FrancophonIA/ELRC3.0 huggingface dataset:
English: Sunset yellow FCF aluminium lake (E110), macrogol 3350 (E1521), polyvinyl alcohol (partially hydrolysed) (E1203), talc (E553B), titanium dioxide (E171), iron oxide yellow (E172) (see section 2 of this leaflet).
Danish: Sunset yellow FCF aluminium lake (E110), macrogol 3350 (E1521), polyvinylalkohol (delvist hydrolyseret) (E1203), talkum (E553B), titandioxid (E171), gul jernoxid (E172) (se punkt 2 i denne indlægsseddel).
English: • trazodone, a medicine used to treat depression
Danish: • trazodon, et lægemiddel, der anvendes til at behandle depression
English: thioridazine, zolpidem, medicines used to treat nervous system disorders
Danish: thioridazin, zolpidem, lægemidler, der anvendes til at behandle lidelser i nervesystemet
English: It is important not to miss a dose of Tybost.
Danish: Det er vigtigt, at De husker at tage hver dosis af Tybost.
English: Tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (HIV-1) infected adults.
Danish: Tybost er indiceret som en farmakokinetisk booster af atazanavir 300 mg én gang dagligt eller darunavir 800 mg én gang dagligt som del af antiretroviral kombinationsterapi hos voksne inficeret med humant immundefekt virus 1 (hiv-1).
English: Renal and urinary disorders: Uncommon:
Danish: Nyrer-og urinveje: Ikke almindelig:
English: The effect of cobicistat on serum creatinine and eGFR in patients switching from ritonavir to cobicistat in Study GS-US-236-0118 was consistent with the effect in treatmentnaïve patients in Study GS-US-216-0114.
Danish: Cobicistats virkning på serum-kreatinin og eGFR hos patienter, som skiftede fra ritonavir til cobicistat i studie GS-US-236-0118, var konsistent med virkningen hos behandlingsnaive patienter i studie GS-US-216-0114.
English: All corticosteroids excluding cutaneous products Corticosteroids primarily metabolised by CYP3A (including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone).
Danish: Alle kortikosteroider med undtagelse af kutane produkter Kortikosteroider, der primært metaboliseres via CYP3A (bl.a. betamethason, budesonid, fluticason, mometason, prednison og triamcinolon).
English: For medicinal products metabolised by CYP3A these higher plasma concentrations may potentially lead to serious and/or life-threatening events (see section 4.3).
Danish: For lægemidler, der metaboliseres af CYP3A, kan sådanne højere plasmakoncentrationer potentielt medføre alvorlige og/eller livstruende hændelser (se pkt.
English: • bosentan, a medicine used to treat pulmonary arterial hypertension
Danish: • bosentan, et lægemiddel, der anvendes til at behandle pulmonal arteriel hypertension
English: The active substance cobicistat is persistent in the environment.
Danish: Det aktive stof cobicistat nedbrydes ikke i miljøet.
English: Female
Danish: Kvinde
English: No dose adjustment of cobicistat is required.
Danish: Ingen dosisjustering af cobicistat er nødvendig.
English: High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 30 film-coated tablets and a silica gel desiccant.
Danish: Højdensitets-polyethylen (HDPE)-tabletbeholder med børnesikret lukke af polypropylen indeholdende 30 filmovertrukne tabletter sammen med silicagel-tørremiddel.
English: Caution should be exercised, including consideration of dose reduction, when co-administering Tybost with tadalafil for the treatment of pulmonary arterial hypertension.
Danish: Der bør udvises forsigtighed, og en dosisreduktion bør overvejes ved samtidig administration af Tybost og tadalafil til behandling af pulmonal arteriel hypertension.
English: In an analysis of treatment-failure subjects in Study GS-US-216-0114 through week 144, evaluable genotypic data from paired baseline and treatment-failure isolates were available for all 21 virologic failures in the cobicistat group.
Danish: I en analyse af forsøgspersoner, hvis behandling svigtede i studiet GS-US-216-0114 til og med uge 144, forelå der evaluerbare genotypiske data fra isolater parret ved baseline og efter behandlingssvigt for alle 21 virologiske svigt i cobicistat-gruppen.
English: Maraviroc is a substrate of CYP3A and its plasma concentration increases when co-administered with potent CYP3A inhibitors.
Danish: Maraviroc er et substrat for CYP3A og dets plasmakoncentration øges, når det administreres samtidig med potente CYP3A-hæmmere.
English: • atorvastatin, fluvastatin, pitavastatin, pravastatin and rosuvastatin, medicines used to lower cholesterol
Danish: • atorvastatin, fluvastatin, pitavastin, pravastatin og rosuvastatin, lægemidler, der anvendes til at sænke kolesterol
English: Stopping Tybost and atazanavir or darunavir may reduce the success of future treatments prescribed by your doctor.
Danish: Tybost samt atazanavir eller darunavir, kan det nedsætte, hvor vellykkede fremtidige behandlinger, ordineret af Deres læge, bliver.
English: HMG Co-A REDUCTASE INHIBITORS Fluvastatin
Danish: HMG CO-A REDUKTASEHÆMMERE Fluvastatin
English: • Talk to your doctor or pharmacist if you have or have had kidney disease, or if tests have shown problems with your kidneys.
Danish: • Tal med lægen eller apotekspersonalet, hvis De har eller har haft nyresygdom, eller hvis prøver har vist problemer med Deres nyrer.
English: NEUROLEPTICS Perphenazine Risperidone Thioridazine
Danish: NEUROLEPTIKA Perphenazin Risperidon Thioridazin
English: Median baseline plasma HIV-1 RNA (range)
Danish: Median plasma hiv-1-rna ved baseline (interval)
English: The most frequently reported adverse reactions to cobicistat-boosted atazanavir were associated with elevated bilirubin levels (see Table 3).
Danish: De hyppigst rapporterede bivirkninger over for cobicistat-boostet atazanavir var forbundet med forhøjede bilirubinniveauer (se tabel 3).
English: Orange, round, biconvex, film-coated tablet of diameter 10.3 mm, debossed with “GSI” on one side of the tablet and plain-faced on the other side of the tablet.
Danish: Orange, rund, bikonveks, filmovertrukken tablet, der er 10,3 mm i diameter, som er præget med "GSI" på den ene side, og glat på den anden side af tabletten.
English: Table 6: Demographic and baseline disease characteristics of antiretroviral treatment-naïve HIV-1 infected adult subjects in Study GS-US-216-0114
Danish: Tabel 6: Demografiske og baseline sygdomskarakteristika for antiretroviral-naive, hiv-1-inficerede voksne personer i studie GS-US-216-0114
English: • buspirone, clorazepate, diazepam, estazolam, flurazepam, perphenazine, risperidone,
Danish: • buspiron, clorazepat, diazepam, estazolam, flurazepam, perphenazin, risperidon,
English: • salmeterol, a medicine used to treat asthma
Danish: • salmeterol, et lægemiddel, der anvendes til at behandle astma
English: Tybost must not be used as a pharmacokinetic enhancer of any other HIV-1 protease inhibitor or any other antiretroviral medicinal product that requires boosting since dosing recommendations for such co-administration have not been established and may result in insufficient plasma level of the antiretroviral medicinal product(s) leading to loss of therapeutic effect and development of resistance (see section 4.2).
Danish: Tybost må ikke anvendes som en farmakokinetisk forstærker til andre hiv-1-proteasehæmmere eller andre antiretrovirale lægemidler, der kræver boosting, idet doseringsanbefalinger for en sådan samtidig administration ikke er klarlagt, og kan resultere i utilstrækkeligt plasmaniveau af de antiretrovirale lægemidler, hvilket kan resultere i tab af terapeutisk virkning og udvikling af resistens (se pkt.
English: Cobicistat reversibly inhibits MATE1, and concentrations of metformin may be increased when co-administered with cobicistat.
Danish: Cobicistat hæmmer MATE1 reversibelt, og koncentrationer af metformin kan øges ved samtidig administration af cobicistat.
English: 30 film-coated tablets 90 (3 bottles of 30) film-coated tablets
Danish: 30 filmovertrukne tabletter 90 (3 tabletbeholdere med 30) filmovertrukne tabletter
English: ANTI-HYPERTENSIVES Metoprolol
Danish: ANTIHYPERTENSIVA Metoprolol
English: Table 7: Virologic outcome of randomised treatment of Study GS-US-216-0114 at weeks 48 and Week 48a
Danish: Tabel 7: Virologisk resultat af randomiseret behandling i studie GS-US-216-0114 ved uge 48 og Uge 48a
English: 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).
Danish: Et farmakokinetikstudie af cobicistat blev udført hos non-hiv-1-inficerede personer med svært nedsat nyrefunktion (estimeret kreatininclearance under 30 ml/min).
English: Co-administration of salmeterol and Tybost is not recommended (see section 4.4).
Danish: Samtidig administration af salmeterol og Tybost anbefales ikke (se pkt.
English: Median baseline CD4+ cell count (range), cells/mm3
Danish: Median CD4+ celletal ved baseline (interval), celler/ mm3
English: ANTIARRHYTHMICS Disopyramide Flecainide
Danish: ANTIARYTMIKA Disopyramid Flecainid
English: Silicon dioxide Croscarmellose sodium Magnesium stearate Microcrystalline cellulose
Danish: Siliciumdioxid Croscarmellosenatrium Magnesiumstearat Mikrokrystallinsk cellulose
English: Co-administration of apixaban, rivaroxaban or edoxaban is not recommended with Tybost.
Danish: Samtidig administration af apixaban, rivaroxaban eller edoxaban og Tybost anbefales ikke.
English: Co-administration of cobicistat with medicinal products such as dihydroergotamine, ergotamine, ergometrine, orally administered midazolam, triazolam, amiodarone, quinidine, pimozide, lurasidone, alfuzosin, simvastatin, lovastatin, and sildenafil which are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated (see section 4.3).
Danish: Samtidig administration af cobicistat med lægemidler, såsom dihydroergotamin, ergotamin, ergometrin, oralt administreret midazolam, triazolam, amiodaron, quinidin, pimozid, lurasidon, alfuzosin, simvastatin, lovastatin og sildenafil, som er stærkt afhængig af CYP3A for clearance, og for hvilket forhøjede plasmakoncentrationer er forbundet med alvorlige og/eller livstruende hændelser, er kontraindiceret (se pkt.
English: Atazanavir 300 mg once daily Darunavir 800 mg once daily
Danish: Atazanavir 300 mg én gang dagligt Darunavir 800 mg én gang dagligt
English: Co-administration of Tybost with sildenafil for the treatment of pulmonary arterial hypertension is contraindicated (see section 4.3).
Danish: Samtidig administration af Tybost og sildenafil til behandling af pulmonal arteriel hypertension er kontraindiceret (se pkt.
English: Other medicines and Tybost Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Tybost Fortæl altid lægen eller apotekspersonalet, hvis De tager anden medicin eller har gjort det for nylig.
English: This effect on serum creatinine, leading to a decrease in the estimated creatine clearance, should be taken into consideration when cobicistat 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 reduktion i den estimerede kreatininclearance skal tages i betragtning, når cobicistat administreres til patienter, hvor den estimerede kreatininclerance anvendes til at monitorering af kliniske behandling, herunder justering af dosering for samtidigt indgivne lægemidler.
English: Tybost contains sunset yellow FCF aluminium lake which may cause allergic reactions.
Danish: Tybost indeholder sunset yellow FCF aluminium lake, som kan forårsage allergiske reaktioner.
English: There are no or limited clinical data with cobicistat in pregnant women.
Danish: Der er ingen eller utilstrækkelige kliniske data fra anvendelsen af cobicistat til gravide kvinder.
English: Unlike ritonavir, cobicistat is not an inducer of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or UGT1A1.
Danish: Til forskel fra ritonavir er cobicistat ikke en induktor af CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 eller UGT1A1.
English: Co-administration with dabigatran etexilate, a P-glycoprotein (P-gp) substrate, is contraindicated (see section 4.5).
Danish: Samtidig administration med dabigatranetexilat, et substrat for P-glykoprotein (P-gp), er kontraindiceret (se pkt.
English: Treatment with cobicistat and darunavir during the second and third trimesters of pregnancy has been shown to result in lower darunavir exposure compared to postpartum.
Danish: Det er påvist, at behandling med cobicistat og darunavir i andet og tredje trimester af graviditeten har medført lavere eksponering for darunavir sammenlignet med postpartum.
English: Do not chew, crush or split the tablet.
Danish: Tabletten må ikke tygges, knuses eller deles.
English: Cobicistat co-administered with atazanavir or darunavir should not be used in combination with another antiretroviral agent that requires pharmacoenhancement by means of co-administration with an inhibitor of CYP3A4 to reach the desired therapeutic plasma concentrations (i.e., another protease inhibitor).
Danish: Cobicistat administreret samtidig med atazanavir eller darunavir må ikke anvendes i kombination med andre antiretrovirale stoffer, der kræver farmakoboosting ved hjælp af samtidig administration af en CYP3A4-hæmmer, for at nå de ønskede terapeutiske plasmakoncentrationer (dvs. en anden proteasehæmmer).
English: Each film-coated tablet contains 150 mg cobicistat.
Danish: Hver filmovertrukken tablet indeholder 150 mg cobicistat.
English: Therefore, Tybost should not be used during breast-feeding.
Danish: Tybost må derfor ikke anvendes under amning.
English: Caution should be exercised when co-administering cobicistat with pitavastatin.
Danish: Der bør udvises forsigtighed ved samtidig administration af cobicistat og pitavastatin.
English: Co-administration of cobicistat with dabigatran is contraindicated.
Danish: Samtidig administration af cobicistat og dabigatran er kontraindiceret.
English: • difficulty sleeping, abnormal dreams, drowsiness, tiredness (fatigue)
Danish: • søvnbesvær, unormale drømme, døsighed, træthed
English: • apixaban, edoxaban, rivaroxaban and warfarin, medicines used to prevent and treat blood clots
Danish: • apixaban, edoxaban, rivaroxaban og warfarin, lægemidler, der anvendes til at forebygge og behandle blodpropper
English: Cobicistat is metabolised via CYP3A (major)- and CYP2D6 (minor)-mediated oxidation and does not undergo glucuronidation.
Danish: Cobicistat metaboliseres via CYP3A (overvejende)- og CYP2D6 (i mindre grad)-medieret oxidation og gennemgår ikke glukuronidation.
English: Cobicistat is not expected to inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9 or CYP2C19.
Danish: Cobicistat forventes ikke at hæmme CYP1A2, CYP2B6, CYP2C8, CYP2C9 eller CYP2C19.
English: Cobicistat should not be co-administered with colchicine to patients with renal or hepatic impairment.
Danish: Cobicistat bør ikke administreres sammen med colchicin til patienter med nedsat nyre- eller leverfunktion
English: Rilpivirine is not expected to affect the plasma concentration of cobicistat.
Danish: Rilpivirin forventes ikke at påvirke plasmakoncentrationen af cobicistat.
English: Co-administration is not recommended (see section 4.4).
Danish: Samtidig administration anbefales ikke (se pkt.
English: Demographic characteristics
Danish: Demografikarakteristika
English: Atazanavir + cobicistat + emtricitabine and tenofovir disoproxil fumarate fixed-dose combination was non-inferior in achieving HIV-1 RNA < 50 copies/ml when compared to atazanavir + ritonavir + emtricitabine and tenofovir disoproxil fumarate fixed-dose combination.
Danish: Atazanavir + cobicistat + emtricitabin og tenofovirdisoproxilfumarat i fastdosis-kombination var non-inferiore med hensyn til at opnå hiv-1-rna < 50 kopier/ml, sammenlignet med atazanavir + ritonavir + emtricitabin og tenofovirdisoproxilfumarat i fastdosis-kombination.
English: Co-administration with CYP3Ametabolised corticosteroids is not recommended unless the potential benefit to the patient outweighs the risk, in which case patients should be monitored for systemic corticosteroid effects.
Danish: Samtidig administration af CYP3Ametaboliserede kortikosteroider anbefales ikke, medmindre den potentielle fordel for patienten opvejer risikoen.
English: Dose of HIV-1 protease inhibitor
Danish: Dosis af hiv-1-proteasehæmmer
English: When co-administration is necessary, do not exceed 10 mg rosuvastatin daily and clinical monitoring for safety (e.g. myopathy) is recommended.
Danish: Når samtidig administration er nødvendig, må dosis af rosuvastatin ikke overstige 10 mg dagligt, og klinisk sikkerhedsmonitorering (f.eks. myopati) anbefales.
English: When co-administration is necessary, it is recommended to start with a dose of atorvastatin 10 mg and titrate based on clinical response while monitoring for safety (e.g. myopathy).
Danish: Når samtidig administration er nødvendig, anbefales det at starte med en dosis atorvastatin på 10 mg og titrere baseret på klinisk respons, mens der monitoreres for sikkerhed (f.eks. myopati).
English: Tybost contains sunset yellow FCF aluminium lake (E110) Tell your doctor if you have an allergy to sunset yellow FCF aluminium lake (E110).
Danish: Tybost indeholder sunset yellow FCF aluminium lake (E110) Fortæl lægen, hvis De er overfølsom over for sunset yellow FCF aluminium lake (E110).
English: The doses of Tybost and the co-administered protease inhibitor, atazanavir or darunavir, are presented in Table 1.
Danish: Doser af Tybost og den samtidigt administrerede proteasehæmmer, atazanavir eller darunavir, er vist i tabel 1.
English: Atazanavir pharmacokinetics parameters
Danish: Atazanavirs farmakokinetiske parametre
English: Co-administration of Tybost and antiretroviral medicinal products Tybost must be co-administered with either atazanavir 300 mg once daily or with darunavir 800 mg once daily (see section 4.2).
Danish: Samtidig administration af Tybost og antiretrovirale lægemidler Tybost skal administreres samtidigt med enten atazanavir 300 mg én gang dagligt eller med darunavir 800 mg én gang dagligt (se pkt.
English: Some patients have reported dizziness when Tybost was taken with atazanavir or darunavir.
Danish: Nogle patienter har indberettet svimmelhed under behandling med Tybost samtidig med atazanavir eller darunavir.
English: See sections 4.2, 4.4, 5.1 and 5.2.
Danish: 4.2, 4.4, 5.1 og 5.2.
English: Consult the Summary of Product Characteristics of atazanavir or darunavir for further information on use in combination with these medicinal products.
Danish: Konsultér produktresuméet for atazanavir eller darunavir for yderligere oplysninger om anvendelse i kombination med disse lægemidler.
English: Treatment with cobicistat and darunavir during pregnancy results in lower darunavir exposure which may be associated with an increased risk of virological failure and an increased risk of mother-to-child transmission of HIV infection.
Danish: Behandling med cobicistat og darunavir under graviditeten medfører lavere eksponering for darunavir, hvilket kan være forbundet med en øget risiko for virologisk svigt og en øget risiko for overførsel af hiv-infektion fra mor til barn.
English: For more information on the side effects of atazanavir or darunavir see the package leaflets for these medicines.
Danish: For yderligere oplysninger om bivirkninger ved atazanavir eller darunavir, se disse lægemidlers indlægssedler.
English: Cobicistat is a selective, mechanism-based inhibitor of cytochromes P450 of the CYP3A subfamily.
Danish: Cobicistat er en selektiv, mekanisme baseret hæmmer af cytokromer P450 fra CYP3A-undergruppen.
English: Patients were randomised in a 1:1 ratio to receive either atazanavir 300 mg + cobicistat 150 mg once daily or atazanavir 300 mg + ritonavir 100 mg once daily, each administered with a fixed background regimen containing tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg administered as a fixed-dose combination tablet.
Danish: Patienterne blev randomiseret i et 1:1 forhold til at modtage enten atazanavir 300 mg + cobicistat 150 mg én gang dagligt eller atazanavir 300 mg + ritonavir 100 mg én gang dagligt, begge administreret med en fastdosis-behandlingsplan, der indeholdt tenofovirdisoproxilfumarat 300 mg og emtricitabin 200 mg administreret som en fastdosis-kombinationstablet.
English: Inhibition of CYP3A-mediated metabolism by cobicistat enhances the systemic exposure of CYP3A substrates (such as atazanavir or darunavir) that have limited oral bioavailability and a short half-life due to CYP3A-dependent metabolism.
Danish: Hæmning af CYP3A-medieret metabolisme af cobicistat øger den systemiske eksponering over for CYP3A-substrater (såsom atazanavir eller darunavir), som har begrænset, oral biotilgængelighed og en kort halveringstid på grund af den CYP3A-afhængige metabolisme.
English: Increased plasma concentrations of medicinal products that are metabolised by CYP3A (including atazanavir and darunavir) are observed on co-administration with cobicistat.
Danish: Øgede plasmakoncentrationer af lægemidler, der metaboliseres af CYP3A (inklusiv atazanavir og darunavir) ses ved samtidig administration af cobicistat.
English: Table 4: Pharmacokinetic parameters [mean ± SD (%CV)] of atazanavir in the pharmacokinetic sub-study of phase 3 Study GS-US-216-0114
Danish: Tabel 4: Farmakokinetiske parametre [middel ± SD (% CV)] af atazanavir i den farmakokinetiske undergruppe i fase 3 (studie GS-US-216-0114)
English: Alternative corticosteroids which are less dependent on CYP3A metabolism e.g. beclomethasone for intranasal or inhalational use should be considered, particularly for long-term use.
Danish: Kortikosteroider, som er mindre afhængige af CYP3Ametabolisering, f.eks. nasal eller inhaleret beclomethason, bør overvejes, navnlig ved langvarig brug.
English: hyperbilirubinaemia Skin and subcutaneous tissue disorders: Common:
Danish: hyperbilirubinæmi Hud og subkutane væv: Almindelig:
English: The safety and efficacy of cobicistat with atazanavir 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).
Danish: Sikkerheden og virkningen af cobicistat med atazanavir 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 baseline estimeret kreatininclearance over 70 ml/min, som var behandlingsnaive (n = 692).
English: The safety of Tybost in 73 HIV-1 infected treatment-experienced patients with mild to moderate renal impairment (eGFR by Cockcroft-Gault method 50-89 ml/min) who switched pharmacokinetic enhancer from ritonavir to cobicistat was evaluated in an open-label clinical Study (GS-US-236-0118) of cobicistat-boosted atazanavir or darunavir plus two NRTIs.
Danish: Tybosts sikkerhed hos 73 hiv-1-inficerede behandlingserfarne patienter med let til moderat nedsat nyrefunktion (eGFR 50-89 ml/min efter Cockcroft-Gault-metoden), som skiftede farmakokinetisk forstærker fra ritonavir til cobicistat, blev evalueret i et åbent klinisk studie (GS-US-236-0118) med cobicistat-boostet atazanavir eller darunavir plus to NRTI'er.
English: Concentrations of itraconazole, fluconazole and posaconazole may be increased when co-administered with cobicistat.
Danish: Koncentrationer af itraconazol, fluconazol og posaconazol kan øges ved samtidig administration af cobicistat.
English: Clorazepate
Danish: Clorazepat
English: Therefore, the use of Tybost is not recommended in these patients (see sections 4.4 and 5.2).
Danish: Tybost anbefales derfor ikke til disse patienter (se pkt.