PREPIDIL GEL

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

DINOPROSTONE

Disponible des:

PFIZER CANADA ULC

Codi ATC:

G02AD02

Designació comuna internacional (DCI):

DINOPROSTONE

Dosis:

0.5MG

formulario farmacéutico:

GEL

Composición:

DINOPROSTONE 0.5MG

Vía de administración:

INTRACERVICAL

Unidades en paquete:

2.5ML

tipo de receta:

Prescription

Área terapéutica:

OXYTOCICS

Resumen del producto:

Active ingredient group (AIG) number: 0111999005; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

1997-08-01

Fitxa tècnica

_PREPIDIL Gel (dinoprostone) Product Monograph _
_Page 1 of 28_
PRODUCT MONOGRAPH
PREPIDIL
®
(DINOPROSTONE GEL)
0.5 MG/2.5 ML SYRINGE (3 GM)
PROSTAGLANDIN
Pfizer Canada Inc
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Date of revision:
05 September 2012
CONTROL NO. 156067
® TM Pharmacia & Upjohn Company LLC
Pfizer Canada Inc., Licensee
© Pfizer Canada Inc. 2012
Distribution :
Paladin Labs Inc.
Montréal (Québec)
_PREPIDIL Gel (dinoprostone) Product Monograph _
_Page 2 of 28_
NAME OF DRUG
PREPIDIL®
(Dinoprostone Gel)
Gel - 0.5 mg / 2.5 ml Syringe (3 gm)
THERAPEUTIC CLASSIFICATION
Prostaglandin
ACTION
PREPIDIL (dinoprostone gel), which contains a prostaglandin E
2
analogue as the active ingredient,
causes cervical ripening preparatory to the onset of labour when it is
administered endocervically.
Although the local effects of prostaglandin E
2
on cervical maturation is not specifically known,
experimental data indicates the drug enhances cervical hemodynamics
which in turn promotes
ripening of the cervix.
INDICATIONS AND CLINICAL USES
PREPIDIL (dinoprostone gel), administered into the cervical canal, is
indicated for inducing
cervical softening and dilatation of the cervix in pregnant women at
or near term, where cervical
features are not conducive to induction.
The use of PREPIDIL in this manner, in patients with unfavourable
induction features prior to
labour induction by conventional methods, has been shown to improve
the overall outcome of
labour induction attempt.
_PREPIDIL Gel (dinoprostone) Product Monograph _
_Page 3 of 28_
CONTRAINDICATIONS
Endocervically administered PREPIDIL (dinoprostone gel) is not
recommended for use in the
following:
l.
Patients in whom oxytocic drugs are generally contraindicated or where
prolonged
contractions of the uterus are considered inappropriate. These include
the following
situations:
(a)
Patients with a history of cesarean section or major uterine surgery;
(b)
Patients with a major degree of cephalopelvic disproportion;
(c)
Patients with a history of difficult