FrancophonIA/ELRC3.0 huggingface dataset:
English: b. The denominator for relapse is the number of subjects with HCV RNA <LLOQ at their last on-treatment assessment.
Danish: b. Benævnelsen for recidiv er antallet af patienter med HCV-rna < LLOQ ved deres seneste vurdering under behandling.
English: Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4 and 5.1).
Danish: Sovaldi er indiceret i kombination med andre lægemidler til behandling af kronisk hepatitis C (CHC) hos voksne (se pkt.
English: Medicinal products that are moderate P-gp inducers in the intestine (e.g. oxcarbazepine and modafinil) may decrease sofosbuvir plasma concentration leading to reduced therapeutic effect of Sovaldi.
Danish: Lægemidler, der er moderate P-gp-inducere i tarmen (f.eks. oxcarbazepin og modafinil), kan nedsætte plasmakoncentrationen af sofosbuvir og medføre reduceret terapeutisk virkning af Sovaldi.
English: • St. John's wort (Hypericum perforatum - herbal medicine used to treat depression);
Danish: • Perikon (Hypericum perforatum - et naturlægemiddel, der anvendes til at behandle depression)
English: However, data indicate at least 10-fold and 20-fold higher exposure to GS-331007 in ESRD compared to normal subjects when Sovaldi was administered 1 hour before or 1 hour after haemodialysis, respectively.
Danish: AUC0-inf for GS-331007 hos personer med ESRD kunne ikke bestemmes på pålidelig vis. Data indikerer imidlertid en mindst 10 gange og 20 gange højere eksponering for GS-331007 hos personer med ESRD, sammenlignet med normale personer, når Sovaldi blev administreret hhv. 1 time før eller 1 time efter hæmodialyse.
English: The pharmacokinetics of sofosbuvir and GS-331007 in paediatric subjects have not been established (see section 4.2).
Danish: Pædiatrisk population Farmakokinetikken af sofosbuvir og GS-331007 hos pædiatriske personer er ikke klarlagt (se pkt.
English: Subjects received 400 mg sofosbuvir and weight-based ribavirin (1,000 mg for subjects weighing <75 kg or 1,200 mg for subjects weighing ≥75 kg).
Danish: Patienterne fik 400 mg sofosbuvir og vægtbaseret ribavirin (1.000 mg til patienter, der vejede < 75 kg eller 1.200 mg for patienter, der vejede ≥ 75 kg).
English: NARCOTIC ANALGESICS Methadonef (Methadone maintenance therapy [30 to
Danish: (Methadon vedligeholdelsesbehandli ng [30 til
English: Table 15 presents the response rates by genotype and exposure to prior HCV treatment.
Danish: Tabel 15 viser responsrater efter genotype og eksponering overfor tidligere HCV-behandling.
English: Table 4: Adverse drug reactions identified with sofosbuvir in combination with ribavirin or peginterferon alfa and ribavirin
Danish: Tabel 4: Bivirkninger identificeret med sofosbuvir i kombination med ribavirin eller peginterferon alfa og ribavirin
English: Table 9 presents the response rates for the treatment groups of sofosbuvir + ribavirin and placebo.
Danish: Tabel 9 viser responsraterne for behandlingsgrupperne med sofosbuvir + ribavirin og placebo.
English: HCV infected subjects, regardless of genotype, with hepatocellular carcinoma (HCC) meeting the MILAN criteria received 400 mg sofosbuvir and 1,000-1,200 mg ribavirin daily for a maximum of 24 weeks, subsequently amended to 48 weeks, or until the time of liver transplantation, whichever occurred first.
Danish: HCV-inficerede patienter, uanset genotype, med hepatocellulært karcinom (HCC), der opfylder MILAN-kriterierne, fik 400 mg sofosbuvir og 1.000-1.200 mg ribavirin dagligt i maks.
English: Table 6: SVR12 rates for selected subgroups in NEUTRINO SOF+PEG+RBV
Danish: Tabel 6: SVR12-rater for udvalgte undergrupper i NEUTRINO SOF+PEG+RBV
English: Sovaldi is always taken with other medicines (see section 1 above).
Danish: Sovaldi tages altid sammen med andre lægemidler (se pkt.
English: No dose adjustment is required for patients with mild or moderate renal impairment.
Danish: Ingen dosisjustering er nødvendig for patienter med let til moderat nedsat nyrefunktion.
English: Haemoglobin in subjects with history of stable cardiac disease
Danish: Hæmoglobin hos personer med tidligere stabil hjertesygdom
English: Table 11 presents the response rates for the treatment groups of sofosbuvir + ribavirin for 12 weeks and 16 weeks.
Danish: Tabel 11 viser responsraterne for behandlingsgrupperne med sofosbuvir + ribavirin efter 12 uger og 16 uger.
English: Table 13 presents the response rates for the treatment groups of sofosbuvir + ribavirin for 12 weeks and 24 weeks.
Danish: Tabel 13 viser responsraterne for behandlingsgrupperne med sofosbuvir + ribavirin efter 12 uger og 24 uger.
English: Table 16 presents the subgroup analysis by genotype for cirrhosis.
Danish: Tabel 16 viser analyse af undergrupper efter genotype for cirrose.
English: Common dyspnoea, dyspnoea exertional, cough dyspnoea exertional Gastrointestinal disorders:
Danish: Almindelig dyspnø, dyspnø under anstrengelse, hoste dyspnø under anstrengelse
English: Clinical studies in subjects with genotype 1, 4, 5 and 6 chronic hepatitis C Treatment-naïve subjects - NEUTRINO (study 110) NEUTRINO was an open-label, single-arm study that evaluated 12 weeks of treatment with sofosbuvir in combination with peginterferon alfa 2a and ribavirin in treatment-naïve subjects with genotype 1, 4, 5 or 6 HCV infection.
Danish: Kliniske studier hos patienter med kronisk hepatitis C med genotype 1, 4, 5 og 6 Behandlingsnaive patienter- NEUTRINO (studie 110) NEUTRINO var et open-label, enarmet studie, der evaluerede 12 ugers behandling med sofosbuvir i kombination med peginterferon alfa 2a og ribavirin hos behandlingsnaive personer med HCV-infektion af genotype 1, 4, 5 eller 6.
English: HERBAL SUPPLEMENTS St. John's wort (Hypericum perforatum)
Danish: NATURMEDICIN Perikon (Hypericum perforatum)
English: Cases of severe bradycardia and heart block have been observed when sofosbuvir is used in combination with another DAA (including daclatasvir, simeprevir and ledipasvir) and concomitant amiodarone and/or other drugs that lower heart rate (see sections 4.4 and 4.5).
Danish: Der er iagttaget tilfælde af svær bradykardi og hjerteblok ved anvendelse af sofosbuvir i kombination med et andet DAA (herunder daclatasvir, simeprevir og ledispavir) samtidig med amiodaron og/eller andre hjertefrekvenssænkende lægemidler (se pkt.
English: Sovaldi is contraindicated with carbamazepine, phenobarbital and phenytoin, potent intestinal P-gp inducers (see section 4.3).
Danish: Sovaldi er kontraindiceret sammen med carbamazepin, phenobarbital og phenytoin, potente P-gp-inducere i tarmen (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Sovaldi 400 mg film-coated tablets sofosbuvir
Danish: LÆGEMIDLETS NAVN Sovaldi 400 mg filmovertrukne tabletter sofosbuvir
English: Sovaldi + ribavirin + peginterferon alfa 12 weeksa,b
Danish: Sovaldi + ribavirin + peginterferon alfa 12 ugera, b
English: Table 16: SVR12 rates for selected subgroups by genotype in study PHOTON-1 HCV genotype 2
Danish: Tabel 16: SVR12-rater for udvalgte undergrupper efter genotype i PHOTON-1-studiet HCV-genotype 2
English: Table 5 presents the response rates for the treatment group of sofosbuvir + peginterferon alfa + ribavirin.
Danish: Tabel 5 viser responsraterne for behandlingsgruppen med sofosbuvir + peginterferon alfa + ribavirin.
English: Table 8: SVR12 rates by cirrhosis and genotype in study FISSION
Danish: Tabel 8: SVR12-rater efter cirrose og genotype i FISSION-studiet Genotype 2
English: Table 7 presents the response rates for the treatment groups of sofosbuvir + ribavirin and peginterferon alfa + ribavirin.
Danish: Tabel 7 viser responsraterne for behandlingsgrupperne med sofosbuvir + ribavirin og peginterferon alfa + ribavirin.
English: Otherc a. The efficacy analysis includes 3 subjects with recombinant genotype 2/1 HCV infection.
Danish: Andetc a. Virkningsanalysen omfatter 3 patienter med rekombinant genotype 2/1 HCV-infektion.
English: HCV/HIV co-infected patients - PHOTON-1 (study 123) Sofosbuvir was studied in an open-label clinical study evaluating the safety and efficacy of 12 or 24 weeks of treatment with sofosbuvir and ribavirin in subjects with genotype 1, 2 or 3 chronic hepatitis C co-infected with HIV-1.
Danish: Klinisk virkning og sikkerhed hos specielle populationer Patienter med samtidig infektion med HCV og hiv - PHOTON-1 (studie 123) Sofosbuvir blev undersøgt i et open-label klinisk studie, der evaluerede sikkerheden og virkningen af 12 eller 24 ugers behandling med sofosbuvir og ribavirin hos patienter med kronisk hepatitis C af genotype 1, 2 eller 3 og samtidig infektion med hiv-1.
English: FUSION was a randomised, double-blinded study that evaluated 12 or 16 weeks of treatment with sofosbuvir and ribavirin in subjects who did not achieve SVR with prior interferon-based treatment (relapsers and nonresponders).
Danish: Tidligere behandlede voksne - FUSION (studie 108) FUSION var et randomiseret, dobbeltblindet studie, der evaluerede 12 eller 16 ugers behandling med sofosbuvir og ribavirin hos patienter, der ikke opnåede SVR med tidligere interferon-baseret behandling (patienter med recidiv og non-responders).
English: Otherb a. The denominator for relapse is the number of subjects with HCV RNA <LLOQ at their last on-treatment assessment.
Danish: Andetb a. Benævnelsen for recidiv er antallet af patienter med HCV-rna < LLOQ ved deres seneste vurdering under behandling.
English: R-methadone ↔ Cmax 0.99 (0.85, ↔ AUC 1.01 (0.85, ↔ Cmin 0.94 (0.77, 1.14) S-methadone ↔ Cmax 0.95 (0.79, ↔ AUC 0.95 (0.77, ↔ Cmin 0.95 (0.74, 1.22) Sofosbuvir ↓ Cmax 0.95c (0.68, 1.33) ↑ AUC 1.30c (1.00, Cmin (NA)
Danish: R-methadon ↔ Cmax 0,99 (0,85; ↔ AUC 1,01 (0,85; ↔ Cmin 0,94 (0,77; 1,14) S-methadon ↔ Cmax 0,95 (0,79; ↔ AUC 0,95 (0,77; ↔ Cmin 0,95 (0,74; 1,22) Sofosbuvir ↓ Cmax 0,95c (0,68; 1,33) ↑ AUC 1,30c (1,00;
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 400 mg of sofosbuvir.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 400 mg sofosbuvir.
English: Sovaldi + ribavirin + peginterferon alfa 12 weeksb
Danish: Sovaldi + ribavirin + peginterferon alfa 12 ugerb
English: Table 5: Response rates in study NEUTRINO SOF+PEG+RBV
Danish: Tabel 5: Responsrater i NEUTRINO-studiet SOF+PEG+RBV
English: Table 12 presents the subgroup analysis by genotype for cirrhosis and response to prior HCV treatment.
Danish: Tabel 12 viser analyse af undergrupper efter genotype for cirrose og respons på tidligere HCV-behandling.
English: Medicinal products that are potent P-gp inducers in the intestine (rifampicin, rifabutin, St. John's wort, carbamazepine, phenobarbital and phenytoin) may significantly decrease sofosbuvir plasma concentration leading to reduced therapeutic effect of Sovaldi and thus are contraindicated with Sovaldi (see section 4.3).
Danish: Lægemidler, der er potente P-gp-inducere i tarmen (rifampicin, rifabutin, perikon, carbamazepin, phenobarbital og phenytoin), kan nedsætte plasmakoncentrationen af sofosbuvir signifikant og medføre reduceret terapeutisk virkning af Sovaldi.
English: Table 14: SVR12 rates for selected subgroups by genotype in study VALENCE Genotype 2
Danish: Tabel 14: SVR12-rater for udvalgte undergrupper efter genotype i VALENCE-studiet Genotype 2
English: Table 14 presents the subgroup analysis by genotype for cirrhosis and exposure to prior HCV treatment.
Danish: Tabel 14 viser analyse af undergrupper efter genotype overfor cirrose og eksponering for tidligere HCV-behandling.
English: The safety profile of sofosbuvir and ribavirin in HCV/HIV co-infected subjects was similar to that observed in mono-infected HCV subjects treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Danish: Sikkerhedsprofilen for sofosbuvir og ribavirin hos personer med samtidige HCV/hiv-infektioner var sammenlignelig med den observerede sikkerhedsprofil hos monoinficerede personer med HCV, der blev behandlet med sofosbuvir og ribavirin i kliniske fase III-studier (se pkt.
English: Table 12: SVR12 rates for selected subgroups by genotype in study FUSION Genotype 2
Danish: Tabel 12: SVR12-rater for udvalgte undergrupper efter genotype i FUSION-studiet Genotype 2
English: Rilpivirine ↔ Cmax 1.05 (0.97, ↔ AUC 1.06 (1.02, ↔ Cmin 0.99 (0.94, 1.04) Sofosbuvir ↑ Cmax 1.21 (0.90, 1.62) ↔ AUC 1.09 (0.94, Cmin (NA)
Danish: Rilpivirin ↔ Cmax 1,05 (0,97; ↔ AUC 1,06 (1,02; ↔ Cmin 0,99 (0,94; 1,04) Sofosbuvir ↑ Cmax 1,21 (0,90; 1,62) ↔ AUC 1,09 (0,94; Cmin (NA)
English: Clinical studies in subjects with genotype 2 and 3 chronic hepatitis C Treatment-naïve adults - FISSION (study 1231)
Danish: Behandlingsnaive voksne - FISSION (studie 1231)
English: Haemoglobin in subjects with no cardiac disease
Danish: Hæmoglobin hos personer uden hjertesygdom
English: Cirrhosis No Yes a. The efficacy analysis includes 3 subjects with recombinant genotype 2/1 HCV infection.
Danish: Cirrose Nej Ja a. Virkningsanalysen omfatter 3 patienter med rekombinant genotype 2/1 HCV-infektion.
English: No dose adjustment of sofosbuvir or ciclosporin is required when sofosbuvir and ciclosporin are used concomitantly.
Danish: Ingen dosisjustering af sofosbuvir eller ciclosporin er nødvendig, når sofosbuvir og ciclosporin anvendes samtidigt.
English: No dose adjustment of sofosbuvir or tacrolimus is required when sofosbuvir and tacrolimus are used concomitantly.
Danish: Ingen dosisjustering af sofosbuvir eller tacrolimus er nødvendig, når sofosbuvir og tacrolimus anvendes samtidigt.
English: • getting a cold (nasopharyngitis)
Danish: • brystsmerter, svaghedsfølelse • forkølelse (nasofaryngitis)
English: Table 21: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 4, 5 and 6 HCV infection
Danish: Tabel 21 Resultater for behandlingsprogram og behandlingsvarighed, en sammenligning af studier af HCV-genotype 4, 5 og 6-infektion
English: Table 11: Response rates in study FUSION SOF+RBV
Danish: Tabel 11: Responsrater i FUSION-studiet SOF+RBV
English: Sofosbuvir was studied in an open-label clinical study evaluating the safety and efficacy of 24 weeks of treatment with sofosbuvir and ribavirin in liver transplant recipients with chronic hepatitis C. Eligible subjects were ≥18 years old and had undergone liver transplantation 6 to 150 months prior to screening.
Danish: Sofosbuvir blev undersøgt i et åbent klinisk studie, der evaluerede sikkerheden og virkningen af 24 ugers behandling med sofosbuvir og ribavirin hos patienter med kronisk hepatitis C, der havde gennemgået en levertransplantation.
English: Treated subjects (n = 419) had a median age of 51 years (range: 19 to 74); 60% of the subjects were male; median body mass index was 25 kg/m2 (range: 17 to 44 kg/m2); the mean baseline HCV RNA
Danish: Behandlede patienter (n = 419) havde en gennemsnitsalder på 51 år (interval: 19 til 74); 60 % af patienter var mænd, gennemsnitlige body mass index var 25 kg/m2 (interval: 17 til 44 kg/m2),
English: HIV ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS Efavirenzf (600 mg once daily)d
Danish: HIV-ANTIVIRALE STOFFER: HIV-PROTEASEHÆMMERE Darunavir boostet med ritonavirf (800/100 mg én gang dagligt)
English: Darunavir ↔ Cmax 0.97 (0.94, ↔ AUC 0.97 (0.94, ↔ Cmin 0.86 (0.78, 0.96) Sofosbuvir ↑ Cmax 1.45 (1.10, 1.92) ↑ AUC 1.34 (1.12, 1.59) Cmin (NA)
Danish: Darunavir ↔ Cmax 0,97 (0,94; ↔ AUC 0,97 (0,94; ↔ Cmin 0,86 (0,78; 0,96) Sofosbuvir ↑ Cmax 1,45 (1,10; 1,92)
English: The safety profile of sofosbuvir and ribavirin in HCV infected subjects prior to liver transplantation was similar to that observed in subjects treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Danish: Sikkerhedsprofilen for sofosbuvir og ribavirin hos personer med HCV-infektion før levertransplantation var sammenlignelig med den observerede sikkerhedsprofil hos personer, der blev behandlet med sofosbuvir og ribavirin i kliniske fase III-studier (se pkt.
English: No dose adjustment of sofosbuvir or tenofovir disoproxil fumarate is required when sofosbuvir and tenofovir disoproxil fumarate are used concomitantly.
Danish: Ingen dosisjustering af sofosbuvir eller tenofovirdisoproxilfumarat er nødvendig, når sofosbuvir og tenofovirdisoproxilfumarat anvendes samtidigt.
English: Table 9: Response rates in study POSITRON SOF+RBV
Danish: Tabel 9: Responsrater i POSITRON-studiet SOF+RBV
English: Relapsea
Danish: Recidiva
English: After a single 400 mg oral dose of [14C]-sofosbuvir, sofosbuvir and GS-331007 accounted for approximately 4% and >90% of drug-related material (sum of molecular weight-adjusted AUC of sofosbuvir and its metabolites) systemic exposure, respectively.
Danish: Efter en enkelt 400 mg oral dosis af [14C]-sofosbuvir udgjorde sofosbuvir og GS-331007 ca. hhv. 4 %
English: Nervous system disorders: Very common headache dizziness, headache
Danish: Meget almindelig hovedpine svimmelhed, hovedpine
English: Table 7: Response rates in study FISSION SOF+RBV
Danish: Tabel 7: Responsrater i FISSION-studiet SOF+RBV
English: Cirrhosis No
Danish: Cirrose Nej
English: Česká republika Gilead Sciences s.r.o.
Danish: Gilead Sciences s.r.o.
English: Table 18: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 1 HCV infection
Danish: Tabel 18: Resultater for behandlingsprogram og behandlingsvarighed, en sammenligning af studier af HCV-genotype 1-infektion
English: (800/100 mg once daily)
Danish: (300 mg én gang dagligt)d
English: Sofosbuvir ↓ Cmax 0.81 (0.60, 1.10) ↔ AUC 0.94 (0.76,
Danish: Sofosbuvir ↓ Cmax 0,81 (0,60; 1,10)
English: Non-cirrhotic
Danish: Uden cirrose
English: Overall SVR12 Genotype 2 Genotype 3 Outcome for subjects without SVR12 On-treatment virologic failure 0/103 Relapse b
Danish: Samlet SVR12 Genotype 2 Genotype 3 Resultat for patienter uden SVR12 Virologisk svigt under behandling Recidivb Andetc a. Virkningsanalysen omfatter 6 patienter med rekombinant genotype 2/1 HCV-infektion.
English: Very common nausea diarrhoea, nausea, vomiting
Danish: Mave-tarm-kanalen: Meget almindelig kvalme diarré, kvalme, opkastning
English: Sovaldi is contraindicated with rifampicin, a potent intestinal P-gp inducer (see section 4.3).
Danish: Sovaldi er kontraindiceret sammen med rifampicin, en kraftig P-gp-inducer i tarmen (se pkt.
English: The safety profile of sofosbuvir and ribavirin in liver transplant recipients with chronic hepatitis C was similar to that observed in subjects treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Danish: Patienter, der har gennemgået en levertransplantation Sikkerhedsprofilen for sofosbuvir og ribavirin hos patienter med kronisk hepatitis C, der har gennemgået en levertransplantation, var sammenlignelig med den observerede sikkerhedsprofil hos personer, der blev behandlet med sofosbuvir og ribavirin i kliniske fase III-studier (se pkt.
English: Sovaldi is contraindicated with rifabutin, a potent intestinal P-gp inducer (see section 4.3).
Danish: Sovaldi er kontraindiceret sammen med rifabutin, en kraftig P-gp-inducer i tarmen (se pkt.
English: The efficacy of sofosbuvir was evaluated in five Phase 3 studies in a total of 1,568 subjects with genotypes 1 to 6 chronic hepatitis C. One study was conducted in treatment-naïve subjects with genotype 1, 4, 5 or 6 chronic hepatitis C in combination with peginterferon alfa 2a and ribavirin and the other four studies were conducted in subjects with genotype 2 or 3 chronic hepatitis C in combination with ribavirin including one in treatment-naïve subjects, one in interferon intolerant,
Danish: Et studie blev udført hos behandlingsnaive patienter med genotype 1, 4, 5 eller 6 kronisk hepatitis C i kombination med peginterferon alfa 2a og ribavirin, og de andre 4 studier blev udført hos patienter med genotype 2 eller 3 kronisk hepatitis C i kombination med ribavirin, herunder et studie hos behandlingsnaivepatienter, et studie hos patienter, som var interferon-intolerante, -uegnede eller -uvillige, et studie hos patienter, der tidligere blev behandlet med et interferon-baseret program, og et studie hos alle patienter, uanset tidligere behandling eller egnethed til at få behandling med interferon.
English: Treated subjects (n = 327) had a median age of 54 years (range: 19 to 70); 64% of the subjects were male; 79% were White; 17% were Black; 14% were Hispanic or Latino; mean body mass index was 29 kg/m2 (range: 18 to 56 kg/m2); 78% had baseline HCV RNA greater than 6 log10 IU/mL; 17% had cirrhosis; 89% had HCV genotype 1 and 11% had HCV genotype 4, 5 or 6.
Danish: Behandlede patienter (n = 327) havde en gennemsnitsalder på 54 år (interval: 19 til 70), 64 % af patienterne var mænd, 79 % var hvide, 17 % var sorte, 14 % var af spansk eller latinamerikansk herkomst, gennemsnitligt body mass index var 29 kg/m2 (interval: 18 til 56 kg/m2), 78 % havde baseline HCV-rna over 6 log10 IE/ml, 17 % havde cirrose, 89 % havde HCV-genotype 1 og 11 % havde HCV-genotype 4, 5 eller 6.
English: Table 20: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 3 HCV infection
Danish: Tabel 20: Resultater for behandlingsprogram og behandlingsvarighed, en sammenligning af studier af HCV-genotype 3-infektion
English: Table 19: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 2 HCV infection
Danish: Tabel 19: Resultater for behandlingsprogram og behandlingsvarighed, en sammenligning af studier af HCV-genotype 2-infektion
English: Medicinal products that are potent P-glycoprotein (P-gp) inducers in the intestine (rifampicin, rifabutin, St. John's wort [Hypericum perforatum], carbamazepine, phenobarbital and phenytoin).
Danish: Samtidig administration af lægemidler, der er potente P-glykoprotein (P-gp)-induktorer i tarmen (rifampicin, rifabutin, perikon [Hypericum perforatum], carbamazepin, phenobarbital og phenytoin) vil nedsætte plasmakoncentrationen af sofosbuvir signifikant og kan medføre manglende virkning af Sovaldi (se pkt.
English: HIV/HCV co-infection
Danish: Anden speciel population/andre specielle populationer Samtidig infektion med hiv/HCV
English: Relapseb
Danish: • vægttab
English: and up to every 4 weeks until the appropriate weight-based dose was reached (1,000 mg daily in subjects <75 kg, 1,200 mg daily in subjects ≥75 kg).
Danish: Hvis personerne opretholdt hæmoglobinniveau ≥ 12 g/dl, blev ribavirindosis øget ved uge 2, 4 og op til hver 4. uge, indtil den passende vægtbaserede dosis (1.000 mg dagligt hos personer < 75 kg, 1.200 mg dagligt hos personer ≥ 75 kg) blev nået.
English: Treated subjects (n = 499) had a median age of 50 years (range: 19 to 77); 66% of the subjects were male; 87% were White; 3% were Black; 14% were Hispanic or Latino; mean body mass index was 28 kg/m2 (range: 17 to 52 kg/m2); 57% had baseline HCV RNA levels greater than 6 log10 IU/mL;
Danish: Behandlede patienter (n = 499) havde en gennemsnitsalder på 50 år (interval: 19 til 77), 66 % af patienterne var mænd, 87 % var hvide, 3 % var sorte, 14 % var af spansk eller latinamerikansk herkomst, gennemsnitligt body mass index var 28 kg/m2 (interval: 17 til 52 kg/m2), 57 % havde baseline HCV-rna-niveauer over 6 log10 IE/ml, 20 % havde cirrose, 72 % havde HCV-genotype 3.
English: Treated subjects (n = 278) had a median age of 54 years (range: 21 to 75); 54% of the subjects were male; 91% were White; 5% were Black; 11% were Hispanic or Latino; mean body mass index was 28 kg/m2 (range: 18 to 53 kg/m2); 70% had baseline HCV RNA levels greater than 6 log10 IU/mL;
Danish: Behandlede patienter (n = 278) havde en gennemsnitsalder på 54 år (interval: 21 til 75), 54 % af patienterne var mænd, 91 % var hvide, 5 % var sorte, 11 % var af spansk eller latinamerikansk herkomst, gennemsnitligt body mass index var 28 kg/m2 (interval: 18 til 53 kg/m2), 70 % havde baseline HCV-rna-niveauer over 6 log10 IE/ml, 16 % havde cirrose, 49 % havde HCV-genotype 3.
English: Vitamin K antagonists
Danish: ANTIKOAGULANTIA Vitamin K-antagonister Interaktion ikke undersøgt.
English: Discontinuation of dosing
Danish: Seponering af dosering
English: SOF+PEG+RBV 12 weeks Overallc
Danish: SOF+PEG+RBV 12 uger Samletc