Actrapid

insulin human (rDNA)

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

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.

This EPAR was last updated on 14/09/2012 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

27/07/2012  Actrapid -EMEA/H/C/000424 -II/0046/G

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Treatment of diabetes mellitus.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents