FrancophonIA/ELRC3.0 huggingface dataset:
English: Mechanism: decrease possibly due to CYP1A2 induction by ritonavir
Danish: Mekanisme: Reduceret cyclobenzapri neksponering skyldes muligvis ritonavirs inducerende virkning på CYP1A2
English: Coadministration with ethinyloestradiol may increase the risk of ALT elevations (see sections 4.3 and 4.4).
Danish: Samtidig administration af ethinyløstradiol kan øge risikoen for forhøjet ALAT (se pkt.
English: Clinical Comments inhibition of OATP1B1/B3 and CYP3A by atazanavir and CYP3A by the additional dose of ritonavir.
Danish: Klinisk kommentar paritaprevireksponering kan skyldes atazanavirs hæmning af OATP1B1/B 3 og CYP3A og den yderligere ritonavirdosis' hæmning af CYP3A.
English: Expected: ↓ombitasvir ↓ paritaprevir ↓ dasabuvir
Danish: Forventet: ↓ombitasvir ↓ paritaprevir ↓ dasabuvir
English: Pitavastatin Mechanism: OATP1B inhibition by paritaprevir
Danish: Pitavastatin Mekanisme: Paritaprevirs hæmning af OATP1B.
English: Compared to the subjects with normal renal function, ombitasvir exposures were comparable in subjects with mild, moderate and severe renal impairment.
Danish: Hos forsøgspersoner med let, moderat og svært nedsat nyrefunktion var ombitasvir-eksponeringen stort set den samme som hos forsøgspersoner med normal nyrefunktion.
English: Arm B: Viekirax and dasabuvir + RBV (24 weeks)
Danish: Gruppe B: Viekirax og dasabuvir med ribavirin (24 uger)
English: For patients coadministered ribavirin refer to the Summary of Product Characteristics of ribavirin.
Danish: Hvis patienten samtidig får ribavirin, skal man også henholde sig til produktresuméet for ribavirin.
English: 300 mg single dose
Danish: 300 mg enkelt dosis
English: Dose decrease and clinical monitoring of calcium channel blockers is recommended when coadministered with Viekirax with and without dasabuvir.
Danish: Reducering af dosis og klinisk monitorering af calciumantagonister anbefales ved samtidig administration med Viekirax med eller uden dasabuvir
English: Viekirax and dasabuvir in combination with ribavirin is recommended for 24 weeks in liver transplant recipients with genotype 1 HCV infection.
Danish: Hos patienter med levertransplantat og HCV genotype 1-infektion anbefales det at give Viekirax og dasabuvir i kombination med ribavirin i 24 uger.
English: Viekirax without dasabuvir duloxetine
Danish: Viekirax uden dasabuvir duloxetin
English: • Each tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir and 50 mg of ritonavir.
Danish: • Aktive stoffer: Hver tablet indeholder 12,5 mg ombitasvir, 75 mg paritaprevir og 50 mg ritonavir.
English: ↑ trazodone
Danish: Esomeprazol
English: Viekirax dasabuvir
Danish: Viekirax med dasabuvir
English: Mechanism: CYP3A4 induction by carbamazepine
Danish: Mekanisme: Carbamazepins inducerende virkning på CYP3A4
English: CYP3A4 inhibition by ritonavir and increase in paritaprevir exposures may be due to OATP/BCRP/ P-gp inhibition by ciclosporin.
Danish: Mekanisme: Indvirkninge n på ciclosporin skyldes ritonavirs hæmning af CYP3A4, og øget paritaprevireksponering som kan skyldes ciclosporins hæmning af OATP/BCRP /P-gp.
English: If rosuvastatin treatment is required during the treatment period, the maximum daily dose of rosuvastatin should be 5 mg (see section 4.5, Table 2).The increase in rosuvastatin when combined with Viekirax without dasabuvir is less pronounced.
Danish: Hvis det er nødvendigt at give patienten rosuvastatin i behandlingsperioden, må den daglige rosuvastatin-dosis højst være 5 mg (se pkt.
English: 400/100 mg twice daily1
Danish: 400/100 mg to gange dagligt1
English: • Vomiting
Danish: • opkastning
English: Compared to the subjects with normal renal function, paritaprevir Cmax values were comparable, but AUC values were 19%, 33% and 45% higher in mild, moderate and severe renal impairment, respectively.
Danish: Hos forsøgspersoner med let, moderat og svært nedsat nyrefunktion var paritaprevirs Cmax af samme størrelsesorden som hos forsøgspersoner med normal nyrefunktion, mens AUC var henholdsvis 19 %, 33 % og 45 % højere end hos forsøgspersoner med normal nyrefunktion.
English: No dose adjustment is necessary for buprenorphine/naloxone and Viekirax with or without dasabuvir.
Danish: Dosisjustering er ikke nødvendig for buprenorphin/naloxon og Viekirax med eller uden dasabuvir.
English: Prior pegIFN/RBV relapser
Danish: pegIFN/RBV-erfarne Med RBV
English: Viekirax + dasabuvir everolimus
Danish: Everolimus Viekirax +
English: ↑ norgestrel ↑ nor elgestromine ombitasvir paritaprevir
Danish: ↑ norgestrel norelgestro min ombitasvir paritaprevir
English: ↑ pimozide ↑ quetiapine ↑ lurasidone
Danish: ↑quetiapin ↑ lurasidon
English: Subjects had a median age of 56 years (range: 32 to 81); 50% were treatment-naïve, 28% were prior pegIFN/RBV null responders; 10% were prior pegIFN/RBV partial responders, 13% were prior pegIFN/RBV relapsers; 70% were male; 17% were Black; 73% had baseline HCV RNA levels of at least 800,000 IU per mL; 17% had platelet counts of less than 90 x 109 per L; and 4% had albumin less than 3.5 mg per dL.
Danish: De behandlede forsøgspersoner havde en median alder på 56 år (interval: 32-81), 50 % var behandlingsnaive, 28 % var tidligere ikke-respondere på pegIFN/RBV; 10 % var tidligere delvise respondere på pegIFN/RBV, 13 % havde tidligere recidiv efter pegIFN/RBV-behandling; 70 % var mænd, 17 % var sorte, 73 % havde et HCV-rna-niveau på mindst 800.000 IE/ml ved baseline; 17 % havde et trombocyttal på under 90 x 109/l og 4 % havde albuminniveau på under 3,5 mg/dl.
English: Mechanism: CYP3A4/Pgp inhibition by clarithromyci n and ritonavir.
Danish: Mekanisme: Clarithromyci n og ritonavirs hæmning af CYP3A4/Pgp .
English: Arm A: Viekirax and dasabuvir + RBV (12 weeks)
Danish: Gruppe A: Viekirax og dasabuvir med ribavirin (12 uger)
English: Concomitant use is contraindicated (see section
Danish: Samtidig brug er kontraindiceret (se pkt.
English: AGATE-1 -treatment-naïve or pegIFN +RBV experienced patients with compensated cirrhosis
Danish: AGATE-1 -behandlingsnaive eller pegIFN + RBV- erfarne patienter med kompenseret cirrose Design:
English: Use of colchicine is contraindicated with Viekirax with or without dasabuvir in patients with renal or hepatic impairment (see sections 4.3 and 4.4).
Danish: Brug af colchicin samtidig med Viekirax med eller uden dasabuvir er kontraindiceret hos patienter med nedsat nyre- eller leverfunktion (se pkt.
English: It is an antiviral medicine used to treat adults with chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).
Danish: Viekirax indeholder de aktive stoffer ombitasvir, paritaprevir og ritonavir.Viekirax er et antiviralt lægemiddel, der bruges til behandling af voksne med kronisk (vedvarende) hepatitis C (en infektionssygdom i leveren, der skyldes hepatitis C-virus).
English: CYP3A4/Pgp inhibition.
Danish: Mekanisme: Hæmning af CYP3A4/Pgp.
English: (≤25% difference in the Least Square Means ratio) for Viekirax with or without dasabuvir, unless otherwise noted.
Danish: Interaktionen ved administration sammen med de lægemidler, der er nævnt i tabel 2, er af samme størrelsesorden (en forskel på ≤ 25 % i mindste kvadraters gennemsnit) for Viekirax-regimer med og uden dasabuvir, medmindre andet er angivet.
English: 25 mg once daily administered in the
Danish: 25 mg én gang dagligt taget om morgenen med mad2
English: Subjects (N=135) had a median age of 51 years (range: 19 to 70); 63,7% were treatment-naïve, 17.0% were prior pegIFN/RBV null responders, 6.7% were prior pegIFN/RBV partial responders, 12.6% were prior pegIFN/RBV relapsers; 65.2%were male; 8.9% were Black, 69.6% had baseline HCV RNA levels at least 800,000 IU/mL; 6.7% had bridging fibrosis (F3).
Danish: Patienter (N = 135) havde en median alder på 51 år (interval: 19-70); 63,7 % var behandlingsnaive, 17,0 % var tidligere ikke-respondere på pegIFN/RBV; 6,7 % var tidligere delvise respondere på pegIFN/RBV, og 12,6 % var patienter med tidligere recidiv efter pegIFN/RBV-behandling; 65,2 % var mænd; 8,9 % var sorte; 69,6 % havde et HCV-rna-niveau på mindst 800.000 IE/ml ved baseline, 6,7 % havde bridging-fibrose (F3).
English: Mechanism: OATP1B inhibition by paritaprevir and BCRP inhibition by paritaprevir, ritonavir or dasabuvir.
Danish: Mekanisme: Paritaprevirs hæmning af OATP1B samt paritaprevir, ritonavir eller dasabuvirs hæmning af BCRP.
English: Fexofenadine
Danish: Fexofenadin
English: No dose adjustment is necessary for norethindrone or Viekirax with or without dasabuvir.
Danish: Dosisjustering er ikke nødvendig for norethindron eller Viekirax med eller uden dasabuvir.
English: GT1b Arm A: Viekirax and dasabuvir + RBV Arm B: Viekirax and dasabuvir
Danish: GT1b Gruppe A: Viekirax og dasabuvir med ribavirin Gruppe B: Viekirax og dasabuvir
English: Treated subjects (N=380) had a median age of 58 years (range: 21 to 71); 42.1% were treatment-naïve, 36.1% were prior pegIFN/RBV null responders; 8.2% were prior pegIFN/RBV partial responders, 13.7% were prior pegIFN/RBV relapsers; 70.3% were male; 3.2% were Black; 14.7% had platelet counts of less than 90 x 109/L; 49.7% had albumin less than 40 g/L; 86.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 24.7% had a history of depression or bipolar disorder; 68.7% had HCV genotype 1a infection, 31.3% had HCV genotype 1b infection.
Danish: De behandlede patienter (N = 380) havde en median alder på 58 år (interval: 21-71); 42,1 % var behandlingsnaive, 36,1 % var tidligere ikke-respondere på pegIFN/RBV; 8,2 % var tidligere delvise respondere på pegIFN/RBV, 13,7 % var patienter med tidligere recidiv efter pegIFN/RBV-behandling; 70,3 % var mænd; 3,2 % var sorte; 14,7 % havde et trombocyttal på under 90 x 109/l; 49,7 % havde et albuminniveau på under 40 g/l; 86,1 % havde et HCV-rna-niveau på mindst 800.000 IE/ml ved baseline; 24,7 % havde depression eller bipolar lidelse i anamnesen; 68,7 % havde HCV genotype 1a-infektion, 31,3 % havde HCV genotype 1b-infektion.
English: Yes (for all three parameters listed above) No (for any parameter listed above) *AFP= serum alpha fetoprotein In subjects with all three favourable baseline laboratory values (AFP < 20 ng/mL, platelets ≥ 90 x 109/L, and albumin ≥ 35 g/L), relapse rates were similar in subjects treated for 12 or 24 weeks.
Danish: Ja (til alle tre parametre ovenfor) Nej (til et eller flere af parametrene ovenfor) *AFP = serum-alfaføtoprotein
English: INSULIN SECRETAGOGUES Repaglinide
Danish: β-CELLE STIMULERENDE MIDLER Repaglinid
English: Prior pegIFN/RBV null responder Prior pegIFN/RBV partial responder Prior pegIFN/RBV relapser Outcome for subjects without SVR12 On-treatment VF
Danish: Patienter med tidligere recidiv efter pegIFN/RBV-behandling Resultat for patienter uden SVR12
English: ↔ ombitasvir/paritaprevir (based on the cross-study comparison)
Danish: ↔ naloxon ↔ ombitasvir/paritaprevir (baseret på en sammenligning på tværs af studier)
English: Clinical Comments and throughout coadministration with Viekirax and dasabuvir and the dose and/or dosing frequency should be adjusted as needed.
Danish: Koncentrationen af tacrolimus i helblod bør overvåges ved start og under samtidig administration med Viekirax og dasabuvir, og dosis og/eller doseringshyppighed bør justeres efter behov.
English: Expected in CYP2C19 Poor Metabolisers:
Danish: Forventet hos personer som har dårlig metaboliseringsevne overfor CYP2C19:
English: No dose adjustment is necessary for raltegravir or Viekirax with or without dasabuvir.
Danish: Dosisjustering er ikke nødvendig for raltegravir eller Viekirax med eller uden dasabuvir.
English: randomised, global multicentre, double-blind, placebo-controlled
Danish: randomiseret, globalt multicenter studie, dobbeltblindet, placebokontrolleret Behandling: Viekirax og dasabuvir med ribavirin baseret på vægt i 12 uger
English: Similar effect is expected as observed with Viekirax + dasabuvir.
Danish: Samme virkning forventes som ved Viekirax + dasabuvir.
English: Mechanism: possible CYP3A4 induction by efavirenz.
Danish: Mekanisme: Muligvis efavirenz' inducerende virkning på CYP3A4.
English: GT1a Arm A: Viekirax and dasabuvir + RBV Arm B: Viekirax and dasabuvir
Danish: GT1a Gruppe A: Viekirax og dasabuvir med ribavirin Gruppe B: Viekirax og dasabuvir
English: Expected: ↑ amiodarone
Danish: ↑amiodaron
English: The EC50 of paritaprevir against genotype 1a-H77 and 1b-Con1 strains in the HCV replicon cell culture assay was 1.0 and 0.21 nM, respectively.
Danish: EC50-værdien for paritaprevir mod genotype 1a-H77- og 1b-Con1-stammer i HCV-replikoncellekulturanalysen var henholdsvis 1,0 og 0,21 nM. Paritaprevirs aktivitet blev 24-27 gange mindre under tilstedeværelse af 40 % humant plasma.
English: Gastrointestinal disorders Very common
Danish: Mave-tarm-kanalen Meget almindelig
English: NA No dose adjustment necessary for paracetamol when administered with Viekirax with or without dasabuvir.
Danish: Dosisjustering er ikke nødvendig for paracetamol ved samtidig administration med Viekirax med eller uden dasabuvir.
English: Treated subjects (N=394) had a median age of 54 years (range: 19 to 71); 49.0% were prior pegIFN/RBV null responders; 21.8/% were prior pegIFN/RBV partial responders, and 29.2% were prior pegIFN/RBV relapsers; 57.6% were male; 8.1% were Black; 20.6% had a history of depression or bipolar disorder; 87.1% had baseline HCV RNA levels of at least 800,000 IU per mL; 17.8% had portal fibrosis (F2) and 14.5% had bridging fibrosis (F3); 58.4% had HCV genotype 1a infection; 41.4% had HCV genotype 1b infection.
Danish: De behandlede patienter (N = 394) havde en median alder på 54 år (interval: 19-71); 49,0 % var tidligere ikke-respondere på pegIFN/RBV; 21,8 % var tidligere delvise respondere på pegIFN/RBV, og 29,2 % var patienter med tidligere recidiv efter pegIFN/RBV-behandling; 57,6 % var mænd; 8,1 % var sorte; 20,6 % havde depression eller bipolar lidelse i anamnesen; 87,1 % havde et HCV-rna-niveau på mindst 800.000 IE/ml ved baseline; 17,8 % havde portal fibrose (F2), og 14,5 % havde bridging fibrose (F3); 58,4 % havde HCV genotype 1a-infektion; 41,4 % havde HCV genotype 1b-infektion.
English: NA No dose adjustment needed for sofosbuvir when administered with Viekirax with or without dasabuvir.
Danish: Dosisjustering er ikke nødvendig for sofosbuvir ved samtidig administration med Viekirax med eller uden dasabuvir.
English: The magnitude of interaction was similar to that observed with Viekirax + dasabuvir.
Danish: Interaktionen var af samme størrelsesorden som for Viekirax + dasabuvir.
English: Mechanism: BCRP and Pgp inhibition by paritaprevir, ritonavir and dasabuvir
Danish: Mekanisme: paritaprevir, ritonavir og dasabuvirs hæmning af BCRP og Pgp
English: Mechanism: CYP2C19 induction and CYP3A4 inhibition by ritonavir
Danish: Mekanisme: Ritonavirs inducerende virkning på CYP2C19 og hæmning af CYP3A4
English: Sirolimus 0.5 mg single dose5
Danish: 0,5 mg enkeltdosis5
English: Quinidine
Danish: ↑quinidin
English: Treated subjects (N=179) had a median age of 57 years (range: 26 to 70); 35.2% were prior pegIFN/RBV null responders; 28.5% were prior pegIFN/RBV partial responders, and 36.3% were prior pegIFN/RBV relapsers; 54.2% were male; 3.9% were Black; 12.8% had a history of depression or bipolar disorder; 87.7% had baseline HCV RNA levels of at least 800,000 IU/mL; 17.9% had portal fibrosis (F2) and 14.0% had bridging fibrosis (F3).
Danish: De behandlede patienter (N = 179) havde en median alder på 57 år (interval: 26-70); 35,2 % var tidligere ikke-respondere på pegIFN/RBV; 28,5 % var tidligere delvise respondere på pegIFN/RBV, og 36,3 % var patienter med tidligere recidiv efter pegIFN/RBV-behandling; 54,2 % var mænd; 3,9 % var sorte;; 12,8 % havde depression eller bipolar lidelse i anamnesen; 87,7 % havde et HCV-rna-niveau på mindst 800.000 IE/ml ved baseline; 17,9 % havde portal fibrose (F2), og 14,0 % havde bridging fibrose (F3).
English: Prior pegIFN/RBV null responder Prior pegIFN/RBV partial responder Prior pegIFN/RBV relapser HCV genotype 1b
Danish: Tidligere ikke-respondere på pegIFN/RBV 56/59 Tidligere delvise respondere på pegIFN/RBV 28/28 Patienter med tidligere recidiv efter pegIFN/RBV-behandling
English: Viekirax without dasabuvir atazanavir
Danish: Viekirax uden dasabuvir atazanavir
English: Carisoprodol
Danish: Carisoprodo l
English: NA No dose adjustment needed for abacavir or lamivudine when coadministered with Viekirax with or without dasabuvir.
Danish: Dosisjustering er ikke nødvendig for abacavir eller lamivudine ved samtidig administration med Viekirax med eller uden dasabuvir.
English: This is due to liver function changes during treatment with Viekirax ± dasabuvir.
Danish: Klinisk kommentar vitamin Kantagonister paritaprevir at leverfunktionen ændres under behandling med Viekirax ± dasabuvir.
English: The EC50 of ombitasvir against genotype 1a-H77 and 1b-Con1 strains in HCV replicon cell culture assays was 14.1 and 5 pM, respectively.
Danish: EC50-værdien for ombitasvir mod genotype 1a-H77- og 1b-Con1-stammer i HCV-replikoncellekulturanalyser var henholdsvis 14,1 og 5 pM. Ombitasvirs aktivitet blev 11-13 gange mindre under tilstedeværelse af 40 % humant plasma.
English: ANTIANGINA/ANTIARRYTHMICS Amiodarone
Danish: PRÆVENTIONSMIDLER Ethinyløstradiol/ norgestimat
English: Viekirax and dasabuvir with weight-based ribavirin for 12 weeks Treated subjects (N=631) had a median age of 52 years (range: 18 to 70); 54.5% were male; 5.4% were Black; 15.2% had a history of depression or bipolar disorder; 79.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 15.4% had portal fibrosis (F2) and 8.7% had bridging fibrosis (F3); 67.7% had HCV genotype 1a infection; 32.3% had HCV genotype 1b infection.
Danish: De behandlede patienter (N = 631) havde en median alder på 52 år (interval: 18-70); 54,5 % var mænd; 5,4 % var sorte; 15,2 % havde depression eller bipolar lidelse i anamnesen; 79,1 % havde et HCV-rna niveau på mindst 800.000 IE/ml ved baseline; 15,4 % havde portal fibrose (F2), og 8,7 % havde bridgingfibrose (F3); 67,7 % havde HCV genotype 1a-infektion; 32,3 % havde HCV genotype 1b-infektion.
English: Expected in CYP2C19 Extensive Metabolisers:
Danish: Forventet hos personer som har kraftig metaboliseringsevne overfor CYP2C19:
English: The doses of paritaprevir were 100 mg and 200 mg and ombitasvir 25 mg.
Danish: Doserne af paritaprevir var 100 mg og 200 mg, og ombitasvir-dosen var 25 mg. Ribavirindosen var baseret på vægt (1.000 mg - 1.200 mg pr. dag).
English: ↔ lopinavir The magnitude of interaction was similar to that observed with Viekirax + dasabuvir.
Danish: ↔ lopinavir Interaktionen var af samme størrelsesorden som for Viekirax + dasabuvir.
English: ERGOT ALKALOIDS Ergotamine
Danish: SEKALEALKALOIDER Ergotamin
English: NA No dose adjustment required for cyclobenzaprine; increase dose if clinically indicated.
Danish: Dosisjustering er ikke nødvendig for cyclobenzaprin; øgning af dosis, hvis klinisk indiceret ombitasvir paritaprevir ↔ dasabuvir
English: Esomeprazole Lansoprazole Mechanism: CYP2C19 induction by ritonavir.
Danish: Mekanisme: Ritonavirs inducerende virkning på CYP2C19 .
English: Viekirax and dasabuvir with RBV 24-week arm
Danish: Viekirax og dasabuvir med ribavirin 24-uger-gruppen
English: No dose adjustment needed for Viekirax with or without dasabuvir.
Danish: Dosisjustering er ikke nødvendig for Viekirax med eller uden dasabuvir.
English: For dosing recommendations with calcineurin inhibitors see section 4.5.
Danish: 4.5 er der doseringsanbefalinger for calcineurin-hæmmere.
English: NA Reduce pravastatin dose by
Danish: Ritonavirs hæmning af
English: Note: For laboratory abnormalities, refer to Table 4
Danish: Bemærk: I tabel 4 er der en oversigt over unormale laboratorieværdier.
English: ↑ pravastatin The magnitude of interaction was similar to that observed with Viekirax + dasabuvir.
Danish: ↑ pravastatin Interaktionen var af samme størrelsesorden som for Viekirax + dasabuvir.
English: Mechanism: CYP3A4 induction apalutamide enzalutamide or mitotane.
Danish: Mekanisme: apalutamid, enzalutamid eller mitotans inducerende virkning på CYP3A4
English: Viekirax and dasabuvir without ribavirin or with weight-based ribavirin for 12 weeks Treated subjects (N=419) had a median age of 50 years (range: 19 to 70), 45.8% were male; 4.8% were Black; 9.3% had a history of depression or bipolar disorder; 73.3% had baseline HCV RNA of at least 800,000 IU/mL; 20.3% had portal fibrosis (F2) and 10.0% had bridging fibrosis (F3).
Danish: De behandlede patienter (N = 419) havde en median alder på 50 år (interval: 19-70); 45,8 % var mænd; 4,8 % var sorte; 9,3 % havde depression eller bipolar lidelse i anamnesen; 73,3 % havde et HCV-rnaniveau på mindst 800.000 IE/ml ved baseline; 20,3 % havde portal fibrose (F2), og 10,0 % havde bridging fibrose (F3).
English: Effect of paritaprevir/ritonavir on ombitasvir and dasabuvir
Danish: Indvirkningen af paritaprevir/ritonavir på ombitasvir og dasabuvir
English: No dose adjustment needed for metformin when co-administered with Viekirax with and without dasabuvir.
Danish: Dosisjustering er ikke nødvendig for metformin ved samtidig administration med Viekirax med eller uden dasabuvir.
English: Mechanism: Effect on everolimus is due to
Danish: Mekanisme: Phenytoins inducerende virkning på
English: nordiazepam
Danish: ↑ pimozid
English: Mechanism: CYP3A4/Pgp inhibition by conivaptan and paritaprevir/ ritonavir/ombi tasvir
Danish: Mekanisme: conivaptan og paritaprevir/ ritonavir/ombitasvirs hæmning af CYP3A4/Pgp
English: Mechanism: increase in dasabuvir possibly due to CYP2C8 inhibition by trimethoprim
Danish: Mekanisme: Øget dasabuvireksponering skyldes muligvis CYP2C8hæmning af trimethoprim paritaprevir (0,61-1,01)
English: Viekirax and dasabuvir with weight-based ribavirin for 12 weeks
Danish: Viekirax og dasabuvir med ribavirin 12 uger
English: Viekirax and dasabuvir without ribavirin or with weight-based ribavirin for 12 weeks Treated subjects (N=305) had a median age of 54 years (range: 19 to 70); 65.2% were male; 11.8% were Black; 20.7% had a history of depression or bipolar disorder; 86.6% had baseline HCV RNA levels of at least 800,000 IU/mL; 18.4% had portal fibrosis (F2) and 17.7% had bridging fibrosis (F3).
Danish: De behandlede patienter (N = 305) havde en median alder på 54 år (interval: 19-70); 65,2 % var mænd; 11,8 % var sorte; 20,7 % havde depression eller bipolar lidelse i anamnesen;; 86,6 % havde et HCV-rna niveau på mindst 800.000 IE/ml ved baseline; 18,4 % havde portal fibrose (F2), og 17,7 % havde bridgingfibrose (F3).
English: Clinical Comments dose
Danish: Klinisk kommentar paritaprevir
English: Effect of ombitasvir on paritaprevir/ritonavir and dasabuvir
Danish: Indvirkningen af ombitasvir på paritaprevir/ritonavir og dasabuvir
English: Treatment:
Danish: Gen-behandling
English: As liver function may change during treatment with Viekirax administered with or without dasabuvir, a close monitoring of International Normalised Ratio (INR) values is recommended.
Danish: Tæt monitorering af International Normalised Ratio (INR) værdier anbefales, da leverfunktionen kan ændres under behandling med Viekirax administreret med eller uden dasabuvir.
English: CYP3A4 induction by phenobarbital.
Danish: Mekanisme: Phenobarbital s inducerende virkning på CYP3A4.
English: Not studied: Similar effect is expected as observed with Viekirax + dasabuvir.
Danish: Ikke undersøgt: Samme virkning forventes som ved Viekirax + dasabuvir.
English: Viekirax and dasabuvir without ribavirin or with weight-based ribavirin for 12 weeks
Danish: randomiseret, globalt multicenter studie, åben Behandling: Viekirax og dasabuvir uden ribavirin eller med ribavirin baseret på vægt i 12 uger
English: Ritonavir dose in Viekirax will provide atazanavir pharmacokinetic enhancement).
Danish: Ritonavir-dosen i Viekirax forstærker atazanavirs farmakokinetik.
English: Mechanism: CYP3A4 induction by rifampicin.
Danish: Mekanisme: Rifampicins inducerende virkning på CYP3A4.
English: Concomitant use with fluvastatin and pitavastatin is not recommended (see section 4.4).
Danish: ↑ pitavastatin anbefales ikke (se pkt.
English: ↑ GS-331007 1.02
Danish: ↑ alprazolam 1,09
English: Mechanism: CYP3A4/Pgp inhibition by ketoconazole and paritaprevir/ ritonavir/ ombitasvir paritaprevir
Danish: Mekanisme: Ketoconazols og paritaprevir/ ritonavir/omb itasvirs hæmning af CYP3A4 og P-gp.