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medac GmbH
Fehlandtstrasse 3, 20354 Hamburg, Germany
Telephone: +44 (0)1786 458086
Fax: +44 (0)1786 458032
Medical Information e-mail: info@medac-uk.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: 06/01/2012
SPC Medac Disodium Pamidronate 3 mg/ml, sterile concentrate

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 06/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   23-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


a new adverse effect to our SPC of Pamidronate: " atypical subtrochanteric and diaphyseal femoral fractures".
Updated on 01/06/2011 and displayed until 06/01/2012
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   09-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Addition of new side-effect, 'atrial fibrillation'
Updated on 14/09/2009 and displayed until 01/06/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   22-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Addition of special warings in adverse events section implemeting "atrial fibrillation" in section 4.8.
New second paragrap in section 4.8.
Addition of category "not known" in Frequency estimates in section 4.8.
Addition of "atrial fibrillation" in tabulated listing of adverse events under "Cardiac disorder / Vascular disorders" in section 4.8.

Change of shelf life in section 6.3 from 36 months to 4 years.
Updated on 12/09/2005 and displayed until 14/09/2009
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Updated on 18/05/2005 and displayed until 12/09/2005
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 13/09/2004 and displayed until 18/05/2005
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  pamidronate disodium