FrancophonIA/ELRC3.0 huggingface dataset:
English: Dolutegravir is not expected to affect the pharmacokinetics of EVOTAZ.
Danish: Dolutegravir forventes ikke at påvirke EVOTAZ's farmakokinetik.
English: If switching from atazanavir boosted with ritonavir to EVOTAZ, caution is required during the first two weeks of treatment with EVOTAZ, particularly if doses of any concomitantly administered medicinal products have been titrated or adjusted during use of ritonavir as a pharmacoenhancer (see section 4.5).
Danish: Ved skift fra atazanavir boostet med ritonavir til EVOTAZ skal der udvises forsigtighed i de første to uger af behandlingen med EVOTAZ, især hvis dosis af eventuelt samtidigt administrerede lægemidler er blevet titreret eller justeret ved brug af ritonavir som en farmakoforstærker (se pkt.
English: As EVOTAZ contains atazanavir and cobicistat, any interactions that have been identified with these active substances individually may occur with EVOTAZ.
Danish: Da EVOTAZ indeholder atazanavir og cobicistat, kan eventuelle interaktioner, som er identificeret med disse aktive stoffer hver især, forekomme med EVOTAZ.
English: Cobicistat inhibits the transporters p-glycoprotein (P-gp), BCRP, MATE1, OATP1B1 and OATP1B3.
Danish: Cobicistat hæmmer transportproteinerne p-glycoprotein (P-gp), BCRP, MATE1, OATP1B1 og OATP1B3.
English: In clinical trials of antiretroviral treatment naive patients treated with unboosted atazanavir, the I50L substitution, sometimes in combination with an A71V change, is the signature resistance substitution for atazanavir.
Danish: I kliniske studier med patienter, der ikke tidligere har modtaget antiretroviral behandling, og som behandles med ikke-boosted atazanavir, er I50L-substitutionen, nogle gange i kombination med A71V-ændring, den kendetegnende resistenssubstitution for atazanavir.
English: Low levels of metabolites are observed in urine and faeces and do not contribute to the CYP3A inhibitory activity of cobicistat.
Danish: Der er observeret lave metabolitniveauer i urin og fæces, og det bidrager ikke til cobicistats CYP3A-hæmmende aktivitet.
English: If you develop signs or symptoms of kidney stones (pain in your side, blood in your urine, pain when you urinate), please inform your doctor immediately if you are taking oral contraceptives ("the Pill") to prevent pregnancy.
Danish: Hvis du får tegn eller symptomer på nyresten (smerter i siden, blod i urinen, smerter ved vandladning), skal du straks kontakte lægen hvis du tager p-piller for at forebygge graviditet.
English: ERECTILE DYSFUNCTION
Danish: EREKTIL DYSFUNKTION
English: The following side effects may occur when taking EVOTAZ.
Danish: Følgende bivirkninger kan forekomme ved behandling med EVOTAZ.
English: Viruses were known to be susceptible to atazanavir, emtricitabine and tenofovir DF at baseline.
Danish: Vira var kendt som værende følsomme over for atazanavir, emtricitabin og tenofovir DF ved baseline.
English: Each bottle contains 30 film-coated tablets and a silica gel dessicant.
Danish: Hver beholder indeholder 30 filmovertrukne tabletter og et tørremiddel af silicagel.
English: Based on the very limited renal elimination of cobicistat and atazanavir, no special precautions or dose adjustments of EVOTAZ are required for patients with renal impairment.
Danish: På baggrund af cobicistats og atazanavirs yderst begrænsede renale elimination er særlige forholdsregler eller dosisjustering af EVOTAZ ikke nødvendig hos patienter med nedsat nyrefunktion.
English: EVOTAZ should not be used in combination with ritonavir or medicinal products containing ritonavir due to similar pharmacological effects of cobicistat and ritonavir on CYP3A (see section 4.5).
Danish: EVOTAZ bør ikke anvendes sammen med ritonavir eller ritonavir-holdige lægemidler på grund af cobicistats og ritonavirs tilsvarende farmakologiske effekt på CYP3A (se pkt.
English: In the pre- and postnatal development assessment in rats, atazanavir produced a transient reduction in body weight in the offspring at a maternally toxic dose.
Danish: I den præ- og postnatale udviklingsvurdering hos rotter frembragte atazanavir en forbigående reduktion i legemsvægten hos afkommet ved en maternel toksisk dosis.
English: e Includes subjects who discontinued for reasons other than an adverse event, death or lack or loss of efficacy,
Danish: e Omfatter personer, som afbrød behandlingen af andre årsager end en bivirkning, død eller manglende eller svigtende virkning, f.eks. tilbagetrækning af samtykke, tabt for opfølgning.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with EVOTAZ in the treatment of HIV-1 infection (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med EVOTAZ til behandling af hiv-1-infektion (se pkt.
English: The overall safety profile of EVOTAZ is based on available data from clinical trials conducted with atazanavir, atazanavir boosted with either cobicistat or ritonavir, and post-marketing data.
Danish: EVOTAZ's overordnede sikkerhedsprofil er baseret på data fra kliniske studier udført med atazanavir, atazanavir boostet med enten cobicistat eller ritonavir og post-marketing data.
English: Steady-state cobicistat Cmax, AUCtau and Ctau (mean ± SD) values were 1.5 ± 0.5 μg/ml, 11.1 ± 4.5 μg•hr/ml and 0.05 ± 0.07 μg/ml, respectively (n=22).
Danish: Steady-state cobicistat Cmax, AUCtau og Ctau (gennemsnitlig ± SD) værdierne var henholdsvis 1,5 ± 0,5 μg/ml, 11,1 ± 4,5 μg•hr/ml og 0,05 ± 0,07 μg/ml (n=22).
English: The frequency of treatment emergent hepatitis or transaminase elevations in co-infected patients was comparable between atazanavir and comparator regimens (see section 4.4).
Danish: Hyppigheden af behandlingskrævende hepatitis eller transaminaseforhøjelser hos samtidigt inficerede patienter var sammenlignelig mellem atazanavir og sammenlignelige regimer (se pkt.
English: When co-administered with tenofovir DF, it is recommended that EVOTAZ and tenofovir DF 300 mg be given together with food.
Danish: Ved samtidig administration med tenofovir anbefales det, at EVOTAZ og tenofovir DF 300 mg gives sammen med mad.
English: 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).
Danish: 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).
English: It is important to tell your doctor if you are taking: Corticosteroids including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone.
Danish: Det er vigtigt at fortælle det til lægen, hvis du bruger: Kortikosteroider herunder betamethason, budesonid, fluticason, mometason, prednison og triamcinolon.
English: 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).
Danish: 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).
English: However, patients should be informed that dizziness has been reported during treatment with regimens containing atazanavir or cobicistat (see section 4.8).
Danish: Patienten bør dog informeres om, at svimmelhed er blevet rapporteret under behandling med regimer indeholdende atazanavir eller cobicistat (se pkt.
English: 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.
Danish: 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.
English: Higher plasma concentrations of coadministered medicinal products can result in increased or prolonged therapeutic effects or adverse reactions.
Danish: Øgede plasmakoncentrationer af samtidigt administrerede lægemidler kan medføre øget eller forlænget terapeutisk effekt eller bivirkninger.
English: 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.
Danish: 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.
English: if you have type A or B haemophilia if you have problems with your kidneys or require haemodialysis.
Danish: hvis du har type A- eller B-blødersygdom hvis du har problemer med nyrerne eller har brug for hæmodialyse.
English: Patients receiving tenofovir disoproxil should be monitored for tenofovir-associated adverse reactions.
Danish: Patienter, der får tenofovirdisoproxil, bør monitoreres for tenofovir-associerede bivirkninger.
English: Combinations of EVOTAZ and indinavir have not been studied and co-administration of these medicinal products is not recommended (see section 4.5).
Danish: Kombinationer af EVOTAZ og indinavir er ikke undersøgt, og samtidig administration af disse lægemidler kan ikke anbefales (se pkt.
English: 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.
Danish: 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.
English: Didanosine should be taken in the fasted state 2 hours after EVOTAZ taken with food.
Danish: Didanosin skal tages fastende, 2 timer efter indtagelse af EVOTAZ, taget til et måltid.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: The effect of EVOTAZ on fertility in humans has not been studied.
Danish: EVOTAZ's effekt på human fertilitet er ikke undersøgt.
English: Effect on atazanavir and ritonavir exposure has not been studied.
Danish: Effekt på atazanavir- og ritonavireksponering er ikke undersøgt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1025/001-002
Danish: EU/1/15/1025/001-002
English: 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.
Danish: 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.
English: EVOTAZ must not be used in combination with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index.
Danish: EVOTAZ må ikke anvendes i kombination med lægemidler, der er CYP3A4-substrater og har et snævert terapeutisk indeks.
English: Endothelin Receptor Antagonists
Danish: Endothelinreceptor-antagonister
English: 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).
Danish: 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).
English: Co-administration with EVOTAZ may cause a large increase in the concentration of these benzodiazepines.
Danish: Administration sammen med EVOTAZ kan medføre en stor stigning i koncentrationen af disse benzodiazepiner.
English: 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.
Danish: 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.
English: Cobicistat is not expected to induce CYP3A4 or P-gp.
Danish: Cobicistat forventes ikke at inducere CYP3A4 eller P-gp.
English: ANTIHISTAMINE AGENTS Astemizole
Danish: ANTIHISTAMINER Astemizol
English: If signs or symptoms of cholelithiasis occurs, temporary interruption or discontinuation of treatment may be considered.
Danish: Hvis der opstår tegn eller symptomer på cholelithiasis, kan midlertidig afbrydelse eller seponering af behandlingen overvejes.
English: Atazanavir, an active component of EVOTAZ, has been detected in human milk.
Danish: Atazanavir, som er et aktivt stof i EVOTAZ, er blevet fundet i human mælk.
English: Protease inhibitors: EVOTAZ in combination with other protease inhibitors is not recommended because co-administration may not provide adequate protease inhibitor exposure.
Danish: Proteasehæmmere: EVOTAZ i kombination med andre proteasehæmmere frarådes, da samtidig administration muligvis ikke medfører tilstrækkelig protesehæmmer-eksponering.
English: Concentrations of ketoconazole, itraconazole, and/or cobicistat may be increased with co-administration of ketoconazole or itraconazole with EVOTAZ.
Danish: Koncentrationen af ketoconazol, itraconazol og/eller cobicistat kan øges ved samtidig administration af ketoconazol eller itraconazol og EVOTAZ.
English: 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.
Danish: 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
English: Cobicistat has not been studied in patients with severe hepatic impairment and is not recommended in these patients.
Danish: Cobicistat er ikke undersøgt hos patienter med svært nedsat leverfunktion og frarådes til disse patienter.
English: In rats, ossification changes in the spinal column and sternebra of foetuses occurred at a dose that produced significant maternal toxicity.
Danish: Hos rotter forekom der ossifikationsændringer i fostres rygsøjle og sternum ved en dosis, der medførte signifikant maternel toksicitet.
English: In long-term carcinogenicity studies of atazanavir in mice and rats, an increased incidence of benign hepatic adenomas was seen in female mice only.
Danish: Der er i længerevarende studier af karcinogenicitet af atazanavir hos mus og rotter set en øget incidens af benigne hepatiske adenomer hos hunmus.
English: 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.
Danish: Samtidig administration af EVOTAZ kan potentielt medføre alvorlige og/eller livstruende blødning pga. øget eksponering for warfarin og er ikke blevet undersøgt.
English: Concentrations of ethinyl estradiol and norethindrone are increased when a combined oral contraceptive containing those agents is co-administered with atazanavir.
Danish: Koncentrationen af ethinylestradiol og norethindron øges, når et kombineret oralt kontraceptivum indeholdende disse stoffer administreres sammen med atazanavir.
English: 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.
Danish: 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.
English: 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).
Danish: Valg af EVOTAZ bør baseres på en individuel, viral resistenstest og patientens behandlingsanamnese (se pkt.
English: Co-administration of EVOTAZ with voxilaprevir-containing products is expected to increase the concentration of voxilaprevir.
Danish: Samtidig administration af EVOTAZ med produkter indeholdende voxilaprevir forventes at øge koncentrationen af voxilaprevir.
English: Patients should not breast-feed while taking EVOTAZ.
Danish: Kvinder bør ikke amme deres barn, mens de tager EVOTAZ.
English: 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.
Danish: 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.
English: Patients with chronic hepatitis B or hepatitis C virus co-infection:
Danish: Patienter med kronisk hepatitis B eller samtidig hepatitis C-virusinfektion:
English: Cobicistat reversibly inhibits MATE1, and concentrations of metformin may be increased when co-administered with EVOTAZ.
Danish: Cobicistat hæmmer MATE1 reversibelt og metformin-koncentration kan øges ved samtidig administration af EVOTAZ.
English: 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.
Danish: 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.
English: It does this by slowing down the breakdown of atazanavir which will make it stay in the body for longer.
Danish: Cobicistat gør dette ved at sænke nedbrydningshastigheden af atazanavir, hvilket vil få atazanavir til at forblive i kroppen i længere tid.
English: 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.
Danish: 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.
English: Atazanavir with cobicistatf (n = 344)
Danish: Atazanavir med cobicistatf (n = 344)
English: Non-nucleoside reverse transcriptase inhibitors (NNRTIs)
Danish: Non-nukleosid reverse transkriptasehæmmere (NNRTI'er)
English: The following statements reflect the pharmacokinetic properties of atazanavir in combination with cobicistat or the individual components of EVOTAZ.
Danish: Følgende redegørelser vedrører atazanavirs farmakokinetiske egenskaber i kombination med cobicistat eller de enkelte indholdsstoffer i EVOTAZ.
English: Two percent of patients treated with atazanavir experienced concurrent Grade 3-4 ALT/AST and Grade 3-4 total bilirubin elevations.
Danish: 2% af patienterne behandlet med atazanavir oplevede samtidig grad 3-4 ALAT/ASAT og grad 3-4 forhøjelser af total-bilirubin.
English: Concomitant use contraindicated
Danish: Samtidig anvendelse er kontraindiceret
English: Psychiatric disorders common insomnia, abnormal dreams uncommon depression, sleep disorder, disorientation, anxiety
Danish: Psykiske forstyrrelser almindelig insomni, abnorme drømme ikke almindelig depression, søvnforstyrrelser, desorientering, ængstelse
English: 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).
Danish: 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.
English: When co-administering tenofovir alafenamide/emtricitabine and EVOTAZ, the recommended dose of tenofovir alafenamide/emtricitabine is 10/200 mg once daily.
Danish: Ved samtidig administration af tenofoviralafenamid/emtricitabin og EVOTAZ er den anbefalede dosis af tenofoviralafenamid/emtricitabin 10/200 mg 1 gang dagligt.
English: If you feel dizzy or lightheaded, please contact your doctor immediately.
Danish: Hvis du føler dig svimmel eller uklar, skal du straks kontakte lægen.
English: 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.
Danish: 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.
English: Tenofovir DF may decrease the AUC and Cmin of atazanavir.
Danish: Tenofovir DF kan reducere atazanavirs AUC og Cmin.
English: If signs or symptoms of nephrolithiasis occurs, temporary interruption or discontinuation of treatment may be considered.
Danish: Hvis der opstår tegn eller symptomer på nephrolithiasis, kan midlertidig afbrydelse eller seponering af behandlingen overvejes.
English: If EVOTAZ is co-administered with irinotecan, patients should be closely monitored for adverse reactions related to irinotecan.
Danish: Hvis EVOTAZ administreres samtidig med irinotecan, bør patienten monitoreres tæt for irinotecan-relaterede bivirkninger.
English: HMG-CoA reductase inhibitors
Danish: HMG-CoA reduktasehæmmere
English: These are listed under Do not take EVOTAZ, at the start of section 2.
Danish: Disse lægemidler er nævnt i starten af afsnit 2 Tag ikke EVOTAZ.