Описание
Состав препарата Герцептин
Один флакон препарата Герцептин с лиофилизатом для приготовления раствора для инфузий 150 мг включает:
- действующее вещество: трастузумаб — 150 мг;
- также: L-гистидина гидрохлорид — 3,36 мг, L-гистидин — 2,16 мг, α,α — трегалозы дигидрат — 136,2 мг и полисорбат 20 — 0,60 мг.
Один многодозовый флакон препарата Герцептин с лиофилизатом для приготовления раствора для инфузий 440 мг включает:
- действующее вещество: трастузумаб — 440 мг;
- также: L-гистидина гидрохлорид — 9,9 мг, L-гистидин — 6,4 мг, α,α- трегалозы дигидрат — 400,0 мг и полисорбат 20-1,8 мг.
Растворитель (бактериостатическая вода для инъекций 20 мл, содержащая 1.1% бензилового спирта в качестве антимикробного консерванта):
- бензиловый спирт — 229,9 мг и вода для инъекций — 20,9 мл.
Описание
- Лиофилизат от светло-желтого до белого цвета.
- Восстановленный раствор — это прозрачная, светло-желтая или слегка опалесцирующая бесцветная жидкость.
Показания к применению препарата Герцептин
Герцептин при раке молочной железы
Перед стартом лечения препаратом Герцептин важно установить наличие гиперэкспрессии HER2 опухоли пациента с помощью метода иммуногистохимии (уровень 3+), молекулярной биологии (выявление амплификации гена HER2 с использованием флуоресцентной гибридизации in situ [FISH] и/или хромогенной гибридизации in situ [CISH]).
Герцептин при метастатическом раке молочной железы
Препарат Герцептин показан для лечения взрослых пациентов с HER2 положительным показателем метастатического рака молочной железы (мРМЖ):
- в качестве монотерапии для лечения больных, получивших не менее 2 курсов химиотерапии лечения метастатической болезни. Предшествующая химиотерапия должна содержать, по крайней мере, 1 антрациклин и 1 таксан (кроме пациентов непригодных для химиотерапии). У больных с раком молочной железы с положительным результатом гормонорецепторного статуса при неэффективности предшествующей гормонотерапии (кроме пациентов, непригодных для гормонотерапии);
- совместно с паклитакселом для лечения больных, которые не получили химиотерапии метастатического заболевания, а также не пригодных для терапии антрациклином;
- совместно с доцетакселом для лечения больных, которые не получили химиотерапию метастатического заболевания;
- совместно с ингибитором ароматазы для лечения больных в постменопаузе с метастатическим раком молочной железы и положительным гормонорецепторным статусом, не получавших ранее лечения трастузумабом.
Нет данных о пациентах, которые уже получали препарат Герцептин как адъювантную терапию при раннем раке молочной железы.
Герцептин при раннем раке молочной железы
Препарат Герцептин показан для лечения больных с HER 2-положительным резултатом раннего рака молочной железы:
- после проведения хирургической операции, химиотерапии (адъювантной или неоадъювантной), а также лучевой терапии (если применимо),
- после получения адъювантной химиотерапии циклофосфамидом и доксорубицином совместно с доцетакселом и паклитакселом,
- совместно с адъювантной химиотерапией карбоплатином и доцетакселом,
- совместно с неоадъювантной химиотерапией, а также последующей адъювантной терапией препаратом при местнораспространенном и воспалительном раке молочной железы или в случаях, когда размер опухоли в диаметре превышает 2 см.
Герцептин при метастатическом раке желудка или рак пищеводно-желудочного соединения
В комбинации с капецитабином или внутривенной формой 5-фторурацила и цисплатином применяют при лечении HER 2-позитивной метастатической аденокарциномы желудка, а также пищеводно-желудочного соединения (не получавших химиотерапии метастатической болезни). Герцептин необходимо применять только пациентам с метастатическим раком желудка с установленной опухолевой гиперэкспрессией HER2 ИГХ 3+ или ИГХ 2+, подтвержденным положительным результатом FISH+, усиленной серебром in situ гибридизации (SISH).
Упаковка
Лиофилизат для приготовления раствора инфузий по 150 мг
По 150 мг трастузумаба содержится во флаконах, изготовленных из бесцветного стекла гидролитического класса I, закупоренные пробками из бутилкаучука с алюминиевыми колпачками и пластмассовыми крышками. По одному флакону вместе с инструкцией помещают в картонную пачку.
Лиофилизат для приготовления раствора инфузий по 440 мг
По 440 мг трастузумаба содержится во флаконах, изготовленных из бесцветного стекла гидролитического класса I ЕФ, закупоренные пробкой из бутилкаучука и обжатые алюминиевым колпачком и закрытый пластмассовой светло-зеленой крышкой.
Также 20 мл бактериостатической воды для инъекций во флаконах из бесцветного стекла гидролитического класса I ЕФ, закупоренные пробкой из бутилкаучука и обжатые алюминиевым колпачком и закрытый пластмассовой белой крышкой.
Один флакон с препаратом и один флакон с растворителем и инструкцией помещают в картонную пачку.
Условия хранения и срок годности
Хранить при температуре 2-8°С в недоступном для детей месте.
Срок годности: 4 года. He использовать препарат по истечении срока годности. Срок годности указывается на упаковке.
Вы можете купить Герцептин 150 мг, не выходя из дома. Наша компания сотрудничает с известными европейскими компаниями, поэтому может осуществить доставку данного лекарственного препарата в кратчайшие сроки. Всю дополнительную информацию вы можете получить связавшись с нами.
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