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How to reconstitute CEPROTIN

CEPROTIN is administered by intravenous injection after reconstitution of the lyophilized powder for solution with sterilized water for injections1

Initiate treatment with CEPROTIN under the supervision of a physician experienced in replacement therapy with coagulation factors/inhibitors where monitoring of protein C activity is feasible.1

How to reconstitute CEPROTIN: Use aseptic technique

1

Bring the CEPROTIN (powder) and Sterile Water for Injection, USP (diluent) to room temperature.

2

Remove caps from the CEPROTIN and diluent vials.

3

Cleanse stoppers with germicidal solution, and allow them to dry prior to use.

4

Remove protective covering from one end of the double-ended transfer needle and insert exposed needle through the center of the diluent vial stopper.

5

Remove protective covering from the other end of the double-ended transfer needle. Invert diluent vial over the upright CEPROTIN vial; then rapidly insert the free end of the needle through the CEPROTIN vial stopper at its center. The vacuum in the vial will draw in the diluent. If there is no vacuum in the vial, do not use the product.

6

Disconnect the two vials by removing the needle from the diluent vial stopper. Then, remove the transfer needle from the CEPROTIN vial. Gently swirl the vial until all powder is dissolved. Be sure that CEPROTIN is completely dissolved; otherwise, active materials will be removed by the filter needle.

Please refer to the full prescribing information for complete information on Dosage and Administration.1

How to dose CEPROTINCEPROTIN manufacturing


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Warnings and Precautions

Hypersensivity: CEPROTIN may contain trace amounts of mouse protein and/or heparin as a result of the manufacturing process. Allergic reactions to mouse protein and/or heparin cannot be ruled out. If symptoms of hypersensitivity/allergic reaction occur, discontinue the injection/infusion. In case of anaphylactic shock, the current medical standards for treatment are to be observed.

References:

  1. CEPROTIN [Protein C Concentrate (Human)] Prescribing information. Lexington, MA: Baxalta US Inc.

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