Home | About the eMC | Help | Mobile
eMC - trusted, up to date and comprehensive information about medicines
Link to eMC medicine guides website
eMC homepage
Advanced search
Get Medicines Compendium UK app here

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: 15/06/2009
SPC Gastrografin

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 15/06/2009 and displayed until Current
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   02-Jun-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 03/06/2009 and displayed until 15/06/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02-Jun-2009
Legal Category:   POM, CE_Mark
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The following changes to the SmPC were made to bring it in line with revisions to the CCDS:

Section 4.2

Therapy of uncomplicated meconium ileus:

An intravenous drip must therefore be set up before the enema is given and

 

fluid plasma should be infused as required.

 

Dosage for Gastrografin in combination with barium sulphate:

If necessary (in cases of pylorospasm or pyloric stenosis), the portion of Gastrografin in the suspension may be further

 

increased reduced.

Section 10 - revision date is now 2 June 2009

 
Updated on 05/01/2009 and displayed until 03/06/2009
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   22-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 ( Contraindications) - editorial change
Section 10 (Date of revision) now 22.09.2008
Updated on 28/07/2008 and displayed until 05/01/2009
Reasons for adding or updating:
  • Change to section 6.2 - Incompatibilities
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • 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:   17-Jul-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 3 (Pharmaceutical form) - Aqueous solution has been changed to Gastroenteral solution.
Section 4.2 (Psology & method of administration) - this section has been re-formatted completely.
Section 6.2 ( Incompatabilities) - "None known" has been replaced with "This medicinal product must not be mixed with other medicinal products except those mentioned in section 4.2."
Section 7 - MAH - Trading as Bayerplc, Bayer Schering Pharma has been inserted.
Section 10 - Revision Date has been updated to 17 July 2008.
Updated on 26/06/2008 and displayed until 28/07/2008
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 7 - Marketing Authorisation Holder
  • 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 number is now PL 00010/ 0537
Section 9: Date of first authorisation is now 1 May 2008
Section 10: Revision date is now 1 May 2008 
Updated on 03/09/2007 and displayed until 26/06/2008
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:   08/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.3: Shelf life has been extended from 3 to 5 years
Section 10: Revision date has been changed to 29 August 2007 
Updated on 20/05/2003 and displayed until 03/09/2007
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 09/08/2001 and displayed until 20/05/2003
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 03/11/2000 and displayed until 09/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 03/11/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  sodium amidotrizoate
  meglumine amidotrizoate