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SUMMARY
- The density of guselkumab 200 mg/20 mL (10 mg/mL) solution in a single-dose vial for intravenous infusion is 1.033 g/mL (at ambient room temperature).1
- The overfill volume of guselkumab 200 mg/20 mL (10 mg/mL) solution in a single-dose vial for intravenous infusion is 0.9 mL.2
| 1 | Data on File. Guselkumab FVP BLA. 3.2.P.2.2.3 Physicochemical and Biological Properties. EDMS-RIM-833533; 2023. |
| 2 | Data on File. Guselkumab FVP BLA. 3.2.P.2.2.1 Drug Product Formulation Development. EDMS-RIM-1142408; 2024. |