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SANOFI

1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 535 432
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.com
Summary of Product Characteristics last updated on medicines.ie: 14/12/2017
SPC Evoltra 1 mg/ml concentrate for solution for infusion

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 14/12/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Improved presentation of SPC
Date of revision of text on the SPC:   14-Nov-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

zTo update SmPC section 4.4 with new headings to improve the readability in order to better find the information
Updated on 30/09/2016 and displayed until 14/12/2017
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   15-Sep-2016
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

PSUSA-00000805-201512 PSUR
Updated on 17/02/2016 and displayed until 30/09/2016
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   14-Jan-2016
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

.
Updated on 29/09/2015 and displayed until 17/02/2016
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   18-Sep-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 4.4 updated with the following:

·         Renal and hepatic function prior to, during active treatment and following therapy.  Clofarabine should be discontinued immediately if substantial increases in creatinine, liver enzymes and/or bilirubin are observed.


Patients who have previously received a hematopoietic stem cell transplant (HSCT) may be at higher risk for hepatotoxicity suggestive of veno-occlusive disease (VOD) following treatment with clofarabine (40 mg/m2) when used in combination with etoposide (100 mg/m2) and cyclophosphamide (440 mg/m2). In the post-marketing period, following treatment with clofarabine, serious hepatotoxic adverse reactions of VOD in paediatric and adult patients have been associated with a fatal outcome.
Cases of hepatitis and hepatic failure, including fatal outcomes, have been reported with clofarabine treatment (see section 4.8).


Section 4.8: Hepato-biliary disorders updated to include 'hepatic failure.  Uncommon: Hepatitis.'
Updated on 07/05/2014 and displayed until 29/09/2015
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Date of revision of text on the SPC:   25-Apr-2014
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Type IIC Bulk - CCDS v5 and 6 to update SPC Sections 4.4 and 4.8 re: haemorrhaging (v42).
Updated on 03/12/2013 and displayed until 07/05/2014
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   24-Oct-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Type IIC Bulk - CCDS SPC update including QRD and Croatia v039.
Updated on 16/12/2011 and displayed until 03/12/2013
Reasons for adding or 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 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   21-Nov-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

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

Updated on 18/04/2011 and displayed until 16/12/2011
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   24-Mar-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



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

Updated on 16/04/2010 and displayed until 18/04/2011
Reasons for adding or updating:
  • New SPC for medicines.ie
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Clofarabine