Ülke: Malezya
Dil: İngilizce
Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Infliximab
CELLTRION HEALTHCARE MALAYSIA SDN. BHD.
Infliximab
1 x 1mL Pre-Filled Syringes; 2 x 1mL Pre-Filled Syringes; 1 x 1mL Pre-Filled Syringes; 2 x 1mL Pre-Filled Syringes
CELLTRION, Inc.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ REMSIMA ® 120MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE (PFS) Infliximab (120mg) 1 WHAT IS IN THIS LEAFLET 1. What Remsima is used for 2. How Remsima works _3._ _ _ Before you use Remsima _ _ 4. How to use Remsima 5. While you are using Remsima 6. Side effects _7._ _ _ Storage and Disposal of Remsima _ _ 8. Product Description 9. Manufacturer and Batch Releaser 10. Product Registration Holder 11. Date of revision 12. Serial Number WHAT REMSIMA IS USED FOR Remsima is used in adults for the following inflammatory diseases: • Rheumatoid arthritis • Ankylosing spondylitis • Psoriatic arthritis • Psoriasis • Crohn’s disease • Fistulizing Crohn’s disease • Ulcerative colitis. HOW REMSIMA WORKS Remsima contains the active substance infliximab. Infliximab is a monoclonal antibody which belongs to a group of medicines called ‘TNF blockers’. Remsima works by selectively attaching to tumour necrosis factor (TNF) alpha and blocking its action, thereby reducing the inflammation in your body. BEFORE YOU USE REMSIMA_ _ - _When you must not use it _ YOU MUST NOT BE GIVEN REMSIMA IF • you are allergic to infliximab or any of the other ingredients of this medicine, • you are allergic to proteins that come from mice, • you have tuberculosis (TB) or another serious infection such as pneumonia or sepsis (serious bacterial infection of the blood), • you have heart failure that is moderate or severe. Do not use Remsima if any of the above applies to you. If you are not sure, talk to your doctor before you are given Remsima. CHILDREN AND ADOLESCENTS Do not give this medicine to children and adolescents under 18 years of age. - _Before you start to use it _ PREGNANCY AND BREAST-FEEDING • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Remsima should only be used during pregnancy or while breast-feeding if your doctor feels it is necessary for you. Belgenin tamamını okuyun
1 1. NAME OF THE MEDICINAL PRODUCT Remsima 120 mg solution for injection in pre-filled syringe Remsima 120 mg solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Remsima 120 mg solution for injection in pre-filled syringe Each 1 mL single dose pre-filled syringe contains 120 mg of infliximab*. Remsima 120 mg solution for injection in pre-filled pen Each 1 mL single dose pre-filled pen contains 120 mg of infliximab*. * Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in murine hybridoma cells by recombinant DNA technology. Excipient(s) with known effect Sorbitol 45 mg per 1 mL For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear to opalescent, colourless to pale brown solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rheumatoid arthritis Infliximab is a “Disease-Controlling Anti-Rheumatic Therapy” (DCART) indicated for: - the reduction of signs and symptoms - prevention of structural joint damage (erosions and joint space narrowing) - improvement in physical function in patients with active disease despite treatment with MTX, and patients with active disease not previously treated with methotrexate. Ankylosing spondylitis Infliximab is indicated for: - reduction of signs and symptoms - improvement in physical function - improvement in quality life in patients with active disease. Psoriatic arthritis Infliximab is indicated for: - the reduction of signs and symptoms of arthritis - improvement in physical function 2 - reduction in psoriasis as measured by PASI (an index which combines symptom evaluation and body surface area) in patients with active psoriatic arthritis. Psoriasis Infliximab is indicated for treatment of moderate to severe plague psoriasis in adults who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA. Crohn’s disease Infliximab is indicated for treatment of moderate to se Belgenin tamamını okuyun