Valsts: Malaizija
Valoda: angļu
Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
RISANKIZUMAB
ABBVIE SDN BHD
RISANKIZUMAB
1 Pre-Filled Syringes
AbbVie S.r.l
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ SKYRIZI SOLUTION FOR INJECTION IN PRE- FILLED SYRINGE 150MG/ML Risankizumab 1 WHAT IS IN THIS LEAFLET 1. What Skyrizi is used for 2. How Skyrizi works 3. Before you use Skyrizi 4. How to use Skyrizi 5. While you are using it 6. Side effects 7. Storage and Disposal of Skyrizi 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT SKYRIZI IS USED FOR Skyrizi contains the active substance risankizumab. Skyrizi is used to treat adults with moderate to severe plaque psoriasis and active psoriatic arthritis. HOW SKYRIZI WORKS This medicine works by stopping a protein in the body called ‘IL-23’, which causes inflammation. PLAQUE PSORIASIS SKYRIZI reduces inflammation and can therefore help to improve skin clearance and the appearance of nails. It also reduces symptoms of plaque psoriasis such as burning, itching, pain, redness, and scaling. PSORIATIC ARTHRITIS SKYRIZI reduces the inflammation and can therefore help to reduce pain, stiffness, and swelling in and around your joints, pain and stiffness in your spine, psoriatic skin rash, psoriatic nail damage, and it may limit damage to the bone and cartilage in your joints. These effects can ease your normal daily activities, reduce tiredness, and improve your quality of life. BEFORE YOU USE SKYRIZI - _When you must not use it_ if you are allergic to risankizumab or any of the other ingredients of this medicine. if you have an infection, including active tuberculosis, which your doctor thinks is important. CHILDREN AND ADOLESCENTS Skyrizi is not recommended for children and adolescents under 18 years of age. This is because Skyrizi has not been studied in this age group. _Pregnancy and lactation_ If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. This is because it is not known how this medicine will affect the baby. If you are a woman who can become pregnant, you should Izlasiet visu dokumentu
1 NAME OF THE MEDICINAL PRODUCT Skyrizi 150 mg solution for injection in pre-filled pen Skyrizi 150 mg solution for injection in pre-filled syringe Skyrizi 75 mg solution for injection in pre-filled syringe QUALITATIVE AND QUANTITATIVE COMPOSITION Skyrizi 150 mg solution for injection in pre-filled pen Each pre-filled pen contains 150 mg risankizumab in 1 mL solution. Skyrizi 150 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 150 mg risankizumab in 1 mL solution. Skyrizi 75 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 75 mg risankizumab in 0.83 ml solution. Risankizumab is a humanised immunoglobulin G1 (IgG1) monoclonal antibody selective to the interleukin (IL)-23 protein produced in Chinese Hamster Ovary cells using recombinant DNA technology. Information about certain excipients SKYRIZI 150 mg/mL and SKYRIZI 75 mg/0.83 mL contain less than 1 mmol sodium (23 mg) per 150 mg dose, i.e., essentially ‘sodium-free’. SKYRIZI 75 mg/0.83 mL contains 68 mg sorbitol per 150 mg dose. For the full list of excipients, see PHARMACEUTICAL PARTICULARS section. PHARMACEUTICAL FORM Solution for injection (injection). Skyrizi 150 mg solution for injection in pre-filled pen and pre-filled syringe The solution is colourless to yellow and clear to slightly opalescent. Skyrizi 75 mg solution for injection in pre-filled syringe The solution is colourless to slightly yellow and clear to slightly opalescent. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS PLAQUE PSORIASIS Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. PSORIATIC ARTHRITIS 2 Skyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). POSOLOGY AND METHOD OF ADMINISTRATION Skyrizi is intended for use under the guidance and supervis Izlasiet visu dokumentu