Pays: Union européenne
Langue: anglais
Source: EMA (European Medicines Agency)
insulin lispro
Sanofi Winthrop Industrie
A10AB04
insulin lispro
Drugs used in diabetes
Diabetes Mellitus
For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Insulin lispro Sanofi is also indicated for the initial stabilisation of diabetes mellitus.
Revision: 9
Authorised
2017-07-19
32 B. PACKAGE LEAFLET 33 PACKAGE LEAFLET: INFORMATION FOR THE USER INSULIN LISPRO SANOFI 100 UNITS/ML SOLUTION FOR INJECTION IN VIAL insulin lispro 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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Insulin lispro Sanofi is and what it is used for 2. What you need to know before you use Insulin lispro Sanofi 3. How to use Insulin lispro Sanofi 4. Possible side effects 5. How to store Insulin lispro Sanofi 6. Contents of the pack and other information 1. WHAT INSULIN LISPRO SANOFI IS AND WHAT IT IS USED FOR Insulin lispro Sanofi is used to treat diabetes. It works more quickly than normal human insulin because the insulin molecule has been changed slightly. You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your blood. Insulin lispro Sanofi is a substitute for your own insulin and is used to control glucose in the long term. It works very quickly and lasts a shorter time than soluble insulin (2 to 5 hours). You should normally use Insulin lispro Sanofi within 15 minutes of a meal. Your doctor may tell you to use Insulin lispro Sanofi as well as a longer-acting insulin. Each kind of insulin comes with another patient information leaflet to tell you about it. Do not change your insulin unless your doctor tells you to. Be very careful if you do change insulin. Insulin lispro Sanofi is suitable for use in adults and children. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE INSULIN LISPRO SANOFI DO NOT USE INSULIN LISPRO SANOFI - if you think HYPOGLYCAEMIA (low blood Lire le document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Insulin lispro Sanofi 100 units/ml solution for injection in vial Insulin lispro Sanofi 100 units/ml solution for injection in cartridge Insulin lispro Sanofi 100 units/ml solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution contains 100 units (equivalent to 3.5 mg) insulin lispro*. Insulin lispro Sanofi 100 units/ml solution for injection in vial Each vial contains 10 ml equivalent to 1,000 units insulin lispro. Insulin lispro Sanofi 100 units/ml solution for injection in cartridge Each cartridge contains 3 ml equivalent to 300 units insulin lispro. Insulin lispro Sanofi 100 units/ml solution for injection in pre-filled pen Each pre-filled pen contains 3 ml equivalent to 300 units insulin lispro. Each pre-filled pen delivers 1-80 units in steps of 1 unit. * Produced in _E.coli_ by recombinant DNA technology For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Insulin lispro Sanofi 100 units/ml solution for injection in vial and in cartridge Solution for injection (injection). Insulin lispro Sanofi 100 units/ml solution for injection in a pre-filled pen Solution for injection (injection) in pre-filled pen (SoloStar). Clear, colourless, aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Insulin lispro Sanofi is also indicated for the initial stabilisation of diabetes mellitus. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose should be determined by the physician, according to the requirement of the patient. 3 Insulin lispro may be given shortly before meals. When necessary insulin lispro can be given soon after meals. Insulin lispro takes effect rapidly and has a shorter duration of activity (2 to 5 hours) given subcutaneously as compared with regular insulin. This rapid onset of activity allows an Insulin Lire le document complet