Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
insulin glargine
Sanofi-aventis Deutschland GmbH
A10AE04
insulin glargine
Drugs used in diabetes
Diabetes Mellitus
Treatment of diabetes mellitus in adults, adolescents and children from the age of 6 years.,
Revision: 35
Authorised
2000-06-26
35 B. PACKAGE LEAFLET 36 PACKAGE LEAFLET: INFORMATION FOR THE USER TOUJEO 300 UNITS/ML SOLOSTAR SOLUTION FOR INJECTION IN A PRE-FILLED PEN Insulin glargine EACH SOLOSTAR PEN DELIVERS 1-80 UNITS IN STEPS OF 1 UNIT. _ _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Toujeo is and what it is used for 2. What you need to know before you use Toujeo 3. How to use Toujeo 4. Possible side effects 5. How to store Toujeo 6. Contents of the pack and other information 1. WHAT TOUJEO IS AND WHAT IT IS USED FOR Toujeo contains insulin called “insulin glargine”. This is a modified insulin, very similar to human insulin. Toujeo contains 3 times more insulin in 1 ml than standard insulin, which contains 100 unit/ml. It is used to treat diabetes mellitus in adults, adolescents and children from the age of 6 years. Diabetes mellitus is an illness where your body does not make enough insulin to control your blood sugar. Toujeo lowers your blood sugar steadily over a long period of time. It is used for once daily dosing. You can change the time of your injection if you need to. This is because this medicine lowers your blood sugar over a long period of time (for more information, see section 3). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TOUJEO DO NOT USE TOUJEO - If you are allergic to insulin glargine or to any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Toujeo. Follow closely the instructions for dose, mo Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 300 units insulin glargine* (equivalent to 10.91 mg). SoloStar pen Each pen _ _ contains 1.5 ml of solution for injection, equivalent to 450 units. DoubleStar pen Each pen contains 3 ml of solution for injection, equivalent to 900 units. * Insulin glargine is produced by recombinant DNA technology in _Escherichia coli_ . For the full list of excipients, see section 6.1. _ _ 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of diabetes mellitus in adults, adolescents and children from the age of 6 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Toujeo is a basal insulin for once-daily administration at any time of the day, preferably at the same time every day. The dose regimen (dose and timing) should be adjusted according to individual response. In type 1 diabetes mellitus, Toujeo must be combined with short-/rapid-acting insulin to cover mealtime insulin requirements. In patients with type 2 diabetes mellitus, Toujeo can also be given together with other anti-hyperglycaemic medicinal products. The potency of this medicinal product is stated in units. These units are exclusive to Toujeo and are not the same as IU or the units used to express the potency of other insulin analogues (see section 5.1). _Flexibility in dosing time _ _ _ When needed, patients can administer Toujeo up to 3 hours before or after their usual time of administration (see section 5.1). _ _ 3 Patients who forget a dose, should be advised to check their blood sugar and then resume their usual once-daily dosing schedule. Patients should be informed not to inject a double dose to make up for a forgotten dose. _Initiation _ _ _ _Patients with type 1 diabet Aqra d-dokument sħiħ