Forxiga

Држава: Нови Зеланд

Језик: Енглески

Извор: Medsafe (Medicines Safety Authority)

Активни састојак:

Dapagliflozin propanediol monohydrate 12.3mg equivalent to Dapaglifozin 10mg;  

Доступно од:

AstraZeneca Limited

INN (Међународно име):

Dapagliflozin propanediol monohydrate 12.3 mg (= to Dapaglifozin 10 mg)

Дозирање:

10 mg

Фармацеутски облик:

Film coated tablet

Састав:

Active: Dapagliflozin propanediol monohydrate 12.3mg equivalent to Dapaglifozin 10mg   Excipient: Colloidal silicon dioxide Crospovidone Opadry II yellow Lactose Magnesium stearate Microcrystalline cellulose

Јединице у пакету:

Blister pack, Al/Al, 7 tablets

Класа:

Prescription

Тип рецептора:

Prescription

Произведен од:

Swords Laboratories Limited Subsidiary of Bristol-Myers Squibb Company

Терапеутске индикације:

MONOTHERAPY Forxiga is indicated in adults with type 2 diabetes mellitus as monotherapy as an adjunct to diet and exercise in patients for whom metformin is otherwise indicated but was not tolerated. INITIAL COMBINATION Forxiga is indicated in adults with type 2 diabetes mellitus as initial combination therapy with metformin, as an adjunct to diet and exercise, to improve glycaemic control when diet and exercise have failed to provide adequate glycaemic control and there are poor prospects for response to metformin monotherapy. ADD-ON COMBINATION Forxiga is indicated in adult patients with type 2 diabetes mellitus in combination with other anti-hyperglycaemic agents to improve glycaemic control, when these together with diet and exercise do not provide adequate glycaemic control. PREVENTION OF HOSPITALISATION FOR HEART FAILURE Forxiga is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalisation for heart. PREVENTION OF NEW OR WORSENING NEPHROPATHY Forxiga is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease for the prevention of new or worsening nephropathy.

Резиме производа:

Package - Contents - Shelf Life: Blister pack, Al/Al - 7 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Al/Al Sample pack - 28 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Al/Al - 28 tablets - 36 months from date of manufacture stored at or below 30°C

Датум одобрења:

2011-05-13

Информативни летак

F
ORXIGA

CMI 170523
Copyright
1(7)
FORXIGA
®
DAPAGLIFLOZIN 10 MG TABLETS.
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about F
ORXIGA
. It does not contain all
the information that is known about F
ORXIGA
.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor will have weighed
the risks of you taking F
ORXIGA
against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT F
ORXIGA IS USED FOR
F
ORXIGA
is a prescription medicine used with diet, exercise and sometimes
other medicines (which may
include metformin; insulin; a sulphonylurea medicine such as
gliclazide, glimepiride and glibenclamide;
or a dipeptidyl peptidase-4 inhibitor [DPP 4 inhibitor] such as
sitagliptin or saxagliptin or a glucagon like
peptide 1 [GLP-1] receptor agonist such as exenatide) to control the
levels of blood sugar (glucose) in
patients with Type 2 diabetes mellitus. It can also help prevent
hospitalisation for heart failure and
kidney disease in patients with type 2 diabetes mellitus.
_TYPE 2 DIABETES MELLITUS _
Type 2 diabetes mellitus (also called non-insulin-dependent diabetes
mellitus, or NIDDM) is the
condition of having high levels of blood sugar (hyperglycaemia). This
is usually because your body
does not make enough insulin and / or the insulin that your body
produces does not work as well as it
should. Left uncontrolled, the build-up of high levels of sugar in
your blood 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, which include kidney
disease, blindness and amputation.
F
ORXIGA
is a member of a class of medicines you take by mouth called SGLT-2
(Sodium Glucose
Cotranspor

Карактеристике производа

F
ORXIGA
®
Data Sheet 140623
Copyright
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
F
ORXIGA
®
10 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
F
ORXIGA
10 mg: Each film-coated tablet contains 10 mg dapagliflozin as
dapagliflozin
propanediol
For the full list of excipients see section 6.1 - List of Excipients.
3.
PHARMACEUTICAL FORM
F
ORXIGA
10 mg tablets are yellow, biconvex, diamond-shaped, film-coated
tablets with “10”
debossed on one side and “1428” debossed on the other side.
Dapagliflozin propanediol is described chemically as D-glucitol,
1,5-anhydro-1-_C_-[4-chloro-3-
[(4-ethoxyphenyl)methyl]phenyl]-,
(1_S_)-,
compounded
with
(2_S_)-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 molecular weight is
502.98. The structural formula is:
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TYPE 2 DIABETES MELLITUS
_Glycaemic control_
F
ORXIGA
is indicated in adults with type 2 diabetes mellitus:

as monotherapy as an adjunct to diet and exercise in patients for whom
metformin is
otherwise indicated but was not tolerated.

as initial combination therapy with metformin, as an adjunct to diet
and exercise, to
improve glycaemic control when diet and exercise have failed to
provide adequate
glycaemic
control
and
there
are
poor
prospects
for
response
to
metformin
monotherapy.
F
ORXIGA
®
Data Sheet 140623
Copyright
2

in combination with other anti-hyperglycaemic agents to improve
glycaemic control,
when these together with diet and exercise, do not provide adequate
glycaemic control
(see section 5.1 Pharmacodynamic Properties – Clinical Efficacy and
Safety, and 4.4
Special Warnings and Precautions for Use for available data on
different add-on
combination therapies).
_Prevention of hospitalisation for heart failure_
F
ORXIGA
is indicated in adults with type 2 diabetes mellitus and established
cardiovascular
disease or risk factors for cardiovascular disease to reduce the risk
of hospitalisation for heart
failure (see section 5.1 P