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Dynastat 40 mg Powder for Solution for Injection

  • Name:

    Dynastat 40 mg Powder for Solution for Injection

  • Company:
    info
  • Active Ingredients:

    Parecoxib 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: 02/11/20

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Summary of Product Characteristics last updated on medicines.ie: 2/11/2020

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Pfizer Healthcare Ireland

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Company Products

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Medicine Name Accupro 20 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 40 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 5 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accuretic 20 mg/12.5 mg Tablets Active Ingredients Hydrochlorothiazide, Quinapril hydrochloride
Medicine Name Aciclovir 25 mg/ml Concentrate for Solution for Infusion. Active Ingredients Aciclovir sodium
Medicine Name Aldactone 100mg film coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 25mg film-coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 50 mg Film-coated tablets. Active Ingredients Spironolactone
Medicine Name Amlodipine Pfizer 10 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Amlodipine Pfizer 5 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Anugesic HC Cream Active Ingredients Balsam Peru, Benzyl Benzoate, Bismuth Oxide, Hydrocortisone Acetate, Pramocaine Hydrochloride, Zinc Oxide
Medicine Name ARICEPT 10 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name ARICEPT 5 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name Aromasin 25 mg coated tablets Active Ingredients Exemestane
Medicine Name Arthrotec 50 Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Arthrotec 75 modified-release tablets Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Ativan 1mg Tablets Active Ingredients Lorazepam
Medicine Name ATIVAN INJECTION Active Ingredients Lorazepam
Medicine Name BeneFIX Active Ingredients nonacog alfa
Medicine Name BESPONSA 1 mg powder for concentrate for solution for infusion Active Ingredients Inotuzumab ozogamicin
Medicine Name Bosulif 100 mg, 400 mg & 500 mg film-coated tablets Active Ingredients Bosutinib monohydrate
Medicine Name Cabaser 1mg Tablet Active Ingredients Cabergoline
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Medicine Name CAMPTO 20 mg/ml, concentrate for solution for infusion Active Ingredients Irinotecan hydrochloride trihydrate
1 - 0 of 230 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 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