FrancophonIA/ELRC3.0 huggingface dataset:
English: Exviera should not be used in patients with severe hepatic impairment (ChildPugh C) (see section 5.2).
Danish: Exviera bør ikke anvendes hos patienter med svær nedsat leverfunktion (Child-Pugh C) (se pkt.
English: Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported postmarketing in patients treated with Exviera with ombitasvir/paritaprevir/ritonavir with and without ribavirin.
Danish: Der er efter markedsføring rapporteret om dekompenseret leversygdom og leversvigt, inklusive levertransplantation og dødeligt udfald, hos patienter, som har været behandlet med Exviera med ombitasvir/paritaprevir/ritonavir med eller uden ribavirin.
English: NAME OF THE MEDICINAL PRODUCT Exviera 250 mg tablets dasabuvir
Danish: LÆGEMIDLETS NAVN Exviera 250 mg tabletter dasabuvir
English: When starting coadministration with Exviera and ombitasvir/paritaprevir/ ritonavir, give one fifth of the total daily dose of ciclosporin once daily with ombitasvir/ paritaprevir /ritonavir.
Danish: Ved administration samtidig med Exviera og ombitasvir/paritaprevir/ ritonavir skal man i starten administrere en femtedel af den samlede daglige dosis ciclosporin
English: Clinical Trial in liver transplant recipients
Danish: Klinisk studie hos patienter med levertransplantat
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 250 mg of dasabuvir (as sodium monohydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 250 mg dasabuvir (som natriummonohydrat).
English: Hepatobiliary Disorders: Hepatic decompensation, hepatic failure have been observed during treatment with Exviera with ombitasvir/paritaprevir/ritonavir, with or without ribavirin (see section 4.4).
Danish: Lever og galdeveje: Der er observeret dekompenseret leversygdom og leversvigt under behandling med Exviera med ombitasvir/paritaprevir/ritonavir med eller uden ribavirin (se pkt.
English: Subjects randomised to the placebo arm received placebo for 12 weeks, after which they received Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin for 12 weeks.
Danish: Forsøgspersonerne i placebogruppen fik placebo i 12 uger, hvorefter de fik Exviera og ombitasvir/paritaprevir/ritonavir i kombination med ribavirin i 12 uger.
English: Exviera safety and efficacy have been established in combination with ombitasvir/ paritaprevir /ritonavir with or without ribavirin.
Danish: Sikkerheden ved og virkningen af Exviera i kombination med ombitasvir/paritaprevir/ritonavir (sammen med eller uden ribavirin) er blevet klarlagt.
English: Treated subjects (N = 63) had a median age of 51 years (range: 31 to 69); 24% of subjects were Black; 81% of subjects had IL28B non-CC genotype; 19% of subjects had compensated cirrhosis; 67% of subjects were HCV treatment-naïve; 33% of subjects had failed prior treatment with pegIFN/RBV; 89% of subjects had HCV genotype 1a infection.
Danish: De behandlede patienter (N = 63) havde en gennemsnitsalder på 51 år (interval: 31-69), 24 % var sorte, 81 % havde genotype IL28B non-C/C, 19 % havde kompenseret cirrose, 67 % var HCVbehandlingsnaive, 33 % havde oplevet behandlingssvigt med pegIFN/RBV, og 89 % havde HCV genotype 1a-infektion.
English: SAPPHIRE-II was a randomised, global multicentre, double-blind, placebo-controlled trial conducted in 394 subjects with genotype 1 chronic hepatitis C virus infection without cirrhosis who did not achieve SVR with prior treatment with pegIFN/RBV.
Danish: SAPPHIRE II er et globalt, randomiseret, dobbeltblindet, placebokontrolleret multicenterstudie med 394 patienter med kronisk hepatitis C genotype 1-infektion uden cirrose, der ikke opnåede SVR ved tidligere behandling med pegIFN/RBV.
English: Arm A: Exviera and ombitasvir/paritaprevir/ritonavir + RBV Arm B: Exviera and ombitasvir/paritaprevir/ritonavir
Danish: Gruppe A: Exviera og ombitasvir/paritaprevir/ritonavir + RBV Gruppe B: Exviera og ombitasvir/paritaprevir/ritonavir
English: Exviera is not recommended in patients with moderate hepatic impairment (Child-Pugh B).
Danish: Det anbefales ikke at bruge Exviera til patienter med moderat nedsat leverfunktion (Child-Pugh B).
English: IRON CHELATORS Deferasirox Exviera ombitas vir/parit aprevir/ ritonavi r
Danish: JERNCHELERENDE MIDLER Deferasirox Exviera + ombitasvir/ paritaprevi r/ritonavir
English: Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin were administered for either 12 or 24 weeks of treatment.
Danish: Exviera og ombitasvir/paritaprevir/ritonavir i kombination med ribavirin blev administreret i enten 12 eller 24 uger.
English: SAPPHIRE-I was a randomised, global multicentre, double-blind, placebo-controlled trial conducted in 631 treatment-naïve adults with genotype 1 chronic hepatitis C virus infection without cirrhosis.
Danish: SAPPHIRE I er et globalt, randomiseret, dobbeltblindet, placebokontrolleret multicenterstudie med 631 behandlingsnaive voksne med kronisk hepatitis C genotype 1-infektion uden cirrose.
English: HIV coinfected patients without suppressive antiretroviral therapy should not be treated with dasabuvir.
Danish: Patienter, der samtidig er hiv-smittede, og som ikke får supprimerende antiretroviral behandling, må ikke behandles med dasabuvir.Hos patienter med samtidig HIV-infektion skal der tages nøje højde for lægemiddelinteraktioner (se nærmere i pkt.
English: PEARL-II was a randomised, global multicentre, open-label trial conducted in 179 adults with chronic genotype 1b hepatitis C virus infection without cirrhosis who did not achieve SVR with prior treatment with pegIFN/RBV.
Danish: PEARL II er et globalt, randomiseret, ikke-blindet multicenterstudie med 179 voksne patienter med kronisk hepatitis C genotype 1b-infektion uden cirrose, der ikke opnåede SVR ved tidligere behandling med pegIFN/RBV.
English: Dose normalized cyclosporine ratios are shown for interaction with Exviera + ombitasvir/paritaprevir/ritonavir.
Danish: Dosisnormaliserede ciclosporin-ratioer er vist for interaktionen med Exviera + ombitasvir/paritaprevir/ritonavir.
English: Exviera and ombitasvir/paritaprevir/ritonavir with RBV for 12 weeks n/N % 95% CI
Danish: Exviera og ombitasvir/paritaprevir/ritonavir med RBV i 12 uger n/N % 95 %-KI
English: buprenorphin e/ naloxone 4-24 mg/16 mg once daily
Danish: 4-24 mg/16 mg én gang
English: HIV/HCV co-infected patients
Danish: Patienter med samtidig HIV- og HCV-infektion
English: PEARL-IV was a randomised, global multicentre, double-blind, controlled trial conducted in 305 treatment-naïve adults with genotype 1a chronic hepatitis C virus infection without cirrhosis.
Danish: PEARL IV er et globalt, randomiseret, dobbeltblindet, kontrolleret multicenterstudie med 305 behandlingsnaive voksne med kronisk hepatitis C genotype 1a-infektion uden cirrose.
English: Subjects randomised to the placebo arm received placebo for 12 weeks, after which they received open-label Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin for 12 weeks.
Danish: Forsøgspersonerne i placebogruppen fik placebo i 12 uger, hvorefter de fik ikke-blindet Exviera og ombitasvir/paritaprevir/ritonavir i kombination med ribavirin i 12 uger.
English: Dose normalized tacrolimus ratios are shown for interaction with Exviera + ombitasvir/paritaprevir/ritonavir.
Danish: Dosisnormaliserede tacrolimus-ratioer er vist for interaktionen med Exviera + ombitasvir/paritaprevir/ritonavir.
English: Subjects were randomised in a 1:1 ratio to receive Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks of treatment.
Danish: Forsøgspersonerne blev randomiseret i forholdet 1:1 til at få Exviera og ombitasvir/paritaprevir/ritonavir med eller uden ribavirin i 12 uger.
English: Subjects were randomised in a 1:2 ratio to receive Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks of treatment.
Danish: Forsøgspersonerne blev randomiseret i forholdet 1:2 til at få Exviera og ombitasvir/paritaprevir/ritonavir med eller uden ribavirin i 12 uger.
English: Psychiatric disorders Very common
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig
English: PEARL-III was a randomised, global multicentre, double-blind, controlled trial conducted in 419 treatment-naïve adults with genotype 1b chronic hepatitis C virus infection without cirrhosis.
Danish: PEARL III er et globalt, randomiseret, dobbeltblindet, kontrolleret multicenterstudie med 419 behandlingsnaive voksne med kronisk hepatitis C genotype 1b-infektion uden cirrose.
English: Arm A: Exviera and ombitasvir/paritaprevir/ritonavir + RBV Arm B: Placebo
Danish: Gruppe A: Exviera og ombitasvir/paritaprevir/ritonavir + RBV Gruppe B: Placebo
English: Mechanism: decrease possibly due to CYP1A2 induction by ritonavir
Danish: Mekanisme: Reduceret cyclobenzapri n-eksponering skyldes muligvis ritonavirs inducerende virkning på CYP1A2
English: 200 mg once daily followed by
Danish: 200 mg én gang dagligt efterfulgt af 200 mg to gange dagligt
English: Arm B: Exviera and ombitasvir/paritaprevir/ritonavir + RBV (24 weeks)
Danish: Gruppe B: Exviera og ombitasvir/paritaprevir/ritonavir + RBV (24 uger)
English: NAME OF THE MEDICINAL PRODUCT Exviera 250 mg film-coated tablets dasabuvir
Danish: LÆGEMIDLETS NAVN Exviera 250 mg filmovertrukne tabletter dasabuvir
English: Emtricitabine/ tenofovir 200 mg once daily/300 mg once daily
Danish: 200 mg én gange dagligt/ 300 mg én gang dagligt
English: Medicinal products metabolised by CYP3A4
Danish: CYP3A4
English: No dose adjustment is necessary for emtricitabine/tenofovir and Exviera + ombitasvir/paritaprevir/ ritonavir.
Danish: Dosisjustering er ikke nødvendig for emtricitabin/tenofovir og Exviera med ombitasvir/ paritaprevir/ritonavir.
English: Table 10 shows the SVR12 rates for treatment-experienced subjects with genotype 1-infection receiving Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin for 12 weeks in SAPPHIRE-II.
Danish: Tabel 10 viser SVR12-raterne for behandlingserfarne forsøgspersoner med genotype 1-infektion, der fik Exviera og ombitasvir/paritaprevir/ritonavir i kombination med ribavirin i 12 uger i SAPPHIRE II.
English: Tacrolimus 2 mg single dose4
Danish: 2 mg enkeltdosis4
English: Arm A: Exviera and ombitasvir/paritaprevir/ritonavir + RBV
Danish: Gruppe A: Exviera og ombitasvir/paritaprevir/ritonavir + RBV
English: Exviera and ombitasvir/paritaprevir/ritonavir were given for 12 weeks of treatment in combination with ribavirin.
Danish: Exviera og ombitasvir/paritaprevir/ritonavir blev administreret i 12 uger i kombination med ribavirin.
English: 500 mg single dose
Danish: 500 mg enkelt dosis
English: 5 mg single dose and other vitamin K antagonists
Danish: Klinisk kommentar og andre vitamin Kantagonister ombitasvir sammen med alle vitamin K-antagonister.
English: NA Concomitant use is contraindicated (see section 4.3).
Danish: Samtidig brug er kontraindiceret (se pkt.
English: 0.94 No dose adjustment is
Danish: (0,80-0,90) Ikke relevant paritaprevir
English: croscarmellose sodium, colloidal anhydrous silica (E551), magnesium stearate (E470b).
Danish: − Tabletkerne: mikrokrystallinsk cellulose (E460(i)), laktosemonohydrat, copovidon, croscarmellosenatrium, kolloid vandfri silica (E551), magnesiumstearat (E470b).
English: Mechanism: CYP2C19 induction by ritonavir.
Danish: Mekanisme: Ritonavirs inducerende virkning på CYP2C19.
English: Caution should be used when sulfasalazine is co-administered with Exviera + ombitasvir/paritaprevir/ ritonavir.
Danish: Der bør udvises forsigtighed, når sulfasalazin administreres sammen Exviera + ombitasvir/paritaprevir/ri tonavir.
English: Arm A: Exviera and ombitasvir/paritaprevir/ritonavir + RBV (12 weeks)
Danish: Gruppe A: Exviera og ombitasvir/paritaprevir/ritonavir + RBV (12 uger)
English: Skin and subcutaneous tissue disorders Very common
Danish: Psykiske forstyrrelser Meget almindelig Søvnløshed Mave-tarm-kanalen Meget almindelig Kvalme Hud og subkutane væv Meget almindelig Pruritus Almindelig
English: Table 8 shows the SVR12 rates for genotype 1b-infected, treatment-naïve subjects who received Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks in PEARL III.
Danish: Tabel 8 viser SVR12-raterne for behandlingsnaive genotype 1b-smittede forsøgspersoner, der fik Exviera og ombitasvir/paritaprevir/ritonavir med eller uden ribavirin i 12 uger i PEARL III.
English: Concomitant use is contra-indicated (see section 4.3).
Danish: Ikke relevant Samtidig brug er kontraindiceret (se pkt.
English: ANTIMYCOBACTERIALS
Danish: ANTIBIOTIKA MED VIRKNING PÅ MYKOBAKTERIER
English: Table 7 shows the SVR12 rates for genotype 1-infected, treatment-naïve subjects receiving Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin for 12 weeks in SAPPHIRE-I.
Danish: Tabel 7 viser SVR12-raterne for behandlingsnaive genotype 1-smittede forsøgspersoner, der fik Exviera og ombitasvir/paritaprevir/ritonavir i kombination med ribavirin i 12 uger i SAPPHIRE I.
English: Arm B: Exviera and ombitasvir/paritaprevir/ritonavir
Danish: Gruppe B: Exviera og ombitasvir/paritaprevir/ritonavir
English: Treated subjects (N=419) had a median age of 50 years (range: 19 to 70); 45.8% were male; 4.8% were Black; 16.5% had a body mass index of at least 30 kg/m2; 9.3% had a history of depression or bipolar disorder; 79.0% had IL28B non-CC genotype; 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; 16,5 % havde et BMI på mindst 30 kg/m2; 9,3 % havde depression eller bipolar lidelse i anamnesen; 79,0 % havde genotype IL28B non-C/C; 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: Exviera and ombitasvir/paritaprevir/ritonavir (12 weeks)
Danish: Exviera og ombitasvir/paritaprevir/ritonavir (12 uger)
English: Table 11 shows the SVR12 rates for genotype 1b-infected, treatment-experienced subjects who received Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks in PEARL II.
Danish: Tabel 11 viser SVR12-raterne for behandlingserfarne genotype 1b-smittede forsøgspersoner, der fik Exviera og ombitasvir/paritaprevir/ritonavir med eller uden ribavirin i 12 uger i PEARL II.
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; 28.4% had a body mass index of at least 30 kg/m2; 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; 81.8% had IL28B non-CC genotype; 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; 28,4 % havde et BMI på mindst 30 kg/m2; 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; 81,8 % havde genotype IL28B non-C/C; 24,7 % havde depression eller bipolar lidelse i anamnesen; 68,7 % havde HCV genotype 1a-infektion, 31,3 % havde HCV genotype 1b-infektion.
English: Treated subjects (N=305) had a median age of 54 years (range: 19 to 70); 65.2% were male; 11.8% were Black; 19.7% had a body mass index of at least 30 kg/m2; 20.7% had a history of depression or bipolar disorder; 69.2% had IL28B non-CC genotype; 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; 19,7 % havde et BMI på mindst 30 kg/m2; 20,7 % havde depression eller bipolar lidelse i anamnesen; 69,2 % havde genotype IL28B non-C/C; 86,6 % havde et HCV-rnaniveau på mindst 800.000 IE/ml ved baseline; 18,4 % havde portal fibrose (F2), og 17,7 % havde bridging fibrose (F3).
English: TURQUOISE-III is a Phase 3b, open-label, single-arm, multicentre study evaluating the efficacy and safety of Exviera and ombitasvir/paritaprevir/ritonavir (without ribavirin) administered for 12 weeks in HCV GT1b-infected, treatment-naïve and pegIFN/RBV treatment-experienced adults with compensated cirrhosis.
Danish: TURQUOISE-III: Klinisk studie af patienter med GT1b-infektion med cirrose uden RBV TURQUOISE-III er et fase 3b, ikke-blindet, enkelt-arm, multicenterstudie, som undersøgte Exviera og ombitasvir/paritaprevir/ritonavirs(uden ribavirin) virkning og sikkerhed ved administration i
English: No dose adjustment is necessary for norethindrone or Exviera + ombitasvir/paritaprevir/ ritonavir.
Danish: Dosisjustering er ikke nødvendig for norethindron eller Exviera med ombitasvir/ paritaprevir/ritonavir.
English: Treated subjects (N=631) had a median age of 52 years (range: 18 to 70); 54.5% were male; 5.4% were Black; 16.2% had a body mass index of at least 30 kg/m2; 15.2% had a history of depression or bipolar disorder; 69.3% had IL28B non-CC genotype; 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; 16,2 % havde et BMI på mindst 30 kg/m2; 15,2 % havde depression eller bipolar lidelse i anamnesen; 69,3 % havde genotype IL28B non-C/C; 79,1 % havde et HCV-rnaniveau på mindst 800.000 IE/ml ved baseline; 15,4 % havde portal fibrose (F2), og 8,7 % havde bridging fibrose (F3); 67,7 % havde HCV genotype 1a-infektion; 32,3 % havde HCV genotype 1binfektion.
English: HCV RNA levels (no response guided algorithm).
Danish: Behandlingsvarigheden var fast i hvert studie og var ikke afhængig af forsøgspersonernes HCV-rna-niveauer (ingen responstilpasset algoritme).
English: Characteristics
Danish: Karateristika
English: Exviera and ombitasvir/paritaprevir/ritonavir for 12 weeks With RBV
Danish: Exviera og ombitasvir/paritaprevir/ritonavir i 12 uger Med RBV
English: Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin was given for 12 weeks of treatment.
Danish: Exviera og ombitasvir/paritaprevir/ritonavir i kombination med ribavirin blev administreret i 12 uger.
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; 21.8% had a body mass index of at least 30 kg/m2; 12.8% had a history of depression or bipolar disorder; 90.5% had IL28B non-CC genotype; 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; 21,8 % havde et BMI på mindst 30 kg/m2; 12,8 % havde depression eller bipolar lidelse i anamnesen; 90,5 % havde genotype IL28B non-C/C; 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: Exviera ombitas vir/parit aprevir/r itonavir cyclobenzap rine
Danish: ombitasvir/pa ritaprevir/rito navir cyclobenzap rin
English: Exviera and ombitasvir/paritaprevir /ritonavir + ribavirin
Danish: Exviera og ombitasvir/paritaprevir /ritonavir + ribavirin
English: Exviera and ombitasvir/paritaprevir/ritonavir with RBV 24-week arm
Danish: Exviera og ombitasvir/paritaprevir/ritonavir med RBV 24-uger-gruppen
English: This is due to liver function
Danish: Nedsat leverfunktion
English: For dosing recommendations with HIV antiviral agents, refer to sections 4.4 and 4.5.
Danish: Hvad angår doseringsanbefalinger for antivirale stoffer mod HIV, henvises til pkt.
English: Mechanism: CYP3A4 induction by enzalutamide or mitotane.
Danish: Mekanisme: enzalutamid eller mitotans inducerende virkning på CYP3A4
English: Clinical Comments ritonavir.
Danish: Klinisk kommentar hæmning af
English: No dose adjustment is necessary for raltegravir or Exviera + ombitasvir/paritaprevir/ ritonavir.
Danish: Dosisjustering er ikke nødvendig for raltegravir eller Exviera med ombitasvir/paritaprevir/ ritonavir.
English: As liver function may change during treatment with Exviera administered with ombitasvir/paritaprevir/ritonavir, 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 Exviera administreret med ombitasvir/paritaprevir/ritonavir.
English: Adverse reactions identified with Exviera in combination with ombitasvir/paritaprevir/ritonavir or ombitasvir/paritaprevir/ritonavir and ribavirin
Danish: Bivirkninger ved indtagelse af Exviera sammen med ombitasvir/paritaprevir/ritonavir med ribavirin:
English: NA No dose adjustment needed for sofosbuvir when administered with Exviera + ombitasvir/paritaprevir /ritonavir.
Danish: Dosisjustering er ikke nødvendig for sofosbuvir ved samtidig administration med Exviera + ombitasvir/paritaprevir/ri tonavir.
English: Exviera ombitas vir/parit aprevir/ ritonavi r atazanavir
Danish: Exviera + ombitasvir/ paritaprevir/ ritonavir atazanavir
English: Exviera and ombitasvir/paritaprevir/ritonavir with RBV 12-week arm
Danish: Exviera og ombitasvir/paritaprevir/ritonavir med RBV 12-uger-gruppen
English: No dose adjustment needed for dolutegravir when administered with Exviera + ombitasvir/paritaprevir/ ritonavir.
Danish: Dosisjustering er ikke nødvendig for dolutegravir ved samtidig administration med Exviera + ombitasvir/paritaprevir/ri tonavir.
English: Exviera is administered with ombitasvir/paritaprevir/ritonavir.
Danish: Exviera administreres med ombitasvir/paritaprevir/ritonavir.
English: NA No dose adjustment is necessary for paracetamol when administered with Exviera + ombitasvir/paritaprevir/ ritonavir.
Danish: Ikke relevant Dosisjustering er ikke nødvendig for paracetamol ved samtidig administration med Exviera med ombitasvir/ paritaprevir/ritonavir.
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse
English: Insomnia
Danish: • søvnbesvær
English: Exviera ombitas vir/parit aprevir/ ritonavi r duloxetine
Danish: Exviera + ombitasvir/ paritaprevir/ ritonavir duloxetin
English: Exviera ombitas vir/parit aprevir/r itonavir hydrocodone
Danish: Exviera + ombitasvir/p aritaprevir/ri tonavir hydrokodon
English: No dose adjustment is necessary for buprenorphine/naloxon e and Exviera + ombitasvir/paritaprevir/ ritonavir.
Danish: Dosisjustering er ikke nødvendig for buprenorphin/naloxon og Exviera med ombitasvir/
English: Mechanism: CYP3A4/Pgp inhibition by ketoconazole and paritaprevir/ ritonavir/ ombitasvir
Danish: Mekanisme: Ketoconazols, og paritaprevir/ ritonavir/ ombitasvirs hæmning af CYP3A4/P-gp.
English: Exviera and ombitasvir/paritaprevir/ritonavir with RBV 12 weeks
Danish: Exviera og ombitasvir/paritaprevir/ritonavir med RBV 12 uger
English: ombitasvir
Danish: Alprazolam
English: Exviera and ombitasvir/paritaprevir/ritonavir
Danish: Exviera og ombitasvir/paritaprevir /ritonavir