Fasturtec
- Name:
Fasturtec
- Company:
Sanofi Genzyme
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/01/21
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Sanofi Genzyme
Company Products
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 8 January 2021 SPC
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 8 January 2021 PIL
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 6 July 2020 PIL
Reasons for updating
- XPIL Removed
Updated on 8 June 2020 PIL
Reasons for updating
- Change in co-marketing arrangement
Free text change information supplied by the pharmaceutical company
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Notification 61.3: Update to Malta representative contact details |
Updated on 1 May 2020 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 8 October 2019 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 13 December 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 13 December 2017 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 8 December 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 8 December 2017 SPC
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.
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MedDRA Organ system classes |
Very common
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Common
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Uncommon
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Rare |
Not known |
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Blood and lymphatic system disorders
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- Haemolysis - Haemolytic anaemia - Methaemoglobinaemia |
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Immune system disorders |
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- Allergy/ allergic reactions (rashes and urticaria) |
- Severe hypersensitivity reactions |
- Anaphylaxis |
- Anaphylactic shock* |
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Nervous system disorders
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- Headache +
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- Convulsion**
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- Muscle contraction involuntary** |
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Vascular disorders |
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- Hypotension |
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Respiratory, thoracic and mediastinal disorders |
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- Bronchospasm |
- Rhinitis
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Gastrointestinal disorders
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- Diarrhoea + - Vomiting++ - Nausea++ |
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General disorders and administration site conditions
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- Fever++
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Updated on 16 July 2015 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 13 April 2015 SPC
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
Updated on 10 March 2015 SPC
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
Updated on 5 March 2015 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 3 November 2014 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 29 October 2014 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 29 October 2014 SPC
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
Updated on 5 March 2014 SPC
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
Updated on 27 February 2014 PIL
Reasons for updating
- Change to side-effects
Updated on 12 July 2013 PIL
Reasons for updating
- Change of contraindications
Updated on 3 January 2013 SPC
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
Updated on 20 December 2012 PIL
Reasons for updating
- Improved electronic presentation
Updated on 29 August 2012 SPC
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
Updated on 20 August 2012 SPC
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
Updated on 13 August 2012 PIL
Reasons for updating
- Improved electronic presentation
Updated on 24 August 2009 PIL
Reasons for updating
- Change to improve clarity and readability
Updated on 19 March 2009 SPC
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
Updated on 19 March 2008 SPC
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
Updated on 24 August 2007 SPC
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
Updated on 18 December 2006 PIL
Reasons for updating
- Improved electronic presentation
Updated on 7 November 2006 PIL
Reasons for updating
- Improved electronic presentation
Updated on 19 October 2006 PIL
Reasons for updating
- Improved electronic presentation
Updated on 25 August 2006 SPC
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
Updated on 8 August 2006 SPC
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
Updated on 6 December 2005 SPC
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 PIL
Reasons for updating
- Improved electronic presentation
Updated on 14 October 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 6 August 2004 SPC
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 4 August 2004 SPC
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 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)