For IV Bolus Technique1
The IV Bolus method uses a weight-based dose of activated DEFINITY® followed by a preservative-free saline flush.
Supplies Needed
- 18-20 gauge unfiltered needles (filtered needles may cause microsphere disruption)
- 3 or 5 cc syringe (or tuberculin syringe)
- 10cc syringe (for saline flush)
- Preservative-free saline
- 3-way stopcock
- Additional needle to vent the vial or INTELLIPIN® Dispensing Pin*
*If INTELLIPIN® is used, there is no need for 18-20 gauge needles.
Dosing
Guidelines for 10 μL/kg IV bolus injection of activated DEFINITY®.
Verify patient’s weight [kg] and total dose [mL] prior to injecting.
Example Weight Conversion to Kilograms |
Weight Conversion to Kilograms
DEFINITY® Dose Calculation
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venting technique uses a second needle as an air vent which allows air to be drawn into the vial as the contrast is withdrawn into the syringe.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 18 or 20 gauge needle to 3 or 5 cc syringe.
- Insert needle into the vial.
- Invert vial and ensure the needle tip is positioned approximately in the middle of the suspension.
- Slowly withdraw 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 A built in venting port allows air to flow into the vial as the contrast is being withdrawn into the syringe.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 activated DEFINITY®.
Administration
- Withdraw preservative-free saline into 10 cc syringe.
- Attach both syringes to 3-way stopcock.
- Administer 10 μL/kg of activated DEFINITY® by slow IV injection over 30-60 seconds (to reduce attenuation artifacts).
- Follow with a 10mL preservative-free saline flush.
- If necessary, this injection can be repeated 30 minutes after the first injection.
- Maximum allowable dose of activated DEFINITY® is 20 μL/kg.
This method of administration for weight-based dosing of activated DEFINITY® was established in clinical trials using fundamental imaging. At that time, ultrasound system technology for contrast imaging was not widely available. With today's advances in instrumentation, this dosing and administration method is less commonly used.
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.
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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 (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.
