Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
IRON SUCROSE (UNII: FZ7NYF5N8L) (FERRIC CATION - UNII:91O4LML611)
Fresenius Medical Care Holdings, Inc.
IRON SUCROSE
FERRIC CATION 20 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Venofer is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). - Known hypersensitivity to Venofer Risk Summary Published studies on intravenous iron sucrose treatment after the first trimester of pregnancy have not shown adverse maternal or fetal outcomes (see Data) . Available reports of intravenous iron sucrose use in pregnant women during the first trimester are insufficient to assess the risk of major birth defects and miscarriage. There are risks to the mother and fetus associated with untreated IDA in pregnancy as well as risks to the fetus associated with maternal severe hypersensitivity reactions (see Clinical Considerations) . Animal reproduction studies of iron sucrose administered to rats and rabbits during the period of organogenesis at elemental iron doses equivalent to the maximum recommended human dose based on body surface area revealed no evidence of harm to the fetus (see Data). The estimated background risk of major birth defects and
Venofer is supplied sterile in 5 mL and 2.5 mL single-dose vials. Each 5 mL vial contains 100 mg elemental iron, and each 2.5 mL vial contains 50 mg elemental iron (20 mg/mL). Contains no preservatives. Store in original carton at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Syringe Stability : Venofer, when diluted with 0.9% NaCl at concentrations ranging from 2 mg to 10 mg of elemental iron per mL, or undiluted (20 mg elemental iron per mL) and stored in a plastic syringe, was found to be physically and chemically stable for 7 days at controlled room temperature (25°C ± 2°C) and under refrigeration (4°C ± 2°C). Intravenous Admixture Stability: Venofer, when added to intravenous infusion bags (PVC or non-PVC) containing 0.9% NaCl at concentrations ranging from 1 mg to 2 mg of elemental iron per mL, has been found to be physically and chemically stable for 7 days at controlled room temperature (25°C ± 2°C). Do not dilute to concentrations below 1 mg/mL. Do not mix Venofer with other medications or add to parenteral nutrition solutions for intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to infusion.
New Drug Application
VENOFER- IRON SUCROSE INJECTION, SOLUTION FRESENIUS MEDICAL CARE HOLDINGS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VENOFER SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VENOFER. VENOFER (IRON SUCROSE) INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2000 INDICATIONS AND USAGE Venofer is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). (1) DOSAGE AND ADMINISTRATION Population Dose Adult patients Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD) (2.2) 100 mg slow intravenous injection or infusion Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD) (2.3) 200 mg slow intravenous injection or infusion Peritoneal Dialysis Dependent-Chronic Kidney Disease (PDD-CKD) (2.4) 300 mg or 400 mg intravenous infusion Pediatric patients HDD-CKD (2.5), PDD-CKD or NDD-CKD (2.6) 0.5 mg/kg slow intravenous injection or infusion DOSAGE FORMS AND STRENGTHS Injection: 50 mg/2.5 mL or 100 mg/5 mL (20 mg/mL) in single-dose vials. (3) CONTRAINDICATIONS Known hypersensitivity to Venofer (4) WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after Venofer administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer Venofer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. (5.1) Hypotension: Venofer may cause hypotension. Monitor for signs and symptoms of hypotension during and following each administration of Venofer. (5.2) Iron Overload: Regularly monitor hematologic responses during Venofer therapy. Do not administer Venofer to patients with iron overload. (5.3) ADVERSE REACTIONS Adult patients: The most common adverse reactions (≥2%) are diarrhea, nausea, vomiting, headache, dizziness, hypotension, pruritus, pain in extremity, arthralgia, back pain, muscl Lire le document complet