16 HOW SUPPLIED/STORAGE AND HANDLING

RECOTHROM Thrombin, topical (Recombinant), is supplied in single-use, preservative-free vials in the following packages:

NDC 28400-105-41	A 5000-unit vial of RECOTHROM with a 5-mL prefilled diluent syringe (containing sterile 0.9% sodium chloride, USP), a sterile needle-free transfer device, a 5-mL sterile empty syringe, and a pre-printed label.
NDC 28400-120-41	A 20,000-unit vial of RECOTHROM with a 20-mL vial of diluent (containing sterile 0.9% sodium chloride, USP), 2 sterile needle-free transfer devices, a 20-mL sterile empty syringe, and a pre-printed label.
NDC 28400-120-50	The 20,000-unit RECOTHROM kit co-packaged with the ZymoGenetics Spray Applicator Kit containing a spray pump, a spray bottle, a syringe spray tip, a syringe, a bowl, and 2 blank labels.

No RECOTHROM kit components contain latex.

Store RECOTHROM sterile powder vials at 2 °C to 25 °C (36 °F to 77 °F).

Reconstituted solutions of RECOTHROM prepared with sterile 0.9% sodium chloride, USP, may be stored for up to 24 hours at 2 °C to 25 °C (36 °F to 77 °F). Discard reconstituted solution after 24 hours.

Manufactured for ZymoGenetics Inc., 1201 Eastlake Avenue East, Seattle, WA 98102

U.S. License No. 1758

RECOTHROM is a registered trademark of ZymoGenetics, Inc. All other trademarks are the property of their respective owners.

RECOTHROM Thrombin, topical (Recombinant), is covered by one or more of the following U.S. patents:

U.S. Pat. No. 5,476,777, U.S. Pat. No. 5,502,034, U.S. Pat. No. 5,527,692

Other U.S. patents pending

Version: 1010-06