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Tri-Legest Review


Tri-Legest is a combination oral contraceptive which contains two female hormones, ethinyl estradiol and norethindrone.

Contents:

Indications for use

  • Pregnancy prevention.

Mechanism of action

The drug suppresses gonadotropins. inhibits ovulation, causes changes in the cervical mucus (which makes it difficult for sperm to get into the uterus) and the endometrium (which reduces the likelihood of implantation).

Dosage and mode of application

Each pack of Tri-Legest contains 21 tablets with hormones. There are no inert tablets.

You can start taking tablets on the first day of your menstrual period or on the first Sunday after the start of the period.

  • Day 1 start: Take the first tablet on the first day of your period, then take one tablet every day at about the same time, for 21 days in a row. Then make a 7-day break and start a new pack of the contraceptive. If you started taking Tri-Legest on day 1 of your period, the contraceptive effect comes immediately, and you do not need to use additional contraceptives. If you take the tablets according to the rules and do not miss them, you also do not need to use additional contraceptives;
  • Sunday start: You can start tablets on the nearest Sunday following the onset of your menstruation (for example, if menstrual bleeding started on Tuesday, then the first tablet should be taken next Sunday). However, in this case, you should consider the possibility of pregnancy if you had unprotected sexual intercourse before starting hormonal contraception. You will also need to use additional contraceptives for 7 days after you start taking the tablets (until next Sunday).

If you take Jess from the first day of your period, the contraceptive effect comes immediately and you no longer need to use condoms.

How to switch to Tri-Legest from another COC?

If you used other birth control pills last month and want to switch to this drug, follow these rules:

  • If the package of the previous COC contained 28 tablets, you should take the first tablet the next day after the end of the previous COC;
  • If the package of the previous COC contained 21 tablets, you should take the first tablet the next day after the end of the previous COC or on the 8th day after the 7-day break.

How to switch to Tri-Legest from a vaginal ring or a hormonal patch?

The first pill should be taken on the day when you removed a vaginal ring or a hormonal patch, or on the day when you need to insert a new vaginal ring or stick a new patch on.

How do I switch to Tri-Legest from an intrauterine device (IUD)?

If you previously used an IUD, the first tablet should be taken on the day the IUD is removed. Use additional backup contraceptives for 7 days.

How to start taking Tri-Legest after an abortion?

After an abortion at an early gestational age (up to 12 weeks), you can start taking tablets on the day of the abortion. If the abortion was late (more than 12 weeks), then taking tablets can be started on day 21 or 28 after the abortion. In this case, it is necessary to use additional backup contraceptives for 7 days. If you had unprotected sex before you started taking birth control pills, you can only start taking them after you are sure that you are not pregnant.

How to start taking Tri-Legest after childbirth?

You can take the first tablet on day 21 or 28 after delivery. In this case, it is necessary to use additional backup contraceptives for 7 days. If you had unprotected sex before you started taking tablets, you can start taking them only after you exclude a possible pregnancy. If you are breastfeeding, the drug is contraindicated.

What to do in case of vomiting or diarrhea?

If vomiting or diarrhea occurred in the first 3-4 hours after taking a pill, its effectiveness may be reduced. In this case, you should take the same measures as in the case of missing a pill (depending on the number of the pill).

If vomiting or diarrhea continues, it is necessary to use additional backup contraceptives for the entire time of the digestive disorder and another 7 days after its termination.

Overdose

  • Symptoms: nausea, vomiting, spotting. There are no available data on the development of serious adverse reactions in the case of overdose;
  • Treatment: symptomatic. There is no specific antidote.

Side effects

The most common side effect is vaginal bleeding. Women taking Tri-Legest had an increased risk of arterial and venous thrombotic and thromboembolic events, including myocardial infarction, stroke, transient ischemic attack, venous thrombosis, and pulmonary thromboembolism.

Other adverse reactions:

  • immune system: rarely – hypersensitivity reactions; unknown frequency – exacerbation of systemic lupus erythematosus;
  • metabolism and nutrition: often – an increase in body weight, fluid retention; rarely, weight loss; unknown frequency – exacerbation of porphyria;
  • mental disorders: often – depressed mood, mood changes; infrequently – decreased libido; rarely – increased libido; unknown frequency – nervousness, depression;
  • nervous system: often – a headache, migraine; unknown frequency – dizziness, exacerbation of chorea;
  • vision: rarely – intolerance to contact lenses (discomfort when wearing them); unknown frequency – optic neuritis;
  • blood vessels: rarely – venous thromboembolism, arterial thromboembolism;
  • digestive tract: often – nausea, vomiting; infrequently – abdominal pain, diarrhea; very rarely – pancreatitis; unknown frequency – bloating, colitis;
  • liver and biliary tract: rarely – cholelithiasis;
  • skin and subcutaneous tissues: infrequently – skin rash; rarely – erythema nodosum, erythema multiforme; unknown frequency – acne, hirsutism, alopecia;
  • genital organs and the mammary gland: often – a feeling of tension, tenderness of the mammary glands, vaginal discharge; infrequently – an increase in the mammary glands; rarely – discharge from the mammary glands; unknown frequency – painful menstrual bleeding, vaginitis, vulvovaginal candidiasis, chest pain.

The following serious side effects have been reported in women using COCs:

  • venous thromboembolic disorders;
  • arterial thromboembolic disorders;
  • cerebrovascular disorders;
  • increase in blood pressure;
  • hypertriglyceridemia;
  • a decrease in glucose tolerance or effect on peripheral insulin resistance;
  • liver tumors (benign and malignant);
  • impaired liver function;
  • chloasma;
  • the onset or deterioration of jaundice and/or itching associated with cholestasis; the formation of gallstones; hemolytic uremic syndrome; herpes pregnant;
  • hearing loss associated with otosclerosis; Crohn’s disease; ulcerative colitis; cervical cancer.

Contraindications

Tri-Legest tablets are contraindicated in the presence of any of the conditions/diseases listed below. If any of these conditions develop for the first time against the background of its use, the drug should be immediately canceled.

  • hypersensitivity to ethinyl estradiol /and norethindrone;
  • thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary thromboembolism, myocardial infarction);
  • conditions preceding thrombosis (including angina);
  • cerebrovascular disease (stroke, transient ischemic attacks), including in the anamnesis;
  • multiple or pronounced risk factors of venous or arterial thrombosis, including complicated by the defeat of valvular heart disease, atrial fibrillation, cerebral vascular disease or coronary arteries of the heart, severe dislipoproteinemia, uncontrolled hypertension, major surgery, prolonged immobilization, flight lasting more than 4 hours, surgery of the lower limbs and the pelvic organs, neurosurgery smoking over the age of 35;
  • congenital or acquired susceptibility to arterial or venous thrombosis (resistance to activated protein C (including Leiden factor V)), antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia, the presence of antibodies to phospholipids (anti-thrombiolipin, lupocenter antioxidant, anti-phospholipids (anti-cardiolipin, anti-glucocidinemia)
  • a migraine with focal neurological symptoms, including in history;
  • diabetes with vascular complications;
  • pancreatitis with severe hypertriglyceridemia, including in history;
  • liver failure and severe liver disease, including Dubin-Johnson and Rotor syndromes (before normalization of liver enzymes);
  • liver tumors (benign or malignant), including in history;
  • identified hormone-dependent malignant neoplasms (including genitals or mammary glands);
  • children and adolescents (before menarche);
  • vaginal bleeding of unknown origin;
  • obesity;
  • extensive injury;
  • galactose intolerance, lactase deficiency or glucose-galactose malabsorption, fructose intolerance or sucrase-isomaltase deficiency (the product contains lactose monohydrate and sucrose);
  • pregnancy (including suspected);
  • breastfeeding period.

With caution:

  • thrombosis and thromboembolic risk factors: smoking, overweight, dislipoproteinemia, hypertension, migraine without focal neurological symptoms, uncomplicated valvular defects, genetic predisposition to thrombosis (thrombosis, myocardial infarction or a violation of cerebral circulation at a young age in one of the closest relatives);
  • other diseases in which disorders of the peripheral blood circulation can be noted: diabetes mellitus, cancer, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn’s disease, ulcerative colitis, sickle cell anemia, phlebitis of superficial veins;
  • hereditary angioedema;
  • hypertriglyceridemia;
  • diseases that first occurred or aggravated during pregnancy or against the background of the previous use of sex hormones (jaundice, cholestasis, gallbladder disease, otosclerosis with impairment of hearing, porphyria, herpes during pregnancy, Sydenham’s chorea);
  • depression;
  • epilepsy;
  • postpartum period.

Interactions

Effect of other drugs on Tri-Legest

The contraceptive may interact with drugs that induce microsomal enzymes of the cytochrome P450 system, as a result of which the clearance of sex hormones (ethinyl estradiol and norethindrone) may increase, which, in turn, may lead to acyclic breakthrough uterine bleeding and/or a decrease in the contraceptive effect.

  • If microsomal enzyme inducer drugs are applied in a short course. Women who receive treatment with microsomal enzyme inducer drugs in addition toTri-Legest should temporarily use a backup method of contraception or choose a different non-hormonal method of birth control. The backup method of contraception (intrauterine devices or condoms) should be used during the entire period of taking concomitant drugs and for another 28 days after their withdrawal;
  • If microsomal enzyme inducer drugs are used for a long time. Women who receive long-term treatment with microsomal enzyme inducers are advised to consider the use of non-hormonal birth control methods to ensure a more reliable contraceptive effect.

Substances that increase clearance of Tri-Legest (impair efficacy by enzyme induction): barbiturates, bosentan, carbamazepine, phenytoin, primidone, rifampicin, HIV drugs – ritonavir, nevirapine, efavirenz and, possibly, oxcarbazepine, topiramate, as well as a set of drugs, antiviral therapy, nevirapine, nevirapine, efavirenz, oxomemazine, preparations containing St. John’s wort Hypericum perforatum.

Substances with different effects on the clearance of Tri-Legest

When used together with the contraceptive, many inhibitors of HIV protease or hepatitis C virus and non-nucleoside reverse transcriptase inhibitors can either increase or decrease the concentration of estrogen or progestins in the blood plasma. In some cases, this effect may be clinically significant. Therefore, before using these drugs, you should first examine the nature of their possible interaction with the contraceptive and in case of any doubt, use additional backup contraceptives.

In case of joint use of the contraceptive with perampanel, dabrafenib, modafinil or rufinamide, the probability of reducing the effectiveness of contraception due to the acceleration of the metabolism of sex hormones should be considered. It is recommended to use additional backup methods of birth control (intrauterine devices or condoms) during the entire course of joint medication and for 2-6 months after its termination.

The substances that reduce the clearance of Tri-Legest (enzyme inhibitors)

Strong and mild inhibitors of CYP3A4 isoenzyme, such as azole antimycotics (for example, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem and grapefruit juice can increase plasma concentrations of estrogen or progestin.

The use of etoricoxib in doses of 60 and 120 mg per day, when taken in conjunction with the contraceptive, increases the concentration of ethinyl estradiol in blood plasma by 1.4 and 1.6 times, respectively. This increase in ethinyl estradiol concentration should be taken into account when selecting the appropriate COC for co-administration with etoricoxib. This fact can lead to an increase in the frequency of thromboembolism by increasing the exposure to ethinyl estradiol.

A decrease in the effective concentration of ethinyl estradiol in the blood plasma is observed with the simultaneous administration of some antibiotics (penicillins, tetracycline) due to changes in the microflora in the intestine, therefore during therapy with antibiotics (except rifampicin and griseofulvin) and within 7 days after their cancellation it is necessary to use additional backup method of contraception .

The effect of Tri-Legest on other drugs

The contraceptive may affect the metabolism of other drugs, so their concentrations in blood plasma and tissues may increase (for example, cyclosporine) or decrease (for example, lamotrigine).

Interaction with drugs-substrates of CYP1A2 isoenzyme

Since ethinyl estradiol is an inhibitor of the CYP1A2 isoenzyme, the combined use of the contraceptive with the drugs of the CYP1A2 isoenzyme (for example clozapine, mirtazapine, olanzapine, theophylline, zolmitriptan) may increase their plasma concentrations, which, in turn, may increase the risk of side effects.

The combined use of Tri-Legest and inhibitors of HIV protease and hepatitis C may increase the frequency of manifestations of hepatotoxicity (increased activity of hepatic transaminases).

Pregnancy and breastfeeding

The drug cannot be used during pregnancy. If pregnancy is detected during the use of birth control pills, stop using them immediately and consult a doctor. However, extensive epidemiological studies have not revealed an increased risk of developmental defects in children born to women who received ethinyl estradiol and norethindrone before pregnancy or when taking these hormones through negligence in the early stages of pregnancy.

Taking COCs can reduce the amount of breast milk and alter its composition, therefore, the use of Tri-Legest is contraindicated during breastfeeding.

What if I miss a pill?

If you forget to take one or more tablets, the following is suggested:

If you miss one tablet:

  • take the missed tablet the day you remember;
  • take the next tablet at your regular time.

If you miss two tablets in a row (Week 1 or Week 2):

  • take the two missed tablets the day you remember;
  • take two more tablets the next day;
  • then keep taking one tablet per day until the pack is empty;
  • use an additional non-hormonal method of contraception for 7 days following the missed tablets.

If you miss two tablets in a row (Week 3):

Sunday-Start Regimen:

  • take one tablet each day until Sunday;
  • throw out the rest of the pack;
  • start a new pack immediately;
  • use an additional non-hormonal method of contraception for 7 days following the missed tablets.

Day-1 Start Regimen:

  • throw out the rest of the pack;
  • start a new pack that same day;
  • use an additional non-hormonal method of contraception for 7 days following the missed tablets.

If you miss three or more tablets in a row;

Sunday-Start Regimen:

  • take one tablet each day until Sunday;
  • on Sunday, throw out the rest of the pack;
  • start a new pack immediately;
  • use an additional non-hormonal method of contraception for 7 days following the missed tablets.

Day-1 Start Regimen:

  • throw out the rest of the pack;
  • start a new pack that same day;
  • use an additional non-hormonal method of contraception for 7 days following the missed tablets.

The possibility of ovulation, spotting or bleeding increases with each missed tablet. This is particularly likely to occur if you forget to take 2 or more tablets in a row.

Precautions

If you have any of the conditions or risk factors listed below, the possibility of using Tri-Legest for birth control should be discussed with a doctor in advance. If any of the conditions or risk factors deteriorate or occur for the first time, you should contact a doctor to decide whether to continue or stop taking the tablets.

Diseases of the cardiovascular system

Risk of venous thromboembolism (VTE)

The use of any COC increases the risk of VTE compared to women who do not take these drugs. This risk is highest in the first year of taking the drug or when you resume its use after a break of 4 weeks or more.

Risk factors for thromboembolic complications

The risk of venous and arterial thromboembolic complications in women taking COCs can increase significantly with additional risk factors, especially if the risk factors are multiple. The drug is contraindicated if a woman has multiple risk factors for VTE or arterial thromyembolism (ATE). If a woman has more than one risk factor, it is possible that the risk of developing thromboembolic complications will be greater than the simple sum of individual factors. If the balance between benefits and risks turns out to be negative, you should not use this drug.

Risk factors for VTE

  • Obesity. The risk increases significantly with increasing BMI. This risk factor is especially important in women with additional risk factors;
  • Prolonged immobilization, extensive surgery, any surgery on the lower limbs or in the pelvic area, neurosurgery or extensive trauma. In such situations, it is recommended to stop using the tablets (in the case of a planned operation, at least 4 weeks before it) and do not resuem contraception within 2 weeks after complete remobilization. To avoid unwanted pregnancy, you should use another method of contraception. It is necessary to consider the need for antithrombotic therapy if the drug was not canceled in advance. Note: Temporary immobilization, including air flight lasting more than 4 hours, can also be a factor for VTE, especially for women with other risk factors;
  • A family history of VTE (among siblings or parents, especially under the age of 50). If you have a genetic predisposition, you should consult a doctor before using any COC;
  • Other medical conditions associated with the development of VTE: cancer, systemic lupus erythematosus, hemolytic-uremic syndrome, chronic bowel disease (Crohn’s disease or ulcerative colitis), and sickle cell anemia;
  • Age (especially over 35).

There is no consensus on the possible role of varicose veins and thrombophlebitis in the development or progression of venous thrombosis.

The increased risk of thromboembolism during the first 6 weeks of the puerperal period should be considered.

Symptoms of VTE (deep vein thrombosis (DVT) and pulmonary thromboembolism (PE)

If you have symptoms of VTE, you should immediately seek emergency medical care and inform the doctor that you are taking COCs.

Symptoms of DVT may include:

  • unilateral edema of the lower limb and/or foot or along the vein in the lower limb;
  • pain in the lower limbs or soreness, which can only be felt when standing or walking;
  • increased skin temperature of the affected lower limb;
  • redness or paleness of the skin of the lower limb.

Symptoms of pulmonary embolism may include:

  • sudden unexplained shortness of breath or rapid breathing;
  • sudden cough, which may be accompanied by hemoptysis;
  • acute chest pain;
  • severe dizziness;
  • frequent or irregular heartbeat.

Some of these symptoms (for example, shortness of breath or cough) are non-specific and may be incorrectly regarded as manifestations of more frequent and less severe conditions (for example, respiratory tract infection).

Other signs of vessel occlusion may include sudden pain, swelling, and mild limb cyanosis.

With ocular occlusion of the eye vessels, the symptoms can range from painless blurred vision to loss of vision. Sometimes the loss of vision can be acute.

Risk of ATE

Epidemiological studies have linked the use of COCs with an increased risk of ATE (myocardial infarction) or cerebrovascular diseases (for example, transient ischemic attack (TIA), stroke). Arterial thromboembolic events can be fatal.

ATE risk factors include:

  • Age (especially over 35);
  • Smoking. A woman should be advised not to smoke if she wants to take Tri-Legest. Women over 35 who continue to smoke should be strongly advised to use another method of contraception;
  • Obesity. The risk increases significantly with increasing BMI. This risk factor is especially important in women with additional risk factors;
  • A family history of ATE (siblings or parents, especially at relatively young age). If you have a genetic predisposition, you should consult a specialist before using any COC;
  • Migraine. Increased frequency or severity of migraines while taking COCs may be grounds for immediate discontinuation of the drug;
  • Other medical conditions associated with adverse vascular events: diabetes mellitus, hyperhomocysteinemia, valvular disease and atrial fibrillation, dyslipoproteinemia and systemic lupus erythematosus.

Symptoms of ATE

If you have symptoms of ATE, you should immediately seek emergency medical care and inform the doctor that you are taking COCs.

Symptoms of cerebrovascular diseases may include:

  • sudden numbness or weakness of the muscles of the face, arm or leg, especially on one side of the body;
  • sudden difficulties in movement, dizziness, loss of balance or coordination;
  • sudden confusion, problems with speech or understanding;
  • sudden, severe or prolonged headache without a specific reason;
  • sudden one or two-sided loss of vision;
  • fainting with or without convulsions.

If these symptoms are observed for no more than a day, then this condition is regarded as an acute transient circulatory disturbance of the ischemic type – transient ischemic attack (TIA).

Symptoms of myocardial infarction (MI) may include:

  • pain, discomfort, pressure, heaviness, feeling of compression or distension in the chest or behind the sternum, radiating to the back, neck, jaw, upper limb, epigastrium;
  • feeling of fullness in the stomach, indigestion or choking; sweating, nausea, vomiting, dizziness;
  • extreme weakness, anxiety or shortness of breath;
  • frequent or irregular heartbeat.

There is evidence of an increase in the incidence of venous and arterial thrombosis and thromboembolism when taking COCs.

However, the incidence of venous thromboembolism (VTE) that develops when taking COCs is less than the frequency of VTE that occurs during pregnancy.

Women taking COCs reported extremely rare cases of thrombosis of other blood vessels, for example, the liver, mesenteric, renal arteries and veins, the central vein of the retina and its branches. The connection with the use of oral contraceptives has not been proven.

Tumors

One of the significant risk factors for cervical cancer is persistent HPV infection. There are reports of an increased risk of developing cervical cancer with prolonged use of COCs. However, the connection with the use of COCs is not proven. This increase may be associated with the identification of cervical pathology during mandatory examinations prior to the use of COC or sexual behavior. The observed increased risk may be due not only to an earlier diagnosis of breast cancer in women using COCs but also to the biological effects of sex hormones or a combination of these two factors. Breast cancer in women who have taken or are taking COCs is usually detected at clinically less pronounced stages than in women who have never taken these drugs.

In rare cases, the medication caused liver tumors. This should be considered when carrying out a differential diagnosis in the event of severe pain in the abdomen, enlarged liver or signs of intra-abdominal bleeding.

Other states

Women with hypertriglyceridemia (or predisposition to this condition) may have an increased risk of developing pancreatitis while taking COCs.

Although the drug may slightly increase your blood pressure, a clinically significant increase in blood pressure was rarely observed. However, if you have a persistent, clinically significant increase in blood pressure while taking the Tri-Legest, you should cancel the drug and begin treatment of arterial hypertension. You can resume hormonal contraception if you achieve normal blood pressure values with the help of antihypertensive therapy.

Jaundice, pruritus associated with cholestasis, gallstones, porphyria, systemic lupus erythematosus, hemolytic-uremic syndrome, Sydenham’s chorea, herpes during pregnancy, hearing loss associated with otosclerosis may develop or worsen both during pregnancy and while taking COCs. Women with hereditary forms of angioedema may experience the symptoms of angioedema while taking COCs.

Cases of Crohn’s disease and ulcerative colitis have also been described with the use of birth control pills.

Acute diseases or exacerbation of chronic liver diseases may require discontinuation of the contraception until the liver function returns to normal. Recurrent cholestatic jaundice, which was observed for the first time during a previous pregnancy or previous intake of sex hormones, requires discontinuation of the drug. Although COCs may influence insulin resistance and glucose tolerance, there is no need to change the dosage regimen of hypoglycemic drugs in diabetic patients who take low-dose COCs. However, women with diabetes should be carefully monitored while taking Tri-Legest.

Sex hormones can worsen the course of endogenous depression and epilepsy.

Women with a tendency to chloasma should avoid prolonged exposure to the sun and exposure to UV radiation.

The drug contains lactose monohydrate and sucrose. Patients with rare congenital forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption, as well as rare congenital forms of fructose intolerance or sucrase-isomaltase deficiency should not take this drug.

Decreased contraceptive effectiveness

The effectiveness of the medication may be reduced by skipping pills, in the case of gastrointestinal disorders (vomiting or diarrhea) or with the simultaneous use of other preparations. In this case, you should keep taking tablets according to your usual schedule and simultaneously use an additional backup method of preventing pregnancy.

Laboratory tests

Tri-Legest active substances may affect the results of some laboratory tests, including indicators of liver function, kidney, thyroid, adrenal glands, the concentration of transport proteins in the blood plasma, carbohydrate metabolism, coagulation system parameters. Changes usually do not go beyond the normal range.

Effect on the menstrual periods

Women taking COCs may have irregular bleeding (spotting or breakthrough bleeding), especially during the first month of use. For this reason, it is advisable to find out the cause of irregular bleeding only after the adaptation of the organism to the drug, i.e. after about 3 months of use. If irregular bleeding continues or occurs after previous regular cycles, appropriate diagnostic procedures should be performed to exclude a malignant tumor or pregnancy.

Some women may not have withdrawal bleeding during a 7-day break between packs. If the drug was taken in accordance with the instructions, the occurrence of pregnancy is unlikely. However, if some tablets were missed or withdrawal bleeding did not occur 2 times in a row, you need to exclude pregnancy before continuing the use of the drug.

Women should remember that hormonal contraceptives may change the frequency and duration of menstrual bleeding, rectal temperature and the properties of cervical mucus.

Medical examinations

Before taking Tri-Legest, you should undergo a thorough general medical and gynecological examination, including a detailed collection of medical history (including a family history). It is necessary to exclude pregnancy and disorders of the blood coagulation system. The frequency and nature of catch-up examinations should be based on existing standards of medical practice, taking into account the individual characteristics of each patient (usually at least 1 time in 6 months)

You should carefully read the package leaflet and follow the recommendations given in it.

Hormonal contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Influence on the ability to drive vehicles and work with mechanisms

Taking into account the registered side effects (visual impairment, dizziness), women taking Tri-Legest must be careful when driving a car and taking up other potentially dangerous activities that require a high concentration of attention and speed of motor and mental reactions.

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