Английская Википедия:Air polymer-type A

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Air polymer-type A, sold under the brand name ExEm Foam, is a drug for the detection of fallopian tube patency (openness) in people with known or suspected infertility.[1][2] It was approved for use in the United States in November 2019.[2][3]

Air polymer-type A is infused into the uterus to allow for visual assessment of fallopian tubes during an ultrasound examination called a sonohysterosalpingography.[2]

The most common adverse reactions are pelvic pain and abdominal pain, nausea and faintness (caused by a nerve and blood vessel reaction called vasovagal reaction) and post-procedure spotting.[2]

History

The U.S. Food and Drug Administration (FDA) approved air polymer-type A based on literature reports.[2] To evaluate how well air polymer-type A works, the FDA primarily used data from two trials.[2] Trial A[4] was conducted at a site in Italy and Trial B[5] at three sites in Poland.[2]

Evaluation of side effects was based on multiple literature reports and collected safety reports from countries where air polymer-type A is already approved.[2]

References

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