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Celgene Ltd
1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, UK
Telephone: +44 (0)208 831 8300
Fax: +44 1753 861 484
Medical Information Direct Line: +353 1800 333 111
Medical Information e-mail: medinfo.uk.ire@celgene.com
Medical Information Facsimile: +353 1800 333 112
Summary of Product Characteristics last updated on medicines.ie: 02/05/2012
SPC Vidaza

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 02/05/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
Date of revision of text on the SPC:   20-Apr-2012
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Section 4.2 (posology and method of administration) - Mathematical symbols substituted for text in the section titled dose adjustment due to haematological toxicity.  In the paragraph concerning Patients without reduced baseline blood counts: greater than or equal to signs are used instead of greater than only.  Symbols have replace text in the section Patients with reduced baseline blood counts.

Section 4.8 (undesirable effects) - Cellulitis has been added to the common side effects, see Table.

Section 5.3 (preclinical safety data) - Microphthalmia has been added to the list of foetal abnormalities. 
Updated on 16/02/2012 and displayed until 02/05/2012
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   22-Dec-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


4.4     Special warnings and precautions for use

        Addition of laboratory tests regarding liver function tests and complete blood counts.


        4.8       Undesirable effects
        Addition of tomour lysis syndrome and injection site necrosis.
Updated on 05/08/2011 and displayed until 16/02/2012
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   01-Aug-2011
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 - An additional line has been added to the excretion section regarding accumulation after subcutaneous administration of azacitidine
Updated on 27/07/2011 and displayed until 05/08/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • 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 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • 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:   01-Jul-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


Section 4.2 - Additional function test added to the Laboratory tests.
                    Additional sentence added to the Method of administration.
Section 4.3 - Replacement of a term (breastfeeding rather than lactation)
Section 4.4 - Additional warning to patients has been added and removal of the term 'rarely' regarding hepatic and renal impairments.
Section 4.6 - Sentences regarding contraception for women of child bearing potential and men moved from the end of the first paragraph to a separate initial paragraph.
                    Replacement of a term (breastfeeding rather than lactation)
Section 4.8 - Modifications to the third and fourth paragraphs regarding frequency of adverse events.
                  - Additional adverse event added to the table and alterations made to another adverse event already listed.  Rare fatalities have been indicated where appropriate. 
                - Minor alterations to the infections sub-heading.
                - Two paragraphs added regarding renal and hepatic adverse reactions.
Section 5.2 - Minor amendments to the excretion section.
Section 6.6 - Two additional sentences added to point 4 of the reconstitution procedure.
Section 7 - Address of the MA holder has been updated.
Updated on 27/05/2011 and displayed until 27/07/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   05-May-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Section 4.2 - removal of the the words "or equal to" in seventh paragraph, so now reads "less than 50 %, or greater than 50 %"

Section 6.6 - Removal of the words "until use" in second paragraph under heading "For later use" so now reads "and kept in the refrigerator for a maximum of 22 hours".
Updated on 24/05/2011 and displayed until 27/05/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   05-May-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Section 4.2 - Dose adjustment due to haematological toxicity, now reads: "Following Vidaza treatment, if the decrease in WBC or ANC or platelets from that prior to treatment is less than or equal to 50 %, or greater than 50 %"


Section 6.6 - Addition of paragraph under heading "Storage of reconsituted product" regarding extended fridge life of up to 22 hours when azacitidine is reconsituted with refrigerator temperature water.

Section 10 - Date of revision of text is now 5th May 2011.
Updated on 05/08/2010 and displayed until 24/05/2011
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   01-Jul-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: In the second paragraph of the Metabolism section, the sentence beginning "In vitro studies" has been altered to "An in vitro study".
Also in the same paragraph, the sentence beginning "In a study to assess inhibition of a series of P450 isoenzymes" has been altered to state "In studies to assess..."
In this same sentence "CYP 2B6 and 2C8" have been added into the brackets after the word isoenzymes and the sentence that stated "The potential to inhibit CYP2B6 or 2C8 has not been studied" has been removed from the end of the metabolism section.
Updated on 30/04/2010 and displayed until 05/08/2010
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   20-Oct-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Additon of hyphens to RAEB-T (previously RAEB T)
Updated on 28/01/2009 and displayed until 30/04/2010
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  azacitidine