Actrapid

human insulin (rDNA)

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This is a summary of the European public assessment report (EPAR) for Actrapid. 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 Actrapid.

What is Actrapid?

Actrapid is a solution for injection that contains the active substance human insulin. It is available as vials, cartridges (Penfill) or prefilled pens (NovoLet, InnoLet or FlexPen).

What is Actrapid used for?

Actrapid is used to treat diabetes.

The medicine can only be obtained with a prescription.

How is Actrapid used?

Actrapid is given by injection under the skin in the thigh, the abdominal wall (at the front of the waist), the deltoid region (shoulder) or the gluteal region (buttocks). 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. Actrapid is given 30 minutes before a meal. Actrapid is a fast-acting insulin and may be used with intermediate or long-acting insulins. Actrapid may also be given intravenously (into a vein) but only by a doctor or a nurse.

How does Actrapid 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. Actrapid is a replacement insulin that is very similar to the insulin made by the pancreas.

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

Actrapid has been studied in patients with type-1 diabetes,when the pancreas cannot produce insulin (two studies involving 1,954 patients), and type-2 diabetes, when the body is unable to use insulin effectively (one study involving 182 patients). The studies compared Actrapid with another replacement insulin called insulin aspart over six months by measuring the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood that has glucose attached. HbA1c gives an indication of how well the blood glucose is controlled.

What benefit has Actrapid shown during the studies?

HbA1c levels remained fairly steady over the six months of treatment with Actrapid.

What is the risk associated with Actrapid?

The most common side effect with Actrapid (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels). For the full description of all side effects reported with Actrapid, see the package leaflet.

Actrapid must not be used in people who are hypersensitive to human insulin or any of the other ingredients.

Why has Actrapid been approved?

The CHMP decided that Actrapid’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Actrapid

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

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

Name Language First published Last updated
Actrapid : EPAR - Summary for the public BG = bălgarski 04/02/2008 28/08/2013
Actrapid : EPAR - Summary for the public ES = español 04/02/2008 28/08/2013
Actrapid : EPAR - Summary for the public CS = čeština 04/02/2008 28/08/2013
Actrapid : EPAR - Summary for the public DA = dansk 04/02/2008 28/08/2013
Actrapid : EPAR - Summary for the public DE = Deutsch 04/02/2008 28/08/2013
Actrapid : EPAR - Summary for the public ET = eesti keel 04/02/2008 28/08/2013
Actrapid : EPAR - Summary for the public EL = elliniká 04/02/2008 28/08/2013
Actrapid : EPAR - Summary for the public EN = English 04/02/2008 28/08/2013
Actrapid : EPAR - Summary for the public FR = français 04/02/2008 28/08/2013
Actrapid : EPAR - Summary for the public IT = italiano 04/02/2008 28/08/2013
Actrapid : EPAR - Summary for the public LV = latviešu valoda 04/02/2008 28/08/2013
Actrapid : EPAR - Summary for the public LT = lietuvių kalba 04/02/2008 28/08/2013
Actrapid : EPAR - Summary for the public HU = magyar 04/02/2008 28/08/2013
Actrapid : EPAR - Summary for the public MT = Malti 04/02/2008 28/08/2013
Actrapid : EPAR - Summary for the public NL = Nederlands 04/02/2008 28/08/2013
Actrapid : EPAR - Summary for the public PL = polski 04/02/2008 28/08/2013
Actrapid : EPAR - Summary for the public PT = português 04/02/2008 28/08/2013
Actrapid : EPAR - Summary for the public RO = română 04/02/2008 28/08/2013
Actrapid : EPAR - Summary for the public SK = slovenčina 04/02/2008 28/08/2013
Actrapid : EPAR - Summary for the public SL = slovenščina 04/02/2008 28/08/2013
Actrapid : EPAR - Summary for the public FI = suomi 04/02/2008 28/08/2013
Actrapid : EPAR - Summary for the public SV = svenska 04/02/2008 28/08/2013

This EPAR was last updated on 22/08/2014 .

Authorisation details

Product details

Product details for Actrapid
NameActrapid
Agency product numberEMEA/H/C/000424
Active substance

human insulin

International non-proprietary name (INN) or common name

human insulin (rDNA)

Therapeutic area Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code A10AB01

Publication details

Publication details for Actrapid
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  Actrapid -EMEA/H/C/000424 -WS/0454

Name Language First published Last updated
Actrapid : EPAR - Product Information SV = svenska 18/02/2009 22/08/2014
Actrapid : EPAR - Product Information SV = svenska 18/02/2009 22/08/2014
Actrapid : EPAR - Product Information SV = svenska 18/02/2009 22/08/2014
Actrapid : EPAR - Product Information SV = svenska 18/02/2009 22/08/2014
Actrapid : EPAR - Product Information SV = svenska 18/02/2009 22/08/2014
Actrapid : EPAR - Product Information SV = svenska 18/02/2009 22/08/2014
Actrapid : EPAR - Product Information SV = svenska 18/02/2009 22/08/2014
Actrapid : EPAR - Product Information SV = svenska 18/02/2009 22/08/2014
Actrapid : EPAR - Product Information SV = svenska 18/02/2009 22/08/2014
Actrapid : EPAR - Product Information SV = svenska 18/02/2009 22/08/2014
Actrapid : EPAR - Product Information SV = svenska 18/02/2009 22/08/2014
Actrapid : EPAR - Product Information SV = svenska 18/02/2009 22/08/2014
Actrapid : EPAR - Product Information SV = svenska 18/02/2009 22/08/2014
Actrapid : EPAR - Product Information SV = svenska 18/02/2009 22/08/2014
Actrapid : EPAR - Product Information SV = svenska 18/02/2009 22/08/2014
Actrapid : EPAR - Product Information SV = svenska 18/02/2009 22/08/2014
Actrapid : EPAR - Product Information SV = svenska 18/02/2009 22/08/2014
Actrapid : EPAR - Product Information SV = svenska 18/02/2009 22/08/2014
Actrapid : EPAR - Product Information SV = svenska 18/02/2009 22/08/2014
Actrapid : EPAR - Product Information SV = svenska 18/02/2009 22/08/2014
Actrapid : EPAR - Product Information SV = svenska 18/02/2009 22/08/2014
Actrapid : EPAR - Product Information SV = svenska 18/02/2009 22/08/2014
Actrapid : EPAR - Product Information SV = svenska 18/02/2009 22/08/2014
Actrapid : EPAR - Product Information SV = svenska 18/02/2009 22/08/2014
Actrapid : EPAR - Product Information SV = svenska 18/02/2009 22/08/2014

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
Actrapid : EPAR - All Authorised presentations SV = svenska 03/04/2006 28/08/2013
Actrapid : EPAR - All Authorised presentations SV = svenska 03/04/2006 28/08/2013
Actrapid : EPAR - All Authorised presentations SV = svenska 03/04/2006 28/08/2013
Actrapid : EPAR - All Authorised presentations SV = svenska 03/04/2006 28/08/2013
Actrapid : EPAR - All Authorised presentations SV = svenska 03/04/2006 28/08/2013
Actrapid : EPAR - All Authorised presentations SV = svenska 03/04/2006 28/08/2013
Actrapid : EPAR - All Authorised presentations SV = svenska 03/04/2006 28/08/2013
Actrapid : EPAR - All Authorised presentations SV = svenska 03/04/2006 28/08/2013
Actrapid : EPAR - All Authorised presentations SV = svenska 03/04/2006 28/08/2013
Actrapid : EPAR - All Authorised presentations SV = svenska 03/04/2006 28/08/2013
Actrapid : EPAR - All Authorised presentations SV = svenska 03/04/2006 28/08/2013
Actrapid : EPAR - All Authorised presentations SV = svenska 03/04/2006 28/08/2013
Actrapid : EPAR - All Authorised presentations SV = svenska 03/04/2006 28/08/2013
Actrapid : EPAR - All Authorised presentations SV = svenska 03/04/2006 28/08/2013
Actrapid : EPAR - All Authorised presentations SV = svenska 03/04/2006 28/08/2013
Actrapid : EPAR - All Authorised presentations SV = svenska 03/04/2006 28/08/2013
Actrapid : EPAR - All Authorised presentations SV = svenska 03/04/2006 28/08/2013
Actrapid : EPAR - All Authorised presentations SV = svenska 03/04/2006 28/08/2013
Actrapid : EPAR - All Authorised presentations SV = svenska 03/04/2006 28/08/2013
Actrapid : EPAR - All Authorised presentations SV = svenska 03/04/2006 28/08/2013
Actrapid : EPAR - All Authorised presentations SV = svenska 03/04/2006 28/08/2013
Actrapid : EPAR - All Authorised presentations SV = svenska 03/04/2006 28/08/2013
Actrapid : EPAR - All Authorised presentations SV = svenska 03/04/2006 28/08/2013
Actrapid : EPAR - All Authorised presentations SV = svenska 03/04/2006 28/08/2013

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
Actrapid : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 18/02/2009 22/08/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Actrapid : EPAR - Procedural steps taken before authorisation SV = svenska 03/04/2006  
Actrapid : EPAR - Scientific Discussion SV = svenska 03/04/2006  

Authorised

This medicine is approved for use in the European Union