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ELELYSO®How Supplied/Storage and Handling (taliglucerase alfa)

16 HOW SUPPLIED/STORAGE AND HANDLING

ELELYSO is supplied as a lyophilized powder in single use vials. Each vial contains 200 units of ELELYSO.

NDC 0069-0106-01, 200 units per vial

Store ELELYSO under refrigeration at 2° C to 8° C (36° F to 46° F). Do not freeze. Protect vials from light.

As ELELYSO contains no preservative, the product should be used immediately once reconstituted. If immediate use is not possible, the reconstituted product may be stored for up to 24 hours at 2 to 8 °C (36 to 46 °F) under protection from light or up to 4 hours at 20 to 25 °C (68 to 77 °F) without protection from light. The diluted product may be stored for up to 24 hours at 2 to 8 °C (36 to 46 °F) under protection from light. Storage of the reconstituted product and the diluted product should not exceed a total of 24 hours. Do not freeze. Discard any unused product.

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