Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
progesterone (UNII: 4G7DS2Q64Y) (progesterone - UNII:4G7DS2Q64Y)
Ferring Pharmaceuticals Inc.
VAGINAL
PRESCRIPTION DRUG
MILPROSA™ is indicated to support embryo implantation and early pregnancy (up to 10 weeks post-embryo transfer) by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women up to and including 34 years of age. Limitation of Use Efficacy in women 35 years of age and older has not been established. MILPROSA is contraindicated in women with: - Known sensitivity to progesterone or any of the ingredients of MILPROSA [see Description (11)] - Undiagnosed vaginal bleeding - Severe hepatic impairment or disease - Known or suspected malignancy of the breast - Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events Risk Summary MILPROSA is indicated to support embryo implantation and early pregnancy as part of an assisted reproductive technology treatment program in vitro fertilization (IVF) with or without intracytoplasmic sperm injection (ICSI) and embryo transfer for infertile women. Maternal risks a
Each MILPROSA (progesterone) vaginal system is a white to off-white, flexible, non-biodegradable silicone ring (toroidal-shaped), which contains 1.78 grams of progesterone and releases an average of 11 mg/day of progesterone over a 7-day period of use. MILPROSA vaginal system has an inner and outer diameter of approximately 38 mm and 55 mm, respectively, and a cross-sectional diameter of approximately 8.5 mm. Each MILPROSA is packed individually in a sealed foil pouch. These pouches are available in cartons packed: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Do not refrigerate or freeze and avoid excessive heat. After use, place in pouch and discard via a drug take-back option if available; otherwise, mix with something undesirable, such as used coffee grounds, dirt, or cat litter to make it less appealing to children and pets. Place the mixture in something that can be closed (a re-sealable zipper storage bag, empty can, or other container) and discard in the household trash. DO NOT flush down toilet. See drug disposal information at www.fda.gov/drugdisposal for more information.
New Drug Application
FERRING PHARMACEUTICALS INC.- PROGESTERONE RING FERRING PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MILPROSA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MILPROSA. MILPROSA™ (PROGESTERONE) VAGINAL SYSTEM INITIAL U.S. APPROVAL: 1974 INDICATIONS AND USAGE MILPROSA is a progesterone indicated to support embryo implantation and early pregnancy (up to 10 weeks post-embryo transfer) by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women. (1) DOSAGE AND ADMINISTRATION The dose of MILPROSA is one vaginal system inserted initially on the day after oocyte retrieval and then replaced weekly, continuing for up to 10 weeks total duration. (2.1) DOSAGE FORMS AND STRENGTHS Vaginal system: 1.78 grams of progesterone in a white to off-white, flexible, non-biodegradable silicone ring (toroidal-shape). Releases an average of 11 mg/day progesterone over 7 days. (3) CONTRAINDICATIONS Previous allergic reactions to progesterone or any of the ingredients of MILPROSA (4) Undiagnosed vaginal bleeding (4) Severe hepatic impairment or disease (4) Known or suspected malignancy of the breast (4) Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events (4) WARNINGS AND PRECAUTIONS Arterial and venous thromboembolic disorders may occur with use of MILPROSA. Discontinue MILPROSA and initiate appropriate treatment measures if any of these are suspected. (5.1) Discontinue MILPROSA use if symptoms worsen in a woman with a history of depression. (5.2) Discontinue MILPROSA use and initiate appropriate treatment measures for women suspected of having toxic shock syndrome based on signs and symptoms including fever, nausea, vomiting, diarrhea, muscle pain, dizziness, faintness or a sunburn-like rash on the face and body. (5.3) Avoid the use of MILPROSA with other vaginal products (such as antifungal products, vaginal lubri Olvassa el a teljes dokumentumot