Средство для замещения синовиальной жидкости ИНТРАДЖЕКТ® по ТУ 32.50.50-002-18527908-2019
Регистрационное удостоверение № РЗН 2019/8831 от 23.08.2019 Технические условия № 32.50.50-002-18527908-2019 Состав Средства ИНТРАДЖЕКТ® в зависимости от концентрации - Концентрация Средства 1,8% Содержание, мг/мл: Гиалуронат натрия - 18 Фосфатный буфер pH 7,4 - 10 Вода для инъекций - До 1000 Внешний вид и свойства: Бесцветный прозрачный однородный вязкий гель без механических примесей Основные параметры и характеристики: -Подлинность При смешивании 1-2 мл средства с 50 мл этилового спирта появляются белые волокна -Динамическая вязкость, мПа Концентрация до 2% 5000 - 45000 -Динамическая вязкость мПа Концентрация от 2% 35000 - 85000 -Водородный показатель, pH 6,5 - 8,0 -Осмолярность, мОсмоль/л 250 - 350 -Стерильность Должен быть стерилен -Бактериальные эндотоксины, БЭ/мл: Не более 0,5 -Извлекаемый объем Средства ИНТРАДЖЕКТ®, мл Средство для замещения синовиальной жидкости ИНТРАДЖЕКТ® по ТУ 32.50.50-002-18527908-2019 - 2 мл в шприце объемом 2.25 мл - От 2,0 до 2,2 Назначение и применение медицинского изделия. Средство ИНТРАДЖЕКТ® предназначено только для внутрисуставного введения и используется для: - временного замещения и восполнения синовиальной жидкости; - снижения болевого синдрома и тугоподвижности, вызванных дегенеративнодистрофическими (при остеоартрите или остеоартрозе) и травматическими изменениями суставов, в т.ч. коленного, тазобедренного, пястно-запястного, голеностопного, височно-нижнечелюстного, фасеточного и др. за счет снижения трения в поврежденном суставе. ВНИМАНИЕ!!! Применение Средства ИНТРАДЖЕКТ® производится специально обученным специалистом (врачом-ревматологом или врачом-хирургом) в условиях специальных отделений лечебно-профилактических учреждений. Область применения - ортопедия, ревматология, травматология, спортивная медицина. Функциональные характеристики. Средство ИНТРАДЖЕКТ® представляет собой стерильный бесцветный прозрачный однородный вязкийгель без механических примесей, полученный методом бактериальной ферментации. Средство ИНТРАДЖЕКТ® не содержит животных белков и не требует предварительного аллерготеста. Гиалуроновая кислота представляет собой природный гликозаминогликан межклеточного матрикса, обладающий наибольшей гигроскопичностью из всех известных естественных мукополисахаридов. Механизм действия. Гиалуроновая кислота - естественный полисахарид, принадлежащий к классу гликозаминогликанов, входящий в состав всех тканей организма и являющийся важнейшим структурным элементом синовиальной жидкости. Гиалуроновая кислота является немодифицированной. Средство ИНТРАДЖЕКТ® содержит в своем составе натриевую соль гиалуроновой кислоты и воду, молекулы которых образуют водородные связи благодаря наличию в структуре молекул гидроксильных групп (ОН-групп), а также наличию большого количества атомов кислорода азота в молекуле гиалуроновой кислоты. Вследствие образования водородных связей с молекулами воды гиалуроновая кислота имеет высокую способность связывать и удерживать воду, приобретая желеобразную структуру. Макромолекулы гиалуроновой кислоты благодаря тем же механизмам образуют внутримолекулярные и межмолекулярные взаимодействия, давая при этом достаточно стабильную трехмерную структуру. Средство ИНТРАДЖЕКТ® имеет упорядоченную структуру геля, которая способна удерживать молекулы гиалуроновой кислоты и воды внутри синовиальной сумки, обеспечивая стабильность Средства ИНТРАДЖЕКТ®, что гарантирует пролонгированное действие изделия. Вязкоэластичные свойства гиалуроновой кислоты, входящей в состав синовиальной жидкости, обеспечивают смазывание и амортизацию суставных поверхностей. Синовиальная жидкость в суставах при дегенеративных заболеваниях (остеоартроз) или травматических изменениях суставов, имеет более низкую вязкость и эластичность, чем в здоровых суставах. Гиалуроновая кислота, входящая в состав Средства ИНТРАДЖЕКТ®, имеет молекулярную массу 2,2 млн. дальтон, близкую к естественной гиалуроновой кислоте человека, и оказывает положительный эффект после введения при диагнозе остеоартроз (остеоартрит). Внутрисуставное введение Средства ИНТРАДЖЕКТ® восстанавливает физиологические и реологические свойства синовиальной жидкости сустава, пораженного остеоартрозом. Вследствие этого уменьшается боль и дискомфорт, улучшается подвижность в суставе. Биодеградация медицинского изделия в организме пациента. Полная биодеградация в организме наступает через 6 месяцев. В ходе движений гиалуронаты попадают в лимфатическую систему суставной капсулы, попадает в общий кровоток, и в итоге абсорбируются печенью, где деградируют до воды и углекислого газа Средство ИНТРАДЖЕКТ® не оказывает метаболического воздействия на организм. После введения Средство ИНТРАДЖЕКТ® не подлежит извлечению или замене. Беременность и лактация. Данных по безопасности Средства ИНТРАДЖЕКТ® при беременности и лактации нет. Использовать Средство ИНТРАДЖЕКТ® при беременности и лактации - с осторожностью и по усмотрению лечащего врача.
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