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Novartis Ireland Limited
Beech House, Beech Hill Office Campus, Clonskeagh, Dublin 4,
Telephone: +353 1 2601255
Fax: +353 1 2601263
Medical Information e-mail: medinfo.dublin@novartis.com
Summary of Product Characteristics last updated on medicines.ie: 15/02/2012
SPC Cardioxane Powder for Solution for 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 15/02/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   20-Jan-2012
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
SmPC has been updated to implement the agreed harmonized EU text following approval of the Article 31 referral procedure.
Updated on 11/08/2010 and displayed until 15/02/2012
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • 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 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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:   05-Aug-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
The document has been changed significantly in the majority of sections in order to bring the text in line with the current EU-MRP approved text. There are too many changes to outline them separately.
Updated on 14/04/2010 and displayed until 11/08/2010
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   19-Mar-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
In section 1, the name has been changed to Cardioxane 500mg Powder for Concentrate for Solution for Infusion.
In section 3, the pharmaceutical form has been changed to Powder for concentrate for solution for infusion.
In section 6.3, "Once reconstituted store for 4 hours at 2-8oC" has been added.
In section 6.6, "For single use only, discard any remaining contents" has been added.
Updated on 04/10/2006 and displayed until 14/04/2010
Reasons for adding or updating:
  • Change to marketing authorisation holder
Date of revision of text on the SPC:   09/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Change to MAH Holder from Chiron Pharmacueticals to Novartis Pharmaceuticals UK Ltd
Updated on 15/08/2005 and displayed until 04/10/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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