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Dynastat 40 mg Powder for Solution for Injection

*
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland

  • Status:

    Updated

  • Legal Category:

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

  • Active Ingredient(s):

    Parecoxib Sodium

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

Updated on 27 March 2024

File name

Adv SPC DY 310 IE CLEAN.pdf

Reasons for updating

  • 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)

Updated on 27 March 2024

File name

Adv PIL DY 330 powder IE and NI CLEAN.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 13 February 2023

File name

Adv SPC DY 30_0 IE CLEAN.pdf

Reasons for updating

  • Document format updated

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

Updated on 22 February 2022

File name

AdvPILDY310powderIEandNIClean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 21 December 2021

File name

Adv SPC DY 30_0 IE CLEAN.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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

The SPC has been updated as follows:

  • Section 4.6 – update fertility, pregnancy and lactation to add the risk of oligohydramnios/foetal renal dysfunction during the second trimester of pregnancy following the receipt of the FDA drug safety notification on 15th October 2020 and its reversible effect upon discontinuation of treatment.

Section 10 – update of revision date

Updated on 17 December 2021

File name

Adv SPC DY 30_0 IE CLEAN.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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 02 November 2020

File name

DEC202072528_Adv SPC DY 29_1 IE-clean.pdf

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 02 November 2020

File name

DEC202072528_Adv PIL DY 30_1 powder IE-clean.pdf

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

File name

DEC202039407_Adv SPC DY 28_0 UK IE-clean.pdf

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

File name

DEC202039407_Adv PIL DY 29_0 powder UK IE-clean.pdf

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

File name

DEC201964139_Adv PIL DY 28_0 powder UK IE- clean.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 24 May 2019

File name

DEC201927150_Adv PIL DY 27_0 powder UK IE - clean.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 24 May 2019

File name

DEC201927150_Adv SPC DY 27_0 UK IE-clean.pdf

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 04 October 2018

File name

Adv PIL DY 26_0 powder UK IE-clean.pdf

Reasons for updating

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

Updated on 04 October 2018

File name

Adv SPC DY 26_0 UK IE -clean.pdf

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

File name

Adv PIL DY 25_0 powder UK & IE-clean.pdf

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

File name

Adv SPC DY 25_0 UK & IE-clean.pdf

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 06 June 2018

File name

Adv_SPC_DY_24_1_uk_&_IE_clean.docx

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 02 November 2017

File name

PIL_8738_927.pdf

Reasons for updating

  • New PIL for new product

Updated on 02 November 2017

Reasons for updating

  • Improved presentation of PIL

Updated on 22 March 2017

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

Reasons for updating

  • Change to side-effects
  • Change to MA holder contact details

Updated on 19 January 2015

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

Reasons for updating

  • Change to packaging
  • Change to side-effects
  • Change to date of revision

Updated on 28 June 2013

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 17 April 2013

Reasons for updating

  • Change to information about pregnancy or lactation

Updated on 09 November 2012

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 01 August 2012

Reasons for updating

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

Updated on 06 February 2012

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

Reasons for updating

  • Change to dosage and administration

Updated on 04 March 2011

Reasons for updating

  • Change to instructions about overdose

Updated on 17 November 2010

Reasons for updating

  • Change to side-effects

Updated on 06 September 2010

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 17 December 2009

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 03 April 2009

Reasons for updating

  • Improved electronic presentation

Updated on 23 March 2009

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

Reasons for updating

  • Correction of spelling/typing errors
  • Addition of manufacturer

Updated on 09 March 2007

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 24 July 2006

Reasons for updating

  • Change to further information section

Updated on 06 June 2006

Reasons for updating

  • Change to marketing authorisation holder
  • Change of licence holder
  • Change of inactive ingredient

Updated on 22 May 2006

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

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to date of revision

Updated on 12 January 2005

Reasons for updating

  • Change of contraindications
  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 16 September 2004

Reasons for updating

  • New PIL for medicines.ie