Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
BUDESONIDE
ABBOTT INDONESIA - Indonesia
BUDESONIDE
9 Mg
TABLET PELEPASAN LAMBAT
DUS, 3 BLISTER @ 10 TABLET PELEPASAN LAMBAT
COSMO SPA - Italy
2020-02-09
PROPOSED PACKAGING MATERIAL Code CORT-I-ID-01.03 Size NA Submission ☒ NDA ☐ Renewal ☐ Variation change detail no.: Code of previous version CORT-I-ID-01.02 Changes Revision shelf-life to 2 years refer to Deficiency Letter 23 Dec 2019. Reference ☐ CCDS version: R-Company Core Data Sheet-23811; ver 2.0 ☐ Core PIL version: R-Core PIL-44677; ver 1.0 ☒ SPC country/version/date: EU MRP Version 4, 02/2016 (Under Renewal Approval) _ _ ☒ LAC no.: 801 Name & Date INS, 01-Jan-2020 CORTIMENT ® BUDESONIDE Prolonged release tablets 9 mg QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 9 mg of budesonide. Excipients: _Tablet Core: _ Stearic Acid (E570), Lecithin (soya) (E322), Microcrystalline cellulose (E460), Hydroxypropylcellulose (E463), Lactose Monohydrate, Silica, Colloidal Hydrated (E551)_, _Magnesium Stearate (E470b)_ _ _Tablet Film-coating: _Methacrylic acid, Talc (E553b), Titanium Dioxide (E171), Triethyl citrate PHARMACEUTICAL FORM Prolonged release tablet. _ _ White to off-white, round, biconvex, film-coated, gastro-resistant tablet, approximately 9.5 mm diameter, approximately 4.7 mm thickness, debossed on one side with “MX9”. THERAPEUTIC INDICATIONS Cortiment is indicated in adults for induction of remission in patients with mild to moderate active ulcerative colitis (UC) where 5-ASA treatment is not sufficient. POSOLOGY AND METHOD OF ADMINISTRATION The recommended daily dose for induction of remission is one 9 mg tablet in the morning, for up to 8 weeks. Method of administration One tablet of Cortiment 9 mg is taken orally in the morning, with or without food. The tablet should be swallowed with a glass of water and must not be broken, crushed or chewed as the film coating is intended to ensure a prolonged release. CONTRAINDICATIONS Hypersensitivity to the active substance, soya oil, peanut oil or to any of the listed excipients. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Cortiment tablets should be used with caution in patients with infections, hypertension, diabetes mellitus, osteop Baca dokumen lengkapnya