Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Insulin human
Sanofi-aventis Deutschland GmbH
A10AB01, A10AC01
insulin human
Drugs used in diabetes
Diabetes Mellitus
Diabetes mellitus where treatment with insulin is required. Insuman Rapid is also suitable for the treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and postoperative stabilisation in patients with diabetes mellitus.
Revision: 33
Authorised
1997-02-21
205 B. PACKAGE LEAFLET 206 PACKAGE LEAFLET: INFORMATION FOR THE USER INSUMAN RAPID 100 IU/ML SOLUTION FOR INJECTION IN A VIAL Insulin human 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 Insuman Rapid is and what it is used for 2. What you need to know before you use Insuman Rapid 3. How to use Insuman Rapid 4. Possible side effects 5. How to store Insuman Rapid 6. Contents of the pack and other information 1. WHAT INSUMAN RAPID IS AND WHAT IT IS USED FOR Insuman Rapid contains the active substance insulin human which is made by a biotechnology process and is identical with the body's own insulin. Insuman Rapid is an insulin solution with a rapid onset and short duration of action. Insuman Rapid is used to reduce high blood sugar in patients with diabetes mellitus who need treatment with insulin. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar. Insuman Rapid may also be used for treating hyperglycaemic coma (coma caused by too much blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar) as well as for controlling blood sugar before, during and after surgery. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE INSUMAN RAPID DO NOT USE INSUMAN RAPID If you are allergic to insulin 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 Insuman Rapid. Follow closely the instruct Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Insuman Rapid 40 IU/ml solution for injection in a vial Insuman Rapid 100 IU/ml solution for injection in a vial 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Insuman Rapid 40 IU/ml in a vial Each ml contains 40 IU insulin human (equivalent to 1.4 mg). Each vial contains 10 ml of solution for injection, equivalent to 400 IU insulin. Insuman Rapid 100 IU/ml in a vial Each ml contains 100 IU insulin human (equivalent to 3.5 mg). Each vial contains 5 ml of solution for injection, equivalent to 500 IU insulin, or 10 ml of solution for injection, equivalent to 1000 IU insulin. One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin * . Insuman Rapid is a neutral insulin solution (regular insulin). * Human insulin is produced by recombinant DNA technology in _Escherichia coli_ . For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Diabetes mellitus where treatment with insulin is required. Insuman Rapid is also suitable for the treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and post-operative stabilisation in patients with diabetes mellitus. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The desired blood glucose levels, the insulin preparations to be used and the insulin dose regimen (doses and timings) must be determined individually and adjusted to suit the patient’s diet, physical activity and life-style. _Daily doses and timing of administration _ There are no fixed rules for insulin dose regimen. However, the average insulin requirement is often 0.5 to 1.0 IU per kg body weight per day. The basal metabolic requirement is 40% to 60% of the total daily requirement. Insuman Rapid is injected subcutaneously 15 to 20 minutes before a meal. In the treatment of severe hyperglycaemia or ketoacidosis in particular, insulin administration is part of a com Read the complete document