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Thiopental Sodium 500 mg Powder for Solution for Injection

  • Name:

    Thiopental Sodium 500 mg Powder for Solution for Injection

  • Company:
    info
  • Active Ingredients:

    Thiopental Sodium

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/03/19

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Summary of Product Characteristics last updated on medicines.ie: 26/3/2019

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Kyowa Kirin International plc

KyowaKirin_BrandLogo_color_1604596269

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1 - 0 of 10 items.Total: Infinity pages

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 March 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 26 March 2019

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

Section 7: Marketing Authorisation Holder updated to Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP Hoofddorp, The Netherlands

Section 8: Marketing Authorisation Number updated to PA 2288/005/001

Section 10: Date of revision of the text changed from Oct 2017 to Dec 2018 

Updated on 21 December 2017

Reasons for updating

  • New SmPC for new product

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

Updated on 21 December 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

In section 7 (Marketing Authorisation Holder)- Archimedes Pharma UK changed to Kyowa Kirin$0$0$0$0In section 8 (Marketing Authorisation Number)- Updated to PA1049/014/001$0$0$0$0$0In section 10 (Date of revision of the text)- Updated to October 2017$0

Updated on 19 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 December 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 12 September 2017 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

Sections 2, 4.4, 4.5 and 5.1: Editorial change$0$0$0$0Sections 4.2: New sub-headings 'Posology', 'Method of administration' and 'Further information' have been added.$0$0                    : New wordings '(For instructions on dilution of the product before administration, see section 6.6) have been added to the text under sub-heading 'Method of                   $0$0                      administration'.$0$0$0$0$0Sections 4.4, 4.5, 4.6 and 4.7: The word 'thiopental' updated to 'thiopental sodium'.$0$0$0$0$0Section 4.6:The section heading changed to 'Fertility, pregnancy and lactation'.$0$0                  : New sub-headings 'Breastfeeding' and 'Pregnancy' have been added.$0$0                  : New wordings ' Therefore, breast-feeding should be temporarily suspended or breast milk expressed before the induction of anaesthesia' have been added to the text   $0$0                    under sub-heading 'Breastfeeding'. $0$0$0$0$0Section 4.8: New sub-headings 'Summary of the safety profile' and 'Tabulated summary of adverse reactions' have been added.$0$0                  : The wordings 'The following effects have been reported and are listed below by body system' have been removed.$0$0                  : New wordings 'Adverse reactions from literature searches, post-marketing experience and spontaneous reports with thiopental sodium are listed in the table below.                               Within the system organ class, the adverse reactions are listed by frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10);                                     uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data)' have been added.$0$0                   : 'Anaphylactic' and 'anaphylactoid reactions' have been added to the adverse reaction list for the Immune system disorder.$0$0$0$0$0Section 6.3: The word 'Unopened' has been removed.$0$0$0$0$0Section 6.4: The words 'Prior to reconstitution' have been removed.                  :$0$0                  : The instructions for After reconstitution have been changed to 'Store reconstituted solution between 20C and 80C in an upright position and use within 7 hours. For $0$0                    storage conditions after reconstitution of the medicinal product, see section 6.3.'$0$0$0$0$0Section 6.6: The section heading has been changed to 'Special precautions for disposal and other handling'.$0$0$0$0$0Section 10: Date of revision has been changed from April 2015 to August 2017.$0$0                    $0$0$0$0

Updated on 11 September 2017 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 31 July 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 31 August 2016 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 27 May 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

Summary of Changes as follows;

Section 7 Marketing Authorisation Holder

Change from;

250 South Oak Way, Green Park, Reading, Berkshire, RG2 6UG, United Kingdom

to;

Galabank Business Park, Galashiels, TD1 1QH, United Kingdom

 

Section 10 Date of Revision of the Text

Change from;

10 February 2015

to;

May 2015

Updated on 22 May 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 10 March 2015 SPC

Reasons for updating

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

Adverse Event reporting contact details changed from IMB to HPRA.

Date of revision of the text 10th Feb 2015 - Please note that amendments approved on 4th March 2015

Updated on 6 March 2015 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 11 March 2014 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 7 March 2014 SPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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

Change in section 6.5 - Nature and contents of container

Previously read - 20 ml Type III clear glass vials with 20mm bromylbutyl caoutchchouc, siliconised grey rubber closures

Now reads - 20 ml type III clear glass vials with 20mm bromobutyl compound closures

Section 10 - Date of revision of the text

Previously read - December 2013

Now reads - 28th February 2014

Updated on 20 December 2013 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

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 4.3 and 4.8 of the SmPC on request of the MHRA for hypokalaemia and hyperkalaemia and addition of adverse event reporting details to SmPC.

Section 4.4 –

 

Addition of following paragraph;

Use in neurological patients with raised intracranial pressure

Thiopental has been associated with reports of severe or refractory hypokalaemia during infusion; severe rebound hyperkalaemia may occur after cessation of thiopental infusion. The potential for rebound hyperkalaemia should be taken into account when stopping thiopental therapy.

Section 4.8 –

 

1.       Addition of ‘hypokalaemia and hyperkalaemia’ to Metabolism and nutrition disorders

Paragraph now reads;

 

Metabolism and nutrition disorders

Frequency not known: Decreased appetite, hypokalaemia and hyperkalaemia.

 

2.        Addition of the following paragraph;

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the online reporting option (preferred method) accessible from the IMB homepage (www.imb.ie). A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via ‘freepost’ (see details below). Alternatively, the traditional post-paid ‘yellow card’ option may also be used.

 

FREEPOST

Pharmacovigilance Section

Irish Medicines Board

Kevin O’Malley House

Earlsfort Centre

Earlsfort Terrace

Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

 

Section 10 –

 

Date of revision of the text mended from October 2013 to December 2013

Updated on 28 November 2013 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Change to Section 2:

After 'each vial contains 500mg Thiopental Sodium', addition of the following wording regarding sodium content;

  • '(as Thiopental Sodium and Sodium Carbonate Ph. Eur.)'; and,
  • 'Contains 53.5mg sodium per vial'

Change to Section 4.4:

Addition of the following wording regarding sodium content - Last paragraph;

  • 'This medicinal product contains 53.5mg sodium per vial. To be taken into consideration by patients on a controlled sodium diet.'

Change to Section 10:

Date of revision of the text now reads;

  • October 2013

Updated on 25 November 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions

Updated on 15 May 2013 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 23 April 2013 SPC

Reasons for updating

  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

None provided