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Jeanine (Ethinylestradiol/Dienogest) 21 tablets

$40.00

5d4298e50299

Description

The instruction for medical use of Zhaninâ medicine the Trade name of Zhaninâ the International unlicensed name Is not present the Dosage form of the Tablet, covered with a sugar cover Structure One tablet contains active agents: ethinylestradiol of 0.03 mg, diyenogest 2.0 mg, excipients: lactoses monohydrate, starch corn, maltodextrin, magnesium stearate, structure of a cover: sucrose, glucose liquid, calcium carbonate, K 25 povidone, macrogoal 35000, titan dioxide (E 171), wax of karnaubskiya. The description the Smooth, white tablets covered with a sugar cover, round shape Pharmacotherapeutic group Sex hormones and modulators of a reproductive system. Hormonal contraceptives for system use. Progestogens and estrogen (the fixed combination). Diyenogest are also oestrogenic. ATX G03AA16 code the Pharmacological Pharmacokinetics of Diyenogest Absorption Later properties of oral administration diyenogest quickly and almost is completely absorbed, its maximum concentration in blood serum, equal 51 ng/ml, is reached approximately in 2.5 hours. The bioavailability in a combination with ethinylestradiol is about 96%. Distribution of Diyenogest contacts albumine of blood serum and does not contact the globulin, connecting sex hormones (G,CSH) and the kortikoid-connecting globulin (KCG). In a free look there are about 10% of the general concentration in blood serum, about 90% – are nonspecific connected with seralbumin. Induction by ethinylestradiol of synthesis of GSPG does not influence linking of the diyenogest with a serumal protein. The seeming distribution volume for the diyenogest is about 37-45 l/kg. Metabolism of Diyenogest is metabolized mainly by hydroxylation and conjugation with formation of inactive metabolites. The specified metabolites quickly are brought out of blood plasma, thus, in plasma any active metabolite is not noted, and it is found only diyenogest in not changed state. The general clearance is about 3.6 l/h after single use. Removal Decrease in level of the diyenogest in blood serum happens to elimination half-life, making about 9 h. Only an insignificant part of the diyenogest is excreted by kidneys in not changed state. At intake of a dose of 0.1 mg the metabolites are brought to body weight kg with urine and bile in the ratio about 3:2. After intake about 86% of the received dose it is removed within 6 days, and the main part, 42% is removed in the first 24 hours, mainly together with urine. Equilibrium concentration Pharmacokinetics of the diyenogest does not depend on the GSPG level. As a result of daily administration of drug the diyenogest level in serum increases approximately by 1.5 times, an equilibrium concentration is reached in 4 days of reception. Ethinylestradiol Absorption After intake ethinylestradiol is quickly and completely absorbed. The maximum concentration in blood serum, equal about 67 pg/ml, is reached in 1.5-4 hours. During absorption and the first passing through a liver ethinylestradiol is metabolized therefore its bioavailability at intake averages about 44%. Distribution Ethinylestradiol almost completely (about 98%), though is not specific, communicates albumine. Ethinylestradiol induces synthesis of GSPG. The seeming volume of distribution of ethinylestradiol is equal to 2.8 – 8.6 l/kg. Ethinylestradiol is exposed to presistemny conjugation, both in mucous a small intestine, and in a liver. Ethinylestradiol is initially metabolized by aromatic hydroxylation, at the same time various hydroxylated and metilirovanny metabolites provided both in the form of free metabolites, and in the form of conjugates with glucuronic and sulfuric acids are formed. Clearance speed is 2.3 – 7 ml/min. of blood plasma. Removal Reduction of concentration of ethinylestradiol in blood serum has two-phase character, the first phase is characterized elimination half-life about 1 hour, the second — 10 — 20 hours. In not changed view from an organism it is not removed. Metabolites of ethinylestradiol are removed with urine and bile in the ratio 4:6 with elimination half-life about 24 h. Equilibrium concentration the Condition of equilibrium concentration is reached during the second half of a cycle of treatment when the serumal level of drug increases approximately twice in comparison with level at reception of a single dose of drug. A pharmacodynamics All hormonal contraceptive drugs have very low indicator of failure of a method if are applied in compliance by the instruction for use (for example, at the admission of tablets). In clinical trials the Perlya index was calculated the following. The Perlya index (corrected) for assessment of failure of a method makes 0.182 (upper bilateral 95% a confidence interval: 0.358). The general Perlya index (which is not corrected failures of a method + errors from the patient): 0.454 (upper bilateral 95% confidence interval: 0.701). Zhaninâ – the oral combined contraceptive drug containing ethinylestradiol and progestogen diyenogest. The contraceptive effect of the drug Zhanin® is based on interaction of various factors, the most important of which are the inhibition of an ovulation and change of secretion of cervical slime. Diyenogest the nortestosterona with affinity to receptors of in vitro progesterone 10-30 times smaller in comparison with other synthetic progestogens is derivative. These in vivo on animals showed powerful progestagenny and anti-androgenic activity. Diyenogest has no essential androgenic, mineralokortikoidny or glucocorticoid activity of in Vivo. It is established what diyenogest promotes ovulation inhibition in a dose of 1 mg a day. When using high-dosage oral contraceptives (0.05 mg of ethinylestradiol) the risk of developing endometrial cancer and ovaries decreases. As far as these data belong to the low-dosed contraceptives, demands further study. Indications – oral contraception (see the section Special Instructions) the Route of administration and doses of the Tablet should be accepted inside on the order specified on packing, every day approximately at the same time with a small amount of water. Accept on one tablet a day continuously within 21 days. Reception of the following packing begins after a 7-day break in reception of tablets during which cancellation bleeding usually takes place. Bleeding, as a rule, begins for 2-3 day after reception of the last tablet and can not end prior to reception of new packing. How to begin reception of Zhanina® in the absence of reception of any hormonal contraceptives last month the Reception of Zhanina® begins in the first day of a menstrual cycle (i.e. in the first day of menstrual bleeding). Upon transition from other the combined oral contraceptives (COC) it is preferable to begin reception of Zhanina® next day after reception of the last gormonsoderzhashchy tablet from the previous packing of the combined oral contraceptive, but by no means no later than the next day after a usual 7-day break (for the drugs containing 21 tablets) or after reception of the last of not containing tablet of hormone for the drugs containing 28 tablets in packing). · Upon transition from a vaginal ring, a transdermalny plaster it is preferable to begin reception of Zhanina® in day of removal of the last ring or plaster, but by no means no later than that day when the following ring or a plaster had to be applied. · Upon transition from the contraceptives containing only gestagena (mini-drank, injection forms, an implant) or from the intrauterine system (Naval Forces) releasing gestagen. The woman can pass with mini-saw on Zhanin® in any day (without interruption), from an implant or an intrauterine contraceptive with gestageny – in day of its removal, from an injection form – from day when the following injection had to be made. In all cases it is necessary to use in addition barrier method of contraception during the first 7 days of reception of tablets. · After abortion in the first trimester of pregnancy the Woman can begin administration of drug immediately. At observance of this condition the woman does not need additional contraceptive protection. · After the delivery or abortion in the second trimester of pregnancy It is recommended to begin administration of drug for 21-28 day after the delivery or abortion. If reception is begun later, it is necessary to use in addition barrier method of contraception during the first 7 days of reception of tablets. However if the woman already led sex life, prior to reception of Zhanina® the pregnancy has to be excluded or it is necessary to wait for the first periods. Information concerning the feeding period a breast see in the section Special Instructions Reception of the Passed Tablets If delay in administration of drug made less than 12 hours, contraceptive protection does not decrease. The woman has to take the passed pill as soon as possible as soon as she remembers, the following pill is taken in usual time. If delay in reception of tablets made more than 12 hours, contraceptive protection can be reduced. At the same time it is possible to be guided by the following two basic rules: · Administration of drug never has to be interrupted, more than for 7 days. · 7 days of continuous reception of tablets are required for achievement of adequate suppression gipotalamo – hypophysial and ovarian regulation. The following advice in daily practice if delay in reception of tablets made more than 12 hours (an interval can be respectively given from the moment of reception of the last tablet more than 36 hours). · The first week of administration of drug the Woman has to take the last passed pill as soon as possible as soon as she remembers (even if it means reception of two tablets at the same time). The following pill is taken in usual time. The barrier method of contraception (for example, condom) during the next 7 days has to be in addition used. If the sexual contact took place within a week before the admission of a tablet, reliability of drug decreases therefore it is necessary to consider pregnancy approach probability. In process of increase in quantity of the passed tablets and approach of the period of a regular break in reception, pregnancy approach probability increases. · The second week of administration of drug the Woman has to take the last passed pill as soon as possible as soon as she remembers (even if it means reception of two tablets at the same time). The following pill is taken in usual time. If the woman took a pill correctly within 7 days preceding the first admission of a tablet there is no need for use of additional contraceptive measures. Otherwise and also at the admission of two and more tablets it is necessary to use in addition barrier methods of contraception (for example, condom) within 7 days. · The third week of administration of drug the Risk of decrease in reliability is inevitable because of the forthcoming break in reception of tablets. Nevertheless, weakening of contraceptive protection nevertheless can be prevented, having corrected the schedule of reception of tablets. Therefore, adhering to one of two schemes offered below, it is possible to do without additional measures of protection provided that within 7 days before was the first tablet is passed, the woman took all pill correctly. Otherwise she should recommend to use the first of the following schemes and in parallel with it to apply additional methods of contraception within 7 days. 1. The woman has to take the last passed pill as soon as possible as soon as she remembers (even if it means, reception of two tablets at the same time). Then it continues to take a pill in usual time. The following packing should be begun at once after completion of reception of tablets from the current packing, that is without interruption in reception of tablets. Bleeding of cancellation is improbable, the second packing will not end yet, but the smearing discharges and breakthrough bleedings can be noted during reception of tablets. 2. The woman can also interrupt reception of tablets from the current packing. Then it has to take a break for 7 days, including day of the admission of a tablet and then begin reception of new packing. If the woman missed reception of tablets, and then during a break in reception of tablets she has no cancellation bleeding, it is necessary to exclude pregnancy. Recommendations in case of gastrointestinal disorders In heavy gastrointestinal disorders the absorption of drug can be incomplete. In this case it is necessary to take additional measures of contraception. If at the woman within 3-4 hours after reception of a tablet the vomiting was observed, it is necessary to be guided by the councils concerning the admission of tablets. If the woman does not want to change the normal mode of administration of drug, she has to take if necessary an additional pill (or 2 tablets from other packing). Change of day of the beginning of a menstrual cycle to delay the beginning of periods, the woman has to continue reception of tablets from new packing of Zhanin® right after all pill from previous, without interruption in reception is taken. A pill from new packing can be taken as long as the woman wishes (until packing does not end). Against the background of administration of drug from the second packing at the woman the smearing discharges or breakthrough uterine bleedings can be noted. It is necessary to resume reception of Zhanin® from a new pack after a usual 7-day break. To transfer day began periods the next day of week, the woman is recommended to truncate duration of the next break in reception of tablets for so many days on how many she will wish. The interval is shorter, the risk is higher that it will have no cancellation bleeding, and further, there will be smearing discharges and breakthrough bleedings during reception of the second packing (just as in case she like to delay the beginning of periods). Additional information for special categories of patients Children and teenagers the Drug Zhanin® is shown only after approach of menarche. Elderly patients it is not applicable. The drug Zhanin® is not shown after approach of a menopause. Patients with disturbances from a liver the Drug Zhanin® is contraindicated to women with a serious illness of a liver (See also section Contraindications). Patients with disturbances from kidneys the Drug Zhanin® specially was not studied at women with renal failures. The available data do not assume dose adjustment at this group of patients. Side effects the frequency of side effects against the background of reception of Zhanina® based on data of clinical trials is given Below: Often (≥1/100, & lt, 1/10) – a headache – mammary gland pain, including discomfort and tension of mammary glands Infrequently (≥1/1,000, & lt, 1/100) – vaginity / a vulvovaginitis, vaginal candidiasis or other fungal vulvovaginal infections – the increased appetite – decrease in mood – dizziness, migraine – arterial hypertension and hypotension – an abdominal pain, including in upper and lower departments, discomfort and feeling of raspiraniye in a stomach, nausea, vomiting, diarrhea – rash, including spotty and acne rash, an alopecia, an itching, including generalized – vaginity / a vulvovaginitis, vaginal candidiasis or others – pathological bleedings of cancellation, including a menorrhagia, a hypomenorrhea, an oligomenorrhea, an amenorrhea, intermenstrual bleedings (vaginal or uterine), increase in the sizes of mammary glands, including swelling and feeling of inflow, hypostasis of mammary glands, a dysmenorrhea, discharges from a genital tract, oothecomas, pains in pelvic area – fatigue, including an indisposition and an asthenia – a body weight increase Seldom (≥1/10,000, & lt, 1/1000) – reactions of hypersensitivity – a salpingo-oophoritis, infections of urinary tract, cystitis, mastitis, a cervicitis, fungal infections, candidiasis, flu, herpes of a mucous membrane of a mouth, bronchitis, sinusitis, upper respiratory tract infections, a viral infection – a uterus leiomyoma, a lipoma of a mammary gland – anemia – virilescence – anorexia – a depression, mental disturbances, insomnia, sleep disorders, aggression – an ischemic stroke, cerebrovascular disturbances, dystonia – xerophthalmus, irritation of eyes, a disorder of vision, an ostsillopsiya – a sudden hearing loss, tinnita, vertigo, a hearing disorder – cardiovascular disturbances, tachycardia – a venous thrombembolia (VTE), an arterial thrombembolia
, an embolism of a pulmonary artery, thrombophlebitises, diastolic hypertensia, orthostatic circulator dysregulation, inflows of heat, a varicosity, changes in veins, vein pains – bronchial asthma, a hyperventilation – dyspepsia, gastritis, enteritis – allergic dermatitis, atopic dermatitis / neurodermatitis, eczema, psoriasis, a hyperhidrosis, a hloazma, disturbances a pigmentation/hyperpegmentation, seborrhea, dandruff, a hirsutism, skin reactions and changes from skin, a symptom of orange skin, an arachnoid nevus – dorsodynias, musculoskeletal discomfort, myalgias, extremity pains – a cervical dysplasia, a cyst of appendages of a uterus, pain in the field of uterus appendages, a lactocele, a fibrocystic disease of mammary glands, the genitals pain connected with sexual intercourse, a galactorrhoea, menstrual disturbances – pains behind a breast, peripheral hypostases, grippopodobny diseases, inflammatory diseases, a pyrexia, irritability – the increased level of triglycerides of plasma, a hypercholesterolemia, decrease in body weight, change in body weight – a demonstration of an asimptomny additional mammary gland With an unknown frequency (are revealed only in the course of post-marketing observations) – change of mood, decrease in a libido, increase in a libido – intolerance of contact lenses – a small tortoiseshell, a knotty erythema, a multiformny erythema – discharges from mammary glands – a liquid delay the Description of separate side reactions the Following side reactions were noted at the women using the combined oral contraceptives which are also described in the section Special Instructions: – frequency of the diagnosis of a breast cancer is slightly increased among the women accepting oral contraceptives. As the breast cancer is noted seldom at women 40 years are younger, increase in number of diagnoses is insignificant in relation to the general risk of developing this disease. Its communication with reception of the combined oral contraceptives is not proved. – liver tumors (benign and malignant) – cervical cancer Other states – at women with a gipertriglitseridemiya is raised risk of developing pancreatitis during reception of the combined oral contraceptives. – arterial hypertension – emergence or deterioration in the following states which communication with reception of the combined oral contraceptives is not proved: jaundice and/or an itching connected with a cholestasia, forming of stones in a gall bladder, a porphyria, a system lupus erythematosus, a hemolytic uraemic syndrome, Sydenham’s chorea, herpes of pregnant women, a hearing loss connected with an otosclerosis – at women with a hereditary Quincke’s disease is provoking or aggravation of symptoms of a disease under the influence of exogenous estrogen – abnormal liver functions – disturbance of tolerance to glucose or effects of peripheral insulin resistance – Crohn’s disease and nonspecific ulcer colitis – a hloazma of Interaction – breakthrough bleedings and/or decrease in contraceptive efficiency of drug owing to interactions of the combined oral contraceptives with medicines (inductors of enzymes of a liver) of the Contraindication the Combined hormonal contraceptives should not be applied in the presence of any of the states which are listed below. If any of these states develop for the first time against the background of reception of the combined hormonal contraceptive, drug has to be immediately cancelled. – existence or risk of a venous thrombembolia · a venous thrombembolia now (on anticoagulating therapy) or in the anamnesis (for example, a deep vein thrombosis, or a pulmonary embolism) · hereditarily the caused or acquired predisposition to a venous thrombembolia (for example, resistance to the activated protein With (including the V Leiden factor), deficiency of antithrombin III, a protein With or S protein · big surgical interventions with a long immobilization · high risk of a venous thrombembolia owing to existence of multiple factors of risk (See also section Special Instructions). – existence or risk of an arterial thrombembolia · an arterial thrombembolia now or in the anamnesis (for example, a myocardial infarction) or the states preceding an arterial thrombembolia (for example, stenocardia) · cerebrovascular disturbances – a stroke now or in the anamnesis or the states preceding cerebrovascular disturbances (for example, the tranzitorny ischemic attacks) · hereditarily the caused or acquired predisposition to an arterial thrombembolia (for example, a gipergomotsisteinemiya and anti-phospholipidic antibodies (antibodies to cardiolipin and lupoid anticoagulant) · migraine with focal neurologic symptoms in the anamnesis · high risk of developing an arterial thrombembolia owing to existence of multiple factors of risk, such, as: – diabetes with vascular complications – the profound arterial hypertension – the expressed dislipoproteinemiya – pancreatitis with the expressed gipertriglitseridemiya now or in the anamnesis. – a serious illness of a liver now or in the anamnesis (before normalization of hepatic tests) – the liver tumor (benign or malignant) now or in the anamnesis – the revealed hormonedependent malignant diseases (for example, genitals or mammary glands) or suspicion of them – vaginal bleeding of not clear genesis – hypersensitivity to any of drug components Medicinal interactions When assigning of the accompanying therapy needs to study the section of medicinal interactions of each of the appointed drugs for identification of potential interactions Effects of other drugs on Jeanine â Vozmozhno interaction with the medicines inducing liver enzymes that can promote increase of clearance of sex hormones and lead to breakthrough bleedings and/or decrease in contraceptive efficiency of drug. Induction of enzymes can be observed after several days of treatment. The maximum enzyme induction is usually shown within several weeks. After the treatment termination the induction of enzymes can remain within 4 weeks. A short-term course of treatment it is recommended to Women at whom the short course of treatment is conducted by the drugs inducing liver enzymes to use a barrier method of contraception in addition to Zhaninuâ or to choose other method of contraception. At the same time the barrier method of contraception should be used during the period of the accompanying administration of drugs and within 28 days after their cancellation. If the period of use of a barrier method of protection comes to an end later, than tablets in packing of Zhaninâ, it is necessary to pass to the following packing of Zhaninaâ without usual break in reception of tablets. A long course of treatment it is recommended to Women at whom the long course of treatment is conducted by the drugs inducing liver enzymes to use other reliable, non-hormonal method of contraception. The substances increasing clearance of the combined oral contraceptives (reducing efficiency of the combined oral contraceptives owing to induction of enzymes of a liver), for example: Phenytoinum, barbiturates, Primidonum, carbamazepine and rifampicin, are also the assumptions concerning an okskarbazepin, the topiramat, the felbamat, griseofulvin and the drugs containing a St. John’s wort. Substances with various effects on clearance of the combined oral contraceptives At the combined use with the combined oral contraceptives many VICh/HCV protease inhibitors and nenukleozidny inhibitors of reverse transcriptase can raise or reduce concentration of estrogen or progestins in blood plasma. The specified changes in certain cases can have relevant value. Therefore, it is necessary to study the instruction for use on the medicines applied together with Zhaninâ to identification of potential interactions and what appointment – or recommendations. The women receiving treatment by inhibitors of protease or nenukleozidny inhibitors of reverse transcriptase in case of doubt should use an additional barrier method of contraception of Substance, reducing clearance of the combined oral contraceptives (inhibitors of enzymes) the Clinical importance of potential interactions with inhibitors of enzymes it is unknown. Combined use with powerful CYP3A4 inhibitors can increase concentration of estrogen or progestin or both substances in blood plasma. The Etorikoksib in a dose from 60 to 120 mg/day increases concentration of ethinylestradiol in plasma by 1.4-1.6 times at a concomitant use with the combined hormonal contraceptives containing 0.035 mg of ethinylestradiol. Influence of Zhanin® on other drugs the Combined oral contraceptives can influence metabolism of other drugs that leads to increase (for example, cyclosporine) or to reduction (for example, a lamotridzhina) their concentration in blood plasma and fabrics. However, proceeding from these researches in vitro, development of inhibition of enzymes of a system of P450 cytochrome when assigning the diyenogest in a therapeutic dose is improbable. Data of clinical trials assume that ethinylestradiol inhibits clearance of CYP1A2 substrates that leads to increase in their concentration in weak degree (for example, theophylline) or in moderated (for example, tizanidin). Other forms of interaction Laboratory tests Intake of contraceptive steroids can affect results of some laboratory researches, including biochemical parameters of function of a liver, thyroid gland, adrenal glands and kidneys, plasma concentration of proteins, for example, of the globulins connecting corticosteroids and fractions of lipids/lipoproteids, parameters of carbohydrate metabolism and parameters of coagulation. Changes usually do not overstep the bounds of normal values. Special instructions the Decision on purpose of Zhaninâ should be made taking into account the risk factors which are available for the woman, in particular development of a venous thrombembolia and assessment of risk of developing a venous thrombembolia against the background of reception of Zhaninaâ in comparison with other combined hormonal contraceptives individually. Precautionary measures and preventions If any of the states/risk factors provided below are available now, it is necessary to discuss expediency of use of Zhaninaâ with the woman. In case of strengthening or the first manifestation of any of these states or risk factors the woman has to consult with the doctor who can make the decision on need of cancellation of Zhaninaâ. At suspicion or confirmation of a venous thrombembolia (VTE) or an arterial thrombembolia (ATE) it is necessary to stop reception of the combined hormonal contraceptives. If to the woman anticoagulating therapy is appointed, it is necessary to provide adequate contraception alternative with method, considering teratogenic effect of anticoagulating therapy (coumarins). · Circulator disturbances Risk of a venous thrombembolia Use of any combined hormonal contraceptives increases risk of development of VTE at patients, in comparison with women, not using them. The drugs containing levonorgestrel norgestimat and Norethisteronum have the smallest risk of development of VTE. It is unknown what risk Zhaninâ in comparison with the specified drugs having low risk has. The decision on use of such drugs, than any other with low risk of VTE, has to be accepted only after joint discussion with the woman. It is necessary for providing a guarantee that the woman is informed on risks of development of VTE against the background of Zhaninaâ and how the risk factors which are available for it will affect the specified risk and also that the risk of VTE is maximum in the first year of use. Besides, there are some proofs that increase in risk can be noted when resuming reception of the combined oral contraceptive after a break in reception within 4 weeks or more. At the women who are not applying the combined hormonal contraceptives and in the absence of pregnancy, VTE develops with a frequency of 2 on 10,000 cases for 1 year. However this risk can increase considerably depending on individual risk factors of each woman (see below). Results of epidemiological researches showed that among the women using the low-dosed combined hormonal contraceptives (& lt, 0.05 mg of VTE ethinylestradiol arise at 9–12 of 10,000 women) within a year. It is supposed that from 10,000 women accepting the combined hormonal contraceptives, containing about levonorgestrel in 6 cases VTE during 1 year develops. Limited data of epidemiological researches demonstrates that risk of development of VTE against the background of reception of KGK containing diyenogest can be similar to risk at reception of KGK containing levonorgestrel. The specified frequency of development of VTE at a course of year is lower, than expected at pregnancy and in a puerperal period. The venous thrombembolia can lead to a lethal outcome in 1-2% of cases. At the women accepting the combined hormonal contraceptives it was extremely seldom reported about cases of development of thrombosis of other blood vessels, for example hepatic, mezenterialny, renal, cerebral arteries and veins and also vessels of a retina. &
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