FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 5: Efficacy response at week 24 (Snapshot approach)
Danish: Tabel 5: Virkningsrespons i uge 24 (Snapshot-metode)
English: What Pifeltro is
Danish: Hvad Pifeltro er
English: Tell your doctor, pharmacist, or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl lægen, apotekspersonalet eller sygeplejersken, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.
English: Do not give this medicine to anybody aged less than 18 years.
Danish: Dette lægemiddel må ikke anvendes til personer under 18 år.
English: Refill your prescription or talk to your doctor before it is all gone.
Danish: Forny din recept, eller kontakt lægen, inden du løber tør.
English: Your doctor may check your blood levels or monitor for side effects if you take the following medicines with Pifeltro:
Danish: Det kan være nødvendigt for lægen at kontrollere medicinindholdet i blodet eller holde øje med, om du får bivirkninger, hvis du tager følgende lægemidler sammen med Pifeltro:
English: • if you are allergic to doravirine or any of the other ingredients of this medicine listed in section 6.
Danish: • hvis du er allergisk over for doravirin eller et af de øvrige indholdsstoffer i Pifeltro (angivet i punkt 6).
English: Expected: ↔ lisinopril
Danish: Forventet: ↔ lisinopril
English: Talk to your doctor before taking the following medicines withPifeltro,as your doctor may need to change thedose ofyour medicines:
Danish: Kontakt lægen, før du tager følgende lægemidler sammen med Pifeltro, da lægen kan blive nødt til at ændre på dosis af din medicin:
English: This medicine must be used in combination with other medicines for HIV.
Danish: Lægemidlet skal anvendes i kombination med andre lægemidler mod hiv.
English: Doravirine is primarily metabolized and eliminated by the liver.
Danish: Doravirin metaboliseres og elimineres primært via leveren.
English: See list under “Do not take Pifeltro” section.
Danish: Se listen under punktet “Tag ikke Pifeltro”.
English: Treatment emergent doravirine resistance associated substitutions may confer cross resistance to efavirenz, rilpivirine, nevirapine, and etravirine.
Danish: Behandlingsrelaterede substitutioner associeret med resistens over for doravirin kan give krydsresistens over for efavirenz, rilpivirin, nevirapin og etravirin.
English: See “Other medicines and Pifeltro” section for a list of medicines.
Danish: Se punktet “Brug af anden medicin sammen med Pifeltro” for en liste over lægemidler.
English: Each carton contains a high density polyethylene (HDPE) bottle with a polypropylene child-resistant closure with silica gel desiccant.
Danish: Hver karton indeholder en højdensitetspolyethylen (HDPE)-flaske med et børnesikret polypropylenlåg med silicagel-tørremiddel.
English: Therefore caution should be used when co-administering doravirine with medicinal products that are sensitive CYP3A substrates that also have a narrow therapeutic window (e.g., tacrolimus and sirolimus).
Danish: Derfor skal der udvises forsigtighed, når doravirin administreres sammen med lægemidler, der er følsomme CYP3A-substrater, og som også har et smalt terapeutisk vindue (f.eks. tacrolimus og sirolimus).
English: Baseline CD4 cell count was carried forward for subjects who discontinued assigned therapy due to lack of efficacy.
Danish: Baseline-CD4-celletal blev “carried forward” for forsøgspersoner, som ophørte med den tildelte behandling på grund af manglende virkning.
English: • The bottle contains a desiccant protecting the tablets from moisture.
Danish: • Flasken indeholder et tørremiddel, som beskytter tabletterne mod fugt.
English: Doravirine has been evaluated in a limited number of patients with NNRTI resistance (K103N n=7, G190A n=1); all patients were suppressed to < 40 copies/mL at week 48.
Danish: Doravirin er blevet evalueret hos et begrænset antal patienter med NNRTI-resistens (K103N n=7, G190A n=1); alle patienter havde suppression til < 40 kopier/ml i uge 48.
English: Animal studies do not indicate harmful effects of doravirine on fertility at exposure levels higher than the exposure in humans at the recommended clinical dose (see section 5.3).
Danish: Dyreforsøg indikerer ingen skadelige virkninger af doravirin på fertilitet ved eksponeringsniveauer højere end eksponeringen hos mennesker ved den anbefalede kliniske dosis (se pkt.
English: The 95 % CIs were calculated using Miettinen and Nurminen's method with weights proportional to the size of each stratum (screening HBV-1 RNA > 100,000 copies/mL or ≤ 100,000 copies/mL.
Danish: 95% CI blev beregnet ved hjælp af Miettinen og Nurminen-metoden med vægtning proportionel til størrelsen på hvert stratum (HBV-1-RNA ved screening > 100.000 kopier/ml eller ≤ 100.000 kopier/ml).
English: The following de novo resistance was seen in the resistance analysis subset (subjects with HIV-1 RNA greater than 400 copies per mL at virologic failure or early study discontinuation and having resistance data).
Danish: Følgende de novo resistens blev set i resistensanalyse-subgruppen (forsøgspersoner med hiv-1-RNA større end 400 kopier pr. ml ved virologisk svigt eller ved udtræden af studiet før tid, og hvor der var resistensdata).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with doravirine in one or more subsets of the paediatric population in treatment of human immunodeficiency virus-1 (HIV-1) infection, as per Paediatric Investigation Plan (PIP) decision in the granted indication.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med doravirin i en eller flere undergrupper af den pædiatriske population ved behandling af humant immundefektvirus-1 (hiv-1)-infektion i henhold til afgørelsen i det Pædiatriske Forsknings- og Udviklingsprogram (PIP) (se pkt.
English: Pifeltro must be used in combination with other medicines for HIV.
Danish: Pifeltro skal anvendes i kombination med andre lægemidler mod hiv.
English: No human data on the effect of doravirine on fertility are available.
Danish: Der foreligger ingen data om doravirins indvirkning på fertilitet hos mennesker.
English: 5, abdominal distension, dyspepsia, faeces soft gastrointestinal motility disorder
Danish: 5, abdominal distension, dyspepsi, blød afføring gastrointestinale motilitetsforstyrrelser
English: Pifeltro contains the active substance doravirine - a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Danish: Pifeltro indeholder det aktive stof doravirin - en non-nukleosid revers transkriptasehæmmer (NNRTI).
English: Rare hypomagnesaemia
Danish: Sjælden hypomagnesiæmi
English: Treatment-naïve adult subjects
Danish: Behandlingsnaive voksne forsøgspersoner
English: Table 6: Efficacy response (Snapshot approach) in the DRIVE-SHIFT study
Danish: Tabel 6: Virkningsrespons (Snapshot-metode) i DRIVE-SHIFT-studiet
English: Table 1: Interactions of doravirine with other medicinal products
Danish: Tabel 1: Doravirins interaktioner med andre lægemidler
English: If you forget to take Pifeltro
Danish: Hvis du har glemt at tage Pifeltro
English: If you take more Pifeltro than you should Do not take more than the recommended dose.
Danish: Du må ikke tage mere end den anbefalede dosis.
English: One subject developed RT M184M/I mutation and phenotypic resistance to 3TC and FTC during treatment with their baseline regimen.
Danish: En forsøgsperson udviklede RT M184M/I-mutation og fænotypisk resistens over for 3TC og FTC under behandlingen med baseline regimet.
English: White, oval-shaped, tablet of dimensions 19.00 mm x 9.50 mm, debossed with the corporate logo and 700 on one side and plain on the other side.
Danish: Hvid, oval tablet, 19,00 mm x 9,50 mm, med virksomhedslogo og 700 præget på den ene side og uden prægning på den anden side.
English: • inflammation of the skin due to allergy, redness on the cheeks, nose, chin or forehead, bumps or pimples on the face
Danish: • inflammation i huden på grund af allergi, rødme på kinder, næse, hage eller pande, buler eller bumser i ansigtet
English: Doravirine steady state pharmacokinetics following administration of 100 mg once daily to HIV-1 infected subjects, based on a population pharmacokinetics analysis, are provided below.
Danish: Doravirins farmakokinetik ved steady state efter administration af 100 mg en gang dagligt til hiv-1-inficerede forsøgspersoner på baggrund af en farmakokinetisk populationsanalyse er vist nedenfor.
English: DOR + 2 NRTIs
Danish: DOR + 2 NRTIer
English: Excipient with known effect Each film-coated tablet contains 222 mg lactose (as monohydrate).
Danish: Hver filmovertrukken tablet indeholder 222 mg lactose (som monohydrat).
English: Patients should be informed that fatigue, dizziness, and somnolence have been reported during treatment with doravirine (see section 4.8).
Danish: Patienterne skal informeres om, at der er rapporteret træthed, svimmelhed og døsighed under behandlingen med doravirin (se pkt.
English: At baseline, the median age of subjects was 43 years, 16 % were female, and 24 % were non-white.
Danish: Ved baseline var forsøgspersonernes gennemsnitsalder 43 år, 16% var kvinder og 24% var ikke kaukasiere.
English: Table 2: Tabulated summary of adverse reactions associated with doravirine used in combination with other antiretrovirals
Danish: Tabel 2: Tabel over bivirkninger associeret med doravirin, som blev anvendt i kombination med andre antiretrovirale lægemidler
English: • nightmares, depression, anxiety, irritability, confusion, suicidal thoughts
Danish: • mareridt, depression, angst, irritabilitet, forvirring, selvmordstanker
English: Each film-coated tablet contains 100 mg of doravirine.
Danish: Hver filmovertrukken tablet indeholder 100 mg doravirin.
English: DRV + r + NRTIs*
Danish: DRV + r + NRTIer*
English: Doravirine is a pyridinone non-nucleoside reverse transcriptase inhibitor of HIV-1 and inhibits HIV-1 replication by non-competitive inhibition of HIV-1 reverse transcriptase (RT).
Danish: Doravirin er en pyridinon-non-nukleosid revers transkriptasehæmmer af hiv-1 og hæmmer hiv-1replikation ved non-kompetitiv hæmning af hiv-1-revers transkriptase (RT).
English: Subjects must have been virologically suppressed (HIV-1 RNA < 40 copies/mL) on their baseline regimen for at least 6 months prior to trial entry, with no history of virologic failure, and a documented absence of RT substitutions conferring resistance to doravirine, lamivudine and tenofovir (see section Resistance).
Danish: Forsøgspersonerne skal have været virologisk supprimerede (hiv-1 RNA < 40 kopier/ml) på deres baseline-regime i mindst 6 måneder før indtræden i studiet, uden virologisk svigt i anamnesen, og med dokumenteret fravær af RT-substitutioner, der kan give resistens over for doravirin, lamivudin og tenofovir (se afsnittet Resistens).
English: In a pooled analysis combining data from two treatment-naïve trials (P007 and DRIVE-AHEAD), a lower proportion of subjects who discontinued due to an adverse event by week 48 was seen for the combined doravirine (100 mg) treatment groups (2.8 %) compared with the combined EFV treatment group (6.1 %) (treatment difference -3.4 %, p-value 0.012).
Danish: I en poolet analyse, hvor data fra to studier med behandlingsnaive forsøgspersoner (P007 og DRIVE-AHEAD) blev kombineret, blev der ved uge 48 set en lavere andel af forsøgspersoner, der var udtrådt af studiet på grund af en bivirkning, for de kombinerede doravirin (100 mg)behandlingsgrupper (2,8%) sammenlignet med den kombinerede EFV-behandlingsgruppe (6,1%) (behandlingsforskel -3,4%; p-værdi 0,012).
English: What you need to know before you take Pifeltro
Danish: Det skal du vide, før du begynder at tage Pifeltro
English: Note: Both doravirine and efavirenz were administered with emtricitabine/tenofovir disoproxil (FTC/TDF).
Danish: Bemærk: Både doravirin og efavirenz blev administreret sammen med emtricitabin/tenofovirdisoproxil (FTC/TDF).
English: • telotristat ethyl (a medicine to treat diarrhoea in people with carcinoid syndrome)
Danish: • telotristatethyl (et lægemiddel til behandling af diarré hos personer med karcinoidsyndrom)
English: Uncommon lipase increased, aspartate aminotransferase increased, amylase increased, haemoglobin decreased
Danish: Ikke almindelig forhøjet lipase, forhøjet aspartataminotransferase, forhøjet amylase, nedsat hæmoglobin
English: Expected: ↔ buprenorphine ↔ naloxone
Danish: Forventet: ↔ buprenorphin ↔ naloxon
English: Respiratory, thoracic and mediastinal disorders Rare dyspnoea, tonsillar hypertrophy
Danish: Luftveje, thorax og mediastinum Sjælden dyspnø, tonsillær hypertrofi
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu .
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Baseline Regimen = ritonavir or cobicistat-boosted PI (specifically atazanavir, darunavir, or lopinavir), or cobicistat-boosted elvitegravir, or NNRTI (specifically efavirenz, nevirapine, or rilpivirine), each administered with two NRTIs.
Danish: Baseline-regime = ritonavir- eller cobicistat-boostet PI (især atazanavir, darunavir eller lopinavir), eller cobicistat-boostet elvitegravir eller NNRTI (især efavirenz, nevirapin eller rilpivirin), hver især administreret sammen med to NRTIer.
English: ↔ elvitegravir cobicistat-boosted elvitegravir
Danish: ↔ elvitegravir cobicistat-boostet elvitegravir
English: DOR/3TC/TDF Once Daily ISG
Danish: DOR/3TC/TDF En gang dagligt ISG
English: Warnings and precautions Talk to your doctor, pharmacist, or nurse before taking Pifeltro.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sygeplejersken, før du tager Pifeltro.
English: In Part I, subjects were randomized to receive one of 4 doses of doravirine or EFV, each in combination with FTC/TDF.
Danish: I del I blev forsøgspersonerne randomiseret til at få en af 4 doser af doravirin eller EFV, hver i kombination med FTC/TDF.
English: *NRTIs in DOR arm: FTC/TDF (333) or ABC/3TC (50); NRTIs in DRV+r arm: FTC/TDF (335) or ABC/3TC (48) **Subjects received FTC/TDF
Danish: *NRTIer i DOR-armen: FTC/TDF (333) eller ABC/3TC (50); NRTIer i DRV+r-armen: FTC/TDF (335) eller ABC/3TC
English: P007 was a Phase 2b trial in antiretroviral treatment-naïve HIV-1 infected adult subjects (n = 340).
Danish: P007 var et fase 2b-studie hos hiv-1-inficerede voksne forsøgspersoner, der ikke tidligere havde fået antiretroviral behandling (n=340).
English: †- boosted PIs (atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, saquinavir, tipranavir)
Danish: †-boostede proteasehæmmere (atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, saquinavir, tipranavir)
English: Metabolism and nutrition disorders Uncommon hypophosphataemia
Danish: Metabolisme og ernæring Ikke almindelig hypofosfatæmi
English: In both parts of the trial, doravirine and EFV were administered as blinded-therapy and FTC/TDF was administered open-label.
Danish: I begge dele af studiet blev doravirin og EFV administreret som blindet behandling, og FTC/TDF blev administreret ublindet.
English: Do not take Pifeltro:
Danish: Tag ikke Pifeltro
English: Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults infected with HIV-1 without past or present evidence of resistance to the NNRTI class (see sections 4.4 and 5.1).
Danish: Pifeltro er, i kombination med andre antiretrovirale lægemidler, indiceret til behandling af hiv-1inficerede voksne uden tidligere eller nuværende tegn på resistens over for NNRTI-klassen (se pkt.
English: What Pifeltro looks like and contents of the pack Pifeltro is available as a white, oval-shaped, film-coated tablet, and is debossed with the corporate logo and 700 on one side and plain on the other side.
Danish: Pifeltro fås som en hvid, oval, filmovertrukken tablet med virksomhedslogo og 700 præget på den ene side og uden prægning på den anden side.
English: Mean CD4 change from baseline (cells/mm
Danish: Gennemsnitlig CD4-ændring fra baseline (celler/mm
English: Effects of doravirine on other medicinal products
Danish: Doravirins indvirkning på andre lægemidler
English: Common NNRTI-resistant mutations (K103N, Y181C) were not selected in the in vitro study.
Danish: Der blev ikke selekteret for almindelige NNRTI-resistente mutationer (K103N, Y181C) i in vitro-studiet.
English: • The active substance is doravirine 100 mg.
Danish: • Aktivt stof: doravirin 100 mg.
English: • Do not use this medicine after the expiry date which is stated on the bottle after EXP.
Danish: • Tag ikke lægemidlet efter den udløbsdato, der står på flasken efter EXP. Lægemidlet skal anvendes inden for 35 dage efter første åbning af flasken.
English: • if you are taking the following medicines: carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for seizures) rifampicin, rifapentine (medicines for tuberculosis) St. John's wort (Hypericum perforatum, a herbal remedy used for depression and anxiety) or products that contain it mitotane (a medicine to treat cancer) enzalutamide (a medicine to treat prostate cancer) lumacaftor (a medicine to treat cystic fibrosis)
Danish: • hvis du tager et eller flere af følgende lægemidler: carbamazepin, oxcarbazepin, phenobarbital, phenytoin (lægemidler mod krampeanfald) rifampicin, rifapentin (lægemidler mod tuberkulose) perikon (Hypericum perforatum, et naturlægemiddel mod depression og angst), eller lægemidler, der indeholder perikon mitotan (et lægemiddel til behandling af kræft) enzalutamid (et lægemiddel til behandling af prostatakræft) lumacaftor (et lægemiddel til behandling af cystisk fibrose).
English: The efficacy of switching from a baseline regimen consisting of two nucleoside reverse transcriptase inhibitors in combination with a ritonavir- or cobicistat-boosted PI, or cobicistat-boosted elvitegravir, or an NNRTI to DOR/3TC/TDF was evaluated in a randomized, open-label trial (DRIVE-SHIFT), in virologically suppressed HIV-1 infected adults.
Danish: Virkningen af skiftet fra et baseline-regime bestående af to nukleosid revers transkriptasehæmmere i kombination med en ritonavir- eller cobicistat-boostet PI, eller cobicistat-boostet elvitegravir, eller en NNRTI til DOR/3TC/TDF blev evalueret i et randomiseret, åbent studie (DRIVE-SHIFT) hos virologisk supprimerede hiv-1-inficerede voksne.
English: Subjects were randomized to either switch to DOR/3TC/TDF at baseline [N = 447, Immediate Switch Group (ISG)], or stay on their baseline regimen until Week 24, at which point they switched to DOR/3TC/TDF [N = 223, Delayed Switch Group (DSG)].
Danish: Forsøgspersonerne blev randomiseret til enten at skifte til DOR/3TC/TDF ved baseline [N=447, Immediate Switch Group (ISG)] eller blive på deres baseline-regime indtil uge 24, hvor de skiftede til DOR/3TC/TDF [N=223, Delayed Switch Group (DSG)].
English: At baseline, the median age of subjects was 31 years (range 18-70 years), 85 % were male, 52 % were non-white, 3% had hepatitis B or C co-infection, 14 % had a history of AIDS, 21 % had HIV-1 RNA > 100,000 copies per mL, and 12 % had CD4
Danish: Ved baseline var forsøgspersonernes medianalder 31 år (interval 18-70 år), 85% var mænd, 52% var ikke kaukasiere, 3% var samtidigt inficeret med hepatitis B- eller C-virus, 14% havde aids i anamnesen, 21% havde hiv-1-RNA > 100.000 kopier pr. ml, og 12% havde et CD4
English: • tacrolimus (a medicine used to control your body's immune response after a transplant)
Danish: • tacrolimus (et lægemiddel, der anvendes til at kontrollere din krops immunrespons efter en transplantation).
English: None of the 24 subjects (11 in the immediate switch group, 13 in the delayed switch group) with baseline NNRTI mutations (RT K103N, G190A, or Y181C) experienced virologic failure through Week 48, or at time of discontinuation.
Danish: Ingen af de 24 forsøgspersoner (11 i den gruppe der skiftede øjeblikkeligt, 13 i den gruppeder skiftede sent) med NNRTI-mutationerne (RT K103N, G190A eller Y181C) ved baseline oplevede virologisk svigt til og med uge 48 eller på tidspunktet for seponering af behandlingen.
English: If co-administration cannot be avoided, one tablet of doravirine should be taken twice daily (approximately 12 hours apart).
Danish: Hvis samtidig administration ikke kan undgås, skal en tablet doravirin tages to gange dagligt (med ca. 12 timers mellemrum).
English: Uncommon: may affect up to 1 in 100 people:
Danish: Ikke almindelig: kan forekomme hos op til 1 ud af 100 personer:
English: In the DRIVE-SHIFT clinical trial, no subjects developed genotypic or phenotypic resistance to DOR, 3TC, or TDF during the initial 48 weeks (immediate switch, N=447) or 24 weeks (delayed switch, N=209) of treatment with DOR/3TC/TDF.
Danish: I det kliniske studie DRIVE-SHIFT var der ingen forsøgspersoner, der udviklede genotypisk eller fænotypisk resistens over for DOR, 3TC eller TDF i de første 48 uger (øjeblikkeligt skift, N=447) eller 24 uger (sent skift, N=209) under behandlingen med DOR/3TC/TDF.
English: Other established NNRTI substitutions yielded a fold change of 5-10 (G190S (5.7), K103N/P225H (7.9), V108I/Y181C (6.9), Y181V (5.1)).
Danish: Andre dokumenterede NNRTI-substitutioner gav en 5-10 gange ændring (G190S (5,7), K103N/P225H (7,9), V108I/Y181C (6,9), Y181V (5,1)).
English: Package leaflet: Information for the user Pifeltro 100 mg film-coated tablets doravirine
Danish: Indlægsseddel: Information til brugeren Pifeltro 100 mg filmovertrukne tabletter doravirin
English: Ritonavir- or Cobicistat-boosted PI
Danish: Ritonavir- eller cobicistat-boostet PI
English: Therefore, caution is advised when doravirine is administered to patients with severe hepatic impairment (see section 5.2).
Danish: Det tilrådes derfor at udvise forsigtighed, når doravirin administreres til patienter med svært nedsat leverfunktion (se pkt.
English: After week 24, all subjects randomized to receive doravirine were switched to (or maintained on) doravirine 100 mg. Additional subjects were randomized in Part II to receive either doravirine 100 mg or EFV, each in combination with FTC/TDF.
Danish: Efter uge 24 blev alle de forsøgspersoner, der var randomiseret til at få doravirin, skiftet over til (eller fastholdt på) doravirin 100 mg. I del II blev yderligere forsøgspersoner randomiseret til at få enten doravirin 100 mg eller EFV, hver i kombination med FTC/TDF.
English: Safety and efficacy of doravirine have not been established in patients younger than 18 years of age.
Danish: Pædiatrisk population Doravirins sikkerhed og virkning hos patienter under 18 år er ikke klarlagt.
English: Effects of other medicinal products on doravirine
Danish: Andre lægemidlers indvirkning på doravirin
English: • constipation, stomach discomfort, swollen or bloated stomach (abdominal distension),
Danish: • forstoppelse, mavegener, hævet eller oppustet mave (abdominal distension),
English: Expected:  doravirine sofosbuvir
Danish: Forventet:  doravirin sofosbuvir
English: Expected: ↔ doravirine ombitasvir/ paritaprevir/ritonavir and dasabuvir+/-ritonavir
Danish: Forventet: ↔ doravirin ombitasvir/ paritaprevir/ritonavir og dasabuvir+/-ritonavir
English: Co-administration of doravirine and medicinal products that are inhibitors of CYP3A may result in increased plasma concentrations of doravirine.
Danish: Samtidig administration af doravirin og lægemidler, der er CYP3A-hæmmere, kan resultere i en øget plasmakoncentration af doravirin.