KOMBIGLYZE XR

Riik: Indoneesia

keel: indoneesia

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

Toimeaine:

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN

Saadav alates:

ASTRAZENECA INDONESIA - Indonesia

INN (Rahvusvaheline Nimetus):

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN

Annus:

500 MG/5 MG

Ravimvorm:

TABLET SALUT SELAPUT

Ühikuid pakis:

DUS, 4 BLISTER @ 7 TABLET SALUT SELAPUT

Valmistatud:

ASTRAZENECA UK LIMITED

Loa andmise kuupäev:

2018-01-24

Toote omadused

1 of 23
Proposed packaging material
Code
Kombiglyze XR 5/500 (28s) FCT-PI-01.01
Submission
NDA
Renewal
Variation change detail no.: MU-34237-59529_ _
Code of previous version
N/A
Changes
CDS Update 2017 - Renal Impairment
BPOM Letter Date 8 Feb 2022 on Pharmacokinetic properties – special
population
Reference
CDS version: 2017
CPIL version:
SmPC country/version/date:
GRL approval: 28 April 2022
Name & Date
SRF (02 June 2022)
KOMBIGLYZE
TM
XR 5 MG/500 MG
_(saxagliptin/metformin HCl extended release) _
FILM-COATED TABLET
QUALITATIVE AND QUANTITATIVE COMPOSITION
KOMBIGLYZE XR is available for oral administration as tablets
containing either 5.58 mg
saxagliptin hydrochloride (anhydrous) equivalent to 5 mg saxagliptin
and 500 mg metformin
hydrochloride (KOMBIGLYZE XR 5 mg/500 mg).
PHARMACEUTICAL FORM
KOMBIGLYZE XR 5 mg/500 mg are light brown to brown, biconvex, capsule
shaped, film-
coated tablet, with 5/500 printed on one side and 4221 printed on the
other side, in blue ink.
THERAPEUTIC INDICATION
KOMBIGLYZE XR 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 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/50