Страна: Европейски съюз
Език: английски
Източник: 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 aged two years and above
Revision: 40
Authorised
2000-06-09
35 B. PACKAGE LEAFLET 36 PACKAGE LEAFLET: INFORMATION FOR THE USER LANTUS 100 UNITS/ML SOLUTION FOR INJECTION IN A VIAL Insulin glargine _ _ 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, 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 Lantus is and what it is used for 2. What you need to know before you use Lantus 3. How to use Lantus 4. Possible side effects 5. How to store Lantus 6. Contents of the pack and other information 1. WHAT LANTUS IS AND WHAT IT IS USED FOR Lantus contains insulin glargine. This is a modified insulin, very similar to human insulin. Lantus 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 LANTUS DO NOT USE LANTUS - If you are allergic to insulin glargine or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Lantus. Follow closely the instructions for posology, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) as discussed with your doctor. If your blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia (see box at the end of this leaflet). Skin changes at the injection site The injection site should be rotated to prevent skin changes such as lumps under the skin. The insulin may not wor Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Lantus 100 units/ml solution for injection in a vial Lantus 100 units/ml solution for injection in a cartridge Lantus SoloStar 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). Lantus 100 units/ml solution for injection in a vial Each vial contains 5 ml of solution for injection, equivalent to 500 units, or 10 ml of solution for injection, equivalent to 1000 units. Lantus 100 units/ml solution for injection in a cartridge, Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen Each cartridge or 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. 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 Lantus contains insulin glargine, an insulin analogue, and has a prolonged duration of action. Lantus 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, Lantus can also be given together with orally active antidiabetic medicinal products. The potency of this medicinal product is stated in units. These units are exclusive to Lantus and are not the same as IU or the units used to express the potency of other insulin analogues (see section 5.1). _ _ _Special population _ _Elderly population (≥65 years old) _ In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements. 3 _Renal impairment _ In patients with renal impairment, insulin requirements may be d Прочетете целия документ