CORTIMENT

국가: 인도네시아

언어: 인도네시아어

출처: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

유효 성분:

BUDESONIDE

제공처:

ABBOTT INDONESIA - Indonesia

INN (International Name):

BUDESONIDE

복용량:

9 Mg

약제 형태:

TABLET PELEPASAN LAMBAT

패키지 단위:

DUS, 3 BLISTER @ 10 TABLET PELEPASAN LAMBAT

Manufactured by:

COSMO SPA - Italy

승인 날짜:

2020-02-09

제품 특성 요약

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