a petrol [0.001:<0.001 101-801 (N=206) 72% 48% 55% 41% 0.003 Time to Delivery (hours) Average Median 101-103 (N=81) 33.7 48.6 14.0 28.6 0.001 25.7 34.5 12.3 24.6 Average Median 101-801 31.1 51.8 52.3 45.9> <0.001 (N=206 25.5 37.2 20.8 27.4 Time to Onset of Labor (hrs) Average Median 101-103 (N=81) 19.9 39.4 6.8 22.4> <0.001 12.0 19.2 6.9 18.3 References Physiology of Labor In: Williams Obstetrics. Eds. Pritchard, J.A., MacDonald, P.C., and Gant, N.F. Appleton-Century-Crofts, Conn, Pp 295-321, (1985). Rall, T.W. and Schliefer, L.S. Oxytocin, prostaglandin, ergot alkaloids, and other drugs; tocolytics agents, In: The Pharmacological Basis of Therapeutics. Eds. Gilman, A.G., Goodman, L.S., Rall, T.W., and Murad, F. MacMillan, Publ. Co., New York, Pp. 926-945, (1985). Casey, M.L. and MacDonald, P.C. The initiation of labor in women: Regulation of phospholipid and arachidonic acid metabolism and of prostaglandin production. Semin. Perinat. 10: 270-275, (1986). Casey, M.L., MacDonald, P.C. and Mitchell, M.D. Stimulation of prostaglandin E 2 production in amnion cells in culture by a substance(s) in human fetal urine. Biochem. Biophys. Res. Comm. 114:1056, (1983). Olson, D.M., Lye, S.J., Skinner, K., and Challis, J.R.G. Prostanoid concentrations in maternal/fetal plasma and amniotic fluid and intrauterine tissue prostanoid output in relation to myometrial contractility during the onset of adrenocorticotropin-induced preterm labor in sheep. 116: 389-397, (1985). Ledger, W.L., Ellwood, D.A., and Taylor, M.J. Cervical softening in late pregnant sheep by infusion of prostaglandin E-2 into cervical artery. J. Reprod. Fert. 69, 511-515, (1983). Olson, D.M., Lye, S.J., Skinner, K., and Challis, J.R.G. Early changes in prostaglandin concentrations in ovine maternal and fetal plasma, amniotic fluid and from dispersed cells of intrauterine tissues before the onset of ACTH-induced pre-term labor. J. Reprod. Fert. 71: 45-55, (1984). Caldeyro-Barcia, R. and Posiero, J. Oxytocin and the contractility of the human uterus, Ann, N.Y. Acad. Sci. 75:813, (1959). Posiero, J. and Noriega-Guerra, L. Dose-response relationships in uterine effects of oxytocin infusion. Oxytocin. Eds., Caldeyro-Barcia, R. and Heller, J. Pergamon Press, New York, (1961). Cibils, L. Enhancement of induction of labor. In: Risks in the Practice of Modern Obstetrics. Aldjem, S. Ed. Mosby Publishing, St. Louis, (1972). Bryman, I., Lindblom, B., and Norstrom, A. Extreme sensitivity of cervical musculature to prostaglandin E 2 in early pregnancy. Lancet, 2:1471, (1982). Thiery, M. Induction of labor with prostaglandins. In: Human Parturition. Eds. Keirse, M.J.N.C., Anderson, A.B.M., and Gravenhorst, J.B. Martinus Nijhoff Publ., Boston, 155-164, (1979). Thiery, M. and Amy, J.J. Induction of labor with prostaglandins. In:Advances in Prostaglandin Research. Prostaglandin and Reproduction. Karim, S.M.M., Ed., MTP, Lancaster, Pp. 149-228, (1975). MacLennan, A.H., Katz, M., and Creasey, R. The morphologic characteristics of cervical ripening induced by the hormones relaxin and prostaglandin F 2 in a rabbit model. Am. J. Obstet. Gynecol, 152:910696, (1985). Bishop, E. Elective induction of labor. Obstet. & Gynecol. 5: 519-527, (1955). Bishop, E. Pelvic scoring for elective induction. Obstet. & Gynecol. 24: 266-268, (1969). Thiery, M. Preinduction cervical ripening. In: Obstetrics and Gynecology Annual, Vol. 12, Ed. Wynn, R.M. Appleton-Century-Crofts, New York, Pp. 103-146, (1983). MacKenzie, I.; Information on File: Ferring Controlled Therapeutics Limited (Scotland). De Abajo FJ et al. Labor induction with Dinoprostone or oxytocin and postpartum disseminated intravascular coagulation: a hospital-based case-control study. Am J Obs Gynecol, 2004, 191: 1637-1643. Mfg by: Ferring Controlled Therapeutics Limited East Kilbride, Scotland, G74 5PB Made in the U.K. Distributed by: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054 Rev. 08/2013 6765-01 PRINCIPAL DISPLAY PANEL - Pouch Carton NDC 55566-9500-1 Dinoprostone 10 mg vaginal insert Contains: One Vaginal Insert containing 10 mg Dinoprostone in 241 mg hydrogel polymer (cross-linked polyethylene oxide/urethane) with polyester retrieval system. Store in a freezer: between -20 C and -10 C (-4 F and 14 F) DINOPROSTONE Dinoprostone insert Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:55566-9500 Route of Administration VAGINAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DINOPROSTONE (DINOPROSTONE) DINOPROSTONE 10 mg in 241 mg Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOLS Product Characteristics Color WHITE Score Shape RECTANGLE Size Flavor Imprint Code Contains Packaging # Item Code Package Description 1 NDC:55566-9500-1 1 POUCH in 1 CARTON 1 10 mg in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020411 02/01/2014 Labeler - Ferring Pharmaceuticals Inc. (103722955) Establishment Name Address ID/FEI Operations Ferring Controlled Therapeutics Ltd 298229634 MANUFACTURE(55566-9500) Revised: 02/2014 Ferring Pharmaceuticals Inc. Next Interactions Print this page Add to My Med List More about dinoprostone topical Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group En Español 6 Reviews Add your own review/rating Drug class: uterotonic agents Consumer resources Dinoprostone topical ... +4 more Professional resources Dinoprostone (AHFS Monograph) Dinoprostone (Wolters Kluwer) Other brands: Cervidil , Prostin E2 , Prepidil Related treatment guides Labor Induction Abortion Trophoblastic Disease> ] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Uterotonic agents Related Drugs uterotonic agents oxytocin , Methergine , Pitocin , mifepristone , Hemabate , Cervidil Abortion misoprostol , Cytotec , oxytocin , Pitocin , mifepristone , Hemabate , Cervidil , carboprost , More... Labor Induction misoprostol , Cytotec , oxytocin , Pitocin , Cervidil , Prostin E2 , Syntocinon , Prepidil , More... Trophoblastic Disease methotrexate , Trexall , Cervidil , Prostin E2 , Cosmegen , dactinomycin , Prepidil , More... Dinoprostone topical Rating 6 User Reviews 3.8 /10 6 User Reviews 3.8 Rate it! the goods
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