Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
insulin aspart, insulin degludec
Novo Nordisk A/S
A10AD06
insulin degludec, insulin aspart
Drugs used in diabetes
Diabetes Mellitus
Treatment of diabetes mellitus in adults, adolescents and children from the age of 2 years.
Revision: 13
Authorised
2013-01-21
34 B. PACKAGE LEAFLET 35 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RYZODEG 100 UNITS/ML SOLUTION FOR INJECTION IN PRE-FILLED PEN 70% insulin degludec / 30% 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 Ryzodeg is and what it is used for 2. What you need to know before you use Ryzodeg 3. How to use Ryzodeg 4. Possible side effects 5. How to store Ryzodeg 6. Contents of the pack and other information 1. WHAT RYZODEG IS AND WHAT IT IS USED FOR Ryzodeg is used to treat diabetes mellitus in adults, adolescents and children from the age of 2 years. It helps your body reduce your blood sugar level. This medicine contains two types of insulin: • Basal insulin called insulin degludec, this has a long blood sugar-lowering effect. • Rapid-acting insulin called insulin aspart, this lowers your blood sugar soon after you inject it. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE RYZODEG DO NOT USE RYZODEG • if you are allergic to insulin degludec, 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 Ryzodeg. Be especially aware of the following: • Low blood sugar (hypoglycaemia) – if your blood sugar is too low, follow the guidance for low blood sugar in section 4. • High blood sugar (hyperglycaemia) – if your blood sugar is too high, follow the guidance for high blood sugar in section 4. • Switching from other insulin medicines – the insulin dos Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ryzodeg 100 units/mL solution for injection in pre-filled pen Ryzodeg 100 units/mL solution for injection in cartridge 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL solution contains 100 units insulin degludec/insulin aspart* in the ratio 70/30 (equivalent to 2.56 mg insulin degludec and 1.05 mg insulin aspart). Ryzodeg 100 units/mL solution for injection in pre-filled pen One pre-filled pen contains 300 units of insulin degludec/insulin aspart in 3 mL solution. Ryzodeg 100 units/mL solution for injection in cartridge One cartridge contains 300 units of insulin degludec/insulin aspart in 3 mL solution. *Produced in _Saccharomyces cerevisiae _ by recombinant DNA technology _._ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Ryzodeg 100 units/mL solution for injection in pre-filled pen Solution for injection (FlexTouch). Ryzodeg 100 units/mL solution for injection in cartridge Solution for injection (Penfill). Clear, colourless, neutral solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of diabetes mellitus in adults, adolescents and children from the age of 2 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology This medicinal product is a soluble insulin product consisting of the basal insulin degludec and the rapid-acting prandial insulin aspart. The potency of insulin analogues, including Ryzodeg, is expressed in units. One (1) unit of this insulin corresponds to 1 international unit of human insulin, 1 unit of insulin glargine, 1 unit of insulin detemir or 1 unit of biphasic insulin aspart. Ryzodeg is to be dosed in accordance with the individual patient’s needs. Dose-adjustments are recommended to be based on fasting plasma glucose measurements. Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness. _Patients with type 2 diabetes mellitus_ Ryzodeg can be administered once or twice daily with Прочетете целия документ