ZYVOX

Riik: Indoneesia

keel: indoneesia

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

Toimeaine:

LINEZOLID

Saadav alates:

PFIZER INDONESIA - Indonesia

INN (Rahvusvaheline Nimetus):

LINEZOLID

Annus:

2 Mg

Ravimvorm:

INFUS

Ühikuid pakis:

POLYBAG @ 300 ML

Valmistatud:

FRESENIUS KABI NORGE AS - Norway

Loa andmise kuupäev:

2022-02-08

Toote omadused

Generic Name: Linezolid
Trade Name: Zyvox
CDS Effective Date: March 12, 2021
Supersedes: September 25, 2017
Approved by BPOM:
PT. PFIZER INDONESIA
Local Product Document
Generic Name: Linezolid
Trade Name: Zyvox
CDS Effective Date: March 12, 2021
Supersedes: September 25, 2017
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of ZYVOX formulations
and other antibacterial drugs, ZYVOX should be used only to treat or
prevent infections that are proven or
strongly suspected to be caused by bacteria.
DESCRIPTION
ZYVOX I.V. Injection contains linezolid, which is a synthetic
antibacterial agent of the oxazolidinone class.
The
chemical
name
for
linezolid
is
(S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]
methyl]-acetamide.
The empirical formula is C
16
H
20
FN
3
O
4
. Its molecular weight is 337.35, and its chemical structure is
represented below:
O
N
C
3
H
F
O
H
C
N
O
O
N
ZYVOX I.V. Injection is supplied as a ready-to-use sterile isotonic
solution for intravenous infusion. Each
mL contains 2 mg of linezolid. Inactive ingredients are sodium
citrate, citric acid, and dextrose in an aqueous
vehicle for intravenous administration. The sodium (Na
+
) content is 0.38 mg/mL (5 mEq per 300-mL bag;
3.3 mEq per 200-mL bag; and 1.7 mEq per 100-mL bag).
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
The mean pharmacokinetic parameters of linezolid in adults after
single and multiple oral and intravenous
(IV) doses are summarized in Table 1. Plasma concentrations of
linezolid at steady-state after oral doses of
600 mg given every 12 hours (q12h) are shown in Figure 1.
2020-0059708, 2020-0066502, 2021-0067771
Page 1 of 26
DISETUJUI OLEH BPOM : 20/12/2021
ID REG : EREG10024112100314
Generic Name: Linezolid
Trade Name: Zyvox
CDS Effective Date: March 12, 2021
Supersedes: September 25, 2017
Approved by BPOM:
TABLE 1. MEAN (STANDARD DEVIATION) PHARMACOKINETIC PARAMETERS OF
LINEZOLID IN ADULTS
DOSE OF LINEZOLID
C
MAX
Μ
G/ML
C
MIN
Μ
G/ML
T
MAX
HRS
AUC*
Μ
G • H/ML
T
1/2
HRS
CL
ML/MIN
600 MG