FrancophonIA/ELRC3.0 huggingface dataset:
English: Drug interactions were evaluated for the Viekirax and dasabuvir regimen, but not for the Viekirax without dasabuvir, with carbamazepine, furosemide, zolpidem, darunavir twice daily, darunavir (evening administration), atazanavir (evening administration), rilpivirine, abacavir/lamivudine, dolutegravir, metformin, sulfamethoxazole/trimethoprim, cyclobenzaprine, carisoprodol, hydrocodone/
Danish: Lægemiddelinteraktioner blev undersøgt for Viekirax med dasabuvir-regimet, men ikke for Viekirax uden dasabuvir-regimet, administreret sammen med carbamazepin, furosemid, zolpidem, darunavir to gange dagligt, darunavir (administreret om aftenen), atazanavir (administreret om aftenen), rilpivirin, abacavir/lamivudin, dolutegravir, metformin, sulfamethoxazol/trimethoprim, cyclobenzaprin, carisoprodol, hydrocodon/paracetamol eller diazepam.
English: Medicinal products renally excreted via transport proteins Ombitasvir, paritaprevir, and ritonavir do not inhibit organic anion transporter (OAT1) in vivo as shown by the lack of interaction with tenofovir (OAT1 substrate).
Danish: Lægemidler, der udskilles renalt via transportproteiner Ombitasvir, paritaprevir og ritonavir hæmmer ikke den organiske aniontransporter (OAT1) in vivo, idet der ikke ses nogen interaktion med tenofovir (OAT1-substrat).
English: Viekirax without dasabuvir may increase the plasma concentrations of dabigatran etexilate.
Danish: Viekirax uden dasabuvir kan øge plasmaconcentrationen af dabigatraetexilat.
English: To maximise absorption, Viekirax should be taken with food without regard to fat or calorie content.
Danish: For at maksimere absorptionen skal Viekirax tages sammen med mad; fedt- og kalorieindholdet er ligegyldigt.
English: Expected ↑ alfuzosin
Danish: Forventet: ↑ alfuzosin
English: Concomitant use of tacrolimus with Viekirax and dasabuvir is not recommended unless the benefits outweigh the risks (see section 4.4).
Danish: Samtidig brug af tacrolimus med Viekirax og dasabuvir anbefales ikke, medmindre fordelene opvejer risici (se pkt 4.4).
English: Potent inhibitors of P-gp, BCRP, OATP1B1 and/or OATP1B3 have the potential to increase the exposure to paritaprevir.
Danish: Potente hæmmere af P-gp, BCRP, OATP1B1 og/eller OATP1B3 kan øge eksponeringen for paritaprevir.
English: CORAL-I: treatment-naïve or pegIFN + RBV-experienced, at least 3 months post liver transplant or 12 months post renal transplant
Danish: CORAL-I: behandlingsnaive eller pegIFN + RBV-erfarne med levertransplantation for mindst 3 måneder siden eller nyretransplantation for mindst 12 måneder siden
English: Atazanavir must be administered at the same time as Viekirax with dasabuvir.
Danish: Atazanavir skal administreres samtidig med Viekirax med dasabuvir.
English: Patients with moderate to severe hepatic impairment (Child-Pugh B or C) (see section 5.2).
Danish: Patienter med moderat til svært nedsat leverfunktion (Child-Pugh B eller C) (se pkt.
English: Viekirax with ribavirin & without dasabuvir was evaluated for 12 weeks in genotype 1 treatment naive and treatment experienced non-cirrhotic subjects in a phase 2 study M11-652 (AVIATOR).
Danish: Viekirax med ribavirin og uden dasabuvir blev undersøgt i 12 uger hos genotype 1 behandlingsnaive forsøgspersoner og behandlingserfarne forsøgspersoner uden cirrose i et fase 2-studie M11-652 (AVIATOR).
English: Studies with ombitasvir and paritaprevir/ritonavir in animals have shown malformations (see section 5.3).
Danish: Dyreforsøg med ombitasvir og paritaprevir/ritonavir har vist misdannelser (se pkt.
English: Expected: ↑ sildenafil
Danish: Forventet: ↑ sildenafil
English: Viekirax and dasabuvir with or without ribavirin were assessed in 68 subjects with genotype 1 infection with or without cirrhosis who have severe renal impairment or ESRD (see Section 5.1).
Danish: Viekirax og dasabuvir med eller uden ribavirin blev undersøgt i 68 patienter med genotype 1-infektion med eller uden cirrose, der havde alvorlig nedsat nyrefunktion eller ESRD (se pkt.
English: If dose adjustments of concomitant medicinal products are made due to treatment with Viekirax or Viekirax with dasabuvir, doses should be re-adjusted after administration of Viekirax or Viekirax with dasabuvir is completed.
Danish: Hvis dosisjustering af samtidigt administrerede lægemidler skyldes behandlingen med Viekirax eller Viekirax med dasabuvir, skal der ske fornyet dosisjustering, når behandlingen med Viekirax eller Viekirax med dasabuvir er afsluttet.
English: Ombitasvir has EC50 values of 12, 4.3, 19, 1.7, 3.2, and 366 pM against replicon cell lines constructed with NS5A from single isolates representing genotypes 2a, 2b, 3a, 4a, 5a, and 6a, respectively.
Danish: Ombitasvir havde EC50-værdier på 12; 4,3; 19; 1,7; 3,2 og 366 pM mod replikoncellelinjer konstrueret med NS5A fra enkeltisolater af henholdsvis genotype 2a, 2b, 3a, 4a, 5a og 6a.
English: Viekirax, when co-administered with dasabuvir, combines three direct-acting antiviral medicinal products with distinct mechanisms of action and non-overlapping resistance profiles to target HCV at multiple steps in the viral lifecycle.
Danish: Ved samtidig administration af Viekirax og dasabuvir kombineres tre direkte virkende antivirale lægemidler med særskilte virkningsmekanismer og ikke-overlappende resistensprofiler, der er målrettet HCV i flere faser af den virale livscyklus.
English: Co-administration of Viekirax with rilpivirine once daily should only be considered in patients without known QTprolongation, and without other QT-prolongation co ombitasvir paritaprevir
Danish: Samtidig administration af Viekirax og rilpivirin én gang dagligt må kun overvejes hos patienter uden kendt QTforlængelse, og som ikke får samtidig behandling med andre QT-forlængende lægemidler.
English: NA A reduction of hydrocodone dose by 50% and/or clinical monitoring should be considered when administered with Viekirax with or without dasabuvir .
Danish: Reducering af hydrokodondosis med 50% og/eller klinisk monitorering bør overvejes ved samtidig administration med Viekirax med eller uden dasabuvir.
English: • quetiapine
Danish: • quetiapin
English: Thus, for these medicinal products, results and dosing recommendations of the Viekirax and dasabuvir regimen can be extrapolated to Viekirax without dasabuvir.
Danish: For disse lægemidler kan resultater og doseringsanbefalinger for behandling med Viekirax med dasabuvir derfor ekstrapoleres til Viekirax uden dasabuvir.
English: Effect of baseline HCV substitutions/polymorphisms on treatment outcome A pooled analysis of subjects with genotype 1 HCV infection, who were treated with ombitasvir, paritaprevir, and dasabuvir (a non-nucleotide NS5B inhibitor) with or without ribavirin in the Phase 2b and 3 clinical trials was conducted to explore the association between baseline NS3/4A, NS5A or NS5B substitutions/polymorphisms and treatment outcome in recommended regimens.
Danish: Virkning af baseline-HCV-substitutioner/polymorfismer på behandlingsresultatet Der blev gennemført en samlet analyse af de forsøgspersoner med genotype 1 HCV-infektion, der blev behandlet med ombitasvir, paritaprevir og dasabuvir (en non-nukleotid NS5B-hæmmer) med eller uden ribavirin i de kliniske fase 2b- og fase 3-studier, for at undersøge sammenhængen mellem NS3/4A-, NS5A- eller NS5B-substitutioner/polymorfismer ved baseline og behandlingsresultatet af de anbefalede regimer.
English: The activity of ombitasvir was reduced by 661-, 77-, 284- and 142-fold against the genotype 1b substitutions L28T, Y93H, R30Q in combination with Y93H, and L31M in combination with Y93H, respectively.
Danish: Aktiviteten af ombitasvir blev reduceret med henholdsvis 661, 77, 284 og 142 gange af genotype 1b-substitutionerne L28T, Y93H, R30Q i kombination med Y93H og L31M i kombination med Y93H.
English: Ritonavir is a strong inhibitor of CYP3A.
Danish: Ritonavir er en stærk CYP3A-hæmmer.
English: Package leaflet: Information for the patient Viekirax 12.5 mg/75 mg/50 mg film-coated tablets ombitasvir/paritaprevir/ritonavir This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patienten Viekirax 12,5 mg/75 mg/50 mg filmovertrukne tabletter ombitasvir/paritaprevir/ritonavir Dette lægemiddel er underlagt supplerende overvågning.
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, apotekspersonalet eller sygeplejersken .
English: Examples of other CYP3A4 substrates which may require dose adjustment and/or clinical monitoring include calcium channel blockers (e.g. nifedipine), and trazodone.
Danish: Eksempler på andre CYP3A4-substrater, der nødvendiggør dosisjustering og/eller klinisk monitorering, omfatter calciumantagonister (f.eks. nifepedin) og trazodon.
English: Following administration of Viekirax, the changes in ombitasvir, paritaprevir, and ritonavir exposures in subjects with mild, moderate and severe renal impairment were similar to those observed when Viekirax was administered with dasabuvir, and are not considered to be clinically significant.
Danish: Efter administration af Viekirax var ændringerne i eksponeringen for ombitasvir, paritaprevir og ritonavir hos forsøgspersoner med let, moderat eller svært nedsat nyrefunktion næsten de samme som ved administration af Viekirax sammen med dasabuvir, og de blev vurderet som ikke klinisk signifikante.
English: Coadministration with enzyme inducers may increase the risk of adverse reactions and ALT elevations (see Table 2).
Danish: Samtidig administration af enzym-inducere kan øge risikoen for bivirkninger og forhøjet ALAT (se tabel 2).
English: Hydrocodone (as given in a fixed-dose hydrocodone/ paracetamol)
Danish: Hydrokodon( givet som fast doseret hydrokodon/p aracetamol)
English: Co-administration of Viekirax with or without dasabuvir with medicinal products primarily metabolized by CYP3A may result in increased plasma concentrations of these medicinal products.
Danish: Samtidig administration af Viekirax med eller uden dasabuvir og lægemidler, der primært metaboliseres af CYP3A, kan medføre øgede plasmakoncentrationer af disse lægemidler.
English: In HCV-infected subjects, in comparison to those without cirrhosis, paritaprevir AUC increased to 2.2- to 2.4-fold for those with compensated cirrhosis (Child-Pugh A) and 3- to 4-fold for those with Child-Pugh B cirrhosis.
Danish: Hos HCV-inficerede patienter steg paritaprevirs AUC til 2,2-2,4 gange for dem med kompenseret cirrose (Child-Pugh A) og 3- til 4 gange for dem med Child-Pugh B cirrose, sammenlignet med dem uden cirrose.
English: Treatment-naïve, without cirrhosis SAPPHIRE I
Danish: Behandlingsnaive, uden cirrose SAPPHIRE I
English: Accumulation is minimal for ombitasvir and approximately 1.5- to 2-fold for ritonavir and paritaprevir.
Danish: Akkumulationen af ombitasvir er minimal, mensakkumulationen af ritonavir og paritaprevir er ca. 1,5-2 gange så stor.
English: Poly(vinyl alcohol) (E 1203) Macrogol (3350) Talc (E 553b)
Danish: Filmovertræk Polyvinylalkohol (E 1203) Macrogol (3350)
English: Substitutions R155C, A156T/V, and D168H/V in HCV NS3 reduced susceptibility to paritaprevir by 40- to 323-fold.
Danish: Substitutionerne R155C, A156T/V og D168H/V i HCV-NS3 reducerede følsomheden over for paritaprevir med 40-323 gange.
English: Cross-resistance is expected among NS5A inhibitors, NS3/4A protease inhibitors, and non-nucleoside NS5B inhibitors by class.
Danish: Krydsresistens forventes blandt NS5A-hæmmere, NS3/4A-proteasehæmmere og non-nukleoside NS5Bhæmmere (efter klasse).
English: With RBV n/N % n/N % n/N %
Danish: Uden RBV n/N % 95 %-KI n/N % 95 %-KI
English: Based on population pharmacokinetic analysis of data from Phase 3 clinical studies, female subjects would have approximately 55% higher, 100% higher and 15% higher ombitasvir, paritaprevir and ritonavir exposures than male subjects.
Danish: På basis af farmakokinetiske populationsanalyser af data fra kliniske fase 3-studier har kvindelige patienter en eksponering for ombitasvir, paritaprevir og ritonavir, der ligger ca. 55%, 100% og 15% højere end mandlige patienters eksponering.
English: Following dosing of ombitasvir/paritaprevir /ritonavir, mean plasma half-life of ritonavir was approximately 4 hours.
Danish: Efter administration af ombitasvir/paritaprevir/ritonavir var den gennemsnitlige plasmahalveringstid for ritonavir ca. 4 timer.
English: Genotype 4, without cirrhosis or with compensated cirrhosis
Danish: Genotype 4, uden cirrose eller med kompenseret cirrose
English: HIV/HCV co-infected patients
Danish: Patienter med samtidig hiv/HCV-infektion
English: Clinical studies in subjects with genotype 1 hepatitis C infection The efficacy and safety of Viekirax in combination with dasabuvir with and without ribavirin was evaluated in eight Phase 3 clinical trials, including two trials exclusively in subjects with cirrhosis (ChildPugh A), in over 2,360 subjects with genotype 1 chronic hepatitis C infection as summarised in Table 6.
Danish: Kliniske studier med patienter med hepatitis C genotype 1-infektion Virkningen af og sikkerheden ved Viekirax i kombination med dasabuvir med og uden ribavirin blev undersøgt i otte kliniske fase 3-studier, hvoraf to udelukkende omfattede patienter med cirrose (ChildPugh A), og som tilsammen omfattede over 2.360 patienter med kronisk hepatitis C genotype 1-infektion (se tabel 6).
English: Transient elevations in serum bilirubin (predominantly indirect) were observed in subjects receiving Viekirax and dasabuvir with ribavirin, related to the inhibition of the bilirubin transporters OATP1B1/1B3 by paritaprevir and ribavirin-induced haemolysis.
Danish: Forbigående forhøjet serum-bilirubin (hovedsagelig ikke-konjugeret (indirekte) bilirubin) sås hos forsøgspersoner, der fik Viekirax og dasabuvir med ribavirin, idet dette var forbundet med paritaprevirs hæmning af bilirubintransporterne OATP1B1/1B3 og ribavirin-induceret hæmolyse.
English: Phase 3 global multicentre studies conducted with Viekirax and dasabuvir with or without ribavirin (RBV).
Danish: Globale, multicenter-, fase 3-studier med Viekirax og dasabuvir med eller uden ribavirin (RBV)
English: Genotype 1a, with compensated cirrhosis
Danish: Genotype 1a, med kompenseret cirrose
English: In another open-label phase 3b study evaluating 12 weeks of Viekirax with or without dasabuvir and without RBV in non-cirrhotic, treatment-naive GT1a and GT4 patients with CKD stage 4 or 5 (Ruby II), the SVR12 rate was 94.4% (17/18), with no subjects experiencing on-treatment virologic failure or relapse.
Danish: I et andet åbent fase 3b-studie med non-cirrose, der undersøgte 12 uger med Viekirax med eller uden dasabuvir og uden ribavirin hos behandlingsnaive GT1a- og GT4-patienter med CKD-stadium 4 eller 5 (Ruby-II), var SVR12-frekvensen 94,4% (17/18) og ingen patienter, der oplevede virologisk svigt eller tilbagefald af behandling.
English: NARCOTIC ANALGESICS Paracetamol (as given in a fixed-dose hydrocodone/ paracetamol)
Danish: OPIOIDER ANALGETIKA Paracetamol (givet som fast doseret hydrokodon/p aracetamol)
English: Unchanged ombitasvir was the predominant component observed in the milk of lactating rats, without effect on nursing pups.
Danish: Uomdannet ombitasvir, der var den primære komponent i mælken hos diegivende rotter, havde ingen indvirkning på de diende unger.
English: Propylene glycol monolaurate Sorbitan monolaurate Colloidal anhydrous silica (E 551) Sodium stearyl fumarate
Danish: Propylenglycolmonolaurat Sorbitanmonolaurat Kolloid vandfri silica (E 551) Natriumstearylfumarat
English: Not Studied.
Danish: Ikke undersøget.
English: What you need to know before you take Viekirax Do not take Viekirax
Danish: Det skal du vide, før du begynder at tage Viekirax Tag ikke Viekirax
English: Use with glucocorticoids metabolised by CYP3A (e.g. fluticasone)
Danish: Samtidig brug af glukokortikoider, der metaboliseres af CYP3A (f.eks. fluticason)
English: Low dose ritonavir, which is part of the fixed dose combination Viekirax, may select for PI resistance in HIV co-infected patients without ongoing antiretroviral therapy.
Danish: Lavdosis-ritonavir, der indgår i den faste kombinationsdosering sammen med Viekirax, kan medføre PIresistens hos patienter med samtidig hiv-infektion, der ikke er i antiretroviral behandling.
English: The doses of ombitasvir, paritaprevir, ritonavir were 25 mg 150 mg, 100 mg once daily in PEARL-I, while the dose of paritaprevir was 100 mg or 150 mg in study M12-536.
Danish: Doserne af ombitasvir, paritaprevir, ritonavir var 25 mg, 150 mg, 100 mg én gang dagligt i PEARL I, mens paritaprevir-dosen var 100 mg eller 150 mg i M12-536-studiet.
English: 0.035/0.25 mg once daily
Danish: 0,035/0,25 m g én gang dagligt
English: Results from the pharmacokinetic evaluation of the combination of ombitasvir 25 mg, paritaprevir 200 mg, and ritonavir 100 mg, with dasabuvir 400 mg can be extrapolated to the combination of ombitasvir 25 mg, paritaprevir 200 mg, and ritonavir 100 mg.
Danish: Resultaterne af den farmakokinetiske evaluering af kombinationen af ombitasvir 25 mg, paritaprevir 200 mg og ritonavir 100 mg sammen med dasabuvir 400 mg kan ekstrapoleres til kombinationen af ombitasvir 25 mg, paritaprevir 200 mg og ritonavir 100 mg.
English: During clinical trials with Viekirax and dasabuvir with or without ribavirin, transient elevations of ALT to greater than 5 times the upper limit of normal occurred in approximately 1% of subjects (35 of 3,039).
Danish: I de kliniske studier af Viekirax og dasabuvir med eller uden ribavirin sås forbigående forhøjet niveau af ALAT til mere end 5 gange den øvre normalgrænse hos ca. 1 % af forsøgspersonerne (35 ud af 3.039).
English: Food increased the exposure (AUC) of ombitasvir, paritaprevir and ritonavir by up to 82%, 211% and 49%, respectively relative to the fasting state.
Danish: Mad øgede eksponeringen (AUC) af ombitasvir, paritaprevir og ritonavir med op til henholdsvis 82 %, 211 % og 49 % i forhold til administration uden mad.
English: Among these subjects, the positive predictive value of SVR12 on SVR24 was 99.8%.
Danish: Blandt disse patienter var den positive prognostiske værdi af SVR12 for SVR24
English: If a patient is already taking medicinal product(s) or initiating a medicinal product while receiving Viekirax with or without dasabuvir for which potential for drug interaction is expected, dose adjustment of the concomitant medicinal product(s) or appropriate clinical monitoring should be considered (Table 2).
Danish: Hvis en patient under sin behandling med Viekirax med eller uden dasabuvir allerede tager eller begynder at tage et eller flere lægemidler, hvor der forventes potentiel lægemiddelinteraktion, skal dosisjustering af disse lægemidler eller klinisk overvågning overvejes (se tabel 2).
English: Following administration of Viekirax and dasabuvir
Danish: Efter administration af Viekirax og dasabuvir
English: Viekirax may be administered with or without dasabuvir.
Danish: Viekirax kan administreres med eller uden dasabuvir.
English: OATP1B1/3 substrates evaluated in drug interaction studies include pravastatin and rosuvastatin (see Table 2).
Danish: De OATP1B1/3-substrater, der er undersøgt i lægemiddelinteraktionsstudier, omfatter pravastatin og rosuvastatin (se tabel 2).
English: Recommendations for co-administration of Viekirax with and without dasabuvir for a number of medicinal products are provided in Table 2.
Danish: Anbefalinger for samtidig administration af Viekirax med eller uden dasabuvir i forhold til en række lægemidler, der ofte ordineres samtidigt, er beskrevet i tabel 2.
English: GT1b Viekirax and dasabuvir (8 weeks) Peginterferon+ribavirin experienced -, without cirrhosis SAPPHIRE II
Danish: GT1b Viekirax og dasabuvir (8 uger) Peginterferon/ribavirin-erfarne, uden cirrose SAPPHIRE II
English: BCRP substrates evaluated in drug interaction studies include rosuvastatin (see Table 2).
Danish: De BCRP-substrater, der er undersøgt i lægemiddelinteraktionsstudier, omfatter rosuvastatin (se tabel 2).
English: In the 67 genotype 1a infected subjects, NS3 variants were observed in 50 subjects, NS5A variants were observed in 46 subjects, NS5B variants were observed in 37 subjects, and treatmentemergent variants were seen in all 3 drug targets in 30 subjects.
Danish: Blandt de 67 genotype 1a-smittede forsøgspersoner blev der observeret NS3varianter hos 50, NS5A-varianter hos 46 og NS5B-varianter hos 37; hos 30 forsøgspersoner sås behandlingsrelaterede varianter i alle 3 lægemiddelmål.
English: Upon completion of Viekirax and dasabuvir treatment, the appropriate dose and dosing frequency of tacrolimus should be guided by assessment of tacrolimus blood concentrations.
Danish: Efter afslutning af behandling med Viekirax med dasabuvir, bør passende tacrolimus-dosis og doseringshyppighed baseres på vurderingen af koncentrationen af tacrolimus i blodet.
English: Paritaprevir was positive in an in vitro human chromosome aberration test. Paritaprevir was negative in a bacterial mutation assay, and in two in vivo genetic toxicology assays (rat bone marrow micronucleus and rat liver Comet tests).
Danish: Paritaprevir var negativt i en bakteriel mutationsanalyse og i to genetiske toksikologi-analyser in vivo (mikronukleusanalyse på knoglemarv fra rotter og Comet-test på rottelever).
English: treatment naïve: Viekirax without ribavirin or with weight-based ribavirin for 12 weeks pegIFN + RBV experienced: Viekirax with weight-based ribavirin for 12 weeks
Danish: Behandling: behandlingsnaive: Viekirax uden ribavirin eller med ribavirin baseret på vægt i 12 uger og pegIFN + RBV-erfarne: Viekirax med ribavirin baseret på vægt i 12 uger
English: Paritaprevir/ritonavir had no effects on embryo-foetal viability or on fertility when evaluated in rats at exposures 2- to 8-fold higher than the exposure in humans at the recommended clinical dose.
Danish: Paritaprevir/ritonavir havde ingen indvirkning på den embryo-føtale levedygtighed eller fertiliteten hos rotter ved eksponeringer, der var 2-8 gange højere end eksponeringen hos mennesker ved den anbefalede kliniske dosis.
English: Of the 2,510 HCV genotype 1 infected subjects who were treated with regimens containing ombitasvir, paritaprevir, and dasabuvir with or without ribavirin (for 8, 12, or 24 weeks) in Phase 2b and 3 clinical trials, a total of 74 subjects (3%) experienced virologic failure (primarily post-treatment relapse).
Danish: Ud af de 2.510 HCV genotype 1-smittede forsøgspersoner, der blev behandlet med regimer indeholdende ombitasvir, paritaprevir og dasabuvir med eller uden ribavirin (i 8, 12 eller 24 uger) i de kliniske fase 2bog fase 3-studier, var der i alt 74 (3 %), som oplevede virologisk svigt (primært recidiv efter behandlingen).
English: CYP3A4 substrates:
Danish: CYP3A4-substrater:
English: Titanium dioxide (E 171) Iron oxide red (E 172)
Danish: Talkum (E 553b) Titaniumdioxid (E 171) Rød jernoxid (E 172)
English: Darunavir combined with Viekirax + dasabuvir is not recommended in patients with extensive PI resistance.
Danish: Darunavir sammen med Viekirax plus dasabuvir anbefales ikke til patienter med udtalt PI-resistens.
English: • If you are allergic to ombitasvir, paritaprevir, ritonavir, or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for ombitasvir, paritaprevir, ritonavir eller et af de øvrige indholdsstoffer i
English: HIV protease inhibitors other than atazanavir and darunavir (e.g., indinavir, saquinavir, tipranavir, lopinavir/ritonavir) are contraindicated (see section 4.3).
Danish: Andre hiv-proteasehæmmere end atazanavir og darunavir (f.eks. indinavir, saquinavir, tipranavir og lopinavir/ritonavir) er kontraindiceret (se pkt.
English: CYP2C19 substrates evaluated in drug interaction studies include omeprazole and escitalopram (see Table 2).
Danish: De CYP2C19-substrater, der er undersøgt i lægemiddelinteraktionsstudier, omfatter omeprazol og escitalopram (se tabel 2).
English: Tell your doctor or pharmacist before taking Viekirax also if you are using hormonal contraceptives.
Danish: Du skal også tale med lægen eller apotekspersonalet, før du tager Viekirax, hvis du tager hormonale præventionsmidler.