XIGDUO XR TABLETS 10MG500MG

Krajina: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktívna zložka:

Dapagliflozin propanediol 12.3mg eqv Dapagliflozin; Metformin 390mg eqv to Metformin hydrochloride

Dostupné z:

ASTRAZENECA SINGAPORE PTE LTD

ATC kód:

A10BD15

Forma lieku:

TABLET, FILM COATED, EXTENDED RELEASE

Zloženie:

Dapagliflozin propanediol 12.3mg eqv Dapagliflozin 10mg; Metformin 390mg eqv to Metformin hydrochloride 500mg

Spôsob podávania:

ORAL

Typ predpisu:

Prescription Only

Výrobca:

AstraZeneca Pharmaceuticals LP

Stav Autorizácia:

ACTIVE

Dátum Autorizácia:

2016-08-30

Súhrn charakteristických

XIGDUO
® XR
(DAPAGLIFOZIN/METFORMIN HCL)
1.
NAME OF THE MEDICINAL PRODUCT
XIGDUO XR tablets, 5 mg/500 mg, 5 mg/1000 mg, 10 mg/500 mg and 10
mg/1000 mg.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
XIGDUO
XR
5 mg/500 mg:
Each
film-coated
tablet
contains
5 mg
dapagliflozin
as
dapagliflozin propanediol and 500 mg metformin HCl extended-release.
XIGDUO
XR
5 mg/1000 mg:
Each
film-coated
tablet
contains
5 mg
dapagliflozin
as
dapagliflozin propanediol and 1000 mg metformin HCl extended-release.
XIGDUO
XR
10 mg/500 mg:
Each
film-coated
tablet
contains
10 mg
dapagliflozin
as
dapagliflozin propanediol and 500 mg metformin HCl extended-release.
XIGDUO
XR 10 mg/1000 mg: Each film-coated
tablet contains
10 mg
dapagliflozin as
dapagliflozin propanediol and 1000 mg metformin HCl extended-release.
3.
PHARMACEUTICAL FORM
XIGDUO XR (dapagliflozin propanediol/metformin HCl extended-release)
tablets contain two
antihyperglycemic drugs used in the management of type 2 diabetes:
dapagliflozin and
metformin hydrochloride.
XIGDUO XR 5 mg/500 mg tablets are orange, capsule shaped, film-coated
tablets debossed
with “1070” and “5/500” on one side and plain on the other
side.
XIGDUO XR 5 mg/1000 mg tablets are pink to dark pink, biconvex, oval
shaped, film-coated
tablets debossed with “1071” and “5/1000” on one side and
plain on the other side.
XIGDUO XR 10 mg/500 mg tablets are pink, biconvex, capsule shaped,
film-coated tablets
debossed with “1072” and “10/500” on one side and plain on the
other side.
XIGDUO XR 10 mg/1000 mg tablets are yellow to dark yellow, biconvex,
oval shaped,
film-coated tablets debossed with “1073” and “10/1000” on one
side and plain on the other side.
For excipients, see section 6.1.
DAPAGLIFLOZIN
Dapagliflozin propanediol is described chemically as D-glucitol,
1,5-anhydro-1-C-[4-chloro-3-
[(4-ethoxyphenyl)methyl]phenyl]-,
(1S)-,
compounded
with
(2S)-1,2-propanediol,
hydrate
(1:1:1). The empirical formula is C
21
H
25
ClO
6
•C
3
H
8
O
2
•H
2
O and the formula weight is 502.98.
T