Land: Israel
Sprache: Englisch
Quelle: Ministry of Health
TOCILIZUMAB
ROCHE PHARMACEUTICALS (ISRAEL) LTD
L04AC07
CONCENTRATE FOR SOLUTION FOR INFUSION
TOCILIZUMAB 20 MG/ML
I.V
Required
HOFFMANN LA ROCHE LTD, SWITZERLAND
TOCILIZUMAB
TOCILIZUMAB
Actemra (tocilizumab), is indicated for reducing signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis who had an inadequate response to one or more DMARDs(Disease Modifying Anti-Rheumatic Drugs) or TNF antagonists or in whom DMARDs cannot be used. Actemra can be used alone or in combination with methotrexate or other DMARDs. 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 in patients 2 years of age and older. Actemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (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. Actemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Actemra in combination with methotrexate (MTX) in indicated for the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX.Actemra is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 3 years of age and older.Actemra is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.
2014-12-31
Roche Pharmaceuticals (Israel) Ltd Drugs regulatory affairs 6 Hacharash St. P.O.B. 6391 Hod Hasharon 4524079 Tel. + 972-9-9737777 Fax + 972-9-9737850 רבמצד 2019 ,ה/רקי ה/אפור ר ,ה/רקי ת/חקו לע םכעידוהל תשקבמ מ"עב )לארשי( הקיטבצמרפ שור תרבח אפורל ןולעב ועצובש םינוכדע רפסמ רישכתה לש . צמ וז העדוהב .הרמחה םיווהמ רשא םינוכדעו םייתוהמ םינוכדע קר םיניו יוותהה תו מושרה תו ל רישכת :לארשיב Actemra (tocilizumab) is indicated for reducing signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis who had an inadequate response to one or more DMARDs (Disease Modifying Anti-Rheumatic Drugs) or TNF antagonists or in whom DMARDs cannot be used. Actemra can be used alone or in combination with methotrexate or other DMARDs. 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 in patients 2 years of age and older. Actemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (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. Actemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Actemra in combination with methotrexate (MTX) in indicated for the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. :רבסה יתחת וק םע טסקט .ןולעל ףסוהש טסקט ןייצמ הצוח וק םע טסקט .ןולעה ןמ רסוהש טסקט ןייצמ ל ןולעב ןייעל שי ףסונ עדימל אפור יפכ חלשנש Lesen Sie das vollständige Dokument
Ref: EMEA/H/C/000955//N/0118 Actemra IV_PI_Ver 12.0 Actemra IV_PI_Ver 12.0 Actemra 20mg/ml I.V. ® TOCILIZUMAB Concentrate for solution for infusion 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 (tocilizumab) is indicated for reducing signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis who had an inadequate response to one or more DMARDs (Disease Modifying Anti-Rheumatic Drugs) or TNF antagonists or in whom DMARDs cannot be used. Actemra can be used alone or in combination with methotrexate or other DMARDs. 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 coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. Actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. Actemra in combination with methotrexate (MTX) is indicated for the treatment o Lesen Sie das vollständige Dokument