Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
Tocilizumab, Quantity: 162 mg
Roche Products Pty Ltd
Tocilizumab
Injection, solution
Excipient Ingredients: polysorbate 80; arginine; arginine hydrochloride; methionine; histidine; histidine hydrochloride monohydrate; water for injections
Subcutaneous
1 syringe, 4 syringes
(S4) Prescription Only Medicine
Rheumatoid Arthritis (IV and SC formulations),Actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients in combination with methotrexate (MTX) or other non-biological disease-modifying anti-rheumatic drugs (DMARDs) in case of either an inadequate response or intolerance to previous therapy with one or more DMARDs.,Actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 Pharmacodynamic Properties, Clinical Trials) in combination with MTX in those not previously treated with MTX.,In the two groups of patients above, Actemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.,Actemra has been shown to inhibit the progression of joint damage in adults, as measured by X-ray, when given in combination with methotrexate.,Giant Cell Arteritis (SC formulations only),Actemra is indicated for the treatment of giant cell arteritis (GCA) in adult patients.,Polyarticular Juvenile Idiopathic Arthritis (IV and SC formulations),Actemra is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (MTX). Actemra can be given alone or in combination with MTX.,Systemic Juvenile Idiopathic Arthritis (IV and SC formulations),Intravenous formulation,Actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.,Subcutaneous formulation,Actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older.,Actemra IV and SC can be given alone or in combination with methotrexate (MTX).
Visual Identification: Clear to strongly opalescent, colourless to slightly yellowish solution; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2016-01-21
ACTEMRA ® AND ACTEMRA ® SC PRE-FILLED SYRINGE PRONOUNCED (ACT-TEM-RA) _contains the active ingredient tocilizumab (rch)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Actemra pre-filled syringe for subcutaneous (under the skin) injection. 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 taking Actemra against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ACTEMRA IS USED FOR Actemra contains the active ingredient tocilizumab. Actemra belongs to a group of medicines called anti-rheumatic agents. There are many different classes of anti-rheumatic agents. Actemra belongs to a class called monoclonal antibodies. Monoclonal antibodies are proteins which specifically recognise and bind to other unique proteins in the body. Actemra for subcutaneous injection is used to treat active moderate to severe rheumatoid arthritis (RA) and giant cell arteritis (GCA) in adults. It is also used to treat active moderate to severe polyarticular juvenile idiopathic arthritis (pJIA) in children over 2 years of age and active systemic juvenile idiopathic arthritis (sJIA) in children and adolescents, aged 1 year and over. Some of the signs and symptoms of these conditions are caused by the actions of a protein called interleukin-6 receptor (IL-6R). Actemra works by binding and blocking IL-6R thereby helping to relieve some of the signs and symptoms of these conditions. For patients with RA, Actemra can also prevent damage occurring to your joints. There are different types of medicines used to treat RA, GCA, pJIA and sJIA. Your doctor, however, may have prescribed Actemra for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ACTEMRA HAS BEEN PRESCRIBED FOR YOU Pročitajte cijeli dokument
Actemra 20220902 1 This medicinal product is subject to additional monitoring in Australia due to provisional approval of an extension of indications. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at https://www.tga.gov.au/reporting-problems. AUSTRALIAN PRODUCT INFORMATION ACTEMRA ® (TOCILIZUMAB) 1. NAME OF THE MEDICINE Tocilizumab 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Actemra 80 mg/ 4 mL concentrate solution for intravenous infusion vial contains 80 mg tocilizumab Actemra 200 mg/ 10 mL concentrate solution for intravenous infusion vial contains 200 mg tocilizumab Actemra 400 mg/ 20 mL concentrate solution for intravenous infusion vial contains 400 mg tocilizumab Actemra 162 mg/ 0.9 mL solution for subcutaneous (SC) injection contains 162 mg tocilizumab Actemra SC 162 mg/ 0.9 mL solution for SC injection contains 162 mg tocilizumab. Excipients with known effect Actemra concentrated solution for intravenous infusion contains sodium. For the full list of excipients, see section 6.1 List of Excipients. 3. PHARMACEUTICAL FORM CONCENTRATED SOLUTION FOR INTRAVENOUS INFUSION Actemra concentrated solution for intravenous (IV) infusion is a clear to opalescent, colourless to pale yellow sterile solution SOLUTION FOR SUBCUTANEOUS INJECTION Actemra solution for subcutaneous (SC) injection is a clear to strongly opalescent, colourless to slightly yellowish sterile solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS RHEUMATOID ARTHRITIS (IV AND SC FORMULATIONS) Actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients in combination with methotrexate (MTX) or other non-biological disease- modifying anti-rheumatic drugs (DMARDs) in case of either an inadequate response or intolerance to previous therapy with one or more DMARDs. ▼ Actemra 20220902 2 Actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poo Pročitajte cijeli dokument