Home | About the eMC | Help | Mobile
eMC - trusted, up to date and comprehensive information about medicines
Link to eMC medicine guides website
eMC homepage
Advanced search
Get Medicines Compendium UK app here

Genzyme Therapeutics
4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford, Oxfordshire, OX4 2SU
Telephone: +44 (0)1865 405 200
Fax: +44 (0)1865 774 172
WWW: http://www.genzyme.co.uk
Medical Information Direct Line: +44 (0)1483 505 515
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.com
Customer Care direct line: +44 (0)1865 405 200
Medical Information Fax: +44(0)1483 554 805

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: 13/04/2011
SPC Fludara 50mg powder for solution for injection or infusion

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 13/04/2011 and displayed until Current
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 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • 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:   10-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changes made to following sections:

 

4.2    Posology and method of administration

Addition of sub heading ‘Posology’

Addition of sub heading ‘Special populations’

Changed sub heading from ‘Children’ to ‘Paediatric population’

Changed  “In patients over the age of 70  years, creatinine clearance should be measured...” to “In patients over the age of 65 years, creatinine clearance should be measured...”

4.4    Special warnings and special precautions for use

Addition of - In patients aged 65 years or older, creatinine clearance should be measured before start of treatment, see “Renal impairment” and section 4.2.

Addition of final paragraph – Excipients - Each vial Fludara 50 mg powder for solution for injection/infusion contains less than 1 mmol sodium (23 mg), i.e. essentially ‘sodium-free’.

4.6    Pregnancy and lactation

Addition of the sub-heading “Fertility”

4.8    Undesirable effects

Addition of the’ Not Known’ column in the table for undesirable effects.

9.           DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Correction of dates

10.       DATE OF REVISION OF THE TEXT
Updated on 11/12/2009 and displayed until 13/04/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • 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:   01-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changes to Sections 7, 8, 9 and 10

In section 7 (Marketing Authorisation Holder), change in ownership
In section 8 (Marketing Authorisation Number), change in number
In section 9 (Date of first Authorisation/Renewal of Authoristion), change of date
In section 10 (Date of revision of text), change of date
Updated on 11/03/2009 and displayed until 11/12/2009
Reasons for adding or updating:
  • 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 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   26-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

In Section 4.3 ( Contraindications) - contraindication for pregancy has been removed.

In Sections 4.4 ( Special warnings and precautions) and ( Pregnancy and lactation) - new warnings and available information have been added.

In Section 5.3 (pre-clinical safety data) - The side effect myelodysplastic syndrome and acute myeloid leukaemia has moved from frequency rare, to common. Additionally the footnote that stated 'Monotherapy with Fludara has not been associated with an increased risk for the development of myelodysplastic syndrome / AML' has been deleted.  Also,  a small amount of additional information has been added to the embryotoxicity preclinical safety data.

Section 10 (Revision date) - this is now 26 February 2009
Updated on 16/05/2008 and displayed until 11/03/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • 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:   01-May-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


All updates are due to change of ownership, from Schering Healthcare Ltd to Bayer Plc effective from 1 May

Section 7: MAH now Bayer plc
Section 8: Licence numbers are now PL 00010/ 0532
Section 9: Date of first authorisation is now 1 May 2008
Section 10: Revision date is now 1 May 2008 
Updated on 25/02/2008 and displayed until 16/05/2008
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.2 - Incompatibilities
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Sections 2, 4.3 & 4.6 - editorial changes only.
Section 4.2 - Rearrangment of sentences & additional cross references. Additional subheading for hepatic impairment ( + elder patients).  Statement that Fludara is not recommended for use in children has been inserted.
Section 4.4 - new layout, subsections including myelosuppression, auto-immune disorder, neutroxicity, tumour lusis syndrome, transfusion-associated graft versus host disease, skin cancer, impaired state of health, renal impairment, the elderly & vaccination.
Section 4.5 - new mention of Dipyridamole and other inhibitors of adrensoine uptake.
Section 4.6 - additional warning/ information re pregnancy and breast feeding.
Section 4.7 - revised wording
Section 4.8 - major update and conversion to MedDRA terminology.
Section 5.1 - additional information including data from phase III clinical trial
Section 5.2 - additional information, editorial amendments and rearrangement of text
Section 5.3 - additional information of local tolerance  
Sections 6.2 & 6.4 - editorial changes
Section 10 - revision date has been updated to February 2008
Updated on 05/12/2005 and displayed until 25/02/2008
Reasons for adding or updating:
  • No reasons supplied
Updated on 21/09/2005 and displayed until 05/12/2005
Reasons for adding or updating:
  • Change to section 1 - trade name
  • 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 4.3 - Contra-indications
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • 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 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
Updated on 20/12/2004 and displayed until 21/09/2005
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 11/02/2003 and displayed until 20/12/2004
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 4.4 - Special Warnings and Precautions for Use
  • Change to section 10 (date of (partial) revision of the text
  • Change to section 5.1 - Pharmacodynamic Properties
Updated on 15/08/2001 and displayed until 11/02/2003
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 05/09/2000 and displayed until 15/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 28/01/2000 and displayed until 05/09/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 28/01/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  fludarabine phosphate