April 29, 2016



Patient Counseling Information

Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis, as the risk of an allergic type hypersensitivity reaction cannot be excluded. In addition, CEPROTIN (protein c concentrate) may contain traces of mouse protein or heparin as a result of the manufacturing process. Allergic reactions to mouse protein or heparin cannot be ruled out. If symptoms of hypersensitivity/allergic reaction occur, patients should immediately discontinue the injection/infusion and inform their physician as soon as possible.

Prior to reconstitution, CEPROTIN (protein c concentrate) should be protected from light.

Reconstitute the lyophilized CEPROTIN (protein c concentrate) powder with the supplied diluent (Sterile Water for Injection) using the sterile transfer needle. Gently swirl the vial until all powder is dissolved.

Visually inspect the solution for discoloration and particulate matter. The reconstituted solution should be colorless to slightly yellowish and clear to slightly opalescent and essentially free from visible particles. CEPROTIN (protein c concentrate) should not be administered if discoloration or particulate matter is observed. The solution is drawn through the sterile filter needle into a sterile disposable syringe.

The reconstituted solution contains no preservatives and is intended for single use only. Once reconstituted, it is recommended that the product be administered by intravenous injection within 3 hours. All unused solution, empty vials and used needles must be discarded appropriately.

The attached CEPROTIN (Protein C Concentrate [Human]) "Information For Patients" contains more detailed instructions on the preparation of CEPROTIN (protein c concentrate) .

Baxter Healthcare Corporation., Westlake Village, CA 91362 USA US License No. 140
This product, or its use, may be covered by one or more US Patents including US Patent No. 5,549,893 in addition to other patents pending.
BAXTER and CEPROTIN (protein c concentrate) are trademarks of Baxter International Inc.
Revision Date: 03/2007
FDA rev date: 3/30/2007

Last reviewed on RxList: 5/18/2007
This monograph has been modified to include the generic and brand name in many instances.

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