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sanofi-aventis

sanofi-aventis
Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 4035600
Fax: +353 1 4035687
Medical Information e-mail: IEmedinfo@sanofi-aventis.com
Summary of Product Characteristics last updated on medicines.ie: 14/05/2010
SPC Lasix 20mg/2ml Solution for Injection or Infusion

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

Updated on 14/05/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-May-2010
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Addition of SJS & TEN to Section 4.8.
Updated on 21/07/2009 and displayed until 14/05/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   01-Jul-2009
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Update section 4.4 and 4.5 of SPC to include warning on concurrent use with risperidone.
Updated on 13/05/2008 and displayed until 21/07/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 17/08/2007 and displayed until 13/05/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   07/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Update
Section 4.4 - statement on use in patients with partial obstruction of urinary output
Seciton 4.8 - additional undesirable effects and reformatting of section
Updated on 23/01/2007 and displayed until 17/08/2007
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:   01/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Update Section 7 - MAH changed to sanofi-aventis Ireland Ltd.
Section 10 - Date of revision of text
Updated on 05/01/2007 and displayed until 23/01/2007
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Update Section-
1 - Change name to Lasix 20mg/2ml Solution for Injection or Infusion
3 - Description included.
8 - Renewal date.
10 - Date of revision
Updated on 05/07/2006 and displayed until 05/01/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Update to Sections - 
4.2 - addition of statement that lowest dose sufficient should be used to achieve desired effect.
4.5 - addition of statement regarding antihypertensive agents, diuretics or other drugs with blood pressure lowering potential, given with furosemide could cause fall in blood pressure.  Addition of statement regarding concomitant use with cyclosporin, ACE inhibitors, patients receiving radiocontrast.
 
Updated on 16/08/2005 and displayed until 05/07/2006
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 30/06/2003 and displayed until 16/08/2005
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 10/06/2003 and displayed until 30/06/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Furosemide

Versions

 
14/05/2010 to Current
21/07/2009 to 14/05/2010
13/05/2008 to 21/07/2009
17/08/2007 to 13/05/2008
23/01/2007 to 17/08/2007
05/01/2007 to 23/01/2007
05/07/2006 to 05/01/2007
16/08/2005 to 05/07/2006
30/06/2003 to 16/08/2005
10/06/2003 to 30/06/2003
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Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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