Details
Stereochemistry | ACHIRAL |
Molecular Formula | F6S |
Molecular Weight | 146.055 |
Optical Activity | NONE |
Defined Stereocenters | 0 / 0 |
E/Z Centers | 0 |
Charge | 0 |
SHOW SMILES / InChI
SMILES
FS(F)(F)(F)(F)F
InChI
InChIKey=SFZCNBIFKDRMGX-UHFFFAOYSA-N
InChI=1S/F6S/c1-7(2,3,4,5)6
SULFUR HEXAFLUORIDE is a component of LUMASON® (sulfur hexafluoride lipid-type A microspheres). It is an ultrasound contrast agent indicated for use in the heart echocardiography and in ultrasonography of the liver and the urinary tract. The sulfur hexafluoride lipid microspheres are composed of SF6 gas in the core surrounded by an outer shell monolayer of phospholipids with palmitic acid as a stabilizer.
Approval Year
Conditions
Condition | Modality | Targets | Highest Phase | Product |
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Diagnostic | LUMASON Approved UseLumason is an ultrasound contrast agent indicated for use
- in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with suboptimal echocardiograms
- in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients
- in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patients Launch Date2014 |
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Diagnostic | LUMASON Approved UseLumason is an ultrasound contrast agent indicated for use
- in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with suboptimal echocardiograms
- in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients
- in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patients Launch Date2014 |
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Diagnostic | LUMASON Approved UseLumason is an ultrasound contrast agent indicated for use
- in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with suboptimal echocardiograms
- in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients
- in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patients Launch Date2014 |
Doses
Dose | Population | Adverse events |
---|---|---|
10.3 mL 1 times / day single, intravenous (mean) Studied dose Dose: 10.3 mL, 1 times / day Route: intravenous Route: single Dose: 10.3 mL, 1 times / day Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.150 |
unhealthy, adult n = 5275 Health Status: unhealthy Age Group: adult Sex: M+F Population Size: 5275 Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.150 |
Other AEs: Nausea, Chest discomfort... Other AEs: Nausea (0.9%) Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.150Chest discomfort (0.6%) Chest pain (0.6%) Injection site pain (0.5%) Headache (2.1%) |
10.3 mL 1 times / day single, intravenous (mean) Studied dose Dose: 10.3 mL, 1 times / day Route: intravenous Route: single Dose: 10.3 mL, 1 times / day Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.161 |
unhealthy, adult n = 5275 Health Status: unhealthy Age Group: adult Sex: M+F Population Size: 5275 Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.161 |
Disc. AE: Bradycardia, Hypotension... AEs leading to discontinuation/dose reduction: Bradycardia (0.02%) Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.161Hypotension (0.04%) Chest pain (0.02%) Electrocardiogram ST segment elevation (0.02%) Hot flush (0.02%) Nausea (0.02%) Swollen tongue (0.02%) Rash (0.02%) Presyncope (0.02%) |
10.3 mL 1 times / day single, intravenous (mean) Studied dose Dose: 10.3 mL, 1 times / day Route: intravenous Route: single Dose: 10.3 mL, 1 times / day Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.58 |
unhealthy, adult n = 5275 Health Status: unhealthy Age Group: adult Sex: M+F Population Size: 5275 Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.58 |
Disc. AE: Injection site vesicles, Cardiac arrest... AEs leading to discontinuation/dose reduction: Injection site vesicles (0.02%) Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.58Cardiac arrest (0.02%) Anaphylactic shock (0.02%) |
AEs
AE | Significance | Dose | Population |
---|---|---|---|
Injection site pain | 0.5% | 10.3 mL 1 times / day single, intravenous (mean) Studied dose Dose: 10.3 mL, 1 times / day Route: intravenous Route: single Dose: 10.3 mL, 1 times / day Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.150 |
unhealthy, adult n = 5275 Health Status: unhealthy Age Group: adult Sex: M+F Population Size: 5275 Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.150 |
Chest discomfort | 0.6% | 10.3 mL 1 times / day single, intravenous (mean) Studied dose Dose: 10.3 mL, 1 times / day Route: intravenous Route: single Dose: 10.3 mL, 1 times / day Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.150 |
unhealthy, adult n = 5275 Health Status: unhealthy Age Group: adult Sex: M+F Population Size: 5275 Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.150 |
Chest pain | 0.6% | 10.3 mL 1 times / day single, intravenous (mean) Studied dose Dose: 10.3 mL, 1 times / day Route: intravenous Route: single Dose: 10.3 mL, 1 times / day Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.150 |
unhealthy, adult n = 5275 Health Status: unhealthy Age Group: adult Sex: M+F Population Size: 5275 Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.150 |
Nausea | 0.9% | 10.3 mL 1 times / day single, intravenous (mean) Studied dose Dose: 10.3 mL, 1 times / day Route: intravenous Route: single Dose: 10.3 mL, 1 times / day Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.150 |
unhealthy, adult n = 5275 Health Status: unhealthy Age Group: adult Sex: M+F Population Size: 5275 Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.150 |
Headache | 2.1% | 10.3 mL 1 times / day single, intravenous (mean) Studied dose Dose: 10.3 mL, 1 times / day Route: intravenous Route: single Dose: 10.3 mL, 1 times / day Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.150 |
unhealthy, adult n = 5275 Health Status: unhealthy Age Group: adult Sex: M+F Population Size: 5275 Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.150 |
Bradycardia | 0.02% Disc. AE |
10.3 mL 1 times / day single, intravenous (mean) Studied dose Dose: 10.3 mL, 1 times / day Route: intravenous Route: single Dose: 10.3 mL, 1 times / day Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.161 |
unhealthy, adult n = 5275 Health Status: unhealthy Age Group: adult Sex: M+F Population Size: 5275 Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.161 |
Chest pain | 0.02% Disc. AE |
10.3 mL 1 times / day single, intravenous (mean) Studied dose Dose: 10.3 mL, 1 times / day Route: intravenous Route: single Dose: 10.3 mL, 1 times / day Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.161 |
unhealthy, adult n = 5275 Health Status: unhealthy Age Group: adult Sex: M+F Population Size: 5275 Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.161 |
Electrocardiogram ST segment elevation | 0.02% Disc. AE |
10.3 mL 1 times / day single, intravenous (mean) Studied dose Dose: 10.3 mL, 1 times / day Route: intravenous Route: single Dose: 10.3 mL, 1 times / day Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.161 |
unhealthy, adult n = 5275 Health Status: unhealthy Age Group: adult Sex: M+F Population Size: 5275 Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.161 |
Hot flush | 0.02% Disc. AE |
10.3 mL 1 times / day single, intravenous (mean) Studied dose Dose: 10.3 mL, 1 times / day Route: intravenous Route: single Dose: 10.3 mL, 1 times / day Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.161 |
unhealthy, adult n = 5275 Health Status: unhealthy Age Group: adult Sex: M+F Population Size: 5275 Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.161 |
Nausea | 0.02% Disc. AE |
10.3 mL 1 times / day single, intravenous (mean) Studied dose Dose: 10.3 mL, 1 times / day Route: intravenous Route: single Dose: 10.3 mL, 1 times / day Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.161 |
unhealthy, adult n = 5275 Health Status: unhealthy Age Group: adult Sex: M+F Population Size: 5275 Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.161 |
Presyncope | 0.02% Disc. AE |
10.3 mL 1 times / day single, intravenous (mean) Studied dose Dose: 10.3 mL, 1 times / day Route: intravenous Route: single Dose: 10.3 mL, 1 times / day Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.161 |
unhealthy, adult n = 5275 Health Status: unhealthy Age Group: adult Sex: M+F Population Size: 5275 Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.161 |
Rash | 0.02% Disc. AE |
10.3 mL 1 times / day single, intravenous (mean) Studied dose Dose: 10.3 mL, 1 times / day Route: intravenous Route: single Dose: 10.3 mL, 1 times / day Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.161 |
unhealthy, adult n = 5275 Health Status: unhealthy Age Group: adult Sex: M+F Population Size: 5275 Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.161 |
Swollen tongue | 0.02% Disc. AE |
10.3 mL 1 times / day single, intravenous (mean) Studied dose Dose: 10.3 mL, 1 times / day Route: intravenous Route: single Dose: 10.3 mL, 1 times / day Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.161 |
unhealthy, adult n = 5275 Health Status: unhealthy Age Group: adult Sex: M+F Population Size: 5275 Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.161 |
Hypotension | 0.04% Disc. AE |
10.3 mL 1 times / day single, intravenous (mean) Studied dose Dose: 10.3 mL, 1 times / day Route: intravenous Route: single Dose: 10.3 mL, 1 times / day Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.161 |
unhealthy, adult n = 5275 Health Status: unhealthy Age Group: adult Sex: M+F Population Size: 5275 Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.161 |
Anaphylactic shock | 0.02% Disc. AE |
10.3 mL 1 times / day single, intravenous (mean) Studied dose Dose: 10.3 mL, 1 times / day Route: intravenous Route: single Dose: 10.3 mL, 1 times / day Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.58 |
unhealthy, adult n = 5275 Health Status: unhealthy Age Group: adult Sex: M+F Population Size: 5275 Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.58 |
Cardiac arrest | 0.02% Disc. AE |
10.3 mL 1 times / day single, intravenous (mean) Studied dose Dose: 10.3 mL, 1 times / day Route: intravenous Route: single Dose: 10.3 mL, 1 times / day Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.58 |
unhealthy, adult n = 5275 Health Status: unhealthy Age Group: adult Sex: M+F Population Size: 5275 Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.58 |
Injection site vesicles | 0.02% Disc. AE |
10.3 mL 1 times / day single, intravenous (mean) Studied dose Dose: 10.3 mL, 1 times / day Route: intravenous Route: single Dose: 10.3 mL, 1 times / day Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.58 |
unhealthy, adult n = 5275 Health Status: unhealthy Age Group: adult Sex: M+F Population Size: 5275 Sources: Page: nda/2014/203684Orig1s000MedR.pdf - p.58 |
Overview
CYP3A4 | CYP2C9 | CYP2D6 | hERG |
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OverviewOther
Other Inhibitor | Other Substrate | Other Inducer |
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Drug as victim
Target | Modality | Activity | Metabolite | Clinical evidence |
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Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203684Orig1s000ClinPharmR.pdf#page=29 Page: 29.0 |
no |
Tox targets
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203684Orig1s000PharmR.pdf#page=38 Page: 38.0 |
Sample Use Guides
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Classification Tree | Code System | Code | ||
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NDF-RT |
N0000175864
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EMA ASSESSMENT REPORTS |
SONOVUE (AUTHORIZED: ECHOCARDIOGRAPHY)
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WHO-ATC |
V08DA05
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NCI_THESAURUS |
C1937
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EMA ASSESSMENT REPORTS |
SONOVUE (AUTHORIZED: ULTRASONOGRPAHY)
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WHO-VATC |
QV08DA05
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1599276
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17358
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m10373
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LL-69
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C84187
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30496
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D013459
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100000091323
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SUB15925MIG
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WS7LR3I1D6
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825
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CHEMBL1796998
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Sulfur Hexafluoride
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WS7LR3I1D6
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219-854-2
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2551-62-4
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4039
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DB11104
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CHEMBL3545306
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DTXSID8029656
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SULFUR HEXAFLUORIDE
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ACTIVE MOIETY