Desferal 500mg Vials

Product Information *

  • Company:

    Novartis Ireland Limited
  • Status:

    No Recent Update
  • Active Ingredients * :

    *Additional information is available upon request

  • Legal Category:

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

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 26 November 2019

Reasons for updating

  • Improved presentation of PIL

Updated on 22 January 2019

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 24 July 2018

Reasons for updating

  • Change to MA holder contact details

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

Updated on 20 July 2017

Reasons for updating

  • New PIL for new product

Updated on 20 July 2017

Reasons for updating

  • Change to section 5 - how to store or dispose

Updated on 28 June 2017

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

In section 6.3, the shelf-life has been changed from 18 Months to 36 Months

In section 6.4, the storage conditions have been changed from "Do not store above 30°C" to "Do not store above 25°C"

Updated on 28 June 2017

Reasons for updating

  • New SPC for new product

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

Updated on 19 May 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to improve clarity and readability

Updated on 18 June 2015

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
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

Section 4.2      Posology and method of administration

Typographical changes have been made

 

 

Section 4.4      Special warnings and precautions for use

 
Information on Precautions related to use and handling has been added

 

In Section 4.8 Undesirable effects

 

Additional side effects have been added

Information on how to report ADRs has been added

 

In Section 6.3 Shelf life

 

Shelf life has been changed from 4 years to 18 Months

 

In Section 6.4 Special precautions for storage

 

Storage conditions has been changed from to “Store below 25 °C” to “Do not store above 30 °C”

Updated on 09 December 2014

Reasons for updating

  • Change due to user-testing of patient information

Updated on 27 January 2014

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company



In Section 4.2 Posology and method of administration;

Information for use in the elderly has been given. Additional information on method of administration by Continuous intravenous infusion has been given.

In Section 4.4 Special warnings and precautions for use; a warning for patients with renal impairment has been added.

Section 4.6 Fertility, pregnancy and lactation; has been fully updated.

Section 4.8 Undesirable effects; has been fully updated.

In Section 5.2 Pharmacokinetic properties; Information on clinical studies has been provided.

Section 6.2 Incompatibilities; has been updated.

Section 6.3 Shelf life; information on shelf life has been expanded.

Section 6.4 Special precautions for storage; has been updated.

Section 6.5 Nature and contents of container; has been updated.

Section 6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product; has been fully updated.



Updated on 27 June 2013

Reasons for updating

  • Change to side-effects

Updated on 28 February 2013

Reasons for updating

  • PIL re-instated

Updated on 25 June 2008

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 17 May 2005

Reasons for updating

  • Improved electronic presentation
  • PIL retired pending re-submission

Updated on 24 August 2004

Reasons for updating

  • New PIL for medicines.ie