Pajjiż: Indoneżja
Lingwa: Indoneżjan
Sors: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
LINEZOLID
PFIZER INDONESIA - Indonesia
LINEZOLID
2 Mg
INFUS
POLYBAG @ 300 ML
FRESENIUS KABI NORGE AS - Norway
2022-02-08
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 Aqra d-dokument sħiħ