FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall, the changes in exposures of Maviret in HCV-infected subjects with renal impairment with or without dialysis were not clinically significant.
Danish: Generelt var ændringerne i Maviret-eksponeringen hos HCV-smittede forsøgspersoner med nedsat nyrefunktion med eller uden dialyse ikke klinisk signifikante.
English: Some substitutions at position 156 reduced susceptibility to glecaprevir (genotypes 1 to 4) by > 100-fold.
Danish: Nogle substitutioner ved position 156 reducerede glecaprevir-følsomheden (genotype 1-4) med > 100 gange.
English: ETHINYL-OESTRADIOL-CONTAINING PRODUCTS Ethinyloestradiol (EE)/Norgestimate
Danish: ETHINYL-ØSTRADIOL-HOLDIGE LÆGEMIDLER Ethinyløstradiol (EE)/norgestimat
English: HIV-ANTIVIRAL AGENTS Atazanavir + ritonavir
Danish: HIV-ANTIVIRALE MIDLER Atazanavir + ritonavir
English: No human data on the effect of glecaprevir and/or pibrentasvir on fertility are available.
Danish: Der foreligger ingen humane data om glecaprevirs og/eller pibrentasvirs indvirkning på fertiliteten.
English: Estimation of the pharmacokinetic parameters using population pharmacokinetic models has inherent uncertainty due to dose non-linearity and cross interaction between glecaprevir and pibrentasvir.
Danish: Estimering af de farmakokinetiske parametre ved hjælp af farmakokinetiske populationsmodeller rummer en indbygget usikkerhed på grund af dosisafhængig ikke-linearitet og krydsinteraktion mellem glecaprevir og pibrentasvir.
English: b. Effect of atazanavir and ritonavir on the first dose of glecaprevir and pibrentasvir is reported.
Danish: b. Der er rapporteret om indvirkning af atazanavir og ritonavir på den første dosis glecaprevir og pibrentasvir.
English: Tell your doctor or pharmacist before taking Maviret, if you are taking any of the medicines in the table below.
Danish: Tal med lægen eller apotekspersonalet, før du tager Maviret, hvis du tager et eller flere af de lægemidler, der er angivet i tabellen nedenfor.
English: Phenytoin, phenobarbital, primidone
Danish: Phenytoin, phenobarbital, primidon
English: The effect of efavirenz/emtricitabine/tenofovir disoproxil fumarate on glecaprevir and pibrentasvir was not directly quantified within this study, but glecaprevir and pibrentasvir exposures were significantly lower than historical controls.
Danish: Indvirkningen af efavirenz/emtricitabin/tenofovirdisoproxilfumarat på glecaprevir og pibrentasvir blev ikke direkte kvantificeret i studiet, men glecaprevirog pibrentasvir-eksponeringen var signifikant lavere sammenlignet med historiske kontroller.
English: The physician in charge of the diabetic care of the patient should be informed when direct acting antiviral therapy is initiated.
Danish: Den læge, der er ansvarlig for patientens diabetesbehandling, bør informeres, når behandling med direkte virkende antivirale lægemidler påbegyndes.
English: Race/ethnicity No dose adjustment of Maviret is required based on race or ethnicity.
Danish: Race/etnisk oprindelse Dosisjustering af Maviret er ikke nødvendig ud fra race og etnisk oprindelse.
English: Substrate of transporter
Danish: Transport Substrat for transporter
English: % Bound to human plasma proteins Blood-to-plasma ratio
Danish: Binding til humane plasmaproteiner i % 97,5 Blod/plasma-ratio
English: Glecaprevir and pibrentasvir are substrates of the efflux transporters P-gp and/or BCRP.
Danish: Glecaprevir og pibrentasvir er substrater for efflukstransporterne P-gp og/eller BCRP.
English: Patients with HIV-1 Co-infection
Danish: Patienter med samtidig HIV-1-infektion
English: Carcinogenicity studies with glecaprevir and pibrentasvir have not been conducted.
Danish: Der er ikke udført karcinogenicitetsstudier med glecaprevir og pibrentasvir.
English: Specifically in genotype 3a, A30K or Y93H had no impact on pibrentasvir activity.
Danish: Specifikt hos genotype 3a havde A30K og Y93H ingen indvirkning på aktiviteten af pibrentasvir.
English: All subjects (15/15) with Y93H and 75% (15/20) with A30K in NS5A at baseline achieved SVR12.
Danish: Alle forsøgspersoner (15/15) med Y93H og 75 % (15/20) med A30K i NS5A ved baseline opnåede SVR12.
English: Contraceptive medicines that contain ethinylestradiol must not be used in combination with Maviret.
Danish: Ethinyløstradiol-holdige præventionsmidler må ikke anvendes i kombination med Maviret.
English: DORA (Part 1) was an open-label study to evaluate safety and efficacy in adolescents aged 12 years to less than 18 years who received Maviret 300 mg/120 mg (three 100 mg/40 mg film-coated tablets), for 8, or 16 weeks.
Danish: DORA (del 1) var et åbent studie til vurdering af sikkerhed og effekt hos unge i alderen fra 12 til under 18 år, der fik Maviret 300 mg/120 mg (tre 100 mg /40 mg filmovertrukne tabletter) i 8 eller 16 uger.
English: A resistance algorithm predictive of the risk for failure by baseline resistance has not been established.
Danish: Der er ikke fastlagt en resistensalgoritme, der kan forudsige risikoen for behandlingssvigt på grundlag af baseline-resistens.
English: Nervous system disorders Very common headache
Danish: Nervesystemet Meget almindelig
English: Very common: may affect more than 1 in 10 people
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 behandlede):
English: Not known: cannot be estimated from the available data • itching
Danish: • Kraftesløshed, manglende energi Hyppighed ukendt: kan ikke estimeres ud fra tilgængelige data
English: Therefore, a therapeutic drug monitoring of tacrolimus is recommended and a dose adjustment of tacrolimus made accordingly.
Danish: Derfor anbefales det at styre tacrolimusbehandlingen ved monitorering og passende justering af tacrolimus-dosen.
English: • you are allergic to glecaprevir, pibrentasvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Danish: • hvis du er allergisk over for glecaprevir, pibrentasvir eller et af de øvrige indholdsstoffer i Maviret (angivet i punkt 6).
English: Co-administration of moderate inducers is not recommended (see section 4.4).
Danish: Samtidig administration af moderate inducere anbefales ikke (se pkt.
English: The highest documented doses administered to healthy volunteers is 1,200 mg once daily for 7 days for glecaprevir and 600 mg once daily for 10 days for pibrentasvir.
Danish: De højeste dokumenterede doser, der er administreret til raske forsøgspersoner, er 1.200 mg én gang dagligt i 7 dage for glecaprevir og 600 mg én gang dagligt i 10 dage for pibrentasvir.
English: ANTIARRHYTHMICS Digoxin
Danish: ANTIARYTMIKA Digoxin
English: Gender/weight No dose adjustment of Maviret is required based on gender or body weight.
Danish: Køn/vægt Dosisjustering af Maviret er ikke nødvendig ud fra køn og vægt.
English: Some combinations of substitutions in genotypes 1a and 3a (including A30K+Y93H in genotype 3a) showed reductions in susceptibility to pibrentasvir.
Danish: Nogle kombinationer af substitutioner hos genotype 1a og 3a (herunder A30K+Y93H hos genotype 3a) udviste nedsat følsomhed over for pibrentasvir.
English: Package leaflet: Information for the user Maviret 100 mg/40 mg film-coated tablets glecaprevir/pibrentasvir This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Maviret 100 mg/40 mg filmovertrukne tabletter glecaprevir/pibrentasvir Dette lægemiddel er underlagt supplerende overvågning.
English: In genotype 3b replicon, the presence of naturally occurring polymorphisms K30 and M31 in NS5A reduced susceptibility to pibrentasvir by 24-fold relative to the activity of pibrentasvir in genotype 3a replicon.
Danish: I genotype 3b replikon reducerede tilstedeværelsen af naturligt forekommende polymorfier K30 og M31 hos NS5A følsomheden for pibrentasvir med 24 gange i forhold til aktiviteten af pibrentasvir i genotype 3a replikon.
English: c. HCV-infected transplant recipients who received a median ciclosporin dose of 100 mg per day had increased glecaprevir exposures to 2.4-fold of those not receiving ciclosporin.
Danish: c. HCV-smittede patienter med levertransplantat, som fik en median ciclosporin-dosis på 100 mg pr. dag havde en glecaprevir-eksponering, der var2,4 gange højere end dem, der ikke fik ciclosporin.
English: Contents of the pack and other information What Maviret contains
Danish: Pakningsstørrelser og yderligere oplysninger Maviret indeholder:
English: General disorders and administration site conditions Very common fatigue
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig
English: • you have severe liver problems other than from hepatitis C.
Danish: • hvis du har andre alvorlige leverproblemer end hepatitis C.
English: Substitutions at amino acid position 80 did not reduce susceptibility to glecaprevir except for Q80R in genotype 3a, which reduced susceptibility to glecaprevir by 21-fold.
Danish: Substitutioner ved aminosyreposition 80 reducerede ikke glecaprevir-følsomheden, bortset fra Q80R hos genotype 3a, der reducerede glecaprevir-følsomheden med 21 gange.
English: No dose adjustment is required.
Danish: Dosisjustering er ikke nødvendigt.
English: The most common adverse reactions in subjects with severe renal impairment were pruritus (17%) and fatigue (12%) in EXPEDITION-4 and pruritus (14.9%) in EXPEDITION-5.
Danish: De mest almindelige bivirkninger hos forsøgspersoner med svært nedsat nyrefunktion var pruritus (17 %) og træthed (12 %) i EXPEDITION-4 og pruritus (14,9%) i EXPEDITION-5.
English: film-coated tablets 21 film-coated tablets
Danish: filmovertrukne tabletter 21 filmovertrukne tabletter
English: The safety of Maviret in HCV GT1-6 infected adolescents is based on data from a Phase 2/3 openlabel study in 47 subjects aged 12 years to <18 years treated with Maviret for 8 to 16 weeks (DORAPart 1).
Danish: Sikkerheden ved Maviret hos HCV GT1-6-inficerede unge er baseret på data fra et fase 2/3 åbent studie med 47 forsøgspersoner i alderen fra 12 år til <18 år, der blev behandlet med Maviret i 8 til 16 uger (DORA-del 1).
English: The direction of the arrow indicates the direction of the change in exposures (Cmax, AUC, and Cmin) in glecaprevir, pibrentasvir, and the coadministered medicinal product (↑ = increase (more than 25%), ↓ = decrease (more than 20%), ↔ = no change (equal to or less than 20% decrease or 25% increase)).
Danish: Pilens retning angiver ændringen i eksponeringen (Cmax, AUC og Cmin) for glecaprevir, pibrentasvir og det samtidigt administrerede lægemiddel ↑ = (stigning (på over 25 %)), ↓ = fald (på over 20 %), ↔ = ingen ændring (svarende til et fald på højst 20 % eller en stigning på højst 25 %).
English: In animal reproduction studies, no adverse developmental effects were observed when the components of Maviret were administered separately during organogenesis at exposures up to 53 times (rats; glecaprevir) or 51 and 1.5 times (mice and rabbits, respectively; pibrentasvir) the human exposures at the recommended dose of Maviret.
Danish: I reproduktionsstudier hos dyr sås ingen uønsket indvirkning på fosterudviklingen ved separat administration af bestanddelene i Maviret under organogenesen ved eksponeringer, der var op til 53 gange (rotter; glecaprevir) eller op til 51 og 1,5 gange (hhv. mus og kaniner; pibrentasvir) eksponeringen hos mennesker ved den anbefalede dosis Maviret.
English: P-gp, BCRP, and OATP1B1/3
Danish: P-gp, BCRP og OATP1B1/3
English: UNIQUE IDENTIFIER - 2D BARCODE UNIQUE IDENTIFIER - HUMAN READABLE DATA
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA
English: Pharmacotherapeutic group: Direct-acting antiviral, ATC code: J05AP57 glecaprevir and pibrentasvir Mechanism of action
Danish: Farmakoterapeutisk klassifikation: Direkte virkende antivirale midler, ATC-kode: J05AP57 glecaprevir og pibrentasvir
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: P-gp and not excluded BCRP a. Median Tmax following single doses of glecaprevir and pibrentasvir in healthy subjects.
Danish: P-gp og BCRP ikke ekskluderet a. Median Tmax efter enkeltdoser af glecaprevir og pibrentasvir hos raske forsøgspersoner.
English: Asymptomatic serum ALT elevations (>5x ULN) were observed in 1 out of 70 healthy subjects following multiple doses of glecaprevir (700 mg or 800 mg) once daily for ≥ 7 days.
Danish: Asymptomatisk forhøjet ALAT i serum (> 5 x ULN) sås hos 1 ud af 70 raske forsøgspersoner efter multiple doser glecaprevir (700 mg eller 800 mg) én gang dagligt i ≥ 7 dage.
English: One subject experienced on-treatment virologic failure (0.6%, 1/168) and no subjects relapsed (0%, 0/166).
Danish: En forsøgsperson oplevede virologisk svigt (0,6%, 1/168) under behandling, og ingen forsøgspersoner oplevede tilbagefald (0%, 0/166).
English: Elevations in total bilirubin of at least 2x upper limit normal (ULN) were observed in 1.3% of subjects related to glecaprevir-mediated inhibition of bilirubin transporters and metabolism.
Danish: Forhøjet total bilirubin på mindst 2 gange den øvre normalgrænse (ULN) sås hos 1,3 % af forsøgspersonerne og var forårsaget af glecaprevir-medieret hæmning af bilirubintransportere og metabolisering.
English: Maternal toxicity (anorexia, lower body weight, and lower body weight gain) with some embryofoetal toxicity (increase in post-implantation loss and number of resorptions and a decrease in mean foetal body weight), precluded the ability to evaluate glecaprevir in the rabbit at clinical exposures.
Danish: Maternel toksicitet (anoreksi, lavere kropsvægt og lavere vægtforøgelse) med en vis embryo-føtal toksicitet (øget antal postimplantationstab og resorptioner samt lavere gennemsnitlig fostervægt) gjorde det ikke muligt at evaluere glecaprevir hos kaniner ved den kliniske eksponering.
English: Medicines you must tell your doctor about before taking Maviret Medicine
Danish: Lægemidler, som lægen skal vide, at du tager, før du tager Maviret Lægemiddel
English: Amino acid substitutions in NS3 or NS5A selected in cell culture or important for the inhibitor class were phenotypically characterized in replicons.
Danish: Aminosyresubstitutioner i NS3 eller NS5A, der er selekteret i cellekultur, eller som har betydning for klassen af hæmmere, blev fænotypisk karakteriseret i replikoner.
English: No effects on mating, female or male fertility, or early embryonic development were observed in rodents at up to the highest dose tested.
Danish: Der er ikke observeret nogen påvirkning af parringsevne, kønsspecifik fertilitet eller tidlig fosterudvikling hos gnavere ved op til den højeste testede dosis.
English: Omeprazole 40 mg once daily (evening without food)
Danish: Omeprazol 40 mg én gang dagligt (om aftenen uden mad)
English: Glecaprevir was fully active against resistance-associated substitutions in NS5A, while pibrentasvir was fully active against resistance-associated substitutions in NS3.
Danish: Glecaprevir udviste fuld aktivitet mod resistensrelaterede substitutioner i NS5A, mens pibrentasvir bibeholdt fuld aktivitet mod resistensrelaterede substitutioner i NS3.
English: Twenty two of the approximately 2,300 subjects treated with Maviret for 8, 12, or 16 weeks in registrational Phase 2 and 3 clinical studies experienced virologic failure (2 with genotype 1, 2 with genotype 2, 18 with genotype 3 infection).
Danish: 22 af de ca. 2.300 forsøgspersoner, der blev behandlet med Maviret i 8, 12 eller 16 uger i kliniske fase 2 og fase 3-registreringsstudier, oplevede virologisk svigt (2 med genotype 1-, 2 med genotype 2og 18 med genotype 3-infektion).
English: • atorvastatin or simvastatin (to lower blood cholesterol)
Danish: • atorvastatin eller simvastatin (mod forhøjet kolesterol)
English: 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 lægen har fortalt dig, at du ikke kan tåle visse sukkerstoffer, skal du kontakte lægen, før du tager dette lægemiddel.
English: Maviret contains lactose
Danish: Maviret indeholder lactose
English: A 12-week treatment duration has been evaluated and is recommended in liver or kidney transplant recipients with or without cirrhosis (see section 5.1).
Danish: En 12-ugers behandlingsvarighed er blevet vurderet og anbefales til lever- eller nyre transplanterede patienter med eller uden cirrose (se pkt.
English: Table 11: Pharmacokinetic properties of the components of Maviret in healthy adult subjects Glecaprevir
Danish: Tabel 11: Farmakokinetiske egenskaber ved Mavirets bestanddele hos raske voksne forsøgspersoner
English: Caution is recommended.
Danish: Der bør udvises forsigtighed.
English: EXPEDITION-5 was an open-label study in 101 HCV GT1-6 infected subjects without cirrhosis or with compensated cirrhosis and chronic kidney disease (CKD) stage 3b, 4, or 5.
Danish: EXPEDITION-5 var et åbent studie i 101 HCV GT1-6-smittede forsøgspersoner uden cirrose eller med kompenseret cirrose og kronisk nyresygdom (CKD) stadie 3b, 4 eller 5.
English: Genotype 1-infected (and a very limited number of genotype 4-infected) patients with prior failure on regimens that may confer resistance to glecaprevir/pibrentasvir were studied in the MAGELLAN-1 study (section 5.1).
Danish: Genotype 1-patienter (og et meget begrænset antal genotype 4-patienter), der tidligere har oplevet svigt af behandlingsregimer, som kan give resistens mod glecaprevir/pibrentasvir, blev undersøgt i MAGELLAN-1-studiet (pkt.
English: Substitutions at amino acid position 168 in NS3 had no impact in genotype 2, while some substitutions at position 168 reduced glecaprevir susceptibility by up to 55-fold (genotypes 1, 3, 4), or reduced susceptibility by > 100-fold (genotype 6).
Danish: Substitutioner ved aminosyreposition 168 i NS3 havde ingen indvirkning på genotype 2, mens visse substitutioner ved position 168 reducerede glecaprevir-følsomheden med op til 55 gange (genotype 1, 3 og 4) eller med > 100 gange (genotype 6).
English: No glecaprevir metabolites were observed in plasma.
Danish: Ingen glecaprevirmetabolitter sås i plasma.
English: There were no developmental effects with either compound in rodent peri/postnatal developmental studies in which maternal systemic exposures (AUC) to glecaprevir and pibrentasvir were approximately 47 and 74 times, respectively, the exposure in humans at the recommended dose.
Danish: Der sås ingen udviklingsmæssig indvirkning ved nogen af bestanddelene hos gnavere i perinatale/postnatale udviklingsstudier, hvor den maternelle systemiske eksponering (AUC) for glecaprevir og pibrentasvir var hhv. ca. 47 og 74 gange eksponeringen hos mennesker ved den anbefalede dosis.
English: Glecaprevir is a pan-genotypic 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: Glecaprevir er en pan-genotypisk hæmmer af HCV-NS3/4A-protease, der er nødvendig for proteolytisk spaltning af det HCV-kodede polyprotein (til modne former af proteinerne NS3, NS4A, NS4B, NS5A og NS5B), og som er afgørende for viral replikation.
English: It contains the active substances glecaprevir and pibrentasvir.
Danish: Det indeholder de aktive stoffer glecaprevir og pibrentasvir.
English: The safety and efficacy of Maviret in children aged less than 12 years have not yet been established.
Danish: Mavirets sikkerhed og virkning hos børn under 12 år er endnu ikke klarlagt.
English: Glecaprevir and pibrentasvir AUC were similar with and without dialysis (≤ 18% difference) in dialysis-dependent non-HCV infected subjects.
Danish: AUC for glecaprevir og pibrentasvir var næsten den samme med og uden dialyse (≤ 18 % forskel) hos dialyseafhængige ikke-HCV-smittede forsøgspersoner.
English: • ethinyl oestradiol-containing medicines (such as contraception medicines, including vaginal rings and tablets)
Danish: • ethinyløstradiol-holdige lægemidler (som f.eks. præventionsmidler, herunder p-ringe (vaginalringe og p-piller)
English: Co-administration may lead to reduced therapeutic effect of Maviret and is contraindicated (see section 4.3).
Danish: Samtidig administration kan medføre nedsat terapeutisk effekt af Maviret og er kontraindiceret (se pkt.
English: Both glecaprevir and pibrentasvir were fully active against substitutions associated with resistance to NS5B nucleotide and non-nucleotide inhibitors.
Danish: Både glecaprevir og pibrentasvir udviste fuld aktivitet mod substitutioner relateret til resistens over for NS5B-nukleotid- og non-nukleotid-hæmmere.
English: • liver problems other than hepatitis C
Danish: • du har andre leverproblemer end hepatitis C
English: HMG-COA REDUCTASE INHIBITORS Atorvastatin
Danish: HMG-CoA-REDUKTASEHÆMMERE Atorvastatin
English: c. Relapse is defined as HCV RNA ≥ LLOQ after end-of-treatment response among those who completed treatment.
Danish: c. Recidiv defineres som HCV-RNA ≥ LLOQ efter respons ved afsluttet behandling hos dem, der gennemførte behandlingen.
English: NS5A from HCV genotypes 1-6 clinical isolates
Danish: eller NS5A fra kliniske isolater af HCV genotype 1-6
English: Each film-coated tablet contains 7.48 mg lactose (as lactose monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 7,48 mg lactose (som lactosemonohydrat).
English: Safety in HCV/HIV-1 Co-infected Subjects
Danish: Sikkerhed hos HCV/HIV-1-smittede personer
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE INDRE ÆSKE
English: There were no virologic failures.
Danish: Der var ingen virologisk svigt.
English: • current or previous infection with the hepatitis B virus
Danish: • du har eller har haft infektion med hepatitis B-virus
English: Glecaprevir and pibrentasvir are weak inhibitors of cytochrome P450 (CYP) 3A and uridine glucuronosyltransferase (UGT) 1A1 in vivo.
Danish: Glecaprevir og pibrentasvir er svage hæmmere af cytokrom P450 (CYP) 3A og uridinglukuronosyltransferase (UGT) 1A1 in vivo.
English: No dose adjustment of Maviret is required in adolescents 12 years and older.
Danish: Dosisjustering af Maviret er ikke nødvendig hos unge fra 12 år og ældre.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with glecaprevir/pibrentasvir in one or more subsets of the paediatric population from 3 years to less than 12 years 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 glecaprevir/pibrentasvir i en eller flere undergrupper af den pædiatriske population (børn og unge i alderen fra 3 til < 12 år) ved behandling af kronisk hepatitis C (se pkt.
English: Subjects without cirrhosis received Maviret for 8 weeks, and subjects with compensated cirrhosis received Maviret for 12 weeks.
Danish: Forsøgspersoner uden cirrose fik Maviret i 8 uger, og forsøgspersoner med kompenseret cirrose fik Maviret i 12 uger.
English: Maternal toxicity associated with embryo-foetal loss has been observed in the rabbit with glecaprevir which precluded evaluation of glecaprevir at clinical exposures in this species (see section 5.3).
Danish: Maternel toksicitet forbundet med embryo-føtale tab er observeret hos kaniner ved brug af glecaprevir, hvorfor det ikke har været muligt at evaluere glecaprevir ved kliniske eksponeringer hos denne dyreart (se pkt.
English: Glecaprevir and pibrentasvir are inhibitors of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and organic anion transporting polypeptide (OATP) 1B1/3.
Danish: Glecaprevir og pibrentasvir er hæmmere af P-glykoprotein (P-gp), brystkræftresistent protein (BCRP) og organisk aniontransporterende polypeptid (OATP) 1B1/1B3.
English: Pibrentasvir is a pan-genotypic inhibitor of HCV NS5A, which is essential for viral RNA replication and virion assembly.
Danish: Pibrentasvir er en pan-genotypisk hæmmer af HCV-NS5A, der er nødvendig for viral RNAreplikation og virionsamling.
English: Use with strong P-gp/CYP3A inducers
Danish: Brug sammen med stærke P-gp/CYP3A-inducere