Mysodelle 200micrograms vaginal delivery system

País: Malta

Idioma: anglès

Font: Medicines Authority

ingredients actius:

MISOPROSTOL

Disponible des:

Ferring Pharmaceuticals Limited Drayton Hall, Church Road, West Drayton UB7 7PS, United Kingdom

Codi ATC:

G02AD06

Designació comuna internacional (DCI):

MISOPROSTOL 200 µg

formulario farmacéutico:

VAGINAL DELIVERY SYSTEM

Composición:

MISOPROSTOL 200 µg

tipo de receta:

POM

Área terapéutica:

OTHER GYNECOLOGICALS

Estat d'Autorització:

Withdrawn

Data d'autorització:

2016-07-08

Informació per a l'usuari

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MYSODELLE 200 MICROGRAMS VAGINAL DELIVERY SYSTEM
MISOPROSTOL
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.
WHAT IS IN THIS LEAFLET
1.
What Mysodelle is and what it is used for
2.
What you need to know before you are given Mysodelle
3.
How you are given Mysodelle
4.
Possible side effects
5.
How to store Mysodelle
6.
Contents of the pack and other information
1.
WHAT MYSODELLE IS AND WHAT IT IS USED FOR
Mysodelle contains the active substance misoprostol.
Mysodelle is used to help start the birth process from 36 weeks of
pregnancy.
Misoprostol belongs to a group of medicines called prostaglandins.
Prostaglandins have two actions during
labour. One is to soften the mouth of the womb (cervix) so that the
baby can more easily be born through the
vagina. The second is to cause contractions to start, which will help
push the baby out of the womb (uterus).
There could be several reasons why you might need help to start this
process. Ask your doctor if you want
more information.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MYSODELLE
DO NOT USE MYSODELLE:
-
if you are allergic to misoprostol or any of the other ingredients of
this medicine (listed in section 6)
-
if labour has started
-
if your baby is not in good health and/ or is distressed
-
if oxytocic drugs (medicines used to facilitate birth) and/or other
medicines to induce labour are being
given (see “Warnings and precautions” and “Other medicines and
Mysodelle” below)
-
if you have had previous cervical or womb surgery including a previous
Caesarean birth for any earlier
babies
-
if you have any womb abnormality such as “heart-shaped” uterus
(bicornate uterus)
-
if your placenta i

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Mysodelle 200 micrograms vaginal delivery system.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mysodelle contains 200 micrograms misoprostol.
Misoprostol is released
_in vivo_
at a mean rate of approximately 7 micrograms/hour over a period of 24
hours. Drug release continues as long as Mysodelle is in the vagina.
Excipients with known effect: 0.13 mg butylated hydroxyanisole per
dose (see Section 4.4).
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Vaginal delivery system.
The polymer insert is contained within a retrieval system consisting
of an inert woven polyester pouch and
tail. The polymer insert is rectangular in shape with radiused
corners, is buff coloured, semi-transparent,
non-biodegradable and measures approximately 30 mm in length, 10 mm in
width and 0.8 mm in thickness.
Mysodelle swells in the presence of moisture.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mysodelle is indicated for induction of labour in women with an
unfavourable cervix, from 36 weeks
gestation, in whom induction is clinically indicated.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Mysodelle 200 micrograms is a controlled release formulation that
releases misoprostol at a rate of
approximately 7 micrograms/hour over a period of 24 hours.
The maximum recommended dose is one Mysodelle vaginal delivery system
(200 micrograms).Remove
Mysodelle:

At the onset of labour:
-
When contractions are rhythmic (3 or more in 10 minutes), firm and of
adequate quality and cause
cervical change and/or at the latest when cervical dilation is 4 cm

If excessive uterine contractions occur:
-
Tachysystole: more than 5 contractions in a 10-minute window, averaged
over a 30 minute window
-
Prolonged contractions: single contractions lasting 2 minutes or more
-
Hypertonic contractions: contractions are too frequent and a high
resting tone in the uterus.

If there is a clinical concern for the mother and/or baby

if 24