Product Specifications
| Specification | Details |
| Manufacturer / Brand | Somerset Pharma LLC |
| Manufacturer SKU / Item # | 70069017110 |
| NDC Number | 70069-0171-10 (Box) / 70069-0171-01 (Vial) |
| Active Ingredient | Cyanocobalamin (Vitamin B12, 1,000 mcg/mL) |
| Concentration / Strength | 1,000 mcg per 1 mL (1 mg/mL) |
| Total Content per Vial | 30,000 mcg (30 mg) Cyanocobalamin / 30 mL |
| Volume per Unit | 30 mL |
| Container Type | Glass Multiple-Dose Vial (MDV) |
| Administration Route | Intramuscular (IM) or Subcutaneous (SC) |
| Formulation | Preservative-Containing (1.5% Benzyl Alcohol) / Sterile / Light-Sensitive |
| Storage Temperature | 20°C to 25°C (68°F to 77°F) (Protect from light) |
| Packaging Configuration | Single Vial |
| Regulatory Category | Prescription-Only (Rx) |
Key Features & Clinical Applications
-
Pernicious Anemia & B12 Deficiency Treatment: Indicated for the treatment of pernicious anemia, gastrointestinal malabsorption (e.g., post-gastrectomy, Crohn’s disease, celiac disease), surgical resection, or dietary inadequacy (strict vegetarianism).
-
Neurological & Hematologic Restoration: Quickly corrects megaloblastic erythropoiesis and prevents irreversible peripheral nerve damage and spinal cord subacute combined degeneration associated with severe B12 deficiency.
-
Preserved Multi-Dose Packaging: Formulated with 1.5% benzyl alcohol to support repeated sterile withdrawals, making it ideal for routine clinical administration schedules.
-
Cost-Effective Bulk Multi-Pack: Packaged in a 10-vial carton of high-capacity 30 mL vials, minimizing per-dose costs for high-volume outpatient clinics and hospital systems.
⚠️ Route Precaution: Intended for Intramuscular (IM) or Subcutaneous (SC) injection only. Do not administer intravenously; rapid renal excretion occurs following IV administration, leading to reduced therapeutic effectiveness.
⚠️ Hypokalemia Warning: Severe hypokalemia and sudden death may occur when severe megaloblastic anemia is treated intensely with Vitamin B12 due to rapid cellular potassium uptake during erythrocyte proliferation. Monitor serum potassium closely.
⚠️ Neonatal Hazard (Benzyl Alcohol Warning): Contains benzyl alcohol as a preservative. Benzyl alcohol is associated with serious adverse events (“gasping syndrome”) and death in neonates and premature infants. Do not use in neonates or low-birth-weight infants.
