ERAXIS® How Supplied/Storage and Handling

(anidulafungin)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

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

Single-Dose Vial of ERAXIS 50 mg

NDC 0049-0114-28

One - 50 mg vial

Single-Dose Vial of ERAXIS 100 mg

NDC 0049-0116-28

One - 100 mg vial

16.2 Storage

ERAXIS 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 25°C (77°F) 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 [see Dosage and Administration (2.3)].

Infusion Solution

ERAXIS infusion solution can be stored at temperatures up to 25°C (77°F) for up to 48 hours. Do not freeze [see Dosage and Administration (2.4)].

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How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

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

Single-Dose Vial of ERAXIS 50 mg

NDC 0049-0114-28

One - 50 mg vial

Single-Dose Vial of ERAXIS 100 mg

NDC 0049-0116-28

One - 100 mg vial

16.2 Storage

ERAXIS 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 25°C (77°F) 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 [see Dosage and Administration (2.3)].

Infusion Solution

ERAXIS infusion solution can be stored at temperatures up to 25°C (77°F) for up to 48 hours. Do not freeze [see Dosage and Administration (2.4)].
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