Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
SODIUM FERRIC GLUCONATE COMPLEX (UNII: CC9149U2QX) (FERRIC CATION - UNII:91O4LML611)
Actavis Pharma, Inc.
SODIUM FERRIC GLUCONATE COMPLEX
FERRIC CATION 12.5 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Sodium ferric gluconate complex in sucrose injection 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. - Known hypersensitivity to sodium ferric gluconate or any of its components. Pregnancy Category B There are no adequate and well-controlled studies with sodium ferric gluconate complex in sucrose injection in pregnant women. Reproduction studies have been performed in mice at doses up to 100 mg/kg/day (300 mg/m2 /day) and in rats at up to 20 mg/kg/day (120 mg/m2 /day). The doses in mice and rats are 4 and 1.5 times the human dose of 125 mg/day (77 mg/m2 /day) on a body surface area basis and have revealed no evidence of harm to the fetus due to sodium ferric gluconate complex in sucrose injection. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly need
How Supplied NDC 0591-0149-87 Sodium ferric gluconate complex in sucrose injection is supplied in colorless glass vials. Each sterile, single-use vial contains 62.5 mg of elemental iron in 5 mL for intravenous use, packaged in cartons of 10 vials. Storage Store at 20 - 25°C (68 - 77°F); excursions permitted to 15 - 30°C (59 - 86°F). See USP Controlled Room Temperature. Do not freeze. Keep out of the reach of children.
Abbreviated New Drug Application
SODIUM FERRIC GLUCONATE COMPLEX- SODIUM FERRIC GLUCONATE COMPLEX INJECTION ACTAVIS PHARMA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION. SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, FOR INTRAVENOUS (IV) USE INITIAL U.S. APPROVAL: 1999 INDICATIONS AND USAGE Sodium ferric gluconate complex in sucrose injection 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. (2.1) 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. (2.2) Do not mix sodium ferric gluconate complex in sucrose injection with other medications or add to parenteral nutrition solutions for intravenous infusion. Administer in 0.9% saline (2) DOSAGE FORMS AND STRENGTHS Sodium ferric gluconate complex in sucrose injection is supplied in a single use vial containing 62.5 mg of elemental iron in 5 mL. (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 sodium ferric gluconate complex in sucrose injection administration for at least 30 minutes and until clinically stable f Przeczytaj cały dokument