Characteristics of the medicine
Actraphane is a series of injectable insulin suspensions. Actraphane is available in vials, cartridges (Penfill) or pre-filled pens (NovoLet, FlexPen or InnoLet). The active substance in Actraphane is human insulin (rDNA). Actraphane is a mixture of fast-acting (soluble) and long-acting (isophane) insulin.
Actraphane 10: 10% soluble insulin and 90% isophane insulin
Actraphane 20: soluble insulin 20% and isophane insulin 80%
Actraphane 30: soluble insulin 30% and isophane insulin 70%
Actraphane 40: soluble insulin 40% and isophane insulin 60%
Actraphane 50: soluble insulin 50% and isophane insulin 50%
Therapeutic indications
Actraphane is used in patients with diabetes.
The medicine can only be obtained with a prescription.
How to use
Actraphane 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 sugar level should be checked regularly to find the lowest effective dose. The usual dose ranges from 0.3 to 1.0 IU / kg / day. Actraphane is normally given once or twice a day if you want a quick initial effect along with a longer lasting effect.
Mechanisms of action
Diabetes is a disease in which the body does not produce enough insulin to control blood sugar. Actraphane is an insulin substitute identical to the insulin made by the pancreas. The active substance in Actraphane, human insulin (rDNA), is produced by a method known as 'recombinant technology': that is, insulin is made by a yeast in which
a gene (DNA) has been entered which makes it able to produce it. Actraphane 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 Actraphane 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 sugar, the symptoms and complications of diabetes are reduced.
Studies carried out
Actraphane 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 properly. effective. About one third of the patients had type 1 diabetes (the rest had type 2 diabetes). In the study, Actraphane 30 was compared with a similar mixture, but prepared using an insulin analogue (insulin aspart). In the study, the level of a substance, glycosylated hemoglobin (HbA1c), was measured after 12 weeks. which gives an "indication of the effectiveness of blood glucose control."
Benefits found following the studies
Actraphane caused a decrease in the level of HbA1c, indicating that blood sugar levels were controlled to a level similar to that seen with other human insulins. Actraphane has been shown to be effective in both type 1 and type 2 diabetes.
Associated Risks
Actraphane can cause hypoglycaemia (low blood glucose). For the full list of side effects reported with Actraphane, see the package leaflet.
Actraphane must not be used in people who may be hypersensitive (allergic) to human insulin (rDNA) or other ingredients of the medicine. Actraphane doses should be adjusted if the medicine is given with other medicines that may have an effect on sugar. blood (the complete list can be found in the package insert).
Reasons for approval
The Committee for Medicinal Products for Human Use (CHMP) decided that Actraphane's benefits are greater than its risks for the treatment of diabetes. The CHMP therefore recommended the granting of the marketing authorization for Actraphane.
Further information
On 7 October 2002, the European Commission granted Novo Nordisk A / S a "Marketing Authorization" for Actraphane, valid throughout the European Union.
For the complete version of the EPAR for Actraphane click here.
Last update of this summary: January 2006
The information on Actraphane - 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.
