Ország: Malajzia
Nyelv: angol
Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TOCILIZUMAB; TOCILIZUMAB
ROCHE (MALAYSIA) SDN. BHD.
TOCILIZUMAB; TOCILIZUMAB
4units Units; 1units Units
F.HOFFMANN-LA ROCHE LTD
_CONSUMER MEDICATION INFORMATION LEAFLET_ ACTEMRA ® Tocilizumab (162mg/0.9ml solution for injection in a pre-filled syringe) WHAT IS IN THIS LEAFLET 1. What Actemra is used for 2. How Actemra works 3. Before you use Actemra 4. How to use Actemra 5. While you are using Actemra 6. Side effects 7. Storage and Disposal of Actemra 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT ACTEMRA IS USED FOR Moderate to severe active rheumatoid arthritis (RA) in adults. Treatment of giant cell arteritis (GCA) in adult patients. Treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older, in combination with methotrexate. Treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older, to be given alone or in combination with MTX. HOW ACTEMRA WORKS Actemra contains the active substance tocilizumab. It is a protein made from specific immune cells (monoclonal antibody), that blocks the action of a specific protein (cytokine) called interleukin-6. Interleukin-6 is involved in inflammatory processes of the body, and blocking it can reduce the inflammation in your body. Actemra helps to reduce symptoms such as pain and swelling in your joints and can also improve your performance of daily tasks. Actemra has been shown to slow the damage to the cartilage and bone of the joints caused by the disease and to improve your ability to do normal daily activities. Actemra is usually given in combination with methotrexate. However, Actemra can be given alone if your doctor determines that methotrexate is inappropriate. Before you use Actemra When you must not use it Do not use Actemra if: You have had an allergic reaction to tocilizumab or any of the other ingredients of this medicine listed at the end of this leaflet. Some symptoms of an allergic reaction: - hives or skin rash - swelling of the face, lips or tongue - wheezing or trouble breathing - faintness You have an active, severe infection. Olvassa el a teljes dokumentumot
PACK INSERT FOR MALAYSIA Actemra ® 162mg/0.9ml Solution for injection in a pre-filled syringe Tocilizumab 1. DESCRIPTION 1.1 Therapeutic / Pharmacologic Class of Drug Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) IgG 1 subclass. ATC Code: L04AC07. 1.2 Type of Dosage Form Subcutaneous (SC) formulation: Ready-to-use sterile liquid solution in a single-use pre-filled syringe (PFS) with needle safety device (NSD). 1.3 Route of Administration Subcutaneous (SC) injection. 1.4 Sterile / Radioactive Statement Sterile. 1.5 Qualitative and Quantitative Composition Active ingredient: tocilizumab. Excipients: L-histidine, L-histidine monohydrochloride monohydrate, L-arginine hydrochloride, L-methionine, polysorbate 80 and water for injection. Tocilizumab solution for subcutaneous (SC) injection is a yellowish, preservative-free liquid supplied in a ready-to-use, single-use pre-filled syringe with needle safety device (PFS+NSD). Each device delivers 0.9 mL (162 mg) of tocilizumab. 2. CLINICAL PARTICULARS 2.1 Therapeutic Indication(s) Rheumatoid Arthritis (RA) Tocilizumab is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients. Tocilizumab can be used alone or in combination with methotrexate (MTX) and/or other disease-modifying anti- rheumatic drugs (DMARDs). Tocilizumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with MTX. Giant Cell Arteritis (GCA) Tocilizumab is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients. Polyarticular Juvenile Idiopathic Arthritis (pJIA) Tocilizumab in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. Tocilizumab can be given a Olvassa el a teljes dokumentumot