What is Insulin Human Winthrop?
Insulin Human Winthrop includes a number of injectable insulin solutions and suspensions. Insulin Human Winthrop is available in single-use vials, cartridges or pre-filled pens (OptiSet and SoloStar).
Insulin Human Winthrop contains the active substance insulin human. The Insulin Human Winthrop range includes fast-acting insulin solutions (Insulin Human Winthrop Rapid and Insulin Human Winthrop Infusat) which contain soluble insulin, an intermediate-acting insulin suspension (Insulin Human Winthrop Basal) which 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, which is 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 insulin treatment is required.
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 achieve stabilization of blood glucose. 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 into the abdominal (belly) wall or thigh as recommended by the doctor. Injection sites should be rotated between
one injection and the next. The expected blood glucose rate, the type of Insulin Human Winthrop to be used, the dosage and administration times are determined by the doctor for each individual patient and are adapted according to the diet, physical activity and the patient's lifestyle. To find the lowest effective dosage, the patient's blood glucose should be monitored regularly. Insulin Human Winthrop must be taken before meals. Please refer to the package leaflet for the correct administration times.
Insulin Human Winthrop Rapid can also be administered into a vein, provided this is done in a hospital setting, where the patient can be closely monitored. Insulin Human Winthrop Infusat has been designed in dedicated ready-to-use infusion pumps.
How does Insulin Human Winthrop work?
Diabetes is a disease caused by the body not producing enough insulin to control the level of glucose in the blood. Insulin Human Winthrop is an insulin analog that is identical to the insulin produced by the body.
The active substance in Insulin Human Winthrop, insulin human, 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. Insulin Human Winthrop contains insulin in different forms: soluble insulin, which acts quickly (within 30 minutes of injection), and isophane and crystalline protamine insulin, 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 cells from the blood.By controlling the blood glucose level, the symptoms and complications of diabetes are reduced.
How has Insulin Human Winthrop been studied?
Insulin Human Winthrop has been studied in two trials involving 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 produce insulin). 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 fasted for at least eight hours) or the levels of a substance in the blood called glycosylated hemoglobin (HbA1c) which gives an "indication of the effectiveness of glucose control in the blood". blood. The studies also looked at the number of patients who developed hypoglycemia (low blood glucose levels).
What benefit has Insulin Human Winthrop shown during the studies?
Insulin Human Winthrop induced a drop in the HbA1c level, demonstrating that blood glucose concentrations were maintained at a level similar to that guaranteed by semi-synthetic human insulin. Insulin Human Winthrop was effective in both type of diabetes. 1 and type 2 diabetes.
What is the risk associated with Insulin Human Winthrop?
Insulin Human Winthrop can cause hypoglycemia. For the full list of side effects reported with Insulin Human Winthrop, see the package leaflet.
Insulin Human Winthrop must not be used in people who may be hypersensitive (allergic) to human insulin or any of the other ingredients. The doses of Insulin Human Winthrop may be adequate when given with other medicines which may have an effect on blood levels. blood glucose. The full 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.
More information about Insulin Human Winthrop
On January 17, 2007, the European Commission granted Sanofi-Aventis Deutschland GmbH an EU-wide "Marketing Authorization" for Insulin Human Winthrop.
For the full version of Insulin Human Winthrop EPAR click here.
Last update of this summary: 12-2008.
The information on Insulin Human Winthrop - 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.
