Optisulin Solostar

البلد: نيوزيلاندا

اللغة: الإنجليزية

المصدر: Medsafe (Medicines Safety Authority)

العنصر النشط:

Insulin glargine 100 IU/mL equivalent to 3.6378mg/mL

متاح من:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

جرعة:

100 IU/mL

الشكل الصيدلاني:

Solution for injection

تركيب:

Active: Insulin glargine 100 IU/mL equivalent to 3.6378mg/mL Excipient: Glycerol Hydrochloric acid Metacresol Sodium hydroxide Water for injection Zinc chloride

نوع الوصفة الطبية :

Prescription

الخصائص العلاجية:

Optisulin/Optisulin Solostar is an insulin analogue indicated for once-daily subcutaneous administration in the treatment of type 1 or type 2 diabetes mellitus patients who require insulin for the control of hyperglycaemia.

ملخص المنتج:

Package - Contents - Shelf Life: Syringe, glass, 3 mL in SoloStar injector pen, Starter pack - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 28 days not refrigerated stored at or below 30°C protect from light. Discard after a total of 28 days non-refrigeration, opened or unopened. Keep away from direct heat. - Syringe, glass, 3 mL in SoloStar injector pen - 5 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 28 days not refrigerated stored at or below 30°C protect from light. Discard after a total of 28 days non-refrigeration, opened or unopened. Keep away from direct heat.

تاريخ الترخيص:

2019-05-13

نشرة المعلومات

Optisulin
®
1
OPTISULIN®
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?
Optisulin contains the active 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?
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?
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?
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?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING OPTISULIN?
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 if you drink Alcohol.
•
Alcohol may mask the symptoms of hypoglycemia.
LOOKING AFTER
YOUR MEDICINE
•
Keep unopened cartridges, pens and vials of Optisulin in a
refrigerator

خصائص المنتج

New Zealand Data Sheet
Optisulin – insulin glargine
optisulin-ccdsv20-dsv3-20jun22
Page 1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Optisulin 100 IU/mL solution for injection in 10 mL vials.
Optisulin 100 IU/mL solution for injection in 3 mL cartridges.
Optisulin SoloStar 100 IU/mL solution for injection in a 3 mL
pre-filled pen.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Optisulin contains 100 IU/mL (3.6378 mg/mL) insulin glargine.
Optisulin 100 IU/mL solution for injection in 10 mL vials - equivalent
to 1000 IU.
Optisulin 100 IU/mL solution for injection in 3 mL cartridges -
equivalent to 300 IU.
Optisulin SoloStar 100 IU/mL solution for injection in a 3 mL
pre-filled pen – equivalent to
300 IU.
Insulin glargine is produced by recombinant DNA technology in
Escherichia coli.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Optisulin is a sterile solution of insulin glargine in vials and
cartridges for use as an injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Optisulin is an insulin analogue indicated for once-daily subcutaneous
administration in the
treatment of type 1 or type 2 diabetes mellitus patients who require
insulin for the control of
New Zealand Data Sheet
Optisulin – insulin glargine
optisulin-ccdsv20-dsv3-20jun22
Page 2
hyperglycaemia.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
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.
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. Blood glucose
monitoring is recommended for all individuals with diabetes.
Dose adjustment may be required, for example, if the patient’s
weight or