Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
insulin degludec
Novo Nordisk A/S
A10AE06
insulin degludec
Drugs used in diabetes
Diabetes Mellitus
Treatment of diabetes mellitus in adults.
Revision: 16
Authorised
2013-01-20
45 B. PACKAGE LEAFLET 46 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TRESIBA 100 UNITS/ML SOLUTION FOR INJECTION IN PRE-FILLED PEN insulin degludec 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 Tresiba is and what it is used for 2. What you need to know before you use Tresiba 3. How to use Tresiba 4. Possible side effects 5. How to store Tresiba 6. Contents of the pack and other information 1. WHAT TRESIBA IS AND WHAT IT IS USED FOR Tresiba is a long-acting basal insulin called insulin degludec. It is used to treat diabetes mellitus in adults, adolescents and children aged 1 year and above. Tresiba helps your body reduce your blood sugar level. It is used for once-daily dosing. On occasions when you cannot follow your regular dosing schedule, you can change the time of dosing because Tresiba has a long blood sugar-lowering effect (see section 3 for ‘Flexibility in dosing time’). Tresiba can be used with meal-related rapid-acting insulin products. In type 2 diabetes mellitus, Tresiba may be used in combination with tablets for diabetes or with injectable antidiabetic medicines, other than insulin. In type 1 diabetes mellitus, Tresiba must always be used in combination with meal-related rapid-acting insulin medicines. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TRESIBA DO NOT USE TRESIBA • if you are allergic to insulin degludec or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Tresiba 100 units/mL solution for injection in pre-filled pen Tresiba 200 units/mL solution for injection in pre-filled pen Tresiba 100 units/mL solution for injection in cartridge 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tresiba 100 units/mL solution for injection in pre-filled pen One pre-filled pen contains 300 units of insulin degludec in 3 mL solution. 1 mL solution contains 100 units insulin degludec* (equivalent to 3.66 mg insulin degludec). Tresiba 200 units/mL solution for injection in pre-filled pen One pre-filled pen contains 600 units of insulin degludec in 3 mL solution. 1 mL solution contains 200 units insulin degludec* (equivalent to 7.32 mg insulin degludec). Tresiba 100 units/mL solution for injection in cartridge One cartridge contains 300 units of insulin degludec in 3 mL solution. 1 mL solution contains 100 units insulin degludec* (equivalent to 3.66 mg insulin degludec). *Produced in _Saccharomyces cerevisiae_ by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tresiba 100 units/mL solution for injection in pre-filled pen Solution for injection (FlexTouch). Tresiba 200 units/mL solution for injection in pre-filled pen Solution for injection (FlexTouch). Tresiba 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 1 year. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology This medicinal product is a basal insulin for once-daily subcutaneous administration at any time of the day, preferably at the same time every day. The potency of insulin analogues, including insulin degludec, is expressed in units. One (1) unit of insulin degludec corresponds to 1 international unit of human insulin, 1 unit of insulin glargine (100 units/mL), or 1 unit of insulin detemir. In pa Прочетете целия документ