Product Specifications
| Specification | Details |
| Manufacturer / Distributor | International Medication Systems, Ltd. (IMS) |
| Manufacturer SKU / Item # | 76329920101 |
| NDC Number | 76329-9201-01 (Carton/Box) / 76329-9201-00 (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 Carton / Pack |
| Regulatory Category | Prescription-Only (Rx) |
| HCPCS Code |
Key Features & Clinical Applications
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Targeted Anemia Management in CKD: Specifically indicated for iron deficiency anemia across non-dialysis dependent (NDD-CKD), hemodialysis dependent (HDD-CKD), and peritoneal dialysis dependent (PDD-CKD) patient populations.
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Rapid Transferrin Saturation Restoration: Quickly replenishes depleted iron stores and elevates transferrin saturation (TSAT) and serum ferritin levels without requiring oral absorption routes.
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Preservative-Free Packaging: Formulated without added preservatives or benzyl alcohol, ensuring compliance and safety during slow intravenous bolus or piggyback administration.
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Superior Safety Profile over High-Molecular Iron Dextrans: Lower incidence of severe hypersensitivity and anaphylactoid reactions compared to traditional iron dextran formulations; does not require a mandatory pre-treatment test dose.
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Convenient 100 mg Unit Dosing: The 5 mL (100 mg) single-dose vial aligns directly with standard dialysis and outpatient clinic maintenance dosing schedules (100 mg to 200 mg per treatment).
⚠️ Hypersensitivity Warning: Serious systemic hypersensitivity reactions, including anaphylactic-type reactions, may occur. Administer under full clinical supervision with immediate availability of resuscitation equipment and trained medical personnel.
⚠️ Administration Limits: Do not administer as a rapid IV push. Intravenous infusion should be diluted only in 0.9% Sodium Chloride Injection (Normal Saline) and infused over the recommended duration (100 mg over at least 2 to 5 minutes for slow IV push, or over 15 minutes for IV infusion).
⚠️ Iron Overload Hazard: Excessive iron administration can lead to hemosiderosis. Periodically monitor hematologic parameters (hemoglobin, hematocrit, serum ferritin, and transferrin saturation).
