Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Secukinumab
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
Secukinumab
1 Units
NOVARTIS PHARMA STEIN AG
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ FRAIZERON ® Secukinumab (300mg/2mL, 150 mg/1mL Solution for injection in a pre-filled pen) WHAT IS IN THIS LEAFLET 1. WHAT FRAIZERON ® IS USED FOR 2. HOW FRAIZERON ® WORKS 3. BEFORE YOU USE FRAIZERON ® 4. HOW TO USE FRAIZERON ® 5. WHILE YOU ARE USING IT 6. SIDE EFFECTS 7. STORAGE AND DISPOSAL OF FRAIZERON ® 8. PRODUCT DESCRIPTION 9. MANUFACTURER AND PRODUCT REGISTRATION HOLDER 10. DATE OF REVISION WHAT FRAIZERON ® IS USED FOR Fraizeron contains the active substance secukinumab. Secukinumab is a fully-human monoclonal antibody. Monoclonal antibodies are proteins that recognise and bind specifically to certain proteins in the body. It belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by neutralizing the activity of a protein called IL-17A, which is present at increased levels in diseases such as psoriasis, psoriatic arthritis and axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis). Fraizeron is used for the treatment of the following inflammatory diseases: _Plaque psoriasis _ Fraizeron is used to treat a skin condition called ‘plaque psoriasis’. Plaque psoriasis causes inflammation affecting the skin. Fraizeron will reduce the inflammation and other symptoms of the disease. Fraizeron is used in patients 6 years and older with moderate to severe plaque psoriasis. _Psoriatic arthritis _ Fraizeron is used to treat a condition called ‘psoriatic arthritis’. The condition is an inflammatory disease of the joints, often accompanied by psoriasis. Fraizeron is given to you to reduce the signs and symptoms of active psoriatic arthritis, improve physical function and slow down the damage to the cartilage and the bone of the joints involved in the disease. Fraizeron is used in adults with active psoriatic arthritis and can be used alone or with another medicine called methotrexate. _Axial spondyloarthritis, including ankylosing _ _spondylitis (axial spondyloarthritis with _ _radiogra Baca dokumen lengkap
Novartis Page 2 Malaysia Package Leaflet 20-Jan-2023 Fraizeron FRAIZERON ® Interleukin inhibitors. DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORMS POWDER FOR SOLUTION FOR INJECTION The powder is a white solid lyophilisate in a 6 mL glass vial. SOLUTION FOR INJECTION IN A PRE-FILLED PEN The solution is colorless to slightly yellow. Certain dosage strengths and dosage forms may not be available in all countries. ACTIVE SUBSTANCE Each vial of powder for solution for subcutaneous injection contains 150 mg of secukinumab when reconstituted with 1 mL water for injection. Each 2 mL pre-filled pen contains 300 mg secukinumab. Each 1 mL pre-filled pen contains 150 mg secukinumab. Secukinumab is a recombinant fully human monoclonal antibody selective for interleukin-17A. Secukinumab is of the IgG1/κ-class produced in Chinese Hamster Ovary (CHO) cells. EXCIPIENTS POWDER FOR SOLUTION FOR SUBCUTANEOUS INJECTION: Sucrose, L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, water for injection. SOLUTION FOR INJECTION (PRE-FILLED PEN): Trehalose dihydrate, L-histidine/histidine hydrochloride monohydrate, L-methionine, polysorbate 80, water for injection. Pharmaceutical formulations may vary between countries. INDICATIONS PLAQUE PSORIASIS Fraizeron is indicated for the treatment of moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy. PSORIATIC ARTHRITIS Fraizeron, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous disease-modifying anti- rheumatic drug (DMARD) therapy has been inadequate. Novartis Page 3 Malaysia Package Leaflet 20-Jan-2023 Fraizeron AXIAL SPONDYLOARTHRITIS (AXSPA) ANKYLOSING SPONDYLITIS (AS, RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS) Fraizeron is indicated for the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy. NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS (NR-AXSPA) F Baca dokumen lengkap