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Fasturtec

*
Pharmacy Only: Prescription

  • Company:

    Sanofi Genzyme

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Rasburicase

    *Additional information is available within the SPC or upon request to the company

Updated on 17 March 2023

File name

1.3.2.1 Mock-up - Package Leaflet- Fasturtec (1).pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 20 December 2022

File name

1.3.2.1 Mock-up Leaflet IE-MT (2).pdf

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer

Updated on 20 December 2022

File name

1.3.1.1 SmPC - IE & UK(NI) (10).pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Updated on 28 November 2022

File name

1.3.1.1 SmPC - IE & UK(NI) (9).pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 14 February 2022

File name

1.3.2.1 Mock-up Leaflet IE-MT.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 07 January 2022

File name

1.3.1.1 SmPC - IE & UK(NI).pdf

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation

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

Updated on 08 January 2021

File name

Fast.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Updated on 08 January 2021

File name

FASTURTEC Leaflet IE-MT.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 06 July 2020

File name

1.3.2.1 Mock-up Leaflet IEMT.pdf

Reasons for updating

  • XPIL Removed

Updated on 08 June 2020

File name

1.3.2.1 Mock-up Leaflet IEMT.pdf

Reasons for updating

  • Change in co-marketing arrangement

Free text change information supplied by the pharmaceutical company

Notification 61.3: Update to Malta representative contact details

Updated on 01 May 2020

File name

1.3.1.3 Leaflet text UKIE.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 08 October 2019

File name

Fasturtec PIL.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 13 December 2017

File name

PIL_9138_542.pdf

Reasons for updating

  • New PIL for new product

Updated on 13 December 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 08 December 2017

Reasons for updating

  • New SPC for new product

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

Updated on 08 December 2017

Reasons for 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
  • 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

4.4     Special warnings and precautions for use

 

Rasburicase like other proteins, has the potential to induce allergic responses in humans, such as anaphylaxis, including anaphylactic shock, with potential fatal outcome. Clinical experience with Fasturtec demonstrates that patients should be closely monitored for the onset of allergic-type undesirable effects, especially severe hypersensitivity reactions including anaphylaxis (see section 4.8). In such cases of severe allergic reaction, treatment should immediately and permanently be discontinued and appropriate therapy initiated.

MedDRA Organ system classes

Very common

 

Common

 

Uncommon

 

Rare

Not known

Blood and lymphatic system disorders

 

 

 

- Haemolysis

- Haemolytic anaemia

- Methaemoglobinaemia

 

 

Immune system disorders

 

- Allergy/ allergic reactions (rashes and urticaria)

- Severe hypersensitivity reactions

- Anaphylaxis

- Anaphylactic shock*

Nervous system disorders

 

- Headache +

 

 

-     Convulsion**

 

 

-   Muscle contraction involuntary**

Vascular disorders

 

 

-     Hypotension

 

 

Respiratory, thoracic and mediastinal disorders

 

 

-     Bronchospasm

- Rhinitis

 

 

Gastrointestinal disorders

 

 

- Diarrhoea +

- Vomiting++

- Nausea++

 

 

 

 

General disorders and administration site conditions

 

- Fever++



 

 

 

 

Updated on 16 July 2015

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 13 April 2015

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

Section 4.8 updated to list all ADRs in a single table and to re-categorise the frequency for nausea, vomiting, headache, fever and diarrhea to 'very common'.

Updated on 10 March 2015

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

Section 4.8 updated to add the adverse reaction ‘convulsion’ with a frequency ‘common’ and the adverse reaction ‘muscle contraction involuntary’ with a frequency ‘unknown’.

Updated on 05 March 2015

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 03 November 2014

Reasons for updating

  • Change to marketing authorisation holder

Updated on 29 October 2014

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

PSUR v41 - update to Nervous system disorders

Updated on 29 October 2014

Reasons for updating

  • Change to marketing authorisation holder

Updated on 05 March 2014

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

Type IA-IN Bulk - V39 Addition of Croatia QRD v9

Updated on 27 February 2014

Reasons for updating

  • Change to side-effects

Updated on 12 July 2013

Reasons for updating

  • Change of contraindications

Updated on 03 January 2013

Reasons for updating

  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

IE Audit Update

Updated on 20 December 2012

Reasons for updating

  • Improved electronic presentation

Updated on 29 August 2012

Reasons for updating

  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

Improved electronic presentation.

Updated on 20 August 2012

Reasons for updating

  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

V33 MAH name and address change.

Updated on 13 August 2012

Reasons for updating

  • Improved electronic presentation

Updated on 24 August 2009

Reasons for updating

  • Change to improve clarity and readability

Updated on 19 March 2009

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 the SPC

Updated on 19 March 2008

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company

Update
Section 4.6 Pregnancy and lactation
Section 4.9 Overdose

Updated on 24 August 2007

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic 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

Section 4.2: Replacement of statement regarding dose adjustment in special populations with more specific statement.
Section 5.1: Addition of paragraph regarding paediatric patients
Section 10: Statement added referring to detailed information available on the European Medicines Agency website (http://www.emea.europa.eu)

Updated on 18 December 2006

Reasons for updating

  • Improved electronic presentation

Updated on 07 November 2006

Reasons for updating

  • Improved electronic presentation

Updated on 19 October 2006

Reasons for updating

  • Improved electronic presentation

Updated on 25 August 2006

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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 4.2 - duration of treatment.

Updated on 08 August 2006

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • 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 to sections - 
2 - administrative.
3 - description of pharmacetical form.
4.1, 4.3 , 4.4, 4.5, 4.6 - administrative.
4.8 - addition of hypotension, rhinitis, haemolytic anaemia, headache, vomiting and nausea to undesirable effects.
4.9, 5.1, 5.3, 6.1, 6.2 - administrative.
6.3 - addition of store in a refrigerator.
6.5, 6.6, 8, 9, 10 - administrative.
 
 

Updated on 06 December 2005

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 18 May 2005

Reasons for updating

  • Improved electronic presentation

Updated on 14 October 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 06 August 2004

Reasons for updating

  • Change to section 10 - Date of revision of the text

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

Updated on 04 August 2004

Reasons for updating

  • 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)

Updated on 30 June 2003

Reasons for updating

  • New SPC for medicines.ie

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