Kraj: Indonezja
Język: indonezyjski
Źródło: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
TOCILIZUMAB
BOEHRINGER INGELHEIM INDONESIA - Indonesia
TOCILIZUMAB
20 MG/ML
INFUS
DUS, 1 VIAL @ 80 MG (4 ML)
F HOFFMANN LA ROCHE - Switzerland
2016-10-31
_Draft_Actemra SC_PI_New Drug Application_CDS11.0_EN_v1 _ ACTEMRA ® Tocilizumab ANTI-HUMAN INTERLEUKIN-6 (IL-6) RECEPTOR 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 Intravenous (IV) formulation/Actemra IV: Concentrate solution for infusion Subcutaneous (SC) formulation/Actemra SC: Ready-to-use sterile liquid solution in a single-use pre-filled syringe (PFS) with needle safety device (NSD) 1.3 ROUTE OF ADMINISTRATION Intravenous (IV) infusion Subcutaneous (SC) injection 1.4 STERILE/RADIOACTIVE STATEMENT Sterile 1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient:_ tocilizumab Actemra IV is a clear to opalescent, colourless to pale yellow liquid, supplied in preservative- free, non-pyrogenic single-use vials. Actemra IV is supplied in vials containing 4 mL or 20 mL of tocilizumab (20 mg/mL) Excipients: Each 80 mg vial contains 0.10 mmol (2.21 mg) sodium Each 400 mg vial contains 0.39 mmol (8.85 mg) sodium Actemra SC is a yellowish, preservative-free liquid supplied in a ready-to-use, single-use pre- filled syringe with needle safety device (PFS+NSD). Each device delivers 0.9 mL (162 mg) of tocilizumab 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATION(S) RHEUMATOID ARTHRITIS (RA) [IV AND SC FORMULATION] Actemra, in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (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 or inappropriate with MTX, DMARD, anti TNF and other established drugs for RA. Actemra has been shown to inhibit progression of joint damage as measured by X-ray and to improve physic Przeczytaj cały dokument