This is a summary of the European public assessment report (EPAR) for Insulatard. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Insulatard.
- What is Insulatard?
Insulatard is a suspension for injection that contains the active substance human insulin. It is available as vials, cartridges (Penfill), or pre-filled pens (InnoLet or FlexPen).
- What is Insulatard used for?
Insulatard is used to treat diabetes. The medicine can only be obtained with a prescription.
- How is Insulatard used?
Insulatard is given by injection under the skin in the thigh, the abdominal wall (at the front of the waist), the gluteal region (buttocks) or the deltoid region (shoulder). The injection site should be changed for each injection. The patient's blood glucose (sugar) should be tested regularly to find the lowest effective dose.
Insulatard is a long-acting insulin. It can be given once or twice a day, with or without a fast-acting insulin (given at meal times), according to the doctor’s recommendation. The usual dose is between 0.3 and 1.0 international units (IU) per kilogram body weight per day.
- How does Insulatard work?
Diabetes is a disease in which the body does not produce enough insulin to control the blood glucose or when the body is unable to use insulin effectively. Insulatard is a replacement insulin which is very similar to the insulin made by the pancreas. The active substance in Insulatard, human insulin, is produced by a method known as ‘recombinant technology’: the insulin is made by yeast cells into which a gene (DNA) has been introduced, which makes them able to produce insulin.
Insulatard contains insulin mixed with another substance, protamine, in an ‘isophane’ form which is absorbed much more slowly during the day. This gives Insulatard a longer duration of action. 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 Insulatard been studied?
Insulatard has been studied in four main clinical trials, which included a total of 557 patients with type 1 diabetes,when the pancreas cannot produce insulin (two studies involving 81 patients), or type 2 diabetes, when the body is unable to use insulin effectively (two studies involving 476 patients). In most patients, Insulatard was compared with other types of human insulin or insulin analogues. The studies measured the levels of fasting blood glucose or glycosylated haemoglobin (HbA1c, the haemoglobin in the blood that has glucose attached). HbA1c gives an indication of how well the blood glucose is controlled. Further studies were also carried out in 225 patients comparing injecting Insulatard using a syringe, or using a pre-filled pen (InnoLet or FlexPen).
- What benefit has Insulatard shown during the studies?
Insulatard led to a decrease in the level of HbA1c, indicating that blood sugar levels had been controlled to a similar level to that seen with other human insulins. Insulatard was effective for both type 1 and type 2 diabetes, and when using a standard injection or one of the pre-filled pens.
- What is the risk associated with Insulatard?
The most common side effect with Insulatard (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels). For the full list of all side effects and restrictions, see the package leaflet.
- Why has Insulatard been approved?
The CHMP decided that Insulatard’s benefits are greater than its risks and recommended that it be given marketing authorisation.
- What measures are being taken to ensure the safe and effective use of Insulatard?
A risk management plan has been developed to ensure that Insulatard is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Insulatard, including the appropriate precautions to be followed by healthcare professionals and patients.
- Other information about Insulatard
The European Commission granted a marketing authorisation valid throughout the European Union for Insulatard on 7 October 2002.
For more information about treatment with Insulatard, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This EPAR was last updated on 21/10/2015 .
17/09/2015 Insulatard -EMEA/H/C/000441 -WS/0776
- 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.
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Drugs used in diabetes
Treatment of diabetes mellitus.
Changes since initial authorisation of medicine
|Name||Language||First published||Last updated|
|Insulatard : EPAR - Procedural steps taken and scientific information after authorisation||SV = svenska||09/12/2009||21/10/2015|
Initial marketing-authorisation documents
|Name||Language||First published||Last updated|
|Insulatard : EPAR - Procedural steps taken before authorisation||SV = svenska||06/09/2006|
|Insulatard : EPAR - Scientific Discussion||SV = svenska||06/09/2006|
This medicine is approved for use in the European Union