Instruction for use: Mirena

Active substance Levonorgestrel

ATX code G02BA03 Plastic IUDs with gestagens

Pharmacological group

Estrogens, gestagens; Their homologues and antagonists

Nosological classification (ICD-10)

N85.0 Endometrial glandular hyperplasia

Hyperplastic processes of the endometrium, Cystic glandular hyperplasia of the endometrium

N92 Abundant, frequent and irregular menstruation

Metromenorragii, Menorrhagia, Menorrhagia primary, Polymenorea, Idiopathic menorrhagia, Menorrhagia, Functional metronormorragia, Primary menorrhagia

Z30 Monitoring contraceptive use

Local Contraception, Contraception oral, Local contraception, Episodic prevention of pregnancy, Hormonal Contraception, Contraception, Prevention of Pregnancy, Prevention of unwanted pregnancy, Contraceptive intrauterine, Contraception in women with androgenization phenomena, Installation and removal of the intrauterine device, Prevention of pregnancy (contraception)

Z30.0 General advice and advice on contraception

Safe sex, Intrauterine device contraception, Contraception, Contraceptive intrauterine, Oral contraception, Oral contraception during lactation and with estrogen contraindications, Postcoital contraception, Prevention of Pregnancy, Prevention of unwanted pregnancy, Emergency Contraception, Episodic prevention of pregnancy, Contraception in adolescents, Prevention of pregnancy (contraception)

Composition

Intrauterine therapy system 1 pc.

active substance:

Levonorgestrel 52 mg

Auxiliary substances: polydimethylsiloxane elastomer - 52 mg

Description of dosage form

The intrauterine therapy system (IUD) is placed in the conductor tube. The system consists of a white or almost white hormonal-elastomeric core placed on a T-shaped body and covered with an opaque membrane regulating the release of levonorgestrel. The T-shaped body is provided with a loop at one end and two shoulders on the other. Loops are attached to the loop to remove the system. The system and the conductor are free of visible impurities.

pharmachologic effect

The pharmacological action is contraceptive, gestagenic.

Pharmacodynamics

MIRENA®-IUD, releasing levonorgestrel, mainly has a local progestational effect. The gestagen (levonorgestrel) is released directly into the uterine cavity, which makes it possible to use it at an extremely low daily dose. High concentrations of levonorgestrel in the endometrium contribute to a decrease in the sensitivity of its estrogenic and progesterone receptors, making the endometrium immune to estradiol and exerting a strong antiproliferative effect. With the use of Mirena®, morphological changes in the endometrium and a weak local reaction to the presence of a foreign body in the uterus are observed. Increasing the viscosity of the secretion of the cervix prevents the penetration of sperm into the uterus. The preparation Mirena® prevents fertilization due to inhibition of mobility and function of spermatozoa in the uterus and fallopian tubes. Some women experience oppression of ovulation.

The prior use of Mirena does not affect the childbearing function. About 80% of women who wish to have a child become pregnant within 12 months after removal of the IUD.

In the first months of the application of Mirena®, due to the inhibition of the proliferation of the endometrium, an initial increase in spotting spotting from the vagina can be observed. Following this, a marked suppression of endometrial proliferation leads to a reduction in the duration and volume of menstrual bleeding in women using Mirena®. Lean bleeding is often transformed into oligo- or amenorrhea. In this case, the function of the ovaries and the concentration of estradiol in the blood plasma remain normal.

The Mirena® drug can be used to treat idiopathic menorrhagia, i.e. Menorrhagia in the absence of hyperplastic processes in the endometrium (endometrial cancer, metastatic uterine lesions, submucous or large interstitial myomatous node leading to deformation of the uterine cavity, adenomyosis), endometritis, extragenital diseases and conditions accompanied by severe hypocoagulation (eg von Willebrand disease, severe thrombocytopenia), The symptoms of which are menorrhagia. After 3 months of using Mirena®, menstrual blood loss in women with menorrhagia is reduced by 62-94% and by 71-95% - after 6 months of use. With the use of MIRENA® for 2 years, the effectiveness of the drug (reduction of menstrual blood loss) is comparable with surgical methods of treatment (ablation or resection of the endometrium). A less favorable response to treatment is possible with menorrhagia caused by submicotic myoma of the uterus. Reducing menstrual blood loss reduces the risk of iron deficiency anemia. The drug Mirena® reduces the severity of symptoms of dysmenorrhea.

The efficacy of Mirena's drug in preventing endometrial hyperplasia during constant estrogen therapy was equally high in both oral and percutaneous estrogen applications.

Pharmacokinetics

Absorption. After the administration of Mirena®, levonorgestrel begins to be released immediately into the uterine cavity, as evidenced by measurements of its concentration in the blood plasma. High local exposure of the drug in the uterine cavity, which is necessary for the local effect of the Miren ® drug on the endometrium, provides a high concentration gradient in the direction from the endometrium to the myometrium (the concentration of levonorgestrel in the endometrium exceeds its concentration in the myometrium by more than 100 times) and low concentrations of levonorgestrel in the plasma Blood (the concentration of levonorgestrel in the endometrium exceeds its concentration in the blood plasma by more than 1000 times).

The rate of release of levonorgestrel into the uterine cavity in vivo is initially about 20 μg / day, and after 5 years it decreases to 10 μg / day.

Distribution. Levonorgestrel binds non-specifically to blood plasma albumin and specifically to SHBG. About 1-2% of circulating levonorgestrel is present as a free steroid, whereas 42-62% is specifically associated with SHBG. During the application of MIRENA, the concentration of SHBG decreases. Accordingly, the fraction associated with SHBG decreases during the period of application of the Mirena® preparation, and the free fraction increases. The average apparent Vd of levonorgestrel is about 106 liters.

After the administration of Mirena®, levonorgestrel is detected in the blood plasma after an hour. Cmax is achieved 2 weeks after the administration of Mirena®. In accordance with the decreasing rate of release, the median concentration of levonorgestrel in plasma in women of reproductive age with a body weight above 55 kg decreases from 206 pg / ml (25th-75th percentile: 151-264 pg / ml), determined 6 months before 194 pg / ml (146-266 pg / ml) after 12 months and up to 131 pg / ml (113-161 pg / ml) after 60 months.

It was shown that the body weight and concentration of SHBG in the blood plasma influence the systemic concentration of levonorgestrel, i.e. At a low body weight and / or high concentration of SHBG, the concentration of levonorgestrel is higher. In women of reproductive age with a low body weight (37-55 kg), the median concentration of levonorgestrel in the blood plasma is approximately 1.5 times higher.

In postmenopausal women who use MIRENA® concomitantly with the use of estrogen intravaginally or transdermally, the median concentration of levonorgestrel in the blood plasma decreases from 257 pg / ml (25th-75th percentile: 186-326 pg / ml), determined after 12 months, Up to 149 pg / ml (122-180 pg / ml) after 60 months. With the use of MIRENA® concomitantly with the oral administration of estrogens, the concentration of levonorgestrel in blood plasma, determined after 12 months, increases to about 478 pg / ml (25th-75th percentile: 341-655 pg / ml), which is due to the induction of HSAG synthesis Globulin, binding sex hormones).

Biotransformation. Levonorgestrel is largely metabolized. The main metabolites in the blood plasma are unconjugated and conjugated forms of 3α, 5β-tetrahydrollevorgestrel. Based on the results of in vitro studies (process or reaction in an artificial medium (in vitro)) and in vivo, the main isoenzyme involved in the metabolism of levonorgestrel is CYP3A4. The isoenzymes CYP2E1 (isoenzyme cytochrome P450), CYP2C19 (cytochrome P450 isoenzyme) and CYP2C9 (cytochrome P450 isoenzyme) can also participate in the metabolism of levonorgestrel, however to a lesser extent.

Elimination. The total clearance of levonorgestrel from plasma is approximately 1 ml / min / kg. In unchanged form, levonorgestrel is excreted only in trace amounts. Metabolites are excreted through the intestine and kidneys with an excretion coefficient of about 1.77. T1 / 2 in the terminal phase, represented mainly by metabolites, is about a day.

Linearity / nonlinearity. The pharmacokinetics of levonorgestrel depends on the concentration of SHBG, which, in turn, is affected by estrogens and androgens. With the use of MIRENA®, a decrease in the average concentration of SHBG by approximately 30% was observed, which was accompanied by a decrease in the concentration of levonorgestrel in the blood plasma. This indicates a nonlinear pharmacokinetics of levonorgestrel over time. Given the predominantly local effect of Mirena®, the effect of changes in the systemic concentrations of levonorgestrel on the effectiveness of Mirena® is unlikely.

Indications

contraception;

Idiopathic menorrhagia;

Prevention of endometrial hyperplasia during estrogen replacement therapy.

Contraindications

Hypersensitivity to the components of the drug;

Pregnancy or suspicion of it;

Existing or recurrent inflammatory diseases of the pelvic organs;

Infections of the lower parts of the urinary and genital tract;

Postpartum endometritis;

Septic abortion within the last 3 months;

Cervicitis;

Diseases accompanied by increased susceptibility to infections;

Dysplasia of the cervix;

Malignant neoplasms of the uterus or cervix;

Progestogen-dependent tumors, incl. mammary cancer;

Pathological uterine bleeding of unclear etiology;

Congenital or acquired abnormalities of the uterus, incl. Fibromiomas leading to deformation of the uterine cavity;

Acute diseases or liver tumors;

MIRENA® has not been studied in women over 65 years of age, so MIRENA® is not recommended for this category of patients.

CAREFULLY

After consultation with a specialist:

Migraine, focal migraine with asymmetric loss of vision or other symptoms indicative of transient ischemia of the brain;

Unusually severe headache;

jaundice;

Severe arterial hypertension;

Severe circulatory disorders, incl. Stroke and myocardial infarction;

Congenital heart disease or heart valve disease (due to the risk of developing septic endocarditis).

We should discuss the expediency of removing the system in the presence or the first occurrence of any of the following conditions.

pregnancy and lactation

Pregnancy. The use of Mirena ® is contraindicated in pregnancy or suspected of it.

Pregnancy in women with MIRENA® is very rare. But if there was a prolapse of the IUD from the uterine cavity, the woman is no longer protected from pregnancy and should use other methods of contraception before consulting a doctor.

During the application of Mirena ®, some women do not have menstrual bleeding. The absence of menses is not necessarily a sign of pregnancy. If a woman does not have menstruation, and at the same time there are other signs of pregnancy (nausea, fatigue, tenderness of the mammary glands), then you need to see a doctor for examination and a pregnancy test.

If pregnancy occurs in a woman during the application of Mirena®, it is recommended that the IUD be removed, Any intrauterine contraceptive left in situ increases the risk of spontaneous abortion and premature birth. Removing Mirena® or probing the uterus can lead to spontaneous abortion. If it is not possible to remove the intrauterine contraceptive gently, the advisability of medical abortion should be discussed. If a woman wants to stay pregnant and the IUD can not be removed, the patient should be informed of the risks, in particular the possible risk of septic abortion in the second trimester of pregnancy, postpartum purulent-septic diseases that can be complicated by sepsis, septic shock and death, and the possible consequences of premature Childbirth. In such cases, the course of pregnancy should be carefully monitored. It is necessary to exclude ectopic pregnancy. A woman should be told that she should report all the symptoms suggesting the complication of pregnancy, in particular about the appearance of spasticity pain in the lower abdomen, bleeding or bloody discharge from the vagina, an increase in body temperature.

The hormone contained in the preparation Mirena® is released into the uterine cavity. This means that the fetus is exposed to a relatively high local concentration of the hormone, although through the blood and the placenta the hormone enters it in small amounts. Because of intrauterine application and local action of the hormone, it is necessary to take into account the possibility of a virilizing effect on the fetus. Due to the high contraceptive effectiveness of Mirena ®, clinical experience related to pregnancy outcomes when it is used is limited. However, a woman should be informed that at the moment there are no certificates of birth defects caused by the use of Mirena® in cases of continued pregnancy before delivery without removing the IUD.

Breastfeeding period. Breastfeeding of a child with Mirena® is not contraindicated. About 0.1% of the dose of levonorgestrel can enter the baby's body during breastfeeding. However, it is unlikely that it would pose a risk to the baby at doses released into the uterus after the installation of Mirena®.

It is believed that the use of Mirena ® in 6 weeks after delivery does not have a harmful effect on the growth and development of the child. Monotherapy with gestagens does not affect the quantity and quality of breast milk. There have been reports of rare cases of uterine bleeding in women using Mirena® during the lactation period.

After the removal of MIRENA®, fertility is restored in women.

Side effects

In most women after the installation of the Mirena ® drug, the character of cyclic bleeding changes. During the first 90 days of MIRENA®, 22% of women report an increase in the duration of bleeding, and irregular bleeding occurs in 67% of women, and the incidence of these events decreases to 3% and 19%, respectively, by the end of the first year of use. Simultaneously, amenorrhea develops in 0%, and rare bleeding - in 11% of patients during the first 90 days of use. By the end of the first year of application, the frequency of these phenomena increases to 16 and 57%, respectively.

With the use of the Mirena® preparation in combination with prolonged estrogen replacement therapy, in most women, during the first year of use, cyclic bleeding gradually ceases.

On the frequency of occurrence of undesirable reactions (HP) are divided into very frequent (≥1 / 10), frequent (from ≥1 / 100 to <1/10), infrequent (from ≥1 / 1000 to <1/100), rare ≥1 / 10000 to <1/1000) and with an unknown frequency. In the table, HP is represented by the classes of the organ system according to MedDRA. The frequency data reflect the approximate incidence of HP, recorded in the clinical trials of the Mirena® drug according to the indications of "contraception" and "idiopathic menorrhagia" involving 5,091 women. HP, reported in the course of clinical studies of the Mirena® preparation as indicated by the "prevention of endometrial hyperplasia in estrogen replacement therapy" (involving 514 women).

To describe specific reactions, their synonyms and associated states, in most cases the terminology corresponding to Mirena is used.

Additional Information

If a woman with an established Mirena® drug becomes pregnant, the relative risk of ectopic pregnancy rises.

A partner can feel the threads during intercourse.

The risk of occurrence of breast cancer when using the Mirena® preparation according to the indication "prophylaxis of endometrial hyperplasia during estrogen replacement therapy" is unknown. Cases of breast cancer have been reported (frequency is unknown, see "With caution" and "Special instructions").

Women in the period of breastfeeding were not included in the clinical studies of Mirena®. At the same time, in large-scale post-marketing studies on the safety of the Mirena® drug, there is an increased risk of perforation of the uterus during breastfeeding.

The following HP has been reported in connection with the procedure for installing or removing Mirena®: pain during the procedure, bleeding during the procedure, vasovagal reaction associated with the installation, accompanied by dizziness or fainting. The procedure can provoke an epileptic seizure in patients suffering from epilepsy.

Infection. After the installation of the IUD, cases of sepsis (including streptococcal group A sepsis) have been reported (see "Special instructions").

Interaction

The metabolism of gestagens can be enhanced by the simultaneous use of substances that are inducers of enzymes, especially cytochrome P450 isoenzymes involved in the metabolism of drugs, such as anticonvulsants (for example, phenobarbital, phenytoin, carbamazepine) and infections (eg rifampicin, rifabutin, nevirapine, efavirenz ). The effect of these drugs on the effectiveness of MIRENA® is unknown, but it is believed that it is unimportant, since the MIRENA® preparation has mainly local action.

Dosing and Administration

Intrauterine. The drug Mirena® is introduced into the uterine cavity and remains effective for five years. The rate of release of levonorgestrel in vivo at the beginning is approximately 20 μg / day and decreases after five years to approximately 10 μg / day. The average release rate of levonorgestrel is approximately 14 μg / day for up to 5 years. Mirena® can be used in women receiving hormone replacement therapy, in combination with oral or transdermal estrogen preparations that do not contain gestagens.

With the correct installation of MIRENA®, carried out in accordance with the instructions for medical use, the Perl index (the indicator reflecting the number of pregnancies in 100 women who use the contraceptive during the year) is approximately 0.2% for 1 year. The cumulative index, reflecting the number of pregnancies in 100 women who use the contraceptive for 5 years, is 0.7%.

Instructions for use and handling of the IUD

The Mirena® preparation is delivered in a sterile package, which is only opened just before the installation of the IUD. It is necessary to follow the rules of asepsis when handling an open system. If the sterility of the package appears to be impaired, the IUD should be destroyed as medical waste. Also should be treated with the removed from the uterus of the IUD, because it contains the remains of the hormone.

Installation, removal and replacement of IUDs

The Mirena® preparation should only be installed by a doctor who has experience with this Navy or is well trained in performing this procedure.

Before installing Mirena®, a woman should be informed about the effectiveness, risks and side effects of this IUD. It is necessary to conduct a general and gynecological examination, including a study of pelvic organs and mammary glands, as well as a study of a smear from the cervix. It is necessary to exclude pregnancy and sexually transmitted diseases, and inflammatory diseases of the genital organs should be completely cured. Determine the position of the uterus and the size of its cavity. If you need to visualize the uterus before the introduction of the Mirena® IUD, ultrasound of the pelvic organs should be performed. After a gynecological examination, a special instrument is introduced into the vagina, the so-called. A vaginal mirror, and treat the cervix with an antiseptic solution. Then, the Mirena® preparation is injected through a thin, flexible plastic tube into the uterus. Particularly important is the correct location of Mirena® in the uterus, which ensures a uniform effect of the gestagene on the endometrium, prevents the expulsion of the IUS and creates conditions for its maximum effectiveness. Therefore, the instructions for installing the Mirena® preparation should be carefully followed. Since the technique of installation in the uterus of different IUDs is different, special attention should be paid to working out the correct technique for installing a particular system.

A woman can feel the introduction of the system, but it should not cause her great pain. Before the introduction, if necessary, you can apply local anesthesia of the cervix.

In some cases, patients may have stenosis of the cervical canal. Do not use excessive force when administering Mirena ® to such patients.

Sometimes after the introduction of IUDs, pain, dizziness, sweating and pallor of the skin are observed. Women are encouraged to rest for some time after the administration of Mirena®. If after a half-hour stay in a calm position these phenomena do not pass, it is possible that the intrauterine system is incorrectly located. A gynecological examination should be performed; If necessary, the system is removed. In some women, the use of Mirena® causes skin allergic reactions.

The woman needs to be re-examined 4-12 weeks after the installation, and then - once a year or more, if there are clinical indications.

In women of childbearing age, Mirena® should be placed in the uterine cavity within seven days of the onset of menstruation. The drug Mirena® can be replaced by a new IUD on any day of the menstrual cycle. The IUD can also be installed immediately after the abortion in the first trimester of pregnancy, provided there are no inflammatory diseases of the genitals.

Postpartum IUD placement should be performed when the uterus involution occurs, but not earlier than 6 weeks after delivery. With prolonged subinvolution, postpartum endometritis should be eliminated and the solution of the issue of the Mirena® drug administered until the end of the involution should be postponed. In case of difficulty in setting the IUD and / or very severe pain or bleeding during or after the procedure, physical examination and ultrasound should be performed immediately to exclude perforation.

For the protection of the endometrium during the substitution of estrogen therapy in women with amenorrhea, Mirena® can be taken at any time; In women with persistent menstruation, the setting is performed in the last days of menstrual bleeding or withdrawal bleeding.

Remove the Mirena® preparation by carefully pulling on the threads gripped with forceps. If the filaments are not visible, and the system is in the uterine cavity, it can be removed using a traction hook for extracting the IUD. This may require an expansion of the cervical canal.

The system should be removed after 5 years after installation. If a woman wants to continue using the same method, the new system can be installed right after removing the previous one.

If further contraception is necessary in women of childbearing age, the removal of the IUD should be performed during menstruation, provided that the menstrual cycle is maintained. If the system is removed in the middle of the cycle and the woman has had sexual intercourse during the previous week, she is at risk of becoming pregnant, unless the new system was installed immediately after the removal of the old one.

The installation and removal of the IUD can be accompanied by certain pain and bleeding. The procedure can cause syncope due to vasovagal reaction, bradycardia or seizure in epileptic patients, especially in patients with a predisposition to these conditions or cervical stenosis.

After removing Mirena®, you should check the system for integrity. With difficulties with the removal of the IUS, there were isolated cases of slipping of the hormone-elastomeric core on the horizontal shoulders of the T-shaped body, as a result of which they were hidden inside the core. Once the integrity of the IUD is confirmed, this situation does not require additional intervention. Limiters on horizontal arms usually prevent complete separation of the core from the T-shaped body.

Additional information for some groups of patients

Children and teenagers. MIRENA® is indicated only after the onset of menarche (setting the menstrual cycle).

Older patients. MIRENA® has not been studied in women older than 65 years, so the use of MIRENA® is not recommended for this category of patients.

MIRENA® does not apply to first-choice drugs for postmenopausal women up to 65 years old with severe uterine atrophy.

Patients with impaired liver function. The drug Mirena® is contraindicated in women with acute diseases or liver tumors (see "Contraindications").

Patients with impaired renal function. The drug Mirena® has not been studied in patients with impaired renal function.

Instructions for the introduction

It is only installed by a doctor using sterile instruments.

MIRENA® is supplied with a conductor in a sterile package that can not be opened before installation.

Do not re-sterilize. Only for single use. Do not use MIRENA® if inner packaging is damaged or open. Do not install MIRENA® after the expiration of the month and year indicated on the package. Before installing, you should read the information on the use of Mirena®.

Preparation for introduction

1. Conduct a gynecological examination to establish the size and position of the uterus and exclude any signs of acute inflammatory diseases of the genitals, pregnancy, or other gynecological contraindications for the installation of Mirena®.

2. Visualize the cervix using mirrors and completely treat the cervix and vagina with antiseptic solution.

3. If necessary, use the assistance of an assistant.

4. Grasp the front lip of the cervix with forceps. With cautious traction forceps to straighten the cervical canal. The forceps should be in this position during the entire period of administration of the Mirena® preparation to ensure cautious traction of the cervix in front of the inserted instrument.

5. Carefully pushing the uterine probe through the cavity to the bottom of the uterus, determine the direction of the cervical canal and the depth of the uterine cavity (the distance from the external throat to the bottom of the uterus), exclude septa in the uterine cavity, synechia and submucosal fibroids. If the cervical canal is too narrow, an extension of the canal is recommended and an anesthetic / paracervical blockade can be used.

Introduction

1. Open the sterile package. After this, all manipulations should be carried out using sterile instruments and in sterile gloves.

2. Push the slider forward in the direction of the arrow to the farthest position in order to draw the IUD inside the conductor.

Important: Do not move the slider in a downward direction, because This can lead to the premature release of Mirena ®. If this happens, the system can not be re-inserted inside the conductor.

3. While holding the slider in the farthest position, set the upper edge of the index ring according to the measured probe distance from the outer throat to the bottom of the uterus.

4. Continuing to hold the slider in the farthest position, push the conductor gently through the cervical canal into the uterus until the index ring is about 1.5-2 cm from the cervix.

Important: do not promote the conductor with effort. If necessary, the cervical canal should be widened.

5. Holding the conductor motionless, slide the slider to the mark to open the horizontal shoulders of the Mirena® preparation. Wait 5-10 seconds until the horizontal hangers completely open.

6. Carefully push the conductor inward until the index ring contacts the cervix. The Mirena® preparation should now be in the foundation position.

7. While holding the conductor in the same position, release the Mirena® preparation by moving the slider as far down as possible. While holding the slider in the same position, carefully remove the conductor by pulling it. Cut the threads so that their length is 2-3 cm from the outer throat of the uterus.

Important: If there is any doubt that the system is installed correctly, you need to check the position of the Mirena® preparation, for example with ultrasound, or, if necessary, remove the system and introduce a new, sterile system. Remove the system if it is not completely in the uterine cavity. The remote system should not be reused.

Removal / replacement of MIRENA®

Before removing / replacing MIRENA®, it is necessary to read the instructions for its use.

The Mirena® preparation is removed by careful pulling by the threads caught by the forceps (Figure 8).

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

Overdose

Not marked.

special instructions

Before the installation of the Mirena® preparation, pathological processes in the endometrium should be avoided, since irregular bleeding / spotting spots are often noted in the first months of use. Also, it is necessary to exclude pathological processes in the endometrium in the event of bleeding after the initiation of estrogen replacement therapy in a woman who continues to use Mirena®, previously prescribed for contraception. Appropriate diagnostic measures must also be taken when irregular bleeding develops during prolonged treatment.

Mirena® is not used for postcoital contraception.

The preparation Mirena® should be used with caution in women with congenital or acquired valvular heart disease, referring to the risk of septic endocarditis. When installing or removing the IUD, these patients should prescribe antibiotics for the purpose of prevention.

Levonorgestrel in low doses can influence glucose tolerance, and therefore its content in the blood should be checked regularly in women with diabetes mellitus using Mirena®. As a rule, correction of a dose of hypoglycemic drugs is not required.

Some manifestations of polyposis or endometrial cancer can be masked by irregular bleeding. In such cases, an additional examination is needed to clarify the diagnosis.

MIRENA® does not apply to first choice drugs for young women who have never been pregnant, nor for postmenopausal women with severe uterine atrophy.

Available data suggest that the use of Mirena® does not increase the risk of developing breast cancer in postmenopausal women under the age of 50 years. Due to the limited data obtained during the study of the Mirena® preparation according to the indication "prophylaxis of endometrial hyperplasia in the conduct of estrogen replacement therapy," the risk of breast cancer when using Mirena® according to this indication can not be confirmed or disproved.

Oligo- and amenorrhea. Oligo- and amenorrhea in women of fertile age develops gradually, approximately in 57 and 16% of cases by the end of the first year of application of Mirena®. If menstruation is absent for 6 weeks after the start of the last period, pregnancy should be excluded. Repeated pregnancy tests for amenorrhea are not necessary if there are no other signs of pregnancy.

When Mirena® is used in combination with estrogen replacement therapy in a continuous mode, most women develop amenorrhea gradually during the first year.

Inflammatory diseases of the pelvic organs (PID). The conductor tube helps to protect the MIRENA® preparation from infection during installation, and the Mirena® drug delivery device is specially designed to minimize the risk of infection.

PID in patients using IUDs are often referred to as sexually transmitted diseases. It has been established that the presence of multiple sexual partners is a risk factor for PID. PID can have serious consequences: they are able to disrupt the reproductive function and increase the risk of ectopic pregnancy.

As with other gynecological or surgical procedures, severe infection or sepsis (including group A streptococcal sepsis) can develop after the IUD insertion, although this happens very rarely. With recurrent endometritis or PID, as well as with severe or acute infections resistant to treatment for several days, the Mirena® preparation should be removed. If a woman has constant pain in the lower abdomen, chills, fever, pain associated with sexual intercourse (dyspareunia), prolonged or profuse bleeding / bleeding from the vagina, changing the nature of vaginal discharge, you should immediately consult a doctor. Severe pain or fever that occurs soon after the IUD insertion may indicate a severe infection that must be treated immediately. Even in cases where only individual symptoms indicate the possibility of infection, bacteriological research and monitoring are indicated.

Expulsion. Possible signs of partial or complete expulsion of any IUD - bleeding and pain. Contractions of the uterine muscles during menstruation sometimes lead to the displacement of the IUD or even expulsion from the uterus, which leads to the termination of the contraceptive effect. Partial expulsion may decrease the effectiveness of Mirena ®. Because Mirena® reduces menstrual blood loss, increasing it can indicate an IUS expulsion. A woman is advised to check the threads with her fingers, for example during a shower. If a woman has detected signs of displacement or prolapse of the IUD or has not groped for the threads, sexual intercourse or other methods of contraception should be avoided, and a doctor should be consulted as soon as possible.

If the position is incorrect, the IUD should be removed. At the same time, a new system can be installed.

It is necessary to explain to a woman how to check the filaments of Mirena®.

Perforation and penetration. Perforation or penetration of the body or cervix of the IUD occurs rarely, mainly during the installation, and may decrease the effectiveness of the Mirena® preparation. In these cases, the system should be removed. If the diagnosis of perforation and migration of the IUS is delayed, complications such as adhesions, peritonitis, intestinal obstruction, intestinal perforation, abscesses, or erosion of adjacent internal organs can occur. The risk of perforation of the uterus is increased in women with breastfeeding. It is possible to increase the risk of perforation during the installation of the IUD after delivery and in women with fixed uterine bend.

Ectopic pregnancy. Women with an ectopic (ectopic) pregnancy in history, who underwent operations on the fallopian tubes or infection of the pelvic organs, are at a higher risk of ectopic pregnancy. The possibility of an ectopic pregnancy should be considered in case of abdominal pain, especially if it is combined with the cessation of menstruation, or when a woman with amenorrhea starts bleeding. The frequency of ectopic pregnancy with the use of MIRENA® is approximately 0.1% per year. The absolute risk of ectopic pregnancy in women using Mirena® is low. However, if a woman with MIRENA® is pregnant, the relative probability of an ectopic pregnancy is higher.

Loss of threads. If gynecological examination of the strand for removal of the IUD can not be detected in the cervical region, pregnancy should be excluded. Threads can be drawn into the uterine cavity or cervical canal and become visible again after another menstrual period. If pregnancy is excluded, the location of the strands can usually be determined by careful probing with the appropriate instrument. If the filaments are not found, the IUS may have expelled from the uterine cavity. To determine the correct location of the system, you can use ultrasound. If it is unavailable or unsuccessful, an X-ray study is used to determine the localization of Mirena®.

Ovarian cysts. Since the contraceptive effect of MIRENA® is mainly due to its local effect, in women of fertile age, ovulatory cycles with rupture of follicles are usually observed. Sometimes atresia of the follicles is delayed, and their development can continue. Such enlarged follicles are clinically impossible to distinguish from ovarian cysts. About ovarian cysts as an adverse reaction was reported in approximately 7% of women who used Mirena®. In most cases, these follicles do not cause any symptoms, although sometimes they are accompanied by pain in the lower abdomen or pain during sexual intercourse. As a rule, ovarian cysts disappear on their own for 2-3 months of observation. If this does not happen, it is recommended to continue monitoring with ultrasound, as well as the provision of medical and diagnostic measures. In rare cases, it is necessary to resort to surgical intervention.

The use of Mirena ® in combination with estrogen replacement therapy. When using MIRENA® in combination with estrogens, the information specified in the instructions for the use of the appropriate estrogen should be taken into account additionally.

Auxiliary substances contained in the Mirena® preparation. The T-shaped base of MIRENA® contains barium sulfate, which becomes visible during X-ray examination.

It should be borne in mind that the preparation Mirena® does not protect against HIV infection and other sexually transmitted diseases.

Additional information for patients

Regular inspections. The doctor should examine the patient 4-12 weeks after the installation of the IUD, in the future, regular medical examinations are required at least once a year.

You should consult your doctor as soon as possible in the following cases:

- the patient has ceased to feel the threads in the vagina;

- the patient can grope for the lower end of the system;

- the patient assumes that she is pregnant;

- the patient feels constant pain in the abdomen, fever, or notes a change in the usual nature of vaginal discharge;

- the patient or her partner feels pain during intercourse;

- the patient noted sudden changes in the menstrual cycle (for example, menstruation was meager or absent, and then there was constant bleeding or pain, or menstruation became excessively plentiful);

- the patient has other medical problems, such as migraine headache or severe recurring headache, sudden visual disturbances, jaundice, increased blood pressure, or any other diseases and conditions listed under "Contraindications" and "With caution."

What to do if the patient wants to become pregnant or to remove MIRENA® for other reasons. The doctor can easily remove the IUD at any time, after which the pregnancy becomes possible. Usually the removal is painless. After removal of Mirena®, the childbearing function is restored.

When pregnancy is undesirable, Mirena® should be removed no later than the 7th day of the menstrual cycle. If the Mirena® preparation is removed after the 7th day of the cycle, barrier methods of contraception (for example, a condom) should be used for at least 7 days before it is removed. If there are no menses during the application of the Mirena® preparation, 7 days before the removal of the IUD, it is necessary to start using barrier contraceptive methods and continue using them until menstruation resumes. You can also install a new IUD immediately after removing the previous one; In this case, no additional measures to prevent pregnancy are required.

How long you can use Mirena®. MIRENA® provides protection against pregnancy for 5 years, after which it should be removed. You can install a new IUD after deleting the old one.

Restoring the ability to conceive (can I get pregnant after stopping the use of Mirena®)? After the Mirena® drug is removed, it ceases to affect normal reproductive function. Pregnancy can occur during the 1st menstrual cycle after the removal of Mirena®.

Influence on the menstrual cycle (can the preparation Mirena ® affect the menstrual cycle). The drug Mirena® influences the menstrual cycle. Under its influence, menstruation can change and acquire the character of mucus discharge, become longer or shorter, leak with more abundant or leaner bleeding than usual, or even stop altogether. In the first 3-6 months after the installation of MIRENA®, many women, in addition to their usual menstruation, have frequent bloody spotting or scarce bleeding. In some cases, very heavy or prolonged bleeding is observed during this period. If the patient has detected these symptoms, especially if they do not disappear, the doctor should be informed. It is most likely that with the use of MIRENA® every month, the number of bleeding days and the amount of blood lost will gradually decrease. Some women eventually find that menstruation has completely stopped. Since the amount of blood lost with menstruation with Mirena® is usually reduced, most women experience an increase in hemoglobin in the blood.

After system removal the menstrual cycle is normalized.

Absence of menstruation. When using Mirena®, it is normal to not have menstruation. If after the installation of Mirena®, the patient noted the disappearance of menstruation, this is due to the influence of the hormone on the mucous membrane of the uterus. Monthly thickening of the mucous membrane does not occur, therefore, there is no rejection of it during menstruation. This does not necessarily mean that the patient has reached menopause or is pregnant. The concentration in the blood plasma of its own hormones remains normal. In fact, the absence of menstruation can be a great advantage for a woman's comfort.

How can I find out about pregnancy. Pregnancy in women using Mirena®, even if they are not menstruating, is unlikely. If the patient does not have menstruation for 6 weeks and she is concerned, a pregnancy test should be performed. In the case of a negative result, additional tests are not necessary if there are no other signs of pregnancy, such as nausea, fatigue or tenderness of the mammary glands.

Whether Mirena® can cause pain or discomfort. Some women experience pain (resembling menstrual pain) in the first 2-3 weeks after the installation of the IUD. If the patient experiences severe pain or if the pain lasts more than 3 weeks after the system is installed, you should consult a doctor or a medical institution where Mirena® is being used.

Does the preparation Mirena ® have sexual intercourse. Neither the patient nor her partner should feel the IUD during intercourse. Otherwise, sexual acts should be avoided until the doctor is satisfied that the system is in the right position.

What time should pass between the installation of Mirena® and sexual intercourse. It is best to let the body rest, refrain from having sexual intercourse within 24 hours after the introduction of Mirena® into the uterus. However, the preparation Mirena® has a contraceptive effect from the moment of installation.

Can I use tampons. It is recommended to use sanitary napkins. If the patient uses tampons, they should be changed very carefully so as not to pull out the threads of the Mirena® preparation.

What happens if the Mirena® drug spontaneously leaves the uterine cavity. Very rarely during menstruation, an IUD can expel from the uterine cavity. An unusual increase in blood loss in menstrual bleeding may mean that the Mirena® drug has fallen through the vagina. Partial expulsion of the IUS from the uterine cavity to the vagina is also possible (the patient and her partner may notice this during sexual intercourse). With the complete or partial release of Mirena® from the uterus, its contraceptive effect is immediately stopped.

By what signs can be judged that the drug Mirena® is in place. The patient can independently check if the MIRENA® threads are still in place after the menstrual period has ended. After the end of menstruation, gently insert a finger into the vagina and grope the threads at the end, near the entrance to the uterus (cervix). Do not pull the thread, tk. It is possible to accidentally pull the MIRENA ® out of the uterus. If the patient is unable to grope the strings, you should consult a doctor.

Influence on the ability to drive vehicles and mechanisms. Not observed.

Form of issue

An intrauterine therapy system, levonorgestrel 20 μg / 24 h. 1 intrauterine therapy system, levonorgestrel 20 μg / 24 h is placed in a sterile blister made of TYVEK and polyester (PETG or ARET). The blister is placed in a cardboard box.

Terms of leave from pharmacies

On prescription.

storage Conditions

In the dark place at a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life

3 years.

Do not use after the expiry date printed on the package.for