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Cephalon Pharma (Ireland) Ltd
Suite 43, Northwood Court, Northwood Business Campus, Santry, Dublin 9,
Telephone: +353 1 8621600
Fax: +353 1 8621601
Medical Information e-mail: UKMedInfo@cephalon.com
Summary of Product Characteristics last updated on medicines.ie: 06/05/2010
SPC Dopacard

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 06/05/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   26-Mar-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


The SmPC has been updated as follows:

-          Section 2 – add standard statement ‘For a full list of excipients, see section 6.6

-          Section 6.2 amended to include statement on mixing the product with other medicinal products except those mentioned in 6.6; not adding Sodium Bicarbonate or any other strongly alkaline solution, as inactivation will occur,

-          Section 6.3 (shelf-life) reworded to make instructions clearer for user

-          Section 6.4 – add ‘to protect from light and moisture’, ‘store below 25◦C & statement about storage of sterile products,

-          Section 6.6 – clarify instructions for dilution of the product.  Amend section 4.2 and refer to section 6.6 for instructions for use/handling

 

 

 

 

 

 
Updated on 29/07/2008 and displayed until 06/05/2010
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 10/01/2007 and displayed until 29/07/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   12/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Change of MA holder from Zeneus to Cepahlon
Updated on 04/01/2006 and displayed until 10/01/2007
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of renewal of authorisation
Updated on 23/06/2003 and displayed until 04/01/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Dopexamine Hydrochloride