Фармакологическое действие — восполняющее дефицит железа, пр... Инструкция
Показания к применению
Лечение железодефицитных состояний в следующих случаях:необходимость быстрого восполнения дефицита железа;у больных, которые не переносят пероральные препараты железа или не соблюдают режим лечения;при наличии активных воспалительных заболеваний кишечника, когда пероральные препараты железа неэффективны.
Противопоказания
повышенная чувствительность к препарату Венофер® или его компонентам;анемия, не связанная с дефицитом железа;признаки перегрузки железом (гемосидероз, гемохроматоз) или нарушение процесса его утилизации;I триместр беременности.С осторожностью: бронхиальная астма, экзема, поливалентная аллергия, аллергические реакции на другие парентеральные препараты ...
Раствор для внутривенного введения1 млактивное вещество:железа (III) гидроксид сахарозный комплекс540 мг(эквивалентно содержанию железа 20 мг)вспомогательные вещества: натрия гидроксид; вода для инъекций— до 1 мл
Описание
Водный раствор коричневого цвета.
Фармакологические свойства
Фармакологическое действие — восполняющее дефицит железа, противоанемическое.
Показания к применению
Лечение железодефицитных состояний в следующих случаях:необходимость быстрого восполнения дефицита железа;у больных, которые не переносят пероральные препараты железа или не соблюдают режим лечения;при наличии активных воспалительных заболеваний кишечника, когда пероральные препараты железа неэффективны.
Противопоказания
повышенная чувствительность к препарату Венофер® или его компонентам;анемия, не связанная с дефицитом железа;признаки перегрузки железом (гемосидероз, гемохроматоз) или нарушение процесса его утилизации;I триместр беременности.С осторожностью: бронхиальная астма, экзема, поливалентная аллергия, аллергические реакции на другие парентеральные препараты железа, низкая железосвязывающая способность сыворотки и/или дефицит фолиевой кислоты; печеночная недостаточность, острые или хронические инфекционные заболевания (в связи с тем, что парентерально вводимое железо может оказывать неблагоприятное действие при наличии бактериальной или вирусной инфекции) и лица, у которых повышены показатели ферритина сыворотки крови.
Применение при беременности и в период грудного вскармливания
Ограниченный опыт применения препарата Венофер® у беременных пациенток показал отсутствие нежелательного влияния сахарата железа на течение беременности и здоровье плода/новорожденного. До настоящего времени не проводилось хорошо контролируемых исследований у беременных женщин. Результаты исследований репродукции у животных не выявили прямых или опосредованных вредных воздействий на развитие эмбриона/плода, роды или постнатальное развитие. Тем не менее, требуется дальнейшее исследование соотношения риск/польза.Поступление неметаболизированного сахарата железа в грудное молоко маловероятно. Таким образом, Венофер® не представляет опасности для младенцев, находящихся на грудном вскармливании.
Способ применения и дозы
В/в.Венофер® вводится только в/в— медленно струйно или капельно, а также в венозный участок диализной системы— и не предназначен для в/м введения. Недопустимо одномоментное введение полной терапевтической дозы препарата.Перед введением первой терапевтической дозы необходимо назначить тест-дозу. Если в течение периода наблюдения возникли явления непереносимости, введение препарата следует немедленно прекратить. Перед вскрытием ампулы нужно осмотреть ее на наличие возможного осадка и повреждений. Можно использовать только коричневый раствор без осадка.Капельное введение: Венофер® предпочтительнее вводить в ходе капельной инфузии для того, чтобы уменьшить риск выраженного снижения АД и опасность попадания раствора в околовенозное пространство. Непосредственно перед инфузией Венофер® нужно развести 0,9% раствором натрия хлорида в соотношении 1:20, например— 1 мл (20 мг железа) в 20 мл 0,9% раствора натрия хлорида. Полученный раствор вводится со следующей скоростью: 100 мг железа— не менее чем за 15 мин; 200 мг железа— в течение 30 мин; 300 мг железа— в течение 1,5 ч; 400 мг железа— в течение 2,5 ч; 500 мг железа— в течение 3,5 ч. Введение максимально переносимой разовой дозы, составляющей 7 мг железа/кг, следует производить в течение минимум 3,5 ч, независимо от общей дозы препарата.Перед первым капельным введением терапевтической дозы препарата Венофер® необходимо ввести тест-дозу: 20 мг железа— взрослым и детям с массой тела более 14 кг и половину дневной дозы (1,5 мг железа/кг)— детям, имеющим массу тела менее 14 кг, в течение 15 мин. При отсутствии нежелательных явлений оставшуюся часть раствора следует вводить с рекомендованной скоростью.Струйное введение: препарат Венофер® также можно вводить в виде неразведенного раствора в/в медленно, со скоростью (норма) 1 мл препарата Венофер® (20 мг железа) в мин, т.о. 5 мл препарата Венофер® (100 мг железа) вводится минимум за 5 мин. Максимальный объем не должен превышать 10 мл препарата Венофер® (200 мг железа) за 1 инъекцию.Перед первым струйным введением терапевтической дозы препарата Венофер® следует назначить тест-дозу: 1 мл препарата Венофер® (20 мг железа)— взрослым и детям массой тела более 14 кг и половину дневной дозы (1,5 мг железа/кг)— детям массой тела менее 14 кг в течение 1–2 мин. При отсутствии нежелательных явлений в течение последующих 15 мин наблюдения оставшуюся часть раствора следует вводить с рекомендованной скоростью. После инъекции больному рекомендуется на некоторое время зафиксировать руку в вытянутом положении.Введение в диализную систему: Венофер® возможно вводить непосредственно в венозный участок диализной системы, строго соблюдая правила, описанные для в/в инъекции.Расчет дозы: доза рассчитывается индивидуально, в соответствии с общим дефицитом железа в организме по формуле:Общий дефицит железа, мг = масса тела, кг × (нормальный уровень Hb − уровень Hb больного), г/л × 0,24* + депонированное железо, мг.Для больных массой тела менее 35 кг: нормальный уровень Hb=130 г/л, количество депонированного железа = 15 мг/кг.Для больных массой тела более 35 кг: нормальный уровень Hb=150 г/л, количество депонированного железа = 500 мг.*Коэффициент 0,24 = 0,0034×0,07×1000 (содержание железа в Hb=0,34%; объем крови = 7% от массы тела; коэффициент 1000 = перевод из «г» в «мг»).Общий объем препарата Венофер®, который необходимо ввести (в мл) = общий дефицит железа (мг)/20 мг/мл (см. табл.).ТаблицаОбщий объем препарата Венофер® для лечения Масса тела, кг Кумулятивная терапевтическая доза препарата Венофер® для введения Hb 60 г/л Hb 75 г/л Hb 90 г/л Hb 105 г/л мг Fe мл мг Fe мл мг Fe мл мг Fe мл 5 160 8 140 7 120 6 100 5 10 320 16 280 14 240 12 220 11 15 480 24 420 21 380 19 320 16 20 640 32 560 28 500 25 420 21 25 800 40 700 35 620 31 520 26 30 960 48 840 42 740 37 640 32 35 1260 63 1140 57 1000 50 880 44 40 1360 68 1220 61 1080 54 940 47 45 1480 74 1320 66 1140 57 980 49 50 1580 79 1400 70 1220 61 1040 52 55 1680 84 1500 75 1300 65 1100 55 60 1800 90 1580 79 1360 68 1140 57 65 1900 95 1680 84 1440 72 1200 60 70 2020 101 1760 88 1500 75 1260 63 75 2120 106 1860 93 1580 79 1320 66 80 2220 111 1940 97 1660 83 1360 68 85 2340 117 2040 102 1720 86 1420 71 90 2440 122 2120 106 1800 90 1480 74 В случае, когда общая терапевтическая доза превышает максимальную допустимую разовую дозу, рекомендуется дробное введение препарата.Если спустя 1–2 нед после начала лечения препаратом Венофер® не происходит улучшения гематологических показателей, необходимо пересмотреть первоначальный диагноз.Расчет дозы для восполнения уровня железа после кровопотери или сдачи аутологичной кровиДоза препарата Венофер® подсчитывается по следующей формуле:- если количество потерянной крови известно: в/в введение 200 мг железа (10 мл препарата Венофер®) приводит к такому же повышению концентрации Hb, как и переливание 1 единицы крови (400 мл с концентрацией Hb=150 г/л).Количество железа, которое необходимо восполнить (мг) = количество единиц потерянной крови × 200илиНеобходимый объем препарата Венофер® (мл) = количество единиц потерянной крови × 10.- при снижении уровня Hb: используйте предыдущую формулу при условии, что депо железа пополнять не требуется.Количество железа, которое нужно восполнить (мг) = масса тела, кг × 0,24 × (нормальный уровень Hb − уровень Hb больного), г/л.Например: масса тела 60 кг, дефицит Hb = 10 г/л " необходимое количество железа » 150 мг " необходимый объем препарата Венофер® = 7,5 мл.Стандартная дозировкаВзрослые и пожилые больные:5–10 мл Венофер® (100–200 мг железа) 1–3 раза в неделю, в зависимости от уровня гемоглобина.Дети: имеются лишь ограниченные данные о применении препарата у детей до 3 лет. Рекомендуемая доза для детей остальных возрастных групп— не более 0,15 мл (3 мг железа) на кг массы тела 1–3 раза в неделю, в зависимости от уровня гемоглобина.Максимально переносимая разовая дозаВзрослые и пожилые больные:- для струйного введения: 10 мл препарата Венофер® (200 мг железа), продолжительность введения не менее 10 мин.- для капельного введения: в зависимости от показаний, разовая доза может достигать 500 мг железа. Максимально допустимая разовая доза составляет 7 мг/кг и вводится 1 раз в неделю, но она не должна превышать 500 мг железа. Время введения препарата и способ разведения см. выше.
Побочное действие
В настоящее время известно о следующих нежелательных явлениях, имеющих временное и возможное причинное отношение к введению препарата Венофер®. Все симптомы наблюдались очень редко (частота возникновения меньше 0,01% и больше или равна 0,001%).Со стороны нервной системы: головокружение, головная боль, потеря сознания, парестезии.Со стороны ССС: сердцебиение, тахикардия, снижение АД, коллаптоидные состояния, чувство жара, приливы крови к лицу, периферические отеки.Со стороны органов дыхания: бронхоспазм, одышка.Со стороны ЖКТ: разлитые боли в животе, боль в эпигастральной области, диарея, извращение вкуса, тошнота, рвота.Со стороны кожных покровов: эритема, зуд, сыпь, нарушение пигментации, повышение потливости.Со стороны опорно-двигательного аппарата: артралгия, боль в спине, отек суставов, миалгия, боль в конечностях.Со стороны иммунной системы: аллергические, анафилактоидные реакции, в т.ч. отек лица, отек гортани.Нарушения общего характера и реакции в месте инъекции: астения, боль в груди, чувство тяжести в груди, слабость, боль и отек в месте введения (особенно при экстравазальном попадании препарата), чувство недомогания, бледность, повышение температуры, озноб.
Передозировка
Передозировка может вызывать острую перегрузку железом, которая проявляется симптомами гемосидероза.Лечение: рекомендуется использовать симптоматические средства и, если необходимо, вещества, связывающие железо (хелаты), например дефероксамин в/в.
Взаимодействие с другими лекарственными средствами
Венофер® не должен назначаться одновременно с лекарственными формами железа для приема внутрь, т.к. способствует уменьшению всасывания железа из ЖКТ. Лечение пероральными препаратами железа можно начинать не ранее чем через 5 дней после последней инъекции.Венофер® можно смешивать в одном шприце только со стерильным физиологическим раствором. Никаких других растворов для в/в введения и терапевтических препаратов добавлять не разрешается, поскольку существует риск преципитации и/или иного фармацевтического взаимодействия. Совместимость с контейнерами из иных материалов, чем стекло, ПЭ и ПВХ не изучена.
Условия хранения
При температуре 4–25°C. В оригинальной упаковке (не замораживать).Хранить в недоступном для детей месте.
Срок годности
3 года. Не применять по истечении срока годности, указанного на упаковке.2000-2017. Регистр лекарственных средств России
Условия отпуска
По рецепту.
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или его компонентам;анемия, не связанная с дефицитом железа;признаки перегрузки железом (гемосидероз, гемохроматоз) или нарушение процесса его утилизации;I триместр беременности.С осторожностью: бронхиальная астма, экзема, поливалентная аллергия, аллергические реакции на другие парентеральные препараты железа, низкая железосвязывающая способность сыворотки и/или дефицит фолиевой кислоты; печеночная недостаточность, острые или хронические инфекционные заболевания (в связи с тем, что парентерально вводимое железо может оказывать неблагоприятное действие при наличии бактериальной или вирусной инфекции) и лица, у которых повышены показатели ферритина сыворотки крови."}}]},{"id":6,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Ограниченный опыт применения препарата Венофер® у беременных пациенток показал отсутствие нежелательного влияния сахарата железа на течение 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До настоящего времени не проводилось хорошо контролируемых исследований у беременных женщин. Результаты исследований репродукции у животных не выявили прямых или опосредованных вредных воздействий на развитие эмбриона/плода, роды или постнатальное развитие. Тем не менее, требуется дальнейшее исследование соотношения риск/польза.Поступление неметаболизированного сахарата железа в грудное молоко маловероятно. Таким образом, Венофер® не представляет опасности для младенцев, находящихся на грудном вскармливании."}}]},{"id":7,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В/в.Венофер® вводится только в/в— медленно струйно или капельно, а также в венозный участок диализной системы— и не предназначен для в/м введения. Недопустимо одномоментное введение полной терапевтической дозы препарата.Перед введением первой терапевтической дозы необходимо назначить тест-дозу. Если в течение периода наблюдения возникли явления непереносимости, введение препарата следует немедленно прекратить. Перед вскрытием ампулы нужно осмотреть ее на наличие возможного осадка и повреждений. Можно использовать только коричневый раствор без осадка.Капельное введение: Венофер® предпочтительнее вводить в ходе капельной инфузии для того, чтобы уменьшить риск выраженного снижения АД и опасность попадания раствора в околовенозное пространство. Непосредственно перед инфузией Венофер® нужно развести 0,9% раствором натрия хлорида в соотношении 1:20, например— 1 мл (20 мг железа) в 20 мл 0,9% раствора натрия хлорида. Полученный раствор вводится со следующей скоростью: 100 мг железа— не менее чем за 15 мин; 200 мг железа— в течение 30 мин; 300 мг железа— в течение 1,5 ч; 400 мг железа— в течение 2,5 ч; 500 мг железа— в течение 3,5 ч. Введение максимально переносимой разовой дозы, составляющей 7 мг железа/кг, следует производить в течение минимум 3,5 ч, независимо от общей дозы препарата.Перед первым капельным введением терапевтической дозы препарата Венофер® необходимо ввести тест-дозу: 20 мг железа— взрослым и детям с массой тела более 14 кг и половину дневной дозы (1,5 мг железа/кг)— детям, имеющим массу тела менее 14 кг, в течение 15 мин. При отсутствии нежелательных явлений оставшуюся часть раствора следует вводить с рекомендованной скоростью.Струйное введение: препарат Венофер® также можно вводить в виде неразведенного раствора в/в медленно, со скоростью (норма) 1 мл препарата Венофер® (20 мг железа) в мин, т.о. 5 мл препарата Венофер® (100 мг железа) вводится минимум за 5 мин. Максимальный объем не должен превышать 10 мл препарата Венофер® (200 мг железа) за 1 инъекцию.Перед первым струйным введением терапевтической дозы препарата Венофер® следует назначить тест-дозу: 1 мл препарата Венофер® (20 мг железа)— взрослым и детям массой тела более 14 кг и половину дневной дозы (1,5 мг железа/кг)— детям массой тела менее 14 кг в течение 1–2 мин. При отсутствии нежелательных явлений в течение последующих 15 мин наблюдения оставшуюся часть раствора следует вводить с рекомендованной скоростью. После инъекции больному рекомендуется на некоторое время зафиксировать руку в вытянутом положении.Введение в диализную систему: Венофер® возможно вводить непосредственно в венозный участок диализной системы, строго соблюдая правила, описанные для в/в инъекции.Расчет дозы: доза рассчитывается индивидуально, в соответствии с общим дефицитом железа в организме по формуле:Общий дефицит железа, мг = масса тела, кг × (нормальный уровень Hb − уровень Hb больного), г/л × 0,24* + депонированное железо, мг.Для больных массой тела менее 35 кг: нормальный уровень Hb=130 г/л, количество депонированного железа = 15 мг/кг.Для больных массой тела более 35 кг: нормальный уровень Hb=150 г/л, количество депонированного железа = 500 мг.*Коэффициент 0,24 = 0,0034×0,07×1000 (содержание железа в Hb=0,34%; объем крови = 7% от массы тела; коэффициент 1000 = перевод из «г» в «мг»).Общий объем препарата Венофер®, который необходимо ввести (в мл) = общий дефицит железа (мг)/20 мг/мл (см. табл.).ТаблицаОбщий объем препарата Венофер® для лечения Масса тела, кг Кумулятивная терапевтическая доза препарата Венофер® для введения Hb 60 г/л Hb 75 г/л Hb 90 г/л Hb 105 г/л мг Fe мл мг Fe мл мг Fe мл мг Fe мл 5 160 8 140 7 120 6 100 5 10 320 16 280 14 240 12 220 11 15 480 24 420 21 380 19 320 16 20 640 32 560 28 500 25 420 21 25 800 40 700 35 620 31 520 26 30 960 48 840 42 740 37 640 32 35 1260 63 1140 57 1000 50 880 44 40 1360 68 1220 61 1080 54 940 47 45 1480 74 1320 66 1140 57 980 49 50 1580 79 1400 70 1220 61 1040 52 55 1680 84 1500 75 1300 65 1100 55 60 1800 90 1580 79 1360 68 1140 57 65 1900 95 1680 84 1440 72 1200 60 70 2020 101 1760 88 1500 75 1260 63 75 2120 106 1860 93 1580 79 1320 66 80 2220 111 1940 97 1660 83 1360 68 85 2340 117 2040 102 1720 86 1420 71 90 2440 122 2120 106 1800 90 1480 74 В случае, когда общая терапевтическая доза превышает максимальную допустимую разовую дозу, рекомендуется дробное введение препарата.Если спустя 1–2 нед после начала лечения препаратом Венофер® не происходит улучшения гематологических показателей, необходимо пересмотреть первоначальный диагноз.Расчет дозы для восполнения уровня железа после кровопотери или сдачи аутологичной кровиДоза препарата Венофер® подсчитывается по следующей формуле:- если количество потерянной крови известно: в/в введение 200 мг железа (10 мл препарата Венофер®) приводит к такому же повышению концентрации Hb, как и переливание 1 единицы крови (400 мл с концентрацией Hb=150 г/л).Количество железа, которое необходимо восполнить (мг) = количество единиц потерянной крови × 200илиНеобходимый объем препарата Венофер® (мл) = количество единиц потерянной крови × 10.- при снижении уровня Hb: используйте предыдущую формулу при условии, что депо железа пополнять не требуется.Количество железа, которое нужно восполнить (мг) = масса тела, кг × 0,24 × (нормальный уровень Hb − уровень Hb больного), г/л.Например: масса тела 60 кг, дефицит Hb = 10 г/л \" необходимое количество железа » 150 мг \" необходимый объем препарата Венофер® = 7,5 мл.Стандартная дозировкаВзрослые и пожилые больные:5–10 мл Венофер® (100–200 мг железа) 1–3 раза в неделю, в зависимости от уровня гемоглобина.Дети: имеются лишь ограниченные данные о применении препарата у детей до 3 лет. Рекомендуемая доза для детей остальных возрастных групп— не более 0,15 мл (3 мг железа) на кг массы тела 1–3 раза в неделю, в зависимости от уровня гемоглобина.Максимально переносимая разовая дозаВзрослые и пожилые больные:- для струйного введения: 10 мл препарата Венофер® (200 мг железа), продолжительность введения не менее 10 мин.- для капельного введения: в зависимости от показаний, разовая доза может достигать 500 мг железа. Максимально допустимая разовая доза составляет 7 мг/кг и вводится 1 раз в неделю, но она не должна превышать 500 мг железа. Время введения препарата и способ разведения см. выше."}}]},{"id":8,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В настоящее время известно о следующих нежелательных явлениях, имеющих временное и возможное причинное отношение к введению препарата Венофер®. Все симптомы наблюдались очень редко (частота возникновения меньше 0,01% и больше или равна 0,001%).Со стороны нервной системы: головокружение, головная боль, потеря сознания, парестезии.Со стороны ССС: сердцебиение, тахикардия, снижение АД, коллаптоидные состояния, чувство жара, приливы крови к лицу, периферические отеки.Со стороны органов дыхания: бронхоспазм, одышка.Со стороны ЖКТ: разлитые боли в животе, боль в эпигастральной области, диарея, извращение вкуса, тошнота, рвота.Со стороны кожных покровов: эритема, зуд, сыпь, нарушение пигментации, повышение потливости.Со стороны опорно-двигательного аппарата: артралгия, боль в спине, отек суставов, миалгия, боль в конечностях.Со стороны иммунной системы: аллергические, анафилактоидные реакции, в т.ч. отек лица, отек гортани.Нарушения общего характера и реакции в месте инъекции: астения, боль в груди, чувство тяжести в груди, слабость, боль и отек в месте введения (особенно при экстравазальном попадании препарата), чувство недомогания, бледность, повышение температуры, озноб."}}]},{"id":9,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Передозировка может вызывать острую перегрузку железом, которая проявляется симптомами гемосидероза.Лечение: рекомендуется использовать симптоматические средства и, если необходимо, вещества, связывающие железо (хелаты), например дефероксамин в/в."}}]},{"id":10,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Венофер® не должен назначаться одновременно с лекарственными формами железа для приема внутрь, т.к. способствует уменьшению всасывания железа из ЖКТ. Лечение пероральными препаратами железа можно начинать не ранее чем через 5 дней после последней инъекции.Венофер® можно смешивать в одном шприце только со стерильным физиологическим раствором. Никаких других растворов для в/в введения и терапевтических препаратов добавлять не разрешается, поскольку существует риск преципитации и/или иного фармацевтического взаимодействия. Совместимость с контейнерами из иных материалов, чем стекло, ПЭ и ПВХ не изучена."}}]},{"id":11,"name":"Условия хранения","slug":"storage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При температуре 4–25°C. В оригинальной упаковке (не замораживать).Хранить в недоступном для детей месте."}}]},{"id":12,"name":"Срок годности","slug":"expiry_date","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"3 года. Не применять по истечении срока годности, указанного на упаковке.2000-2017. 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