Страна: Європейський Союз
мова: англійська
Джерело: EMA (European Medicines Agency)
insulin aspart
Sanofi Winthrop Industrie
A10AB05
insulin aspart
Drugs used in diabetes
Diabetes Mellitus
Insulin aspart Sanofi is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Revision: 4
Authorised
2020-06-25
32 B. PACKAGE LEAFLET 33 PACKAGE LEAFLET: INFORMATION FOR THE USER INSULIN ASPART SANOFI 100 UNITS/ML SOLUTION FOR INJECTION IN VIAL insulin aspart 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 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 Insulin aspart Sanofi is and what it is used for 2. What you need to know before you use Insulin aspart Sanofi 3. How to use Insulin aspart Sanofi 4. Possible side effects 5. How to store Insulin aspart Sanofi 6. Contents of the pack and other information 1. WHAT INSULIN ASPART SANOFI IS AND WHAT IT IS USED FOR Insulin aspart Sanofi is a modern insulin (insulin analogue) with a rapid-acting effect. Modern insulin products are improved versions of human insulin. Insulin aspart Sanofi 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. Treatment with nsulin aspart helps to prevent complications from your diabetes. Insulin aspart will start to lower your blood sugar 10–20 minutes after you inject it, a maximum effect occurs between 1 and 3 hours after the injection and the effect lasts for 3–5 hours. Due to this short action insulin aspart should normally be taken in comb Прочитайте повний документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 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 Insulin aspart Sanofi 100 units/ml solution for injection in vial Insulin aspart Sanofi 100 units/ml solution for injection in cartridge Insulin aspart Sanofi 100 units/ml solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg). Insulin aspart Sanofi 100 units/ml solution for injection in vial Each vial contains 10 ml equivalent to 1,000 units insulin aspart. Insulin aspart Sanofi 100 units/ml solution for injection in cartridge Each cartridge contains 3 ml equivalent to 300 units insulin aspart. Insulin aspart Sanofi 100 units/m l solution for injection in pre-filled pen Each pre-filled pen contains 3 ml equivalent to 300 units insulin aspart. Each pre-filled pen delivers 1-80 units in steps of 1 unit. *produced in _Escherichia coli_ by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear, colourless, aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Insulin aspart Sanofi is indicated for the 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 aspart, is expressed in units, whereas the potency of human insulin is expressed in international units. Insulin aspart Sanofi dosing is individual and determined in accordance with the needs of the patient. It should normally be used in combination with intermediate-acting or long-acting insulin. 3 Moreover, Insulin aspart Sanofi vial can be used for continuous subcutaneous insulin infusion (CSII Прочитайте повний документ