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Kyowa Kirin Ltd

Unit 11CB, Industrial Park, Westport, CO. Mayo , Ireland
Medical Information Direct Line: + 44 (0)1896 664 000
Medical Information e-mail: medinfo@kyowakirin.com
Summary of Product Characteristics last updated on medicines.ie: 12/09/2017
SPC Thiopental Sodium 500 mg Powder for Solution for Injection

When a pharmaceutical company changes an SPC or PIL, 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 12/09/2017 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   01-Aug-2017
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 27/05/2015 and displayed until 12/09/2017
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   20-May-2015
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 10/03/2015 and displayed until 27/05/2015
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Date of revision of text on the SPC:   10-Feb-2015
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 07/03/2014 and displayed until 10/03/2015
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   28-Feb-2014
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 20/12/2013 and displayed until 07/03/2014
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   16-Dec-2013
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 28/11/2013 and displayed until 20/12/2013
Reasons for adding or 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
Date of revision of text on the SPC:   18-Oct-2013
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 23/04/2013 and displayed until 28/11/2013
Reasons for adding or updating:
  • New SPC for medicines.ie
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Thiopental Sodium