Air polymer-type a intrauterine

Important Pre-Administration Information To ensure that the patient is not pregnant prior to ExEm Foam administration [see Contraindications and Warnings and Precautions ]: Confirm that the patient has a negative pregnancy test within the 24 hours before ExEm Foam administration . Confirm the patient is in the pre-ovulatory phase of her menstrual cycle (cycle days 6 through 11).

Recommended Dosage The recommended initial dose of ExEm Foam is 2 mL to 3 mL by intrauterine infusion using a 5-Fr or larger catheter with luer connection. The dose may be repeated in increments of 2 mL to 3 mL, as needed, to achieve visualization of the fallopian tubes. Maximum total dose is 10 mL.

Preparation and Administration The ExEm Foam kit includes the following components: Syringe A containing 5 mL clear Gel [polymer type A (hydroxyethyl cellulose), glycerin and purified water] Syringe B containing 5 mL Sterile Purified Water Combifix Adapter (coupling device) Preparation Examine the package and do not use if package has been previously opened or damaged.

Ensure the kit is at room temperature. Handle products following aseptic practices (e.g. sterile gloves). Generate foam by mixing Syringe A (Gel) with Syringe B (Sterile Purified Water) included in the package as described in Figure 1. Infuse foam within 5 minutes of reconstitution. FIGURE 1: Reconstitution of ExEm Foam Unscrew and discard the caps from each syringe when ready to prepare the foam.

Push and screw Syringe A to one end of the Combifix Adapter. Push and screw Syringe B to the other end of the Combifix Adapter. Make sure these syringes are attached tightly to avoid loss of liquid when mixing. Push the plunger of one syringe vigorously to transfer, and begin mixing the contents from one syringe to the other syringe.

Repeat this process at least 10 times. The reconstituted foam is completely milky white (opaque) in color After mixing, transfer all of the foam into one syringe, then disconnect the adapter and other syringe. Approximately 10 mL of ExEm Foam is created by mixing Syringe A of clear Gel with Syringe B of Sterile Purified Water.

Infuse within 5 minutes of mixing to ensure adequate imaging. Figure Figure Administration Administer through a 5-Fr or larger catheter with luer connection only. If there is resistance when infusing foam use a larger catheter. Do not infuse forcefully. Infuse 1 mL of foam to confirm proper placement of the catheter tip in the cervix and access to the uterine cavity.

Slowly infuse 2 mL to 3 mL of the foam at a time to avoid patient discomfort. Discard unused portion after use.