Tracrium 10mg/ml, Solution for Injection or Infusion, ampoules
- Name:
Tracrium 10mg/ml, Solution for Injection or Infusion, ampoules
- Company:
Aspen
- 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: 16/06/20

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Aspen

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 16 June 2020 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to date of revision
Updated on 23 May 2019 PIL
Reasons for updating
- New PIL for new product
Updated on 22 May 2019 SPC
Reasons for updating
- File format updated to PDF
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 16 August 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 16 August 2017 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- 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
Text in red = new text
Text strikethrough = deleted text
7. MARKETING AUTHORISATION HOLDER
GlaxoSmithKline (Ireland) Limited
12 Riverwalk,
Citywest Business Campus,
Dublin 24
Aspen Pharma Trading Limited,
3016 Lake Drive,
Citywest Business Campus,
Dublin 24,
Ireland
8. MARKETING AUTHORISATION NUMBER
PA 1077/81/1 PA 1691/029/001
10. DATE OF (PARTIAL) REVISION OF THE TEXT
28 Jan 2016 August 2017
Updated on 16 August 2017 PIL
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Text in red = new text
Text strikethrough = deleted text
7. MARKETING AUTHORISATION HOLDER
GlaxoSmithKline (Ireland) Limited
12 Riverwalk,
Citywest Business Campus,
Dublin 24
Aspen Pharma Trading Limited,
3016 Lake Drive,
Citywest Business Campus,
Dublin 24,
Ireland
8. MARKETING AUTHORISATION NUMBER
PA 1077/81/1 PA 1691/029/001
10. DATE OF (PARTIAL) REVISION OF THE TEXT
28 Jan 2016 August 2017
Updated on 2 February 2016 SPC
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
- 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
QRD V9 updates to the following sections:
4.2 Posology and method of administration
4.3 Contraindications
4.8 Undesirable effects
Updated on 2 February 2016 PIL
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
- Change to section 4.2 - Posology and method of administration
Free text change information supplied by the pharmaceutical company
QRD V9 updates to the following sections:
4.2 Posology and method of administration
4.3 Contraindications
4.8 Undesirable effects
Updated on 15 July 2015 PIL
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Updated on 15 July 2015 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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 7 April 2014 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.4 - Special precautions for storage
- 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 4.5 - spelling and grammer changes throughout
Section 5.1 - addition of headings, addition of ATC code
Section 5.2 - addition of headings and reformatting
Section 6.4 - additional wording on precautions for storage
Updated on 7 April 2014 PIL
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Section 4.5 - spelling and grammer changes throughout
Section 5.1 - addition of headings, addition of ATC code
Section 5.2 - addition of headings and reformatting
Section 6.4 - additional wording on precautions for storage
Updated on 31 March 2014 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
Section 5.1 - additional wording on paediatric population
Updated on 31 March 2014 PIL
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
Free text change information supplied by the pharmaceutical company
Section 5.1 - additional wording on paediatric population
Updated on 18 September 2013 PIL
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Free text change information supplied by the pharmaceutical company
Section 4.4 - Special warnings and precautions for use,
Section 4.5 - Interaction with other medicinal products and other forms of interaction,
Section 4.6 - Pregnancy and lactation,
Section 4.7 - Effects on ability to drive and use machines,
Section 6.6 - Special precautions for disposal
Updated on 18 September 2013 SPC
Reasons for updating
- New individual SPC (was previously included in combined SPC)
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 - Special warnings and precautions for use,
Section 4.5 - Interaction with other medicinal products and other forms of interaction,
Section 4.6 - Pregnancy and lactation,
Section 4.7 - Effects on ability to drive and use machines,
Section 6.6 - Special precautions for disposal