порошок для приготовления суспензии для приема внутрь.
Состав
на 1 мл
препарата:
Действующие
вещества: кальция
карбонат (в пересчете на кальций) – 0,1 г (40 мг); колекальциферол (в
пересчете на 100 % колекальциферол) – 0,27 мкг (10 ME), в виде
гранул, содержащих: колекальциферол, D,L-альфа-токоферол, триглицериды
среднецепочечные, сахарозу, камедь акации, кукурузный крахмал, кальция фосфат
(Е 341), воду очищенную;
порошок белого или почти белого цвета с характерным запахом апельсина.
Описание
приготовленной суспензии: однородная
суспензия белого или почти белого цвета с характерным запахом апельсина.
Фармакотерапевтическая группа
кальциево-фосфорного
обмена регулятор
Код ATX: [А12АХ]
Фармакологические свойства
Комбинированный
препарат, предназначенный для восполнения дефицита кальция и витамина D3
в организме.
Фармакодинамика. Кальций участвует в формировании
костной ткани, повышает ее плотность, участвует в минерализации зубов, в
регуляции нервной проводимости и мышечных сокращений, в поддержании
стабильности сердечной деятельности, в процессе свертывания крови.
Витамин D3
(колекальциферол) регулирует обмен кальция и фосфора в организме, повышает
всасывание кальция в кишечнике, способствует минерализации костей, формированию
костного скелета и зубов у детей. Препарат снижает выработку паратиреоидного
гормона, который является стимулятором повышенной костной резорбции.
Показания к применению
Профилактика
дефицита кальция и витамина D3 у детей раннего возраста.
Почечная недостаточность,
доброкачественный гранулематоз, прием сердечных гликозидов и тиазидных
диуретиков, беременность, период лактации.
Применение при беременности и в период грудного вскармливания
При беременности и в
период грудного вскармливания применение препарата возможно по рекомендации
врача.
Суточная доза не
должна превышать 1500 мг кальция и 600 ME витамина D3.
Гиперкальциемия на
фоне передозировки и избыточное поступление витамина D3 в период
беременности могут оказывать неблагоприятное воздействие на развивающийся плод.
Кальций и витамин D3
могут проникать в грудное молоко, поэтому при приеме препарата матерью в период
грудного вскармливания необходимо учитывать поступление кальция и витамина D из
других источников.
Способ применения и дозы
Препарат принимается
внутрь, во время еды. Лекарственная форма специально разработана для детей
раннего возраста до 3-х лет.
Приготовление
суспензии из порошка: Перед
приготовлением суспензии флакон, содержащий порошок, хорошо встряхнуть для
отделения частиц порошка от дна и стенок, добавить прокипяченной и охлажденной
воды на 2/3 объема флакона, тщательно встряхивать (в течение 1-2 минут).
Добавить прокипяченную воду до объема 100 мл (догорловины флакона) и
повторно встряхивать до получения однородной суспензии.
Перед каждым приемом
взбалтывать содержимое флакона.
В 5 мл полученной
суспензии содержится кальция карбоната в пересчете на элементарный кальций –
200 мг, колекальциферола – 50 ME.
Детям в возрасте
старше 1 года – 5-10 мл 1 раз в сутки; детям до 1 года – по 5 мл суспензии 1
раз в сутки, по рекомендации врача. Дозирование препарата для других возрастных
групп – в соответствии с рекомендациями врача.
Продолжительность
курса профилактики – 1 месяц, более продолжительный курс – по назначению врача.
Побочное действие
Аллергические
реакции. При применении препарата в рекомендуемых дозах других побочных
эффектов не выявлено. При превышении рекомендуемых доз или одновременном приеме
других препаратов, содержащих кальций, возможно развитие гиперкальциемии и
гиперкальциурии (повышения содержания кальция в крови и моче).
К возможным побочным
эффектам витамина D3 также относятся: снижение аппетита, полиурия,
запоры, головная боль, миалгия, артралгия, повышение АД, аритмии, нарушение
функции почек, обострение туберкулезного процесса в легких.
К возможным побочным
эффектам карбоната кальция также относятся: гастралгия, запоры или диарея,
метеоризм, тошнота, вторичное усиление желудочной секреции.
Передозировка
Симптомы: жажда,
полиурия, снижение аппетита, тошнота, рвота, запоры, головокружение, слабость,
головная боль, обморок, кома; при длительном применении кальциноз сосудов и
тканей.
Лабораторные
показатели при передозировке: гиперкальциурия, гиперкальциемия.
Лечение: прекращение
приема препарата, обращение к врачу, диета с ограничением кальция,
регидратация, диуретики, глюкокортикостероиды, в тяжелых случаях - гемодиализ.
Взаимодействие с другими лекарственными средствами
Препараты кальция и
витамина D3 снижают всасывание бисфосфонатов, дигоксина, препаратов
железа и антибиотиков тетрацикпинового ряда (необходим интервал между приемом
препаратов не менее 2-3 часов).
Возможно усиление
действия сердечных гликозидов (при одновременном приеме необходим контроль ЭКГ
и состояния больного).
Фенитоин, барбитураты,
примидон снижают действие витамина D3 за счет усиления его
метаболизма.
Глюкокортикостероиды
снижают абсорбцию ионов кальция в кишечнике.
Колестирамин,
колестипол и минеральные масла снижают абсорбцию витамина D3 и требуют
повышения его дозировки.
Тиазидные диуретики
увеличивают риск развития гиперкальциемии.
Витамин D
увеличивает абсорбцию фосфорсодержащих препаратов и риск возникновения
гиперфосфатемии. При одновременном применении с натрия фторидом интервал между
приемом должен составлять не менее 2 ч; с пероральными формами тетрациклинов -
не менее 3 ч. Длительная терапия витамином D3 на фоне одновременного
применения Аl3+ и Mg2+ - содержащих
антацидов увеличивает их концентрацию в крови и риск возникновения интоксикации
(особенно при наличии ХПН).
Одновременное
применение с другими аналогами витамина D и препаратами кальция повышает риск
развития гипервитаминоза D.
Особые указания
Во избежание
передозировки не применять одновременно с витаминными комплексами, содержащими
кальций и витамин D3.
При профилактическом
применении витамина D3 необходимо иметь в виду возможность
передозировки, особенно у детей (не следует назначать более 10-15 мг в год).
Продолжительное применение в высоких дозах приводит к хроническому
гипервитаминозу D3. При длительном лечении необходимо контролировать
концентрацию Са2+ в крови и моче (особенно при сочетании с тиазидными
диуретиками).
Следует иметь в
виду, что чувствительность к витамину D у разных пациентов индивидуальна и у
ряда пациентов прием даже терапевтических доз может вызвать явления
гипервитаминоза.
Чувствительность
новорожденных к витамину D может быть различной, некоторые из них могут быть
чувствительными даже к очень низким дозам, поэтому профилактика должна
проводиться под контролем врача. Новорожденные, находящиеся на грудном
вскармливании, особенно рожденные матерями с темной кожей и/или получавшие
недостаточную инсоляцию, имеют высокий риск возникновения дефицита витамина D.
Влияние на способность управлять автомобилем и движущимися механизмами
Данные о влиянии
препарата на способность управления транспортным средством и выполнения
потенциально опасных видов деятельности, требующих повышенной концентрации
внимания и быстроты психомоторных реакций, отсутствуют.
Форма выпуска
Порошок для
приготовления суспензии для приема внутрь, 40 мг/1 мл+10 МЕ/1 мл.
По 43,0 г во
флаконы из темного (янтарного) стекла 3 гидролитического класса вместимостью
100 мл, укупоренные крышками.
На флакон наклеивают
самоклеящуюся этикетку или этикетку из бумаги этикеточной или писчей.
По 1 флакону вместе
с инструкцией по применению и мерной ложкой из полипропилена помещают в пачку
из картона.
Условия хранения
Хранить при
температуре не выше 25 °С.
Приготовленную
суспензию хранить при температуре не выше 25 °С. Не замораживать.
Хранить в
недоступном для детей месте.
Срок годности
Порошок для
приготовления суспензии для приема внутрь - 3 года.
Приготовленная
суспензия - не более 60 сут.
Не использовать по истечении
срока годности.
Условия отпуска
Отпускают без
рецепта.
Производитель
ОАО
"Фармстандарт-Лексредства", 305022, Россия, г. Курск, ул. 2-я
Агрегатная, 1а/18, тел./факс: (4712) 34-03-13, www.pharmstd.ru
Организация, принимающая претензии потребителей
АО
"Отисифарм", Россия, 123112, г. Москва, ул. Тестовская, д. 10
Для описания товара использована информация от партнера 36.6
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приготовления суспензии для приема внутрь."}}]},{"id":4,"name":"Состав","slug":"ingredients","body":[{"type":"paragraph","data":{"text":"\u003cb\u003eна 1 мл\nпрепарата:\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"\u003ci\u003eДействующие\nвещества:\u003c/i\u003e кальция\nкарбонат (в пересчете на кальций) – 0,1 г (40 мг); колекальциферол (в\nпересчете на 100 % колекальциферол) – 0,27 мкг (10 ME), в виде\nгранул, содержащих: колекальциферол, D,L-альфа-токоферол, триглицериды\nсреднецепочечные, сахарозу, камедь акации, кукурузный крахмал, кальция фосфат\n(Е 341), воду очищенную;"}},{"type":"paragraph","data":{"text":"\u003ci\u003eВспомогательные\nвещества:\u003c/i\u003e сорбитол\n– 295,85 мг, крахмал прежелатинизированный – 30,0 мг, кремния диоксид\nколлоидный – 2,15 мг, ароматизатор апельсиновый – 2,0 мг."}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"порошок белого или почти белого цвета с характерным запахом апельсина."}},{"type":"paragraph","data":{"text":"\u003cb\u003eОписание\nприготовленной суспензии: \u003c/b\u003eоднородная\nсуспензия белого или почти белого цвета с характерным запахом апельсина."}}]},{"id":6,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"кальциево-фосфорного\nобмена регулятор "}},{"type":"paragraph","data":{"text":"\u003cb\u003eКод ATX: \u003c/b\u003e[А12АХ]"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"Комбинированный\nпрепарат, предназначенный для восполнения дефицита кальция и витамина D\u003csub\u003e3\u003c/sub\u003e\nв организме."}},{"type":"paragraph","data":{"text":"\u003ci\u003eФармакодинамика.\u003c/i\u003e Кальций участвует в формировании\nкостной ткани, повышает ее плотность, участвует в минерализации зубов, в\nрегуляции нервной проводимости и мышечных сокращений, в поддержании\nстабильности сердечной деятельности, в процессе свертывания крови."}},{"type":"paragraph","data":{"text":"Витамин D\u003csub\u003e3\u003c/sub\u003e\n(колекальциферол) регулирует обмен кальция и фосфора в организме, повышает\nвсасывание кальция в кишечнике, способствует минерализации костей, формированию\nкостного скелета и зубов у детей. Препарат снижает выработку паратиреоидного\nгормона, который является стимулятором повышенной костной резорбции."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Профилактика\nдефицита кальция и витамина D\u003csub\u003e3\u003c/sub\u003e у детей раннего возраста."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Гиперчувствительность,\nгиперкальциемия, гиперкальциурия, кальциевый нефроуролитиаз, гипервитаминоз D,\nдекальцинирующие опухоли (миелома, костные метастазы, саркоидоз), остеопороз,\nобусловленный иммобилизацией, активная форма туберкулеза легких; дефицит\nсахаразы/изомальтазы, непереносимость фруктозы, глюкозо-галактозная\nмальабсорбция."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Почечная недостаточность,\nдоброкачественный гранулематоз, прием сердечных гликозидов и тиазидных\nдиуретиков, беременность, период лактации."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"При беременности и в\nпериод грудного вскармливания применение препарата возможно по рекомендации\nврача."}},{"type":"paragraph","data":{"text":"Суточная доза не\nдолжна превышать 1500 мг кальция и 600 ME витамина D\u003csub\u003e3\u003c/sub\u003e."}},{"type":"paragraph","data":{"text":"Гиперкальциемия на\nфоне передозировки и избыточное поступление витамина D\u003csub\u003e3\u003c/sub\u003e в период\nбеременности могут оказывать неблагоприятное воздействие на развивающийся плод."}},{"type":"paragraph","data":{"text":"Кальций и витамин D\u003csub\u003e3\u003c/sub\u003e\nмогут проникать в грудное молоко, поэтому при приеме препарата матерью в период\nгрудного вскармливания необходимо учитывать поступление кальция и витамина D из\nдругих источников."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Препарат принимается\nвнутрь, во время еды. Лекарственная форма специально разработана для детей\nраннего возраста до 3-х лет."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПриготовление\nсуспензии из порошка: \u003c/i\u003eПеред\nприготовлением суспензии флакон, содержащий порошок, хорошо встряхнуть для\nотделения частиц порошка от дна и стенок, добавить прокипяченной и охлажденной\nводы на 2/3 объема флакона, тщательно встряхивать (в течение 1-2 минут).\nДобавить прокипяченную воду до объема 100 мл (до\u003cb\u003e \u003c/b\u003eгорловины флакона) и\nповторно встряхивать до получения однородной суспензии.\u003cb\u003e\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"Перед каждым приемом\nвзбалтывать содержимое флакона."}},{"type":"paragraph","data":{"text":"В 5 мл полученной\nсуспензии содержится кальция карбоната в пересчете на элементарный кальций –\n200 мг, колекальциферола – 50 ME."}},{"type":"paragraph","data":{"text":"Детям в возрасте\nстарше 1 года – 5-10 мл 1 раз в сутки; детям до 1 года – по 5 мл суспензии 1\nраз в сутки, по рекомендации врача. Дозирование препарата для других возрастных\nгрупп – в соответствии с рекомендациями врача."}},{"type":"paragraph","data":{"text":"Продолжительность\nкурса профилактики – 1 месяц, более продолжительный курс – по назначению врача."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Аллергические\nреакции. При применении препарата в рекомендуемых дозах других побочных\nэффектов не выявлено. При превышении рекомендуемых доз или одновременном приеме\nдругих препаратов, содержащих кальций, возможно развитие гиперкальциемии и\nгиперкальциурии (повышения содержания кальция в крови и моче)."}},{"type":"paragraph","data":{"text":"К возможным побочным\nэффектам витамина D\u003csub\u003e3\u003c/sub\u003e также относятся: снижение аппетита, полиурия,\nзапоры, головная боль, миалгия, артралгия, повышение АД, аритмии, нарушение\nфункции почек, обострение туберкулезного процесса в легких."}},{"type":"paragraph","data":{"text":"К возможным побочным\nэффектам карбоната кальция также относятся: гастралгия, запоры или диарея,\nметеоризм, тошнота, вторичное усиление желудочной секреции."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы: жажда,\nполиурия, снижение аппетита, тошнота, рвота, запоры, головокружение, слабость,\nголовная боль, обморок, кома; при длительном применении кальциноз сосудов и\nтканей."}},{"type":"paragraph","data":{"text":"Лабораторные\nпоказатели при передозировке: гиперкальциурия, гиперкальциемия."}},{"type":"paragraph","data":{"text":"Лечение: прекращение\nприема препарата, обращение к врачу, диета с ограничением кальция,\nрегидратация, диуретики, глюкокортикостероиды, в тяжелых случаях - гемодиализ."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Препараты кальция и\nвитамина D\u003csub\u003e3\u003c/sub\u003e снижают всасывание бисфосфонатов, дигоксина, препаратов\nжелеза и антибиотиков тетрацикпинового ряда (необходим интервал между приемом\nпрепаратов не менее 2-3 часов)."}},{"type":"paragraph","data":{"text":"Возможно усиление\nдействия сердечных гликозидов (при одновременном приеме необходим контроль ЭКГ\nи состояния больного)."}},{"type":"paragraph","data":{"text":"Фенитоин, барбитураты,\nпримидон снижают действие витамина D\u003csub\u003e3\u003c/sub\u003e за счет усиления его\nметаболизма."}},{"type":"paragraph","data":{"text":"Витамин А,\nтокоферол, аскорбиновая кислота, пантотеновая кислота, тиамин, рибофлавин\nослабляют токсическое действие витамина D\u003csub\u003e3\u003c/sub\u003e."}},{"type":"paragraph","data":{"text":"Глюкокортикостероиды\nснижают абсорбцию ионов кальция в кишечнике."}},{"type":"paragraph","data":{"text":"Колестирамин,\nколестипол и минеральные масла снижают абсорбцию витамина D3 и требуют\nповышения его дозировки."}},{"type":"paragraph","data":{"text":"Тиазидные диуретики\nувеличивают риск развития гиперкальциемии."}},{"type":"paragraph","data":{"text":"Витамин D\nувеличивает абсорбцию фосфорсодержащих препаратов и риск возникновения\nгиперфосфатемии. При одновременном применении с натрия фторидом интервал между\nприемом должен составлять не менее 2 ч; с пероральными формами тетрациклинов -\nне менее 3 ч. Длительная терапия витамином D\u003csub\u003e3\u003c/sub\u003e на фоне одновременного\nприменения Аl\u003csup\u003e3+\u003c/sup\u003e и Mg\u003csup\u003e2+\u003c/sup\u003e - содержащих\nантацидов увеличивает их концентрацию в крови и риск возникновения интоксикации\n(особенно при наличии ХПН)."}},{"type":"paragraph","data":{"text":"Одновременное\nприменение с другими аналогами витамина D и препаратами кальция повышает риск\nразвития гипервитаминоза D."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Во избежание\nпередозировки не применять одновременно с витаминными комплексами, содержащими\nкальций и витамин D\u003csub\u003e3\u003c/sub\u003e."}},{"type":"paragraph","data":{"text":"При профилактическом\nприменении витамина D\u003csub\u003e3\u003c/sub\u003e необходимо иметь в виду возможность\nпередозировки, особенно у детей (не следует назначать более 10-15 мг в год).\nПродолжительное применение в высоких дозах приводит к хроническому\nгипервитаминозу D\u003csub\u003e3\u003c/sub\u003e. При длительном лечении необходимо контролировать\nконцентрацию Са\u003csup\u003e2+\u003c/sup\u003e в крови и моче (особенно при сочетании с тиазидными\nдиуретиками)."}},{"type":"paragraph","data":{"text":"Следует иметь в\nвиду, что чувствительность к витамину D у разных пациентов индивидуальна и у\nряда пациентов прием даже терапевтических доз может вызвать явления\nгипервитаминоза."}},{"type":"paragraph","data":{"text":"Чувствительность\nноворожденных к витамину D может быть различной, некоторые из них могут быть\nчувствительными даже к очень низким дозам, поэтому профилактика должна\nпроводиться под контролем врача. Новорожденные, находящиеся на грудном\nвскармливании, особенно рожденные матерями с темной кожей и/или получавшие\nнедостаточную инсоляцию, имеют высокий риск возникновения дефицита витамина D."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Данные о влиянии\nпрепарата на способность управления транспортным средством и выполнения\nпотенциально опасных видов деятельности, требующих повышенной концентрации\nвнимания и быстроты психомоторных реакций, отсутствуют."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Порошок для\nприготовления суспензии для приема внутрь, 40 мг/1 мл+10 МЕ/1 мл."}},{"type":"paragraph","data":{"text":"По 43,0 г во\nфлаконы из темного (янтарного) стекла 3 гидролитического класса вместимостью\n100 мл, укупоренные крышками."}},{"type":"paragraph","data":{"text":"На флакон наклеивают\nсамоклеящуюся этикетку или этикетку из бумаги этикеточной или писчей."}},{"type":"paragraph","data":{"text":"По 1 флакону вместе\nс инструкцией по применению и мерной ложкой из полипропилена помещают в пачку\nиз картона."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Хранить при\nтемпературе не выше 25 °С."}},{"type":"paragraph","data":{"text":"Приготовленную\nсуспензию хранить при температуре не выше 25 °С. Не замораживать."}},{"type":"paragraph","data":{"text":"Хранить в\nнедоступном для детей месте."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"Порошок для\nприготовления суспензии для приема внутрь - 3 года."}},{"type":"paragraph","data":{"text":"Приготовленная\nсуспензия - не более 60 сут."}},{"type":"paragraph","data":{"text":"Не использовать по истечении\nсрока годности."}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"Отпускают без\nрецепта."}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"ОАО\n\"Фармстандарт-Лексредства\", 305022, Россия, г. Курск, ул. 2-я\nАгрегатная, 1а/18, тел./факс: (4712) 34-03-13, www.pharmstd.ru\u003cb\u003e\u003c/b\u003e"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"АО\n\"Отисифарм\", Россия, 123112, г. Москва, ул. 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