Dynastat 40 mg Powder for Solution for Injection
- Name:
Dynastat 40 mg Powder for Solution for Injection
- Company:
Pfizer Healthcare Ireland
- 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: 02/11/20

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Pfizer Healthcare Ireland

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 2 November 2020 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
The SPC has been updated as follows: UK: - Update to sodium statement and moved to end of Section 4.4 IE: - Update to sodium statement and moved to end of Section 4.4 - Separate IE SPC created. UK AE reporting details removed from section 4.8. IE AE reporting details updated in line with abbreviated HPRA wording |
Updated on 2 November 2020 PIL
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 6 - manufacturer
Updated on 24 June 2020 SPC
Reasons for updating
- Change to section 4.3 - Contraindications
- 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 24 June 2020 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 19 November 2019 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 24 May 2019 PIL
Reasons for updating
- Change to section 6 - date of revision
Updated on 24 May 2019 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 4 October 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 4 October 2018 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: SPC section 7:
Marketing authorisation holder change to Pfizer EEIG.
Updated on 25 July 2018 PIL
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 25 July 2018 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update of sections 4.2, 4.4 and 5.1 of the SmPC in order to update the information on the use of parecoxib beyond 3 days.
Updated on 6 June 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 4.4 of the SPC with safety related information pertaining to alcohol use and gastrointestinal (GI) risk.
Section 4.6 of the SPC with safety related information pertaining to oligohydramnios if the product is used during second or third trimester of pregnancy.
The opportunity was also taken to include updates to address QRD and other admin related changes in Annex I SPC
Note that the CHMP opinion included the refusal of the update of the safety information related to cardiovascular risk information in SPC section 4.4.
Updated on 2 November 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 2 November 2017 PIL
Reasons for updating
- Improved presentation of PIL
Updated on 22 March 2017 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 - interactions with other medicines, food or drink
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 25 June 2015 PIL
Reasons for updating
- Change to side-effects
- Change to MA holder contact details
Updated on 19 January 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to drug interactions
- Change to date of revision
Updated on 22 October 2014 PIL
Reasons for updating
- Change to packaging
- Change to side-effects
- Change to date of revision
Updated on 28 June 2013 PIL
Reasons for updating
- Change to side-effects
- Change to information about pregnancy or lactation
Updated on 17 April 2013 PIL
Reasons for updating
- Change to information about pregnancy or lactation
Updated on 9 November 2012 PIL
Reasons for updating
- Change to drug interactions
- Change to date of revision
Updated on 1 August 2012 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 6 February 2012 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to date of revision
- Change to dosage and administration
Updated on 11 July 2011 PIL
Reasons for updating
- Change to dosage and administration
Updated on 4 March 2011 PIL
Reasons for updating
- Change to instructions about overdose
Updated on 17 November 2010 PIL
Reasons for updating
- Change to side-effects
Updated on 6 September 2010 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 17 December 2009 PIL
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 3 April 2009 PIL
Reasons for updating
- Improved electronic presentation
Updated on 23 March 2009 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Improved electronic presentation
- Change to date of revision
- Change to marketing authorisation holder
Updated on 14 August 2008 PIL
Reasons for updating
- Correction of spelling/typing errors
- Addition of manufacturer
Updated on 9 March 2007 PIL
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 24 July 2006 PIL
Reasons for updating
- Change to further information section
Updated on 6 June 2006 PIL
Reasons for updating
- Change to marketing authorisation holder
- Change of licence holder
- Change of inactive ingredient
Updated on 22 May 2006 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to date of revision
Updated on 25 April 2005 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to date of revision
Updated on 12 January 2005 PIL
Reasons for updating
- Change of contraindications
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 16 September 2004 PIL
Reasons for updating
- New PIL for medicines.ie