Propess 10 mg vaginal delivery system

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Dinoprostone

Tilgængelig fra:

Ferring Ireland Ltd

ATC-kode:

G02AD; G02AD02

INN (International Name):

Dinoprostone

Dosering:

10 milligram(s)

Lægemiddelform:

Vaginal delivery system

Recept type:

Product subject to prescription which may not be renewed (A)

Terapeutisk område:

Prostaglandins; dinoprostone

Autorisation status:

Marketed

Autorisation dato:

2018-07-06

Indlægsseddel

PM-3530/2
Package leaflet: Information for the user
PROPESS
®
10 MG VAGINAL DELIVERY SYSTEM
dinoprostone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE
GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your
doctor or nurse.
-
If you get any side effects, talk to your doctor
or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
-
PROPESS should only be used under the
supervision of an appropriate specialist.
WHAT IS IN THIS LEAFLET:
1.
What PROPESS is and what it is used for
2.
What you need to know before you are given
PROPESS
3.
How you are given PROPESS
4.
Possible side effects
5.
How to store PROPESS
6.
Contents of the pack and other information
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USED FOR
PROPESS contains the active substance
dinoprostone 10 mg and is used to help start the
birth process provided that 37 weeks of pregnancy
have been completed. The dinoprostone opens the
part of the birth canal known as the cervix, to allow
the baby through. There can be several reasons why
you might need help starting this process. Ask your
doctor if you would like to know more.
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YOU ARE GIVEN PROPESS
DO NOT USE PROPESS
You must not be given PROPESS:
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if the size of your baby’s head may cause any
problem during delivery
•
if your baby is not in the correct position in the
womb, to be born naturally
•
if your baby is not in good health and/or is
distressed
•
if you have had previous major surgery or rupture
of the cervix
•
if you have untreated pelvic
disease
(an infection in the womb, ovaries, tubes and/or
cervix)
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if the placenta is obstructing the birth canal
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if you have or have had any unexplained vaginal
bleeding during this pregnancy
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if you have had previous womb surgery including
a previous Caesarean birth for any previous babies
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if you are hypersensitive (allergic) to dinop

Produktets egenskaber

Health Products Regulatory Authority
13 March 2023
CRN00D3ZL
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Propess 10 mg vaginal delivery system
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vaginal delivery system consists of a non-biodegradable polymeric
drug delivery device containing 10 mg dinoprostone
(Prostaglandin E
2
) dispersed throughout its matrix and releases approximately 0.3
mg/hour dinoprostone over a 24-hour
period.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Vaginal delivery system
PROPESS is presented as a 0.8 mm thin, flat semi-transparent polymeric
vaginal delivery system which is rectangular in shape
(29 mm by 9.5 mm) with rounded corners contained within a knitted
polyester retrieval system.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Initiation of cervical ripening in patients, at term (from 37
completed weeks of gestation).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
PROPESS should only be administered by qualified healthcare personnel
in hospitals and clinics with specialised obstetric units
with facilities for continuous fetal and uterine monitoring.
After insertion, uterine activity and fetal condition must be
carefully and regularly monitored.
Posology
One vaginal delivery system is administered high into the posterior
vaginal fornix.
The vaginal delivery system should be removed after 24 hours
irrespective of whether cervical ripening has been achieved.
A dosing interval of at least 30 minutes is recommended for the
sequential use of oxytocin following the removal of the vaginal
delivery system. Only one application of PROPESS is recommended
_Paediatric population_
The safety and efficacy of PROPESS in pregnant women aged less than 18
years has not been established. No data are
available.
_ _
Method of administration
_Administration_
PROPESS should be removed from the freezer just prior to the
insertion. No thawing is required prior to use.
There is a "tear mark" on the side of the foil sachet. Open the
package along t