Prostin E2

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Dinoprostone 0.8 mg/mL

Tilgængelig fra:

Pfizer New Zealand Limited

INN (International Name):

Dinoprostone 0.8 mg/mL

Dosering:

2mg/3g

Lægemiddelform:

Vaginal gel

Sammensætning:

Active: Dinoprostone 0.8 mg/mL Excipient: Colloidal silicon dioxide Triacetin

Enheder i pakken:

Syringe, 1 x 2.5 mL, 2.5 mL

Klasse:

Prescription

Recept type:

Prescription

Fremstillet af:

Pharmacia & Upjohn Company LLC

Terapeutiske indikationer:

PROSTIN E2 is indicated for the induction of labour in term or near term women who have favourable induction features; and who have singleton pregnancy with a vertex position.

Produkt oversigt:

Package - Contents - Shelf Life: Syringe, - 2.5 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Autorisation dato:

1988-10-14

Indlægsseddel

PROSTIN
®
E2
1
PROSTIN
® E2 VAGINAL
GEL
_dinoprostone _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Prostin E2.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given Prostin
E2 against the benefits they expect it
to provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT PROSTIN E2 IS
USED FOR
Prostin E2 can be used to bring on
(induce) labour in women who have
a normal pregnancy. It works by
softening and dilating the neck of the
womb and stimulating contractions.
Your doctor may have prescribed
Prostin E2 for another reason. Ask
your doctor if you have any questions
about why Prostin E2 has been
prescribed for you.
This medicine is available only with
a doctor's prescription. It is not
addictive.
BEFORE YOU ARE GIVEN
PROSTIN E2
YOUR DOCTOR WILL DECIDE IF PROSTIN
E2 IS SUITABLE FOR YOU.
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU SHOULD NOT BE GIVEN PROSTIN
E2:
•
at the same time with other drugs
that are used to make the muscles
of your womb contract e.g.
oxytocin
•
if you have an allergy to
dinoprostone, the active
ingredient or any of the
ingredients listed at the end of
this leaflet
•
if the packaging is torn or shows
signs of tampering
•
after the expiry date (EXP)
printed on the pack
•
if you have given birth six or
more times
•
if the baby's head is not well
down in the pelvis
•
if you have had previous surgery
involving the womb
•
if the head of the baby is too big
or your pelvis is too small for a
normal delivery
•
if there has been any evidence
that the baby is unwell or not
growing
•
if the baby is not in the normal
position for birth
•
if you have had unexplained
vaginal discharge or bleeding
during the current pregnancy
•
if you are carrying more than one
fetus.
IF YOU ARE NOT SURE

Produktets egenskaber

Version: pfdproeg10119
Supersedes: pfdproeg10112
Page 1 of 6
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
PROSTIN
®
E2 1 mg or 2 mg vaginal gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 3 g gel (2.5 mL) syringe contains 1 mg or 2 mg dinoprostone.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Vaginal gel. Prostin E2 is a translucent, thixotropic gel.
4.
CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS
Prostin E2 is indicated for the induction of labour in term or near
term women who have
favourable induction features; and who have singleton pregnancy with a
vertex position.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
An initial dose of 1 mg should be inserted into the posterior fornix.
After 6 hours a second
dose of either 1 mg or 2 mg may be administered depending on need,
i.e., an absence of
response to the initial 1 mg doses indicates the 2 mg dose should be
given, while a 1mg dose
should be suggested to augment an already present response to the
initial dose.
SPECIAL POPULATIONS
ELDERLY
Not applicable.
PAEDIATRIC POPULATION
Not applicable.
METHOD OF ADMINISTRATION
Vaginally. The gel should be inserted high into the posterior fornix
avoiding administration
into the cervical canal. The patient should be instructed to remain
recumbent for at least 30
minutes.
Version: pfdproeg10119
Supersedes: pfdproeg10112
Page 2 of 6
4.3 CONTRAINDICATIONS
Dinoprostone should not be used in patients with a hypersensitivity to
dinoprostone or any
other component of the product.
Dinoprostone
should
not
be
used
in
patients
in
whom
oxytocic
drugs
are
generally
contraindicated such as:
•
Multiple gestation
•
Grand multiparity (6 or more previous term pregnancies)
•
Engagement of the head not taken place
•
Previous uterine surgery (e.g. caesarean section, hysterotomy)
•
Cephalopelvic disproportion
•
Fetal heart rate pattern suggests incipient fetal compromise
•
Obstetric conditions where either maternal or fetal benefit/risk ratio
favours surgical
intervention
•
Unexplaine