.alpha.1-proteinase inhibitor human

Preparation Inspect the vial of GLASSIA. The solution should be clear and colorless to yellow-green and may contain a few protein particles. Do not use if the product is cloudy. Infusion can be made directly from the vial or alternatively, vials may be pooled in an empty, sterile intravenous container. When infusing directly from the vial, use a vented spike adapter and a 5 micron in-line filter (neither is supplied).

When infusing from a sterile intravenous container, attach an appropriate intravenous administration set to the intravenous container. Use a vent filter (not supplied) to withdraw the material from the vial and then use the supplied 5 micron filter needle to transfer the product into the infusion container. In addition, during infusion, it is recommended to use a 5 micron in-line filter (not supplied).

Administer intravenously to the patient as described in section 2.3.

Administration Inspect parenteral products visually for particulate matter and discoloration prior to administration whenever solution and container permit. Administer GLASSIA within three hours of entering the vials to avoid the potential ill effect of any inadvertent microbial contamination. Administer GLASSIA at room temperature through an appropriate intravenous administration set at a rate not greater than 0.04 mL/kg body weight per minute.

The recommended dosage of 60 mg/kg takes approximately 60-80 minutes to infuse. Monitor the infusion rate closely during administration and observe the patient for signs of infusion related reactions. If infusion related adverse reactions occur, reduce the rate or interrupt the infusion until the symptoms subside. You may then resume the infusion at a rate tolerated by the patient.

Following administration, discard all open vials, unused solution and administration equipment.