Suliqua

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

insulin glargine, lixisenatide

Saatavilla:

Sanofi Winthrop Industrie

ATC-koodi:

A10AE

INN (Kansainvälinen yleisnimi):

insulin glargine, lixisenatide

Terapeuttinen ryhmä:

Drugs used in diabetes

Terapeuttinen alue:

Diabetes Mellitus, Type 2

Käyttöaiheet:

Suliqua 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.,

Tuoteyhteenveto:

Revision: 12

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2017-01-11

Pakkausseloste

39
B. PACKAGE LEAFLET
40
PACKAGE LEAFLET: INFORMATION FOR THE USER
SULIQUA 100 UNITS/ML + 50 MICROGRAMS/ML SOLUTION FOR INJECTION IN
PRE-FILLED PEN
Insulin glargine + lixisenatide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Suliqua is and what it is used for
2.
What you need to know before you use Suliqua
3.
How to use Suliqua
4.
Possible side effects
5.
How to store Suliqua
6.
Contents of the pack and other information
1.
WHAT SULIQUA IS AND WHAT IT IS USED FOR
Suliqua 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.
Suliqua is used to treat adults with type 2 diabetes, to help control
blood sugar levels when they are
too high, it is an adjunct to diet and exercise. It is given, with
metformin with or without sodium-
glucose co-transporter-2 (SGLT2) inhibitors (gliflozin products), when
other medicines are not enough
on their own to control your blood sugar levels.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SULIQUA
DO NOT USE SULIQUA:
•
if you are allergic to insulin glargine or lixisenatide or to any of
the other ingredients of this
medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Suliqua if:
•
you have ty

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Suliqua 100 units/ml + 50 micrograms/ml solution for injection in
pre-filled pen
Suliqua 100 units/ml + 33 micrograms/ml solution for injection in
pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Suliqua 100 units/ml + 50 microgram/ml solution for injection in
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 of
lixisenatide.
Each dose step contains 1 unit of insulin glargine and 0.5 micrograms
of lixisenatide
Suliqua 100 units/ml + 33 microgram/ml solution for injection in
pre-filled pen
Each pre-filled pen contains 300 units of insulin glargine and 100
micrograms of lixisenatide in 3 ml
solution.
Each ml contains 100 units of insulin glargine and 33 micrograms of
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.
For the full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled pen (SoloStar)
Clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Suliqua 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
sodium-glucose co-transporter-2 (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
Suliqua is available in two pre-filled pens, providing different
dosing options, i.e., Suliqua
(10-40) pen,
Suliqua (30-60) pen respectively. The differentiation between the pen
strengths is