Last Updated on eMC 16-11-2017 View medicine  | Ferring Pharmaceuticals Ltd Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • 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

Date of revision of text on the SPC:26-10-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

QRD update

Reasons for adding or updating:

  • 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 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties

Date of revision of text on the SPC:19-01-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.1 - definition of "term" changed to 37 completed weeks.

Section 4.2 -  Information on Paediatric population included

Section 4.3 - addition of: other labour induction agents
                    - update to: who have had previous major surgery (e.g. other than biopsies and cervical abrasion) or rupture of the uterine cervix

Section 4.4 - addition of: PROPESS should be used with caution when the woman has had more than three full term deliveries. No studies in woman with more than three full term deliveries have been performed.

Section 4.5 - addition of:  No dedicated interaction studies have been performed with PROPESS.

Section 4.6 - whole section update to: Pregnancy PROPESS should not be used during pregnancy prior to 37 completed weeks of gestation.

                                                             Breast-feeding No studies have been performed to investigate the amount of dinoprostone in colostrum or breast milk following the use of PROPESS.

                                                             Dinoprostone may be excreted in colostrum and breast milk, but the level and duration is expected to be very limited and should not hinder breastfeeding.
                                                             No effects on the breastfed new-borns have been observed in the clinical studies conducted with PROPESS.

Section 4.8 - Whole section re-written

Section 4.9 - Re-written

Section 5.1 - removal of:  "marked relaxation of the cervical smooth muscle fibres" and replaced with "transformation" 

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC:15-04-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



section 4.4: additional information -

 


The Clinician should be alert that, as with other labour induction methods, use of dinoprostone may result in inadvertent disruption and subsequent embolization of antigenic tissue causing in rare circumstances the development of Anaphylactoid Syndrome of Pregnancy (Amniotic Fluid Embolism).


section 4.8: additional side effects -

Frequency: Not known (cannot be estimated from the available data)
MedDRA system: Pregnancy, puerperium and perinatal conditions
Adverse events: Anaphylactoid syndrome of pregnancy (amniotic fluid embolism)

Reasons for adding or updating:

  • Change to MA holder contact details

Date of revision of text on the SPC:31-10-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

New MAH address: Drayton Hall, Church Road, West Drayton, UB7 7PS

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of Excipients
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-02-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

section 1 - To add R in a circle next to the Product name.
section 2 - To add "FULL List", to the statement on excipients.
section 6.1 - To replace the following excipients with Crosslinked polyethylene glycol (hydrogel) and Polyester yarn
 

Hydrogel Polymer

Prepared with:

Macrogol 8000

Dicyclohexyl methane-4, 4’-diisocyanate

1,2,6-Hexanetriol

Polyester Retrieval System
 
section 10 - To change the text revision date.

Reasons for adding or updating:

  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • New SPC for new product