COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM)- estradiol/norethindrone acetate transdermal system patch, extended release

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E), NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S)

থেকে পাওয়া:

Noven Therapeutics, LLC

INN (আন্তর্জাতিক নাম):

ESTRADIOL

রচনা:

ESTRADIOL 0.05 mg in 1 d

প্রশাসন রুট:

TRANSDERMAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

CombiPatch is indicated in a woman with a uterus for: - Treatment of moderate to severe vasomotor symptoms due to menopause. - Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. - Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure. CombiPatch is contraindicated in women with any of the following conditions: - Undiagnosed abnormal genital bleeding. - Known, suspected, or history of breast cancer. - Known or suspected estrogen-dependent neoplasia. - Active DVT, PE, or history of these conditions. - Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions. - Known anaphylactic reaction or angioedema or hypersensitivity with CombiPatch. - Known liver impairment or disease. - Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. - Known or suspected pregnancy. CombiPatch (käm-bē `pach) (estradiol/norethindrone acetate transdermal system) Step 1. Pick the days you will change your CombiPatch. - You will need to change your patch every 3 to 4 days (twice weekly). Step 2. Remove CombiPatch from the pouch. - Tear open the protective pouch at the slit (do not use scissors) and remove the patch. See Figure A. - The pouch should not be opened until you are ready to put the patch on. Step 3. Remove the adhesive liner. - Peel off one side of the protective liner. See Figure B. - Do not touch the sticky part of the patch with your fingers. See Figure B. Step 4. Placing the CombiPatch on your skin. - Put the sticky side of the patch on the lower abdomen (below the panty line). See Figure C. - Peel off the second side of the protective liner. See Figure C. - Press the patch firmly in place with your hand for about 10 seconds. See Figure D. Note: - Avoid the waistline, since clothing and belts may cause the CombiPatch to be rubbed off. - Do not apply the CombiPatch to or near your breasts. - Only apply the CombiPatch to skin that is clean, dry, and free of any powder, oil, or lotion. - You should not apply the CombiPatch to injured, burned, or irritated skin, or areas with skin conditions (such as birth marks, tattoos, or that is very hairy). Step 5. Press the CombiPatch firmly onto your skin. - Rub the edges of the CombiPatch with your fingers to make sure that it will stick to your skin. See Figure E. Note: - Bathing, swimming, or showering will not affect the CombiPatch. - Once in place, the patch should not be exposed to the sun for prolonged periods of time. - If your CombiPatch falls off reapply it. If you cannot reapply the CombiPatch, apply a new CombiPatch to another area (See Figures C , D and E) and continue to follow your original placement schedule. - If you stop using your CombiPatch or forget to apply a new CombiPatch as scheduled you may have spotting, or bleeding, and your symptoms may come back. Step 6. Throwing away your used CombiPatch. - When it is time to change your CombiPatch, remove the old CombiPatch before you apply a new one. - To throw away the patch, fold the sticky side of the patch together, place it in a sturdy child-proof container, and place this container in the trash. Used patches should not be flushed in the toilet. This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration. Manufactured by: Noven Pharmaceuticals Inc. Miami, FL 33186 Distributed by: Noven Therapeutics, LLC Miami, FL 33186 For more information call 1-800-455-8070 or visit www.combipatch.com. © 2024 Noven Pharmaceuticals, Inc. 102538-5 02/2024

পণ্য সারাংশ:

CombiPatch estradiol/NETA transdermal delivery system is available in: Storage Conditions Store CombiPatch in the refrigerator at 36℉ to 46℉ (2℃ to 8℃). Store the systems in the sealed foil pouch. Do not store the system in areas where extreme temperatures can occur. Keep this and all medicines out of the reach of children. Vivelle® is a registered trademark of Novartis Corporation. & Vivelle-Dot ® is a registered trademark of Novartis AG.

অনুমোদন অবস্থা:

New Drug Application

পণ্য বৈশিষ্ট্য

COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM)-
ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM PATCH, EXTENDED
RELEASE
NOVEN THERAPEUTICS, LLC
----------
COMBIPATCH
(ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM)
RX ONLY
PRESCRIBING INFORMATION
®
WARNING:
CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER, AND
PROBABLE
DEMENTIA
ESTROGEN PLUS PROGESTIN THERAPY
CARDIOVASCULAR DISORDERS AND PROBABLE DEMENTIA
ESTROGEN PLUS PROGESTIN THERAPY SHOULD NOT BE USED FOR THE PREVENTION
OF CARDIOVASCULAR
DISEASE OR DEMENTIA. (SEE CLINICAL STUDIES and WARNINGS,
CARDIOVASCULAR DISORDERS and
PROBABLE DEMENTIA).
THE WOMEN’S HEALTH INITIATIVE (WHI) ESTROGEN PLUS PROGESTIN SUBSTUDY
REPORTED AN INCREASED
RISK OF DEEP VEIN THROMBOSIS (DVT), PULMONARY EMBOLISM (PE), STROKE
AND MYOCARDIAL
INFARCTION (MI) IN POSTMENOPAUSAL WOMEN (50 TO 79 YEARS OF AGE) DURING
5.6 YEARS OF
TREATMENT WITH DAILY ORAL CONJUGATED ESTROGENS (CE) [0.625 MG]
COMBINED WITH
MEDROXYPROGESTERONE ACETATE (MPA) [2.5 MG], RELATIVE TO PLACEBO. (SEE
CLINICAL STUDIES
AND WARNINGS, CARDIOVASCULAR DISORDERS).
THE WHI MEMORY STUDY (WHIMS) ESTROGEN PLUS PROGESTIN ANCILLARY STUDY
OF THE WHI REPORTED
AN INCREASED RISK OF DEVELOPING PROBABLE DEMENTIA IN POSTMENOPAUSAL
WOMEN 65 YEARS OF AGE
OR OLDER DURING 4 YEARS OF TREATMENT WITH DAILY CE (0.625 MG) COMBINED
WITH MPA (2.5 MG),
RELATIVE TO PLACEBO. IT IS UNKNOWN WHETHER THIS FINDING APPLIES TO
YOUNGER POSTMENOPAUSAL
WOMEN. (SEE CLINICAL STUDIES and WARNINGS, PROBABLE DEMENTIA and
PRECAUTIONS,
GERIATRIC USE).
BREAST CANCER
THE WHI ESTROGEN PLUS PROGESTIN SUBSTUDY DEMONSTRATED AN INCREASED
RISK OF INVASIVE BREAST
CANCER. (SEE CLINICAL STUDIES and WARNINGS, MALIGNANT NEOPLASMS,
BREAST CANCER).
IN THE ABSENCE OF COMPARABLE DATA, THESE RISKS SHOULD BE ASSUMED TO BE
SIMILAR FOR OTHER
DOSES OF CE AND MPA, AND OTHER COMBINATIONS AND DOSAGE FORMS OF
ESTROGENS AND PROGESTINS.
ESTROGENS WITH OR WITHOUT PROGESTINS SHOULD BE PRESCRIBED AT THE
LOWEST EFFECTIVE DOSES AND
FOR THE SHORTEST DURATION CONSISTE