ZINFORO

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Bahan aktif:

CEFTAROLINEFOSAMIL ACETIC ACID SOLVATE MONOHYDRATE

Tersedia dari:

PFIZER INDONESIA - Indonesia

INN (Nama Internasional):

CEFTAROLINEFOSAMIL ACETIC ACID SOLVATE MONOHYDRATE

Dosis:

600 MG

Bentuk farmasi:

SERBUK INJEKSI

Unit dalam paket:

DUS, 10 VIAL @ 600 MG

Diproduksi oleh:

ACS DOBFAR S.P.A - Italy

Tanggal Otorisasi:

2018-12-04

Karakteristik produk

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