NIKP Micafungin For Injection Caution For Usage

Incompatibilities: This medicinal product must not be mixed or co-infused with other medicinal products except those mentioned in Special precautions for disposal and other handling as follows.
Special precautions for disposal and other handling: Any unused product or waste material should be disposed of in accordance with local requirements.
Micafungin NIKP for Injection must not be mixed or co-infused with other medicinal products except those mentioned as follows. Using aseptic techniques at room temperature, Micafungin NIKP for Injection is reconstituted and diluted as follows: 1. The plastic cap must be removed from the vial and the stopper disinfected with alcohol.
2. Five ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion (taken from a 100 ml bottle/bag) should be aseptically and slowly injected into each vial along the side of the inner wall. Although the concentrate will foam, every effort should be made to minimise the amount of foam generated. A sufficient number of vials of Micafungin NIKP for Injection must be reconstituted to obtain the required dose in mg (see table as follows).
3. The vial should be rotated gently. DO NOT SHAKE. The powder will dissolve completely. The concentrate should be used immediately. The vial is for single use only. Therefore, unused reconstituted concentrate must be discarded immediately.
4. All of the reconstituted concentrate should be withdrawn from each vial and returned into the infusion bottle/bag from which it was originally taken. The diluted infusion solution should be used immediately. Chemical and physical in-use stability has been demonstrated for 96 hours at 25°C when protected from light and diluted as described previously.
5. The infusion bottle/bag should be gently inverted to disperse the diluted solution but NOT agitated in order to avoid foaming. The solution must not be used if it is cloudy or has precipitated.
6. The infusion bottle/bag containing the diluted infusion solution should be inserted into a closable opaque bag for protection from light.
Preparation of the solution for infusion: See Table 7.

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After reconstitution and dilution, the solution should be administered by intravenous infusion over approximately 1 hour.