Toujeo 300unitsml solution for injection 1.5ml pre-filled SoloStar pen

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Insulin glargine

Available from:

Sanofi

ATC code:

A10AE04

INN (International Name):

Insulin glargine

Dosage:

300unit/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

VMP not recommended to prescribe - patient training required

Product summary:

BNF:

Patient Information leaflet

LEGENDE / LEGEND
SAP-Nr. / Plant PM code:
539680
Sprachvariante / Country code:
103
Version:
2
Datum / Date:
22.11.2017 PE
Abmessungen / Dimensions:
594 × 420 mm
Schriftgröße / Font size:
9 Pt
Zeilenabstand / Line spacing:
10 Pt
Seite / Page:
1/2
Druckbare Farben / Printing colours
Black
Technische Information / Technical information
Kontur / Outline
PACKAGE LEAFLET: INFORMATION FOR THE USER
Toujeo
®
300 UNITS/ML
SOLUTION FOR INJECTION IN A PRE-FILLED PEN
insulin glargine
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. 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

Summary of Product characteristics

OBJECT 1
TOUJEO 300 UNITS/ML SOLUTION FOR INJECTION IN A
PRE-FILLED PEN
Summary of Product Characteristics Updated 23-Nov-2017 | SANOFI
1. Name of the medicinal product
Toujeo 300 units/ml 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).
Each pen contains 1.5 ml of solution for injection, equivalent to 450
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). SoloStar
Clear colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of diabetes mellitus in adults.
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).
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 diabetes mellitus_
Toujeo is to be used once-daily with meal-time insulin and requires
individual dose adjustments.
_Patients with type 2 diabetes mellitus_
The recomme