Indication
Ferric Carboxymaltose is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients.
who have an intolerance to oral iron or have an unsatisfactory response to oral iron.
who have non–dialysis-dependent chronic kidney disease.
Dosage and Administration
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Route of administration: IV
Method of administration
FerricCarboxymaltose must only be administered by the intravenous route:
- by injection or
- by infusion or
- during a hemodialysis session undiluted directly into the venous limb of the dialyzer.
Ferric Carboxymaltose must not be administered by the subcutaneous or intramuscular route.
Administration of Intravenous Injection
FerricCarboxymaltose may be administered by intravenous injection using undilutedsolution.
Administration rates for intravenous injection ofFerric Carboxymaltose
| Volume of Ferric Carboxymaltose Required | Equivalent iron dose | Administration rate/ Minimum administration time |
| 2 ml | 100 mg | No minimal prescribed time |
| 10 ml | 500 mg | 100 mg iron/min |
| 20 ml | 1000 mg | 15 minutes |
Administration of Intravenous infusion
FerricCarboxymaltose may be administered by intravenous infusion for which it must bediluted.
For infusion,Ferric Carboxymaltose must only be diluted in sterile 0.9% w/v sodium chloride solution as shown.
Note: For stability reasons, Ferric Carboxymaltose should not be diluted toconcentrations less than 2 mg iron/ml (not including thevolume of the Ferric Carboxymaltose solution).
Dilution plan of Ferric Carboxymaltose forintravenous infusion
| Volume of Ferric Carboxymaltose Required | Maximum amount of sterile 0.9% m/V sodium chloride solution | Minimum administration time |
| 2 ml | 50 ml | 6 minutes |
| 10 ml | 100 ml | 15 minutes |
| 20 ml | 250 ml | 15 minutes |
OR, AS DIRECTEDBY PHYSICIAN.
Composition
Hemojet 100: Each 2 ml ampoule contains 322.58 mg of Ferric Carboxymaltose INN equivalent to 100 mg of Iron.
Hemojet 500: Each 10 ml vial contains 1612.90 mg of Ferric Carboxymaltose INN equivalent to 500 mg of Iron.
Hemojet 1000: Each 20 ml nvial contains 3225.80 mg of Ferric Carboxymaltose INN equivalent to 1000 mg of Iron.