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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

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 14/03/2011
SPC Magnevist

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 14/03/2011 and displayed until Current
Reasons for adding or updating:
  • 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:   28-Feb-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.3 (Preclinical safety data) an introductory summary statement has been included at the start of this section in line with the Company Core Data Sheet and current SmPC guidance. The more detailed text previously in this section has been removed - Section 5.3 is consequently now considerably shorter.

Section 10 (Revision Date) this is now 28 February 2011
Updated on 17/08/2010 and displayed until 14/03/2011
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • 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:   03-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Extensive changes have been made to the SmPC  to add additional information regarding NSF, including a tracking label to allow tracking of Gadolinium contrast agent administered and dose, following the Article 31 Referral Procedure for all Gadolinium-containing contrast agents.

Revision date is now 3 August 2010
Updated on 13/06/2008 and displayed until 17/08/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
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 numbers are now PL 00010/ 0542 & 0543
Section 9: Date of first authorisation is now 1 May 2008
Section 10: Revision date is now 1 May 2008 
Updated on 16/05/2008 and displayed until 13/06/2008
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 6.2 - Incompatibilities
  • 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:   08-Feb-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.

Section 10: Date of revision has been updated to 8 February 2008 
Updated on 27/09/2007 and displayed until 16/05/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   06/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 Posology and method of administration -  insertion of missing text
Section 6.5 Nature and contents of container - updated in line with separate SmPCs
Section 10 : revision date amended for vials and pfs to 27 June 2007 
Updated on 25/09/2007 and displayed until 27/09/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   06/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 - Posology and method of administration - insertion of missing text " T1 - weighted ................................."
Section 6.5 - Nature and contents of container - Updated in line with approved SmPC
Section 10 - Date of (partial) revision of the text - both vials and pre-filled syringe date has been amended to 27 June 2007
Updated on 03/07/2007 and displayed until 25/09/2007
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   06/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SPC wording has been updated with the NSF warning.
This affects the following sections:
 
Section 4.3 - Contraindications
Section 4.4 - Special Warnings and special precautions for use ( renal function, newborn and infants)
Section 4.8 - Undesirable effects - cases of NSF have been reported with magnevist
Section 10 - revision date has been updated to June 2007 
Updated on 20/12/2004 and displayed until 03/07/2007
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
Updated on 30/01/2003 and displayed until 20/12/2004
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 31/10/2001 and displayed until 30/01/2003
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.9 - Overdose
  • Change to section 10 (date of (partial) revision of the text
Updated on 19/07/2001 and displayed until 31/10/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 06/09/1999 and displayed until 19/07/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  dimeglumine gadopentetate