Ülke: Birleşik Krallık
Dil: İngilizce
Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tocilizumab
Roche Products Ltd
L04AC07
Tocilizumab
20mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010300; GTIN: 5000471007015
1 uk-ie-mt-pil-RoActemra-clean-180406-20mg-inf PACKAGE LEAFLET: INFORMATION FOR THE USER ROACTEMRA 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Tocilizumab READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 or nurse. • This medicine has been prescribed for you only. • If you get any side effects, talk to your doctor 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 are given RoActemra 3. How RoActemra is given 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 helps to reduce 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 by the disease and to improve your ability to do normal daily activities. • 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. RoActemra is usually given in combination with methotrexate. However, RoActemra can be given alone if your doctor determines that methotrexate is inappropriate. • RoActemra can also Belgenin tamamını okuyun
OBJECT 1 ROACTEMRA 20MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 27-Apr-2018 | Roche Products Limited 1. Name of the medicinal product RoActemra 20 mg/ml concentrate for solution for infusion. 2. Qualitative and quantitative composition Each ml concentrate contains 20 mg tocilizumab*. Each vial contains 80 mg of tocilizumab* in 4 ml (20 mg/ml). Each vial contains 200 mg of tocilizumab* in 10 ml (20 mg/ml). Each vial contains 400 mg of tocilizumab* in 20 ml (20 mg/ml). *humanised IgG1 monoclonal antibody against the human interleukin-6 (IL-6) receptor produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Excipients with known effects Each 80 mg vial contains 0.10 mmol (2.21 mg) sodium. Each 200 mg vial contains 0.20 mmol (4.43 mg) sodium. Each 400 mg vial contains 0.39 mmol (8.85 mg) sodium. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Concentrate for solution for infusion (sterile concentrate). Clear to opalescent, colourless to pale yellow 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 is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequatel Belgenin tamamını okuyun