• المركز الأردني للمعلومات الدوائية والسموم



  • 29/03/2023

    تعميم من مؤسسة الغذاء و الدواء الصادر في 14/12/2022

    إشارة الى معلومات المأمونية الدوائية المستجدة و الصادرة من قبل السلطة الدوائية الأوروبية (EMA) بتاريخ 30/9/2022 و المتعلق بالأدوية المحتوية على المادة الفعالة  ((Terlipressin حيث ورد التالي:

     

    ·  A higher than previously known risk of respiratory failure has been reported when using  terlipressin- containing medicines for the treatment of type 1 hepatorenal syndrome (HRS-1). In addition, a new risk of sepsis has been identified with the use of terlipressin - containing medicines for HRS-1.

    Terlipressin -containing medicines should be  avoided in patients with advanced renal dysfunction (serum creatinine ≥ 442µmol/l (5.0mg/dl) and in patients with acute -on chronic liver failure grade 3 and/or model for end-stage liver disease (MELD) score ≥ 39 MELD score, unless the benefits outweigh the risks.

    ·     Patients with new onset of breathing difficulties or worsening of existing respiratory disease should be stabilized before treatment with terlipressin- containing medicines and should be closely monitored during treatment. If patients develop respiratory symptoms,  dose reduction of human albumin should be considered, if applicable.       

    If symptoms are severe or do not resolve, terlipressin should be discontinued.

    ·     Patients should be closely monitored for symptoms of infection.

     

    In addition, healthcare professionals can consider giving teripressin- containing medicines as continues intravenous infusion as an alternative to bolus injection, as continues infusion may reduce the risk of severe adverse events compared to bolus injection.