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Exem Foam
  • Professionals
  • FDA PI

Exem Foam

Generic name: air polymer-type a intrauterine
Dosage form: foam, kit

Indications and Usage for Exem Foam

ExEm ® Foam is indicated for sonohysterosalpingography to assess fallopian tube patency in women with known or suspected infertility.

Exem Foam Dosage and Administration

Important Pre-Administration Information

To ensure that the patient is not pregnant prior to Exem Foam administration [see Contraindications (4) and Warnings and Precautions (5.1)]:

  • 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

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