Ország: Indonézia
Nyelv: indonéz
Forrás: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
LOPINAVIR, RITONAVIR
ABBOTT INDONESIA - Indonesia
LOPINAVIR, RITONAVIR
200 MG /50 MG
TABLET SALUT SELAPUT
BOTOL PLASTIK @ 120 TABLET SALUT SELAPUT
ABBVIE DEUTSCHLAND GMBH & CO. KG - Federal Republic of Germany
2021-12-06
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: Page 1 of 51 ALUVIA 200 & 100 mg Safety Update ccds 23 21102020 DISETUJUI OLEH BPOM: 15/11/2021 EREG100346VR12100143 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 ferric oxide E172, and polysorbate 80 100/25 mg Tablets: Olvassa el a teljes dokumentumot