Active Substance: insulin human
Common Name: insulin human (rDNA)
ATC Code: A10AD01
Marketing Authorisation Holder: Novo Nordisk A/S
Active Substance: insulin human
Authorisation Date: 2002-10-07
Therapeutic Area: Diabetes Mellitus
Pharmacotherapeutic Group: Drugs used in diabetes
Treatment of diabetes mellitus.
What is Actraphane?
Actraphane is a range of insulin suspensions for injection. Actraphane is supplied in vials, cartridges (PenFill) or prefilled pens (NovoLet, FlexPen or InnoLet). Actraphane contains the active ingredient insulin human (rDNA). Actraphane contains both fast-acting (soluble) and long-acting (isophane) insulin:
- Actraphane 10: soluble insulin 10% and isophane insulin 90%;
- 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%.
What is Actraphane used for?
Actraphane is used in patients with diabetes.
The medicine can only be obtained with a prescription.
How is Actraphane used?
Actraphane 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 (bottom) or the deltoid region (shoulder). The patient's blood 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 per day. Actraphane is usually given once or twice daily when a rapid initial effect together with a more long-lasting effect is needed.
How does Actraphane work?
Diabetes is a disease in which the body does not produce enough insulin to control the blood sugar. Actraphane is a replacement insulin which is identical to the insulin made by the pancreas. The active ingredient of Actraphane, 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. Actraphane 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 Actraphane 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 sugar, the symptoms and complications of diabetes are reduced.
How has Actraphane been studied?
Actraphane 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 (the others had type-2 diabetes). The study compared Actraphane 30 to a similar mix, but made up using an insulin analogue (insulin aspart). The study measured after 12 weeks the level of a substance (glycosylated haemoglobin, HbA1c), which gives an indication of how well the blood glucose is controlled.
What benefit has Actraphane shown during the studies?
Actraphane led to a decrease in the level of HbA1c, indicating that blood sugar levels had been controlled to a similar level to that seen with other human insulin. Actraphane was effective for both type-1 and type-2 diabetes.
What is the risk associated with Actraphane?
Actraphane may cause hypoglycaemia (low blood glucose). For the full description of the side effects reported with Actraphane, please see the package leaflet.
Actraphane should not be used in people who may be hypersensitive (allergic) to insulin human (rDNA) or to any of the other ingredients. Actraphane doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood sugar (the full list is available in the package leaflet).
Why has Actraphane been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Actraphane’s benefits are greater than its risks for the treatment of diabetes. They recommended that Actraphane be given marketing authorisation.
Other information about Actraphane
The European Commission granted a marketing authorisation valid throughout the European Union, for Actraphane to Novo Nordisk A/S on 7 October 2002.
Source: European Medicines Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.