Kraj: Singapur
Język: angielski
Źródło: HSA (Health Sciences Authority)
Dapagliflozin propanediol 12.3mg eqv Dapagliflozin; Metformin 780mg eqv to Metformin hydrochloride
ASTRAZENECA SINGAPORE PTE LTD
A10BD15
TABLET, FILM COATED, EXTENDED RELEASE
Dapagliflozin propanediol 12.3mg eqv Dapagliflozin 10mg; Metformin 780mg eqv to Metformin hydrochloride 1000mg
ORAL
Prescription Only
AstraZeneca Pharmaceuticals LP
ACTIVE
2016-08-30
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 Przeczytaj cały dokument