per-FLOO-tren PROE-teen type A MYE-kroe-sfeers
Serious cardiopulmonary reactions, including fatalities, have occurred during or following perflutren-containing microsphere administration with the most serious reactions occurring within 30 minutes of administration. Assess all patients for any condition that precludes use of this product. Always have resuscitation equipment and trained personnel available .
Diagnostic Agent, Cardiac Function
The albumin microspheres sonicated preparation is an ultrasound contrast agent. Ultrasound contrast agents are used to help provide a clear picture during ultrasound. Ultrasound is a special kind of diagnostic procedure. It uses high-frequency sound waves to create images or “pictures” of certain areas inside the body. The sound waves produced by the ultrasound equipment can be reflected (bounced off) by different parts of the body, like for example, the heart. As the sound waves return they are electronically converted into images on a television screen. Unlike x-rays, ultrasound does not involve ionizing radiation.
The albumin microspheres sonicated preparation contains very small gas-filled albumin microspheres that reflect the sound waves and help create a better picture. The albumin microspheres sonicated preparation is given by injection into a vein before ultrasound to help diagnose problems of the heart.
The albumin microspheres sonicated preparation is to be given only by or under the direct supervision of a doctor with specialized training in ultrasound procedures.
In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Studies on this agent have been done only in adult patients, and there is no specific information comparing use of albumin microspheres sonicated in children with use in other age groups.
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. There is no specific information comparing use of albumin microspheres sonicated in the elderly with use in other age groups.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this diagnostic test, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Receiving this diagnostic test with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:
Your doctor may have special instructions for you in preparation for your test. If you do not understand the instructions you receive or if you have not received such instructions, check with your doctor in advance.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
There are no special precautions to observe after having this test.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.