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Prostin E2 1mg/ml Concentrate for Solution for Infusion

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Updated on 17 October 2024

File name

Reg-HCP Leafet PR 12_0 and PIL PR 12_0-Prostin E2 1mgml-IE clean.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

The PIL has been updated to reflect the SPC change for the MAH name and address.

Updated on 17 October 2024

File name

Reg SPC PR 11_0 1mgml IE clean.pdf

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

The SPC has been updated as follows:

Section 7 Change of MAH name and address

Updated on 27 August 2024

File name

Reg-HCP Leafet PR 11_0 and PIL PR 11_0-Prostin E2 1mgml-IE CLEAN.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 14 February 2023

File name

DEC202150087_Reg SPC PR 10_1 1mgml 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 10_1 1mgml 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 Leafet PR 10_1 and PIL PR 10_1-Prostin E2 1mgml-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 6 - date of revision
  • Change to information for healthcare professionals

Updated on 30 June 2021

File name

DEC202144050_Reg SPC PR 8_1 1mgml IE-clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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 SPC has been updated as follows:

Sections 2, 4.4 & 4.7 were updated to reflect ethanol content information.

Section 4.8 was updated to reflect updated adverse event reporting requirements.

Updated on 30 June 2021

File name

DEC202144050_Reg SPC PR 8_1 1mgml IE-clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Sections 2, 4.4 & 4.7 were updated to reflect ethanol content information.

Section 4.8 was updated to reflect updated adverse event reporting requirements.

Updated on 30 June 2021

File name

DEC202144050_Reg-HCP Leafet PR 9_1 and PIL PR 9_1-Prostin E2 1mgml-IE-clean.pdf

Reasons for updating

  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 28 November 2018

File name

Reg SPC PR 7_1 1mgml 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_7_1_1mgml_IE_clean.pdf

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

File name

Reg_SPC _PR_7_1_1mgml IE_clean.docx

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 04 May 2018

File name

Reg-HCP Leafet PR 8_1 and PIL PR 8_1-Prostin E2 1mgml-IE clean.pdf

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

File name

PIL_11520_777.pdf

Reasons for updating

  • New PIL for new product

Updated on 11 April 2016

Reasons for updating

  • Change to storage instructions

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

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

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

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

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

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

Reasons for updating

  • Change of licence holder

Updated on 30 April 2012

Reasons for updating

  • Change to date of revision

Updated on 18 October 2011

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

Reasons for updating

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

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 10 November 2009

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 09 November 2009

Reasons for updating

  • Change to date of revision
  • Change to product name

Updated on 10 February 2009

Reasons for updating

  • Change to storage instructions

Updated on 09 February 2009

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

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 05 January 2007

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 05 January 2007

Reasons for updating

  • New PIL for medicines.ie

Updated on 07 July 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to restricted prescription (C)

Pfizer Healthcare Ireland Unlimited Company

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