Tracrium 10mg/ml, Solution for Injection or Infusion, ampoules

*
Pharmacy Only: Prescription
  • Company:

    Aspen
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

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

Updated on 20 November 2023

File name

Atra_Inj_IE_P_10mg-ml_v8.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 06 September 2023

File name

Atra_Inj_IE_S_10mg-ml_2.5ml5ml_v3.pdf

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)

Updated on 06 September 2023

File name

Atra_Inj_IE_P_10mg-ml_v7.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 12 June 2023

File name

Atra_Inj_IE_S_10mg-ml_2.5ml5ml_v2.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 12 June 2023

File name

Atra_Inj_IE_P_10mg-ml_v6.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 08 August 2022

File name

Atra_Inj_IE_P_10mg-ml_v5.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change of manufacturer

Updated on 16 June 2020

File name

Atra_Inj_IE_P_10mg-ml_v4.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to date of revision

Updated on 23 May 2019

File name

Atra_Inj_IE_P_10mg-ml_Combined_v3.pdf

Reasons for updating

  • New PIL for new product

Updated on 22 May 2019

File name

Atra_Inj_IE_S_10mg-ml_2.5ml5ml_Aug2017_v1 ampoules.pdf

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

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

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

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 02 February 2016

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 02 February 2016

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

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

Section 7 - change to Ireland MAH address

Updated on 15 July 2015

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

Section 7 - change to Ireland MAH address

Updated on 07 April 2014

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 4.2 - reformatting eg "use in children" replaced "children"

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 07 April 2014

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 4.2 - reformatting eg "use in children" replaced "children"

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

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 - additional wording on use in neonates
Section 5.1 - additional wording on paediatric population

Updated on 31 March 2014

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 4.2 - additional wording on use in neonates
Section 5.1 - additional wording on paediatric population

Updated on 18 September 2013

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

Changes to:

 

 

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

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Free text change information supplied by the pharmaceutical company

Changes to:

 

 

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