Ország: Indonézia
Nyelv: indonéz
Forrás: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
VEDOLIZUMAB
TAKEDA INDONESIA - Indonesia
VEDOLIZUMAB
300 MG
SERBUK INFUS
DUS, 1 VIAL @ 300 MG
TAKEDA PHARMACEUTICAL COMPANY LIMITED - Japan
2021-04-01
1. NAME OF THE MEDICINAL PRODUCT ENTYVIO 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 300 mg of vedolizumab. After reconstitution, each mL contains 60 mg of vedolizumab. For excipients, see section 6.1. 3. PHARMACEUTICAL FORM White to off-white lyophilized cake or powder for solution for infusion 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ULCERATIVE COLITIS_ Vedolizumab is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist. _CROHN’S DISEASE_ Vedolizumab is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DOSAGE _ULCERATIVE COLITIS_ The recommended dose regimen of vedolizumab is 300 mg administered by intravenous infusion at zero, two and six weeks and then every eight weeks thereafter. Therapy for patients with ulcerative colitis should be discontinued if no evidence of therapeutic benefit is observed by Week 14 _(see_ _ _ _section 5.1)_. Some patients who have experienced a decrease in their response may benefit from an increase in dosing frequency to vedolizumab 300 mg every four weeks. In patients wh o have responded to treatment with vedolizumab, corticosteroids may be reduced and/or discontinued in accordance with standard of care. Page 1 of 20 DISETUJUI OLEH BPOM 7 APRIL 2021 NO AJU : EREG10023512100017 _CROHN’S DISEASE_ The recommended dose regimen of vedolizumab is 300 mg administered by intravenous infusion at zero, two and six weeks and then every eight weeks thereafter. Patients with Crohn’s disease, who have not shown a response may benefit from a dose of vedolizumab 300 mg at Week 10. Continue therapy every ei Olvassa el a teljes dokumentumot