For Continuous IV Infusion Technique
Activated DEFINITY® is the only echocardiography contrast agent approved by the FDA for this method of administration. Continuous IV Infusion provides a consistent, steady enhancement of contrast and is well suited for exams which are performed over an extended period of time. This method can allow the infusion rate to be adjusted to provide optimal image enhancement.
Supplies Needed
- 18 - 20 gauge unfiltered needles (filtered needles may cause microsphere disruption)
- 3 or 5 cc syringe
- 50 mL bag of preservative-free saline
- Additional needle to vent the vial or INTELLIPIN® Dispensing Pin*
*If INTELLIPIN® is used, there is no need for 18-20 gauge needles or 3-way stopcock
Two Methods of Preparation
When withdrawing activated DEFINITY® from the vial it is important to use a venting method. Venting avoids negative pressure in the vial and allows for easier contrast withdrawal. Air should never be injected into the vial.
Venting with standard needle
This venting technique uses a second needle as an air vent which allows air to be drawn into the vial as the contrast is withdrawn into the syringe.
- Following activation with VIALMIX®, remove DEFINITY® vial cap and insert venting needle into the vial.
- Attach 10 or 20 gauge needle to 3 or 5 cc syringe.
- Insert needle into the vial.
- Invert vial and ensure the needle tip is poisitioned approximately in the middle of the suspension.
- Slowly withdraw 1.3 mL of activated DEFINITY®.
Venting with INTELLIPIN®
This technique eliminates the use of a second needle. A built in venting port allows air to flow into the vial as the contrast is being withdrawn into the syringe.
- Following activation with VIALMIX®, remove DEFINITY® vial cap and insert INTELLIPIN® into vial.
- Remove blue cap from female port of INTELLIPIN® and attach 3 or 5 cc syringe to female port.
- Invert vial and slowly withdraw 1.3mL of activated DEFINITY®.
- Attach 18 or 20 gauge needle to syringe.
Administration
- Add 1.3mL activated DEFINITY® to 50 mL of preservative-free saline.
- Gently squeeze IV bag to evenly distribute miscrospheres.
- Initiate at 4.0 mL/minute; maximum 10.0 mL/minute.
- Adjust flow rate for optimal image enhancement.
- DEFINITY package insert, April 2008, Lantheus Medical Imaging, Inc.
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.
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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.