Ástralía - enska - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - tenofovir alafenamide, quantity: 10 mg; darunavir, quantity: 800 mg; cobicistat, quantity: 150 mg; emtricitabine, quantity: 200 mg - tablet, film coated - excipient ingredients: magnesium stearate; croscarmellose sodium; silicon dioxide; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - symtuza is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg). genotypic testing should guide the use of symtuza (see section 4.2 dose and method of administration, section 4.4 special warnings and precautions for use and section 5.1 pharmacodynamic properties).

Evrópusambandið - enska - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir, cobicistat, emtricitabine, tenofovir alafenamide - hiv infections - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - symtuza is indicated for the treatment of human immunodeficiency virus type 1 (hiv‑1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg).genotypic testing should guide the use of symtuza.

Evrópusambandið - hollenska - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir, cobicistat, emtricitabine, tenofovir alafenamide - hiv-infecties - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - symtuza is geïndiceerd voor de behandeling van infectie met het humaan immunodeficiëntievirus type 1 (hiv-1) bij volwassenen en adolescenten (12 jaar en ouder met een lichaamsgewicht van ten minste 40 kg). genotypic testing should guide the use of symtuza.

Evrópusambandið - búlgarska - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir, кобицистат, emtricitabine, tenofovir alafenamide - ХИВ инфекции - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - symtuza е показан за лечение на човешкия имунодефицитен вирус тип 1 инфекция (hiv‑1) при възрастни и юноши (на възраст 12 години и повече с тяло тегло поне 40 кг). genotypic testing should guide the use of symtuza.

Bandaríkin - enska - 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

Evrópusambandið - maltneska - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir, kobikistat, emtricitabine, tenofovir alafenamide - infezzjonijiet ta 'hiv - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - symtuza huwa indikat għat-trattament tal-virus ta ' immunodefiċjenza umani tat-tip 1 (hiv‑1) infezzjoni fl-adulti u l-adolexxenti (età 12-il sena u aktar antiki mal-korp tal-mill-inqas 40 kg piż). genotypic testing should guide the use of symtuza.

Evrópusambandið - litháíska - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir, cobicistat, emtricitabine, tenofovir alafenamide - Živ infekcijos - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - simtuza skiriama 1 tipo žmogaus imunodeficito viruso (Živ-1) infekcijos gydymui suaugusiesiems ir paaugliams (12 metų ir vyresniems vaikams, kurių kūno svoris ne mažesnis kaip 40 kg). genotypic testing should guide the use of symtuza.

Evrópusambandið - danska - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir, cobicistat, emtricitabine, tenofovir alafenamide - hiv infektioner - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - symtuza er indiceret til behandling af infektion med human immunodeficiency virus type 1 (hiv-1) hos voksne og unge (i alderen 12 år og ældre med kropsvægt mindst 40 kg). genotypic testing should guide the use of symtuza.

Evrópusambandið - franska - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir, le cobicistat, l'emtricitabine, ténofovir alafenamide - infections au vih - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - symtuza est indiqué pour le traitement de l'infection par le virus de l'immunodéficience humaine de type 1 (vih-1) chez les adultes et les adolescents (âgés de 12 ans et plus ayant un poids corporel d'au moins 40 kg). genotypic testing should guide the use of symtuza.

Evrópusambandið - hollenska - EMA (European Medicines Agency)

krka, d.d., novo mesto - emtricitabine, tenofovir disoproxil succinaat - hiv-infecties - antivirale middelen voor systemisch gebruik - emtricitabine / tenofovir disoproxil krka d. is geïndiceerd voor antiretrovirale combinatietherapie voor de behandeling van met hiv-1 geïnfecteerde volwassenen. emtricitabine / tenofovir disoproxil krka d. is ook geïndiceerd voor de behandeling van hiv-1 geïnfecteerde adolescenten, met nrti weerstand of vergiftigingen zich verzet tegen het gebruik van de eerste lijn agenten, in de leeftijd van 12 tot < 18 jaar.