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Sertohol 300 mg hard (20 capsules)


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The instruction for medical use of Sertokhol Torgovoye medicine a name Sertokhol Mezhdunarodnoye the unlicensed name Ursodezoksikholevaya acid the Dosage form solid capsules of 300 mg Structure One capsule contains active agent – ursodezoksikholevy acid of 300 mg, excipients: corn starch, silicon dioxide colloidal anhydrous, magnesium stearate structure of a gelatin capsule: gland (III) oxide red (E172), titan dioxide (E171), gelatin. The description gelatinous solid capsules, 0 in size, opaque, with the body of pink color and a lid of scarlet-red color. Contents of capsules – powder of white or almost white color Pharmacotherapeutic group Drugs for treatment of diseases of a liver and biliary tract. Drugs for treatment of diseases of a gall bladder. Drugs of bile acids. Ursodezoksikholevy acid. The ATX A05AA02 code the Pharmacological Pharmacokinetics of Ursodezoksikholevaya properties acid (UDHK) is soaked up in a small intestine due to passive diffusion (about 90%), and in an ileal gut – by means of active transport. The maximum concentration of UDHK in plasma is reached in 30-60 min. after intake. At systematic reception, ursodezoksikholevy acid becomes the main bile acid in serum, making about 48% of total amount of bile acids in blood. Linking with proteins of plasma – about 96-99%. The therapeutic effect depends generally on concentration of ursodezoksikholevy acid in bile, but not in blood serum. Concentration in bile depends on a dose: at increase in a daily dose the content of ursodezoksikholevy acid in bile respectively increases. The maximum concentration in bile is noted at a daily dose 10-14 mg/kg. UDHK gets through a placental barrier. At further increase in a dose the concentration of ursodezoksikholevy acid in bile does not increase. The pharmacodynamics of Ursodezoksikholevaya acid represents bile acid which is capable to reduce cholesterol content in bile, mainly by dissolution of cholesterol and formation of a liquid crystal phase. The mucoviscidosis at children On the basis of results of clinical trials ursodezoksikholevy acid is applied more than 10 years at children with the mucoviscidosis caused by liver diseases. There are proofs that treatment of UDHK can reduce proliferation of bile ducts, progressing of histologic defeats, and even to eliminate changes of a liver at an initiation of treatment at early stages of a mucoviscidosis. Treatment of UDHK should be begun with the diagnosis moment at once that will allow to optimize efficiency of treatment. Indications – for dissolution of cholesteric stones of a gall bladder. Cholesteric stones should not look as blackout on the roentgenogram and should not exceed 15 mm in the diameter (despite existence of stones, function of a gall bladder should not be broken) – for treatment of the gepatobiliarny disturbances connected with a mucoviscidosis at children from 6 to 18 years. – primary biliary cirrhosis in the absence of signs of a decompensation the Route of administration and doses For dissolution of cholesteric gallstones select the Dose of drug individually. Usually daily dose of drug makes 10 – 15 mg/kg of body weight. A pill is recommended to be taken once a day before going to bed and washing down with a small amount of water. Treatment duration for dissolution of the available concrements has to be from 6 to 12 months. Each 6 months it is necessary to control efficiency of therapy by means of ultrasonic or X-ray inspection. If after 6 months of treatment of reduction of the sizes of gallstones it is not observed, then further continuation of therapy is inexpedient. For prevention of a recurrence of cholelithiasis it is recommended to continue administration of drug for 3-4 months after dissolution of the available concrements. For treatment of primary biliary cirrhosis the Daily dose of drug is selected the doctor individually and usually makes 10-15 mg/kg of body weight. For the first months of treatment it is recommended to divide a daily dose into 2-3 receptions. At improvement of indicators of hepatic function the dose of drug can be accepted one-time in the evening. Therapy can be carried out beyond all bounds long. The Daily dose at children from 6 to 18 years makes a mucoviscidosis 20мг/кг/день divided into 2-3 receptions, if necessary the dose can raise to 30мг/кг/день. Duration of therapy is from 6 months to several years. The Daily dose (mg/kg) Solid capsules of 300 mg Morning Put the body weight (kg) Evening 20 – 29 17-25 1 – 1 30 – 39 19-25 1 1 1 40 – 49 20-25 1 1 2 50 – 59 21-25 1 2 2 60 – 69 22-25 2 2 2 70 – 79 22-25 2 2 3 80 – 89 22-25 2 3 3 90 – 99 23-25 3 3 3 100 – 109 23-25 3 3 4 & gt, 110 3 4 4 Side effects Often (& gt, 1/100, & lt, 1/10), infrequently (& gt, 1/1000, & lt, 1/100), it is rare (& gt, 1/10000, & lt, 1/1000), is very rare (& lt, 1/10000, including isolated cases). Disturbances from digestive tract: Reports on a pasty chair or diarrhea are very distributed in clinical trials. Very seldom during treatment of primary biliary cirrhosis there were severe pains in a stomach, on the right side. Disturbances from a liver and biliary tract: During treatment the calcination of stones can arise ursodeoksikholevy acid very seldom. During treatment of late stages of primary biliary cirrhosis the cirrhosis decompensation which disappears after drug withdrawal was very seldom observed. Hypersensitivity reactions: Seldom or never there can be allergic rash (urticaria). Contraindications – acute inflammatory diseases of a gall bladder and bile ducts – impassability of bile ducts (occlusion of the general bile ducts or vesical channels) – frequent episodes of hepatic gripes – disturbance of sokratitelny function of a gall bladder – hypersensitivity for ursodezoksikholevy acid or auxiliary components of the drug Sertokhol it is not suitable for dissolution of rentgenpolozhitelny gallstones with the high content of calcium. Sertokhol it is not necessary to apply at pregnancy and planning of pregnancy. Sertokhol patients should not apply with active ulcer of stomach or duodenum, diseases of a liver and intestines in which enterogepatichesky circulation of bile acids, for example, a resection or an ostomy of an ileal gut, a regional ileitis is broken, out of – or an intra hepatic cholestasia, heavy sharp and chronic a liver disease. In case of use for children: – an unsuccessful portoenterostomiya or lack of restoration of a stream of bile at children with an atresia of bile ducts. Medicinal interactions Colestyraminum, kolestipol, the activated carbon or antacids containing aluminum hydroxide or smectite (aluminum oxide), reduce absorption of ursodezoksikholevy acid in intestines and thus reduce its absorption and efficiency. If use of the drugs containing at least one of these substances nevertheless is necessary, it is necessary to take them a minimum for 2 h before Sertokhol’s reception. Ursodezoksikholevy acid can strengthen absorption of cyclosporine from intestines. Therefore at the patients accepting cyclosporine, the doctor has to check concentration of cyclosporine in blood and correct a cyclosporine dose in case of need. In some cases Sertokhol can reduce ciprofloxacin absorption. In clinical trials it is shown that ursodezoksikholevy acid (500 mg/days) can slightly increase concentration of rosuvastatin in plasma at a concomitant use. The clinical importance of this interaction concerning other statines is unknown. There is a probability of induction of enzymes of P450 3A cytochrome ursodezoksikholevy acid noted in the message about decrease in therapeutic effect of dapsone and also in results of the researches in vitro. Such interaction is noted in an interaction research with budesonidy which is the known substrate of P450 3A cytochrome. Hypolipidemic drugs (especially Clofibratum), are oestrogenic, oral contraceptives on the basis of estrogen increase bile saturation by cholesterol and can reduce ability to dissolve cholesteric bilious concrements. The doctor should control special instructions for the first three months of treatment parameters of function of a liver, such as nuclear heating plant (SGOT), ALT (SGPT) and GGT each 4 weeks, then each 3 months. Besides definition of PBC of patients answering and not responding to treatment this monitoring has to also allow to find at early stages possible aggravations of symptoms of a liver, especially in patients with the started PBC stages. At treatment of the started stages of primary biliary cirrhosis: The decompensation of cirrhosis which partially regresses after the treatment termination is seldom or never observed. At patients with PBC the deterioration in clinical symptoms at the beginning treatment in rare instances can be observed, for example, the itching can amplify. In this case the dose should be lowered to 250 mg and then to increase gradually to the recommended doses. When developing diarrhea the dose should be lowered, and in case of constant diarrhea to stop treatment. At use for dissolution of gallstones: To estimate progress in treatment, and for early detection of symptoms of calcification of stones depending on the size of stones the gall bladder should be visualized (the oral cholecystography) with survey of blackouts in a standing position and lying on spin (ultrasonography) in 6-10 months after an initiation of treatment. If the gall bladder cannot be visualized on x-rays or in cases of calcification of stones, weak contractility of a gall bladder or frequent attacks of gripes, the drug Sertokhol should not be used. The women receiving Sertokhol for destruction of stones of a gall bladder should use effective non-hormonal methods of contraception as hormonal contraceptives can promote formation of stones. Pregnancy and the period of a lactation Are absent sufficient data on use of ursodezoksikholevy acid, especially in the first trimester of pregnancy. It is not necessary to use the Sertokhol capsules during pregnancy needlessly. Women of childbearing age have to take the drug if uses contraceptive means. It is recommended to use non-hormonal methods of contraception, or with the low content of estrogen. At the patients receiving Sertokhol for destruction of stones of a gall bladder it is necessary to use non-hormonal methods of contraception as hormonal contraceptives can promote formation of stones. It is unknown whether ursodezoksikholevy acid gets into mother’s milk. Thus, in the period of a lactation it is not necessary to take the drug. Use in pediatrics Drug is not recommended for use for children up to 6 years. At children 6 years with body weight more than 20 kg are more senior it is applied only in cystous fibrosis of a liver. Features of influence on ability to run the vehicle or potentially dangerous mechanisms the Overdose Symptoms does not influence: in case of overdose of drug the development of diarrhea is possible. In general, development of other symptoms of overdose is improbable since at increase in the accepted dose the absorption of ursodezoksikholevy acid decreases and increases its removal with excrements. Treatment: at overdose performing specific therapy is not required, consequences of diarrhea it is necessary to treat symptomatic by means of rehydration and substitution of electrolytes. Prolonged use of high doses of ursodezoksikholevy acid (28-30 mg/kg/days) by patients with primary sclerosing cholangitis (use out of the registered indications) is connected with higher frequency of the serious undesirable phenomena. The form of release and packing of 10 capsules place in blister strip packaging from a film of polinivilkhloridny and aluminum foil. On the 2nd blister strip packagings together with the instruction for medical use in the state and Russian languages place in a pack from cardboard Storage conditions to Store at a temperature not above 25 °C. To store out of children’s reach! A period of storage 3 years not to apply after a period of storage Prescription status According to the prescription the Producer “Uorld Meditsin Ilach Sang. ve Tidzh. A.Sh.”, Turkey Address: Bagdzhylar Ilchesi, Gyuneshli, Evren Makhallesi, Dzhami Yolu Dzhad. No. 50 K. 1B Zemin 4-5-6, Istanbul. Owner of the registration certificate of Dr Sertus Ilach Sanayi Ve Tidzharet Limited Shirketi, Turkey Address: 34212 Evren Makhallesi, Dzhami Yolu Dzhaddesi No. 50, Girish Kat, Gyuneshli, Bagdzhylar, Istanbul, Turkey the Name, the address and a contact information (phone, the fax, e-mail) of the organization of the claim (offer) on quality of medicines accepting in the territory of the Republic of Kazakhstan from consumers and responsible for post-registration observation of safety of medicine.: TROKA-S PHARMA LLP, Almaty, Suyunbaya Avenue 222-b
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