MONOFERRIC (Iron Isomaltoside 1000 for Injection) 1 Indications

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Canada
 

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MONOFERRIC® (ferric derisomaltose for injection) is indicated for:

  • the treatment of iron deficiency anemia in adult patients who have intolerance or unresponsiveness to oral iron therapy.

The diagnosis must be based on laboratory tests.

1.1 Pediatrics:

Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.

1.2 Geriatrics:

A careful risk benefit assessment is required before MONOFERRIC is used in patients aged > 65 years and close monitoring for adverse events is required (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Geriatrics).