Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
insulin aspart
Novo Nordisk A/S
A10AB05
insulin aspart
Drugs used in diabetes
Diabetes Mellitus
NovoRapid is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Revision: 32
Authorised
1999-09-07
56 B. PACKAGE LEAFLET 57 PACKAGE LEAFLET: INFORMATION FOR THE USER NOVORAPID 100 UNITS/ML SOLUTION FOR INJECTION IN VIAL 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, 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 with 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 NovoRapid is and what it is used for 2. What you need to know before you use NovoRapid 3. How to use NovoRapid 4. Possible side effects 5. How to store NovoRapid 6. Contents of the pack and other information 1. WHAT NOVORAPID IS AND WHAT IT IS USED FOR NovoRapid is a modern insulin (insulin analogue) with a rapid-acting effect. Modern insulin products are improved versions of human insulin. NovoRapid 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 NovoRapid helps to prevent complications from your diabetes. NovoRapid 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 NovoRapid should normally be taken in combination with intermediate-acting or long-acting insulin preparations. Moreover NovoRapid can be used for continuous infusion in a pump system. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NOVORAPID DO NOT USE NOVORAPID ► If you are allergic to insulin aspart, or any of the other ingredients in this medicine (see section 6, Conten Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT NovoRapid 100 units/ml solution for injection in vial NovoRapid Penfill 100 units/ml solution for injection in cartridge NovoRapid FlexPen 100 units/ml solution for injection in pre-filled pen NovoRapid InnoLet 100 units/ml solution for injection in pre-filled pen NovoRapid FlexTouch 100 units/ml solution for injection in pre-filled pen NovoRapid PumpCart 100 units/ml solution for injection in cartridge 2. QUALITATIVE AND QUANTITATIVE COMPOSITION NovoRapid vial 1 vial contains 10 ml equivalent to 1,000 units.1 ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg). NovoRapid Penfill 1 cartridge contains 3 ml equivalent to 300 units.1 ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg). NovoRapid FlexPen/NovoRapid InnoLet/NovoRapid FlexTouch 1 pre-filled pen contains 3 ml equivalent to 300 units.1 ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg). NovoRapid PumpCart 1 cartridge contains 1.6 ml equivalent to 160 units.1 ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg). *Insulin aspart 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 NovoRapid 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 aspart, is expressed in units, whereas the potency of human insulin is expressed in international units. NovoRapid 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 NovoRapid vial and NovoRapid PumpCart can be used for continuous subcutaneous insulin infusion (CSII) in pum Lestu allt skjalið