Država: Evropska unija
Jezik: angleščina
Source: EMA (European Medicines Agency)
insulin lispro
Eli Lilly Nederland B.V.
A10AB04, A10AD04
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. Liprolog is also indicated for the initial stabilisation of diabetes mellitus.
Revision: 30
Authorised
2001-08-01
104 B. PACKAGE LEAFLET 105 PACKAGE LEAFLET: INFORMATION FOR THE USER LIPROLOG 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 Liprolog is and what it is used for 2. What you need to know before you use Liprolog 3. How to use Liprolog 4. Possible side effects 5. How to store Liprolog 6. Contents of the pack and other information 1. WHAT LIPROLOG IS AND WHAT IT IS USED FOR Liprolog is used to treat diabetes. Liprolog 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. Liprolog 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 Liprolog within 15 minutes of a meal. Your doctor may tell you to use Liprolog 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. Liprolog is suitable for use in adults and children. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LIPROLOG DO NOT USE LIPROLOG - if you think HYPOGLYCAEMIA (low blood sugar) is starting. Further in this leaflet it tells you how to deal with mild hypoglycaemia (see Section 3: If you take more Liprolog than you need). - if you Preberite celoten dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Liprolog 100 units/ml, solution for injection in vial Liprolog 100 units/ml, solution for injection in cartridge Liprolog 100 units/ml KwikPen, solution for injection in a pre-filled pen Liprolog 100 units/ml Junior KwikPen, solution for injection in a pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 100 units insulin lispro* (equivalent to 3.5mg). Vial Each vial contains 1000 units of insulin lispro in 10 ml solution. Cartridge Each cartridge contains 300 units of insulin lispro in 3 ml solution. KwikPen Each pre-filled pen contains 300 units of insulin lispro in 3 ml solution. Each KwikPen delivers 1-60 units in steps of 1 unit. Junior KwikPen Each pre-filled pen contains 300 units of insulin lispro in 3 ml solution. Each Junior KwikPen delivers 0.5 – 30 units in steps of 0.5 units. *produced in _E.coli_ by recombinant DNA technology. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. 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. Liprolog is also indicated for the initial stabilisation of diabetes mellitus. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosage should be determined by the physician, according to the requirement of the patient. _Junior KwikPen _ Liprolog 100 units/ml Junior KwikPen is suitable for patients who may benefit from finer insulin dose adjustments. Liprolog may be given shortly before meals. When necessary Liprolog can be given soon after meals. 3 Liprolog takes effect rapidly and has a shorter duration of activity (2 to 5 hours) given subcutaneously as compared with soluble insulin. This rapid onset of activity allows a Liprolog injection (or, in the case of administration by continuous subcutaneous infusion, a Liprolog bolus) to be given very close to Preberite celoten dokument