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ERAXIS® (anidulafungin) How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

ERAXIS (anidulafungin) for Injection is supplied in a single-use vial of sterile, lyophilized, preservative-free, powder. ERAXIS (anidulafungin) is available in the following packaging configuration:

Single-Use Vial of ERAXIS 50 mg
NDC 0049-0114-28 One - 50 mg vial
Single-Use Vial of ERAXIS 100 mg
NDC 0049-0116-28 One - 100 mg vial

16.2 Storage

Unreconstituted vials

ERAXIS unreconstituted vials should be stored in a refrigerator at 2°C – 8°C (36°F – 46°F). Do not freeze.

Excursions for 96 hours up to 25ºC (77ºF) are permitted, and the vial can be returned to storage at 2°C – 8°C (36°F – 46°F).

Reconstituted solution

ERAXIS reconstituted solution can be stored at up to 25°C (77°F) for up to 24 hours.

Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 24 hours at 25ºC (77ºF).

From a microbiological point of view, following good aseptic practices, the reconstituted solution can be utilized for up to 24 hours when stored at 25ºC.

Infusion Solution

ERAXIS infusion solution can be stored at temperatures up to 25°C (77°F) for up to 48 hours. Do not freeze.

Chemical and physical in-use stability of the infusion solution has been demonstrated for 48 hours at 25°C (77°F).

From a microbiological point of view, following good aseptic practices, the infusion solution can be utilized for up to 48 hours from preparation when stored at 25ºC.

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