دواعي استعمال ادفاجراف 5 مجم 50 كبسولة

Advagraf (tacrolimus) 5 mg prolonged-release capsules, pack of 50.

• Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.الفئة: AdultsEuropean Medicines Agency (EMA)
• Treatment of allograft rejection resistant to other immunosuppressive medicinal products in adults.الفئة: AdultsEuropean Medicines Agency (EMA)

• Very common: diabetes mellitus/hyperglycaemia, hyperkalaemia, insomnia, headache, tremor, hypertension, diarrhoea, nausea, renal impairment, abnormal liver function tests.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)

• Hypersensitivity to tacrolimus or any excipient; hypersensitivity to other macrolides.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)

• Do not switch between immediate- and prolonged-release tacrolimus formulations without transplant-specialist supervision and therapeutic drug monitoring; unsupervised switching has caused graft rejection or toxicity.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
• CYP3A4 inhibitors may raise tacrolimus levels (nephrotoxicity, neurotoxicity, QT prolongation); inhibitors or inducers should only be co-administered after consulting a transplant specialist.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)

• Tacrolimus crosses the placenta; neonatal hyperkalaemia reported. Use in pregnancy only when no safer alternative and benefit justifies risk; monitor the newborn.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
• Excreted in breast milk; women should not breast-feed while receiving Advagraf.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)

• Early post-transplant: monitor blood pressure, ECG, neurological and visual status, fasting glucose, electrolytes (especially potassium), liver and renal function, haematology, coagulation and plasma proteins; frequent trough-level monitoring in the first two weeks.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)