Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
insulin glulisine
sanofi-aventis Deutschland GmbH
A10AB06
insulin glulisine
Drugs used in diabetes
Diabetes Mellitus
Treatment of adults, adolescents and children, six years or older with diabetes mellitus, where treatment with insulin is required.
Revision: 32
Authorised
2004-09-27
35 B. PACKAGE LEAFLET 36 PACKAGE LEAFLET: INFORMATION FOR THE USER APIDRA 100 UNITS/ML SOLUTION FOR INJECTION IN A VIAL Insulin glulisine _ _ 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 Apidra is and what it is used for 2. What you need to know before you use Apidra 3. How to use Apidra 4. Possible side effects 5. How to store Apidra 6. Contents of the pack and other information 1. WHAT APIDRA IS AND WHAT IT IS USED FOR Apidra is an antidiabetic agent, used to reduce high blood sugar in patients with diabetes mellitus; it may be given to adults, adolescents and children, 6 years of age and older. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar. It is made by biotechnology. It has a rapid onset within 10-20 minutes and a short duration, about 4 hours. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE APIDRA DO NOT USE APIDRA - If you are allergic to insulin glulisine or any of the other ingredients of this medicine (listed in section 6). - If your blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia (see box at the end of this leaflet). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Apidra. Follow closely the instructions for dose, monitoring (blood tests), diet and physical activity (physical work and exercise) as discussed with your doctor. Special patient groups If you have liver or kidney problems, speak to your doctor as you may need a lower dose. There is insuff Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Apidra 100 Units/ml solution for injection in a vial Apidra 100 Units/ml solution for injection in a cartridge Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 100 Units insulin glulisine (equivalent to 3.49 mg). _ _ _Apidra 100 Units/ml solution for injection in a vial _ Each vial contains 10 ml of solution for injection, equivalent to 1000 Units. _ _ _Apidra 100 Units/ml solution for injection in a cartridge _ Each cartridge contains 3 ml of solution for injection, equivalent to 300 Units. _ _ _Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen _ Each pen contains 3 ml of solution for injection, equivalent to 300 Units. Insulin glulisine is produced by recombinant DNA technology in _Escherichia coli_ . For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM _Apidra 100 Units/ml solution for injection in a vial _ Solution for injection in a vial. _Apidra 100 Units/ml solution for injection in a cartridge _ Solution for injection in a cartridge. _Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen _ Solution for injection in a pre-filled pen. Clear, colourless, aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of adults, adolescents and children 6 years or older, with diabetes mellitus, where treatment with insulin is required. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The potency of this preparation is stated in units. These units are exclusive to Apidra and are not the same as IU or the units used to express the potency of other insulin analogues (see section 5.1). Apidra should be used in regimens that include an intermediate or long acting insulin or basal insulin analogue and can be used with oral hypoglycaemic agents. The dose of Apidra should be individually adjusted. 3 Special populations _Renal impairment _ The pharmacokinetic properties of insulin Lestu allt skjalið