Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Insulin human
Novo Nordisk A/S
A10AB01
insulin human (rDNA)
Drugs used in diabetes
Diabetes Mellitus
Treatment of diabetes mellitus.
Revision: 5
Withdrawn
2002-10-07
Medicinal product no longer authorised 22 B. PACKAGE LEAFLET Medicinal product no longer authorised 23 PACKAGE LEAFLET: INFORMATION FOR THE USER VELOSULIN 100 IU/ML SOLUTION FOR INJECTION IN A VIAL Insulin human (rDNA) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING YOUR INSULIN. – Keep this leaflet. You may need to read it again. – If you have any further questions, ask your doctor, diabetes nurse or your pharmacist. – This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. – If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or your pharmacist. 1. WHAT VELOSULIN IS AND WHAT IT IS USED FOR VELOSULIN IS HUMAN INSULIN TO TREAT DIABETES. Velosulin is a fast-acting insulin. This means that it will start to lower your blood sugar about half an hour after you take it. 2. BEFORE YOU USE VELOSULIN DO NOT USE VELOSULIN IF YOU ARE ALLERGIC (HYPERSENSITIVE) to this insulin product, metacresol or any of the other ingredients (see_ 7 Further information)_. Look out for the signs of allergy in _5 Possible side _ _effects_ IF YOU FEEL A HYPO coming on (a hypo is short for a hypoglycaemic reaction and is a symptom of low blood sugar). See _4 What to do in an emergency_ for more about hypos. TAKE SPECIAL CARE WITH VELOSULIN IF YOU HAVE TROUBLE with your kidneys or liver, or with your adrenal, pituitary or thyroid glands IF YOU ARE DRINKING ALCOHOL: watch for signs of a hypo and never drink alcohol on an empty stomach IF YOU ARE EXERCISING more than usual or if you want to change your usual diet IF YOU ARE ILL: carry on taking your insulin IF YOU ARE GOING ABROAD: travelling over time zones may affect your insulin needs and the timing of your injections. USING OTHER MEDICINES Many medicines affect the way glucose works in your body and they may influence your insulin dose. Listed below are the most common medicines which may affect your insuli Прочетете целия документ
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Velosulin 100 IU/ml solution for injection or infusion in a vial. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Insulin human, rDNA (produced by recombinant DNA technology in _Saccharomyces cerevisiae_). 1 ml contains 100 IU of insulin human. 1 vial contains 10 ml equivalent to 1000 IU. One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection or infusion in a vial. Clear, colourless, aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of diabetes mellitus. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This phosphate-buffered soluble insulin is intended for continuous subcutaneous insulin infusion (CSII) in external insulin infusion pumps. Velosulin is a fast-acting insulin and may be used in combination with certain long-acting insulin products. For incompatibilities see section 6.2. Dosage Dosage is individual and determined by the physician in accordance with the needs of the patient. Usually, 40-60% of the total daily dose is given as a continuous basal rate and the remaining 40-60% as boluses divided between the three main meals. In general, when patients are transferred from injection to infusion therapy, it may be advisable to reduce the dosage by initiating the patient at 90% of the previous total daily dosage, with 40% as basal rate and 50% as boluses divided between the three main meals. Dosage is individual and determined in accordance with the needs of the patient. The individual insulin requirement is usually between 0.3 and 1.0 IU/kg/day. The daily insulin requirement may be higher in patients with insulin resistance (e.g. during puberty or due to obesity) and lower in patients with residual, endogenous insulin production. In patients with diabetes mellitus optimised glycaemic control delays the onset of Прочетете целия документ