darunavir 600 MG Oral Tablet Prezista
1 INDICATIONS AND USAGE PREZISTA, co-administered with ritonavir (PREZISTA/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations (8.4) and Clinical Studies (14) ] . PREZISTA is a human immunodeficiency virus (HIV-1) protease inhibitor indicated for the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older. PREZISTA must be co-administered with ritonavir (PREZISTA/ritonavir) and with other antiretroviral agents. ( 1 )
Janssen Products LP
OVAL ORANGE 600MG TMC
600MG TMC OVAL ORANGE
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16 HOW SUPPLIED/STORAGE AND HANDLING PREZISTA ® (
DARUNAVIR) 100 mg per mL oral suspension is a white to off-white opaque liquid supplied in amber-colored multiple-dose bottles containing 100 mg of
DARUNAVIR per mL packaged with a 6 mL oral dosing syringe with 0.2 mL gradations. PREZISTA ® (
DARUNAVIR) 75 mg tablets are supplied as white, caplet-shaped, film-coated tablets debossed with "75" on one side and "TMC" on the other side. PREZISTA ® (
DARUNAVIR) 150 mg tablets are supplied as white, oval-shaped, film-coated tablets debossed with "150" on one side and "TMC" on the other side. PREZISTA ® (
DARUNAVIR) 600 mg tablets are supplied as orange, oval-shaped, film-coated tablets debossed with "600MG" on one side and "TMC" on the other side. PREZISTA ® (
DARUNAVIR) 800 mg tablets are supplied as dark red, oval-shaped, film-coated tablets debossed with "800" on one side and "T" on the other side. PREZISTA is packaged in bottles in the following configuration: 100 mg/mL oral suspension – 200 mL bottles (NDC 59676-565-01) 75 mg tablets — bottles of 480 (NDC 59676-563-01) 150 mg tablets — bottles of 240 (NDC 59676-564-01) 600 mg tablets — bottles of 60 (NDC 59676-562-01) 800 mg tablets — bottles of 30 (NDC 59676-566-30) Storage PREZISTA Oral Suspension Store at 25°C (77°F); with excursions permitted to 15°–30°C (59°–86°F). Do not refrigerate or freeze. Avoid exposure to excessive heat. Store in the original container. Shake well before each usage. PREZISTA Tablets Store at 25°C (77°F); with excursions permitted to 15°–30°C (59°–86°F). Keep PREZISTA out of reach of children.
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