Summary of Product Characteristics
last updated on the eMC:
16/12/2011
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 16/12/2011 and displayed until Current
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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 4.4 - Special warnings and precautions for Use
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Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 21-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| In section
4.2 (Posology and method of administration), paragraph 8 new text added
In section 4.4 (Special warnings and precautions for use) new text added
in section 5.2 (Pharmacokinetic properties) new text added
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Updated on 18/04/2011 and displayed until 16/12/2011
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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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 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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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: 24-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Changes made to the following sections:
3. PHARMACEUTICAL form
Deletion of “(sterile concentrate)”
4.2 Posology and method of administration
Addition of heading “Posology”
Change to sub headers “Adult population” and “Paediatric population “
First sentence for “Method of administration”
changed from –
“Method of administration: Evoltra 1 mg/ml concentrate for solution for infusion must be diluted prior to administration (see section 6.6).”
To –
“Method of administration” – sub header
“For instructions on dilution of the medicinal product before administration, see section 6.6”
4.6 Fertility, pregnancy and lactation
Addition of following paragraph section “Contraception in males and females”
“Females of childbearing potential and sexually active males must use effective methods of contraception during treatment.”
4.8 Undesirable effects
Addition of the highlighted sections in this paragraph – “The information provided is based on data generated from clinical trials in which 115 patients (> 1 and ≤ 21 years old) with either ALL or acute myeloid leukaemia (AML) received at least one dose of clofarabine at the recommended dose of 52 mg/m2 daily x 5. Adverse reactions are listed by system organ class and frequency (very common (³1/10); common (³1/100 to <1/10), uncommon (³1/1,000 to <1/100; rare (³1/10,000 to <1/1,000) and very rare (<1/10,000)) in the table below. Adverse reactions reported during the post-marketing period are also included in the table under the frequency category “not known” (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.”
Sections of the table have been moved around.
5.1 Pharmacodynamic properties
This paragraph has been moved to the end of this section after the table - “This medicinal product has been authorised under “Exceptional Circumstances”. This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicinal product. The European Medicines Agency (EMEA) will review any new information which may become available every year and this SPC will be updated as necessary.”
6.6 Special precautions for disposal and other handling
Addition to “and other handling” in the sub header
Addition of this sentence at the end of this section “Any unused product or waste material should be disposed of in accordance with local requirements.”
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of latest renewal added.
10. DATE OF REVISION OF THE TEXT
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Updated on 07/04/2010 and displayed until 18/04/2011
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.8 - Undesirable Effects
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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: 19-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Scope of changes:
Safety changes following PSUR review and alignment with CCDS.
Sections 4.4, 4.5 and 4.8 have been revised to include recommendations drawing attention to supportive care measures of adequate hydration, treatment of sepsis and hypotension, prophylactic treatment to mitigate risk of tumour lysis syndrome, and avoidance of nephrotoxic medications and drugs eliminated by renal secretion.
have been revised to include recommendations drawing attention to supportive care measures of adequate hydration, treatment of sepsis and hypotension, prophylactic treatment to mitigate risk of tumour lysis syndrome, and avoidance of nephrotoxic medications and drugs eliminated by renal secretion.
Sections 4.4 and 4.8 were updated to include information regarding enterocolitis, neutropaenic colitis and Clostridium difficile colitis. Also addition of information on bone marrow suppression, clorafabine’s anti-emetic effects and haematological laboratory abnormalities.
were updated to include information regarding enterocolitis, neutropaenic colitis and colitis. Also addition of information on bone marrow suppression, clorafabine’s anti-emetic effects and haematological laboratory abnormalities.
Section 10 - date of revision
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Updated on 05/08/2009 and displayed until 07/04/2010
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Reasons for adding or updating:
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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: 01-Jun-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Section 10 - Change of date for revision of text
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Updated on 03/06/2009 and displayed until 05/08/2009
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Reasons for adding or updating:
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Introduction of new pack/pack size
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| Date of revision of text on the SPC: 19-May-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Section 8: Addition of a 1 pack
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Updated on 28/05/2009 and displayed until 03/06/2009
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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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: 04-May-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| 4.4 Special warnings and precautions for use:
· Information included on use of IV fluids during treatment
· Prophylactic steroids may be used in preventing signs / symptoms of SIRS or capillary leak.
· Information on Grade 4 neutropenia
· Information on risks for patients who have previously received a hematopoietic stem cell transplant (HSCT); they may experience Veno-occlusive disease (VOD)
· Information on patients experiencing a severe non-hematologic toxicity on a 3rd occasion
· Information on severe hepatotoxic events in paediatric patients with relapsed or refractory acute leukaemia
4.8 Undesirable effects
Updates to MEDRA table of Adverse Events table and update to the text
5.1 Pharmacodynamic properties
Update to Efficacy results from a pivotal study in patients (≤ 21 years old at initial diagnosis) with relapsed or refractory ALL after at least two prior regimens; the Median overall survival (CR+CRp) has increased from 66.6 weeks to 69.5 weeks
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Updated on 04/09/2008 and displayed until 28/05/2009
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Reasons for adding or updating:
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Change of Marketing Authorisation Holder
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| Date of revision of text on the SPC: 16-Jun-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Change of MAH from Bioenvision to Genzyme
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Updated on 09/06/2006 and displayed until 04/09/2008
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Reasons for adding or updating:
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