PROSTIN E2 2MG VAGINAL GEL

Country: Կիպրոս

language: հունարեն

source: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

active_ingredient:

DINOPROSTONE

MAH:

PFIZER HELLAS AE (0000003442) 243 MESSOGHION AVENUE, NEO PSYCHIKO, ATHENS, 15451

ATC_code:

G02AD02

INN:

DINOPROSTONE

dosage:

2MG

pharmaceutical_form:

VAGINAL GEL

composition:

DINOPROSTONE (0000363246) 0,666MG

administration_route:

VAGINAL USE

prescription_type:

Ειδική άδεια άρθρο 126A

leaflet_short:

Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 1 PRE-FILLED SYRINGE X 3G () 1 SYRINGE - Εγκεκριμένο - Με Ιατρική Συνταγή

PIL

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2021-0069533
PROSTIN ® E2 1 MG AND 2 MG VAGINAL GELS
DINOPROSTONE
PHYSICIAN LEAFLET
PROSTIN® E2 1 MG AND 2 MG VAGINAL GELS
(dinoprostone)
PRESENTATION
Translucent, thixotropic gel containing 1 or 2 mg dinoprostone per 3 g
(2.5 ml).
USES
Oxytocic. Prostin E2 Vaginal Gel is indicated
for induction of labour, when there are no foetal or
maternal contraindications.
DOSAGE AND ADMINISTRATION
Usage is restricted to qualified health care professionals and to
hospitals and clinics with specialised
obstetric units with facilities for continuous monitoring.
The recommended dose should not be exceeded, and the dosing interval
should not be shortened as this
increases the risk of uterine hyperstimulation, uterine rupture,
uterine haemorrhage, foetal and neonatal
death.
In primigravida patients with unfavourable induction features (Bishop
score of 4 or less), an initial dose
of 2 mg should be administered vaginally. In other patients an initial
dose of 1 mg should be administered
vaginally.
In both groups of patients, a second dose of 1 mg or 2 mg may be
administered after 6 hours as follows:
1 mg should be used where uterine activity is insufficient for
satisfactory progress of labour.
2 mg may be used where response to the initial dose has been minimal.
Maximum dose 4 mg in unfavourable primigravida patients or 3 mg in
other patients (see section 4.4 of
SmPC).
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.
CONTRAINDICATIONS, WARNINGS, ETC.
_Contraindications: _
Prostin E2 Vaginal Gel should not be used where the patient is
sensitive to prostaglandins or other
constituents of the gel.
Prostin E2 Vaginal Gel is not recommended in the following
circumstances:
1. For patients in whom oxytocic drugs are generally contraindicated
or where prolonged contractions of
the uterus are considered inappropriate such as:
•
Cases with a history of Caesarean section or major uterine surge