Exem Foam Kit

ExEm ® Foam is indicated for sonohysterosalpingography to assess fallopian tube patency in women with known or suspected infertility. ExEm ® Foam is an ultrasound contrast agent indicated for sonohysterosalpingography to assess fallopian tube patency in women with known or suspected infertility. ( 1 )

ExEm Foam is contraindicated for use in: Pregnancy [see Warnings and Precautions (5.1) ] . Patients with known or suspected lower genital tract inflammation or infection [see Warnings and Precautions (5.2) ]. Patients who have had a gynecologic procedure within the last 30 days [see Warnings and Precautions (5.2) ]. Patients with vaginal bleeding Due to the risk of intravasation of ExEm Foam as a result of exposure of the endometrial vessels during bleeding, and Due to the potential risk of endometriosis as a result of seeding the peritoneum with endometrial tissue.

Patients with known or suspected reproductive tract neoplasia due to the risk of peritoneal spread of neoplasm . ExEm Foam is contraindicated in: Pregnancy ( 4 ) Patients with known or suspected lower genital tract inflammation or infection ( 4 ) Patients who have had a gynecologic procedure within the last 30 days ( 4 ) Patients with vaginal bleeding ( 4 ) Patient with known or suspected reproductive tract neoplasia.

( 4 )

Risk for fetal harm: Confirm that the patient has a negative pregnancy test within the 24 hours before ExEm Foam administration and confirm that the patient is in the pre-ovulatory phase of her menstrual cycle (cycle days 6 through 11). ( 4 , 5.1 ) Risk for Post-Procedure Gynecologic Infections: Do not use in contraindicated situations even if the patient is receiving antimicrobial therapy. ( 4 , 5.2 )

5.1Risk for Fetal Harm ExEm

Foam is contraindicated for use in pregnancy due to the potential risk of fetal harm from an intrauterine procedure. To ensure that the patient is not pregnant prior to ExEm Foam administration, confirm that the patient has a negative pregnancy test within the 24 hours before ExEm Foam administration and confirm that the patient is in the pre-ovulatory phase of her menstrual cycle (cycle days 6 through 11) [see Contraindications (4) ].

5.2