Trinovin

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

Trifolium pratense

Commercializzato da:

Pharmacare Laboratories Pty Ltd

INN (Nome Internazionale):

Trifolium pratense

Classe:

Medicine Listed

Stato dell'autorizzazione:

Listed

Foglio illustrativo

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 5 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 vaginal delivery is not suitable
e.g. herpes genitalis
•
if you are carrying

Scheda tecnica

Version: pfpproeg10320
Supersedes pfpproeg10112
Page 1 of 10
AUSTRALIAN PRODUCT INFORMATION - PROSTIN
® E
2
VAGINAL GEL (DINOPROSTONE)
1.
NAME OF THE MEDICINE
Dinoprostone.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PROSTIN E2 Vaginal Gel contains either 1 mg or 2 mg dinoprostone, as
the active ingredient in each
unit dose of 3 grams (2.5 mL).
3.
PHARMACEUTICAL FORM
Vaginal Gel.
PROSTIN E2 Vaginal Gel is a translucent triacetin-based, thixotropic
gel formulation.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Induction of labour in term or near-term pregnant women who have
favourable induction features;
and who have singleton pregnancy with a vertex presentation.
4.2 DOSE AND METHOD OF ADMINISTRATION
For labour induction at or near term, in women with favourable
induction features with singleton
pregnancy and vertex presentation, the initial dose is 1 mg of PROSTIN
E2 Vaginal Gel.
1. Remove the syringe containing the gel from refrigeration at least
30 minutes prior to use and allow
to warm to room temperature.
2. The gel should be inserted high into the posterior fornix of the
vagina, avoiding administration into
the cervical canal.
3. The patient should be instructed to remain recumbent for at least
30 minutes.
Each syringe containing a prescribed amount of PROSTIN E2 Vaginal Gel
(1 mg or 2 mg) is for single
use only. Discard after initial use.
Version: pfpproeg10320
Supersedes pfpproeg10112
Page 2 of 10
A further dose of either 1 or 2 mg of PROSTIN E2 Vaginal Gel may be
given after 6 hours on the basis
of clinical assessment of response on the proviso that the maximum
dose of PROSTIN E2 Vaginal Gel
does not exceed 3 mg (or 60 μg/kg for a 50 kg woman) over a 6 hour
period.
Use of PROSTIN E2 Vaginal Gel in situations other than that indicated
is inappropriate and is not
recommended.
METHOD OF ASSEMBLY
STEP ONE:
Remove protective end cap (to serve as plunger rod).
STEP TWO:
Insert protective end cap into the syringe.
STEP THREE:
Administer syringe content.
4.3 CONTRAINDICATIONS
PROSTIN E2 Vaginal Gel shoul