TOUJEO 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: 10.91 mg/mL

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Insulin glargine

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Subcutaneous

Units in package:

5 pen injector, 3 pen injector, 1 pen injector

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: Clear colourless solution, practically free from particles; Container Type: Cartridge; Container Material: Glass; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-06-30

Patient Information leaflet

TOUJEO
® SOLOSTAR
®
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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 Toujeo SoloStar 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 doct

Summary of Product characteristics

toujeo-ccdsv5-piv4-17feb21
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AUSTRALIAN PRODUCT INFORMATION – TOUJEO
® SOLOSTAR
®
(INSULIN GLARGINE)
1
NAME OF THE MEDICINE
Insulin glargine 300 units/mL
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Toujeo SoloStar pre-filled disposable pen injector contains 1.5 mL
solution for injection.
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 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
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.
INITIATION OF TOUJEO
Before using Toujeo 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
toujeo-ccdsv5-piv4-17feb21
Page 2 of 27
amyloidosis. (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
and
4.8 ADVERSE EFFECTS (UNDESIRABLE EFFECTS).
Toujeo must not be administered intravenously. The prolonged duration
of action of Toujeo
is dependent on its injection into subcutaneous tissue. Intravenous
administration of the usu