Fludara 50 mg powder for solution for injection or infusion
- Name:
Fludara 50 mg powder for solution for injection or infusion
- Company:
Sanofi Genzyme
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 14/05/19
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Sanofi Genzyme
Company Products
When a pharmaceutical company changes any document, 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 May 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 14 May 2019 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
7.MARKETING AUTHORISATION HOLDER
Genzyme Europe B.V.
Paasheuvelweg 25
1105 BP Amsterdam
The Netherlands
Updated on 10 April 2019 PIL
Reasons for updating
- Previous version of PIL reinstated
Updated on 10 April 2019 SmPC
Reasons for updating
- Previous version of SmPC reinstated
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 15 March 2019 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
Updated on 15 March 2019 SmPC
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 7 - Marketing authorisation holder
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
7 MARKETING AUTHORISATION HOLDER
Genzyme Europe B.V.
Gooimeer 10
1411 DD Naarden
Paasheuvelweg 25
1105 BP Amsterdam
The Netherlands
8 MARKETING AUTHORISATION NUMBER(S)
Updated on 9 March 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 9 March 2016 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 20 January 2016 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 20 January 2016 SmPC
Reasons for 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 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 23 December 2014 PIL
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 17 February 2012 PIL
Reasons for updating
- Change to name of manufacturer
Updated on 12 April 2011 SmPC
Reasons for 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 renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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 12 April 2011 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 20 April 2010 PIL
Reasons for updating
- Change to improve clarity and readability
Updated on 19 April 2010 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 19 April 2010 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)