vial of 50mg: add 10ml of solvent to obtain a concentration of 5mg oxaliplatin/ml.
For a vial of 100mg: add 20ml of solvent to obtain a concentration of 5 mg oxaliplatin/ml.
From a microbiological and chemical point of view, the reconstituted solution should be diluted immediately with 5% glucose solution.
Inspect visually prior to use. Only clear solutions without particles should be used.
The medicinal product is for single use only. Any unused solution should be discarded.
Dilution before infusion: Withdraw the required amount of reconstituted solution from the vial(s) and then dilute with 250ml to 500ml of a 5% glucose solution to give an oxaliplatin concentration not less than 0.2mg/ml.
Administer by IV infusion.
Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C.
From a microbiological point of view, this infusion preparation 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 24 hours at 2°C to 8°C unless dilution has taken place in controlled and validated aseptic conditions.
Inspect visually prior to use. Only clear solutions without particles should be used.
The medicinal product is for single use only. Any unused solution should be discarded.
NEVER use sodium chloride solution for either reconstitution or dilution.
Infusion: The administration of oxaliplatin does not require prehydration.
Oxaliplatin diluted in 250 to 500ml of a 5% glucose solution to give a concentration not less than 0.2mg/ml must be infused either by peripheral vein or central venous line over 2 to 6 hours. When oxaliplatin is administered with 5-fluorouracil, the oxaliplatin infusion should precede that of 5-fluorouracil.
Disposal: Remnants of the medicinal product as well as all materials that have been used for reconstitution, for dilution and administration must be destroyed according to hospital standard procedures applicable to cytotoxic agents with due regard to current laws related to the disposal of hazardous waste.
Incompatibilities: DO NOT use in association with alkaline drugs or solutions (in particular 5-fluorouracil, basic solutions, trometamol and folinic acid products containing trometamol as an excipient).
DO NOT reconstitute or dilute for infusion with saline solution.
DO NOT mix with other drugs in the same infusion bag or infusion line (see Instructions for use/handling for instructions concerning simultaneous administration with folinic acid).
DO NOT use injection equipment containing aluminium.