MONOFERRIC (Iron Isomaltoside 1000 for Injection) 6 Dosage Forms, Strengths, Composition and Packaging

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Table 1: Dosage Forms, Strengths, Composition and Packaging

Route of Administration

Dosage Form / Strength / Composition

Non-medicinal Ingredients

Intravenous

solution

100 mg/mL elemental iron (as ferric derisomaltose)

hydrochloric acid, sodium hydroxide, water for injection

MONOFERRIC (ferric derisomaltose [also known as iron isomaltoside 1000] for injection) is a dark brown, non-transparent, sterile aqueous colloidal preservative-free solution. Each mL of MONOFERRIC contains the equivalent of 100 mg of elemental iron in Water for Injection (WFI). Hydrochloric acid and sodium hydroxide may be added to adjust the pH.

MONOFERRIC is available in glass single use vials.

MONOFERRIC is available in the following formats:

Single dose vial size

Number of vials per box

1 mL

5

5 mL

1

10 mL

1