Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
Insulin glargine, Quantity: 100 U/mL
Maxx Pharma Pty Ltd
Injection, solution
Excipient Ingredients: sodium hydroxide; glycerol; water for injections; hydrochloric acid; metacresol; zinc chloride
Subcutaneous
5 pens with 1 x 3mL cartridge each, 1 pen with 1 x 3mL cartridge
(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 the control of hyperglycaemia.
Visual Identification: Clear, colourless solution, free from particles.; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2018-03-28
SEMGLEE ® _contains the active ingredient insulin glargine (in-sue-lin glar-jeen)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Semglee. 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 Semglee 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 SEMGLEE IS USED FOR Semglee is used to reduce high blood sugar (glucose) levels in people with diabetes mellitus. Semglee is a modified insulin that is very similar to human insulin. It is a substitute for the insulin produced by the pancreas. Semglee is a long-acting insulin. Other names for this insulin include insulin glargine and Lantus. Your doctor may tell you to use a rapid- acting human insulin or oral diabetes medication in combination with Semglee. Semglee is not addictive. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY SEMGLEE HAS BEEN PRESCRIBED FOR YOU. BEFORE YOU USE SEMGLEE _WHEN YOU MUST NOT USE_ _SEMGLEE_ DO NOT USE SEMGLEE: IF YOU HAVE AN ALLERGY TO: • any medicine containing insulin • any of the ingredients contained in Semglee 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 (HYPOGLYCAEMIA - A "HYPO"). If you have a lot of hypos discuss appropriate treatment with your doctor. AFTER THE EXPIRY DATE PRINTED ON THE PACK OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. If you use Semglee after the expiry date has passed, it may not work as wel Prečítajte si celý dokument
AUSTRALIAN PRODUCT INFORMATION SEMGLEE _Insulin glargine solution for injection _ 1 NAME OF THE MEDICINE Insulin glargine SEMGLEE is a biosimilar medicine to Lantus. The comparability of SEMGLEE to Lantus has been demonstrated with regard to physiochemical characteristics, efficacy and safety outcomes. The evidence for comparability supports the use of SEMGLEE for the listed indications. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SEMGLEE [insulin glargine injection {rDNA origin}] is a recombinant human insulin analogue produced by DNA technology. The SEMGLEE injector pen provides insulin glargine for subcutaneous injection. The 3 mL cartridge inside the injector pen contains 100 IU/mL (3.64 mg/mL) of insulin glargine as the active ingredient. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Solution for injection. SEMGLEE is a sterile, clear, colourless solution free from particles. 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 SEMGLEE 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. SEMGLEE is for individual patient use only. SEMGLEE is given subcutaneously once a day. It may be administered at any time during the day, however, at the same time every day. SEMGLEE is not intended for intravenous administration. The desired blood glucose levels as well as the doses and timing of any antidiabetic medication, including SEMGLEE, must be determined and adjusted individually. In a clinical study in insulin- naïve patients with type 2 diabetes, insulin glargine was started at a dose of 10.8 ±4.9 IU (mean ±SD; median dose 10 IU) insulin glargine once daily and subsequently a Prečítajte si celý dokument