Prostin E2 1 mg Vaginal Gel;
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
No Recent UpdateLegal Category:
Product subject to restricted prescription (C)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 17 October 2024
File name
Reg HCP PR 10_0 PIL PR 11_0 1mg&2mg Gels 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 7_0 1mg gel 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 PR 9_1 PIL PR 10_0 1mg&2mg Gels 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 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:-
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
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
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
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)
Pfizer Healthcare Ireland Unlimited Company
Address:
The Watermarque Building, Ringsend Road, Dublin 4, D04 K7N3, IrelandTelephone:
+353 1 467 6500Fax:
+353 1 467 6501Website:
https://www.pfizermedicalinformation.ie/Medical Information Direct Line:
1 800 633 363