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    brand:

    MIRENA®

    origin:

    The origin of this product is Europe

    manufacturer:

    Bayer

    strength:

    52mg

    pack size:

    1 T-Shaped IUD

    other known names:

    Other Known Names MIRENA® Hormonal IUD with levonorgestrel

    accessories:

    Accessories Package insert

    INFORMATION

    MIRENA® is a 52 mg intrauterine delivery system (IUS) designed to be placed inside the womb (uterus) where it gradually releases the hormone levonorgestrel. This system is primarily used for three purposes:

    • Contraception: Effective long-term reversible method for pregnancy prevention, lasting up to 8 years.
    • Heavy Menstrual Bleeding (Menorrhagia): Reduces menstrual blood flow, suitable for up to 5 years.
    • Endometrial Hyperplasia Prevention During Menopause: Used in combination with estrogen replacement therapy for up to 5 years to prevent excessive growth of the womb lining.

    How MIRENA® Works

    MIRENA® functions as a contraceptive by several mechanisms:

    • Controls Monthly Womb Lining Development: Prevents thickening of the lining, making it less suitable for pregnancy.
    • Thickens Cervical Mucus: Hinders sperm from reaching and fertilizing the egg.
    • Prevents Ovulation: Inhibits egg release in some women.

    In the treatment of heavy menstrual bleeding, MIRENA® reduces monthly bleeding by thinning the womb lining. During menopause, it supplements the body’s declining hormone production, protecting against abnormal growth of the womb lining.

    Contraindications and Precautions

    MIRENA® should not be used in certain situations:

    • Pregnancy or suspected pregnancy.
    • Progestogen-dependent tumors, such as breast cancer.
    • Pelvic Inflammatory Disease (PID) or a history of it.
    • Inflammation of the cervix or unusual vaginal discharge.
    • Recent infections after childbirth or abortion.
    • Liver disease or cancer.

    Caution is advised in women who are breast-feeding, have migraines, high blood pressure, or a history of stroke or heart attack. MIRENA® does not protect against HIV (AIDS) or other sexually transmitted diseases.

    Administration and Use

    MIRENA® should be inserted by a trained healthcare professional, and the timing of insertion is crucial:

    • Contraception or Heavy Menstrual Bleeding: Insert within 7 days of menstrual period start to ensure immediate effectiveness. If inserted later, additional contraceptive methods should be used for 7 days.
    • Postpartum: Insert no earlier than 6 weeks after delivery.
    • Post-abortion/Miscarriage: Can be inserted immediately if no genital infections are present.
    • Replacement: Can replace a previous MIRENA® anytime during the menstrual cycle.

    Effectiveness and Safety

    MIRENA® is highly effective in preventing pregnancy, with a failure rate of approximately 0.2% in the first year. For heavy menstrual bleeding, it typically reduces blood loss within 3 to 6 months. The hormone in MIRENA® provides immediate protection of the womb lining during menopause.

    Side Effects

    Side effects are more common in the first months after insertion and tend to decrease over time. The most frequent side effects include:

    • Very Common: Headache, abdominal/pelvic pain, changes in vaginal bleeding patterns, including spotting or absent periods.
    • Common: Depression, migraine, back pain, nausea, weight gain, reduced libido, acne, and excessive hair growth.
    • Uncommon: Uterine perforation, hair loss, brown skin patches.
    • Rare but Serious: Severe pain or fever after insertion may indicate severe infection, perforation, or ectopic pregnancy.

    Patients should seek immediate medical attention if they experience severe pain, unusual bleeding, or signs of infection.

    Aftercare and Follow-up

    After insertion, MIRENA® should be checked after 6 weeks, then at 12 months, and yearly afterward. Women are advised to check the threads regularly to ensure MIRENA® is in place. Expulsion is possible, especially during menstruation, which may lead to loss of contraceptive protection.

    Storage and Handling

    MIRENA® should be stored in its original package, protected from moisture and direct sunlight, and should be used before the expiry date. The product should be disposed of by a healthcare professional to protect the environment.

    Additional Information

    The active substance in MIRENA® is levonorgestrel 52 mg, with the delivery system made from polydimethylsiloxane elastomer, polyethylene, and barium sulfate for X-ray visibility. The device is designed for single use only and should be handled by healthcare professionals under sterile conditions.

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