FrancophonIA/ELRC3.0 huggingface dataset:
English: The significance of phospholipidosis in humans is unknown.
Danish: Relevansen af phospholipidosis hos mennesker kendes ikke.
English: At both week 24 and week 120, responder rates were higher for patients on 3 or more active substances (in vitro) in their background regimen.
Danish: Både i uge 24 og uge 120 var responsraterne højere hos patienter, der fik 3 eller flere aktive stoffer (in vitro) i deres baggrundsregime.
English: This study included patients of all three resistance categories (MDRH&R-, pre-XDR- and XDR-TB).
Danish: Dette studie inkluderede patienter fra alle tre resistenskategorier (MDRH&R-, præ-XDR- og XDR-TB).
English: • There must be at least 48 hours in between each time you take SIRTURO.
Danish: • Der skal gå mindst 48 timer mellem to doser SIRTURO.
English: After the end of SIRTURO treatment (i.e. after week 24), QTcF increases in the SIRTURO group gradually became less pronounced.
Danish: Efter endt behandling med SIRTURO (dvs. efter uge 24) blev øgningerne af QTcF i SIRTURO-gruppen gradvist mindre udtalte.
English: There are limited data on the use of SIRTURO in pregnant women.
Danish: Der foreligger begrænsede data om anvendelse af SIRTURO til gravide kvinder.
English: • Skip the missed dose and take the next dose as usual
Danish: • Spring den glemte dosis over, og tag den næste dosis som sædvanligt.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: Der henvises til officielle vejledninger i korrekt anvendelse af antibakterielle midler.
English: Therefore, bedaquiline should be taken with food to enhance its oral bioavailability.
Danish: Derfor bør bedaquilin indtages sammen med et måltid for at øge dens orale biotilgængelighed.
English: • Clinically significant ventricular arrhythmia
Danish: • klinisk signifikant ventrikulær arytmi
English: The total duration of treatment with SIRTURO is 24 weeks.
Danish: Den samlede behandlingsvarighed med SIRTURO er 24 uger.
English: SIRTURO must always be taken together with other medicines for treating tuberculosis.
Danish: SIRTURO skal altid tages sammen med andre lægemidler til behandling af tuberkulose.
English: SIRTURO was administered as 400 mg once daily for the first 2 weeks, and as 200 mg 3 times/week for the following 22 weeks.
Danish: SIRTURO blev administreret som 400 mg en gang dagligt i de første 2 uger, og som 200 mg 3 gange om ugen i de følgende 22 uger.
English: • increased liver enzymes (shown in blood tests)
Danish: • forhøjede leverenzymtal (i blodprøver)
English: Patients should be monitored throughout the treatment course, since the increases in liver enzymes were slow to appear and increased gradually during the 24 weeks.
Danish: Patienterne bør monitoreres under hele behandlingsforløbet, eftersom stigningerne i leverenzymer var længe om at indtræffe og steg gradvist i løbet af de 24 uger.
English: Removal of unabsorbed bedaquiline may be aided by the administration of activated charcoal.
Danish: Fjernelse af ikkeabsorberet bedaquilin kan fremmes ved administration af aktivt kul.
English: After the 24-week investigational period, the background regimen was continued to complete 18 to 24 months of total multi-drug resistant Mycobacterium tuberculosis treatment.
Danish: Efter den 24 uger lange studieperiode fortsattes med baggrundsregimet for at gennemføre 18-24 måneders behandling for total multiresistent Mycobacterium tuberculosis.
English: Environmental risk assessment studies have shown that bedaquiline has the potential to be persistent, bioaccumulative and toxic to the environment (see section 6.6).
Danish: Undersøgelser af miljørisikovurdering har vist, at bedaquilin potentielt kan være persistent, bioakkumulerende og giftigt for miljøet (se pkt.
English: Treatment with the other agents in the regimen should continue after completion of treatment with SIRTURO.
Danish: Behandling med regimets andre lægemidler bør fortsættes efter gennemførelse af behandlingen med SIRTURO.
English: Resistance to bedaquiline
Danish: Resistens over for bedaquilin
English: Those patients studied all had CD4+ cell counts greater than 250 x 10
Danish: Alle de undersøgte patienter havde et CD4+ celletal > 250 x 10
English: Bedaquiline may have a minor influence on the ability to drive and use machines.
Danish: Bedaquilin kan i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Patients should be advised to take SIRTURO exactly as prescribed and to complete the full course of therapy.
Danish: Patienterne bør rådes til at tage SIRTURO nøjagtigt som anvist af lægen og til at gennemføre hele behandlingsforløbet.
English: Efflux-based mutations have been seen in preclinical and clinical isolates.
Danish: Efflux-baserede mutationer er blevet set i prækliniske og kliniske isolater.
English: Bedaquiline prolongs the QTc interval.
Danish: Bedaquilin forlænger QTc-intervallet.
English: If this happens do not drive or operate machinery.
Danish: I så fald må du ikke køre bil eller betjene maskiner.
English: Your doctor will decide which other medicines you should take with SIRTURO.
Danish: Lægen fastsætter, hvilke andre lægemidler du skal tage sammen med SIRTURO.
English: The plasma protein binding of the N-monodesmethyl metabolite (M2) in humans is at least 99.8%.
Danish: Plasmaproteinbindingen af metabolitten N-monodesmethyl (M2) hos mennesker er mindst 99,8 %.
English: Bedaquiline is a diarylquinoline.
Danish: Bedaquilin er et diarylquinolin.
English: Tablets are packaged in aluminium/aluminium foil blisters.
Danish: Tabletterne er pakket i blister af aluminium/aluminiumsfolie.
English: There is no experience with the treatment of acute overdose with SIRTURO.
Danish: Der er ingen erfaring med behandling af akut overdosering med SIRTURO.
English: Body weight decreases in pups were noted in high dose groups during the lactation period after exposure to bedaquiline via milk and were not a consequence of in utero exposure.
Danish: Fald i legemsvægten hos afkommet kunne observeres i højdosis grupper under diegivningsperioden efter eksponering for bedaquilin gennem mælken og var ikke en følge af in utero-eksponering.
English: Administration of bedaquiline with food increased the relative bioavailability by about 2-fold compared to administration under fasted conditions.
Danish: Administration af bedaquilin med føde øgede den relative biotilgængelighed med ca. faktor 2 sammenlignet med administration under fastende betingelser.
English: Pharmacotherapeutic group: Antimycobacterials, drugs for treatment of tuberculosis, ATC code: J04AK05
Danish: Farmakoterapeutisk klassifikation: Antimykobakterika, andre stoffer til behandling af tuberkulose, ATC-kode: J04AK05
English: Do not give this medicine to children and adolescents (under 18 years of age).
Danish: SIRTURO må ikke gives til børn og unge (under 18 år).
English: An electrocardiogram should be obtained before initiation of treatment and at least monthly after starting treatment with bedaquiline.
Danish: Der skal optages EKG, før behandlingen initieres og mindst en gang om måneden efter påbegyndt behandling med bedaquilin.
English: Cavitation in one lung was seen in 58% of patients, and in both lungs in 16%.
Danish: Kavernedannelse i den ene lunge sås hos 58 % af patienterne; og kavernedannelse i begge lunger sås hos 16 %.
English: Response rates at week 24 and week 120 (i.e. around 6 months after stopping all therapy) are presented in table 1.
Danish: Responsrater i uge 24 og uge 120 (det vil sige ca. 6 måneder efter ophør af al behandling) er vist i tabel 1.
English: The imbalance in deaths is unexplained; no evidence has been found for a causal relationship with SIRTURO treatment.
Danish: Den skæve fordeling af dødsfald er ikke afklaret; der er ikke fundet bevis for en årsagssammenhæng med SIRTURO-behandling.
English: Minimal inhibitory concentration (MIC) breakpoints are as follows: Epidemiological Cut-Off (ECOFF)
Danish: Grænseværdier for mindste hæmmende koncentration (MIC) er følgende: Epidemiologiske cut-off-værdier (ECOFF)
English: One death in the SIRTURO group and one death in the placebo group were reported after the week 120 window.
Danish: Der blev indberettet ét dødsfald i SIRTURO-gruppen og ét dødsfald i placebogruppen efter 120-ugers vinduet.
English: Based on the preclinical studies, the bulk of the administered dose is eliminated in faeces.
Danish: Baseret på de prækliniske studier elimineres hovedparten af den administrerede dosis i fæces.
English: The following are examples of medicines patients with multi-drug resistant tuberculosis may take and which may potentially interact with SIRTURO:
Danish: Nedenfor vises eksempler på lægemidler, som kan tages af patienter med multiresistent tuberkulose, og som muligvis reagerer med SIRTURO:
English: If a dose is missed during the first two weeks of treatment, patients should not make up the missed dose, but should continue the usual dosing schedule.
Danish: Hvis patienten glemmer en dosis i løbet af de første to ugers behandling, bør den glemte dosis ikke erstattes, men patienten skal fortsætte i henhold til den sædvanlige behandlingsplan.
English: When available, the clinical microbiology laboratory should provide the physician with the results of in vitro susceptibility test results for antimicrobial medicinal products used in resident hospitals as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens.
Danish: Når de foreligger, skal klinisk mikrobiologisk laboratorium forsyne lægen med analyseresultaterne for in vitro-følsomhed af de antibakterielle lægemidler, der anvendes, som periodiske rapporter, der beskriver følsomhedsprofilen af hospitals- eller samfundserhvervede patogener.
English: Any unused medicine should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel og rester heraf skal bortskaffes i overensstemmelse med lokale krav.
English: If a dose is missed from week three onwards, patients should take the missed dose of 200 mg as soon as possible and then resume the three times a week regimen.
Danish: Hvis en dosis glemmes fra og med uge 3, skal patienten tage den glemte dosis på 200 mg snarest muligt og derefter genoptage behandlingsplanen med tre doser ugentligt.
English: The other nine deaths among those treated with SIRTURO occurred after completion of treatment with this agent (range 86 911 days post SIRTURO; median 344 days).
Danish: De øvrige ni dødsfald blandt dem, der blev behandlet med SIRTURO, indtraf efter gennemførelse af behandlingen med dette lægemiddel (interval 86-911 dage efter SIRTURO; median 344 dage).
English: There were no documented cases of Torsade de Pointes in the safety database (see section 4.4).
Danish: Der forelå ingen dokumenterede tilfælde af torsades de pointes i sikkerhedsdatabasen (se pkt.
English: • you have had an abnormal heart reading (ECG) or heart failure;
Danish: • hvis du har et unormalt hjertediagram (EKG) eller hjertesvigt
English: Central laboratory drug susceptibility testing results became available for one additional placebo subject after the week 24 interim analysis.
Danish: Centrallaboratoriets analyseresultater for lægemiddelfølsomhed blev tilgængelige for en yderligere placeboforsøgsperson efter interimanalysen i uge 24
English: SIRTURO should be used in combination with at least three medicinal products to which the patient's isolate has been shown to be susceptible in vitro.
Danish: SIRTURO bør anvendes i kombination med mindst tre lægemidler, som patientens isolat har vist sig følsomt over for in vitro.
English: • Take SIRTURO with food.
Danish: • Tag SIRTURO i forbindelse med et måltid.
English: The mean terminal elimination half-life of both bedaquiline and the active N-monodesmethyl metabolite (M2) is about 5 months (ranging from 2 to 8 months).
Danish: Den gennemsnitlige terminale eliminationshalveringstid både for bedaquilin og den aktive metabolit N-monodesmethyl (M2) er ca. 5 måneder (spændende fra 2 til 8 måneder).
English: Of the 163 patients who were responders at week 24, 139 patients (85.3%) were still responders at week 120.
Danish: Af de 163 patienter, som responderede i uge 24, responderede 139 patienter (85,3 %) fortsat i uge 120.
English: If the benefit outweighs the risk, SIRTURO may be used with caution when co-administered with lopinavir/ritonavir.
Danish: Hvis fordelene opvejer risikoen, kan SIRTURO administreres med forsigtighed sammen med lopinavir/ritonavir.
English: Cmax and the area under the plasma concentration-time curve (AUC) increased proportionally up to the highest doses studied (700 mg single-dose and once daily 400 mg multiple doses).
Danish: Cmax og arealet under plasmakoncentration-tidskurven (AUC) steg proportionalt op til de højeste undersøgte doser (700 mg som enkeltdosis og 400 mg en gang dagligt som gentagne doser).
English: It is therefore not expected that mild or moderate renal impairment will have a clinically relevant effect on the exposure to bedaquiline.
Danish: Det forventes derfor ikke, at let eller moderat nedsat nyrefunktion vil have en klinisk relevant effekt på eksponeringen for bedaquilin.
English: There was no effect of maternal treatment with bedaquiline at any dose level on sexual maturation, behavioural development, mating performance, fertility or reproductive capacity of the F1 generation animals.
Danish: Der sås ingen virkninger efter behandling af moderdyr med bedaquilin uanset dosisniveau på seksuel modning, adfærdsmæssig modning, parringsadfærd, fertilitet eller reproduktionsevne hos dyr af F1-generationen.
English: QT interval and concomitant clofazimine use
Danish: QT-interval og samtidig brug af clofazimin
English: It is recommended that SIRTURO is administered by directly observed therapy (DOT).
Danish: Det anbefales at administrere SIRTURO under overvågning som DOT (directly observed therapy).
English: The basis of assessment of causality between the adverse drug reactions and SIRTURO was not restricted to these trials, but also on review of the pooled Phase I and Phase IIa safety data.
Danish: Grundlaget for at vurdere årsagssammenhængen mellem bivirkninger og SIRTURO var ikke begrænset til disse studier, men blev også baseret på gennemgang af de poolede sikkerhedsdata fra fase I- og fase IIa-studier.
English: There is limited information available on the potential for a pharmacodynamic interaction between bedaquiline and medicinal products that prolong the QT interval.
Danish: Der foreligger begrænsede oplysninger om risikoen for farmakodynamisk interaktion mellem bedaquilin og lægemidler, der forlænger QT-intervallet.
English: SIRTURO contains the active substance bedaquiline.
Danish: SIRTURO indeholder det aktive stof bedaquilin.
English: No human data on the effect of bedaquiline on fertility are available.
Danish: Der foreligger ingen humane data om bedaquilins virkninger på fertilitet.
English: Other hepatotoxic medicinal products and alcohol should be avoided while on SIRTURO, especially in patients with diminished hepatic reserve.
Danish: Andre hepatotoksiske lægemidler samt alkohol bør undgås under behandling med SIRTURO, især hos patienter med nedsat leverfunktion.
English: The primary efficacy endpoint was the time to sputum culture conversion during treatment with SIRTURO (median 57 days, for 205 patients with sufficient data).
Danish: Det primære effektmål var tid til konvertering af ekspektoratdyrkning under behandling med SIRTURO (median 57 dage for 205 patienter med tilstrækkelige data).
English: In the SIRTURO group, all of the five deaths due to tuberculosis occurred in patients whose sputum culture status at last visit was ‘not converted'.
Danish: I SIRTUROgruppen indtraf alle de fem dødsfald, der skyldtes tuberkulose, hos patienter, hvis status efter dyrkning af ekspektorat ved det sidste besøg var ‘ikke konverteret'.
English: In patients with extensive drug resistance, where SIRTURO is considered necessary beyond 24 weeks to obtain a curative treatment, a longer duration of therapy may be considered only on a case by case basis and under close safety surveillance (see section 4.8).
Danish: For patienter med omfattende lægemiddelresistens, hvor Sirturo anses for nødvendigt ud over 24 uger for at opnå helbredende behandling, kan en længere varighed af behandlingen kun overvejes fra sag til sag og under tæt overvågning af sikkerheden (se pkt.
English: In the MPS of all species, pigment-laden and/or foamy macrophages were also seen in various tissues, consistent with phospholipidosis.
Danish: I MPS hos alle arter blev der også set hyperpigmenterede og/eller skummende makrofager i diverse væv, svarende til phospholipidosis.
English: An in vitro study indicated a potential for bedaquiline to inhibit BCRP at the concentrations achieved in the intestine after oral administration.
Danish: Et in vitrostudie indikerede potentiale for, at bedaquilin hæmmer BCRP ved de koncentrationer, der opnås i tarmen efter oral administration.
English: In the Phase IIb, open label study (C209), 6.9% (16/233) patients died.
Danish: I det åbne fase IIb-studie (C209) døde 6,9 % (16/233) af patienterne.
English: • Resume the three times a week schedule.
Danish: • Genoptag behandlingen med 3 doser om ugen.
English: • A history of Torsade de Pointes;
Danish: • anamnestisk torsades de pointes
English: During the trial, there was no evidence of antecedent significant QT prolongation or clinically significant dysrhythmia in any of the patients that died.
Danish: Under studiet blev der ikke påvist forudgående signifikant QT-forlængelse eller klinisk signifikant dysrytmi hos de patienter, der afgik ved døden.
English: White HDPE bottle with child-resistant polypropylene (PP) closure with aluminium induction seal liner containing 188 tablets.
Danish: Hvid beholder af HDPE med børnesikret lukke af polypropylen (PP) med aluminumsforsegling indeholdende 188 tabletter.
English: Bedaquiline was associated with effects in target organs which included monocytic phagocytic system (MPS), skeletal muscle, liver, stomach, pancreas and heart muscle.
Danish: Bedaquilin var associeret med påvirkning af målorganerne, der omfattede monocyt og fagocyt systemet (MPS), skeletmuskulatur, lever, mave, pancreas og hjertemuskel.
English: • Interim IDMC recommendation when half of the patients reach W76: 4Q2020
Danish: • Interim IDMCanbefaling, når halvdelen af patienterne når uge 76: 4. kvartal
English: There are no safety data from bedaquiline multiple dose trials which utilised a dose higher than the indicated dose.
Danish: Der foreligger ingen sikkerhedsdata fra studier med gentagne doser bedaquilin, hvor doseringen var højere end den indicerede dosis.
English: Acquired resistance mechanisms that affect bedaquiline MICs include mutations in the atpE gene, which codes for the ATP synthase target, and in the Rv0678 gene, which regulates the expression of the MmpS5-MmpL5 efflux pump.
Danish: Erhvervede resistensmekanismer, der påvirker bedaquilins MIC-værdi, inkluderer mutationer i atpEgenet, som koder for target for ATP-syntase, og i Rv0678-genet, som regulerer ekspressionen af MmpS5-MmpL5-effluxpumpen.
English: SIRTURO has not been studied in patients with severe hepatic impairment and is not recommended in this population.
Danish: SIRTURO er ikke undersøgt hos patienter med svært nedsat leverfunktion, og det anbefales ikke til denne population.
English: Renal excretion of unchanged bedaquiline is insignificant (< 0.001%).
Danish: Der ses kun ubetydelig renal udskillelse af uomdannet bedaquilin (< 0,001 %).
English: Serum potassium, calcium, and magnesium should be obtained at baseline and corrected if abnormal.
Danish: Der skal bestemmes serumværdier af kalium, calcium og magnesium ved baseline, og abnorme værdier bør korrigeres.
English: In vitro, bedaquiline does not significantly inhibit the activity of any of the CYP450 enzymes tested (CYP1A2, CYP2A6, CYP2C8/9/10, CYP2C19, CYP2D6, CYP2E1, CYP3A4, CYP3A4/5 and CYP4A) and does not induce CYP1A2, CYP2C9 or CYP2C19 activities.
Danish: In vitro hæmmer bedaquilin ikke i væsentlig grad aktiviteten af de testede CYP-enzymer (CYP1A2, CYP2A6, CYP2C8/9/10, CYP2C19, CYP2D6, CYP2E1, CYP3A4, CYP3A4/5 og CYP4A), ligesom det ikke inducerer aktivitet af CYP1A2, CYP2C9 eller CYP2C19.
English: • QT interval as corrected by the Fridericia method (QTcF) > 450 ms (confirmed by repeat electrocardiogram);
Danish: • QT-interval korrigeret med Fridericia-metoden (QTcF) > 450 ms (bekræftet af gentaget elektrokardiogram)
English: Extent of resistance based on central laboratory drug susceptibility testing results was not available for 20 subjects in the mITT population (12 in the SIRTURO group and 8 in the placebo group).
Danish: Grad af resistens baseret på centrallaboratoriets analyseresultater for lægemiddelfølsomhed var ikke tilgængelig for 20 forsøgspersoner i mITT-populationen (12 i SIRTURO-gruppen og 8 i placebogruppen).
English: If AST or ALT exceeds 5 times the upper limit of normal then the regimen should be reviewed and SIRTURO and/or any hepatotoxic background medicinal product should be discontinued.
Danish: Hvis ASAT eller ALAT overstiger 5 gange øvre grænse for normalområdet (ULN), bør behandlingen tages op til fornyet vurdering, og SIRTURO og/eller et eventuelt hepatotoksisk baggrundslægemiddel bør seponeres.
English: SIRTURO treatment must be discontinued if the patient develops:
Danish: SIRTURO-behandlingen skal seponeres, hvis patienten får:
English: Patients receiving SIRTURO alone with no other QT prolonging medicinal product developed a maximal mean QTcF increase over baseline of 23.7 ms with no QT duration in excess of 480 ms, whereas patients with at least 2 other QT prolonging medicinal products developed a maximal mean QTcF prolongation of 30.7 ms over baseline, resulting in a QTcF duration in excess of 500 ms in one patient.
Danish: Hos patienter, der fik SIRTURO alene uden andre QT-forlængende lægemidler, var den maksimale gennemsnitlige øgning af QTcF-forlængelsen i forhold til baseline 23,7 ms, og QT-varigheden var i intet tilfælde over 480 ms, mens patienter der fik mindst 2 andre QT-forlængende lægemidler udviklede en maksimal gennemsnitlig QTcF-forlængelse på 30,7 ms i forhold til baseline, hvilket hos den ene patient resulterede i en QTcF-varighed over 500 ms.
English: Treatment with SIRTURO should be initiated and monitored by a physician experienced in the management of multi-drug resistant Mycobacterium tuberculosis.
Danish: Behandling med SIRTURO bør indledes og monitoreres af en læge med erfaring i behandling af multiresistent Mycobacterium tuberculosis.
English: In an interaction study of bedaquiline and ketoconazole, a greater effect on QTc was observed after repeated dosing with bedaquiline and ketoconazole in combination than after repeated dosing with the individual medicinal products.
Danish: I et interaktionsstudie af bedaquilin og ketoconazol sås en større påvirkning af QTc efter gentagne doser bedaquilin og ketoconazol i kombination end efter gentagne doser af de to lægemidler hver for sig.
English: SIRTURO has mainly been studied in patients with normal renal function.
Danish: SIRTURO er hovedsageligt undersøgt hos personer med normal nyrefunktion.
English: There are no clinical data on the use of SIRTURO to treat:
Danish: Der foreligger ingen kliniske data om anvendelse af SIRTURO til behandling af:
English: If in vitro testing results are unavailable, treatment may be initiated with SIRTURO in combination with at least four medicinal products to which the patient's isolate is likely to be susceptible.
Danish: Hvis der ikke foreligger in vitro-analyseresulter, kan der indledes behandling med SIRTURO i kombination med mindst fire andre lægemidler, som det er sandsynligt, at patientens isolat vil være følsomt over for.
English: In animals, bedaquiline and its active N-monodesmethyl metabolite (M2) are extensively distributed to most tissues, however, brain uptake was low.
Danish: Hos dyr fordeler bedaquilin og dets aktive metabolit N-monodesmethyl (M2) sig i omfattende grad i de fleste væv, omend der sås lav optagelse i hjernen.