Фармакологическое действие — восполняющее дефицит синовиальн... Инструкция
Показания к применению
Для ослабления боли и скованности в коленном, тазобедренном, голеностопном и плечевом суставах пациентов, страдающих остеоартрозом легкой или средней степени тяжести, возникшим в результате дегенеративных и травматических изменений синовиального сустава.
Противопоказания
Не вводить при воспалении или наличии признаков кожных заболеваний в месте инъекции. Не применять у пациентов с известной гиперчувствительностью к гиалуронату натрия.
Действующее вещество: Натрия гиалуронат (Sodium hyaluronate) Концентрация действующего вещества (мг): 10 мг вспомогательные вещества: хлорида натрия Ph. Eur — 9 мг; двузамещенного фосфата натрия Ph. Eur. — 0,092 мг; воды для инъекций Ph. Eur. — достаточное количество Гиалуронат натрия в составе является биополимером, состоящим из повторяющихся дисахаридных звеньев D-глюкуроновой кислоты и N-ацетил-D-глюкозамина (длинноцепочечный полисахарид). Показано, что этот биополимер, синтезируемый бактерией Streptococcus equi, идентичен гиалуронату натрия, содержащемуся в организме человека. Гиалуронан, содержащийся в составе, дополняет естественный гиалуронан, содержащийся в синовиальной оболочке, количество которого снизилось вследствие дегенеративных изменений или травматических повреждений коленного сустава. Гиалуронат натрия является естественным компонентом организма человека. Ферматрон Протез синовиальной жидкости и Ферматрон Плюс Протез синовиальной жидкости имеют pH, сходный с pH синовиальной жидкости.
Фармакологические свойства
Фармакологическое действие — восполняющее дефицит синовиальной жидкости. Ферматрон Протез синовиальной жидкости представляет собой прозрачный стерильный раствор 1% гиалуроната натрия в солевом растворе фосфатного буфера, помещенный в предварительно заполненный шприц для однократной внутрисуставной инъекции в синовиальное пространство сустава.
Показания к применению
Для ослабления боли и скованности в коленном, тазобедренном, голеностопном и плечевом суставах пациентов, страдающих остеоартрозом легкой или средней степени тяжести, возникшим в результате дегенеративных и травматических изменений синовиального сустава.
Противопоказания
Не вводить при воспалении или наличии признаков кожных заболеваний в месте инъекции. Не применять у пациентов с известной гиперчувствительностью к гиалуронату натрия.
Применение при беременности и в период грудного вскармливания
Безопасность применения во время беременности и лактации не установлена.
Способ применения и дозы
Внутрисуставно. Инъекции должны выполняться только врачом, прошедшим обучение соответствующей технике. Перед введением место инъекции необходимо обработать антисептиком. При наличии суставного выпота его необходимо отсосать до инъекции. Содержимое шприца стерильно. Введение следует производить с помощью стерильной иглы соответствующего калибра (рекомендуется использовать от 18 до 21G/19 до 20G) (для Ферматрон Плюс Протез синовиальной жидкости, Ферматрон С Протез синовиальной жидкости/Ферматрон Протез синовиальной жидкости соответственно). Шприц имеет разъем Luer Lok™ (6%) для надежного присоединения иглы к шприцу. Шприц и иглу утилизировать после разового применения. Для больных с остеоартрозом коленных суставов легкой и средней степени тяжести рекомендуется вводить 2 мл препарата в синовиальную полость коленного сустава 1 раз в неделю в течение 1–3/1–5 нед (для Ферматрон Плюс Протез синовиальной жидкости/Ферматрон Протез синовиальной жидкости соответственно). Медицинский работник должен уточнять режим дозирования для инъекций в синовиальное пространство тазобедренного, голеностопного и плечевого суставов. Рекомендуется выполнять инъекции в тазобедренный, голеностопный и плечевой суставы под ультразвуковым или рентгеноскопическим контролем. Длительность эффекта у пациентов с остеоартрозом коленного сустава легкой или средней степени тяжести составляет до 6 мес. Длительность эффекта при введении в тазобедренный, голеностопный и плечевой сустав не установлена.
Побочное действие
При внутрисуставном введении возможна временная проходящая боль и припухлость. В редких случаях могут возникнуть воспалительная реакция, септический артрит или артралгия, которые могут быть связаны или не связаны с применением.
Особые указания
Запрещается использовать, если упаковка повреждена. Шприц, входящий в состав, — одноразовое устройство, предназначенное только для одного пациента. При использовании для второго пациента будет нарушена стерильность, и возникнет риск реакции на инородное тело или инфекции. Не подлежит повторной стерилизации, т.к. это может нарушить функционирование устройства. Необходимо использовать стерильную иглу, которую следует выбрасывать после одноразового применения. Запрещается использовать после истечения срока годности. Гиалуронат натрия получен путем ферментации бактерий Streptococcus equi и тщательно очищен. Тем не менее, врач должен учитывать иммунологическое воздействие и потенциальный риск, связанный с инъекционным введением любых биологических веществ. Не предназначен для детей. Для безопасного использования и ликвидации игл необходимо соблюдать общегосударственные и местные правила и нормы.
Условия хранения
В защищенном от света месте, при температуре 2–25 °C. Не замораживать. Продукт стерилен. Только для однократного применения. Хранить в недоступном для детей месте.
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