TRIFERIC AVNU Solution for injection Ref.[10336] Active ingredients:

2.1 Recommended Dosage

The recommended dosage of Triferic AVNU is 6.75 mg iron (III) undiluted as a slow continuous intravenous infusion over 3 to 4 hours via the pre-dialyzer infusion line, post-dialyzer infusion line, or via a separate connection to the venous blood line during hemodialysis.

Administer Triferic AVNU at each dialysis procedure for as long as patients are receiving maintenance hemodialysis therapy for CKD.

The dosage of Triferic AVNU solution is expressed as mg of iron (III). Each mL of Triferic AVNU injection for intravenous administration contains 1.5 mg iron as iron (III).

2.2 Preparation and Administration

Each ampule of Triferic AVNU is intended for single-use only.

Use aseptic technique to prepare Triferic AVNU as follows:

• Visually inspect Triferic AVNU solution for signs of precipitation prior to use. The solution should be clear and slightly yellow-green in color.
• Holding the top of the ampule, shake with one single downward movement in order to remove the solution remaining in the cap.
• To open, twist the ampule body and the ampule head in opposite directions until the neck breaks off the top.
• Attach a 10 mL or 20 mL luer-lock syringe to the ampule and withdraw the contents (6.75 mg in 4.5 mL).
• Connect the syringe to the attached pre-dialyzer infusion line, post-dialyzer infusion line, or to a separate connection to the venous blood line.
• Mount the syringe on an infusion pump and administer as a slow continuous infusion of Triferic AVNU (4.5 mL) over 3 to 4 hours.
• Discard unused portion.

Store ampules protected from light in the aluminum pouch at controlled room temperature (20° to 25°C [68° to 77°F]); excursions permitted to 15°-30°C (59° to 86°F) [See USP Controlled Room Temperature]. Do not freeze.