Información de la droga para EPOPROSTENOL (GeneraMedix Inc ): PATIENT COUNSELING INFORMATION

Patients receiving Epoprostenol for Injection should receive the following information.

Epoprostenol for Injection must be reconstituted only with as directed using only Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. Epoprostenol is infused continuously through a permanent indwelling central venous catheter via a small, portable infusion pump. Thus, therapy with epoprostenol requires commitment by the patient to drug reconstitution, drug administration, and care of the permanent central venous catheter. Sterile technique must be adhered to in preparing the drug and in the care of the catheter, and even brief interruptions in the delivery of epoprostenol may result in rapid symptomatic deterioration. A patient’s decision to receive epoprostenol should be based upon the understanding that there is a high likelihood that therapy with epoprostenol will be needed for prolonged periods, possibly years. The patient's ability to accept and care for a permanent intravenous catheter and infusion pump should also be carefully considered.

Manufactured for:

GeneraMedix Inc

150 Allen Road

Liberty Corner, NJ 07938

Manufactured by:

Hollister-Stier Laboratories, LLC

3525 N. Regal

Spokane, WA 99207

PI90000.01

June 2008