Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Insulin detemir
Novo Nordisk A/S
A10AE05
insulin detemir
Drugs used in diabetes
Diabetes Mellitus
Treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Revision: 29
Authorised
2004-06-01
40 B. PACKAGE LEAFLET 41 PACKAGE LEAFLET: INFORMATION FOR THE USER LEVEMIR 100 UNITS/ML SOLUTION FOR INJECTION IN CARTRIDGE insulin detemir 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, nurse or pharmacist. • 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Levemir is and what it is used for 2. What you need to know before you use Levemir 3. How to use Levemir 4. Possible side effects 5. How to store Levemir 6. Contents of the pack and other information 1. WHAT LEVEMIR IS AND WHAT IT IS USED FOR Levemir is a modern insulin (insulin analogue) with a long-acting effect. Modern insulin products are improved versions of human insulin. Levemir is used to reduce the high blood sugar level in adults, adolescents and children aged 1 year and above with diabetes mellitus (diabetes). Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar. Levemir can be used with meal-related rapid acting insulin medicines. In treatment of type 2 diabetes mellitus, Levemir may also be used in combination with tablets for diabetes and/or with injectable anti-diabetic products, other than insulin. Levemir has a long and steady blood-sugar-lowering action within 3 to 4 hours after injection. Levemir provides up to 24 hours of basal insulin coverage. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LEVEMIR DO NOT USE LEVEMIR ► If you are allergic to insulin detemir or any of the other ingredients in this medicine, see section 6, Contents of the pack and other information. ► If you suspect hypoglycaemia (low blood sugar) is Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Levemir Penfill 100 units/ml solution for injection in cartridge. Levemir FlexPen 100 units/ml solution for injection in pre-filled pen. Levemir InnoLet 100 units/ml solution for injection in pre-filled pen. Levemir _ _ FlexTouch 100 units/ml solution for injection in pre-filled pen. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Levemir Penfill 1 ml of the solution contains 100 units insulin detemir* (equivalent to 14.2 mg). 1 cartridge contains 3 ml equivalent to 300 units. Levemir FlexPen/Levemir InnoLet/Levemir FlexTouch 1 ml of the solution contains 100 units insulin detemir* (equivalent to 14.2 mg). 1 pre-filled pen contains 3 ml equivalent to 300 units. *Insulin detemir is produced in _Saccharomyces cerevisiae_ by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. The solution is clear, colourless and aqueous. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levemir is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The potency of insulin analogues, including insulin detemir, is expressed in units, whereas the potency of human insulin is expressed in international units. 1 unit insulin detemir corresponds to 1 international unit of human insulin. Levemir can be used alone as the basal insulin or in combination with bolus insulin. It can also be used in combination with oral antidiabetic medicinal products and/or GLP-1 receptor agonists. When Levemir is used in combination with oral antidiabetic medicinal products or when added to GLP-1 receptor agonists it is recommended to use Levemir once daily, initially at a dose of 0.1– 0.2 units/kg or of 10 units IN ADULT PATIENTS . The dose of Levemir should be titrated based on the individual patient’s needs. When a GLP-1 receptor agonist is added to Levemir, it is recommended to reduce the dose of Levemi Прочетете целия документ