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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: 16/02/2011
SPC Proleukin Powder for 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 16/02/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   10-Feb-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Section 4.8 updated to add the term eosinophilia in the table of ADRs with a frequency unknown and complete the existing statement in the SmPC about eosinophilia below the table of ADRs as follows: During treatment most patients experience lymphocytopenia and eosinophilia, with a rebound lymphocytosis within 24 to 48 hours following treatment. These may be related to the mechanism of antitumour activity of Proleukin. Severe manifestations of eosinophilia have been reported, involving eosinophilic infiltration of cardiac and pulmonary tissues.
Updated on 24/01/2011 and displayed until 16/02/2011
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   23-Dec-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Section 5.2 updated to include the following text:

The pharmacokinetic parameters of IL-2, following an intravenous or subcutaneous administration of aldesleukin in metastatic renal cell carcinoma and metastatic malignant melanoma patients is as follows:

 

Following a continuous intravenous infusion-fixed and continuous intravenous infusion-decrescendo administration of aldesleukin, the mean tmax of IL-2 was 11 hours and 4.4 hours, respectively.  Compared to the serum levels following the subcutaneous administration, the observed serum levels following the continuous intravenous infusion-fixed and continuous intravenous infusion-decrescendo administration of aldesleukin are 3.20 and 1.95-fold higher.

 
Updated on 21/06/2010 and displayed until 24/01/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC:   21-May-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 4.8 (undesirable effects) :
Neutropenia and neutropenic fever were added to Blood and Lymphatic System disorders; 
Intracranial/cerebral haemorrhage, cerebrovascular accident and leukoencephalopathy were added to Nervous System disorders;
Cardiac arrest, pericardial effusion and cardiac temponade were added to Cardiac disorders and
Gastrointestinal perforation including necrosis/gangrene were added to Gastrointestinal disorders
all with a frequency of "not known".
Additional information on rare reports of leukoencephalopathy was also included in this section.

In section 6.4 (special precautions for storage) the statement "Store in the original package in order to protect from light" was added.
Updated on 08/04/2009 and displayed until 21/06/2010
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 18/08/2008 and displayed until 08/04/2009
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 05/10/2006 and displayed until 18/08/2008
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

MAH holder changed from Chiron Pharmacueticals to Novartis Pharmaceuticals UK Ltd
Updated on 11/08/2004 and displayed until 05/10/2006
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
Updated on 10/08/2004 and displayed until 11/08/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Aldesleukin