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Eloxatin 5mg/ml Concentrate for Solution for Infusion

  • Name:

    Eloxatin 5mg/ml Concentrate for Solution for Infusion

  • Company:
    info
  • Active Ingredients:

    Oxaliplatin

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 24/04/19

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Summary of Product Characteristics last updated on medicines.ie: 24/4/2019

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When a pharmaceutical company changes any document, 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 24 April 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 24 April 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.8.      Undesirable effects

MedDRA Organ system classes Injury, poisoning, and procedural complications

Common - Fall

Updated on 10 October 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 9 October 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 12 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 12 December 2017 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 16 August 2016 PIL

Reasons for updating

  • Change to side-effects

Updated on 2 August 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 2 August 2016 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Delayed hypersensitivity has also been reported with oxaliplatin hours or even days after the infusion.

 

Skin and Subcutaneous tissue disorders

 

Post-marketing experience with frequency not known:

Hypersensitivity vasculitis.

Updated on 21 April 2016 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

C.I.4 Changes in the SPC/ PIL- CCDS v13- Chnage relates to causal association between oxaliplatin and hypocalcemia

Updated on 24 November 2015 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 and 4.8 updated.

-Disseminated INtravascular Coagulation reported
-QT prolongation interval should be monitored before and after administration
-Reports of Rhabdomyolysis

4.8

-Musculoskeletal and connective tissue disorders added
-Rhabdomyolysis frequency unknown.

Updated on 11 November 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 3 June 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 1 April 2015 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 updated to include:

Myelosuppressive effects may be additive to those of concomitant chemotherapy. Patient with severe and persistent myelosuppression are at high risk of infectious complications. Sepsis, neutropenic sepsis and septic shock have been reported in patients treated with oxaliplatine including fatal outcomes (see section 4.8.). If any of these events occurs, oxaliplatin should be discontinued.


Section 4.8 updated with information on Infections and infestations




Updated on 14 July 2014 SmPC

Reasons for updating

  • 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Type II No. C.I.4 variation to update section 4.8 Undesirable Effects of the SPC for the above mentioned product with the addition of “laryngospasm” to comply with the latest Company Core Safety Information.  As a result of this update the leaflet is also being updated to include “spasm of the throat causing difficulty in breathing” to section 4 Possible Side Effects.

Updated on 7 July 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 14 September 2012 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 12 September 2012 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Type IAIN variation for a change in the name of the Marketing Authorisation Holder in Portugal and Ireland (Mutual Recognition Procedure number: FR/H/0284/IA/040/G)

Updated on 21 June 2011 SmPC

Reasons for 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 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update Sections
4.2 - dosage in renal impairment
4.3 - administrative
4.4 - additional information in renal impairment, hypersensitivity reactions, RPLS & admnistrative
4.8 - additional side effects

Updated on 15 January 2009 SmPC

Reasons for updating

  • Change to section 4.7 - Effects on ability to drive and use machines

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to section 4.7 of SPC.

Updated on 17 December 2008 PIL

Reasons for updating

  • Change to side-effects
  • Improved electronic presentation

Updated on 17 December 2008 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update Section 4.8 of SPC.

Updated on 15 July 2008 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update sections 4.2, 5.1, 5.2, 10.

Updated on 13 July 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 15 June 2007 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sections affected are:
Part II Section 2: New 200mg presentation
Part II Section 6.5: New 40mg vial
Part II Section 10: Date changed to March

Updated on 21 March 2007 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update
Section 7 - Change MAH to sanofi-aventis Ireland Ltd.
Section 8 - MA Number
Section 10 - Date of Revision

Updated on 18 December 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 19 October 2006 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 10 October 2006 SmPC

Reasons for 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 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update information in section 4.2, 4.4, 4.8.

Updated on 23 August 2006 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Updates to -
Section 4.1, 4.2, 4.4, 4.8, 5.1 following approval of the new indication 'Adjuvant treatment of stage III (Duke's C) colon cancer after complete resection of primary tumor'.
 
Section 6.3, 6.6 - New storage conditions

Updated on 31 May 2006 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)