What is Insulatard?
Insulatard includes a series of injectable insulin suspensions. Insulatard is available in vials, cartridges (Penfill) or pre-filled pens (InnoLet, NovoLet and FlexPen). Insulatard contains the active substance insulin human (rDNA).
What is Insulatard used for?
Insulatard is indicated in patients with diabetes.
The medicine can only be obtained with a prescription.
How is Insulatard used?
Insulatard is given as injections under the skin, usually in the thigh. If appropriate, injection into the abdominal wall (belly), gluteal region (buttocks) or deltoid region (shoulder) may be given. To find the lowest effective dosage, the glucose (sugar) level should be monitored regularly. Insulatard is a "long-acting insulin. It can be given once or twice a day, alone or in combination with fast-acting insulin (with meals), as directed by your doctor.
How does Insulatard work?
Diabetes mellitus is a disease in which the body does not make enough insulin to control glucose levels in the blood. Insulatard is an insulin analog that is identical to the insulin produced by the pancreas. The active substance in Insulatard, human insulin ( DNAr), is produced by a method known as "recombinant DNA technique": it is made by a yeast with a gene (DNA) that makes it capable of producing insulin. Insulatard contains insulin mixed with "another substance, protamine, a form of" isophane insulin "which is absorbed much more slowly throughout the day. This gives Insulatard a" longer action. Replacement insulin has the same mechanisms of action as natural insulin and promotes the penetration of glucose into cells through the blood. By controlling the level of glucose in the blood, it reduces the symptoms and complications of diabetes.
How has Insulatard been studied?
Insulatard has been studied in four major clinical trials involving a total of 557 people with type 1 diabetes (when the pancreas is unable to produce insulin [two studies involving 81 patients]) or in type 2 (when the body is unable to use insulin effectively [two studies involving 476 patients]). In most of the subjects, Insulatard was compared with other types of human insulin or with "insulin. These studies measured the fasting blood concentration of glucose or a substance in the blood called glycosylated hemoglobin (HbA1c) which gives an "indication of how well the blood glucose is controlled." Other studies involved 225 patients, in whom the medicine was administered via a syringe or pre-filled pen (InnoLet, NovoPen or FlexPen).
What benefit has Insulatard shown during the studies?
Insulatard induced a drop in the level of HbA1c, demonstrating that blood sugar concentrations were maintained at a level similar to that guaranteed by other human insulins. Insulatard has been shown to be effective in both forms of diabetes (type 1 and type 2 diabetes), regardless of the method of administration (injection or pen).
What is the risk associated with Insulatard?
Like all insulins, Insulatard can cause hypoglycaemia (a low level of glucose in the blood). For the full list of side effects reported with Insulatard, see the package leaflet.
Insulatard must not be used in people who are hypersensitive (allergic) to human insulin (rDNA) or to any of the other ingredients. The doses of Insulatard may need to be adjusted if they are taking other medicines which may have an effect on the blood glucose level. blood (for the complete list see the package leaflet)
Why has Insulatard been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Insulatard's benefits are greater than its risks for the treatment of diabetes. The committee therefore recommended the granting of a marketing authorization for Insulatard.
Learn more about Insulatard
On 7 October 2002, the European Commission granted Novo Nordisk A / S a "Marketing Authorization" for Insulatard, valid throughout the European Union. The "Marketing Authorization" was renewed on 7 October 2007.
The full version of the evaluation (EPAR) can be found here.
Last updated: 10 - 2007
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