Mix2Vial® Transfer SetRECONSTITUTION AT A GLANCE

Reconstitution with the Mix2Vial® Transfer Set

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1 Ensure ZEMAIRA and Sterile Water for Injection vials are at room temperature.

2 Remove flip caps from the ZEMAIRA and Sterile Water for Injection vials.

3 Wipe the rubber stopper of the Sterile Water for Injection vial with the alcohol swab provided and allow to dry prior to opening the Mix2Vial® package.

4 Open the Mix2Vial® filter transfer set by peeling off the lid. Do not remove the transfer set from the blister package.

5 Place the Sterile Water for Injection vial on an even, clean surface and hold the vial tight. Take the transfer set together with the blister package and push the spike of the blue adapter end straight down through the Sterile Water for Injection vial stopper.

6 Carefully remove the blister package from the transfer set by holding at the rim, and pulling vertically upwards. Make sure that you only pull away the blister package and not the transfer set.

7 Place the ZEMAIRA vial on an even and firm surface. Invert the Sterile Water for Injection vial with the transfer set attached and push the spike of the transparent adapter end straight down through the ZEMAIRA vial stopper. The Sterile Water for Injection will automatically flow into the ZEMAIRA vial.

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Note: If the vacuum in the ZEMAIRA vial is accidentally lost during reconstitution with the Mix2Vial® device, the transfer with the transfer set will not work.

In this case, separate the set into two pieces as illustrated in Fig. 2 above; do not discard the Sterile Water for Injection vial. Place the ZEMAIRA vial aside on a flat surface. Remove the blue adapter end from the Sterile Water for Injection vial of the transfer set (Fig. 1) by lifting and bending the blue adapter to the side until it disconnects from the Sterile Water for Injection vial.

For reconstitution:

• Using a separate sterile needle and syringe, withdraw the remaining Sterile Water for Injection. Remove the needle from the syringe.

• Attach the syringe to the transparent adapter of the ZEMAIRA vial as illustrated in Fig. 3 above, and transfer the entire Sterile Water for Injection volume into the ZEMAIRA vial. Remove syringe.

• Gently swirl the ZEMAIRA vial to ensure the product is fully dissolved. Do not shake.

• Proceed to step 10.

If this process does not work, please call 1-800-504-5434.

Fig. 1 Fig. 2 Fig. 3

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8 With one hand, grasp the ZEMAIRA-side of the transfer set and with the other hand grasp the Sterile Water for Injection-side and unscrew the set carefully counterclockwise into two pieces. Discard the Sterile Water for Injection vial with the blue Mix2Vial® adapter attached.

9 Gently swirl the ZEMAIRA vial with the transparent adapter attached until the substance is fully dissolved. Do not shake.

10 Draw air into an empty, sterile syringe. While the ZEMAIRA vial is upright, connect the syringe to the Mix2Vial®’s Luer Lock fitting by screwing clockwise. Inject air into the ZEMAIRA vial.

11 While keeping the syringe plunger pressed, turn the system upside down and draw the solution into the syringe by pulling the plunger back slowly.

12 Now that the solution has been transferred into the syringe, firmly hold on to the barrel of the syringe (keeping the syringe plunger facing down) and disconnect the transparent Mix2Vial® adapter from the syringe by unscrewing counterclockwise. Attach the syringe to a suitable intravenous administration set.

13 Administer through a suitable 5-micron infusion filter (not supplied) at room temperature within 3 hours after reconstitution.

If more than 1 vial of ZEMAIRA is needed to achieve the required dose, use aseptic technique to transfer the reconstituted solution from the vials into the administration container (eg, empty intravenous bag or glass bottle).

Ease the burden of Alpha-1 therapy

Mix2Vial® is a registered trademark of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc.

ZEMAIRA offers convenience for you and your patients with:

Room-temperature storage

Low volume—a 180-pound patient will require approximately 100 mL of solution

Mix2Vial® Transfer Set

Innovation:

Helps prevent vacuum loss

Less frequent spillage

Guided technique leads to safer handling

Visit AlphaNet at zemaira.alphanetprofessionaled.org to access the online Continuing Nursing Education Programs.

Important Safety Information

Alpha1-Proteinase Inhibitor (Human), ZEMAIRA® is indicated to raise the plasma level of alpha1-proteinase inhibitor (A1-PI) in patients with A1-PI deficiency and related emphysema. The effect of this raised level on the frequency of pulmonary exacerbations and the progression of emphysema have not been established in clinical trials.

ZEMAIRA may not be suitable for everyone; for example, people with known hypersensitivity to components used to make ZEMAIRA, those with a history of anaphylaxis or severe systemic response to A1-PI products, and those with certain IgA deficiencies. If you think any of these may apply to you, ask your doctor.

Early signs of hypersensitivity reactions to ZEMAIRA include hives, rash, tightness of the chest, unusual breathing difficulty, wheezing, and feeling faint. Immediately discontinue use and consult with physician if such symptoms occur.

In clinical studies, the following adverse reactions were reported in at least 5% of subjects receiving ZEMAIRA: headache, sinusitis, upper respiratory infection, bronchitis, fatigue, increased cough, fever, injection-site bleeding, nasal symptoms, sore throat, and swelled blood vessels.

Because ZEMAIRA is made from human blood, the risk of transmitting infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.

Please see enclosed full prescribing information for ZEMAIRA.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please contact CSL Behring Medical Information if you have any questions regarding how to use the Mix2Vial®

Phone: 1-800-504-5434 Email: MedInfoNA@cslbehring.com

ZEMAIRA is manufactured and distributed by CSL Behring LLC. ZEMAIRA® and Biotherapies for Life® are registered trademarks of CSL Behring LLC.

© 2019 CSL Behring LLC

1020 First Avenue, PO Box 61501, King of Prussia, PA 19406-0901 USA www.CSLBehring.com www.ZEMAIRA.com ZMR-0305-AUG19