Valsts: Indonēzija
Valoda: indonēziešu
Klimata pārmaiņas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
LOPINAVIR; RITONAVIR
ABBOTT INDONESIA - Indonesia
LOPINAVIR; RITONAVIR
200/50 MG
TABLET SALUT SELAPUT
BOTOL @ 120 TABLET SALUT SELAPUT
ABBVIE DEUTSCHLAND GmbH & Co. KG., Jerman
2017-06-05
Page 1 of 45 ALUVIA 200 & 100 mg Posology Update 16032020 ALUVIA TM LOPINAVIR/RITONAVIR TABLETS PRODUCT NAME Lopinavir/ritonavir TRADE NAMES Aluvia TM DESCRIPTION Lopinavir/ritonavir is a co-formulation of lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV-1 and HIV-2 proteases. As co-formulated in Aluvia, ritonavir inhibits the cytochrome P450 3A (CYP3A)-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir. Lopinavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Lopinavir is chemically designated as [1S-[1R*,(R*), 3R*, 4R*]]-N-[4-[[2,6- dimethylphenoxy)acetyl]amino]-3- hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro- alpha-( _1_ -methylethyl)-2-oxo- 1(2H)-pyrimidineacetamide. Its molecular formula is C 37 H 48 N 4 O 5 , and its molecular weight is 628.80. Lopinavir has the following structural formula: Ritonavir is chemically designated as 10-Hydroxy-2-methyl-5-(1-methylethyl)-1- [2-(1- methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13- oic acid, 5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C 37 H 48 N 6 O 5 S 2 , and its molecular weight is 720.95. Ritonavir has the following structural formula: DISETUJUI OLEH BPOM : 22/05/2020 218245429 - 218245430 Page 2 of 45 ALUVIA 200 & 100 mg Posology Update 16032020 Lopinavir/ritonavir film coated tablets are available for oral administration in a strength of 200 mg of lopinavir and 50 mg of ritonavir or 100 mg of lopinavir and 25 mg of ritonavir with the following inactive ingredients: copovidone sorbitan laurate, colloidal anhydrous silica, and sodium stearyl fumarate. The following are the ingredients in the film coating: 200/50 mg Tablets: Strength and Color of Tablet List of ingredients in the film coating 200/50 mg Red tablet Hypromellose, titanium dioxide, macrogols type 400, hydroxypropyl cellulose, talc, colloidal anhydrous silica, macrogols type 3350, red Izlasiet visu dokumentu