Mysodelle 200micrograms vaginal delivery system

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Misoprostol

Available from:

Ferring Pharmaceuticals Ltd

ATC code:

G02AD06

INN (International Name):

Misoprostol

Dosage:

7microgram/1hour

Pharmaceutical form:

Vaginal delivery system

Administration route:

Vaginal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07010100; GTIN: 5015919822037

Patient Information leaflet

Mysodelle can cause strong and prolonged womb contractions.
When using Mysodelle the mother and unborn baby will be closely
monitored to ensure that Mysodelle is removed timely. Sometimes
it is necessary to add another medication (tocolytic treatment),
which in most cases will resolve the contractions.
Mysodelle should only be used under the supervision of an
appropriate specialist and where necessary hospital facilities
are readily available.
- when labour starts when contractions are becoming regular
- in case of irregular contractions that are too strong, prolonged
or too frequent and/or changes in the neck of the womb
- if your baby becomes distressed
- if 24 hours have elapsed since insertion
THIS LEAFLET WAS LAST REVISED IN 11/2017.
Very common: may affect more than 1 in 10 people:
•
The unborn baby’s heart rate changes during labour
which may be a reason for concern (foetal heart
rate disorder)
•
The mother’s womb contracts too frequently with
and without affecting the newborn which may be a
reason for concern (uterine contractions abnormal)
•
The mother’s womb contracts too frequently and
the unborn baby’s heart rate may be affected which
may be a reason for concern (abnormal labour
affecting foetus)
•
The baby has a bowel movement in the womb
which may be a reason for concern (meconium in
amniotic fluid)
Common: may affect up to 1 in 10 people:
•
The baby has difficulty in breathing immediately after birth
(neonatal respiratory depression; transient tachypnoea of the
newborn)
•
Excessive vaginal bleeding after birth (postpartum haemorrhage)
•
A contraction that lasts too long and may be a reason for
concern (uterine hypertonus)
•
Overall newborn condition depressed at birth (apgar score
low)
•
Increased acidity in the baby’s blood (foetal acidosis)
Uncommon: may affect up to 1 in 100 people:
•
Brain affected in the baby due to not enough oxygen
(hypoxic-ischaemic encephalopathy)
•
Nausea
•
Vomiting
•
Rash
•
Unexpected bleeding from the vagina before delivery
(antepar

Summary of Product characteristics

OBJECT 1
MYSODELLE 200 MICROGRAMS VAGINAL DELIVERY
SYSTEM.
Summary of Product Characteristics Updated 05-Jan-2018 | Ferring
Pharmaceuticals Ltd
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
restin