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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories
Millbank House, Arkle Road, Sandyford, Dublin 18, Ireland
Telephone: +353 1 206 3800
Fax: +353 1 294 5104
Medical Information e-mail: info@mundipharma.ie
Summary of Product Characteristics last updated on medicines.ie: 14/07/2011
SPC DepoCyte suspension for 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 14/07/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • 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 6.3 - Shelf life
  • 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:   07-Jul-2011
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 extensively in the listed sections.
Updated on 22/07/2010 and displayed until 14/07/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   04-Jun-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
4.2  All patients should be started on dexamethasone 4mg twice daily either orally or intraveneously (underlined words have been added)

4.4 Blockage or reduction of CSF flow may result in increased free cytarbine concentrations in the CSF with increased risk of neutroxicity. (underlined words have been added).

"Therefore, as with any intrathecal cytotoxic therapy, consideration should be given to the need for assessment of CSF flow before treatment is started" jas been added

4.8  All patients receiving Depocyte should be treated concurrently with corticosteroids (e.g) dexamethasone (underlined words have been deleted).

"In some cases, a combination of neurological signs and symptoms have been reported as Cauda Equina Syndrome" has been added.

6.6  All patients should be started on dexamethasone 4mg twice daily either orally or intraveneously (underlined words have been added)

7.  Change of address of Marketing Authorisation holder.
     
Updated on 19/06/2009 and displayed until 22/07/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   28-May-2008
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


Section 4.4 – (special warning and precautions of use) to add a warning on blindness (to state that it can be permanent).  This change will only impact on the SPC and not on the PIL (as blindness is already stated as a side effect).
Updated on 15/04/2009 and displayed until 19/06/2009
Reasons for adding or updating:
  • Change to marketing authorisation holder address
Date of revision of text on the SPC:   03/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section Change in MAH address
Updated on 22/05/2008 and displayed until 15/04/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   05/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Change to section 7 ( Marketing Authorisation Holder) now reads:
 
 

Pacira Ltd

MG House

Rumbolds Hill

Midhurst, West Sussex

GU29 9BY

UK
Updated on 16/01/2007 and displayed until 22/05/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.2 updated to reference section 5.1
 
Section 5.1 additional paediatric study added
 
section 10 date of  revision amended
Updated on 07/09/2006 and displayed until 16/01/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   09/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update section 4.2 administration under supervision of an experienced  physician and not recommended for use in children and adolescentd
 
Section 4.4 updated Arachnoiditis if left untreated  may be fatal. Infectious meningitis anf hydrocephalus lso associated with admin.
 
Section 4.8 updated Table 1 updated and Table 2 new.
 
Section 6.3 Shelf life changed from 2 years to 18 months
 
Section 9 date of revision amended due to renewal.
 
 
Updated on 09/08/2004 and displayed until 07/09/2006
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  Cytarabine