Product Information
Registration Status: ActiveFERINJECT SOLUTION FOR INJECTION 50MG/ML is approved to be sold in Singapore with effective from 2011-10-19. It is marketed by VIFOR PHARMA ASIA PACIFIC PTE LTD, with the registration number of SIN14035P.
This product contains Ferric Carboxymaltose 50mg in the form of INJECTION, SOLUTION. It is approved for INTRAVENOUS DRIP, INTRAVENOUS BOLUS use.
This product is manufactured by BIPSO GmbH in GERMANY.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
Ferric Carboxymaltose is an iron replacement product and chemically, an iron carbohydrate complex. FDA approved on July 25, 2013.
Indication
Ferric carboxymaltose is a iron replacement product 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 or those who have non-dialysis dependent chronic kidney disease.
Mechanism of Action
Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that release iron.
Pharmacokinetics
- Absorption
- When a single dose of 100 to 1000 mg of iron was given to iron deficient patients, the maximum serum concentration (Cmax) was 37 μg/mL to 333 μg/mL. These levels were obtained 15 minutes to 1.21 hours post dose (Tmax).
- Distribution
- 3 L
- Metabolism
- Elimination
Toxicity
The most common adverse reactions (>2%) are nausea, hypertension, flushing, hypophosphatemia, and dizziness.
Active Ingredient/Synonyms
Iron Carboxymaltose | Iron Dextri-Maltose | VIT 45 | Ferric Carboxymaltose |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.