FrancophonIA/ELRC3.0 huggingface dataset:
English: Viekirax is not recommended for administration as monotherapy and must be used in combination with other medicinal products for the treatment of hepatitis C infection (see sections 4.2 and 5.1).
Danish: Det anbefales ikke at bruge Viekirax som monoterapi; Viekirax skal bruges i kombination med andre lægemidler til behandling af hepatitis C-infektion (se pkt.
English: S-warfarin paritaprevir
Danish: S-warfarin paritaprevir ombitasvir
English: Concomitant use with efavirenz is contraindicated (see section 4.3).
Danish: Samtidig brug af efavirenz er kontraindiceret (se pkt.
English: Nifedipine Mechanism: CYP3A4 inhibition
Danish: Nifedipin Mekanisme: Hæmning af CYP3A4
English: The impact of prior ombitasvir, paritaprevir or dasabuvir treatment experience on the efficacy of other NS5A inhibitors, NS3/4A protease inhibitors, or NS5B inhibitors has not been studied.
Danish: Det er ikke undersøgt, hvilken betydning tidligere ombitasvir-, paritaprevir- eller dasabuvir-behandling har for effekten af andre NS5A-hæmmere, NS3/4A-proteasehæmmere eller NS5Bhæmmere.
English: In Part 2, subjects with HCV GT1 received Viekirax and dasabuvir with or without ribavirin for 12 or 24 weeks.
Danish: I del 2 blev alle forsøgspersoner med HCV GT1 behandlet med Viekirax og dasabuvir med eller uden ribavirin i 12 eller 24 uger.
English: In genotype 4a, resistance to paritaprevir or ombitasvir by variants in NS3 or NS5A, respectively, selected in cell culture were phenotypically characterised.
Danish: Resistens over for paritaprevir og ombitasvir fremkaldt af varianter i henholdsvis NS3 og NS5A udvalgt i cellekultur blev fænotypisk karakteriseret i genotype 4a.
English: Clinical monitoring and dose adjustment maybe needed for s-mephenytoin.
Danish: Klinisk monitorering og dosisjustering kan være nødvendig for smephenytoin.
English: Based on population pharmacokinetic analysis of data from Phase 3 clinical studies, a 10 year increase or decrease in age from 54 years (median age in the Phase 3 studies) would result in approximately 10%
Danish: På basis af farmakokinetiske populationsanalyser af data fra kliniske fase 3-studier vil en stigning eller et fald på 10 år i alder fra 54 år (median alder i fase 3-studierne) medføre en ændring på < 10 % i eksponeringen for ombitasvir og ≤ 20% ændring i eksponering for paritaprevir.
English: 800/100 mg once daily
Danish: 800/100 mg én gang dagligt
English: In genotype 1a, substitutions M28T/V, Q30E/R, L31V, H58D, Y93C/H/N, and M28V + Q30R in HCV NS5A reduced susceptibility to ombitasvir.
Danish: I genotype 1a reducerede substitutionerne M28T/V, Q30E/R, L31V, H58D, Y93C/H/N og M28V + Q30R i HCV-NS5A følsomheden over for ombitasvir.
English: NA No dose adjustment required for carisoprodol; increase dose if clinically indicated.
Danish: Dosisjustering er ikke nødvendig for for carisoprodol; øgning af dosis, hvis klinisk indiceret ombitasvir
English: Subjects with liver transplant and GT4 infection were dosed with Viekirax with RBV (non-cirrhotic for 12 weeks [n=2] and cirrhotic for 24 weeks [n=1].
Danish: Levertransplanterede forsøgspersoner med GT4-infektion blev doseret med Viekirax med RBV (uden cirrose i 12 uger [n = 2] og med cirrose i 24 uger [n = 1].
English: Table 19.
Danish: Tabel 19.
English: This is because serious or lifethreatening effects can occur when Viekirax is taken with these medicines.
Danish: • hvis du tager et eller flere af de lægemidler, der er angivet i nedenstående tabel, da der kan opstå alvorlige eller livstruende virkninger, hvis Viekirax tages sammen med disse lægemidler.
English: No study related adverse reactions with paritaprevir, ritonavir, or ombitasvir were observed.
Danish: Der sås ingen forsøgsrelaterede bivirkninger med paritaprevir, ritonavir og ombitasvir.
English: SAPPHIRE-I - genotype 1, treatment-naïve, without cirrhosis
Danish: SAPPHIRE I - genotype 1, behandlingsnaive, uden cirrose
English: SVR12 for genotype 1-infected peginterferon+ribavirin-experienced subjects in SAPPHIRE-II
Danish: SVR12 for peginterferon+ribavirin-erfarne genotype 1-smittede forsøgspersoner i SAPPHIRE II
English: − Notice swelling of your stomach area
Danish: − hvis du bemærker, at din mave svulmer op.
English: NA Concomitant use of Viekirax with dasabuvir is contraindicated (see section 4.3).
Danish: Samtidig brug af Viekirax og dasabuvir er kontraindiceret (se pkt.
English: Table 2 provides the Least Squares Means Ratio (90% Confidence Interval) effect on concentration of Viekirax with or without dasabuvir and concomitant medicinal products.
Danish: Tabel 2 viser indvirkningen på koncentrationen af Viekirax med eller uden dasabuvir og samtidigt administrerede lægemidler baseret på mindste kvadraters gennemsnit (90 %-konfidensinterval).
English: NA If clinically indicated higher doses of omeprazole should be used.
Danish: Hvis det er klinisk indiceret, skal der bruges højere doser omeprazol ombitasvir
English: TURQUOISE-III: treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis Design:
Danish: TURQUOISE-III: behandlingsnaive eller pegIFN + RBV-erfarne med kompenseret cirrose Design:
English: In subjects with mild hepatic impairment, paritaprevir, ritonavir and ombitasvir mean Cmax and AUC values decreased by 29% to 48%, 34% to 38% and up to 8%, respectively, compared to subjects with normal hepatic function.
Danish: Hos forsøgspersoner med let nedsat leverfunktion var gennemsnitlig Cmax og AUC for paritaprevir, ritonavir og ombitasvir henholdsvis 29-48 %, 34-38 % og op til 8 % lavere end hos forsøgspersoner med normal leverfunktion.
English: How to store Viekirax 6.
Danish: Sådan skal du tage Viekirax 4.
English: Pharmacokinetics of the combination of ombitasvir 25 mg, paritaprevir 200 mg, and ritonavir 100 mg, with dasabuvir 400 mg were evaluated in non-HCV infected subjects with mild (Child-Pugh A), moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment.
Danish: Farmakokinetikken for kombinationen af ombitasvir 25 mg, paritaprevir 200 mg og ritonavir 100 mg med dasabuvir 400 mg blev undersøgt hos non-HCV inficerede patienter med let nedsat leverfunktion (ChildPugh A), moderat nedsat leverfunktion (Child-Pugh B) og svært nedsat leverfunktion (Child-Pugh C).
English: Note: The following variants were selected in cell culture but were not treatment-emergent: NS3 variants A156T in genotype 1a, and R155Q and D168H in genotype 1b; NS5A variants Y93C/H in genotype 1a, and L31F/V or Y93H in combination with L28M, L31F/V or P58S in genotype 1b; and NS5B variants Y448H in genotype 1a, and M414T and Y448H in genotype 1b.
Danish: Bemærk: Følgende varianter blev selekteret i cellekultur, men var ikke behandlingsrelaterede: NS3varianter: A156T hos genotype 1a samt R155Q og D168H hos genotype 1b. NS5A-varianter: Y93C/H
English: St. John's Wort (hypericum perforatum)
Danish: prikbladet perikon (hypericum perforatum)
English: ANTICONVULSANTS Carbamazepine
Danish: ANTIKONVULSIVE MIDLER Carbamazepin
English: Viekirax + dasabuvir duloxetine
Danish: Viekirax + dasabuvir duloxetin
English: Pharmacokinetics of the combination of ombitasvir 25 mg, paritaprevir 200 mg, and ritonavir 100 mg were not evaluated in subjects with mild (Child-Pugh A), moderate (Child-Pugh B) and severe (ChildPugh C) hepatic impairment.
Danish: Farmakokinetikken for kombinationen af ombitasvir 25 mg, paritaprevir 200 mg og ritonavir 100 mg blev ikke undersøgt hos patienter med let nedsat leverfunktion (Child-Pugh A), moderat nedsat leverfunktion (Child-Pugh B) og svært nedsat leverfunktion (Child-Pugh C).
English: Viekirax + dasabuvir atazanavir ombitasvir paritaprevir
Danish: Viekirax med dasabuvir atazanavir ombitasvir paritaprevir
English: In Part 1a, all subjects received Viekirax and dasabuvir with ribavirin for 12 or 24 weeks.
Danish: I del 1a blev alle forsøgspersoner behandlet med Viekirax og dasabuvir med ribavirin i 12 eller 24 uger.
English: Methylergom etrine
Danish: Ergonovin methylergom etrin
English: Viekirax with or without dasabuvir coadminstered with or without weight-based ribavirin for 12 or 24 weeks
Danish: Behandling: Viekirax med eller uden dasabuvir administreret med eller uden ribavirin baseret på vægt i 12 eller 24 uger
English: Dose normalized tacrolimus ratios are shown for interaction with Viekirax with or without dasabuvir.
Danish: Dosisnormaliserede tacrolimus-ratioer er vist for interaktionen med Viekirax med eller uden dasabuvir.
English: Clinical trial in subjects with compensated cirrhosis TURQUOISE-II - treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis Design:
Danish: Klinisk studie med patienter med kompenseret cirrose TURQUOISE II - behandlingsnaive eller pegIFN + RBV-erfarne med kompenseret cirrose Design:
English: Simvastatin, lovastatin and atorvastatin are contraindicated (see sections 4.3 and 4.5).
Danish: Simvastatin, lovastatin og atorvastatin er kontraindicerede (se pkt.
English: 800/160 mg twice daily
Danish: 800/160 mg to gange dagligt
English: Dose normalized cyclosporine ratios are shown for interaction with Viekirax with or without dasabuvir.
Danish: Dosisnormaliserede ciclosporin-ratioer er vist for interaktionen med Viekirax med eller uden dasabuvir.
English: No dose adjustment needed for Viekirax with dasabuvir.
Danish: Dosisjustering er ikke nødvendig for Viekirax med dasabuvir.
English: Medicinal Product/Poss ible Mechanism of Interaction
Danish: Lægemiddel/ mulig interaktionsmekanisme
English: Tél/Tel: +32 10 477811
Danish: Belgique/Belgien Tél/Tel: +32 10 477811
English: A reduction in colchicine dosage or an interruption of colchicine treatment is recommended in patients with normal renal or hepatic function if treatment with Viekirax with or without dasabuvir is required (see section 4.5).
Danish: Det anbefales at nedsætte colchicin-dosen eller afbryde colchicin-behandlingen hos patienter med normal nyre- og leverfunktion, hvis behandling med Viekirax med eller uden dasabuvir er nødvendig (se pkt.
English: Effect of dasabuvir on paritaprevir/ritonavir and ombitasvir
Danish: Indvirkningen af dasabuvir på paritaprevir/ritonavir og ombitasvir
English: No dose adjustment of Viekirax with and without dasabuvir is required for patients with mild, moderate or severe renal impairment , or end-stage-renal disease on dialysis (see section 4.2).
Danish: Dosisjustering af Viekirax med og uden dasabuvir anbefales ikke hos HCV-smittede patienter med let, moderat eller svært nedsat nyrefunktion eller hos patienter i dialyse med nyresygdom i slutstadiet (se pkt.
English: In subjects with severe hepatic impairment, paritaprevir mean Cmax and AUC values increased by 3.2-to 9.5-fold; ritonavir mean Cmax values were 35% lower and AUC values were 13% higher and ombitasvir mean Cmax and AUC values decreased by 68% and 54%, respectively, compared to subjects with normal hepatic function, therefore, Viekirax must not be used in patients with severe hepatic impairment (see sections 4.2 and 4.4).
Danish: Hos forsøgspersoner med svært nedsat leverfunktion var gennemsnitlig Cmax og AUC for paritaprevir 3,29,5 gange højere end hos patienter med normal leverfunktion; gennemsnitlig Cmax for ritonavir var 35 % lavere, og AUC for ritonavir var 13 % højere end hos patienter med normal leverfunktion, og gennemsnitlig Cmax og AUC for ombitasvir var henholdsvis 68 % og 54 % lavere end hos patienter med normal leverfunktion.
English: Each film-coated tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir and 50 mg of ritonavir.
Danish: Hver filmovertrukket tablet indeholder 12,5 mg ombitasvir, 75 mg paritaprevir og 50 mg ritonavir.
English: Paritaprevir /ritonavir was not carcinogenic in a 6-month transgenic mouse study up to the highest dosage tested (300 mg/30 mg/kg/day), resulting in paritaprevir AUC exposures approximately 38-fold higher than those in humans at the recommended dose of 150 mg.
Danish: Paritaprevir/ritonavir var ikke karcinogene i et 6-måneders studie med transgene mus, der fik op til den højeste testede dosis (300 mg/30 mg/kg/dag); paritaprevir-eksponeringen (målt ud fra AUC) var ca. 38 gange højere end hos mennesker ved den anbefalede dosis på 150 mg.
English: The safety and efficacy of Viekirax in children less than 18 years of age have not been established.
Danish: Pædiatrisk population Viekirax' sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: 20 mg single dose
Danish: 20 mg enkeltdosis
English: On-treatment virologic failure Post-treatment relapse Other
Danish: Virologisk svigt under behandling
English: Co-administration of Viekirax with or without dasabuvir with strong inhibitors of CYP3A may increase paritaprevir concentrations (see section 4.3 and Table 2).
Danish: Samtidig administration af Viekirax med eller uden dasabuvir og stærke CYP3A-hæmmere kan øge paritaprevir-koncentrationen (se pkt.
English: Viekirax with or without dasabuvir
Danish: Viekirax med eller uden dasabuvir
English: Paritaprevir, ritonavir and dasabuvir are inhibitors of BCRP in vivo.
Danish: Paritaprevir, ritonavir og dasabuvir er hæmmere af BCRP in vivo.
English: Similarly, ombitasvir was not carcinogenic in a 2-year rat study up to the highest dose tested (30 mg per kg per day), resulting in ombitasvir exposures approximately 16-fold higher than those in humans at 25 mg.
Danish: Ombitasvir var heller ikke karcinogent i et 2-årigt rotte-studie ved doser op til den højeste testede dosis (30 mg/kg/dag), der medførte en ombitasvir-eksponering, der var ca. 16 gange højere end ved 25 mg hos mennesker.
English: ↑ nifedipine
Danish: Forventet: ↑ nifedipine
English: PEARL-IV - genotype 1a, treatment-naïve, without cirrhosis
Danish: PEARL IV - genotype 1a, behandlingsnaive uden cirrose
English: Mechanism: possibly due to UGT1A1 inhibition by paritaprevir, dasabuvir and ombitasvir and CYP3A4 inhibition by ritonavir
Danish: Mekanisme: Skyldes muligvis paritaprevir, ombitasvir og dasabuvirs hæmning af UGT1A1 og ritonavirs hæmning af CYP3A4
English: 600/300 mg once daily
Danish: 600/300 mg en gang dagligt
English: Caution should be used when sulfasalazine is coadministered with Viekirax with or without dasabuvir.
Danish: Der bør udvises forsigtighed, når sulfasalazin administreres sammen med Viekirax med eller uden dasabuvir
English: Compared to subjects without cirrhosis, in subjects with compensated cirrhosis there was an increased rate of indirect hyperbilirubinemia when ribavirin was part of the regimen.
Danish: Der var en øget hyppighed af inddirekte hyperbilirubinæmi hos patienter med cirrose sammenlignet med patienter uden cirrose, når ribavirin var en del af behandlingsregimet.
English: How long to take Viekirax for
Danish: Så længe skal du tage Viekirax
English: Relapse rates in GT1a cirrhotic subjects by baseline laboratory values are presented in Table 14.
Danish: Recidivraten hos patienter med genotype 1a og cirrose ud fra laboratorieværdier ved baseline vises i tabel
English: Number of subjects treated
Danish: Antal behandlede forsøgspersoner2
English: Ombitasvir treatment-emergent variants M28T, M28V or Q30R in NS5A were observed in 32 subjects.
Danish: Følgende ombitasvir-behandlingsrelaterede varianter i NS5A blev observeret hos 32 forsøgspersoner: M28T, M28V eller Q30R.
English: HCV Genotype 1a Viekirax and dasabuvir with RBV
Danish: HCV genotype 1a Viekirax og dasabuvir med ribavirin
English: Drug interactions need to be carefully taken into account in the setting of HIV co-infection (for details see section 4.5, Table 2).
Danish: Hos patienter med samtidig hiv-infektion skal der tages nøje højde for lægemiddelinteraktioner (se nærmere i pkt.
English: Viekirax 12.5 mg / 75 mg / 50 mg film-coated tablets ombitasvir / paritaprevir / ritonavir
Danish: Viekirax 12,5 mg / 75 mg / 50 mg filmovertrukne tabletter Ombitasvir / paritaprevir / ritonavir
English: Increase in paritaprevir exposures may be due to inhibition of OATP1B1/B3 and CYP3A by atazanavir.
Danish: Mekanisme: Øget paritaprevireksponering kan skyldes atazanavirs hæmning af OATP1B1/B 3 og CYP3A.
English: Ethinyloestradiolcontaining oral contraceptives are contraindicated (see section 4.3).
Danish: Ethinyløstradiol-holdige præventionsmidler er kontraindicerede (se pkt.
English: On-treatment VF Relapse
Danish: VF under behandling Recidiv
English: Ombitasvir was not carcinogenic in a 6-month transgenic mouse study up to the highest dosage tested (150 mg/kg/day), resulting in ombitasvir AUC exposures approximately 26-fold higher than those in humans at the recommended clinical dose of 25 mg.
Danish: I et 6-måneders studie med transgene mus var ombitasvir ikke karcinogent ved doser op til den højeste testede dosis (150 mg/kg/dag), dvs. en ombitasvir-eksponering målt ud fra AUC, der var ca. 26 gange højere end hos mennesker ved den anbefalede kliniske dosis på 25 mg.
English: ↑ colchicine
Danish: ↑ colchicin
English: In subjects with moderate hepatic impairment, ombitasvir and ritonavir mean Cmax and AUC values decreased by 29% to 30% and 30 to 33%, respectively, while paritaprevir mean Cmax and AUC values increased by 26% to 62% compared to subjects with normal hepatic function.
Danish: Hos patienter med moderat nedsat leverfunktion var gennemsnitlig Cmax og AUC for ombitasvir og ritonavir henholdsvis 29-30 % og 30-33 % lavere end hos forsøgspersoner med normal leverfunktion, mens gennemsnitlig Cmax og AUC for paritaprevir var 26-62 % højere (se pkt.
English: How to take Viekirax
Danish: Sådan skal du tage Viekirax
English: Similarly, paritaprevir/ritonavir was not carcinogenic in a 2-year rat study up to the highest dosage tested (300 mg/30 mg/kg/day), resulting in paritaprevir AUC exposures approximately 8-fold higher than those in humans at 150 mg.
Danish: Tilsvarende var paritaprevir/ritonavir ikke karcinogene i et 2-årigt studie med rotter op til den højeste testede dosis (300 mg/30 mg/kg/dag); paritaprevir-eksponeringen (målt ud fra AUC) var ca. 8 gange højere end hos mennekser ved en dosis på 150 mg.
English: Methadone ↔ paritaprevir /ombitasvir/dasabuvir (based on the cross study comparison)
Danish: ↔ paritaprevir/ombitasvir/dasabuvir (baseret på en sammenligning på tværs af studier)
English: Treated subjects (N = 22) had a median age of 54 years (range: 34 to 68); 41% were Black; 14% had compensated cirrhosis; 86% were HCV treatment-naïve; 14% had failed prior treatment with pegIFN/RBV; 68% had HCV genotype 1a infection.
Danish: De behandlede forsøgspersoner (N = 22) havde en gennemsnitsalder på 54 år (interval: 34-68), 41 % var sorte, 14 % havde kompenseret cirrose, 86 % var HCV-behandlingsnaive, 14 % havde oplevet behandlingssvigt med pegIFN/RBV, og 68 % havde HCV genotype 1a-infektion.
English: 800 mg once daily (given at the same time)
Danish: 800 mg én gang dagligt (administreret på samme tidspunkt) Mekanisme:
English: Viekirax and dasabuvir without ribavirin for 12 weeks 60 patients were randomized and treated, and 60/60 (100%) achieved SVR12.
Danish: 60 patienter blev randomiseret og behandlet, og 60/60 (100 %) opnåede SVR 12.
English: Viekirax and dasabuvir + ribavirin
Danish: Viekirax og dasabuvir + ribavirin
English: No dose adjustment is necessary for emtricitabine/tenofovir and Viekirax with or without dasabuvir.
Danish: Dosisjustering er ikke nødvendig for emtricitabin/tenofovir og Viekirax med eller uden dasabuvir.
English: (see sections 4.2, 4.4, and
Danish: 4.2, 4.4 og 4.8).
English: Viekirax with or without dasabuvir was administered as multiple doses in all the drug interaction studies except the drug interaction studies with carbamazepine, gemfibrozil, ketoconazole, and sulfamethoxazole/trimethoprim..
Danish: Den opnåede dasabuvireksponering var af samme størrelsesorden for formuleringen på 400 mg og for tabletter på 250 mg. Viekirax med eller uden dasabuvir blev givet som multiple doser i alle lægemiddelinteraktionsstudierne, bortset fra lægemiddelinteraktionsstudier med carbamazepin, ketaconazol og sulfamethoxazol/trimethoprim.
English: Treated subjects (N=166) had a median age of 53 years (range: 22 to 82); 56.6% were female; 3.0% were Asian; 0.6% were Black; 7.2% had baseline HCV RNA levels of at least 6,000,000 IU per mL; 9% had advanced fibrosis (F3) and 98.2% had HCV genotype 1b infection (one subject each had genotype 1a, 1d, and 6 infection).
Danish: De behandlede patienter (N = 166) havde en medianalder på 53 år (22-82); 56,6 % var kvinder; 3,0 % var asiater; 0,6 % var sorte; 7,2 % havde HCV-rna ≥ 6.000.000 IE/ml ved baseline; 9 % havde avanceret fibrose (F3), og 98,2 % havde HCV-genotype 1b-infektion (én forsøgsperson hver med hhv. genotype 1a-, 1d- og 6-infektion)
English: Mechanism: possibly due to UGT inhibition by paritaprevir, ombitasvir and dasabuvir.
Danish: Mekanisme: Skyldes muligvis paritaprevir, ombitasvir og dasabuvirs hæmning af UGT.
English: Treated subjects (N = 63) had a median age of 51 years (range: 31 to 69); 24% were Black; 19% had compensated cirrhosis; 67% were treatment-naïve; 33% had failed prior treatment with pegIFN/RBV; 89% had HCV genotype 1a infection.
Danish: De behandlede patienter (N = 63) havde en gennemsnitsalder på 51 år (interval: 31-69), 24 % var sorte, 19 % havde kompenseret cirrose, 67 % var behandlingsnaive, 33 % havde oplevet behandlingssvigt med pegIFN/RBV, og 89 % havde HCV genotype 1a-infektion.
English: Co-administration of Viekirax with or without dasabuvir with medicinal products that are strong or moderate enzyme inducers is expected to decrease ombitasvir, paritaprevir, and ritonavir plasma concentrations and reduce their therapeutic effect and must not be co-administered (see section 4.5).
Danish: Samtidig administration af Viekirax med eller uden dasabuvir og lægemidler, der er stærke eller moderate enzym-inducere, forventes at reducere plasmakoncentrationen af ombitasvir, paritaprevir og ritonavir og deres terapeutiske virkning og må derfor ikke administreres samtidig.
English: SVR12 for genotype 1b-infected peginterferon+ribavirin-experienced subjects in PEARL II
Danish: SVR12 for peginterferon+ribavirin-erfarne genotype 1b-smittede forsøgspersoner i PEARL II
English: Nearly the entire plasma radioactivity after a single 600 mg dose of 14C-ritonavir oral solution in humans was attributed to unchanged ritonavir.
Danish: Efter en enkeltdosis på 600 mg 14C-ritonavir i oral opløsning hos mennesker blev næsten hele radioaktiviteten i plasma tilskrevet uomdannet ritonavir.
English: 5 days after completion of Viekirax + dasabuvir treatment, the sirolimus dose and dosing frequency prior to receiving Viekirax should be resumed, along with routine monitoring of sirolimus blood concentrations.
Danish: Sirolimus-dosis og doseringshyppighed, som før brug af Viekirax, kan sammen med rutinemæssig monitorering af sirolimus i blodet genoptages 5 dage efter afslutning af Viekirax + dasabuvir behandling ombitasvir paritaprevir ↔ dasabuvir
English: Mechanism: CYP3A inhibition by ritonavir
Danish: Mekanisme: Ritonavirs hæmning af CYP3A
English: 600/100 mg twice daily
Danish: 600/100 mg to gange dagligt
English: DIURETICS Furosemide
Danish: DIURETIKA Furosemid
English: Concomitant use of sirolimus with Viekirax and dasabuvir is not recommended unless the benefits outweigh the risks
Danish: Samtidig brug af sirolimus med Viekirax og dasabuvir anbefales ikke medmindre fordelene opvejer risiciene (se pkt.
English: 500 mg single dose
Danish: 500 mg enkeltdosis
English: ↑ fusidic acid
Danish: ↑ fusidinsyre
English: • Serious allergic reactions, signs may include: o Difficulty breathing or swallowing o Dizziness or light-headedness, which may be due to low blood pressure o Swelling of the face, lips, tongue or throat o Rash and itching of the skin
Danish: • Svimmelhed eller omtågethed, som kan skyldes lavt blodtryk
English: 10 mg single dose
Danish: 10 mg enkeltdosis
English: Viekirax and dasabuvir for 12 weeks With RBV
Danish: Viekirax og dasabuvir i 12 uger Med RBV
English: for many different conditions including serious illnesses and allergies trazodone for anxiety and depression warfarin and other similar medicines called vitamin K antagonists*
Danish: Warfarin og andre lignende lægemidler, de såkaldte vitamin K-antagonister*
English: GT1 Arm A: Viekirax and dasabuvir + RBV Arm B: Placebo
Danish: GT1 Gruppe A: Viekirax og dasabuvir med ribavirin Gruppe B: Placebo