Cervidil Vaginal Delivery System 10mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Dinoprostone

Available from:

FERRING PHARMACEUTICALS PRIVATE LIMITED

ATC code:

G02AD02

Dosage:

10mg

Pharmaceutical form:

OTHER

Composition:

Dinoprostone 10mg

Administration route:

VAGINAL

Prescription type:

Prescription Only

Manufactured by:

Ferring Controlled Therapeutics Limited

Authorization status:

ACTIVE

Authorization date:

2011-07-04

Patient Information leaflet

PACKAGE INSERT 

NAME OF THE MEDICINAL PRODUCT 

Cervidil 10 mg 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-opaque polymeric
vaginal delivery system which is 
rectangular in shape with radiused corners contained within
a knitted polyester retrieval system. 

PHARMACOLOGICAL PROPERTIES 

PHARMACODYNAMIC PROPERTIES 

Pharmacotherapeutic group: oxytocics, ATC-code: G02AD02 

Prostaglandin E
2
 (PGE
2
) is a naturally occurring compound found in low
concentrations in most 
tissues of the body. It functions as a local hormone. 

Prostaglandin E
2
 plays an important role in the complex set of biochemical and
structural 
alterations involved in cervical ripening. Cervical
ripening involves a marked relaxation of the 
cervical smooth muscle fibres of the uterine cervix which must be transformed
from a rigid 
structure to a soft, dilated configuration to allow passage of
the fetus through the birth canal. This 
process involves activation of the enzyme collagenase which is
responsible for the breakdown of 
the collagen. 

Local
administration of dinoprostone to the cervix results in cervical ripening
which then induces 
the subsequent events which complete labour. 

PHARMACOKINETIC PROPERTIES 

PGE
2
 is rapidly metabolised primarily in the tissue
of synthesis. Any which escapes local 
inactivation is rapidly cleared from the circulation with a
half-life generally estimated as 1-3 
minutes. 

No correlation could be established between PGE
2
 release and plasma concentrations of its�

Summary of Product characteristics

NAME OF THE MEDICINAL PRODUCT
CERVIDIL
®
10 mg 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 or near term, who have
favourable induction features and in
whom there is a medical or obstetrical indication for induction of
labour.
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 the insertion. No
thawing is required prior to
use.
There is a “tear mark” on side of the foil sachet. Open the
package along the tear mark across the top of the
sachet. Do not use scissors or other sharp objects which may cut the
retrieval system.
The vaginal deliver