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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: 04/04/2012
SPC Gadovist 1.0 mmol/ml

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 04/04/2012 and displayed until Current
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 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   19-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Sections 4.1, 4.2 & 5.2 have all been updtaed to include information on paediatric indication for children aged 2-6 years.
Section 10 - revision date is now 19 March 2012.
Updated on 06/02/2012 and displayed until 04/04/2012
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 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic Properties
  • 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:   11-Nov-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
The key changes are to update sections 4.2, 4.4, 4.8, 4.9, 5.1, 5.2 and 5.3 of the SPC and consequently, the PIL based on data from new non-clinical and clinical studies conducted within the scope of development of gadovist for regions outside the EU. 
Updated on 05/08/2011 and displayed until 06/02/2012
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 7 (MAH) this has been amended from Bayer Schering Pharma AG to Bayer Pharma AG
Section 10 - revision date is July 2011
Updated on 02/02/2011 and displayed until 05/08/2011
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   27-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 6.3 ( Shelf life) this has been amended for the prefilled syringe/cartridge presentation only from 2 to 3 years.
Section 10 ( Revision date) - date for revision of prefilled syringe text is now 27 January 2011.
Updated on 26/10/2010 and displayed until 02/02/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - 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 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • 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:   14-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Substantial amendments have been made throughout the SmPC in line with recommended text from Art 31 Referral and renewal procedure.

Revision date is now 14 October 2010. 
Updated on 24/12/2009 and displayed until 26/10/2010
Reasons for adding or updating:
  • 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:   15-Dec-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.8 ( undesirable effects) - the following sentence has been added :

No impairment of renal functions has been observed during clinical trials performed on a limited number of patients. Data are too limited to exclude the possibility of renal toxicity or aggravation of renal impairment."

Section 10 (Revision date) - this is now 15 December 2009 
Updated on 25/09/2009 and displayed until 24/12/2009
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 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   09-Sep-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Sections 4.1( Therapeutic indications),4.2 ( Posology & method of administration), 5.1 ( Pharmacodynamic properties) & 5.2 (Pharmacokinetic properties) have all been updated to reflect approval of paediatric indication in children aged 7 - 17 years.

Section 10 (Revision date) this is now 09.09.2009.
Updated on 26/02/2009 and displayed until 25/09/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   17-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
The main changes are:

Section 4.4 (Special warnings) :
Addition of statement that hypersensitivity reactions are not predictable. 
All patients, espcially those over 65, should be screened for renal dysfunction.
NFS warning has been updated to expand warning to include patients in perioperative aliver transplantation.
Expansion of warning that due to risk of NSF, gadovist should only be used in those at essential risk.

Section 4.8 (Undesirable effects)
NSF has been added as a rare side effect.

Section 4.9 ( Overdose)
Information concerning patients with renal insufficiency has been added.

Section 10 (Date of revision)
This has been updated to 17 February 2009. 
Updated on 24/07/2008 and displayed until 26/02/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 1 -Name of the Medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   01-May-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 1 - Trade name has been amended to include cartridge
Section 3 - Pharmaceutical form has been amended to include cartridge
Section 4.2 - Pososlogy and method of administration now includes a paragraph about cartridges.
Section 6.3 - Shelf life now includes a 2 year shelf life for cartridges
Section 6.5 - Nature and contents of container - a pragraph has been inserted to describe 65ml cartridge & pack size of  1 & 5 cartridges has been added.
Updated on 29/05/2008 and displayed until 24/07/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   01-May-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 12/05/2008 and displayed until 29/05/2008
Reasons for adding or updating:
  • 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
  • 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):   YES

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

Section 7: MAH now Bayer plc
Section 8: Licence numbers are now PL 00010/ 0527 & 0528
Section 9: Date of first authorisation is now 1 May 2008
Section 10: Revision date is now 1 May 2008 
Updated on 13/08/2007 and displayed until 12/05/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.4 : Addition of NSF warning
Section 10: Revision date amended to 23 May 2007
Updated on 11/09/2006 and displayed until 13/08/2007
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 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   06/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

Section 4.1: Addition of text - Contrast enhanced MRI of liver and kidneys.

Section 4.2: Addition of text - CE-MRI of liver and kidneys: The recommended dose for adults is 0.1mmol per kilogram body weight (mmol/kgBW).  This is equivalent to 0.1ml/kg BW of the 1.0M solution.

Section 4.4: Additional paragraph has been inserted - No impairment of renal function has been observed during clinical trials performed on a limited number of patients. Data are too limited to exclude the possibility of renal toxicity or aggravation of renal impairment.  Also the following sentence has been added - In rare cases delayed anaphylactoid reactions (after hours to days) have been observed.

Section 4.8: - A table has been inserted indicating adverse reactions from clinical trial data and additional adverse reactions from postmarketing spontaneous reporting. 

Under additional safety information the following paragraph has been added.  Hypersensitivity reactions (e.g. urticaria, rash, vasodilatation) have been uncommonly reported and were mostly of mild to moderate intensity.  In rare cases anaphylactoid reactions ranging to shock may occur.  Delayed anaphylactoid reactions (after hours to days) have been observed rarely (see section 4.4).

Section 5.1: The following text has been added -

In a pivotal phase III liver study average sensitivity in combined pre and post-contrast MRI for Gadovist-treated pateints was 79% and specificity was 81% for lesion detection and classification of suspected malignant liver lesions (patient-based analysis). 

In a pivotal phase III kidney study average sensitivity was 91% (patient-based analysis) and 85% (lesion-based analysis) for classification of malignant and benign renal lesions.  Average specificity in a patient-based anyalysis was 52% and in a lesion based analysis 82%.

The increase of sensitivity from pre-contrast to combined pre and post-contrast MRI for Gadovist-treated patients was 33% in the liver study (patient-based analysis) and 18% in the kidney study (patient based analysis as well as lesion-based analysis).  The increase in specificity from pre-contrast to combined pre and post-contrast MRI was 9% in the liver study (patient based analysis) while there was no increase in specificity in the kidney study (patient-based analysis as well as lesion-based analysis).  All results are average results obtained in blinded reader studies.

Section 10: Date of revision of the text has been amended to 22 June 2006

 
Updated on 28/06/2005 and displayed until 11/09/2006
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 09/01/2004 and displayed until 28/06/2005
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 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 (date of (partial) revision of the text
Updated on 25/07/2002 and displayed until 09/01/2004
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  gadobutrol