NovoRapid - insulin aspart
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 2 years of age with diabetes.
The medicine can only be obtained with a prescription.
How is NovoRapid used?
Novorapid is given by injection under the skin (under the skin) into the abdominal wall (belly), thigh, upper arm, shoulder or buttock. NovoRapid is a "fast-acting insulin. Normally it is given immediately before a meal, but, if needed, it can be given after a meal. NovoRapid is usually used with an" intermediate-acting or long-acting insulin given at least once a day. To find the lowest effective dose, the patient should have his blood glucose (sugar) checked regularly. The usual dose varies between 0.5 and 1.0 U / kg / day. When taken with a meal, 50 to 70% of the insulin requirement is provided by NovoRapid and the remainder by an "intermediate or long-acting" insulin. NovoRapid can be administered to pregnant women.
NovoRapid can also be used with a continuous insulin infusion pump system. It can be given into a vein, but only by a doctor or nurse.
How does NovoRapid work?
Diabetes is a disease in which the body does not produce enough insulin to control the level of glucose in the blood. NovoRapid is a "replacement insulin, which is very similar to the insulin the body makes." The active substance in NovoRapid, 'insulin aspart, is produced by a method known as the' recombinant DNA technique '; that is, it is made by a yeast that has a gene (DNA) inserted into it, which makes it able to produce insulin. aspart.
Insulin aspart differs very little from human insulin; thanks to this difference, it is absorbed more quickly by the body, so it can act faster than human insulin. Replacement insulin acts like naturally produced insulin and promotes the penetration of glucose into cells from the blood.By controlling the level of glucose in the blood, the symptoms and complications of diabetes are reduced.
How has NovoRapid been studied?
NovoRapid has been studied in two studies involving 1954 patients with type 1 diabetes (in which the pancreas is unable to produce insulin) and in one study involving 182 patients with type 2 diabetes (in which the body is not able to produce insulin). able to use insulin effectively). In these studies, NovoRapid was compared to human insulin by measuring the level in the blood of a substance called glycosylated hemoglobin (HbA1c) which gives an indication of how well the blood glucose is controlled. The safety of NovoRapid was also compared with that of human insulin in two studies involving 349 pregnant women with type 1 diabetes or gestational diabetes (caused by pregnancy). NovoRapid has not been tested in children less than two years of age.
What benefit has NovoRapid shown during the studies?
NovoRapid gave about the same results as human insulin. In the two type 1 diabetes studies, NovoRapid reduced HbA1c levels by 0.12% and 0.15%, respectively, than human insulin did after six months. NovoRapid used during pregnancy exhibited the same safety profile as human insulin.
What is the risk associated with NovoRapid?
The most common side effect with NovoRapid (seen in 1 to 10 patients in 100) is hypoglycaemia (low blood glucose levels). For the full list of side effects reported with NovoRapid, see the package leaflet.
NovoRapid must not be used in people who may be hypersensitive (allergic) to insulin aspart or to any of the other ingredients. In addition, the doses of NovoRapid may need to be adjusted when given together with other medicines which may have an effect on blood levels. blood glucose. The complete list can be found 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 authorization.
More information about NovoRapid
On 7 September 1999, the European Commission granted Novo Nordisk A / S a "Marketing Authorization" for NovoRapid, valid throughout the European Union. The "Marketing Authorization" was renewed on 7 September 2004 and on September 7, 2009.
For the complete version of NovoRapid's EPAR click here.
Last update of this summary: 09-2009.
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