Country: Հայաստան
language: անգլերեն
source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
tocilizumab
F. Hoffmann-La Roche Ltd.
tocilizumab
20mg/ml
concentrate for solution for i/v infusion
Prescription
ACTEMRA ® Tocilizumab 1. DESCRIPTION 1.1 THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) IgG 1 subclass. ATC Code: L04AC07. 1.2 TYPE OF DOSAGE FORM Concentrate solution for infusion. 1.3 ROUTE OF ADMINISTRATION Intravenous (IV) infusion. 1.4 STERILE / RADIOACTIVE STATEMENT Sterile. 1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: tocilizumab. Tocilizumab is a clear to opalescent, colorless to pale yellow liquid, supplied in preservative-free, nonpyrogenic single-use vials. Tocilizumab is supplied in 10 ml and 20 ml vials containing 4 ml, 10 ml or 20 ml of tocilizumab (20 mg/ml). Excipients: polysorbate 80, sucrose, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate and water for injections. 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATION(S) RHEUMATOID ARTHRITIS (RA) Tocilizumab is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients. Tocilizumab can be used alone or in combination with methotrexate (MTX) and/or other disease- modifying anti-rheumatic drugs (DMARDs). Tocilizumab has been shown to inhibit progression of joint damage as measured by X-ray and to improve physical function. POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS (PJIA) Tocilizumab is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Tocilizumab can be given alone or in combination with MTX. SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) Tocilizumab is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. Tocilizumab can be given alone or in combination with MTX. 2.2 DOSAGE AND ADMINISTRATION _General_ Tocilizumab should be diluted by a health care professional with sterile 0.9% w/v sodium chloride solution using aseptic technique (see section 4.2 Special Instructions for Use, Handling and Disposal). Tocilizumab is read_full_document
March 2014 Summary of Product Characteristics Ro-4877533 Actemra March 2014 1 ACTEMRA® Tocilizumab 1. DESCRIPTION 1.1 THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) IgG 1 subclass. ATC Code: L04AC07. 1.2 TYPE OF DOSAGE FORM Concentrate solution for infusion. 1.3 ROUTE OF ADMINISTRATION Intravenous (i.v.) infusion. 1.4 STERILE / RADIOACTIVE STATEMENT Sterile. 1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: tocilizumab. Tocilizumab is a clear to opalescent, colourless to pale yellow liquid, supplied in preservative-free, non-pyrogenic single-use vials. Tocilizumab is supplied in 10 ml and 20 ml vials containing 4 ml, 10 ml or 20 ml of tocilizumab (20 mg/ml). Excipients: Polysorbate 80, sucrose, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate and water for injections. 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATION(S) RHEUMATOID ARTHRITIS (RA) Tocilizumab is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients. Tocilizumab can be used alone or in combination with methotrexate (MTX) and/or other disease-modifying anti-rheumatic drugs (DMARDs). Tocilizumab has been shown to inhibit progression of joint damage as measured by X-ray and to improve physical function. SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) March 2014 Summary of Product Characteristics Ro-4877533 Actemra March 2014 2 Tocilizumab is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. Tocilizumab can be given alone or in combination with MTX. 2.2 DOSAGE AND ADMINISTRATION _General _ RHEUMATOID ARTHRITIS The recommended dose of tocilizumab for adult patients is 8 mg/kg given once every four weeks as an i.v. infusion. Tocilizumab can be used alone or in combination with MTX and/or other DMARDs. Tocilizumab should be diluted to 100 ml by a healthcare professional with sterile 0.9% w/ read_full_document