Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Skyrizi 150 mg solution for injection in pre-filled pen and pre-filled syringe 
Trehalose dihydrate
Sodium acetate trihydrate
Polysorbate 20
Acetic acid, glacial
Water for injection

Skyrizi 75 mg solution for injection in pre-filled syringe
Sorbitol
Disodium succinate hexahydrate
Polysorbate 20
Succinic acid
Water for injection

6.2   Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3   Shelf life

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.
Keep the pre-filled pen or the pre-filled syringe(s) in the outer carton in order to protect from light.

Skyrizi 150 mg pre-filled pen or pre-filled syringe may be stored out of the refrigerator (up to a maximum of 25°C) for up to 24 hours in the original carton to protect from light.


6.5   Nature and contents of container
Skyrizi 150 mg solution for injection in pre-filled pen

Pre-filled glass syringe assembled in a pre-filled pen with an automatic needle sleeve.

Skyrizi 150 mg solution for injection in pre-filled syringe
Pre-filled glass syringe with a fixed needle and needle cover, assembled in an automatic needle guard.

Skyrizi 150 mg is available in packs containing 1 pre-filled pen or 1 pre-filled syringe.

Skyrizi 75 mg solution for injection in pre-filled syringe

Pre-filled glass syringe with a fixed needle and needle cover, assembled in an automatic needle guard.
Skyrizi 75 mg is available in packs containing 2 pre-filled syringes and 2 alcohol pads.

Not all presentations may be marketed.

6.6   Special precautions for disposal and other handling

Skyrizi 150 mg solution for injection in pre-filled pen
Before injecting, patients should remove the carton from the refrigerator and allow to reach room temperature out of direct sunlight (30 to 90 minutes) without removing the pre-filled pen from the carton.

The solution should be colourless to yellow and clear to slightly opalescent.

Skyrizi 150 mg solution for injection in pre-filled syringe
Before injecting, patients may remove the carton from the refrigerator and allow to reach room temperature out of direct sunlight (15 to 30 minutes) without removing the pre-filled syringe from the carton.

The solution should be colourless to yellow and clear to slightly opalescent.

Skyrizi 75 mg solution for injection in pre-filled syringe
Before injecting, patients may remove the carton from the refrigerator and allow to reach room temperature out of direct sunlight (15 to 30 minutes) without removing the pre-filled syringes from the carton.

The solution should be colourless to slightly yellow and clear to slightly opalescent.

Two pre-filled syringes should be injected for the full 150 mg dose.
General special precautions

Prior to use, a visual inspection of each pre-filled pen or pre-filled syringe is recommended. The solution may contain a few translucent to white 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 or pre-filled syringe.

Comprehensive instructions for use are provided in the package leaflet.

Each pre-filled pen or pre-filled syringe is for single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.