Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
insulin glargine
Eli Lilly Nederland B.V.
A10AE04
insulin glargine
Drugs used in diabetes
Diabetes Mellitus
Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
Revision: 12
Authorised
2014-09-09
57 B. PACKAGE LEAFLET 58 PACKAGE LEAFLET: INFORMATION FOR THE USER ABASAGLAR 100 UNITS/ML SOLUTION FOR INJECTION IN A CARTRIDGE insulin glargine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. THE INSTRUCTIONS FOR USING THE INSULIN PEN ARE PROVIDED WITH YOUR INSULIN PEN. REFER TO THEM BEFORE USING YOUR MEDICINE. - 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 ABASAGLAR is and what it is used for 2. What you need to know before you use ABASAGLAR 3. How to use ABASAGLAR 4. Possible side effects 5. How to store ABASAGLAR 6. Contents of the pack and other information 1. WHAT ABASAGLAR IS AND WHAT IT IS USED FOR ABASAGLAR contains insulin glargine. This is a modified insulin, very similar to human insulin. ABASAGLAR is used to treat diabetes mellitus in adults, adolescents and children aged 2 years and above. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar. Insulin glargine has a long and steady blood-sugar-lowering action. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ABASAGLAR _ _ DO NOT USE ABASAGLAR If you are allergic to insulin glargine 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 ABASAGLAR. Follow closely the instructions for posology, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) as discussed with your doctor. If your blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia (see box at the end of Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT ABASAGLAR 100 units/mL solution for injection in a cartridge 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains 100 units insulin glargine* (equivalent to 3.64 mg). Each cartridge contains 3 mL of solution for injection, equivalent to 300 units. *produced by recombinant DNA technology in _Escherichia coli_ . For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ABASAGLAR contains insulin glargine, an insulin analogue and has a prolonged duration of action. ABASAGLAR should be administered once daily at any time but at the same time each day. The dose regimen (dose and timing) should be individually adjusted. In patients with type 2 diabetes mellitus, ABASAGLAR can also be given together with orally active antidiabetic medicinal products. The potency of this medicinal product is stated in units. These units are exclusive to insulin glargine and are not the same as IU or the units used to express the potency of other insulin analogues (see section 5.1). _Special populations _ _ _ _Elderly population (≥65 years old) _ In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements. _Renal impairment _ In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism. _ _ _Hepatic impairment _ In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism. 3 _Paediatric population _ _ _ _Adolescents and children aged 2 years and older _ The safety and efficacy of insulin glargine have been established in adolescents and children aged 2 years and older (see section 5.1). The dose Aqra d-dokument sħiħ