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Sodium Ferric Gluconate Complex (Ferrlecit)

Trade Name : Ferrlecit

sanofi-aventis U.S. LLC

INJECTION

Strength 12.5 mg/mL

SODIUM FERRIC GLUCONATE COMPLEX Iron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Sodium Ferric Gluconate Complex (Ferrlecit) which is also known as Ferrlecit and Manufactured by sanofi-aventis U.S. LLC. It is available in strength of 12.5 mg/mL per ml. Read more

Sodium Ferric Gluconate Complex (Ferrlecit) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • 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 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. ()
  • The dosage of Ferrlecit is expressed in terms of mg of elemental iron. Each 5 mL sterile, single-dose 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.
  • 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. ()
  • 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. ()
  • Do not mix Ferrlecit with other medications or add to parenteral nutrition solutions for intravenous infusion.
  • Administer in 0.9% saline. ()
  • Ferrlecit is available as a single-dose vial, containing 62.5 mg of elemental iron in 5 mL volume.
  • Ferrlecit is supplied in a single-dose vial containing 62.5 mg of elemental iron in 5 mL. ()
  • Known hypersensitivity to sodium ferric gluconate or any of its inactive components. ()
  • No data
  • 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. ()
  • Hypotension: Ferrlecit may cause hypotension. Monitor patients for signs and symptoms of hypotension during and following each Ferrlecit dose. ()
  • Iron Overload: Regularly monitor hematologic responses during Ferrlecit therapy. Do not administer Ferrlecit to patients with iron overload. ()
  • Benzyl Alcohol Toxicity: Premature and low-birth-weight infants may be more likely to develop toxicity. ()
  • The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
  • The most commonly reported adverse reactions (u226510%) in adult patients were nausea, vomiting and/or diarrhea, injection site reaction, hypotension, cramps, hypertension, dizziness, dyspnea, chest pain, leg cramps, and pain. In patients 6 to 15 years of age the most common adverse reactions (u226510%) were hypotension, headache, hypertension, tachycardia and vomiting. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Drug-drug interactions involving Ferrlecit have not been studied. Ferrlecit may reduce the absorption of concomitantly administered oral iron preparations.
  • No data
  • Pregnancy: Use only if clearly needed (contains benzyl alcohol). ()
  • Nursing Mothers: Caution should be exercised when administered to a nursing woman (contains benzyl alcohol). ()
  • Pediatric Use: Safety and effectiveness have not been established in pediatric patients <6 years of age. ()
  • The Ferrlecit iron complex is not dialyzable.
  • No data is available regarding overdose of Ferrlecit in humans. Excessive dosages of Ferrlecit may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. Do not administer Ferrlecit to patients with iron overload ].
  • Individual doses exceeding 125 mg may be associated with a higher incidence and/or severity of adverse events n
  • Ferrlecit at elemental iron doses of 125 mg/kg, 78.8 mg/kg, 62.5 mg/kg and 250 mg/kg caused deaths in mice, rats, rabbits, and dogs respectively. The major symptoms of acute toxicity were decreased activity, staggering, ataxia, increases in the respiratory rate, tremor, and convulsions.
  • 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 u2013 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 [NaFeO(CHO)(CH0)5]n
  • Each sterile, single-dose 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 7.7u20139.7.
  • Each mL contains 9 mg of benzyl alcohol as an inactive ingredient.
  • No data
  • Long term carcinogenicity studies of sodium ferric gluconate in animals were not performed.
  • Sodium ferric gluconate was not genotoxic in the Ames test or the rat micronucleus test. Sodium ferric gluconate produced a clastogenic effect in an chromosomal aberration assay in Chinese hamster ovary cells.
  • Studies to assess the effects of sodium ferric gluconate on fertility were not conducted.
  • Two clinical studies (Studies A and B) were conducted in adults and one clinical study was conducted in pediatric patients (Study C) to assess the efficacy and safety of Ferrlecit.
  • No data
  • Prior to Ferrlecit administration:
  • Advise patients that Ferrlecit may reduce the absorption of concomitantly administered oral iron preparations n
  • sanofi-aventis U.S. LLCBridgewater, NJ 08807A SANOFI COMPANY
  • PREMIERProRx is a registered trademark of Premier Healthcare Alliance, L.P., used under license.
  • u00a92019 sanofi-aventis U.S. LLCFerrlecit is a registered trademark of A. Nattermann & Cie. GmbH
  • NDC 0024-2794-10n n
  • Ferrlecitn
  • sodium ferric gluconatecomplex in sucrose injection
  • 62.5n- 5n- Vial
  • FOR INTRAVENOUS USE ONLY
  • 10 x 5
  • PREMIER

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