International name:
Dosage form: dragee
Pharmachologic effect:
Indications:
Gravistat 125
International name:
Dosage form:
Pharmachologic effect:
Indications:
Klimonorm
International name: Estradiol + Levonorgestrel (Estradiol + Levonorgestrel)
Dosage form: dragee
Pharmachologic effect: Combined estrogen-progestogen drug. Replenishes the lack of female sex hormones during menopause. Eliminates somatic, mental...
Indications: Replacement therapy for a lack of female sex hormones after normal, premature or surgically caused onset...
Levonova
International name: Levonorgestrel
Dosage form:
Pharmachologic effect:
Indications:
Microgynon
International name: Ethinyl estradiol + Levonorgestrel (Ethinylestradiol + Levonorgestrel)
Dosage form: dragees, tablets, film-coated tablets
Pharmachologic effect: Contraceptive combined estrogen-progestogen drug. When taken orally, it inhibits the pituitary secretion of gonadotropic hormones. Contraceptive...
Indications: Contraception, functional disorders of the menstrual cycle (including dysmenorrhea without an organic cause, dysfunctional metrorrhagia, premenstrual syndrome).
Microlute
International name: Levonorgestrel
Dosage form: dragee
Pharmachologic effect: Synthetic gestagen with a contraceptive effect. Increases the viscosity of cervical mucus, which interferes with the advancement of sperm. Depressing...
Indications: Contraception as an additional drug in women using non-hormonal methods, as well as in the presence of contraindications to the use of estrogen-gestagen drugs.
Miniziston
International name: Ethinyl estradiol + Levonorgestrel (Ethinylestradiol + Levonorgestrel)
Dosage form: dragees, tablets, film-coated tablets
Pharmachologic effect: Contraceptive combined estrogen-progestogen drug. When taken orally, it inhibits the pituitary secretion of gonadotropic hormones. Contraceptive...
Indications: Contraception, functional disorders of the menstrual cycle (including dysmenorrhea without an organic cause, dysfunctional metrorrhagia, premenstrual syndrome).
Miranova
International name: Ethinyl estradiol + Levonorgestrel (Ethinylestradiol + Levonorgestrel)
Dosage form: dragees, tablets, film-coated tablets
Pharmachologic effect: Contraceptive combined estrogen-progestogen drug. When taken orally, it inhibits the pituitary secretion of gonadotropic hormones. Contraceptive...
Indications: Contraception, functional disorders of the menstrual cycle (including dysmenorrhea without an organic cause, dysfunctional metrorrhagia, premenstrual syndrome).
Mirena
International name: Levonorgestrel
Dosage form: intrauterine therapy system
Pharmachologic effect: Contraceptive gestagenic agent. Levonorgestrel as part of an IUD has a direct local effect on the endometrium, causing its temporary...
Indications: Contraception (long-term), menorrhagia, prevention of endometrial hyperplasia during estrogen replacement therapy.
Instructions for medical use of the drug
Description of pharmacological action
Indications for use
Inside. Emergency post-coital contraception in women (including after unprotected sexual intercourse and if the method of contraception used cannot be considered reliable).
For intrauterine therapeutic system. Contraception (long-term), idiopathic menorrhagia, prevention of endometrial hyperplasia during estrogen replacement therapy.
Release form
powder substance; two-layer polyethylene bag (pouch) 1 kg;
powder substance; two-layer polyethylene bag (pouch) 10 kg;
powder substance; two-layer polyethylene bag (bag) 15 kg;
powder substance; two-layer polyethylene bag (bag) 2 kg;
powder substance; two-layer polyethylene bag (bag) 20 kg;
powder substance; two-layer polyethylene bag (pouch) 25 kg;
powder substance; two-layer polyethylene bag (bag) 3 kg;
powder substance; two-layer polyethylene bag (bag) 5 kg;
Pharmacodynamics
Causes inhibition of ovulation and changes in the endometrium, prevents the implantation of a fertilized egg. Increases the viscosity of cervical mucus, which interferes with the advancement of sperm.
As part of an intrauterine therapeutic system (IUD), levonorgestrel has a direct local effect on the endometrium, fallopian tubes and viscosity of cervical mucus.
Pharmacokinetics
After oral administration, it is quickly and completely absorbed from the gastrointestinal tract, bioavailability is about 100%. Cmax in plasma after taking a single dose of 0.75 mg is observed after (1.6±0.7) hours and is (14.1±7.7) ng/ml. Binds to serum albumin (approximately 50%) and sex hormone-binding globulin (47.5%). Metabolized in the liver, the metabolites are pharmacologically inactive. T1/2 - (24.4±5.3) hours. Excreted mainly in urine, a small amount - in feces.
When using an IUD, the rate of release of levonorgestrel into the uterine cavity is approximately 20 mcg/day at the beginning and decreases after five years to approximately 11 mcg/day. The average release rate of levonorgestrel is approximately 14 mcg/day for up to 5 years. IUDs can be used in women receiving hormone replacement therapy in combination with oral or transdermal estrogen preparations that do not contain progestogens.
Use during pregnancy
Contraindicated during pregnancy.
Contraindications for use
Hypersensitivity, pregnancy (or suspicion of it); for oral administration (additionally) - severe diseases of the liver or biliary tract, jaundice (including a history), puberty, breastfeeding; for the IUD (additionally) - existing or recurrent inflammatory diseases of the pelvic organs, infections of the lower genitourinary tract, postpartum endometritis, septic abortion within the last 3 months, cervicitis, diseases accompanied by increased susceptibility to infections; cervical dysplasia, malignant neoplasms of the uterus or cervix, progestogen-dependent tumors, incl. mammary cancer; pathological uterine bleeding of unknown etiology, congenital or acquired anomalies of the uterus, incl. fibroids leading to deformation of the uterine cavity; acute liver diseases or tumors.
Side effects
In clinical trials, the most common symptoms observed in women taking levonorgestrel orally (0.75 mg) were nausea (23.1%), abdominal pain (17.6%), fatigue (16.9%), and headache (16. 8%), menstrual irregularities, incl. heavy menstrual bleeding (13.8%), scanty menstrual bleeding (12.5%), dizziness (11.2%), breast tension (10.7%), vomiting (5.6%), diarrhea (5. 0%).
When using an IUD
From the nervous system and sensory organs: ≥1%,
From the gastrointestinal tract: ≥1%,
From the genitourinary system: ≥1% - uterine/vaginal bleeding, spotting, oligo- and amenorrhea, benign ovarian cysts; ≥1%,
From the skin: ≥1%,
Other: ≥1%,
Directions for use and doses
Inside, intrauterine. Orally, used in the first 96 hours after sexual intercourse at a dose of 0.75–1.5 mg. It is not recommended to use emergency contraception more than once every 4–6 months.
Intrauterine, the IUD is inserted into the uterine cavity.
Interactions with other drugs
When taking inducers of cytochrome P450 isoenzymes simultaneously, the metabolism of levonorgestrel may increase and the effect may decrease. The following drugs may reduce the effectiveness of levonorgestrel: amprenavir, lansoprazole, nevirapine, oxcarbazepine, tacrolimus, topiramate, tretinoin, barbiturates (including primidone), phenytoin and carbamazepine, drugs containing St. John's wort (Hypericum perforatum), as well as rifampicin, ritonavir, ampicillin, tetracycline , rifabutin, griseofulvin. Levonorgestrel reduces the effectiveness of hypoglycemic drugs and anticoagulants (coumarin derivatives, phenindione), increases plasma concentrations of glucocorticosteroids. Drugs containing levonorgestrel may increase the risk of cyclosporine toxicity due to inhibition of its metabolism.
Precautions for use
Repeated use of the drug orally during the same menstrual cycle should be avoided due to the possibility of menstrual dysfunction. The use of the oral form as a means of regular and continuous contraception is not allowed, because this leads to a decrease in the effectiveness of the drug and an increase in adverse reactions. If menstruation is delayed by more than 5–7 days after emergency postcoital contraception, pregnancy must be excluded, and if uterine bleeding occurs, a gynecological examination is recommended.
In adolescents under 16 years of age, use for emergency postcoital contraception is possible only in exceptional cases (including rape) and only after consultation with a gynecologist.
Before installing an IUD, it is necessary to conduct a general medical and gynecological examination, including examination of the pelvic organs and mammary glands, as well as a smear examination from the cervix. The woman should be re-examined 4–12 weeks after IUD insertion, and then once a year or more often, if clinically indicated. The IUD remains effective for five years. Installation should only be performed by a physician who has experience with this IUD or is well trained in this procedure.
The results of some recent studies show that women taking progestogen-only contraceptives may have an increased risk of venous thrombosis; however, these results are not well defined. However, if symptoms of venous thrombosis appear, appropriate diagnostic and treatment measures should be taken immediately.
After removal of the IUD, the ability to bear children is restored in 50% of women after 6 months, and in 96.4% after 12 months.
Storage conditions
List B: In a dry place, protected from light, at a temperature not exceeding 25 °C.
Best before date
ATX classification:
** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before starting to use Levonorgestrel, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.
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Gross formula
C21H28O2Pharmacological group of the substance Levonorgestrel
Nosological classification (ICD-10)
CAS code
797-63-7Characteristics of the substance Levonorgestrel
Synthetic progestogen with a molecular weight of 315.45.
Pharmacology
pharmachologic effect- contraceptive, gestagenic.Pharmacodynamics
Levonorgestrel is a synthetic gestagen with a contraceptive effect, pronounced gestagenic and antiestrogenic properties.
When taken orally at the recommended dosage regimen, levonorgestrel suppresses ovulation and fertilization if sexual intercourse occurs in the preovulatory phase, when the possibility of fertilization is greatest. It can also cause changes in the endometrium that prevent a fertilized egg from implanting. Increases the viscosity of cervical secretions, which interferes with the advancement of sperm. Levonorgestrel is not effective if implantation has already occurred.
Efficiency: It is recommended to start taking levonorgestrel as soon as possible (but no later than 72 hours) after sexual intercourse, if no protective contraceptive measures have been used. The more time passes between sexual intercourse and taking the drug, the lower its effectiveness (95% during the first 24 hours, 85% from 24 to 48 hours and 58% from 48 to 72 hours). At the recommended dose, levonorgestrel does not have a significant effect on blood clotting factors, lipid and carbohydrate metabolism.
As part of the intrauterine therapeutic system (IUT), the released levonorgestrel has mainly a local gestagenic effect. Progestin (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 help to reduce the sensitivity of its estrogen and progesterone receptors, making the endometrium resistant to estradiol and having a strong antiproliferative effect. When using levonorgestrel as part of a VTS, 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 uterus. Levonorgestrel in the VTS prevents fertilization due to inhibition of sperm motility and function in the uterus and fallopian tubes. In some women, ovulation is also suppressed. Previous use of levonorgestrel as part of the VTS does not affect reproductive function. Approximately 80% of women wishing to have a child become pregnant within 12 months after VTS removal.
In the first months of using levonorgestrel as part of the VTS, due to the process of suppressing endometrial proliferation, an initial increase in spotting and spotting 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 levonorgestrel as part of the ITC. Scanty bleeding often transforms into oligo- or amenorrhea. At the same time, ovarian function and the concentration of estradiol in the blood plasma remain normal.
Levonorgestrel as part of VTS 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 (for example, von Willebrand disease, severe thrombocytopenia), the symptoms of which are menorrhagia. After 3 months of using levonorgestrel as part of the VTS, menstrual blood loss in women with menorrhagia is reduced by 62-94% and by 71-95% after 6 months of use. When levonorgestrel is used as part of VTS for two years, its effectiveness (reduction of menstrual blood loss) is comparable to surgical treatment methods (ablation or resection of the endometrium). A less favorable response to treatment is possible with menorrhagia caused by submucous uterine fibroids. Reducing menstrual blood loss reduces the risk of iron deficiency anemia. Levonorgestrel in VTS reduces the severity of dysmenorrhea symptoms.
The effectiveness of levonorgestrel in VTS in preventing endometrial hyperplasia during chronic estrogen therapy was equally high with both oral and transdermal estrogen administration.
Pharmacokinetics
Absorption
When taken orally, levonorgestrel is rapidly and almost completely absorbed. Absolute bioavailability is 100% of the dose taken.
After administration of VTS, levonorgestrel begins to be immediately released into the uterine cavity, as evidenced by measurements of its concentration in blood plasma. The high local exposure of levonorgestrel in the uterine cavity, necessary for its local effect 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 blood plasma ( the concentration of levonorgestrel in the endometrium exceeds its concentration in the blood plasma by more than 1000 times). Rate of release of levonorgestrel into the uterine cavity in vivo initially is approximately 20 mcg/day, and after 5 years it decreases to 10 mcg/day.
Distribution
After taking a dose of 0.75 mg or 1.5 mg, the Cmax of levonorgestrel in the blood plasma is 14.1 or 18.5 ng/ml, respectively, and the Tmax is 1.6 or 2 hours, respectively. After reaching Cmax, the concentration of levonorgestrel decreases.
Levonorgestrel binds nonspecifically to plasma albumin and specifically to SHBG. About 1-2% of circulating levonorgestrel is present as the free steroid, while 42-62% is specifically bound to SHBG.
During the use of levonorgestrel as part of the VTS, the concentration of SHBG decreases. Accordingly, the fraction associated with SHBG decreases during this period, and the free fraction increases. The average apparent V d of levonorgestrel is about 106 L.
After the start of administration as part of the VTS, levonorgestrel is detected in the blood plasma an hour later, Tmax is 2 weeks. In accordance with the decreasing release rate, the median plasma concentration of levonorgestrel in women of reproductive age with a body weight above 55 kg decreases from 206 pg/ml (25-75th percentile: 151-264 pg/ml), determined after 6 months, to 194 pg/ml (146-266 pg/ml) after 12 months and up to 131 pg/ml (113-161 pg/ml) after 60 months.
Body weight and plasma SHBG concentrations have been shown to influence systemic levonorgestrel concentrations, i.e. with low body weight and/or high SHBG concentrations, levonorgestrel concentrations are higher. In women of reproductive age with low body weight (37-55 kg), the median concentration of levonorgestrel in blood plasma is approximately 1.5 times higher.
In postmenopausal women using levonorgestrel as part of the VTS simultaneously with the use of estrogens intravaginally or transdermally, the median concentration of levonorgestrel in the blood plasma decreases from 257 pg / ml (25-75th percentile: 186-326 pg / ml), determined after 12 months , up to 149 pg/ml (122-180 pg/ml) after 60 months. When levonorgestrel is used as part of a VTS simultaneously with oral administration of estrogens, the concentration of levonorgestrel in the blood plasma, determined after 12 months, increases to approximately 478 pg/ml (25-75th percentile: 341-655 pg/ml), which is due to the induction of SHBG synthesis .
Biotransformation
Levonorgestrel is extensively metabolized. The main metabolites in blood plasma are unconjugated and conjugated forms of 3α-, 5β-tetrahydrolevonorgestrel. Pharmacologically active metabolites of levonorgestrel are unknown. Based on research results in vitro And in vivo, the main isoenzyme involved in the metabolism of levonorgestrel is CYP3A4. CYP2E1 isoenzymes may also be involved in the metabolism of levonorgestrel. CYP2C19 And CYP2C9, however to a lesser extent.
Elimination
The total plasma clearance of levonorgestrel is approximately 1 ml/min/kg. Unchanged levonorgestrel is excreted only in trace amounts. Metabolites are excreted through the intestines and kidneys with an excretion coefficient equal to 1.77. T1/2 after oral administration and when using levonogestrel as part of the VTS (in the terminal phase, represented mainly by metabolites), is about a day.
Linearity/nonlinearity
VTS. The pharmacokinetics of levonorgestrel depends on the concentration of SHBG, which, in turn, is influenced by estrogens and androgens. When using levonorgestrel as part of the VTS, 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 the nonlinearity of the pharmacokinetics of levonorgestrel over the time of its use as part of the VTS. Given the predominantly local action of levonorgestrel in the VTS, the influence of changes in systemic concentrations of levonorgestrel on its effectiveness in this case is unlikely.
Use of the substance Levonorgestrel
Inside. Emergency post-coital contraception in women (after unprotected intercourse or unreliability of the contraceptive method used).
For VTS. Contraception (long-term), idiopathic menorrhagia, prevention of endometrial hyperplasia during estrogen replacement therapy.
Contraindications
Inside. Hypersensitivity to levonorgestrel; severe liver failure; pregnancy (including suspected); breastfeeding period; age up to 16 years.
For VTS. Pregnancy or suspicion of it; existing or recurrent inflammatory diseases of the pelvic organs; infections of the lower urinary and genital tracts; postpartum endometritis; septic abortion within the last 3 months; cervicitis; diseases accompanied by increased susceptibility to infections; cervical dysplasia; malignant neoplasms of the uterus or cervix; progestogen-dependent tumors, incl. mammary cancer; pathological uterine bleeding of unknown etiology; congenital or acquired anomalies of the uterus, incl. fibroids leading to deformation of the uterine cavity; acute liver diseases or tumors; hypersensitivity to levonorgestrel.
The use of levonorgestrel as part of VTS has not been studied in women over 65 years of age, and therefore is not recommended for this category of patients.
Restrictions on use
Inside. Diseases of the liver or biliary tract, jaundice (including a history), Crohn's disease; a history of pelvic inflammatory disease or ectopic pregnancy; the presence of a hereditary or acquired predisposition to thrombosis.
For VTS. After consultation with a specialist: migraine, focal migraine with asymmetric vision loss or other symptoms indicating transient cerebral ischemia; unusually severe headache; jaundice; severe arterial hypertension; severe circulatory disorders, incl. stroke and myocardial infarction; congenital heart defects or heart valve disease (due to the risk of developing septic endocarditis); diabetes.
Use during pregnancy and breastfeeding
Levonorgestrel should not be taken during pregnancy. If pregnancy develops while taking it, then, based on the available data, no adverse effect of levonorgestrel on the fetus is expected.
MTC. The use of levonorgestrel as part of VTS is contraindicated during pregnancy or suspected pregnancy. Pregnancy in women who have a VTS containing levonorgestrel is extremely rare. But if the VTS falls out of the uterine cavity, the woman is no longer protected from pregnancy and should use other methods of contraception before consulting a doctor.
Some women experience no menstrual bleeding while using levonorgestrel as part of the ITC. The absence of menstruation does not necessarily indicate 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 pregnancy occurs in a woman while using levonorgestrel as part of the VTS, it is recommended to remove the VTS, because any intrauterine contraceptive device left in situ, increases the risk of spontaneous abortion, infection or premature birth. Removing the VTS or probing the uterus can lead to spontaneous abortion. If careful removal of the intrauterine contraceptive device is not possible, the feasibility of medical abortion should be discussed. If a woman wants to continue the pregnancy and it is impossible to remove the VTS, the patient should be informed about the risks, in particular about 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, as well as possible consequences premature birth for the baby.
In such cases, the course of pregnancy should be carefully monitored. It is necessary to exclude ectopic pregnancy. The woman should be explained that she must inform the doctor about all symptoms that suggest pregnancy complications, in particular the appearance of cramping pain in the lower abdomen, bleeding or spotting from the vagina, and increased body temperature. Levonorgestrel as part of the VTS is released into the uterine cavity. This means that the fetus is exposed to a relatively high local concentration of the hormone, although the hormone enters it in small quantities through the blood and placenta. Due to the intrauterine use 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 efficacy of levonorgestrel in the ITC, clinical experience regarding pregnancy outcomes with its use is limited. However, the woman should be informed that at this time there is no evidence of congenital defects caused by the use of levonorgestrel as part of the VTS in cases of pregnancy continuing until delivery without removal of the VTS.
Levonorgestrel passes into breast milk. After taking it, breastfeeding should be stopped for 24 hours.
VTS. Breastfeeding a child when using levonorgestrel as part of the VTS is not contraindicated. About 0.1% of the dose of levonorgestrel can enter the child's body during breastfeeding. However, it is unlikely to pose a risk to the baby at doses released into the uterine cavity after insertion of a VTS.
It is believed that the use of levonorgestrel as part of VTS 6 weeks after birth 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. Rare cases of uterine bleeding have been reported in women using levonorgestrel as part of the VTS during lactation.
Fertility. After removal of the VTS, women's fertility is restored.
Side effects of the substance Levonorgestrel
Frequency of side effects (AD) after taking levonorgestrel: very common (≥1/10); often (≥1/100,<1/10).
Often- nausea, feeling tired, abdominal pain, acyclic spotting (bleeding).
Often- vomiting, diarrhea, dizziness, headache, tenderness of the mammary glands, tension in the mammary glands, dysmenorrhea, heavy menstrual bleeding, delayed menstruation (no more than 5-7 days; if menstruation does not occur for a longer period, it is necessary to exclude pregnancy). Allergic reactions are possible: hives, rash, itching, swelling of the face.
VTS. In most women, after installation of a levonorgestrel-containing VTS, the nature of cyclic bleeding changes. During the first 90 days of use, an increase in the duration of bleeding is noted by 22% of women, and irregular bleeding is observed in 67% of women; the frequency of these phenomena decreases to 3 and 19%, respectively, by the end of the 1st year of VTS use. At the same time, 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 use, the frequency of these events increases to 16 and 57%, respectively.
When using levonorgestrel as part of VTS in combination with long-term estrogen replacement therapy, cyclic bleeding gradually stops in most women during the 1st year of use.
Below are data on the incidence of PD reported with the use of levonorgestrel as part of the VTS. Frequency of occurrence of PD: very common (≥1/10); often (≥1/100,<1/10); нечасто (≥1/1000, <1/100); редко (≥1/10000, <1/1000); частота неизвестна. ПД представлены по классам системы органов согласно MedDRA. Incidence data reflect the estimated incidence of PD reported during clinical trials of levonorgestrel in ITC for contraception and idiopathic menorrhagia in 5091 women.
PDs reported in clinical trials of levonorgestrel in VTS for the indication “prevention of endometrial hyperplasia during estrogen replacement therapy” (involving 514 women) were observed at the same frequency, except for cases indicated by asterisks (*, **) .
From the immune system: frequency unknown - hypersensitivity to levonorgestrel, including rash, urticaria and angioedema.
From the mental side: often - depressed mood, depression.
From the nervous system: very often - headache; often - migraine.
From the gastrointestinal tract: very often - abdominal pain, pain in the pelvic area; often - nausea.
For the skin and subcutaneous tissues: often - acne, hirsutism; uncommon - alopecia, itching, eczema.
From the musculoskeletal system and connective tissue: often - back pain**.
From the reproductive system and mammary glands: very often - changes in the volume of blood loss, including an increase and decrease in the intensity of bleeding, spotting, oligomenorrhea, vulvovaginitis*, discharge from the genital tract*; often - infections of the pelvic organs, ovarian cysts, dysmenorrhea, pain in the mammary glands**, engorgement of the mammary glands, expulsion of the VTS (complete or partial); rarely - uterine perforation (including penetration).
Survey results: frequency unknown - increased blood pressure.
* Often for the indication “prevention of endometrial hyperplasia during estrogen replacement therapy.”
** Very often for the indication “prevention of endometrial hyperplasia during estrogen replacement therapy.”
To describe certain reactions, their synonyms and associated conditions, in most cases the terminology corresponding to MedDRA.
Interaction
With the simultaneous use of drugs that are inducers of microsomal liver enzymes, the metabolism of levonorgestrel is accelerated.
The following drugs may reduce the effectiveness of levonorgestrel: amprenavir, lansoprazole, nevirapine, oxcarbazepine, tacrolimus, topiramate, tretinoin, barbiturates (including primidone), phenobarbital, phenytoin and carbamazepine, drugs containing St. John's wort (Hypericum perforatum), as well as rifampicin, ritonavir, ampicillin, tetracycline, rifabutin, griseofulvin, efavirenz. Reduces the effectiveness of hypoglycemic and anticoagulant (coumarin derivatives, phenindione) drugs. Increases plasma concentrations of GCS. Medicines containing levonorgestrel may increase the risk of cyclosporine toxicity due to suppression of its metabolism.
Levonorgestrel may reduce the effectiveness of ulipristal by competitively acting on the progesterone receptor. Therefore, the simultaneous use of drugs containing levonorgestrel with ulipristal preparations is not recommended.
For military-technical cooperation(additionally). The effect of liver microsomal enzyme inducers on the effectiveness of levonorgestrel in VTS is unknown, but is believed to be insignificant since levonorgestrel in VTS has mainly local effects.
Overdose
Symptoms: nausea, vomiting, spotting/bleeding.
Treatment: symptomatic, there is no specific antidote.
For VTS. Not applicable.
Routes of administration
Inside, intrauterine.
Precautions for the substance Levonorgestrel
When taken orally
Levonorgestrel should be taken exclusively for emergency contraception. Repeated use within one menstrual cycle is not recommended.
Levonorgestrel should be taken as soon as possible, but no later than 72 hours after unprotected intercourse. The effectiveness of emergency contraception with delayed use is significantly reduced.
Levonorgestrel does not replace the use of permanent methods of contraception. In most cases, it does not affect the nature of the menstrual cycle. However, acyclic bleeding and a delay of menstruation for several days are possible. If menstruation is delayed by more than 5-7 days and its character changes (scanty or heavy discharge), pregnancy must be excluded. The appearance of pain in the lower abdomen and fainting may indicate an ectopic (ectopic) pregnancy.
In adolescents under 16 years of age, the use of levonorgestrel is possible only in exceptional cases (including rape) and only after consultation with a gynecologist. After emergency contraception, a second consultation with a gynecologist is recommended.
In diseases of the gastrointestinal tract (for example, Crohn's disease), as well as in women with excess body weight, the effectiveness of levonorgestrel may be reduced.
Levonorgestrel should be used with caution in women with liver or biliary tract diseases, a history of pelvic inflammatory disease or ectopic pregnancy, or a hereditary or acquired predisposition to thrombosis.
When using VTS
Before installing a VTS containing levonorgestrel, pathological processes in the endometrium should be excluded, since irregular bleeding/spotting is often observed in the first months of its use. Pathological processes in the endometrium should also be excluded if bleeding occurs after the start of estrogen replacement therapy in a woman who continues to use levonorgestrel as part of the VTS, previously established for contraception. Appropriate diagnostic measures must also be taken when irregular bleeding develops during long-term treatment.
Levonorgestrel as part of the VTC is not used for postcoital contraception.
Levonorgestrel as part of VTS should be used with caution in women with congenital or acquired valvular heart disease, keeping in mind the risk of septic endocarditis. When inserting or removing a VTS, these patients should be prescribed antibiotics for prophylactic purposes.
Levonorgestrel in low doses can affect glucose tolerance, and therefore its concentration in the blood plasma should be regularly monitored in women with diabetes mellitus using levonorgestrel as part of the VTS. As a rule, dose adjustment of hypoglycemic drugs is not required.
Some manifestations of polyposis or endometrial cancer may be masked by irregular bleeding. In such cases, additional examination is necessary to clarify the diagnosis.
Levonorgestrel as part of the VTS is not the first choice drug for either young women who have not previously been pregnant or for postmenopausal women with severe uterine atrophy.
Available evidence suggests that the use of levonorgestrel in ITC does not increase the risk of developing breast cancer in postmenopausal women under 50 years of age. Due to the limited data obtained during the study of this drug for the indication “prevention of endometrial hyperplasia during estrogen replacement therapy,” the risk of breast cancer when used for this indication cannot be confirmed or refuted.
Oligo- and amenorrhea. Oligo- and amenorrhea in women of fertile age develops gradually, in approximately 57 and 16% of cases by the end of the first year of using levonorgestrel as part of the VTS, respectively. If menstruation is absent within 6 weeks after the start of the last menstrual period, pregnancy should be excluded. Repeated pregnancy tests for amenorrhea are not necessary if there are no other signs of pregnancy.
When levonorgestrel in VTS is used in combination with continuous estrogen replacement therapy, most women gradually develop amenorrhea within the first year.
Inflammatory diseases of the pelvic organs (PID). The guide tube helps protect the levonorgestrel-containing VTS from infection during insertion, and the device for inserting the VTS is specially designed to minimize the risk of infection. PID in patients using VTS is often classified as a sexually transmitted disease. Having multiple sexual partners has been found to be a risk factor for PID. PID can have serious consequences: it can impair fertility and increase the risk of ectopic pregnancy.
As with other gynecologic or surgical procedures, severe infection or sepsis (including group A streptococcal sepsis) may develop after VTS placement, although this is extremely rare.
For recurrent endometritis or PID, or for severe or acute infections that are refractory to treatment for several days, the levonorgestrel-containing VTS should be removed. If a woman has persistent pain in the lower abdomen, chills, fever, pain associated with sexual intercourse (dyspareunia), prolonged or heavy spotting/bleeding from the vagina, or changes in the nature of vaginal discharge, you should immediately consult a doctor. Severe pain or fever that occurs soon after VTS insertion may indicate a severe infection that must be treated immediately. Even in cases where only individual symptoms indicate the possibility of infection, bacteriological examination and monitoring are indicated.
Expulsion. Possible signs of partial or complete expulsion of any VTS are bleeding and pain. Contractions of the uterine muscles during menstruation sometimes lead to the displacement of the VTS or even to its expulsion from the uterus, which leads to the cessation of the contraceptive effect. Partial expulsion may reduce the effectiveness of VTS containing levonorgestrel. Since levonorgestrel in the VTS reduces menstrual blood loss, its increase may indicate expulsion of the VTS. A woman is advised to check the threads with her fingers, for example while taking a shower. If a woman finds signs of displacement or prolapse of the VTS or cannot feel the threads, she should avoid sexual intercourse or use other methods of contraception, and consult a doctor as soon as possible.
If the position in the uterine cavity is incorrect, the VTS must be removed. A new system may be installed at this time.
Perforation and penetration. Perforation or penetration of the body or cervix of the VTS occurs rarely, mainly during insertion, and may reduce the effectiveness of levonorgestrel in the VTS. In these cases, the system should be removed. If there is a delay in diagnosing perforation and migration of the VTS, complications such as adhesions, peritonitis, intestinal obstruction, intestinal perforation, abscesses or erosions of adjacent internal organs may occur. The risk of uterine perforation is increased in women who are breastfeeding. There may be an increased risk of perforation when installing a VTS after childbirth and in women with a fixed uterine flexion.
Ectopic pregnancy. Women with a history of ectopic (ectopic) pregnancy, tubal surgery or pelvic infection are at higher risk of ectopic pregnancy. The possibility of ectopic pregnancy should be considered in the case of lower abdominal pain, especially if it is combined with cessation of menstruation or when a woman with amenorrhea begins to bleed. The incidence of ectopic pregnancy with levonorgestrel-containing ITC is approximately 0.1% per year. The absolute risk of ectopic pregnancy in women using this drug is low. However, if a woman with an established levonorgestrel-containing VTS becomes pregnant, the relative likelihood of an ectopic pregnancy is higher.
Loss of threads. If, during a gynecological examination, threads for removing VTS cannot be detected in the cervical area, it is necessary to exclude pregnancy. The threads can be drawn into the uterine cavity or cervical canal and become visible again after the next menstruation. If pregnancy is excluded, the location of the threads can usually be determined by careful probing with an appropriate instrument. If the threads cannot be detected, it is possible that the VTS has been expulsed from the uterine cavity. Ultrasound can be used to determine the correct placement of the system. If it is unavailable or unsuccessful, X-ray examination is used to determine the localization of VTS.
Ovarian cysts. Since the contraceptive effect of levonorgestrel as part of the VTS is mainly due to its local action, women of fertile age usually experience ovulatory cycles with rupture of the follicles. Sometimes follicular atresia is delayed and follicular development may continue. Such enlarged follicles cannot be clinically distinguished from ovarian cysts. Ovarian cysts have been reported as an adverse reaction in approximately 7% of women using VTS containing levonorgestrel. In most cases, these follicles do not cause any symptoms, although sometimes they are accompanied by pain in the lower abdomen or pain during intercourse.
As a rule, ovarian cysts disappear on their own within two to three months of observation. If this does not happen, it is recommended to continue monitoring with ultrasound, as well as therapeutic and diagnostic measures. In rare cases, it is necessary to resort to surgical intervention.
The use of levonorgestrel as part of VTS in combination with estrogen replacement therapy. When using levonorgestrel as part of a VTS in combination with estrogens, it is necessary to additionally take into account the information specified in the instructions for use of the corresponding estrogen.
Impact on the ability to drive vehicles and operating machinery. The effect of levonorgestrel on the ability to drive vehicles and operate machines has not been studied. If dizziness develops, you should refrain from driving vehicles and operating machinery that require increased concentration and speed of psychomotor reactions.
A woman’s ability to conceive and bear a child and the regularity of her cycle is determined by the interaction of two hormones in her body. These are the so-called “female” and “male” hormones estrogen and progesterone. Estrogen ensures the stability and regularity of the cycle, that is, the timely maturation and release of the egg into the uterine cavity, and progesterone prepares the uterus for pregnancy.
At the beginning of the 20th century, doctors noticed the ability of large doses of progesterone to suppress ovulation. A little later, it was synthesized artificially, and in the form of many derivatives called progestins or progestogens. One of them - levonorgestrel, a synthetic hormone , a progesterone analogue derived from testosterone.
How does levonorgestrel affect a woman’s body?
Once in the blood, even in a microdose, this synthetic hormone acts as follows:
- thickens cervical mucus, thereby narrowing the cervical canal and preventing sperm from entering the uterine cavity;
- reduces the patency of the fallopian tubes for sperm;
- reversibly suppresses ovulation - that is, after stopping the intake, the cycle is restored after some time without consequences.
Levonorgestrel as a contraceptive
Thanks to these properties levonorgestrel widely used in the production of variouscontraceptivesproducts both separately and in combination with synthetic estrogen analogues.
To contraceptive drugs that contain exclusively levonorgestrel include:
- so-called mini-pills, progestin-based contraceptives pills . They contain microdoses of the hormone and are designed to be taken for a month;
- emergency contraception (“morning after pills” or “Plan B” pills). The dose of the hormone in them is slightly higher than in the mini-pill, so they can urgently prevent unwanted conception within a few days after unprotected intimate contact. These remedies are most effective within 72 hours after sexual intercourse. To ensure contraceptive action, only 1-2 tablets are enough, depending on the drug.
In addition, in combination with synthetic estrogen analogs, levonorgestrel is included in a variety of combined oral contraceptives, vaginal rings, intrauterine devices, and implants.
Who is suitable for levonorgestrel-based contraceptives?
It should be remembered that hormonal contraceptives can only be taken as prescribed by a doctor. If you are taking combined hormonal medications or using contraceptives based on them, you must follow all precautions prescribed for such medications. In particular, they cannot be used during pregnancy and breastfeeding, in the presence of estrogen-dependent diseases and a tendency to thrombosis, and they are also undesirable for women who smoke over the age of 35 years.
Contraindications to the use of monohormonal drugs, such as mini-pills or emergency contraceptive pills, are: hypersensitivity to any component of the drug; age up to 16 years; severe liver failure; pregnancy; rare hereditary diseases such as lactose intolerance, lactase deficiency or glucose-lactose malabsorption. These drugs should be used with caution in diseases of the liver or biliary tract, jaundice (including a history), Crohn's disease, and lactation. Side effects of drugs containing levonorgestrel rarely include nausea, dizziness, abdominal pain or headache, and fatigue.
Only new delusions save us from despair after the loss of old ones.
Felix Hvalibug
Without struggle there would be no evolution or progress. We are alive because we struggle and work.
A clash of personalities, interests, and constant obstacles are the key to movement. And so it is in everything. When a technical innovation appears, its defenders and opponents immediately appear, considering everything absurd. A new drug appears - and we hear enthusiastic reviews from those who were healed and negative reviews from those who did not experience the effect. But it’s not for nothing that the sages advised turning everything negative into experience, and a useful one at that. Criticism is also one of the engines of progress. Although often disapproval from reasonable criticism develops into something more - into misconceptions and myths.
We are seeing this, for example, in connection with the growing popularity in Russia and throughout the world of intrauterine hormonal contraceptives. Let's look at the most common judgments. What useful things can you take away from them and how can you avoid getting lost yourself? We turned to obstetrician-gynecologist Yulia Zhigalova with this question.
“I want to install an intrauterine hormonal system, but I’m afraid that pimples will appear and the condition of the skin will change.”
This common misconception appears whenever hormones are discussed. Moreover, those who are mistaken do not even try to figure out what specific hormones we are talking about. Male sex hormones - androgens - most often have an adverse effect on the skin.
The intrauterine hormonal system contains a completely different hormone, in structure - an analogue of the female sex hormone progesterone (gestagen), which actually has no effect on the condition of the skin. In addition, the active substance is released directly into the uterine cavity. Thus, a minimal amount enters the bloodstream and is not capable of in any way affecting the general background of the body, including the condition of the skin. According to statistics, from 1 to 10% of women who had an intrauterine hormonal system installed complained of acne, but only during the first time of use. These phenomena refer to adaptation reactions, which usually disappear 3-6 months after installation of the system.
“I have a difficult relationship with my husband: there is almost no intimacy, we are always in some kind of tension. We have two small children. Of course, we are both tired. There is coldness in the relationship. I am trying to solve this problem, I am consulting with a psychologist. I understand what is needed build intimacy and at the same time resolve the issue in the most effective way contraception. It seems that my choice fell on the intrauterine hormonal system, but I heard from some friends that with it, on the contrary, the desire disappears. And it seems like you can have sex as much as you want, but you don’t want to.”
The intrauterine hormonal system cannot influence sexual desire, because the hormone acts locally. Insignificant concentrations enter the blood. But even if we theoretically assume its effect on libido, it will most likely turn out to be a plus, because levonorgestrel has minimal residual androgenic activity, which means it can only increase sexual desire.
If women note a lack of desire when an intrauterine hormonal system is installed, theoretically there may be another explanation. In the first months after installation, the body adapts to the new regime. He needs time to get used to it. Therefore, sometimes a slight fatigue occurs, slight cramps in the lower abdomen - everything that may appear in the first months - this simply does not allow a woman to relax and completely surrender to her feelings. But as soon as the discomfort of this period passes and the woman fully experiences all the benefits of the method, believe me, there will be no problems with desire.
“Why do some people notice a change in the menstrual cycle after the installation of an intrauterine hormonal system? I’m just being examined to have it installed, and now I’m thinking about it.”
Gestagen, which is in the system, protects the endometrium (the inner lining of the uterus) from proliferation (excessive growth). Under the influence of it, menstruation may change and acquire the character of spotting, become longer or shorter, occur with more or less bleeding than usual, or stop altogether. After 3-6 months, for most women, the adaptation period ends and the menstrual cycle is established. Moreover, menstruation in most women becomes scanty, short and painless. There is also no need to worry about suppression of ovarian function (after all, periods are very scanty) - the ovaries work as usual, and many studies have confirmed the presence of ovulation in a large number of women.
“I really want to find an effective method of contraception. I’m breastfeeding my second baby and definitely don’t plan on a third in the coming years. I’ve just gotten back into shape after giving birth, and it’s important for me that the contraceptive, in addition to its main effect, does not affect weight. I spent a lot of effort trying to reduce it. Besides, my tendency to be overweight is hereditary. Will the intrauterine hormonal system affect my weight?”
The intrauterine hormonal system does not affect weight. This has been proven by many studies.
Often, the intrauterine hormonal system is used by women for therapeutic purposes, including those with metabolic syndrome, pathology of carbohydrate metabolism, and hidden diseases of the thyroid gland. It can be assumed that in such situations weight gain is possible. And one more nuance. The system lasts a long time - about 5 years. A woman becomes five years older - her metabolism changes, and muscle mass is gradually lost with age, which contributes to the breakdown of fat. Weight gain is much faster. And in order to stay fit at this age, you need to monitor your diet and give your body certain physical activities. And it’s not about the system at all, but about the way of life.
“I don’t have children yet. And I don’t even plan to. And I need reliable contraception. I wanted to install an intrauterine hormonal system, but I heard that it can fall out or grow into the uterus.”
This is truly a myth. It is most likely associated with conventional metal-containing IUDs, which, by their mechanism of action, cause increased contraction of the uterus and, as a result, the IUD may fall out.
Indeed, when using VMGS, expulsion (loss) of the spiral may occur, but this is most often associated with a technically incorrectly installed system. To a greater extent, spontaneous prolapse is associated with conventional metal-containing IUDs, which, by their mechanism of action, cause increased contractions of the uterus. And VMGS has a relaxing effect on the uterus, which prevents the system from being pushed out of the body. For the same reason, for many women, menstruation becomes less painful and flows easier.
As for ingrowth, this term is more common. And it again applies to a greater extent to metal-containing spirals. More precisely, to cases of their incorrect installation, when the spiral perforates the wall of the uterus, resulting in an inflammatory reaction and the endometrium begins to grow. The intrauterine system helps reduce proliferation (growth) of the endometrium, so the term “ingrowth” is not applicable to it.
“I used the system for 4 years, I feel great, menstruation lasts 1-2 days, it’s scanty. Now I’ve decided to get pregnant again, I’m going to remove the system, but I’m afraid that after removal there may be severe bleeding.”
Levonorgestrel, located in the system, affects the endometrium, causing its thinning. As a result, for most women, like you, menstruation becomes very scanty. But the action continues exactly as long as the system remains in the uterine cavity. After the system is removed, the endometrium begins to grow again. In this case, menstruation is restored to its original level.
“I need to remove the system because the expiration date has expired, but I heard that there is a risk of pregnancy immediately. How long does the contraceptive effect last after removal?”
Of course, the contraceptive effect is achieved only during the presence of the system in the uterine cavity. When pregnancy is not desired, other methods of contraception must be started after removal of the system. You can also install a new system immediately after removing the previous one; in this case, no additional measures to prevent pregnancy are required.
“Why bother and buy such an expensive product? It’s better to put in a regular IUD and take pills (COCs) at the same time - the effect will be the same.”
A fundamentally incorrect and dangerous misconception. A regular spiral has incomparably more side effects than the system. COCs taken orally act systemically and may have more side effects than levonorgestrel from the intrauterine system, which is released directly into the uterine cavity.
Moreover, the meaning of such a combination is not at all clear. COCs will independently provide a reliable contraceptive effect. Why combine them with a regular spiral? It can increase the pain and profuseness of menstruation, and it often causes inflammatory diseases of the pelvic organs. And the intrauterine system is precisely a unique combination of the advantages of both methods minus their disadvantages.
“I’m afraid to install an intrauterine system; will it provoke irritability?”
The intrauterine system acts locally, Levonorgestrel enters the uterine cavity and has virtually no systemic effect on the body. However, on the contrary, many studies have noted a decrease in premenstrual syndrome and associated irritability.
Even the most unpleasant side effect is a situation that requires careful analysis with your doctor. Often, it’s not so much about the drug, but about the accompanying circumstances, and before, as they say, cutting from the shoulder, you need to figure everything out.
The uniqueness of the intrauterine system method lies in the targeted delivery of the active substance directly to the uterus - the place where it should have an effect, therefore the risk of side effects with this system is significantly reduced.
And don’t forget, if myths are invented, it means someone needs it. To someone, but not to you! You need objective information.
Discussion
When I was wondering whether to use this very system, I asked on the manufacturer’s website whether one single “system” with the same dose of the hormone was suitable for everyone. My question was quickly erased. And this article also does not cover why COCs are selected, but they are ready to supply this “system” to any woman. It seems to me that they want to use us as guinea pigs.
06/19/2010 17:31:32, Marina27Comment on the article "The History of Misconceptions, or Let's Figure It Out"
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