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ULTOMIRIS should only be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection as diluent.
Instruction for Use: Each vial of ULTOMIRIS is intended for single use only.
Intravenous use: ULTOMIRIS 100 mg/mL requires dilution to a final concentration of 50 mg/mL.
Aseptic technique must be used.
Prepare ULTOMIRIS as follows: 1. The number of vials to be diluted is determined based on the individual patient's weight and the prescribed dose, see Dosage & Administration.
2. Prior to dilution, the solution in the vials should be visually inspected; the solution should be free of any particulate matter or precipitation. Do not use if there is evidence of particulate matter or precipitation.
3. The calculated volume of medicinal product is withdrawn from the appropriate number of vials and diluted in an infusion bag using sodium chloride 9 mg/mL (0.9%) solution for injection as diluent. Refer to the administration reference tables as follows. The product should be mixed gently. It should not be shaken.
4. After dilution, the final concentration of the solution to be infused is 50 mg/mL for ULTOMIRIS 100 mg/mL.
5. The prepared solution should be administered immediately following preparation. Do not administer as an intravenous push or bolus injection. Refer to the administration reference Table 18 and Table 19 in Dosage & Administration for minimum infusion duration. Infusion must be administered through a 0.2 μm filter.
6. If the medicinal product is not used immediately after reconstitution, storage times at 2°C - 8°C (36°F - 46°F) must not exceed 24 hours taking into account the expected infusion time.
The loading, maintenance, and supplemental dose administration reference tables for ULTOMIRIS 100 mg/mL are provided in Table 21, Table 22 and Table 23, respectively. (See Tables 21, 22 and 23.)
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Click on icon to see table/diagram/image
Click on icon to see table/diagram/image