Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tocilizumab
Roche Products Ltd
L04AC07
Tocilizumab
180mg/1ml
Solution for injection
Subcutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF:
1 uk-ie-mt-pil-RoActemra-clean-180412-162mg-pfs PACKAGE LEAFLET: INFORMATION FOR THE USER ROACTEMRA 162 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Tocilizumab READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it onto others. It may harm them even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. In addition to this leaflet, you will be given a PATIENT ALERT CARD, which contains important safety information that you need to be aware of before and during treatment with RoActemra. WHAT IS IN THIS LEAFLET: 1. WHAT ROACTEMRA IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ROACTEMRA 3. HOW TO USE ROACTEMRA 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE ROACTEMRA 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT ROACTEMRA IS AND WHAT IT IS USED FOR RoActemra contains the active substance tocilizumab, which is a protein made from specific immune cells (monoclonal antibody), that blocks the action of a specific protein (cytokine) called interleukin-6. This protein is involved in inflammatory processes of the body, and blocking it can reduce the inflammation in your body. RoActemra is used to treat: • ADULTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS (RA), an autoimmune disease, if previous therapies did not work well enough. • ADULTS WITH SEVERE, ACTIVE AND PROGRESSIVE RHEUMATOID ARTHRITIS (RA), who have not had previous treatment with methotrexate. RoActemra helps to reduce RA symptoms such as pain and swelling in your joints, and can also improve your performance of daily tasks. RoActemra has been shown to slow the damage to the cartilage and bone of the joints caused Prečítajte si celý dokument
OBJECT 1 ROACTEMRA 162 MG SOLUTION FOR INJECTION IN PRE- FILLED SYRINGE Summary of Product Characteristics Updated 27-Apr-2018 | Roche Products Limited 1. Name of the medicinal product RoActemra 162 mg solution for injection in pre-filled syringe. 2. Qualitative and quantitative composition Each pre-filled syringe contains 162 mg of tocilizumab in 0.9 ml. Tocilizumab is a recombinant humanized, anti-human monoclonal antibody of the immunoglobulin G1 (IgG1) sub-class directed against soluble and membrane-bound interleukin 6 receptors. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for injection (injection). A colourless to slightly yellowish solution. 4. Clinical particulars 4.1 Therapeutic indications RoActemra, in combination with methotrexate (MTX), is indicated for • the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. • the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients. 4.2 Posology and method o Prečítajte si celý dokument