Alpha-1-proteinase inhibitor human

When reconstituted as directed, Zemaira ® may be administered intravenously at a rate of approximately 0.08 mL/kg/min as determined by the response and comfort of the patient. The recommended dosage of 60 mg/kg body weight will take approximately 15 minutes to infuse. Preparation Each product package contains one Zemaira ® single use vial, one 20 mL vial of Sterile Water for Injection, USP (diluent) and one color-coded vented transfer device with air inlet filter.

Administer within three hours after reconstitution. Reconstitution 1. Bring both product (green cap) vial and diluent (white cap) vial to room temperature prior to reconstitution. 2. Remove the plastic flip-top caps from the vials. Aseptically cleanse the rubber stoppers with antiseptic solution and allow them to dry. [See table below.] 3.

Allow the vacuum in the Zemaira ® vial to pull the diluent into the Zemaira ® vial. 6. During diluent transfer, wet the lyophilized cake completely by gently tilting the Zemaira ® vial. (Fig. 4) Do not allow the air inlet filter to face downward. Care should be taken not to lose the vacuum, as this will prolong reconstitution of the product. 7.

Gently swirl the Zemaira ® vial until the powder is completely dissolved. (Fig. 5) DO NOT SHAKE . 9. Inspect parenteral drug products visually for particulate matter and discoloration prior to administration. Administer at room temperature within three hours after reconstitution. Fig. 2 Fig. 3 Fig. 4 Fig. 5 Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Pooling Reconstituted Vials If more than one vial of Zemaira ® is needed to achieve the required dose, use an aseptic technique to transfer the reconstituted solution from the vials into the administration container (e.g., empty I.V. bag or glass bottle).

Administration Parenteral drug preparations should be inspected visually for particulate matter and discoloration prior to administration. Administer at room temperature within three hours after reconstitution. Filter the reconstituted solution during administration. To ensure proper filtration of Zemaira ® , use an I.V. administration set with a suitable 5 micron infusion filter (not supplied).

Follow the appropriate procedure for I.V. administration. After administration, any unused solution and administration equipment should be discarded in accordance with biohazard procedures.