FrancophonIA/ELRC3.0 huggingface dataset:
English: CMV is a virus that a lot of people have without knowing.
Danish: CMV er en virus, som mange mennesker har, uden at de er klar over det.
English: Median (90% Prediction Interval)*
Danish: Median (90 % prædiktionsinterval)*
English: Additional blood tests may be needed to monitor the following medicinal products:
Danish: Yderligere blodprøver kan være nødvendige for at monitorere følgende lægemidler:
English: Take your next dose at the usual time.
Danish: Tag din næste dosis på det sædvanlige tidspunkt.
English: (The net effect is not known).
Danish: (Nettoeffekten er ukendt).
English: Weeks Post-Transplant
Danish: Uger efter transplantation
English: Variations of colour within this range do not affect the quality of the product.
Danish: Farvevariationer inden for dette område påvirker ikke produktets kvalitet.
English: • Take it with or without food.
Danish: • Tag medicinen med eller uden mad.
English: The categories of failure are mutually exclusive and based on the hierarchy of categories in the order listed.
Danish: Kategorierne for failure udelukker hinanden og er baseret på hierarkiet af kategorier i den anførte rækkefølge.
English: *This table is not all inclusive.
Danish: *Denne tabel er ikke udtømmende.
English: • Take PREVYMIS at the same time every day.
Danish: • Tag Prevymis på samme tidspunkt hver dag.
English: N = number of subjects in each treatment group.
Danish: N = Antal forsøgspersoner i hver behandlingsgruppe.
English: Serum creatinine levels should be closely monitored in these patients.
Danish: Serumkreatininniveauerne skal monitoreres nøje hos disse patienter.
English: This should be taken into consideration by patients on a controlled sodium diet.
Danish: Dette skal der tages hensyn til hos patienter på en kontrolleret natriumdiæt.
English: The potential interaction between letermovir and these medicinal products have not been investigated.
Danish: Den potentielle interaktion mellem letermovir og disse lægemidler er ikke undersøgt.
English: There are no data from the use of letermovir in pregnant women.
Danish: Der er ingen data fra anvendelse af letermovir til gravide kvinder.
English: The relative importance of these pathways is unknown.
Danish: Den relative betydning af disse eliminationsveje er ukendt.
English: Cross-resistance is not likely with medicinal products with a different mechanism of action.
Danish: Krydsresistens er ikke sandsynlig med lægemidler med en anden virkningsmekanisme.
English: • Compatible medicinal products are listed below.
Danish: • Kompatible lægemidler er anført nedenfor.
English: This is because your doctor may have to change your medicines or change the dose of your medicines:
Danish: Dette skyldes, at lægen kan blive nødt til at ændre på din medicin eller ændre på dosis af din medicin:
English: 31 May 2020 (PACMP Step 2)
Danish: 31. maj 2020 (PACMP trin 2)
English: Normally, CMV just stays in their body and it does not hurt them.
Danish: Normalt forbliver CMVvirus i kroppen, og det skader dem ikke.
English: If a dose is missed, it should be given to the patient as soon as possible.
Danish: Hvis en dosis glemmes, skal den gives til patienten så hurtigt som muligt.
English: Note that the table is not extensive but provides examples of clinically relevant interactions.
Danish: Bemærk, at tabellen ikke er udtømmende, men giver eksempler på klinisk relevante interaktioner.
English: The relevance to humans is unknown.
Danish: Relevansen for mennesker kendes ikke.
English: Each vial is packaged in a carton.
Danish: Hvert hætteglas er pakket i en karton.
English: • swelling of hands or feet
Danish: • hævede hænder eller fødder.
English: You will get PREVYMIS once a day.
Danish: Du vil få Prevymis en gang om dagen.
English: The preparation and administration instructions are the same for either dose.
Danish: Instruktionerne vedrørende klargøring og administration er de samme for begge doser.
English: The tablet should be swallowed whole and may be taken with or without food.
Danish: Tabletten skal sluges hel og kan tages med eller uden mad.
English: Some saturation was observed at lower concentrations.
Danish: En vis grad af mætning blev observeret ved lavere koncentrationer.
English: Monitoring of CMV DNA
Danish: Monitorering af CMV-DNA
English: Interaction at steady state not studied.
Danish: Interaktion ved steady state er ikke undersøgt.
English: Monitoring is also recommended if changing route of administration.
Danish: Monitorering anbefales også ved skift af administrationsvej.
English: Detailed information is presented below.
Danish: Yderligere information findes nedenfor.
English: General information
Danish: Generel information
English: Immunosuppressive Regimen
Danish: Immunsuppressivt regime
English: It is unknown whether letermovir is excreted in human milk.
Danish: Det er ukendt, om letermovir udskilles i human mælk.
English: The median time to starting letermovir was 9 days after transplantation.
Danish: Mediantiden til opstart med letermovir var 9 dage efter transplantation.
English: The safety and efficacy of letermovir use for more than 100 days has not been studied in clinical trials.
Danish: Sikkerhed og virkning ved brug af letermovir i mere end 100 dage er ikke undersøgt i kliniske studier.
English: Chemical and physical in-use stability has been demonstrated for 48 hours at 25 °C and for 48 hours at 2 to 8 °C.
Danish: Kemisk og fysisk i-brug-stabilitet er påvist i 48 timer ved 25 °C og i 48 timer ved 2-8 °C.
English: Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) or very rare (< 1/10,000).
Danish: Hyppighederne er defineret på følgende måde: Meget almindelig (≥ 1/10), Almindelig (≥ 1/100 til < 1/10), Ikke almindelig (≥ 1/1.000 til < 1/100), Sjælden (≥ 1/10.000 til < 1/1.000) eller Meget sjælden (< 1/10.000).
English: EC50 values for these mutations are 13- to 8,262-fold higher than those for the wild-type reference virus.
Danish: EC50-værdierne for disse mutationer er 13 til 8.262 gange højere end værdierne for vildtype-referencevirusset.
English: See also general information on induction above regarding time courses of the interaction.
Danish: Se også den generelle information om induktion ovenfor vedrørende tidsforløb for interaktion.
English: A 1-sided p-value ≤0.0249 was used for declaring statistical significance.
Danish: En ensidet p-værdi på ≤ 0,0249 blev brugt til at angive statistisk signifikans.
English: Clinical monitoring and dose adjustment may be needed.
Danish: Klinisk monitorering og dosisjustering kan være nødvendig.
English: After oral administration of radio-labeled letermovir, 93.3% of radioactivity was recovered in faeces.
Danish: Efter oral administration af radioaktivt mærket letermovir blev 93,3 % af radioaktiviteten genvundet i fæces.
English: There were no differences in the incidence of or time to engraftment between the PREVYMIS and placebo groups.
Danish: Der var ingen forskel i incidensen af eller tid til engraftment mellem PREVYMIS-gruppen og placebogruppen.
English: n (%) = Number (percent) of subjects in each sub-category.
Danish: n (%) = Antal forsøgspersoner i procent i hver underkategori.
English: You will get PREVYMIS as an infusion (drip) into a vein and it will take about 1 hour.
Danish: Du vil få Prevymis som en infusion (drop) i en vene, og det vil tage omkring 1 time.
English: For adequate contraceptive effect to be ensured with an oral contraceptive, products containing EE and LNG should be chosen.
Danish: For at sikre tilstrækkelig kontraceptiv virkning med et oralt kontraceptivum skal der vælges præparater indeholdende EE og LNG.
English: Efficacy and safety has not been demonstrated for patients with ESRD.
Danish: Virkning og sikkerhed er ikke påvist for patienter med ESRD.
English: This is because PREVYMIS may affect the way other medicines work, and other medicines may affect how PREVYMIS works.
Danish: Årsagen er, at Prevymis kan påvirke, hvordan andre lægemidler virker, og andre lægemidler kan påvirke, hvordan Prevymis virker.
English: The full induction effect can be expected after 10-14 days of letermovir treatment.
Danish: Den fulde indvirkning af induktionen kan forventes efter 10-14 dages behandling med letermovir.
English: The adverse reactions are listed below by body system organ class and frequency.
Danish: Bivirkningerne er anført nedenfor efter systemorganklasse og hyppighed.
English: There is a theoretical risk of reduced exposure due to induction but the size of the effect and thus clinical relevance is presently unknown.
Danish: Der er en teoretisk risiko for nedsat eksponering som følge af induktion, men effektens omfang og herved den kliniske relevans kendes ikke på nuværende tidspunkt.
English: Also tell your doctor if you are taking any of the following medicines.
Danish: Fortæl det også til lægen, hvis du tager et eller flere af følgende lægemidler.
English: Clinically significant CMV infection
Danish: Klinisk signifikant CMV-infektion
English: Opioid agonists Examples: alfentanil, fentanyl
Danish: Opioid-agonister Eksempler: alfentanil, fentanyl
English: Effect on concentration Mean ratio (90 % confidence interval) for AUC, Cmax (likely mechanism of action)
Danish: Indvirkning på koncentration Gennemsnitsratio (90 % konfidensinterval) for AUC, Cmax (sandsynlig interaktionsmekanisme)
English: This difference is not clinically relevant.
Danish: Denne forskel er ikke klinisk relevant.
English: This is because PREVYMIS has not been tested in this age group.
Danish: Dette skyldes, at Prevymis ikke er blevet undersøgt hos denne aldersgruppe.
English: 2220 Heist-op-den-Berg
Danish: 2220 Heist-op-den-Berg Belgien
English: Approach to handling missing values: Non-Completer=Failure (NC=F) approach.
Danish: Metode til håndtering af manglende værdier: Non-Completer = Failure (NC = F)-metoden.
English: Pharmacotherapeutic group: Antivirals for systemic use, direct acting antivirals, ATC code: J05AX18
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug, direkte virkende antivirale midler, ATC-kode: J05AX18
English: It is unknown whether dialysis will result in meaningful removal of PREVYMIS from systemic circulation.
Danish: Det vides ikke, om dialyse vil resultere i signifikant fjernelse af PREVYMIS fra det systemiske kredsløb.
English: If you experience any of these effects, do not drive or use machines until the effect wears off.
Danish: Hvis du får nogle af disse bivirkninger, må du ikke køre bil eller betjene maskiner, før bivirkningerne er aftaget.
English: Reduced intensity conditioning (n=86, 48)
Danish: Konditionering med nedsat intensitet (n=86, 48)
English: The time needed to reach steady state of a specific affected medicinal product will also influence the time needed to reach full effect on the plasma concentrations.
Danish: Den tid, der er nødvendig for at nå steady state for et specifikt påvirket lægemiddel, vil også påvirke den tid, der er nødvendig for at nå den fulde indvirkning på plasmakoncentrationen.
English: Use of letermovir prophylaxis for greater than 100 days requires a careful assessment of the benefit-risk balance.
Danish: Profylaktisk brug af letermovir i mere end 100 dage kræver en nøje vurdering af benefit/risk-forholdet.
English: Consideration should be given to official guidance on the appropriate use of antiviral agents.
Danish: De officielle retningslinjer vedrørende korrekt brug af antivirale midler bør følges.
English: The estimated treatment difference of -23.5% was statistically significant (one-sided p-value <0.0001).
Danish: Den estimerede behandlingsforskel på -23,5 % var statistisk signifikant (ensidet p-værdi < 0,0001).
English: The net effect in vivo on the other listed enzymes and transporters is not known.
Danish: Nettoeffekten in vivo på andre anførte enzymer og transportører er ukendt.
English: The inter-individual variability for CL is estimated to be 24.6%.
Danish: Den inter-individuelle variabilitet for clearance estimeres at være 24,6 %.
English: The net effect in vivo is unknown.
Danish: Nettoeffekten in vivo er ukendt.
English: Due to time dependent inhibition and simultaneous induction the net enzyme inhibitory effect may not be reached until after 10-14 days.
Danish: Som følge af tidsafhængig hæmning og simultan induktion kan nettoeffekten af den enzymatiske hæmning først nås efter 10-14 dage.
English: PREVYMIS is not for use in children and adolescents under 18 years old.
Danish: Prevymis må ikke anvendes til børn og unge under 18 år.
English: No major metabolites are detected in plasma.
Danish: Der er ikke påvist betydningsfulde metabolitter i plasma.
English: Table 2: Adverse reactions identified with PREVYMIS Frequency
Danish: Tabel 2: Bivirkninger identificeret med PREVYMIS Hyppighed
English: Dose adjustment of midazolam should be considered
Danish: Dosisjustering af midazolam bør overvejes
English: A dose adjustment may also be needed when changing route of administration or immunosuppressant.
Danish: En dosisjustering kan også være nødvendig ved skift af administrationsvej eller immunsuppressivum.
English: At baseline, 50% of subjects received a myeloablative regimen, 52% were receiving cyclosporine, and 42% were receiving tacrolimus.
Danish: Ved baseline fik 50 % af forsøgspersonerne et myeloablativt regime, 52 % fik ciclosporin, og 42 % fik tacrolimus.
English: • If you forget a dose, take it as soon as you remember.
Danish: • Hvis du glemmer en dosis, skal du tage den, så snart du kommer i tanke om det.
English: The inter-individual variability for bioavailability was estimated to be approximately
Danish: Den inter-individuelle variabilitet for biotilgængelighed blev estimeret til at være ca. 37 %.
English: These data are the effect of rifampicin on letermovir 24 hours after final rifampicin dose.
Danish: Disse data er rifampicins indvirkning på letermovir 24 timer efter sidste rifampicindosis.
English: No dose adjustment is required based on age.
Danish: Det er ikke nødvendigt at justere dosis på baggrund af alder.
English: In order to optimise the sterility assurance level (SAL) of the manufacturing process, the marketing authorisation holder should implement the measures outlined in the Post Approval Change Management Protocol (PACMP) agreed with the CHMP concerning development, validation and introduction of terminal sterilisation.
Danish: For at optimere sterilitetssikringsniveauet (SAL) for fremstillingsprocessen skal indehaveren af markedsføringstilladelsen implementere de foranstaltninger, der er anført i PACMP (Post Approval Change Management Protocol), som er aftalt med CHMP vedrørende udvikling, validering og indførelse af terminalsterilisering.
English: CMV mutants with reduced susceptibility to letermovir have been confirmed in cell culture.
Danish: CMV-mutanter med nedsat følsomhed over for letermovir er blevet bekræftet i cellekultur.
English: • Do not take two doses of PREVYMIS at the same time to make up for a missed dose.
Danish: • Du må ikke tage en dobbeltdosis af Prevymis på samme tid som erstatning for den glemte dosis.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis infusionsvæsken ikke anvendes straks, er i-brug-opbevaringstider og -forhold forud for anvendelse brugerens ansvar og må ikke overstige 24 timer ved 2-8 °C, medmindre fortynding har fundet sted under kontrollerede og validerede aseptiske forhold.
English: You can ask your doctor or pharmacist for a list of medicines that may interact with PREVYMIS.
Danish: Du kan anmode lægen eller apotekspersonalet om en liste over de lægemidler, der kan interagere med Prevymis.
English: When changing the route of administration, or if changing immunosuppressant, the recommendation concerning co-administration should be revisited.
Danish: Ved skift af administrationsvej eller ved skift af immunsuppressivum skal anbefalingen vedrørende samtidig administration revurderes.
English: Effect of cyclosporine
Danish: Ciclosporins indvirkning
English: Cyclosporin A (n=162, 90)
Danish: Ciclosporin A (n=162, 90)
English: Your doctor or pharmacist will tell you if it is safe to take PREVYMIS with other medicines.
Danish: Lægen eller apotekspersonalet vil fortælle dig, om det er sikkert at tage Prevymis sammen med andre lægemidler.
English: The most common primary reasons for transplant were acute myeloid leukemia (38%), myeloblastic syndrome (15%), and lymphoma (13%).
Danish: De mest almindelige primære årsager til transplantation var akut myeloid leukæmi (38 %), myeloblastisk syndrom (15 %) og lymfom (13 %).
English: Letermovir was administered either orally or IV; the dose of letermovir was the same regardless of the route of administration.
Danish: Letermovir blev administreret enten oralt eller intravenøst; dosis af letermovir var den samme uanset administrationsvej.
English: The tablets shall be swallowed whole with some water.
Danish: Tabletterne skal sluges hele med vand.
English: The majority of letermovir-related components in plasma is unchanged parent (96.6%).
Danish: Størstedelen af letermovir-relaterede komponenter i plasma er uomdannet moderstof (96,6 %).
English: When letermovir is combined with cyclosporine:
Danish: Når letermovir kombineres med ciclosporin:
English: If you are also taking a medicine for high cholesterol (see list of medicines in section “Other medicines and PREVYMIS” below) you must tell your doctor immediately if you have unexplained muscle aches or pains especially if you feel unwell or have a fever.
Danish: Hvis du også tager et lægemiddel mod forhøjet kolesterol (se listen over medicin i punktet “Brug af anden medicin sammen med Prevymis” nedenfor), skal du straks kontakte din læge, hvis du har uforklarlige muskelsmerter, især hvis du føler dig utilpas eller har feber.
English: Cumulative proportion of subjects with CMV DNAemia or disease (%)
Danish: Kumulativ andel af forsøgspersoner med CMV-DNAæmi eller -sygdom (%)
English: Letermovir may be administered orally with or without food as has been done in the clinical studies (see section 4.2).
Danish: Letermovir kan administreres oralt med eller uden mad, som det er blevet gjort i de kliniske studier (se pkt.
English: The medicine helps stop you from getting ill from CMV (‘cytomegalovirus').
Danish: Lægemidlet hjælper med at forhindre, at du bliver syg af CMV (‘cytomegalovirus').
English: Other systemically acting oral contraceptive steroids
Danish: Andre systemisk virkende orale kontraceptive steroider
English: Letermovir reached steady-state in 9 to 10 days with an accumulation ratio of 1.2 for AUC and 1.0 for Cmax.
Danish: Letermovir nåede steady state efter 9-10 dage med et akkumuleringsforhold på 1,2 for AUC og 1,0 for Cmax.
English: The estimated difference (95% CI for the difference) was -26.1% (-45.9%, -6.3%), with a nominal one-sided p-value <0.0048.
Danish: Den estimerede forskel (95 % CI for forskellen) var -26,1 % (-45,9 %; -6,3 %), med en nominel ensidet p-værdi <0,0048.
English: Haploidentical donor
Danish: Haploidentisk donor
English: Do not stop taking PREVYMIS without talking to your doctor first.
Danish: Du må ikke holde op med at tage Prevymis uden først at have talt med lægen.
English: Effect of food
Danish: Fødevarers indvirkning
English: In case of overdose, it is recommended that the patient be monitored for adverse reactions and appropriate symptomatic treatment instituted.
Danish: I tilfælde af overdosering anbefales det, at patienten monitoreres for bivirkninger, og passende symptomatisk behandling iværksættes.
English: See list under “Do not take PREVYMIS if you take either of these medicines.”
Danish: Se listen under “Tag ikke Prevymis, hvis du tager et eller flere af disse lægemidler.”
English: These DNA polymerase inhibitors are fully active against viral populations with substitutions conferring resistance to letermovir.
Danish: Disse DNA-polymerasehæmmere er fuldt aktive mod virale populationer med substitutioner, der giver resistens over for letermovir.
English: Compatible intravenous solutions and other medicinal products
Danish: Kompatible intravenøse opløsninger og andre lægemidler
English: • bosentan - for high blood pressure in the vessels in the lungs
Danish: • bosentan - mod højt blodtryk i blodkarrene i lungerne
English: Plasma concentrations of medicinal products transported by OAT3 may be increased.
Danish: Plasmakoncentrationen for de lægemidler, som transporteres af OAT3, kan øges.
English: • high blood creatinine - shown in blood tests
Danish: • forhøjet kreatinin i blodet - fremgår af blodprøveresultater
English: Therapeutic drug monitoring (TDM) is therefore recommended for voriconazole.
Danish: Terapeutisk lægemiddelovervågning anbefales derfor for voriconazol.
English: *Refer to the prescribing information to confirm compatibility of simultaneous co-administration.
Danish: *Se produktresuméet for at bekræfte kompatibilitet ved simultan administration.
English: No dose recommendation can be made for patients with end stage renal disease (ESRD) with or without dialysis.
Danish: Der kan ikke gives dosisanbefalinger for patienter med terminal nyresygdom (ESRD) med eller uden dialyse.
English: • glyburide, repaglinide - for high blood sugar
Danish: • glyburid, repaglinid - mod for højt blodsukker
English: Subjects with ESRD have not been studied.
Danish: Forsøgspersoner med ESRD er ikke blevet undersøgt.
English: Manufacturer Schering-Plough Labo NV Industriepark 30 - Zone A B-2220 Heist-op-den-Berg Belgium
Danish: Schering-Plough Labo NV Industriepark 30 - Zone A B-2220 Heist-op-den-Berg Belgien
English: However, if your immune system is weak after you get a bone marrow transplant, you may be at high risk of becoming ill from CMV.
Danish: Hvis du har et svækket immunsystem, efter at du har gennemgået en knoglemarvstransplantation, kan du imidlertid have en høj risiko for CMV-sygdom.
English: PREVYMIS should be started after HSCT.
Danish: Behandlingen med PREVYMIS bør initieres efter HSCT.
English: Recommendations concerning coadministration with PREVYMIS
Danish: Anbefalinger vedrørende administration sammen med PREVYMIS
English: Therefore, the plasma concentrations of medicinal products that are substrates of these enzymes or transporters may increase or decrease when co-administered with letermovir.
Danish: Derfor kan plasmakoncentrationen af lægemidler, som er substrater for disse enzymer eller transportører, stige eller falde, når de administreres sammen med letermovir.
English: Medicinal products mainly eliminated through metabolism or influenced by active transport Letermovir is a general inducer in vivo of enzymes and transporters.
Danish: Lægemidler, som hovedsageligt elimineres via metabolisering eller påvirkes af aktiv transport Letermovir er en generel induktor af enzymer og transportører in vivo.
English: Carcinogenesis Carcinogenicity studies with letermovir have not been conducted.
Danish: Der er ikke udført karcinogenicitetsstudier med letermovir.
English: Yes (n=49, 17)
Danish: Ja (n=49, 17)
English: HIV antivirals (ritonavir, lopinavir)
Danish: hiv-antivirale midler (ritonavir, lopinavir)
English: Urinary excretion of letermovir was negligible (<2% of dose).
Danish: Udskillelse af letermovir i urinen var ubetydelig (< 2 % af dosis).
English: Patients should be instructed that if they miss a dose of PREVYMIS, they should take it as soon as they remember.
Danish: Patienterne skal informeres om, at hvis de glemmer at tage en dosis af PREVYMIS, skal de tage den, så snart de kommer i tanke om det.
English: In the pre- and post-natal developmental study, letermovir was administered orally to pregnant rats.
Danish: I studiet af præ- og postnatal udvikling blev letermovir administreret oralt til drægtige rotter.
English: Development
Danish: Udvikling
English: • Cyclosporine, tacrolimus, sirolimus
Danish: • Ciclosporin, tacrolimus, sirolimus
English: Concomitant use of repaglinide and letermovir with or without cyclosporine is not recommended.
Danish: Samtidig anvendelse af repaglinid og letermovir med eller uden ciclosporin anbefales ikke.