FrancophonIA/ELRC3.0 huggingface dataset:
English: • fever, chills, flu-like symptoms
Danish: • feber, kulderystelser, influenzalignende symptomer
English: a. For previously treated patients with HCV genotype 1 infection, no data exists with the combination of Sovaldi, ribavirin and peginterferon alfa (see section 4.4).
Danish: a. For tidligere behandlede patienter med infektion af HCV-genotype 1, eksisterer der ingen data med kombinationen af Sovaldi, ribavirin og peginterferon alfa (se pkt.
English: The pharmacokinetics of sofosbuvir, and GS-331007 were studied in HCV-infected patients with ESRD requiring dialysis treated with ledipasvir/sofosbuvir (n = 94) for 8, 12, or 24 weeks or sofosbuvir/velpatasvir (n = 59) for 12 weeks, and compared to patients without renal impairment in the ledipasvir/sofosbuvir and sofosbuvir/velpatasvir Phase 2/3 trials (see section 4.4).
Danish: Farmakokinetikken af sofosbuvir og GS-331007 blev undersøgt hos HCV-inficerede patienter med ESRD, der krævede dialyse, og som blev behandlet med ledipasvir/sofosbuvir (n=94) i 8, 12 eller 24 uger, eller sofosbuvir/velpatasvir (n = 59) i 12 uger, og sammenlignet med patienter uden nedsat nyrefunktion i fase II-/III-studierne med ledipasvir/sofosbuvir og sofosbuvir/velpatasvir (se pkt.
English: Other medicines and Sovaldi
Danish: Brug af anden medicin sammen med Sovaldi
English: Therefore, Sovaldi should not be used during breast-feeding.
Danish: Derfor må Sovaldi ikke anvendes under amning.
English: As a precautionary measure, it is preferable to avoid the use of Sovaldi during pregnancy.
Danish: For en sikkerheds skyld bør Sovaldi undgås under graviditeten.
English: Table 7: Response rates in study NEUTRINO
Danish: Tabel 7: Responsrater i NEUTRINO-studiet
English: Table 10: SVR12 rates by cirrhosis and genotype in study FISSION
Danish: Tabel 10: SVR12-rater efter cirrose og genotype i FISSION-studiet
English: Dose modification in adolescents Dose reduction of Sovaldi is not recommended.
Danish: Dosismodifikation hos unge Dosisreduktion af Sovaldi frarådes.
English: Study 0154 was an open-label clinical study that evaluated the safety and efficacy of 24 weeks of treatment with sofosbuvir in combination with ribavirin in 20 genotype 1 or 3 HCV-infected patients with severe renal impairment not requiring dialysis.
Danish: Studie 0154 var et åbent klinisk studie, som evaluerede sikkerheden og effekten af 24 ugers behandling med sofosbuvir kombineret med ribavirin hos 20 genotype 1 eller 3 HCV-inficerede patienter med svært nedsat nyrefunktion, som ikke krævede dialyse.
English: No dose adjustment of Sovaldi is required when concomitantly used with rifabutin.
Danish: Dosisjustering af Sovaldi er ikke nødvendig, når det anvendes samtidigt med rifabutin.
English: Drug interaction information for Sovaldi with potential concomitant medicinal products is summarised in Table 5 below (where 90% confidence interval (CI) of the geometric least-squares mean (GLSM)
Danish: Information om lægemiddelinteraktion for Sovaldi med mulige samtidige lægemidler er opsummeret i tabel 5 nedenfor (hvor 90 % konfidensintervallet (CI) af forholdet af det geometriske mindste kvadraters gennemsnit (GLSM) var inden for ”↔”, strakte sig over ”↑” eller strakte sig under ”↓” de ækvivalensgrænser, der var bestemt på forhånd).
English: 12 weeksb
Danish: 12 ugerb
English: FISSION was a randomised, open-label, active-controlled study that evaluated 12 weeks of treatment with sofosbuvir and ribavirin compared to 24 weeks of treatment with peginterferon alfa 2a and ribavirin in treatment-naïve patients with genotype 2 or 3 HCV infection.
Danish: FISSION var et randomiseret, open-label, aktivt kontrolleret studie, der evaluerede 12 ugers behandling med sofosbuvir og ribavirin, sammenlignet med 24 ugers behandling med peginterferon alfa 2a og ribavirin hos behandlingsnaive patienter med HCV-infektion af genotype 2 eller 3.
English: Safety data are limited in patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) and ESRD requiring haemodialysis.
Danish: Der foreligger begrænsede sikkerhedsdata hos patienter med svært nedsat nyrefunktion (eGFR < 30 ml/min/1,73 m2) og ESRD, der kræver hæmodialyse.
English: Severe RI (eGFR <30 mL/min/1.7 3m2)
Danish: Svært RI (eGFR < 30 ml/min/ 1,73 m2)
English: Table 17 presents the response rates by genotype and exposure to prior HCV treatment.
Danish: Tabel 17 viser responsrater efter genotype og eksponering overfor tidligere HCV-behandling.
English: b. The denominator for relapse is the number of patients 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: Close monitoring is recommended if this medicinal product is administered with Sovaldi (see sections 4.4 and 4.8).
Danish: Tæt overvågning anbefales, hvis dette lægemiddel administreres med Sovaldi (se pkt.
English: • shortness of breath when exercising
Danish: • stakåndethed, når der dyrkes motion
English: Sofosbuvir and GS-331007 are not inhibitors of drug transporters P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 and OCT1.
Danish: Sofosbuvir og GS-331007 er ikke hæmmere af lægemiddeltransporterne P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 eller OCT1.
English: Treatment-naïve (NEUTRINO)
Danish: Behandlingsnaive (NEUTRINO)
English: Patients with genotype 2 CHC
Danish: Patienter med genotype 2 CHC
English: Patients with genotype 1, 4, 5 or 6 CHC
Danish: Patienter med CHC af genotype 1, 4, 5 eller 6
English: Treatment-naïve co-infected with HIV (PHOTON-1)
Danish: Behandlingsnaive med samtidig hiv-infektion (PHOTON-1)
English: Table 11 presents the response rates for the treatment groups of sofosbuvir + ribavirin and placebo.
Danish: Tabel 11 viser responsraterne for behandlingsgrupperne med sofosbuvir + ribavirin og placebo.
English: Table 9: Response rates in study FISSION
Danish: Tabel 9: Responsrater i FISSION-studiet
English: Treatment-experienced co-infected with HIV (PHOTON-1)
Danish: Behandlingserfarne med samtidig hiv-infektion (PHOTON-1)
English: The recommended co-administered medicinal product(s) and treatment duration for Sovaldi combination therapy are provided in Table 1.
Danish: Anbefalet samtidigt administret lægemiddel/anbefalede samtidigt administrerede lægemidler og behandlingsvarighed for Sovaldi kombinationsbehandling er anført i tabel 1.
English: HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS Raltegravirf (400 mg twice daily)
Danish: HIV-ANTIVIRALE STOFFER: INTEGRASEHÆMMERE Raltegravirf (400 mg to gange dagligt)
English: • muscle aches and pains, pain in the joints
Danish: • muskelømhed og -smerter, ledsmerter
English: Outcome for patients without SVR12 On-treatment virologic failure Relapseb
Danish: Resultat for patienter uden SVR12 Virologisk svigt under behandling
English: Table 6: Adverse drug reactions identified with sofosbuvir in combination with ribavirin or peginterferon alfa and ribavirin
Danish: Tabel 6: Bivirkninger identificeret med sofosbuvir i kombination med ribavirin eller peginterferon alfa og ribavirin
English: Ethinyl estradiol ↔ Cmax 1.14 (0.96, 1.36)
Danish: Ethinylestradiol ↔ Cmax 1,14 (0,96; 1,36)
English: Respiratory, thoracic and mediastinal disorders: Very common dyspnoea, cough
Danish: Luftveje, thorax og mediastinum: Meget almindelig dyspnø, hoste
English: Patients with genotype 3 CHC
Danish: Patienter med genotype 3 CHC
English: Medicinal products that are moderate P-gp inducers in the intestine (e.g. modafinil, oxcarbazepine and rifapentine) may decrease sofosbuvir plasma concentration leading to reduced therapeutic effect of Sovaldi.
Danish: Lægemidler, der er moderate P-gp-inducere i tarmen (f.eks. modafinil, oxcarbazepin og rifapentin), kan nedsætte plasmakoncentrationen af sofosbuvir og medføre reduceret terapeutisk virkning af Sovaldi.
English: and <50 mL/min/1.73 m2)
Danish: < 50 ml/min/ 1,73m2)
English: Overall No cirrhosis Cirrhosis
Danish: Samleta Uden cirrosea Cirrosea
English: Safety data are limited in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2) and end stage renal disease (ESRD) requiring haemodialysis.
Danish: Der foreligger begrænsede sikkerhedsdata hos patienter med svært nedsat nyrefunktion (estimeret glomulær filtrationshastighed [eGFR] < 30 ml/min/1,73 m2) og nyresygdom i slutstadiet (ESRD), der kræver hæmodialyse.
English: Table 13: Response rates in study FUSION
Danish: Tabel 13: Responsrater i FUSION-studiet
English: Sovaldi is always taken with other medicines to treat hepatitis C (see section 1 above).
Danish: Sovaldi tages altid sammen med andre lægemidler til behandling af hepatitis C (se pkt.
English: No dose adjustment of sofosbuvir is recommended for patients with mild, moderate and severe hepatic impairment (see section 4.2).
Danish: Der anbefales ingen dosisjustering af sofosbuvir for patienter med let, moderat eller svært nedsat leverfunktion (se pkt.
English: No dose adjustment of sofosbuvir or ciclosporin is required at initiation of co-administration.
Danish: Ingen dosisjustering af sofosbuvir eller ciclosporin er nødvendig ved påbegyndelse af samtidig administration.
English: SOFa + RBVb
Danish: Hyppighed SOFa + RBVb
English: Sovaldi is contraindicated with rifampicin (see section 4.3).
Danish: Sovaldi er kontraindiceret sammen med rifampicin (se pkt.
English: Table 8: SVR12 rates for selected subgroups in NEUTRINO
Danish: Tabel 8: SVR12-rater for udvalgte undergrupper i NEUTRINO
English: Study 4063 was an open-label study that evaluated a fixed dose combination of sofosbuvir and ledipasvir in 95 patients with HCV-infection and ESRD requiring dialysis.
Danish: Studie 4063 var et åbent studie, som evaluerede en fast dosiskombination af sofosbuvir og ledipasvir hos 95 patienter med HCV-infektion og ESRD, som krævede dialyse.
English: Clinical studies in patients with genotype 1, 4, 5 and 6 chronic hepatitis C Treatment-naïve adult patients - 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 patients 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 voksne 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 patienter med HCV-infektion af genotype 1, 4, 5 eller 6.
English: HCV infected patients, 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: Very common haemoglobin decreased anaemia, neutropenia, lymphocyte count decreased, platelet count decreased
Danish: Meget almindelig nedsat hæmoglobin anæmi, neutropeni, nedsat lymfocyttal, nedsat trombocyttal
English: Genotype 2/3 treatment-naïve SOF+RBV 12 weeks (n = 68)
Danish: Genotype 2/3 behandlingsnaive SOF+RBV 12 uger (n = 68)
English: Table 15 presents the response rates for the treatment groups of sofosbuvir + ribavirin for 12 weeks and 24 weeks.
Danish: Tabel 15 viser responsraterne for behandlingsgrupperne med sofosbuvir + ribavirin efter 12 uger og 24 uger.
English: No dose adjustment of sofosbuvir or tacrolimus is required at initiation of co-administration.
Danish: Ingen dosisjustering af sofosbuvir eller tacrolimus er nødvendig ved påbegyndelse af samtidig administration.
English: Table 13 presents the response rates for the treatment groups of sofosbuvir + ribavirin for 12 weeks and 16 weeks.
Danish: Tabel 13 viser responsraterne for behandlingsgrupperne med sofosbuvir + ribavirin efter 12 uger og 16 uger.
English: Table 18 presents the subgroup analysis by genotype for cirrhosis.
Danish: Tabel 18 viser analyse af undergrupper efter genotype for cirrose.
English: • changes in your mood, feeling depressed, feeling anxious and feeling agitated
Danish: • humørsvingninger, depression, angstfølelse og ophidselse
English: In HCV-infected patients with severe renal impairment treated with sofosbuvir 200 mg with ribavirin (n=10) or sofosbuvir 400 mg with ribavirin (n=10) for 24 weeks or ledipasvir/sofosbuvir 90/400 mg (n=18) for 12 weeks, the pharmacokinetics of sofosbuvir and GS-331007 were consistent with that observed in HCV negative patients with severe renal impairment.
Danish: Hos HCV-inficerede patienter med svært nedsat nyrefunktion, som blev behandlet med en dosis på 200 mg sofosbuvir med ribavirin (n=10) eller 400 mg sofosbuvir med ribavirin (n=10) i 24 uger, eller med 90/400 mg ledipasvir/sofosbuvir (n=18) i 12 uger, var farmakokinetikken af sofosbuvir og GS
English: Study 4062 was an open-label study that evaluated a fixed dose combination of sofosbuvir and velpatasvir in 59 HCV-infected patients with ESRD requiring dialysis.
Danish: Studie 4062 var et åbent klinisk forsøg, som evaluerede en fast dosiskombination af sofosbuvir og velpatasvir hos 59 HCV-inficerede patienter med ESRD, der krævede dialyse.
English: Genotype 1 treatment-naïve SOF+RBV 24 weeks (n = 114)
Danish: Genotype 1 behandlingsnaive SOF+RBV 24 uger (n = 114)
English: Treatment-naïvea (NEUTRINO)
Danish: Behandlingsnaivea (NEUTRINO)
English: Regimen/Duration
Danish: Behandlingsprogram/varighed
English: No dose adjustment of norgestimate/ethinyl estradiol is required when sofosbuvir and norgestimate/ethinyl estradiol are used concomitantly.
Danish: Ingen dosisjustering af norgestimat/ethinylestradiol er nødvendig, når sofosbuvir og norgestimat/ethinylestradiol anvendes samtidigt.
English: How to take Sovaldi
Danish: Sådan skal du tage Sovaldi
English: Gastrointestinal disorders: Very common nausea diarrhoea, nausea, vomiting
Danish: Mave-tarm-kanalen: Meget almindelig kvalme diarré, kvalme, opkastning
English: NARCOTIC ANALGESICS Methadonef (Methadone maintenance therapy [30 to
Danish: NARKOTISKE ANALGETIKA Methadonf (Methadon vedligeholdelsesbehandling [30 til 130 mg/dagligt])
English: Interferon-free therapy for genotype 1, 4, 5 and 6 HCV infection
Danish: Interferonfri behandling af HCV-genotype 1, 4, 5 og 6-infektion
English: Table 7 presents the response rates for the treatment group of sofosbuvir + peginterferon alfa + ribavirin.
Danish: Tabel 7 viser responsraterne for behandlingsgruppen med sofosbuvir + peginterferon alfa + ribavirin.
English: Table 11: Response rates in study POSITRON
Danish: Tabel 11: Responsrater i POSITRON-studiet
English: Other special population(s)
Danish: Anden speciel population/andre specielle populationer
English: FUSION was a randomised, double-blinded study that evaluated 12 or 16 weeks of treatment with sofosbuvir and ribavirin in patients 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: The efficacy of sofosbuvir was evaluated in five Phase 3 studies in a total of 1,568 adult patients with genotypes 1 to 6 chronic hepatitis C. One study was conducted in treatment-naïve patients 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 patients with genotype 2 or 3 chronic hepatitis C in combination with ribavirin including one in treatment-naïve patients, one in interferon intolerant, ineligible or unwilling patients, one in patients previously treated with an interferon-based regimen, and one in all patients irrespective of prior treatment history or ability to receive treatment with interferon.
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: Otherb a. The denominator for relapse is the number of patients 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: Table 14 presents the subgroup analysis by genotype for cirrhosis and response to prior HCV treatment.
Danish: Tabel 14 viser analyse af undergrupper efter genotype for cirrose og respons på tidligere HCV-behandling.
English: Table 9 presents the response rates for the treatment groups of sofosbuvir + ribavirin and peginterferon alfa + ribavirin.
Danish: Tabel 9 viser responsraterne for behandlingsgrupperne med sofosbuvir + ribavirin og peginterferon alfa + ribavirin.
English: Cases of severe bradycardia and heart block have been observed when sofosbuvir containing-regimes are used in combination with amiodarone and/or other medicinal products 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 amiodaron og/eller andre hjertefrekvenssænkende lægemidler (se pkt.
English: Table 16 presents the subgroup analysis by genotype for cirrhosis and exposure to prior HCV treatment.
Danish: Tabel 16 viser analyse af undergrupper efter genotype overfor cirrose og eksponering for tidligere HCV-behandling.
English: HCV/HIV co-infected adult 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 patients with genotype 1, 2 or 3 chronic hepatitis C co-infected with HIV-1.
Danish: Klinisk virkning og sikkerhed hos specielle populationer Voksne 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: Genotype 4, 5 or 6 Cirrhosis
Danish: Genotype 4, 5 eller 6 97 % (34/35) Cirrose
English: For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.
Danish: For genotypespecifik aktivitet af hepatitis C-virus (HCV), se pkt.
English: Common disturbance in attention migraine, memory impairment, disturbance in attention
Danish: Almindelig koncentrationsbesvær migræne, hukommelsessvigt, koncentrationsbesvær
English: Common dyspnoea, dyspnoea exertional, cough dyspnoea exertional
Danish: Almindelig dyspnø, dyspnø under anstrengelse, hoste dyspnø under anstrengelse
English: Exposure to sofosbuvir in rodent studies could not be detected likely due to high esterase activity; however, exposure to the major metabolite GS-331007 at the adverse dose was 29 times (rat) and 123 times (dog) higher than the clinical exposure at 400 mg sofosbuvir.
Danish: Eksponeringen for den primære metabolit, GS-331007, ved den dosis, der forårsagede bivirkninger, var imidlertid 29 gange (rotter) og 123 gange (hunde) højere end den kliniske eksponering ved 400 mg sofosbuvir.
English: Musculoskeletal and connective tissue disorders: Very common arthralgia, myalgia
Danish: Knogler, led, muskler og bindevæv: Meget almindelig artralgi, myalgi
English: No dose adjustment of sofosbuvir or darunavir (ritonavir boosted) is required when sofosbuvir and darunavir are used concomitantly.
Danish: Ingen dosisjustering af sofosbuvir eller darunavir (ritonavir-boostet) er nødvendig, når sofosbuvir og darunavir anvendes samtidigt.
English: Treatment-experienced patients with genotype 1, 4, 5 and 6 HCV infection
Danish: Behandlingserfarne patienter med HCV-genotype 1, 4, 5 og 6-infektion
English: Co-administration of such medicinal products is not recommended with Sovaldi (see section 4.5).
Danish: Samtidig administration af sådanne lægemidler og Sovaldi anbefales ikke (se pkt.
English: Table 18: SVR12 rates for selected subgroups by genotype in study PHOTON-1
Danish: Tabel 18: SVR12-rater for udvalgte undergrupper efter genotype i PHOTON-1-studiet
English: - a wide-spread severe rash with peeling skin which may be accompanied by fever, flu-like symptoms, blisters in the mouth, eyes, and/or genitals (Stevens-Johnson syndrome).
Danish: influenzalignende symptomer, blærer i munden, øjnene og/eller på kønsorganerne
English: • stomach discomfort, constipation, dry mouth, indigestion, acid reflux
Danish: • mavebesvær, forstoppelse, mundtørhed, fordøjelsesbesvær, sure opstød
English: Medicinal products that are strong P-gp inducers in the intestine (carbamazepine, phenobarbital, phenytoin, rifampicin and St. John's wort) 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 stærke P-gp-inducere i tarmen (carbamazepin, phenobarbital, phenytoin, rifampicin og perikon), kan nedsætte plasmakoncentrationen af sofosbuvir signifikant og medføre reduceret terapeutisk virkning af Sovaldi.
English: Table 12: SVR12 rates for selected subgroups by genotype in POSITRON
Danish: Tabel 12: SVR12-rater for udvalgte undergrupper efter genotype i POSITRON
English: Common abdominal discomfort, constipation, dyspepsia constipation, dry mouth, gastroesophageal reflux
Danish: Almindelig mavebesvær, forstoppelse, dyspepsi forstoppelse, mundtørhed, mave-tarm refluks
English: Genotype Genotype 1
Danish: Genotype 1
English: Sovaldi is contraindicated with carbamazepine (see section 4.3).
Danish: Sovaldi er kontraindiceret sammen med carbamazepin (se pkt.
English: Common weight decreased
Danish: Nedsat leverfunktion
English: The safety profile of sofosbuvir and ribavirin in HCV/HIV co-infected adult patients was similar to that observed in mono-infected HCV patients treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Danish: Sikkerhedsprofilen for sofosbuvir og ribavirin hos voksne patienter med samtidige HCV/hiv-infektioner var sammenlignelig med den observerede sikkerhedsprofil hos monoinficerede patienter med HCV, der blev behandlet med sofosbuvir og ribavirin i kliniske fase III-studier (se pkt.
English: Otherc a. The efficacy analysis includes 6 patients with recombinant genotype 2/1 HCV infection.
Danish: Andetc a. Virkningsanalysen omfatter 6 patienter med rekombinant genotype 2/1 HCV-infektion.
English: Co-administration of Sovaldi with oxcarbazepine is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of Sovaldi.
Danish: Administration af Sovaldi sammen med oxcarbazepin forventes at nedsætte koncentrationen af sofosbuvir og føre til en nedsat terapeutisk virkning af Sovaldi.
English: (eGFR ≥30
Danish: ≥ 30 og
English: Co-administration of Sovaldi with rifapentine is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of Sovaldi.
Danish: Administration af Sovaldi sammen med rifapentin forventes at nedsætte koncentrationen af sofosbuvir og føre til en nedsat terapeutisk virkning af Sovaldi.
English: Common arthralgia, back pain, muscle spasms, myalgia back pain, muscle spasms
Danish: Almindelig artralgi, rygsmerter, muskelspasmer, myalgi rygsmerter, muskelspasmer
English: Table 14: SVR12 rates for selected subgroups by genotype in study FUSION
Danish: Tabel 14: SVR12-rater for udvalgte undergrupper efter genotype i FUSION-studiet