natgillin/translations-raw huggingface dataset:
Patienter med kronisk hepatitis B eller C, som er behandlet med antiretroviral kombinationsbehandling, har øget risiko for svære og potentielt dødelige leverbivirkninger (se pkt.
Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions (see section 4.8).
Eksponering af clarithromycin forventes at stige ved samtidig administration af EVOTAZ.
Exposure to clarithromycin is expected to increase if co-administered with EVOTAZ.
Cobicistat Cobicistat er ikke undersøgt hos patienter med svært nedsat leverfunktion (Child-Pugh klasse C).
Cobicistat Cobicistat has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Atazanavir bør anvendes med forsigtighed hos patienter med let (Child-Pugh klasse A) nedsat leverfunktion.
Atazanavir should be used with caution in patients with mild (Child-Pugh Class A) hepatic impairment.
Cobicistat er en selektiv, mekanisme-baseret hæmmer af cytokrom P450 fra CYP3A-undergruppen.
Cobicistat is a selective, mechanism-based inhibitor of cytochromes P450 of the CYP3A subfamily.
AUC: ↔ Cmax: ↑41% Cmin: ikke bestemt
Cmax: ↑41% Cmin: not determined
Da EVOTAZ indeholder atazanavir og cobicistat, kan der forventes bivirkninger, som er associeret med hver enkelt af de to indholdsstoffer.
As EVOTAZ contains atazanavir and cobicistat, the adverse reactions associated with each of the individual components may be expected.
Udslæt er ofte lette til moderate makulopapuløse huderuptioner, der optræder inden for de første 3 uger efter påbegyndelse af behandling med atazanavir.
Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first 3 weeks of starting therapy with atazanavir.
Dosisjustering af cobicistat er ikke nødvendig hos patienter med let eller moderat nedsat leverfunktion.
No dose adjustment of cobicistat is required in patients with mild or moderate hepatic impairment.
Luftveje, thorax og mediastinum ikke almindelig dyspnø
Respiratory, thoracic and mediastinal disorders uncommon dyspnoea
Der blev ikke observeret nogen betydningsfulde forskelle i farmakokinetikken for cobicistat hos personer med svært nedsat nyrefunktion og hos raske personer, hvilket er i overensstemmelse med cobicistats lave nyreclearance.
No meaningful differences in cobicistat pharmacokinetics were observed between subjects with severe renal impairment and healthy subjects, consistent with low renal clearance of cobicistat.
Samtidig brug af EVOTAZ og fluticason, eller andre glukokortikoider, som metaboliseres af CYP3A4, frarådes, medmindre de potentielle fordele ved behandlingen opvejer risikoen for systemiske bivirkninger forårsaget af kortikosteroider, herunder Cushings syndrom og binyrebarksuppression (se pkt.
Concomitant use of EVOTAZ and fluticasone or other glucocorticoids that are metabolized by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression (see section 4.5).
Samtidig administration af EVOTAZ kan medføre højere koncentration af salmeterol og øget risiko for salmeterol-relaterede bivirkninger.
Co-administration with EVOTAZ may result in increased concentrations of salmeterol and an increase in salmeterol-associated adverse events.
Cobicistat har vist sig at nedsætte estimeret kreatininclearance på grund af hæmningen af tubulær kreatininudskillelse uden påvirkning af den egentlige renale glomerulære funktion.
Cobicistat has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine without affecting actual renal glomerular function.
Klinisk monitorering anbefales, når dabigatran administreres med P-gp-hæmmere.
Clinical monitoring is recommended when dabigatran is co-administered with P-gp inhibitors.
Et farmakokinetikstudie af cobicistat blev udført hos ikke-hiv-1-inficerede personer med moderat nedsat leverfunktion (Child-Pugh klasse B).
A study of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with moderate hepatic impairment (Child-Pugh Class B).
Didanosin (med mad) Didanosin AUC ↓34% (↓40%
Didanosine (with food) Didanosine AUC ↓34% (↓40%
Buprenorphin AUC: ↑35% Buprenorphin Cmax: ↑66% Buprenorphin Cmin: ↑12%
Buprenorphine AUC: ↑35% Buprenorphine Cmax: ↑66% Buprenorphine Cmin: ↑12%
Ved uge 48 og 144 i studie GS-US-216-0114 var gennemsnitlig stigning fra baseline i CD4+ celletal henholdsvis 213 og 310 celler/mm3 hos patienter, der fik atazanavir boostet med cobicistat og henholdsvis 219 og 332 celler/mm3 hos patienter, der fik atazanavir boostet med ritonavir.
In study GS-US-216-0114, the mean increase from baseline in CD4+ cell count at weeks 48 and 144 were 213 and 310 cells/mm3 in patients receiving atazanavir boosted with cobicistat and 219 and 332 cells/mm3 in patients receiving atazanavir boosted with ritonavir, respectively.
Hos raske forsøgspersoner er en EVOTAZ tablet bioækvivalent med 1 atazanavir kapsel (300 mg) plus 1 cobicistat tablet (150 mg) efter en enkelt oral dosis sammen med et let måltid (n=62).
One EVOTAZ tablet is bioequivalent to one atazanavir capsule (300 mg) plus one cobicistat tablet (150 mg) following single oral dose administration with a light meal in healthy subjects (n=62).
Rosuvastatin AUC: ↑ 242% Rosuvastatin Cmax: ↑ 958% Rosuvastatin Cmin: Ikke beregnet
Rosuvastatin AUC: ↑ 242% Rosuvastatin Cmax: ↑ 958% Rosuvastatin Cmin: Not calculated
Samtidig administration af nevirapin og EVOTAZ forventes at øge nevirapin plasmakoncentrationerne, som kan øge risikoen for nevirapin-associeret toksicitet (se pkt.
Co-administration of nevirapine and EVOTAZ is expected to increase nevirapine plasma concentrations which may increase the risk of nevirapine-associated toxicity (see section 4.4).
Samtidig administration af EVOTAZ og rifabutin frarådes.
Co-administration of EVOTAZ and rifabutin is not recommended.
Blandt behandlingserfarne patienter som fik atazanavir 300 mg én gang dagligt med 100 mg ritonavir én gang dagligt i gennemsnitligt 95 uger, havde 53% grad 3-4 forhøjelse af total-bilirubin.
Among experienced patients treated with atazanavir 300 mg once daily with 100 mg ritonavir once daily for a median duration of 95 weeks, 53% had Grade 3-4 total bilirubin elevations.
Samtidig administration af boceprevir og EVOTAZ frarådes.
Co-administration of boceprevir and EVOTAZ is not recommended.
Digoxin (0,5 mg som enkeltdosis)/cobicistat (150 mg gentagne doser)
Digoxin (0.5 mg single dose)/cobicistat (150 mg multiple doses)
PDE5-hæmmere
PDE5 Inhibitors
Patienterne blev randomiseret i forholdet 1:1 til at modtage enten atazanavir 300 mg + cobicistat 150 mg én gang dagligt eller atazanavir 300 mg + ritonavir 100 mg én gang dagligt, begge administreret med en fastdosisbehandlingsplan, der indeholdt tenofovir DF 300 mg og emtricitabin 200 mg administreret som en fastdosiskombinationstablet.
Patients were randomised in a 1:1 ratio to receive either atazanavir 300 mg with cobicistat 150 mg once daily or atazanavir 300 mg with ritonavir 100 mg once daily, each administered with a fixed background regimen containing tenofovir DF 300 mg and emtricitabine 200 mg administered as a fixed-dose combination tablet.
Patienter i behandling med EVOTAZ, som har forhøjede levertransaminaser og forhøjet bilirubin samtidig, bør evalueres for alternative ætiologier.
Hepatic transaminase elevations that occur with elevated bilirubin in patients receiving EVOTAZ should be evaluated for alternative etiologies.
Se produktresuméet for maraviroc for yderligere oplysninger.
For further details, consult the Summary of Product Characteristics for maraviroc.
ANTINEOPLASTISKE OG IMMUNSUPRIMERENDE MIDLER
ANTINEOPLASTICS AND IMMUNOSUPRESSANTS
KORTIKOSTEROIDER
CORTICOSTEROIDS
Glecaprevir AUC: ↑553% (↑424% Glecaprevir Cmax: ↑306% (↑215% Glecaprevir Cmin: ↑1330% (↑885% Pibrentasvir AUC: ↑64% (↑48% Pibrentasvir Cmax: ↑29% (↑15% Pibrentasvir Cmin: ↑129% (↑95% Atazanavir AUC: ↑11% (↑3% Atazanavir Cmax: ↔ 0% (↓ Atazanavir Cmin: ↑16% (↑7% * Der er rapporteret effekt af atazanavir og ritonavir på den første dosis af glecaprevir og pibrentasvir.
Glecaprevir AUC : ↑553% Glecaprevir Cmax : ↑306% (↑215% Glecaprevir Cmin : ↑1330% (↑885% Pibrentasvir AUC : ↑64% (↑48% Pibrentasvir Cmax : ↑29% (↑15% Pibrentasvir Cmin: ↑129% (↑95% Atazanavir AUC : ↑11% (↑3% Atazanavir Cmax : ↔ 0% (↓ Atazanavir Cmin: ↑16% (↑7% * Effect of atazanavir and ritonavir on the first dose of glecaprevir and pibrentasvir is reported.
Drospirenon AUC: ↑ 130% Drospirenon Cmax: ↔ Drospirenon Cmin: Ikke beregnet
Drospirenone AUC: ↑ 130% Drospirenone Cmax: ↔ Drospirenone Cmin: Not calculated
Atorvastatin AUC: ↑ 822% Atorvastatin Cmax: ↑ 1785% Atorvastatin Cmin: Ikke beregnet
Atorvastatin AUC: ↑ 822% Atorvastatin Cmax: ↑ 1785% Atorvastatin Cmin: Not calculated
Samtidig administration af nevirapin og cobicistat forventes at nedsætte cobicistat plasmakoncentrationerne, mens nevirapin plasmakoncentrationerne kan øges.
Co-administration of nevirapine and cobicistat is expected to decrease cobicistat plasma concentrations while nevirapine plasma concentrations may be increased.
Hvis du har glemt at tage en dosis i 12 timer eller længere efter det tidspunkt, du normalt tager EVOTAZ, skal du ikke tage den glemte dosis.
If you miss a dose and it is more than 12 hours from the time you should have taken EVOTAZ, do not take the missed dose.
Eftersom atazanavir og cobicistat i udstrakt grad bindes til plasmaproteiner, er det ikke sandsynligt, at de vil fjernes i signifikant grad ved hæmodialyse eller peritonealdialyse (se pkt.
As atazanavir and cobicistat are highly bound to plasma proteins, it is unlikely that they will be significantly removed by haemodialysis or peritoneal dialysis (see sections 4.2 and 5.2).
Klinisk monitorering anbefales ved samtidig administration med EVOTAZ.
Clinical monitoring is recommended upon co-administration with EVOTAZ.
Anvendelse af andre antitrombotiske midler, som ikke påvirkes af CYP-hæmning ellerinduktion (f.eks. prasugrel) anbefales (se pkt.
Use of other antiplatelets not affected by CYP inhibition or induction (e.g. prasugrel) is recommended (see section 4.3).
Telaprevir 750 mg tre gange dagligt (cobicistat 150 mg én gang dagligt i kombination med elvitegravir)
Telaprevir 750 mg three times daily (cobicistat 150 mg once daily in combination with elvitegravir)
Cobicistats aktivitet som farmakokinetisk forstærker er påvist i farmakokinetiske forsøg.
The activity of cobicistat as a pharmacokinetic enhancer to atazanavir has been demonstrated in pharmacokinetic trials.
Indinavir er associeret med indirekte ukonjugeret hyperbilirubinæmi pga. UGT-hæmning.
Indinavir is associated with indirect unconjugated hyperbilirubinaemia due to inhibition of UGT.
Lægemidler, der påvirker atazanavir/cobicistat-eksponering Atazanavir metaboliseres i leveren via CYP3A4.
Medicinal products that affect atazanavir/cobicistat exposure Atazanavir is metabolised in the liver through CYP3A4.
Tenofoviralafenamid AUC ↑75% (↑55% ↑98%) Cmax ↑80% (↑48% ↑118%)
Tenofovir alafenamide AUC ↑75% (↑55% ↑98%) Cmax ↑80% (↑48% ↑118%)
I hunmus var atazanavir-eksponering ved en dosis, der frembragte enkeltcellenekrose, 12 gange optagelsen hos mennesker, der havde fået 400 mg én gang dagligt.
In female mice, atazanavir exposure at a dose that produced single-cell necrosis was 12 times the exposure in humans given 400 mg once daily.
I løbet af de 144 ugers behandling i studie GS-US-216-0114 var hyperbilirubinæmi (> 1 x ULN) almindelig: 7% i cobicistat-boostet atazanavir plus emtricitabin og tenofovir DF i fastdosiskombination-gruppen og 97,4% i ritonavir-boostet atazanavir plus emtricitabin og tenofovir DF i fastdosiskombination-gruppen.
In study GS-US-216-0114, through 144 weeks of treatment hyperbilirubinaemia (> 1 x ULN) was common: 97.7% in the atazanavir boosted with cobicistat plus emtricitabine and tenofovir DF fixed-dose combination group, and 97.4% in the atazanavir boosted with ritonavir plus emtricitabine and tenofovir DF fixed-dose combination group.
Atazanavir med cobicistat
Atazanavir with cobicistat
I disse farmakokinetiske forsøg var eksponering for atazanavir 300 mg med cobicistat 150 mg den samme som eksponeringen, når det blev boostet med ritonavir 100 mg. EVOTAZ er bioækvivalent med atazanavir 300 mg 1 gang dagligt i kombination med cobicistat 150 mg 1 gang dagligt administreret som enkeltdosis (se pkt.
In these pharmacokinetic trials, the exposure of atazanavir 300 mg with cobicistat 150 mg was consistent with that observed when boosted with ritonavir 100 mg. EVOTAZ is bioequivalent to atazanavir 300 mg once daily in combination with cobicistat 150 mg once daily coadministered as single agents (see section 5.2).
Rifampicin nedsætter i væsentlig grad plasmakoncentrationerne af atazanavir, hvilket kan medføre tab af EVOTAZ's terapeutiske effekt og udvikling af resistens over for atazanavir.
Rifampicin substantially decreases plasma concentrations of atazanavir, which may result in loss of therapeutic effect of EVOTAZ and development of resistance to atazanavir.
Denne indlægsseddel blev senest ændret <{MM/ÅÅÅÅ}> <{måned ÅÅÅÅ}.>
This leaflet was last revised in.
Denne effekt kan skyldes CYP3A4induktion.
This effect may be due to an induction of CYP3A4.
Øget monitorering for bivirkninger anbefales.
Increase monitoring for adverse reactions.
Samtidig brug af EVOTAZ og kortikosteroider, der metaboliseres via CYP3A (f.eks. fluticasonpropionat eller andre inhalerede eller nasale kortikosteroider) kan øge risikoen for udvikling af systemiske kortikosteroidvirkninger, herunder Cushings syndrom og binyrebarksuppression.
Concomitant use of EVOTAZ and corticosteroids that are metabolised by CYP3A (e.g. fluticasone propionate or other inhaled or nasal corticosteroids) may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Lægemidler, der kan påvirkes af atazanavir/cobicistat Atazanavir er en CYP3A4- og UGT1A1-hæmmer.
Medicinal products that may be affected by atazanavir/cobicistat Atazanavir is an inhibitor of CYP3A4 and UGT1A1.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukket tablet indeholder atazanavirsulfat svarende til 300 mg atazanavir og 150 mg cobicistat.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains atazanavir sulphate corresponding to 300 mg atazanavir and 150 mg of cobicistat.
Mave-tarm-kanalen meget almindelig kvalme almindelig opkastning, diarre, dyspepsi, mavesmerter, abdominal distension, flatulens, mundtørhed ikke almindelig pankreatitis, gastritis, aftøsstomatitis
Gastrointestinal disorders very common nausea common vomiting, diarrhoea, dyspepsia, abdominal pain, abdominal distension, flatulence, dry mouth uncommon pancreatitis, gastritis, stomatitis aphthous
Der foreligger ingen farmakokinetiske data for atazanavir i kombination med cobicistat hos patienter med nyreinsufficiens.
There are no pharmacokinetic data available for atazanavir in combination with cobicistat in patients with renal insufficiency.
Laboratoriemæssige anormaliteter
Laboratory abnormalities
Atazanavir med cobicistatf
Atazanavir with cobicistatf
Kontakt lægen, hvis du lægger mærke til ændringer i dit helbred.
Tell your doctor if you notice anything unusual about your health.
Der er utilstrækkelige kliniske data fra anvendelsen af cobicistat til gravide kvinder.
There are limited clinical data with cobicistat in pregnant women.
Plasmakoncentrationerne af atazanavir kan falde pga. gastrisk pH-stigning, hvis antacida, inklusive lægemidler med buffer, administreres samtidigt med EVOTAZ.
Reduced plasma concentrations of atazanavir may be the consequence of increased gastric pH if antacids, including buffered medicinal products, are administered with EVOTAZ.
Interaktionsmekanismen mellem efavirenz og atazanavir eller efavirenz og cobicistat er efavirenzs CYP3A4-induktion.
The mechanism of interaction between efavirenz and atazanavir, or efavirenz and cobicistat is CYP3A4 induction by efavirenz.
Voriconazol bør ikke administreres sammen med EVOTAZ, medmindre det vurderes, at fordel/risiko-forholdet for patienten berettiger brug af voriconazol (se pkt.
Voriconazole should not be co-administered with EVOTAZ unless the benefit/risk assessment justifies the use of voriconazole (see section 4.4).
Udslæt er ofte lette til moderate makulopapuløse huderuptioner, der optræder inden for de første 3 uger efter påbegyndelse af behandling med atazanavir, et af indholdsstofferne i EVOTAZ.
Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first 3 weeks of starting therapy with atazanavir, a component of EVOTAZ.
Der er i kliniske studier observeret dosisrelaterede, asymptomatiske forlængelser i PR-intervallet med atazanavir, som er et indholdsstof i EVOTAZ.
Dose related asymptomatic prolongations in PR interval with atazanavir, a component of EVOTAZ have been observed in clinical studies.
Hyppigere monitorering af terapeutiske koncentrationer anbefales for disse immunsuppressiva ved samtidig administration af EVOTAZ.
More frequent therapeutic concentration monitoring is recommended for immunosuppressant agents when co-administered with EVOTAZ.
Der er risiko for manglende terapeutisk effekt og resistensudvikling over for atazanavir (se pkt.
There is a risk of loss of therapeutic effect and development of resistance to atazanavir (see section 4.3).
Samtidig administration af bosentan og cobicistat kan medføre nedsatte plasmakoncentrationer.
Co-administration of bosentan with cobicistat may lead to decreased cobicistat plasma concentrations.
Interaktionsmekanismen er atazanavirs hæmning af metabolisme.
The mechanism of interaction is inhibition of metabolism by atazanavir.
Samtidig administration af EVOTAZ kan medføre øget koncentration af PDE5-hæmmeren og øget risiko for PDE5-relaterede bivirkninger, inklusive hypotension, synsforstyrrelser og priapisme.
Co-administration with EVOTAZ may result in increased concentrations of the PDE5 inhibitor and an increase in PDE5-associated adverse events, including hypotension, visual changes, and priapism.
Atazanavir og fluconazol-koncentrationer ændredes ikke signifikant ved samtidig administration af atazanavir/ritonavir og fluconazol.
Atazanavir and fluconazole concentrations were not significantly modified when atazanavir/ritonavir was co-administered with fluconazole.
EVOTAZ bør anvendes med forsigtighed til patienter med allerede eksisterende overledningsproblemer (anden grads- eller højere atrioventrikulær eller kompleks knude-grenblok), og kun såfremt fordelene opvejer risikoen (se pkt.
In patients with pre-existing conduction problems (second degree or higher atrioventricular or complex bundle-branch block), EVOTAZ should be used with caution and only if the benefits exceed the risk (see section 5.1).
Koncentrationen af fluconazol kan øges ved samtidig administration af cobicistat.
Concentration of fluconazole may be increased if co-administered with cobicistat.
EVOTAZ er en pink, oval, bikonveks, filmovertrukket tablet med omtrentlige dimensioner på 19 mm x 10,4 mm og præget med ”3641” på den ene side og glat på den anden side.
What EVOTAZ looks like and contents of the pack EVOTAZ tablets are pink, oval, biconvex, film coated tablet of approximate dimensions of 19 mm x 10.4 mm, debossed on one side with "3641" and plain-faced on the other side of the tablet.
Dosisjustering er ikke nødvendig for raltegravir ved samtidig administration med EVOTAZ.
No dose adjustment is required for raltegravir if co-administered with EVOTAZ.
EVOTAZ kan påvirke din nyrefunktion.
EVOTAZ may affect how well your kidneys work.
EVOTAZ bør anvendes med forsigtighed hos patienter med let nedsat leverfunktion.
EVOTAZ should be used with caution in patients with mild hepatic impairment.
Se produktresuméet for REYATAZ for flere oplysninger.
For more information consult the REYATAZ Summary of Product Characteristics.
EVOTAZ bør ikke initieres hos patienter med kreatininclearance under 70 ml/min, hvis en eller flere af samtidigt administrerede lægemidler dosisjusteres på baggrund af kreatininclearance (f.eks. emtricitabin, lamivudin, tenofovirdisoproxil eller adefovir; se pkt.
EVOTAZ should not be initiated in patients with creatinine clearance less than 70 ml/min if one or more co-administered agent requires dose adjustment based on creatinine clearance (e.g. emtricitabine, lamivudine, tenofovir disoproxil or adefovir; see sections 4.2, 4.8 and 5.2).
Blandt behandlingsnaive patienter, der fik atazanavir 300 mg én gang dagligt med 100 mg ritonavir én gang dagligt med en median behandlingsvarighed på 96 uger, havde 48% grad 3-4 forhøjelse af total-bilirubin (se pkt.
Among naïve patients treated with atazanavir 300 mg once daily with 100 mg ritonavir once daily for a median duration of 96 weeks, 48% had Grade 3-4 total bilirubin elevations (see section 4.4).
Samtidig administration af simvastatin eller lovastatin og EVOTAZ er kontraindiceret på grund af øget risiko for myopati, inklusive rabdomyolyse (se pkt.
Co-administration of simvastatin or lovastatin with EVOTAZ is contraindicated due to an increased risk of myopathy including rhabdomyolysis (see section 4.3).
Samtidig administration af etravirin og EVOTAZ forventes at nedsætte atazanavir- og cobicistat-plasmakoncentrationerne.
Co-administration of etravirine and EVOTAZ is expected to decrease atazanavir and cobicistat plasma concentrations.
Lever og galdeveje meget almindelig gulsot almindelig hyperbilirubinæmi ikke almindelig hepatitis, cholelithiasisa, kolestasea sjælden hepatosplenomegali, cholecystitisa
Hepatobiliary disorders very common jaundice common hyperbilirubinaemia uncommon hepatitis, cholelithiasisa, cholestasisa rare hepatosplenomegaly, cholecystitisa
Dette kan medføre tab af EVOTAZ's terapeutiske effekt og udvikling af resistens over for atazanavir (se pkt.
This may result in loss of therapeutic effect of EVOTAZ and development of resistance to atazanavir (see section 4.4).
Atazanavir metaboliseres primært via leveren, og der er observeret forhøjede plasmakoncentrationer hos patienter med nedsat leverfunktion (se pkt.
Atazanavir is primarily hepatically metabolised and increased plasma concentrations were observed in patients with hepatic impairment (see sections 4.2 and 5.2).
Koncentrationen af disse calciumkanalblokkere kan øges ved samtidig administration af EVOTAZ.
Concentrations of these calcium channel blockers may be increased when co-administered with EVOTAZ.
Samtidig administration af EVOTAZ og lægemidler, der indeholder ritonavir eller cobicistat, som er kraftige CYP3A-hæmmere, kan resultere i yderligere boosting og øget plasmakoncentration af atazanavir.
Co-administration of EVOTAZ with medicinal products containing ritonavir or cobicistat, which are strong inhibitors of CYP3A, may result in additional boosting and increased plasma concentration of atazanavir.
Nyrer og urinveje ikke almindelig nephrolithiasisa, hæmaturi, proteinuri, pollakisuri, interstitiel nefritis, kronisk nyresygdoma sjælden nyresmerter
Renal and urinary disorders uncommon nephrolithiasisa, haematuria, proteinuria, pollakiuria, interstitial nephritis, chronic kidney diseasea rare kidney pain
Mekanismen bag dette fald er ukendt (se pkt.
The mechanism of this decrease is unknown (see sections 4.2 and 4.4.)
Koncentrationen af disse sedativa/hypnotika kan øges ved samtidig administration af EVOTAZ.
Concentrations of these sedatives/hypnotics may be increased when co-administered with EVOTAZ.
En filmovertrukket tablet indeholder 300 mg atazanavir (som sulfat) og 150 mg cobicistat.
Each film-coated tablet contains 300 mg of atazanavir (as sulphate), and 150 mg cobicistat.
Tabletkerne mikrokrystallinsk cellulose (E460(i)) croscarmellosenatrium (E468) natriumstivelsesglycolat crospovidon (E1202) stearinsyre (E570) magnesiumstearat (E470b) hydroxypropylcellulose (E463) silica (E551)
Tablet core microcrystalline cellulose (E460(i)) croscarmellose sodium (E468) sodium starch glycolate crospovidone (E1202) stearic acid (E570) magnesium stearate (E470b) hydroxypropyl cellulose (E463) silicon dioxide (E551)
Interaktion er ikke undersøgt, hvad angår indholdsstofferne i EVOTAZ.
Interaction not studied with any of the components of EVOTAZ.