Summary of Product Characteristics
last updated on the eMC:
25/04/2012
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 25/04/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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Change to section 4.8 - Undesirable Effects
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Change to section 6. 6 - Instructions for use, handling and disposal
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 10 date of revision of the text
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Change to section 2 - Qualitative and quantitative composition
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| Date of revision of text on the SPC: 21-Mar-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section
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Summary of change
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2.
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Addition of the words- “with known effect” after “Excipient”
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4.3
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Addition of “listed in section 6.1” after the sentence
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4.8
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Addition of Rhabdomyolysis as a rare side effect
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6.6
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Addition of the word “medicinal” in final sentence
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9.
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Addition of the words “date of first authorisation” also change date format
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10.
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Updated date
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Updated on 24/04/2012 and displayed until 25/04/2012
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.3 - Contraindications
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Change to section 4.8 - Undesirable Effects
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Change to section 6. 6 - Instructions for use, handling and disposal
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 21-Mar-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section
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Summary of change
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2.
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Addition of the words - “with known effect” after “Excipient”
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4.3
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Addition of “listed in section 6.1” after the sentence
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4.8
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Addition of Rhabdomyolysis as a rare side effect
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6.6
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Addition of the word “medicinal” in final sentence
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9.
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Addition of the words “date of first authorisation” also change date format
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10.
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Updated date
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Updated on 10/01/2011 and displayed until 24/04/2012
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 10 date of revision of the text
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 29-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Sections changed:
4.2 Revision of information and formatting update
4.6 Revision of information and formatting update
10 Change of revision date of text
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Updated on 12/12/2008 and displayed until 10/01/2011
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 19-Nov-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 - Nelarabine is not diluted prior to administration. The appropriate dose of nelarabine is transferred into polyvinylchloride (PVC) or ethyl vinyl acetate (EVA) infusion bags or glass containers and administered as a two-hour infusion in adult patients and as a one-hour infusion in paediatric patients.
Section 5.1 - The monophosphate metabolite is subsequently converted to the active 5-triphosphate form, ara-GTP.
Section 5.2 - Gender has no effect on nelarabine or ara-G plasma pharmacokinetics.
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Updated on 22/09/2008 and displayed until 12/12/2008
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 05-Aug-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 6.3 - Shelf life: 3 years
Section 10 - Approval date: 5 August 2008
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Updated on 11/09/2007 and displayed until 22/09/2008
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Reasons for adding or updating:
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