Prostin E2 1mg/ml Concentrate for Solution for Infusion

  • Name:

    Prostin E2 1mg/ml Concentrate for Solution for Infusion

  • Company:
    info
  • Active Ingredients:

    Dinoprostone

  • Legal Category:

    Product subject to restricted prescription (C)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/05/18

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Summary of Product Characteristics last updated on medicines.ie: 28/11/2018

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

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1 - 0 of 227 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 28 November 2018 SmPC

Reasons for updating

  • Improved presentation of SmPC

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Improved presentation of SPC uploaded

Updated on 28 August 2018 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows

1mg and 2 mg gels. The QRD format of the product name has been adopted. QRD statement of storage has been adopted (the actual storage condition is unchanged). QRD naming of excipients has been adopted

 

1mg/ml solution. QRD statement of storage has been adopted (the actual storage condition is unchanged).

Updated on 21 May 2018 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

1 mg/ml sterile sol

6.4, 10

Updated on 4 May 2018 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 11 April 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 11 April 2016 PIL

Reasons for updating

  • Change to storage instructions

Updated on 20 August 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to restricted prescription (C)

Updated on 20 August 2015 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4 - Clinical particulars
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5 - Pharmacological properties
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 5.4 - Radiation dosimetry
  • Change to section 6 - Pharmaceutical particulars
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 11 - Dosimetry
  • Change to section 12 - Instructions for preparation of radiopharmaceuticals

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

All sections – Updated in line with QRD

Updated on 18 August 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 20 June 2013 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 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 restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 4.8 Undesirable Effects, has been updated to include the specific event terms Anaphylactic reaction, Anaphylactic shock and Anaphylactoid reaction as examples of hypersensitivity reactions, an event term already listed in the labelling documents for dinoprostone, which may occur during treatment.

The other sections of  SmPCs have also been updated

Updated on 18 June 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of separate PILs covering individual presentations

Updated on 30 July 2012 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Improved electronic presentation

Updated on 18 July 2012 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

SPC (Section 7: MARKETING AUTHORISATION HOLDER)

Updated on 13 July 2012 PIL

Reasons for updating

  • Change of licence holder

Updated on 30 April 2012 PIL

Reasons for updating

  • Change to date of revision

Updated on 18 October 2011 SmPC

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 restricted prescription (C)

Free text change information supplied by the pharmaceutical company

SmPC change of the name of MA holder from Pharmacia Ireland Limited to Pharmacia Ireland

Updated on 17 October 2011 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 26 July 2011 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability
  • Change due to user-testing of patient information

Updated on 10 November 2009 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6 - Pharmaceutical particulars

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

The product name has been amended to include the strength first and further changes to the qualitative and pharmaceutical particulars have been made in sections 2 and 6 of the SmPC.

Updated on 9 November 2009 PIL

Reasons for updating

  • Change to date of revision
  • Change to product name

Updated on 10 February 2009 PIL

Reasons for updating

  • Change to storage instructions

Updated on 9 February 2009 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

 

The following text has been added to section 6.4:

"Once the ampoule is opened, prepare the diluted solution immediately and discard any unused contents remaining in the ampoule"

Updated on 24 January 2007 PIL

Reasons for updating

  • Improved electronic presentation
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to information about drinking alcohol
  • Change to information about driving or using machinery
  • Change to marketing authorisation holder
  • Change to name of manufacturer

Updated on 5 January 2007 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.6 - Pregnancy and lactation
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 4.8 - Undesirable effects
  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Sections: 1, 4.3, 4.4 and 4.6 the name “Prostin E2 Sterile Solution 1 mg/ml” has been changed to “Prostin E2 Concentrate for Solution for Infusion”.
 
 
Section 4.3  - addition of new contra-indications
SEction 4.4 addition of new warnings
section 6.1 addition of the word 'anhydrous'
section 6.3 more detailed wording has been included
section 6.6 more detailed wording has been included
 
 
 
Section 7: address change

Updated on 5 January 2007 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 7 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to restricted prescription (C)