What is Insuman?
Insuman includes a number of injectable insulin solutions and suspensions. Insuman is available in single-use vials, cartridges or pre-filled pens (OptiSet and SoloStar).
Insuman contains the active substance insulin human. The Insuman range includes fast-acting insulin solutions (Insuman Rapid and Insuman Infusat) which contain soluble insulin, an intermediate-acting insulin suspension (Insuman Basal) which contains isophane insulin, and a combination of fast-acting insulin and insulin intermediate action 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 indicated in patients with diabetes when insulin treatment is required.
Insuman Rapid is also suitable for the treatment of hyperglycemic coma (coma caused by an excessive level of glucose [sugar] in the blood), ketoacidosis (high concentrations of ketones [acids] in the blood) and to achieve stabilization of blood glucose before , after or during surgery.
The medicine can only be obtained with a prescription.
How is Insuman used?
Insuman is injected under the skin, usually in the abdominal (belly) wall or thigh, according to the doctor's recommendations. The injection sites must be rotated between one injection and the next. The expected blood glucose rate, the type of Insuman to be used, the dosage and timing of administration are determined by the physician for each individual patient and are adapted to the diet , to the physical activity and lifestyle of the patient. To find the lowest effective dosage it is necessary to regularly monitor the patient's blood glucose level. Insuman must be taken before meals. Please refer to the package leaflet for the correct administration times. Insuman Rapid can also be administered into a vein, provided this is done in a hospital setting, where the patient can be closely monitored. Insuman Infusat has been designed in dedicated ready-to-use infusion pumps.
How does Insuman work?
Diabetes is a disease in which the body does not produce enough insulin to control glucose levels in the blood. Insuman is an insulin analog, identical to the insulin produced by the body.
The active substance in Insuman, human insulin, is produced by a method known as 'recombinant DNA technology': it is made by a bacterium with a gene (DNA) that makes it able to produce insulin. Insuman contains insulin. in different forms: soluble insulin, which acts quickly (within 30 minutes of injection), and forms of isophane insulin and crystalline protamine, which are absorbed much more slowly during the day giving them a longer lasting effect.
Replacement insulin acts just like natural insulin and promotes the penetration of glucose into cells from the blood. By controlling the blood glucose level, the symptoms and complications of diabetes are reduced.
How has Insuman been studied?
Insuman has been studied in two trials involving 611 patients with type 1 diabetes (in which the pancreas is unable to produce insulin) or type 2 diabetes (in which the body is unable to use the "insulin effectively). In one of the two studies, Insuman was used in an insulin pump. In the other study, Insuman Comb 25 was compared with semisynthetic human insulin. These studies measured the fasting concentration of glucose in the blood (measured when patients had fasted for at least eight hours) or a substance in the blood called glycosylated hemoglobin (HbA1c) which gives an "indication of how well the blood glucose is controlled. The studies also looked at the number of patients who they had developed hypoglycemia (low blood glucose levels).
What benefit has Insuman shown during the studies?
Insuman induced a drop in the level of HbA1c, demonstrating that blood glucose concentrations were maintained at a level similar to that guaranteed by human semi-synthetic insulin. Insuman was effective in both type 1 diabetes and diabetes. type 2.
What is the risk associated with Insuman?
Insuman can cause hypoglycaemia. For the full list of side effects reported with Insuman, see the package leaflet.
Insuman must not be used in people who may be hypersensitive (allergic) to human insulin or any of the other ingredients. The doses of Insuman may need to be adjusted when taking other medicines which may have an effect on the glucose level. in the blood. For a full list of these medicines, see 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 the granting of a marketing authorization for Insuman.
Learn more about Insuman
On 21 February 1997 the European Commission granted Sanofi-Aventis Deutschland GmbH a "Marketing Authorization" for Insuman, valid throughout the European Union. The "Marketing Authorization" was renewed on 21 February 2002 and on February 21, 2007.
For the full version of Insuman's EPAR click here.
Last update of this summary: 12-2008
The information on Insuman - human insulin published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
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