Negara: Singapura
Bahasa: Inggris
Sumber: HSA (Health Sciences Authority)
Lopinavir; Ritonavir
ABBVIE PTE. LTD.
J05AR10
100mg
TABLET, FILM COATED
Lopinavir 100mg; Ritonavir 25mg
ORAL
Prescription Only
AbbVie Deutschland GmbH & Co. KG
ACTIVE
2009-10-21
KALETRA® (LOPINAVIR/RITONAVIR) TABLETS (LOPINAVIR/RITONAVIR) ORAL SOLUTION ALERT: FIND OUT ABOUT MEDICINES THAT SHOULD NOT BE TAKEN WITH KALETRA. Please also read the section "MEDICINES YOU SHOULD NOT TAKE WITH KALETRA." PATIENT INFORMATION LEAFLET KALETRA® (kuh-LEE-tra) Generic Name: lopinavir/ritonavir (lop-IN-uh-veer/rit-ON-uh-veer) Read this leaflet carefully before you start taking KALETRA. Also, read it each time you get your KALETRA prescription refilled, in case something has changed. This information does not take the place of talking with your doctor when you start this medicine and at check ups. Ask your doctor if you have any questions about KALETRA. Before taking your medicine, make sure you have received the correct medicine. Compare the name above with the name on your bottle and the appearance of your medicine with the description provided below. Contact your pharmacist immediately if you believe a dispensing error has occurred. WHAT IS KALETRA AND HOW DOES IT WORK? KALETRA is a combination of two medicines. They are lopinavir and ritonavir. KALETRA is a type of medicine called an HIV (human immunodeficiency virus) protease (PRO-tee-ase) inhibitor. KALETRA is always used in combination with other anti- HIV medicines to treat people with human immunodeficiency virus (HIV) infection. KALETRA is for adults and for children age 6 months and older. HIV infection destroys CD 4 (T) cells, which are important to the immune system. After a large number of T cells are destroyed, acquired immune deficiency syndrome (AIDS) develops. KALETRA blocks HIV protease, a chemical which is needed for HIV to multiply. KALETRA reduces the amount of HIV in your blood and increases the number of T cells. Reducing the amount of HIV in the blood reduces the chance of death or infections that happen when your immune system is weak (opportunistic infections). DOES KALETRA CURE HIV OR AIDS? KALETRA DOES NOT CURE HIV INFECTION OR AIDS. THE LONG-TERM EFFECTS OF KALETRA ARE NOT KNOWN AT THIS TIME. PEOPLE TAKING KALETRA MAY STIL Baca dokumen lengkapnya
1 KALETRA® (LOPINAVIR/RITONAVIR) TABLETS (LOPINAVIR/RITONAVIR) ORAL SOLUTION INDICATIONS AND USAGE KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV-infection. This indication is based on analyses of plasma HIV RNA levels and CD 4 cell counts in controlled studies of KALETRA of 48 weeks duration and in smaller uncontrolled dose-ranging studies of KALETRA of 144-360 weeks duration. CLINICAL PHARMACOLOGY MICROBIOLOGY MECHANISM OF ACTION Lopinavir, an inhibitor of the HIV protease, prevents cleavage of the Gag-Pol polyprotein, resulting in the production of immature, non-infectious viral particles. ANTIVIRAL ACTIVITY IN_ _VITRO The in_ _vitro antiviral activity of lopinavir against laboratory HIV strains and clinical HIV isolates was evaluated in acutely infected lymphoblastic cell lines and peripheral blood lymphocytes, respectively. In the absence of human serum, the mean 50% effective concentration (EC 50 ) of lopinavir against five different HIV-1 laboratory strains ranged from 10-27 nM (0.006-0.017 µg/mL, 1 µg/mL = 1.6 µM) and ranged from 4-11 nM (0.003-0.007 µg/mL) against several HIV-1 clinical isolates (n = 6). In the presence of 50% human serum, the mean EC 50 of lopinavir against these five laboratory strains ranged from 65-289 nM (0.04- 0.18 µg/mL), representing a 7- to 11-fold attenuation. Combination drug activity studies with lopinavir and other protease inhibitors or reverse transcriptase inhibitors have not been completed. RESISTANCE HIV-1 isolates with reduced susceptibility to lopinavir have been selected in vitro. The presence of ritonavir does not appear to influence the selection of lopinavir-resistant viruses in vitro_._ The selection of resistance to KALETRA in antiretroviral treatment naïve patients has not yet been characterized. In a Phase III study of 653 antiretroviral treatment naive patients (Study 863), plasma viral isolates from each patient on treatment with plasma HIV > 400 copies/mL at Week 24, 32, 40 and/or 48 were analyzed. No ev Baca dokumen lengkapnya