Exem Foam
Generic name: air polymer-type a intrauterine
Dosage form: foam, kit
On This Page
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Contraindications
- Warnings and Precautions
- Adverse Reactions/Side Effects
- Use In Specific Populations
- Description
- Clinical Pharmacology
- Nonclinical Toxicology
- Clinical Studies
- How Supplied/Storage and Handling
- Patient Counseling Information
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
MEDICAL DEPARTMENTS
Cardiology
Pediatrics
Diabetes Care
Pre-natal Care
Ultrasound Echocardiogram
|