Pajjiż: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
Abatacept, Quantity: 125.875 mg
Bristol-Myers Squibb Australia Pty Ltd
Abatacept
Injection
Excipient Ingredients: sucrose; water for injections; monobasic sodium phosphate; poloxamer; nitrogen; dibasic sodium phosphate
Subcutaneous
1mL Prefilled syringe with Autoinjector (4 per pack)
(S4) Prescription Only Medicine
ORENCIA in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have had an insufficient response or intolerance to other disease modifying anti-rheumatic drugs (DMARDs), such as methotrexate or tumour necrosis factor (TNF) blocking agents. A reduction in the progression of joint damage and improvement in physical function have been demonstrated during combination treatment with ORENCIA and methotrexate.,ORENCIA in combination with methotrexate is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.,ORENCIA is indicated for reducing signs and symptoms in paediatric patients 6 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). ORENCIA may be used as monotherapy or concomitantly with methotrexate (MTX). (There is no clinical trial data for the use of ORENCIA subcutaneous formulation in children, therefore its use in children cannot be recommended.),ORENCIA is indicated for the treatment of active psoriatic arthritis (PsA) in adults when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. ORENCIA can be used with or without non-biologic DMARDs.,ORENCIA should not be administered concurrently with other biological DMARDs (eg, TNF inhibitors, rituximab, or anakinra).
Visual Identification: Clear to slightly opalescent, colourless to pale yellow solution; Container Type: Syringe; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2015-06-17
ORENCIA ® (OR-EN-SEE-AH) _Abatacept (ab-ah-ta-sept) (rch) Powder for intravenous infusion; Abatacept (rch) solution for Injection_ _(pre-filled syringe, pre-filled autoinjector)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ORENCIA. It does not contain all of 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 receiving ORENCIA against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR. YOU SHOULD READ THIS LEAFLET CAREFULLY AND KEEP IT IN A SAFE PLACE TO REFER TO IT LATER. WHAT ORENCIA IS USED FOR ORENCIA contains abatacept; a medicine which is used to treat: • moderate to severe rheumatoid arthritis in adults; • severe, active and progressive rheumatoid arthritis, • psoriatic arthritis in adults, and • polyarticular juvenile idiopathic arthritis. RHEUMATOID ARTHRITIS Rheumatoid arthritis is a disease that causes pain and joint inflammation (tenderness and swelling). It can also cause joint damage. You may be given ORENCIA and methotrexate to: • Reduce the signs and symptoms of your disease. • Slow down the damage to your bones and joints. • Improve your physical function and your ability to do normal daily activities. PSORIATIC ARTHRITIS Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, an inflammatory disease of the skin. If you have active psoriatic arthritis you will first be given other medicines. If you do not respond well enough to these medicines, you may be given ORENCIA. POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS ORENCIA infused intravenously is also used to treat moderate to severe polyarticular juvenile idiopathic arthritis in children and adolescents 6 years of age and older who have had an inadequate response to one or more disease-modifying anti- rheumatic drugs. It is not recommended to use the Aqra d-dokument sħiħ
AU_PI_Orencia_V19.0 1 AUSTRALIAN PRODUCT INFORMATION ORENCIA ® (ABATACEPT) 1 NAME OF THE MEDICINE abatacept 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Abatacept is a fusion protein produced by recombinant DNA technology in Chinese hamster ovary cells. LYOPHILIZED POWDER FOR IV INFUSION Each vial contains 250 mg abatacept. EXCIPIENT WITH KNOWN EFFECT Each vial contains 8.625 mg sodium. SOLUTION FOR SUBCUTANEOUS ADMINISTRATION Each 1 mL pre-filled syringe or autoinjector contains 125 mg abatacept. EXCIPIENT WITH KNOWN EFFECT Each syringe or autoinjector contains 0.322 mg sodium. For the full list of excipients, see section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM LYOPHILIZED POWDER FOR IV INFUSION ORENCIA is a sterile, white, preservative-free, lyophilized powder for parenteral administration. Following reconstitution with 10 mL of sterile water for injection, the solution of ORENCIA is clear, colourless to pale yellow, with a pH range of 7.2 to 7.8. SOLUTION FOR SUBCUTANEOUS ADMINISTRATION ORENCIA, solution for injection, pre-filled syringe or autoinjector is supplied as a sterile, preservative- free, ready-to-use solution for subcutaneous injection. The subcutaneous solution is clear, colourless to pale yellow with a pH of 6.8 to 7.4. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ORENCIA in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have had an insufficient response or intolerance to other disease modifying anti-rheumatic drugs (DMARDs), such as methotrexate or tumour necrosis factor (TNF) blocking agents. A reduction in the progression of joint damage and improvement in physical function have been demonstrated during combination treatment with ORENCIA and methotrexate. ORENCIA in combination with methotrexate is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. ORENCIA is indicated for reducing signs and symptoms in paediatri Aqra d-dokument sħiħ