OPTISULIN 100IU/mL insulin glargine (rbe) 3mL solution for injection cartridge

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

Insulin glargine, Quantity: 3.6378 mg/mL

Tillgänglig från:

Sanofi-Aventis Australia Pty Ltd

INN (International namn):

Insulin glargine

Läkemedelsform:

Injection, solution

Sammansättning:

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

Administreringssätt:

Subcutaneous

Enheter i paketet:

5 x 3mL, 1 x 3mL Patient Starter Pack

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

Insulin glargine is an insulin analogue indicated for once-daily subcutaneous administration in the treatment of type 1 diabetes mellitus in adults and children and type 2 diabetes mellitus in adults who require insulin for control of hyperglycaemia.

Produktsammanfattning:

Visual Identification: clear colourless solution in glass cartridge; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Bemyndigande status:

Licence status A

Tillstånd datum:

2009-11-05

Bipacksedel

OPTISULIN
® AND OPTISULIN
® SOLOSTAR
O
P
T
I
S
U
L
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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 OPTISULIN OR OPTISULIN SOLOSTAR?
Optisulin contains the active ingredient insulin glargine. Optisulin
is used to reduce high blood sugar (glucose) levels in people with
diabetes mellitus.
For more information, see Section 1. Why am I using Optisulin? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE OPTISULIN OR OPTISULIN SOLOSTAR?
Do not use if you have ever had an allergic reaction to Optisulin or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Optisulin or Optisulin SoloSTAR? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Optisulin 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 OPTISULIN OR OPTISULIN SOLOSTAR?
Your doctor will tell you how much Optisulin you need to use each day.
Your doctor may increase or decrease the dose, depending
on your blood sugar levels.
More instructions can be found in Section 4. How do I use Optisulin or
Optisulin SoloSTAR? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING OPTISULIN OR OPTISULIN SOLOSTAR?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Optisulin.
•
Measure your blood sugar level regularly.
•
Keep using Optisulin even if you feel well.
•
Tell your doctor if you often have hypoglycaemia or if you have ever
become unconscious after using
Optisulin.
•
Always carry some sugary food or drink with you.
•
Tell your doctor or anybody else treating you if you are travelling.
DRINKING
ALCOHOL
•
Tell your doctor i

Produktens egenskaper

optisulin-ccdsv20-piv14-29nov21
Page 1 of 25
AUSTRALIAN PRODUCT INFORMATION – OPTISULIN/OPTISULIN
SOLOSTAR (INSULIN GLARGINE)
1
NAME OF THE MEDICINE
Insulin glargine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Optisulin 3mL cartridge contains 3mL of insulin glargine 100 units/mL.
Optisulin pre-filled pen contains 3mL of insulin glargine 100 units
/mL.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection.
Optisulin is a clear to colourless, particle free solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Insulin glargine is an insulin analogue indicated for once-daily
subcutaneous administration
in the treatment of type 1 diabetes mellitus in adults and children
and type 2 diabetes mellitus
in adults who require insulin for the control of hyperglycaemia.
4.2
DOSE AND METHOD OF ADMINISTRATION
Optisulin is an insulin analogue, equipotent to human insulin, with a
peakless glucose
lowering profile and a prolonged duration of action that permits once
daily dosing.
Optisulin is for individual patient use only.
DOSAGE
Optisulin is given subcutaneously once a day. It may be administered
at any time during the
day, however, at the same time every day.
Optisulin is not intended for intravenous administration.
optisulin-ccdsv20-piv14-29nov21
Page 2 of 25
Blood glucose monitoring is recommended for all individuals with
diabetes. The desired
blood glucose levels as well as the doses and timing of any
antidiabetic medication, including
Optisulin, must be determined and adjusted individually. In a clinical
study in insulin-naïve
patients with type 2 diabetes, Optisulin was started at a dose of 10.8

4.9 IU (mean

SD;
median dose 10 IU) Optisulin once daily and subsequently adjusted
individually.
Dose adjustment may also be required, for example, if the patient’s
weight or lifestyle
change, change in timing of insulin dose or other circumstances arise
that increase
susceptibility to hypo- or hyperglycaemia. Any change of insulin dose
should be made
c