Special precautions for disposal and other handling: Each pre-filled pen/on-body injector with cartridge/vial is for single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
150 mg/360 mg: Before injecting, the carton should be removed from the refrigerator and allow to reach room temperature out of direct sunlight for 30 to 90 minutes without removing the pre-filled pen from the carton or for 45 to 90 minutes without removing the cartridge from the carton.
The solution should be colourless to yellow and clear to slightly opalescent.
General special precautions: Prior to use, a visual inspection of each pre-filled pen/cartridge is recommended. For the pre-filled pen (150 mg), the solution may contain a few translucent to white product-related particles. For the solution for injection (360 mg), the solution is free from foreign particles and practically free from product-related particles. Skyrizi should not be used if the solution is cloudy or discoloured, or contains large particles. Do not shake the pre-filled pen/cartridge.
Comprehensive instructions for use are provided in the package leaflet.
600 mg: The solutions should be visually inspected for particulate matter or discoloration prior to administration. The solution should be colourless to slightly yellow and clear to slightly opalescent. The liquid may contain tiny white or clear particles. The medicinal product and its dilutions should not be used if the solution is discoloured or cloudy, or if foreign particulate matter is present.
Instructions for dilution: This medicinal product should be prepared by a healthcare professional using aseptic technique. It must be diluted before administration.
The solution for infusion is prepared by dilution of the concentrate into an intravenous infusion bag or glass bottle containing 5% dextrose in water (D5W) or sodium chloride 9 mg/mL (0.9%) solution for infusion to a final concentration of approximately 1.2 mg/mL to 6 mg/mL. Refer to the table as follows for dilution instructions based on patient's indication. (See Table 11.)
Click on icon to see table/diagram/imagePrior to the start of the intravenous infusion, the content of the intravenous infusion bag or glass bottle should be at room temperature.
Infuse the diluted solution over a period of at least one hour for the 600 mg dose.
The solution in the vial and the dilutions should not be shaken.
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