Cervidil Controlled Release Vaginal Pessary 10mg

Country: Մալայզիա

language: անգլերեն

source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

active_ingredient:

DINOPROSTONE

MAH:

Ferring Sdn. Bhd.

INN:

DINOPROSTONE

units_in_package:

1 Units

manufactured_by:

FERRING CONTROLLED THERAPEUTICS LTD

SPC

PROPOSED PACKAGING MATERIAL
Code
PROP-I-MY-02.01
Size
Submission
☐
NDA
☐
Renewal
☒
Variation change detail no.: #200534
_ _
Code of previous version
PROP-I-MY-01.01
Changes
#200534 update according to CCDS v 3.0
☒
CCDS version: 3.0
☐
Core PIL version:
☐
SPC country/version/date:
☐
LAC no.:
Name & Date
JIWO, 01-Nov-2022
PACKAGE INSERT
NAME OF THE MEDICINAL PRODUCT
CERVIDIL 10 mg Controlled Release Vaginal Delivery System
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vaginal delivery system consists of a non-biodegradable polymeric
drug delivery device containing 10 mg
dinoprostone (Prostaglandin E
2
) dispersed throughout its matrix. It also contains crosslinked
polyethylene glycol
(hydrogel) and polyester yarn.
PHARMACEUTICAL FORM
Vaginal delivery system
CERVIDIL is presented as a thin, flat semi-transparent polymeric
vaginal delivery system which is rectangular in shape
with rounded corners contained within a knitted polyester retrieval
system.
THERAPEUTIC INDICATIONS
Initiation of cervical ripening in patients, at term (from 37
completed weeks of gestation).
POSOLOGY AND METHOD OF ADMINISTRATION
CERVIDIL should only be administered by qualified healthcare personnel
in hospitals and_ _clinics with obstetric units
with facilities for continuous fetal and uterine monitoring.
After insertion, uterine activity and fetal condition must be
carefully and regularly monitored.
_Posology _
One vaginal delivery system is administered high into the posterior
vaginal fornix.
The vaginal delivery system should be removed after 24 hours
irrespective of whether cervical ripening has been
achieved.
In case of subsequent administration of uterotonic drugs, a dosing
interval of at least 30 minutes is recommended
following the removal of the vaginal delivery system.
_Paediatric population _
The safety and efficacy of CERVIDIL in pregnant woman aged less than
18 years has not been established. No data
are available.
_Method of Administration _
_Administration _
CERVIDIL should be removed from the freezer just prior to