FERRLECIT- sodium ferric gluconate complex injection

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

SODIUM FERRIC GLUCONATE COMPLEX (UNII: CC9149U2QX) (FERRIC CATION - UNII:91O4LML611)

Tillgänglig från:

sanofi-aventis U.S. LLC

INN (International namn):

sodium ferric gluconate complex

Sammansättning:

ferric cation 12.5 mg in 1 mL

Administreringssätt:

INTRAVENOUS

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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. Ferrlecit is contraindicated in patients with known hypersensitivity to sodium ferric gluconate or any of its components. Reactions have included anaphylaxis [see Warnings and Precautions (5.1)] . Risk Summary Parenteral iron administration may be associated with hypersensitivity reactions [see Warnings and Precautions (5.1)] , which may have serious consequences, such as fetal bradycardia (see Clinical Considerations) . Advise pregnant women of the potential risk to the fetus. Available data from postmarketing reports with Ferrlecit use in pregnancy are insufficient to assess the risk of major birth defects and miscarriage. Ferrlecit contains benzyl alcohol as a preservative. Because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is

Produktsammanfattning:

How Supplied Ferrlecit is a clear, dark brown liquid supplied in colorless glass vials. Each sterile, single-dose vial contains 62.5 mg of elemental iron in 5 mL for intravenous use. Discard unused portion. Carton containing 10 vials: NDC 0024-2792-10 Storage Store at 20°C–25°C (68°F–77°F); excursions permitted to 15°C–30°C (59°F–86°F). See USP Controlled Room Temperature. Do not freeze. Keep out of the reach of children.

Bemyndigande status:

New Drug Application

Produktens egenskaper

FERRLECIT- SODIUM FERRIC GLUCONATE COMPLEX INJECTION
SANOFI-AVENTIS U.S. LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FERRLECIT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FERRLECIT.
FERRLECIT (SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE), INJECTION,
FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Ferrlecit is an iron replacement product for 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. (1)
DOSAGE AND ADMINISTRATION
Adult Patients - The recommended adult dosage is 10 mL (125 mg of
elemental iron) diluted in 100 mL
of 0.9% sodium chloride administered by intravenous infusion over 1
hour per dialysis session or
undiluted as a slow intravenous injection (at a rate of up to 12.5
mg/min) per dialysis session. (2.2)
Pediatric Patients - The recommended pediatric dosage is 0.12 mL/kg
(1.5 mg/kg of elemental iron)
diluted in 25 mL 0.9% sodium chloride and administered by intravenous
infusion over 1 hour per dialysis
session. (2.3)
Do not mix Ferrlecit with other medications or add to parenteral
nutrition solutions for intravenous
infusion.
Administer in 0.9% saline. (2)
DOSAGE FORMS AND STRENGTHS
Injection: 62.5 mg/5 mL (12.5 mg/mL) in single-dose vial. (3)
CONTRAINDICATIONS
Known hypersensitivity to sodium ferric gluconate or any of its
inactive components. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Monitor patients for signs and symptoms of
hypersensitivity during and after
Ferrlecit administration for at least 30 minutes and until clinically
stable following completion of the
infusion. Only administer Ferrlecit when personnel and therapies are
immediately available for the
treatment of anaphylaxis and other hypersensitivity reactions. (5.1)
Hypotension: Ferrlecit may cause hypotension. Monitor patients for
signs and symptoms of
hypotension du