Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
tocilizumab
F. Hoffmann-La Roche Ltd.
L04AC07
tocilizumab
20mg/ml
concentrate for solution for i/v infusion
glass vial 10ml
Prescription
Registered
2021-11-23
PACKAGE LEAFLET: INFORMATION FOR THE USER ACTEMRA 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 Actemra. WHAT IS IN THIS LEAFLET : 1. What Actemra is and what it is used for 2. What you need to know before you are given Actemra 3. How Actemra is given 4. Possible side effects 5. How to store Actemra 6. Contents of the pack and other information 1. WHAT ACTEMRA IS AND WHAT IT IS USED FOR Actemra 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. Actemra helps to reduce symptoms such as pain and swelling in your joints and can also improve your performance of daily tasks. Actemra 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. • ACTEMRA IS USED TO TREAT ADULTS with moderate to severe active rheumatoid arthritis (RA), an autoimmune disease, if previous therapies did not work well enough. Actemra is usually given in combination with methotrexate. However, Actemra can be given alone if your doctor determines that methotrexate is inappropriate. • Actemra can also be used to treat adults who have not had previous methotrexate treatment Прочитать полный документ
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Actemra 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 Actemra, 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, Actemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Actemra 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. Actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. Actemra can be given as monotherapy (in case of Прочитать полный документ