Toujeo (previously Optisulin)

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

insulin glargine

Beschikbaar vanaf:

Sanofi-aventis Deutschland GmbH

ATC-code:

A10AE04

INN (Algemene Internationale Benaming):

insulin glargine

Therapeutische categorie:

Drugs used in diabetes

Therapeutisch gebied:

Diabetes Mellitus

therapeutische indicaties:

Treatment of diabetes mellitus in adults, adolescents and children from the age of 6 years.,

Product samenvatting:

Revision: 35

Autorisatie-status:

Authorised

Autorisatie datum:

2000-06-26

Bijsluiter

35
B. PACKAGE LEAFLET
36
PACKAGE LEAFLET: INFORMATION FOR THE USER
TOUJEO 300 UNITS/ML SOLOSTAR SOLUTION FOR INJECTION IN A PRE-FILLED
PEN
Insulin glargine
EACH SOLOSTAR PEN DELIVERS 1-80 UNITS IN STEPS OF 1 UNIT.
_ _
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 Toujeo is and what it is used for
2.
What you need to know before you use Toujeo
3.
How to use Toujeo
4.
Possible side effects
5.
How to store Toujeo
6.
Contents of the pack and other information
1.
WHAT TOUJEO IS AND WHAT IT IS USED FOR
Toujeo contains insulin called “insulin glargine”. This is a
modified insulin, very similar to human
insulin.
Toujeo contains 3 times more insulin in 1 ml than standard insulin,
which contains 100 unit/ml.
It is used to treat diabetes mellitus in adults, adolescents and
children from the age of 6 years. Diabetes
mellitus is an illness where your body does not make enough insulin to
control your blood sugar.
Toujeo lowers your blood sugar steadily over a long period of time. It
is used for once daily dosing.
You can change the time of your injection if you need to. This is
because this medicine lowers your
blood sugar over a long period of time (for more information, see
section 3).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TOUJEO
DO NOT USE TOUJEO
-
If you are allergic to insulin glargine 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 Toujeo.
Follow closely the instructions for dose, mo

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled
pen
Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled
pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 300 units insulin glargine* (equivalent to 10.91 mg).
SoloStar pen
Each pen
_ _
contains 1.5 ml of solution for injection, equivalent to 450 units.
DoubleStar pen
Each pen contains 3 ml of solution for injection, equivalent to 900
units.
* Insulin glargine is produced by recombinant DNA technology in
_Escherichia coli_
.
For the full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of diabetes mellitus in adults, adolescents and children
from the age of 6 years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Toujeo is a basal insulin for once-daily administration at any time of
the day, preferably at the same
time every day.
The dose regimen (dose and timing) should be adjusted according to
individual response.
In type 1 diabetes mellitus, Toujeo must be combined with
short-/rapid-acting insulin to cover
mealtime insulin requirements.
In patients with type 2 diabetes mellitus, Toujeo can also be given
together with other
anti-hyperglycaemic medicinal products.
The potency of this medicinal product is stated in units. These units
are exclusive to Toujeo and are
not the same as IU or the units used to express the potency of other
insulin analogues (see section 5.1).
_Flexibility in dosing time _
_ _
When needed, patients can administer Toujeo up to 3 hours before or
after their usual time of
administration (see section 5.1).
_ _
3
Patients who forget a dose, should be advised to check their blood
sugar and then resume their usual
once-daily dosing schedule. Patients should be informed not to inject
a double dose to make up for a
forgotten dose.
_Initiation _
_ _
_Patients with type 1 diabet