Soliqua SoloStar 100unitsmL+33mcgmL solution for injection in a pre-filled pen

Country: Malaysia

Language: English

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

Active ingredient:

Insulin Glargine; Lixisenatide

Available from:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (International Name):

Insulin Glargine; Lixisenatide

Units in package:

3 Pieces; 5 Pieces

Manufactured by:

Sanofi-Aventis Deutschland GmbH

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
_ _
SOLIQUA
® SOLOSTAR
®
SOLUTION FOR INJECTION IN A PRE-FILLED PEN
Insulin glargine + lixisenatide
(100 units/ml + 33 micrograms/ml)
_ _
WHAT IS IN THIS LEAFLET
1. What Soliqua is used for
2. How Soliqua works
3. Before you use Soliqua
4. How to use Soliqua
5. While you are using it
6. Side effects
7. Storage and Disposal of Soliqua
8. Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
WHAT SOLIQUA IS USED FOR
Soliqua is used to treat adults with type
2 diabetes, to help control blood sugar
levels when they are too high, as an
adjunct to diet and exercise. It is given
with metformin with or without SGLT-
2 inhibitors, when other medicines are
not enough on their own to control your
blood sugar levels.
If
you
use
another
anti-diabetic
medicine,
discuss
with
your
doctor
whether you should stop using that
medicine when starting Soliqua.
HOW SOLIQUA WORKS
Soliqua
is
an
injectable
diabetes
medicine
that
contains
two
active
substances:

insulin glargine: a long-acting type
of insulin which helps control blood
sugar (glucose) throughout the day.

lixisenatide:
a
“GLP-1
analogue”
that helps the body produce its own
additional
insulin
in
response
to
increases in blood sugar, and slows
the absorption of sugar from foods.
BEFORE YOU USE SOLIQUA
_-When you must not use it _
If you are allergic to insulin glargine or
lixisenatide
or
to
any
of
the
other
ingredients of this medicine.
_-Before you start to use it _
Warnings and precautions
Talk
to
your
doctor,
pharmacist
or
nurse before using Soliqua if:

you have type 1 diabetes, as Soliqua
is used for type 2 diabetes and this
medicine will not be right for you.

you
have
diabetic
ketoacidosis
(a
complication of diabetes that occurs
when
the
body
is
unable
to
use
glucose because there is not enough
insulin) since this medicine will not
be right for you.

you have a severe stomach or gut
problem such as a disease of the
muscles
of
the
stomach
called
“gastroparesis�

Summary of Product characteristics

MY/SLQ/0421/CCDS v3_SmPC Aug20
1
1.
NAME OF THE MEDICINAL PRODUCT
Soliqua Solostar 100 units/ml + 50 micrograms/ml solution for
injection in a pre-filled pen
Soliqua Solostar 100 units/ml + 33 micrograms/ml solution for
injection in a pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Soliqua Solostar 100 units/ml + 50 microgram/ml solution for injection
in a pre-filled pen
Each pre-filled pen contains 300 units of insulin glargine* and 150
micrograms lixisenatide in 3 ml
solution.
Each ml contains 100 units of insulin glargine and 50 micrograms
lixisenatide.
Each dose step contains 1 unit of insulin glargine and 0.5 micrograms
of lixisenatide
Soliqua Solostar 100 units/ml + 33 microgram/ml solution for injection
in a pre-filled pen
Each pre-filled pen contains 300 units of insulin glargine and 100
micrograms Lixisenatide in 3 ml solution.
Each ml contains 100 units of insulin glargine and 33 micrograms
lixisenatide.
Each dose step contains 1 unit of insulin glargine and 0.33 micrograms
of lixisenatide
*Insulin glargine is produced by recombinant DNA technology in
_Escherichia coli_
.
The dose window on the pen shows the number of dose steps.
Excipient(s) with known effects:
Each ml contains 2.7 milligrams of metacresol as preservative
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection). SoloStar
Clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Soliqua 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 metformin with or without
SGLT-2 inhibitors. (For study results with respect to effect on
glycaemic control, and the populations
studied, see section 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Soliqua is available in two pens, providing different dosing options,
i.e. Soliqua Solostar (10-40) pen,
Soliqua Solostar (30-60) pen respectively. The differentiation between
the pen strengths is