Prostin E2 1 mg Vaginal Gel

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Dinoprostone

Dostupné z:

Pfizer Healthcare Ireland

ATC kód:

G02AD; G02AD02

INN (Medzinárodný Name):

Dinoprostone

Dávkovanie:

1 milligram(s)

Forma lieku:

Vaginal gel

Typ predpisu:

Product subject to Restricted Prescription (C)

Terapeutické oblasti:

Prostaglandins; dinoprostone

Stav Autorizácia:

Marketed

Dátum Autorizácia:

1987-03-13

Príbalový leták

Page 1 of 10
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

Súhrn charakteristických

Health Products Regulatory Authority
22 July 2021
CRN00CGG5
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prostin E2 1 mg Vaginal Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 3g gel (2.5 ml) contains 1 mg dinoprostone.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Vaginal gel.
Translucent, thixotropic gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Induction of labour in the absence of foetal and maternal
contraindications.
4.2 POSOLOGY AND METHOD OF 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.
_Adults:_ 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).
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.
After insertion of the gel the patient should be under observation
using continual external cardiotocography to monitor foetal
heart rate and uterine activity.
_Elderly:_ Not applicable.
_Paediatric population: _Not applicable.
4.3 CONTRAINDICATIONS
Hypersensitivity to dinoprostone, other prostaglandins or to any of
the excipients li