Šalis: Indonezija
kalba: indoneziečių
Šaltinis: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 10 VIAL @ 50 MG
2022-07-15
Generic Name: Tigecycline Trade Name: TYGACIL TM CDS Effective Date: December 01, 2020 Supersedes: November 15, 2019 Approved by BPOM: 2020-0065601 Page 1 of 24 PT PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Generic Name: Tigecycline Trade Name: TYGACIL TM CDS Effective Date: December 01, 2020 Supersedes: November 15, 2019 ℞ only DESCRIPTION TYGACIL (tigecycline) is a glycylcycline antibacterial for intravenous infusion. The chemical name of tigecycline is (4_S_,4a_S_,5a_R_,12a_S_)-9-[2-(_tert_-butylamino)acetamido]- 4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11- dioxo-2-naphthacenecarboxamide. The empirical formula is C 29 H 39 N 5 O 8 and the molecular weight is 585.65. The following represents the chemical structure of tigecycline: TYGACIL is an orange lyophilized powder or cake. Each TYGACIL vial contains 50 mg tigecycline lyophilized powder for intravenous infusion. Each vial contains 100 mg of lactose monohydrate. The pH is adjusted with hydrochloric acid, and if necessary sodium hydroxide. CLINICAL PHARMACOLOGY Anti-infective Glycylcycline antibacterial ATC code: J01C XXX PHARMACOKINETICS The mean pharmacokinetic parameters of tigecycline after single and multiple intravenous doses are summarized in Table 1. Intravenous infusions of tigecycline were administered over approximately 30 to 60 minutes. TABLE 1. MEAN (CV%) PHARMACOKINETIC PARAMETERS OF TIGECYCLINE Single Dose 100 mg Multiple Dose a 50 mg q 12h C max ( µ g/mL) b 1.45 (22%) 0.87 (27%) C max ( µ g/mL) c 0.90 (30%) 0.63 (15%) AUC ( µ g·h/mL) 5.19 (36%) -- AUC 0-24h ( µ g·h/mL) -- 4.70 (36%) C min ( µ g/mL) -- 0.13 (59%) DISETUJUI OLEH BPOM: 26/08/2021 ID: EREG10024112100344 Generic Name: Tigecycline Trade Name: TYGACIL TM CDS Effective Date: December 01, 2020 Supersedes: November 15, 2019 Approved by BPOM: 2020-0065601 Page 2 of 24 t 1/2 (h) 27.1 (53%) 42.4 (83%) CL (L/h) 21.8 (40%) 23.8 (33%) CL r (mL/min) 38.0 (82%) 51.0 (58%) V ss (L) 568 (43%) 639 (48%) a 100 mg initially, followed by 50 mg every 12 ho Perskaitykite visą dokumentą