Ferring Pharmaceuticals Inc. (Page 4 of 4)

Instructions for Use MILPROSA (mil-PRO-sah) (progesterone) vaginal system

Read this Instructions for Use carefully before you use MILPROSA and each time you get a refill. This information does not take the place of talking with your healthcare provider who specializes in women’s health. If you have any questions about MILPROSA, ask your healthcare provider.

Follow the steps below to insert MILPROSA:

  1. Wash and dry your hands.
  2. Remove the MILPROSA vaginal system from its foil pouch. Keep the foil pouch so you can place your used MILPROSA in it before you throw it away. See “To throw away (dispose of) MILPROSA” instructions at the end of this Instructions for Use.
  3. Choose the position that is most comfortable for you such as lying down, squatting, or standing with 1 leg up.
    ImageImageImage
  4. Hold MILPROSA between your thumb and index finger and gently squeeze the sides of MILPROSA together.
    ImageImage
  5. Use your other hand and hold open the folds of skin around your vagina.Image
  6. Place the tip of MILPROSA in the vaginal opening and then use your index finger to push the folded MILPROSA gently into your vagina. Push MILPROSA up towards your lower back as far as you can. If you can feel MILPROSA, it may not be placed back far enough in your vagina. Use your index finger to push MILPROSA back a bit further. Put MILPROSA where it is comfortable for you. There is no danger of MILPROSA being pushed too far up in the vagina or getting lost.
    ImageImageImage

    In 7 days remove the old MILPROSA and replace with a new MILPROSA.
    MILPROSA should remain in place for a minimum of 23 hours each day. You can remove MILPROSA for sexual intercourse, although this is not necessary.
    If MILPROSA is expelled, removed, or dropped, it should be rinsed with cool to lukewarm (not hot) water and reinserted as soon as possible, except if MILPROSA touches or has feces on it. If MILPROSA touches or has feces on it, replace it with a new MILPROSA.

To remove MILPROSA:

  1. Wash your hands.
  2. Choose the position that is the most comfortable for you such as lying down, squatting, or standing with 1 leg up.
  3. Put a finger into your vagina and hook it through MILPROSA.
  4. Gently pull downwards and forward to remove MILPROSA. Image

To throw away (dispose of) MILPROSA:

  1. Place the used MILPROSA in the foil pouch. If available, throw it away through a drug take-back option.
    or
  2. Place the used MILPROSA in the foil pouch and mix it with coffee grounds, dirt or cat litter.
  3. Place the foil pouch mixture in something that can be closed like a zipper storage bag, empty can, or other container and throw it away in your household trash out of the reach of children and pets.
  4. Do not flush the foil pouch down the toilet.

For more information on drug disposal see www.fda.gov/drugdisposal.

If you have other questions call your healthcare provider.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Manufactured For:

Ferring Pharmaceuticals Inc.
Parsippany, NJ 07054 USA

Issued: 04/2020

PRINCIPAL DISPLAY PANEL — 2 Ring Pouch Carton

NDC 55566-9400-1
Contains 2 vaginal systems with
each individually packaged in a pouch

Once-weekly
Milprosaâ„¢
(progesterone) Vaginal System
releases 11 mg per day

For Vaginal Use Only

Do not use if the pouch is broken.

Instruction to the pharmacist:
Dispense with patient information.
Dispense in original carton only.

Recommended Dosage: Insert 1 Milprosa
vaginally and replace every 7 days.
See prescribing information.

FERRING PHARMACEUTICALS

Rx only

PRINCIPAL DISPLAY PANEL -- 2 Ring Pouch Carton
(click image for full-size original)
FERRING PHARMACEUTICALS INC. progesterone ring
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55566-9400
Route of Administration VAGINAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
progesterone (progesterone) progesterone 11 mg in 1 d
Inactive Ingredients
Ingredient Name Strength
Light Mineral Oil
Product Characteristics
Color WHITE (to OFF-WHITE) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55566-9400-1 2 POUCH in 1 CARTON contains a POUCH (55566-9400-0)
1 NDC:55566-9400-0 7 d in 1 POUCH This package is contained within the CARTON (55566-9400-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201110 05/01/2022
Labeler — Ferring Pharmaceuticals Inc. (103722955)
Establishment
Name Address ID/FEI Operations
Teva Women’s Health, Inc. 017038951 MANUFACTURE (55566-9400), PACK (55566-9400), LABEL (55566-9400), ANALYSIS (55566-9400)

Revised: 07/2021 Ferring Pharmaceuticals Inc.

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