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معلومات الدواء

التفاصيل الكاملة
عن الدواءAbout the medicine

Lenalidomide 5 mg hard capsules (Revlimid), thalidomide-analogue immunomodulatory antineoplastic agent.

Lenalidomide 5 mg hard capsules (Revlimid), thalidomide-analogue immunomodulatory antineoplastic agent.

دواعي الاستعمالUses
  • Multiple myeloma: maintenance after autologous stem cell transplantation (monotherapy); previously untreated transplant-ineligible patients in combination with dexamethasone, bortezomib/dexamethasone or melphalan/prednisone; and patients with at least one prior therapy in combination with dexamethasone (adults).الفئة: AdultsEuropean Medicines Agency (EMA)
  • Transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes with isolated deletion 5q when other options are insufficient (adults).الفئة: AdultsEuropean Medicines Agency (EMA)
  • Relapsed or refractory mantle cell lymphoma (adults, monotherapy).الفئة: AdultsEuropean Medicines Agency (EMA)
عرض الكل (4)
  • Multiple myeloma: maintenance after autologous stem cell transplantation (monotherapy); previously untreated transplant-ineligible patients in combination with dexamethasone, bortezomib/dexamethasone or melphalan/prednisone; and patients with at least one prior therapy in combination with dexamethasone (adults).Population: AdultsEuropean Medicines Agency (EMA)
  • Transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes with isolated deletion 5q when other options are insufficient (adults).Population: AdultsEuropean Medicines Agency (EMA)
  • Relapsed or refractory mantle cell lymphoma (adults, monotherapy).Population: AdultsEuropean Medicines Agency (EMA)
Show all (4)
الآثار الجانبيةSide effects
  • With maintenance after ASCT, adverse reactions more frequent than placebo included neutropenia, bronchitis, diarrhoea, nasopharyngitis, muscle spasms, leucopenia, asthenia, cough and thrombocytopenia; serious reactions included pneumonia and lung infection.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
  • With maintenance after ASCT, adverse reactions more frequent than placebo included neutropenia, bronchitis, diarrhoea, nasopharyngitis, muscle spasms, leucopenia, asthenia, cough and thrombocytopenia; serious reactions included pneumonia and lung infection.International label, same product · European Medicines Agency (EMA)
موانع الاستعمالContraindications
  • Hypersensitivity to the active substance or any excipient.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
  • Women who are pregnant.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
  • Women of childbearing potential unless all conditions of the Pregnancy Prevention Programme are met.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
  • Hypersensitivity to the active substance or any excipient.International label, same product · European Medicines Agency (EMA)
  • Women who are pregnant.International label, same product · European Medicines Agency (EMA)
  • Women of childbearing potential unless all conditions of the Pregnancy Prevention Programme are met.International label, same product · European Medicines Agency (EMA)
تحذيرات واحتياطاتWarnings & precautions
  • Teratogenicity: lenalidomide is structurally related to thalidomide and a teratogenic effect in humans is expected; the Pregnancy Prevention Programme (contraception, pregnancy testing, condom use by male patients) must be followed.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
  • Boxed warning: embryo-fetal toxicity, hematologic toxicity (neutropenia and thrombocytopenia), and venous and arterial thromboembolism; available only through a restricted distribution programme in the US.نشرة دولية لنفس المنتج · DailyMed (U.S. National Library of Medicine)
  • Increased risk of venous thromboembolism (mainly deep vein thrombosis and pulmonary embolism) and arterial thromboembolism, particularly in combination with dexamethasone in multiple myeloma.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
عرض الكل (4)
  • Teratogenicity: lenalidomide is structurally related to thalidomide and a teratogenic effect in humans is expected; the Pregnancy Prevention Programme (contraception, pregnancy testing, condom use by male patients) must be followed.International label, same product · European Medicines Agency (EMA)
  • Boxed warning: embryo-fetal toxicity, hematologic toxicity (neutropenia and thrombocytopenia), and venous and arterial thromboembolism; available only through a restricted distribution programme in the US.International label, same product · DailyMed (U.S. National Library of Medicine)
  • Increased risk of venous thromboembolism (mainly deep vein thrombosis and pulmonary embolism) and arterial thromboembolism, particularly in combination with dexamethasone in multiple myeloma.International label, same product · European Medicines Agency (EMA)
Show all (4)
التداخلات الدوائيةDrug interactions
  • DigoxinLenalidomide 10 mg daily increased digoxin plasma exposure by about 14%; monitoring of digoxin concentration is advised.European Medicines Agency (EMA)
  • WarfarinNo pharmacokinetic interaction shown, but the effect during clinical use with dexamethasone is unknown; close monitoring of warfarin concentration is advised.European Medicines Agency (EMA)
  • DigoxinLenalidomide 10 mg daily increased digoxin plasma exposure by about 14%; monitoring of digoxin concentration is advised.European Medicines Agency (EMA)
  • WarfarinNo pharmacokinetic interaction shown, but the effect during clinical use with dexamethasone is unknown; close monitoring of warfarin concentration is advised.European Medicines Agency (EMA)
الحمل والرضاعةPregnancy & breastfeeding
  • Contraindicated in pregnancy; if taken during pregnancy a teratogenic effect in humans is expected.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
  • It is not known whether lenalidomide is excreted in breast milk; breast-feeding should be discontinued during therapy.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
  • Contraindicated in pregnancy; if taken during pregnancy a teratogenic effect in humans is expected.International label, same product · European Medicines Agency (EMA)
  • It is not known whether lenalidomide is excreted in breast milk; breast-feeding should be discontinued during therapy.International label, same product · European Medicines Agency (EMA)
كيف يعمل الدواءHow it works
  • ليناليدوميد: Immunomodulatory, antiangiogenic and antineoplastic actions (cereblon-mediated); thalidomide analogue.
  • Lenalidomide: Immunomodulatory, antiangiogenic and antineoplastic actions (cereblon-mediated); thalidomide analogue.

نفس المادة الفعالة والتركيز. اسأل الصيدلي قبل الاستبدال.

مثائل ريفليميد 5مجم 21 كبسول بنفس المادة الفعالة والتركيز، مرتبة من الأرخص
اميونومايد 5مجم 21 كبسولةImmunomide 5 mg 21 capsHikma Specialized Pharmaceuticals · كبسولات · 5 mgالأرخصالسعر6,999ج.م333.29ج.م للوحدةالفرق عن الأصليأرخص 98,001ج.م (93.3%)

البدائل (26)

كل البدائل (26)

مادة فعالة مختلفة من نفس المجموعة العلاجية. لا تستبدل دواءك ببديل إلا بأمر الطبيب.

بدائل ريفليميد 5مجم 21 كبسول من نفس المجموعة العلاجية بمادة فعالة مختلفة، مرتبة من الأرخص
ازاثيوبرين بي سي اتش 50مجم 10 اقراصAzathioprine PCH 50 mg 10 tabletsCopad Pharma · أقراص · 50 mgغير متوفرالسعر8ج.م0.8ج.م للوحدة
ازارين 50 مجم 30 قرصAzarin 50 mg 30 tabletsHi-Pharm · أقراص · 50 mgالسعر24ج.م0.8ج.م للوحدة
ايموتركسات 2.5مجم 10 اقراصImutrexate 2.5 mg 10 tabs.Eva Pharma · قرص · 2.5 mgالسعر51ج.م5.1ج.م للوحدة
ازاثيوبرين -ايفافارما 25 مجم 30 قرصAzathioprine-evapharma 25 mg 30 f.c.tabs.Eva pharma · أقراص مغلفة · Azathioprine 25 mgالسعر60ج.م2ج.م للوحدة
ايموتركسات 5مجم 10 اقراصImutrexate 5 mg 10 tabs.Eva Pharma · قرص · 5 mgالسعر77ج.م7.7ج.م للوحدة
ميثوتريكسات 2.5مجم 30 قرصMethotrexate (Orion) 2.5 mg 30 tabletsS.M. Pharma · أقراص · 2.5 mgالسعر84ج.م2.8ج.م للوحدة
ايموتركسات 7.5مجم 10 اقراصImutrexate 7.5 mg 10 tabs.Eva Pharma · قرص · 7.5 mgالسعر89ج.م8.9ج.م للوحدة
ازاثيوبرين -ايفا فارما 50 مجم 30 قرصAzathioprine-evapharma 50 mg 30 f.c.tabs.Eva pharma · أقراص مغلفة · Azathioprine 50 mgالسعر96ج.م3.2ج.م للوحدة
ايموتريكسات 10 مجم 10 قرصImutrexate 10 mg 10 tabs.Eva Pharma · قرص · 10 mgالسعر100ج.م10ج.م للوحدة
ازاثيوبرين -ايفافارما 75 مجم 30 قرصAzathioprine-evapharma 75 mg 30 f.c.tabs.Eva pharma · أقراص مغلفة · Azathioprine 75 mgالسعر123ج.م4.1ج.م للوحدة

المعرّفات

مراجع علمية للمادة الفعالة

المصادر

تعليقات

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