Yhdysvallat - englanti - NLM (National Library of Medicine)

remedyrepack inc. - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), rilpivirine hydrochloride (unii: 212wax8kdd) (rilpivirine - unii:fi96a8x663), tenofovir alafenamide fumarate (unii: fwf6q91tzo) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine 200 mg - odefsey is indicated as a complete regimen for the treatment of hiv-1 infection in adult and pediatric patients weighing at least 35 kg: - as initial therapy in those with no antiretroviral treatment history with hiv-1 rna less than or equal to 100,000 copies per ml or - to replace a stable antiretroviral regimen in those who are virologically-suppressed (hiv-1 rna less than 50 copies per ml) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of odefsey [see microbiology (12.4) and clinical studies (14)]. : limitations of use : - more rilpivirine-treated subjects with no antiretroviral treatment history with hiv-1 rna greater than 100,000 copies/ml at the start of therapy experienced virologic failure (hiv-1 rna ≥ 50 copies/ml) compared to rilpivirine-treated subjects with hiv-1 rna less than or equal to 100,000 copies/ml [see clinical studies (14.2, 14.3)]. more rilpivirine-treated subjects with no antiretroviral t

Yhdysvallat - englanti - NLM (National Library of Medicine)

gilead sciences, inc. - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), rilpivirine hydrochloride (unii: 212wax8kdd) (rilpivirine - unii:fi96a8x663), tenofovir alafenamide fumarate (unii: fwf6q91tzo) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine 200 mg - odefsey is indicated as a complete regimen for the treatment of hiv-1 infection in adult and pediatric patients weighing at least 35 kg: - as initial therapy in those with no antiretroviral treatment history with hiv-1 rna less than or equal to 100,000 copies per ml or - to replace a stable antiretroviral regimen in those who are virologically-suppressed (hiv-1 rna less than 50 copies per ml) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of odefsey [see microbiology (12.4) and clinical studies (14)]. limitations of use: - more rilpivirine-treated subjects with no antiretroviral treatment history with hiv-1 rna greater than 100,000 copies/ml at the start of therapy experienced virologic failure (hiv-1 rna ≥ 50 copies/ml) compared to rilpivirine-treated subjects with hiv-1 rna less than or equal to 100,000 copies/ml [see clinical studies (14.2,14.3)]. odefsey is contraindicated when coadministered with the followin

Israel - englanti - Ministry of Health

gilead sciences israel ltd - emtricitabine; tenofovir alafenamide fumarate - film coated tablets - tenofovir alafenamide fumarate 10 mg; emtricitabine 200 mg - tenofovir disoproxil and emtricitabine - descovy is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus type 1 (hiv 1).

Israel - englanti - Ministry of Health

gilead sciences israel ltd - emtricitabine; tenofovir alafenamide fumarate - film coated tablets - tenofovir alafenamide fumarate 10 mg; emtricitabine 200 mg - tenofovir disoproxil and emtricitabine - descovy is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus type 1 (hiv 1).בקשה לשינוי התוויה: 14/8/19addition of new info to posology section: patients undergoing haemodialysis

Israel - englanti - Ministry of Health

gilead sciences israel ltd - emtricitabine; tenofovir alafenamide fumarate - film coated tablets - tenofovir alafenamide fumarate 25 mg; emtricitabine 200 mg - tenofovir disoproxil and emtricitabine - descovy is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus type 1 (hiv 1).

Israel - englanti - Ministry of Health

gilead sciences israel ltd - emtricitabine; tenofovir alafenamide fumarate - film coated tablets - tenofovir alafenamide fumarate 25 mg; emtricitabine 200 mg - tenofovir disoproxil and emtricitabine - descovy is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus type 1 (hiv 1).בקשה לשינוי התוויה: 14/8/19addition of new info to posology section: patients undergoing haemodialysis

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

arrotex pharmaceuticals pty ltd - tenofovir disoproxil fumarate, quantity: 300 mg - tablet - excipient ingredients: hyprolose; hypromellose; indigo carmine aluminium lake; lactose; colloidal anhydrous silica; calcium stearate; titanium dioxide; crospovidone; macrogol 8000 - tenofovir disoproxil fumarate in combination with other antiretroviral agents is indicated for the treatment of hiv-infected adults and paediatric patients 12 years of age and older.,tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis b in adults (see clinical trials).,tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis b in paediatric patients 12 years of age and older with compensated liver disease and with evidence of immune active disease, i.e. active viral replication, persistently elevated serum alt levels or evidence of active inflammation.

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

arrotex pharmaceuticals pty ltd - tenofovir disoproxil fumarate, quantity: 300 mg - tablet - excipient ingredients: lactose; crospovidone; colloidal anhydrous silica; hypromellose; hyprolose; indigo carmine aluminium lake; titanium dioxide; calcium stearate; macrogol 8000 - tenofovir disoproxil fumarate in combination with other antiretroviral agents is indicated for the treatment of hiv-infected adults and paediatric patients 12 years of age and older.,tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis b in adults (see clinical trials).,tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis b in paediatric patients 12 years of age and older with compensated liver disease and with evidence of immune active disease, i.e. active viral replication, persistently elevated serum alt levels or evidence of active inflammation.

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

gilead sciences pty ltd - tenofovir disoproxil fumarate, quantity: 300 mg; emtricitabine, quantity: 200 mg; elvitegravir, quantity: 150 mg; cobicistat, quantity: 150 mg - tablet, film coated - excipient ingredients: hyprolose; lactose monohydrate; microcrystalline cellulose; silicon dioxide; croscarmellose sodium; magnesium stearate; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake - stribild is indicated as a single tablet regimen for the treatment of hiv infection in treatment-na?ve adults. stribild is also indicated in certain virologically suppressed (hiv1 rna <50 copies/ml) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see clinical trials). patients must not have a history of treatment failure or known mutations associated with resistance to the antiretroviral components of stribild (tenofovir df, emtricitabine or elvitegravir). stribild is a fixed dose combination of one integrase inhibitor, one pharmacokinetic enhancer and two nucleos(t)ide hiv-1 reverse transcriptase inhibitors.

Yhdistynyt kuningaskunta - englanti - MHRA (Medicines & Healthcare Products Regulatory Agency)

gilead sciences international ltd - emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate - tablet - 200mg ; 25mg ; 245mg