Iron

Fematos 500

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IM/IV Injection -10 ml vial

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Description

Fematos 500 mg IM/IV Injection

Description
Ferric Carboxymaltose is a colloidal iron (III) hydroxide in complex with Carboxymaltose, a Carbohydrate polymer that releases iron.

Indications
Ferric Carboxymaltose injection is indicated for the treatment of iron deficiency anemia in adult patients:
who have intolerance to oral iron or have had unsatisfactory response to oral iron.
who have non-dialysis dependent chronic kidney disease.

Dosage & Administration
The posology of Ferric Carboxymaltose follows a stepwise approach:
determination of the individual iron need
calculation and administration of the iron dose(s)
post-iron repletion assessments.
Step 1: Determination of the iron need: The individual iron need for repletion using Fematos is determined based on the patient’s body weight and haemoglobin (Hb) level. The following list for determination of the iron need:

Hb <10 g/dl below 35 kg: 500 mg 35 kg to <70 kg: 1500 mg 70 kg and over: 2000 mg Hb 10 to 14 g/dl below 35 kg: 500 mg 35 kg to <70 kg: 1000 mg 70 kg and over: 1500 mg Hb >14 g/dl
below 35 kg: 500 mg
35 kg to <70 kg: 500 mg 70 kg and over: 500 mg Step 2: Calculation and administration of the maximum individual iron dose(s): Based on the iron need determined above the appropriate dose(s) of Ferric Carboxymaltose should be administered taking into consideration the following: A single Ferric Carboxymaltose administration should not exceed: 15 mg iron/kg body weight (for administration by intravenous injection) or 20 mg iron/kg body weight (for administration by intravenous infusion) 1,000 mg of iron (20 ml Ferric Carboxymaltose) The maximum recommended cumulative dose of Ferric Carboxymaltose is 1000 mg of iron per week. Step 3: Post-iron repletion assessments: Re-assessment should be performed by the clinician based on the individual patient's condition. The Hb level should be re-assessed no earlier than 4 weeks post final Ferric Carboxymaltose administration to allow adequate time for erythropoiesis and iron utilisation. In the event the patient requires further iron repletion, the iron need should be recalculated using above list.

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