Generic name: perflutren
Dosage form: injectable suspension
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
DEFINITY® IS INTENDED FOR ADMINISTRATION ONLY AFTER ACTIVATION IN THE VIALMIX® APPARATUS. Before injection, this product must be activated and prepared according to the instructions outlined below. The Vialmix® apparatus should be ordered from Bristol-Myers Squibb Medical Imaging, 331 Treble Cove Road, North Billerica, MA 01862. For customer orders call 1-800-299-3431.
DEFINITY® may be injected by either an intravenous bolus or infusion.
Bolus: The recommended dose for activated DEFINITY® is 10 microliters (µL)/kg of the activated product by intravenous bolus injection within 30-60 seconds, followed by a 10 mL saline flush. If necessary, a second 10 microliters (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: The recommended dose for activated DEFINITY® is via an IV infusion of 1.3 mL added to 50 mL of preservative-free saline. The rate of infusion should be initiated at 4.0 mL/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute.
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.
Imaging: After baseline non-contrast echocardiography is completed, the mechanical index for the ultrasound device should be set at 0.8 or below (see WARNINGS). Then inject activated DEFINITY® (as described above) and begin ultrasound imaging immediately. The activated DEFINITY® echocardiogram images should be evaluated in combination with the non-contrast echocardiogram images.
DEFINITY® ACTIVATION, PREPARATION AND HANDLING INSTRUCTIONS:
- Allow the vial to warm to room temperature before starting the activation procedure.
- Activate DEFINITY® by shaking the vial for 45 seconds using a Vialmix®.
Note: illustrations of this procedure are contained in the Vialmix® Users Guide.
WARNING: DO NOT USE THIS DRUG UNLESS IT HAS COMPLETED A FULL 45 SECOND ACTIVATION CYCLE IN THE VIALMIX®. DEFINITY® WILL NOT BE PROPERLY ACTIVATED UNLESS THE FULL 45 SECOND ACTIVATION CYCLE IS COMPLETED. DO NOT REACTIVATE the vial if Vialmix® did not complete a full 45 second cycle. DO NOT REACTIVATE a successfully activated DEFINITY® vial (see step 3). DO NOT USE a Vialmix® that is not functioning properly. Refer to the "VIALMIX® User's Guide" for the "VIALMIX® CALIBRATION AND REPLACEMENT PROCEDURES" to ensure that a properly functioning Vialmix® is used.
- Immediately after activation in the Vialmix®, activated DEFINITY® appears as a milky white suspension and may be used immediately after activation. If the product is not used within 5 minutes of Vialmix® activation, the microspheres should be resuspended by 10 seconds of hand agitation by inverting the vial before the product is withdrawn in a syringe. The activated DEFINITY® may be used for up to 12 hours from the time of Vialmix®, but only after the microspheres are resuspended by hand agitation. Store the activated DEFINITY® at room temperature in the original product vial.
- Invert the vial and withdraw the activated milky white suspension using the Intellipin™ (Dispensing Pin) or 18 to 20 gauge syringe needle. Withdraw the material from the middle of the liquid in the inverted vial. DO NOT INJECT AIR INTO THE DEFINITY® VIAL.
- Use the product immediately after its withdrawal from the vial; do not allow the product to stand in the syringe.
FOR SINGLE USE ONLY: DEFINITY® does not contain bacterial preservative. Bacterial contamination with the risk of post-administration septicemia can occur following the puncture of the elastomeric septum. It is essential to follow directions for activation of DEFINITY® carefully and to adhere to strict aseptic procedures during preparation.
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- Drug class: ultrasound contrast media
Other brands: Optison