MIRENA®

Description

Name: MIRENA®
Manufacturer: Bayer
Active Substance(s): PROGESTOGEN LEVONORGESTREL
Strength: 20mg
Pack Size: 20mg – 1 IUD
Accessories: 1 T-Shaped IUD

MIRENA® is a 20 mg intrauterine delivery system (IUS) that releases levonorgestrel, a progestogen hormone, directly into the uterus. It is used as a long-term, reversible contraceptive method, as well as for treatment of heavy menstrual bleeding and protection against endometrial hyperplasia during estrogen replacement therapy. MIRENA is designed to last up to 8 years, depending on the indication, and begins working immediately if inserted within the first 7 days of the menstrual cycle.

• Triple Indication: Provides contraception, reduces heavy menstrual bleeding, and protects the endometrium during estrogen therapy.
• Long Duration of Action: Effective for up to 8 years for contraception and 5 years for therapeutic use.
• Local Hormone Delivery: Minimizes systemic side effects by releasing levonorgestrel directly into the uterus.

MIRENA is packaged in a sterile blister pack, preloaded in a disposable inserter. The device must remain sealed until use and should only be handled by a healthcare professional trained in its application. Each package includes a patient reminder card and must be opened under aseptic conditions.

Composition:

• Active Substance: 20 mg of levonorgestrel
• Sleeve: Polydimethylsiloxane elastomer with anhydrous colloidal silica
• T-Frame: Polyethylene with barium sulfate for X-ray visibility
• Threads: Polyethylene and iron oxide (brown removal threads)

The T-shaped device is designed for intrauterine placement, with visible threads to assist in checking for proper positioning.

MIRENA is indicated for three primary medical purposes, offering both contraceptive and therapeutic benefits. It is suitable for women of reproductive age and postmenopausal women on estrogen therapy.

Indications:

• Contraception: Effective for up to 8 years
• Idiopathic menorrhagia (heavy periods): Up to 5 years
• Endometrial protection during estrogen therapy: Up to 5 years

Contraindications:

• Pregnancy or suspected pregnancy
  Breast cancer (current or history)
• Pelvic inflammatory disease, cervicitis, or uterine infections
• Uterine abnormalities (fibroids, malformations)
• Unexplained vaginal bleeding
• Severe liver disease or tumors
• Hypersensitivity to levonorgestrel or other components

Side Effects:

Very common (≥1 in 10):

• Headache
• Abdominal/pelvic pain
• Menstrual changes (spotting, absence, or irregular bleeding)

Common (≤1 in 10):

• Depression or mood changes
• Acne, breast pain, nausea
• Back pain, weight gain
• Genital infections

Uncommon or rare:

• Uterine perforation
• Ovarian cysts
• Hair loss, chloasma
• Allergic reactions (rash, angioedema)

MIRENA must be inserted by a qualified healthcare provider using a sterile technique. The insertion should be timed carefully depending on the indication, usually within 7 days of menstruation onset or immediately post-abortion under specific conditions.

Administration Steps:

1. Gynecological exam to confirm uterine position and exclude contraindications.
2. Sterile preparation of cervix and vagina.
3. Insertion using the preloaded inserter, adjusting to measured uterine depth.
4. Activation of the arms and placement at the fundus.
5. Thread trimming to leave 2–3 cm visible for later checks or removal.

Insertion timing:

• Within 7 days of period onset for immediate contraceptive effect
• ≥6 weeks postpartum
• Immediately post-miscarriage/abortion if no infection is present
• Replacement at any time if no pregnancy is suspected

Hormone Release:

• Initial release: ~19 mcg/day
• Decreases to ~7 mcg/day by year 8
• Average over 5 years: 15 mcg/day, over 8 years: 13 mcg/day

Storage Instructions:

• Store in original packaging to protect from moisture and sunlight.
• Do not open or use if the package seal is broken.
• Keep out of reach of children.
• Do not use past expiration date indicated on packaging.

Proper storage and handling ensure sterility, effectiveness, and user safety. Only healthcare professionals should dispose of used devices in accordance with environmental and medical waste guidelines.

Warning! The product is intended solely for professional use in a medical environment and under professional supervision. The product is supplied to medical professionals who specialize in aesthetic medicine (plastic surgery, facial treatments) and work under individual medical licenses as aestheticians or in dedicated clinics. Unprofessional use by individuals without a medical background may lead to severe adverse effects and health harm.