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Visan 2 mg (28 tablets)




The instruction for medical use of Vizanna Torgovoye medicine Vizann Mezhdunarodnoye’s name the unlicensed name Diyenogest Lekarstvennaya a form of the Tablet of 2 mg Structure One tablet contains active agent – diyenogest micronized 2 mg, excipients: lactoses monohydrate, potato starch, cellulose microcrystalline, K25 povidone, talc, krospovidon, magnesium stearate. The description of the Tablet of white or almost white color of round shape with a flat surface and slanted edges with an engraving In on one party, with a diameter of 7 mm. Pharmacotherapeutic group Sex hormones and modulators of a reproductive system. Progestogens. Pregnadiene derivatives. Diyenogest. The ATX G03DB08 code the Pharmacological Pharmacokinetics Absorption Later properties of oral administration diyenogest is quickly and almost completely soaked up. The maximum concentration in blood serum making 47 ng/ml is reached approximately in 1.5 h after single dose inside. The bioavailability is about 91%. The diyenogest pharmacokinetics in the dose range from 1 to 8 mg is characterized by dependence on a dose. Distribution of Diyenogest contacts albumine of plasma and does not contact the globulin, connecting sex hormones (G,CSH) or the corticosteroid-the connecting globulin (CCG). In a free look there are 10% of the general concentration in blood serum whereas about 90% are nonspecific connected with seralbumin. The seeming distribution volume for the diyenogest (Vd/F) is 40 l. Metabolism of Diyenogest is almost completely metabolized by the known ways of metabolism of steroids, mainly with formation endocrinological of inactive metabolites. Proceeding from results of the researches in vitro and in Vivo, the main enzyme participating in metabolism of the diyenogest is CYP3A4. Metabolites are removed very quickly, thus, the prevailing fraction in blood plasma is not changed diyenogest. Speed of metabolic clearance (Cl/F) is 64 ml/min. of blood serum. Elimination Concentration of the diyenogest in blood serum decreases dvukhfazno. Elimination half-life in a terminal phase makes about 9-10 h. After intake in a dose of 0.1 mg/kg diyenogest it is removed in the form of metabolites which are allocated with urine and excrements in the ratio about 3:1. Elimination half-life of metabolites at their excretion with urine makes 14 h. After intake about 86% of the received dose it is removed within 6 days, and the main part 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 1.24 times, an equilibrium concentration is reached in 4 days of reception. The diyenogest pharmacokinetics after repeated reception of Vizanny® can be predicted on the basis of pharmacokinetics after single reception. The pharmacodynamics of Diyenogest represents derivative a nortestosteron, not having androgenic activity, but having substantially anti-androgenic effect which is about one third of activity of a tsiproteron of acetate. Diyenogest contacts progesterone receptors in a uterus of the person, possessing at the same time only 10% of relative affinity of progesterone. Despite low affinity to progesterone receptors, diyenogest it is characterized by powerful progestagenny effect of in Vivo. Diyenogest has no essential androgenic, mineralokortikoidny or glucocorticoid activity of in Vivo. Diyenogest influences endometriosis, reducing endogenous products of oestradiol and by that, suppressing its trophic effects both on eutopichesky, and on ectopic endometrium. At continuous use diyenogest creates a hypoestrogenic, gipergestagenny endocrine environment, causing an initial detsidualization of fabric of endometrium with the subsequent atrophy of the endometrioid centers. Data on efficiency Superiority of Vizanny® over placebo was shown in the course of the 3kh-month research with participation of 198 patients with endometriosis. The pelvic pain connected with endometriosis was measured by means of a visual analog scale (0-100 mm). In 3 months of the Vizanna® drug treatment the significant distinction in comparison with placebo was shown (Δ = 12.3 mm, 95% of D (Confidence interval): 6.4–18.1, p&lt, 0.0001) and clinically significant reduction of pains in comparison with initial level (an indicator of decrease in =27.4 mm +22.9) In 3 months of treatment, at 37.3% of patients the pelvic pains connected with endometriosis decreased by 50% and more without increase in the accompanying intake of the anesthetizing drugs (placebo: 19.8%), reduction of pelvic pain by 75% and more without the accompanying increase in intake of the anesthetizing drugs is reached at 18.6% of the patients accepting Vizannu® (placebo: 7.3%). During an additional open phase of this placebo – a controlled research further reduction of pelvic pains in the course of treatment lasting up to 15 months was observed. Besides, the efficiency of Vizanny®, concerning the pelvic pain connected with endometriosis, was shown in the course of the 6-month comparative research Vizanny® and an analog of gonadotrophin-rileasing-hormone (AGTRG) of the leyprorelin acetate (LA) including 252 patients with endometriosis from whom 120 patients received Vizannu®. In three researches with participation in general 252 patients receiving diyenogest in a dose of 2 mg a day after 6 months of treatment were shown significant reduction of the endometrioid centers. In a research with small sample (N = 8) daily reception of the diyenogest in a dose of 1 mg suppressed an ovulation in 1 month of treatment. The contraceptive effect of Vizanny® in larger researches was not studied. Data on safety during treatment of Vizannoy® levels of endogenous estrogen are suppressed only in moderate degree. Now long-term data on the mineral density of a bone (MDB) and risk of changes when using the drug Vizanna® are not available. Bone mineral density (MPK) was estimated at 21 adult patients prior to treatment and in 6 months of treatment, at the same time reduction of an average value of bone mineral density was not noted. At 29 patients receiving a leyprorelin acetate (LA), average decrease by 4.04% ± 4.84 it was noted for the same period (Δ between groups = 4.29%, 95% of D: 1.93 – 6.66, r & lt, 0.0003). Against the background of reception of Vizanny® within 15 months (n=168) the significant effect on standard laboratory parameters, including hematologic and biochemical parameters of blood, liver enzymes, lipids and HbA1C (glikozilirovanny hemoglobin) is not revealed. Safety at teenagers Safety of Vizanny® concerning MPK was studied in uncontrollable clinical trial lasting 12 months with participation of 111 patients of teenagers aged from 12 up to 18 years with clinically expected or confirmed endometriosis. At measurement of MPK at 103 patients the average relative change of an indicator of MPK of lumbar department of a backbone (L2 vertebrae – L4) in comparison with an initial indicator which was-1.2% was shown. The subsequent measurement executed in 6 months after the end of treatment at group of patients with a reduced indicator of MPK showed increase in MPK to-0.6%. Indications – treatment of endometriosis the Route of administration and doses the Route of administration For intake. The dosing mode Reception of tablets can be begun in any day of a menstrual cycle. Accept on one tablet a day without interruption, preferably at the same time every day, if necessary washing down with liquid. A pill needs to be taken continuously regardless of vaginal bleedings. After completion of one packing begin reception of the following packing without interruption in reception of tablets. Experience of use of Vizanny® in treatment of endometriosis lasting more than 15 months is absent. It is necessary to stop reception of any hormonal contraceptives before an initiation of treatment the drug Vizanna®. In need of contraception it is necessary to use non-hormonal methods of contraception (for example, a barrier method). The efficiency of Vizanny® can decrease at the admission of tablets, in vomiting and/or diarrhea (if it occurs within 3-4 hours after reception of a tablet). In case of the admission of one or several tablets the woman should take only one pill as soon as she remembers it, and then next day to continue reception of tablets in usual time. The tablet which is not absorbed owing to vomiting or diarrhea should be replaced with additional reception of one tablet. Additional information on special populations of patients Use in pediatrics the Drug Vizanna® is not shown for girls before menarche. Safety and efficiency of the drug Vizanna® was studied in uncontrollable clinical trial lasting 12 months with participation of 111 patients of teenagers aged from 12 up to 18 years with clinically expected or confirmed diagnosis endometriosis (see the sections Special Instructions and Pharmacodynamics). Elderly patients patients of advanced age do not have Vizanny® corresponding indications. Patients with a liver failure the Drug Vizanna® is contraindicated in the presence of a serious illness of a liver in the past and now. The patient with a renal failure is not available the data indicating the need to dose adjustment at patients with a renal failure. Side effects Side effects arise in the first months of reception more often Vizanny® and their frequency decreases in the course of drug treatment. The changes in the nature of bleedings, such as, smearing discharges, irregular bleedings or an amenorrhea can be noted. The following side effects were noted at women against the background of reception of Vizanny®. To the most frequent side effects in the course of treatment of Vizannoy®, belong: a headache (9.0%), discomfort in mammary glands (5.4%), depressive mood (5.1%) and an acne (5.1%). Besides, at most of the patients treated with Vizannoy® changes in the nature of menstrual bleedings were observed. Menstrual bleedings were systematically estimated on the basis of diaries of patients, and analyzed by means of the 90-day reporting period by a method of WHO. During the first 90 days of the Vizanna® drug treatment the following nature of bleedings was observed (n=290, 100%): an amenorrhea (1.7%), infrequent bleedings (27.2%), frequent bleedings (13.4%), irregular bleedings (35.2%), long bleedings (38.3%), normal bleedings, i.e. any of above-mentioned (19.7%). During the fourth reporting period the following nature of bleedings was observed: (n=149, 100%): an amenorrhea (28.2%), infrequent bleedings (24.2%), frequent bleedings (2.7), irregular bleedings (21.5%), long bleedings (4.0%), normal bleedings, i.e., any of above-mentioned (22.8%). Changes of nature of menstrual bleedings were seldom reported by patients as side effect. The undesirable medicinal reactions distributed on classes of a system of bodies according to MedDRA – the Medical dictionary for regulatory activity are given below. Side effects in each frequency group are provided in decreasing order of frequency. Indicators of frequency are based on the integrated data of four clinical trials with participation of 332 patients (100%). Often (≥1/100 and & lt, 1/10) – a body weight increase – depressive mood, changes of mood, a sleep disorder, nervousness, loss of a libido – a headache, migraine – nausea, an abdominal pain, a flatulention, an abdominal distension, vomiting – an acne, an alopecia – dorsodynias – discomfort in mammary glands, an oothecoma, inflows of heat, matochnye* / the vaginal bleedings including smearing discharges – asthenic states, irritability Infrequently (≥1/1000 to & lt, 1/100)) – anemia – decrease in body weight, the increased appetite – concern, a depression, mood swings – an imbalance of the autonomic nervous system, disturbance of attention – xerophthalmus – a ring in ears – nonspecific disturbances of blood circulation, heartbeat, arterial hypotension – short wind – an ulitis, discomfort in a stomach, diarrhea, a constipation, inflammatory diseases of digestive tract – dryness of integuments, a hyperhidrosis, an itching, a hirsutism, an onikhoklaziya, dandruff, dermatitis, a growth disorder of hair, reactions of photosensitivity, pigmentation disturbance – ostealgias, muscular spasms, extremity pains, heavy feeling in extremities – infections of urinary tract – vaginal candidiasis, dryness in vulvovaginal area, discharges from a genital tract, pains in pelvic area, an atrophic vulvovaginitis, sites of consolidation in a mammary gland, fibrous and cystous mastopathy, the general consolidation of mammary glands – hypostases For designation of specific side reaction is given the most suitable term from MedDRA – the Medical dictionary for regulatory activity (version 11.0). Synonyms or the accompanying states are not listed, but they also should be taken into account. * the nature of the observed bleedings: the amenorrhea, infrequent bleedings, frequent bleedings, irregular bleedings, long bleedings, normal bleedings i.e. which are not getting in one of the previous categories. Reduction of bone mineral density In uncontrollable clinical trial with participation of 111 patients (12 – 18 years) receiving the Vizanna® drug treatment at 103 patients took measurement of MPK. Approximately at 72% of patients of this research the decrease in MPK of lumbar department of a backbone (L2 vertebrae – L4) after use of drug for 12 months was revealed. Contraindications of Vizannu® should not be applied in the presence of any of the listed below states, a part from which is given on the basis of the available information on other drugs containing only a gestagenny component. If any of these states develops against the background of reception of Vizanny®, use of drug should be stopped immediately. – active venous thromboembolic disturbances – a heart disease and arteries (for example, a myocardial infarction, cerebrovascular disturbances, coronary heart disease) now or in the past – diabetes with vascular complications – a serious illness of a liver now or in the past until indicators of hepatic function do not return to normal – liver tumors (benign and malignant) now or in the past – the revealed or suspected malignant tumors dependent on sexual steroids – vaginal bleeding of not clear genesis – hypersensitivity to active agent or to any of excipients Medicinal interactions the Note: it is necessary to study the instruction for medical use of at the same time applied medicines for identification of potential interactions. Influence of other medicines on Vizannu® Separate inductors or inhibitors of enzymes (CYP3A isoenzyme) Progestins, including diyenogest, are metabolized mainly with participation of the system of P450 3A4 cytochrome (CYP3A4) localized both in mucous intestines and in a liver. Therefore, inductors or CYP3A4 inhibitors can influence metabolism of gestagenny drugs. The increased clearance of sex hormones caused by induction of enzymes can lead to decrease in therapeutic effect of Vizanny® and also cause side effects, for example, change of nature of uterine bleedings. Decrease in clearance of sex hormones in connection with inhibition of enzymes can increase exposure of the diyenogest that can lead to development of side effects. – The substances increasing clearance of sex hormones (decrease in efficiency by induction of enzymes), for example: Phenytoinum, barbiturates, Primidonum, carbamazepine, rifampicin and also, perhaps, okskarbazepin, topiramat, felbamat, the griseofulvin and means containing a St. John’s wort. Induction of enzymes, as a rule, is noted in several days after the beginning of therapy, the maximum induction is noted within several weeks and then about 4 weeks after the therapy termination can remain. The effect of the inductor CYP3A4 of rifampicin was studied at healthy women in a postmenopause. At simultaneous use of rifampicin with the tablets containing oestradiol a valerate/diene
gest the significant decrease in equilibrium concentration and system exposure of the diyenogest and oestradiol was noted. The system exposure of the diyenogest and oestradiol at equilibrium concentration determined by the size AUC (0-24 h) was reduced by 83% and 44% respectively. – Substances with variable influence on clearance of sex hormones, for example: At combined use with sex hormones many drugs for treatment of HIV and hepatitis C and nenukleozidny inhibitors of reverse transcriptase can increase or reduce concentration of progestins in blood plasma. In certain cases such changes can be clinically significant. – The substances reducing clearance of sex hormones (inhibitors of enzymes) of Diyenogest is substrate of P450 (CYP) 3A4 cytochrome. The clinical importance of possible interaction with inhibitors of enzymes is not known. The accompanying use with strong inhibitors of enzymes (CYP) 3A4 can increase concentration of the diyenogest in blood plasma. At combined use of strong inhibitor of a ketokonazol the increase in the AUC diyenogest (0-24 h) in an equilibrium state was made by 2.9. At a concomitant use of moderate inhibitor of AUC erythromycin of the diyenogest (0-24 h) in an equilibrium state increased by 1.6. Influence of Vizanny® on other medicines Proceeding from these researches of inhibition in vitro, is improbable development of clinically significant interaction of Vizanny® with metabolism of other medicinal substances with participation of enzymes of a system of P450 cytochrome. Interaction with foodstuff the Standardized meal with the high content of fats did not influence bioavailability of Vizanny®. Laboratory tests Intake of progestogens 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 before reception of Vizanny® it is necessary to exclude pregnancy (see the section Pregnancy and Lactation’). At the pregnancy which arose at the women using contraceptive drugs only with a gestagenny component (for example, minipit) high probabilities of its ectopic localization, in comparison with the pregnancy which arose against the background of reception of the combined oral contraceptives. Therefore the question of use of Vizanny® for women with an extrauterine pregnancy in the anamnesis or with dysfunction of uterine tubes has to be solved only after careful assessment of a ratio of advantages and risks. As Vizanna® represents drug only with a gestagenny component, it is possible to assume that special cautions and precautionary measures for use of other drugs with a gestagenny component, are also applicable also for use of Vizanny® though not all cautions and precautionary measures are based on the corresponding results in the course of clinical trials of Vizanny®. At existence or aggravation of any of the listed below states or risk factors, before the beginning or continuation of reception of Vizanny® it is necessary to carry out the individual assessment of a ratio risk/advantage. Blood circulation disturbances indicate Results of epidemiological researches in insignificant degree presence of interrelation between use of drugs only with a gestagenny component and the increased risk of developing a myocardial infarction or thrombembolia of vessels of a brain. Risk of development of cardiovascular disturbances and disturbances of cerebral circulation is connected more likely with increase in age of the woman, presence of arterial hypertension and smoking. Against the background of administration of drugs only with a gestagenny component can raise a little risk of developing a stroke at the women having arterial hypertension. Some researches demonstrate insignificant, but significant increase in risk of developing a venous thrombembolia (a deep vein thrombosis, an embolism of a pulmonary artery) against the background of use of drugs only with a gestagenny component. The age, obesity, a long immobilization, large surgical intervention or an extensive injury belong to the conventional risk factors of developing a venous thrombembolia the corresponding family anamnesis (presence of a thrombembolia ever at close relatives or parents at rather young age). In case of a long immobilization it is desirable to stop reception of Vizanny® (in case of the planned operation, at least, in four weeks prior to it) and not to resume reception within two weeks after the termination of an immobilization. It is necessary to consider the increased risk of developing a thrombembolia in a puerperal period. At emergence or suspicion on any symptoms of arterial or venous thrombosis it is necessary to stop administration of drug immediately. Tumors Meta-analysis of 54 epidemiological researches revealed small increase in relative risk (RR=1.24) in development of a breast cancer in the women using oral contraceptives at the time of the research, is mainly oestrogenic-gestagennye drugs. The increased risk gradually disappears within 10 years after the termination of use of the combined oral contraceptives. Because the breast cancer is noted seldom at women 40 years are younger, increase in number of diagnoses of a breast cancer at the women accepting the combined oral contraceptives now or accepting recently is insignificant in relation to the general risk of developing this disease. Risk of developing a breast cancer at the women using hormonal contraceptives only with a gestagenny component, perhaps is similar in size to the corresponding risk in connection with use of the combined oral contraceptives. However the facts relating to drugs only with a gestagenny component are based on much populations of the women, smaller on number, using them and therefore are less convincing, than data on the combined oral contraceptives. On the basis of these researches the relationship of cause and effect is not proved. Observed increase in risk can be a consequence of earlier diagnosis of a breast cancer at the women applying the combined oral contraceptives, biological effects of the combined oral contraceptives or a combination of both factors. At the women ever using the combined oral contraceptives earlier stages of a breast cancer, than at women, never their applying, as a rule, come to light. In some cases, tumors of a liver can lead to zhizneugrozhayushchy intraabdominal bleedings. In case of appearance of severe pains in upper area of a stomach, increase in a liver or symptoms of intraabdominal bleeding at the woman accepting Vizannu® when carrying out the differential diagnosis it is necessary to consider a liver tumor. Change of nature of bleedings At most of women reception of Vizanny® affects the nature of menstrual bleedings (see the section Side effects). Serious uterine bleedings Against the background of use of Vizanny® can amplify uterine bleedings, for example, at women with an adenomyosis or a leiomyoma of a uterus. Plentiful and enduring bleedings can lead to anemia (in certain cases heavy). In such cases it is necessary to consider a question of cancellation of Vizanny®. Osteoporosis of Change in bone mineral density (MPK) Use of the drug Vizanna® for teenagers (12-18 years) during the period of treatment lasting 12 months was connected with decrease in MPK of lumbar department of a backbone (L2-L4). Average relative decrease in MPK from initial level by the end of treatment was 1.2% with a range of-6% and 5% (IC of 95%:-1.70% and 0.78%, n=103). Repeated measurement of MPK in 6 months after the end of treatment in group with reduced indicators showed a tendency to increase in MPK (average relative decrease from an initial indicator by the end of treatment was 2.3%, and in 6 months after the end of treatment of 0.6% in the range of-9% and 6% (IC of 95%:-1.20% and 0.06% (n=60). Decrease in MPK causes some concerns at teenage age and at the advanced teenage age as this period is critical in a growth ratio of bones. It is unknown whether decrease in MPK influences the maximum bone weight at this population and increase in risk of changes further. Patients with high risk of developing osteoporosis should carry out carefully the assessment advantage risk before prescribing of drug as levels of endogenous estrogen are suppressed only in moderate degree during treatment of Vizannoy®. To women of any age sufficient consumption of calcium and vitamin D with food or in the form of vitamin supplements is important for health of a bone tissue. Other conditions of the Patient with a depression in the anamnesis need careful observation. If the depression recurs in a serious form, drug should be cancelled. In general, Vizanna®, does not influence the level of arterial blood pressure at normotensive women. However if against the background of reception of Vizanny® there is persistent clinically apparent arterial hypertension, it is recommended to cancel administration of drug and to carry out hypotensive treatment. At a recurrence of cholestatic jaundice and/or cholestatic itching, for the first time arisen against the background of pregnancy or the previous use of sexual steroids, reception of Vizanny® needs to be cancelled. Визанна® can have insignificant impact on peripheral insulin resistance and tolerance to glucose. During reception of Vizanny® it is necessary to watch carefully the women having diabetes, in particular in the presence of gestational diabetes (during pregnancy) in the anamnesis. In certain cases there can be a development of a hloazma, especially at women from hloazmy pregnant women in the anamnesis. To the women inclined to development of a hloazma, during reception of Vizanny® it is necessary to avoid influence of the sun or ultraviolet radiation. During use of Vizanny® there can be persistent follicles of ovaries (which are often called functional cysts of ovaries). The majority of such follicles has symptomless character though some can be followed by pains in the field of a basin. Lactose contains In one tablet Vizanny® 62.8 mg of lactose of monohydrate. At the patients with rare inherited disorders, such as intolerance of a galactose, deficiency of Lapp lactase or glyukozo-galaktozny malabsorption who are on a delactosed diet it is necessary to consider amount of the lactose which is contained in Vizanne®. Medical examination Before the beginning or resuming of reception of Vizanny® it is necessary to get acquainted in detail with a case history of the patient and to perform physical and gynecologic examination, taking into account contraindications and special instructions. Inspections should be repeated periodically during reception of Vizanny®. Frequency and the nature of such inspections are defined for each woman individually, but in general it is necessary to include a research of arterial blood pressure, a condition of mammary glands, abdominal organs and a small pelvis, including a cytologic research of cervical slime. The fertility, pregnancy and the period of a lactation the pregnancy Period Data on use of the drug Vizanna® during pregnancy are limited. Preclinical trials and data on influence of the diyenogest at women during pregnancy did not reveal specific risks on pregnancy, development of an embryo/fruit, the birth and development of the child. Nevertheless, Vizannu® should not appoint during pregnancy as there is no need for treatment of endometriosis during pregnancy. The period of a lactation is not recommended treatment of Vizannoy® in the period of a lactation. It is unknown whether gets diyenogest to breast milk. Physical and chemical properties and data of preclinical trials demonstrate excretion of the diyenogest with breast milk. The decision on expediency of the termination of chest feeding, or cancellation of reception of Vizanny®, has to be accepted taking into account advantage of chest feeding for the baby and advantage of therapy for the woman. The fertility According to the available data, during reception of Vizanny® at most of patients occurs suppression of an ovulation. However Vizanna® is not contraceptive means. In need of contraception it is necessary to use a non-hormonal method (see the section Special Instructions). According to the available data, the menstrual cycle is restored within 2 months after the termination of reception of Vizanny®. Use in pediatrics the Drug Vizanna® is not shown for girls before menarche. Safety and efficiency of the drug Vizanna® was studied in uncontrollable clinical trial lasting 12 months with participation of 111 patients of teenagers aged from 12 up to 18 years with clinically expected or confirmed diagnosis endometriosis (see the sections Special Instructions and Pharmacodynamics). Preclinical data on safety do not indicate the Preclinical data obtained during the standard researches of pharmacological safety, toxicity at repeated introduction of doses, genotoxicity, the cancerogenic potential and toxicity for a reproductive system presence of specific risks for people. Nevertheless, it must be kept in mind that sexual steroids can stimulate growth of some hormone – dependent tumors and fabrics. Features of influence of medicine on ability to run motor transport and potentially dangerous mechanisms. Does not affect ability to run motor transport and mechanisms. Overdose Results of the conducted researches of acute toxicity do not indicate existence of risk of acute side effects at accidental reception of the dose several times exceeding a daily therapeutic dose of drug. The diyenogest dose a day (at 10-15 times exceeding the dose which is contained in the drug Vizanna®) was very well transferred to 20-30 mg within 24 weeks. Treatment: special antidote does not exist. The form of release and packing On 14 tablets place in blister strip packaging from PVH/PVDH of green color and aluminum foil. On 2 planimetric packs together with the instruction for medical use in the state and Russian languages place in a cardboard box. To Store storage conditions at a temperature not above 30 °C. To store out of children’s reach! Not to use a period of storage of 5 years after the expiry date specified on packing. Prescription status According to the prescription the Producer Bayer Weimar GmbH and To. KG, 99427 Weimar, Germany the Owner of the registration certificate of Bayer Pharm AG, Berlin, Germany the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of a product (goods): TOO Bayer KAZ Timiryazev St., 42, business center Expo-City, peahens. 15 050057 Almaty, Republic of Kazakhstan
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