Presentation and Status in Health Basket
5 X 10 mg
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.
A dosing interval of at least 30 minutes is recommended for the sequential use of oxytocin following the removal of the vaginal delivery system.
Paediatric population: The safety and efficacy of PROPESS in pregnant woman aged less than 18 years has not been established. No data are available.
Administration: PROPESS should be removed from the freezer in direct connection with the insertion. No thawing is required prior to use.
There is a “tearmark” 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 delivery system should be inserted high into the posterior vaginal fornix using only small amounts of water soluble lubricants to aid insertion. After the vaginal delivery system has been inserted, the withdrawal tape may be cut with scissors always ensuring there is sufficient tape outside the vagina to allow removal. No attempt should be made to tuck the end of the tape into the vagina as this may make retrieval more difficult.
The patient should be recumbent for 20 minutes to 30 minutes after insertion. As dinoprostone will be released continuously over a period of 24 hours, it is important to monitor uterine contractions and fetal condition at frequent regular intervals.
Removal: The vaginal delivery system can be removed quickly and easily by gentle traction on the retrieval tape.
It is necessary to remove the vaginal delivery system to terminate drug administration when cervical ripening is judged to be complete or for any of the reasons listed below.
1. Onset of labour. For the purposes of induction of labour with PROPESS, the onset of labour is defined as the presence of regular painful uterine contractions occurring every 3 minutes irrespective of any cervical change.
There are two important points to note:
(i) Once regular, painful contractions have been established with PROPESS they will not reduce in frequency or intensity as long as PROPESS remains in situ because dinoprostone is still being administered.
(ii) Patients, particularly multigravidae, may develop regular painful contractions without any apparent cervical change. Effacement and dilatation of the cervix may not occur until uterine activity is established. Because of this, once regular painful uterine activity is established with PROPESS in-situ, the vaginal delivery system should be removed irrespective of cervical state to avoid the risk of uterine hyperstimulation.
2. Spontaneous rupture of the membranes or amniotomy.
3. Any suggestion of uterine hyperstimulation or hypertonic uterine contractions.
4. Evidence of fetal distress.
5. Evidence of maternal systemic adverse dinoprostone effects such as nausea, vomiting, hypotension or tachycardia.
At least 30 minutes prior to starting an intravenous infusion of oxytocin, as there is a much greater risk of hyperstimulation if the dinoprostone source is not removed before administration of oxytocin.
The opening on one side of the retrieval device is present only to allow the manufacturer to enclose the vaginal delivery system into the retrieval device during manufacture. The vaginal delivery system should NEVER be removed from the retrieval device.
On removal of the product from the vagina, the vaginal delivery system will have swollen to 2-3 times its original size and be pliable.
Initiation and / or continuation of cervical ripening in patients, at term (from 37 completed weeks of gestation) with bishop score of 6 or less.
1. When labour has started.
2. When oxytocic drugs are being given/or other labour induction agents are being given.
3. 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.
b. with cephalopelvic disproportion
c. with fetal malpresentation
d. with suspicion or evidence of fetal distress
e. who have had previous surgery (e.g. other than biopsies and cervical abrasion) or rupture of the cervix
4. When there is current pelvic inflammatory disease, unless adequate prior treatment has been instituted.
5. When there is hypersensitivity to dinoprostone or to any of the excipients.
6. When there is placenta previa or unexplained vaginal bleeding during the current pregnancy.
The condition of the cervix should be assessed carefully before treatment. Uterine activity and fetal condition must be monitored regularly. Patients with a previous history of uterine hypertony, glaucoma, or asthma. medication with non-steroidal anti-inflammatory drugs, including aspirin, should be stopped before administration of PGE2. If uterine contractions are prolonged or excessive. Remove the pessary should epidural anesthesia be given in anticipation of labor before membrane rupture.
See prescribing information for full details.
The most commonly reported adverse drug reactions in placebo-controlled and active comparator efficacy clinical trials (N=1116) were “foetal heart rate disorder” (6,9%), “uterine contractions abnormal” (6,2%) and “abnormal labour affecting foetus” (2.6 %).
See prescribing information for full details.
No dedicated interaction studies have been performed with PROPESS.
Prostaglandins potentiate the uterotonic effect of oxytocic drugs. Therefore, PROPESS should not be used concurrently with the use of oxytocic drugs.
Pregnancy and Lactation
Pregnancy: PROPESS should not be used during pregnancy prior to 37 completed weeks of gestation.
Breast-feeding: No studies have been performed to investigate the amount of dinoprostone in colostrum or breast milk following the use of PROPESS.
Dinoprostone may be excreted in colostrum and breast milk, but the level and duration is expected to be very limited and should not hinder breastfeeding. No effects on the breastfed newborns have been observed in the clinical studies conducted with PROPESS.
Overdosage or hypersensitivity may lead to hyperstimulation of the uterine muscle with or without foetal distress. If foetal distress occurs, remove PROPESS immediately and manage in accordance with local protocol.