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Miralyust 5 mg 28’s chewing tablets


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Instruction for medical use of Miralyust Torgovoye medicine name of Miralyust International unlicensed name Montelukast Dosage Form chewable tablets, 5 mg. Structure One tablet contains active agent: montelukast of sodium of 5.190 mg (it is equivalent to montelukast of 5.0 mg) excipients: Mannitolum (type 200 SD), cellulose microcrystalline (type 101), sodium of a kroskarmelloz, hydroxypropyl cellulose (Klucel LF), aspartame (E 951), magnesium stearate, fragrance cherry Cherry 502450 TP0551, gland (III) oxide red (E 172) the Description of the Tablet of kremogo-pink color, round shape, with a biconvex surface, with an engraving ‘5’ on one party and Pharmacotherapeutic group with a diameter of 9.5 mm Drugs for treatment of obstructive respiratory diseases. Other drugs for treatment of obstructive respiratory diseases for system use. Leukotriene receptors antagonists. Montelukast. ATX R03DC03 code Pharmacological Pharmacokinetics Absorption properties. Montelukast after intake is soaked up quickly. After intake on an empty stomach of drug average maximum concentration in plasma (Cmax) is reached after 3 hours (Tmax). The average bioavailability after oral administration is 64%. Standard meal does not affect bioavailability and Cmax after oral administration of drug. Distribution. Montelukast contacts proteins of plasma more than for 99%. Metabolism. Montelukast is exposed to intensive metabolic changes. Metabolites does not render therapeutic effect. Discharge. The plasma clearance of montelukast at healthy adults is, on average, 45 ml/minute. After oral administration it is radioactive marked montelukast of 86% of radioactivity it is removed for 5 days with a stake and & lt, 0.2% is removed with urine. Considering bioavailability of montelukast after oral administration, it indicates that montelukast and its metabolites are removed, almost completely, with bile. A pharmacodynamics Cysteic leukotrienes (LTC4, LTD4, LTE4) are eicosanoids with considerable inflammatory effect, are released from various cells, including mast cells and eosinophils. The effect of these pro-asthmatic mediators is carried out through tsisteinil-leukotriene receptors (CysLT) which are present at airways of the person and shown by a bronchospasm, mucifying, increase in permeability of vessels and migration of eosinophils. Montelukast is active connection which competitively ties CysLT1-receptors with sharp selectivity and chemical affinity and causes a bronkhodilatation within 2 hours after oral administration. Montelukast also has additive effect on effect of agonists of β-adrenoceptors. Treatment by montelukast suppresses a bronchospasm both on early, and on late stages, reducing reaction to antigens. Treatment by montelukast considerably reduces quantity of eosinophils in airways (it is confirmed with the analysis of a phlegm) and in peripheral blood, improving clinical control of asthma at adults and children. At children from 6 to 14 years montelukast at use of 5 mg showed once a day considerable improvements of respiratory function (according to spirography) and decrease in need for the forced use of agonists of β-adrenoceptors. The comparative research of efficiency of montelukast and an inhalation flutikazon at children aged from 6 up to 14 years with persistent asthma of weak severity showed that montelukast did not concede to a flutikazon in increase in percentage of days without the need for emergency measures. The efficiency of montelukast for prevention of the bronchospasm caused by physical activity is shown in two placebos the controlled researches conducted for adult and children’s groups from 6 to 14 years. At the patients with asthma and hypersensitivity to acetylsalicylic acid receiving the accompanying treatment by inhalation and/or oral corticosteroids the treatment by montelukast in comparison with placebo led to significant improvement of control of asthma (change from the initial volume of the forced exit in 1 second (OFV1) of 8.55% against – 1.74% and to decrease in total amount of use of β-agonists from the initial level of-27.78% against 2.09%). Indications addition to basic therapy of bronchial asthma for patients of 6-14 years with persistent asthma easy and moderate severity (at insufficient efficiency of inhalation corticosteroids and agonists of β-adrenoceptors of short action) an alternative way of treatment of asthma for patients of 6-14 years instead of low doses of inhalation corticosteroids at patients with persistent asthma of easy degree (without the serious attacks of bronchial asthma demanding reception of oral corticosteroids and also at intolerance of inhalation corticosteroids) for prevention of the attacks of a bronchospasm connected with physical activities for patients from 6 years the Route of administration and doses to Children aged from 6 up to 14 years: on one chewable tablet of 5 mg once a day, in the evening. Miralyust it is necessary to accept in 1 hour prior to food or 2 hours later after a meal. In this age group of change of a dosage it is not required. General recommendations. Therapeutic effect of the drug Miralyust on indicators of control of asthma is noticeable in the first day after an initiation of treatment. It is necessary to inform patients that administration of drug of Miralyust should be continued and when symptoms of asthma are under control, and during the periods of exacerbation of asthma. Change of a dosage is not required from patients with a renal failure and abnormal liver functions easy and moderately severe. There are no data on patients with heavy abnormal liver functions. The medicine dosage is identical to men and women. Use of the drug Miralyust instead of small doses of inhalation corticosteroids at patients with chronic asthma benign. Montelukast is not recommended to be applied as monotherapy at patients with moderately severe chronic asthma. Use of montelukast instead of small doses of inhalation corticosteroids at children with chronic asthma benign can be considered only if lately they had no heavy attacks of asthma demanding use of inhalation corticosteroids and if they cannot accept inhalation corticosteroids. According to definition, chronic asthma is benign characterized by manifestation of symptoms of asthma more often than once a week, but less than once a day, manifestation of night symptoms of asthma is more often than two times a month, but is more rare than once a week and normal functioning of lungs between the next episodes. If after the control visit (as a rule, within a month) it is not possible to suppress sufficiently asthma symptoms, it is necessary to think of use of additional or other anti-inflammatory medicine according to the scheme of step treatment of asthma. It is necessary to estimate extent of suppression of symptoms of asthma periodically. Miralyust drug treatment and other methods of treatment of asthma. During use of Miralyust as auxiliary medicine in addition to inhalation corticosteroids, inhalation corticosteroids should not be replaced with the drug Miralyust. Side effects Side effects are distributed on groups with the following frequency of their emergence: very often (≥1/10), it is frequent (≥1/100 & lt, 1/10), is not frequent (≥1/1000 & lt, 1/100), is rare (≥1/10000 & lt, 1/1000), is very rare (& lt, 1/10000) it is frequent: headache thirst abdominal pain Very often: upper respiratory tract infection Often: diarrhea, nausea, vomiting the increased level of transaminases in blood serum (ALaT, ASaT) pour temperature increase Infrequently: dryness in a mouth, hematoma dyspepsia, a small tortoiseshell, an itching an asthenia / increased fatigue, sensation of discomfort, hypostases of reaction of hypersensitivity, including anaphylactic reactions unusual dreams, including nightmares, insomnia, a sleep-walking, impatience, excitement, including agressive behavior or hostility, depressions, a disorientation nasal bleeding, a pulmonary eosinophilia slackness, dizziness, a paresthesia/hypesthesia, spasms an arthralgia, myalgia, including muscular spasms Very seldom: hepatitis (including cholestatic, hepatocellular, damages of a liver of the mixed genesis) a knotty erythema, a multiformny erythema eosinophilic infiltrates in a hallucination liver, suicide intentions and behavior (including attempts of a suicide) a syndrome of Charga – Strossa (CSS) it is rare: a Quincke’s disease disturbance of attention, a memory impairment, psychomotor hyperactivity (including irritability, uneasiness and a tremor) tendency to bleeding the Contraindication cardiopalmus hypersensitivity to active agent or auxiliary components of drug. the children’s age up to 6 years pregnancy and the period of a lactation Medicinal interactions Montelukast can be applied along with other drugs which are usually applied to prevention and long therapy of asthma. According to researches of medicinal interaction, montelukast in the recommended dosage had no significant clinical effect on pharmacokinetics of the following drugs: theophylline, Prednisonum, Prednisolonum, oral contraceptives (etiniloestradiol with norethindrone in the ratio 35:1), terfenadin, digoxin and warfarin. At the persons which are at the same time accepting phenobarbital, the area under a curve of concentration of montelukast in plasma (AUC) decreased approximately by 40%. Special indications of Miralyust should not be applied to treatment of bad attacks of asthma. At a sharp course of bronchial asthma the patients should appoint medicines for carrying out the therapy asthma stopping and warning attacks. It is not necessary to use montelukast as replacement of inhalation or oral corticosteroids. There are no data indicating a possibility of reduction of a dose of oral corticosteroids during treatment by montelukast. In rare instances at the patients taking antiasthmatic medicine including montelukast, there can be a system eosinophilia, sometimes with clinical symptoms of inflammation of blood vessels (vasculites) that corresponds to a syndrome of Charga – Stross to whose treatment corticosteroids of general purpose are often applied. Cases of emergence of this syndrome often though not always, are connected with reduction of a dosage or interruption of treatment by oral corticosteroids. It is impossible neither exclude, nor to confirm communication between reception of antagonists of leukotriene receptors and emergence of a syndrome of Charga – Strossa (CSS). Doctors should pay special attention to such symptoms as an eosinophilia, rash of vascular origin, deterioration in pulmonary symptoms, cardiological complications and (or) neuropathies. Patients with the specified symptoms it is necessary to survey and include corrections in the scheme of treatment repeatedly. Patients with asthma and hypersensitivity to acetylsalicylic acid, except treatment by montelukast, should avoid intake of acetylsalicylic acid and other non-steroidal anti-inflammatory drugs. Miralyust contains the aspartame which is a xenylamine source. The patients having phenylketonuria should take into account that each chewable tablet of 5 mg contains 0.842 mg of xenylamine. Pregnancy and the period of a lactation of Miralyust it is not recommended for use during pregnancy and a lactation. To feature of influence on ability to run the vehicle or potentially dangerous mechanisms Vliyaniya Miralyust on ability of control of vehicles and service of mechanisms it is not observed. However in extremely exceptional cases are possible: drowsiness and dizziness Overdose Symptoms: abdominal pain, drowsiness, thirst, headache, vomiting and psychomotor hyperactivity. Treatment: drug withdrawal, symptomatic therapy. It is unknown whether montelukast at peritoneal dialysis is removed or at a hemodialysis. A form of release and packing On 7 tablets in blister strip packaging from a foil of PAS/aluminium/PVC / aluminum. On 4 planimetric packs together with the instruction for use in the state and Russian languages put in a pack from cardboard. To Store storage conditions in the dry, protected from light place at a temperature not above 25 °C. To store out of children’s reach! 2 years not to use a period of storage after an expiration date. Prescription status According to the prescription the Applicant of Pharmaceutical Works Adamed Pharma Joint Stock Company, 33, Szkolna Str., 95-054 Ksawerów, Poland Pharmaceutical Works Polfa in Pabianice Joint Stock Company 5, marsz.J.Pilsudskiego str., 95-200 Pabianice Producer, Poland the Owner of the registration certificate of Pharmaceutical Works Adamed Pharma Joint Stock Company, 33, Szkolna Str., 95-054 Ksawerów, Poland the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) Representative office of JSC Pabianice Pharmaceutical Plant Polfa in PK 059000, Almaty, the street of Abay, house 109B, business center Globus, floor 13, office 13-2
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