крышка: титана диоксид Е 171, краситель хинолиновый желтый Е 104, краситель синий патентованный Е 131, краситель бриллиантовый черный Е 151, желатин.
Описание
Капсулы № 2 белого цвета с крышечкой зеленого цвета. Содержимое капсул - микрогранулы (пеллеты) шарообразной формы, покрытые оболочкой белого или почти белого цвета.
Фармакотерапевтическая группа
Желез желудка секрецию понижающее средство - протонового насоса ингибитор
Фармакологические свойства
Фармакодинамика:
Ингибитор протонного насоса снижает кислотопродукцию - ингибирует Н+/К+-АТФ-азу париетальных клеток желудка и блокирует тем самым заключительную стадию секреции соляной кислоты. Препарат является пролекарством и активируется в кислой среде секреторных канальцев париетальных клеток слизистой оболочки желудка.Снижает базальную и стимулированную секрецию независимо от природы раздражителя. Антисекреторный эффект после приема 20 мг наступает в течение первого часа максимум - через 2 часа Ингибирование 50 % максимальной секреции продолжается 24 часа. Однократный прием в сутки обеспечивает быстрое и эффективное угнетение дневной и ночной желудочной секреции достигающее своего максимума через 4 дня лечения и исчезающее к исходу 3-4 дня после окончания приема. У больных с язвенной болезнью 12-перстной кишки прием 20 мг омепразола поддерживает внутрижелудочный pH на уровне 3 в течение 17 часов.
Фармакокинетика:
Омепразол быстро абсорбируется из желудочно-кишечного тракта максимальная концентрация в плазме крови достигается через 05-1 час. Биодоступность составляет 30-40 % (при печеночной недостаточности возрастает практически до 100 %) обладая высокой липофильностью легко проникает в париетальные клетки желудка. При повторном приеме биодоступность достигает 60-70 % и зависит от принятой дозы. Связь с белками плазмы - 90 %. Омепразол практически полностью метаболизируется в печени с участием ферментной системы CYP2C19 с образованием 6 метаболитов (гидроксиомепразол сульфидные и сульфоновые производные и другие) фармакологически неактивных. Является ингибитором изофермента CYP2C19.
Период полувыведения - 05-1 час (при печеночной недостаточности - 3 часа) клиренс - 500-600 мл/мин. Выводится в основном почками (70-80 %) в виде метаболитов и с желчью (20-30 %). При хронической почечной недостаточности выведение снижается пропорционально снижению клиренса креатинина. У пожилых пациентов выведение уменьшается биодоступность возрастает.
Показания к применению
- Язвенная болезнь желудка и 12-перстной кишки (в том числе профилактика рецидивов);
Почечная и/или печеночная недостаточность сахарный диабет (в связи с наличием сахара в составе препарата).
Применение при беременности и в период грудного вскармливания
Применение омепразола при беременности возможно только в том случае если предполагаемая польза для матери превышает потенциальный риск для плода.
Омепразол проникает в грудное молоко. При необходимости применения препарата в период лактации следует прекратить грудное вскармливание.
Способ применения и дозы
Внутрь запивая небольшим количеством воды (непосредственно перед едой или во время приема пищи). Капсулы обычно принимают утром. Капсулы нельзя разжевывать.
При обострении язвенной болезни рефлюкс-эзофагите язвах и эрозиях желудка и 12-перстной кишки вызванных приемом нестероидных противовоспалительных препаратов - по 20 мг 1 раз в сутки. Пациентам с тяжелым течением рефлюкс-эзофагита дозу увеличивают до 40 мг 1 раз в сутки. Курс лечения при язвенной болезни 12-перстной кишки - 2-3 недели при необходимости - 4-5 недель; при язвенной болезни желудка и эзофагите - 4-8 недель. Больным резистентным к лечению другими противоязвенными лекарственными средствами назначают по 40 мг 1 раз в сутки. Курс лечения при язвенной болезни 12-перстной кишки - 4 недели при язвенной болезни желудка и рефлюкс- эзофагите - 8 недель. Для профилактики рецидивов язвенной болезни - по 10 мг 1 раз в сутки.
При синдроме Золлингера-Эллисона - по 60 мг 1 раз в сутки; при необходимости дозу увеличивают до 80-120 мг в сутки (в этом случае ее назначают в 2-3 приема). Профилактика синдрома Мендельсона - по 40 мг за 1 час до операции (в случае проведения операции дольше 2 часов необходимую дозу препарата следует ввести повторно).
Для эрадикации Helicobacter pyloriиспользуют трехкомпонентную схему лечения (в течение 1 недели: омепразол 20 мг амоксициллин 1 г кларитромицин 500 мг - по 2 раза в сутки; либо омепразол 20 мг кларитромицин 250 мг метронидазол 400 мг - по 2 раза в сутки; либо омепразол 40 мг 1 раз в сутки амоксициллин 500 мг и метронидазол 400 мг - по 3 раза в сутки) или двухкомпонентную схему лечения (в течение 2 недель: омепразол 20-40 мг и амоксициллин 750 мг - по 2 раза в сутки; либо омепразол 40 мг - 1 раз в сутки и кларитромицин 500 мг - 3 раза в сутки или амоксициллин 075-15 г - 2 раза в сутки).
Побочное действие
Со стороны пищеварительной системы: диарея или запор боль в животе тошнота рвота метеоризм повышение активности "печеночных" ферментов нарушения вкуса сухость слизистой оболочки полости рта стоматит у больных с предшествующим тяжелым заболеванием печени - гепатит (в том числе с желтухой) нарушение функции печени.
Со стороны органов кроветворения: лейкопения тромбоцитопения агранулоцитоз панцитопения.
Со стороны нервной системы: у больных с тяжелыми сопутствующими соматическими заболеваниями - головокружение головная боль возбуждение депрессия у больных с предшествующим тяжелым заболеванием печени - энцефалопатия.
Со стороны опорно-двигательного аппарата: артралгия миастения миалгия.
Со стороны кожных покровов: кожная сыпь и/или зуд фотосенсибилизация мультиформная экссудативная эритема алопеция.
Прочие: гинекомастия недомогание нарушение зрения периферические отеки усиление потоотделения образование желудочных гландулярных кист во время длительного лечения (следствие ингибирования секреции соляной кислоты; носит доброкачественный обратимый характер).
Передозировка
Симптомы: спутанность сознания нечеткость зрения сонливость сухость во рту головная боль тошнота тахикардия аритмия.
Лечение: проведение симптоматической терапии. Специфического антидота нет.
Гемодиализ недостаточно эффективен для удаления омепразола из организма в связи с высокой степенью его связывания с белками плазмы.
Взаимодействие с другими лекарственными средствами
Может снижать абсорбцию эфиров ампициллина солей железа итраконазола и кетоконазола и других лекарственных средств (ЛC) всасывание которых зависит от значения pH.
Являясь ингибитором цитохрома Р450 омепразол может повышать концентрацию и снижать выведение диазепама антикоагулянтов непрямого действия фенитоина (ЛC которые метаболизируются в печени посредством изофермента CYP2C19) что в некоторых случаях может потребовать снижения доз этих ЛC. В то же время длительное применение омепразола в дозе 20 мг 1 раз в сутки в комбинации с кофеином теофиллином пироксикамом диклофенаком напроксеном метопрололом пропранололом этанолом циклоспорином лидокаином хинидином и эстрадиолом не приводит к изменению их концентрации в плазме.
Не отмечено клинически значимого взаимодействия омепразола с одновременно принимаемыми антацидными препаратами.
Усиливает ингибирующее действие на систему кроветворения других ЛC.
Не отмечено взаимодействия омепразола с одновременно принимаемыми антацидами. Концентрации омепразола и кларитромицина в плазме возрастают при совместном применении этих препаратов.
Особые указания
Перед началом терапии необходимо исключить наличие злокачественного процесса (особенно при язве желудка) так как лечение маскируя симптоматику может отсрочить постановку правильного диагноза.
Прием одновременно с пищей не влияет на эффективность препарата.
Больным сахарным диабетом следует обратить внимание на содержание сахара в составе препарата. В одной капсуле Омепразола содержится 637 мг сахарозы (соответствует 0005 хлебным единицам (ХЕ)).
Влияние на способность управлять автомобилем и движущимися механизмами
Учитывая возможные побочные действия препарата следует соблюдать осторожность при управлении автотранспортом или другими потенциально опасными механизмами.
Форма выпуска
Капсулы кишечнорастворимые 20 мг.
Условия хранения
В защищенном от света месте при температуре не выше 25 °С.
Хранить в недоступном для детей месте.
Срок годности
2 года.
Не использовать после истечения срока годности указанного на упаковке.
Условия отпуска
По рецепту
Производитель
Акционерное общество "Валента Фармацевтика" (АО "Валента Фарм"), 141101, Московская обл., г. Щелково, ул. Фабричная, д. 2, Россия
Организация, принимающая претензии потребителей
АО "Валента Фарм"
Для описания товара использована информация от партнера 36.6
Мобильное приложение «Все аптеки»
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краситель бриллиантовый черный Е 151, желатин."}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"Капсулы № 2 белого цвета с крышечкой зеленого цвета. Содержимое капсул - микрогранулы (пеллеты) шарообразной формы, покрытые оболочкой белого или почти белого цвета."}}]},{"id":6,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"Желез желудка секрецию понижающее средство - протонового насоса ингибитор"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"header","data":{"text":"Фармакодинамика:","level":3}},{"type":"paragraph","data":{"text":"Ингибитор протонного насоса снижает кислотопродукцию - ингибирует Н+/К+-АТФ-азу париетальных клеток желудка и блокирует тем самым заключительную стадию секреции соляной кислоты. Препарат является пролекарством и активируется в кислой среде секреторных канальцев париетальных клеток слизистой оболочки желудка.Снижает базальную и стимулированную секрецию независимо от природы раздражителя. Антисекреторный эффект после приема 20 мг наступает в течение первого часа максимум - через 2 часа Ингибирование 50 % максимальной секреции продолжается 24 часа. Однократный прием в сутки обеспечивает быстрое и эффективное угнетение дневной и ночной желудочной секреции достигающее своего максимума через 4 дня лечения и исчезающее к исходу 3-4 дня после окончания приема. У больных с язвенной болезнью 12-перстной кишки прием 20 мг омепразола поддерживает внутрижелудочный pH на уровне 3 в течение 17 часов."}},{"type":"header","data":{"text":"Фармакокинетика:","level":3}},{"type":"paragraph","data":{"text":"Омепразол быстро абсорбируется из желудочно-кишечного тракта максимальная концентрация в плазме крови достигается через 05-1 час. Биодоступность составляет 30-40 % (при печеночной недостаточности возрастает практически до 100 %) обладая высокой липофильностью легко проникает в париетальные клетки желудка. При повторном приеме биодоступность достигает 60-70 % и зависит от принятой дозы. Связь с белками плазмы - 90 %. Омепразол практически полностью метаболизируется в печени с участием ферментной системы CYP2C19 с образованием 6 метаболитов (гидроксиомепразол сульфидные и сульфоновые производные и другие) фармакологически неактивных. Является ингибитором изофермента CYP2C19."}},{"type":"paragraph","data":{"text":"Период полувыведения - 05-1 час (при печеночной недостаточности - 3 часа) клиренс - 500-600 мл/мин. Выводится в основном почками (70-80 %) в виде метаболитов и с желчью (20-30 %). При хронической почечной недостаточности выведение снижается пропорционально снижению клиренса креатинина. У пожилых пациентов выведение уменьшается биодоступность возрастает."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"- Язвенная болезнь желудка и 12-перстной кишки (в том числе профилактика рецидивов);"}},{"type":"paragraph","data":{"text":"- рефлюкс-эзофагит;"}},{"type":"paragraph","data":{"text":"- гиперсекреторные состояния (синдром Золлингера-Эллисона стрессовые язвы желудочно-кишечного тракта полиэндокринный аденоматоз системный мастоцитоз);"}},{"type":"paragraph","data":{"text":"- профилактика аспирации кислого содержимого желудка в дыхательные пути во время общей анестезии (синдром Мендельсона);"}},{"type":"paragraph","data":{"text":"- язвы и эрозии желудка и 12-перстной кишки вызванные приемом нестероидных противовоспалительных препаратов;"}},{"type":"paragraph","data":{"text":"- эрадикация Helicobacter pylori у инфицированных больных с язвенной болезнью желудка и 12-перстной кишки (в составе комбинированной терапии)."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"- Повышенная чувствительность к компонентам входящим в состав препарата;"}},{"type":"paragraph","data":{"text":"- дефицит сахаразы/изомальтазы непереносимость фруктозы непереносимость лактозы дефицит лактазы глюкозо-галактозная мальабсорбция (из-за наличия сахарозы и лактозы);"}},{"type":"paragraph","data":{"text":"- детский возраст до 18 лет;"}},{"type":"paragraph","data":{"text":"- период лактации."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Почечная и/или печеночная недостаточность сахарный диабет (в связи с наличием сахара в составе препарата)."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Применение омепразола при беременности возможно только в том случае если предполагаемая польза для матери превышает потенциальный риск для плода."}},{"type":"paragraph","data":{"text":"Омепразол проникает в грудное молоко. При необходимости применения препарата в период лактации следует прекратить грудное вскармливание."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутрь запивая небольшим количеством воды (непосредственно перед едой или во время приема пищи). Капсулы обычно принимают утром. Капсулы нельзя разжевывать."}},{"type":"paragraph","data":{"text":"При обострении язвенной болезни рефлюкс-эзофагите язвах и эрозиях желудка и 12-перстной кишки вызванных приемом нестероидных противовоспалительных препаратов - по 20 мг 1 раз в сутки. Пациентам с тяжелым течением рефлюкс-эзофагита дозу увеличивают до 40 мг 1 раз в сутки. Курс лечения при язвенной болезни 12-перстной кишки - 2-3 недели при необходимости - 4-5 недель; при язвенной болезни желудка и эзофагите - 4-8 недель. Больным резистентным к лечению другими противоязвенными лекарственными средствами назначают по 40 мг 1 раз в сутки. Курс лечения при язвенной болезни 12-перстной кишки - 4 недели при язвенной болезни желудка и рефлюкс- эзофагите - 8 недель. Для профилактики рецидивов язвенной болезни - по 10 мг 1 раз в сутки."}},{"type":"paragraph","data":{"text":"При синдроме Золлингера-Эллисона - по 60 мг 1 раз в сутки; при необходимости дозу увеличивают до 80-120 мг в сутки (в этом случае ее назначают в 2-3 приема). Профилактика синдрома Мендельсона - по 40 мг за 1 час до операции (в случае проведения операции дольше 2 часов необходимую дозу препарата следует ввести повторно)."}},{"type":"paragraph","data":{"text":"Для эрадикации Helicobacter pyloriиспользуют трехкомпонентную схему лечения (в течение 1 недели: омепразол 20 мг амоксициллин 1 г кларитромицин 500 мг - по 2 раза в сутки; либо омепразол 20 мг кларитромицин 250 мг метронидазол 400 мг - по 2 раза в сутки; либо омепразол 40 мг 1 раз в сутки амоксициллин 500 мг и метронидазол 400 мг - по 3 раза в сутки) или двухкомпонентную схему лечения (в течение 2 недель: омепразол 20-40 мг и амоксициллин 750 мг - по 2 раза в сутки; либо омепразол 40 мг - 1 раз в сутки и кларитромицин 500 мг - 3 раза в сутки или амоксициллин 075-15 г - 2 раза в сутки)."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Со стороны пищеварительной системы: диарея или запор боль в животе тошнота рвота метеоризм повышение активности \"печеночных\" ферментов нарушения вкуса сухость слизистой оболочки полости рта стоматит у больных с предшествующим тяжелым заболеванием печени - гепатит (в том числе с желтухой) нарушение функции печени."}},{"type":"paragraph","data":{"text":"Со стороны органов кроветворения: лейкопения тромбоцитопения агранулоцитоз панцитопения."}},{"type":"paragraph","data":{"text":"Со стороны нервной системы: у больных с тяжелыми сопутствующими соматическими заболеваниями - головокружение головная боль возбуждение депрессия у больных с предшествующим тяжелым заболеванием печени - энцефалопатия."}},{"type":"paragraph","data":{"text":"Со стороны опорно-двигательного аппарата: артралгия миастения миалгия."}},{"type":"paragraph","data":{"text":"Со стороны кожных покровов: кожная сыпь и/или зуд фотосенсибилизация мультиформная экссудативная эритема алопеция."}},{"type":"paragraph","data":{"text":"Аллергические реакции: крапивница ангионевротический отек лихорадка бронхоспазм интерстициальный нефрит и анафилактический шок."}},{"type":"paragraph","data":{"text":"Прочие: гинекомастия недомогание нарушение зрения периферические отеки усиление потоотделения образование желудочных гландулярных кист во время длительного лечения (следствие ингибирования секреции соляной кислоты; носит доброкачественный обратимый характер)."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы: спутанность сознания нечеткость зрения сонливость сухость во рту головная боль тошнота тахикардия аритмия."}},{"type":"paragraph","data":{"text":"Лечение: проведение симптоматической терапии. Специфического антидота нет."}},{"type":"paragraph","data":{"text":"Гемодиализ недостаточно эффективен для удаления омепразола из организма в связи с высокой степенью его связывания с белками плазмы."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Может снижать абсорбцию эфиров ампициллина солей железа итраконазола и кетоконазола и других лекарственных средств (ЛC) всасывание которых зависит от значения pH."}},{"type":"paragraph","data":{"text":"Являясь ингибитором цитохрома Р450 омепразол может повышать концентрацию и снижать выведение диазепама антикоагулянтов непрямого действия фенитоина (ЛC которые метаболизируются в печени посредством изофермента CYP2C19) что в некоторых случаях может потребовать снижения доз этих ЛC. В то же время длительное применение омепразола в дозе 20 мг 1 раз в сутки в комбинации с кофеином теофиллином пироксикамом диклофенаком напроксеном метопрололом пропранололом этанолом циклоспорином лидокаином хинидином и эстрадиолом не приводит к изменению их концентрации в плазме."}},{"type":"paragraph","data":{"text":"Не отмечено клинически значимого взаимодействия омепразола с одновременно принимаемыми антацидными препаратами."}},{"type":"paragraph","data":{"text":"Усиливает ингибирующее действие на систему кроветворения других ЛC."}},{"type":"paragraph","data":{"text":"Не отмечено взаимодействия омепразола с одновременно принимаемыми антацидами. Концентрации омепразола и кларитромицина в плазме возрастают при совместном применении этих препаратов."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Перед началом терапии необходимо исключить наличие злокачественного процесса (особенно при язве желудка) так как лечение маскируя симптоматику может отсрочить постановку правильного диагноза."}},{"type":"paragraph","data":{"text":"Прием одновременно с пищей не влияет на эффективность препарата."}},{"type":"paragraph","data":{"text":"Больным сахарным диабетом следует обратить внимание на содержание сахара в составе препарата. В одной капсуле Омепразола содержится 637 мг сахарозы (соответствует 0005 хлебным единицам (ХЕ))."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Учитывая возможные побочные действия препарата следует соблюдать осторожность при управлении автотранспортом или другими потенциально опасными механизмами."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Капсулы кишечнорастворимые 20 мг."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"В защищенном от света месте при температуре не выше 25 °С."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей месте."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"2 года."}},{"type":"paragraph","data":{"text":"Не использовать после истечения срока годности указанного на упаковке."}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"По рецепту"}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"Акционерное общество \"Валента Фармацевтика\" (АО \"Валента Фарм\"), 141101, Московская обл., г. Щелково, ул. Фабричная, д. 2, Россия"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"АО \"Валента Фарм\""}}]}],"source":null},"description_toggle":false,"short_description":"Ингибитор протонного насоса снижает кислотопродукцию - ингибирует Н+/К+-АТФ-азу париетальных клеток желудка и блокирует тем самым заключительную стадию секреции соляной кислоты. Препарат является пролекарством и активируется в кислой среде секреторных канальцев париетальных клеток слизистой оболочки желудка.Снижает базальную и стимулированную секрецию независимо от природы раздражителя. Антисекреторный эффект после приема 20 мг наступает в течение первого часа максимум - через 2 часа Ингибирование 50 % максимальной секреции продолжается 24 часа. Однократный прием в сутки обеспечивает быстрое и эффективное угнетение дневной и ночной желудочной секреции достигающее своего максимума через 4 дня лечения и исчезающее к исходу 3-4 дня после окончания приема. У больных с язвенной болезнью 12-перстной кишки прием 20 мг омепразола поддерживает внутрижелудочный pH на уровне 3 в течение 17 часов. Омепразол быстро абсорбируется из желудочно-кишечного тракта максимальная концентрация в плазме крови достигается через 05-1 час. Биодоступность составляет 30-40 % (при печеночной недостаточности возрастает практически до 100 %) обладая высокой липофильностью легко проникает в париетальные клетки желудка. При повторном приеме биодоступность достигает 60-70 % и зависит от принятой дозы. Связь с белками плазмы - 90 %. Омепразол практически полностью метаболизируется в печени с участием ферментной системы CYP2C19 с образованием 6 метаболитов (гидроксиомепразол сульфидные и сульфоновые производные и другие) фармакологически неактивных. Является ингибитором изофермента CYP2C19. Период полувыведения - 05-1 час (при печеночной недостаточности - 3 часа) клиренс - 500-600 мл/мин. Выводится в основном почками (70-80 %) в виде метаболитов и с желчью (20-30 %). При хронической почечной недостаточности выведение снижается пропорционально снижению клиренса креатинина. У пожилых пациентов выведение уменьшается биодоступность возрастает.","substance":[{"id":137,"title":"Омепразол","title_latin":"Omeprazolum","slug":"omeprazol_137"}],"branding":null,"valid_for_quick_buy":false,"is_available_to_delivery":false,"comments":null,"image_alt":"Омепразол - фото упаковки","image_share":{"isTouch":{"default":null},"isFromTablet":{"default":null}},"diseases":[],"other_packages":[{"id":183097,"title":"Омепразол","subtitle":{"full":"Капсулы, 30 шт, 20 мг","short":"Капсулы, 30 шт, 20 мг","package":"30 шт, 20 мг"},"prescription":true,"catalog_section_id":146,"manufacturer":{"id":186,"title":"Канонфарма Продакшн","slug":"kanonfarma_prodakshn_186","logo":{"isTouch":{"retina":null,"default":null},"isFromTablet":{"retina":null,"default":null}}},"is_advert":false,"product_form":"Капсулы","slug":"183097-omeprazol","attributes":{"count":"30 шт","dose":"20 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