Source: FDA, National Drug Code (US) Revision Year: 2020
Monoferric is an iron replacement product containing ferric derisomaltose for intravenous infusion. Ferric derisomaltose is an iron carbohydrate complex with a matrix structure composed of interchanging layers of ferric hydroxide and the carbohydrate derisomaltose. Derisomaltose consists of linear, hydrogenated isomaltooligosaccharides with an average molecular weight of 1000 Da and a narrow molecular weight distribution that is almost devoid of mono- and disaccharides.
Ferric derisomaltose has an average molecular weight of 155,000 Da and has the following empirical formula:
{FeO(1-3X) (OH)(1+3X) (C6H5O73-)X}, (H20)T, -
(C6H10O6)R (C6H10O5)Z (C6H13O5)R, (NaCl)Y
X = 0.0311; T = 0.25; R = 0.14; Z = 0.49; Y = 0.14
Iron atoms placed in the electronegative cavities of the 3-D structure between and within the derisomaltose molecules. A schematic representation is presented below
Monoferric is a sterile, dark brown, non-transparent aqueous solution with pH 5.0-7.0, containing ferric derisomaltose dissolved in water for injections and filled into Type I glass vials.
Each 1 mL of solution contains 100 mg of elemental iron as ferric derisomaltose in water for injection.
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Monoferric is a sterile, dark brown, non-transparent aqueous solution available as:
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Monoferric injection is a sterile, dark brown, non-transparent aqueous solution supplied in cartons as single-dose vials (10 mL, 5 mL or 1 mL) in the following configurations:
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| Drug | Countries | |
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| MONOFERRIC | Canada, United States |
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