Special Precautions for disposal and other handling: Each vial is for single use only.
Doripenem is reconstituted and then further diluted prior to infusion.
Preparation of 500 mg dose of solution for infusion: 1. Add 10 mL of sterile water for injection or sodium chloride 9 mg/mL (0.9%) solution for injection to the vial and shake it to form a suspension.
2. Inspect the suspension visually for foreign matter.
Note: The suspension is not for direct infusion.
3. Withdraw the suspension using a syringe and needle and add it to an infusion bag containing 100 mL of either sodium chloride 9 mg/mL (0.9%) solution for injection to dextrose 50 mg/mL (5%) solution for injection and mix to complete dissolution. Infuse all of this solution to administer a 500 mg dose of doripenem.
Doripenem solutions for infusion range from clear, colourless solutions to solutions that are clear and slightly yellow. Variations in color within this range do not affect the potency of the product.
Any unused product or waste material should be disposed of in accordance with local requirements.
Storage of reconstituted solutions: Upon reconstitution with sterile water for injections or sodium chloride 9 mg/mL (0.9%) solution, doripenem suspension in the vial may be held for up to 1 hour below 30°C prior to transfer and dilution in the infusion bag.
Following dilution in the infusion bag with sodium chloride 9 mg/mL (0.9%) solution for injection or dextrose 50 mg/mL (5%) solution for injection, doripenem infusions stored at controlled room temperature or under refrigeration should be completed according to the times in the following table: See Table 4.
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Chemical and physical in-use stability has been demonstrated for the times and solutions shown in the previous table.
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°C-8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.