FrancophonIA/ELRC3.0 huggingface dataset:
English: • amiodarone, disopyramide, dronedarone, quinidine, ranolazine
Danish: • amiodaron, disopyramid, dronedaron, quinidin, ranolazin
English: The major, inactive human metabolites of ombitasvir were not teratogenic in mice at exposures approximately 26 times higher than in humans at the recommended clinical dose.
Danish: De største inaktive humane ombitasvir-metabolitter var ikke teratogene hos mus ved eksponeringer, der var ca. 26 gange højere end hos mennesker ved den anbefalede kliniske dosis.
English: Viekirax with dasabuvir is expected to increase the exposure to rosuvastatin more than 3-fold.
Danish: Viekirax med dasabuvir forventes at øge eksponeringen for rosuvastatin med mere end 3 gange.
English: Summary of study design
Danish: Overblik over forsøgsdesign
English: 300/100 mg once daily (administered 12 hours apart)
Danish: 300/100 mg én gang dagligt (administreret med 12 timers mellemrum)
English: Haemoglobin <100-80 g/L (grade 2) <80-65 g/L (grade 3) <65 g/L (Grade 4)
Danish: Hæmoglobin < 100-80 g/l (grad 2) < 80-65 g/l (grad 3) < 65 g/l (grad 4)
English: What you need to know before you take Viekirax 3.
Danish: Det skal du vide, før du begynder at tage Viekirax 3.
English: ALT >5-20 × ULN* (Grade 3) >20 × ULN (Grade 4)
Danish: ALAT > 5-20 × ULN* (grad 3) > 20 × ULN (grad 4)
English: Viekirax should not be used during pregnancy or in women of childbearing potential not using effective contraception.
Danish: Viekirax bør ikke anvendes under graviditet eller til kvinder i den fødedygtige alder, som ikke bruger sikker præventionsmetode.
English: • oral midazolam, triazolam
Danish: • oralt midazolam, triazolam
English: Ombitasvir, paritaprevir and ritonavir are highly bound to plasma proteins.
Danish: Ombitasvir, paritaprevir og ritonavir har en høj bindingsgrad til plasmaproteiner.
English: The following section describes the specific transporters and metabolizing enzymes that are affected by Viekirax with or without dasabuvir.
Danish: I det følgende afsnit beskrives de specifikke transportere og metaboliserende enzymer, der påvirkes af Viekirax med eller uden dasabuvir.
English: If more than 12 hours have passed since Viekirax is usually taken, the missed dose should NOT be taken and the patient should take the next dose per the usual dosing schedule.
Danish: Hvis der er gået mere end 12 timer siden det tidspunkt, hvor patienten normalt tager sin dosis Viekirax, må den manglende dosis IKKE tages, idet patienten skal vente til den efterfølgende dosis i henhold til doseringsplanen.
English: Paritaprevir was approximately 97-98.6% bound to human plasma proteins.
Danish: Paritaprevir var ca. 97-98,6 % bundet til humane plasmaproteiner.
English: ↑ cisapride
Danish: ↑ cisaprid
English: Clinical trial in patients receiving opioid substitution therapy
Danish: Klinisk studie hos patienter i opioidsubstitutionsbehandling
English: All other double substitutions of Y93H in combination with substitutions at positions 28, 31, or 58 reduced the activity of ombitasvir by more than 400-fold.
Danish: Alle andre Y93H-dobbeltsubstitutioner i kombination med substitutioner ved position 28, 31, eller 58 reducerede aktiviteten af ombitasvir med mere end 400 gange.
English: With RBV
Danish: Med RBV
English: Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when Viekirax is taken in combination with ribavirin.
Danish: Der skal træffes skærpede forholdsregler for at undgå graviditet hos kvindelige patienter og hos mandlige patienters kvindelige partnere, når Viekirax administreres i kombination med ribavirin.
English: Clinical monitoring and dose adjustment may be required for levothyroxine
Danish: Klinisk overvågning og dosisjustering kan være nødvendig for levothyroxin
English: Although some cases had previous history of depression, psychiatric illness and/or substance abuse, a causal relation with Viekirax with or without dasabuvir treatment cannot be excluded.
Danish: Selvom nogle tilfælde havde anamnese med depression, psykisk sygdom og/eller stofmisbrug, kan en årsagssammenhæng med Viekirax- behandling med eller uden dasabuvir ikke udelukkes.
English: Sulfamethoxazole, Trimethoprim
Danish: Sulfamethoxazol, trimethoprim
English: Fatigue *Data set includes all genotype 1-infected subjects in Phase 2 and 3 trials including subjects with cirrhosis.
Danish: Træthed *Datasættet omfatter alle genotype 1-smittede patienter i fase 2- og fase 3-studier, herunder patienter med cirrose.
English: Extra precautions are needed if Viekirax is taken together with ribavirin.
Danish: Der er behov for ekstra forsigtighed, hvis Viekirax tages sammen med ribavirin.
English: The dose of ribavirin was left to the discretion of the investigator, with most subjects receiving 600 to 800 mg per day as a starting dose, and most subjects also receiving 600 to 800 mg per day at the end of treatment.
Danish: Ribavirin-dosis blev fastsat individuelt efter investigators skøn, hvor de fleste forsøgspersoner modtog 600 til 800 mg som begyndelsesdosis, og de fleste forsøgspersoner fik også 600 til 800 mg dagligt i slutningen af behandlingen.
English: No increase in incidence of ALT elevations was observed with other types of estrogens commonly used for hormone replacement therapy (e.g. oestradiol and conjugated estrogens).
Danish: Der sås ingen stigning i incidensen af ALAT-forhøjelser med andre typer af østrogen, som normalt bruges i hormonbehandling (f.eks. østradiol og konjugerede østrogener).
English: Caution should be used when administering Viekirax with fluticasone or other glucocorticoids that are metabolised by CYP3A4.
Danish: Der skal udvises forsigtighed, når Viekirax administreres sammen med fluticason eller andre glukokortikoider, der metaboliseres af CYP3A4.
English: The blood to plasma concentration ratios in humans ranged from 0.6 to 0.8 indicating that ombitasvir and paritaprevir were preferentially distributed in the plasma compartment of whole blood.
Danish: Ratioen for blod/plasmakoncentrationen hos mennesker var 0,6-0,8, og det indikerer, at ombitasvir og paritaprevir fortrinsvis fordeles i plasmakompartmentet i helblod.
English: In contrast, the rate of ALT elevations in subjects using other types of oestrogens as typically used in hormonal replacement therapy (i.e., oral and topical oestradiol and conjugated oestrogens) was similar to the rate observed in subjects who were not using oestrogen-containing products (approximately 1% in each group).
Danish: Til gengæld var forekomsten af forhøjet ALAT hos forsøgspersoner, som anvendte andre typer af østrogener, herunder dem, der typisk anvendes til hormonerstatningsbehandling (dvs. østradiol til oral og topikal anvendelse samt konjugerede østrogener), den samme som hos forsøgspersoner, der ikke brugte østrogenholdige lægemidler (ca. 1% i hver gruppe).
English: CYP2D6 substrates (e.g. desipramine, metoprolol and dextromethorphan) are not expected to require dose adjustments.
Danish: CYP2D6-substrater (f.eks. desipramin, metoprolol og dextromethorphan) forventes ikke at nødvendiggøre dosisjustering.
English: Concerning cross-resistance, see also section 5.1.
Danish: 5.1, hvad angår krydsresistens.
English: Tell your doctor or pharmacist before taking Viekirax, if you are taking any of the medicines in the table below.
Danish: Tal med lægen eller apotekspersonalet, før du tager Viekirax, hvis du tager et eller flere af de lægemidler, der er angivet i tabellen nedenfor.
English: ANTIFUNGALS Ketoconazole 400 mg once daily
Danish: ANTIMYKOTIKA Ketoconazol 400 mg én gang dagligt
English: Y56H alone could not be evaluated due to poor replication capacity, however, the combination of Y56H and D168A/V/Y reduced the activity of paritaprevir by 700- to 4118fold.
Danish: Y56H alene kunne ikke vurderes på grund af ringe replikationsevne, men kombinationen af Y56H og D168A/V/Y reducerede aktiviteten af paritaprevir med 700-4.118 gange.
English: Concomitant use of inhaled glucocorticoids metabolised with CYP3A can increase systemic exposures of the glucocorticoids, and cases of Cushing's syndrome and subsequent adrenal suppression have been reported with ritonavir-containing regimens.
Danish: Samtidig brug af inhalationsglukokortikoider, der metaboliseres af CYP3A, kan øge den systemiske glukokortikoid-eksponering, og der er indberettet tilfælde af Cushings syndrom og efterfølgende binyresuppression ved regimer, der indeholder ritonavir.
English: In mice, an increased incidence of open eye lid was present in foetuses of dams administered ombitasvir; however, the relationship to treatment with ombitasvir is uncertain.
Danish: Hos mus sås forhøjet forekomst af åbne øjenlåg hos fostre af moderdyr, der havde fået ombitasvir; det er dog usikkert, om dette er relateret til ombitasvir-behandlingen.
English: No clinically relevant changes in dasabuvir, paritaprevir and ombitasvir exposures (based on comparison with historical data) were observed during co-administration.
Danish: Der sås ingen klinisk relevante ændringer i dasabuvir-, paritaprevir- og ombitasvir-eksponeringen (baseret på en sammenligning med historiske data) ved samtidig administration.
English: • Treatment should be discontinued in patients who develop evidence of hepatic decompensation.
Danish: Behandlingen skal afbrydes hos patienter, som udvikler tegn på dekompenseret leversygdom.
English: b. Other includes early drug discontinuation not due to virologic failure missing HCV RNA values in the SVR12
Danish: b. 'Andet' omfatter tidlig stop i behandlingen som ikke skyldes virologisk svigt og manglende HCV-rna værdier i SVR12-vinduet).
English: Oral midazolam Triazolam
Danish: Oralt midazolam Triazolam
English: In the presence of dasabuvir, paritaprevir exposures increased by 50% to 65% while there was no change in ombitasvir exposures.
Danish: Når dasabuvir var til stede, steg eksponeringen for paritaprevir med 50-65 %, mens der ikke sås nogen ændring i eksponeringen for ombitasvir.
English: Ritonavir was greater than 99% bound to human plasma proteins.
Danish: Ritonavir var mere end 99 % bundet til humane plasmaproteiner.
English: • pimozide
Danish: • pimozid
English: Emergent amino acid substitutionsa
Danish: Opståede aminosyresubstitutionera
English: Contraceptive medicines that contain ethinyloestradiol cannot be used in combination with Viekirax.
Danish: Prævention, der indeholder ethinyløstradiol, kan ikke anvendes i kombination med Viekirax.
English: You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medicines after starting Viekirax.
Danish: Det kan være, at dit blodsukker skal overvåges tættere, og/eller at din diabetesmedicin skal justeres efter påbegyndelse af behandling med Viekirax.
English: When co-administered, they exert mutual effects on each other (see section 5.2).
Danish: Når stofferne administreres samtidig, har de en gensidig indvirkning på hinanden (se pkt.
English: The long-term clinical impact of the emergence or persistence of virus containing Viekirax- and dasabuvir-resistance-associated substitutions on future treatment is unknown.
Danish: Den kliniske langtidseffekt på fremtidig behandling ved forekomst af eller persistens hos virus, som indeholder Viekirax- og dasabuvirresistensrelaterede substitutioner, kendes ikke.
English: HIV co-infected patients without suppressive antiretroviral therapy should not be treated with Viekirax.
Danish: Patienter med samtidig hiv-infektion, der ikke er i supprimerende antiretroviral behandling, må ikke få Viekirax.
English: Although buprenorphine and zolpidem are also metabolized by CYP3A, drug interaction studies indicate that no dose adjustment is needed when co-administering these medicinal products with Viekirax with or without dasabuvir (see Table 2).
Danish: Selvom buprenorphin og zolpidem også metaboliseres af CYP3A, tyder lægemiddelinteraktionsstudier på, at dosisjustering ikke er nødvendig, når disse lægemidler gives samtidig med Viekirax med eller uden dasabuvir (se tabel 2).
English: • ergotamine, dihydroergotamine, ergonovine, methylergometrine
Danish: • ergotamin, dihydroergotamin, ergonovin, methylergometrin
English: Use with colchicine
Danish: Samtidig brug af colchicin
English: Cases of depression and more rarely of suicidal ideation and suicide attempt have been reported with Viekirax with or without dasabuvir treatment in combination with ribavirin in the majority of the cases.
Danish: Tilfælde af depression og mere sjældent selvmordstanker og selvmordsforsøg er rapporteret ved Viekiraxbehandling med eller uden dasabuvir, i de fleste tilfælde i kombination med ribavirin.
English: It is not known whether the active substances in Viekirax (ombitasvir, paritaprevir and ritonavir) pass into breast milk.
Danish: Det er ukendt, om de aktive stoffer i Viekirax (ombitasvir, paritaprevir og ritonavir) udskilles i human mælk.
English: As the incidence of such elevations was 26% among women taking a concomitant ethinyloestradiol-containing medicinal product, such medicinal products are contraindicated with Viekirax with or without dasabuvir.
Danish: Da incidensen af sådanne forhøjelser var 26 % blandt de kvinder, der samtidig tog et ethinyløstradiol-holdigt lægemiddel, er ethinyløstradiol-holdige lægemidler kontraindiceret med Viekirax med eller uden dasabuvir.
English: • alfuzosin hydrochloride
Danish: • alfuzosinhydrochlorid
English: • Feeling weak or lack of energy (asthenia)
Danish: • kraftesløshed, manglende energi (asteni)
English: General disorders and administration and administration site conditions Very common
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig
English: Tell your doctor or pharmacist if you notice any of the following side effects.
Danish: Fortæl det til lægen eller apotekspersonalet, hvis du får en eller flere af følgende bivirkninger.
English: Co-administration of efavirenz (enzyme inducer) based regimens with paritaprevir /ritonavir + dasabuvir resulted in ALT elevations and therefore, early discontinuation of the study.
Danish: Regimer baseret på efavirenz (enzym-inducer) administreret samtidig med paritaprevir/ritonavir + dasabuvir resulterede i forhøjet ALAT og dermed afslutning af studiet før tid.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Viekirax in one or more subsets of the paediatric populations in the treatment of chronic hepatitis C (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Viekirax i en eller flere undergrupper af den pædiatriske population ved behandling af kronisk hepatitis C (se pkt.
English: Treatment-naïve Without RBV
Danish: Behandlingsnaive Uden RBV
English: GLUCOCORTICOIDS (INHALED) Fluticasone
Danish: GLUKOKORTIKOIDER (TIL INHALATION) Fluticason
English: The efficacy of Viekirax in patients previously exposed to Viekirax, or to medicinal products of the same classes as those of Viekirax (NS3/4A inhibitors or NS5A inhibitors), has not been demonstrated.
Danish: Virkningen af Viekirax hos patienter, der tidligere er blevet eksponeret for Viekirax eller for lægemidler af samme klasse som Viekirax (NS3/4A-hæmmere eller NS5A-hæmmere), er ikke undersøgt.
English: Paritaprevir and its hydrolysis product M13 were the predominant components observed in the milk of lactating rats, without effect on nursing pups.
Danish: Paritaprevir og dets hydrolyseprodukt M13, der var de primære komponenter i mælken hos diegivende rotter, havde ingen indvirkning på de diende unger.
English: Y93H, Y93N or M28V in combination with Q30R reduced the activity of ombitasvir by more than 42,802-fold.
Danish: Y93H, Y93N eller M28V i kombination med Q30R reducerede aktiviteten af ombitasvir med over 42.802 gange.
English: Lurasidone Pimozide Quetiapine
Danish: Lurasidon Pimozid Quetiapin
English: Ribavirin dose modification did not impact SVR rates.
Danish: Ændringen af ribavirindosen havde ingen indvirkning på SVR-raterne.
English: Substitution L28V in HCV NS5A reduced the susceptibility to ombitasvir by 21-fold.
Danish: L28V-substitutionen i HCVNS5A reducerede følsomheden over for ombitasvir med 21 gange.
English: Treatment outcome
Danish: Behandlingsresultat
English: The treatment-experienced subjects studied were primarily pegIFN/RBV null responders.
Danish: De behandlingserfarne forsøgspersoner, der blev undersøgt, var fortrinsvis ikke-respondere på pegIFN/RBV.
English: For a general comment on treatment of HIV co-infected patients, including a discussion on different antiretroviral regimens that may be used, please see section 4.4 (Treatment of HIV co-infected patients).
Danish: HIV-ANTIVIRALE MIDLER: PROTEASEHÆMMERE For generelle kommentarer til behandling af patienter med samtidig hiv-infektion, inklusive diskussion af forskellige antiretrovirale regimer, som kan anvendes, se pkt.4.4 (behandling af patienter med samtidig hiv-infektion).
English: Impact of ribavirin dose adjustment on probability of SVR
Danish: Effekt ved justering af ribavirin-dosis på sandsynligheden for SVR
English: Co-administration of Viekirax with everolimus is not recommended because of a significant increase in everolimus exposures which cannot be properly dose adjusted with available dose strengths (see section 4.4).
Danish: Viekirax med everolimus anbefales ikke, på grund af signifikant stigning i eksponering af everolimus, som ikke kan justeres tilstrækkeligt med de tilgængelige dosis-styrker (se pkt.
English: • Hepatic laboratory testing including direct bilirubin levels should be performed at baseline, during the first 4 weeks of starting treatment and as clinically indicated thereafter.
Danish: Laboratorietest for leverfunktion, inklusive niveau af konjugeret bilirubin skal udføres ved baseline, i løbet af de første 4 ugers behandling og herefter, når det er klinsik indiceret.
English: The recommended dose of atazanavir is 300 mg, without ritonavir, in combination with Viekirax with dasabuvir.
Danish: Den anbefalede dosis atazanavir er 300 mg, uden ritonavir, i kombination med Viekirax med dasabuvir.
English: Administration of Viekirax with or without dasabuvir with erythromycin may result in increased concentrations of erythromycin and paritaprevir.
Danish: Administration af Viekirax med eller uden dasabuvir med erythromycin kan give forhøjede koncentrationer af erythromycin og paritaprevir.
English: Ombitasvir and its major inactive human metabolites (M29, M36) were not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo mouse micronucleus assays.
Danish: Ombitasvir og dets største inaktive humane metabolitter (M29, M36) var ikke genotoksiske i et batteri af in vitro- og in vivo-analyser, der bl.a. omfattede bakteriel mutagenicitet, kromosomafvigelse i lymfocytter fra humant perifert blod og in vivo-analyser af mikronukleus hos mus.
English: Based on population pharmacokinetic analysis of data from Phase 3 clinical studies, Asian subjects had 18% to 21% higher ombitasvir exposures, and 37% to 39% higher paritaprevir exposures than non-Asian subjects.
Danish: På basis af farmakokinetiske populationsanalyser af data fra kliniske fase 3-studier havde asiatiske patienter en eksponering for ombitasvir, der lå 18% til 21% højere og en eksponering for paritaprevir, der lå 37% til 39% højere end ikke-asiatiske patienters eksponering.
English: Contents of the pack and other information What Viekirax contains
Danish: Pakningsstørrelser og yderligere oplysninger Viekirax indeholder:
English: Available pharmacokinetic data in animals have shown excretion of active substance and metabolite in milk (see section 5.3).
Danish: De tilgængelige farmakokinetiske data fra dyreforsøg viser, at det aktive stof og dets metabolitter udskilles i mælk (se pkt.
English: While ombitasvir exposures increased in a dose proportional manner, paritaprevir and ritonavir exposures increased in a more than dose proportional manner.
Danish: Ombitasvir-eksponeringen steg proportionalt med dosis, og paritaprevir- og ritonavir eksponeringen steg mere end proportionalt med dosis.
English: Rilpivirine exposure is substantially increased (3-fold) when rilpivirine is given in combination with Viekirax and dasabuvir, with a consequent potential for QT-prolongation.
Danish: Rilpivirin-eksponeringen øges markant (med 3 gange), når rilpivirin administreres i kombination med Viekirax og dasabuvir, og risikoen for QT-forlængelse øges som følge deraf.
English: Paritaprevir is an inhibitor of HCV NS3/4A protease which is necessary for the proteolytic cleavage of the HCV encoded polyprotein (into mature forms of the NS3, NS4A, NS4B, NS5A, and NS5B proteins) and is essential for viral replication.
Danish: Paritaprevir er en hæmmer af HCV-NS3/4A-protease, der er nødvendig for den proteolytiske spaltning af det HCV-kodede polyprotein (til modne former af proteinerne NS3, NS4A, NS4B, NS5A og NS5B), og som er afgørende for den virale replikation.
English: A side-by-side tabulation is shown to simplify presentation; direct comparison across trials should not be made due to differing trial designs.
Danish: Ændringerne er opstillet ved siden af hinanden i tabelform for overblikkets skyld, men på grund af forskellige forsøgsdesign kan der ikke foretages direkte sammenligninger på tværs af studierne.
English: Potential for other medicinal products to affect the pharmacokinetics of ombitasvir, paritaprevir, and dasabuvir
Danish: Andre lægemidlers mulighed for at påvirke ombitasvirs, paritaprevirs og dasabuvirs farmakokinetik
English: Two patients discontinued Viekirax and dasabuvir due to elevated ALT, including one on ethinyloestradiol.
Danish: To patienter seponerede Viekirax og dasabuvir på grund af forhøjet ALAT, herunder én, der fik ethinyløstradiol.
English: − Tablet film-coating: poly(vinyl alcohol) (E 1203), macrogol (3350), talc (E 553b), titanium dioxide (E 171) and red iron oxide (E 172).
Danish: − Filmovertræk: polyvinylalkohol (E 1203), macrogol (3350), talkum (E 553b), titaniumdioxid (E 171), og rød jernoxid (E 172).
English: • colchicine in patients with renal or hepatic impairment
Danish: • colchicin hos patienter med nedsat nyre- eller leverfunktion
English: Table 17 shows the primary efficacy analysis of SVR12 performed on subjects with HCV GT1/HIV-1 coinfection that received recommended regimen in Part 2 of the TURQUOISE-I study.
Danish: Tabel 17 viser den primære effektanalyse af SVR12 udført på forsøgspersoner med samtidig HCV GT1 og hiv-1-infektion, der modtog det anbefalede regime i del 2 af TURQUOISE-I-studiet.
English: − Feel sick (nauseous), are sick (vomit) or lose your appetite
Danish: − hvis du får kvalme, kaster op eller mister appetitten
English: Interactions between Viekirax with or without dasabuvir and other medicinal products
Danish: Interaktioner mellem Viekirax med eller uden dasabuvir og andre lægemidler
English: Because of the potential for adverse reactions from the medicinal product in breastfed infants, a decision must be made whether to discontinue breast-feeding or discontinue treatment with Viekirax, taking into account the importance of the therapy to the mother.
Danish: På grund af de potentielle bivirkninger for det diende barn skal det besluttes, om amning eller behandling med lægemidlet skal ophøre, idet der skal tages højde for behandlingens betydning for moderen.
English: In subjects who received the recommended regimen, 97% achieved SVR overall (among which 181 subjects with compensated cirrhosis achieved 97% SVR), while 0.5% experienced virologic breakthrough and 1.2% experienced post-treatment relapse.
Danish: Blandt de patienter, der fik det anbefalede regime, var der samlet set 97 %, der opnåede SVR (heraf var der 181 patienter med kompenseret cirrose, der opnåede SVR på 97 %); 0,5 % oplevede virologisk gennembrud, og 1,2 % fik recidiv efter behandlingen.
English: The activity of paritaprevir in genotype 1a was not significantly affected (less than or equal to 3-fold) by single substitutions V36A/M, V55I, Y56H, Q80K or E357K.
Danish: Aktiviteten af paritaprevir i genotype 1a blev ikke væsentligt påvirket (mindre end eller lig med 3 gange) af enkeltsubstitutionerne V36A/M, V55I, Y56H, Q80K eller E357K.