PRINCIPAL DISPLAY PANEL
1 x 60 mg Single-Dose Prefilled Syringe
60 mg/mL Injection – For Subcutaneous Use Only.
Single-dose Prefilled Syringe. Discard unused portion.
Sterile Solution – No Preservative.
Refrigerate at 2° to 8°C (36° to 46°F). Do not freeze. Avoid excessive shaking. Protect from direct light and heat.
This Product Contains Dry Natural Rubber.Manufactured by: Amgen Inc., Thousand Oaks, CA 91320-1799
Product of Singapore
| PROLIA denosumab injection |
|Product Information |
|Product Type ||HUMAN PRESCRIPTION DRUG ||Item Code (Source) ||NDC:55513-710 |
|Route of Administration ||SUBCUTANEOUS ||DEA Schedule || |
|Active Ingredient/Active Moiety |
|Ingredient Name ||Basis of Strength ||Strength |
|DENOSUMAB (DENOSUMAB) ||DENOSUMAB ||60 mg in 1 mL |
|Inactive Ingredients |
|Ingredient Name ||Strength |
| SORBITOL ||47 mg in 1 mL |
| SODIUM ACETATE ||1 mg in 1 mL |
| POLYSORBATE 20 ||0.1 mg in 1 mL |
| SODIUM HYDROXIDE || |
| WATER || |
|# ||Item Code ||Package Description ||Multilevel Packaging |
| 1 ||NDC:55513-710-01 ||1 SYRINGE in 1 CARTON ||contains a SYRINGE |
| 1 || ||1 mL in 1 SYRINGE ||This package is contained within the CARTON (55513-710-01) |
| Marketing Information |
|Marketing Category ||Application Number or Monograph Citation ||Marketing Start Date ||Marketing End Date |
|BLA ||BLA125320 ||06/05/2010 || |
|Labeler — Amgen Inc
| Establishment |
|Name ||Address ||ID/FEI ||Operations |
|Amgen Manufacturing Ltd || ||785800020 ||ANALYSIS (55513-710), LABEL (55513-710), MANUFACTURE (55513-710), PACK (55513-710) |
Revised: 05/2021 Amgen Inc
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