FrancophonIA/ELRC3.0 huggingface dataset:
English: HCV subtype
Danish: HCVundertype
English: Maviret 100 mg/40 mg film-coated tablets glecaprevir/pibrentasvir
Danish: Maviret 100 mg/40 mg filmovertrukne tabletter glecaprevir/pibrentasvir
English: Genotype 3: For subjects who received the recommended regimen (n=309), baseline polymorphisms in NS5A (Y93H included) or NS3 did not have a relevant impact on treatment outcomes.
Danish: Genotype 3: For så vidt angår de forsøgspersoner, der fik det anbefalede regime (n = 309), havde polymorfismer i NS5A (inkl.
English: All of the genotype 1-infected virologic failure subjects had one or more NS5A substitutions L/M28M/T/V, Q30E/G/H/K/L/R, L31M, P32 deletion, H58C/D, or Y93H at baseline, with additional treatment-emergent NS5A substitutions M28A/G, P29Q/R, Q30K, H58D, or Y93H observed in 7 of the subjects at the time of failure.
Danish: Hos alle de forsøgspersoner, der havde genotype 1-infektion, og som oplevede virologisk svigt, sås en eller flere af NS5A-substitutionerne L/M28M/T/V, Q30E/G/H/K/L/R, L31M, P32-deletion, H58C/D eller Y93H ved baseline, idet der hos 7 af forsøgspersonerne yderligere sås behandlingsrelateret NS5A-substitution M28A/G, P29Q/R, Q30K, H58D eller Y93H på tidspunktet for behandlingssvigt.
English: Clinical Study in Renally Impaired Subjects
Danish: Klinisk studie hos forsøgspersoner med nedsat nyrefunktion
English: ↑ simvastatin acid
Danish: ↑ simvastatin ↑ simvastatinsyre
English: Simvastatin 5 mg once daily
Danish: Simvastatin 5 mg én gang dagligt
English: 300/100 mg once dailyb
Danish: 300/100 mg én gang dagligtb
English: Rifampicin 600 mg once dailya
Danish: Rifampicin 600 mg én gang dagligta
English: Maviret 100 mg/40 mg tablets glecaprevir/pibrentasvir
Danish: Maviret 100 mg/40 mg, tabletter glecaprevir/pibrentasvir
English: In TN subjects without cirrhosis who received the recommended duration of 8 weeks, 97.5% (749/768) achieved SVR12, while 0.1% (1/768) experienced on-treatment virologic failure and 0.7% (5/755) experienced post-treatment relapse.
Danish: I TN-forsøgspersoner uden cirrose, som fik behandling af den anbefalede varighed på 8 uger, opnåede 97,5% (749/768) SVR12, mens 0,1% (1/768) oplevede virologisk svigt under behandling og 0,7% (5/755) oplevede recidiv efter behandling.
English: The overall SVR12 rates were 97.2% (352/362) and 99.4% (159/160) in VOYAGE-1 and VOYAGE-2, respectively.
Danish: De samlede SVR12-rater i VOYAGE-1 og VOYAGE-2 var henholdsvis 97,2% (352/362) og 99,4%
English: Among the 10 genotype 1-infected subjects with virologic failure, treatment-emergent NS3 substitutions V36A/M, R155K/T, A156G/T/V, or D168A/T were observed in 7 subjects.
Danish: Hos 7 af de 10 forsøgspersoner med genotype 1-infektion, der oplevede virologisk svigt, sås behandlingsrelateret NS3-substitution V36A/M, R155K/T, A156G/T/V eller D168A/T.
English: ↑ EE ↑ norgestrel norethidrone or norgestimate as contraceptive progestagen.
Danish: Dosisjustering er ikke nødvendigt ved brug af levonorgestrel, norethidron eller norgestimat som progestagenprævention.
English: GT 1, 2, 4, 5, 6 8 weeks
Danish: GT 1, 2, 4, 5, 6
English: • If you notice within 18 hours of the time you usually take Maviret take the dose as soon as possible.
Danish: • Hvis der er gået mindre end 18 timer, siden du skulle have taget din dosis Maviret, skal du tage den så hurtigt som muligt.
English: Each film-coated tablet contains 100 mg glecaprevir and 40 mg pibrentasvir.
Danish: Hver filmovertrukket tablet indeholder 100 mg glecaprevir og 40 mg pibrentasvir.
English: SVR Outcome for subjects without SVR12 On-treatment VF Relapsea Otherb SVR by cirrhosis status No Cirrhosis
Danish: SVR Resultat for patienter uden SVR12 Virologisk svigt under behandling Recidiva Andetb SVR ud fra cirrosestatus Ingen cirrose
English: (P-gp, BCRP, and OATP inhibition by cobicistat, OATP inhibition by elvitegravir)
Danish: (Cobicistats hæmning af P-gp, BCRP og OATP; elvitegravirs hæmning af OATP)
English: e. GT1, 4 from MAGELLAN-1 Part 1 - Maviret for 12 weeks (n=22); GT1, 4 from MAGELLAN-1 Part 2Maviret for 12 weeks (n=44) or 16 weeks (n=47).
Danish: e. GT1, 4 fra MAGELLAN-1 del 1 - Maviret i 12 uger (n = 22); GT1,4 fra MAGELLAN-1, del 2 - Maviret i 12 uger (n = 44) eller 16 uger (n = 47).
English: A low dose of the statin is recommended at the initiation of the DAA treatment.
Danish: En lav dosis af statiner anbefales ved påbegyndelse af behandling med direkte virkende antivirale lægemidler.
English: The type and severity of adverse reactions in subjects with cirrhosis were overall comparable to those seen in subjects without cirrhosis.
Danish: Bivirkningerne var overordnet set af samme art og sværhedsgrad hos forsøgspersoner med cirrose som hos forsøgspersoner uden cirrose.
English: At the clinical dose, compared to non-HCV infected subjects with normal hepatic function, glecaprevir AUC was 33% higher in Child-Pugh A subjects, 100% higher in Child-Pugh B subjects, and increased to 11-fold in Child-Pugh C subjects.
Danish: Ved den kliniske dosis var AUC for glecaprevir 33 % højere hos forsøgspersoner med Child-Pugh A, 100 % højere hos forsøgspersoner med Child-Pugh B og 11 gange højere hos forsøgspersoner med Child-Pugh C sammenholdt med ikke-HCV-smittede forsøgspersoner med normal leverfunktion.
English: Clinical studies in treatment-naïve or treatment-experienced subjects with or without cirrhosis Of the 2,409 subjects with compensated liver disease (with or without cirrhosis) treated who were treatment-naïve or treatment-experienced to combinations of peginterferon, ribavirin and/or sofosbuvir, the median age was 53 years (range: 19 to 88); 73.3% were treatment-naïve, 26.7% were treatment-experienced to a combination containing either sofosbuvir, ribavirin and/or peginterferon; 40.3% were HCV genotype 1; 19.8% were HCV genotype 2; 27.8% were HCV genotype 3; 8.1% were HCV genotype 4; 3.4% were HCV genotype 5-6; 13.1% were ≥65 years; 56.6% were male; 6.2% were Black; 12.3% had cirrhosis; 4.3% had severe renal impairment or end stage renal disease; 20.0% had a body mass index of at least 30 kg per m2; 7.7% had HIV-1 coinfection and the median baseline HCV RNA level was 6.2 log10 IU/mL
Danish: Hos de 2.409 behandlede forsøgspersoner, der havde kompenseret leversygdom (med eller uden cirrose), og som var behandlingsnaive eller behandlingserfarne, hvad angår kombinationer af peginterferon, ribavirin og/eller sofosbuvir, var den mediane alder 53 år (interval: 19-88); 73,3 % var behandlingsnaive, 26,7 % var behandlingserfarne, hvad angår en kombination indeholdende enten sofosbuvir, ribavirin og/eller peginterferon; 40,3 % havde HCV genotype 1; 19,8 % havde HCV genotype 2; 27,8 % havde HCV genotype 3; 8,1 % havde HCV genotype 4; 3,4 % havde HCV genotype 5-6; 13,1 % var ≥ 65 år; 56,6 % var mænd; 6,2 % var sorte; 12,3 % havde cirrose; 4,3 % havde svært nedsat nyrefunktion eller terminal nyresygdom; 20,0 % havde et BMI på mindst 30 kg pr. m2; 7,7 % var HIV-1 smittede og det mediane HCV-RNA-niveau ved baseline var 6,2 log10 IE/ml.
English: Pack containing 84 (4 x 21) film-coated tablets.
Danish: Pakning med 84 filmovertrukne tabletter (4 x 21 tabletter).
English: In patients with chronic hepatitis C infection without cirrhosis, following 3 days of monotherapy with either glecaprevir 300 mg per day (N=6) or pibrentasvir 120 mg per day (N=8) alone, geometric mean AUC24 values were 13600 ng∙h/mL for glecaprevir and 459 ng∙h/mL for pibrentasvir.
Danish: Hos patienter med kronisk hepatitis C-infektion uden cirrose var de geometriske gennemsnitlige AUC24-værdier 13.600 ng∙time/ml for glecaprevir og 459 ng∙time/ml for pibrentasvir efter 3 dages enkelstofsbehandling med enten glecaprevir 300 mg pr. dag (N = 6) eller pibrentasvir 120 mg pr. dag (N = 8).
English: Patients who failed a prior regimen containing an NS5A- and/or an NS3/4A-inhibitor
Danish: Patienter, der har oplevet svigt af en tidligere behandling med en NS5A- og/eller en NS3/4A-hæmmer
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V.
English: Of the 280 subjects treated, the median age was 60 years (range: 34 to 88); 81.8% had HCV genotype 1, 10% had HCV genotype 2, 4.6% had HCV genotype 4, 0.4% had HCV genotype 5; 3.2% had HCV genotype 6; 60% were male; 9.6% were Black.
Danish: Medianalderen for de 280 behandlede forsøgspersoner var 60 år (interval: 34 til 88); 81,8% havde HCV genotype 1; 10% havde HCV genotype 2; 4,6% havde HCV genotype 4; 0,4% havde HCV genotype 5; 3,2% havde HCV genotype 6; 60% var mænd; 9,6% var sorte.
English: (Inhibition of OATP1B1/3, P-gp, BCRP, CYP3A)
Danish: (Hæmning af OATP1B1/3, P-gp, BCRP, CYP3A)
English: Serum HCV RNA values were measured during the clinical studies using the Roche COBAS AmpliPrep/COBAS Taqman HCV test (version 2.0) with a lower limit of quantification (LLOQ) of
Danish: Serumværdierne af HCV-RNA blev målt i de kliniske studier ved brug af HCV-testen Roche COBAS AmpliPrep/COBAS Taqman (version 2.0) med en nedre kvantificeringsgrænse (LLOQ) på 15 IE/ml (undtagen for SURVEYOR-1 og SURVEYOR-2, der anvendte RT-PCR-analysen (Roche COBAS TaqMan real-time reverse transcriptase-PCR) v. 2.0 med en LLOQ på 25 IE/ml).
English: No dose adjustment of Maviret is required in adolescents aged 12 to <18 years (see sections 5.1 and 5.2).
Danish: Dosisjustering af Maviret er ikke nødvendig hos unge fra 12 til <18 år (se pkt.
English: Recommended treatment duration No cirrhosis
Danish: Anbefalet behandlingsvarighed Uden cirrose Med cirrose
English: Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir.
Danish: Hver tablet indeholder 100 mg glecaprevir og 40 mg pibrentasvir.
English: In TN or TE-PRS subjects with compensated cirrhosis who received the recommended duration, 97.0% (288/297) achieved SVR12 (among which 98.0% [192/196] of TN subjects achieved SVR12), while 0.7% (2/297) experienced on-treatment virologic failure and 1.0% (3/289) experienced posttreatment relapse.
Danish: I TN eller TE-PRS forsøgspersoner med kompenseret cirrose, som fik behandling af den anbefalede varighed, opnåede 97,0% (288/297) SVR12 (heraf opnåede 98,0% [192/196] af TN-patienter SVR12), mens 0,7% (2/297) oplevede virologisk svigt af behandling, og 1,0% (3/289) oplevede recidiv efter behandling.
English: Of the 84 subjects treated, the median age was 59 years (range 24-79); 27% had HCV genotype 5, 73% had HCV genotype 6; 54% were female, 30% were White, 68% were Asian; 90% were HCV TN; 11% had compensated cirrhosis.
Danish: Hos 84 af de behandlede forsøgspersoner var medianalderen 59 år (interval: 24-79); 27% havde HCV-genotype 5, 73% havde HCV-genotype 6; 54% var kvinder, 30% var hvide, 68% var asiater; 90% var HCV BN og 11% havde kompenseret cirrose.
English: The median age was 14 years (range: 12 to 17); 79% had HCV genotype 1, 6% had HCV genotype 2, 9% had HCV genotype 3, 6% had HCV genotype 4; 55% were female; 11% were Black; 77% were HCV treatment-naïve; 23% were treatment-experienced to interferon; 4% had HIV-coinfection; none had cirrhosis; the mean weight was 59 kg (range: 32 to 109 kg).
Danish: Medianalderen var 14 år (interval: 12 år til 17 år); 79% havde HCV-genotype 1, 6% havde HCV-genotype 2, 9% havde HCV-genotype 3, 6% havde HCV-genotype 4; 55% var kvinder; 11% var sorte; 77% var HCV-behandlingsnaive; 23% var interferon behandlingserfarne; 4% havde samtidig HIV-infektion; ingen havde cirrose; den gennemsnitlige vægt var 59 kg (interval: 32 kg til 109 kg).
English: Genotype (GT) Clinical study Summary of study design TN and PRS-TE subjects without cirrhosis
Danish: Klinisk forsøg Oversigt over forsøgsdesign Behandlingsnaive (BN) og PRS-behandlingserfarne (BE) forsøgspersoner uden cirrose GT1
English: Co-administration of Maviret with ethinyloestradiolcontaining products is contraindicated due to the risk of ALT elevations (see section 4.3).
Danish: ↑ norgestrel holdige lægemidler er kontraindiceret pga. risikoen for forhøjet ALAT (se pkt.
English: In TE-PRS subjects without cirrhosis who received the recommended duration, 98.2% (215/219) achieved SVR12, while 0.5% (1/219) experienced on-treatment virologic failure and 1.4% (3/218) experienced post-treatment relapse.
Danish: I TE-PRS forsøgspersoner uden cirrose, som fik behandling af den anbefalede varighed, opnåede 98,2% (215/219) SVR12, mens 0,5% (1/219) oplevede virologisk svigt ved behandling, og 1,4% (3/218) oplevede recidiv efter behandling.
English: ENDURANCE-1a Maviret for 8 weeks (n=351) or 12 weeks (n=352) SURVEYOR-1 Maviret for 8 weeks (n=34)
Danish: Maviret i 8 uger (n = 351) eller 12 uger (n = 352) SURVEYOR-1 Maviret i 8 uger (n = 34)
English: Subjects with Genotype 1, 2, 4, 5, or 6 Infection with Cirrhosis who received 8 weeks of Maviret The safety and efficacy of Maviret given for 8 weeks in GT 1, 2, 4, 5 or 6 treatment naïve subjects with compensated cirrhosis was evaluated in a single-arm, open-label study (EXPEDITION-8).
Danish: Sikkerheden og virkningen af Maviret givet i 8 uger til GT 1, 2, 4, 5 eller 6 behandlingsnaive personer med kompenseret cirrose blev evalueret i et enkelt-arms åbent studie (EXPEDITION-8).
English: Baseline polymorphisms in NS3 were detected in 1.1% (9/845), 0.8% (3/398), 1.6% (10/613), 1.2% (2/164), 41.9% (13/31), and 2.9% (1/34) of subjects with HCV genotype 1, 2, 3, 4, 5, and 6 infection, respectively.
Danish: Polymorfismer i NS3 ved baseline blev detekteret hos 1,1 % af genotype 1patienterne (9/845), 0,8 % af genotype 2-patienterne (3/398), 1,6 % af genotype 3-patienterne (10/613), 1,2 % af genotype 4-patienterne (2/164), 41,9 % af genotype 5-patienterne (13/31) og 2,9 % af genotype 6-patienterne (1/34).
English: Elderly No dose adjustment of Maviret is required in elderly patients (see sections 5.1 and 5.2).
Danish: Ældre Det er ikke nødvendigt at justere dosis hos ældre patienter (se pkt.
English: Belgique/Belgien Tél/Tel: +32 10 477811
Danish: Tél/Tel: +32 10 477811
English: Baseline polymorphisms in NS5A were detected in 26.8% (225/841), 79.8% (331/415), 22.1% (136/615), 49.7% (80/161), 12.9% (4/31), and 54.1% (20/37) of subjects with HCV genotype 1, 2, 3, 4, 5, and 6 infection, respectively.
Danish: Polymorfismer i NS5A ved baseline blev detekteret hos 26,8 % af genotype 1-patienterne (225/841), 79,8 % af genotype 2-patienterne (331/415), 22,1 % af genotype 3patienterne (136/615), 49,7 % af genotype 4-patienterne (80/161), 12,9 % af genotype 5-patienterne (4/31) og 54,1 % af genotype 6-patienterne (20/37).
English: Maviret for 12 weeks (TN only, n=64) or 16 weeks (TE only, n=51)
Danish: SURVEYOR-2d Maviret i 12 uger (kun BN, n = 64) eller 16 uger (kun BE, n = 51)
English: b. GT2 from SURVEYOR-2 Parts 1 and 2 - Maviret for 8 weeks (n=54) or 12 weeks (n=25); GT2 from SURVEYOR-2 Part 4 - Maviret for 8 weeks (n=145).
Danish: b. GT2 fra SURVEYOR-2 del 1 og 2 - Maviret i 8 uger (n = 54) eller 12 uger (n = 25); GT2 fra SURVEYOR-2 del 4 - Maviret i 8 uger (n = 145).
English: Of the 101 subjects treated, the median age was 58 years (range 32-87); 53% had HCV genotype 1; 27% had HCV genotype 2; 15% had HCV genotype 3; 4% had HCV genotype 4; 59% were male; 73% were White; 80% were HCV treatment-naïve; 13% had cirrhosis and 65% had a baseline fibrosis state of F0 or F1; 7% were CKD stage 3b; 17% were CKD Stage 4, and 76% were CKD Stage 5 (all receiving dialysis); 84 subjects received 8 weeks of treatment, 13 subjects received 12 weeks of treatment, and 4 subjects received 16 weeks of treatment.
Danish: Af de 101 behandlede personer var medianalderen 58 år (interval 32-87); 53% havde HCV genotype 1; 27% havde HCV genotype 2; 15% havde HCV genotype 3; 4% havde HCV genotype 4; 59% var mænd; 73% var hvide; 80% var HCV-behandlings-naive; 13% havde cirrose og 65% havde en baseline fibrose tilstand på F0 eller F1; 7% var CKD stadium 3b; 17% var CKD stadium 4, og 76% var CKD-stadium 5 (alle modtog dialyse); 84 forsøgspersoner modtog 8 ugers behandling, 13 forsøgspersoner modtog 12 ugers behandling, og 4 forsøgspersoner modtog 16 ugers behandling.
English: ↑ lovastatin acid
Danish: ↑ lovastatinsyre
English: 50 mg single dose
Danish: 50 mg enkeltdosis
English: ENDURANCE-2 Maviret (n=202) or Placebo (n=100) for 12 weeks SURVEYOR-2b
Danish: ENDURANCE-2 Maviret (n = 202) eller placebo (n = 100) i 12 uger SURVEYOR-2b Maviret i 8 uger (n = 199) eller 12 uger (n = 25)
English: (Inhibition of OATP1B1/3, P-gp, BCRP)
Danish: (Hæmning af OATP1B1/3, P-gp, BCRP)
English: 10 mg once daily
Danish: 10 mg én gang dagligt
English: Lovastatin 10 mg once daily
Danish: Lovastatin 10 mg én gang dagligt
English: • If you notice 18 hours or more after the time you usually take Maviret, wait and take the next dose at your usual time.
Danish: • Hvis der er gået 18 timer eller derover, siden du skulle have taget din dosis Maviret, skal du vente med at tage en dosis til det næste planlagte tidspunkt.
English: Studies in subjects with or without compensated cirrhosis who were treatment-experienced to NS3/4A protease and/or NS5A inhibitors
Danish: Studier med NS3/4A-proteasehæmmer- og/eller NS5A-hæmmer-erfarne forsøgspersoner med eller uden kompenseret cirrose
English: Patients with severe hepatic impairment (Child-Pugh C) (see sections 4.2, 4.4, and 5.2).
Danish: Patienter med svært nedsat leverfunktion (Child-Pugh C) (se pkt.
English: • headache
Danish: • Hovedpine
English: Adverse reactions observed in greater than or equal to 5% of subjects receiving Maviret for 12 weeks were headache (17%), fatigue (16%), nausea (8%) and pruritus (7%).
Danish: Bivirkninger som hovedpine (17%), træthed (16%), kvalme (8%) og kløe (7%) blev set hos 5% eller flere af patienterne, der fik Maviret i 12 uger.
English: NA
Danish: IT
English: d. GT3 with cirrhosis from SURVEYOR-2 Part 2 - Maviret for 12 weeks (n=24) or 16 weeks (n=4); GT3 with cirrhosis from SURVEYOR-2 Part 3 - Maviret for 12 weeks (n=40) or 16 weeks (n=47).
Danish: d. GT3 med cirrose fra SURVEYOR-2 del 2 - Maviret i 12 uger (n = 24) eller 16 uger (n = 4); GT3 med cirrose fra SURVEYOR-2 del 3 - Maviret i 12 uger (n = 40) eller 16 uger (n = 47).
English: 100 mg single dose
Danish: 100 mg enkeltdosis
English: ↔ glecaprevir ↔ pibrentasvir tacrolimus exposure is expected.
Danish: Øget eksponering for tacrolimus forventes.
English: c. GT3 without cirrhosis from SURVEYOR-2 Parts 1 and 2 - Maviret for 8 weeks (n=29) or 12 weeks (n=54); GT3 without cirrhosis from SURVEYOR-2 Part 3 - Maviret for 12 weeks (n=22) or 16 weeks (n=22).
Danish: c. GT3 uden cirrose fra SURVEYOR-2 del 1 og 2 - Maviret i 8 uger (n = 29) eller 12 uger (n = 54); GT3 uden cirrose fra SURVEYOR-2 del 3 - Maviret i 12 uger (n = 22) eller 16 uger (n = 22).
English: (Inhibition of OATP1B1/3, BCRP)
Danish: (Hæmning af OATP1B1/3, BCRP)
English: If vomiting occurs within 3 hours of dosing, an additional dose of Maviret should be taken.
Danish: Ved opkastning mindre end 3 timer efter indtagelse af Maviret bør der straks tages en ekstra dosis.
English: Other medicines and Maviret
Danish: Brug af anden medicin sammen med Maviret
English: Pravastatin 10 mg once daily
Danish: Pravastatin 10 mg én gang dagligt
English: (P-gp/BCRP inhibition)
Danish: (Hæmning af P-gp/BCRP)
English: The recommended dose for adults and adolescents (12 to <18 years old) is three tablets of Maviret 100mg/40mg taken together, once a day.
Danish: Den anbefalede dosis er tre tabletter Maviret 100 mg/40 mg samtidigt én gang dagligt for voksne og unge (fra 12 til <18 år).
English: Accumulating double class resistance was a general finding for patients who failed re-treatment with glecaprevir/pibrentasvir in MAGELLAN-1.
Danish: Et almindeligt fund hos patienter, der oplevede behandlingssvigt ved fornyet behandling med glecaprevir/pibrentasvir i MAGELLAN-1, var akkumulerende dobbeltklasse-resistens.
English: 16 weeks (GT3 TE only) (n=3)
Danish: (GT3 kun BE) (n=3)
English: ENDURANCE-4 Maviret for 12 weeks (n=121) ENDURANCE-5,6 Maviret for 8 weeks (n=75) SURVEYOR-1 Maviret for 12 weeks (n=32) SURVEYOR-2c
Danish: Maviret i 8 uger (n=75) SURVEYOR-1 Maviret i 12 uger (n = 32) SURVEYOR-2c Maviret i 8 uger (n = 58)
English: Relapsec
Danish: Træthed
English: Hepatic impairment
Danish: Diarré, kvalme
English: VF=virologic failure a. Percent of subjects with prior treatment experience to PRS is 26%, 14%, 24%, 0%, and 13% for genotypes 1, 2, 4, 5, and 6, respectively.
Danish: SVR12 hos forsøgspersoner uden cirrose 8 uger Resultat for patienter uden SVR12 Virologisk svigt under behandling Recidivc Andetd SVR12 hos forsøgspersoner med cirrose 12 uger 8 uger Resultat for patienter uden SVR12 Virologisk svigt under behandling Recidivc Andetd a. Andelen af forsøgspersoner med PRS-erfaring er hhv. 26 %, 14 %, 24 %, 0 % og 13 % for genotype 1, 2, 4, 5 og 6.
English: Co-administration is not recommended with several medicinal products as detailed in section 4.5.
Danish: Samtidig administration med en række andre lægemidler frarådes; se pkt.
English: Method of administration
Danish: Virkningsmekanisme
English: • feeling very tired (fatigue)
Danish: • Usædvanlig træthed
English: Maviret for 8 weeks (n=199) or 12 weeks (n=25)
Danish: EXPEDITION-2 Maviret i 8 uger (n=137) eller 12 uger (n=16)
English: Transport
Danish: Administration
English: Efavirenz/emtricitab ine/tenofovir disoproxil fumarate 600/200/300 mg once daily
Danish: Efavirenz/ emtricitabin/ tenofovirdisoproxilfumarat
English: Close monitoring of INR is recommended with all vitamin K antagonists.
Danish: INR anbefales for alle vitamin Kantagonister pga. leverfunktionsændringer under behandling med
English: What Maviret is and what it is used for 2.
Danish: Virkning og anvendelse 2.
English: ENDURANCE-5,6 Maviret for 12 weeks (n=9)
Danish: ENDURANCE-4 Maviret i 12 uger (n = 121) ENDURANCE
English: Film coating
Danish: Filmovertræk:
English: What Maviret looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: For dosing recommendations with HIV antiviral agents, refer to section 4.5.
Danish: For så vidt angår doseringsanbefalinger med HIVantivirale stoffer, se pkt.
English: HCV Subtype
Danish: Forsøgspersoner med HCV genotype 3
English: However, in some cases this does not happen.
Danish: I visse tilfælde forekommer dette ikke.
English: • Risk Management Plan (RMP) Not applicable.
Danish: • Risikostyringsplan (RMP) Ikke relevant.
English: All patients recovered with conventional treatment.
Danish: Alle patienter kom sig med konventionel behandling.
English: * see below
Danish: * se nedenfor
English: Date of first authorisation: 29 July 2004 Date of renewal: 29 July 2009
Danish: Dato for første tilladelse: 29. juli 2004 Dato for seneste fornyelse af tilladelsen: 29. juli 2009
English: These are detailed below:
Danish: Disse er angivet nedenfor:
English: The following information is intended for medical or healthcare professionals only:
Danish: Følgende oplysninger er tiltænkt læger og sundhedspersonale:
English: PK-PD relationship
Danish: PK-PD relation
English: Not relevant
Danish: Ikke relevant
English: This can cause heart problems in your baby.
Danish: Dette kan medføre hjerteproblemer hos Deres barn.
English: EXP From a microbiological point of view, the product should be used immediately
Danish: EXP Fra et mikrobiologisk synspunkt bør produktet anvendes med det samme.
English: The expiry date refers to the last day of that month.
Danish: Udløbsdatoen EXP er den sidste dag i den nævnte måned.
English: To facilitate the administration an infusion pump may be used.
Danish: For at lette administrationen kan der anvendes en infusionspumpe.
English: This leaflet was last approved in
Danish: Denne indlægsseddel blev sidst godkendt den
English: The central volume of distribution may depend on the status of the ductus and decrease as the ductus closes.
Danish: Det centrale fordelingsvolumen kan afhænge af status for ductus og falder, efterhånden som ductus lukker.
English: The apparent volume of distribution is on average 200 ml/kg (62 to 350 according to various studies).
Danish: Det tilsyneladende fordelingsvolumen er gennemsnitligt 200 ml/kg (62 til 350 ifølge forskellige undersøgelser).