How to Use DEFINITY®: Using the VIALMIX®
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. |
 |
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.
Removing the Vial
- When the full activation cycle is complete, open the VIALMIX® cover.
- Press the lever downward and to the left to open the carrier.
- Remove the activated DEFINITY® vial. (Vial will be warm to the touch.)
- Close the cover.
Note: VIALMIX® can be turned off using the switch on the back of the unit.
VIALMIX® Ordering Information
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.
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 uncommonly during or following perflutren-containing microsphere administration [See WARNINGS AND PRECAUTIONS (5.1)]. Most serious reactions occur within 30 minutes of administration.
|
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 (6)]. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions [See Postmarketing Experience (6.2)]. 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, including boxed WARNING regarding serious cardiopulmonary reactions.
