propess use and administration video video

the abbreviated prescribing information
is found at the end of this video.

the full summary of product characteristic is available from ferring pharmaceuticals limited

or the website http://emc.medicine.org.uk

For a pregnancy to progress naturally to spontaneous labor at term

and a successful vaginal delivery,

the process of cervical ripening is crucial.

if a woman is post date.

or when complications arise from mother or child

medical intervention may be needed
to induce cervical ripening

and ultimately labor.

Propess, with its virginal controlled-release delivery system

is a well-established treatment

to stimulate ripening of the cervix from the 38th week gestation

the Propess virginal insert consists of a thin hydrogel polymer matrix

within a one-piece polyester pouch and retrieval tape.

the active substance Dinoprostonestone is a prostaglandin e2

that helps to decrease cirvical rigidity

by inducing changes in
the collagen structure in the connective tissue.

it also facilitates relaxation of the smooth muscles of the cervix

and consequently leads to cervical dilation and defacement.

How to use Propess

Propess virginal insert is ready to use immediately after removal from the freezer.

to open the foil primary pack

tear the notch on the side near the top

do not use scissors or other sharp objects.

now put on a pair of examination gloves

and remove the Propess insert

gently by pulling at the end of the retrieval tape

examine the insert

to ensure the plastics slab is safely contained
within the retrieval tape

water-soluble obstetric gel may be applied to
the index and middle fingers of one hand

now pick up the Propess insert between these two fingers

and extend the tape with the other hand

gently insert your two fingers into the vagina

with the insert securely held between them

place the insert high up in the posterior vaginal fornix

Then, tongue the retrieval tape just inside vagina

this will ensure it is secure from being dislodged inadvertently

the retrieval cape may be cut with scissors

always ensuring there is sufficient tape
outside the vagina to allow removal

after insertion of Propess,

the patient is to stay in the recumbent position for 20 to 30 minutes

the Propess vaginal insert may remain in place
for a maximum period of 24 hours

it should be removed, however, at the onset of labor

in cases of spontaneous rupture of membranes or amniotomy

evidence of fetal distress

evidence of maternal systemic adverse dinoprostone effects

such as nausea, vomiting, hypotension or tachycardia

and at least 30 minutes prior to starting
an intravenous infusion of oxytocin

to remove the propess insert

locate the retrieval tape and pull on it gently

until the product is fully outside the vagina

following removal

check if the hydrogel polymers slab
is still inside the retrieval tape

this is easily determined of the insert had swollen while in place

the half-life of the active substance dinoprostone is around 1 to 3 minutes.

ensuring the propess is rapidly cleared from the circulation

(Manufacture of thePropess vaginal insert)

both the innovative hydro gel polymer technology

and the retrieval system for quick removal of propess

have been developed at ferring-controlled therapeutics limited in Scotland

at this facility the hydrogel polymer insert are formed

by chemically cross-linking chains of polyethylene oxide

in a three-dimensional lattice

the inserts are hydrated

and then loaded with ten milligrams of dinoprostone

during drying, a matrix contracts and traps the drug, creating a reservoir

in a final step

the polymer slab is placed into a woven polyester retrieval tape

once inside the vagina,

the polymer slab absorbs moisture and swells

the resulting concentration gradient

enables the controlled-release of 0.3 milligrams of dinoprostone

every hour over a period of up to 24 hours

Summary and safety infomation

using the propess vaginal insert has a number of advantages

it is easy to administer without the use of stirrups, a speculum or a syringe

and provides accurate control of the release of dinoprostone

in the location of the cervix.

the reservoir of 10 milligrams

releases dinoprostone at a contolled and constant rate

with the time of vaginal delivery

significantly shorter compared to placebo

the retrieval system allows fast removal of the Propess insert

Propess for initiation of cervical ripening at term.

contraindications

the propess vaginal insert should not be used

or should be removed under the following circumstances:

when labor has started

when oxytocin drugs are being given

when strong prolonged uterine contractions would be inappropriate such as in patients

a who have had previous major uterine surgery,

e.g. caesarean section, myomectomy, etc.

see section 4.4 and 4.8

b. with cephalopelvic disproportion

c. with fetal malpresentation

d. with suspicion or evidence of fetal distress

e. who had more than three full term deliveries

f. previous surgery or rupsture of the cervix

when there is current pelvic inflammatory disease

unless adequate prior treatment has been instituted.

when there is hypersensitivity to
dinoprostone or to any of the excipients

when there is placenta previa or unexplained vaginal bleeding during the current pregnancy.

warnings and precautions

after insertion of propess,

uterine activity and fetal condition must be monitored regularly

the vaginal delivery system should be removed from the vagina,

if there is any suggestion of maternal-fetal complications,

if adverse effects occur,

if uterine contractions are prolonged or excessive,

if there is possibility of uterine hypertonus or rupture.

Propess should be used with caution in patients

with ruptured membranes,

a previous history of uterine hypertony,

glaucoma, asthma,

when there is a multiple pregnancy

at risk of disseminated intravascular coagulation

medication with non-steroidal anti-inflammatory drugs,

including acetylsalicylic acid,

should be stopped before administration of dinoprostone.

Propess should not be administered to

patients with a history of previous cesarean section or uterine surgery

given the potential risk for uterine
rupture

and associated obstetric complications

not recommended in patients with diseases

which could affect the metabolism
or excretion of dinoprostone,

e.g. lung, liver or renal disease.

a second dose of propess is not recommended.

always consult the full summary of product characteristics before prescribing.