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Napp Pharmaceuticals Limited
Cambridge Science Park, Milton Road, Cambridge, Cambridgeshire, CB4 0GW
Telephone: +44 (0)1223 424 444
Fax: +44 (0)1223 424 441
WWW: http://www.napp.co.uk
Medical Information Fax: +44 (0)1223 424 912

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 14/07/2011
SPC DepoCyte 50 mg suspension for injection

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 14/07/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The document has been changed extensively in the sections listed.
Updated on 22/07/2010 and displayed until 14/07/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to MA holder contact details
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   04-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

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 cytarabine concentrations in the CSF with increased risk of neurotoxicity. Therefore, as with any intrathecal cytotoxic therapy, consideration should be given to the need for assessment of CSF flow before treatment is started.  (words underlined have been added).


4.8  All patients receiving Depocyte should be treated concurrently with corticosteroids (e.g. (words underlined 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.  Address of MA holder has been changed.
Updated on 16/07/2009 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-2009
Legal Category:   POM
Black Triangle (CHM):   NO

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 20/04/2009 and displayed until 16/07/2009
Reasons for adding or updating:
  • Change to MA holder contact details
Date of revision of text on the SPC:   25-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change in hte address of the MAH
Updated on 22/05/2008 and displayed until 20/04/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   01-Jan-2007
Legal Category:   POM
Black Triangle (CHM):   NO

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:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 updated to include "Safety and efficacy in children have not been adequately demonstrated (see section 5.1)."
 
Section 5.1 updated final paragraph to include additional paediactric study
 
Section 10 date of revision updated
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
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 updated to be administered under supervision of a physician and not recommended for use in children and adolescents.
 
Section 4.4 updated to include untreated arachnoiditis left untreated may be fatal. Infectious meningitis and Hydrocephalus reported.
 
Section 4.8 Table 1 updated, table 2 added with additional data
 
Section 6.3 Shelf life decreased from 2 ytears to 18 months
 
Section 10 date of revision of text updated following renewal
Updated on 06/09/2006 and displayed until 07/09/2006
Reasons for adding or updating:
  • Removal of Black Triangle
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Removal of black triangle.
 
Updated date of  revision of text
Updated on 27/10/2004 and displayed until 06/09/2006
Reasons for adding or updating:
  • Addition of Black Triangle
Updated on 20/09/2004 and displayed until 27/10/2004
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  cytarabine