natgillin/translations-raw huggingface dataset:
I gruppen, der fik atazanavir 300 mg administreret sammen med ritonavir 100 mg, forelå der evaluerbare genotypiske data for alle 19 virologiske svigt (5%, 19/348).
In the group receiving atazanavir 300 mg co-administered with ritonavir 100 mg, evaluable genotypic data was available for all 19 virologic failures (5%, 19/348).
Det er vigtigt at fortælle det til lægen, hvis du bruger: Kortikosteroider herunder betamethason, budesonid, fluticason, mometason, prednison og triamcinolon.
It is important to tell your doctor if you are taking: Corticosteroids including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone.
Den oftest rapporterede laboratoriemæssige anormalitet hos patienter, der fik regimer indeholdende atazanavir og én eller flere NRTIer, var forhøjet total-bilirubin, primært indberettet som indirekte forhøjet [ukonjugeret] bilirubin (87% grad 1, 2, 3 eller 4).
The most frequently reported laboratory abnormality in patients receiving regimens containing atazanavir and one or more NRTIs was elevated total bilirubin reported predominantly as elevated indirect [unconjugated] bilirubin (87% Grade 1, 2, 3, or 4).
Patienten bør dog informeres om, at svimmelhed er blevet rapporteret under behandling med regimer indeholdende atazanavir eller cobicistat (se pkt.
However, patients should be informed that dizziness has been reported during treatment with regimens containing atazanavir or cobicistat (see section 4.8).
I toksicitetsstudier med gentagne doser i mus, rotter og hunde var atazanavirrelaterede fund generelt begrænset til leveren og omfattede generelt minimale til milde forhøjelser af serum bilirubin og leverenzymer, hepatocellulær vacuolation og hypertrofi, og kun i hunmus hepatisk enkeltcellenekrose.
In repeat-dose toxicity studies, conducted in mice, rats, and dogs, atazanavir-related findings were generally confined to the liver and included generally minimal to mild increases in serum bilirubin and liver enzymes, hepatocellular vacuolation and hypertrophy, and, in female mice only, hepatic single-cell necrosis.
Øgede plasmakoncentrationer af samtidigt administrerede lægemidler kan medføre øget eller forlænget terapeutisk effekt eller bivirkninger.
Higher plasma concentrations of coadministered medicinal products can result in increased or prolonged therapeutic effects or adverse reactions.
Ved samtidig administration blev der ikke observeret nogen tydelig additiv eller synergistisk kardiovaskulær effekt ved atazanavir og cobicistat koncentrationer mindst 2 gange højere end de frie atazanavir og cobicistat koncentrationer ved RHD Cmax.
When administered in combination, no clear additive or synergistic cardiovascular effects were observed at atazanavir and cobicistat concentrations at least 2-fold higher than the free atazanavir and cobicistat concentrations at the RHD Cmax.
hvis du har type A- eller B-blødersygdom hvis du har problemer med nyrerne eller har brug for hæmodialyse.
if you have type A or B haemophilia if you have problems with your kidneys or require haemodialysis.
Patienter, der får tenofovirdisoproxil, bør monitoreres for tenofovir-associerede bivirkninger.
Patients receiving tenofovir disoproxil should be monitored for tenofovir-associated adverse reactions.
Kombinationer af EVOTAZ og indinavir er ikke undersøgt, og samtidig administration af disse lægemidler kan ikke anbefales (se pkt.
Combinations of EVOTAZ and indinavir have not been studied and co-administration of these medicinal products is not recommended (see section 4.5).
Cobicistat-eksponering er non-lineær og større end dosis-proportional i området 50 mg til 400 mg, og i overensstemmelse med den mekanisme-baserede CYP3A-hæmmer.
Cobicistat exposures are non-linear and greater than dose-proportional over the range of 50 mg to 400 mg, consistent with a mechanism-based CYP3A inhibitor.
Didanosin skal tages fastende, 2 timer efter indtagelse af EVOTAZ, taget til et måltid.
Didanosine should be taken in the fasted state 2 hours after EVOTAZ taken with food.
Du må kun bruge disse lægemidler, hvis andre lægemidler ikke kan anvendes, og kun efter en lægelig vurdering og under tæt lægelig overvågning for kortikosteroid-bivirkninger.
If alternatives cannot be used, its use should only take place after medical evaluation and under close monitoring by your doctor for corticosteroid side effects.
Af disse 692 patienter, modtog 613 (300 atazanavir med cobicistat og 313 atazanavir med ritonavir) og 496 (250 atazanavir med cobicistat og 246 atazanavir med ritonavir) henholdsvis mindst 48 og 144 ugers behandling.
Of these 692 patients, 613 (300 atazanavir with cobicistat and 313 atazanavir with ritonavir) and 496 (250 atazanavir with cobicistat and 246 atazanavir with ritonavir) received at least 48 and 144 weeks of treatment, respectively.
EVOTAZ's effekt på human fertilitet er ikke undersøgt.
The effect of EVOTAZ on fertility in humans has not been studied.
Effekt på atazanavir- og ritonavireksponering er ikke undersøgt.
Effect on atazanavir and ritonavir exposure has not been studied.
Anbefalet dosis af colchicin ved samtidig administration med EVOTAZ hos patienter uden nedsat nyre- eller leverfunktion: hvis behandling med EVOTAZ er påkrævet, anbefales dosisreduktion af colchicin eller afbrydelse af colchicinbehandling hos patienter med normal nyre- eller leverfunktion.
Recommended dosage of colchicine when administered with EVOTAZ in patients without renal or hepatic impairment: a dose reduction in colchicine dosage or an interruption of colchicine treatment is recommended in patients with normal renal or hepatic function if treatment with EVOTAZ is required.
EVOTAZ må ikke anvendes i kombination med lægemidler, der er CYP3A4-substrater og har et snævert terapeutisk indeks.
EVOTAZ must not be used in combination with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index.
Endothelinreceptor-antagonister
Endothelin Receptor Antagonists
Almene symptomer og reaktioner på administrationsstedet almindelig træthed ikke almindelig pyreksi, asteni, brystsmerter, ubehag sjælden gangforstyrrelser a Disse bivirkninger blev identificeret under post--marketing-overvågning, men hyppigheden er dog estimeret ud fra en statistisk beregning baseret på det totale antal patienter, der har været eksponeret for atazanavir (med og uden ritonavir) i randomiserede, kontrollerede og andre tilgængelige kliniske studier (n = 2.321).
General disorders and administration site conditions common fatigue uncommon pyrexia, asthenia, chest pain, malaise rare gait disturbance a These adverse reactions were identified through post-marketing surveillance; however, the frequencies were estimated from a statistical calculation based on the total number of patients exposed to atazanavir (with and without ritonavir) in randomised controlled and other available clinical trials (n = 2321).
Administration sammen med EVOTAZ kan medføre en stor stigning i koncentrationen af disse benzodiazepiner.
Co-administration with EVOTAZ may cause a large increase in the concentration of these benzodiazepines.
Koncentrationen af disse lægemidler kan øges ved samtidig administration af EVOTAZ, hvilket medfører risiko for et øget antal bivirkninger, der normalt associeres med anticancer lægemidler.
Concentrations of these medicinal products may be increased when co-administered with EVOTAZ resulting in the potential for increased adverse events usually associated with these anticancer medicinal products.
Cobicistat forventes ikke at inducere CYP3A4 eller P-gp.
Cobicistat is not expected to induce CYP3A4 or P-gp.
ANTIHISTAMINER Astemizol
ANTIHISTAMINE AGENTS Astemizole
Hvis der opstår tegn eller symptomer på cholelithiasis, kan midlertidig afbrydelse eller seponering af behandlingen overvejes.
If signs or symptoms of cholelithiasis occurs, temporary interruption or discontinuation of treatment may be considered.
Atazanavir, som er et aktivt stof i EVOTAZ, er blevet fundet i human mælk.
Atazanavir, an active component of EVOTAZ, has been detected in human milk.
Proteasehæmmere: EVOTAZ i kombination med andre proteasehæmmere frarådes, da samtidig administration muligvis ikke medfører tilstrækkelig protesehæmmer-eksponering.
Protease inhibitors: EVOTAZ in combination with other protease inhibitors is not recommended because co-administration may not provide adequate protease inhibitor exposure.
Koncentrationen af ketoconazol, itraconazol og/eller cobicistat kan øges ved samtidig administration af ketoconazol eller itraconazol og EVOTAZ.
Concentrations of ketoconazole, itraconazole, and/or cobicistat may be increased with co-administration of ketoconazole or itraconazole with EVOTAZ.
Hos patienter, der ikke tager tenofovir, bør EVOTAZ administreres 1 gang dagligt i forbindelse med et måltid samtidig med og/eller mindst 10 timer efter en dosis af
For patients not taking tenofovir, EVOTAZ once daily with food should be administered simultaneously with, and/or at least 10 hours after, a dose of the H2-receptor antagonist.
Cobicistat er ikke undersøgt hos patienter med svært nedsat leverfunktion og frarådes til disse patienter.
Cobicistat has not been studied in patients with severe hepatic impairment and is not recommended in these patients.
Hos rotter forekom der ossifikationsændringer i fostres rygsøjle og sternum ved en dosis, der medførte signifikant maternel toksicitet.
In rats, ossification changes in the spinal column and sternebra of foetuses occurred at a dose that produced significant maternal toxicity.
Der er i længerevarende studier af karcinogenicitet af atazanavir hos mus og rotter set en øget incidens af benigne hepatiske adenomer hos hunmus.
In long-term carcinogenicity studies of atazanavir in mice and rats, an increased incidence of benign hepatic adenomas was seen in female mice only.
Samtidig administration af EVOTAZ kan potentielt medføre alvorlige og/eller livstruende blødning pga. øget eksponering for warfarin og er ikke blevet undersøgt.
Co-administration with EVOTAZ has the potential to produce serious and/or life-threatening bleeding due to increased exposure to warfarin and has not been studied.
Koncentrationen af ethinylestradiol og norethindron øges, når et kombineret oralt kontraceptivum indeholdende disse stoffer administreres sammen med atazanavir.
Concentrations of ethinyl estradiol and norethindrone are increased when a combined oral contraceptive containing those agents is co-administered with atazanavir.
Hvis patienten bliver opmærksom på den glemte dosis mere end 12 timer efter det tidspunkt, hvor den normalt tages, må den glemte dosis ikke tages, og patienten skal genoptage den sædvanlige doseringsplan.
If this is noticed later than 12 hours of the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule.
Valg af EVOTAZ bør baseres på en individuel, viral resistenstest og patientens behandlingsanamnese (se pkt.
The choice of EVOTAZ in adult patients should be based on individual viral resistance testing and the patient's treatment history (see section 5.1).
Samtidig administration af EVOTAZ med produkter indeholdende voxilaprevir forventes at øge koncentrationen af voxilaprevir.
Co-administration of EVOTAZ with voxilaprevir-containing products is expected to increase the concentration of voxilaprevir.
Kvinder bør ikke amme deres barn, mens de tager EVOTAZ.
Patients should not breast-feed while taking EVOTAZ.
EVOTAZ bør ikke anvendes sammen med et andet retroviralt lægemiddel, som kræver farmakokinetisk forstærkning (dvs. en anden proteasehæmmer eller elvitegravir), da dosisanbefalinger for sådanne kombinationer ikke er klarlagt og kan medføre nedsatte plasmakoncentrationer af atazanavir og/eller det andet retrovirale lægemiddel, hvilken kan resultere i tab af terapeutisk effekt og udvikling af resistens.
EVOTAZ should not be used in combination with another antiretroviral that requires pharmacokinetic enhancement (i.e., another protease inhibitor or elvitegravir) since dosing recommendations for such combinations have not been established and may result in decreased plasma concentrations of atazanavir and/or the other antiretroviral leading to loss of therapeutic effect and development of resistance.
Patienter med kronisk hepatitis B eller samtidig hepatitis C-virusinfektion:
Patients with chronic hepatitis B or hepatitis C virus co-infection:
Cobicistat hæmmer MATE1 reversibelt og metformin-koncentration kan øges ved samtidig administration af EVOTAZ.
Cobicistat reversibly inhibits MATE1, and concentrations of metformin may be increased when co-administered with EVOTAZ.
Da atazanavir og cobicistat i udtalt grad metaboliseres i leveren og er udtalt proteinbundet, er det usandsynligt, at dialyse i signifikant grad kan bidrage til fjernelse af dette lægemiddel.
Since atazanavir and cobicistat are extensively metabolised by the liver and highly protein bound, dialysis is unlikely to be beneficial in significant removal of this medicinal product.
Cobicistat gør dette ved at sænke nedbrydningshastigheden af atazanavir, hvilket vil få atazanavir til at forblive i kroppen i længere tid.
It does this by slowing down the breakdown of atazanavir which will make it stay in the body for longer.
Anbefalingerne i Tabel 1 er baseret på enten lægemiddelinteraktionsforsøg med ikke-boostet atazanavir, atazanavir boostet med ritonavir, cobicistat eller forventede interaktioner ud fra det forventede omfang af interaktion og mulige bivirkninger eller tab af terapeutisk effekt af EVOTAZ.
The recommendations shown in Table 1 are based on either drug interaction trials of unboosted atazanavir, atazanavir boosted with ritonavir, cobicistat or predicted interactions due to the expected magnitude of the interaction and potential for serious adverse reactions or loss of therapeutic effect of EVOTAZ.
Atazanavir med cobicistatf (n = 344)
Atazanavir with cobicistatf (n = 344)
Non-nukleosid reverse transkriptasehæmmere (NNRTI'er)
Non-nucleoside reverse transcriptase inhibitors (NNRTIs)
Følgende redegørelser vedrører atazanavirs farmakokinetiske egenskaber i kombination med cobicistat eller de enkelte indholdsstoffer i EVOTAZ.
The following statements reflect the pharmacokinetic properties of atazanavir in combination with cobicistat or the individual components of EVOTAZ.
2% af patienterne behandlet med atazanavir oplevede samtidig grad 3-4 ALAT/ASAT og grad 3-4 forhøjelser af total-bilirubin.
Two percent of patients treated with atazanavir experienced concurrent Grade 3-4 ALT/AST and Grade 3-4 total bilirubin elevations.
Samtidig anvendelse er kontraindiceret
Concomitant use contraindicated
Psykiske forstyrrelser almindelig insomni, abnorme drømme ikke almindelig depression, søvnforstyrrelser, desorientering, ængstelse
Psychiatric disorders common insomnia, abnormal dreams uncommon depression, sleep disorder, disorientation, anxiety
Autoimmune lidelser (såsom Graves sygdom og autoimmun hepatitis) er også rapporteret; tiden til udbrud er imidlertid mere variabel, og udbrud kan optræde mange måneder efter behandlingsstart (se pkt.
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Ved samtidig administration af tenofoviralafenamid/emtricitabin og EVOTAZ er den anbefalede dosis af tenofoviralafenamid/emtricitabin 10/200 mg 1 gang dagligt.
When co-administering tenofovir alafenamide/emtricitabine and EVOTAZ, the recommended dose of tenofovir alafenamide/emtricitabine is 10/200 mg once daily.
Hvis du føler dig svimmel eller uklar, skal du straks kontakte lægen.
If you feel dizzy or lightheaded, please contact your doctor immediately.
Atazanavir er blevet undersøgt hos voksne patienter med alvorligt nedsat nyrefunktion (n=20), inklusive patienter i hæmodialyse, ved multiple doser på 400 mg en gang dagligt.
Atazanavir has been studied in adult patients with severe renal impairment (n=20), including those on haemodialysis, at multiple doses of 400 mg once daily.
Tenofovir DF kan reducere atazanavirs AUC og Cmin.
Tenofovir DF may decrease the AUC and Cmin of atazanavir.
Hvis der opstår tegn eller symptomer på nephrolithiasis, kan midlertidig afbrydelse eller seponering af behandlingen overvejes.
If signs or symptoms of nephrolithiasis occurs, temporary interruption or discontinuation of treatment may be considered.
Hvis EVOTAZ administreres samtidig med irinotecan, bør patienten monitoreres tæt for irinotecan-relaterede bivirkninger.
If EVOTAZ is co-administered with irinotecan, patients should be closely monitored for adverse reactions related to irinotecan.
HMG-CoA reduktasehæmmere
HMG-CoA reductase inhibitors
Disse lægemidler er nævnt i starten af afsnit 2 Tag ikke EVOTAZ.
These are listed under Do not take EVOTAZ, at the start of section 2.
Forhøjede koncentrationer kan forstærke tenofovir-associerede bivirkninger, herunder nyresygdomme.
Higher concentrations could potentiate tenofovir-associated adverse reactions, including renal disorders.
Samtidig administration af boceprevir og atazanavir/ritonavir medførte lavere atazanavir og ritonavir-eksponering.
Concomitant administration of boceprevir and atazanavir/ritonavir resulted in reduced exposures to atazanavir and ritonavir.
Tabel 2: Tabel over bivirkninger
Table 2: Tabulated summary of adverse reactions
PDE5-hæmmere til behandling af erektil dysfunktion
PDE5 inhibitors used for the treatment of erectile dysfunction
Atazanavir er en svag til moderat CYP2C8-hæmmer.
Atazanavir is a weak to moderate inhibitor of CYP2C8.
Kortikosteroider, der primært metaboliseres via CYP3A(bl.a. betamethason, budesonid, fluticason, mometason, prednison og triamcinolon).
Corticosteroids primarily metabolised by CYP3A (including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone).
Der bør ligeledes udvises forsigtighed, hvis der under den første behandling skiftes farmakoforstærker fra ritonavir til cobicistat (se pkt.
Caution is also required during the first time of treatment if switching the pharmacoenhancer from ritonavir to cobicistat (see section 4.4).
Forhøjede plasmakoncentrationer af lægemidler, der metaboliseres af CYP3A, CYP2C8, CYP2D6 og/eller UGT1A1 forventes ved samtidig administration med EVOTAZ.
Increased plasma concentrations of medicinal products that are metabolised by CYP3A, CYP2C8, CYP2D6 and/or UGT1A1 are expected when co-administered with EVOTAZ.
Atazanavir med ritonavirf (n = 348)
Atazanavir with ritonavirf (n = 348)
Ved samtidig administration med EVOTAZ bør digoxin-dosis titreres og digoxin-koncentrationen bør monitoreres.
When co-administering with EVOTAZ, titrate the digoxin dose and monitor digoxin concentrations.
Median CD4+ celletal ved baseline var 352 celler/mm3 (1-1.455) og 16,9% havde CD4+
The median baseline CD4+ cell count was 352 cells/mm3 (range: 1-1455) and 16.9% had CD4+ cell counts ≤200 cells/mm3.
Sikkerheden og virkningen af atazanavir med cobicistat hos hiv-1 inficerede patienter blev evalueret i et randomiseret, dobbeltblindet, aktivt-kontrolleret fase 3 studie GS-US-216-0114 hos hiv-1-inficerede patienter med estimeret kreatininclearance ved baseline over 70 ml/min, som var behandlingsnaive (n = 692).
The safety and efficacy of atazanavir with cobicistat in HIV-1 infected patients were evaluated in the randomised, double-blind, active-controlled phase 3 study GS-US-216-0114 in HIV-1 infected patients with baseline estimated creatinine clearance above 70 ml/min who were treatment-naïve (n = 692).
Patienterne bør advares om risikoen for disse bivirkninger ved brug af PDE5-hæmmere mod erektil dysfunktion samtidig med EVOTAZ (se pkt.
Patients should be warned about these possible side effects when using PDE5 inhibitors for erectile dysfunction with EVOTAZ (see section 4.4).
EVOTAZ 300 mg/150 mg filmovertrukne tabletter atazanavir/cobicistat
EVOTAZ 300 mg/150 mg film-coated tablets atazanavir/cobicistat
Amiodaron, dronedaron, quinidin og systemisk lidocain har et snævert terapeutisk indeks og er kontraindiceret pga. EVOTAZ's potentielle CYP3A-hæmning (se pkt.
Amiodarone, dronedarone, quinidine and systemic lidocaine have a narrow therapeutic window and are contraindicated due to potential inhibition of CYP3A by EVOTAZ (see section 4.3).
I et ex vivo farmakologistudie i kaniner blev isolerede hjerter eksponeret for atazanavir, cobicistat eller en kombination af disse to.
In an ex vivo rabbit pharmacology study, isolated hearts were exposed to atazanavir, cobicistat, or atazanavir and cobicistat in combination.
Maraviroc er et CYP3A-substrat og dets plasmakoncentration øges ved samtidig administration med potente CYP3A-hæmmere.
Maraviroc is a substrate of CYP3A and its plasma concentration increases when co-administered with potent CYP3A inhibitors.
Der er begrænset erfaring med akut human overdosering med EVOTAZ.
Human experience of acute overdose with EVOTAZ is limited.
Metabolisme og ernæring almindelig øget appetit ikke almindelig vægttab, vægtstigning, anoreksi
Metabolism and nutrition disorders common increased appetite uncommon weight decreased, weight gain, anorexia
Regelmæssig overvågning af patienternes nyrefunktion bør opretholdes igennem hele behandlingsforløbet (se pkt.
Regular monitoring of the renal function of patients should be maintained throughout the treatment duration (see section 4.4)
Ethinylestradiol AUC: ↔ Ethinylestradiol Cmax: ↔ Ethinylestradiol Cmin: Ikke beregnet
Ethinyloestradiol AUC: ↔ Ethinyloestradiol Cmax: ↔ Ethinyloestradiol Cmin: Not calculated
Der foreligger kun begrænsede data om udvikling af resistens over for atazanavir boostet med cobicistat.
Limited data are available on the development of resistance to atazanavir boosted with cobicistat.
EVOTAZ er indiceret i kombination med andre antiretrovirale lægemidler til behandling af hiv-1inficerede voksne uden kendte mutationer associeret med resistens over for atazanavir (se pkt.
EVOTAZ is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults without known mutations associated with resistance to atazanavir (see sections 4.4 and 5.1).
Andre markante, kliniske laboratoriemæssige anormaliteter (grad 3 eller 4) rapporteret hos ≥2% af patienterne, der fik regimer indeholdende atazanavir og én eller flere NRTIer omfattede: forhøjet kreatinkinase (7%), forhøjet alaninaminotransferase/serum-glutamin-pyrudrue transaminase (ALAT/SGPT) (5%), lav neutrofiltælling (5%), forhøjet aspartataminotransferase/serumglutamin-oxalsyretransaminase (ASAT/SGOT) (3%) og forhøjet lipase (3%).
Other marked clinical laboratory abnormalities (Grade 3 or 4) reported in ≥ 2% of patients receiving regimens containing atazanavir and one or more NRTIs included: elevated creatine kinase (7%), elevated alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT) (5%), low neutrophils (5%), elevated aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) (3%), and elevated lipase (3%).
Samtidig administration af EVOTAZ hos patienter, der får lægemidler som er substrater af transportproteinerne P-gp, BCRP, MATE1, OATP1B1 og OATP1B3 kan resultere i forhøjede plasmakoncentrationer af de samtidigt administrerede lægemidler (se pkt.
Co-administration of EVOTAZ in patients receiving medicinal products that are substrates of the transporters P-gp, BCRP, MATE1, OATP1B1 and OATP1B3 may result in increased plasma concentrations of the co-administered medicinal products (see section 4.4).
Et farmakokinetikstudie af cobicistat blev udført hos ikke-hiv-1-inficerede personer med svært nedsat nyrefunktion (estimeret kreatininclearance under 30 ml/min).
A study of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with severe renal impairment (estimated creatinine clearance below 30 ml/min).
Hos hiv-inficerede patienter med svær immuninsufficiens kan der ved påbegyndelse af antiretroviral kombinationsbehandling (CART) opstå inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske infektioner.
In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.