Country: Nýja-Sjáland
Tungumál: enska
Heimild: Medsafe (Medicines Safety Authority)
Tocilizumab 162mg; ; ; ; Tocilizumab 162mg
Roche Products (NZ) Ltd
Tocilizumab 162 mg
162 mg/0.9mL
Solution for injection
Active: Tocilizumab 162mg Excipient: Arginine Arginine hydrochloride Histidine Histidine hydrochloride monohydrate Methionine Polysorbate 80 Water for injection Active: Tocilizumab 162mg Excipient: Arginine hydrochloride Histidine Histidine hydrochloride monohydrate Methionine Polysorbate 20 Water for injection
Prescription
Genentech Inc
Actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients: - in combination with methotrexate (MTX) in those not previously treated with MTX - 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 - 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.
Package - Contents - Shelf Life: Syringe, prefilled type 1 glass, with needle safety device - 4 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 14 days not refrigerated stored at or below 30°C protect from light
2013-03-05
_ _ Actemra 230629 1 CONSUMER MEDICINE INFORMATION ACTEMRA ® SOLUTION FOR SUBCUTANEOUS INJECTION TOCILIZUMAB 162 mg/0.9 mL solution for subcutaneous injection 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. 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 is used to treat moderate to severe rheumatoid arthritis (RA) in adults.For RA, Actemra can also prevent damage occurring to your joints and improve your ability to do your normal daily activities. Actemra is also used to treat giant cell arteritis (GCA). Some of the signs and symptoms of RA and GCA are caused by the actions of a protein called interleukin-6 (IL-6) binding to the interleukin-6 receptor (IL-6R). Actemra works by binding and blocking IL-6R thereby helping to relieve some of the signs and symptoms of RA and GCA. Actemra is approved to treat GCA and RA, however your doctor may have prescribed Actemra for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ACTEMRA HAS BEEN PRESCRIBED FOR YOU. Actemra is not addictive. This medicine is available only with a doctor’s prescription. BEFORE YOU USE ACTEMRA _WHEN YOU MUST NOT USE ACTEMRA _ DO NOT USE ACTEMRA IF: 1. YOU HAVE HAD AN ALLERGIC REACTION TO ACTEMRA OR ANY ING Lestu allt skjalið
Actemra 231115 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Actemra ® 20 mg/mL, concentrate for solution for intravenous (IV) infusion Actemra ® 162 mg/0.9 mL, solution for subcutaneous (SC) injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION CONCENTRATE FOR SOLUTION FOR IV INFUSION Each vial contains 20 mg/mL tocilizumab (vials: 80 mg tocilizumab in 4 mL, 200 mg tocilizumab in 10 mL and 400 mg tocilizumab in 20 mL). SOLUTION FOR SC INJECTION Each pre-filled syringe contains 162 mg/0.9 mL tocilizumab. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Actemra concentrated solution for IV infusion is a clear to opalescent, colourless to pale yellow sterile solution. Actemra solution for 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) in those not previously treated with MTX; 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; or 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 alone or in combination with methotrexate. GIANT CELL ARTERITIS (SC FORMULATION ONLY) Actemra is indicated for the treatment of giant cell arteritis (GCA) in adult patients. Actemra 231115 2 CORONAVIRUS DISEASE 2019 (COVID-19) (IV FORMULATION ONLY) Actemra is indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS (PJIA Lestu allt skjalið