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 (DNAr). Mixtard is a mixture of fast-acting (soluble) insulin and long-acting insulin (isophane).
- Mixtard 10: 10% soluble insulin and 90% isophane insulin
- Mixtard 20: 20% soluble insulin and 80% isophane insulin
- Actraphane 30: 30% soluble insulin and 70% isophane insulin
- Mixtard 40: 40% soluble insulin and 60% isophane insulin
- Mixtard 50: 50% soluble insulin and 50% isophane insulin
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 subcutaneous injection (under the skin), normally in the abdominal region (belly), but it can also be administered, if more convenient, in the gluteal region (buttocks) or in the deltoid region (shoulder). It is advisable to regularly check the glucose level in the patient's blood 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 normally 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 made by the pancreas. The active ingredient in Mixtard, human insulin (DNAr), is produced by a method known as "recombinant technology": that is, insulin is produced by a yeast in which a gene (DNA) has been introduced that makes it able to produce it. Mixtard contains insulin in two forms: the soluble form, which acts 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 the 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 not able 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 others had type 2 diabetes. In the study, Mixtard 30 was compared to a similar mixture but prepared using an insulin analog ( insulin aspart ). In the study, the level of a substance in the blood called glycosylated hemoglobin (HbA1c) was measured after 12 weeks, which gives an indication of the effectiveness of blood glucose control.
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 found with other human insulins. Mixtard has been shown to be as effective in both type 1 and type 2 diabetes.
What is the risk associated with Mixtard?
As with all insulins, Mixtard may cause hypoglycaemia (low blood glucose). For the full list of all side effects reported with Mixtard, see the Package Leaflet.
Actraphane should not be used in people who may be hypersensitive (allergic) to human insulin (DNAr) or other substances in the medicine. Doses of Actraphane should be adjusted if the medicine is given with other medicines that may have an effect on blood glucose. For the full list of usage restrictions, 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 that Mixtard be given marketing authorization.
Other information on Mixtard:
On 7 October 2002, the European Commission issued a marketing authorization for Mixtard, valid throughout the European Union, to Novo Nordisk A / S. The marketing authorization was renewed on 7 October 2007.
The full EPAR for Mixtard can be found here.
Last update of this summary: 10-2007
