MONOFERRIC Solution for injection Ref.[10064] Active ingredients:

2.1 Recommended Dosage

For patients weighing 50 kg or more: Administer 1,000 mg of Monoferric by intravenous infusion over at least 20 minutes as a single dose. Repeat dose if iron deficiency anemia reoccurs.

For patients weighing less than 50 kg: Administer Monoferric as 20 mg/kg actual body weight by intravenous infusion over at least 20 minutes as a single dose. Repeat dose if iron deficiency anemia reoccurs.

The dosage of Monoferric is expressed in mg of elemental iron. Each mL of Monoferric contains 100 mg of elemental iron.

Only administer Monoferric when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions (Warnings and Precautions (5.1)).

2.2 Preparation and Administration

Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives.

Each vial of Monoferric is single-dose only. Discard unused portion.

• Withdraw the appropriate volume of Monoferric and dilute in 100 mL to 500 mL of 0.9% Sodium Chloride Injection, USP.
• Final diluted concentration should be more than 1 mg iron/mL.
• Compatibility of Monoferric with other drugs has not been established. Monoferric should not be mixed with or physically added to solutions containing other drugs.
• Administer the prepared solution via intravenous infusion over at least 20 minutes.
• Following dilution with 0.9% Sodium Chloride Injection, USP, Monoferric solution may be stored at room temperature for up to 8 hours.
• Extravasation of Monoferric may cause brown discoloration at the extravasation site which may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Monoferric administration at that site.

Excessive dosages of Monoferric may lead to accumulation of iron in storage sites potentially leading to hemosiderosis and hemochromatosis. Avoid use of Monoferric in patients with iron overload (see Warnings and Precautions (5.2)).

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). See the USP controlled room temperature.

Do not freeze.

When added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, Monoferric solution may be stored for up to 8 hours at room temperature.