Ferring Pharmaceuticals Inc. (Page 3 of 4)
16 HOW SUPPLIED/STORAGE AND HANDLING
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:
- 2 vaginal systems per carton (NDC 55566-9400-1)
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.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Instructions for Use).
Inform women:
- Of the importance of reporting irregular vaginal bleeding to their doctor as soon as possible.
- Of the possible side effects of progesterone therapy such as headaches, abdominal pain, breast tenderness, bloating, mood swings, irritability, and drowsiness.
- To leave the vaginal system in place continuously (for a minimum of 23 hours per day) [see Dosage and Administration (2.2)]. It may be removed for sexual intercourse, although this is not necessary.
- MILPROSA is not recommended for use with other vaginal products (such as antifungal products, vaginal lubricants, diaphragms, and condoms) as this concomitant use has not been studied and may alter the progesterone release and absorption from the vaginal system [see Warnings and Precautions (5.4) and Drug Interactions (7)].
MANUFACTURED FOR:
Ferring Pharmaceuticals Inc.
100 Interpace ParkwayParsippany, NJ 07054 USA
This Patient Information has been approved by the U.S. Food and Drug Administration | Issued: 04/2020 | |||||||
Patient InformationMILPROSA (mil-PRO-sah) (progesterone)vaginal system | ||||||||
Read this Patient Information before you start using MILPROSA and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. Your healthcare provider may do a physical examination before prescribing MILPROSA. | ||||||||
What is MILPROSA?
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Do not use MILPROSA if you:
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Before you use MILPROSA, tell your healthcare provider about all of your medical conditions, including if you:
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How should I use MILPROSA?
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What are the possible side effects of MILPROSA?MILPROSA may cause serious side effects, including:
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Call your healthcare provider or get medical help right away if you have: | ||||||||
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Common side effects of MILPROSA include: | ||||||||
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Other side effects of progesterone use include:
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How should I store MILPROSA?
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General information about the safe and effective use of MILPROSA. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use MILPROSA for a condition for which it was not prescribed. Do not give MILPROSA to other women, even if they have the same condition as you do. It may harm them. You can ask your pharmacist or healthcare provider for information about MILPROSA that is written for healthcare professionals. | ||||||||
What are the ingredients in MILPROSA? Active ingredient: progesterone.Inactive ingredients: light mineral oil, silicone elastomer.For more information call Ferring Pharmaceuticals Inc. at 1-888-FERRING (1-888-337-7464). |
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