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Aspen
12/13 Exchange Place , I.F.S.C., Dublin 1, Ireland
Telephone: +44 1748 828 798
Medical Information Direct Line: 0080000404142 - Freephone
Medical Information e-mail: aspenglobal@professionalinformation.co.uk
Summary of Product Characteristics last updated on medicines.ie: 04/05/2011
SPC Alkeran Injection

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 04/05/2011 and displayed until Current
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:   01-Jan-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Product ownership transfered from GSK to Aspen
New PL numbers and revision of text
Updated on 20/04/2010 and displayed until 04/05/2011
Reasons for adding or updating:
  • Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC:   31-Mar-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Change to Secrtion 6.4:  sentence 'Store in originla packaging' has been changed to the following 'Keep the vial in the outer carton, in order to protect from light'.
Updated on 30/01/2009 and displayed until 20/04/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
Date of revision of text on the SPC:   12/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
 

New text is highlighted in red:

 

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

Excipients: When reconstituted each vial contains 2mmol (46mg) of Sodium and 0.52ml (0.4mg) of Ethanol.

 

3.         PHARMACEUTICAL FORM

 

The pH of the reconstituted solution is pH 6.5.

 

6.1       List of Excipients

 

Freeze-dried Powder:

Povidone

Hydrochloric acid, (for pH-adjustment)

 

Solvent:

Propylene glycol

Sodium citrate

Ethanol, (96% per cent)

Water for Injections

 

6.3       Shelf-Life

 

Unopened: 3 years

Once reconstituted the product should be used immediately. Any unused portion should be discarded.

Updated on 29/10/2008 and displayed until 30/01/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 02/04/2007 and displayed until 29/10/2008
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 25/05/2005 and displayed until 02/04/2007
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
  • Change to section 6.6 - Special precautions for disposal and other handling
Updated on 05/08/2004 and displayed until 25/05/2005
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Updated on 01/07/2003 and displayed until 05/08/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Melphalan