What is optison made of?

Each mL of OPTISON contains 5.0-8.0×108 protein-type A microspheres, 10 mg Albumin Human, USP, 0.22 ± 0.11 mg/mL perflutren, 0.2 mg N-acetyltryptophan, and 0.12 mg caprylic acid in 0.9% aqueous sodium chloride. The headspace of the vial is filled with perflutren gas.

How do you do Optison contrast?

OPTISON is administered via an intravenous injection to allow the microspheres to enter the heart chamber and fill the left heart chamber. OPTISON is injected during the ultrasound examination in order to allow the doctor to assess the function of your heart. The recommended dose is 0.5 ml – 3.0 ml per patient.

What is the contrast used in echocardiogram?

Contrast is used during an echocardiogram to see the flow of blood through the heart and the heart muscle better. Saline (sterile salt water) and Definity are contrast solutions which may be used. Each can show the flow of blood through the heart and enhance the pictures of the heart.

How do I administer Optison?

The recommended dose of Optison is 0.5 mL injected into a peripheral vein. If the contrast enhancement is inadequate after the dose of 0.5 mL, additional doses in increments of 0.5 mL may be repeated for further contrast enhancement as needed. The maximum total dose should not exceed 5 mL in any 10 minute period.

Is optison a blood product?

Optison is classified by the FDA as a medical imaging drug product; it is not a blood product, even though the microsphere shell is made from a naturally occurring blood protein, albumin.

Where is optison manufactured?

As a result of the FDA’s action, GE Healthcare will provide a supply of Optison to the US and European markets from its manufacturing facility in Oslo, Norway, becoming the only contrast media manufacturer to supply its own stock to the US.

What is Optison used for?

Optison is used to obtain a clearer scan of the chambers of the heart, especially of the left ventricle, during echocardiography (a diagnostic test where an image of the heart is obtained using ultrasound).

Where is Optison manufactured?

Does an echocardiogram require dye?

Ultrasound contrast agents, unlike agents used for other types of medical imaging, do not contain dye and ultrasound procedures do not utilize ionizing radiation. Ultrasound contrast agents are liquid suspensions of tiny microbubbles that are biocompatible and biodegradable.

What is contrast imaging in ultrasound?

Contrast-enhanced ultrasound (CEUS) is the application of ultrasound contrast medium to traditional medical sonography. Ultrasound contrast agents rely on the different ways in which sound waves are reflected from interfaces between substances. This may be the surface of a small air bubble or a more complex structure.

What is optison used for?

Is dye injected for echocardiogram?

During the test, a special dye (contrast agent) is injected into your vein to help show structures in the heart better.

Will the FDA continue to monitor ultrasound contrast agents?

As part of the FDA’s routine monitoring, we will continue to monitor ultrasound contrast agents for safety issues and will take appropriate action to protect public health.

Does Optison improve the accuracy of non-contrast ultrasound?

Similarly, in comparison to non-contrast ultrasound, Optison significantly improved the qualitative ability to delineate each of the left ventricular segments, though the effect was less for the septal segments.

Does Optison improve visualization of cardiac and pulmonary structures?

This study did not assess the effect of Optison on visualization of cardiac or pulmonary structures. Optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders.

What is the chemical composition of Optison?

Each mL of Optison contains 5.0-8.0×10 8 protein-type A microspheres, 10 mg Albumin Human, USP, 0.22 ± 0.11 mg/mL perflutren, 0.2 mg N-acetyltryptophan, and 0.12 mg caprylic acid in 0.9% aqueous sodium chloride. The headspace of the vial is filled with perflutren gas. The pH is adjusted to 6.4-7.4.