What is Mixtard?
Mixtard is a series of injectable insulin suspensions. Mixtard is available in vials, cartridges (Penfill) or pre-filled pens (NovoLet, FlexPen or InnoLet). The active substance in Mixtard is human insulin (rDNA). Mixtard is a mixture of fast-acting (soluble) and long-acting (isophane) insulin.
- Mixtard 10: 10% soluble insulin and 90% isophane insulin
- Mixtard 20: soluble insulin 20% and isophane insulin 80%
- Mixtard 30: soluble insulin 30% and isophane insulin 70%
- Mixtard 40: soluble insulin 40% and isophane insulin 60%
- Mixtard 50: soluble insulin 50% and isophane insulin 50%
What is Mixtard used for?
Mixtard is used in patients with diabetes.
The medicine can only be obtained with a prescription.
How is Mixtard used?
Mixtard is given by injection under the skin (under the skin), usually in the abdominal region (belly), but it can also be given, if more convenient, in the gluteal region (buttocks) or the deltoid region (shoulder). The patient's blood glucose level should be checked regularly to find the lowest effective dose. The usual dose ranges from 0.3 to 1.0 international units (IU) per kilogram of body weight per day. Mixtard is usually given once or twice a day if you want a quick initial effect along with a longer lasting effect.
How does Mixtard work?
Diabetes is a disease in which the body does not produce enough insulin to control the level of glucose in the blood. Mixtard is an insulin substitute identical to the insulin produced by the pancreas. The active substance in Mixtard, human insulin (rDNA), is produced by a method known as 'recombinant technology': insulin is made by a yeast that has received a gene (DNA), which makes it able to produce it. Mixtard contains insulin in two forms: the soluble form, which works quickly (within 30 minutes of injection) and the 'isophane' form, which is absorbed much more slowly during the day, which gives Mixtard a longer lasting effect. The insulin substitute acts like naturally produced insulin and promotes the penetration of glucose into cells from the blood. By controlling blood glucose, the symptoms and complications of diabetes are reduced.
How has Mixtard been studied?
Mixtard has been studied in a total of 294 patients with type 1 diabetes, in which the pancreas is unable to produce insulin, and type 2, in which the body is unable to use insulin in a manner effective. About one third of the patients had type 1 diabetes and the rest had type 2 diabetes. In the study, Mixtard 30 was compared with a similar mixture made using an insulin analog (insulin aspart). The study measured the level of a substance in the blood called glycosylated hemoglobin (HbA1c) after 12 weeks, which provides an "indication of how well the blood glucose is controlled."
What benefit has Mixtard shown during the studies?
Mixtard caused a decrease in the level of HbA1c, indicating that blood glucose levels were controlled to a level similar to that seen with other human insulins. Mixtard has been shown to be effective in both type 1 and type 2 diabetes.
What is the risk associated with Mixtard?
As is the case with all insulins, Mixtard can cause hypoglycaemia (low blood glucose). For the full list of side effects reported with Mixtard, see the package leaflet.
Mixtard must not be used in people who may be hypersensitive (allergic) to human insulin (rDNA) or other substances in the medicine. The doses of Mixtard should be adjusted if the medicine is given with other medicines that may have an effect on glucose. For the full list of restrictions on use, see the Package Leaflet.
Why has Mixtard been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Mixtard's benefits are greater than its risks for the treatment of diabetes. The Committee therefore recommended the granting of a marketing authorization for Mixtard.
Other information about Mixtard:
On 7 October 2002, the European Commission granted Novo Nordisk A / S a "Marketing Authorization" for Mixtard, valid throughout the European Union. The "Marketing Authorization" was renewed on 7 October 2007.
For the full version of the Mixtard EPAR click here.
Last update of this summary: 10-2007
The information on Mixtard 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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