natgillin/translations-raw huggingface dataset:
Klinisk kontrol anbefales dog, da der kan opstå behov for at justere methadondosen hos nogle patienter under vedligeholdelsesbehandling. 
However, clinical monitoring is recommended as the dose of methadone during maintenance therapy may need to be adjusted in some patients.
- Velkontrolleret thyroideafunktion (TSH) - Beregnet kreatininclearance ≥ 50 ml/min 
- Adequately controlled thyroid function (TSH) - Calculated creatinine clearance ≥ 50 ml/min
Over 90% af alle udslæt var lette til moderate. 
More than 90% of rashes were of mild or moderate severity.
Hos tidligere null responders bør det overvejes at udføre en yderligere HCV-RNA-test mellem uge 4 og uge 12. 
In prior null responders, consideration should be given to conduct an additional HCV RNA test between weeks 4 and 12.
Fortæl det til lægen, hvis du har en hepatitis B-leverbetændelse, så lægen kan afgøre, om INCIVO er den rette behandling til dig. 
Tell your doctor if you have an hepatitis B infection so that your doctor can decide if INCIVO
Desuden anvendtes kvantificeringsgrænsen på 25 IE/ml til at bestemme SVR. 
In addition, the limit of quantification of 25 IU/ml was used to determine SVR.
Dosisjustering af fentanyl eller alfentanil kan være nødvendig. 
Dosage adjustment of fentanyl or alfentanil may be necessary.
C-telaprevir hos raske forsøgspersoner blev 90% af den totale radioaktivitet genfundet i fæces, urin og eksspirationsluft inden for 96 timer efter indgift. 
C-telaprevir in healthy subjects, 90% of total radioactivity was recovered in faeces, urine and expired air within 96 hours post-dose.
Efter oral anvendelse estimeredes tilsyneladende total clearance (Cl/F) til 32,4 l/time med en interindividuel variabilitet på 27,2%. 
After oral administration, the apparent total clearance (Cl/F) was estimated to be 32.4 l/h with an inter-individual variability of 27.2%.
I rotter og hunde blev telaprevir associeret med et reversibelt fald i erytrocytparametre ledsaget af et regenerativt respons. 
In rats and dogs, telaprevir was associated with a reversible reduction of red blood cell parameters accompanied by a regenerative response.
Der blev påvist flere metabolitter i fæces, plasma og urin. 
Multiple metabolites were detected in faeces, plasma, and urine.
Lægen vil kontrollere blodets indhold af virus i 4. og 12. uge for at fastsætte, hvor længe din behandling skal vare. 
Your doctor will measure blood levels of your virus at weeks 4 and 12 to determine your treatment duration.
Ribavirin kan genoptages i henhold til vejledningen for dosisændringer for ribavirin. 
Ribavirin may be restarted per the dosing modification guidelines for ribavirin.
- for at kontrollere, om du har anæmi (fald i de røde blodlegemer). 
- to check if you have anaemia (decrease in your red blood cells).
Samme andel af patienter i de 2 behandlingsgrupper havde varianter, der var resistente over for telaprevir, på tidspunktet for svigt. 
Similar proportions of patients in both treatment groups had telaprevir-resistant variants at the time of failure.
In vitro-studier med rekombinant UGT1A3 tyder på, at telaprevir kan hæmme dette enzym. 
In vitro studies with recombinant UGT1A3 suggested that telaprevir may inhibit this enzyme.
Tabel 2 viser dosisrekommandationer som følge af lægemiddelinteraktioner med INCIVO. 
Table 2 provides dosing recommendations as a result of drug interactions with INCIVO.
Disse ændringer skal baseres på hyppig monitorering af plasmakoncentrationen af tacrolimus eller ciclosporin under behandlingen med INCIVO. 
These changes should be based on frequent monitoring of tacrolimus or cyclosporine A plasma concentrations during INCIVO treatment.
Ved moderat udslæt, der progredierer til alvorligt udslæt (≥ 50% legemsoverflade) skal INCIVO seponeres permanent (se nedenfor). 
For moderate rash that progresses to severe (≥ 50% body surface area), permanently discontinue INCIVO (see below).
Andre enzymer er også involveret i metaboliseringen (se pkt. 
Other enzymes are also involved in the metabolism (see section 5.2).
(7,0-8,9 g/dl eller ethvert fald ≥ 4,5 g/dl) 
(7.0-8.9 g/dl or any decrease ≥ 4.5 g/dl)
Anvendelse af INCIVO til behandling af andre HCV-genotyper Der foreligger ikke tilstrækkelige kliniske data til at forsvare behandling af patienter med andre HCV-genotyper end genotype1. 
Use of INCIVO in treatment of other HCV genotypes There are not sufficient clinical data to support the treatment of patients with HCV genotypes other than genotype 1.
Enhver form for prævention kan svigte, og derfor er det vigtigt, at du og din partner anvender mindst to sikre former for prævention under og efter behandling med INCIVO. 
Any birth control method can fail, and, therefore, you and your partner must use at least two effective birth control methods during INCIVO therapy and afterwards.
Replika med enkeltsubstitutioner ved position 155 eller 156 og dobbeltvarianter med substitutioner ved position 36 og 155 viste krydsresistens over for alle proteasehæmmere testet med et bredt interval af følsomhed. 
Replicons with single substitutions at position 155 or 156 and double variants with substitutions at residues 36 and 155 showed cross-resistance to all protease inhibitors tested with a wide range of sensitivities.
Anvendelse af INCIVO bør undgås hos patienter med medfødt QT-forlængelse eller familiær anamnese med medfødt QT-forlængelse eller pludselig død. 
Use of INCIVO should be avoided in patients with congenital QT prolongation, or a family history of congenital QT prolongation or sudden death.
Tadalafil til behandling af erektil dysfunktion kan anvendes med forsigtighed som en enkelt dosis, der ikke overstiger 10 mg i løbet af 72 timer, og ved øget samtidig kontrol for bivirkninger associeret med tadalafil. 
Tadalafil for treatment of erectile dysfunction can be used with caution at a single dose not exceeding 10 mg dose in 72 hours and with increased monitoring for tadalafil associated adverse events.
ANTIMYKOTIKA ketoconazol* itraconazol posaconazol voriconazol 
ANTIFUNGALS ketoconazole* itraconazole posaconazole voriconazole
Hvis behandlingen ikke virker på dig, kan lægen vælge at stoppe medicinen. 
If your treatment is not working, your doctor may stop your medicines.
Der foreligger indberetninger af tilfælde med dødeligt forløb hos patienter med progredierende udslæt og systemiske symptomer, der fortsatte med INCIVOkombinationsbehandling efter konstatering af en alvorlig hudreaktion. 
Fatal cases have been reported in patients with progressive rash and systemic symptoms who continued to receive INCIVO combination treatment after a serious skin reaction was identified.
Overvåges for progression eller systemiske symptomer, indtil udslættet forsvinder. 
Monitor for progression or systemic symptoms until the rash is resolved.
Der sås ingen relevant effekt 
No relevant effect of gender was identified.
Detekterbart HCV-RNA under den nedre kvantificeringsgrænse bør ikke anvendes som erstatning for ”ikke-detekterbart” (HCV-RNA ikke påvist) til at træffe afgørelser om behandlingsvarighed, da det ville kunne føre til en utilstrækkelig varighed af behandlingen og højere relapse-rater. 
Detectable HCV RNA below the lower limit of assay quantification should not be used as a substitute for “undetectable” (target not detected), for making decisions on treatment duration, as this may lead to an insufficient duration of therapy and higher relapse rates.
Bemærk, at de virologiske stopregler, der er taget højde for i denne analyse af behandlingsresultater, er faktiske stopregler, dvs. afledt af dispositions- og eksponeringsdata til forskel fra matematiske stopregler, dvs. afledt 
Note that the virologic stopping rules taken into account in this treatment outcome analysis are actual stopping rules, i.e., those derived from disposition and exposure data, as opposed to mathematical stopping rules, i.e., derived from the
Rifampicin reducerer telaprevirs plasma-AUC med ca. 92%, og INCIVO må derfor ikke anvendes 
Rifampicin reduces the telaprevir plasma AUC by approximately 92%.
55 ud af 60 patienter fik ribavirin i en fast dosis på 800 mg/dag, og de resterende 5 patienter fik en vægtbaseret dosis ribavirin. 
Fifty-five out of 60 patients received ribavirin at a fixed dose of 800 mg/day and the remaining 5 patients received a weight-based ribavirin dose.
Generelt var eksponeringsniveauet lavere i farmakologiske og toksikologiske dyrestudier i forhold til værdier hos mennesker. 
In general, exposure levels in relation to human values were low in animal pharmacology and toxicology studies.
I tabel 8 vises SVR-rater for patienterne i de enkelte undergrupper. 
Table 8 shows SVR rates for patient subgroups.
Telaprevir udviste ikke teratogent potentiale hos rotter eller mus. 
Telaprevir did not have any teratogenic potential in rat or mouse.
INCIVO må ikke anvendes til børn og unge, da det ikke er undersøgt tilstrækkeligt hos patienter under 
INCIVO is not for use in children or adolescents, because it has not been sufficiently studied in
Ud fra in vitro-studier kan telaprevir potentielt øge plasmakoncentrationen af lægemidler, hvis elimination afhænger af MATE1 og MATE2-K (MATE = multidrug and toxin extrusion) (se tabel 2). 
Based on in vitro studies, telaprevir may potentially increase plasma concentrations of medicinal products in which excretion is dependent upon multidrug and toxin extrusion (MATE)-1 and MATE2-K (see table 2).
Forsigtighed tilrådes ved brug af andre lægemidler associeret med alvorlige kutane reaktioner under administration af INCIVO-kombinationsbehandling for at undgå potentiel usikkerhed med hensyn til, hvilket lægemiddel kunne have medvirket til en alvorlig kutan reaktion. 
Other medicinal products associated with severe cutaneous reactions should be used with caution during administration of INCIVO combination treatment to avoid potential confusion as to which medicinal product could be contributing to a severe cutaneous reaction.
Kombinationen bør derfor anvendes med forsigtighed, og anden behandling bør overvejes. 
Therefore this combination should be used with caution or alternatives should be considered.
T12/PR Alle patienter N=540 
T12/PR All Patients N=540
Hver beholder indeholder en eller to poser med tørremiddel til at holde tabletterne tørre. 
Each bottle contains one pouch or two pouches of desiccant to keep the tablets dry.
Ekg-vurderinger bør udføres ved baseline og regelmæssigt under behandling med telaprevir. 
ECG should be monitored at baseline and regularly during telaprevir treatment.
INCIVO skal altid tages i forbindelse med et måltid. 
INCIVO must always be taken together with food.
Lægen kan foreskrive yderligere kontrol under din behandling med INCIVO. 
Your doctor may request additional monitoring during your INCIVO treatment.
Virologisk svigt under behandlingen med telaprevir var overvejende associeret med mere resistente varianter, og relapse var overvejende associeret med mindre resistente varianter eller vildtype-virus. 
On-treatment virologic failure during telaprevir treatment was predominantly associated with higher-level resistant variants, and relapse was predominantly associated with lower-level resistant variants or wild-type virus.
Telaprevir er oralt tilgængelig og absorberes formentlig i tyndtarmen, mens absorption i colon ikke er påvist. 
Telaprevir is orally available, most likely absorbed in the small intestine, with no evidence for absorption in the colon.
Den kliniske relevans heraf er usikker, da administration af telaprevir sammen med en enkelt dosis buprenorphin, et partielt substrat for UGT1A3, til raske voksne forsøgspersoner ikke førte til øget eksponering for buprenorphin. 
The clinical relevance of this is uncertain as administration of telaprevir with a single dose of buprenorphine, a partial UGT1A3 substrate, to healthy adult subjects did not result in increases in buprenorphine exposures.
- som tidligere er blevet behandlet med interferon-alfa (pegyleret eller ikke-pegyleret) alene eller i kombination med ribavirin, inklusive relapsers, partial responders og null responders (se 
- who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders (see
Kontakt straks lægen eller apoteket for at spørge dem til råds. 
Contact your doctor or pharmacist immediately to ask for advice.
Hypoalbuminæmi og lavt trombocyttal er blevet identificeret som prædiktorer for svære komplikationer af leversygdom såvel som af interferonbaserede terapier (f.eks.dekompenseret leverlidelse, alvorlige bakterieinfektioner). 
Hypoalbuminaemia and low platelet counts have been identified as predictors of severe complications of liver disease as well as of interferon-based therapies (e.g., hepatic decompensation, serious bacterial infections).
INCIVO kan anvendes til patienter med kronisk hepatitis C, som aldrig tidligere har været i behandling, eller det kan anvendes til patienter med kronisk hepatitis C, som tidligere har fået en behandling, der omfattede et interferon. 
INCIVO can be used for patients with chronic hepatitis C infection who have never been treated before or can be used in patients with chronic hepatitis C infection who have been treated previously with an interferon-based regimen.
Patienter, der anvender østrogener til hormonerstatningsterapi, bør monitoreres klinisk for symptomer på østrogenmangel. 
Patients using oestrogens as hormone replacement therapy should be clinically monitored for signs of oestrogen deficiency.
INCIVO kan påvirke behandling med anden medicin, eller anden medicin kan påvirke behandling med INCIVO. 
INCIVO may affect other medicines or other medicines may affect INCIVO.
Den samlede dosis er 6 tabletter dagligt eller - 2 tabletter INCIVO hver 8. time i forbindelse med et måltid. 
The total dose is 6 tablets or - 2 tablets of INCIVO every 8 hours with food.
Hvis trazodon eller anvendes sammen med telaprevir, skal der udvises forsigtighed ved denne kombination, og det bør overvejes at give en lavere dosis af trazodon. 
If trazodone is used with telaprevir, the combination should be used with caution and a lower dose of trazodone should be considered.
oralt midazolam* 
oral midazolam*
Tabel 14: Poolede responsrater: Studie C208 
Table 14: Pooled response rates: Study C208
Data fra dyrestudier er utilstrækkelige, hvad angår human reproduktionstoksicitet (se pkt. 
Animal studies are insufficient with respect to human reproductive toxicity (see section 5.3).
I to dobbeltblinde, randomiserede, placebo- og aktivt-kontrollerede studier, der blev udført for at evaluere virkningen på QT-intervallet, var telaprevir monoterapi i en dosis på 750 mg hver 8. time ikke forbundet med en klinisk relevant påvirkning af QTcF-intervallet. 
In two double-blind, randomised, placebo- and active-controlled studies conducted to evaluate the effect on the QT interval, telaprevir monotherapy at a dose of 750 mg every 8 hours was not associated with a clinically relevant effect on QTcF interval.
Forstyrrelser i elektrolytbalancen (f.eks., hypokaliæmi, hypomagnesiæmi og hypocalcæmi) bør kontrolleres og korrigeres efter behov før indledning af og under behandlingen med INCIVO. 
Electrolyte disturbances (e.g., hypokalaemia, hypomagnesaemia and hypocalcaemia) should be monitored and corrected, if necessary, prior to initiation and during INCIVO therapy.
Meget almindelige bivirkninger (forekommer hos flere end 1 ud af 10 behandlede) 
Very common side effects (affects more than 1 in 10 people):
• Incidensen af udslæt og alvorlige kutane reaktioner 
• Incidence of rash and severe cutaneous reactions
Hvis INCIVO anvendes til patienter med fremskreden leversygdom, anbefales meget tæt monitorering og tidlig behandling af uønskede 
When INCIVO is used in patients with advanced liver disease very close monitoring and early management of adverse events is recommended.
Initialdosis af digoxin bør være den lavest mulige dosis. 
The lowest dose of digoxin should be initially prescribed.
Disse patienter bør kontrolleres nøje inklusive ekg. 
Such patients should be closely monitored, including ECG assessments.
Kvindelige patienter i den fertile alder og deres mandlige partnere samt mandlige patienter og deres kvindelige partnere skal anvende 2 forskellige sikre kontraceptionsmetoder under INCIVO-behandling og efterfølgende som anbefalet i produktresumeet for ribavirin og som beskrevet nedenfor. 
Female patients of childbearing potential and their male partners as well as male patients and their female partners must use 2 effective contraceptive methods during INCIVO treatment and afterwards as recommended in the Summary of Product Characteristics for ribavirin, and as described below.
INCIVO indeholder stoffet telaprevir og hører til en gruppe medicin, der kaldes ”NS3-4A-proteasehæmmere”. 
INCIVO contains a substance called telaprevir and belongs to a group of medicines called ‘NS3-4A protease inhibitors'.
Det er vigtigt at indtage rigelig væske under INCIVO kombinationsbehandling. 
It is important to stay hydrated with fluids during INCIVO combination treatment.
Eftersom det er højst usandsynligt, at patienter med utilstrækkeligt viralt respons opnår et vedvarende virologisk respons (sustained virologic response, SVR), anbefales det, at patienter med HCV-RNA > 1.000 IE/ml i uge 4 eller uge 12 stopper med behandlingen (se tabel 1). 
Since it is highly unlikely that patients with inadequate viral responses will achieve a sustained virologic response (SVR), it is recommended that patients with HCV RNA > 1,000 IU/ml at week 4 or week 12 discontinue therapy (refer to table 1).
Der er ikke foretaget studier af INCIVO for virkningen på evnen til at føre motorkøretøj og betjene maskiner. 
No studies on the effects of INCIVO on the ability to drive and use machines have been performed.
Hyperbilirubinæmi ses ofte med denne kombination. 
Hyperbilirubinaemia is frequent with this combination.
Klinisk monitorering anbefales. 
Clinical monitoring is recommended.
Ethvert udslæt bør overvåges for progression, indtil udslættet forsvinder. 
All rashes should be monitored for progression and until the rash is resolved.
Klinisk anmærkning 
Clinical comment
Halvdelen af udslættene opstod i de første 4 uger, men der kan forekomme udslæt når som helst under INCIVO-kombinationsbehandling. 
Half the rashes started during the first 4 weeks, but rash can occur at any time during INCIVO combination treatment.
In vitro fandtes det, at telaprevir og VRT-127394 supprimerer CYP-enzymer reguleret via de nukleære receptorer CAR, PXR og Ah i humane hepatocytter. 
Suppression by telaprevir and VRT-127394 of CYP enzymes regulated via CAR, PXR and Ah nuclear receptors was observed in vitro in human hepatocytes.
Hæmatologisk evaluering (inklusive differentialtælling af leukocytter) anbefales i uge 2, 4, 8 og 12 og 
Haematology evaluations (including white cell differential count) are recommended at weeks 2, 4, 8
Ingen eller minimal fibrose eller portal fibrose 
No or minimal fibrosis or portal fibrosis
Interaktioner mellem telaprevir og antiretrovirale midler mod hiv er hyppige, og anbefalingerne i tabel 2, pkt. 
Interactions between telaprevir and HIV antiretroviral agents are frequent, and the recommendations in table 2, section 4.5, should be carefully followed.
Patienterne, der fik pegyleret interferon-alfa-2b, fik dog hyppigere viralt gennembrud og var mindre tilbøjelige til at opfylde kriterierne for en afkortet samlet behandlingsvarighed (se pkt. 
However, patients treated with peginterferon alfa-2b experienced more frequent viral breakthrough, and were less likely to meet the criteria for shortened total treatment duration (see section 5.1).
Hvis lægen stopper INCIVO på grund af bivirkninger, eller fordi behandlingen ikke virker, må du ikke 
If your doctor stops INCIVO because of side effects or because your treatment is not working,
oralt triazolam 
oral triazolam
I en HCV-subtype 1b replicon assay var telaprevirs IC50-værdi mod en vildtype-HCV 0,354 µM, hvilket svarede til en IC50 på 0,28 µM i et subtype 1a virusinfektionsassay. 
In an HCV subtype 1b replicon assay, the telaprevir IC50 value against wild-type HCV was 0.354 µM similar to a subtype 1a infectious virus assay IC50 of 0.28 µM.
Responsraten i Pbo/PR-gruppen var højere end i andre kliniske studier af pegyleret interferon baseret 2-stof behandling (historiske SVR-rater < 36%). 
The response rate in the Pbo/PR arm was higher than that seen in other clinical studies of peginterferon bitherapy (historical SVR rates < 36%).
I løbet af denne periode bør kvindelige patienter i den fertile alder anvende to sikre ikke-hormonale kontraceptionsmetoder. 
During this time, female patients of childbearing potential should use two effective non-hormonal methods of contraception.
INCIVO anbefales ikke til børn og unge under 18 år, da sikkerhed og virkning ikke er klarlagt hos 
INCIVO is not recommended for use in children and adolescents younger than 18 years of age because the safety and efficacy has not been established in this population.
Kvindelige patienter i den fødedygtige alder og deres mandlige partnere P-piller (hormonale kontraceptiva) er muligvis ikke effektive under behandling med INCIVO. 
Female patients of childbearing age and their male partners A hormonal contraceptive (‘the pill') may not be reliable during the treatment with INCIVO.
astemizol, terfenadin til at behandle symptomerne på allergi (antihistaminer) 
astemizole, terfenadine to treat allergy symptoms (antihistamines)
I tilfælde af manglende data i vinduet for uge 72 anvendtes de sidste HCV-RNA-datapoint fra og med uge 12 i studiets opfølgning. 
In the case of missing data within the week 72 window, the last HCV RNA data point from week 12 of follow-up onwards was used.
Telaprevir er en stærk hæmmer af det vigtige lægemiddelmetaboliserende enzym CYP3A4. 
Telaprevir is a strong inhibitor of the important drug metabolising enzyme CYP3A4.
Det fremgik af studier, der anvendte humane rekombinante CYP-supersomer, at telaprevir er en CYP3A4-hæmmer, og telaprevirs tids- og koncentrationsafhængige hæmning af CYP3A4 blev observeret i humane levermikrosomer. 
Studies using recombinant human CYP supersomes showed that telaprevir was a CYP3A4 inhibitor, and a time- and concentration-dependent inhibition of CYP3A4 by telaprevir was observed in human liver microsomes.
HCV-varianter associeret med virologisk svigt eller relapse under behandlingen blev evalueret ved hjælp af site-directed mutagenese i replicon-analysen. 
HCV variants associated with on-treatment virologic failure or relapse were evaluated by site-directed mutagenesis in the replicon assay.
Kontakt straks lægen, hvis du eller din kvindelige partner bliver gravid under behandling med INCIVO eller i månederne efter behandlingen (se afsnittet "Prævention til mænd og kvinder” 
If you or your female partner become pregnant during INCIVO treatment or the months that follow, you must contact your doctor immediately (see section 'Pregnancy precautions for men and women' below).
Telaprevir metaboliseres delvist i leveren af CYP3A, og det er et substrat for P-glykoprotein (P-gp). 
Telaprevir is partly metabolised in the liver by CYP3A and is a P-glycoprotein (P-gp) substrate.
INCIVO påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner. 
INCIVO has no or negligible influence on the ability to drive and use machines.
Pilens retning (↑ = stigning, ↓ = fald, ↔ = ingen ændring) for de enkelte farmakokinetiske parametre er baseret på, at 90%-konfidensintervallet for den geometriske gennemsnitsratio ligger inden for (↔), under (↓) eller over (↑) 80-125%-intervallet. 
The direction of the arrow (↑ = increase, ↓ = decrease, ↔ = no change) for each pharmacokinetic parameter is based on the 90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 80-125% range.
Der er påvist signifikant teratogenicitet og/eller fosterdød hos alle dyrearter efter eksponering for ribavirin, hvorfor det er yderst vigtigt at undgå graviditet hos kvindelige patienter samt hos mandlige 
Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin, therefore, extreme care must be taken to avoid pregnancy in female patients and