Страна: Европейский союз
Язык: английский
Источник: EMA (European Medicines Agency)
insulin aspart
Novo Nordisk A/S
A10AB05
insulin aspart
Drugs used in diabetes, Insulins and analogues for injection, fast-acting
Diabetes Mellitus
Treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Revision: 8
Authorised
2017-01-09
52 B. PACKAGE LEAFLET 53 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FIASP 100 UNITS/ML FLEXTOUCH SOLUTION FOR INJECTION IN PRE-FILLED PEN insulin aspart 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1 What Fiasp is and what it is used for 2 What you need to know before you use Fiasp 3 How to use Fiasp 4 Possible side effects 5 How to store Fiasp 6 Contents of the pack and other information 1. WHAT FIASP IS AND WHAT IT IS USED FOR Fiasp is a mealtime insulin with a fast-acting blood sugar lowering effect. Fiasp is a solution for injection containing insulin aspart and is used to treat diabetes mellitus in adults, adolescents and children aged 1 year and above. Diabetes is a disease where your body does not produce enough insulin to control the level of blood sugar. Treatment with Fiasp helps to prevent complications from your diabetes. Fiasp should be injected up to 2 minutes before the start of the meal, with an option to inject up to 20 minutes after starting the meal. This medicine has its maximum effect between 1 and 3 hours after the injection and the effect lasts for 3 to 5 hours. This medicine should normally be used in combination with intermediate-acting or long-acting insulin preparations. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FIASP _ _ DO NOT USE FIASP • if you are allergic to insulin aspart, 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 Fiasp. Be especially awa Прочитать полный документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Fiasp 100 units/mL FlexTouch solution for injection in pre-filled pen Fiasp 100 units/mL Penfill solution for injection in cartridge Fiasp 100 units/mL solution for injection in vial Fiasp 100 units/mL PumpCart solution for injection in cartridge 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL of the solution contains 100 units of insulin aspart* (equivalent to 3.5 mg). Fiasp 100 units/mL FlexTouch solution for injection in pre-filled pen Each pre-filled pen contains 300 units of insulin aspart in 3 mL solution. Fiasp 100 units/mL Penfill solution for injection in cartridge Each cartridge contains 300 units of insulin aspart in 3 mL solution. Fiasp 100 units/mL solution for injection in vial Each vial contains 1,000 units of insulin aspart in 10 mL solution. Fiasp 100 units/mL PumpCart solution for injection in cartridge Each cartridge contains 160 units of insulin aspart in 1.6 mL solution. *Insulin aspart is produced in _Saccharomyces cerevisiae _ by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Fiasp 100 units/mL FlexTouch solution for injection in pre-filled pen Solution for injection (FlexTouch). Fiasp 100 units/mL Penfill solution for injection in cartridge Solution for injection (Penfill). Fiasp 100 units/mL solution for injection in vial Solution for injection. Fiasp 100 units/mL PumpCart solution for injection in cartridge Solution for injection (PumpCart). Clear, colourless, aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 3 Treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Fiasp is a mealtime insulin for subcutaneous administration up to 2 minutes before the start of the meal, with the option to administer up to 20 minutes after starting the meal (see section 5.1). Dosing with Fiasp is individual and determined in accordance with the needs of the patient. Fia Прочитать полный документ