MIRENA- levonorgestrel intrauterine device

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW)

可用日期:

Bayer HealthCare Pharmaceuticals Inc.

INN（国际名称）:

LEVONORGESTREL

组成:

LEVONORGESTREL 52 mg

给药途径:

INTRAUTERINE

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Mirena is indicated for prevention of pregnancy for up to 8 years; replace after the end of the eighth year. Mirena is indicated for the treatment of heavy menstrual bleeding for up to 5 years in women who choose to use intrauterine contraception as their method of contraception; replace after the end of the fifth year if continued treatment of heavy menstrual bleeding is needed. The use of Mirena is contraindicated when one or more of the following conditions exist: The use of Mirena is contraindicated in pregnancy or with a suspected pregnancy and Mirena may cause adverse pregnancy outcomes [see Contraindications (4 ), Warnings and Precautions (5.1 , 5.2 )]. If a woman becomes pregnant with Mirena in place, the likelihood of ectopic pregnancy is increased and there is an increased risk of miscarriage, sepsis, premature labor, and premature delivery. Remove Mirena, if possible, if pregnancy occurs in a woman using Mirena. If Mirena cannot be removed, follow the pregnancy closely [see Warnings and Precautio

產品總結:

Mirena (levonorgestrel-releasing intrauterine system), containing a total of 52 mg LNG, is available in a carton of one sterile unit NDC# 50419-423-01. Mirena is supplied sterile. Mirena is sterilized with ethylene oxide. Do not resterilize. For single use only. Do not use if the inner package is damaged or open. Insert before the end of the month shown on the label. Store at 25°C (77°F); with excursions permitted between 15–30°C (59–86°F) [see USP Controlled Room Temperature].

授权状态:

New Drug Application

产品特点

MIRENA- LEVONORGESTREL INTRAUTERINE DEVICE
BAYER HEALTHCARE PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MIRENA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MIRENA.
MIRENA (LEVONORGESTREL-RELEASING INTRAUTERINE SYSTEM)
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Mirena is a progestin-containing intrauterine system (IUS) indicated
for:
•
•
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
•
•
•
•
•
•
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
Indications and Usage, Contraception (1.1) 8/2022
Prevention of pregnancy for up to 8 years (1.1)
Treatment of heavy menstrual bleeding for women who choose to use
intrauterine contraception as
their method of contraception for up to 5 years. (1.2)
Release rate of levonorgestrel (LNG) is 21 mcg/day after 24 days; this
rate is reduced to about 11
mcg/day after 5 years and 7 mcg/day after 8 years. (2.1)
To be inserted by a trained healthcare provider using strict aseptic
technique. Follow insertion
instructions exactly as described. (2.2)
Patient should be re-examined and evaluated 4 to 6 weeks after
insertion; then, yearly or more often
if clinically indicated. (2.3)
One sterile intrauterine system consisting of a T-shaped polyethylene
frame with a steroid reservoir
containing 52 mg levonorgestrel packaged within a sterile inserter (3)
Pregnancy or suspicion of pregnancy. Cannot be used for post-coital
contraception (emergency
contraception) (4).
Congenital or acquired uterine anomaly if it distorts the uterine
cavity (4)
Acute pelvic inflammatory disease (PID) or a history of PID unless
there has been a subsequent
intrauterine pregnancy (4)
Postpartum endometritis or infected abortion in the past 3 months (4)
Known or suspected uterine or cervical malignancy (4)
Known or suspected breast cancer or other progestin-sensitive cancer
(4)
Uterine bleeding of unknown etiology