Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
rituximab, Quantity: 100 mg
Celltrion Healthcare Australia Pty Ltd
Injection, concentrated
Excipient Ingredients: polysorbate 80; water for injections; sodium chloride; sodium citrate dihydrate
Intravenous Infusion
2
(S4) Prescription Only Medicine
Non-Hodgkin?s Lymphoma Truxima is indicated for treatment of patients with: -CD20 positive, previously untreated, Stage III/IV follicular, B-cell non-Hodgkin?s lymphoma; - CD20 positive, relapsed or refractory low grade or follicular, B-cell non-Hodgkin's lymphoma; - CD20 positive, diffuse large B-cell non-Hodgkin?s lymphoma, in combination with chemotherapy.,Chronic Lymphocytic Leukaemia Truxima is indicated for the treatment of patients with CD20 positive chronic lymphocytic leukaemia (CLL) in combination with chemotherapy.,Rheumatoid Arthritis Truxima (rituximab) in combination with methotrexate is indicated for the treatment of adult patients with severe, active rheumatoid arthritis who have had an inadequate response or intolerance to at least one tumour necrosis factor (TNF) inhibitor therapy. Truxima has been shown to reduce the rate of progression of joint damage as measured by xray when given in combination with methotrexate.,Granulomatosis with polyangiitis (Wegener?s) (GPA) and Microscopic polyangiitis (MPA) Truxima in combination with glucocorticoids is indicated for the induction of remission in patients with severely active Granulomatosis with polyangiitis (GPA, also known as Wegener?s granulomatosis) and Microscopic polyangiitis (MPA). The efficacy and safety of retreatment with rituximab have not been established.
Visual Identification: Clear to opalescent, colourless to pale yellow liquid; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2018-04-16
Celltrion Healthcare Australia CONSUMER MEDICINE INFORMATION Rituximab 500 mg/100 mg Concentrate Solution for Intravenous Infusion TRUXIMA ® INTRAVENOUS INFUSION _FOR THE TREATMENT OF RHEUMATOID ARTHRITIS & GRANULOMATOSIS WITH POLYANGIITIS AND _ _MICROSCOPIC POLYANGIITIS, NON-HODGKIN'S LYMPHOMA AND CHRONIC LYMPHOCYTIC _ _LEUKAEMIA _ _contains the active ingredient rituximab (rch) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Truxima ® intravenous infusion. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you being given Truxima ® against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT TRUXIMA ® IS USED FOR Truxima ® contains the active ingredient rituximab, which is a monoclonal antibody. Monoclonal antibodies are proteins which specifically recognise and bind to other unique proteins in the body. Truxima ® is used to treat rheumatoid arthritis (RA), Granulomatosis with polyangiitis (Wegener's) (GPA) and Microscopic polyangiitis (MPA). RA is an inflammatory disease of the joints. GPA and MPA are inflammatory diseases of the blood vessels. Truxima ® works by binding to a protein on the surface of certain white blood cells known as B lymphocytes. B lymphocytes play a role in the inflammation observed in RA, GPA and MPA. By binding to the protein Truxima ® reduces the ability of B lymphocytes to cause inflammation. In RA Truxima ® can also slow down the damage to your joints and improve your ability to do your normal daily activities. Your doctor may have prescribed Truxima ® for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS WHY TRUXIMA ® HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. BEFORE YOU ARE GIVEN TRU Lue koko asiakirja
1 Ver 06-0521 AUST R 285815, 285816 Celltrion Healthcare Australia Pty Ltd PRODUCT INFORMATION Rituximab 500 mg/100 mg Concentrate Solution for Intravenous Infusion AUSTRALIAN PRODUCT INFORMATION TRUXIMA RITUXIMAB (RCH) 1 NAME OF THE MEDICINE Truxima ® rituximab (rch) Concentrate for solution for intravenous (IV) infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE INGREDIENT Truxima ® contains the active ingredient rituximab (rch). Truxima ® is supplied at a concentration of 10 mg/mL in either 100 mg (10 mL) or 500 mg (50 mL) single-use glass vials. EXCIPIENTS For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Truxima ® concentrate for solution for IV infusion is a sterile, clear, colourless, preservative-free, concentrated solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _NON-HODGKIN’S LYMPHOMA_ Truxima ® is indicated for treatment of patients with: • CD20 positive, previously untreated, Stage III/IV follicular, B-cell non-Hodgkin’s lymphoma, • CD20 positive, relapsed or refractory low grade or follicular, B-cell non-Hodgkin's lymphoma, • CD20 positive, diffuse large B-cell non-Hodgkin’s lymphoma, in combination with chemotherapy. WARNING USE OF TRUXIMA ® MAY BE ASSOCIATED WITH AN INCREASED RISK OF PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML), AN OPPORTUNISTIC VIRAL INFECTION OF THE BRAIN THAT USUALLY LEADS TO DEATH OR SEVERE DISABILITY. PATIENTS MUST BE MONITORED FOR ANY NEW OR WORSENING NEUROLOGICAL SYMPTOMS OR SIGNS SUGGESTIVE OF PML. IF SUCH SYMPTOMS OCCUR, FURTHER ADMINISTRATION OF TRUXIMA ® SHOULD BE IMMEDIATELY SUSPENDED UNTIL A DIAGNOSIS OF PML HAS BEEN EXCLUDED. TO ESTABLISH OR EXCLUDE A DIAGNOSIS OF PML EVALUATION INCLUDING MRI SCAN, CSF TESTING FOR JC VIRAL DNA AND REPEAT NEUROLOGICAL ASSESSMENTS, SHOULD BE CONSIDERED. IF A DIAGNOSIS OF PML IS CONFIRMED TRUXIMA ® MUST BE PERMANENTLY DISCONTINUED (SEE SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). 2 Ver 06-0521 AUST R 285815, 285816 Celltrion Healthcare Aust Lue koko asiakirja