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Venofer 100 Mg/5 Ml Vial

  • Manufacturer Name : American Regent
  • MFG # : 00517234025
  • NDC : 00517234025
  • Distributor Name : Curascript - SAGEBRUSH
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Product Information

NDC Package Code0517-2340-25
Proprietary NameVenofer
Non-Proprietary NameIron Sucrose
Package25 VIAL, SINGLE-DOSE in 1 TRAY (0517-2340-25) > 5 mL in 1 VIAL, SINGLE-DOSE
Dosage FormINJECTION, SOLUTION
RouteINTRAVENOUS
Active Ingredient Strength20
Active Ingredient Unitsmg/mL
Substance NameIRON SUCROSE

Description

Venofer is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).

Venofer (iron sucrose injection, USP), an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula:. [Na2Fe5O8(OH) ·3(H2O)]n ·m(C12H22O11). where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide. Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Venofer is available in 10 mL single-dose vials (200 mg elemental iron per 10 mL), 5 mL single-dose vials (100 mg elemental iron per 5 mL), and 2.5 mL single-dose vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL).  Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L.

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Venofer 100 Mg/5 Ml Vial is manufactured by American Regent.
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