Χώρα: Ινδονησία
Γλώσσα: Ινδονησιακά
Πηγή: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
CEFTAROLINE FOSAMIL
PFIZER INDONESIA - Indonesia
CEFTAROLINE FOSAMIL
600,0 MG
SERBUK INFUS
DUS, 10 VIAL @ 600 MG
ACS DOBFAR S.P.A. - Italy
2020-06-22
Generic Name: Ceftaroline fosamil_ _ Trade Name: ZINFORO TM CDS Effective Date: March 03, 2020 Supersedes: August 11, 2016 Approved by BPOM: 2019-0049521 Page 1 of 11 DISETUJUI OLEH BPOM: 02/03/2023 NO. ID: EREG10024112000185 PT PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Generic Name: Ceftaroline fosamil Trade Name: ZINFORO TM CDS Effective Date: March 03, 2020 Supersedes: August 11, 2016 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains ceftaroline fosamil acetic acid solvate monohydrate equivalent to 600 mg ceftaroline fosamil that equivalent to 530 mg ceftaroline. For excipients, see section _List of excipients_. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion A pale yellowish-white to light yellow powder THERAPEUTIC INDICATION ZINFORO TM is indicated for the treatment of adult (≥18 years of age) patients with complicated skin and soft tissue infections (cSSTI) caused by susceptible isolates of the designated microorganism: _Staphylococcus aureus_ (including methicillin-susceptible and –resistant isolates), _Streptococcus _ _pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumonia_ and _Klebsiella oxytoca_. _USAGE: _ To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftaroline and other antibacterial drugs, ceftaroline should be used to treat only cSSTI that are proven or strongly suspected to be caused by susceptible bacteria. Appropriate specimens for microbiological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to ceftaroline. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. POSOLOGY AND METHOD OF ADMINISTRATION The recommended dosage of ZINFORO TM is 600 mg administered every 12 hours by intravenous infusion over 5 to 60 minutes (st Διαβάστε το πλήρες έγγραφο