TOUJEO

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

INSULIN GLARGINE

Available from:

SANOFI ISRAEL LTD

ATC code:

A10AE04

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

INSULIN GLARGINE 300 U/ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

SANOFI - AVENTIS DEUTSCHLAND GMBH, GERMANY

Therapeutic area:

INSULIN GLARGINE

Therapeutic indications:

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

Authorization date:

2020-12-31

Patient Information leaflet

TOUJEO (INSULIN GLARGINE 300 U/ML)
TOUJEO SOLOSTAR PRE-FILLED PEN CONTAINS 450 UNITS IN 1.5 ML
TOUJEO DOUBLESTAR PRE-FILLED PEN CONTAINS 900 UNITS IN 3 ML
IMPORTANT INFORMATION DURING THE INITIAL WEEKS WHEN
PRESCRIBED TOUJEO
•
Insulin glargine 300 U/mL (Toujeo) and insulin glargine 100 U/mL are
NOT BIOEQUIVALENT AND ARE THEREFORE
NOT DIRECTLY INTERCHANGEABLE.
DOSE ADJUSTMENT MAY BE REQUIRED (this means the drugs are not the same
and you must not switch
between them without adjusting the dose by your healthcare provider).
•
The switch between insulin therapies should only be done when
prescribed by your healthcare provider.
The dose recommended by your healthcare provider should always be
followed.
•
Your blood glucose needs to be monitored closely during the switch and
the initial weeks thereafter.
•
INSULIN GLARGINE 300 U/ML IS AVAILABLE IN TWO DIFFERENT PRESENTATIONS:
PLEASE CONSULT YOUR HEALTHCARE PROFESSIONAL FOR FURTHER INFORMATION.
BEFORE INJECTING TOUJEO READ THE INSTRUCTIONS FOR USE THAT COME WITH
THE PACKAGE LEAFLET.
IF YOU GET ANY MEDICATION ERROR OR SIDE EFFECTS, TALK TO YOUR DOCTOR
OR PHARMACIST. THIS INCLUDES ANY
POSSIBLE SIDE EFFECTS NOT LISTED IN THIS LEAFLET.
GUIDE FOR PATIENTS AND/OR CARERS:
•
IF YOU ARE PRESCRIBED TOUJEO YOU MUST BE TRAINED ON HOW TO USE THE
TOUJEO PEN BY YOUR HEALTHCARE
PROFESSIONAL AND YOU MUST READ THE FULL INSTRUCTIONS FOR USE LEAFLET
ACCOMPANYING THE PEN.
•
THIS DOCUMENT IS PROVIDED AS A GUIDE ONLY.
•
START WITH THE DOSE IN UNITS WRITTEN ON YOUR MEDICAL PRESCRIPTION.
THE FORMAT AND CONTENT OF THIS PATIENT GUIDE WAS CHECKED AND APPROVED
BY THE MINISTRY OF HEALTH IN
SEPTEMBER 2023.SUSPECTED ADVERSE REACTIONS COULD BE REPORTED TO THE
MINISTRY OF HEALTH BY USING AN
ONLINE FORM
HTTPS://SIDEEFFECTS.HEALTH.GOV.IL
. ALSO COULD BE REPORTED DIRECTLY TO SANOFI COMPANY 09-8633081
THE DOSE INCREMENT IN TOUJEO SOLOSTAR IS
1 U THE DOSE INCREMENT IN TOUJEO DOUBLESTAR IS
2 U
The dose delivered is the one shown in the dose window.
TOUJEO SOLOSTAR
(CONTAINS 450 U OF INSULIN IN 1

Summary of Product characteristics

_Toujeo SPC version 7.0 April 2023 _
1
_ _
_ _
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Toujeo 300 units/ml solution for injection in a pre-filled pen
SoloStar
Toujeo 300 units/ml solution for injection in a pre-filled pen
DoubleStar
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).
_ _
_ _
_ _
_Toujeo SPC version 7.0 April 2023 _
2
_ _
_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).
_ _
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