I-Antibiotic Zevtera (Ceftobiprole medocaril) egunyazwe yi-FDA yokwelashwa kwe-CABP, ABSSSI kanye ne-SAB 

I-cephalosporin yesizukulwane sesihlanu esibanzi-spectrum i-antibiotic, Zevtera (I-Ceftobiprole medocaril i-sodium Inj.) ivunyelwe ngu FDA¹ Okwe ukwelashwa zezifo ezintathu okungukuthi.  

1. Izifo ze-Staphylococcus aureus bloodstream (i-bacteremia) (SAB), kuhlanganise nalabo abane-endocarditis ye-infective kwesokudla;  

2. izifo eziyingozi ze-bacterial isikhumba kanye nesakhiwo sesikhumba (ABSSSI); futhi  

3. inyumoniya yebhaktheriya etholwa umphakathi (CABP).  

Lokhu kulandela imiphumela yokuhlolwa kwemitholampilo yesigaba sesi-3 egculisayo.  

I-Ceftobiprole medocaril igunyazwe emazweni amaningi ase-Europe, kanye naseCanada ukuze zelashwe inyumoniya etholwa esibhedlela (ngaphandle kwenyumoniya etholwa yi-ventilator) kanye nenyumoniya etholwa umphakathi kubantu abadala.².  

E-UK, i-Ceftobiprole medocaril okwamanje isesivivinyweni somtholampilo sesigaba sesi-III³ nokho, yamukelwe ukusetshenziswa okukhawulelwe ngaphakathi kwe-NHS Scotland⁴.  

E-EU, ivela ku-Union Register yemikhiqizo yokwelapha enqatshiwe ukuze isetshenziswe abantu⁵. 

I-Ceftobiprole medocaril, isizukulwane sesihlanu ububanzi obubanzi I-cephalosporin isebenza ngempumelelo ngokumelene namagciwane e-Gram-positive afana ne-methicillin-resistant Staphylococcus aureus kanye ne-penicillin-resistant Streptococcus pneumoniae, kanye namagciwane angenayo i-Gram-negative njenge-Pseudomonas aeruginosa. Itholwe iwusizo ekwelapheni inyumoniya etholwe ngumphakathi kanye nenyumoniya ye-nosocomial, ngaphandle kwenyumoniya ehambisana ne-ventilator.^6,7. 

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References:  

1. FDA Ukukhishwa kwezindaba. FDA Igunyaza Okusha I-antibiotic Ukusetshenziswa Okuthathu Okuhlukene. Kuthunyelwe ngomhla ka-03 Ephreli 2024. Itholakala e- https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibiotic-three-different-uses/ 

2. U-Jame W., u-Basgut B., kanye no-Abdi A., 2024. I-Ceftobiprole mono-therapy ngokumelene nenhlanganisela noma uhlobo olungahlanganisi olujwayelekile kwemithi elwa namagciwane ukwelashwa kwezifo eziyinkimbinkimbi: Ukubuyekezwa okuhlelekile nokuhlaziywa kwemeta. Ukuxilonga Microbiology kanye Nezifo Ezithathelwanayo. Itholakala ku-inthanethi ngomhla ka-16 Mashi 2024, 116263. DOI: https://doi.org/10.1016/j.diagmicrobio.2024.116263  

3. I-NIHR. I-Health Technology Briefing November 2022. I-Ceftobiprole medocaril yokwelapha inyumoniya etholwa esibhedlela noma inyumoniya etholwe umphakathi edinga ukulaliswa esibhedlela ezinganeni. Itholakala ngo https://www.io.nihr.ac.uk/wp-content/uploads/2023/04/28893-Ceftobiprole-medocaril-for-pneumonia-V1.0-NOV2022-NONCONF.pdf  

4. I-Scottish Medicine Consortium. I-Ceftobiprole medocaril (Zevtera). Itholakala ngo https://www.scottishmedicines.org.uk/medicines-advice/ceftobiprole-medocaril-zevtera-resubmission-94314/  

5. Ikhomishini yaseYurophu. Irejista Yenyunyana yemikhiqizo yemithi eyenqatshiwe ukuze isetshenziswe abantu. Igcine ukubuyekezwa ngomhla ka-21 February 2024. Itholakala ngo https://ec.europa.eu/health/documents/community-register/html/ho10801.htm 

6. Lupia T., et al 2022. Umbono we-Ceftobiprole: Izinkomba Zamanje Nezingenzeka Zesikhathi esizayo. Nemithi Elwa Namagciwane Umqulu 10 Ikhishwe 2. DOI: https://doi.org/10.3390/antibiotics10020170  

7. Méndez1 R., Latorre A., kanye no-González-Jiménez P., 2022. Ceftobiprole medocaril. Rev Esp Quimioter. 2022; 35(Okwengeziwe 1): 25-27. Ishicilelwe ku-inthanethi 2022 Apr 22. DOI: https://doi.org/10.37201/req/s01.05.2022  

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