País: Nova Zelândia
Língua: inglês
Origem: Medsafe (Medicines Safety Authority)
Tocilizumab 20mg; ; ;
Roche Products (NZ) Ltd
Tocilizumab 20 mg
20 mg/mL
Concentrate for infusion
Active: Tocilizumab 20mg Excipient: Dibasic sodium phosphate dodecahydrate Monobasic sodium phosphate dihydrate Polysorbate 80 Sucrose Water for injection
Vial, glass, 400mg/20mL, 1 dose unit
Prescription
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; 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 in combination with methotrexate
Package - Contents - Shelf Life: Vial, glass, 400mg/20mL - 1 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours diluted stored at or below 30°C 14 days diluted stored at 2° to 8°C (Refrigerate, do not freeze). When the solution has been prepared in controlled and validated aseptic conditions - Vial, glass, 200mg/10mL - 1 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours diluted stored at or below 30°C 14 days diluted stored at 2° to 8°C (Refrigerate, do not freeze). When the solution has been prepared in controlled and validated aseptic conditions - Vial, glass, 80mg/4mL - 1 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours diluted stored at or below 30°C 14 days diluted stored at 2° to 8°C (Refrigerate, do not freeze). When the solution has been prepared in controlled and validated aseptic conditions
2008-02-05
_ _ Actemra 230629 1 CONSUMER MEDICINE INFORMATION ACTEMRA ® CONCENTRATE FOR INTRAVENOUS INFUSION TOCILIZUMAB 80 mg in 4 mL, 200 mg in 10 mL and 400 mg in 20 mL concentrate for solution for infusion WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Actemra 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 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. Actemra is also used to treat active systemic juvenile idiopathic arthritis (sJIA) and active polyarticular juvenile idiopathic arthritis (pJIA) in children over 2 years of age. Actemra is used for the treatment of coronavirus disease 2019 (COVID-19) in adults who have been hospitalised and are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. For RA, Actemra can also prevent damage occurring to your joints and improve your ability to do your normal daily activities. Some of the signs and symptoms of RA, pJIA and sJIA 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 RA, pJIA, sJIA and COVID-19. Actemra is approved to treate RA, pJIA and sJIA, however your doctor may have prescribed Actemra for another purpose. A Leia o documento completo
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 Leia o documento completo