Insulin Human Winthrop - human insulin

What is Insulin Human Winthrop?

Insulin Human Winthrop includes a series of injectable insulin solutions and suspensions. Insulin Human Winthrop is available in vials, cartridges or prefilled disposable pens (OptiSet and SoloStar).

Insulin Human Winthrop contains the active substance insulin human. The range of Insulin Human Winthrop includes fast-acting insulin solutions (Insulin Human Winthrop Rapid and Insulin Human Winthrop Infusat) that contain soluble insulin, an intermediate-acting insulin suspension (Insulin Human Winthrop Basal) that contains isophane insulin, and a combination of fast-acting insulin and intermediate-acting insulin in various proportions (Insulin Human Winthrop Comb):

Insulin Human Winthrop Comb 15: 15% soluble insulin and 85% crystalline protamine insulin;
Insulin Human Winthrop Comb 25: 25% soluble insulin and 75% crystalline protamine insulin;
Insulin Human Winthrop Comb 30: 30% soluble insulin and 70% crystalline protamine insulin;
Insulin Human Winthrop Comb 50: 50% soluble insulin and 50% crystalline protamine insulin.

The medicine is similar to Insuman, already authorized in the European Union (EU). The company that makes Insuman has agreed that its scientific data can be used for Insulin Human Winthrop.

What is Insulin Human Winthrop used for?

Insulin Human Winthrop is indicated in patients with diabetes when treatment with insulin is needed.

Insulin Human Winthrop is also suitable for the treatment of hyperglycemic coma (coma caused by an excessive level of glucose [sugar] in the blood) and ketoacidosis (high concentrations of ketones [acids] in the blood) and to obtain a stabilization of glucose in the blood before, after or during surgery.

The medicine can only be obtained with a prescription.

How is Insulin Human Winthrop used?

Insulin Human Winthrop is injected under the skin, usually in the abdominal wall (belly) or thigh according to the doctor's recommendations. The injection sites must be rotated between

one injection and the next. The expected blood glucose level, the type of Insulin Human Winthrop to be used, the dosage and the timing of administration are determined by the doctor for each individual patient and are adapted according to the patient's diet, physical activity and lifestyle. To find the minimum effective dosage, glucose should be monitored regularly in the patient's blood. Insulin Human Winthrop should be taken before meals. Please refer to the package leaflet for the correct administration times.

Insulin Human Winthrop Rapid can also be given into a vein, provided this is done in a hospital setting where the patient can be monitored closely. Insulin Human Winthrop Infusat was designed in special infusion pumps ready for use.

How does Insulin Human Winthrop work?

Diabetes is a disease due to the fact that the body does not produce enough insulin to control the level of glucose in the blood. Insulin Human Winthrop is an insulin analog that is identical to the body's own insulin.

The active ingredient of Insulin Human Winthrop, human insulin, is produced by a method known as "recombinant DNA technology": it is obtained from a bacterium with a gene (DNA) that makes it capable of producing insulin. Insulin Human Winthrop contains insulin in different forms: soluble insulin, which acts quickly (within 30 minutes of injection), and isophane insulin and crystalline protamine, which are absorbed much more slowly during the day giving them a longer lasting effect.

The insulin analog acts like naturally produced insulin and promotes the penetration of glucose into the cells from the blood. By controlling the level of glucose in the blood, the symptoms and complications of diabetes are reduced.

How has Insulin Human Winthrop been studied?

Insulin Human Winthrop has been studied in two trials of 611 patients with type 1 diabetes (in which the body is unable to produce insulin) or type 2 diabetes (in which the body is unable to to use insulin effectively). In one of the studies Insulin Human Winthrop was used in an insulin pump. In the other study, Insulin Human Winthrop Comb 25 was compared with semi-synthetic human insulin. These studies measured the fasting blood glucose concentration (measured when patients had been fasting for at least eight hours) or the levels of a substance in the blood called glycosylated hemoglobin (HbA1c) which gives an indication of the efficacy of glucose control in the blood. The studies also looked at the number of patients who developed hypoglycemia (low blood glucose concentrations).

What benefit has Insulin Human Winthrop shown during the studies?

Insulin Human Winthrop induced a decrease in the level of HbA1c, demonstrating that blood glucose concentrations were maintained at a level similar to that guaranteed by human semi-synthetic insulin. Insulin Human Winthrop has been shown to be effective in both type 1 diabetes and type 2 diabetes.

What is the risk associated with Insulin Human Winthrop?

Insulin Human Winthrop may cause hypoglycaemia. For the full list of all side effects reported with Insulin Human Winthrop, see the Package Leaflet.

Insulin Human Winthrop should not be used in people who may be hypersensitive (allergic) to human insulin or any of the other ingredients. Insulin Human Winthrop doses may be appropriate when given with other medicines that may have an effect on blood glucose levels. The complete list of these drugs is available in the package leaflet.

Why has Insulin Human Winthrop been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Insulin Human Winthrop's benefits are greater than its risks for the treatment of diabetes mellitus. The Committee therefore recommended the granting of a marketing authorization for Insulin Human Winthrop.