Generic name: SULFUR HEXAFLUORIDE 60.7mg in 1mg, DISTEAROYLPHOSPHATIDYLCHOLINE, DL- .19mg in 1mg, SODIUM 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL) .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 Dosage
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.
The recommended dose of Lumason after reconstitution is 1 mL. The bladder may be refilled with normal saline for a second cycle of voiding and imaging, without the need of a second Lumason administration.
2.3 Reconstitution Instructions
- Inspect the Lumason kit and its components for signs of damage. Do not use the kit if the protective caps on the Lumason vial and prefilled syringe with 5 mL Sodium Chloride 0.9% Injection are not intact or if the kit shows other signs of damage.
- Under aseptic conditions, reconstitute Lumason by injecting the prefilled syringe with 5 mL Sodium Chloride 0.9% Injection 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. For intravenous administration, immediately connect the syringe to a dose administration line (20 G) and administer as directed under the Administration Instructions below. For intravesical administration, immediately connect the syringe to a sterile urinary catheter (6 french to 8 french) and administer as directed under the Administration Instructions below.
- Following reconstitution, Lumason suspension contains 1.5 to 5.6 x108 microspheres/mL with 45 mcg/mL of sulfur hexafluoride.
- 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.
2.4 Administration Instructions
Inspect visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The reconstituted suspension is milky-white, and does not contain visible particulate matter. Do not use the single-patient use vial for more than one patient.
- Insert a sterile 6 french to 8 french urinary catheter into the bladder under sterile conditions;
- Empty the bladder of urine, and then fill the bladder with saline (sterile 0.9% sodium chloride solution) to approximately one third or half of its predicted total volume. The total bladder volume in children is calculated as [(age in years + 2) x 30] mL;
- Administer Lumason as an intravesical bolus injection through the urinary catheter;
- Continue filling the bladder with saline until the patient has the urge to micturate or at the first sign of back pressure to the infusion.
- Immediately following the first voiding, the bladder may be refilled with normal saline for a second cycle of voiding and imaging, without the need of a second Lumason administration
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. Continue ultrasound imaging following Lumason injection.
After baseline non-contrast ultrasound examination of the kidney and bladder, switch the scanner to low mechanical index (≤0.4) contrast specific imaging. Perform continuous alternate ultrasound imaging of the bladder, ureters, and kidneys during filling and voiding of the bladder.
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- Drug class: diagnostic radiopharmaceuticals