Kraj: Indonezja
Język: indonezyjski
Źródło: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
TOLTERODINE
PFIZER INDONESIA - Indonesia
TOLTERODINE
2 MG
TABLET SALUT SELAPUT
DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT
PFIZER ITALIA S.R.L - Italy
2016-06-13
Product Document Title: Tolterodine L-TartrateTolterodine Trade Name : DETRUSITOL Product Document No.:756 Date: April 11, 2008 Supercedes: February 23, 2007 Approved by BPOM: June 13, 2016 2020-0061491 1 [PFI1] PT. PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Product Document Title: Tolterodine L-TartrateTolterodine [PFI2] Trade Name: DETRUSITOL Product Document No.:756 Date: April 11, 2008 Supercedes: February 23, 2007 [FN3] QUALITATIVE AND QUANTITATIVE COMPOSITION Tolterodine L-tartrate 2 mg corresponding 1.37 mg tolterodine (rINN) respectively. [FN4] PHARMACEUTICAL FORM Film Coated Tablet CLINICAL PARTICULARS THERAPEUTIC INDICATIONS For the treatment of overactive bladder with symptoms of urinary urgency, frequency, or urge incontinence. POSOLOGY AND METHODS OF ADMINISTRATION The recommended dose is 2 mg b.i.d. The dose may be reduced from 2 mg to 1 mg b.i.d., based on individual tolerability. Safety and effectiveness in children have not yet been established. Therefore, Detrusitol is not recommended for children until more information is available. Use in Impaired Renal Function The recommended total daily dose is 2 mg (i.e., tolterodine tablets 1 mg twice daily) for patients with impaired renal function (see Section – SPECIAL WARNINGS AND PRECAUTIONS FOR USE). Use in Impaired Hepatic Function The recommended total daily dose is 2 mg (i.e., tolterodine tablets 1 mg twice daily) for patients with impaired hepatic function (see Section – SPECIAL WARNINGS AND PRECAUTIONS FOR USE). Use with Potent CYP3A4 Inhibitors The recommended total daily dose is 2 mg (i.e., tolterodine tablets 1 mg twice daily) for patients receiving concomitant ketoconazole or other potent CYP3A4 inhibitors (see Section – SPECIAL WARNINGS AND PRECAUTIONS FOR USE, CYP3A4 INHIBITORS, and Section – INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION). After 6 months the need for further treatment should be considered. PADA PROSES PEMBUATANNYA BERSINGGUNGAN DENGAN BAHAN BERSUMBER BABI DISETUJUI OLEH BPOM : 02/10/2020 I Przeczytaj cały dokument