The instruction for medical use of Proviron® medicine the Trade name of Proviron® the International unlicensed name Mesterolon Lekarstvennaya a form of the Tablet of 25 mg Structure One tablet contains active agent – mesterolon 25 mg, excipients: lactoses monohydrate, starch corn, PVP 25000, magnesium stearate, methylparahydroxybenzoate (E218), propilparagidroksibenzoat (E216). The description of the Tablet, round shape, white color with risky on one party and an engraving AH in a hexagon on other party. Pharmacotherapeutic group Sex hormones and modulators of a reproductive system. Androgens. Derivatives of a 5-androstenon. Mesterolon. The ATX G03BB01 code the Pharmacological Pharmacokinetics Later properties of oral administration mesterolon quickly and almost is completely absorbed in the wide range of doses from 25 to 100 mg. The maximum levels of drug in serum are 3.1+1.1 ng/ml after 1.6 + 0.6 hours. Then drug level in serum decreases with final elimination half-life of 12-13 hours. 98% of a mesterolon contact proteins of serum. Linking with albumine makes 40% while linking with GSPS (the globulin connecting sexual steroids) – 58%. Mesterolon is quickly metabolized. Speed of metabolic clearance in serum is 4.4 + 1.6 ml · mines-1 · kg-1. Drug is not removed by kidneys in steady-state condition. The main metabolite is 1α-метил-андростерон which conjugated form makes 55-70% of the metabolites excreted by kidneys. The ratio of the main metabolite of a glucuronide to its sulfate makes about 12:1. Other metabolite making about 3% of the metabolites excreted by kidneys is 1α-метил-5α-андростан-3α, 17β-диол. Metabolic conversion in estrogen or corticosteroids does not happen. About 77% of a dose of a mesterolon are removed in the form of metabolites with urine and about 13% of a dose with excrements. Within 7 days 90% of a dose which 50% are removed by kidneys within 24 hours are excreted. The absolute bioavailability of a mesterolon at intake is about 3%. The pharmacodynamics of Proviron® is androgenic drug for intake. Existence of S-1 of methyl group in structure of drug causes special characteristics of this steroid: unlike testosterone and its derivatives applied to androgenic therapy it is not metabolized in estrogen. This distinction fully explains data of observations according to which in the standard therapeutic dose applied at healthy men, Proviron® does not cause significant suppression of release of gonadotrophins from a hypophysis. In this regard Proviron® (1) does not influence a spermatogenesis and (2) does not influence development by an organism of own testosterone that distinguishes it from other androgens which substitute testosterone levels with suppression of development of endogenous androgens. Unlike other androgens for intake, the good tolerance of Provirona® from a liver is noted that it is perhaps connected with lack of alkyl substitution in provision S-17 of a steroid kernel. Indications – insufficiency of androgens or the male infertility connected with primary or secondary men’s hypogonadism. Route of administration and doses Adult: Initial dose: 3 or 4 tablets daily within several months, and then maintenance therapy: 2-3 tablets (50-75mg) daily. Children: it is not recommended to children. Side effects In some cases – frequent or very long erections of the Contraindication – a prostate cancer (as androgens can stimulate growth of the existing tumor) – liver tumors or in the anamnesis – hypersensitivity to a mesterolon or to any other component of drug Medicinal interactions are not known now Special instructions healthy faces cannot accept Androgens for strengthening of muscles or increase in the general physical functional capacity of an organism. During treatment regular carrying out researches of a prostate, for an exception of a prostate cancer is recommended. If frequent or very long erections take in some cases place, then it is necessary to reduce a dose or to stop treatment in order to avoid complications as a result of a long erection. In rare instances against the background of use of the substances with hormonal activity including which are a part of the drug Proviron® were observed benign, and is even more rare – malignant tumors in a liver which in some cases can carry out to zhizneugrozhayushchy intraabdominal bleedings. In case of appearance of severe pains in a stomach, increase in a liver or symptoms of intraabdominal bleeding, it is necessary to consider a possibility of presence of a tumor of a liver at differential diagnostics. To patients with inherited disorders, such as intolerance of fructose, deficiency of Lapp-lactases enzyme or glyukozo-galaktozny malabsorption, it is necessary to consider amount of the lactose which is contained in Provirone®. Features of influence of medicine on ability to run motor transport and potentially dangerous mechanisms. Overdose Symptoms are not known: it was not reported about any adverse effects owing to overdose therefore treatment usually is not required. Treatment: if from the moment of overdose there passed no more than two-three hours, and the overdose was so considerable that purpose of therapy is represented reasonable, in such cases the gastric lavage can be a safe method. A form of release and packing On 10 tablets in blister strip packaging from a film polyvinylchloride and a foil of color aluminum. On the 2nd blister strip packagings together with the instruction for medical use in the state and Russian languages place in a cardboard pack. To Store storage conditions at a temperature not over 300 With to Store out of children’s reach! Not to use a period of storage of 5 years after a drug expiration date. 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) of Bayer of KAZ LLP, Timiryazev St., 42, business center Expo-City, peahens. 15 050057 Almaty, Republic of Kazakhstan ph. +7 727 258 80 40, fax: +7 727 258 80 39, e-mail: email@example.com
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