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SONOVUE is a brand name for Sulfur Hexafluoride, supplied as a powder for suspension. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SonoVue (sulfur hexafluoride) is indicated for use with ultrasound imaging to enhance the echogenicity of the blood, which results in an improved signal-to-noise ratio. SonoVue should only be used in patients where examination without contrast enhancement is inconclusive. Endocardial Border Delineation: SonoVue can…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment Endocardial Border Delineation: The recommended dose of SonoVue for visualization of cardiac chambers and endocardial borders delineation is 2 mL administered as an intravenous bolus injection during echocardiography performed at rest or stress.
The recommended rate of administration of the injection is 2 mL over a period of 1 second. During a single examination, a second injection of 2 mL may be administered when deemed necessary by the physician. 2 mL administered as an intravenous bolus injection during Doppler ultrasound.
2 mL over 2-3 seconds is recommended to reduce blooming artifacts. 2 mL may be administered when deemed necessary by the physician. 9% w/v), which is intended to enhance the imaging process. 9% for this flush, the user must have this immediately available from another source.
Ultrasonography of the Excretory Urinary Tract:
The recommended dose of SonoVue for ultrasonography of the excretory urinary tract is 1 mL of reconstituted solution by intravesical administration. Introduce a sterile 6F-8F urinary catheter into the bladder under sterile conditions.
9% sodium chloride solution) to approximately one third or half of its predicted total volume [(age in years + 2) x 30] mL. SonoVue® (sulfur hexafluoride suspension for injection) Page 6 of 38 Inject the SonoVue dose and then continue filling the bladder with saline until the patient has the urge to micturate or there is the first slight 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 SonoVue administration. 9%) to give a final concentration of 8 μL/mL of sulfur hexafluoride microbubbles.
After adding the sodium chloride solution, the vial should be shaken vigorously for twenty seconds after which the desired volume of the product is withdrawn into a syringe for administration to the patient. 9%, intended for the intravenous flush following injection of SonoVue, the user must have this immediately available from another source.
The method of reconstitution of the lyophilized product is as follows:
5 Post-Market Adverse Reactions). Serious cardiopulmonary reactions, including fatalities, have occurred during or following the injection of SonoVue (see 7 WARNINGS AND PRECAUTIONS – Cardiovascular). Most serious reactions occur within 30 minutes of administration.
Assess all patients for the presence of any condition that precludes SonoVue administration (see 2 CONTRAINDICATIONS). Always have resuscitation equipment and trained personnel readily available (see 7 WARNINGS AND PRECAUTIONS).
2 Recommended Dose and Dosage Adjustment Endocardial Border Delineation: The recommended dose of SonoVue for visualization of cardiac chambers and endocardial borders delineation is 2 mL administered as an intravenous bolus injection during echocardiography performed at rest or stress.
The recommended rate of administration of the injection is 2 mL over a period of 1 second. During a single examination, a second injection of 2 mL may be administered when deemed necessary by the physician. 2 mL administered as an intravenous bolus injection during Doppler ultrasound.
2 mL over 2-3 seconds is recommended to reduce blooming artifacts. 2 mL may be administered when deemed necessary by the physician. 9% w/v), which is intended to enhance the imaging process. 9% for this flush, the user must have this immediately available from another source.
Ultrasonography of the Excretory Urinary Tract:
The recommended dose of SonoVue for ultrasonography of the excretory urinary tract is 1 mL of reconstituted solution by intravesical administration. Introduce a sterile 6F-8F urinary catheter into the bladder under sterile conditions.
9% sodium chloride solution) to approximately one third or half of its predicted total volume [(age in years + 2) x 30] mL. SonoVue® (sulfur hexafluoride suspension for injection) Page 6 of 38 Inject the SonoVue dose and then continue filling the bladder with saline until the patient has the urge to micturate or there is the first slight sign of back pressure to the infusion.
1 Special Populations). The product should be administered under the supervision of a qualified health professional who is experienced in the use of the diagnostic ultrasound contrast agents and in the management of hypersensitivity reactions, including severe allergic reactions.
Appropriate management of therapy and complications is only possible when adequate diagnostic and treatment facilities are readily available. 2 CONTRAINDICATIONS SonoVue® is contraindicated in: Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container.
For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS COMPOSITION AND PACKAGING. Patients with known right-to-left cardiac shunts. In these patients, microbubbles can bypass filtering by the lung and directly enter the arterial circulation.
Patients with severe pulmonary hypertension (pulmonary artery pressure >90 mmHg), uncontrolled systemic hypertension, and adult respiratory distress syndrome. SonoVue® (sulfur hexafluoride suspension for injection) Page 5 of 38 SonoVue should not be used in combination with dobutamine in patients with conditions suggesting cardiovascular instability where dobutamine is contraindicated.
3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Severe allergic reactions have been experienced with the use of SonoVue (see 7 WARNINGS AND PRECAUTIONS – Immune and
SonoVue® is contraindicated in: Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS COMPOSITION AND PACKAGING.
Patients with known right-to-left cardiac shunts. In these patients, microbubbles can bypass filtering by the lung and directly enter the arterial circulation. Patients with severe pulmonary hypertension (pulmonary artery pressure >90 mmHg), uncontrolled systemic hypertension, and adult respiratory distress syndrome.
SonoVue® (sulfur hexafluoride suspension for injection) Page 5 of 38 SonoVue should not be used in combination with dobutamine in patients with conditions suggesting cardiovascular instability where dobutamine is contraindicated.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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SonoVue® (sulfur hexafluoride suspension for injection) Page 7 of 38 1) Connect the plunger rod by screwing it clockwise into the syringe. 2) Open Mini-Spike Plus 6/8R blister and remove syringe tip cap. 3) Open transfer system cap and connect the syringe to the transfer system by screwing it in clockwise.
4) Remove Flip cap plastic protective disk from the vial. Slide the vial into the transparent sleeve of the transfer system and press firmly to lock the vial in place. 5) Empty the contents of the syringe into the vial by pushing on the plunger rod.
6) Shake vigorously for 20 seconds to mix all the contents in the vial (white milky liquid). 7) For preparation of doses greater than or equal to 1 mL, invert the system and carefully withdraw SonoVue into the syringe. 2 mL graduations between the 1 mL and 2 mL marks.
8) Unscrew the syringe from the transfer system. Single dose product. As with all parenteral drug products, syringes should be inspected visually for clarity, particulate matter, precipitate, discoloration and leakage prior to administration whenever solution and container permit.
Solutions showing haziness, particulate matter, precipitate, discoloration or leakage should not be used. Following reconstitution of the lyophilisate and prior to injecting the product, it is mandatory to inspect the suspension to make sure that a homogeneous white milky liquid has been obtained.
Discard the product if the suspension is not white, not milky, not homogeneous and/or if solid parts of the lyophilisate are seen in the suspension. Reconstituted product should be used within 6 hours. Discard unused portion.
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 SonoVue administration. 9%) to give a final concentration of 8 μL/mL of sulfur hexafluoride microbubbles.
After adding the sodium chloride solution, the vial should be shaken vigorously for twenty seconds after which the desired volume of the product is withdrawn into a syringe for administration to the patient. 9%, intended for the intravenous flush following injection of SonoVue, the user must have this immediately available from another source.
The method of reconstitution of the lyophilized product is as follows:
SonoVue® (sulfur hexafluoride suspension for injection) Page 7 of 38 1) Connect the plunger rod by screwing it clockwise into the syringe. 2) Open Mini-Spike Plus 6/8R blister and remove syringe tip cap. 3) Open transfer system cap and connect the syringe to the transfer system by screwing it in clockwise.
4) Remove Flip cap plastic protective disk from the vial. Slide the vial into the transparent sleeve of the transfer system and press firmly to lock the vial in place. 5) Empty the contents of the syringe into the vial by pushing on the plunger rod.
6) Shake vigorously for 20 seconds to mix all the contents in the vial (white milky liquid). 7) For preparation of doses greater than or equal to 1 mL, invert the system and carefully withdraw SonoVue into the syringe. 2 mL graduations between the 1 mL and 2 mL marks.
8) Unscrew the syringe from the transfer system. Single dose product. As with all parenteral drug products, syringes should be inspected visually for clarity, particulate matter, precipitate, discoloration and leakage prior to administration whenever solution and container permit.
Solutions showing haziness, particulate matter, precipitate, discoloration or leakage should not be used. Following reconstitution of the lyophilisate and prior to injecting the product, it is mandatory to inspect the suspension to make sure that a homogeneous white milky liquid has been obtained.
Discard the product if the suspension is not white, not milky, not homogeneous and/or if solid parts of the lyophilisate are seen in the suspension. Reconstituted product should be used within 6 hours. Discard unused portion. 5 OVERDOSAGE No clinical signs or symptoms of overdosage with SonoVue have been reported to date.
Repeated bolus doses of up to 52 mL of SonoVue (3 successive injections over 60 minutes) were administered to healthy volunteers in a safety study without any serious adverse events. 5 mL). Eighty-five percent of subjects received cumulative doses ranging from >1to 10 mL.
In the event of overdosage, treatment is directed toward the support […]