FrancophonIA/ELRC3.0 huggingface dataset:
English: SEDATIVES/HYPNOTICS Buspirone
Danish: SEDATIVA/HYPNOTIKA Buspiron
English: These medicines are used to treat allergies, asthma, inflammatory bowel diseases, inflammatory conditions of the eyes, joints and muscles and other inflammatory conditions.
Danish: Disse lægemidler anvendes til behandling af allergier, astma, inflammatoriske (betændelseslignende) tarmsygdomme, inflammatoriske tilstande i øjne, led og muskler samt andre inflammatoriske tilstande.
English: Then take the next dose as usual in combination with atazanavir or darunavir.
Danish: Derefter tages den næste dosis som sædvanligt i kombination med atazanavir eller darunavir.
English: Tybost should not be used in combination with other medicinal products containing cobicistat or with ritonavir due to similar effects of cobicistat and ritonavir on CYP3A.
Danish: Tybost må ikke anvendes i kombination med andre lægemidler, der indeholder cobicistat, eller med samtidig med produkter ritonavir på grund af lignende virkninger af cobicistat og ritonavir på CYP3A.
English: Dose titration may be required for most medicinal products of the SSRI class, when co-administered with Tybost.
Danish: Dosistitrering kan være nødvendig for de fleste lægemidler i SSRI-klassen, når de administreres samtidig med Tybost.
English: • neuroleptics/antipsychotics: pimozide, lurasidone
Danish: • neuroleptika/antipsykotika: pimozid, lurasidon
English: INHALED BETA AGONISTS Salmeterol
Danish: INHALERET BETA-AGONIST Salmeterol
English: PHOSPHODIESTERASE TYPE-5 (PDE-5) INHIBITORS Sildenafil
Danish: PHOSPHODIESTERASE TYPE-5 (PDE-5) -HÆMMERE Sildenafil
English: No teratogenic effects were observed in rats and rabbit developmental toxicity studies.
Danish: Der blev ikke observeret nogen teratogene virkninger i udviklingstoksicitetsstudier med rotter og kaniner.
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 tumorgenicitet specifikt for denne art, som vurderes at være af ringe relevans for mennesker.
English: Plasma levels of cobicistat and consequently of atazanavir may decrease significantly during pregnancy.
Danish: Plasmaniveauer af cobicistat og følgelig af atazanavir kan nedsættes betydeligt under graviditet.
English: It does this by slowing down the breakdown of atazanavir and darunavir which will make them stay in the body for longer.
Danish: Tybost gør dette ved at sænke nedbrydningshastigheden af atazanavir og darunavir, hvilket vil få dem til at forblive i kroppen i længere tid.
English: Itraconazole Voriconazole Posaconazole Fluconazole
Danish: Itraconazol Voriconazol Posaconazol Fluconazol
English: Concentrations of these medicinal products may be increased when co-administered with Tybost resulting in the potential for increased adverse events usually associated with these anticancer medicinal products.
Danish: Koncentrationerne af disse lægemidler kan øges, når de administreres samtidig med Tybost, hvilket resulterer i risikoen for øgede bivirkninger, der sædvanligvis forbindes med disse anti-cancer lægemidler.
English: Darunavir given with low dose ritonavir may be considered as an alternative.
Danish: Darunavir givet sammen med lavdosis ritanavir kan overvejes som alternativ.
English: Drospirenone:
Danish: Drospirenon:
English:  Tell your doctor if you are taking these or any other medicines.
Danish:  Fortæl lægen, hvis De tager disse eller andre lægemidler.
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 en ikke måleligt viral load (< 50 hiv-1-rna-kopier/ml).
English: Systemic lidocaine Mexiletine
Danish: Systemisk lidocain Mexiletin Propafenon
English: • Tybost must be taken with atazanavir (300 mg) or darunavir (800 mg).
Danish: • Tybost må ikke tages sammen med atazanavir (300 mg) eller darunavir (800 mg).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with cobicistat in one or more subsets of the paediatric population in 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 cobicistat i en eller flere undergrupper af den pædiatriske population ved behandlingen af hiv-1-infektion (se pkt.
English: The safety and efficacy of cobicistat in children aged 0 to less than 18 years have not been established (see section 5.1).
Danish: Cobicistats sikkerhed og virkning hos børn i alderen 0 til under 18 år er ikke klarlagt (se pkt.
English: Increased monitoring for rifabutin-associated adverse reactions including neutropenia and uveitis is warranted due to an expected increase in exposure to desacetyl-rifabutin.
Danish: Det er nødvendigt at udføre øget overvågning for rifabutin-associerede bivirkninger, herunder neutropeni og uveitis på grund af en forventet øget eksponering over for desacetyl-rifabutin.
English: • ciclosporin, sirolimus and tacrolimus, medicines used to control your body's immune response after a transplant
Danish: • ciclosporin, sirolimus og tacrolimus, lægemidler, der anvendes til at kontrollere kroppens immunrespons efter en transplantation
English: If a patient misses a dose of Tybost by more than 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Danish: Hvis patienten glemmer at tage en dosis Tybost i mere end 12 timer, skal patienten ikke tage den manglende dosis, men blot fortsætte med den normale doseringsplan.
English: • high sugar levels in the blood (hyperglycaemia)
Danish: • høje sukkerniveauer i blodet (hyperglykæmi)
English: It is recommended that the international normalised ratio (INR) be monitored upon co-administration with Tybost.
Danish: Det anbefales at overvåge den internationale normaliserede ratio (INR) ved samtidig administration af Tybost.
English: • metformin, medicine used for the treatment of type 2 diabetes
Danish: • metformin, lægemiddel, der anvendes til at behandle type 2-diabetes
English: Cmin: NC Ethinyloestradiol:
Danish: Cmin: NC Ethinylestradiol:
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: Raterne for seponering af lægemidlet på grund af bilirubin-relaterede bivirkninger var lave og sammenlignelige i de 2 grupper (4,9 % i den cobicistat-boostede gruppe og 4,0 % i den ritonavir-boostede gruppe).
English: • protein in the urine (proteinuria)
Danish: • protein i urinen (proteinuri)
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 en lav risiko for QT-forlængelse, og kan forlænge PR-intervallet let og reducere den venstre ventrikelfunktion ved gennemsnitlige koncentrationer, der er mindst10 gange højere end den humane eksponering ved den anbefalede daglige dosis på 150 mg.
English: • aching muscles, weakness
Danish: • ømme muskler, svaghed
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: Der er på nuværende tidspunkt ikke tilstrækkelige data til at afgøre, om samtidig administration af tenofovirdisoproxil og cobicistat er forbundet med en højere risiko for nyrebivirkninger sammenlignet med behandling, der inkluderer tenofovirdisoproxil uden cobicistat.
English: For the treatment of erectile dysfunction, it is recommended that a single dose of sildenafil no more than 25 mg in 48 hours, vardenafil no more than 2.5 mg in 72 hours, or tadalafil no more than 10 mg in 72 hours be co-administered with Tybost.
Danish: Til behandling af erektionsproblemer anbefales det, at en enkeltdosis af sildenafil på ikke over 25 mg hver 48. time, vardenafil på ikke over 2,5 mg hver 72. time eller tadalafil på ikke over 10 mg hver 72. time administreres sammen med Tybost.
English: • antimycobacterials: rifampicin
Danish: • antimykobakterielle lægemidler: rifampicin
English: Metabolism and nutrition disorders: Common:
Danish: Metabolisme og ernæring: Almindelig:
English: Cmin: NC Ethinyloestradiol: AUC: ↓ 30%
Danish: Cmin: NC Ethinylestradiol: AUC: ↓ 30 %
English: Tybost [Outer packaging only]
Danish: Tybost [kun på den ydre emballage]
English: Of these 692 patients, 613 (300 atazanavir/cobicistat and 313 atazanavir/ritonavir) and 496 (250 atazanavir/cobicistat and 246 atazanavir/ritonavir) received at least 48 and 144 weeks of treatment, respectively.
Danish: Ud af disse 692 patienter fik 613 (300 atazanavir/cobicistat og 313 atazanavir/ritonavir) og 496 (250 atazanavir/cobicistat og 246 atazanavir/ritonavir) hhv. mindst 48 og 144 ugers behandling.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of cobicistat/metabolites in milk.
Danish: De tilgængelige farmakodynamiske/toksikologiske data fra dyrestudier viser, at cobicistat/metabolitter udskilles i mælk.
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 adverse event, død eller manglende eller svigtende virkning, f.eks. tilbagetrækning af samtykke, tabt for opfølgning.
English: Some examples include, but are not limited to, etravirine, efavirenz, nevirapine, and bosentan (see Table 2).
Danish: Sådanne eksempler omfatter, men er ikke begrænset til etravirin, efavirenz, nevirapin og bosentan (se tabel 2).
English: Discontinued study drug due to other reasons and last available HIV-1 RNA < 50 copies/mle
Danish: Seponerede studiemedicin som følge af andre årsager, og sidste tilgængelige hiv-1-rna < 50 kopier/mle
English: An increase of > 3 x ULN in alanine aminotransferase or aspartate aminotransferase was recorded in 12.8% of subjects in the cobicistatboosted 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: No data are available on which to make a dose recommendation for patients over the age of 65 years (see section 5.2).
Danish: Ældre Der foreligger ingen data, hvorpå der kan laves en dosisanbefaling til patienter over 65 år (se pkt.
English: • ergot derivatives: dihydroergotamine, ergometrine, ergotamine
Danish: • ergot-derivativer: dihydroergotamin, ergometrin, ergotamin
English: Other types of medicine: • ketoconazole, itraconazole, voriconazole, posaconazole and fluconazole, medicines used to treat fungal infections
Danish: Andre typer lægemidler: • ketoconazol, itraconazol, voriconazol, posaconazol og fluconazol, lægemidler, der anvendes til at behandle svampeinfektioner
English: If the patient misses a dose of Tybost within 12 hours of the time it is usually taken, the patient should take Tybost with food as soon as possible and resume their normal dosing schedule in combination with atazanavir or darunavir.
Danish: Hvis patienten glemmer at tage en dosis Tybost i mindre end 12 timer efter tidspunktet, hvor patienten normalt tager dosen, skal patienten tage Tybost sammen med mad så snart som muligt og derefter fortsætte med deres normale doseringsplan i kombination med atazanavir eller darunavir.
English: • Do not breast-feed during treatment with Tybost.
Danish: • De må ikke amme, mens De er i behandling med Tybost.
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 hhv. 86 % og 8,2 % af dosis genfundet i fæces og urin.
English: Following oral administration of cobicistat with food in HIV-1 infected subjects, peak plasma concentrations were observed 4 hours post-dose for cobicistat.
Danish: Efter oral administration af cobicistat sammen med mad hos hiv-1-inficerede personer blev maksimale plasmakoncentrationer observeret 4 timer efter dosering for cobicistat.
English: Animal studies do not indicate harmful effects of cobicistat on fertility.
Danish: Dyrestudier indikerer ikke skadelige virkninger af cobicistat på fertiliteten.
English: Discontinued study drug due to AE or deathd
Danish: Seponerede studiemedicin som følge af AE (adverse event) eller dødd
English: Contents of the pack and other information What Tybost contains
Danish: Pakningsstørrelser og yderligere oplysninger Tybost indeholder:
English: • increased levels of bilirubin in the blood (hyperbilirubinaemia)
Danish: • øgede niveauer af bilirubin i blodet (hyperbilirubinæmi)
English: At week 96 the mean change in serum creatinine was 0.07 ± 0.15 mg/dl and the mean change in eGFR by Cockcroft-Gault method was -6.2 ± 9.07 ml/min.
Danish: Ved uge 96 var middelændringen i serum-kreatinin 0,07 ± 0,15 mg/dl, og middelændringen i eGFR var -6,2 ± 9,07 ml/min efter Cockcroft-Gault-metoden.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter alvorlighed.
English: Recommendation concerning co-administration with cobicistat 150 mg and atazanavir or darunavir
Danish: samtidig administration af cobicistat 150 mg og atazanavir eller darunavir
English: Animal studies do not indicate direct or indirect harmful effects of cobicistat with respect to reproductive toxicity (see section 5.3).
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger af cobicistat hvad angår reproduktionstoksicitet (se pkt.
English: Viruses were known to be susceptible to atazanavir, emtricitabine and tenofovir disoproxil fumarate at baseline.
Danish: Vira var kendt som værende følsomme over for atazanavir, emtricitabin og tenofovirdisoproxilfumarat ved baseline.
English: What you need to know before you take Tybost Do not take Tybost
Danish: Det skal De vide, før De begynder at tage Tybost Tag ikke Tybost
English: • PDE-5 inhibitors: sildenafil for treatment of pulmonary arterial hypertension
Danish: • PDE-5-hæmmere: sildenafil til behandling af pulmonal arteriel hypertension
English: Co-administration of cobicistat and rifabutin is not recommended.
Danish: Samtidig administration af cobicistat og rifabutin anbefales ikke.
English: ANTI-INFECTIVES Antifungals Ketoconazole
Danish: ANTI-INFEKTIVA Antimykotika Ketoconazol
English: Medicinal products that are extensively metabolised by CYP3A and have high first pass metabolism appear to be the most susceptible to large increases in exposure when co-administered with cobicistat.
Danish: Lægemidler, der i udstrakt grad metaboliseres af CYP3A og har høj førstepassage-metabolisme, synes at være mest påvirkelige over for store stigninger i eksponering, når de administreres samtidigt med cobicistat.
English: PDE-5 inhibitors are primarily metabolised by CYP3A.
Danish: PDE-5-hæmmere metaboliseres primært af CYP3A.
English: • vomiting, diarrhoea, stomach pain, problems with digestion resulting in pain after meals
Danish: • opkastning, diarré, mavesmerter, fordøjelsesproblemer, som resulterer i smerter efter måltider
English: • anticonvulsants: carbamazepine, phenobarbital, phenytoin
Danish: • antikonvulsiva: carbamazepin, phenobarbital, phenytoin
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: No human data on the effect of cobicistat on fertility are available.
Danish: Der foreligger ingen humane data vedrørende virkningen af cobicistat på fertilitet.
English: ANTI-NEOPLASTICS Dasatinib
Danish: ANTI-NEOPLASTIKA Dasatinib
English: • Talk to your doctor or pharmacist if you have or have had severe liver disease, or if tests have shown problems with your liver.
Danish: • Tal med lægen eller apotekspersonalet, hvis De har eller har haft svær leversygdom, eller hvis prøver har vist problemer med Deres lever.
English: Cobicistat is primarily metabolised and eliminated by the liver.
Danish: Cobicistat metaboliseres og udskilles primært i leveren.
English: It is recommended to start with the lowest recommended dose of rosuvastatin and titrate based on clinical response while monitoring for safety (e.g. myopathy).
Danish: Det anbefales at starte med den laveste anbefalede dosis rosuvastatin og titrere baseret på klinisk respons, mens der monitoreres for sikkerhed (f.eks. myopati).
English: Cobicistat inhibits the transporters P-gp, BCRP, MATE1, OATP1B1 and OATP1B3.
Danish: Cobicistat hæmmer transportstofferne P-gp, BCRP, MATE1, OATP1B1 og OATP1B3.
English: Tybost film-coated tablets are orange, round, biconvex tablets, debossed on one side with “GSI” and plain-faced on the other side of the tablet.
Danish: Tybost filmovertrukne tabletter er orange, runde, bikonvekse tabletter, som er præget med "GSI" på den ene side og glatte på den anden side af tabletten.
English: For these neuroleptics, consider reducing the dose of the neuroleptic upon co-administration with Tybost.
Danish: For disse neuroleptika skal en reduktion af dosis af neuroleptika overvejes ved samtidig administration af Tybost.
English: • antiarrhythmics: amiodarone, quinidine
Danish: • antiarytmika: amiodaron, quinidin
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 eksponeringer er non-lineare og større end dosis-proportionale i området 50 mg til 400 mg, og i overensstemmelse med den mekanisme baserede CYP3A-hæmmer.
English: When administering ketoconazole with Tybost, the maximum daily dose of ketoconazole should not exceed 200 mg per day.
Danish: Når der administreres ketoconazol samtidig med Tybost, bør den maksimale daglige dosis af ketoconazol ikke overskride 200 mg dagligt.
English: If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8).
Danish: Ved overdosering skal patienten monitoreres for tegn på toksicitet (se pkt.
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: De 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: Among the 19 patients, 1 developed the emtricitabine-associated resistance substitution M184V with no tenofovir- or primary protease inhibitor-associated resistance substitutions.
Danish: Blandt de 19 patienter udviklede 1 emtricitabin-associeret resistenssubstitution M184V uden tenofovir- eller primær proteasehæmmer-associerede resistenssubstitutioner.
English: Tybost should be taken orally, once daily with food (see section 5.2).
Danish: Tybost skal tages oralt, én gang dagligt, sammen med mad (se pkt.
English: When administering with cobicistat, the maximum daily dose of itraconazole should not exceed 200 mg per day.
Danish: Ved samtidig administration af cobicistat bør den maksimale daglige dosis af itraconazol ikke overskride 200 mg dagligt.
English: Cobicistat has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine.
Danish: Cobicistat reducerer den estimerede kreatininclearance på grund af hæmning af den tubulære sekretion af kreatinin.
English: Macrolide antibiotics Clarithromycin
Danish: Makrolidantibiotika Clarithromycin
English: Some examples include, but are not limited to, itraconazole, ketoconazole, and voriconazole (see Table 2).
Danish: Nogle eksempler omfatter, men er ikke begrænset til itraconazol, ketoconazol og voriconazol (se tabel 2).
English: hyperglycaemia, increased appetite Psychiatric disorders:
Danish: hyperglykæmi, øget appetit Psykiske forstyrrelser: Almindelig:
English: The substantial reduction in darunavir exposure may result in virological failure and an increased risk of mother-to-child transmission of HIV infection.
Danish: Den væsentlige nedsættelse i eksponering for darunavir kan medføre virologisk svigt og en øget risiko for overførsel af hiv-infektion fra mor til barn.
English: • sildenafil and vardenafil, medicines used to treat impotence, and tadalafil, a medicine used to treat impotence and pulmonary hypertension
Danish: • sildenafil og vardenafil, lægemidler, der anvendes til at behandle impotens og tadalafil, et lægemiddel, der anvendes til at behandle impotens og pulmonal hypertension
English: When co-administering maraviroc and Tybost patients should receive maraviroc 150 mg twice daily.
Danish: Når der administreres maraviroc og Tybost samtidig, skal patienten have maraviroc 150 mg to gange dagligt.
English: headache, dizziness, somnolence, dysgeusia
Danish: hovedpine, svimmelhed, somnolens, dysgeusi
English: Cobicistat is a weak CYP2D6 inhibitor and is metabolised to a minor extent by CYP2D6.
Danish: Cobicistat er en svag CYP2D6-hæmmer, og metaboliseres i mindre grad af CYP2D6.
English: The effect of severe hepatic impairment (Child-Pugh Class C) on the pharmacokinetics of cobicistat has not been studied.
Danish: Virkningen af svært nedsat leverfunktion (Child-Pugh klasse C) på cobicistats farmakokinetik er ikke undersøgt.
English: Tablet core Croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicon dioxide.
Danish: Tabletkerne Croscarmellosenatrium, magnesiumstearat, mikrokrystallinsk cellulose, siliciumdioxid.
English: • sleep disorder
Danish: • søvnforstyrrelse
English: The steady-state mean Cmax, AUCtau, and Ctrough (mean ± SD) following multiple doses of cobicistat in HIV-1 infected subjects (n = 68), respectively, were 1.2 ± 0.3 µg/ml, 10.9 ± 3.8 µg•h/ml, and 0.07 ± 0.07 µg/ml.
Danish: Steady-state gennemsnitlige værdier for hhv. Cmax, AUCtau og Ctrough (gennemsnit ± SD) efter flere doser af cobicistat hos hiv-1-inficerede personer (n = 68), var 1,2 ± 0,3 μg/ml, 10,9 ± 3,8 μg•t/ml og 0,07 ± 0,07 μg/ml.
English: Therefore, Tybost should not be co-administered with medicinal products that include, but are not limited to, the following (see sections 4.4 and 4.5):
Danish: Derfor bør Tybost ikke administreres samtidig med lægemidler, som omfatter, men ikke er begrænset til, de følgende (se pkt.
English: Higher plasma concentrations of co-administered medicinal products can result in increased or prolonged therapeutic effects or adverse reactions.
Danish: Højere plasmakoncentrationer af samtidigt indgivne lægemidler kan resultere i øgede eller forlængede terapeutiske virkninger eller bivirkninger.
English: Percentage of subjects with CD4+ cell count ≤ 200 cells/mm3
Danish: Procentdel af personer med CD4+ celletal < 200 celler/mm3
English: Adverse reactions for cobicistat-boosted atazanavir were consistent with the safety profile of ritonavirboosted atazanavir.
Danish: Bivirkninger for cobicistat-boostet atazanavir var konsistente med sikkerhedsprofilen for ritonavirboostet atazanavir.
English: ANTICOAGULANTS Dabigatran
Danish: ANTICOAGULANTIA Dabigatran
English: If you do miss a dose and notice:
Danish: Hvis De har glemt at tage en dosis og kommer i tanker om det:
English: Tybost taken with atazanavir or darunavir should not be used with another antiviral medicine that requires boosting.
Danish: Tybost taget med atazanavir eller darunavir må ikke anvendes sammen med andre antivirale lægemidler, der kræver forstærkning.