Rx Item-Sodium Ferric Gluconate 62.5Mg/5Ml Vial 10X5Ml By Actavis Pharma

FERRLECIT- sodium ferric gluconate complex injection
sanofi-aventis U.S. LLC
1 INDICATIONS AND USAGE

Ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.
2 DOSAGE AND ADMINISTRATION

The dosage of Ferrlecit is expressed in terms of mg of elemental iron. Each 5 mL sterile, single-use vial contains 62.5 mg of elemental iron (12.5 mg/mL).

Do not mix Ferrlecit with other medications, or add to parenteral nutrition solutions for intravenous infusion. The compatibility of Ferrlecit with intravenous infusion vehicles other than 0.9% sodium chloride has not been evaluated. Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever the solution and container permit. If diluted, use immediately.

Ferrlecit treatment may be repeated if iron deficiency reoccurs.
DOSAGE FORMS AND STRENGTHS

Ferrlecit is available as a single use vial, containing 62.5 mg of elemental iron in 5 mL volume.
4 CONTRAINDICATIONS

Known hypersensitivity to sodium ferric gluconate or any of its components.

DESCRIPTION

Ferrlecit� (sodium ferric gluconate complex in sucrose injection), an iron replacement product, is a stable macromolecular complex with an apparent molecular weight on gel chromatography of 289,000 � 440,000 daltons. The macromolecular complex is negatively charged at alkaline pH and is present in solution with sodium cations. The product has a deep red color indicative of ferric oxide linkages. The chemical name is D-Gluconic acid, iron (3+) sodium salt.

The structural formula is considered to be [NaFe2 O3 (C6 H11 O7 )(C12 H22 011 )5]n?200�

Each sterile, single-use vial of 5 mL of Ferrlecit for intravenous injection contains 62.5 mg (12.5 mg/mL) of elemental iron as the sodium salt of a ferric ion carbohydrate complex in an alkaline aqueous solution with approximately 20% sucrose w/v (195 mg/mL) in water for injection, pH 7.7 � 9.7.

Each mL contains 9 mg of benzyl alcohol as an inactive ingredient.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action

Ferrlecit is used to replete the body content of iron. Iron is critical for normal hemoglobin synthesis to maintain oxygen transport. Additionally, iron is necessary for metabolism and various enzymatic processes.

RX ITEM-Sodium Ferric Gluconate 62.5Mg/5
NDC 00591-0149-87 UPC/GTIN No.3-05910-14987-1 Mfg.Part No.14987

Sodium Ferric Gluconate 62.5Mg/5Ml Vial
BRAND: SODIUM FERRIC GLUCONATE NDC: 00591-0149-87,591014987 UPC: 3-05910-14987-1,305910149871

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