TOUJEO MAX SOLOSTAR insulin glargine 300 units/mL solution for injection injector pen

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Insulin glargine, Quantity: 32.74 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: metacresol; zinc chloride; glycerol; sodium hydroxide; hydrochloric acid; water for injections

Administration route:

Subcutaneous

Units in package:

1, 3, 9, 6

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of diabetes mellitus in adults

Product summary:

Visual Identification: a sterile clear colourless solution; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-11-05

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

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AUSTRALIAN PRODUCT INFORMATION –TOUJEO
® MAX
SOLOSTAR
® (INSULIN GLARGINE)
1
NAME OF THE MEDICINE
Insulin glargine
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_
.
For 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 Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
The
“U300” is highlighted in honey gold on the label.
Toujeo is for subcutaneous use only and should be administered by
injection in the abdominal
wall, the deltoid or the thigh. Injection sites must be rotated within
a given injection area
from one injection to the next in order to reduce the risk of
lipodystrophy and localised
cutaneous amyloidosis. Do not inject into areas of lipodystrophy and
localised cutaneous
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amyloidosis. (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
and
4.8 ADVERSE EFFECTS (UNDESIRABLE EFFECTS)).
Toujeo must not be administered intr