Sulfur hexafluoride lipid type A microspheres (injection, intravenous)

Sulfur hexafluoride lipid type A microspheres (injection, intravenous)

Sulfur hexafluoride lipid type A microspheres (injection, intravenous) Intravenous administration (powder for suspension)

Occasionally, serious cardiopulmonary reactions, including fatalities, have occurred during or after injection of ultrasound contrast media, including sulfur hexafluoride lipid type A microspheres. The most serious reactions occur within 30 minutes of administration. Evaluate all patients for the presence of a medical condition that precludes administration and always have resuscitation equipment and trained personnel available.

Used for sulfur hexafluoride lipid type A microspheres

Sulfur hexafluoride lipid type A microspheres is an ultrasound contrast agent. In order to provide a clear image during the ultrasound examination, ultrasound contrast agents are used. Ultrasound is a special kind of diagnostic procedure. It uses high-frequency sound waves to create images or “pictures” of specific areas inside the body. The sound waves produced by the ultrasound machine can be reflected (bounced) off different parts of the body, such as the heart or liver. When the sound waves return, they are electronically converted into images on a television screen. Unlike X-rays, ultrasound does not use ionizing radiation. The ultrasonicated lipid microsphere contains very small gas-filled lipid microspheres that reflect the sound waves and help produce a better image.

This medicine should only be administered by or under the direct supervision of a doctor who has specialized training in ultrasound procedures.

Before using sulfur hexafluoride lipid type A microspheres

When deciding to use a diagnostic test, any risks associated with the test must be weighed against the benefits it provides. This is a decision that you and your doctor will make. Other things can also influence the test results. For this test the following should be taken into account:

Allergies

Tell your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also tell your doctor if you have other allergies, such as to foods, dyes, preservatives or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatrics

Related studies conducted to date have not demonstrated any pediatric-specific problems that would limit the utility of sulfur hexafluoride lipid type A microsphere injection for echocardiograms, liver and urinary tract ultrasound in children. Safety and effectiveness have been proven.

geriatrics

Related studies conducted to date have not demonstrated any geriatric-specific problems that would limit the benefit of sulfur hexafluoride lipid type A microspheres injection in the elderly. However, older patients are more sensitive to the effects of this drug than younger adults.

Breastfeeding

There are insufficient studies in women to determine the risk to infants when using this drug while breast-feeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug interactions

Although certain medicines should not be used together at all, in other cases two different medicines can be used together, although interactions may occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. Tell your doctor if you are taking other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with food/tobacco/alcohol

Certain medicines should not be taken during or near food or consumption of certain foods because interactions may occur. Consuming alcohol or tobacco with certain medications can also lead to interactions. Discuss using your medicine with food, alcohol or tobacco with your doctor.

Other medical problems

The presence of other medical problems may affect the use of this diagnostic test. Be sure to tell your doctor if you have any other medical problems, especially:

• Allergie gegen Polyethylenglykol – Sollte bei Patienten mit dieser Erkrankung nicht angewendet werden.

• Herzinsuffizienz, instabil oder
• Herzinfarkt, akut oder
• Herzerkrankungen (z. B. Koronararteriensyndrom), akute oder
• Herzrhythmusstörungen (z. B. ventrikuläre Arrhythmie) oder
• Herzshunt oder
• Lungenerkrankung – Kann das Risiko schwerwiegenderer Nebenwirkungen erhöhen.

Proper Use of Sulfur Hexafluoride Lipid Type A Microspheres

A doctor or other trained health professional will give you or your child this medicine. This medicine is given through a needle into one of your veins or into your bladder before the ultrasound scan.

Your doctor may have specific instructions for preparing for your test. If you do not understand or have not received the instructions you have been given, contact your doctor in advance.

Precautions when using sulfur hexafluoride lipid type A microspheres

It is very important that your doctor closely monitors you or your child's progress while you are receiving this medicine. This will help your doctor determine whether the medicine is working properly and decide whether you should continue to receive it.

Serious heart or lung problems may occur while taking this medication. Tell your doctor right away if you or your child have chest pain, fast, slow, pounding, or irregular heartbeat, lightheadedness, dizziness, fainting, or trouble breathing.

This medicine can cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor immediately if you experience rash, itching, hoarseness, difficulty breathing, difficulty swallowing, or swelling of your hands, face, or mouth after taking this medication.

Side effects of sulfur hexafluoride lipid type A microspheres

In addition to the necessary effects, a medicine may also have some undesirable effects. Although not all of these side effects may occur, medical attention may be required if they occur.

Contact your doctor or nurse immediately if any of the following side effects occur:

Incident not known

• Verschwommene Sicht
• kalte, feuchte Haut
• Verwirrung
• Husten
• Schwierigkeiten beim Atmen oder Schlucken
• Schwindel
• Schwindel, Ohnmacht oder Benommenheit beim plötzlichen Aufstehen aus einer liegenden oder sitzenden Position
• Ohnmacht
• schneller, hämmernder oder unregelmäßiger Herzschlag oder Puls
• schneller, schwacher Puls
• Hitzegefühl, Rötung der Haut
• Kopfschmerzen
• Nesselsucht oder Striemen
• Große, bienenstockartige Schwellung im Gesicht, an Augenlidern, Lippen, Zunge, Hals, Händen, Beinen, Füßen oder Geschlechtsorganen
• Benommenheit
• Nervosität
• kein Blutdruck oder Puls
• keine Atmung
• lautes Atmen
• in den Ohren hämmern
• Schwellungen oder Schwellungen der Augenlider oder um die Augen, das Gesicht, die Lippen oder die Zunge
• Anfälle
• Juckreiz, Hautausschlag oder Rötung der Haut
• Herzstillstand
• Schwitzen
• Schwellung von Gesicht, Rachen oder Zunge
• Schwellung der Hände, Knöchel, Füße oder Unterschenkel
• Engegefühl in der Brust
• Bewusstlosigkeit
• ungewöhnliche Müdigkeit oder Schwäche
• ungewöhnlich warme Haut

Some side effects may occur that usually do not require medical attention. These side effects may disappear during treatment as your body gets used to the medicine. Your doctor may also be able to give you ways to prevent or reduce some of these side effects. If any of the following side effects persist or are bothersome, or if you have any questions, contact your doctor:

Rarely

• Geschmacksveränderung
• Geschmacksverlust
• Brechreiz
• Schmerzen oder Wärme an der Injektionsstelle

Some patients may also experience other side effects not listed. If you notice other side effects, contact your doctor.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Commonly used brand names

In the USA

• Lumason

Available dosage forms:

• Pulver zur Suspension

Therapeutic class: Diagnostic agent

More information