natgillin/translations-raw huggingface dataset:
Som en konservativ forholdsregel set i lyset af de begrænsede data hos behandlingserfarne patientertidlige respondenter - anbefales det at forlænge den samlede behandlingsvarighed til 48 uger sammenlignet med den undersøgte varighed på 36 ugers samlet behandlingsvarighed (undersøgt RGT) med en konsolideringsfase med peginterferon ribavirin på 12 uger efter afslutningen af trestofbehandlingen i uge 36. 
As a conservative measure in view of limitations of the data, in treatment experienced patients early responders, the total treatment duration is recommended to be prolonged to 48 weeks as compared to the tested 36 weeks total treatment duration (tested RGT), with a 12 weeks of peginterferon ribavirin consolidation phase after the end of the tritherapy at week 36.
Hvis andre hcv-RNA-værdier var tilgængelige efter FW 24, blev den sidst tilgængelige værdi i perioden efter FW 24 anvendt. 
If other HCV-RNA values were available after FW 24, the last available value in the period after FW 24 was used.
Behandlingsvarighed ved anvendelse af Response Guided Therapy (RGT)-retningslinjer hos patienter uden cirrose, der ikke tidligere er blevet behandlet eller med tidligere svigt af behandling med interferon og ribavirin 
Table 1 Duration of therapy using Response-Guided Therapy (RGT) guidelines in patients without cirrhosis who are previously untreated or who have failed previous therapy to interferon and ribavirin therapy
Der er set alvorlige, akutte overfølsomhedsreaktioner (f.eks. urticaria, angioødem) ved kombinationsbehandling med Victrelis, peginterferon alfa og ribavarin. 
Serious, acute hypersensitivity reactions (e.g., urticaria, angioedema) have been observed during combination therapy with Victrelis, peginterferon alfa, and ribavirin.
Kombineret brug med peginterferon alfa-2a, se specifikt afsnit under pkt. 
Combined use with peginterferon alfa-2a see specific section in section 4.4.
Ubrugt lægemiddel eller affald fra dette skal bortskaffes i overenstemmelse med lokale krav. 
Any unused product or waste material should be disposed of in accordance with local requirements.
Derfor skal kvindelige fertile patienter anvende effektiv antikonception under behandlingen og i fire måneder efter ophørt behandling. 
Therefore, female patients of childbearing potential must use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
• hvis du glemmer en dosis, og der er mere end 2 timer til du skal tage din næste dosis, tages den glemte dosis sammen med mad. 
• If you forget a dose and it is more than 2 hours before your next dose is due, take the missed dose with food.
Boceprevir/metabolitter udskilles i rottemælk (se pkt. 
Boceprevir/metabolites are excreted in rat milk (see section 5.3).
* Fuldt analysesæt (Full Analysis Set) bestod af alle forsøgspersoner, der blev anæmiske (serumhæmoglobin ≤ ca. 6,2 mmol/l (≤ 10 g/dl) i behandlingsperioden), og som blev randomiseret til enten reduktion af ribavirindosis eller erythropoietin (N=500). 
* The Full Analysis Set (FAS) consisted of all subjects who became anaemic (serum haemoglobin of approximately ≤10 g/dL within the treatment period) and were randomized to using either ribavirin dose reduction or erythropoietin (N=500).
Plasmakoncentration af Victrelis blev reduceret ved samtidig administration af efavirenz. 
Plasma trough concentrations of Victrelis were decreased when administered with efavirenz.
Forsøgspersoner, der deltog i PROVIDE inden for 2 uger efter den sidste dosis PR i primærstudiet fik Victrelis 800 mg tre gange dagligt + PR i 44 uger. 
Subjects who enrolled in PROVIDE within 2 weeks after the last dose of PR in the parent study received Victrelis 800 mg three times daily + PR for 44 weeks.
Interferon-følsomhed (defineret som ≥ 1 log10 fald i viral-load i behandlingsuge 4) var prædiktiv for SVR. 
Interferon-responsiveness (as defined by ≥ 1-log10 decline in viral load at TW 4) was predictive of SVR.
Tilføjelsen af Victrelis til den aktuelle standardbehandling (peginterferon alfa og ribavirin) øgede i begge studier det vedvarende virologiske respons (SVR) i betydelig grad sammenlignet med den aktuelle standardbehandling. 
In both studies, the addition of Victrelis to the current standard of care (peginterferon alfa and ribavirin) significantly increased sustained virologic response (SVR) rates compared to the current standard of care alone.
Der er ikke foretaget studier af boceprevir hos patienter med dekompenseret cirrose (se pkt. 
Boceprevir has not been studied in patients with decompensated cirrhosis (see section 5.2).
57 % (208/368) af forsøgspersonerne i Victrelis-RGT-armen og 56 % (204/366) af forsøgspersonerne i Victrelis-PR48-armen havde ikke-detekterbart hcv-RNA i behandlingsuge 8 sammenlignet med 17 % (60/363) af forsøgspersonerne i PR-armen. 
Fifty-seven percent (208/368) of subjects in the Victrelis-RGT arm and 56% (204/366) of subjects in the Victrelis-PR48 arm had undetectable HCV-RNA at TW 8 compared with 17% (60/363) of
Hvis patienten har bekræftet, detekterbart hcv-RNA i behandlingsuge 24, afsluttes trestofbehandlingen. 
If the patient has confirmed, detectable HCV-RNA at TW 24; then discontinue three-medicine
I en poolet analyse af forsøgspersoner, der ikke var tidligere behandlet, og forsøgspersoner hvor tidligere behandling havde svigtet, og som fik fire ugers peginterferon alfa-2b og ribavirin efterfulgt af boceprevir 800 mg tre gange dagligt, i kombination med peginterferon alfa-2b og ribavirin, i to fase III-studier, blev post-baseline RAVer påvist hos 15 % af samtlige forsøgspersoner. 
In a pooled analysis of subjects who were previously untreated and subjects who have failed previous therapy who received four weeks of peginterferon alfa-2b and ribavirin followed by boceprevir 800 mg three times daily in combination with peginterferon alfa-2b and ribavirin in two Phase III studies, post-baseline RAVs were detected in 15% of all subjects.
De hyppigst rapporterede bivirkninger var træthed, anæmi (se pkt. 
The most frequently reported adverse reactions were fatigue, anaemia (see section 4.4), nausea,
Racefordelingen blandt forsøgspersonerne var: 77 % hvide, 19 % sorte og 4 % andre. 
The race distribution of subjects was as follows: 77% White, 19% Black, and 4% others.
Studiet omfattede 5 forsøgspersoner med cirrose 
The study included 5 subjects with cirrhosis and 4 were in the
Hos boceprevirbehandlede forsøgspersoner, der ikke opnåede vedvarende virologisk respons (SVR), og hvis prøver blev analyseret, blev post-baseline RAVer påvist hos 53 %. 
In boceprevir-treated subjects who did not attain sustained virologic response (SVR) for whom samples were analysed, 53% had post
Blandt patienter med ringe interferonrespons over for peginterferon alfa-2b/ribavirin i lead-in perioden på 4 uger forekom boceprevirs virkning dog at være reduceret for de, der ved baseline fik påvist varianterne V36M, T54S, V55A eller R155K. 
However, among poorly interferon-responsive patients to peginterferon alfa-2b/ribavirin during the 4-week lead-in period, the efficacy of boceprevir appeared to be reduced for those who had variants V36M, T54S, V55A or R155K detected at baseline.
Farmakokinetiske resultater var de samme hos raske forsøgspersoner som hos hcv 
Pharmacokinetic results were similar between healthy subjects and HCV-infected subjects.
SVR-rater (med “manglende=svigt”-metoden) var 17/80 [21,3 %] for PR48, 94/162 [58,0 %] for Victrelis-RGT, 106/161 [65,8 %] for Victrelis-PR48. 
SVR rates with “missing=failure” approach were 17/80 [21.3%] for PR48, 94/162 [58.0%] for Victrelis-RGT,
SVR-raterne (med "manglende=svigt"-metoden) var identiske med raterne i tabellen: 69,9 % (174/249) for forsøgspersoner randomiseret til reduktion af ribavirindosis; 68,5 % (172/251) for forsøgspersoner randomiseret til erythropoietin. 
SVR rates with “missing=failure” approach were similar to those in the table: 69.9% (174/249) for subjects randomized to receive ribavirin dose reduction; 68.5% (172/251) for subjects randomized to receive
Niveauerne for hcv-RNA skal monitoreres i behandlingsuge 8, 12 og 24 og på andre klinisk relevante 
HCV-RNA levels should be monitored at Treatment Weeks 8, 12, and 24, and for other time points as
Vedvarende virologisk respons (SVR) hos patienter, der har fået samme behandling indtil uge 36 
Sustained Virologic Response (SVR) in patients receiving similar therapy up to treatment week 36
• svampemidler - ketoconazol, itraconazol, posaconazol, voriconazol 
• antifungal medicines - ketaconazole, itraconazole, posaconazole, voriconazole
Den hyppigste hivproteasehæmmer var atazanavir efterfulgt af lopinavir og darunavir. 
The most common HIV PI taken was atazanavir followed by lopinavir and darunavir.
Samtidig administration af oral midazolam, oral triazolam og Victrelis er kontraindiceret (se pkt. 
Co-administration of oral midazolam and oral triazolam with Victrelis is contraindicated (see section 4.3).
Transfusionsraten var 4 % (10/249) hos forsøgspersoner randomiseret til reduktion af ribavirindosis og 2 % (5/251) hos forsøgspersoner randomiseret til erythropoietin. 
The transfusion rate was 4% (10/249) in subjects randomized to receive ribavirin dose reduction and 2% (5/251) in subjects randomized to receive erythropoietin.
Gennemsnitsalderen for de randomiserede forsøgspersoner var 43,6 år. 
Mean age of subjects randomized was 43.6 years.
Hos det begrænsede antal co-inficerede forsøgspersoner, der ikke opnåede SVR, og hvor der var foretaget sekventering af populationen, var prævalensen af post-baseline RAVer højere end hos mono-inficerede forsøgspersoner i SPRINT-2 studiet. 
In the limited number of co-infected subjects who did not achieve SVR and for whom population sequencing was performed, the prevalence of post-baseline RAVs was higher than that in mono
Gennemsnitsalderen for de randomiserede forsøgspersoner var 49,1 år. 
Mean age of subjects randomized was 49.1 years.
Hjerte eller kredsløb: unormal eller hurtig hjertefrekvens; hjertesygdom på grund af dårligt 
Heart or circulation: abnormal or rapid heart rate; heart disease caused by poor blood flow in
Anvendelse hos patienter med svigt af tidligere behandling med en hcv-proteasehæmmer 
Use in patients who have previously failed treatment with an HCV protease inhibitor
Hvis en patient glemmer at tage en dosis, og der er mindre end 2 timer til næste dosis skal tages, skal 
If a patient misses a dose and it is less than 2 hours before the next dose is due, the missed dose
• intravenøs beroligende medicin - benzodiazepiner (f.eks. alprazolam, midazolam, triazolam) 
• intravenous sedatives - benzodiazepines (e.g., alprazolam, midazolam, triazolam)
Patienter, der får dabigatran, skal monitoreres efter behov. 
Patients receiving dabigatran should be monitored appropriately.
† ved reduktion af ribavirindosis versus erythropoietin i behandlingen af anæmi hos tidligere ubehandlede personer 
† Rates for using ribavirin dose reduction versus erythropoietin in the management of anaemia in previously untreated subjects
Hjertemislyd, forhøjet hjertefrekvens Nedsat glomerulær filtrationshastighed * Omfatter bivirkninger, der kan være alvorlige ifølge investigatoren af kliniske forsøgspersoner. 
Glomerular filtration rate decreased * Includes adverse reactions which may be serious as assessed by the investigator in clinical trial
Kombinationen af boceprevir med disse lægemidler frarådes (se pkt. 
The combination of boceprevir with these medicines is not recommended (see section 4.4).
I tilfælde af alvorlig bivirkning med mulig relation til peginterferon alfa og/eller ribavirin, kan dosis af peginterferon alfa og/eller ribavirin reduceres. 
If a patient has a serious adverse reaction potentially related to peginterferon alfa and/or ribavirin, the peginterferon alfa and/or ribavirin dose should be reduced.
Amenorré, menorragi, metroragi 
Erectile dysfunction Amenorrhoea, menorrhagia, metrorrhagia
Hæmoragisk diatese, lymfeknudesvulst, lymfopeni 
Haemorrhagic diathesis, lymphadenopathy, lymphopenia
• Opbevares uden for køleskab ved eller under 30 °C i en periode på højst 3 måneder indtil udløbsdato. 
• Store outside of the refrigerator at or below 30°C for a period of not more than 3 months until expiry.
Boceprevir, i kombination med peginterferon alfa og ribavirin, er blevet evalueret hos i alt 98 patienter (64 i boceprevir-armen), der var co-inficerede med humant immundefektvirus (hiv) og hcv genotype-1, og som ikke tidligere havde været behandlet for kronisk hcv-infektion (se pkt. 
Boceprevir, in combination with peginterferon alfa and ribavirin, was evaluated in a total of 98 patients (64 in the boceprevir arm) co-infected with Human Immunodeficiency Virus (HIV) and HCV genotype 1 who were previously untreated for chronic HCV infection (see section 4.8 and 5.1).
Generelt: besvær med at trække vejret og synke; svulst i skjoldbruskkirtlen; infektion i blodet; hævelse eller knuder i kroppens organer; sygdom, der fører til tiltagende muskellammelse; sygdom i hjernen - tegnene kan være hovedpine og feber, lammelse af dele af kroppen, stiv 
General: difficult breathing and swallowing; tumour of the thyroid; infection of the blood; swelling or lumps in organs of the body; disease which leads to increasing muscle paralysis; disease of the brain - signs may include headache and fever, paralysis of a part of the body, a stiff neck or being sensitive to light
Der kræves ingen dosisjustering for Victrelis eller tenofovir. 
No dose adjustment required for Victrelis or tenofovir.
De hyppigst (> 25 % af forsøgspersonerne) påviste post-baseline RAVer hos disse forsøgspersoner var aminosyre-substitutionerne V36M (61 %) og R155K (68 %) hos forsøgspersoner inficeret med genotype 1a-vira og T54A (42 %), T54S (37 %), A156S (26 %) og V170A (32 %) hos forsøgspersoner inficeret med genotype 1b-vira. 
The most frequently (> 25% of subjects) detected post-baseline RAVs in these subjects were amino acid substitutions V36M (61%) and R155K (68%) in subjects infected with genotype 1a viruses and T54A (42%), T54S (37%), A156S (26%) and V170A (32%) in subjects infected with genotype 1b
Sammenlignet med kombinationen af boceprevir og peginterferon alfa-2b og ribavirin blev kombinationen af boceprevir med peginterferon alfa-2a og ribavirin forbundet med en højere forekomst af neutropeni (inklusiv grad 4 neutropeni) samt en højere infektionsrate. 
As compared to the combination of boceprevir with peginterferon alfa-2b and ribavirin, the combination of boceprevir with peginterferon alfa-2a and ribavirin was associated with a higher rate of neutropenia (including grade 4 neutropenia) and a higher rate of infections.
Dette er ikke set hos mus eller aber. 
This is not observed in mice
(CYP3A-hæmning og/eller P 
(CYP3A inhibition and/or P-gp
Victrelis' effekt ved behandling af kronisk hepatitis C genotype 1-infektion blev undersøgt i fase IIIkliniske studier hos cirka 1.500 voksne forsøgspersoner, der ikke tidligere var behandlet (SPRINT-2), eller hvor tidligere behandling havde svigtet (RESPOND-2). 
The efficacy of Victrelis as a treatment for chronic hepatitis C genotype 1 infection was assessed in approximately 1,500 adult subjects who were previously untreated (SPRINT-2) or who had failed previous therapy (RESPOND-2) in Phase III clinical studies.
Der er rapporteret om tilfælde af pancytopeni hos patienter, der får Victrelis i kombination med peginterferon alfa og ribavirin. 
Cases of pancytopenia have been reported in patients receiving Victrelis in combination with peginterferon alfa and ribavirin.
Samtidig administration af Victrelis og tacrolimus kræver væsentlig dosisreduktion og forlængelse af dosisintervallet for tacrolimus med tæt monitorering af tacrolimusblodkoncentrationen og hyppig vurdering af nyrefunktion og tacrolimus-relaterede bivirkninger. 
Concomitant administration of Victrelis with tacrolimus requires significant dose reduction and prolongation of the dosing interval of tacrolimus, with close monitoring of tacrolimus blood concentrations and frequent assessments of renal function and tacrolimus-related side effects.
SVR-raterne hos forsøgspersoner, der var randomiseret til reduktion af ribavirindosis og til at få 
The SVR rates in subjects randomized to receive ribavirin dose reduction and randomized to receive
• tidligere har oplevet, at behandling med en hcv-proteasehæmmer har svigtet 
• were a patient who has previously failed treatment with an HCV protease inhibitor
Monoterapi med hcv-proteasehæmmer 
HCV protease monotherapy
Victrelis bruges sammen med peginterferon alfa og ribavirin til behandling af kronisk hepatitis C virusinfektion hos voksne (også kaldet hcv-infektion). 
Victrelis, in combination with peginterferon alfa and ribavirin, is used for chronic hepatitis C virus infection in adults (also called HCV infection).
Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden. 
Do not throw away any medicine via wastewater or household waste.
Hvis der ikke er en sådan værdi, overføres FW 
If there is no such value, the FW 12 value was carried forward.
I kliniske forsøg var andelen af forsøgspersoner, der fik erythropoietin til behandling af anæmi 43 % (667/1.548) af forsøgspersonerne i de Victrelis-indeholdende arme sammenlignet med 24 % (131/547) af forsøgspersonerne, der kun fik peginterferon alfa-2b og ribavirin. 
In clinical trials, the proportion of subjects who received erythropoietin for the management of anaemia was 43% (667/1,548) of subjects in the Victrelis-containing arms compared to 24% (131/547) of subjects receiving peginterferon alfa-2b and ribavirin alone.
Tél/Tel: 0800 38 693 (+32 (0)27766211) 
Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)
Der bør udvises forsigtighed hos patienter med lidelser, der prædisponerer til hyperkaliæmi eller hos patienter, der tager kalium-besparende diuretika (se pkt. 
Caution should be exercised in patients with conditions that predispose them to hyperkalaemia or patients taking potassiumsparing diuretics (see section 4.4).
Se produktresumeet for peginterferon alfa og ribavirin for hvilke laboratorieprøver, der anbefales ved baseline, under behandling og efter behandling, herunder hæmatologiske, klinisk-kemiske (inklusive leverfunktionsprøver) og graviditetstests. 
Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin for baseline, ontreatment and post-treatment laboratory testing recommendations including haematology, biochemistry (including hepatic function tests), and pregnancy testing.
Hjælpestof, som behandleren skal være opmærksom på Hver kapsel indeholder 56 mg lactosemonohydrat. 
Each capsule contains 56 mg of lactose monohydrate.
Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug, proteasehæmmere, ATC 
Pharmacotherapeutic group: antivirals for systemic use, protease inhibitors, ATC code: J05AE12
Svimmelhed*, hovedpine* 
Dizziness*, headache*
Hud og hår: rødmen i huden; bakteriel hudinfektion Mave og tarme: problemer med at fordøje maden; opkastning af blod; opkastning, diarré og svære smerter i øvre højre del af maven (bughulesmerter) 
Skin and hair: reddening of the skin; bacterial skin infection Stomach and gut: problems digesting food; vomiting blood; vomiting, diarrhoea, and severe right upper corner stomach (abdominal) pain
Samtidig administration af Victrelis og alfuzosin og silodosin er kontraindiceret (se pkt. 
Co-administration of Victrelis with alfuzosin and silodosin is contraindicated (see section 4.3).
• tyrosinkinasehæmmere - medicin til behandling af kræft 
• tyrosine kinase inhibitors - used as anti-cancer medicines
Se produktresumeet for ribavirin for information vedrørende dosisreduktion og/eller seponering af ribavirin. 
Refer to the Summary of Product Characteristics for ribavirin for information regarding dose reduction and/or discontinuation of ribavirin.
Hos alle forsøgspersoner med detekterbart hcv-RNA i plasma i behandlingsuge 12 blev behandling seponeret. 
All subjects with detectable HCV-RNA in plasma at TW 12 were discontinued from treatment.
Samtidig administration af Victrelis og sirolimus kræver væsentlig dosisreduktion og forlængelse af dosisintervallet for sirolimus med tæt monitorering af sirolimusblodkoncentrationen samt hyppig overvågning af nyrefunktion og for sirolimusrelaterede bivirkninger. 
Concomitant administration of Victrelis with sirolimus requires significant dose reduction and prolongation of the dosing interval for sirolimus, with close monitoring of sirolimus blood concentrations and frequent assessments of renal function and sirolimus-related side effects.
• medicin til behandling af uregelmæssig hjerterytme - amiodaron, quinidin 
• antiarrhythmic medicines- amiodarone, quinidine
Seponeringsraten på grund af anæmi var 2 % (5/249) hos forsøgspersoner randomiseret til reduktion af ribavirindosis og 2 % (6/251) hos de forsøgspersoner, der var randomiseret til erythropoietin. 
The treatment discontinuation rate due to anaemia was 2% (5/249) in subjects randomized to receive ribavirin dose reduction and 2% (6/251) in subjects randomized to receive erythropoietin.
Det anbefales at seponere behandlingen hos alle patienter med 1. hcv-RNA-koncentration højere end eller lig med 1.000 IE/ml i behandlingsuge 8, eller 2. hcv-RNA-koncentration højere end eller lig med 100 IE/ml i behandlingsuge 12, eller 3. bekræftet, detekterbart hcv-RNA i behandlingsuge 24. 
Discontinuation of therapy is recommended in all patients with 1) HCV-RNA levels of greater than or equal to 1,000 IU per mL at TW 8; or 2) HCV-RNA levels of greater than or equal to 100 IU per mL at TW 12; or 3) confirmed, detectable HCV-RNA levels at TW 24.
• Peginterferon alfa-2b + ribavirin i 48 uger (PR48). 
• Peginterferon alfa-2b + ribavirin for 48 weeks (PR48).
Victrelis' sikkerhed og virkning i kombination med peginterferon alfa og ribavirin er ikke undersøgt hos patienter med dekompenseret cirrose. 
Safety and efficacy of Victrelis, in combination with peginterferon alfa and ribavirin, have not been studied in patients with decompensated cirrhosis.
1 plasma hcv-RNA ved opfølgningsuge (FW) 24. 
1 plasma HCV-RNA at Follow-up Week (FW) 24.
Hvis patientens hepatitis C-virus RNA (hcv-RNA)-koncentration er større end eller lig med 1.000 IE/ml i behandlingsuge 8, afsluttes tre-stofbehandlingen. 
If the patient has hepatitis C virus ribonucleic acid (HCV-RNA) results greater than or equal to 1,000 IU/mL at TW 8; then discontinue three-medicine regimen.
Samtidig administration af darunavir/ritonavir og Victrelis frarådes. 
It is not recommended to co-administer darunavir/ritonavir and Victrelis.
Calciumantagonisternes plasmakoncentration kan stige, når de administreres sammen med Victrelis. 
Plasma concentrations of calcium channel blockers may increase when administered with Victrelis.
4.4), lægemiddelinduceret udslæt med eosinofili og systemiske symptomer (DRESSsyndrom), Stevens-Johnsons syndrom 
Angioedema (see section 4.4), drug rash with eosinophilia and systemic symptoms (DRESS) syndrome, Stevens-Johnson syndrome Musculoskeletal and connective tissue disorders Arthralgia, myalgia
Da Victrelis bliver ordineret sammen med peginterferon alfa og ribavirin, henvises også til produktresumeerne for henholdsvis peginterferon alfa og ribavirin. 
Since Victrelis is prescribed with peginterferon alfa and ribavirin, please also refer to the respective Summary of Product Characteristics of peginterferon alfa and ribavirin.
• lumefantrin og halofantrin - medicin til behandling af malaria 
• lumefantrine and halofantrine - anti-malaria medicines
Dosisjustering er ikke nødvendig ved administration sammen med Victrelis. 
No dose adjustment is necessary when coadministered with Victrelis.
• Hvis der derimod er mindre end 2 timer til, at du skal tage din næste dosis, skal du springe den 
• However, if it is less than 2 hours before your next dose is due, skip the missed dose.