Χώρα: Ευρωπαϊκή Ένωση
Γλώσσα: Αγγλικά
Πηγή: EMA (European Medicines Agency)
insulin glargine
Merck Sharp & Dohme B.V.
A10AE04
insulin glargine
Drugs used in diabetes
Diabetes Mellitus
Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.,
Revision: 2
Withdrawn
2017-01-03
29 B. PACKAGE LEAFLET Medicinal product no longer authorised 30 PACKAGE LEAFLET: INFORMATION FOR THE USER LUSDUNA 100 UNITS/ML SOLUTION FOR INJECTION IN A PRE-FILLED PEN Insulin glargine This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY INCLUDING THE LUSDUNA NEXVUE PRE-FILLED PEN INSTRUCTIONS FOR USE, 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, 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What LUSDUNA is and what it is used for 2. What you need to know before you use LUSDUNA 3. How to use LUSDUNA 4. Possible side effects 5. How to store LUSDUNA 6. Contents of the pack and other information 1. WHAT LUSDUNA IS AND WHAT IT IS USED FOR LUSDUNA contains insulin glargine. This is a modified insulin, very similar to human insulin. LUSDUNA is used to treat diabetes mellitus in adults, adolescents and children aged 2 years and above. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar. Insulin glargine has a long and steady blood-sugar-lowering action. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LUSDUNA DO NOT USE LUSDUNA - If you are allergic to insulin glargine or any of the other ingredients of this medicine (listed in section 6). LUSDUNA is only suitable for injection just under the skin. Speak to your doctor if you need to inject your insulin by another method. WARNINGS AND PRECAUTIONS Talk to your Διαβάστε το πλήρες έγγραφο
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT LUSDUNA 100 units/mL solution for injection in a pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains 100 units insulin glargine* (equivalent to 3.64 mg). Each pen contains 3 mL of solution for injection, equivalent to 300 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). Nexvue. Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology LUSDUNA contains insulin glargine, an insulin analogue, and has a prolonged duration of action. LUSDUNA should be administered once daily at any time but at the same time each day. The dose regimen (dose and timing) should be individually adjusted. In patients with type 2 diabetes mellitus, LUSDUNA can also be given together with oral antidiabetic medicinal products. The potency of this medicinal product is stated in units. These units are exclusive to insulin glargine and are not the same as IU or the units used to express the potency of other insulin analogues (see section 5.1). Special populations _Elderly population (≥ 65 years old)_ In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements. _Renal impairment_ In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism. Medicinal product no longer authorised 3 _Hepatic impairment_ In patients with hepatic impairment, insulin r Διαβάστε το πλήρες έγγραφο