FrancophonIA/ELRC3.0 huggingface dataset:
English: In GS-US-216-0114, 3.6% of subjects were hepatitis B virus surface antigen positive and 5.3% were hepatitis C virus seropositive.
Danish: I studie GS-US-216-0114 blev 3,6% af forsøgspersonerne testet positive for hepatitis B-virus overfladeantigen, og 5,3% var hepatitis C-virus seropositive.
English: QTc prolongationa, oedema, palpitation
Danish: QTc-forlængelsea, ødem, palpitation
English: The safety and efficacy of atazanavir have not been established in patients with significant underlying liver disorders.
Danish: Sikkerhed og virkning af atazanavir er ikke bestemt hos patienter med signifikante underliggende leversygdomme.
English: Further dosage reduction of rifabutin to 150 mg twice weekly on set days is recommended for patients in whom the 150 mg dose 3 times per week is not tolerated.
Danish: Yderligere reduktion af rifabutin-dosis til 150 mg 2 gange ugentligt på fastsatte dage anbefales til patienter, der ikke tolererer 150 mg 3 gange ugentligt.
English: Following oral administration of [14C]cobicistat, 99% of circulating radioactivity in plasma was unchanged cobicistat.
Danish: Efter oral administration af [14C]cobicistat var 99% af den cirkulerende radioaktivitet i plasma fra uændret cobicistat.
English: SEDATIVES/HYPNOTICS Midazolam
Danish: SEDATIVA/HYPNOTIKA Midazolam
English: Not all packages may be marketed in your country.
Danish: Ikke alle pakningsstørrelser er nødvendigvis markedsført i alle lande.
English: An alternate (non-hormonal) reliable method of contraception is recommended.
Danish: En alternativ (ikke-hormonel) sikker kontraceptionsmetode bør anvendes.
English: It is not known whether atazanavir administered to the mother during pregnancy will exacerbate physiological hyperbilirubinaemia and lead to kernicterus in neonates and infants.
Danish: Det vides ikke, om atazanavir administreret til moderen under graviditet, vil forstærke fysiologisk hyperbilirubinæmi og medføre kernicterus hos nyfødte og spædbørn.
English: Randomisation was stratified by screening HIV-1 RNA level (≤100,000 copies/ml or >100,000 copies/ml).
Danish: Randomiseringen blev stratificeret ved screening af hiv-1-RNA-niveau (≤100.000 kopier/ml eller > 100.000 kopier/ml).
English: Atazanavir increases tenofovir concentrations.
Danish: Atazanavir øger tenofovir-koncentrationen.
English: Resistance levels to atazanavir ranged from 3.5- to 29-fold without evidence of phenotypic cross resistance to other PIs.
Danish: Resistensniveauerne over for atazanavir strakte sig fra 3,5 til 29 gange uden tegn på fænotypekrydsresistens over for andre PI'er.
English: In some cases, nephrolithiasis has been associated with acute renal failure or renal insufficiency.
Danish: I nogle tilfælde er nephrolithiasis blevet forbundet med akut nyresvigt eller nyreinsufficiens.
English: This effect on serum creatinine, leading to a decrease in the estimated creatine clearance, should be taken into consideration when EVOTAZ is administered to patients in whom the estimated creatinine clearance is used to guide aspects of their clinical management, including adjusting doses of co-administered medicinal products.
Danish: Denne effekt på serumkreatinin, som medfører en reduktion af estimeret kreatinclearance, bør tages i betragtning, når EVOTAZ administreres til patienter, hvor estimeret kreatininclearance anvendes som vejledning i en del af den kliniske behandling, herunder justering af samtidigt administrerede lægemidler.
English: Disopyramide Flecainide Mexiletine Propafenone
Danish: Disopyramid Flecainid Mexiletin Propafenon
English: The compound selectively inhibits the virus-specific processing of viral Gag-Pol proteins in HIV-1 infected cells, thus preventing formation of mature virions and infection of other cells.
Danish: Stoffet blokerer den virusspecifikke bearbejdning af virale gag-pol-proteiner i hiv-1 inficerede celler og hindrer dermed dannelsen af modne virioner og infektion af andre celler.
English: 90 (3 bottles of 30) film-coated tablets.
Danish: 90 (3 beholdere á 30) filmovertrukne tabletter.
English: If overdose occurs with EVOTAZ, the patient must be monitored for evidence of toxicity.
Danish: I tilfælde af overdosering med EVOTAZ bør patienten monitoreres for tegn på toksicitet.
English: Also see PULMONARY ATERIAL HYPERTENSION in this table for further information regarding co-administration of EVOTAZ with sildenafil.
Danish: Se også PULMONAL ARTERIEL HYPERTENSION i denne tabel for yderligere information om samtidig administration af EVOTAZ og sildenafil.
English: The percentage of subjects with baseline viral loads >100,000 copies/ml was 39.7%.
Danish: Procentdelen af forsøgspersoner med viral load >100.000 kopier/ml ved baseline var 39,7%.
English: cobicistat, a booster (pharmacokinetic enhancer) to help improve the effects of atazanavir.
Danish: cobicistat, en booster (farmakokinetisk forstærkende stof) til at hjælpe med at forbedre atazanavirs virkning.
English: Buprenorphine/naloxone in combination with cobicistat
Danish: Buprenorphin/naloxon i kombination med cobicistat
English: If the combination is needed, the recommended dose of rifabutin is 150 mg 3 times per week on set days (for example Monday-Wednesday-Friday).
Danish: Hvis kombinationen er påkrævet, er den anbefalede rifabutin-dosis 150 mg 3 gange ugentligt på fastsatte dage (for eksempel mandag-onsdag-fredag).
English: Virologic response rate was evaluated in both treatment arms and virologic response was defined as achieving an undetectable viral load (<50 HIV-1 RNA copies/ml).
Danish: Virologisk responshastighed blev evalueret i begge behandlingsgrupper og virologisk respons blev defineret som opnåelse af et ikke målbart viralt load (< 50 hiv-1-RNA-kopier/ml).
English: Atazanavir increased opacity of bovine corneas in an in vitro ocular irritation study, indicating it may be an ocular irritant upon direct contact with the eye.
Danish: Atazanavir øgede opaciteten af bovine corneae i et in vitro okulært irritationsstudie, hvilket tyder på, at det kan være en okulær irritant ved direkte kontakt med øjet.
English: Although this study presented some limitations (i.e., unbound drug concentrations not studied), results suggested that the atazanavir pharmacokinetic parameters were decreased by 30% to 50% in patients undergoing haemodialysis compared to patients with normal renal function.
Danish: Selvom dette studie havde nogle begrænsninger (f.eks. blev koncentrationen af ubundet lægemiddel ikke undersøgt), antydede resultaterne, at de farmakokinetiske parametre for atazanavir blev nedsat med 30-50% hos patienter i hæmodialysebehandling i forhold til patienter med en normal nyrefunktion.
English: Advice on missed doses
Danish: Anbefalinger ved glemte doser
English: How to take EVOTAZ 4.
Danish: Sådan skal du tage EVOTAZ 4.
English: Buspirone Clorazepate Diazepam Estazolam Flurazepam Zolpidem
Danish: Buspiron Clorazepat Diazepam Estazolam Flurazepam Zolpidem
English: If EVOTAZ is co-administered with parenteral midazolam, it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Danish: Hvis EVOTAZ administreres sammen med parenteral midazolam, bør dette foregå på en intensivafdeling eller tilsvarende afdeling, som sikrer tæt klinisk monitorering og relevant behandling i tilfælde af respirationsdepression og/eller forlænget sedation.
English: No significant effect on didanosine and stavudine concentrations was observed.
Danish: Der er ikke set signifikant påvirkning af didanosin- og stavudin-koncentrationerne.
English: Based on these data and because cobicistat is not expected to have a significant impact on the pharmacokinetics of NRTIs, the co-administration of EVOTAZ with these medicinal products is not expected to significantly alter the exposure of the co-administered medicinal products.
Danish: Baseret på disse data, og fordi cobicistat ikke forventes at have signifikant effekt på NRTI'ers farmakokinetik, forventes samtidig administration af EVOTAZ og disse lægemidler ikke at påvirke de samtidig administrerede lægemidlers eksponering i signifikant grad.
English: The recommended adult dose of EVOTAZ is one tablet daily by mouth and with food, in combination with other anti-HIV medicines.
Danish: Den anbefalede dosis af EVOTAZ til voksne er en tablet dagligt, taget gennem munden i forbindelse med et måltid og i kombination med anden hiv-medicin.
English: Increased monitoring for rifabutin-associated adverse reactions including neutropenia and uveitis is warranted due to an expected increase in exposure to rifabutin.
Danish: Øget overvågning for rifabutinassocierede bivirkninger, inklusive neutropeni og uveitis, er påkrævet pga. en forventet øget rifabutin-eksponering.
English: Co-administration of EVOTAZ and rivaroxaban may result in increased exposure to rivaroxaban and may lead to increased bleeding.
Danish: Samtidig administration af EVOTAZ og rivaroxaban kan medføre øget eksponering for rivaroxaban og kan medføre øget blødning.
English: EVOTAZ may be used by adults aged 18 years of age and older who are infected with HIV, the virus that causes acquired immunodeficiency syndrome (AIDS).
Danish: EVOTAZ kan anvendes af voksne fra 18 år og derover, som er smittet med hiv-virus, som fører til aids (acquired immunodeficiency syndrom - erhvervet immundefektsyndrom).
English: Atazanavir has been shown in vivo not to induce its own metabolism, nor to increase the biotransformation of some medicinal products metabolised by CYP3A4.
Danish: Atazanavir har vist sig hverken at inducere dets egen metabolisme in vivo eller at øge biotransformationen af visse lægemidler, der metaboliseres af CYP3A4.
English: Eye disorders very common ocular icterus
Danish: Øjne meget almindelig okulær icterus
English: A long-term carcinogenicity study of cobicistat in rats revealed tumourigenic potential specific for this species that is regarded as of no relevance for humans.
Danish: Et langvarigt karcinogenicitetsstudie af cobicistat hos rotter afslørede tumorgenicitetspotentiale specifikt for denne art, hvilket vurderes at være uden relevans for mennesker.
English: Given that cobicistat has been shown to have no significant effect on methadone concentrations, no interaction is expected if methadone is co-administered with EVOTAZ.
Danish: Eftersom cobicistat har vist sig ikke at have nogen signifikant effekt på methadon-koncentrationen, forventes der ikke nogen interaktion, hvis methadon administreres sammen med EVOTAZ.
English: Some examples include, but are not limited to, itraconazole, ketoconazole and voriconazole (see Table 1).
Danish: Eksempler omfatter, men er ikke begrænset til, itraconazol, ketoconazol og voriconazol (se Tabel 1).
English: Following a single 400 mg dose of [14C]atazanavir, 79% and 13% of the total radioactivity was recovered in the faeces and urine, respectively.
Danish: Efter en enkelt dosis på 400 mg [14C]-atazanavir, blev henholdsvis 79% og 13% af den totale radioaktivitet genfundet i fæces og urin.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT AND BOTTLE LABEL 1.
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON OG ETIKET TIL BEHOLDER 1.
English: It is unknown if cobicistat, the other component of EVOTAZ, is excreted in human milk but it has been shown in animals that it is excreted in milk.
Danish: Det vides ikke, om cobicistat, som er det andet stof i EVOTAZ, udskilles i modermælken hos mennesker, men det er påvist hos dyr, at det udskilles i mælken.
English: In clinical studies, paediatric patients 3 months to less than 18 years of age had a mean duration of treatment with atazanavir of 115 weeks.
Danish: Pædiatriske patienter fra 3 måneder til under 18 år havde i kliniske studier en gennemsnitlig behandlingsvarighed med atazanavir på 115 uger.
English: Alternative antiretroviral therapy to EVOTAZ may be considered if jaundice or scleral icterus is unacceptable to a patient.
Danish: Anden antiretroviral behandling end EVOTAZ kan overvejes såfremt gulsot eller scleral icterus ikke er acceptabelt for patienten.
English: The rates of study drug discontinuation due to bilirubin-related adverse events were low and similar in both groups (4.9% in the cobicistat-boosted group and 4.0% in the ritonavir-boosted group).
Danish: Antallet af seponeringer af lægemidlet på grund af bilirubin-relaterede bivirkninger var lavt og sammenligneligt i de to grupper (4,9% i den cobicistat-boostede gruppe og 4,0% i den ritonavir-boostede gruppe).
English: Haemophiliac patients should, therefore, be made aware of the possibility of increased bleeding.
Danish: Hæmofilipatienter bør derfor være opmærksomme på risikoen for øget blødning.
English: ANTIPSYCHOTICS Pimozide
Danish: ANTIPSYKOTIKA Pimozid
English: Sildenafil is also used for the treatment of erectile dysfunction.
Danish: Sildenafil bruges også til behandling af erektil dysfunktion.
English: EVOTAZ or any other medicinal product containing atazanavir should be discontinued if severe rash develops.
Danish: EVOTAZ eller ethvert andet lægemiddel, der indeholder atazanavir, bør seponeres, hvis der udvikles alvorligt udslæt.
English: Particular caution should be used when prescribing PDE5-inhibitors (sildenafil, tadalafil, vardenafil, or avanafil) for the treatment of erectile dysfunction in patients receiving EVOTAZ.
Danish: Der bør udvises særlig forsigtighed ved ordinering af PDE5-hæmmere (sildenafil, tadalafil, vardenafil eller avanafil) til behandling af erektil dysfunktion hos patienter, der får EVOTAZ.
English: A moderate amount of data in pregnant women (between 300-1000 pregnancy outcomes) indicates no malformative toxicity of atazanavir.
Danish: Data fra anvendelse af atazanavir hos et begrænset antal gravide kvinder (mellem 300-1000 graviditeter) indikerer ingen misdannelser.
English: Data from concomitant use of parenteral midazolam with other protease inhibitors suggest a possible 3-4 fold increase in midazolam plasma levels.
Danish: Data vedrørende samtidig brug af parenteral midazolam og andre proteasehæmmere tyder på en mulig 3-4 gange stigning i midazolamplasmaniveauerne.
English: A long-term carcinogenicity study in mice did not show any carcinogenic potential.
Danish: Et langvarigt karcinogenicitetsstudie med mus viste ingen karcinogenicitet.
English: A safe and effective dose in combination with EVOTAZ has not been established for sildenafil when used to treat pulmonary arterial hypertension.
Danish: Der er ikke fastlagt en sikker og effektiv dosis for sildenafil i kombination med EVOTAZ til behandling af pulmonal arteriel hypertension.
English: It is important that you do not miss any doses of EVOTAZ or your other anti-HIV medicines.
Danish: Det er vigtigt, at du ikke glemmer at tage EVOTAZ eller anden hiv-medicin.
English: What you need to know before you take EVOTAZ 3.
Danish: Det skal du vide, før du begynder at tage EVOTAZ 3.
English: The recommendations given for concomitant use of atazanavir and other medicinal products may, therefore, differ depending on whether atazanavir is boosted with ritonavir or cobicistat.
Danish: Anbefalingerne vedrørende samtidig brug af atazanavir og andre lægemidler kan derfor være forskellige afhængig af, om atazanavir boostes med ritonavir eller cobicistat.
English: The recommended dose of EVOTAZ is one tablet once daily taken orally with food (see section 5.2).
Danish: Den anbefalede dosis af EVOTAZ er en tablet en gang dagligt indtaget oralt med mad (se pkt.
English: For patients who are taking tenofovir DF, it is not recommended to co-administer EVOTAZ with an H2-receptor antagonist.
Danish: Hos patienter, som tager tenofovir DF, bør EVOTAZ ikke administreres med en H2-receptorantagonist.
English: Co-administration of EVOTAZ and hormonal contraceptives should be avoided.
Danish: Samtidig administration af EVOTAZ og hormonelle antikonceptionsmidler bør undgås.
English: Atazanavir demonstrates nonlinear pharmacokinetics with greater than dose-proportional increases in AUC and Cmax values over the dose range of 200 mg to 800 mg once daily.
Danish: Atazanavir udviser non-lineær farmakokinetik med større end dosis-proportionale stigninger i AUC og Cmax-værdier i dosisintervallet 200 mg til 800 mg en gang dagligt.
English: There are limited data from the use of EVOTAZ in pregnant women.
Danish: Der foreligger kun begrænsede data for anvendelse af EVOTAZ hos gravide kvinder.
English: Similar concentrations of atazanavir increased by 13% the action potential duration (APD90) in rabbit Purkinje fibres study.
Danish: Tilsvarende atazanavir-koncentration øgede varigheden af aktionspotentialet (ADP90) med 13% i et studie af kanin Purkinjefibre.
English: The median baseline plasma HIV-1 RNA was 4.81 log10 copies/ml (range: 3.21-6.44).
Danish: Median plasma hiv-1 RNA ved baseline var 4,81 log10 kopier/ml (3,21-6,44).
English: Dose titration of the calcium channel blockers should be considered.
Danish: Dosistitrering af calciumkanalblokkerne bør ovevejes.
English: For the treatment of erectile dysfunction, it is recommended that when co-administered with EVOTAZ, sildenafil should be used with caution at reduced doses of 25 mg every 48 hours; tadalafil should be used with caution at reduced doses of 10 mg every 72 hours; vardenafil should be used with caution at reduced doses of no more than 2.5 mg every 72 hours.
Danish: Til behandling af erektil dysfunktion og ved samtidig administration af EVOTAZ bør sildenafil anvendes med forsigtighed og ved reduceret dosis på 25 mg hver 48. time; tadalafil bør anvendes med forsigtighed ved reduceret dosis på 10 mg hver 72. time; vardenafil bør anvendes med forsigtighed ved reduceret dosis på højst 2,5 mg hver 72. time.
English: However, a higher percentage of subjects in the atazanavir boosted with cobicistat group had increases in total bilirubin > 2 x ULN than those in the atazanavir boosted with ritonavir group (88.0% versus 80.9%).
Danish: Imidlertid havde en højere procentdel af personerne i den cobicistat-boostede atazanavir-gruppe forhøjelser i total-bilirubin > 2 x ULN end i den ritonavirboostede atazanavir-gruppe (88,0% versus 80,9%).
English: Some examples include, but are not limited to etravirine, nevirapine, efavirenz, boceprevir, fluticasone and bosentan (see Table 1).
Danish: Eksempler omfatter, men er ikke begrænset til, etravirin, nevirapin, efavirenz, boceprevir, fluticason og bosentan (se Tabel 1).
English: Talk to your doctor about breast-feeding if you are taking EVOTAZ.
Danish: Tal med lægen om amning, hvis du tager EVOTAZ.
English: Carbamazepine Phenobarbital Phenytoin
Danish: Carbamazepin Phenobarbital Phenytoin
English: Co-administration warrants clinical monitoring for sedation and cognitive effects.
Danish: Samtidig administration kræver overvågning for sedation og kognitiv påvirkning.
English: Ex vivo rabbit studies and in vivo dog studies suggest that cobicistat has a low potential for QT prolongation, and may slightly prolong the PR interval and decrease left ventricular function at mean concentrations at least 10-fold higher than the human exposure at the recommended 150 mg daily dose.
Danish: Ex vivo-studier af kaniner og in vivo-studier af hunde tyder på, at cobicistat har et lavt potentiale for QT-forlængelse, og kan forlænge PR-intervallet let og reducere den venstre ventrikelfunktion ved gennemsnitlige koncentrationer, der er mindst 10 gange højere end den humane eksponering ved den anbefalede daglige dosis på 150 mg.
English: In in vivo studies in rats, atazanavir did not induce micronuclei in bone marrow, DNA damage in duodenum (comet assay), or unscheduled DNA repair in liver at plasma and tissue concentrations exceeding those that were clastogenic in vitro.
Danish: I in vivo-studier hos rotter inducerede atazanavir ikke mikronukleus i knoglemarv, DNA-beskadigelse i duodenum (comet assay) eller ikke-planlagt DNA-reparation i leveren ved plasma- og vævskoncentrationer, der overskrider dem, der var klastogene in vitro.
English: In a multiple-dose study in HIV-infected patients dosed with 400 mg of atazanavir once daily with a light meal for 12 weeks, atazanavir was detected in the cerebrospinal fluid and semen.
Danish: I et flerdosis-studie med hiv-inficerede patienter, der fik 400 mg atazanavir én gang dagligt med et let måltid i 12 uger, kunne atazanavir påvises i cerebrospinalvæsken og sæd.
English: Co-administration with antiretroviral medicinal products EVOTAZ is indicated for use with other antiretrovirals for the treatment of HIV-1 infection.
Danish: Samtidig administration af antiretrovirale lægemidler EVOTAZ er indiceret til anvendelse sammen med andre antiretrovirale lægemidler til behandling af hiv-1-infektion.
English: There are currently inadequate data to determine whether co-administration of tenofovir disoproxil and cobicistat is associated with a greater risk of renal adverse reactions compared with regimens that include tenofovir disoproxil without cobicistat.
Danish: På nuværende tidspunkt foreligger der ikke tilstrækkelig data til at kunne fastslå om samtidig administration af tenofovirdisoproxil og cobicistat er associeret med en øget risiko for nyrebivirkninger sammenlignet med samtidig behandling med tenofovirdisoproxil uden cobicistat.
English: Discontinued study drug due to other reasons and last available HIV-1 RNA <50 copies/mle
Danish: Seponeret studielægemiddel som følge af andre årsager, og sidste tilgængelige hiv-1 RNA <50 kopier/mle
English: EVOTAZ should not be used in combination with products containing the same active components including atazanavir, cobicistat or with fixed-dose products that contain cobicistat.
Danish: EVOTAZ bør ikke anvendes sammen med lægemidler med det samme aktive stof, inklusiv atazanavir, cobicistat eller med lægemidler med fast dosering, som indeholder cobicistat.
English: Stevens-Johnson syndromea,b, vesiculobullous rash, eczema, vasodilatation
Danish: Stevens-Johnsons syndroma,b, vesikulobulløst udslæt, eksem, vasodilatation
English: Hyperbilirubinaemia (an increase in the level of bilirubin in the blood) has occurred in patients receiving EVOTAZ.
Danish: Gulsot (hyperbilirubinæmi, stigning i niveauet af bilirubin i blodet) er forekommet hos patienter, som tager EVOTAZ.
English: No subject developed the tenofovir-associated resistance substitution K65R or K70E or any primary resistance substitution associated with protease inhibitors.
Danish: Ingen af forsøgspersonerne udviklede den tenofovir-relaterede resistenssubstitution K65R eller K70E eller nogen anden primær resistenssubstitution associeret med proteasehæmmere.
English: EVOTAZ film-coated tablets are supplied in bottles of 30 tablets.
Danish: EVOTAZ filmovertrukne tabletter fås i beholder med 30 tabletter.
English: Effects of co-administration of EVOTAZ on progestin and estrogen are unknown.
Danish: Effekten af samtidig administration af EVOTAZ på progestin og østrogen er ukendt.
English: Amlodipine Felodipine Nicardipine Nifedipine Verapamil
Danish: Amlodipin Felodipin Nicardipin Nifedipin Verapamil
English: Following oral administration of [14C]cobicistat, 86% and 8.2% of the dose were recovered in faeces and urine, respectively.
Danish: Efter oral administration af [14C]cobicistat blev henholdsvis 86% og 8,2% af dosis genfundet i fæces og urin.
English: Plasma levels of cobicistat and consequently of atazanavir may decrease significantly during pregnancy.
Danish: Cobicistatplasmaniveauerne, og som følge deraf atazanavirplasmaniveauerne, kan reduceres betydeligt under graviditet.
English: An increase of > 3 x ULN in alanine aminotransferase or aspartate aminotransferase was recorded in 12.8% of subjects in the cobicistat-boosted group and 9.0% in the ritonavir-boosted group.
Danish: En stigning på > 3 x ULN i alaninaminotransferase eller aspartataminotransferase blev registreret hos 12,8% af forsøgspersonerne i den cobicistat-boostede gruppe og hos 9,0% i den ritonavir-boostede gruppe.
English: If EVOTAZ is missed within 12 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of EVOTAZ with food as soon as possible.
Danish: Hvis EVOTAZ glemmes i mindre end 12 timer efter tidspunktet, hvor det normalt tages, bør patienten instruereres i at tage den ordinerede dosis EVOTAZ sammen med mad så hurtigt som muligt.