Pharmaceutical particulars : מידע רוקחי

6      PHARMACEUTICAL PARTICULARS


6.1    List of excipients
Trehalose dihydrate
Sodium acetate trihydrate
Polysorbate 20

SKY 360-600 API FEB24_CL                                                       Page 13 of 16 Acetic acid glacial
Water for injection

6.2    Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. Skyrizi 600mg should only be diluted in a 5% dextrose in water (D5W) or 0.9% saline IV infusion bag or glass bottle. Skyrizi 600mg should not be administered concomitantly in the same intravenous line with other medicinal products.

6.3    Shelf life
Skyrizi 600mg
Unopened vial: the expiry date of the product is indicated on the packaging materials.
Diluted solution for intravenous infusion:
The prepared infusion should be used immediately. If not used immediately, the diluted Skyrizi solution can be stored (protected from light) for up to 20 hours between 2°C to 8°C. Immediately after preparation or removal from refrigerator, the diluted Skyrizi solution can be stored at room temperature (protected from sunlight) for 4 hours (cumulative time from start of dilution to start of infusion). Exposure to indoor light is acceptable during room temperature storage and administration. Do not freeze.
Skyrizi 360 mg
The expiry date of the product is indicated on the packaging materials.


6.4    Special precautions for storage
Store in a refrigerator (2°C - 8°C). Do not freeze.
The cartridge may be stored out of the refrigerator (up to a maximum of 25°C) for up to 24 hours.
Keep the Pre-filled cartridge or the vial in the outer carton in order to protect from light.
For Skyrizi 600 mg storage conditions after dilution, see section 6.3 
6.5    Nature and contents of container
Skyrizi 600mg
10.0 mL concentrate solution for infusion in a glass vial closed with a coated rubber stopper.
Skyrizi 600 mg is available in packs containing 1 vial pack.


Skyrizi 360mg
A 360 mg solution in a single-use cartridge made with cyclic olefin resin with rubber septum and rubber piston as product-contact materials, and a resin cap. The cartridge is assembled with a telescopic screw assembly. The cartridge assembly is co-packed with an on-body injector (administration device). The fluid path within the on-body injector contains polyvinyl chloride tubing and a stainless steel 29-gauge needle. The on-body injector contains silver oxide-zinc batteries and an adhesive skin patch made 

SKY 360-600 API FEB24_CL                                                          Page 14 of 16 from polyester with an acrylic adhesive. The administration device is designed for use with the provided 360 mg cartridge.
Skyrizi 360 mg is available in packs containing 1 pre-filled cartridge and 1 on-body injector.


6.6    Special precautions for disposal
Skyrizi 600mg
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 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
Skyrizi should be prepared by a healthcare professional using aseptic technique.
Skyrizi medicinal product must be diluted before administration.
Solutions of Skyrizi for intravenous administration are prepared by dilution of the drug product into an intravenous infusion bag or glass bottle containing 5% dextrose in water (D5W) or 0.9% saline (600 mg/10 mL in 100 mL, 250 mL or 500 mL) to a final drug concentration of approximately 1.2 mg/mL to 6 mg/mL.
Prior to the start of the intravenous infusion, the content of the IV infusion bag or glass bottle should be at room temperature.
Infuse the diluted solution over a period of at least one hour.
The solution in the vial and the dilutions should not be shaken.
Each vial is for single use only and any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Skyrizi 360mg
Skyrizi is intended for use under the guidance and supervision of a healthcare professional.
Prior to use, a visual inspection of the cartridge is recommended. 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.
The solution should be colourless to yellow and clear to slightly opalescent.
Do not inject into areas where the skin is tender, bruised, erythematous, indurated or affected by any lesions.
Patients may self-inject Skyrizi using the cartridge with on-body injector after training in subcutaneous injection technique. Provide proper training to patients and/or caregivers on the subcutaneous injection technique of Skyrizi.
Before injecting, patients should remove the carton from the refrigerator and allow to reach room temperature (up to 25oC), out of direct sunlight, for 45 to 90 minutes without removing the cartridge from the carton.
Comprehensive instructions for use are provided in the package leaflet.


SKY 360-600 API FEB24_CL                                                          Page 15 of 16 Each on-body injector with cartridge is for single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.