Product Specifications
| Specification | Details |
| Manufacturer / Brand | American Regent, Inc. / Venofer® |
| Manufacturer SKU / Item # | 00517231005 |
| NDC Number | 00517-2310-05 (Box) / 00517-2310-01 (Vial) |
| Active Ingredient | Iron Sucrose (Ferric Hydroxide-Sucrose Complex) |
| Elemental Iron Content | 20 mg/mL (200 mg elemental iron per 10 mL vial) |
| Total Content per Vial | 200 mg Elemental Iron / 10 mL |
| Volume per Unit | 10 mL |
| Container Type | Glass Single-Dose Vial (SDV) |
| Administration Route | Intravenous (IV) Slow Injection or IV Infusion |
| Formulation | Preservative-Free / Aqueous Solution / pH 10.5 to 11.1 |
| Storage Temperature | 20°C to 25°C (68°F to 77°F) (Do not freeze) |
| Packaging Configuration | 5 Vials per Box / Pack |
| Regulatory Category | Prescription-Only (Rx) |
| HCPCS Code |
Key Features & Clinical Applications
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Targeted Anemia Management in CKD: Indicated for iron deficiency anemia in non-dialysis dependent (NDD-CKD), hemodialysis dependent (HDD-CKD), and peritoneal dialysis dependent (PDD-CKD) patients.
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Higher Dose Capacity: The 10 mL (200 mg) vial is structured for clinical protocols requiring higher single-dose iron administration, such as non-dialysis dependent CKD regimen dosing.
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Preservative-Free Formulation: Formulated without added preservatives or benzyl alcohol for safe IV administration.
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Lower Anaphylaxis Risk: Demonstrates a lower risk of severe hypersensitivity reactions compared to traditional high-molecular weight iron dextrans and does not require a test dose.
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Flexible IV Delivery: Can be administered undiluted via slow IV injection or diluted in 0.9% Sodium Chloride Injection for IV infusion.
⚠️ Hypersensitivity Warning: Serious systemic hypersensitivity reactions, including anaphylactic-type reactions, may occur. Administer under clinical supervision with emergency resuscitation equipment available.
⚠️ Administration Guidelines: Do not give as a rapid IV push. Administer 200 mg doses either as an undiluted slow IV injection over at least 2 to 5 minutes or as an infusion diluted in 0.9% Sodium Chloride over at least 15 to 30 minutes.
⚠️ Iron Overload Precaution: Regularly monitor serum ferritin, hemoglobin, and transferrin saturation to avoid iron overload.
