What do you need to know about Mirena NDA?
NDA 21225 Mirena FDA Approved 08 June 2017 FULL PRESCRIBING INFORMATION. 1 INDICATIONS AND USAGE. Mirena is indicated for intrauterine contraception for up to 5 years. Mirena is also indicated for the treatment of heavy menstrual bleeding in women who choose to use intrauterine contraception as their method of contraception.
When to use Mirena as a contraception method?
Mirena is a progestin-containing intrauterine system indicated for: Intrauterine contraception for up to 5 years (1) Treatment of heavy menstrual bleeding for women who choose to use. intrauterine contraception as their method of contraception.
How big is the insertion tube for Mirena?
Advance the inserter through the cervix until the flange is approximately 1.5–2 cm from the cervix and then pause (Figure 4). NDA 21225 Mirena FDA Approved 08 June 2017 Figure 4. Advancing insertion tube until flange is 1.5 to 2 cm from the cervix. Do not force the inserter.
When was Mirena approved for use in the US?
Bayer Healthcare Pharmaceuticals, Inc . Approval Date: December 22, 2015 Indications:Mirena is a progestin-containing intrauterine system indicated for: • Intrauterine contraception for up to 5 years ; • Treatment of heavy menstrual bleeding for women who choose to use intrauterine contraception as their method of contraception.
What should I do if my Mirena comes out?
If you have persistent pelvic or stomach pain, or excessive bleeding after placement, tell your healthcare professional (HCP). If Mirena comes out, call your HCP and avoid intercourse or use non-hormonal back-up birth control (such as condoms or spermicide).
When does the Mirena coil need to be inserted?
Mirena is a T-shaped plastic device that is inserted through the vagina and placed into the uterus by a doctor. The device is usually inserted within 7 days after the start of a menstrual period. You may feel pain or dizziness during insertion of the intrauterine device. You may also have minor vaginal bleeding.