CERVIDIL- dinoprostone insert

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

DINOPROSTONE (UNII: K7Q1JQR04M) (DINOPROSTONE - UNII:K7Q1JQR04M)

Tilgjengelig fra:

Ferring Pharmaceuticals Inc.

INN (International Name):

DINOPROSTONE

Sammensetning:

DINOPROSTONE 10 mg in 241 mg

Administreringsrute:

VAGINAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

CERVIDIL is indicated for the initiation and/or continuation of cervical ripening in pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of labor. CERVIDIL is contraindicated in patients with: - Known hypersensitivity to prostaglandins [see Adverse Reactions (6.2)] - Evidence or clinical suspicion of fetal distress where delivery is not imminent - Unexplained vaginal bleeding in the current pregnancy - Evidence or clinical suspicion of marked cephalopelvic disproportion - Conditions for which induction of labor is contraindicated - Conditions for which oxytocic drugs are contraindicated - Previous cesarean section or other uterine surgery expected to affect uterine integrity (such as myomectomy) - Conditions under which prolonged contraction of the uterus may be detrimental to fetal safety - Concurrent use with intravenous oxytocic agents [see Warnings and Precautions (5.4) and Drug Interactions (7)] - Six or more previous term pregnancies Risk Summary CERVIDI

Produkt oppsummering:

How Supplied CERVIDIL vaginal insert contains 10 mg dinoprostone in a hydrogel polymer (NDC 55566-2800-1). The vaginal insert is beige-colored, semi-opaque, thin, flat, and rectangular in shape with rounded corners, measuring 29 mm by 9.5 mm by 0.8 mm, and is contained within an off-white knitted polyester pouch retrieval system. CERVIDIL is enclosed in an aluminum/polyethylene pack. Storage and Handling Store in a freezer between -20°C and -10°C (-4°F and 14°F). CERVIDIL, enclosed in its aluminum/polyethylene pack, is stable when stored in a freezer for a period of three years. Vaginal inserts exposed to high humidity will absorb moisture from the air and thereby alter the release characteristics of dinoprostone.

Autorisasjon status:

New Drug Application

Preparatomtale

CERVIDIL- DINOPROSTONE INSERT
FERRING PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CERVIDIL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CERVIDIL.
CERVIDIL (DINOPROSTONE) VAGINAL INSERT
INITIAL U.S. APPROVAL: 1977
INDICATIONS AND USAGE
CERVIDIL is a prostaglandin analog indicated for the initiation and/or
continuation of cervical ripening in
pregnant women at or near term in whom there is a medical or
obstetrical indication for the induction of
labor. (1)
DOSAGE AND ADMINISTRATION
Administer a single vaginal insert (10 mg) for up to 12 hours of use
(approximately 0.3 mg of
dinoprostone is released per hour) (2.1)
Remove upon onset of active labor or 12 hours after insertion. (2.1)
Carefully monitor for uterine activity, fetal status and the
progression of cervical dilatation and
effacement. (2.1)
CERVIDIL should be administered only by trained obstetrical personnel
in a hospital setting with
appropriate obstetrical care facilities (2.2).
See full prescribing information for complete preparation,
administration, and removal instructions.
(2.2, 2.3)
DOSAGE FORMS AND STRENGTHS
Vaginal Insert: 10 mg of dinoprostone contained within a knitted
polyester pouch retrieval system. (3)
CONTRAINDICATIONS
CERVIDIL is contraindicated for:
Known hypersensitivity to prostaglandins (4)
Evidence or clinical suspicion of fetal distress, where delivery is
not imminent (4)
Unexplained vaginal bleeding in the current pregnancy (4)
Evidence or clinical suspicion of marked cephalopelvic disproportion
(4)
Contraindication to induction of labor (4)
Concurrent use with intravenous oxytocic agents (4)
History of previous cesarean section or other uterine surgery (such as
myomectomy) (4)
Conditions under which prolonged contraction of the uterus may be
detrimental to fetal safety. (4)
Six or more previous term pregnancies (4)
WARNINGS AND PRECAUTIONS
Disseminated Intravascular Coagulation: Assess for evolving
fibrinolysis in the immedia