Mixtard

insulin human (rDNA)

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Mixtard?

Mixtard is a range of insulin suspensions for injection. Mixtard is supplied in vials, cartridges (PenFill) or pre-filled pens (NovoLet, FlexPen or InnoLet). Mixtard contains the active substance insulin human (rDNA). Mixtard contains both fast-acting (soluble) and long-acting (isophane) insulin:

• Mixtard 10: soluble insulin 10% and isophane insulin 90%;
• 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 subcutaneously (under the skin) by injection, usually in the abdominal wall (tummy). If convenient it may also be given in the gluteal region (buttocks) or the deltoid region (shoulder). The patient's blood glucose (sugar) should be tested regularly to find the lowest effective dose. The usual dose is between 0.3 and 1.0 international units (IU) per kilogram body weight per day. Mixtard is usually given once or twice a day when a rapid initial effect together with a more long-lasting effect is needed.

How does Mixtard work?

Diabetes is a disease in which the body does not produce enough insulin to control the blood glucose. Mixtard is a replacement insulin which is identical to the insulin made by the pancreas. The active substance in Mixtard, insulin human (rDNA), is produced by a method known as ‘recombinant technology’: the insulin is made by a yeast that has received a gene (DNA), which makes it able to produce insulin. 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. This gives Mixtard a longer duration of action. The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood. By controlling the 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, when the pancreas cannot produce insulin, and type-2 diabetes, when the body is unable to use insulin effectively. About one third of the patients had type-1 diabetes and the remainder had type-2 diabetes. The study compared Mixtard 30 to a similar mix, but made up using an insulin analogue (insulin aspart). The study measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c) after 12 weeks, which gives an indication of how well the blood glucose is controlled.

What benefit has Mixtard shown during the studies?

Mixtard led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with other human insulin. Mixtard was effective for 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. 

Mixtard should not be used in people who may be hypersensitive (allergic) to insulin human (rDNA) or to any of the other ingredients. Mixtard doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood glucose. The full list is available in 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 recommended that Mixtard be given marketing authorisation.

Other information about Mixtard

The European Commission granted a marketing authorisation valid throughout the European Union, for Mixtard to Novo Nordisk A/S on 7 October 2002. The marketing authorisation was renewed on 7 October 2007.

This EPAR was last updated on 14/09/2012 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

27/06/2012  Mixtard -EMEA/H/C/000428 -II/0052/G

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Treatment of diabetes mellitus.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents