Qtern 5 mg10 mg Film-Coated Tablets

Riik: Malaisia

keel: inglise

Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Toimeaine:

SAXAGLIPTIN HYDROCHLORIDE; Dapagliflozin Propanediol

Saadav alates:

ASTRAZENECA SDN. BHD.

INN (Rahvusvaheline Nimetus):

SAXAGLIPTIN HYDROCHLORIDE; Dapagliflozin Propanediol

Ühikuid pakis:

28 Tablets

Valmistatud:

AstraZeneca Pharmaceuticals LP

Infovoldik

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
QTERN
®
5 MG/10 MG FILM-COATED TABLETS
SAXAGLIPTIN 5 MG & DAPAGLIFLOZIN 10 MG
1
WHAT IS IN THIS LEAFLET
1.
What QTERN is used for
2.
How QTERN works
3.
Before you use QTERN
4.
How to use QTERN
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
QTERN
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT QTERN IS USED FOR
QTERN contains the active
substances saxagliptin and
dapagliflozin. Each belongs to a
group of medicines called “oral
anti-diabetics”.
•
This medicine is taken by mouth
for type 2 diabetes mellitus.
•
This medicine is used if your
type 2 diabetes mellitus cannot
be controlled with other oral
diabetes medicines, along with
diet and exercise.
_Type 2 diabetes mellitus _
Type 2 diabetes mellitus is a
condition in which your body does
not make enough insulin and the
insulin that your body produces
does not work as well as it should.
Your body can also make too
much sugar. When this happens,
sugar (glucose) builds up in the
blood and can lead to serious
medical problems.
The main goal of treating type 2
diabetes is to control your blood
sugar to a normal level. Lowering
and controlling blood sugar may
help prevent or delay
complications of diabetes, such as
heart disease, kidney disease,
blindness and amputation.
Your doctor may have prescribed
this medicine for another reason.
Ask your doctor if you have any
questions about why QTERN has
been prescribed for you.
QTERN is not addictive.
HOW QTERN WORKS
QTERN contains two active
ingredients, saxagliptin and
dapagliflozin. Saxagliptin belongs
to a class of medicines called DPP-
4 inhibitors (dipeptidyl peptidase-4
inhibitors), and dapagliflozin
belongs to a class of medicines
called SGLT-2 (sodium glucose
cotransporter-2) inhibitors.
Saxagliptin and dapagliflozin
together to lower blood sugar
levels in patients with type 2
diabetes mellitus.
BEFORE YOU USE QTERN
-
_When you must not use it _
_ _
Do not take QTERN if yo

Toote omadused

1 (31)
QTERN
®
5 MG/10 MG
FILM-COATED TABLETS
saxagliptin/dapagliflozin
NAME OF THE MEDICINE
QTERN
(saxagliptin/dapagliflozin)
fixed
dose
combination
tablets
contain
two
oral
antihyperglycaemic
drugs
used
in
the
management
of
type
2
diabetes:
saxagliptin
and
dapagliflozin.
SAXAGLIPTIN
Saxagliptin is an orally-active inhibitor of the dipeptidyl
peptidase-4 (DPP-4) enzyme.
Saxagliptin is described chemically as
(1S,3S,5S)-2-[(2S)-2-amino-2-(3-hydroxytricyclo [3.3.1.1
3,7
]
dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile,
monohydrate.
The chemical structure of saxagliptin is:
CAS number: 945667-22-1
Molecular formula: C
18
H
25
N
3
O
2
•
H
2
O
Molecular weight: 333.43 (monohydrate)
DAPAGLIFLOZIN
Dapagliflozin propanediol monohydrate is an orally-active inhibitor of
the human renal sodium-
glucose co-transporter 2 (SGLT2), the major transporter responsible
for renal glucose reabsorption.
Dapagliflozin
is
described
chemically
as
(1
_S_
)-1,5-Anhydro-1-C-[4-chloro-3-[(4-
ethoxyphenyl)methyl]phenyl]-D-glucitol, (
_S_
)-propylene glycol, monohydrate.
The chemical structure of dapagliflozin propanediol monohydrate is:
2 (31)
O
HO
H
Cl
O
CH
3
OH
HO
HO
H
3
C
OH
OH
H
.
.
H
2
O
CAS Number: 960404-48-2
Molecular formula: C
21
H
25
ClO
6
•C
3
H
8
O
2
•H
2
O
Molecular weight: 502.98
DESCRIPTION
SAXAGLIPTIN
Saxagliptin is a white to light yellow or light brown powder,
non-hygroscopic, crystalline. It is
soluble in polyethylene glycol 400, acetone, acetonitrile, ethanol,
isopropyl alcohol, methanol;
sparingly soluble in water and slightly soluble in ethyl acetate.
DAPAGLIFLOZIN
Dapagliflozin drug substance is a white to off-white powder, is
non-hygroscopic, crystalline.
Dapagliflozin is non-ionisable; thus, its aqueous solubility and
partition coefficient are not affected
by changes in pH. Dapagliflozin is a Biopharmaceutical Classification
System (BCS) Class III
drug.
QTERN
QTERN 5/10 is available as a film-coated tablet containing 5 mg
saxagliptin as saxagliptin
hydrochloride and dapagliflozin propanediol monohy