ETONOGESTREL/ETHINYL ESTRADIOL- etonogestrel and ethinyl estradiol insert, extended release

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

ETONOGESTREL (UNII: 304GTH6RNH) (ETONOGESTREL - UNII:304GTH6RNH), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Հասանելի է:

Prasco Laboratories

Կառավարման երթուղին:

VAGINAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

FOR VAGINAL USE ONLY Etonogestrel/Ethinyl Estradiol Vaginal Ring is indicated for use by females of reproductive age to prevent pregnancy. Etonogestrel/Ethinyl Estradiol Vaginal Ring is contraindicated in females who are known to have or develop the following conditions: - A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)] Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)] Have cerebrovascular disease [see Warnings and Precautions (5.1)] Have coronary artery disease [see Warnings and Precautions (5.1)] Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)] Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)] Have uncontrolled hypertension [see Warnin

Ապրանքի ամփոփագիր:

Each Etonogestrel/Ethinyl Estradiol Vaginal Ring is individually packaged in a reclosable aluminum laminate sachet consisting of three layers, from outside to inside: polyester, aluminum foil, and low-density polyethylene. The ring should be replaced in this reclosable sachet after use and discarded in a waste receptacle out of the reach of children and pets. It should not be flushed down the toilet. Prior to dispensing to the user, store refrigerated 2-8°C (36-46°F). After dispensing to the user, Etonogestrel/Ethinyl Estradiol Vaginal Ring can be stored for up to 4 months at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Avoid storing Etonogestrel/Ethinyl Estradiol Vaginal Ring in direct sunlight or at temperatures above 30°C (86°F). For the Dispenser: When Etonogestrel/Ethinyl Estradiol Vaginal Ring is dispensed to the user, place an expiration date on the label. The date should not exceed either 4 months from the date of dispensing or the expiration date, whichever comes first.

Լիազորման կարգավիճակը:

New Drug Application Authorized Generic

Ապրանքի հատկությունները

ETONOGESTREL/ETHINYL ESTRADIOL- ETONOGESTREL AND ETHINYL
ESTRADIOL INSERT, EXTENDED RELEASE
PRASCO LABORATORIES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ETONOGESTREL/ETHINYL
ESTRADIOL VAGINAL RING SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
ETONOGESTREL/ETHINYL ESTRADIOL VAGINAL RING.
ETONOGESTREL/ETHINYL ESTRADIOL VAGINAL RING
INITIAL U.S. APPROVAL: 2001
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WOMEN OVER 35 YEARS OLD WHO SMOKE SHOULD NOT USE ETONOGESTREL/ETHINYL
ESTRADIOL
VAGINAL RING. (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM
COMBINATION HORMONAL CONTRACEPTIVE (CHC) USE. (4)
RECENT MAJOR CHANGES
Warnings and Precautions (5.14)
4/2022
INDICATIONS AND USAGE
Etonogestrel/Ethinyl Estradiol Vaginal Ring is an estrogen/progestin
combination hormonal contraceptive
(CHC) indicated for use by women to prevent pregnancy. (1)
DOSAGE AND ADMINISTRATION
One Etonogestrel/Ethinyl Estradiol Vaginal Ring is inserted in the
vagina. The ring must remain in place
continuously for three weeks, followed by a one-week ring-free
interval. (2)
DOSAGE FORMS AND STRENGTHS
Etonogestrel/Ethinyl Estradiol Vaginal Ring is a polymeric vaginal
ring containing 11.7 mg etonogestrel and
2.7 mg ethinyl estradiol, which releases on average 0.12 mg/day of
etonogestrel and 0.015 mg/day of
ethinyl estradiol. (3)
CONTRAINDICATIONS
A high risk of arterial or venous thrombotic diseases (4)
Breast cancer (4)
Liver tumors or liver disease (4)
Undiagnosed abnormal uterine bleeding (4)
Pregnancy (4)
Hypersensitivity, including anaphylaxis and angioedema, to any of the
components of
Etonogestrel/Ethinyl Estradiol Vaginal Ring (4)
Co-administration with Hepatitis C drug combinations containing
ombitasvir/paritaprevir/ritonavir, with
or without dasabuvir (4)
WARNINGS AND PRECAUTIONS
Vascular risks: Stop Etonogestrel/Ethinyl Estradiol Vaginal Ring use
if