Instructions For Use, Handling and Disposal: Use aseptic technique during the reconstitution and further dilution of pemetrexed for intravenous infusion administration.
Calculate the dose and the number of PEMIREX For Inj. 100 mg or 500 mg vials needed. Each vial contains an excess of pemetrexed to facilitate delivery of label amount.
Reconstitute each vial with sodium chloride 9 mg/mL (0.9%) solution for injection, without preservative, resulting in a solution containing 25 mg/mL pemetrexed. Gently swirl each vial until the powder is completely dissolved. The resulting solution is clear and ranges in color from colorless to yellow or green-yellow without adversely affecting product quality. The pH of the reconstituted solution is between 6.6 and 7.8. Further dilution is required. (See Table 9.)
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The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 mL with sodium chloride 9 mg/mL (0.9%) solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.
Pemetrexed infusion solutions prepared as directed previously are compatible with polyvinyl chloride- and polyolefin-lined administration sets and infusion bags.
Parenteral medicinal products must be inspected visually for particulate matter and discolouration prior to administration. If particulate matter is observed, do not administer.
Pemetrexed solutions are for single use only. Any unused medicinal product or waste material must be disposed of in accordance with local requirements.
Preparation and administration precautions: As with other potentially toxic anti-cancer agents, care should be exercised in the handling and preparation of pemetrexed infusion solutions. The use of gloves is recommended. If a pemetrexed solution contacts the skin, wash the skin immediately and thoroughly with soap and water. If pemetrexed solutions contact the mucous membranes, flush thoroughly with water. Pemetrexed is not a vesicant. There is not a specific antidote for extravasation of pemetrexed. There have been few reported cases of pemetrexed extravasation, which were not assessed as serious by the investigator. Extravasation should be managed by local standard practice as with other non-vesicants.
Incompatibility: Pemetrexed is physically incompatible with diluents containing calcium, including lactated Ringer’s injection. In the absence of compatibility studies (with other drugs and diluents), this medicinal product must not be mixed with other medicinal products.