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Bayer plc
Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
Telephone: +44 (0)1635 563 000
Fax: +44 (0)1635 563 393
WWW: http://www.bayer.co.uk

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Summary of Product Characteristics last updated on the eMC: 29/11/2010
SPC Magnevist 2mmol/l solution for injection

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 29/11/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


 

The key changes to the SmPC are:

  • Section 4.9 (Overdose) - a sentence regarding acute toxicity has been removed.
  • Section 5.3 (Preclinical safety data) - an introductory summary statement has been included at the start of this section.
Updated on 09/02/2010 and displayed until 29/11/2010
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
Date of revision of text on the SPC:   11-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.3 (Pre-clinical safety data) - A sentence concerning Reproductive Toxicity has been deleted.
 
Revision date remains as 11 August 2008
Updated on 02/11/2009 and displayed until 09/02/2010
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.3 - Preclinical Safety Data
Date of revision of text on the SPC:   11-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.6 ( Pregnancy and lactation) - no new information has been added but this section has been updated in line with current guidelines and terminiology.  A sentence regarding toxicological studies has been moved from section 4.6 to 5.3 (preclinical safety data).

The revision date has not been changed as this approval was backdated by MHRA to 11 August 2008.
Updated on 15/08/2008 and displayed until 02/11/2009
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   11-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.3 ( shelf life) shelf life has been extended from 2years to 3 years.
Section 10 (Revision date) has been amended to 11 August 2008
Updated on 18/06/2008 and displayed until 15/08/2008
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   01-May-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


All updates are due to change of ownership, from Schering Healthcare Ltd to Bayer Plc effective from 1 May 2008

Section 7: MAH now Bayer plc
Section 8: Licence number is now PL 00010/ 0544
Section 9: Date of first authorisation is now 1 May 2008
Section 10: Revision date is now 1 May 2008 
Updated on 23/04/2008 and displayed until 18/06/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   17-Mar-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.2 Posology and Method of Administration

Statements that Magnevist 2mmol/l is for diagnostic use by intraarticular administration only and is not recommended in paediatrics until further data become available.

Section 4.4 Special warnings and special precautions for use
Updated hypersensitivity warnings.

Section 4.8 Undesirable Effects
Updated to include a tabulated summary of adverse events based on experience in more than 4900 patients, classified by MedDRA System Organ Classes.

Section 6.5 Nature and contents of container
Update material of luer lock adapter from polycarbonate to polysulphone

Section 6.6 Instructions for use and handling

Advice that tip cap should only be removed from prefilled syringe immediately before use; strengthening of the statement to discard product not used in one examination.

Scetion 10: Date of revision has been amended to 17 March 2008
Updated on 08/12/2004 and displayed until 23/04/2008
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
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