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.
|