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CERVIDIL is a brand name for Dinoprostone, supplied as a insert. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: CERVIDIL® (dinoprostone vaginal insert) is indicated for: 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 labour. 1.1 Pediatrics Pediatrics (<18 years of age): CERVIDIL has not been studied in this patient…
Verbatim from this product's HC label. Tap a section to expand.
08/2022 7 WARNINGS AND PRECAUTIONS, General 08/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS .............................................................................................................. 1 Pediatrics ..........................................................................................................
2 Geriatrics........................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations .......................................................................................
2 Recommended Dose and Dosage Adjustment..................................................... 3 Reconstitution ................................................................................................... 4 Administration...................................................................................................
5 Missed Dose ...................................................................................................... 8 5 OVERDOSAGE .............................................................................................................
8
). g. other than biopsies and cervical abrasion) or rupture of the uterine cervix. Multipara with 6 or more previous term pregnancies. Patients with a history of difficult labour and/or traumatic delivery. Patients with overdistension of uterus (multiple pregnancy, polyhydramnios).
Patients with fetal malpresentation. Patients with a history of epilepsy whose seizures are poorly controlled. CERV IDIL dinoprostone Page 5 of 25 CERVIDIL should not be used simultaneously with other uterotonic drugs and/or other labour induction agents (See 7 WARNINGS AND PRECAUTIONS).
CERVIDIL should not be used when there is a history of, or current pelvic inflammatory disease, unless adequate prior treatment has been instituted. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions For Hospital Use Only: CERVIDIL should be administered only by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities.
1 Dosing Considerations 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. 2 Recommended Dose and Dosage Adjustment CERVIDIL is used as a single dosage in a single application.
3 mg/hour over a 12 hour period. , uterine hyperstimulation. 3 Reconstitution CERVIDIL requires no reconstitution prior to use. 4 Administration CERVIDIL should be removed from the freezer just prior to the insertion. No thawing is required prior to use.
To remove CERVIDIL from the packaging, first tear the foil along the top of the sachet. Do not use scissors or sharp implements to cut the foil as this may damage the product. Use the retrieval system to gently pull the product out of the sachet.
CERVIDIL is a thin, flat, semi-transparent polymeric slab which is rectangular in shape with rounded corners contained within a knitted polyester retrieval system. CERV IDIL dinoprostone Page 6 of 25 Insertion One CERVIDIL is placed transversely high in the posterior fornix of the vagina immediately after removal from its foil package.
, General 08/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS .............................................................................................................. 1 Pediatrics ..........................................................................................................
2 Geriatrics........................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations .......................................................................................
2 Recommended Dose and Dosage Adjustment..................................................... 3 Reconstitution ................................................................................................... 4 Administration...................................................................................................
5 Missed Dose ...................................................................................................... 8 5 OVERDOSAGE .............................................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The insertion of the vaginal insert does not require sterile conditions. The vaginal insert must not be used without its retrieval system. There is no need for previous warming of the product. A minimal amount of water-miscible lubricant may be used to assist in insertion of CERVIDIL.
Care should be taken not to permit excess contact or coating with the lubricant and thus prevent optimal swelling and release of dinoprostone from the vaginal insert. Patients should remain in the supine position for 2 hours following insertion, but thereafter may be ambulatory.
It is important to monitor uterine contractions and fetal condition at frequent regular intervals. How to properly insert CERVIDIL Start Pick up the insert between 2 fingers, positioning the slab end to be inserted first, and extend the tape Prepare Apply a minimal amount of water-miscible lubricant to 2 fingers (not to the slab itself) Insert Gently place your 2 fingers with the insert into the vagina CERV IDIL dinoprostone Page 7 of 25 Properly Position Insert Position the insert transversely (like a boomerang) high in the posterior vaginal fornix Secure After inserting, the retrieval tape may be cut with scissors, leaving a small portion of the tail outside of the vagina to allow for removal Don’t Do not wrap the tape around the insert or cut the tape from the slab Removal The retrieval system consists of a one-piece knitted polyester pouch and retrieval tape.
This ensures easy and reliable removal of the insert when the patient’s requirement for PGE2 has been fulfilled or an obstetric event makes it necessary to stop further drug administration. CERVIDIL can be removed quickly and easily by pulling gently on the retrieval tape.
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. After removal from the patient, ensure that the entire product (vaginal delivery system and retrieval system) has been removed from the vagina.
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 CERVIDIL, 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 CERVIDIL, they will not reduce in frequency or intensity as long as CERVIDIL 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 CERV IDIL dinoprostone Page 8 of 25 not occur until uterine activity is established.
Because of this, once regular painful uterine activity is established with CERVIDIL 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. 6. At least 30 minutes prior to starting an intravenous infusion of uterotonic drugs.
5 Missed Dose Not applicable. CERVIDIL is only used once. 5 OVERDOSAGE Overdosage […]
8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 8 7 WARNINGS AND PRECAUTIONS .................................................................................. 1 Special Populations ..........................................................................................
1 Pregnant Women ....................................................................................... 2 Breast-feeding............................................................................................ 3 Pediatrics ...................................................................................................
4 Geriatrics ................................................................................................... 11 8 ADVERSE REACTIONS ................................................................................................
2 Clinical Trial Adverse Reactions ........................................................................ 3 Less Common Clinical Trial Adverse Reactions .................................................. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ......................................................................................................
5 Post-Market Adverse Reactions........................................................................ 13 9 DRUG INTERACTIONS................................................................................................ 4 Drug-Drug Interactions ....................................................................................
5 Drug-Food Interactions .................................................................................... 6 Drug-Herb Interactions .................................................................................... 7 Drug-Laboratory Test Interactions ....................................................................
14 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action.................................................................................. 2 Pharmacodynamics ....................................................................................
3 Pharmacokinetics....................................................................................... 15 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 16 12 Special Handling Instructions ....................................................................................
16 PART II: SCIENTIFIC INFORMATION ...................................................................................... 17 13 PHARMACEUTICAL INFORMATION............................................................................ 17 14 CLINICAL TRIALS........................................................................................................
1 Trial Design and Study Demographics ......................................................... 2 Study Results ............................................................................................. 17 16 NON-CLINICAL TOXICOLOGY .....................................................................................
18 PATIENT MEDICATION INFORMATION ................................................................................. 19 CERV IDIL dinoprostone Page 4 of 25 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS CERVIDIL® (dinoprostone vaginal insert) is indicated for: 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 labour.
1 Pediatrics Pediatrics (<18 years of age): CERVIDIL has not been studied in this patient population and is not recommended for use. 2 Geriatrics Geriatrics (> 65 years of age): CERVIDIL has not been studied in this patient population and is not […]