GlaxoSmithKline UK

Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328
Medical Information e-mail: customercontactuk@gsk.com

Summary of Product Characteristics last updated on the eMC: 12/08/2009
SPC Fortum 500 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 12/08/2009 and displayed until Current
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:   31-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.8 - interstitial nephritis and acute renal failure added under new heading 'renal and urinary disorders'
Section 10 - Date of approval added
Updated on 26/11/2008 and displayed until 12/08/2009
Reasons for adding or updating:
  • 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:   13-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 6.5 - details added to include pack size of 1 and not all sizes may be marketed

Section 10 - added the date of approval
Updated on 08/08/2008 and displayed until 26/11/2008
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • 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 5.1 - Whole section has been updated. 

Section 10 - Added the date of approval
Updated on 01/06/2007 and displayed until 08/08/2008
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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:   05/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.5: Updated to include possible interactions with oral contraceptives
Section 4.8: Punctuation correction, and changed into MedDRA
Section 10: Updated to 31/05/2007
Updated on 24/11/2006 and displayed until 01/06/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 24/11/2006 and displayed until 24/11/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 22/11/2006 and displayed until 24/11/2006
Reasons for adding or updating:
  • Addition of separate SPCs covering individual presentations
Date of revision of text on the SPC:   02/2003
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441

Active Ingredients/Generics

 
   ceftazidime pentahydrate