How to Use DEFINITY^®: Using the VIALMIX^®

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VIALMIX® is the activation device used with DEFINITY®. When properly used, it ensures consistent activation of DEFINITY® each and every time. How to use VIALMIX® is fully explained in the VIALMIX® User's Guide. You'll find additional activation tips below.

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Activation Quick Tips

(Refer to the VIALMIX^® User's Guide for more detailed instructions.)

• Ensure that the DEFINITY^® vial is at room temperature prior to activation.
  (Before use, DEFINITY^® should be stored in a refrigerator.)
• Switch power "ON" (located on back of unit).
• Open VIALMIX^® and press the lever downward and to the left to open the carrier.
• Hold the DEFINITY^® vial between thumb and forefinger.
  • Load vial by first placing the top of the vial in the left cup of carrier.
  • Position the vial between two cups.
• Release the lever, then close the VIALMIX^® cover.
• Press "START," and VIALMIX^® will automatically begin the activation process. (You will see a countdown from "45" to "0" in the display.) Do not open while activation is in progress. Do not use the vial unless a full 45–second activation cycle is completed.

If any error messages appear, see VIALMIX^® User's Guide.

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Removing the Vial

1. When the full activation cycle is complete, open the VIALMIX^® cover.
2. Press the lever downward and to the left to open the carrier.
3. Remove the activated DEFINITY^® vial. (Vial will be warm to the touch.)
4. Close the cover.

Note: VIALMIX^® can be turned off using the switch on the back of the unit.

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The VIALMIX^® User's Guide is available for download as an Acrobat PDF file (131K).

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VIALMIX^® Ordering Information

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INDICATIONS

Activated DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.

The safety and efficacy of DEFINITY® with exercise stress or pharmacologic stress testing have not been established.

CONTRAINDICATIONS

Do not administer DEFINITY® to patients with known or suspected right-to-left, bi-directional or transient right-to-left cardiac shunts, by intra-arterial injection, or to patients with known hypersensitivity to perflutren.

IMPORTANT SAFETY INFORMATION

WARNING: Serious Cardiopulmonary Reactions  Serious cardiopulmonary reactions, including fatalities, have occurred during or following perflutren-containing microsphere administration. Assess all patients for the presence of any condition that precludes DEFINITY® administration (see CONTRAINDICATIONS). In patients with pulmonary hypertension or unstable cardiopulmonary conditions, monitor vital sign measurements, electrocardiography and cutaneous oxygen saturation during and for at least 30 minutes after DEFINITY® administration (see WARNINGS). Always have resuscitation equipment and trained personnel readily available.

In post marketing use, rare but serious cardiopulmonary or anaphylactoid reactions have been reported during or shortly following perflutren-containing microsphere administration (see ADVERSE REACTIONS). The risk for these reactions may be increased among patients with pulmonary hypertension or unstable cardiopulmonary conditions. It is not always possible to reliably establish a causal relationship to drug exposure due to the presence of underlying cardiopulmonary disease.

Please See Full Prescribing Information and Letter to Healthcare Providers.

This site is intended for U.S. Healthcare Professionals only. DEFINITY, VIALMIX and INTELLIPIN are registered trademarks of Lantheus Medical Imaging, Inc. Use of the information on this site is subject to the terms of our Legal Notice and Privacy Policy. © 2009 Lantheus Medical Imaging, Inc. All Rights Reserved.