Mixtard

insulin human (rDNA)

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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 Mixtard?

Mixtard 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). Mixtard contains both fast-acting (soluble) and long-acting (isophane) insulin:

  • Mixtard 30: soluble insulin 30% and isophane insulin 70%;
  • Mixtard 40: soluble insulin 40% and isophane insulin 60%;
  • Mixtard 50: soluble insulin 50% and isophane insulin 50%.
What is Mixtard used for?

Mixtard is used in patients with diabetes.

The medicine can only be obtained with a prescription.

How is Mixtard used?

Mixtard 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.

The usual dose is between 0.3 and 1.0 international units (IU) per kilogram body weight per day. Mixtard is given 30 minutes before a meal. It is usually given once or twice a day when a rapid initial effect together with a more long-lasting effect is needed.

How does Mixtard 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. Mixtard is a replacement insulin which is very similar to the insulin made by the pancreas.

The active substance in Mixtard, human insulin, is produced by a method known as ‘recombinant technology’: the insulin is made by a yeast cells into which a gene (DNA) has been introduced, which makes them able to produce insulin. Mixtard contains insulin in two forms: a soluble form, which acts quickly (within 30 minutes of injection) and an ‘isophane’, form which is absorbed much more slowly during the day. This gives Mixtard 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 Mixtard been studied?

Mixtard has been studied in a total of 294 patients with type-1 diabetes, when the pancreas cannot produce insulin, and type-2 diabetes, when the body is unable to use insulin effectively. About one third of the patients had type-1 diabetes and the remainder had type-2 diabetes. The study compared Mixtard 30 to a similar mix, but made up using an insulin analogue (insulin aspart). The study measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c) after 12 weeks, which gives an indication of how well the blood glucose is controlled.

What benefit has Mixtard shown during the studies?

Mixtard led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with other human insulin. Mixtard was effective for both type-1 and type-2 diabetes.

What is the risk associated with Mixtard?

The most common side effect with Mixtard (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 Mixtard been approved?

The CHMP decided that Mixtard’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 Mixtard?

A risk management plan has been developed to ensure that Mixtard 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 Mixtard, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Mixtard

The European Commission granted a marketing authorisation valid throughout the European Union for Mixtard on 7 October 2002.

For more information about treatment with Mixtard, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Mixtard : EPAR - Summary for the public BG = bălgarski 03/02/2008 18/09/2014
Mixtard : EPAR - Summary for the public ES = español 03/02/2008 18/09/2014
Mixtard : EPAR - Summary for the public CS = čeština 03/02/2008 18/09/2014
Mixtard : EPAR - Summary for the public DA = dansk 03/02/2008 18/09/2014
Mixtard : EPAR - Summary for the public DE = Deutsch 03/02/2008 18/09/2014
Mixtard : EPAR - Summary for the public ET = eesti keel 03/02/2008 18/09/2014
Mixtard : EPAR - Summary for the public EL = elliniká 03/02/2008 18/09/2014
Mixtard : EPAR - Summary for the public EN = English 03/02/2008 18/09/2014
Mixtard : EPAR - Summary for the public FR = français 03/02/2008 18/09/2014
Mixtard : EPAR - Summary for the public IT = italiano 03/02/2008 18/09/2014
Mixtard : EPAR - Summary for the public LV = latviešu valoda 03/02/2008 18/09/2014
Mixtard : EPAR - Summary for the public LT = lietuvių kalba 03/02/2008 18/09/2014
Mixtard : EPAR - Summary for the public HU = magyar 03/02/2008 18/09/2014
Mixtard : EPAR - Summary for the public MT = Malti 03/02/2008 18/09/2014
Mixtard : EPAR - Summary for the public NL = Nederlands 03/02/2008 18/09/2014
Mixtard : EPAR - Summary for the public PL = polski 03/02/2008 18/09/2014
Mixtard : EPAR - Summary for the public PT = português 03/02/2008 18/09/2014
Mixtard : EPAR - Summary for the public RO = română 03/02/2008 18/09/2014
Mixtard : EPAR - Summary for the public SK = slovenčina 03/02/2008 18/09/2014
Mixtard : EPAR - Summary for the public SL = slovenščina 03/02/2008 18/09/2014
Mixtard : EPAR - Summary for the public FI = suomi 03/02/2008 18/09/2014
Mixtard : EPAR - Summary for the public SV = svenska 03/02/2008 18/09/2014

This EPAR was last updated on 18/09/2014 .

Authorisation details

Product details

Product details for Mixtard
NameMixtard
Agency product numberEMEA/H/C/000428
Active substance

insulin human

International non-proprietary name (INN) or common name

insulin human (rDNA)

Therapeutic area Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code A10AD01

Publication details

Publication details for Mixtard
Marketing-authorisation holder

Novo Nordisk A/S

Revision12
Date of issue of marketing authorisation valid throughout the European Union07/10/2002

Contact address:

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsvaerd
Denmark

Product information

Product information

26/06/2014  Mixtard -EMEA/H/C/000428 -WS/0454

Name Language First published Last updated
Mixtard : EPAR - Product Information SV = svenska 18/02/2009 18/09/2014
Mixtard : EPAR - Product Information SV = svenska 18/02/2009 18/09/2014
Mixtard : EPAR - Product Information SV = svenska 18/02/2009 18/09/2014
Mixtard : EPAR - Product Information SV = svenska 18/02/2009 18/09/2014
Mixtard : EPAR - Product Information SV = svenska 18/02/2009 18/09/2014
Mixtard : EPAR - Product Information SV = svenska 18/02/2009 18/09/2014
Mixtard : EPAR - Product Information SV = svenska 18/02/2009 18/09/2014
Mixtard : EPAR - Product Information SV = svenska 18/02/2009 18/09/2014
Mixtard : EPAR - Product Information SV = svenska 18/02/2009 18/09/2014
Mixtard : EPAR - Product Information SV = svenska 18/02/2009 18/09/2014
Mixtard : EPAR - Product Information SV = svenska 18/02/2009 18/09/2014
Mixtard : EPAR - Product Information SV = svenska 18/02/2009 18/09/2014
Mixtard : EPAR - Product Information SV = svenska 18/02/2009 18/09/2014
Mixtard : EPAR - Product Information SV = svenska 18/02/2009 18/09/2014
Mixtard : EPAR - Product Information SV = svenska 18/02/2009 18/09/2014
Mixtard : EPAR - Product Information SV = svenska 18/02/2009 18/09/2014
Mixtard : EPAR - Product Information SV = svenska 18/02/2009 18/09/2014
Mixtard : EPAR - Product Information SV = svenska 18/02/2009 18/09/2014
Mixtard : EPAR - Product Information SV = svenska 18/02/2009 18/09/2014
Mixtard : EPAR - Product Information SV = svenska 18/02/2009 18/09/2014
Mixtard : EPAR - Product Information SV = svenska 18/02/2009 18/09/2014
Mixtard : EPAR - Product Information SV = svenska 18/02/2009 18/09/2014
Mixtard : EPAR - Product Information SV = svenska 18/02/2009 18/09/2014
Mixtard : EPAR - Product Information SV = svenska 18/02/2009 18/09/2014
Mixtard : EPAR - Product Information SV = svenska 18/02/2009 18/09/2014

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.


Name Language First published Last updated
Mixtard : EPAR - All Authorised presentations SV = svenska 31/08/2006 18/09/2014
Mixtard : EPAR - All Authorised presentations SV = svenska 31/08/2006 18/09/2014
Mixtard : EPAR - All Authorised presentations SV = svenska 31/08/2006 18/09/2014
Mixtard : EPAR - All Authorised presentations SV = svenska 31/08/2006 18/09/2014
Mixtard : EPAR - All Authorised presentations SV = svenska 31/08/2006 18/09/2014
Mixtard : EPAR - All Authorised presentations SV = svenska 31/08/2006 18/09/2014
Mixtard : EPAR - All Authorised presentations SV = svenska 31/08/2006 18/09/2014
Mixtard : EPAR - All Authorised presentations SV = svenska 31/08/2006 18/09/2014
Mixtard : EPAR - All Authorised presentations SV = svenska 31/08/2006 18/09/2014
Mixtard : EPAR - All Authorised presentations SV = svenska 31/08/2006 18/09/2014
Mixtard : EPAR - All Authorised presentations SV = svenska 31/08/2006 18/09/2014
Mixtard : EPAR - All Authorised presentations SV = svenska 31/08/2006 18/09/2014
Mixtard : EPAR - All Authorised presentations SV = svenska 31/08/2006 18/09/2014
Mixtard : EPAR - All Authorised presentations SV = svenska 31/08/2006 18/09/2014
Mixtard : EPAR - All Authorised presentations SV = svenska 31/08/2006 18/09/2014
Mixtard : EPAR - All Authorised presentations SV = svenska 31/08/2006 18/09/2014
Mixtard : EPAR - All Authorised presentations SV = svenska 31/08/2006 18/09/2014
Mixtard : EPAR - All Authorised presentations SV = svenska 31/08/2006 18/09/2014
Mixtard : EPAR - All Authorised presentations SV = svenska 31/08/2006 18/09/2014
Mixtard : EPAR - All Authorised presentations SV = svenska 31/08/2006 18/09/2014
Mixtard : EPAR - All Authorised presentations SV = svenska 31/08/2006 18/09/2014
Mixtard : EPAR - All Authorised presentations SV = svenska 31/08/2006 18/09/2014
Mixtard : EPAR - All Authorised presentations SV = svenska 31/08/2006 18/09/2014
Mixtard : EPAR - All Authorised presentations SV = svenska 31/08/2006 18/09/2014

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Treatment of diabetes mellitus.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Mixtard : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 18/02/2009 18/09/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Mixtard : EPAR - Procedural steps taken before authorisation SV = svenska 31/08/2006  
Mixtard : EPAR - Scientific Discussion SV = svenska 31/08/2006  

Authorised

This medicine is approved for use in the European Union