Generic name: SULFUR HEXAFLUORIDE 60.7mg in 1mg, DISTEAROYLPHOSPHATIDYLCHOLINE, DL- .19mg in 1mg, 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL), SODIUM SALT .19mg in 1mg;
Dosage form: injection, suspension
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2.1 Important Administration Instructions
Do not administer Lumason by intra-arterial injection [see Warnings and Precautions (5.3)].
2.2 Recommended Dose
The recommended dose of Lumason after reconstitution is 2 mL administered as an intravenous bolus injection during echocardiography. During a single examination, a second injection of 2 mL may be administered to prolong contrast enhancement. Follow each Lumason injection with an intravenous flush using 5 mL of 0.9% Sodium Chloride Injection.
The recommended dose of Lumason after reconstitution in adult patients is 2.4 mL administered as an intravenous injection during ultrasonography of the liver. During a single examination, a second injection of 2.4 mL may be administered, if needed. Follow Lumason injection with an intravenous flush using 5 mL of 0.9% Sodium Chloride Injection.
The recommended dose of Lumason after reconstitution in pediatric patients is 0.03 mL per kg administered as an intravenous injection during ultrasonography of the liver. During a single examination, a second injection of 0.03 mL per kg may be administered, if needed. Do not exceed 2.4 mL per injection. Follow Lumason injection with an intravenous flush of 0.9% Sodium Chloride Injection.
- a clear glass vial labeled as Lumason (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, 25 mg lipid-type A /60.7 mg powder and headspace filled with sulfur hexafluoride,
- a prefilled syringe with 5 mL Sodium Chloride 0.9% Injection, USP, (Diluent),
- a Mini-Spike.
- Inspect the Lumason kit and its components for signs of damage. Do not use the kit if the protective caps on the vial and prefilled syringe are not intact or if the kit shows other signs of damage.
- Under aseptic conditions, reconstitute Lumason by injecting the prefilled syringe contents (5 mL Sodium Chloride 0.9% Injection, USP) into the Lumason vial using the following illustrated steps:
4. Remove the flip cap plastic protective cap from the vial, remove the Mini-Spike spike protection and position the spike in the center of the rubber stopper of the vial. Press firmly inward until the spike is fully inserted in the stopper (see Figure 4).
7. For preparation of doses greater than or equal to 1 mL, invert the system and slowly withdraw the intended volume of suspension into the syringe (see Figure 7). For preparation of doses less than 1 mL, withdraw 2 mL of the reconstituted suspension into the 5 mL syringe and measure the volume of Lumason to inject by using the 0.2 mL graduations between the 1 mL and 2 mL marks.
8. Unscrew the syringe from the Mini-Spike (see Figure 8). Peel and remove the diluent label to display the reconstituted product label. Immediately connect the syringe to the dose administration line (20 G) and administer as directed under Lumason Administration section below.
- Administer Lumason as an intravenous bolus injection.
- Use immediately after reconstitution. If the suspension is not used immediately after reconstitution, resuspend the microspheres for a few seconds by hand agitation before the suspension is drawn into the syringe. Reconstituted suspension within a vial may be used for up to 3 hours from the time of its reconstitution. Maintain the vial containing the reconstituted suspension at room temperature.
- Lumason is for single use only. Discard unused portions of the reconstituted suspension in accordance with regulations dealing with the disposal of such materials. Syringe and other materials used should also be properly disposed of after single use.
2.4 Imaging Guidelines
After baseline non-contrast echocardiography is complete, the mechanical index for the ultrasound device should be adjusted to 0.8 or lower. Ultrasound imaging is then continued following Lumason injection.
After identification of the target focal lesion on non-contrast ultrasound examination, hold transducer still while switching scanner to low mechanical index (≤ 0.4) contrast-specific imaging. Ultrasound imaging is then continued following Lumason injection.