NovoRapid

insulin aspart

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 their 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 NovoRapid?

NovoRapid is a solution for injection that contains the active substance insulin aspart. It is available in vials, cartridges (PenFill) and pre-filled pens (NovoLet, FlexPen and InnoLet).

What is NovoRapid used for?

NovoRapid is used to treat adults, adolescents and children over the age of two years who have diabetes.

The medicine can only be obtained with a prescription.

How is NovoRapid used?

NovoRapid is given as an injection under the skin in the abdominal (tummy) wall, the thigh, the upper arm, the shoulder or the buttock. NovoRapid is a rapid-acting insulin. It is usually given immediately before a meal, although it may be given after a meal if necessary. NovoRapid is normally used with an intermediate- or long-acting insulin given at least once a day. The patient’s blood glucose (sugar) should be tested regularly to find the lowest effective dose. The usual dose is between 0.5 and 1.0 U/kg/day. When it is used with meals, 50 to 70% of the insulin requirement may be provided by NovoRapid and the remainder by an intermediate or long-acting insulin. NovoRapid can be used in pregnant women.

NovoRapid can also be used in a pump system for continuous insulin infusion. It can be given into a vein but only by a doctor or a nurse. 

How does NovoRapid work?

Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose. NovoRapid is a replacement insulin that is very similar to the insulin made by the body.

The active substance in NovoRapid, insulin aspart, is produced by a method known as ‘recombinant DNA technology’: it is made by a yeast that has received a gene (DNA), which makes it able to produce insulin aspart.

Insulin aspart is very slightly different from human insulin. The change means that it is absorbed faster by the body, and can therefore act faster that human insulin. The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood. By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced. 

How has NovoRapid been studied?

NovoRapid has been studied in two studies involving 1,954 patients with type 1 diabetes (when the pancreas cannot produce insulin) and in one study involving 182 patients with type 2 diabetes (when the body is unable to use insulin effectively). The studies compared NovoRapid with human insulin 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. The safety of NovoRapid has also been compared with that of human insulin in two studies involving 349 pregnancies in women with type 1 or gestational diabetes (diabetes caused by pregnancy). NovoRapid has not been studied in children below two years of age.

What benefit has NovoRapid shown during the studies?

NovoRapid gave almost identical results to human insulin. In the two studies in type 1 diabetes, NovoRapid reduced HbA1c levels by 0.12% and by 0.15% more than human insulin did after six months. NovoRapid had the same safety profile as human insulin when used during pregnancy.

What is the risk associated with NovoRapid?

The most common side effect with NovoRapid (seen in between 1 and 10 patients in 100) is hypoglycaemia (low blood glucose levels). For the full list of all side effects reported with NovoRapid, see the Package Leaflet.

NovoRapid should not be used in people who may be hypersensitive (allergic) to insulin aspart or any of the ingredients. NovoRapid doses might also need to be adjusted when given with some of other medicines that may have an effect on blood glucose levels. The full list is available in the Package Leaflet.

Why has NovoRapid been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that NovoRapid’s benefits are greater than its risks for the treatment of diabetes mellitus. The Committee recommended that NovoRapid be given marketing authorisation.

Other information about NovoRapid

The European Commission granted a marketing authorisation valid throughout the European Union for NovoRapid to Novo Nordisk A/S on 7 September 1999. The marketing authorisation was renewed on 7 September 2004 and on 7 September 2009.

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

31/07/2012  NovoRapid -EMEA/H/C/000258 -II/0091

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 in adults, adolescents and children aged 2 years and above.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents