What is Actrapid?
Actrapid is a solution for injection. It is available in vials, cartridges (PenFill) or pre-filled pens (NovoLet, FlexPen or InnoLet). The active substance in Actrapid is human insulin (rDNA).
What is Actrapid used for?
Actrapid is indicated in patients with diabetes.
The medicine can only be obtained with a prescription.
How is Actrapid used?
Actrapid is administered subcutaneously (under the skin) by injection, usually in the abdominal wall (belly). The thigh, the deltoid region (shoulder) or that of the buttocks (buttocks) can also be used. It is advisable to regularly check the level of glucose (sugar) in the patient's blood to find the lowest effective dose. The usual dose varies between 0.3 and 1.0 international units (IU) per kilogram of body weight per day. Actrapid is given 30 minutes before a meal. Actrapid is a fast-acting insulin and can be used with long-acting insulins. It can be administered intravenously (in a vein), but only by a doctor or nurse.
How does Actrapid work?
Diabetes is a disease in which the body does not produce enough insulin to control the level of glucose in the blood. Actrapid is a replacement insulin identical to the insulin produced by the pancreas. The active ingredient in Actrapid, human insulin (DNAr), is produced by a method known as "recombinant technique": the insulin derives from a yeast in which a gene (DNA) has been introduced that makes it able to produce it . Replacement insulin acts like naturally produced insulin and helps glucose penetrate cells from the blood. By controlling the level of glucose in the blood, the symptoms and complications of diabetes are reduced.
How has Actrapid been studied?
Actrapid has been studied in patients with type 1 diabetes, in which the pancreas is unable to produce insulin (two studies involving 1954 patients) as well as type 2 diabetes, in which the body is unable to use the 'insulin effectively (a study involving 182 patients). The studies compared Actrapid with a human insulin analogue ( insulin aspart ), measuring the level of a substance in the blood, called glycosylated hemoglobin (HbA1c), which indicates the effectiveness of the glucose level in the course of six months. blood.
What benefit has Actrapid shown during the studies?
HbA1c levels remained fairly stable over the six months of Actrapid treatment.
What is the risk associated with Actrapid?
As with all insulins, Actrapid can cause hypoglycemia (reduced blood glucose level). For the full list of all side effects reported with Actrapid, see the Package Leaflet.
Actrapid should not be used in patients who may be allergic to human insulin (rDNA) or to any of the other ingredients. The doses of Actrapid must be adjusted when given with a certain number of other medicines that can affect the level of glucose in the blood. For the full list of usage restrictions, see the package leaflet.
Why has Actrapid been approved?
The Committee for Medicinal Products for Human Use (CHMP) considered that Actrapid's benefits for treating diabetes mellitus outweigh the risks. The Committee therefore recommended that Actrapid be given marketing authorization.
More information on Actrapid:
On 7 October 2002, the European Commission issued a marketing authorization for Actrapid, valid throughout the European Union, to Novo Nordisk A / S. The marketing authorization was renewed on 7 October 2007.
The full EPAR for Actrapid can be found here.
Last update of this summary: 10-2007
