FrancophonIA/ELRC3.0 huggingface dataset:
English: The mutations map to UL56 and occur in amino acid residues between 231 and 369 (V231A, V231L, V236L, V236M, E237D, L241P, T244K, T244R, L257I, F261C, F261L, F261S, Y321C, C325F, C325R, C325W, C325Y, M329T, R369G, R369M, R369S).
Danish: Mutationerne opstår i UL56 og finder sted i aminosyrer mellem 231 og 369 (V231A, V231L, V236L, V236M, E237D, L241P, T244K, T244R, L257I, F261C, F261L, F261S, Y321C, C325F, C325R, C325W, C325Y, M329T, R369G, R369M, R369S).
English: Antibiotics nafcillin
Danish: Antibiotika nafcillin
English: Do not use the vial if the solution is discoloured or contains visible particles.
Danish: Brug ikke hætteglasset, hvis opløsningen er misfarvet eller indeholder synlige partikler.
English: Letermovir is a moderate inducer of enzymes and transporters.
Danish: Letermovir er en moderat induktor af enzymer og transportører.
English: FAS=Full analysis set; FAS includes randomised subjects who received at least one dose of study medicine, and excludes subjects with detectable CMV DNA at baseline.
Danish: FAS = Fuldt analysesæt; FAS omfatter randomiserede forsøgspersoner, der fik mindst en dosis studiemedicin, og omfatter ikke forsøgspersoner med detekterbart CMV-DNA ved baseline.
English: Incompatible medicinal products
Danish: Inkompatible lægemidler
English: CYP2C9 is likely also induced.
Danish: CYP2C9 induceres sandsynligvis også.
English: Letermovir exposure increased in a greater than doseproportional manner with both oral or IV administration.
Danish: Eksponeringen for letermovir steg mere end dosisproportionalt med både oral og intravenøs administration.
English: It is unknown whether letermovir may affect the exposure of piperacillin/tazobactam, amphotericine B and micafungin.
Danish: Det vides ikke, om letermovir kan påvirke eksponeringen for piperacillin/tazobactam, amphotericin B og micafungin.
English: High Risk (n=102, 45) Low Risk (n=223, 125)
Danish: Høj risiko (n=102, 45) Lav risiko (n=223, 125)
English: There are some medicines you must not take with PREVYMIS.
Danish: Der er visse lægemidler, som du ikke må tage sammen med Prevymis.
English: No (n=276, 153)
Danish: Nej (n=276, 153)
English: Among the 565 treated subjects, 373 subjects received letermovir (including 99 subjects who received at least one IV dose) and 192 received placebo (including 48 subjects who received at least one IV dose).
Danish: Af de 565 behandlede forsøgspersoner fik 373 forsøgspersoner letermovir (herunder 99 forsøgspersoner, der fik mindst en intravenøs dosis), og 192 fik placebo (herunder 48 forsøgspersoner, der fik mindst en intravenøs dosis).
English: The increase in midazolam plasma concentration may be greater when oral midazolam is administered with letermovir at the clinical dose than with the dose studied.
Danish: Stigningen i plasmakoncentrationen af midazolam kan være højere, når oralt midazolam administreres sammen med letermovir ved den kliniske dosis end med den undersøgte dosis.
English: Concomitant use is not recommended glyburide
Danish: Samtidig anvendelse anbefales ikke glyburid
English: General information about differences in exposure between different letermovir treatment regimens -The estimated letermovir plasma exposure is different depending on the dose regimen used (see table in section 5.2).
Danish: Generel information om forskelle i eksponering mellem forskellige letermovir-regimer - Den estimerede eksponering for letermovir i plasma er forskellig afhængigt af det anvendte dosisregime (se tabellen i pkt.
English: Polyamide/Aluminium/PVC - Aluminium blister cards.
Danish: Polyamid/aluminium/PVC - aluminiumblisterkort.
English: PREVYMIS may have minor influence on the ability to drive or use machines.
Danish: PREVYMIS kan i mindre grad påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: • significant decrease of concomitant medicinal product plasma concentrations which may lead to reduced therapeutic effect of the concomitant medicinal product.
Danish: • signifikant fald i plasmakoncentrationerne af samtidigt anvendte lægemidler, hvilket kan føre til nedsat terapeutisk virkning af det samtidigt anvendte lægemiddel.
English: The tablet is 21.2 mm long and 10.3 mm wide.
Danish: Tabletten er 21,2 mm lang og 10,3 mm bred.
English: Table 1 provides a listing of established or potentially clinically significant medicinal product interactions.
Danish: Tabel 1 indeholder en oversigt over dokumenterede eller potentielt klinisk signifikante lægemiddelinteraktioner.
English: Prophylaxis with PREVYMIS should continue through 100 days post-transplant.
Danish: Profylaktisk behandling med PREVYMIS skal fortsættes i 100 dage efter transplantation.
English: PREVYMIS may have minor influence on your ability to drive and use machines (see section 4 Possible Side Effects below).
Danish: Prevymis kan i mindre grad påvirke din evne til at køre bil og betjene maskiner (se punkt 4 Bivirkninger nedenfor).
English: Sodium hydroxide (E524) Water for injections
Danish: Natriumhydroxid (E524) Vand til injektionsvæsker
English: • midazolam - used as a sedative
Danish: • midazolam - anvendes som et beroligende middel (sedativ)
English: Letermovir vs Placebo Stratified log-rank test, two-sided p-value <0.0001
Danish: Letermovir versus placebo Stratificeret log-rank-test, tosidet p-værdi <0,0001
English: PREVYMIS may be started on the day of transplant and no later than 28 days post-transplant.
Danish: PREVYMIS kan initieres på transplantationsdagen og senest 28 dage efter transplantation.
English: This change is not clinically relevant.
Danish: Denne ændring er ikke klinisk relevant.
English: • cyclosporine, tacrolimus, sirolimus - used to prevent transplant rejection
Danish: • ciclosporin, tacrolimus, sirolimus - anvendes til at forebygge afstødning af transplantat
English: Efficacy consistently favoured letermovir across subgroups including low and high risk for CMV reactivation, conditioning regimens, and concomitant immunosuppressive regimens (see Figure 2).
Danish: Virkningen var konsekvent til fordel for letermovir på tværs af subgrupperne, herunder lav og høj risiko for CMV-reaktivering, konditioneringsregimer og samtidig behandling med immunsupprimerende regimer (se figur 2).
English: It is known that hydroxypropylbetadex can cause kidney vacuolation in rats when given intravenously at doses greater than 50 mg/kg/day.
Danish: Det vides, at hydroxypropylbetadex kan forårsage vakuolisering i nyrerne hos rotter, når det gives intravenøst ved doser højere end 50 mg/kg/dag.
English: See the package leaflet for your other medicine for further information.
Danish: Se indlægssedlen for anden medicin, du får, for yderligere oplysninger.
English: Letermovir was initiated after HSCT (Day 0-28 post-transplant) and continued through Week 14 post-transplant.
Danish: Letermovir blev initieret efter HSCT (dag 0-28 efter transplantation) og fortsatte til og med uge 14 efter transplantation.
English: Table 4: Letermovir AUC (ng•hr/mL) values in HSCT Recipients Treatment Regimen
Danish: Tabel 4: Letermovirs AUC (ng•t/ml)-værdier hos HSCT-recipienter Behandlingsregime
English: Letermovir was absorbed rapidly with a median time to maximum plasma concentration (Tmax) of 1.5 to 3.0 hours and declined in a biphasic manner.
Danish: Letermovir blev absorberet hurtigt med en mediantid til maksimal plasmakoncentration (Tmax) på 1,5 til 3,0 timer, og koncentrationen aftog på en bifasisk måde.
English: In HSCT recipients, letermovir AUC was estimated using population pharmacokinetic analyses using Phase 3 data (see Table 4).
Danish: Hos HSCT-recipienter blev letermovirs AUC estimeret ved hjælp af farmakokinetiske populationsanalyser ved brug af fase 3-data (se tabel 4).
English: • amiodarone - used to correct irregular heartbeats
Danish: • amiodaron - anvendes til at afhjælpe uregelmæssig hjerterytme
English: The safety and efficacy of letermovir has been established in patients with a negative CMV DNA test result prior to initiation of prophylaxis.
Danish: Letermovirs sikkerhed og virkning er klarlagt hos patienter med et negativt CMV-DNA-testresultat forud for initieringen af profylaktisk behandling.
English: Risk of ↓ contraceptive steroids Letermovir may reduce plasma concentrations of other oral contraceptive steroids thereby affecting their efficacy.
Danish: Risiko for ↓ kontraceptive steroider Letermovir kan nedsætte plasmakoncentrationerne af andre orale kontraceptive steroider og derved påvirkes deres virkning.
English: Statinassociated adverse events such as myopathy should be closely monitored.
Danish: Statinrelaterede bivirkninger, f.eks. myopati, bør monitoreres nøje.
English: Expected: ↑ quinidine
Danish: Forventet: ↑ quinidin
English: Differences in exposure across treatment regimens are not clinically relevant; efficacy was consistent across the range of exposures observed in P001.
Danish: Forskelle i eksponering på tværs af behandlingsregimer er ikke klinisk relevante; virkningen var konsistent på tværs af de eksponeringsintervaller, der blev observeret i P001.
English: Fatigue and vertigo have been reported in some patients during treatment with PREVYMIS, which may influence a patient's ability to drive and use machines (see section 4.8).
Danish: Træthed og vertigo er rapporteret hos nogle patienter under behandlingen med PREVYMIS, hvilket kan påvirke patientens evne til at føre motorkøretøj og betjene maskiner (se pkt.
English: One subject had a letermovir-resistant GV (V236M).
Danish: En forsøgsperson havde en letermovir-resistent GV (V236M).
English: • Famotidine
Danish: • Famotidin
English: Frequent monitoring for adverse reactions related to these medicinal products is recommended during co-administration.
Danish: Der anbefales hyppig monitorering for bivirkninger relateret til disse lægemidler under samtidig administration.
English: Unless otherwise specified, interaction studies have been performed with oral letermovir without cyclosporine.
Danish: Medmindre andet er angivet, er der udført interaktionsstudier med oralt letermovir uden ciclosporin.
English: 95% CIs and p-value for the treatment differences in percent response were calculated using stratumadjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (high or low risk).
Danish: 95 % konfidensintervaller og p-værdi for behandlingsforskel i procent respons blev beregnet ved hjælp af en stratumjusteret Mantel-Haenszel-metode med forskellen vægtet efter det harmoniske gennemsnit af stikprøvestørrelse pr. arm for hvert stratum (høj eller lav risiko).
English: General toxicity
Danish: Generel toksicitet
English: Therefore, letermovir may potentially lead to decreased plasma exposure and possibly reduced efficacy of co-administered medicinal products that are mainly eliminated through metabolism or by active transport.
Danish: Derfor kan letermovir potentielt medføre nedsat plasmaeksponering og eventuelt reduceret virkning af samtidigt administrerede lægemidler, som hovedsagligt elimineres via metabolisering eller ved aktiv transport.
English: When ending treatment, it takes 10-14 days for the inhibitory effect to disappear.
Danish: Ved behandlingsophør tager det 10-14 dage før den hæmmende effekt er forsvundet.
English: The tablet should not be divided, crushed, or chewed.
Danish: Tabletten må ikke deles, knuses eller tygges.
English: This will give the medicine the best chance to keep you from becoming ill from CMV after you get a bone marrow transplant.
Danish: Derved får lægemidlet de bedste betingelser for at forhindre, at du bliver syg af CMV, efter at du har gennemgået en knoglemarvstransplantation.
English: If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: The CMV genes UL56 and UL89 encode subunits of CMV DNA terminase.
Danish: CMV-generne UL56 og UL89 koder for underenheder af CMV-DNA-terminase.
English: Letermovir - Placebo Difference (%) and 95% C.I.
Danish: Letermovir - placebo, forskel (%) og 95% CI
English: The dose of atorvastatin should not exceed 20 mg daily when co-administered with PREVYMIS
Danish: Atorvastatin-dosis må ikke overstige 20 mg dagligt ved administration sammen med PREVYMIS
English: • This medicinal product must not be mixed with other medicinal products except those listed below.
Danish: • Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført nedenfor.
English: There is no specific antidote for overdose with PREVYMIS.
Danish: Der findes ingen specifik modgift i tilfælde af overdosering med PREVYMIS.
English: • possible clinically significant adverse reactions from greater exposure of concomitant medicinal products or letermovir.
Danish: • mulige klinisk signifikante bivirkninger fra større eksponering for samtidigt anvendte lægemidler eller letermovir.
English: In vitro results indicate that letermovir is a substrate of P-gp/BCRP.
Danish: In vitro-resultater indikerer, at letermovir er et P-gp-/BCRP-substrat.
English: The median EC50 value of letermovir against a collection of clinical CMV isolates in a cell-culture model of infection was 2.1 nM (range = 0.7 nM to 6.1 nM, n=74).
Danish: Letermovirs mediane EC50-værdi mod en samling af kliniske CMV-isolater i en cellekulturmodel af infektion var 2,1 nM (interval = 0,7 nM til 6,1 nM, n=74).
English: Letermovir is fully active against viral populations with substitutions conferring resistance to CMV DNA polymerase inhibitors (ganciclovir, cidofovir, and foscarnet).
Danish: Letermovir er fuldt aktiv mod virale populationer med substitutioner, der giver resistens over for CMV-DNApolymerasehæmmere (ganciclovir, cidofovir og foscarnet).
English: Patients should not double their next dose or take more than the prescribed one.
Danish: Patienterne må ikke tage en dobbeltdosis af deres næste dosis eller tage mere end den ordinerede dosis.
English: PREVYMIS contains cyclodextrin
Danish: Prevymis indeholder cyclodextrin
English: Antiepileptic medicinal products (see also general text) carbamazepine, phenobarbital
Danish: Antiepileptika (se også generel tekst) carbamazepin, phenobarbital
English: Hydroxypropylbetadex (cyclodextrin) Sodium chloride
Danish: Hydroxypropylbetadex (cyclodextrin) Natriumchlorid
English: -An example of a medicinal product which is mainly eliminated by CYP2C8 is repaglinide (see Table 1).
Danish: - Et eksempel på et lægemiddel, som hovedsageligt elimineres af CYP2C8, er repaglinid (se tabel 1).
English: Metabolism and nutrition disorders Uncommon decreased appetite
Danish: Metabolisme og ernæring Ikke almindelig appetitløshed
English: PREVYMIS is a medicine for adults who have recently had a bone marrow transplant.
Danish: Prevymis er et lægemiddel til voksne, som for nylig har gennemgået en knoglemarvstransplantation.
English: Your medicine or dose may then need to be changed.
Danish: Det kan i så fald være nødvendigt at ændre din medicin eller din dosis.
English: Concomitant use of dabigatran should be avoided due to the risk of reduced dabigatran efficacy.
Danish: Samtidig anvendelse af dabigatran skal undgås på grund af risikoen for nedsat virkning af dabigatran.
English: No maternal or developmental effects were noted at the dose of 50 mg/kg/day (approximately 2.5-fold the AUC at the RHD).
Danish: Der blev ikke bemærket nogen maternel eller udviklingsmæssig indvirkning ved en dosis på 50 mg/kg/dag (ca. 2,5 gange AUC ved RHD).
English: quinidine
Danish: quinidin
English: The following adverse reactions were identified in patients taking PREVYMIS in clinical trials.
Danish: Nedenstående bivirkninger blev identificeret hos patienter, der fik PREVYMIS i kliniske studier.
English: Viral resistance
Danish: Viral resistens
English: (15.0%) subjects were 65 years of age or older: 58% were male; 82% were White; 10% were Asian; 2% were Black or African; and 7% were Hispanic or Latino.
Danish: Medianalderen var 54 år (interval: 18-78 år), 56 (15,0 %) forsøgspersoner var 65 år eller derover, 58 % var mænd, 82 % var kaukasere, 10 % var asiatere, 2 % var negroide eller afrikanere, og 7 % var latinamerikanere.
English: Hepatobiliary disorders Uncommon alanine aminotransferase increased, aspartate aminotransferase increased
Danish: Lever og galdeveje Ikke almindelig forhøjet alaninaminotransferase, forhøjet aspartataminotransferase
English: Close monitoring and/or dose adjustment of co-administered CYP3A substrates is recommended (see section 4.5).
Danish: Nøje monitorering og/eller dosisjustering af samtidigt administrerede CYP3A-substrater anbefales (se pkt.
English: Table 1: Interactions and dose recommendations with other medicinal products.
Danish: Tabel 1: Lægemiddelinteraktioner med andre lægemidler og dosisanbefalinger.
English: Twelve percent (12%) of subjects were positive for CMV DNA at baseline.
Danish: 12 % af forsøgspersonerne var CMV-DNA-positive ved baseline.
English: Expected: ↓ pantoprazole
Danish: Forventet: ↓ pantoprazol
English: Prolonged letermovir prophylaxis beyond 100 days post-transplant may be of benefit in some patients at high risk for late CMV reactivation (see section 5.1).
Danish: Langtidsprofylaktisk behandling med letermovir ud over 100 dage efter transplantation kan være en fordel for nogle patienter med høj risiko for sen CMV-reaktivering (se pkt.
English: One subject (who received 60 mg/day) had a letermovir resistant genotypic variant (GV) (V236M).
Danish: En forsøgsperson (der fik 60 mg/dag) havde en letermovir-resistent genotypevariant (GV) (V236M).
English: Table 3: P001: Efficacy results in HSCT recipients (NC=F Approach, FAS Population) Letermovir
Danish: Tabel 3: P001: Virkningsresultater hos HSCT-recipienter (NC = F-metoden, FAS-population) Letermovir
English: ↑ or ↓ efavirenz (CYP2B6 inhibition or induction)
Danish: ↑ eller ↓ efavirenz (CYP2B6-hæmning eller -induktion)
English: The acyl-glucuronide is unstable in faeces.
Danish: Acylglucuronid er ustabilt i fæces.
English: Store in the original carton in order to protect from light.
Danish: Opbevares i den originale yderkarton for at beskytte mod lys.
English: Letermovir inhibits CYP2C8 in vitro but may also induce CYP2C8 based on its induction potential.
Danish: Letermovir hæmmer CYP2C8 in vitro, men kan også inducere CYP2C8 på basis af dets induktionspotentiale.
English: The majority of letermovir was biliary excreted as unchanged parent with a minor amount (6% of dose) as an acyl-glucuronide metabolite in faeces.
Danish: Størstedelen af letermovir blev udskilt biliært som uomdannet moderstof med en mindre betydelig mængde (6 % af dosis) som en acylglucuronid-metabolit i fæces.
English: Both elimination pathways involve active uptake into the hepatocyte through the hepatic uptake transporters OATP1B1/ 3.
Danish: Begge eliminationsveje involverer aktiv optagelse i hepatocytten via de hepatiske optagelsestransportører OATP1B1/3.
English: • rifabutin, rifampicin - for mycobacterial infections
Danish: • rifabutin, rifampicin - mod mykobakterielle infektioner
English: See also the general text on DDIs above.
Danish: Se også den generelle tekst vedrørende lægemiddelinteraktioner ovenfor.
English: Factors associated with CMV DNAemia after Week 14 post-transplant among letermovir-treated subjects included high risk for CMV reactivation at baseline, GVHD, use of corticosteroids, and CMV negative donor serostatus.
Danish: Faktorer associeret med CMV-DNAæmi efter uge 14 efter transplantation blandt letermovirbehandlede forsøgspersoner omfattede høj risiko for CMV-reaktivering ved baseline, GVHD, brug af kortikosteroider og negativ CMV-serostatus hos donor.
English: Do not break, crush, or chew the tablet.
Danish: Du må ikke dele, knuse eller tygge tabletten.
English: CMV DNAemia warranting anti-CMV PET
Danish: CMV-DNAæmi, som indicerer anti-CMV PET
English: Peripheral blood (n=241, 117)
Danish: Stamcellekilde Perifert blod (n=241, 117)
English: This needs to be considered when the letermovir regimen is changed during treatment with an OATP1B1/3 substrate.
Danish: Dette skal tages i betragtning, når der skiftes letermovir-regime under behandlingen med et OATP1B1/3-substrat.
English: In the fertility and early embryonic development studies in the rat, there were no effects of letermovir on female fertility.
Danish: I studierne af fertilitet og tidlig embryonal udvikling hos rotter var der ingen indvirkning af letermovir på fertiliteten hos hunner.
English: This is because it is not known if PREVYMIS gets in your breast milk and will be passed to your baby.
Danish: Det er ukendt, om Prevymis udskilles i modermælken og overføres til dit barn.
English: Randomisation was stratified by investigational site and risk (high vs. low) for CMV reactivation at the time of study entry.
Danish: Randomiseringen blev stratificeret efter forsøgssted og risiko (høj versus lav) for CMVreaktivering på tidspunktet for indtrædelse i studiet.
English: • you are allergic to letermovir or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for letermovir eller et af de øvrige indholdsstoffer i Prevymis (angivet i punkt 6).
English: You should not be given PREVYMIS if any of the above apply to you.
Danish: Du må ikke få Prevymis, hvis noget af ovenstående gælder for dig.
English: PVC, polyethylene (PE), polybutadiene (PBD), silicone rubber (SR), styrene-butadiene copolymer (SBC), styrene-butadiene-styrene copolymer (SBS), polystyrene (PS)
Danish: PVC, polyethylen (PE), polybutadien (PBD), siliconegummi (SR), styren-butadien-copolymer (SBC), styren-butadien-styren-copolymer (SBS) og polystyren (PS).
English: Oral anticoagulants warfarin
Danish: Orale antikoagulantia warfarin
English: Note: The proportion of subjects with detectable CMV viral DNA on Day 1 that developed clinically significant CMV infection in the letermovir group was 64.6% (31/48) compared to 90.9% (20/22) in the placebo group through Week 24 post-transplant.
Danish: Bemærk: Andelen af forsøgspersoner med detekterbart viralt CMV-DNA på dag 1, som udviklede klinisk signifikant CMV-infektion i letermovir-gruppen, var 64,6 % (31/48) sammenlignet med 90,9 % (20/22) i placebogruppen til og med uge 24 efter transplantation.
English: The safety and efficacy of PREVYMIS in patients below 18 years of age have not been established.
Danish: PREVYMIS' sikkerhed og virkning hos patienter under 18 år er ikke klarlagt.
English: PREVYMIS is an antiviral prescription medicine that contains the active substance letermovir.
Danish: Prevymis er et antiviralt (virusbekæmpende) receptpligtigt lægemiddel, der indeholder det aktive stof letermovir.
English: • If cyclosporine dosing is temporarily interrupted due to high cyclosporine levels, no dose adjustment of PREVYMIS is needed.
Danish: • Hvis doseringen af ciclosporin afbrydes midlertidigt på grund af høje niveauer af ciclosporin, er det ikke nødvendigt at justere dosis af PREVYMIS.
English: PREVYMIS should be used with caution with medicinal products that are CYP3A substrates with narrow therapeutic ranges (e.g., alfentanil, fentanyl, and quinidine) as co-administration may result in increases in the plasma concentrations of CYP3A substrates.
Danish: PREVYMIS bør anvendes med forsigtighed sammen med lægemidler, der er CYP3A-substrater med smalle terapeutiske intervaller (f.eks. alfentanil, fentanyl og quinidin), da samtidig administration kan resultere i stigninger i plasmakoncentrationerne af CYP3A-substrater.