STORAGE AND HANDLING

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Intended for a US Healthcare Professional Audience Only.

Storage and handling1,3

To ensure the safety and efficacy of OBIZUR, Antihemophilic Factor (Recombinant), Porcine Sequence, please adhere to the following guidelines.

How to Store OBIZUR

Refrigerate.
Do NOT freeze.

Store OBIZUR at refrigeration temperature of 2°C to 8°C [36°F to 46°F].

Leave in original package before use.

Store vials in the original package to protect from light.

Handling OBIZUR

Expiration date printed on carton and vial.

Do NOT use beyond the expiration date printed on the carton or vial.

Use OBIZUR within 3 hours after reconstitution.

Discard any unused reconstituted product if not used within 3 hours after reconstitution.

Examine solution before use.

Do not use OBIZUR if the reconstituted solution is cloudy or has particulate matter.

Obizur
Obizur

How Supplied1

OBIZUR is supplied as a white lyophilized powder in single-use vials in the following package sizes:

How Supplied

Nominal Strength

Package Size

Kit NDC

 

1-vial package

0944-5001-01

500 units

5-vial package

0944-5001-05

 

10-vial package

0944-5001-10

Each package contains one package insert and the appropriate number of each of the components listed below, correlating to the vial package size:

  • Single-use vial of OBIZUR [NDC 0944-5011-01]
  • Pre-filled syringe with 1 mL Sterile Water for Injection [NDC 0944-0011-01]
  • Vial adapter with filter

The actual amount of OBIZUR, in units, is stated on the label of each vial.