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Prostin E2 Vaginal Gel 2 mg

*
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_1 2mg 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_1 2mg 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 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 2mg 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_2mg_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_2mg_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 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

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 25 January 2013

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 25 January 2013

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Free text change information supplied by the pharmaceutical company

None provided