Oxitan Caution For Usage

Incompatibilities: The diluted medicinal product should not be mixed with other medications in the same infusion bag or infusion line. Under Instruction for use described in for handling and disposal section, oxaliplatin can be coadministered with folinic acid via a Y-line.
Do not mix with alkaline drugs or solutions, in particular 5-fluorouracil, folinic acid preparations containing trometamol as an excipient and trometamol salts of other drugs. Alkaline drugs or solutions will adversely affect the stability of oxaliplatin.
Do not dilute oxaliplatin with saline or other solutions containing chloride ions (including calcium, potassium or sodium chlorides).
Do not mix with other drugs in the same infusion bag or infusion line.
Do not use injection equipment containing aluminium.
Handling and Disposal: 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 required 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 integrity of the product, the protection of the environment and in particular the protection of the personnel handling the medicines, in accordance with the hospital policy. 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 goggles, 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 containers. See Disposal as follows.
If oxaliplatin concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with water.
If oxaliplatin concentrate or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Special precautions for administration: Do not use injection equipment containing aluminium.
Do not administer undiluted.
Only 5% Dextrose Injection is to be used as a diluent. Do not dilute for infusion with sodium chloride or chloride containing solutions.
Do not mix with any other medication in the same infusion bag or administer simultaneously by the same infusion line.
Do not mix with alkaline drugs or solutions, in particular 5-fluorouracil, folinic acid preparations containing trometamol as an excipient and trometamol salts of others drugs.
Alkaline drugs or solutions will adversely affect the stability of oxaliplatin.
Instruction for use with folinic acid (as calcium folinate or disodium folinate): Oxaliplatin 85 mg/m² IV infusion in 250 to 500 mL of 5% Dextrose Injection is given at the same time as folinic acid IV infusion in 5% Dextrose Injection, over 2 to 6 hours, using a Y-line placed immediately before the site of infusion. These two drugs should not be combined in the same infusion bag. Folinic acid must not contain trometamol as an excipient and must only be diluted using isotonic 5% Dextrose Injection, never in alkaline solutions or sodium chloride or chloride containing solutions.
Instruction for use with 5-fluorouracil: Oxaliplatin should always be administered before fluoropyrimidines- i.e. 5-fluorouracil.
After oxaliplatin administration, flush the line and then administer 5-fluorouracil.
For additional information on drugs combined with oxaliplatin, see the corresponding manufacturer's summary of product characteristics.
Concentrate for solution for infusion: Inspect visually prior to use. Only clear solutions without particles should be used. The medicinal product is for single use only. Any unused concentrate should be discarded.
Disposal: Any unused medicinal product or waste material should be disposed of according to standard procedures applicable to cytotoxic agents in accordance with local requirements.