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

janssen products, lp - ad26.cov2.s (unii: jt2ns6183b) (ad26.cov2.s - unii:jt2ns6183b) - janssen covid-19 vaccine is authorized for use under an emergency use authorization (eua) for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 18 years of age and older for whom other fda-authorized or approved covid-19 vaccines are not accessible or clinically appropriate, and in individuals 18 years of age and older who elect to receive the janssen covid-19 vaccine because they would otherwise not receive a covid-19 vaccine. do not administer the janssen covid-19 vaccine to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the janssen covid-19 vaccine [see description (13)] . do not administer the janssen covid-19 vaccine to individuals with a history of thrombosis with thrombocytopenia following the janssen covid-19 vaccine or any other adenovirus-vectored covid-19 vaccine (e.g., astrazeneca's covid-19 vac

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

janssen products, lp - bedaquiline fumarate (unii: p04qx2c1a5) (bedaquiline - unii:78846i289y) - bedaquiline 100 mg - sirturo is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary multi-drug resistant tuberculosis (mdr-tb). reserve sirturo for use when an effective treatment regimen cannot otherwise be provided. this indication is approved under accelerated approval based on time to sputum culture conversion [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. limitations of use: - do not use sirturo for the treatment of: latent infection due to mycobacterium tuberculosis drug-sensitive tuberculosis extra-pulmonary tuberculosis infections caused by non-tuberculous mycobacteria - latent infection due to mycobacterium tuberculosis - drug-sensitive tuberculosis - extra-pulmonary tuberculosis - infections caused by non-tuberculous myco

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

janssen products, lp - erythropoietin (unii: 64fs3bfh5w) (erythropoietin - unii:64fs3bfh5w) - erythropoietin 2000 [iu] in 1 ml - procrit is indicated for the treatment of anemia due to chronic kidney disease (ckd), including patients on dialysis and not on dialysis to decrease the need for red blood cell (rbc) transfusion. procrit is indicated for the treatment of anemia due to zidovudine administered at ≤ 4200 mg/week in patients with hiv-infection with endogenous serum erythropoietin levels of ≤ 500 munits/ml. procrit is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. procrit is indicated to reduce the need for allogeneic rbc transfusions among patients with perioperative hemoglobin > 10 to ≤ 13 g/dl who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. procrit is not indicated for patients who are willing to donate autologous blood pre-operatively. procrit has not been shown to improve quali

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

janssen products lp - darunavir (unii: yo603y8113) (darunavir - unii:yo603y8113), cobicistat (unii: lw2e03m5pg) (cobicistat - unii:lw2e03m5pg), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir alafenamide (unii: el9943ag5j) (tenofovir anhydrous - unii:w4hfe001u5) - symtuza is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and pediatric patients weighing at least 40 kg: - who have no prior antiretroviral treatment history or - who are virologically suppressed (hiv-1 rna less than 50 copies per ml) on a stable antiretroviral regimen for at least 6 months and have no known substitutions associated with resistance to darunavir or tenofovir. darunavir and cobicistat are both inhibitors of the cytochrome p450 3a (cyp3a) isoform. symtuza 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 symtuza with cyp3a inducers is expected to lower plasma concentrations of darunavir and cobicistat which may lead to loss of efficacy

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

Australia - English - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - abiraterone acetate, quantity: 500 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; sodium lauryl sulfate; silicified microcrystalline cellulose; hypromellose; magnesium stearate; silicon dioxide; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - janssen abiraterone is indicated in combination with prednisone or prednisolone for the treatment of: ? newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (adt), or ? patients with metastatic advanced prostate cancer (castration resistant prostate cancer, mcrpc) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (adt) or ? patients with mcrpc who have received prior chemotherapy containing a taxane.

Australia - English - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - abiraterone acetate, quantity: 250 mg - tablet - excipient ingredients: colloidal anhydrous silica; povidone; microcrystalline cellulose; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; croscarmellose sodium - janssen abiraterone is indicated in combination with prednisone or prednisolone for the treatment of: ? newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (adt), or ? patients with metastatic advanced prostate cancer (castration resistant prostate cancer, mcrpc) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (adt) or ? patients with mcrpc who have received prior chemotherapy containing a taxane.

Australia - English - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - apalutamide, quantity: 60 mg - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; hypromellose acetate succinate; croscarmellose sodium; silicified microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; iron oxide black - janssen apalutamide (apalutamide) is indicated for the treatment of patients with: ? metastatic castration-sensitive prostate cancer (mcspc) or ? non-metastatic, castration-resistant prostate cancer (nmcrpc).

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

janssen pharmaceutica n.v. - imazalil present as imazalil sulphate; pyrimethanil - suspension concentrate - imazalil present as imazalil sulphate imidazole active 200.0 g/l; pyrimethanil pyrimidine active 200.0 g/l - fungicide - citrus | grapefruit | lemon | lime | mandarin | orange - blue and green moulds

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

janssen pharmaceutica n.v. - imazalil present as the sulfate - water soluble granules - imazalil present as the sulfate imidazole active 750.0 g/kg - fungicide - citrus - post-harvest dip | potato tuber - blue mould on citrus - p. italicum | fusarium dry rot | gangrene - phoma exigua | green mould | silver scurf