البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
IRON SUCROSE (UNII: FZ7NYF5N8L) (FERRIC CATION - UNII:91O4LML611)
A-S Medication Solutions
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
Product: 50090-4541 NDC: 50090-4541-0 5 mL in a VIAL, SINGLE-USE
New Drug Application
VENOFER- IRON SUCROSE INJECTION, SOLUTION A-S MEDICATION SOLUTIONS ---------- 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, 100 mg/5 mL, or 200 mg/10 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: May cause hypotension. Monitor for signs and symptoms of hypotension during and following each administration. (5.2) Iron Overload: Regularly monitor hematologic responses during therapy. Do not administer 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, muscle cramp, injection site reactions اقرأ الوثيقة كاملة