Emergency Live | FDA approves Recarbio to treat hospital-acquired and ventilator-associated bacterial pneumonia

FDA e amohela Recarbio ho phekola pneumonia e fumanoeng sepetlele le bakuli

By LITABA On Jun 16, 2020

US Food and Drug Administration (FDA) e amohetse Recarbrio (motsoako oa imipenem, cilastatin le relebactam) bakeng sa kalafo ea pneumonia e fumanoeng sepetlele le pneumonia e sebetsanang le "bacterial" pneumonia (HABP / VABP) ho bakuli ba lilemo li 18 le ho feta .

Recarbrio e kile ea amoheloa ke FDA bakeng sa ts'oaetso e rarahaneng ea ts'ebetso ea moroto le kalafo e rarahaneng ea ka mpeng. Hona joale, FDA e phatlalatsa hore e ka ba lithibela-mafu bakeng sa pneumonia.

Recarbrio, na e ka ba lithibela-mafu tse sebetsang bakeng sa pneumonia e fumanoeng sepetlele?

Tšireletseho le katleho ea Recarbrio bakeng sa matšoao ana a mang li ile tsa hlahlojoa tlhahlobo e laoloang e sa laoleheng e fumanehang ho batho ba baholo ba 535 ba le sepetlele ba nang le HABP / VABP ka lebaka la libaktheria tse se nang Gram: bakuli ba 266 ba ile ba phekoloa ka Recarbrio le bakuli ba 269 ba nang le piperacillin-tazobactam.

Ka kakaretso, ka letsatsi la 28 la thuto, 16% ea bakuli ba ileng ba phekoloa ka Recarbrio le 21% ea ba bang ba ne ba hlokahetse.

Antibiotic bakeng sa pneumonia ea baktheria: karabelo e atisang ho hlaha

Liphetoho tse atileng haholo tse hlokometsoeng ho bakuli ba tšoaroang ke Recarbrio li kenyellelitse ho eketseha ha aspartate / alanine aminotransferase, anemia, lets'ollo, hypokalemia le hyponatraemia.

Recarbrio e amohetse lebitso la Qualified tšoaetso ea tšoaetso ea (QIDP) tlasa FDA Security and Innovation Act's Generating Antibiotic Incentives Now (GAIN), eo mokhatlo oa Amerika o reng ke li-antibacterials le li-antifungals tse reretsoeng ho phekola tšoaetso e kholo kapa e behang bophelo kotsing. E le karolo ea lebitso la QIDP, Recarbrio e khethiloe hore e be Bohlokoa ba Boikarabello 'me e amohetsoe ka Fast Track.