Mirena, intrauterine device with levonogestrel 52 mg (20 mcg/24 hours) 1pc — Made in Finland — Free Delivery

Product description 

• contraception;
• idiopathic menorrhagia;
• hypermenorrhea;
• dysmenorrhea;
• topical progestogen therapy during estrogen replacement treatment.

Compound

Contraindications

• Pregnancy or suspected pregnancy
• progestogen-dependent tumors, such as breast cancer;
• acute or recurrent pelvic inflammatory disease
• cervicitis,
• infectious disease of the lower genital tract
• postpartum endometritis
• infected miscarriage or abortion within the last 3 months
• conditions associated with increased susceptibility to infectious diseases;
• cervical dysplasia;
• confirmed or suspected malignant tumors of the cervix or uterus;
• uterine bleeding, the cause of which is not clear;
• congenital or acquired pathology of the uterus, including leiomyoma, in case of deformation of the uterine cavity;
• acute liver disease or liver tumors
• hypersensitivity to the active substance or to excipients of the preparation.

Dosage and administration

Use for contraception

For women of reproductive age, the Mirena system can be inserted into the uterine cavity within 7 days from the onset of menstruation. You can replace the Mirena system with a new system on any day of the menstrual cycle. The system can be administered immediately after an abortion.

Postpartum administration should be delayed until complete uterine involution, but not earlier than 6 weeks postpartum. If involution occurs slowly, it is advisable to consider the introduction of the system 12 weeks after birth. In the event of difficulty inserting the system and/or unusual pain or bleeding during or after insertion, a physical examination and ultrasound should be performed immediately to rule out perforation. Performing only a physical examination (checking the threads) may not be sufficient to rule out partial perforation.

The Mirena system cannot be used as a postcoital contraceptive. When used for contraception, the Mirena system must be removed after five years. If a woman wishes to use the same method of contraception, then a new system can be introduced.

If the patient does not wish to become pregnant, a woman of reproductive age should have the system removed within seven days of the onset of menstruation if the menstrual cycle is maintained. If the system is removed in the middle of a menstrual cycle, or if a woman does not have regular menstrual bleeding and if the woman had sexual intercourse a week before removal, she is at risk of becoming pregnant. To ensure a permanent / continuous contraceptive effect, you should immediately install a new system or start using an alternative method of contraception.

Use of the Mirena system to protect the endometrium during estrogen replacement therapy.

For women who use the Mirena system as part of hormone replacement therapy, it can be used in combination with oral or transdermal preparations containing estrogens. Since spotting during the first months of treatment is common, before the introduction of the Mirena system, it is necessary to take a scraping from the uterine cavity in order to assess the condition of the endometrium. If a woman continues to use the Mirena system as part of hormone replacement therapy when there is no longer a need for contraception, endometrial scrapings should be taken only if bleeding occurs after the start of estrogen therapy or if it occurs later in the course of therapy. Mirena can be administered to women with amenorrhea on any day or during the last days of menstruation or withdrawal bleeding.

During the treatment of menorrhagia and during local treatment with progestogens in combination with estrogen therapy, the Mirena system releases enough levonorgestrel for 5 years to prevent endometrial proliferation. When replacing the Mirena system with a new one, it can be immediately inserted into the uterine cavity.

The Mirena system should be removed carefully by pulling the threads with surgical tweezers. If the threads are invisible and the system is in the uterine cavity, it can be removed using a suitable instrument. This may require cervical dilatation or other measures. The introduction or removal of the system may be accompanied by short-term pain and bleeding. The procedure may provoke a vasovagal reaction or seizure in women with epilepsy.

After removal, the Mirena system should be checked to ensure that it has been completely removed. During difficult removals, isolated cases were recorded when a cylinder with a hormone passed along the horizontal shoulders, hiding them inside. This does not require further intervention if it has been determined that the entire system has been removed. Horizontal hanger knots usually prevent the cylinder from completely separating from the T-body.

With the correct introduction of the Mirena system according to the instructions, the probability of pregnancy is approximately 0.2% per year for 5 years, the cumulative probability of pregnancy is approximately 0.7%. The likelihood of pregnancy may increase with expulsion (exit) of the system or perforation of the uterus.

Instructions for inserting the levonorgestrel intrauterine system Mirena (20 mcg / 24 h)

Preparing the patient before the introduction of the system

Conduct a gynecological examination of a woman to determine the size and position of the uterus, to determine if the patient has acute infectious diseases of the genital organs or other contraindications for the use of the Mirena system, and also to exclude pregnancy.

Position the vaginal speculum so that you can see the cervix and thoroughly clean the cervix and vagina with an appropriate antiseptic solution.

If necessary, you can use the help of an assistant.

Grab the upper lip of the cervix with a clamp. When the uterus is bent, grab the lower lip of the cervix with a clamp. As practice shows, the cervical canal straightens if you slightly pull the clamp. During the insertion procedure, the clamp remains in place to maintain a slight tension on the cervix against the pushing force during insertion.

Carefully move the probe along the uterine cavity to the bottom to determine the direction of the cervical canal and the depth of the uterine cavity (according to the results of probing) and to exclude the presence of uterine pathologies (for example, uterine septum, submucosal fibroids) or the presence of an unremoved intrauterine contraceptive. If the cervical canal is too narrow, it is recommended to dilate the canal, which may include the use of analgesics or a paracervical blockade.

Introduction

First, fully open the sterile package. Then use sterile equipment and gloves.

Push the slider forward in the direction of the arrow to the far position to charge the Mirena system into the insertion tube. IMPORTANT! It is not necessary to pull the slider down, as this may lead to premature release of the Mirena system. Once released, the system cannot be charged into the device again.

Keep the slider in the far position and set the top edge of the flange according to the depth of the uterus determined with the probe.

Keeping the slider in the distal position, advance the insertion device through the cervical canal into the uterus until the flange is 1.5-2 cm from the cervix. IMPORTANT! Do not push the input device too hard. If necessary, expand the cervical canal.

Hold the insertion device firmly and pull the slider to the mark to open the horizontal hangers of the Mirena system. For full disclosure, you must wait 5-10 seconds.

Advance the inserter gently towards the fundus until the flange touches the cervix. Now the Mirena system is in position at the bottom of the uterus.

While firmly holding the inserter in one position, remove it from the Mirena system by pulling the slide all the way down. Carefully withdraw the inserter from the uterus, keeping the slider in the distal position. Cut the threads, leaving about 2-3 cm outside the cervix. IMPORTANT! If you suspect that the system is installed in the wrong position, you should check its location (for example, using ultrasound). Remove the system if it is incorrectly positioned in the uterine cavity.

A removed system cannot be installed a second time.

Removal / replacement

The Mirena system can be removed by pulling the clip on the threads.

You can install a new Mirena system immediately after removing the old one.

Application features

Use during pregnancy or lactation

Pregnancy

The use of the Mirena system is contraindicated during pregnancy or if pregnancy is suspected.

If a woman becomes pregnant with the Mirena system installed, it is recommended that the system be removed because any intrauterine contraceptives that remain in the uterus during pregnancy increase the risk of miscarriage and premature birth. Removal of the Mirena system may lead to spontaneous abortion. If the intrauterine system cannot be carefully removed, termination of the pregnancy should be considered. If a woman wishes to continue the pregnancy and is unable to remove the system, she should be informed of the risk to the baby and the possible consequences of preterm labor. The course of such a pregnancy requires careful monitoring. An ectopic pregnancy should be excluded. The physician should advise the woman to inform him of any symptoms that may be associated with pregnancy complications, such as crampy abdominal pain with fever.

It is impossible to completely exclude virilization due to the local effect of the hormone. Due to the high contraceptive efficacy, clinical experience with the results of pregnancies with the Mirena system is limited. However, at the moment, no congenital malformations have been identified in children due to the use of the Mirena system by mothers in cases where the pregnancy continued with the Mirena system installed.

Lactation

The daily dose and plasma concentration of levonorgestrel is lower with the Mirena system than with many other methods of hormonal contraception, but levonorgestrel has been found in breast milk. About 0.1% of a dose of levonorgestrel enters the baby's body during breastfeeding. Hormonal contraceptives are not recommended as the first choice for lactation, but progestogen-only preparations are the preparations of choice after non-hormonal methods. No harmful effect on the growth and development of the child was found when using the system six weeks after birth. Methods using only progestogens have shown no effect on the quantity or quality of breast milk.

Fertility

After the removal of Mirena, the woman's fertility is restored.

Children

The preparation is indicated for use before the onset of menarche.

The ability to influence the reaction rate when driving vehicles or operating other mechanisms

A study of the effect of the preparation on the ability to drive vehicles or other mechanisms has not been conducted.

Overdose

Impossible.

Adverse reactions

Subjective side effects may occur in the first months after the introduction of the system, they usually weaken over time. In addition to the adverse reactions indicated in the "Peculiarities of use" section, the following adverse reactions were observed in women who used the Mirena system.

Very common adverse reactions (which have been observed in more than 10% of women) include uterine/vaginal bleeding (including spotting), oligomenorrhea, amenorrhea, mild follicular enlargement.

In women of reproductive age, the number of bleeding days per month decreases gradually from nine to four days during the first six months of use. After the first month of use, 20% of women experience prolonged bleeding (more than eight days). In many women, after this, the duration of menstruation is reduced, and after three months of use, prolonged bleeding was observed in only 3% of women. In clinical studies, 17% of women experienced amenorrhea lasting at least three months during the first year of using the system.

When using the Mirena system as a local progestogen therapy in combination with estrogen replacement therapy, most women experience spotting and irregular bleeding during the first months of treatment. Bleeding and spotting gradually decrease and in almost 40% of women stop altogether during the last three months of the first year of using the system. In perimenopausal women, menstrual bleeding disorders are observed more often than in postmenopausal women.

The frequency of detection of benign ovarian cysts depends on the diagnostic method that is used. In 7% of women who used the system, benign ovarian cysts were diagnosed as an adverse reaction. In most cases, follicular enlargement is asymptomatic and disappears spontaneously within three months.

Interaction with other medicinal products and other forms of interaction

Interactions are possible with simultaneous use with agents that induce hepatic enzymes and may lead to an increase in the clearance of sex hormones.

Active substances that increase the clearance of levonorgestrel, such as phenytoin, barbiturates, primidone, carbamazepine, rifampicin and possibly oxcarbazepine, topiromate, felbamate, griseofulvin and herbal remedies containing St. John's wort extract (Hypericum perforatum).

The effect of these preparatios on the contraceptive effectiveness of the Mirena system is unknown, but it is believed that it is insignificant due to the predominantly local mechanism of action of the preparation.

Active substances with a variable effect on the clearance of levonorgestrel, for example, when used simultaneously with sex hormones, a large number of HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors can increase or decrease plasma concentrations of estrogen or progestins.

Levonorgestrel clearance-lowering agents (enzyme inhibitors): Concomitant use of strong and moderate CYP3A4 inhibitors such as azole antifungals (eg fluconazole, itraconazole, ketoconazole, voriconazole), verapamil, macrolides (eg clarithromycin, erythromycin), diltiazem, and grapefruit juice may increase the concentration of progestin in the blood plasma.

Storage conditions

Store at a temperature not exceeding 30°C in a place protected from moisture and direct sunlight. Keep out of the reach of children.

Shelf life - 3 years.