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

Celgene Ltd
1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB , UK
Telephone: +44 (0)208 831 8300
Medical Information Direct Line: UK: 08448 010 045 Ireland: 1800 333 111
Medical Information e-mail: medinfo.uk.ire@celgene.com
Medical Information Fax: UK: 08448 010 046 Ireland: 1800 333 112

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: 02/05/2012
SPC Vidaza 25 mg/ml powder for 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 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:   POM
Black Triangle (CHM):   YES

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:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company




4.4     Special warnings and precautions for use
A section regarding laboratory tests has been added regarding liver function tests and complete blood counts.

4.8       Undesirable effects
Tumour lysis syndrome and injection site necrosis have both been added to the rare side effects.

 

 
Updated on 10/08/2011 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:   POM
Black Triangle (CHM):   YES

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 10/08/2011
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic Properties
  • 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 6. 6 - Instructions for use, handling and disposal
  • Change to MA holder contact details
Date of revision of text on the SPC:   01-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   YES

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 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   05-May-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 6.6 - Second paragraph recomval of the words "unitl use". Sentence now reads "...and kept in the refrigerator for a maximum of 22 hours."

Section 4.2 - Seventh paragraph removal of the words "or equal to" therefore sentence now reads "is less than 50 %, or greater than 50 %"

(NB: These alterations were added in error to the previous SPC and require removal.)
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 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05-May-2011
Legal Category:   POM
Black Triangle (CHM):   YES

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 03/08/2010 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:   POM
Black Triangle (CHM):   YES

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 13/03/2009 and displayed until 03/08/2010
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  azacitidine