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Prostin E2 1 mg Vaginal Gel;

*
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to restricted prescription (C)

  • Active Ingredient(s):

    Dinoprostone

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

Updated on 14 February 2023

File name

DEC202150087_Reg SPC PR 6_0 1mg gel IE-clean.pdf

Reasons for updating

  • Document format updated

Legal category:Product subject to restricted prescription (C)

Updated on 26 July 2021

File name

DEC202150087_Reg SPC PR 6_0 1mg gel IE-clean.pdf

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

The SPCs have been updated to align with the PRAC mandatory wording. The following sections of the SmPC were updated:

Section 4.2: to include wording to restrict usage to qualified health care professionals and hospitals and clinics with specialised obstetric units with facilities for continuous monitoring and a strengthening of the warning regarding the maximum recommended dose/dosing interval.

Section 4.3 and Section 4.4: to further strengthen the contraindications and warnings and precautions for use measures as follows:

Section 4.3: removed contraindications: patients with ruptured membranes, grand multiparae with over 5 previous term pregnancies

Section 4.4: include statements regarding:-

  • the risks of uterine hyperstimulation and uterine rupture and their serious complications, including foetal and neonatal death
  • the recommendation for monitoring of uterine activity and foetal heart rate and appropriate management of the patient if these develop

Section 4.5: the recommendation against the concurrent use of other oxytocic agents and for the appropriate dosing interval for sequential use of dinoprostone and oxytocin (at least 6 hours following administration of PROSTIN).

Section 4.8: to add ‘foetal death, stillbirth and neonatal death’ as an adverse reaction with frequency not known.

Where applicable Section 4.8 has been updated with the required adverse event reporting requirements.

There are also minor editorial updates to the SmPC (no content changes, formatting only).

Updated on 26 July 2021

File name

DEC202150087_Reg HCP PR 9_1 PIL PR 9_1 1mg&2mg Gels IE-clean.pdf

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 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 29 October 2020

File name

DEC202071217_Reg HCP PR 8_1 PIL PR 8_1 1mg&2mg Gels IE-clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 26 October 2020

File name

DEC202071217_Reg HCP PR 8_1 PIL PR 8_1 1mg&2mg Gels IE-clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 28 November 2018

File name

Reg SPC PR 5_2 1mg gel IE.doc.pdf

Reasons for updating

  • Improved presentation of SPC

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

File name

Reg_SPC_PR_5_2_1mg_gel_IE_clean.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 6.1 - List of excipients
  • 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 04 May 2018

File name

Reg HCP PR 7_1 PIL PR 7_2 1mg&2mg Gels IE clean.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
  • Change to name of medicinal product
  • Change to information for healthcare professionals

Updated on 03 May 2018

File name

Reg_SPC_PR_5_2_1mg_gel_IE_clean.docx

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 6.1 - List of excipients
  • 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

Updated on 20 August 2015

Reasons for updating

  • New SPC for new product

Legal category:Product subject to restricted prescription (C)

Updated on 20 August 2015

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

File name

PIL_9602_502.pdf

Reasons for updating

  • New PIL for new product

Updated on 18 August 2015

Reasons for updating

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

Updated on 25 January 2013

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Update to Section 7 and Section 8

Updated on 24 January 2013

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder
  • Change to MA holder contact details

Updated on 14 May 2012

Reasons for updating

  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability
  • Correction of spelling/typing errors

Updated on 14 March 2012

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

SPC: change to description of anaphylactic reactions in section 4.8 plus minor administrative changes.

Updated on 26 July 2011

Reasons for updating

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

Updated on 19 August 2010

Reasons for updating

  • Change to date of revision
  • Change due to harmonisation of PIL

Updated on 01 September 2009

Reasons for updating

  • Improved electronic presentation

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

watermark removed from bottom of document

Updated on 14 November 2008

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 13 November 2008

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 4.4 has been revised to include the following statement:

The Clinician should be alert that the intracervical placement of dinoprostone gel may result in advertent disruption and subsequent embolization of antigenic tissue causing in rare circumstances the development of Anaphylactoid Syndrome of Pregnancy (Amniotic Fluid Embolism)

Updated on 05 July 2007

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 2:  Wording has changed to say “For full list of excipients, see 6.1” in line with IMB guidance.

Section 10: Date of last revision of text is now April 2007

Updated on 03 May 2007

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

 

Section 9 - DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION

This has now been changed to say 13 March 2007

Updated on 08 May 2006

Reasons for updating

  • Change of manufacturer

Updated on 11 May 2005

Reasons for updating

  • New PIL for medicines.ie

Updated on 09 May 2005

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to restricted prescription (C)

Updated on 03 July 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to restricted prescription (C)