FrancophonIA/ELRC3.0 huggingface dataset:
English: At baseline, 31% of subjects were at high risk for reactivation as defined by one or more of the following criteria: Human Leukocyte Antigen (HLA)-related (sibling) donor with at least one mismatch at one of the following three HLA-gene loci: HLA-A, -B or -DR, haploidentical donor; unrelated donor with at least one mismatch at one of the following four HLA-gene loci: HLA-A, -B,C and -DRB1; use of umbilical cord blood as stem cell source; use of ex vivo T-cell-depleted grafts; Grade 2 or greater Graft-Versus-Host Disease (GVHD), requiring systemic corticosteroids.
Danish: Ved baseline havde 31 % af forsøgspersonerne en høj risiko for reaktivering, hvilket var defineret ud fra et eller flere af følgende kriterier: humant leukocyt-antigen (HLA)-beslægtet (søster eller bror) donor med mindst et mismatch ved et af følgende tre HLA-gen-loci: HLA-A, -B eller -DR, haploidentisk donor; ubeslægtet donor med mindst et mismatch ved et af følgende fire HLA-gen-loci: HLA-A, -B, -C og -DRB1; brug af navlestrengsblod som stamcellekilde; brug af transplantater udtømt for T-celler ex vivo; graft-versus-host-sygdom (GVHD) af grad 2 eller højere, som kræver behandling med systemiske kortikosteroider.
English: Additional effects of other products on letermovir relevant when combined with cyclosporine
Danish: Yderligere indvirkninger fra andre lægemidler på letermovir, som er relevant ved kombination med ciclosporin
English: The European Medicines Agency has deferred the obligation to submit the results of studies with PREVYMIS in one or more subsets of the paediatric population for prophylaxis of cytomegalovirus infection (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med PREVYMIS i en eller flere undergrupper af den pædiatriske population for profylakse mod cytomegalovirus-infektion (se pkt.
English: There is no experience with human overdose with PREVYMIS.
Danish: Der er ingen erfaring med overdosering med PREVYMIS hos mennesker.
English: Nervous system disorders Uncommon dysgeusia, headache
Danish: Nervesystemet Ikke almindelig dysgeusi, hovedpine
English: Reproduction
Danish: Reproduktion
English: In cases of clinically significant CMV DNAemia or disease, letermovir prophylaxis was stopped and standard-of-care pre-emptive therapy (PET) or treatment was initiated.
Danish: I tilfælde af klinisk signifikant CMV-DNAæmi eller -sygdom blev profylaktisk behandling med letermovir stoppet, og præemptiv standardbehandling (PET) eller behandling blev initieret.
English: Effect of letermovir on other medicinal products
Danish: Letermovirs indvirkning på andre lægemidler
English: Based on population pharmacokinetic analyses, there is no effect of age on letermovir pharmacokinetics.
Danish: På basis af farmakokinetiske populationsanalyser er der ingen indvirkning af alder på letermovirs farmakokinetik.
English: During Phase 1 clinical trials, 86 healthy subjects received doses ranging from 720 mg/day to 1440 mg/day of PREVYMIS for up to 14 days.
Danish: Under kliniske fase 1studier fik 86 raske forsøgspersoner doser af PREVYMIS fra 720 mg/dag til 1.440 mg/dag i op til 14 dage.
English: In preclinical distribution studies, letermovir is distributed to organs and tissues with the highest concentrations observed in the gastrointestinal tract, bile duct and liver and low concentrations in the brain.
Danish: I prækliniske fordelingsstudier fordeles letermovir til organer og væv med de højeste koncentrationer observeret i mave-tarm-kanalen, galdegangen og leveren og lave koncentrationer i hjernen.
English: Any intravenous bags or infusion set materials not listed below should not be used.
Danish: Intravenøse infusionsposer og infusionssæt, der ikke er anført nedenfor, må ikke anvendes.
English: No known letermovir resistance mutations map to UL89.
Danish: Ingen kendte letermovir-resistens-mutationer opstår i UL89.
English: The major elimination pathways of letermovir is biliary excretion as well as direct glucuronidation.
Danish: De primære eliminationsveje for letermovir er biliær udskillelse såvel som direkte glucuronidering.
English: The tablet is 16.5 mm long and 8.5 mm wide.
Danish: Tabletten er 16,5 mm lang og 8,5 mm bred.
English: Ear and labyrinth disorders Uncommon vertigo
Danish: Øre og labyrint Ikke almindelig vertigo
English: Letermovir affects the formation of proper unit length genomes and interferes with virion maturation.
Danish: Letermovir påvirker dannelsen af genomer med reel enhedslængde og interfererer med modning af virioner.
English: Letermovir is extensively bound (98.2%) to human plasma proteins, independent of the concentration range (3 to 100 mg/L) evaluated, in vitro.
Danish: Letermovir har en høj bindingsgrad (98,2 %) til humane plasmaproteiner, uafhængigt af det evaluerede koncentrationsinterval (3 til 100 mg/l), in vitro.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of letermovir in milk (see section 5.3).
Danish: De tilgængelige farmakodynamiske/toksikologiske data fra dyreforsøg viser, at letermovir udskilles i mælk (se pkt.
English: Non-myeloablative (n=85, 37)
Danish: Non-myeloablativt (n=85, 37)
English: Medicinal products transported by OATP1B1/3
Danish: Lægemidler, der transporteres af OATP1B1/3
English: Letermovir is partly eliminated by glucuronidation mediated by UGT1A1/1A3.
Danish: Letermovir elimineres delvist ved glucuronidering medieret af UGT1A1/1A3.
English: Expected: ↓ dabigatran
Danish: Forventet: ↓ dabigatran
English: • efavirenz, etravirine, nevirapine, lopinavir, ritonavir - for HIV
Danish: • efavirenz, etravirin, nevapirin, lopinavir, ritonavir - mod hiv
English: Based on population pharmacokinetic analyses, letermovir AUC is estimated to be 18.7% lower in subjects weighing 80-100 kg compared to subjects weighing 67 kg.
Danish: På basis af farmakokinetiske populationsanalyser estimeres letermovirs AUC at være 18,7 % lavere hos forsøgspersoner, der vejer 80-100 kg, sammenlignet med forsøgspersoner, der vejer 67 kg.
English: If dose adjustments of concomitant medicinal products are made due to treatment with PREVYMIS, doses should be readjusted after treatment with PREVYMIS is completed.
Danish: Hvis der foretages dosisjustering af samtidigt anvendte lægemidler på grund af behandling med PREVYMIS, bør doserne genjusteres, når behandlingen med PREVYMIS er afsluttet.
English: Uncommon abdominal pain
Danish: Ikke almindelig abdominalsmerter
English: Induction may give rise to reduced plasma concentrations of some metabolised and transported medicinal products (see section 4.5).
Danish: Induktion kan medføre nedsatte plasmakoncentrationer af nogle metaboliserede og transporterede lægemidler (se pkt.
English: Expected: ↑ amiodarone
Danish: Forventet: ↑ amiodaron
English: Expected: ↑ CYP3A metabolised opioids
Danish: Forventet: ↑ CYP3A-metaboliserede opioider
English: Medicinal products metabolised by CYP2C9 and/or CYP2C19
Danish: Lægemidler, der metaboliseres af CYP2C9 og/eller CYP2C19
English: In healthy subjects, oral administration of 480 mg single dose of letermovir with a standard high fat and high calorie meal did not have any effect on the overall exposure (AUC) and resulted in approximately 30% increase in peak levels (Cmax) of letermovir.
Danish: Hos raske forsøgspersoner havde oral administration af en enkelt dosis af letermovir på 480 mg sammen med et fedt- og kalorieholdigt standardmåltid ingen indvirkning på den samlede eksponering (AUC) og resulterede i en stigning på ca. 30 % i letermovirs peak-niveau (Cmax).
English: PREVYMIS is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).
Danish: PREVYMIS er indiceret til profylakse mod cytomegalovirus (CMV)-reaktivering og -sygdom hos voksne CMV-seropositive recipienter [R+] af allogen hæmatopoietisk stamcelletransplantation (HSCT).
English: • If you miss your appointment to get PREVYMIS, call your doctor straight away to reschedule your appointment.
Danish: • Hvis du glemmer din aftale om at få Prevymis, skal du straks kontakte lægen for at få en ny aftale.
English: Blood to plasma partitioning of letermovir is 0.56 and independent of the concentration range (0.1 to 10 mg/L) evaluated in vitro.
Danish: Fordelingen af letermovir i blod i forhold til plasma er 0,56 og uafhængig af koncentrationsintervallet (0,1-10 mg/l) vurderet in vitro.
English: The adverse reaction profile was similar to that of the clinical dose of 480 mg/day.
Danish: Bivirkningsprofilen var sammenlignelig med bivirkningsprofilen ved den kliniske dosis på 480 mg/dag.
English: Additional monitoring may be recommended; refer to the prescribing information for such medicinal products.
Danish: Det tilrådes at foretage yderligere monitorering; se produktresuméet for sådanne lægemidler.
English: • omeprazole, pantoprazole - for stomach ulcers and other stomach problems
Danish: • omeprazol, pantoprazol - mod mavesår eller andre maveproblemer
English: Changes in letermovir plasma concentrations due to inhibition of P-gp/BCRP are not anticipated to be clinically relevant.
Danish: Ændringer i letermovirs plasmakoncentration som følge af P-gp-/BCRP-hæmning forventes ikke at være klinisk relevante.
English: Letermovir demonstrated superior efficacy over placebo in the analysis of the primary endpoint, as shown in Table 3.
Danish: Det blev påvist, at letermovir havde bedre (superior) virkning end placebo i analysen af det primære virkningsmål, som vist i tabel 3.
English: Each mL of concentrate contains 20 mg/mL.
Danish: Hver ml koncentrat indeholder 20 mg/ml.
English: When PREVYMIS is co-administered with these statins, a statin dose reduction may be necessary
Danish: Når PREVYMIS administreres sammen med disse statiner, kan det være nødvendigt at reducere dosis af statiner
English: This is equivalent to 1.15% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 1,15 % af det anbefalede maksimale daglige indtag af natrium for voksne.
English: The safety assessment of PREVYMIS was based on a Phase 3 clinical trial (P001) in HSCT recipients who received PREVYMIS or placebo through Week 14 post-transplant and were followed for safety through Week 24 post-transplant (see section 5.1).
Danish: Vurderingen af PREVYMIS' sikkerhed blev baseret på et klinisk fase 3-studie (P001) med HSCTrecipienter, som fik PREVYMIS eller placebo til og med uge 14 efter transplantation og blev fulgt med hensyn til sikkerhed til og med uge 24 efter transplantation (se pkt.
English: This needs to be considered when the letermovir regimen is changed during treatment with a CYP2C9 or CYP2C19 substrate.
Danish: Dette skal tages i betragtning, når der skiftes letermovir-regime under behandling med et CYP2C9- eller CYP2C19-substrat.
English: Expected: ↑ or ↓ repaglinide
Danish: Forventet: ↑ eller ↓ repaglinid
English: Donor mismatch Matched related (n=108, 58)
Danish: Donor-mismatch Match beslægtet (n=108, 58)
English: • Magnesium sulfate
Danish: Magnesiumsulfat
English: However, if it is nearly time for the next dose, skip the missed dose.
Danish: Hvis det dog næsten er tid til den næste dosis, så spring den manglende dosis over.
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Danish: Fortæl lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: • nafcillin - for bacterial infections
Danish: • nafcillin - mod bakterieinfektioner
English: If you forget to take PREVYMIS
Danish: Hvis du har glemt at tage Prevymis
English: Plasticizers Diethylhexyl-phthalate (DEHP), tris (2-ethylhexyl) trimellitate (TOTM), butyl benzyl phthalate (BBP)
Danish: Blødgøringsmidler Diethylhexylphthalat (DEHP), tris (2-ethylhexyl)-trimellitat (TOTM) og butylbenzylphthalat (BBP).
English: The most frequently reported adverse reactions that led to discontinuation of PREVYMIS were nausea (1.6%), vomiting (0.8%), and abdominal pain (0.5%).
Danish: De hyppigst rapporterede bivirkninger, der førte til seponering af PREVYMIS, var kvalme (1,6 %), opkastning (0,8 %) og abdominalsmerter (0,5 %).
English: PREVYMIS tablets and concentrate for solution for infusion may be used interchangeably at the discretion of the physician, and no dose adjustment is necessary.
Danish: PREVYMIS tabletter og koncentrat til infusionsvæske, opløsning, er indbyrdes ombyttelige efter lægens vurdering, og det er ikke nødvendigt at justere dosis.
English: In patients with moderate or severe renal impairment (creatinine clearance less than 50 mL/min) receiving PREVYMIS, accumulation of hydroxypropylbetadex, could occur (see section 5.3).
Danish: Hos patienter med moderat nedsat eller svært nedsat nyrefunktion (kreatininclearance under 50 ml/min), som får PREVYMIS, kan der forekomme akkumulering af hydroxypropylbetadex (se pkt.
English: In patients in whom letermovir prophylaxis was initiated and the baseline CMV DNA test was subsequently found to be positive, prophylaxis could be continued if PET criteria had not been met (see section 5.1).
Danish: Hos de patienter, som fik initieret profylaktisk behandling med letermovir, og hvis CMV-DNA-test ved baseline efterfølgende viste sig at være positiv, kunne profylaktisk behandling fortsættes, hvis PET-kriterierne ikke var opfyldt (se pkt.
English: The most commonly reported adverse reactions occurring in at least 1% of subjects in the PREVYMIS group and at a frequency greater than placebo were: nausea (7.2%), diarrhoea (2.4%), and vomiting
Danish: De hyppigst rapporterede bivirkninger, der forekom hos mindst 1 % af forsøgspersonerne i PREVYMIS-gruppen og med en højere hyppighed i forhold til placebo, var kvalme (7,2 %), diarré (2,4 %) og opkastning (1,9 %).
English: Based on population pharmacokinetic analyses, there is no difference in letermovir pharmacokinetics in females compared to males.
Danish: På basis af farmakokinetiske populationsanalyser er der ingen forskel i letermovirs farmakokinetik hos kvinder sammenlignet med mænd.
English: PREVYMIS may be started before or after engraftment.
Danish: PREVYMIS kan initieres før eller efter engraftment (anslag af transplantatet).
English: Letermovir has the potential to decrease the exposure of CYP2C9 and/or CYP2C19 substrates potentially resulting in subtherapeutic levels.
Danish: Letermovir har potentiale til at nedsætte eksponeringen for CYP2C9- og/eller CYP2C19-substrater, hvilket potentielt resulterer i subterapeutiske niveauer.
English: Expected: ↓ letermovir (P-gp/UGT induction)
Danish: Forventet: ↓ letermovir (P-gp/UGT-induktion)
English: The other ingredients are: hydroxypropylbetadex (cyclodextrin), sodium chloride, sodium hydroxide (E524), water for injections.
Danish: - Øvrige indholdsstoffer: hydroxypropylbetadex (cyclodextrin), natriumchlorid, natriumhydroxid (E524), vand til injektionsvæsker.
English: If they do not remember until it is time for the next dose, they should skip the missed dose and go back to the regular schedule.
Danish: Hvis de ikke kommer i tanke om det, før det er tid til den næste dosis, skal de springe den glemte dosis over og vende tilbage til det normale doseringsskema.
English: The process involves the hepatic uptake transporters OATP1B1 and 3 followed by UGT1A1/3 catalysed glucuronidation.
Danish: Processen involverer de hepatiske optagelsestransportører OATP1B1 og 3 efterfulgt af UGT1A1/3-katalyseret glucuronidering.
English: Intravenous use after dilution.
Danish: Intravenøs anvendelse efter fortynding.
English: Comparing letermovir regimen administered without cyclosporine, the effect is more marked after iv than oral letermovir.
Danish: Ved sammenligning med et letermovir-regime administreret uden ciclosporin er indvirkningen mere udtalt efter intravenøs administration af letermovir end efter oral administration af letermovir.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from PREVYMIS therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med PREVYMIS skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: • If you are not sure what to do, call your doctor or pharmacist.
Danish: • Hvis du er i tvivl om, hvad du skal gøre, skal du kontakte lægen eller apotekspersonalet.
English: Based on population pharmacokinetic analyses, letermovir AUC is estimated to be 33.2% higher in Asians compared to Whites.
Danish: På basis af farmakokinetiske populationsanalyser estimeres letermovirs AUC at være 33,2 % højere hos asiater sammenlignet med kaukasere.
English: PREVYMIS concentrate for solution for infusion contains hydroxypropylbetadex.
Danish: PREVYMIS koncentrat til infusionsvæske, opløsning, indeholder hydroxypropylbetadex.
English: • alfentanil - for severe pain
Danish: • alfentanil - mod stærke smerter
English: See Table 1 for steps to prevent or manage these known or potentially significant medicinal product interactions, including dosing recommendations (see sections 4.3 and 4.5).
Danish: Se tabel 1 for anbefalinger vedrørende forebyggelse eller håndtering af disse dokumenterede eller potentielt signifikante lægemiddelinteraktioner, herunder doseringsanbefalinger (se pkt.
English: Amphotericin B (lipid complex) is compatible with PREVYMIS.
Danish: Amphotericin B (lipidkompleks) er kompatibelt med Prevymis.
English: How to take • Swallow the tablet whole with some water.
Danish: Sådan skal du tage tabletterne • Slug tabletten hel med vand.
English: Unless a particular enzyme or transporter is also inhibited (see below) induction can be expected.
Danish: Der kan forventes induktion, medmindre et specifikt enzym eller en specifik transportør også bliver hæmmet (se nedenfor).
English: Letermovir was not genotoxic in a battery of in vitro or in vivo assays, including microbial mutagenesis assays, chromosomal aberration in Chinese Hamster Ovary cells, and in an in vivo mouse micronucleus study.
Danish: Letermovir var ikke genotoksisk i en række in vitro- og in vivo-analyser, herunder mikrobielle mutageneseanalyser, kromosomafvigelse i ovarieceller fra kinesiske hamstere og i et in vivomikronukleusstudie med mus.
English: PREVYMIS is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: PREVYMIS bør ikke anvendes under graviditeten og til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: Medicinal products metabolised by CYP2B6, UGT1A1 or transported by BCRP or OATP2B1 Letermovir is a general inducer in vivo but has also been observed to inhibit CYP2B6, UGT1A1, BCRP, and OATP2B1 in vitro.
Danish: Lægemidler, der metaboliseres af CYP2B6, UGT1A1 eller transporteres af BCRP eller OATP2B1 Letermovir er en generel induktor in vivo, men er også blevet observeret hæmme CYP2B6, UGT1A1, BCRP og OATP2B1 in vitro.
English: The effect is expected to be less pronounced for oral letermovir without cyclosporine, than IV letermovir with or without cyclosporine, or oral letermovir with cyclosporine.
Danish: Indvirkningen forventes at være mindre udtalt for oralt administreret letermovir uden ciclosporin end for intravenøst administreret letermovir med eller uden ciclosporin, eller oralt administreret letermovir med ciclosporin.
English: • statins, such as atorvastatin, fluvastatin, rosuvastatin, simvastatin, pravastatin, pitavastatin - for high cholesterol
Danish: • statiner, f.eks. atorvastatin, fluvastatin, rosuvastatin, simvastatin, pravastatin, pitavastatin - mod for højt kolesteroltal
English: This toxicity was characterized by seminiferous tubular degeneration, and oligospermia and cell debris in the epididymides, with decreased testicular and epididymides weights.
Danish: Denne toksicitet var karakteriseret ved degeneration af sædkanalerne og oligospermi og henfaldent cellevæv i bitestiklerne, med nedsat testikel- og bitestikelvægt.
English: Based on population pharmacokinetic analyses, the mean steady-state volume of distribution is estimated to be 45.5 L following intravenous administration in HSCT recipients.
Danish: På basis af farmakokinetiske populationsanalyser estimeres det gennemsnitlige fordelingsvolumen ved steady state at være 45,5 l efter intravenøs administration hos HSCT-recipienter.
English: Letermovir is a moderate inhibitor of CYP3A in vivo.
Danish: Letermovir er en moderat CYP3A-hæmmer in vivo.
English: -Examples of medicinal products transported by OAT3 includes ciprofloxacin, tenofovir, imipenem, and cilastin.
Danish: - Eksempler på lægemidler, der transporteres af OAT3, er ciprofloxacin, tenofovir, imipenem og cilastin.
English: • dabigatran, warfarin - used to thin the blood or for blood clots
Danish: • dabigatran, warfarin - anvendes som blodfortyndende middel eller mod blodpropper
English: Effect of other medicinal products on letermovir
Danish: Andre lægemidlers indvirkning på letermovir
English: Immune system disorders Uncommon hypersensitivity
Danish: Immunsystemet Ikke almindelig overfølsomhed
English: Letermovir may increase the plasma concentrations of medicinal products transported by OATP1B1/3 such as many of the statins (see section 4.5 and Table 1).
Danish: Letermovir kan øge plasmakoncentrationen af lægemidler, der transporteres af OATP1B1/3, såsom mange af statinerne (se pkt.
English: Renal and urinary disorders Uncommon blood creatinine increased
Danish: Nyrer og urinveje Ikke almindelig forhøjet kreatinin i blodet
English: Subjects received CMV DNA monitoring weekly until post-transplant week 14 and then bi-weekly until post-transplant week 24, with initiation of standard-of-care CMV pre-emptive therapy if CMV DNAemia was considered clinically significant.
Danish: Forsøgspersonerne blev monitoreret for CMV-DNA en gang om ugen indtil uge 14 efter transplantation og herefter hver anden uge indtil uge 24 efter transplantation, med initiering af præemptiv CMV-standardbehandling, hvis CMV-DNAæmi blev anset for at være klinisk signifikant.
English: Do not shake.
Danish: Omryst ikke.
English: Rifampicin co-administration resulted in an initial increase in letermovir plasma concentrations (due to OATP1B1/3 and/or P-gp inhibition) that is not clinically relevant, followed by clinically relevant decreases in letermovir plasma concentrations (due to induction of P-gp/UGT) with continued rifampicin co-administration (see Table 1).
Danish: Administration sammen med rifampicin resulterede i en initial stigning i plasmakoncentrationen af letermovir (på grund af OATP1B1/3 og/eller P-gp-hæmning), som ikke er klinisk relevant, efterfulgt af klinisk relevante fald i plasmakoncentrationen af letermovir (på grund af P-gp/UGT-induktion) ved fortsat administration sammen med rifampicin (se tabel 1).
English: Thirty-seven percent (37%) of subjects were engrafted at baseline.
Danish: 37 % af forsøgspersonerne havde engraftment ved baseline.
English: The pharmacokinetics of letermovir have been characterized following oral and IV administration in healthy subjects and HSCT recipients.
Danish: Letermovirs farmakokinetik er blevet karakteriseret efter oral og intravenøs administration hos raske forsøgspersoner og HSCT-recipienter.
English: In monkeys administered letermovir, there was no evidence of testicular toxicity based on histopathologic evaluation, measurement of testicular size, blood hormone analysis (follicle stimulating hormone, inhibin B and testosterone) and sperm evaluation (sperm count, motility and morphology) at systemic exposures approximately 2-fold the AUC in humans at the RHD.
Danish: Hos aber, der fik administreret letermovir, var der ingen tegn på testikeltoksicitet på baggrund af histopatologisk vurdering, måling af testikelstørrelse, blodhormonanalyse (follikelstimulerende hormon, inhibin B og testosteron) og vurdering af sæd (sædtal, -motilitet og -morfologi) ved systemiske eksponeringer på ca. 2 gange AUC hos mennesker ved RHD.
English: Posology PREVYMIS is also available for oral administration (240 mg and 480 mg film-coated tablets).
Danish: PREVYMIS fås også til oral administration (240 mg og 480 mg filmovertrukne tabletter).