Nomides 75 mg (10 capsules)
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The instruction for medical use of Nomides Torgovoye medicine nazvanieNomidesMezhdunarodnyy unlicensed nazvanieOseltamivirLekarstvennyy formakapsula of 30 mg, 45 mg, 75 mgsostav on 1 capsule: active agent: Oseltamivir of 30 mg 45 mg 75 mg (in the form of an oseltamivir of phosphate) 39.4 mg 59,1 98,5 excipients: silicon dioxide colloidal (aerosil), kopovidon, starch prezhelatinizirovanny, croscarmellose sodium, natriyastearilfumarat, talc. structure of capsules: for a dosage of 30 mg: sodium lauryl sulfate, the titan dioxide (E171), vodaochishchenny, gelatin, for a dosage of 45 mg: sodium lauryl sulfate, the titan dioxide (E171), krasitelbrilliantovy blue (E133), the water purified, gelatin, for a dosage of 75 mg: sodium lauryl sulfate, titan dioxide (E171), krasitelsolnechny decline yellow (E110), dye crimson
(E124), vodaochishchenny, gelatin. OpisanieDlya of a dosage of 30 mg: solid gelatin capsules No. 3, belogotsvet body, lid of white color. For a dosage of 45 mg: solid gelatin capsules No. 2, golubogotsvet body, lid of blue color. For a dosage of 75 mg: solid gelatin capsules No. 1, belogotsvet body, lid of orange color. Contents of capsules: powder, white or white with a yellowish shade. Pharmacotherapeutic gruppaprotivovirusny drugs of direct action. Neuraminidase inhibitors. Oseltamivir. The ATH J05AH02Farmakologicheskie code to a svoystvaFarmakokinetikaPosla of oral administration of an oseltamivir phosphate is easily soaked up a vzheludochno-intestinal path and highly turns in aktivnyymetabolit under the influence of hepatic esterases. Concentration of the aktivnogometabolit in plasma are defined within 30 minutes, reach pochtimaksimalny level in 2–3 hours after reception and significantly (more, chemv 20 times) concentration of pro-medicine exceed. Not less than 75% prinyatoyvnutr doses get to a system blood stream in the form of an active metabolite, less than 5% – in the form of initial drug. Plasma concentration both pro-drugs, and an active metabolite are proportional to a dose and do not depend an otpriyema of food. The average volume of distribution (V ss) active metabolite is primerno23 liters. Linking of an active metabolite with proteins of plasma krovineznachitelno (about 3%). Linking of pro-medicine with proteins of plasma krovisostavlyat 42% that it is not enough to serve as the reason of sushchestvennykhlekarstvenny interactions. Oseltamivira phosphate highly turns into an active metabolitpod effect of the esterases which are mainly in a liver and intestines. Neither an oseltamivira phosphate, nor an active metabolite are not substratamiil inhibitors of isoenzymes of a system of P450 cytochrome. Oseltamivir is brought, mainly (& gt, 90%), by transformation a vaktivny metabolite – an oseltamivira carboxylate which not podvergayetsyadalneyshy transformation and is removed with urine. At the majority patsiyentovperiod semi-removal of an active metabolite from plasma makes 6–10 hours. The active metabolite is removed completely by renal excretion. The renal clearance (18.8 l/hour) exceeds the glomerular filtration rate (7.5 l/hour) that indicates that drug is removed also putemkanaltsevy secretion. With a stake less than 20% of the marked drug taken vnutrradioaktivno are removed. Pharmacokinetics in special gruppakhpatsiyenta with dysfunction of a pochekpra the Nomides's appointment on 75 mg 2 times a day within 5 days to patients srazlichny extent of damage of kidneys of the area under a curve a koncentratsiiaktivny metabolite in plasma – time (AUC) back to a proportsionalnysnizheniye of function of kidneys. The pharmacokinetics of an oseltamivir at the patients a sterminalny stage of a renal failure (with clearance of creatinine of ≤10 ml/min.) who are not on dialysis was not studied. Patients with dysfunction a pecheniissledovaniye of in vitro showed that at patients from hepatic the patologiyeyvelichina of AUC of an oseltamivir of phosphate is much not raised, and AUCaktivnogo of a metabolite is not reduced.Elderly to a patsiyenty of patients of old age (65–78 years) AUC of an active metabolite a vravnovesny state was 25-35% higher, than at more young people of a patsiyentovpra purpose of similar doses of Nomides. Elimination half-life to a preparata elderly significantly did not differ from that at more young people of patsiyentovvzrosly age. Taking into account data on AUC drug and shipping, at treatment and prevention of flu it is not required to elderly patients of dose adjustment. DetiFarmakokinetika Nomides was studied at children from 1 year to 16 years a vpharmakokinetichesky research with single dose of drug and in clinical trial at a small number of children at the age of 3–12 years. Udetya of younger age observed faster removal of a prolekarstvaa of an active metabolite, than at adults that led to lower AUCpo to the relation to a specific dose. Administration of drug in a dose of 2 mg/kg gives to a takuyuzha of AUC of an oseltamivir of carboxylate what is reached at adults of postsingle dose of the capsule from 75 mg of drug (that is equivalent approximately 1mg/kg). The pharmacokinetics of an oseltamivir at children is more senior than 12 years is similar about a takovoya of adults. At children of 6-12 months the purpose of an oseltamivir in a dose of 3 mg/kg twice in sutkiobespechivat the plasma level of an active metabolite similar to the level showing clinical performance at children of advanced age of ivzrosly. FarmakodinamikaProtivovirusnyy drug. Oseltamivira phosphate is pro-medicine, its active metabolite (an oseltamivira carboxylate) competitively iizbiratelno inhibits a neuraminidase of influenza viruses of type A and B – the enzyme catalyzing process of release of again obrazovannykhvirusny particles of the infected cells, their penetrations in a kletkiepiteliya of airways and further spread of a virus a vorganizm. Oseltamivira carboxylate acts out of cells. Growth of a virus grippain vitro oppresses and suppresses replication of a virus and its pathogenicity of in Vivo, an umenshayetvydeleniye of influenza viruses And yes In from an organism. Its concentration necessary for suppression of activity of enzyme for 50% (IC50) are unizhny border of nanomolar range. At Nomides's reception for the purpose of post-contact (7 days) and seasonal (42 days) prevention of flu of resistance to drug is not noted. Frequency of tranzitorny discharge of an influenza virus with a neuraminidase snizhennoychuvstvitelnost to an oseltamivir to carboxylate at vzroslykhpatsiyent flu is 0.4%. Elimination of a resistant virus comes from an organism of the patients receiving Nomides without ukhudsheniyaklinichesky condition of patients. Indications to primeneniyu treatment of flu at adults and children, including the full-term newborns, ukotory are observed flu symptoms when a population tsirkuliruyetsreda influenza virus. The efficiency of drug was shown at a nachaleterapiya within 2 days after the first emergence of symptoms grippa prevention of flu at adults and children: prevention of flu at adults and children is more senior than 1 year after the sluchayevkontakt with persons with clinically confirmed flu when the virusgrippa circulates among naseleniya prevention of flu at children 1 years during a flu pandemic are younger. Drug Nomides is not vaccination replacement. Primeneniyeprotivovirusny drugs for treatment and prevention of flu, dolzhnobyt it is based on official recommendations. Decisions, kasayushchiyesyaprimeneniye of an oseltamivir for treatment and prevention of flu to sleduyetprinimat, considering the known information on harakteristikakhtsirkuliruyushchy influenza viruses, sensitivity forms to the lekarstvennympreparata intended for treatment of flu depending on a season, a disease ivliyaniya in various geographical zones and populyatsiyakhpatsiyent. The route of administration and dozynomides is accepted inside, at meal time or irrespective of meal. Unekotory patients the tolerance of drug improves if egoprinimat at meal time. Treatment it is necessary to begin in the first or second denpoyavleniye of symptoms of flu.In cases when adults, teenagers ≥ 12 years and children with the body weight & gt, 40 kgil ≥ 8 years have a problem with ingestion of capsules, neobkhodimootkryt the capsule and to pour out its contents in a small amount (at most 1 teaspoon) of the suitable sweetened food product (chocolate syrup (with the normal content of sugar or without soderzhaniyasakhar), the honey dissolved in water, a sweet dessert, condensed milk sugar, apple puree or yogurt) to hide bitter taste. Mix needs to be mixed and given carefully to the patient entirely. To Sleduyetproglotit mix at once after preparation. The standard mode dozirovaniyavzrosly and teenagers is more senior than 13 years (with body weight more than 40 kg): Treatment the gripparekomendovanny mode of dosing Nomides – on one capsule of 75 mg 2 razav day inside within 5 days or on 75 mg of suspension 2 times a day inside within 5 days. Prevention of flu the Recommended dose Nomides for prevention of flu after contact by the sinfitsirovanny person – on 75 mg of 1 times a day inside within 10 days. Administration of drug needs to be begun no later than in the first 2 days of postcontact. The recommended dose for prevention during a seasonal flu epidemic – on 75 mg of 1 times a day, is shown efficiency and safety of drug to its pripriyema within 6 weeks. Preventive action prodolzhayetsyastolko how many administration of drug lasts. Children from 1 year to 12 years: Treatment of flu: Body weight the Recommended dosage within 5 days of 10 - 15 kg 30 mg two times in den15 – 23 kg 45 mg two times in den23 – 40 kg 60 mg two times in день>, 40 kg 75 mg two times in a denprofilaktik of flu: Body weight the Recommended dosage within 10 days of 10 - 15 kg 30 mg once in den15 – 23 kg 45 mg once in den23 – 40 kg 60 mg once in день>, 40 kg 75 mg once in a denyeffektivnost Nomides for prevention during seasonal an epidemiigripp at children is younger than 12 years was not studied. Children up to 1 godalecheniye of flu: The recommended dose for children aged till 1 year makes 3 mg/kg of a massytel twice a day. Body weight the Recommended dosage within 5 days of 3 kg 9 mg two times in den4 kg of 12 mg two times in den5 kg of 15 mg two times in den6 kg of 18 mg two times in den7 kg of 21 mg two times in den8 kg of 24 mg two times in den9 kg of 27 mg two times in den10 the kg of 30 mg two times in the dendanny mode of dosing is inapplicable to premature newborns (i.e., given rise till 36 weeks). On dosing at given gruppypatsiyent there is an insufficient amount of data. Prevention a gripparekomendovanny dose Nomides for prevention of flu during a pandemic udety is younger than 1 year makes a half of a medical dose – once pass 3 mg/kg within 10 days. The efficiency Nomides for prevention in a vremyasezonny flu epidemic at children is younger than 1 year was not studied. Dosing in special sluchayakhpatsiyenta with an abnormal liver function dose adjustment is not required to Patients with an abnormal liver function. Researches at children with abnormal liver functions were not conducted. Patients with dysfunction the pocheklecheniye is recommended to grippavzrosly patients and teenagers (13-17 years) with dysfunctions of pochekumerenny or heavy severity selection of a dose. The recommended doses are described in the table below. The clearance of creatinine Recommended дозы>, 60 ml/min. 75 mg 2 times in сутки>, 30 - 60 ml/min. 30 mg (suspension or capsules) 2 times in сутки>, 10 - 30 ml/min. 30 mg (suspension or capsules) of 1 times a day ≤ 10 ml/min. is not recommended (data are absent) Patients on a gemodiliza of 30 mg after each procedure of a gemodializapatsiyenta on a peritoneal hemodialysis * 30 mg (suspension or capsules) once * by results of these researches conducted with participation of the patients who are on chronic peritoneal dialysis in out-patient conditions (HPDA) when using the mode of the automatic peritoneal dialysis (APD) the clearance of an oseltamivir of carboxylate can be higher. The mode dializamozht to be switched with APD to HPDA according to the decision of the nephrologist.Prevention is recommended to grippavzrosly patients and teenagers (13-17 years) with dysfunctions of pochekumerenny or heavy severity selection of a dose. The recommended doses are described in the table below. The clearance of creatinine Recommended дозы>, 60 ml/min. 75 mg of 1 times in сутки>, 30 - 60 ml/min. 30 mg (suspension or capsules) of 1 times in сутки>, 10 - 30 ml/min. 30 mg (suspension or capsules) of 1 times every other day ≤ 10 ml/min. is not recommended (data are absent) Patients on a hemodialysis of 30 mg after every second procedure of a hemodialysis Patients on a peritoneal hemodialysis * 30 mg (suspension or capsules) once a week * by results of these researches conducted with participation of the patients who are on chronic peritoneal dialysis in out-patient conditions (HPDA) when using the mode of the automatic peritoneal dialysis (APD) the clearance of an oseltamivir of carboxylate can be higher. The mode dializamozht to be switched with APD to HPDA according to the decision of the nephrologist. Recommendations about drug dosing at babies and children up to 12 years snarusheniye of function of kidneys are absent in connection with nedostatochnostyyuklinichesky data. Elderly patients Dose adjustment is not required, except for cases when imeyutsyapriznak of renal failures of moderate or heavy severity. Ex-temporal preparation of NomidesV cases when adults, teenagers and children have a problem a sproglatyvaniye of capsules, and Nomides in a dosage form suspension dlyaprigotovleniye powder for intake is absent or at nalichiipriznak of ageing of capsules, it is necessary to open the capsule and to pour out eesoderzhimy in a small amount (at most 1 teaspoon) of the suitable sweetened food product to hide gorkiyvkus. Mix needs to be mixed and given carefully to the patient entirely. It is necessary to swallow mix at once after preparation. If patients need a dose of 75 mg, then it is necessary to follow sleduyushchimiinstruktion: 1. Holding one Nomides capsule of 75 mg over small capacity, akkuratnoraskryt the capsule and to pour out powder in capacity.2. To add a small amount (no more than 1 teaspoon) of podhodyashchegopodslashchenny food product (to hide bitter taste) and to horoshoperemeshat. 3. To carefully mix mix and to drink it at once after preparation. If in capacity there was a small amount of mix, then to sleduyetopolosnut capacity a small amount of water and to drink ostavshuyusyasmes. If doses of 30-60 mg are required for patients, then for the correct dozirovaniyaneobkhodimo to follow the following iinstruktion: 1. Holding one Nomides capsule of 75 mg over small capacity, akkuratnoraskryt the capsule and to pour out powder in capacity.2. To add to powder 5 ml of water by means of the syringe with the tags showing amount of the gathered liquid. To Tshchatelnoperemeshat within 2 minutes.3. To gain in the syringe necessary amount of mix from capacity to the soglasnonizheprivedenny table: Body weight the Recommended dose Amount of the mix Nomides on one priem15 kg of 30 mg 2 мл>, 15-23 kg 45 mg 3 мл>, 23-40 kg 60 mg 4 mlnt need for an intake of not dissolved white powder, poskolkuon is inactive filler. Having pressed the syringe piston, to enter all its contents into the second capacity. Ostavshuyusyaneispolzovanny mix needs to be utilized. 4. To add a small amount (no more than 1 chaynoylozhka) of the suitable sweetened food product that skrytgorky taste, and it is good to mix to the second capacity. 5. To carefully mix mix and to drink it at once after preparation. If in capacity there was a small amount of mix, then it is necessary to rinse capacity with a small amount of water and to drink ostavshuyusyasmes. Collateral to a deystviya of adults/teenagers, nausea and vomiting in treatment researches, and the takzhetoshnot in researches on prevention were the most frequent undesirable (collateral) reactions (NR). About the majority of data Nrsoobshchalos once or for the first, or second day of treatment and it is spontaneous within 1-2 days. Children of the most frequent NR had a vomiting. For bolshinstvapatsiyent these NR did not demand the introduction termination Nomides. About the following serious undesirable reactions it was reported seldom from those porkak oseltamivir entered the market: anaphylactic and anafilaktoidnyereaktion, liver diseases (lightning hepatitis, disorder of a funktsiipechena and jaundice), Quincke's disease, Stephens-Johnson's syndrome itoksichesky epidermal necrolysis, gastrointestinal bleedings ipsikhonevrologichesky disorders. The list of undesirable reactions in a look tablitsynr, listed below in tables, are divided into the following categories: ochenchasto (≥1/10), it is frequent (from ≥1/100 to & lt, 1/10), infrequently (from ≥ 1/1000 to & lt, 1/100), r
(from ≥ 1/10000 to & lt, 1/1000) and is very rare (& lt, 1/10000). NR bring vsootvetstvuyushchy category in tables according to with generalized analizomklinichesky researches. Treatment and prevention of flu at adults and teenagers: NR most of which often arose at the recommended dose (75 mg two razav day within 5 days for treatment and 75 mg a day during the period up to 6 weeks for prevention) during the research of treatment and prevention uvzroslykh / teenagers, are given in Table 1. The profile of safety of the patients receiving recommended a dozunomidesa for prevention (75 mg once a day within 6 weeks) is bylkachestvenno similar to that which was observed during the treatment research, despite longer term of administration of drug during an issledovaniyaprofilaktika. Table 1. Undesirable reactions of Nomides for treatment of an iprofilaktika of flu at adults and teenagers or in hodepostmarketingovy observations. System organnyyklass the Undesirable phenomena on frequency Very often Often Infrequently Seldom Infectious iparazitarnyezabolevaniye Bronchitis, a herpes simplex, a nasopharyngitis, infektsiiverkhnikhdykhatelnykhputy, Narusheniyaso's sinusitis of a storonykrova of the ilimfatichesky Narusheniyaso's Thrombocytopenia of a Storonyimmunnoysistema of Reaktsiyagiperchuvstvitelnosti system Anaphylactic reactions, anaphylactoid reactions of Narusheniyapsikhiki Vozbuzhdyonnoyesostoyaniye, a nenormalnoyepovedeniye, uneasiness, a sputannostsoznaniye, nonsense, a delirium, hallucinations, nochnyekoshmara, Narusheniyaso's mutilation of a storonynervnoysistema Golovnayabol Bessonnitsa Izmenyonnoyesostoyaniyesoznaniya, Narusheniyaso's convulsions of a storonyorganazreniye of Narusheniyezreniya Narusheniyaso of storonyserdets of Serdechnayaaritmiya Narusheniyaso of a storonyorganovdykhaniye, a grudnoykletka of an isredosteniye Cough, pain to a vgorla, Narusheniyaso's rhinorrhea of the Nausea Vomiting storonyzheludochno-kishechnogotrakt, pain to a vzhivota (incl. pain in stomach verkhneychast), dyspepsia of Zheludochno-kishechnyekrovotecheniya, gemorragicheskiykolit Narusheniyaso of a storonypechena of izhelchevyvodyashchy ways Molniyenosnyygepatit Raised urovenfermentovpechen, a pechyonochnayanedostatochnost, the hepatitis Narusheniyaso of a storonykozha ipodkozhnykhtkany Eczema, dermatitis, rash, urticaria of Obshchiyerasstroystvai narusheniyav Bol's mestevvedeniya, dizziness (incl. vertigo), fatigue, a hyperthermia, extremity pain are given In table 2 the most frequent NR during the pediatricheskikhklinichesky researches. Table 2. Undesirable reactions of Nomides for treatment of an iprofilaktika of flu at children (age/weight on the basis of a dose
). System organnyyklass the Undesirable phenomena on frequency Very often Often Infrequently Seldom Infectious iparazitarnyezabolevaniye Average otitis of Narusheniyaso of a storonynervnoysistema the Headache of Narusheniyaso of a storonyorganazreniye Conjunctivitis (including pokrasneniyeglaz, vydeleniyaiz an eye and pain vglaza) Narusheniyaso of the party the Otalgia of Disturbance of a sostorona of body of a slukhaa of balance of a barabannoypereponka of Narusheniyaso of a storonyorganovdykhaniye, grudnoykletka of an isredosteniye Cough, a zalozhennostnosa Narusheniyaso's Rhinorrhea of the Vomiting of the Abdominal Pain storonyzheludochno-kishechnogotrakt (incl. pain vverkhny the chastizhivot), dyspepsia, Narusheniyaso's nausea of a storonykozha ipodkozhnykhtkany Dermatitis (atopicheskiydermatit vklyuchayaallergicheskiy) the Description separate undesirable reaktsiypsikhichesky disorders and disorders from a nervous sistemygripp can be connected with various neurologic and povedencheskimisimptoma which can include hallucinations, nonsense inenormalny behavior, and in certain cases leads to a smertelnomuiskhod. These phenomena can occur against the background of ilientsefalopatiya encephalitis, but can be shown without obvious serious illness. From the patients with flu receiving Nomides during a postmarketingovogoissledrovaniye messages about spasms and deliriums (including takiyesimptoma as the changed condition of consciousness, confusion of a sosznaniye, abnormal behavior, nonsense, hallucinations, excitement, alarm, nochnyekoshmara), seldom or never arrived – about mutilation or a letalnomiskhoda. These phenomena were registered generally among children of ipodrostok, and often had the rough beginning and a fast outcome. VliyanieNomides on these phenomena is unknown. About such psychoneurological to a yavleniyakhtakzha it was reported from the patients with flu who were not accepting NomidesGepatobiliarnyy narusheniyagepatobiliarny disturbances, including hepatitis and raised liver urovenferment at patients with grippopodobny diseases. These sluchaivklyuchat lightning hepatitis / a liver failure a sosmertelny outcome. Others special populyatsiipediatrichesky population (newborns are younger than one year) Not enough data for children who have an age after conception sostavlyaetmeny 36 weeks. Safety profile for children of early age of mladsheodny year is similar to the established safety profile for children a vvozrasta of one year and is more senior. Elderly people and patients with chronic zabolevaniyamiserdtsa / respiratory the puteypopulyation included in researches of treatment of flu consist from zdorovykhvzroslykh / teenagers and patients of risk group (patients with povyshennymrisky development of the complications connected with flu, for example elderly people of an ipatsiyenta with chronic diseases of heart or airways). In general patients of risk group had safety profile kachestvennopodoben to a profile of other healthy adults / teenagers. Children with previous bronchial astmoyv whole side effects at children with previous bronchial astmoykachestvenno are similar to that at healthy children. Messages about expected collateral the reaktsiyakhpredostavleniye of data on expected side reactions preparatayavlyatsya by very important point allowing to carry out a ratio nepreryvnyymonitoring risk/advantage of medicine. Meditsinskimrabotnikam it is necessary to provide information on any predpolagayemykhneblagopriyatny reactions on the contacts specified at the end of the instruction, an atakzha through the national system of collection of information. Protivopokazaniya hypersensitivity to an oseltamivir to phosphate or a lyubomukomponent preparata chronic kidney disease (a constant hemodialysis, chronic peritoneal dialysis, clearance of creatinine ≤ 10 ml/min.) Medicinal the vzaimodeystviyainformation received in pharmacological and pharmakokineticheskikhissledovaniye of an oseltamivir of phosphate, allows to consider klinicheskiznachimy medicinal interactions improbable. The medicinal interactions caused by the competition and binding by the saktivny centers of the esterases turning an oseltamivir phosphate into an aktivnoyeveshchestvo in literature in detail are not lit. Low degree of a svyazyvaniyaoseltamivir and an active metabolite with proteins do not allow to osnovaniypredpolagat existence of the interactions connected from vytesneniyemlekarstvenny means from communication with proteins. Neither an oseltamivira phosphate, nor an active metabolite not yavlyayutsyapredpochtitelny substrate for multifunctional oxidases of a sistemytsitokhrom of P450 or for glyukuroniltransferaz. There is no formal basis of a dlyavzaimodeystviye with oral contraceptives. Cimetidinum, nonspecific inhibitor of isoenzymes of a system tsitokhromar450, does not affect plasma concentration of an oseltamivir and its aktivnogometabolit. Co-administration of a probenetsid leads to increase in AUCaktivnogo of a metabolite approximately twice. However dose adjustment priodnovremenny use with probenetsidy is not required. The concomitant use with amoxicillin does not influence plazmennyekoncentration of both drugs. Clinically significant intermedicinal interactions connected with the competition for canalicular secretion are improbable, taking in vnimaniyerezerv safety for the majority of the similar drugs, ways of a vyvedeniyaaktivny metabolite of an oseltamivir (glomerular filtration and anionnayakanaltsevy secretion) and also the removing ability of each of ways. Despite this, it is necessary to show care at Nomidesodnovremenno's appointment with drugs with similar ways of removal and an uzkimterapevtichesky range (chlorpropamide, a methotrexate, phenylbutazone). Pharmacokinetic interactions between oseltamiviry or an egoosnovny metabolite at a concomitant use with paracetamol, acetylsalicylic acid, Cimetidinum or antiacid means (magnesium and aluminum hydroxide, calcium a carbonate), remantadin ivarfariny are not revealed. Special ukazaniyapreparat Nomides is effective only concerning an influenza virus. Given to a poeffektivnost Nomides in any diseases caused by drugimivozbuditel except influenza viruses, no. Nomides is not vaccination replacement. Prescribing of drug not dolzhnovliyat on the recommendation to annual vaccination. Action prodolzhayetsyastolko how many administration of drug lasts. Nomides it is necessary to appoint dlyaprofilaktik and treatments of flu in the presence of the confirmed data of an otsirkulyation of an influenza virus. The sensitivity of the circulating strains of a virusagripp to an oseltamivir considerably varies. For this reason at a prinyatiiresheniya about prescribing of the drug Nomides it is necessary to use samuyuposledny information on sensitivity of the circulating strains of a virusagripp to drug. Information concerning safety and efficiency of an oseltamivir of the upatsiyent which are in serious or unstable condition, trebuyushchikhnemedlenny hospitalization is not available. The efficiency of an oseltamivir in prevention and treatment of flu at patients simmunodefitsity is not established. The efficiency of an oseltamivir in treatment of patients with hronicheskimizabolevaniye of heart and/or respiratory diseases is not established. Children's vozrastdanny, allowing to establish the recommended doses at premature children (& lt, 36 weeks), no. To children 13 years with body weight less than 40 kg are younger it is recommended ispolzovaniyenomides in the form of powder for preparation of suspension for intake. Heavy renal individual selection of a dose is recommended to a nedostatochnost of adults and teenagers (13-17 years) with the available heavy pochechnoynedostatochnost. Insufficient data on use of drug for babies and children in vozraste1 are also more senior than year do not allow to establish recommendations about dosing. Neuromental it narusheniyasoobshchatsya about cases of development of disturbance of mentality in the period of a primeneniyanomides, especially at children and teenagers. The similar phenomena takzhenablyudatsya in lack of therapy by the drug Nomides. To Sleduyetcontrolirovat a condition of patients and to carefully estimate advantage / riskprodolzheniya treatments in each individual case. Pregnancy and the period of laktatsiicontroliruyemy clinical trials according to Nomidesu's safety of pregnant women it was not carried out. Nomides it is necessary to appoint in a vremyaberemennost or a lactation only if vozmozhnyepreimushchestvo from its use exceed potential risk for a plodaila of the baby and the assessment of safety, a patogennostikonkretny influenza strain and the state of health of a beremennoyzhenshchina is carried out. During preclinical trials oseltamivir and active metabolitpronikat in milk of the lactating rats. Data on excretion of an oseltamivir and to use of an oseltamivir of a kormyashchimizhenshchinama are limited to sgrudny milk at the person. Oseltamivir and his active metabolite in nebolshikhkolichestvo get into breast milk, creating subterapevticheskiyekoncentration in the baby's blood. When assigning the oseltamivirakormyashchy women should consider also an associated disease an ipatogennost of the circulating influenza strain. In the period of a breastfeeding beremennostiya oseltamivir apply only in a case, the eslipredpolagayemy advantage for mother exceeds potential risk for a fruit of an irebenkaosobennost of influence on ability to manage transport sredstvamiit potentially dangerous to the mekhanizmamena vliyaetperedozirovkav the present of cases of overdose is not described, odnakopredpolagayemy symptoms of acute overdose will be nausea from a rvotoyila without it. Single doses Nomides up to 1000 mg were transferred well, a zaisklyucheniye of nausea and vomiting. A form of release and upakovkapo 5 or 10 capsules in blister strip packaging from the plenkipolivinilkhloridny and printing aluminum foil varnished. On 20, 30 capsules in bank polymeric of polyethylene of low pressure the skryshka tense with control of the first opening from polietilenavysoky pressure. The free space is filled with medical cotton. Nabank paste labels from paper label or writing or izpolimerny materials, self-adhesive. On the 1 or 2 blister strip packaging together with the instruction to pomeditsinsky use in the state and Russian languages place a vpachka from cardboard for a retail container. Packs place in group packing. After 1 bank together with the instruction for medical use nagosudarstvenny and Russian languages place in a pack from cardboard of a dlyapotrebitelsky container. Packs place in group packing. Conditions to hraneniyakhranit in original packing at a temperature not above 25 °C. To store out of children's reach! Term hraneniya3 years. Not to use after the expiration date specified on packing. Prescription status from aptekpo retseptuproizvoditelyao Pharmasintez, 664040, Irkutsk, R. Luxemburg St., 184. E-mail address: info@pharmasyntez.comvladelets registration udostovereniyaao Pharmasintez the Name and the country of the Pharmasintez organization-proizvoditelyaAO, RossiyaAdres of the organization taking in the territory of the Republic of Kazakhstanpretenziya from consumers on quality of products (goods) iotvetstvenny for post-registration observation for bezopasnostyyulekarstvenny a sredstvag. Almaty, TOO SonsultAsia Shevchenko St. of 165 B
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(E124), vodaochishchenny, gelatin. OpisanieDlya of a dosage of 30 mg: solid gelatin capsules No. 3, belogotsvet body, lid of white color. For a dosage of 45 mg: solid gelatin capsules No. 2, golubogotsvet body, lid of blue color. For a dosage of 75 mg: solid gelatin capsules No. 1, belogotsvet body, lid of orange color. Contents of capsules: powder, white or white with a yellowish shade. Pharmacotherapeutic gruppaprotivovirusny drugs of direct action. Neuraminidase inhibitors. Oseltamivir. The ATH J05AH02Farmakologicheskie code to a svoystvaFarmakokinetikaPosla of oral administration of an oseltamivir phosphate is easily soaked up a vzheludochno-intestinal path and highly turns in aktivnyymetabolit under the influence of hepatic esterases. Concentration of the aktivnogometabolit in plasma are defined within 30 minutes, reach pochtimaksimalny level in 2–3 hours after reception and significantly (more, chemv 20 times) concentration of pro-medicine exceed. Not less than 75% prinyatoyvnutr doses get to a system blood stream in the form of an active metabolite, less than 5% – in the form of initial drug. Plasma concentration both pro-drugs, and an active metabolite are proportional to a dose and do not depend an otpriyema of food. The average volume of distribution (V ss) active metabolite is primerno23 liters. Linking of an active metabolite with proteins of plasma krovineznachitelno (about 3%). Linking of pro-medicine with proteins of plasma krovisostavlyat 42% that it is not enough to serve as the reason of sushchestvennykhlekarstvenny interactions. Oseltamivira phosphate highly turns into an active metabolitpod effect of the esterases which are mainly in a liver and intestines. Neither an oseltamivira phosphate, nor an active metabolite are not substratamiil inhibitors of isoenzymes of a system of P450 cytochrome. Oseltamivir is brought, mainly (& gt, 90%), by transformation a vaktivny metabolite – an oseltamivira carboxylate which not podvergayetsyadalneyshy transformation and is removed with urine. At the majority patsiyentovperiod semi-removal of an active metabolite from plasma makes 6–10 hours. The active metabolite is removed completely by renal excretion. The renal clearance (18.8 l/hour) exceeds the glomerular filtration rate (7.5 l/hour) that indicates that drug is removed also putemkanaltsevy secretion. With a stake less than 20% of the marked drug taken vnutrradioaktivno are removed. Pharmacokinetics in special gruppakhpatsiyenta with dysfunction of a pochekpra the Nomides's appointment on 75 mg 2 times a day within 5 days to patients srazlichny extent of damage of kidneys of the area under a curve a koncentratsiiaktivny metabolite in plasma – time (AUC) back to a proportsionalnysnizheniye of function of kidneys. The pharmacokinetics of an oseltamivir at the patients a sterminalny stage of a renal failure (with clearance of creatinine of ≤10 ml/min.) who are not on dialysis was not studied. Patients with dysfunction a pecheniissledovaniye of in vitro showed that at patients from hepatic the patologiyeyvelichina of AUC of an oseltamivir of phosphate is much not raised, and AUCaktivnogo of a metabolite is not reduced.Elderly to a patsiyenty of patients of old age (65–78 years) AUC of an active metabolite a vravnovesny state was 25-35% higher, than at more young people of a patsiyentovpra purpose of similar doses of Nomides. Elimination half-life to a preparata elderly significantly did not differ from that at more young people of patsiyentovvzrosly age. Taking into account data on AUC drug and shipping, at treatment and prevention of flu it is not required to elderly patients of dose adjustment. DetiFarmakokinetika Nomides was studied at children from 1 year to 16 years a vpharmakokinetichesky research with single dose of drug and in clinical trial at a small number of children at the age of 3–12 years. Udetya of younger age observed faster removal of a prolekarstvaa of an active metabolite, than at adults that led to lower AUCpo to the relation to a specific dose. Administration of drug in a dose of 2 mg/kg gives to a takuyuzha of AUC of an oseltamivir of carboxylate what is reached at adults of postsingle dose of the capsule from 75 mg of drug (that is equivalent approximately 1mg/kg). The pharmacokinetics of an oseltamivir at children is more senior than 12 years is similar about a takovoya of adults. At children of 6-12 months the purpose of an oseltamivir in a dose of 3 mg/kg twice in sutkiobespechivat the plasma level of an active metabolite similar to the level showing clinical performance at children of advanced age of ivzrosly. FarmakodinamikaProtivovirusnyy drug. Oseltamivira phosphate is pro-medicine, its active metabolite (an oseltamivira carboxylate) competitively iizbiratelno inhibits a neuraminidase of influenza viruses of type A and B – the enzyme catalyzing process of release of again obrazovannykhvirusny particles of the infected cells, their penetrations in a kletkiepiteliya of airways and further spread of a virus a vorganizm. Oseltamivira carboxylate acts out of cells. Growth of a virus grippain vitro oppresses and suppresses replication of a virus and its pathogenicity of in Vivo, an umenshayetvydeleniye of influenza viruses And yes In from an organism. Its concentration necessary for suppression of activity of enzyme for 50% (IC50) are unizhny border of nanomolar range. At Nomides's reception for the purpose of post-contact (7 days) and seasonal (42 days) prevention of flu of resistance to drug is not noted. Frequency of tranzitorny discharge of an influenza virus with a neuraminidase snizhennoychuvstvitelnost to an oseltamivir to carboxylate at vzroslykhpatsiyent flu is 0.4%. Elimination of a resistant virus comes from an organism of the patients receiving Nomides without ukhudsheniyaklinichesky condition of patients. Indications to primeneniyu treatment of flu at adults and children, including the full-term newborns, ukotory are observed flu symptoms when a population tsirkuliruyetsreda influenza virus. The efficiency of drug was shown at a nachaleterapiya within 2 days after the first emergence of symptoms grippa prevention of flu at adults and children: prevention of flu at adults and children is more senior than 1 year after the sluchayevkontakt with persons with clinically confirmed flu when the virusgrippa circulates among naseleniya prevention of flu at children 1 years during a flu pandemic are younger. Drug Nomides is not vaccination replacement. Primeneniyeprotivovirusny drugs for treatment and prevention of flu, dolzhnobyt it is based on official recommendations. Decisions, kasayushchiyesyaprimeneniye of an oseltamivir for treatment and prevention of flu to sleduyetprinimat, considering the known information on harakteristikakhtsirkuliruyushchy influenza viruses, sensitivity forms to the lekarstvennympreparata intended for treatment of flu depending on a season, a disease ivliyaniya in various geographical zones and populyatsiyakhpatsiyent. The route of administration and dozynomides is accepted inside, at meal time or irrespective of meal. Unekotory patients the tolerance of drug improves if egoprinimat at meal time. Treatment it is necessary to begin in the first or second denpoyavleniye of symptoms of flu.In cases when adults, teenagers ≥ 12 years and children with the body weight & gt, 40 kgil ≥ 8 years have a problem with ingestion of capsules, neobkhodimootkryt the capsule and to pour out its contents in a small amount (at most 1 teaspoon) of the suitable sweetened food product (chocolate syrup (with the normal content of sugar or without soderzhaniyasakhar), the honey dissolved in water, a sweet dessert, condensed milk sugar, apple puree or yogurt) to hide bitter taste. Mix needs to be mixed and given carefully to the patient entirely. To Sleduyetproglotit mix at once after preparation. The standard mode dozirovaniyavzrosly and teenagers is more senior than 13 years (with body weight more than 40 kg): Treatment the gripparekomendovanny mode of dosing Nomides – on one capsule of 75 mg 2 razav day inside within 5 days or on 75 mg of suspension 2 times a day inside within 5 days. Prevention of flu the Recommended dose Nomides for prevention of flu after contact by the sinfitsirovanny person – on 75 mg of 1 times a day inside within 10 days. Administration of drug needs to be begun no later than in the first 2 days of postcontact. The recommended dose for prevention during a seasonal flu epidemic – on 75 mg of 1 times a day, is shown efficiency and safety of drug to its pripriyema within 6 weeks. Preventive action prodolzhayetsyastolko how many administration of drug lasts. Children from 1 year to 12 years: Treatment of flu: Body weight the Recommended dosage within 5 days of 10 - 15 kg 30 mg two times in den15 – 23 kg 45 mg two times in den23 – 40 kg 60 mg two times in день>, 40 kg 75 mg two times in a denprofilaktik of flu: Body weight the Recommended dosage within 10 days of 10 - 15 kg 30 mg once in den15 – 23 kg 45 mg once in den23 – 40 kg 60 mg once in день>, 40 kg 75 mg once in a denyeffektivnost Nomides for prevention during seasonal an epidemiigripp at children is younger than 12 years was not studied. Children up to 1 godalecheniye of flu: The recommended dose for children aged till 1 year makes 3 mg/kg of a massytel twice a day. Body weight the Recommended dosage within 5 days of 3 kg 9 mg two times in den4 kg of 12 mg two times in den5 kg of 15 mg two times in den6 kg of 18 mg two times in den7 kg of 21 mg two times in den8 kg of 24 mg two times in den9 kg of 27 mg two times in den10 the kg of 30 mg two times in the dendanny mode of dosing is inapplicable to premature newborns (i.e., given rise till 36 weeks). On dosing at given gruppypatsiyent there is an insufficient amount of data. Prevention a gripparekomendovanny dose Nomides for prevention of flu during a pandemic udety is younger than 1 year makes a half of a medical dose – once pass 3 mg/kg within 10 days. The efficiency Nomides for prevention in a vremyasezonny flu epidemic at children is younger than 1 year was not studied. Dosing in special sluchayakhpatsiyenta with an abnormal liver function dose adjustment is not required to Patients with an abnormal liver function. Researches at children with abnormal liver functions were not conducted. Patients with dysfunction the pocheklecheniye is recommended to grippavzrosly patients and teenagers (13-17 years) with dysfunctions of pochekumerenny or heavy severity selection of a dose. The recommended doses are described in the table below. The clearance of creatinine Recommended дозы>, 60 ml/min. 75 mg 2 times in сутки>, 30 - 60 ml/min. 30 mg (suspension or capsules) 2 times in сутки>, 10 - 30 ml/min. 30 mg (suspension or capsules) of 1 times a day ≤ 10 ml/min. is not recommended (data are absent) Patients on a gemodiliza of 30 mg after each procedure of a gemodializapatsiyenta on a peritoneal hemodialysis * 30 mg (suspension or capsules) once * by results of these researches conducted with participation of the patients who are on chronic peritoneal dialysis in out-patient conditions (HPDA) when using the mode of the automatic peritoneal dialysis (APD) the clearance of an oseltamivir of carboxylate can be higher. The mode dializamozht to be switched with APD to HPDA according to the decision of the nephrologist.Prevention is recommended to grippavzrosly patients and teenagers (13-17 years) with dysfunctions of pochekumerenny or heavy severity selection of a dose. The recommended doses are described in the table below. The clearance of creatinine Recommended дозы>, 60 ml/min. 75 mg of 1 times in сутки>, 30 - 60 ml/min. 30 mg (suspension or capsules) of 1 times in сутки>, 10 - 30 ml/min. 30 mg (suspension or capsules) of 1 times every other day ≤ 10 ml/min. is not recommended (data are absent) Patients on a hemodialysis of 30 mg after every second procedure of a hemodialysis Patients on a peritoneal hemodialysis * 30 mg (suspension or capsules) once a week * by results of these researches conducted with participation of the patients who are on chronic peritoneal dialysis in out-patient conditions (HPDA) when using the mode of the automatic peritoneal dialysis (APD) the clearance of an oseltamivir of carboxylate can be higher. The mode dializamozht to be switched with APD to HPDA according to the decision of the nephrologist. Recommendations about drug dosing at babies and children up to 12 years snarusheniye of function of kidneys are absent in connection with nedostatochnostyyuklinichesky data. Elderly patients Dose adjustment is not required, except for cases when imeyutsyapriznak of renal failures of moderate or heavy severity. Ex-temporal preparation of NomidesV cases when adults, teenagers and children have a problem a sproglatyvaniye of capsules, and Nomides in a dosage form suspension dlyaprigotovleniye powder for intake is absent or at nalichiipriznak of ageing of capsules, it is necessary to open the capsule and to pour out eesoderzhimy in a small amount (at most 1 teaspoon) of the suitable sweetened food product to hide gorkiyvkus. Mix needs to be mixed and given carefully to the patient entirely. It is necessary to swallow mix at once after preparation. If patients need a dose of 75 mg, then it is necessary to follow sleduyushchimiinstruktion: 1. Holding one Nomides capsule of 75 mg over small capacity, akkuratnoraskryt the capsule and to pour out powder in capacity.2. To add a small amount (no more than 1 teaspoon) of podhodyashchegopodslashchenny food product (to hide bitter taste) and to horoshoperemeshat. 3. To carefully mix mix and to drink it at once after preparation. If in capacity there was a small amount of mix, then to sleduyetopolosnut capacity a small amount of water and to drink ostavshuyusyasmes. If doses of 30-60 mg are required for patients, then for the correct dozirovaniyaneobkhodimo to follow the following iinstruktion: 1. Holding one Nomides capsule of 75 mg over small capacity, akkuratnoraskryt the capsule and to pour out powder in capacity.2. To add to powder 5 ml of water by means of the syringe with the tags showing amount of the gathered liquid. To Tshchatelnoperemeshat within 2 minutes.3. To gain in the syringe necessary amount of mix from capacity to the soglasnonizheprivedenny table: Body weight the Recommended dose Amount of the mix Nomides on one priem15 kg of 30 mg 2 мл>, 15-23 kg 45 mg 3 мл>, 23-40 kg 60 mg 4 mlnt need for an intake of not dissolved white powder, poskolkuon is inactive filler. Having pressed the syringe piston, to enter all its contents into the second capacity. Ostavshuyusyaneispolzovanny mix needs to be utilized. 4. To add a small amount (no more than 1 chaynoylozhka) of the suitable sweetened food product that skrytgorky taste, and it is good to mix to the second capacity. 5. To carefully mix mix and to drink it at once after preparation. If in capacity there was a small amount of mix, then it is necessary to rinse capacity with a small amount of water and to drink ostavshuyusyasmes. Collateral to a deystviya of adults/teenagers, nausea and vomiting in treatment researches, and the takzhetoshnot in researches on prevention were the most frequent undesirable (collateral) reactions (NR). About the majority of data Nrsoobshchalos once or for the first, or second day of treatment and it is spontaneous within 1-2 days. Children of the most frequent NR had a vomiting. For bolshinstvapatsiyent these NR did not demand the introduction termination Nomides. About the following serious undesirable reactions it was reported seldom from those porkak oseltamivir entered the market: anaphylactic and anafilaktoidnyereaktion, liver diseases (lightning hepatitis, disorder of a funktsiipechena and jaundice), Quincke's disease, Stephens-Johnson's syndrome itoksichesky epidermal necrolysis, gastrointestinal bleedings ipsikhonevrologichesky disorders. The list of undesirable reactions in a look tablitsynr, listed below in tables, are divided into the following categories: ochenchasto (≥1/10), it is frequent (from ≥1/100 to & lt, 1/10), infrequently (from ≥ 1/1000 to & lt, 1/100), r
(from ≥ 1/10000 to & lt, 1/1000) and is very rare (& lt, 1/10000). NR bring vsootvetstvuyushchy category in tables according to with generalized analizomklinichesky researches. Treatment and prevention of flu at adults and teenagers: NR most of which often arose at the recommended dose (75 mg two razav day within 5 days for treatment and 75 mg a day during the period up to 6 weeks for prevention) during the research of treatment and prevention uvzroslykh / teenagers, are given in Table 1. The profile of safety of the patients receiving recommended a dozunomidesa for prevention (75 mg once a day within 6 weeks) is bylkachestvenno similar to that which was observed during the treatment research, despite longer term of administration of drug during an issledovaniyaprofilaktika. Table 1. Undesirable reactions of Nomides for treatment of an iprofilaktika of flu at adults and teenagers or in hodepostmarketingovy observations. System organnyyklass the Undesirable phenomena on frequency Very often Often Infrequently Seldom Infectious iparazitarnyezabolevaniye Bronchitis, a herpes simplex, a nasopharyngitis, infektsiiverkhnikhdykhatelnykhputy, Narusheniyaso's sinusitis of a storonykrova of the ilimfatichesky Narusheniyaso's Thrombocytopenia of a Storonyimmunnoysistema of Reaktsiyagiperchuvstvitelnosti system Anaphylactic reactions, anaphylactoid reactions of Narusheniyapsikhiki Vozbuzhdyonnoyesostoyaniye, a nenormalnoyepovedeniye, uneasiness, a sputannostsoznaniye, nonsense, a delirium, hallucinations, nochnyekoshmara, Narusheniyaso's mutilation of a storonynervnoysistema Golovnayabol Bessonnitsa Izmenyonnoyesostoyaniyesoznaniya, Narusheniyaso's convulsions of a storonyorganazreniye of Narusheniyezreniya Narusheniyaso of storonyserdets of Serdechnayaaritmiya Narusheniyaso of a storonyorganovdykhaniye, a grudnoykletka of an isredosteniye Cough, pain to a vgorla, Narusheniyaso's rhinorrhea of the Nausea Vomiting storonyzheludochno-kishechnogotrakt, pain to a vzhivota (incl. pain in stomach verkhneychast), dyspepsia of Zheludochno-kishechnyekrovotecheniya, gemorragicheskiykolit Narusheniyaso of a storonypechena of izhelchevyvodyashchy ways Molniyenosnyygepatit Raised urovenfermentovpechen, a pechyonochnayanedostatochnost, the hepatitis Narusheniyaso of a storonykozha ipodkozhnykhtkany Eczema, dermatitis, rash, urticaria of Obshchiyerasstroystvai narusheniyav Bol's mestevvedeniya, dizziness (incl. vertigo), fatigue, a hyperthermia, extremity pain are given In table 2 the most frequent NR during the pediatricheskikhklinichesky researches. Table 2. Undesirable reactions of Nomides for treatment of an iprofilaktika of flu at children (age/weight on the basis of a dose
). System organnyyklass the Undesirable phenomena on frequency Very often Often Infrequently Seldom Infectious iparazitarnyezabolevaniye Average otitis of Narusheniyaso of a storonynervnoysistema the Headache of Narusheniyaso of a storonyorganazreniye Conjunctivitis (including pokrasneniyeglaz, vydeleniyaiz an eye and pain vglaza) Narusheniyaso of the party the Otalgia of Disturbance of a sostorona of body of a slukhaa of balance of a barabannoypereponka of Narusheniyaso of a storonyorganovdykhaniye, grudnoykletka of an isredosteniye Cough, a zalozhennostnosa Narusheniyaso's Rhinorrhea of the Vomiting of the Abdominal Pain storonyzheludochno-kishechnogotrakt (incl. pain vverkhny the chastizhivot), dyspepsia, Narusheniyaso's nausea of a storonykozha ipodkozhnykhtkany Dermatitis (atopicheskiydermatit vklyuchayaallergicheskiy) the Description separate undesirable reaktsiypsikhichesky disorders and disorders from a nervous sistemygripp can be connected with various neurologic and povedencheskimisimptoma which can include hallucinations, nonsense inenormalny behavior, and in certain cases leads to a smertelnomuiskhod. These phenomena can occur against the background of ilientsefalopatiya encephalitis, but can be shown without obvious serious illness. From the patients with flu receiving Nomides during a postmarketingovogoissledrovaniye messages about spasms and deliriums (including takiyesimptoma as the changed condition of consciousness, confusion of a sosznaniye, abnormal behavior, nonsense, hallucinations, excitement, alarm, nochnyekoshmara), seldom or never arrived – about mutilation or a letalnomiskhoda. These phenomena were registered generally among children of ipodrostok, and often had the rough beginning and a fast outcome. VliyanieNomides on these phenomena is unknown. About such psychoneurological to a yavleniyakhtakzha it was reported from the patients with flu who were not accepting NomidesGepatobiliarnyy narusheniyagepatobiliarny disturbances, including hepatitis and raised liver urovenferment at patients with grippopodobny diseases. These sluchaivklyuchat lightning hepatitis / a liver failure a sosmertelny outcome. Others special populyatsiipediatrichesky population (newborns are younger than one year) Not enough data for children who have an age after conception sostavlyaetmeny 36 weeks. Safety profile for children of early age of mladsheodny year is similar to the established safety profile for children a vvozrasta of one year and is more senior. Elderly people and patients with chronic zabolevaniyamiserdtsa / respiratory the puteypopulyation included in researches of treatment of flu consist from zdorovykhvzroslykh / teenagers and patients of risk group (patients with povyshennymrisky development of the complications connected with flu, for example elderly people of an ipatsiyenta with chronic diseases of heart or airways). In general patients of risk group had safety profile kachestvennopodoben to a profile of other healthy adults / teenagers. Children with previous bronchial astmoyv whole side effects at children with previous bronchial astmoykachestvenno are similar to that at healthy children. Messages about expected collateral the reaktsiyakhpredostavleniye of data on expected side reactions preparatayavlyatsya by very important point allowing to carry out a ratio nepreryvnyymonitoring risk/advantage of medicine. Meditsinskimrabotnikam it is necessary to provide information on any predpolagayemykhneblagopriyatny reactions on the contacts specified at the end of the instruction, an atakzha through the national system of collection of information. Protivopokazaniya hypersensitivity to an oseltamivir to phosphate or a lyubomukomponent preparata chronic kidney disease (a constant hemodialysis, chronic peritoneal dialysis, clearance of creatinine ≤ 10 ml/min.) Medicinal the vzaimodeystviyainformation received in pharmacological and pharmakokineticheskikhissledovaniye of an oseltamivir of phosphate, allows to consider klinicheskiznachimy medicinal interactions improbable. The medicinal interactions caused by the competition and binding by the saktivny centers of the esterases turning an oseltamivir phosphate into an aktivnoyeveshchestvo in literature in detail are not lit. Low degree of a svyazyvaniyaoseltamivir and an active metabolite with proteins do not allow to osnovaniypredpolagat existence of the interactions connected from vytesneniyemlekarstvenny means from communication with proteins. Neither an oseltamivira phosphate, nor an active metabolite not yavlyayutsyapredpochtitelny substrate for multifunctional oxidases of a sistemytsitokhrom of P450 or for glyukuroniltransferaz. There is no formal basis of a dlyavzaimodeystviye with oral contraceptives. Cimetidinum, nonspecific inhibitor of isoenzymes of a system tsitokhromar450, does not affect plasma concentration of an oseltamivir and its aktivnogometabolit. Co-administration of a probenetsid leads to increase in AUCaktivnogo of a metabolite approximately twice. However dose adjustment priodnovremenny use with probenetsidy is not required. The concomitant use with amoxicillin does not influence plazmennyekoncentration of both drugs. Clinically significant intermedicinal interactions connected with the competition for canalicular secretion are improbable, taking in vnimaniyerezerv safety for the majority of the similar drugs, ways of a vyvedeniyaaktivny metabolite of an oseltamivir (glomerular filtration and anionnayakanaltsevy secretion) and also the removing ability of each of ways. Despite this, it is necessary to show care at Nomidesodnovremenno's appointment with drugs with similar ways of removal and an uzkimterapevtichesky range (chlorpropamide, a methotrexate, phenylbutazone). Pharmacokinetic interactions between oseltamiviry or an egoosnovny metabolite at a concomitant use with paracetamol, acetylsalicylic acid, Cimetidinum or antiacid means (magnesium and aluminum hydroxide, calcium a carbonate), remantadin ivarfariny are not revealed. Special ukazaniyapreparat Nomides is effective only concerning an influenza virus. Given to a poeffektivnost Nomides in any diseases caused by drugimivozbuditel except influenza viruses, no. Nomides is not vaccination replacement. Prescribing of drug not dolzhnovliyat on the recommendation to annual vaccination. Action prodolzhayetsyastolko how many administration of drug lasts. Nomides it is necessary to appoint dlyaprofilaktik and treatments of flu in the presence of the confirmed data of an otsirkulyation of an influenza virus. The sensitivity of the circulating strains of a virusagripp to an oseltamivir considerably varies. For this reason at a prinyatiiresheniya about prescribing of the drug Nomides it is necessary to use samuyuposledny information on sensitivity of the circulating strains of a virusagripp to drug. Information concerning safety and efficiency of an oseltamivir of the upatsiyent which are in serious or unstable condition, trebuyushchikhnemedlenny hospitalization is not available. The efficiency of an oseltamivir in prevention and treatment of flu at patients simmunodefitsity is not established. The efficiency of an oseltamivir in treatment of patients with hronicheskimizabolevaniye of heart and/or respiratory diseases is not established. Children's vozrastdanny, allowing to establish the recommended doses at premature children (& lt, 36 weeks), no. To children 13 years with body weight less than 40 kg are younger it is recommended ispolzovaniyenomides in the form of powder for preparation of suspension for intake. Heavy renal individual selection of a dose is recommended to a nedostatochnost of adults and teenagers (13-17 years) with the available heavy pochechnoynedostatochnost. Insufficient data on use of drug for babies and children in vozraste1 are also more senior than year do not allow to establish recommendations about dosing. Neuromental it narusheniyasoobshchatsya about cases of development of disturbance of mentality in the period of a primeneniyanomides, especially at children and teenagers. The similar phenomena takzhenablyudatsya in lack of therapy by the drug Nomides. To Sleduyetcontrolirovat a condition of patients and to carefully estimate advantage / riskprodolzheniya treatments in each individual case. Pregnancy and the period of laktatsiicontroliruyemy clinical trials according to Nomidesu's safety of pregnant women it was not carried out. Nomides it is necessary to appoint in a vremyaberemennost or a lactation only if vozmozhnyepreimushchestvo from its use exceed potential risk for a plodaila of the baby and the assessment of safety, a patogennostikonkretny influenza strain and the state of health of a beremennoyzhenshchina is carried out. During preclinical trials oseltamivir and active metabolitpronikat in milk of the lactating rats. Data on excretion of an oseltamivir and to use of an oseltamivir of a kormyashchimizhenshchinama are limited to sgrudny milk at the person. Oseltamivir and his active metabolite in nebolshikhkolichestvo get into breast milk, creating subterapevticheskiyekoncentration in the baby's blood. When assigning the oseltamivirakormyashchy women should consider also an associated disease an ipatogennost of the circulating influenza strain. In the period of a breastfeeding beremennostiya oseltamivir apply only in a case, the eslipredpolagayemy advantage for mother exceeds potential risk for a fruit of an irebenkaosobennost of influence on ability to manage transport sredstvamiit potentially dangerous to the mekhanizmamena vliyaetperedozirovkav the present of cases of overdose is not described, odnakopredpolagayemy symptoms of acute overdose will be nausea from a rvotoyila without it. Single doses Nomides up to 1000 mg were transferred well, a zaisklyucheniye of nausea and vomiting. A form of release and upakovkapo 5 or 10 capsules in blister strip packaging from the plenkipolivinilkhloridny and printing aluminum foil varnished. On 20, 30 capsules in bank polymeric of polyethylene of low pressure the skryshka tense with control of the first opening from polietilenavysoky pressure. The free space is filled with medical cotton. Nabank paste labels from paper label or writing or izpolimerny materials, self-adhesive. On the 1 or 2 blister strip packaging together with the instruction to pomeditsinsky use in the state and Russian languages place a vpachka from cardboard for a retail container. Packs place in group packing. After 1 bank together with the instruction for medical use nagosudarstvenny and Russian languages place in a pack from cardboard of a dlyapotrebitelsky container. Packs place in group packing. Conditions to hraneniyakhranit in original packing at a temperature not above 25 °C. To store out of children's reach! Term hraneniya3 years. Not to use after the expiration date specified on packing. Prescription status from aptekpo retseptuproizvoditelyao Pharmasintez, 664040, Irkutsk, R. Luxemburg St., 184. E-mail address: info@pharmasyntez.comvladelets registration udostovereniyaao Pharmasintez the Name and the country of the Pharmasintez organization-proizvoditelyaAO, RossiyaAdres of the organization taking in the territory of the Republic of Kazakhstanpretenziya from consumers on quality of products (goods) iotvetstvenny for post-registration observation for bezopasnostyyulekarstvenny a sredstvag. Almaty, TOO SonsultAsia Shevchenko St. of 165 B
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