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GENOTROPIN® (somatropin) How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

GENOTROPIN lyophilized powder is available in the following packages:

5 mg two-chamber cartridge (with preservative)

Concentration of 5 mg/mL

For use with the GENOTROPIN PEN® 5 Growth Hormone Delivery Device.

Package of 1NDC 0013-2626-81

12 mg two-chamber cartridge (with preservative)

Concentration of 12 mg/mL

For use with the GENOTROPIN PEN 12 Growth Hormone Delivery Device.

Package of 1NDC 0013-2646-81

GENOTROPIN MINIQUICK Growth Hormone Delivery Device containing a two-chamber cartridge of GENOTROPIN (without preservative)

After reconstitution, each GENOTROPIN MINIQUICK delivers 0.25 mL, regardless of strength. Available in the following strengths, each in a package of 7:

0.2 mgNDC 0013-2649-02
0.4 mgNDC 0013-2650-02
0.6 mgNDC 0013-2651-02
0.8 mgNDC 0013-2652-02
1.0 mgNDC 0013-2653-02
1.2 mgNDC 0013-2654-02
1.4 mgNDC 0013-2655-02
1.6 mgNDC 0013-2656-02
1.8 mgNDC 0013-2657-02
2.0 mgNDC 0013-2658-02

Storage and Handling

Except as noted below, store GENOTROPIN lyophilized powder under refrigeration at 36°F to 46°F (2°C to 8°C).Do not freeze. Protect from light.

The 5 mg and 12 mg cartridges of GENOTROPIN contain a diluent with a preservative. Thus, after reconstitution, they may be stored under refrigeration for up to 28 days.

The GENOTROPIN MINIQUICK Growth Hormone Delivery Device should be refrigerated prior to dispensing, but may be stored at or below 77°F (25°C) for up to three months after dispensing. The diluent has no preservative. After reconstitution, the GENOTROPIN MINIQUICK may be stored under refrigeration for up to 24 hours before use. The GENOTROPIN MINIQUICK should be used only once and then discarded.

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