Xaliptine Caution For Usage

Special precautions for disposal and other 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 healthcare 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 specialists personnel with knowledge of the medicines used, in conditions that guarantee the 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 solution for infusion should come into contact with skin, wash immediately and thoroughly with water.
If oxaliplatin concentrate or solution for infusion should come into contact with mucous membranes, wash immediately and thoroughly with water.
Special precautions for administration: DO NOT use injection material containing aluminum.
DO NOT administer undiluted.
Only glucose 5% infusion solution 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 medicinal products in the same infusion bag or administer simultaneously by the same infusion line.
DO NOT mix with alkaline medicinal products or solutions, in particular 5-fluorouracil, folinic acid products containing trometamol as an excipient and trometamol salts of other products. Alkaline medicinal products or solution will adversely affect the stability of oxaliplatin.
Instructions for use with folinic acid (as calcium folinate or disodium folinate): Oxaliplatin 85 mg/m² IV infusion in 250 to 500 mL of 5% glucose solution is given at the same time as folinic acid IV infusion in 5% glucose solution, over 2 to 6 hours, using a Y-line placed immediately before the site of infusion. These two medicinal products 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% glucose solution, never in alkaline solutions or sodium chloride or chloride containing solutions.
Instructions 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 medicinal products combined with oxaliplatin, see the corresponding manufacturer's summary of product characteristics. Inspect visually prior to use. Only clear solutions free from visible particles should be used.
This medicinal product is for single use only. Any unused concentrate should be discarded.
Dilution for intravenous infusion: Withdraw the required amount of concentrate from the vial(s) and then dilute with 250 mL to 500 mL of a 5% glucose solution to give an oxaliplatin concentration not less than 0.2 mg/mL. Administer by IV infusion.
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 24 hours at 2-8°C, unless diution has taken place in controlled and validated aseptic conditions.
Chemical and physical in-use stability has been demonstrated for 48 hours at 2 to 8°C when diluted to the concentrations of 0.2 mg/mL and 2.0 mg/mL with glucose 5% as well as for 6 hours at 20-25°C when diluted to the concentration of 0.2 mg/mL and 2.0 mg/mL with glucose 5%.
Inspect visually prior to use. Only clear solutions free from visible particles should be used.
The medicinal product is for single use only. Any unused infusion solution should be discarded (see chapter Disposal as follows.)
NEVER use sodium chloride solution for either reconstitution or dilution.
Infusion: The administration of oxaliplatin does not require prehydration.
Oxaliplatin diluted in 250 to 500 mL of a 5% glucose solution to give a concentration not less than 0.2 mg/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 must precede the administration 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 and in accordance with local requirements related to the disposal of hazardous waste.
Incompatibilities: This medicinal product must not be mixed with other medicinal products except those mentioned in Special precautions for disposal and other handling: DO NOT mix with alkaline medicinal products or solutions, in particular 5-fluorouracil, trometamol and folinic acid products containing trometamol as an excipient and trometamol salts of other medicinal products. Alkaline medicinal products or solutions will adversely affect the stability of oxaliplatin (see Precautions).
DO NOT dilute oxaliplating with saline or other slutions containing chloride ions (including calcium, potassium, or sodium chlorides).
DO NOT mix with other medicinal products in the same infusion bag or infusion line (see Instructions for use w/ folinic acid (as calcium folinate or disodium folinate as previously mentioned for instructions concerning simultaneuous administration with folinic acid).
DO NOT use injection equipment containing aluminium.