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Proper Administration of CERVIDIL will help optimize drug delivery1
Pick up the insert between 2 fingers and lightly coat with water-miscible lubricant.
Gently place your fingers with the insert into the vagina. Position the insert transversely in the posterior vaginal fornix. Take care not to dislodge the insert when removing fingers. Slightly tuck the retrieval tape into the vagina.
To retrieve, locate the retrieval tape and pull it gently until the product is fully removed.
Upon removal of CERVIDIL, it is essential to ensure that the slab has been removed, as it will continue delivering the active ingredient.
CERVIDIL must be kept frozen until use and is stable when stored in a freezer for a period of 3 years
There is no need for previous warming of the product
Insert immediately after removal from its foil package
CERVIDIL does not require sterile conditions
CERVIDIL must not be used without its retrieval system
Do not wrap the retrieval tape around the insert before insertion
Do not overlubricate; excess lubricant could prevent optimal swelling and release of dinoprostone from the vaginal insert
Patients should remain in the recumbent position for 2 hours following insertion, but thereafter may be ambulatory
Just One Dose
A single dose to help ripen the cervix1
Controlled-release drug delivery
– Formulated to release 0.3 mg/hr for up to 12 hours
Releases drug at the cervix
Up to 12 hours of drug delivery without multiple administrations
Removed In Seconds Cleared In Minutes
Maintain control and retrieve with ease1
Long tape facilitates immediate removal
The half-life of dinoprostone is 2.5 to 5 minutes
When to remove CERVIDIL
12 hours after insertion or upon onset of active labor, or whichever comes first
Prior to amniotomy
With any evidence of uterine hyperstimulation, sustained uterine contractions, fetal distress, and other fetal or maternal adverse reactions
Before oxytocin administration is initiated; the patient’s uterine activity should be carefully monitored for uterine hyperstimulation
Take the challenge!
When administering CERVIDIL, it is inappropriate to wrap the long retrieval tape around the insert.
CERVIDIL Vaginal Insert (dinoprostone, 10 mg) is indicated for the initiation and/or continuation of cervical ripening in patients at or near term in whom there is a medical or obstetrical indication for the induction of labor.
CERVIDIL is designed to be released at approximately 0.3 mg/hour over a 12-hour period. CERVIDIL should be removed upon onset of active labor or 12 hours after insertion.
Upon removal of CERVIDIL, it is essential to ensure that the slab has been removed as it may have separated from the knitted polyester retrieval system and will continue delivering the active ingredient.
IMPORTANT SAFETY INFORMATION
CERVIDIL is contraindicated in:
Patients with known hypersensitivity to prostaglandins
Patients in whom there is a clinical suspicion or definitive evidence of fetal distress where delivery is not imminent
Patients with unexplained vaginal bleeding during this pregnancy
Patients in whom there is evidence or strong suspicion of marked cephalopelvic disproportion
Patients in whom oxytocic drugs are contraindicated or when prolonged contraction of the uterus may be detrimental to fetal safety or uterine integrity, such as previous cesarean section or uterine surgery (given the potential risk for uterine rupture and associated obstetrical complications, including the need for hysterectomy and the occurrence of fetal or neonatal death)
Multipara with 6 or more previous term pregnancies
Warnings and Precautions
CERVIDIL is for hospital use only and should be administered only by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities.
Use of dinoprostone may result in inadvertent disruption and subsequent embolization of antigenic tissue causing, in rare circumstances, the development of Anaphylactoid Syndrome of Pregnancy (Amniotic Fluid Embolism).
Prostaglandins, including CERVIDIL, may augment the activity of oxytocic agents and their concomitant use is not recommended. CERVIDIL must be removed before oxytocin administration is initiated and a dosing interval of at least 30 minutes is recommended for the sequential use of oxytocin.
Uterine activity, fetal status, and the progression of cervical dilatation and effacement should be carefully monitored whenever the CERVIDIL vaginal insert is in place. With any evidence of uterine hyperstimulation, sustained uterine contractions, fetal distress, or other fetal or maternal adverse reactions, the vaginal insert should be removed. CERVIDIL should also be removed prior to amniotomy.
Caution should be exercised in the administration of CERVIDIL for cervical ripening in patients with ruptured membranes, in cases of non-vertex or non-singleton presentation, and in patients with a history of previous uterine hypertony, glaucoma, or a history of childhood asthma, even though there have been no asthma attacks in adulthood.
Long-term carcinogenicity and fertility studies have not been conducted with CERVIDIL. No evidence of mutagenicity has been observed with prostaglandin E2 in the Unscheduled DNA Synthesis Assay, the Micronucleus Test, or Ames Assay.
Prostaglandin E2 has produced an increase in skeletal anomalies in rats and rabbits. No effect would be expected clinically, when used as indicated, since CERVIDIL is administered after the period of organogenesis. Prostaglandin E2 has been shown to be embryotoxic in rats and rabbits, and any dose that produces sustained increased uterine tone could put the embryo or fetus at risk.
The safety and efficacy of CERVIDIL has been established in women of a reproductive age and women who are pregnant. Although safety and efficacy has not been established in pediatric patients, safety and efficacy are expected to be the same for adolescents.
Women aged 30 years or older, those with complications during pregnancy and those with a gestational age over 40 weeks have been shown to have an increased risk of postpartum disseminated intravascular coagulation. In addition, these factors may further increase the risk associated with labor induction. In these women, use of dinoprostone should be undertaken with caution. Measures should be applied to detect as soon as possible an evolving fibrinolysis in the immediate postpartum period. An increased risk of postpartum disseminated intravascular coagulation has been described in patients whose labor was induced by physiologic means, either with dinoprostone or oxytocin.
In clinical trials, the most commonly occurring adverse reactions were uterine hyperstimulation with fetal distress (2.8% vs 0.3% for placebo), uterine hyperstimulation without fetal distress (4.7% vs 0%), and fetal distress without uterine hyperstimulation (3.8% vs 1.2%).
Drug-related fever, nausea, vomiting, diarrhea, and abdominal pain were noted in less than 1% of patients who received CERVIDIL.