NovoMix 30 FlexPen

NovoMix 30 FlexPen (prefilled pens) contains the active substance 30% soluble (rapid-acting) insulin aspart and 70% protamine-crystallised (intermediate-acting) insulin aspart. NovoMix 30 FlexPen is used to treat diabetes. NovoMix 30 FlexPen can be used in patients aged 10 years or over.

NovoMix 30 FlexPen is injected under the skin of the abdominal wall (tummy) or the thigh. It can also be injected under the skin in the deltoid (shoulder) or gluteal (buttock) regions, if convenient. The patient’s blood glucose (sugar) levels should be tested regularly to find the lowest effective dose. NovoMix is given immediately before a meal, but may be given after a meal if necessary. The usual dose is between 0.5 and 1.0 U per kilogram body weight per day.

In type 2 diabetes, NovoMix can be given on its own or together with metformin (another antidiabetes medicine). NovoMix 30 can also be used with other antidiabetes medicines that are taken by mouth, but it should only be used with pioglitazone once the doctor has evaluated the patient’s risk of fluid-related side effects. For more information, see the summary of product characteristics (also part of the EPAR).

Patients can inject themselves with NovoMix once they have been trained appropriately.

Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose. NovoMix is a replacement insulin that is very similar to the insulin made by the pancreas.

The active substance in NovoMix, insulin aspart, is produced by a method known as recombinant DNA technology it is made by a yeast that has received a gene (DNA), which makes it able to produce insulin aspart.

Insulin aspart is very slightly different from human insulin. The change means that it is absorbed faster by the body than human insulin, and therefore starts to work sooner. NovoMix contains insulin aspart in two forms: the soluble form, which works within 10 minutes of injection and the crystallised form, which is absorbed much more slowly during the day. The replacement insulin acts in the same way as naturally produced insulin and helps glucose enter cells from the blood. By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.

NovoMix 30 FlexPen gave almost identical results to biphasic human insulin 30 at the end of the studies. Adding NovoMix 30 to other antidiabetes medicines also resulted in better control of blood glucose than the other medicines taken alone.

The most common side effect with NovoMix (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels). For the full list of all side effects reported with NovoMix, see the Package Leaflet.

NovoMix 30 FlexPen should not be used in people who may be hypersensitive (allergic) to insulin aspart or to any of the other ingredients. NovoMix doses might also need to be adjusted when given with other medicines that may have an effect on blood glucose levels. For the full list of these medicines, see the Package Leaflet.