SOLIQUA insulin glargine (rbe) 100 units/mL and lixisenatide 50 microgram/mL solution for injection injector pen

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

Insulin glargine,lixisenatide

Mevcut itibaren:

Sanofi-Aventis Australia Pty Ltd

Yetkilendirme durumu:

Registered

Bilgilendirme broşürü

SOLIQUA
®
1
SOLIQUA
®
_insulin glargine + lixisenatide _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Soliqua.
It does not contain all the available
information. It does not take the
place of talking to your doctor,
pharmacist or diabetes educator.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Soliqua against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SOLIQUA IS USED
FOR
Soliqua contains two active
substances, insulin glargine and
lixisenatide.
Soliqua is used to reduce high blood
glucose (sugar) levels in people with
Type 2 diabetes mellitus; it is given
by injection once a day.
Soliqua is used in combination with
metformin when other medicines are
not enough on their own to control
your blood glucose levels. These
other medicines may include oral
glucose-lowering medicinal products
or insulin.
If you use another oral glucose-
lowering medicinal product, discuss
with your doctor whether you should
stop using that medicine when
starting Soliqua.
Soliqua is not addictive.
Type 2 Diabetes mellitus is a
condition in which your pancreas
does not produce enough insulin to
control your blood glucose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY SOLIQUA HAS
BEEN PRESCRIBED FOR YOU.
This medicine is only available with
a doctor’s prescription.
BEFORE YOU USE
SOLIQUA
_WHEN YOU MUST NOT USE _
_SOLIQUA _
DO NOT USE SOLIQUA IF:
•
You have type 1 diabetes or
diabetic ketoacidosis (often
caused by high blood glucose
levels)
•
You are allergic to any medicine
containing insulin or lixisenatide
or any of the ingredients
contained in Soliqua listed at
the end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
redness, swelling, rash and
itching at the injection site
•
rash, itching or hives on the skin
•
shortness of breath
�

Ürün özellikleri

soliqua-ccdsv4-piv2-04nov20
Page 1 of 30
AUSTRALIAN PRODUCT INFORMATION – SOLIQUA
(INSULIN GLARGINE AND LIXISENATIDE)
1
NAME OF THE MEDICINE
Insulin glargine and lixisenatide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Soliqua is available in two SoloStar pre-filled disposable pen
injectors containing 3 mL of
solution. See below:
10 TO 40 PRE-FILLED PEN
(PEACH COLOUR)
RATIO OF 2 UNITS : 1 ΜG
30 TO 60 PREFILLED PEN
(OLIVE COLOUR)
RATIO 3 UNITS: 1 ΜG
100 units/mL insulin glargine
50 μg/mL lixisenatide
100 units/mL insulin glargine
33 μg/mL lixisenatide
1 unit of Soliqua contains:
1 unit of insulin glargine (100 units/mL)
0.5 μg lixisenatide
1 unit of Soliqua contains:
1 unit of insulin glargine (100 units/mL)
0.33 μg lixisenatide
Daily Dosing Range:
10 to 40 units insulin glargine
5 to 20 μg lixisenatide
Daily Dosing Range:
30 to 60 units insulin glargine
10 to 20 μg lixisenatide
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection.
Soliqua is a sterile clear colourless solution of insulin glargine
(100 units/mL) and
lixisenatide in titratable fixed ratio doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Soliqua is indicated in combination with metformin for the treatment
of adults with type 2
diabetes mellitus to improve glycaemic control when this has not been
provided by
metformin alone or metformin combined with another oral glucose
lowering medicinal
product or with basal insulin.
soliqua-ccdsv4-piv2-04nov20
Page 2 of 30
4.2
DOSE AND METHOD OF ADMINISTRATION
Soliqua should be administered subcutaneously once a day, within 1
hour prior to the first
meal each day.
GENERAL
Soliqua is titratable and available in two pens, providing different
dosing options. The
differentiation between the pen strengths is based on the dose range
of the pen.
10 TO 40 PRE-FILLED PEN
(PEACH COLOUR)
RATIO OF 2 UNITS: 1 ΜG
30 TO 60 PREFILLED PEN
(OLIVE COLOUR)
RATIO 3 UNITS: 1 ΜG
100 units/mL insulin glargine
50 μg/mL lixisenatide
100 units/mL insulin glar