Actraphane

insulin human (rDNA)

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

What is Actraphane?

Actraphane is a suspension for injection that contains the active substance human insulin. It is available as vials, cartridges (Penfill) or prefilled pens (InnoLet or FlexPen). Actraphane contains both fast-acting (soluble) and long-acting (isophane) insulin:

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

Actraphane is used to treat diabetes.

The medicine can only be obtained with a prescription.

How is Actraphane used?

Actraphane 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. Actraphane 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 Actraphane 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. Actraphane is a replacement insulin which is very similar to the insulin made by the pancreas.

The active substance in Actraphane, 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. Actraphane 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 Actraphane 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 Actraphane been studied?

Actraphane 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 Actraphane 30 to a similar mix, but made up using an insulin analogue (insulin aspart). The study measured the level of glycosylated haemoglobin (HbA1c) after 12 weeks, 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 Actraphane shown during the studies?

Actraphane 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. Actraphane was effective for both type 1 and type 2 diabetes.

What is the risk associated with Actraphane?

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

The CHMP decided that Actraphane’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 Actraphane?

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

Other information about Actraphane

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

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

Name Language First published Last updated
Actraphane : EPAR - Summary for the public BG = bălgarski 2006-08-31 2015-06-12
Actraphane : EPAR - Summary for the public ES = español 2006-08-31 2015-06-12
Actraphane : EPAR - Summary for the public CS = čeština 2006-08-31 2015-06-12
Actraphane : EPAR - Summary for the public DA = dansk 2006-08-31 2015-06-12
Actraphane : EPAR - Summary for the public DE = Deutsch 2006-08-31 2015-06-12
Actraphane : EPAR - Summary for the public ET = eesti keel 2006-08-31 2015-06-12
Actraphane : EPAR - Summary for the public EL = elliniká 2006-08-31 2015-06-12
Actraphane : EPAR - Summary for the public EN = English 2006-08-31 2015-06-12
Actraphane : EPAR - Summary for the public FR = français 2006-08-31 2015-06-12
Actraphane : EPAR - Summary for the public IT = italiano 2006-08-31 2015-06-12
Actraphane : EPAR - Summary for the public LV = latviešu valoda 2006-08-31 2015-06-12
Actraphane : EPAR - Summary for the public LT = lietuvių kalba 2006-08-31 2015-06-12
Actraphane : EPAR - Summary for the public HU = magyar 2006-08-31 2015-06-12
Actraphane : EPAR - Summary for the public MT = Malti 2006-08-31 2015-06-12
Actraphane : EPAR - Summary for the public NL = Nederlands 2006-08-31 2015-06-12
Actraphane : EPAR - Summary for the public PL = polski 2006-08-31 2015-06-12
Actraphane : EPAR - Summary for the public PT = português 2006-08-31 2015-06-12
Actraphane : EPAR - Summary for the public RO = română 2006-08-31 2015-06-12
Actraphane : EPAR - Summary for the public SK = slovenčina 2006-08-31 2015-06-12
Actraphane : EPAR - Summary for the public SL = slovenščina 2006-08-31 2015-06-12
Actraphane : EPAR - Summary for the public FI = suomi 2006-08-31 2015-06-12
Actraphane : EPAR - Summary for the public SV = svenska 2006-08-31 2015-06-12
Actraphane : EPAR - Summary for the public HR = Hrvatski 2006-08-31 2015-06-12

This EPAR was last updated on 12/02/2016 .

Authorisation details

Product details

Product details for Actraphane
NameActraphane
Agency product numberEMEA/H/C/000427
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 Actraphane
Marketing-authorisation holder

Novo Nordisk A/S

Revision14
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

21/12/2015  Actraphane -EMEA/H/C/000427 -IG/0642

Name Language First published Last updated
Actraphane : EPAR - Product Information HR = Hrvatski 2009-02-18 2016-02-12
Actraphane : EPAR - Product Information HR = Hrvatski 2009-02-18 2016-02-12
Actraphane : EPAR - Product Information HR = Hrvatski 2009-02-18 2016-02-12
Actraphane : EPAR - Product Information HR = Hrvatski 2009-02-18 2016-02-12
Actraphane : EPAR - Product Information HR = Hrvatski 2009-02-18 2016-02-12
Actraphane : EPAR - Product Information HR = Hrvatski 2009-02-18 2016-02-12
Actraphane : EPAR - Product Information HR = Hrvatski 2009-02-18 2016-02-12
Actraphane : EPAR - Product Information HR = Hrvatski 2009-02-18 2016-02-12
Actraphane : EPAR - Product Information HR = Hrvatski 2009-02-18 2016-02-12
Actraphane : EPAR - Product Information HR = Hrvatski 2009-02-18 2016-02-12
Actraphane : EPAR - Product Information HR = Hrvatski 2009-02-18 2016-02-12
Actraphane : EPAR - Product Information HR = Hrvatski 2009-02-18 2016-02-12
Actraphane : EPAR - Product Information HR = Hrvatski 2009-02-18 2016-02-12
Actraphane : EPAR - Product Information HR = Hrvatski 2009-02-18 2016-02-12
Actraphane : EPAR - Product Information HR = Hrvatski 2009-02-18 2016-02-12
Actraphane : EPAR - Product Information HR = Hrvatski 2009-02-18 2016-02-12
Actraphane : EPAR - Product Information HR = Hrvatski 2009-02-18 2016-02-12
Actraphane : EPAR - Product Information HR = Hrvatski 2009-02-18 2016-02-12
Actraphane : EPAR - Product Information HR = Hrvatski 2009-02-18 2016-02-12
Actraphane : EPAR - Product Information HR = Hrvatski 2009-02-18 2016-02-12
Actraphane : EPAR - Product Information HR = Hrvatski 2009-02-18 2016-02-12
Actraphane : EPAR - Product Information HR = Hrvatski 2009-02-18 2016-02-12
Actraphane : EPAR - Product Information HR = Hrvatski 2009-02-18 2016-02-12
Actraphane : EPAR - Product Information HR = Hrvatski 2009-02-18 2016-02-12
Actraphane : EPAR - Product Information HR = Hrvatski 2009-02-18 2016-02-12

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
Actraphane : EPAR - All Authorised presentations HR = Hrvatski 2006-04-03 2014-08-22
Actraphane : EPAR - All Authorised presentations HR = Hrvatski 2006-04-03 2014-08-22
Actraphane : EPAR - All Authorised presentations HR = Hrvatski 2006-04-03 2014-08-22
Actraphane : EPAR - All Authorised presentations HR = Hrvatski 2006-04-03 2014-08-22
Actraphane : EPAR - All Authorised presentations HR = Hrvatski 2006-04-03 2014-08-22
Actraphane : EPAR - All Authorised presentations HR = Hrvatski 2006-04-03 2014-08-22
Actraphane : EPAR - All Authorised presentations HR = Hrvatski 2006-04-03 2014-08-22
Actraphane : EPAR - All Authorised presentations HR = Hrvatski 2006-04-03 2014-08-22
Actraphane : EPAR - All Authorised presentations HR = Hrvatski 2006-04-03 2014-08-22
Actraphane : EPAR - All Authorised presentations HR = Hrvatski 2006-04-03 2014-08-22
Actraphane : EPAR - All Authorised presentations HR = Hrvatski 2006-04-03 2014-08-22
Actraphane : EPAR - All Authorised presentations HR = Hrvatski 2006-04-03 2014-08-22
Actraphane : EPAR - All Authorised presentations HR = Hrvatski 2006-04-03 2014-08-22
Actraphane : EPAR - All Authorised presentations HR = Hrvatski 2006-04-03 2014-08-22
Actraphane : EPAR - All Authorised presentations HR = Hrvatski 2006-04-03 2014-08-22
Actraphane : EPAR - All Authorised presentations HR = Hrvatski 2006-04-03 2014-08-22
Actraphane : EPAR - All Authorised presentations HR = Hrvatski 2006-04-03 2014-08-22
Actraphane : EPAR - All Authorised presentations HR = Hrvatski 2006-04-03 2014-08-22
Actraphane : EPAR - All Authorised presentations HR = Hrvatski 2006-04-03 2014-08-22
Actraphane : EPAR - All Authorised presentations HR = Hrvatski 2006-04-03 2014-08-22
Actraphane : EPAR - All Authorised presentations HR = Hrvatski 2006-04-03 2014-08-22
Actraphane : EPAR - All Authorised presentations HR = Hrvatski 2006-04-03 2014-08-22
Actraphane : EPAR - All Authorised presentations HR = Hrvatski 2006-04-03 2014-08-22
Actraphane : EPAR - All Authorised presentations HR = Hrvatski 2006-04-03 2014-08-22

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
Actraphane : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2009-02-18 2016-02-12

Initial marketing-authorisation documents

Name Language First published Last updated
Actraphane : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2006-04-03  
Actraphane : EPAR - Scientific Discussion HR = Hrvatski 2006-04-03  

Authorised

This medicine is approved for use in the European Union