Insuman

insulin human

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Insuman?

Insuman is a range of insulin solutions and suspensions for injection. It is supplied in vials, cartridges and prefilled disposable pens (OptiSet and SoloStar).

Insuman contains the active substance insulin human. The Insuman range is comprised of fast-acting insulin solutions (Insuman Rapid and Insuman Infusat) that contain soluble insulin, an intermediate-acting insulin suspension (Insuman Basal) that contains isophane insulin, and combinations of fast- and intermediate-acting insulins in various proportions (Insuman Comb):

• Insuman Comb 15: 15% soluble insulin and 85% crystalline protamine insulin;
• Insuman Comb 25: 25% soluble insulin and 75% crystalline protamine insulin;
• Insuman Comb 30: 30% soluble insulin and 70% crystalline protamine insulin;
• Insuman Comb 50: 50% soluble insulin and 50% crystalline protamine insulin.

What is Insuman used for?

Insuman is used in patients with diabetes who need treatment with insulin.

Insuman Rapid can also be used for the treatment of hyperglycaemic coma (coma caused by too much blood glucose [sugar]) and ketoacidosis (high levels of ketones [acids] in the blood), and to control blood glucose before, during or after an operation.

The medicine can only be obtained with a prescription.

How is Insuman used?

Insuman is given by injection under the skin, generally in the abdominal wall (tummy) or the thigh, according to the doctor’s recommendations. The injection site is changed for each injection. The desired blood glucose levels, the type of Insuman to be used, and the dose and timing of injections are determined by the doctor for each patient individually, and are adjusted to suit the patient’s diet, physical activity and lifestyle. The patient’s blood glucose should be tested regularly to find the lowest effective dose. Insuman should be given before meals. See the package leaflet for exact timings.

Insuman Rapid may also be given into a vein, but only in hospital where the patient can be closely monitored. Insuman Infusat is specially prepared ready to be used in infusion pumps.

How does Insuman work?

Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose. Insuman is a replacement insulin that is identical to the insulin made by the body.

The active substance in Insuman, insulin human, is produced by a method known as ‘recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce insulin. Insuman contains insulin in various forms: the soluble form, which acts quickly (within 30 minutes of injection), and the isophane and crystalline-protamine forms, which are absorbed much more slowly during the day, giving them a longer duration of action.

The replacement insulin acts in the same way as naturally produced insulin and helps glucose enter cells from the blood. By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.

How has Insuman been studied?

Insuman has been studied in two trials in 611 patients with either type-1 diabetes (when the pancreas cannot produce insulin) or type-2 diabetes (when the body is unable to use insulin effectively). In one of the studies, Insuman was used in an insulin pump. In the other study, Insuman Comb 25 was compared with semisynthetic human insulin. The studies measured the ‘fasting’ blood glucose levels (measured when the patient had not eaten for at least eight hours) or a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled. The studies also looked at the number of patients who developed hypoglycaemia (low blood glucose levels).

What benefit has Insuman shown during the studies?

Insuman led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with semisynthetic human insulin. Insuman was effective for both type-1 and type-2 diabetes.

What is the risk associated with Insuman?

Insuman may cause hypoglycaemia. For the full list of all side effects reported with Insuman, see the package leaflet.

Insuman should not be used in people who may be hypersensitive (allergic) to insulin human or any of the other ingredients. Insuman doses might also need to be adjusted when it is given with other medicines that may have an effect on blood glucose levels. The full list of these medicines is available in the package leaflet.

Why has Insuman been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Insuman’s benefits are greater than its risks for the treatment of diabetes mellitus. The Committee recommended that Insuman be given marketing authorisation.

Other information about Insuman

The European Commission granted a marketing authorisation valid throughout the European Union for Insuman to Sanofi-Aventis Deutschland GmbH on 21 February 1997. The marketing authorisation was renewed on 21 February 2002 and on 21 February 2007.

This EPAR was last updated on 20/03/2013 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

13/12/2012  Insuman -EMEA/H/C/000201 -IG/0246/G

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

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.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents