Definity

/ Medison

For Single Use Only: DEFINITY® (perflutren injectable suspension) contains no preservative. Bacterial contamination with the risk of postadministration septicemia can occur following the puncture of the elastomeric septum. It is essential to follow directions for preparation of DEFINITY® carefully and to adhere to strict aseptic procedures during preparation.
The DEFINITY® vial must be activated prior to use with a mechanical shaking device (Vialmix®). Upon activation, DEFINITY® appears as a milky white suspension. The activated product has an initial concentration of perflutren of
150±100 µl/mL.
Bolus Administration: The recommended dose for DEFINITY® is a single dose of 10 µl/kg of the activated product by intravenous bolus injection over 30-60 seconds, followed by a 10-mL saline flush. If necessary, a second 10 µl/kg dose followed by a second 10-mL saline flush may be administered 30 minutes after the first injection to prolong contrast enhancement.
Infusion: DEFINITY® may also be administered via an I.V. infusion of 1.3 mL added to 50 mL of preservative-free saline. The rate of infusion is suggested to be initiated at 4.0 mL/minute and could be titrated as necessary to achieve optimal image enhancement but should not exceed 10 mL/min. The total dose administered per kg will range from approximately 14.4 µl/kg (90 kg person) to 21.7 µl/kg (60 kg person). Note: DEFINITY® should be used immediately after dilution with preservative-free saline.
The maximum dose is either two bolus doses or one single intravenous infusion. The safety of bolus and infusion dosing in combination or in sequence, has not been studied.
See prescribing information for full details.

Echocardiography: For contrast-enhanced ultrasound imaging of cardiac structures (ventricular chambers and endocardial borders) and function (regional wall motion) in adult patients with suboptimal echocardiograms. Abdominal ultrasound: For contrast-enhanced ultrasound imaging of the liver and kidneys in adult patients to improve the evaluation of pathology.

Hypersensitivity to ingredients, patients with cardiac shunts.
DEFINITY® should not be injected by direct intra-arterial injection.
Gas Contrast Agents, for use in diagnostic ultrasound examinations, should not be administered within 24 hours prior to extracorporeal shock wave lithotripsy.

Should be used only by a physician with knowledge and prerequisite training in diagnostic microbubbles of gas.

See prescribing information for full details.

During clinical trials there was no incidence of an overdose with DEFINITY® (perflutren injectable suspension). Should an overdose be suspected, supportive measures should be taken in response to symptoms.