Mirena intrauterine spiral 20mkg / 24hours, No. 1

• contraception;

• idiopathic menorrhagia;

• prevention of endometrial hyperplasia during hormone replacement therapy (HRT) with estrogens.

The MirenaЃ IUD is inserted into the uterine cavity. The effectiveness lasts for 5 years.

The release rate of levonorgestrel in vivo at the beginning of use is approximately 20 ?g / day and decreases to approximately 18 ?g / day after a year and to approximately 10 ?g / day after 5 years. The average release rate of levonorgestrel is approximately 15 mcg / day for up to 5 years.

The MirenaЃ IUD can be used in women receiving oral or transdermal hormone replacement therapy (HRT) containing only estrogen.

With the correct installation of the MirenaЃ IUD, carried out in accordance with the instructions for medical use, the Pearl index (an indicator reflecting the number of pregnancies in 100 women using contraceptives during the year) is approximately 0.2%. The cumulative indicator reflecting the number of pregnancies in 100 women using contraceptives for 5 years is 0.7%.

Instructions for use of the MirenaЃ IUD

The MirenaЃ IUD is supplied in sterile packaging, which is opened only immediately before the IUD insertion. It is necessary to observe the rules of asepsis when handling the opened system. If the sterility of the packaging appears to be compromised, the IUD should be disposed of as medical waste. The same should be handled with the IUD removed from the uterus, since it contains the remnants of the hormone.

Installation, removal and replacement of the IUD

It is recommended that the MirenaЃ IUD is installed only by a physician who has experience with the IUD or is well trained in this procedure.

Before installing the MirenaЃ IUD, a woman should be informed about the effectiveness, risks and side effects of the IUD. A general and gynecological examination should be carried out, including an examination of the pelvic organs and mammary glands. If necessary, by the decision of the doctor, a smear test from the cervix should be carried out. Pregnancy and sexually transmitted diseases should be ruled out, and pelvic inflammatory disease should be completely cured. Determine the position of the uterus and the size of its cavity. If it is necessary to visualize the uterus before inserting the MirenaЃ IUD, an ultrasound of the pelvic organs should be performed. After a gynecological examination, a vaginal speculum is inserted into the vagina and the cervix is ??treated with an antiseptic solution. Then the MirenaЃ IUD is inserted through a thin flexible plastic tube into the uterus.Particularly important is the correct positioning of the MirenaЃ IUD in the fundus of the uterus, which ensures a uniform effect of gestagen on the endometrium, prevents IUD expulsion and creates conditions for its maximum effectiveness. Therefore, you should carefully follow the instructions for installing the IUD MirenaЃ. 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 severe pain. Before the introduction, if necessary, you can apply paracervical blockade and / or analgesics.Therefore, you should carefully follow the instructions for installing the IUD MirenaЃ. 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. The woman can feel the introduction of the system, but it should not cause her severe pain. Before the introduction, if necessary, you can apply paracervical blockade and / or analgesics.Therefore, you should carefully follow the instructions for installing the IUD MirenaЃ. 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. The woman can feel the introduction of the system, but it should not cause her severe pain. Before the introduction, if necessary, you can apply paracervical blockade and / or analgesics.

In some cases, patients may have cervical stenosis. Excessive force should not be applied when the MirenaЃ IUD is inserted into such patients.

Sometimes, after the insertion of the IUD, pain, dizziness, sweating, and pallor of the skin are noted. Women are advised to rest for some time after the introduction of the MirenaЃ IUD. If, after a half-hour stay in a calm position, these phenomena do not go away, it is possible that the IUD is incorrectly positioned. A gynecological examination should be performed; if necessary, the system is removed. In some women, the use of the MirenaЃ IUD causes allergic skin reactions.

The woman needs to be re-examined 4-12 weeks after installation, and then once a year or more often if clinically indicated.

In women of reproductive age, the MirenaЃ IUD should be inserted into the uterine cavity within 7 days from the onset of menstruation.

The MirenaЃ IUD can be replaced with a new IUD on any day of the menstrual cycle. The IUD can also be installed immediately after an abortion in the first trimester of pregnancy, provided that there are no inflammatory diseases of the genital organs.

The use of an IUD is recommended for women with a history of at least one birth. Installation of the MirenaЃ IUD in the postpartum period should be carried out only after complete involution of the uterus, but not earlier than 6 weeks after delivery. With prolonged subinvolution, it is necessary to exclude postpartum endometritis and postpone the decision to insert the MirenaЃ IUD until the involution is complete. In case of difficulty in inserting an IUD and / or very severe pain or bleeding during or after the procedure, the possibility of perforation should be taken into account and appropriate measures such as physical examination and ultrasound should be taken.

For the prevention of endometrial hyperplasia during HRT with drugs containing only estrogen, in women with amenorrhea, MirenaЃ IUD can be installed at any time; in women with preserved menses, the setting is performed in the last days of menstrual bleeding or 'withdrawal' bleeding.

The MirenaЃ IUD is removed by gently pulling on the threads captured by forceps. If the threads are not visible and the system is in the uterine cavity, it can be removed with a traction hook to remove the IUD. In this case, the expansion of the cervical canal may be required.

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

If further contraception is necessary in women of reproductive age, the removal of the IUD should be performed within 7 days after the onset of menstruation, provided that the woman has regular menstruation. If the system is removed at a different time in the cycle, or if the woman has irregular periods and had sexual intercourse in the previous week, the woman is at risk of becoming pregnant. To ensure continuous contraception, a new IUD must be inserted immediately after the previous IUD has been removed, or an alternative method of contraception must be initiated.

Insertion and removal of an IUD can be accompanied by certain pain and bleeding. The procedure can cause fainting due to a vasovagal reaction, bradycardia or seizure seizure in patients with epilepsy, especially if there is a predisposition to these conditions or in the case of cervical stenosis.

After removal of the MirenaЃ IUD, the system should be checked for integrity. With difficulties with the removal of the IUD, there were isolated cases of slipping of the hormonal-elastomeric core onto 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. The restraints on the horizontal arms usually prevent the core from completely separating from the T-body.

Additional information for some patient groups

Children and adolescents under 18 years of age: MirenaЃ IUD is indicated only after the onset of menarche (establishment of the menstrual cycle).

Elderly patients: the MirenaЃ IUD has not been studied in women over the age of 65, therefore the use of the MirenaЃ IUD is not recommended for this category of patients. The MirenaЃ IUD does not belong to the first choice drugs for postmenopausal women up to 65 years of age with severe uterine atrophy.

Patients with impaired liver function: MirenaЃ IUD is contraindicated in women with acute liver diseases or tumors.

Patients with impaired renal function: The MirenaЃ IUD has not been studied in patients with impaired renal function.

Instructions for the introduction of the IUD

Installed only by a doctor using sterile instruments.

The MirenaЃ IUD is supplied with a guidewire in a sterile package that must not be opened prior to installation.

Do not re-sterilize. For single use only. Do not use MirenaЃ IUD if inner packaging is damaged or opened. Do not install the MirenaЃ IUD after the expiration date indicated on the package.

Before installation, you should read the information on the use of the MirenaЃ IUD.

Preparation for the introduction

• Conduct a gynecological examination to establish the size and position of the uterus and to exclude any signs of acute inflammatory diseases of the genital organs, pregnancy or other gynecological contraindications for the installation of the MirenaЃ IUD.

• The cervix should be visualized using mirrors and the cervix and vagina should be completely treated with an antiseptic solution.

• If necessary, you should use the help of an assistant.

• The anterior lip of the cervix should be grasped with forceps. Straighten the cervical canal with sharp traction with forceps. Forceps should be in this position during the entire time of insertion of the MirenaЃ IUD to ensure careful traction of the cervix towards the inserted instrument.

• Carefully advancing the uterine probe through the cavity to the bottom of the uterus, one should determine the direction of the cervical canal and the depth of the uterine cavity (the distance from the external os to the bottom of the uterus), exclude septa in the uterine cavity, synechiae and submucosal fibroids. If the cervical canal is too narrow, widening of the canal is recommended and pain relievers / paracervical block may be used.

Introduction

1. Open the sterile packaging. After that, all manipulations should be carried out using sterile instruments and sterile gloves.

2. Move the slider forward to the farthest position to pull the IUD into the guide tube.

Do not move the slider downward, because this can lead to premature release of the MirenaЃ IUD. If this happens, the system will not be able to re-fit inside the conductor.

3. Holding the slider in the farthest position, set the upper edge of the index ring in accordance with the distance measured by the probe from the external os to the fundus of the uterus.

4. Continuing to hold the slider in the farthest position, advance the guide wire carefully through the cervical canal into the uterus until the index ring is at a distance of about 1.5-2 cm from the cervix.

Do not push the guidewire forcibly. If necessary, the cervical canal should be widened.

5. Keeping the guide wire still, move the slider up to the mark for opening the horizontal shoulders of the MirenaЃ Naval Forces. Wait 5-10 seconds until the horizontal shoulders open completely.

6. Carefully slide the guidewire inward until the index ring contacts the cervix. The MirenaЃ IUD must be in the fundus.

7. While holding the conductor in the same position, release the MirenaЃ IUD by moving the slider down as far as possible. While holding the slider in the same position, carefully remove the wire by pulling on it. Cut the threads so that their length is 2-3 cm from the external os of the uterus.

If the doctor has doubts that the system is installed correctly, the position of the MirenaЃ IUD should be checked, for example, using an ultrasound scan or, if necessary, remove the system and introduce a new, sterile system. The system should be removed if it is not completely in the uterine cavity. The remote system should not be reused.

Removal / replacement of the MirenaЃ IUD

Before removing / replacing the MirenaЃ IUD, you should read the instructions for use of the MirenaЃ IUD.

The MirenaЃ IUD is removed by gently pulling on the threads captured by forceps.

The new MirenaЃ IUD can be installed immediately after removing the previous one.

An intrauterine therapeutic system (IUD) is a T-shaped levonorgestrel-releasing device that is placed in a guide tube (guide wire components: insertion tube, plunger, index ring, handle, and slider). The IUD consists of a white or nearly white hormone-elastomeric core placed on a T-shaped body and covered with an opaque membrane that regulates the release of levonorgestrel (20 ?g / 24 h). The T-shaped body is provided with a loop at one end and two shoulders at the other; brown threads are attached to the loop to remove the system. The T-shaped structure contains barium sulfate, which makes it visible on X-ray examination. The IUD is free of visible impurities.

1 IUD

levonorgestrel (micronized) 52 mg

Excipients: polydimethylsiloxane elastomer core; membrane of polydimethylsiloxane elastomer containing silicon dioxide colloidal anhydrous 30-40% of the mass.

• pregnancy or suspicion of it;

• acute or recurrent inflammatory diseases of the pelvic organs;

• infections of the external and internal genital organs;

• postpartum endometritis;

• septic abortion within the last 3 months;

• cervicitis;

• diseases accompanied by increased susceptibility to infections;

• dysplasia of the cervix;

• diagnosed or suspected malignant neoplasms of the uterus or cervix;

• diagnosed progestogen-dependent tumors or suspicion of them, incl. mammary cancer;

• bleeding from the genital tract of unknown etiology;

• congenital and acquired anomalies of the uterus, incl. fibroids leading to deformation of the uterine cavity;

• acute liver disease or liver tumors;

• age over 65 years (studies in this category of patients have not been conducted);

• hypersensitivity to levonorgestrel or any of the excipients of the drug.

Carefully

For the diseases / conditions / risk factors listed below, MirenaЃ IUD should be used with caution after consulting a specialist:

• congenital heart defects or heart valve disease (due to the risk of developing septic endocarditis);

• diabetes.

Consideration should be given to the advisability of removing the system if any of the following diseases / conditions / risk factors are present or occurring for the first time:

• migraine, focal migraine with asymmetric loss of vision or other symptoms indicating transient cerebral ischemia;

• unusually severe headache;

• jaundice;

• severe arterial hypertension;

• severe circulatory disorders, incl. stroke and myocardial infarction.

pharmachologic effect

The MirenaЃ IUD, which releases levonorgestrel, has a predominantly local progestogenic effect. Gestagen (levonorgestrel) is released directly into the uterine cavity, which allows it to be used in an extremely low daily dose. High concentrations of levonorgestrel in the endometrium contribute to a decrease in the sensitivity of its estrogen and progesterone receptors, making the endometrium immune to estradiol and having a strong antiproliferative effect. When using the MirenaЃ IUD, morphological changes in the endometrium and a weak local reaction to the presence of a foreign body in the uterus are observed. An increase in the viscosity of the cervical secretion prevents the penetration of sperm into the uterine cavity, due to a decrease in sperm motility and changes in the endometrium, the likelihood of egg fertilization decreases.In some women, ovulation is suppressed.

Previous use of the MirenaЃ IUD does not affect reproductive function. Approximately 80% of women who wish to have a baby will become pregnant within 12 months of having the IUD removed.

In the first months of using the MirenaЃ IUD, due to the process of inhibition of endometrial proliferation, an initial increase in 'smearing' bleeding from the vagina may be observed. Following this, a pronounced suppression of endometrial proliferation leads to a decrease in the duration and volume of menstrual bleeding in women using the MirenaЃ IUD. Lean bleeding often transforms into oligo- or amenorrhea. In this case, the function of the ovaries and the concentration of estradiol in the blood plasma remain normal.

The MirenaЃ IUD can be used to treat idiopathic menorrhagia, i.e. menorrhagia in the absence of hyperplastic processes in the endometrium (endometrial cancer, metastatic lesions of the uterus, 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 thrombosis) symptoms of which are menorrhagia. After 3 months of using the MirenaЃ IUD, menstrual blood loss in women with menorrhagia is reduced by 62-94% and by 71-95% after 6 months of use. When using the MirenaЃ IUD for 2 years, the effectiveness of the drug (reducing menstrual blood loss) is comparable to surgical methods of treatment (ablation or resection of the endometrium).A less favorable response to treatment is possible with menorrhagias caused by submucous uterine myoma. Reducing menstrual blood loss reduces the risk of iron deficiency anemia. IUD MirenaЃ reduces the severity of symptoms of dysmenorrhea.

The effectiveness of the MirenaЃ IUD in the prevention of endometrial hyperplasia during continuous estrogen therapy was equally high with both oral and transdermal estrogen use.

Application during pregnancy and lactation

Pregnancy

The use of the MirenaЃ IUD is contraindicated during pregnancy or suspected pregnancy.

Pregnancy in women who have the MirenaЃ IUD installed is extremely rare. But if there is a prolapse of the IUD from the uterine cavity, the woman is no longer protected from pregnancy and must use other methods of contraception before consulting a doctor.

During the use of the MirenaЃ IUD, some women do not have menstrual bleeding.

Missing your period 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, breast tenderness), then it is necessary to consult a doctor for examination and a pregnancy test.

If a woman becomes pregnant while using the MirenaЃ IUD, it is recommended to remove the IUD, because Any IUD left in situ increases the risk of miscarriage, infection, or premature birth. Removal of the MirenaЃ IUD or probing of the uterine cavity can lead to spontaneous abortion. Ectopic pregnancy must be ruled out.

?сли осторожно удалить внутриматочный контрацептив невозможно, следует обсудить целесообразность медицинского аборта. ?сли женщина хочет сохранить беременность и ¬ћ— удалить невозможно, следует проинформировать пациентку о рисках, в частности, о возможном риске септического аборта во II триместре беременности, послеродовых гнойно-септических заболевани¤х, которые могут осложнитьс¤ сепсисом, септическим шоком и летальным исходом, а также возможных последстви¤х преждевременных родов дл¤ ребенка. ¬ подобных случа¤х за течением беременности следует тщательно наблюдать. ?енщине следует объ¤снить, что она должна сообщать врачу обо всех симптомах, позвол¤ющих предположить осложнени¤ беременности, в частности о по¤влении боли спастического характера внизу живота, сопровождающейс¤ повышением температуры тела.

vормон, содержащийс¤ в ¬ћ— ћиренаЃ, высвобождаетс¤ в полость матки. Ёто означает, что плод подвергаетс¤ воздействию относительно высокой местной концентрации гормона, хот¤ через кровь и плацентарный барьер гормон поступает в него в незначительных количествах. »з-за внутриматочного применени¤ и местного действи¤ гормона необходимо прин¤ть во внимание возможность возникновени¤ вирилизующего действи¤ на плод. ¬ св¤зи с высокой противозачаточной эффективностью ¬ћ— ћиренаЃ клинический опыт, относ¤щийс¤ к исходам беременности при его применении, ограничен. ќднако женщине следует сообщить, что на данный момент времени свидетельства о врожденных эффектах, вызванных применением препарата ћиренаЃ в случа¤х продолжени¤ беременности до родов без удалени¤ ¬ћ—, отсутствуют.

ѕериод грудного вскармливани¤

vрудное вскармливание ребенка при применении ¬ћ— ћиренаЃ не противопоказано. ќколо 0.1% дозы левоноргестрела может поступить в организм ребенка в процессе грудного вскармливани¤. “ем не менее, маловеро¤тно, чтобы он представл¤л риск дл¤ ребенка при дозах, высвобождающихс¤ в полость матки после установки ¬ћ— ћиренаЃ.

—читаетс¤, что применение ¬ћ— ћиренаЃ через 6 недель после родов не оказывает вредного вли¤ни¤ на рост и развитие ребенка. ћонотерапи¤ гестагенами не оказывает вли¤ни¤ на количество и качество грудного молока.

‘ертильность

ѕосле удалени¤ препарата ћиренаЃ у женщин происходит восстановление фертильности.

ѕрименение при нарушени¤х функции печени

ѕротивопоказан при острых заболевани¤х печени, опухол¤х печени.

ѕрименение при нарушени¤х функции почек

¬ћ— ћиренаЃ не изучалась у пациенток с нарушени¤ми функции почек.

ѕрименение у детей

¬ћ— ћиренаЃ показана только после наступлени¤ менархе.

ѕрименение у пожилых пациентов

ѕротивопоказано применение у пациенток старше 65 лет.

ѕередозировка

Ќе применимо.

Ћекарственное взаимодействие

¬ли¤ние других лекарственных средств на ¬ћ— ћиренаЃ

¬озможно взаимодействие с лекарственными средствами, индуцирующими или ингибирующими микросомальные ферменты печени, в результате чего может увеличиватьс¤ или снижатьс¤ клиренс половых гормонов.

¬ещества, увеличивающие клиренс левоноргестрела, например: фенитоин, барбитураты, примидон, карбамазепин, рифампицин, и, возможно, также окскарбазепин, топирамат, фелбамат, гризеофульвин, а также препараты, содержащие зверобой продыр¤вленный. ¬ли¤ние данных веществ на контрацептивную эффективность ¬ћ— ћиренаЃ неизвестно, но предполагаетс¤, что оно не имеет важного значени¤ в св¤зи с местным механизмом действи¤.

Substances with different effects on the clearance of levonorgestrel: when used together with sex hormones, many inhibitors of HIV or hepatitis C virus proteases and non-nucleoside reverse transcriptase inhibitors can both increase and decrease the concentration of gestagen in blood plasma.

Substances that reduce the clearance of levonorgestrel (enzyme inhibitors), for example: strong and moderate CYP3A4 inhibitors, such as antifungals in the azole group (for example, fluconazole, itraconazole, ketoconazole, voriconazole), verapamil, macrolide antibiotics (for example, clarithromycin) and grapefruit juice may increase plasma progestogen concentrations.