FrancophonIA/ELRC3.0 huggingface dataset:
English: Each film-coated tablet contains 50 mg elbasvir and 100 mg grazoprevir.
Danish: Hver filmovertrukken tablet indeholder 50 mg elbasvir og 100 mg grazoprevir.
English: Interaction studied with elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (fixed-dose combination)
Danish: Interaktion er undersøgt med elvitegravir/cobicistat/emtricitabin/ tenofovirdisoproxilfumarat (fastdosiskombination)
English: • unusual hair loss or thinning
Danish: • usædvanligt hårtab eller udtynding af håret
English: Table 1: Recommended ZEPATIER therapy for treatment of chronic hepatitis C infection in patients with or without compensated cirrhosis (Child-Pugh A only) HCV genotype
Danish: Tabel 1: Anbefalet behandling med ZEPATIER ved behandling af kronisk hepatitis C-infektion hos patienter med eller uden kompenseret cirrose (kun Child-Pugh A) HCV-genotype
English: • check for side effects
Danish: • kontrollere, om der er bivirkninger
English: Patients should be informed that fatigue has been reported during treatment with ZEPATIER (see section 4.8).
Danish: Patienterne skal informeres om, at der er rapporteret om træthed ved behandling med ZEPATIER (se pkt.
English: If vomiting occurs more than 4 hours after dosing, no further dose is needed.
Danish: Hvis de kaster op mere end 4 timer efter dosering, er en ekstra tablet ikke nødvendig.
English: Table 5: Activities of elbasvir and grazoprevir in GT1a, GT1b and GT4 reference sequences and clinical isolates in replicon cells
Danish: Tabel 5: Elbasvirs og grazoprevirs aktivitet i GT1a-, GT1b- og GT4-referencesekvenser og kliniske isolater i replikon-celler
English: Elbasvir and grazoprevir are substrates of CYP3A and P-gp.
Danish: Elbasvir og grazoprevir er substrater for CYP3A og P-gp.
English: ORAL CONTRACEPTIVES
Danish: ORALE KONTRACEPTIVA
English: Based on in vitro data, clinically significant interactions with ZEPATIER as an inhibitor of other CYP enzymes, UGT1A1, esterases (CES1, CES2, and CatA), OAT1, OAT3, and OCT2 are not expected.
Danish: Baseret på in vitro-data forventes der ikke klinisk signifikante interaktioner med ZEPATIER pga. hæmning af andre CYP-enzymer, UGT1A1, esteraser (CES1, CES2 og CatA), OAT1, OAT3 og OCT2.
English: Your doctor may have to change your medicines or change the dose of your medicines.
Danish: Det kan være nødvendigt, at din læge giver dig et andet lægemiddel eller justerer dosis af det lægemiddel, du tager.
English: • If you or your partner becomes pregnant while taking ZEPATIER with ribavirin or in the months that follow, tell your doctor straight away.
Danish: • Hvis du/ din partner bliver gravid under behandling med ZEPATIER og ribavirin, eller i de efterfølgende måneder, skal du straks kontakte lægen.
English: Plasma protein binding is not meaningfully altered in patients with renal or hepatic impairment.
Danish: Plasmaproteinbindingen er ikke nævneværdigt ændret hos patienter med nedsat nyre- eller leverfunktion.
English: Treatment-emergent substitutions observed in the viral populations of these subjects based on genotypes are shown in Table 6.
Danish: Behandlingsrelaterede substitutioner, som blev observeret i viruspopulationer hos disse forsøgspersoner, er vist i tabel 6 på basis af genotype.
English: Co-administration with grazoprevir did not result in clinically relevant increases in exposures of CYP3A substrates.
Danish: Administration sammen med grazoprevir resulterede ikke i klinisk relevante stigninger i eksponeringen for CYP3Asubstrater.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ZEPATIER therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med ZEPATIER skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Multi-arm, multi-stage study.
Danish: Flertrinsstudie med flere behandlingsarme.
English: Subjects were not excluded or discontinued from the trial based on a positive urine drug screen.
Danish: Forsøgspersonerne blev ikke ekskluderet og udtrådte ikke af studiet på grund af en positiv urinprøve ved rusmiddeltestning.
English: Do not use the medicine after the expiry date which is stated on the carton and blister packaging after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og blisterpakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Beige, oval tablet of dimensions 21 mm x 10 mm debossed with “770” on one side and plain on the other.
Danish: Oval beige tablet, 21 mm x 10 mm, med “770” præget på den ene side og uden prægning på den anden side.
English: The pharmacokinetics of elbasvir/grazoprevir in paediatric patients less than 18 years of age have not been established (see section 4.2).
Danish: Farmakokinetikken for elbasvir/grazoprevir hos pædiatriske patienter under 18 år er ikke klarlagt (se pkt.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with ZEPATIER 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 ZEPATIER i en eller flere undergrupper af den pædiatriske population ved behandling af kronisk hepatitis C (se pkt.
English: Elbasvir and grazoprevir are partially eliminated by oxidative metabolism, primarily by CYP3A.
Danish: Elbasvir og grazoprevir elimineres delvist ved oxidativ metabolisering, hovedsageligt via CYP3A.
English: For grazoprevir, the absolute bioavailability after a 200 mg single dose ranged from 15 - 27% and after multiple 200 mg doses ranged from 20 - 40%.
Danish: For grazoprevir lå den absolutte biotilgængelighed efter enkelt dosis på 200 mg i intervallet 15-27%, og efter flere doser på 200 mg lå den i intervallet 20-40%.
English: • If it has been more than 16 hours since you should have taken your dose, do not take the missed dose.
Danish: • Hvis der er gået mere end 16 timer, siden du skulle have taget din dosis, må du ikke tage den manglende dosis.
English: Sustained virologic response (SVR) was the primary endpoint in all studies and was defined as HCV RNA less than the lower limit of quantification (LLOQ: 15 HCV RNA IU/mL except in C-WORTHY and C-SCAPE [25 HCV RNA IU/mL]) at 12 weeks after the cessation of treatment (SVR12).
Danish: Vedvarende virologisk respons (SVR) var det primære endepunkt i alle studier og blev defineret som HCV-RNA under den nedre kvantificeringsgrænse (LLOQ: 15 HCV-RNA IE/ml undtagen i CWORTHY og C-SCAPE [25 HCV-RNA IE/ml]) 12 uger efter behandlingsophør (SVR12).
English: Talk to your doctor or pharmacist before taking ZEPATIER if you:
Danish: Kontakt lægen eller apotekspersonalet, før du tager ZEPATIER, hvis du:
English: • have had a liver transplant
Danish: • har gennemgået en levertransplantation
English: • If it has been less than 16 hours since you should have taken your dose, take the missed dose as soon as possible.
Danish: • Hvis der er gået mindre end 16 timer, siden du skulle have taget din dosis, skal du hurtigst muligt tage den manglende dosis.
English: Grazoprevir oral exposures are approximately 2-fold greater in HCV-infected subjects as compared to healthy subjects.
Danish: Orale eksponeringer for grazoprevir er cirka 2 gange højere hos HCV-inficerede forsøgspersoner sammenlignet med raske forsøgspersoner.
English: Co-administration of ZEPATIER with sunitinib may increase sunitinib concentrations leading to an increased risk of sunitinib-associated adverse events.
Danish: Administration af ZEPATIER sammen med sunitinib kan øge koncentrationen af sunitinib, hvilket fører til en øget risiko for sunitinibassocierede bivirkninger.
English: The following adverse reactions were identified in patients taking ZEPATIER without ribavirin for 12 weeks.
Danish: Følgende bivirkninger blev identificeret hos patienter, der har taget ZEPATIER uden ribavirin i 12 uger.
English: ZEPATIER for 16 weeks plus ribavirin
Danish: ZEPATIER i 16 uger plus ribavirin
English: Do not stop taking ZEPATIER
Danish: Du må ikke holde op med at tage ZEPATIER
English: Use with caution; dose adjustment of sunitinib may be required.
Danish: Dosisjustering af sunitinib kan være nødvendig.
English: Table 2: Interactions and dose recommendations with other medicinal products
Danish: Tabel 2: Lægemiddelinteraktioner med andre lægemidler og dosisanbefalinger
English: Expected: ↑ Grazoprevir
Danish: Forventet: ↑ Grazoprevir
English: Human experience of overdose with ZEPATIER is limited.
Danish: Der er begrænset erfaring med overdosering af ZEPATIER hos mennesker.
English: ZEPATIER treatment should be initiated and monitored by a physician experienced in the management of patients with CHC.
Danish: Behandling med ZEPATIER skal initieres og monitoreres af en læge med erfaring i behandling af patienter med kronisk hepatitis C.
English: If you are taking ZEPATIER with ribavirin, please make sure that you read the "Do not take" section of the ribavirin package leaflet.
Danish: Hvis du tager ZEPATIER sammen med ribavirin, skal du sørge for at læse punktet ”Tag ikke” i indlægssedlen for ribavirin.
English: • you are taking any of the following medicines: o rifampicin, usually given for tuberculosis o HIV protease inhibitors such as atazanavir, darunavir, lopinavir, saquinavir, or tipranavir o efavirenz or etravirine for HIV o elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide for HIV o ciclosporin to stop organ transplant rejection or to treat serious inflammatory illnesses of eyes, kidney, joints or skin o bosentan for pulmonary arterial hypertension o carbamazepine or phenytoin, mainly used for epilepsy and seizures o modafinil to help people who cannot stay awake o St. John's wort (Hypericum perforatum, a herbal medicine) for depression or other problems
Danish: • hvis du tager et af følgende lægemidler: o rifampicin, der normalt anvendes til behandling af tuberkulose o proteasehæmmere såsom atazanavir, darunavir, lopinavir, saquinavir eller tipranavir til behandling af hiv-infektion o efavirenz eller etravirin til behandling af hiv-infektion o elvitegravir/cobicistat/emtricitabin/tenofovirdisoproxilfumarat eller elvitegravir/cobicistat/emtricitabin/tenofoviralafenamid til behandling af hiv-infektion o ciclosporin, der bruges til at forebygge, at et transplanteret organ afstødes, eller til behandling af alvorlige betændelseslignende (inflammatoriske) sygdomme i øjne, nyrer, led eller hud o bosentan til behandling af højt blodtryk i lungekredsløbet (pulmonal arteriel hypertension (PAH)) o carbamazepin eller phenytoin, der hovedsageligt anvendes til behandling af epilepsi og til forebyggelse af krampeanfald o modafinil, der hjælper folk med at holde sig vågne o perikon (Hypericum perforatum, et naturlægemiddel) mod depression eller andre problemer.
English: Expected: ↑ Fluvastatin (primarily due to intestinal BCRP inhibition)
Danish: Forventet: ↑ Fluvastatin (primært på grund af intestinal BCRPhæmning)
English: Subjects were randomised in a 1:1:1:1 ratio to the study arms.
Danish: Forsøgspersonerne blev randomiseret i forholdet 1:1:1:1 til studiearmene.
English: The efficacy of ZEPATIER in patients previously exposed to ZEPATIER, or to medicinal products of the same classes as those of ZEPATIER (NS5A inhibitors or NS3/4A inhibitors other than telaprevir, simeprevir, boceprevir), has not been demonstrated (see section 5.1).
Danish: Virkning af ZEPATIER er ikke påvist hos patienter, der tidligere har været eksponeret for ZEPATIER eller for lægemidler af samme klasse som ZEPATIER (NS5A-hæmmere eller NS3/4A-hæmmere bortset fra telaprevir, simeprevir, boceprevir) (se pkt.
English: Includes subjects from C-EDGE TN, C-EDGE COINFECTION, C-EDGE TE and C-SCAPE.
Danish: Inkluderer forsøgspersoner fra C-EDGE TN, C-EDGE COINFECTION, C-EDGE TE og C-SCAPE.
English: The safety of ZEPATIER was assessed based on 3 placebo-controlled studies and 7 uncontrolled Phase 2 and 3 clinical studies in approximately 2,000 subjects with chronic hepatitis C infection with compensated liver disease (with or without cirrhosis).
Danish: ZEPATIERs sikkerhed blev vurderet på basis af 3 placebokontrollerede studier og 7 ikkekontrollerede kliniske fase II- og III-studier hos cirka 2.000 forsøgspersoner med kronisk hepatitis Cinfektion med kompenseret leversygdom (med eller uden cirrose).
English: Elbasvir is an inhibitor of HCV NS5A, which is essential for viral RNA replication and virion assembly.
Danish: Elbasvir hæmmer HCV-NS5A, som er afgørende for viral RNA-replikation og samling af virioner.
English: Following once daily administration of elbasvir/grazoprevir to HCV-infected subjects, elbasvir and grazoprevir reached steady state within approximately 6 days.
Danish: Efter administration af elbasvir/grazoprevir en gang dagligt til HCV-inficerede forsøgspersoner blev steady state for elbasvir og grazoprevir opnået inden for cirka 6 dage.
English: In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.
Danish: I tilfælde af overdosering anbefales det at overvåge patienten for symptomer på bivirkninger og iværksætte behandling af eventuelle symptomer.
English: Table 3: Adverse reactions identified with ZEPATIER Frequency
Danish: Tabel 3: Bivirkninger, som blev identificeret med ZEPATIER* Hyppighed
English: Elbasvir pharmacokinetics were approximately dose-proportional over the range of 5-100 mg once daily.
Danish: Elbasvirs farmakokinetik var nogenlunde dosisproportional inden for et interval på 5-100 mg en gang dagligt.
English: Expected: ↔ Elbasvir ↔ Grazoprevir ↔ Lamivudine ↔ Abacavir ↔ Entecavir
Danish: Forventet: ↔ Elbasvir ↔ Grazoprevir ↔ Lamivudin ↔ Abacavir ↔ Entecavir
English: HCV ANTIVIRAL AGENTS
Danish: HCV-ANTIVIRALE MIDLER
English: The safety and efficacy of elbasvir/grazoprevir (co-administered as a fixed-dose combination; EBR/GZR) or elbasvir + grazoprevir (co-administered as single agents; EBR + GZR) were evaluated in 8 clinical studies in approximately 2,000 subjects (see Table 8).
Danish: Sikkerheden og virkningen af elbasvir/grazoprevir (administreret samtidigt som en fastdosiskombination; EBR/GZR) eller elbasvir + grazoprevir (administreret samtidigt som enkeltstoffer; EBR + GZR) blev vurderet i 8 kliniske studier med cirka 2.000 forsøgspersoner (se tabel 8).
English: This allows the infection to be permanently removed from the body.
Danish: Dette gør det muligt at bekæmpe infektionen fuldstændigt.
English: HCV/HBV (hepatitis B virus) co-infection
Danish: Co-infektion med HCV og HBV (hepatitis B-virus)
English: If you take more ZEPATIER than you should, talk to a doctor straight away.
Danish: Hvis du har taget for meget ZEPATIER, skal du straks kontakte lægen.
English: Animal studies do not indicate harmful effects of elbasvir or grazoprevir on fertility at elbasvir and grazoprevir exposures higher than the exposure in humans at the recommended clinical dose (see section 5.3).
Danish: Dyrestudier indikerer ingen skadelige virkninger af elbasvir eller grazoprevir på fertilitet ved eksponering for elbasvir og grazoprevir, der var højere end eksponeringen hos mennesker ved den anbefalede kliniske dosis (se pkt.
English: Grazoprevir is an inhibitor of the 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: Grazoprevir hæmmer HCV-NS3/4A-protease, der er nødvendig for proteolytisk spaltning af det HCVkodede polyprotein (til modne former af proteinerne NS3, NS4A, NS4B, NS5A og NS5B), og som er afgørende for viral replikation.
English: Emergent Amino Acid Substitutions
Danish: Opståede aminosyresubstitutioner
English: Elbasvir and grazoprevir are inhibitors of the drug transporter BCRP at the intestinal level in humans and may increase plasma concentrations of co-administered BCRP substrates.
Danish: Elbasvir og grazoprevir hæmmer lægemiddeltransportøren BCRP på intestinalt niveau hos mennesker og kan øge plasmakoncentrationen af samtidigt administrerede BCRP-substrater.
English: The safety and efficacy of ZEPATIER have not been established in liver transplant recipients.
Danish: ZEPATIERs sikkerhed og virkning er ikke klarlagt hos patienter, der har gennemgået en levertransplantation.
English: If more than 16 hours have passed since ZEPATIER is usually taken, then the patient should be instructed that the missed dose should NOT be taken and to take the next dose per the usual dosing schedule.
Danish: Hvis der er gået mere end 16 timer, efter ZEPATIER normalt skulle tages, skal patienten IKKE tage den glemte dosis og blot tage den næste dosis i henhold til det normale doseringsskema.
English: The frequency of serious adverse reactions and discontinuations due to adverse reactions in subjects with compensated cirrhosis were comparable to those seen in subjects without cirrhosis.
Danish: Hyppigheden af alvorlige bivirkninger og seponering som følge af bivirkninger hos forsøgspersoner med kompenseret cirrose var sammenlignelig med hyppigheden hos forsøgspersoner uden cirrose.
English: Includes subjects from C-EDGE TN, C-EDGE COINFECTION, C-EDGE TE, C-WORTHY and C-SURFER.
Danish: Inkluderer forsøgspersoner fra C-EDGE TN, C-EDGE COINFECTION, C-EDGE TE, C-WORTHY og CSURFER.
English: EBR with GZR + RBV
Danish: EBR med GZR + RBV
English: Available pharmacokinetic data in animals has shown excretion of elbasvir and grazoprevir in milk.
Danish: De tilgængelige farmakokinetiske data fra dyrestudier viser, at elbasvir og grazoprevir udskilles i mælk.
English: Viral populations with treatment-emergent NS5A resistance-associated substitutions were generally more persistent than NS3 resistance associated substitutions.
Danish: Viruspopulationer med behandlingsrelaterede NS5A-resistens-associerede substitutioner var generelt mere persistente end NS3-resistens-associerede substitutioner.
English: ZEPATIER 50 mg/100 mg film-coated tablets
Danish: ZEPATIER 50 mg/100 mg filmovertrukne tabletter
English: Table 7: SVR in GT1a-, GT1b- or treatment-experienced GT4-infected subjects bearing baseline NS5A or NS3 polymorphisms SVR12 by Treatment Regimen ZEPATIER, 12 Weeks
Danish: Tabel 7: SVR hos GT1a-, GT1b- eller behandlingserfarne GT4-inficerede forsøgspersoner, der bærer NS5A- eller NS3-polymorfismer ved baseline SVR12 ud fra behandlingsregime ZEPATIER, 12 uger
English: C-SURFER (double-blind)
Danish: C-SURFER (dobbeltblindet)
English: Carcinogenicity studies for grazoprevir and elbasvir have not been conducted.
Danish: Der er ikke udført karcinogenicitetsstudier med elbasvir og grazoprevir.
English: If you are lactose intolerant, or if you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Danish: Hvis du ikke tåler lactose (mælkesukker), eller hvis lægen har fortalt dig, at du ikke kan tåle visse sukkerarter, skal du kontakte lægen, før du tager dette lægemiddel.
English: Due to the limited number of genotype 4-infected subjects with treatment emergent NS5A and NS3 resistance associated substitutions, trends in persistence of treatment emergent substitutions in this genotype could not be established.
Danish: På grund af et begrænset antal genotype 4-inficerede forsøgspersoner med behandlingsrelaterede NS5A- og NS3-resistens-associerede substitutioner kunne tendenser i persistensen af behandlingsrelaterede substitutioner ikke klarlægges hos denne genotype.
English: The EC50 values of elbasvir and grazoprevir against full-length or chimeric replicons encoding NS5A or NS3 sequences from reference sequences and clinical isolates are presented in Table 5.
Danish: EC50-værdierne for elbasvir og grazoprevir mod replikoner i fuld længde eller kimære replikoner, der koder NS5A- eller NS3-sekvenser fra referencesekvenser og kliniske isolater, er vist i tabel 5.
English: Table 6: Treatment-emergent amino acid substitutions in the pooled analysis of ZEPATIER with and without ribavirin regimens in Phase 2 and Phase 3 clinical studies
Danish: Tabel 6: Aminosyresubstitutioner, der opstod under behandlingen, i den puljede analyse af ZEPATIER med og uden ribavirin i kliniske fase II- og III-studier Mål
English: What ZEPATIER is ZEPATIER is an antiviral medicine that contains the active substances elbasvir and grazoprevir.
Danish: ZEPATIER virker mod virus (antiviralt lægemiddel), som indeholder de aktive stoffer elbasvir og grazoprevir.
English: Sodium laurilsulfate Vitamin E polyethylene glycol succinate Copovidone
Danish: Natriumlaurilsulfat E-vitamin, polyethylenglycolsuccinat Copovidon
English: ZEPATIER is not for use in children and adolescents under 18 years of age.
Danish: ZEPATIER må ikke anvendes til børn og unge under 18 år.
English: • joint pain or painful, swollen joints
Danish: • ledsmerter eller hævede og smertefulde led
English: In the clinical studies, the dose of ribavirin was weight-based (< 66 kg = 800 mg/day, 66 to 80 kg = 1,000 mg/day, 81 to 105 kg = 1,200 mg/day, > 105 kg = 1,400 mg/day) administered in two divided doses with food.
Danish: I de kliniske studier var ribavirin-dosis vægtbaseret (< 66 kg = 800 mg/dag; 66-80 kg = 1.000 mg/dag; 81-105 kg = 1.200 mg/dag; > 105 kg = 1.400 mg/dag), og dosis blev fordelt på to doser sammen med mad.
English: Elbasvir is not a CYP3A inhibitor in vitro and grazoprevir is a weak CYP3A inhibitor in humans.
Danish: Elbasvir hæmmer ikke CYP3A in vitro, og grazoprevir er en svag CYP3A-hæmmer hos mennesker.
English: Less than 1 % of subjects treated with ZEPATIER with or without ribavirin had serious adverse reactions (abdominal pain, transient ischaemic attack and anaemia).
Danish: Under 1% af forsøgspersonerne, der fik ZEPATIER med eller uden ribavirin, havde alvorlige bivirkninger (abdominalsmerter, transitorisk cerebral iskæmi og anæmi).
English: Grazoprevir has been shown to cross the placenta in rats and rabbits.
Danish: Det er vist, at grazoprevir passerer placenta hos rotter og kaniner.
English: Grazoprevir is a substrate of OATP1B drug transporters.
Danish: Grazoprevir er substrat for OATP1B-lægemiddeltransportører.
English: Film-coated tablet 28 film-coated tablets
Danish: Filmovertrukne tabletter 28 filmovertrukne tabletter
English: The substitutions associated with resistance to NS5B inhibitors do not affect the activity of elbasvir or grazoprevir.
Danish: Substitutioner, der er associeret med resistens over for NS5B-hæmmere, påvirker ikke elbasvirs eller grazoprevirs aktivitet.
English: Elbasvir pharmacokinetics are similar in healthy subjects and HCV-infected subjects.
Danish: Farmakokinetikken for elbasvir er sammenlignelig hos raske forsøgspersoner og HCV-inficerede forsøgspersoner.
English: No circulating metabolites of either elbasvir or grazoprevir were detected in human plasma.
Danish: Der blev hverken påvist cirkulerende metabolitter af elbasvir eller af grazoprevir i humant plasma.
English: Patients should be instructed that if vomiting occurs within 4 hours of dosing, an additional tablet can be taken up to 8 hours before the next dose.
Danish: Patienterne skal informeres om, at de kan tage en ekstra tablet op til 8 timer før næste dosis, hvis de kaster op inden for 4 timer efter dosering.
English: Grazoprevir pharmacokinetics increased in a greater than dose-proportional manner over the range of 10-800 mg once daily in HCV-infected subjects.
Danish: Grazoprevirs farmakokinetik steg mere end dosisproportionalt inden for et interval på 10800 mg en gang dagligt hos HCV-inficerede forsøgspersoner.
English: (CYP3A or P-gp induction)
Danish: (CYP3A- eller P-gp-induktion)