Toujeo

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Insulin glargine 300 IU/mL equivalent to 10.91 mg/mL

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Insulin glargine 300 IU/mL (equivalent to 10.91 mg/mL)

Dosage:

300 IU/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Insulin glargine 300 IU/mL equivalent to 10.91 mg/mL Excipient: Glycerol Hydrochloric acid Metacresol Sodium hydroxide Water for injection Zinc chloride

Prescription type:

Prescription

Manufactured by:

Sanofi-Aventis Deutschland GmbH

Therapeutic indications:

Treatment of diabetes mellitus in patients 6 years of age and older.

Product summary:

Package - Contents - Shelf Life: Cartridge, glass, Type I (USP/Ph. Eur.) in a Solostar pre-filled (1.5 mL fill) disposable pen injector - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 28 days opened stored at or below 30°C protect from light. Protect from direct heat. Do not refrigerate. Do not freeze. - Cartridge, glass, Type I (USP/Ph. Eur.) in a Solostar pre-filled (1.5 mL fill) disposable pen injector - 3 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 28 days opened stored at or below 30°C protect from light. Protect from direct heat. Do not refrigerate. Do not freeze. - Cartridge, glass, Type I (USP/Ph. Eur.) in a Solostar pre-filled (1.5 mL fill) disposable pen injector - 5 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 28 days opened stored at or below 30°C protect from light. Protect from direct heat. Do not refrigerate. Do not freeze.

Authorization date:

2015-07-23

Patient Information leaflet

Toujeo
®
SoloStar
®
1
TOUJEO® SOLOSTAR®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING TOUJEO SOLOSTAR?
Toujeo SoloStar contains the active ingredient insulin glargine 300
units/mL. Toujeo SoloStar is used to reduce high blood sugar
(hyperglycaemia) in patients 6 years of age and older, who have
diabetes.
For more information, see Section 1. Why am I using Toujeo SoloStar?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TOUJEO SOLOSTAR?
Do not use if you have ever had an allergic reaction to insulin or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU:
•
HAVE DIABETIC KETOACIDOSIS (OFTEN CAUSED BY HIGH BLOOD SUGAR LEVELS)
•
HAVE ANY OTHER MEDICAL CONDITIONS, INCLUDING KIDNEY OR LIVER PROBLEMS
•
TAKE ANY OTHER MEDICINES
•
ARE PREGNANT, OR PLAN TO BECOME PREGNANT, OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Toujeo SoloStar? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Toujeo SoloStar and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE TOUJEO SOLOSTAR?
•
Toujeo SoloStar should be injected under the skin. Your doctor will
tell you when and how much you need to use each day.
•
Your doctor may change your dose, depending on your blood sugar
levels.
•
Use Toujeo SoloStar until your doctor tells you to stop. Too much or
too little insulin can cause serious effects.
•
Toujeo SoloStar should be used once a day, at the same time every day.
More instructions can be found in Section 4. How do I use Toujeo
SoloStar?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TOUJEO SOLOSTAR?
THINGS YOU
SHOULD DO
•
It is very important that you manage your diabetes carefully. Measure
your blood sugar levels regularly.
•
Tell your doctor if you often have low blo

Summary of Product characteristics

toujeo-ccdsv5-dsv7-20jun22
Page 120
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Toujeo (insulin glargine 300 IU/mL*) solution for injection
* 300 IU/mL is equivalent to 300 units/mL
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 300 units of insulin glargine (equivalent to
10.91mg).
Each pen contains 1.5mL of solution for injection, equivalent to 450
units.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for injection.
A sterile clear, colourless solution of insulin glargine 300 units/mL
in cartridges for use as an
injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of diabetes mellitus in patients 6 years of age and older.
4.2
DOSE AND METHOD OF ADMINISTRATION
Toujeo (insulin glargine 300 units/mL) is a basal insulin for
once-daily subcutaneous
administration at any time of the day, preferably at the same time
every day.
Before using Toujeo Solostar pre-filled pen (referred hereafter as
“Toujeo”), the instructions for
use included in the package leaflet must be read carefully. Insulin
labels must always be checked
before each injection to avoid medication errors between Toujeo and
other insulins (see Section
4.4). The “U300” is highlighted in honey gold on the label.
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Page 220
BEFORE FIRST USE
The pen must be stored at room temperature at least 1 hour before use.
After use it should be kept
at room temperature (below 30°C)
Inspect the cartridge; it must only be used if the solution is clear,
colourless, with no solid
particles visible, and if it is of water-like consistency. Since
Toujeo is a solution, it does not
require resuspension before use.
To prevent the possible transmission of disease, each pen must be used
by one patient only.
DOSE
_PATIENTS WITH TYPE 1 DIABETES MELLITUS _
Toujeo is to be used once-daily as a basal insulin and requires
subsequent individual dose
adjustments.
In type 1 diabetes mellitus, Toujeo must be combined with
short/rapid-acting insulin to cover
mealtime insulin requirements.
_PATIENTS W