KOMBIGLYZE XR
देश: इंडोनेशिया
भाषा: इंडोनेशियाई
स्रोत: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
उत्पाद विशेषताएं
(SPC)
31-12-2022
इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।
अनुरोध भेजा।
पैकेज में यूनिट:
DUS, 4 BLISTER @ 7 TABLET PELEPASAN LAMBAT
प्राधिकरण की तारीख:
2022-12-31
उत्पाद विशेषताएं
1 of 25
PROPOSED PACKAGING MATERIAL
Code
KOMBIGLYZE XR 5/1000 MG T-PI-01.04
Submission
NDA
Renewal
Variation change detail no.: MU-30321-105619 (Pra-Reg), MU-30321-
107138 (Reg), MU-34237-59529 (Renal Impairment)_ _
Code of previous version
KOMBIGLYZE XR 5/1000 MG T-PI-01.03
Changes
Revision dosage form as per BPOM HAQ date 7 Dec 2022
Reference
CDS version: 2017
CPIL version:
SmPC country/version/date:
GRL approval
:
1 November 2022
Name & Date
RM (7 December 2022)
KOMBIGLYZE
TM
XR 5 MG/1000 MG
_(saxagliptin/metformin HCl) _
_Extended-Release Tablet _
QUALITATIVE AND QUANTITATIVE COMPOSITION
•
KOMBIGLYZE XR is available for oral administration as extended release
tablets
containing: 5 mg saxagliptin and 1000 mg metformin hydrochloride
(KOMBIGLYZE XR 5
mg/1000 mg).
PHARMACEUTICAL FORM
•
KOMBIGLYZE XR 5 mg/1000 mg pink, biconvex, capsule shaped, extended
release
tablet, with 5/1000 printed on one side and 4223 printed on the other
side, in blue ink.
THERAPEUTIC INDICATION
KOMBIGLYZE XR 5/1000 is indicated as an adjunct to diet and exercise
to improve
glycemic control in adults with type 2 diabetes mellitus inadequately
controlled on their
maximally tolerated dose of metformin alone and/or those already being
treated with the
combination of saxagliptin and metformin as separate tablets.
KOMBIGLYZE XR is not indicated for initial treatment of type 2
diabetes mellitus.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Recommended Dosage _
The dosage of antihyperglycemic therapy with KOMBIGLYZE XR should be
individualized
on the basis of the patient’s current regimen, effectiveness, and
tolerability while not
exceeding the maximum recommended dose of saxagliptin and metformin
extended release.
KOMBIGLYZE XR should generally be administered once daily with the
evening meal, with
gradual dose titration to reduce the gastrointestinal side effects
associated with metformin,
as appropriate. The following dosage forms are available:
•
KOMBIGLYZE XR (saxagliptin/metformin HCl) extended release tablets 5
mg/500 mg
•
KO
पूरा दस्तावेज़ पढ़ें
