Optimark

gadoversetamide

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

What is Optimark?

Optimark is a solution for injection that contains the active substance gadoversetamide. It is available in prefilled syringes and in vials.

What is Optimark used for?

Optimark is for diagnostic use. It is used in adults and in children from two years of age who are undergoing magnetic resonance imaging (MRI), a type of scan where images of the internal organs are taken. Optimark is used to obtain a clearer scan in patients who have or are thought to have abnormalities in the brain, spine or liver.

The medicine can only be obtained with a prescription.

How is Optimark used?

Optimark should only be given by a doctor who has experience in using MRI. It is given as an injection into a vein, usually a vein in an arm. The recommended dose is 0.2 ml per kilogram body weight.

Optimark allows images to be taken for up to an hour after it has been injected, although the best time to take a scan depends on the location and type of abnormality that is being examined. When looking at certain abnormalities in the brain, Optimark may need to be used at a higher dose, or the dose may need to be repeated. A repeated dose is not recommended in children, in patients with kidney problems or in elderly patients.

Patients who have moderate problems with their kidneys should only receive Optimark if their doctor has carefully balanced the benefits and risks of using it. These patients should receive no more than one dose of Optimark during each MRI scan, and there should be a gap of at least a week between each Optimark injection.

How does Optimark work?

The active substance in Optimark, gadoversetamide, contains gadolinium, a ‘rare-earth’ metal element. Gadolinium is used as a ‘contrast agent’ to help obtain better images with MRI scans. MRI is an imaging method that relies on the tiny magnetic fields produced by water molecules in the body. Once injected, gadolinium interacts with the water molecules. As a result of this interaction, the water molecules give a stronger signal, and this helps to obtain a brighter picture. In Optimark, the gadolinium is attached to another chemical so that the metal is not released in the body but stays ‘trapped’ until it is eliminated from the body in the urine.

How has Optimark been studied?

Optimark has been studied in four main studies involving a total of 804 patients who had or were thought to have abnormalities in the brain or spine (two studies in 401 patients) or in the liver (two studies in 403 patients). In all of the studies, the effects of Optimark were compared with those of gadopentetate dimeglumine (another contrast agent containing gadolinium). The main measure of effectiveness was the difference in the ability to see the abnormalities on MRI scans taken with and without the contrast agent. Each scan’s clarity was scored on a four-point scale. The scans were analysed by three radiologists (doctors specialised in carrying out and interpreting scans of the body).

The radiologists did not know what treatment the patient had received beforehand, to make sure that the studies’ findings were as accurate as possible.

What benefit has Optimark shown during the studies?

In all of the studies, Optimark was as effective as the comparator contrast agent in improving the ability to see abnormalities on the scans.

In the two studies of brain and spine abnormalities taken together, scans taken with Optimark had a score increase of 0.63 points on average from a ‘baseline’ of 1.58 points without Optimark. This compared with an increase of 0.66 points with the comparator contrast agent, from a baseline of 1.60 points.

In the studies of liver abnormalities, both medicines increased the score by an average of 0.38 points from a baseline of 1.82 points.

What is the risk associated with Optimark?

The most common side effects with Optimark (seen in between 1 and 10 patients in 100) are headache, dysgeusia (taste disturbances) and feeling hot. For the full list of all side effects reported with Optimark, see the package leaflet.

Optimark must not be used in people who are hypersensitive (allergic) to gadoversetamide, any of the other ingredients or other medicines containing gadolinium. It must not be used in patients who have severely reduced kidney function, in patients who have had or are about to have a liver transplant, or in babies aged less than four weeks, due to a risk of a condition called nephrogenic systemic fibrosis (NSF). NSF causes thickening of the skin and connective tissues.

Why has Optimark been approved?

The CHMP decided that Optimark’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 Optimark?

The company that markets Optimark will ensure that all healthcare professionals who are expected to use this medicine are informed that it should not be used in children below 2 years as the effect of the medicine in this age group, such as its effect on immature kidneys, has not been studied.

In addition, the company will provide annual reviews of cases of NSF and conduct a study on the accumulation of gadolinium in the bone.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Optimark have also been included in the summary of product characteristics and the package leaflet.

Other information about Optimark

The European Commission granted a marketing authorisation valid throughout the European Union for Optimark on 23 July 2007.

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

Name Language First published Last updated
Optimark : EPAR - Summary for the public BG = bălgarski 02/08/2007 16/06/2016
Optimark : EPAR - Summary for the public ES = español 02/08/2007 16/06/2016
Optimark : EPAR - Summary for the public CS = čeština 02/08/2007 16/06/2016
Optimark : EPAR - Summary for the public DA = dansk 02/08/2007 16/06/2016
Optimark : EPAR - Summary for the public DE = Deutsch 02/08/2007 16/06/2016
Optimark : EPAR - Summary for the public ET = eesti keel 02/08/2007 16/06/2016
Optimark : EPAR - Summary for the public EL = elliniká 02/08/2007 16/06/2016
Optimark : EPAR - Summary for the public EN = English 02/08/2007 16/06/2016
Optimark : EPAR - Summary for the public FR = français 02/08/2007 16/06/2016
Optimark : EPAR - Summary for the public IT = italiano 02/08/2007 16/06/2016
Optimark : EPAR - Summary for the public LV = latviešu valoda 02/08/2007 16/06/2016
Optimark : EPAR - Summary for the public LT = lietuvių kalba 02/08/2007 16/06/2016
Optimark : EPAR - Summary for the public HU = magyar 02/08/2007 16/06/2016
Optimark : EPAR - Summary for the public MT = Malti 02/08/2007 16/06/2016
Optimark : EPAR - Summary for the public NL = Nederlands 02/08/2007 16/06/2016
Optimark : EPAR - Summary for the public PL = polski 02/08/2007 16/06/2016
Optimark : EPAR - Summary for the public PT = português 02/08/2007 16/06/2016
Optimark : EPAR - Summary for the public RO = română 02/08/2007 16/06/2016
Optimark : EPAR - Summary for the public SK = slovenčina 02/08/2007 16/06/2016
Optimark : EPAR - Summary for the public SL = slovenščina 02/08/2007 16/06/2016
Optimark : EPAR - Summary for the public FI = suomi 02/08/2007 16/06/2016
Optimark : EPAR - Summary for the public SV = svenska 02/08/2007 16/06/2016
Optimark : EPAR - Summary for the public HR = Hrvatski 02/08/2007 16/06/2016

This EPAR was last updated on 23/08/2016 .

Authorisation details

Product details

Product details for Optimark
NameOptimark
Agency product numberEMEA/H/C/000745
Active substance

gadoversetamide

International non-proprietary name (INN) or common name

gadoversetamide

Therapeutic area Magnetic Resonance Imaging
Anatomical therapeutic chemical (ATC) code V08CA06
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Optimark
Marketing-authorisation holder

Mallinckrodt Deutschland GmbH

Revision13
Date of issue of marketing authorisation valid throughout the European Union23/07/2007

Contact address:

Mallinckrodt Deutschland GmbH
Josef-Dietzgen-Str, 1
53773 Hennef
Germany

Product information

Product information

20/07/2016  Optimark -EMEA/H/C/000745 -IB/0036

Name Language First published Last updated
Optimark : EPAR - Product Information HR = Hrvatski 23/04/2009 23/08/2016
Optimark : EPAR - Product Information HR = Hrvatski 23/04/2009 23/08/2016
Optimark : EPAR - Product Information HR = Hrvatski 23/04/2009 23/08/2016
Optimark : EPAR - Product Information HR = Hrvatski 23/04/2009 23/08/2016
Optimark : EPAR - Product Information HR = Hrvatski 23/04/2009 23/08/2016
Optimark : EPAR - Product Information HR = Hrvatski 23/04/2009 23/08/2016
Optimark : EPAR - Product Information HR = Hrvatski 23/04/2009 23/08/2016
Optimark : EPAR - Product Information HR = Hrvatski 23/04/2009 23/08/2016
Optimark : EPAR - Product Information HR = Hrvatski 23/04/2009 23/08/2016
Optimark : EPAR - Product Information HR = Hrvatski 23/04/2009 23/08/2016
Optimark : EPAR - Product Information HR = Hrvatski 23/04/2009 23/08/2016
Optimark : EPAR - Product Information HR = Hrvatski 23/04/2009 23/08/2016
Optimark : EPAR - Product Information HR = Hrvatski 23/04/2009 23/08/2016
Optimark : EPAR - Product Information HR = Hrvatski 23/04/2009 23/08/2016
Optimark : EPAR - Product Information HR = Hrvatski 23/04/2009 23/08/2016
Optimark : EPAR - Product Information HR = Hrvatski 23/04/2009 23/08/2016
Optimark : EPAR - Product Information HR = Hrvatski 23/04/2009 23/08/2016
Optimark : EPAR - Product Information HR = Hrvatski 23/04/2009 23/08/2016
Optimark : EPAR - Product Information HR = Hrvatski 23/04/2009 23/08/2016
Optimark : EPAR - Product Information HR = Hrvatski 23/04/2009 23/08/2016
Optimark : EPAR - Product Information HR = Hrvatski 23/04/2009 23/08/2016
Optimark : EPAR - Product Information HR = Hrvatski 23/04/2009 23/08/2016
Optimark : EPAR - Product Information HR = Hrvatski 23/04/2009 23/08/2016
Optimark : EPAR - Product Information HR = Hrvatski 23/04/2009 23/08/2016
Optimark : EPAR - Product Information HR = Hrvatski 23/04/2009 23/08/2016

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
Optimark : EPAR - All Authorised presentations HR = Hrvatski 02/08/2007  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 02/08/2007  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 02/08/2007  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 02/08/2007  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 02/08/2007  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 02/08/2007  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 02/08/2007  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 02/08/2007  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 02/08/2007  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 02/08/2007  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 02/08/2007  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 02/08/2007  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 02/08/2007  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 02/08/2007  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 02/08/2007  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 02/08/2007  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 02/08/2007  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 02/08/2007  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 02/08/2007  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 02/08/2007  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 02/08/2007  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 02/08/2007  

Pharmacotherapeutic group

Contrast media

Therapeutic indication

This medicinal product is for diagnostic use only.

Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver. It provides contrast enhancement and facilitates visualisation and helps with the characterisation of focal lesions and abnormal structures in the CNS and liver in patients with known or highly suspected pathology.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Optimark : EPAR - Scientific Discussion HR = Hrvatski 30/05/2008  
Optimark : EPAR - Procedural steps taken before authorisation HR = Hrvatski 02/08/2007  

Authorised

This medicine is approved for use in the European Union

Patient safety


More information on Optimark