Each 5 mL contains 100 mg (20 mg/mL) of elemental iron as an iron (111)-hydroxide sucrose complex in water for injection.
AVOFER (iron (III) hydroxide sucrose complex injection, USP), an iron replacement product, is a sterile, brown, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron (III) hydroxide sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula: [Na2Fe5O8(OH) · 3(H2O)]n · m(C12H22O11).
where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (111)-hydroxide. Each mL contains 20 mg elemental iron as iron (III) hydroxide sucrose in water for injection. A VOFER is available in 5 mL single-use vials (100 mg elemental iron per 5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and has a pH of 10.5 to 1 L 1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L.
Excipients/Inactive Ingredients: Each vial contains: Water for injection Sodium hydroxide.