Scintimun

besilesomab

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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 their 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 for the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

What is Scintimun?

Scintimun is a kit for the preparation of a radioactive solution for injection. It contains the active substance besilesomab.

What is Scintimun used for?

Scintimun is not used on its own, but must be radiolabelled before use. Radiolabelling is a technique where a substance is labelled with a radioactive compound. Scintimun is radiolabelled by mixing it with a solution of radioactive technetium (99mTc).

Scintimun is for diagnostic use only. It is used to locate areas of infection or inflammation in adults with suspected osteomyelitis (bone infection) in the limbs, in combination with other appropriate imaging methods.

Scintimun should not be used to diagnose diabetic foot infection (infection that occurs in the feet of patients with diabetes).

The medicine can only be obtained with a prescription.

How is Scintimun used?

Scintimun should only be used in hospitals with a nuclear medicine department and should only be handled by authorised staff.

A radioactive Scintimun solution is made by mixing the powder and solvent provided in the kit and then radiolabelling it with technetium (99mTc). The solution is given to the patient as one injection into a vein. The amount of besilesomab injected varies between 0.25 to 1 mg, depending on how much radioactivity is required.

Three to six hours after the injection, the doctor takes a scan of the limbs to locate the areas in the bones affected by osteomyelitis.

How does Scintimun work?

The active substance in Scintimun, besilesomab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in the body. Besilesomab has been designed to attach to an antigen called NCA-95, which is found on the surface of granulocytes, a type of white blood cell involved in inflammation and fighting infection.

When Scintimun is radiolabelled, the radioactive compound technetium (99mTc) becomes attached to besilesomab. When the radiolabelled medicine is injected into the patient, the monoclonal antibody carries the radioactivity to the target antigen on the granulocytes. As large numbers of granulocytes gather at the site of an infection, the radioactivity will accumulate in areas affected by osteomyelitis, where it can be detected by scans. The images will show where besilesomab has accumulated, which the doctor will use to locate the areas of infection or inflammation.

How has Scintimun been studied?

In one main study in 130 patients who had or were suspected to have osteomyelitis in their limbs, radiolabelled Scintimun was compared with a standard diagnostic technique using the patients’ own white blood cells that were radiolabelled before being injected back into the patient. Patients limbs were then scanned and the images obtained using both techniques were compared. The main measure of effectiveness for Scintimun was based on how much the assessment of the images obtained with Scintimun agreed with that obtained with the radiolabelled white blood cells.

What benefit has Scintimun shown during the studies?

Scintimun produced comparable results to the radiolabelled white blood cells when used to diagnose and locate osteomyelitis in limbs. The agreement rate was 83%.

What is the risk associated with Scintimun?

The most common side effect with Scintimun (seen in more than 1 patient in 10) is the production of anti-mouse antibodies. For the full list of all side effects reported with Scintimun, see the package leaflet. Scintimun must not be used in people who are hypersensitive (allergic) to besilesomab, to other mouse antibodies or to any of the other ingredients. Scintimun must not be used in patients who have tested positive for human anti-mouse antibody (HAMA) and must not be used in pregnant women. As for all radioactive substances used in medicine, patients should be exposed to the lowest possible dose of Scintimun.

Why has Scintimun been approved?

The CHMP decided that Scintimun’s benefits are greater than its risks. The Committee recommended that Scintimun be given marketing authorisation.

What measures are being taken to ensure the safe use of Scintimun?

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

In addition the company that makes Scintimun will make sure that all doctors who are expected to use it are provided with a letter explaining the risks associated with the medicine.

Other information about Scintimun:

The European Commission granted a marketing authorisation valid throughout the European Union for Scintimun on 11 January 2010.

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

Name Language First published Last updated
Scintimun : EPAR - Summary for the public BG = bălgarski 2010-03-15 2014-09-30
Scintimun : EPAR - Summary for the public ES = español 2010-03-15 2014-09-30
Scintimun : EPAR - Summary for the public CS = čeština 2010-03-15 2014-09-30
Scintimun : EPAR - Summary for the public DA = dansk 2010-03-15 2014-09-30
Scintimun : EPAR - Summary for the public DE = Deutsch 2010-03-15 2014-09-30
Scintimun : EPAR - Summary for the public ET = eesti keel 2010-03-15 2014-09-30
Scintimun : EPAR - Summary for the public EL = elliniká 2010-03-15 2014-09-30
Scintimun : EPAR - Summary for the public EN = English 2010-03-15 2014-09-30
Scintimun : EPAR - Summary for the public FR = français 2010-03-15 2014-09-30
Scintimun : EPAR - Summary for the public IT = italiano 2010-03-15 2014-09-30
Scintimun : EPAR - Summary for the public LV = latviešu valoda 2010-03-15 2014-09-30
Scintimun : EPAR - Summary for the public LT = lietuvių kalba 2010-03-15 2014-09-30
Scintimun : EPAR - Summary for the public HU = magyar 2010-03-15 2014-09-30
Scintimun : EPAR - Summary for the public MT = Malti 2010-03-15 2014-09-30
Scintimun : EPAR - Summary for the public NL = Nederlands 2010-03-15 2014-09-30
Scintimun : EPAR - Summary for the public PL = polski 2010-03-15 2014-09-30
Scintimun : EPAR - Summary for the public PT = português 2010-03-15 2014-09-30
Scintimun : EPAR - Summary for the public RO = română 2010-03-15 2014-09-30
Scintimun : EPAR - Summary for the public SK = slovenčina 2010-03-15 2014-09-30
Scintimun : EPAR - Summary for the public SL = slovenščina 2010-03-15 2014-09-30
Scintimun : EPAR - Summary for the public FI = suomi 2010-03-15 2014-09-30
Scintimun : EPAR - Summary for the public SV = svenska 2010-03-15 2014-09-30
Scintimun : EPAR - Summary for the public HR = Hrvatski 2010-03-15 2014-09-30

This EPAR was last updated on 27/10/2016 .

Authorisation details

Product details

Product details for Scintimun
NameScintimun
Agency product numberEMEA/H/C/001045
Active substance

besilesomab

International non-proprietary name (INN) or common name

besilesomab

Therapeutic area Radionuclide ImagingOsteomyelitis
Anatomical therapeutic chemical (ATC) code V09HA03

Publication details

Publication details for Scintimun
Marketing-authorisation holder

CIS bio international
 

Revision5
Date of issue of marketing authorisation valid throughout the European Union11/01/2010

Contact address:

CIS bio international
Route Nationale 306, BP 32
F-91192 Gif-sur-Yvette
Cedex
France

Product information

Product information

22/09/2016  Scintimun -EMEA/H/C/001045 -II/0010/G

Name Language First published Last updated
Scintimun : EPAR - Product Information HR = Hrvatski 2010-03-15 2016-10-27
Scintimun : EPAR - Product Information HR = Hrvatski 2010-03-15 2016-10-27
Scintimun : EPAR - Product Information HR = Hrvatski 2010-03-15 2016-10-27
Scintimun : EPAR - Product Information HR = Hrvatski 2010-03-15 2016-10-27
Scintimun : EPAR - Product Information HR = Hrvatski 2010-03-15 2016-10-27
Scintimun : EPAR - Product Information HR = Hrvatski 2010-03-15 2016-10-27
Scintimun : EPAR - Product Information HR = Hrvatski 2010-03-15 2016-10-27
Scintimun : EPAR - Product Information HR = Hrvatski 2010-03-15 2016-10-27
Scintimun : EPAR - Product Information HR = Hrvatski 2010-03-15 2016-10-27
Scintimun : EPAR - Product Information HR = Hrvatski 2010-03-15 2016-10-27
Scintimun : EPAR - Product Information HR = Hrvatski 2010-03-15 2016-10-27
Scintimun : EPAR - Product Information HR = Hrvatski 2010-03-15 2016-10-27
Scintimun : EPAR - Product Information HR = Hrvatski 2010-03-15 2016-10-27
Scintimun : EPAR - Product Information HR = Hrvatski 2010-03-15 2016-10-27
Scintimun : EPAR - Product Information HR = Hrvatski 2010-03-15 2016-10-27
Scintimun : EPAR - Product Information HR = Hrvatski 2010-03-15 2016-10-27
Scintimun : EPAR - Product Information HR = Hrvatski 2010-03-15 2016-10-27
Scintimun : EPAR - Product Information HR = Hrvatski 2010-03-15 2016-10-27
Scintimun : EPAR - Product Information HR = Hrvatski 2010-03-15 2016-10-27
Scintimun : EPAR - Product Information HR = Hrvatski 2010-03-15 2016-10-27
Scintimun : EPAR - Product Information HR = Hrvatski 2010-03-15 2016-10-27
Scintimun : EPAR - Product Information HR = Hrvatski 2010-03-15 2016-10-27
Scintimun : EPAR - Product Information HR = Hrvatski 2010-03-15 2016-10-27
Scintimun : EPAR - Product Information HR = Hrvatski 2010-03-15 2016-10-27
Scintimun : EPAR - Product Information HR = Hrvatski 2010-03-15 2016-10-27

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
Scintimun : EPAR - All Authorised presentations HR = Hrvatski 2010-03-15  
Scintimun : EPAR - All Authorised presentations HR = Hrvatski 2010-03-15  
Scintimun : EPAR - All Authorised presentations HR = Hrvatski 2010-03-15  
Scintimun : EPAR - All Authorised presentations HR = Hrvatski 2010-03-15  
Scintimun : EPAR - All Authorised presentations HR = Hrvatski 2010-03-15  
Scintimun : EPAR - All Authorised presentations HR = Hrvatski 2010-03-15  
Scintimun : EPAR - All Authorised presentations HR = Hrvatski 2010-03-15  
Scintimun : EPAR - All Authorised presentations HR = Hrvatski 2010-03-15  
Scintimun : EPAR - All Authorised presentations HR = Hrvatski 2010-03-15  
Scintimun : EPAR - All Authorised presentations HR = Hrvatski 2010-03-15  
Scintimun : EPAR - All Authorised presentations HR = Hrvatski 2010-03-15  
Scintimun : EPAR - All Authorised presentations HR = Hrvatski 2010-03-15  
Scintimun : EPAR - All Authorised presentations HR = Hrvatski 2010-03-15  
Scintimun : EPAR - All Authorised presentations HR = Hrvatski 2010-03-15  
Scintimun : EPAR - All Authorised presentations HR = Hrvatski 2010-03-15  
Scintimun : EPAR - All Authorised presentations HR = Hrvatski 2010-03-15  
Scintimun : EPAR - All Authorised presentations HR = Hrvatski 2010-03-15  
Scintimun : EPAR - All Authorised presentations HR = Hrvatski 2010-03-15  
Scintimun : EPAR - All Authorised presentations HR = Hrvatski 2010-03-15  
Scintimun : EPAR - All Authorised presentations HR = Hrvatski 2010-03-15  
Scintimun : EPAR - All Authorised presentations HR = Hrvatski 2010-03-15  
Scintimun : EPAR - All Authorised presentations HR = Hrvatski 2010-03-15  

Pharmacotherapeutic group

Diagnostic radiopharmaceuticals

Therapeutic indication

This medicinal product is for diagnostic use only and the approved indication is scintigraphic imaging, in conjunction with other appropriate imaging modalities, for determining the location of inflammation/infection in peripheral bone in adults with suspected osteomyelitis. Scintimun should not be used for the diagnosis of diabetic foot infection.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Scintimun : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2011-11-11 2016-10-27

Initial marketing-authorisation documents

Name Language First published Last updated
Scintimun : EPAR - Public assessment report HR = Hrvatski 2010-03-15  
Committee for Medicinal Products for Human use Summary of positive opinion for Scintimun HR = Hrvatski 2009-10-22  

Authorised

This medicine is approved for use in the European Union