Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
insulin aspart
Novo Nordisk A/S
A10AD05
insulin aspart
Drugs used in diabetes
Diabetes Mellitus
Treatment of diabetes mellitus.
Revision: 29
Authorised
2000-08-01
43 B. PACKAGE LEAFLET VV-LAB-103275 1 . 0 . 44 PACKAGE LEAFLET: INFORMATION FOR THE USER NOVOMIX 30 PENFILL 100 UNITS/ML SUSPENSION FOR INJECTION IN A CARTRIDGE 30% soluble insulin aspart and 70% insulin aspart crystallised with protamine 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 NovoMix 30 is and what it is used for 2. What you need to know before you use NovoMix 30 3. How to use NovoMix 30 4. Possible side effects 5. How to store NovoMix 30 6. Contents of the pack and other information 1. WHAT NOVOMIX 30 IS AND WHAT IT IS USED FOR NovoMix 30 is a modern insulin (insulin analogue) with both a rapid-acting and an intermediate-acting effect, in the ratio 30/70. Modern insulin products are improved versions of human insulin. NovoMix 30 is used to reduce the high blood sugar level in adults, adolescents and children aged 10 years 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. NovoMix 30 will start to lower your blood sugar 10–20 minutes after you inject it, the maximum effect occurs between 1 and 4 hours after the injection, and the effect lasts for up to 24 hours. In treatment of type 2 diabetes mellitus, NovoMix 30 may be used in combination with tablets for diabetes and/or with injectable antidiabetic products. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NOVOMIX 30 DO NOT USE NOVOMIX 30 ► If you are allergic to insulin aspart or any of the other ingredients in t Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS VV-LAB-103275 1 . 0 . 2 1. NAME OF THE MEDICINAL PRODUCT NovoMix 30 Penfill 100 units/ml suspension for injection in cartridge NovoMix 30 FlexPen 100 units/ml suspension for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ NovoMix 30 Penfill 1 ml of the suspension contains 100 units soluble insulin aspart*/protamine-crystallised insulin aspart* in the ratio 30/70 (equivalent to 3.5 mg). 1 cartridge contains 3 ml equivalent to 300 units. NovoMix 30 FlexPen 1 ml of the suspension contains 100 units soluble insulin aspart*/protamine-crystallised insulin aspart* in the ratio 30/70 (equivalent to 3.5 mg). 1 pre-filled pen contains 3 ml equivalent to 300 units. *Insulin aspart is produced in _Saccharomyces cerevisiae_ by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. The suspension is cloudy, white and aqueous. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NovoMix 30 is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 10 years 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. NovoMix 30 dosing is individual and determined in accordance with the needs of the patient. Blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal glycaemic control. _ _ In patients with type 2 diabetes, NovoMix 30 can be given as monotherapy. NovoMix 30 can also be given in combination with oral antidiabetic medicinal products and/or GLP-1 receptor agonists. For patients with type 2 diabetes, the recommended starting dose of NovoMix 30 is 6 units at breakfast and 6 units at dinner (evening meal). NovoMix 30 can also be initiated once daily with 12 units at dinner (evening meal). When using NovoMix 30 once daily, it is generally recommended to move to twice Pročitajte cijeli dokument