Toujeo Max

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

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

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

Dosage:

300 IU/mL

Pharmaceutical form:

Solution for injection

Composition:

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

Prescription type:

Prescription

Therapeutic indications:

Treatment of diabetes mellitus in adults.

Product summary:

Package - Contents - Shelf Life: Cartridge, glass, Type I (USP/Ph. Eur.) in a Solostar pre-filled (3 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 42 days not refrigerated stored at or below 30°C protect from light. do not refrigerate or freeze - Cartridge, glass, Type I (USP/Ph. Eur.) in a Solostar pre-filled (3 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 42 days not refrigerated stored at or below 30°C protect from light. do not refrigerate or freeze - Cartridge, glass, Type I (USP/Ph. Eur.) in a Solostar pre-filled (3 mL fill) disposable pen injector - 6 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 42 days not refrigerated stored at or below 30°C protect from light. do not refrigerate or freeze - Cartridge, glass, Type I (USP/Ph. Eur.) in a Solostar pre-filled (3 mL fill) disposable pen injector - 9 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 42 days not refrigerated stored at or below 30°C protect from light. do not refrigerate or freeze

Authorization date:

2020-01-30

Patient Information leaflet

TOUJEO
®
MAX SOLOSTAR
®
1
TOUJEO
® MAX SOLOSTAR
®
_ (TOU-JEO) _
_insulin glargine (in-sue-lin glar-jeen) _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Toujeo Max
SoloStar.
It does not contain all the available
information. It does not take the
place of talking to your doctor,
pharmacist or diabetes educator.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Toujeo Max
SoloStar against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TOUJEO MAX
SOLOSTAR IS USED FOR
Toujeo Max SoloStar contains the
active substance insulin glargine.
Toujeo Max SoloStar is used to
reduce high blood sugar (glucose)
levels in adults with diabetes
mellitus.
Toujeo Max SoloStar is a modified
insulin that is very similar to human
insulin. It is a substitute for the
insulin produced by the pancreas.
Toujeo Max SoloStar is a long-acting
insulin. Your doctor may tell you to
use a rapid-acting insulin or oral anti-
diabetic medication in combination
with Toujeo Max SoloStar.
Toujeo Max SoloStar is not
addictive.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY TOUJEO MAX
SOLOSTAR HAS BEEN PRESCRIBED FOR
YOU.
BEFORE YOU USE TOUJEO
MAX SOLOSTAR
_WHEN YOU MUST NOT USE _
_TOUJEO MAX SOLOSTAR _
DO NOT USE TOUJEO MAX SOLOSTAR IF:
•
You have diabetic ketoacidosis
(often caused by high blood
glucose levels)
•
you are allergic to any medicine
containing insulin or any of the
ingredients contained in Toujeo
Max SoloStar listed at the end of
this leaflet
Some of the symptoms of an allergic
reaction may include:
•
redness, swelling, rash and
itching at the injection site
•
rash, itching or hives on the skin
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
−
IF YOU ARE EXPERIENCING LOW
BLOOD SUGAR LEVELS
(HYPOG

Summary of Product characteristics

toujeo-mx-ccdsv3-dsv1-13oct22
Page 1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Toujeo Max SoloStar 300 IU/mL solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Toujeo Max SoloStar pre-filled disposable pen injector contains 3 mL
solution for injection. Each
mL contains 300 units of insulin glargine (equivalent to 10.91 mg
insulin glargine).
Insulin glargine is produced by recombinant DNA technology in
_Escherichia coli._
Contains metacresol 8.1mg (preservative).
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection.
A sterile clear colourless solution of insulin glargine in cartridges
for use as an injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of diabetes mellitus in adults.
4.2
DOSE AND METHOD OF ADMINISTRATION
Insulin glargine is a basal insulin for once-daily subcutaneous
administration at any time of the
day, preferably at the same time every day.
INITIATION OF TOUJEO
Before using Toujeo Max SoloStar (referred hereafter as “Toujeo”)
pre-filled pen, 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
toujeo-mx-ccdsv3-dsv1-13oct22
Page 2
Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). The “U300”
is
highlighted in honey gold on the label.
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 with meal-time insulin and requires
subsequent individual dose
adjustments