Active Substance: insulin human
Common Name: insulin human (rDNA)
ATC Code: A10AB01
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 Actrapid?
Actrapid is a solution for injection. It is available in a vial, a cartridge (PenFill) or in a prefilled pen (NovoLet, FlexPen or InnoLet). Actrapid contains the active substance insulin human (rDNA).
What is Actrapid used for?
Actrapid is used in patients who have diabetes.
The medicine can only be obtained with a prescription.
How is Actrapid used?
Actrapid is administered subcutaneously (under the skin) by injection, usually into the abdominal wall (tummy). The thigh, the deltoid region (shoulder) or the gluteal region (buttocks) may also be used. 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. Actrapid is given 30 minutes before a meal. Actrapid is a fast-acting insulin and may be used with long-acting insulins. Actrapid may also be given intravenously (into a vein) but only by a doctor or a nurse.
How does Actrapid work?
Diabetes is a disease in which the body does not produce enough insulin to control the blood glucose. Actrapid is a replacement insulin that is identical to the insulin made by the pancreas. The active substance in Actrapid, 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. 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 Actrapid been studied?
Actrapid has been studied in patients with type-1 diabetes, when the pancreas cannot produce insulin (two studies involving 1,954 patients), and type-2 diabetes, when the body is unable to use insulin effectively (one study involving 182 patients). The studies compared Actrapid to a human insulin analogue (insulin aspart) over six months by measuring the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
What benefit has Actrapid shown during the studies?
HbA1c levels remained fairly steady over the six months of treatment with Actrapid.
What is the risk associated with Actrapid?
As with all insulins, Actrapid may cause hypoglycaemia (low blood glucose). For the full description of all side effects reported with Actrapid, see the package leaflet.
Actrapid should not be used in people who may be hypersensitive to insulin human (rDNA) or any of the other ingredients. Actrapid 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 Actrapid been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Actrapid’s benefits are greater than its risks for the treatment of diabetes mellitus. The Committee recommended that Actrapid be given marketing authorisation.
Other information about Actrapid
The European Commission granted a marketing authorisation valid throughout the European Union for Actrapid to Novo Nordisk A/S on 7 October 2002. The marketing authorisation was renewed on 7 October 2007.
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.