Product Specifications
| Specification | Details |
| Manufacturer / Brand | American Regent, Inc. / Venofer® |
| Manufacturer SKU / Item # | 00517234010 |
| NDC Number | 00517-2340-10 (Box) / 00517-2340-01 (Vial) |
| Active Ingredient | Iron Sucrose (Ferric Hydroxide-Sucrose Complex) |
| Elemental Iron Content | 20 mg/mL (100 mg elemental iron per 5 mL vial) |
| Total Content per Vial | 100 mg Elemental Iron / 5 mL |
| Volume per Unit | 5 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 | 10 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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Rapid Iron Store Replenishment: Effectively increases ferritin and transferrin saturation (TSAT) levels to support red blood cell production.
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Preservative-Free Formulation: Formulated without preservatives or benzyl alcohol for safe IV administration.
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Lower Anaphylaxis Risk: Features a lower risk of hypersensitivity reactions compared to traditional high-molecular weight iron dextrans and does not require a test dose.
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Standard 100 mg Dosing Unit: The 5 mL (100 mg) single-dose vial aligns with routine dialysis and outpatient clinical administration protocols.
⚠️ Hypersensitivity Warning: Serious systemic hypersensitivity reactions, including anaphylactic-type reactions, may occur. Administer under supervision with emergency resuscitation equipment available.
⚠️ Administration Guidelines: Do not give as rapid IV push. Dilute only in 0.9% Sodium Chloride Injection (Normal Saline) for infusion, or administer slowly via undiluted slow IV injection over 2 to 5 minutes.
⚠️ Iron Overload Precaution: Regularly monitor serum ferritin, hemoglobin, and transferrin saturation to prevent iron overload.
