Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
Insulin glargine, Quantity: 3.6378 mg/mL
Sanofi-Aventis Australia Pty Ltd
Insulin glargine
Injection, solution
Excipient Ingredients: water for injections; metacresol; glycerol; zinc chloride; sodium hydroxide; hydrochloric acid
Subcutaneous
1 pen with 1 x 3mL cartridge, 5 pens with 1 x 3mL cartridge each
(S4) Prescription Only Medicine
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.
Visual Identification: Clear colourless solution, free from particles.; Container Type: Cartridge; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2009-11-05
OPTISULIN ® AND OPTISULIN ® SOLOSTAR O P T I S U L I N ® 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 Lesen Sie das vollständige Dokument
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 Lesen Sie das vollständige Dokument