New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - darunavir ethanolate 162.52mg equivalent to darunavir 150 mg - film coated tablet - 150 mg - active: darunavir ethanolate 162.52mg equivalent to darunavir 150 mg excipient: colloidal silicon dioxide crospovidone magnesium stearate opadry white 85f18422 purified water silicified microcrystalline cellulose - adult patients: prezista (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adult patients.

United States - English - NLM (National Library of Medicine)

state of florida doh central pharmacy - darunavir ethanolate (unii: 33o78xf0bw) (darunavir - unii:yo603y8113) - darunavir ethanolate 400 mg - prezista® , co-administered with ritonavir (prezista/ritonavir), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection. this indication is based on analyses of plasma hiv rna levels and cd4+ cell counts from 2 controlled phase 3 trials of 48 weeks duration in antiretroviral treatment-naïve and treatment-experienced patients and 2 controlled phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients. prezista, co-administered with ritonavir (prezista/ritonavir), and with other antiretroviral agents, is indicated for the treatment of hiv infection in pediatric patients 6 years of age and older [see use in specific populations (8.4) ]. this indication is based on 24-week analyses of plasma hiv rna levels and cd4+ cell counts from an open-label phase 2 trial in antiretroviral treatment-experienced pediatric patients 6 to < 18 years of age. in treatment-experienced adult and pediatric patients, the following poi

Canada - English - Health Canada

auro pharma inc - darunavir (darunavir propylene glycolate) - tablet - 400mg - darunavir (darunavir propylene glycolate) 400mg - hiv protease inhibitors

Canada - English - Health Canada

auro pharma inc - darunavir (darunavir propylene glycolate) - tablet - 600mg - darunavir (darunavir propylene glycolate) 600mg - hiv protease inhibitors

Canada - English - Health Canada

auro pharma inc - darunavir (darunavir propylene glycolate) - tablet - 800mg - darunavir (darunavir propylene glycolate) 800mg - hiv protease inhibitors

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - darunavir ethanolate (unii: 33o78xf0bw) (darunavir - unii:yo603y8113) - darunavir 600 mg - 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)] . co-administration of prezista/ritonavir is contraindicated with drugs that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index). these drugs and other contraindicated drugs (which may lead to reduced efficacy of darunavir) are listed in table 6 . due to the need for co-administration of prezista with ritonavir, please refer to ritonavir prescribing information for a description of ritonavir contraindications. co-administration of prezista/ritonavir is contraindicated with drugs that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - darunavir ethanolate (unii: 33o78xf0bw) (darunavir - unii:yo603y8113), cobicistat (unii: lw2e03m5pg) (cobicistat - unii:lw2e03m5pg) - darunavir 800 mg - prezcobix ® is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions (v11i, v32i, l33f, i47v, i50v, i54l, i54m, t74p, l76v, i84v, l89v). prezcobix is contraindicated in patients receiving the following co-administered drugs prezcobix is contraindicated in patients receiving the following co-administered drugs [see drug interactions (7.3) and clinical pharmacology (12.3)]. - alpha 1-adrenoreceptor antagonist: alfuzosin - anticonvulsants: carbamazepine, phenobarbital, phenytoin - anti-gout: colchicine, in patients with renal and/or hepatic impairment - antimycobacterial: rifampin - antipsychotics: lurasidone, pimozide - cardiac disorders: dronedarone, ivabradine, ranolazinecardiac disorders: dronedarone, ivabradine, ranolazine - ergot derivatives, e.g. dihydroergotamine, ergotamine, methylergonovine - gi motility agent: cisapride - he

United States - English - NLM (National Library of Medicine)

janssen products lp - darunavir ethanolate (unii: 33o78xf0bw) (darunavir - unii:yo603y8113) - darunavir 75 mg - 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)] . co-administration of prezista/ritonavir is contraindicated with drugs that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index). examples of these drugs and other contraindicated drugs (which may lead to reduced efficacy of darunavir) are listed below [see drug interactions (7.3)] . due to the need for co-administration of prezista with ritonavir, please refer to ritonavir prescribing information for a description of ritonavir contraindications. - alpha 1-adrenoreceptor antagonist: alfuzosin - anti-gout: colchicine, in patients with renal a

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - darunavir ethanolate (unii: 33o78xf0bw) (darunavir - unii:yo603y8113) - darunavir 400 mg - prezista® , co-administered with ritonavir (prezista/ritonavir), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection. this indication is based on analyses of plasma hiv-1 rna levels and cd4+ cell counts from 2 controlled phase 3 trials of 48 weeks duration in antiretroviral treatment-naïve and treatment-experienced patients and 2 controlled phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients. prezista, co-administered with ritonavir (prezista/ritonavir), and with other antiretroviral agents, is indicated for the treatment of hiv-1 infection in pediatric patients 3 years of age and older [see use in specific populations (8.4) ]. this indication is based on 24-week analyses of plasma hiv-1 rna levels and cd4+ cell counts from 2 open-label phase 2 trials in antiretroviral treatment-experienced pediatric patients (one trial in patients 6 to less than 18 years of age and one trial in patients 3 to less t

United States - English - NLM (National Library of Medicine)

janssen products lp - darunavir ethanolate (unii: 33o78xf0bw) (darunavir - unii:yo603y8113), cobicistat (unii: lw2e03m5pg) (cobicistat - unii:lw2e03m5pg) - darunavir 800 mg - prezcobix is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in treatment-naïve and treatment-experienced adults and pediatric patients weighing at least 40 kg with no darunavir resistance-associated substitutions (v11i, v32i, l33f, i47v, i50v, i54l, i54m, t74p, l76v, i84v, l89v). darunavir and cobicistat are both inhibitors of the cytochrome p450 3a (cyp3a) isoform. prezcobix should not be co-administered with medicinal products that are highly dependent on cyp3a for clearance and for which increased plasma concentrations are associated with serious and/or life threatening events (narrow therapeutic index). darunavir and cobicistat are both substrates of the cytochrome p450 3a (cyp3a) isoform. co-administration of prezcobix with cyp3a inducers may lead to lower exposures of darunavir and cobicistat and potential loss of efficacy of darunavir and possible resistance. examples of drugs that are contraindicated for co-administration w