Xultophy 100 unitsmL + 3.6 mgmL Solution for Injection

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LIRAGLUTIDE; Insulin Degludec

Boleh didapati daripada:

NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

LIRAGLUTIDE; Insulin Degludec

Unit dalam pakej:

3 Pre-Filled Syringes; 5 Pre-Filled Syringes

Dikeluarkan oleh:

NOVO NORDISK A/S

Risalah maklumat

XULTOPHY
®
100 UNITS/ML + 3.6 MG/ML
SOLUTION FOR INJECTION
INSULIN DEGLUDEC + LIRAGLUTIDE
_ _
_ _
_ _
_Consumer Medication Information Leaflet (RiMUP) _
1
WHAT IS IN THIS LEAFLET
1.
What Xultophy
®
is used for
2.
How Xultophy
®
works
3.
Before you use Xultophy
®
4.
How to use Xultophy
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
Xultophy
®
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
1. WHAT XULTOPHY
® IS USED FOR
Xultophy
®
is used to improve blood
glucose (sugar) levels in adult patients
with type 2 diabetes mellitus. You
have diabetes because your body:

does not make enough insulin to
control the level of sugar in your
blood or

is
not
able
to
use
the
insulin
properly.
2. HOW XULTOPHY
® WORKS
Xultophy
®
contains
two
active
substances that help your body control
your blood sugar:

insulin degludec – a long-acting
basal insulin which lowers your
blood sugar levels

liraglutide – a ‘GLP-1 analogue’
that helps your body make more
insulin during meals and lowers
the amount of sugar made by your
body.
XULTOPHY
® AND ORAL MEDICINES FOR
DIABETES
Xultophy
®
is used with oral medicines
for
diabetes
(such
as
metformin,
pioglitazone
and
sulfonylurea
medicines).
It
is
prescribed
when
these medicines (used alone or with
GLP-1 treatment or with basal insulin)
are not enough to control your blood
sugar levels.
IF YOU USE GLP-1 TREATMENT
You
should
stop
your
GLP-1
treatment
prior
to
starting
on
Xultophy
®
.
IF YOU USE INSULIN
You
should
stop
your
insulin
treatment
prior
to
starting
on
Xultophy
®
.
3. BEFORE YOU USE XULTOPHY
®
_- WHEN YOU MUST NOT USE IT _
Do not use Xultophy
®

if
you
are
allergic
to
insulin
degludec, liraglutide or any of the
other ingredients of this medicine
(listed
in
section
8
_Product _
_Description_).
_- BEFORE YOU START TO USE IT _
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or
nurse before using Xultophy
®
.

If
you
are
also
taking
a
sulfonylurea (such as glimepiride
or
gli

Ciri produk

Xultophy
®
Professional Leaflet STF-Dec-2020_8-9553-00-018-1
Based on EU text: 20200603_EN_06953_XUL_17-2
1
XULTOPHY
®
100 units/ml + 3.6 mg/ml
Solution for injection.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 100 units insulin degludec* and 3.6 mg
liraglutide*.
*Produced in _Saccharomyces cerevisiae _by recombinant DNA technology.
One pre-filled pen contains 3 ml equivalent to 300 units insulin
degludec and 10.8 mg liraglutide.
One dose step contains 1 unit of insulin degludec and 0.036 mg of
liraglutide.
For the full list of excipients, see _List of excipients._
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless, isotonic solution.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Xultophy
®
is indicated for the treatment of adults with insufficiently
controlled type 2 diabetes mellitus to
improve glycaemic control as an adjunct to diet and exercise in
addition to other oral medicinal products for
the treatment of diabetes. For study results with respect to
combinations, effects on glycaemic control, and
the populations studied, see _Special warnings and precautions for
use, Interaction with other medicinal _
_products and other forms of interaction_ and _Pharmacodynamic
properties._
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Xultophy
®
is given once daily by subcutaneous administration. Xultophy
®
can be administered at any time of
the day, preferably at the same time of the day.
Xultophy
®
is to be dosed in accordance with the individual patient’s needs. It
is recommended to optimise
glycaemic control via dose adjustment based on fasting plasma glucose.
Adjustment of dose may be necessary if patients undertake increased
physical activity, change their usual
diet or during concomitant illness.
Patients who forget a dose are advised to take it upon discovery and
then resume their usual once-daily
dosing schedule. A minimum of 8 hours between injections should always
be ensured. This also applies
when administration at the same time of the day is not possible.
Xultophy
®