natgillin/translations-raw huggingface dataset:
Af de 42 patienter, som var non-respondere i uge 24, forekom der bekræftet dyrkningskonvertering efter uge 24 (dvs. efter afslutning af bedaquilin-dosering, men fortsat på baggrundsregime) hos 9 patienter (21,4 %), og dette var bibeholdt i uge 120. 
Of the 42 patients who were non-responders at week 24, confirmed culture conversion after week 24 (i.e., after bedaquiline dosing ended but the background regimen was continued) occurred in 9 patients (21.4%) and was maintained at week 120.
Indehaveren af markedsføringstilladelsen vil vurdere yderligere data for bedaquilins effekt og sikkerhed i forskellige behandlingsregimer sammenlignet med et behandlingsregime, der ikke omfatter bedaquilin (bekræftende fase III studie) efter en aftalt protokol. 
The MAH will evaluate additional efficacy and safety data of bedaquiline in different treatment regimen compared to a regimen that does not include bedaquiline (confirmatory phase III study) following an agreed protocol.
Hepatisk sikkerhed 
Hepatic safety
Mycobacterium xenopi, Mycobacterium novocastrense, Mycobacterium shimoidei og non-mycobakterielle arter anses for naturligt resistente over for bedaquilin. 
Mycobacterium xenopi, Mycobacterium novocastrense, Mycobacterium shimoidei and non-mycobacterial species are considered inherently resistant to bedaquiline.
Patienterne fik SIRTURO (n = 79) eller placebo (n = 81) i 24 uger, begge i kombination med et foretrukkent baggrundsregime (BR) bestående af 5 lægemidler, der omfattede ethionamid, kanamycin, pyrazinamid, ofloxacin og cycloserin/terizidon. 
Patients received SIRTURO (n = 79) or placebo (n = 81) for 24 weeks, both in combination with a preferred 5-drug background regimen (BR) consisting of ethionamide, kanamycin, pyrazinamide, ofloxacin, and cycloserine/terizidone.
In vitro- og in vivo-genotoksicitetstests indikerede, at bedaquilin ikke udviste mutagene eller clastogene effekter. 
In vitro and in vivo genotoxicity tests indicated that bedaquiline did not have any mutagenic or clastogenic effects.
4.5 under "QT-interval og samtidig brug af clofazimin" for yderligere oplysninger om samtidig anvendelse af clofazimin. 
See section 4.5, QT interval and concomitant clofazimine use, for further information regarding patients using clofazimine concomitantly.
• hvis du eller nogen i din familie har en hjertelidelse kaldet “medfødt langt QT-syndrom” 
• you have a personal or family history of a heart problem called “congenital long QT syndrome”;
Publicerede data fra patienter behandlet med bedaquilin som del af en behandling for lægemiddelresistent TB og lopinavir/ritonavirbaseret antiretroviral behandling har vist, at eksponeringen (AUC) for bedaquilin over 48 timer steg cirka 2 gange. 
Published data on patients treated with bedaquiline as part of therapy for drugresistant TB and lopinavir/ritonavir-based ART have shown that bedaquiline exposure (AUC) over 48 hours was increased approximately 2 fold.
I SIRTURO-gruppen observeredes ingen eller kun mindre forskelle i tid til konvertering af dyrkningsprøver og konverteringsrater for dyrkningsprøver mellem patienter med præ-XDR-TB og patienter med MDRH&R-TB. 
In the SIRTURO group, no or only minor differences in time to culture conversion and culture conversion rates were observed between patients with pre-XDR-TB and patients with MDRH&R-TB.
Forholdet mellem farmakokinetik/farmakodynamik 
Pharmacokinetic/pharmacodynamic relationship
Bedaquilin er bakteriostatisk for mange non-tuberkuløse mykobakterielle arter. 
Bedaquiline is bacteriostatic for many non-tuberculous mycobacterial species.
Hos de resterende forsøgspersoner, der fik SIRTURO, var dødsårsagerne alkoholforgiftning, hepatitis/levercirrose, septisk chok/peritonitis, cerebrovakulær hændelse og ulykke med motorkøretøj. 
The causes of death in the remaining SIRTURO subjects were alcohol poisoning, hepatitis/hepatic cirrhosis, septic shock/peritonitis, cerebrovascular accident and motor vehicle accident.
Der foreligger ingen kliniske data om anvendelse af SIRTURO som led i kombinationsregime til at behandle lægemiddelfølsomt Mycobacterium tuberculosis. 
There are no clinical data on the use of SIRTURO as part of combination regimens used to treat drug-susceptible Mycobacterium tuberculosis.
Hos rotter sås ingen bivirkninger i et præ- og postnatalt udviklingsstudie efter eksponering af maternel plasma (AUC) svarende til eksponeringen hos mennesker, og eksponering af afkommet var 3 gange højere end hos voksne mennesker. 
In the rat, no adverse effects were observed in a pre- and post-natal development study at maternal plasma exposure (AUC) similar to humans and exposure in the offspring 3-fold higher than in adult humans.
Hæmning af ATP-syntase medfører bactericide virkninger på både replikerende og ikke-replikerende tuberkelbaciller. 
The inhibition of ATP synthase leads to bactericidal effects for both replicating and non-replicating tubercle bacilli.
Der foreligger begrænsede kliniske data (n = 2) om anvendelse af SIRTURO til tuberkulosepatienter i alderen > 65 år. 
There is limited clinical data (n = 2) on the use of SIRTURO in tuberculosis patients aged 65 years and older.
Graden af resistens baseret på centrallaboratoriets analyseresultater for lægemiddelfølsomhed var ikke tilgængelig for 32 forsøgspersoner i mITT-populationen. 
Extent of resistance based on central laboratory drug susceptibility testing results was not available for 32 subjects in the mITT population.
Hvis du springer doser over eller ikke gennemfører hele behandlingen: 
Skipping doses or not completing the full course of therapy may:
Bedaquilin og M2 hæmmede ikke transportørerne P-gp, OATP1B1, OATP1B3, BCRP, OAT1, OAT3, OCT1, OCT2, MATE1 og MATE2 in vitro ved klinisk relevante koncentrationer. 
Bedaquiline and M2 did not inhibit the transporters P-gp, OATP1B1, OATP1B3, BCRP, OAT1, OAT3, OCT1, OCT2, MATE1 and MATE2 at clinically relevant concentrations in vitro.
Den tilsvarende plasmaeksponering (AUC) var 2 gange så høj hos rotter i forhold til hos mennesker. 
The corresponding plasma exposure (AUC) was 2-fold higher in rats compared to humans.
I musemodellen for TB-infektion har bedaquilin udvist baktericide og steriliserende virkninger. 
In the mouse model for TB infection, bedaquiline has demonstrated bactericidal and sterilizing activities.
Bedaquilin metaboliseres af CYP3A4. 
Bedaquiline is metabolised by CYP3A4.
Størstedelen af isolater, der er fenotype resistente over for bedaquilin, er krydsresistente over for clofazimin. 
The majority of isolates that are phenotypically resistant to bedaquiline are cross-resistant to clofazimine.
Æske, der indeholder 4 tryk-ud blisterstrip (med 6 tabletter per strip). 
A carton containing 4 push-through blister strips (containing 6 tablets per strip).
Metabolitten N-monodesmethyl (M2) menes ikke at bidrage i væsentlig grad til den kliniske virkning på grund af den lavere gennemsnitlige eksponering for denne metabolit (23 % til 31 %) hos mennesker og begrænsede virkning mod mykobakterier (3-6 gange lavere) sammenlignet med moderstoffet. 
The N-monodesmethyl metabolite (M2) is not thought to contribute significantly to clinical efficacy given its lower average exposure (23% to 31%) in humans and lower antimycobacterial activity (3- to 6-fold lower) compared to the parent compound.
5.1 for yderligere oplysninger om dødsfald i C209-studiet. 
For additional information on deaths in the C209 trial, see section 5.1.
efavirenz, etravirin, lopinavir/ritonavir til at behandle hiv-infektioner (antiretrovirale non-nukleosid revers transkriptasehæmmere, antiretrovirale proteasehæmmere) 
efavirenz, etravirine, lopinavir/ritonavir to treat HIV infection (antiretroviral non-nucleoside reverse transcriptase inhibitors, antiretroviral protease inhibitors)
Udskillelse i urinen af uomdannet bedaquilin udgjorde < 0,001 % af dosis i kliniske studier, hvilket indikerer, at kun en ubetydelig del af det aktive stof udskilles uomdannet gennem nyrerne. 
The urinary excretion of unchanged bedaquiline was < 0.001% of the dose in clinical studies, indicating that renal clearance of unchanged active substance is insignificant.
• Uge 3-24: 200 mg (2 tabletter a 100 mg) tre gange ugentligt (med mindst 48 timers interval mellem doserne). 
• Weeks 3-24: 200 mg (2 tablets of 100 mg) three times per week (with at least 48 hours between doses).
clofazimin mod visse infektioner såsom lepra 
clofazimine to treat some infections like leprosy
Der sås ingen strukturelle forandringer i testikler og bitestikler efter op til 6 måneders behandling med bedaquilin. 
No structural abnormalities in the testes and epididymides were seen after up to 6-months of bedaquiline treatment.
Tre af 24 hanrotter behandlet med højdosis bedaquilin fik intet afkom i fertilitetsstudiet. 
Three of 24 male rats treated with high bedaquiline doses failed to produce offspring in the fertility study.
Der kunne ikke observeres et påviseligt mønster mellem død og konvertering af ekspektoratatdyrkning, recidiv, følsomhed over for andre lægemidler mod tuberkulose, hiv-status eller sygdommens sværhedsgrad. 
No discernible pattern between death and sputum culture conversion, relapse, sensitivity to other medicinal products used to treat tuberculosis, human immunodeficiency virus status, or severity of disease could be observed.
Det er ikke nødvendigt at justere dosis af isoniazid eller pyrazinamid under samtidig administration af bedaquilin. 
No dose-adjustment of isoniazid or pyrazinamide is required during co-administration with bedaquiline.
Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned. 
Do not use this medicine after the expiry date which is stated on the carton after “EXP”.
Der foreligger kun begrænsede data om bedaquilins virkning på hiv-inficerede patienter, der ikke får antiretrovirale (ARV) midler. 
There are only limited clinical data on the efficacy of bedaquiline in HIV-infected patients not receiving antiretroviral (ARV) therapy.
Recidiv blev i dette studie defineret som positiv ekspektoratdyrkning efter eller under behandlingen efter tidligere konvertering af ekspektoratdyrkning. 
Relapse was defined in the trial as having a positive sputum culture after or during treatment following prior sputum culture conversion.
Hver tablet indeholder bedaquilinfumarat svarende til 100 mg bedaquilin. 
Each tablet contains bedaquiline fumarate equivalent to 100 mg bedaquiline.
Den største gennemsnitlige øgning af baselineværdier af QTcF under de 24 ugers behandling med SIRTURO var 15,7 ms (i uge 18). 
The largest mean increase from baseline values in QTcF during the 24 weeks of SIRTURO treatment was 15.7 ms (at week 18).
• infektioner, der skyldes andre arter af mykobakterier end Mycobacterium tuberculosis 
• infections due to mycobacterial species other than Mycobacterium tuberculosis
Efter at have nået Cmax faldt bedaquilins plasmakoncentration tre-eksponentielt. 
After reaching Cmax, bedaquiline concentrations decline tri-exponentially.
SIRTURO's bivirkninger blev påvist i poolede data fra kliniske fase IIb-studier (såvel kontrollerede som ikke kontrollerede), der omfattede 335 patienter, som fik SIRTURO i kombination med et baggrundsregime af tuberkulostatika. 
Adverse drug reactions for SIRTURO were identified from pooled Phase IIb clinical trial data (both controlled and uncontrolled) containing 335 patients who received SIRTURO in combination with a background regimen of tuberculosis medicinal products.
Et placebokontrolleret, dobbeltblindt, randomiseret fase IIb-studie (C208) evaluerede SIRTURO's antibakterielle virkning, sikkerhed og tolerabilitet hos nydiagnosticerede patienter med pulmonal MDRH&R- og præ-XDR-TB med mikroskopi-positive ekspektorater. 
A Phase IIb, placebo-controlled, double-blind, randomised trial (C208) evaluated the antibacterial activity, safety, and tolerability of SIRTURO in newly diagnosed patients with sputum smear-positive pulmonary MDRH&R- and pre-XDR-TB.
Brug af SIRTURO sammen med alkohol Undgå at drikke alkohol under behandlingen med SIRTURO. 
SIRTURO with alcohol You should not drink alcohol while taking SIRTURO.
Det primære resultatparameter var tid til konvertering af ekspektoratprøver (dvs. interval mellem den første indgift af SIRTURO og den første af to på hinanden følgende dyrkningsnegative flydende ekspektoratprøver udtaget med mindst 25 dages mellemrum) under behandling med SIRTURO eller placebo (median tid til konvertering var 83 døgn for SIRTURO-gruppen, 125 døgn for placebogruppen (hazard ratio, 95 % CI: 2,44 [1,57; 3,80]), p < 0,0001). 
The primary outcome parameter was the time to sputum culture conversion (i.e. the interval between the first SIRTURO intake and the first of two consecutive negative liquid cultures from sputum collected at least 25 days apart) during treatment with SIRTURO or placebo (median time to conversion was 83 days for the SIRTURO group, 125 days for the placebo group (hazard ratio, 95% CI: 2.44 [1.57; 3.80]), p < 0.0001).
En børnesikret beholder indeholder 188 tabletter. 
A plastic bottle containing 188 tablets.
Bedaquilin er virksomt mod Mycobacterium tuberculosis med en MIC-værdi (minimal inhibitory concentration) for såvel lægemiddelfølsomme som lægemiddelresistente stammer (multiresistente stammer, herunder præ-ekstremt og ekstremt resistente stammer i området ≤ 0,008-0,12 mg/l. 
Bedaquiline has activity against Mycobacterium tuberculosis with a minimal inhibitory concentration (MIC) for drug-sensitive as well as drug-resistant strains (multi-drug resistant including preextensively drug resistant strains, extensively drug resistant strains) in the range of ≤ 0.008-0.12 mg/l.
Patienterne bør monitoreres for symptomer og have udført laboratorieundersøgelser (ALAT, ASAT, basisk fosfatase og bilirubin) ved baseline, hver måned under behandlingen og ellers efter behov. 
Monitor symptoms and laboratory tests (ALT, AST, alkaline phosphatase, and bilirubin) at baseline, monthly while on treatment, and as needed.
Forsigtighed tilrådes ved ordination af bedaquilin samtidig med lægemidler med kendt risiko for QT-forlængelse. 
Caution is recommended when prescribing bedaquiline concomitantly with medicinal products with a known risk of QT prolongation.
For en sikkerheds skyld skal SIRTURO undgås under graviditeten, medmindre fordelene ved behandlingen anses at opveje risikoen. 
As a precautionary measure, avoid the use of SIRTURO during pregnancy unless the benefit of therapy is considered to outweigh the risks.
Sammenlignet med de eksponeringer (AUC), der observeredes hos individer med MDR-TB i fase IIforsøgene med bedaquilin, var eksponeringerne (AUC) hos rotter ved høje doser sammenlignelige hos hanner og 2 gange så høj hos hunner for bedaquilin og 3 gange så høj hos hanner og 2 gange så høj hos hunner for M2. 
Compared to the exposures (AUC) observed in subjects with MDR-TB in the bedaquiline phase II trials, the exposures (AUC) in rats at high doses were similar in males and 2-fold higher in females for bedaquiline, and 3-fold higher in males and 2-fold higher in females for M2.
Tag ikke SIRTURO: 
Do not take SIRTURO if:
Bedaquilins farmakokinetiske egenskaber blev evalueret hos voksne raske forsøgspersoner og voksne patienter inficeret med multiresistent tuberkulose. 
The pharmacokinetic properties of bedaquiline have been evaluated in adult healthy subjects and in adult multi-drug resistant tuberculosis-infected patients.
Mikrokrystallinsk cellulose Croscarmellosenatrium Silica, vandfri kolloid Magnesiumstearat 
Microcrystalline cellulose Croscarmellose sodium Silica, colloidal anhydrous Magnesium stearate
For patienter med fuld resistensundersøgelse var 76 % (84/111) inficeret med en MDRH&R-TB-stamme, og 24 % (27/111) med en præ-XDR-TB-stamme. 
For patients with full characterisation of resistance status, 76% (84/111) were infected with an MDRH&R-TB strain and 24% (27/111) with a pre-XDR-TB strain.
I en populationfarmakokinetisk analyse af tuberkulosepatienter, der blev behandlet med SIRTURO, var eksponeringen for bedaquilin lavere hos sorte patienter end hos patienter af andre racer. 
In a population pharmacokinetic analysis of tuberculosis patients treated with SIRTURO, exposure to bedaquiline was found to be lower in Black patients than in patients from other race categories.
Pædiatriske patienter SIRTURO's farmakokinetik er ikke blevet evalueret hos pædiatriske patienter. 
Paediatric patients The pharmacokinetics of SIRTURO in paediatric patients have not been evaluated.
Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med SIRTURO i en eller flere undergrupper af den pædiatriske population ved behandling af multiresistent Mycobacterium tuberculosis (se pkt. 
The European Medicines Agency has deferred the obligation to submit the results of studies with SIRTURO in one or more subsets of the paediatric population in the treatment of multi-drug resistant Mycobacterium tuberculosis (see section 4.2 for information on paediatric use).
I C208, som er et 120-ugers studie, hvor SIRTURO blev administreret i 24 uger i kombination med et baggrundsregime, forekom der flere dødsfald i SIRTURO-gruppen end i placebogruppen (se pkt. 
In the 120-week C208 trial where SIRTURO was administered for 24 weeks in combination with a background regimen, more deaths occurred in the SIRTURO treatment group than in the placebo group (see section 5.1).
Bivirkningerne er opstillet efter systemorganklasse og hyppighed. 
Adverse drug reactions are listed by system organ class (SOC) and frequency.
Inden for det koncentrationsområde, som opnås med den terapeutiske dosis, blev der ikke observeret et forhold mellem farmakokinetik og farmakodynamik hos patienterne. 
Within the concentration range achieved with the therapeutic dose, no pharmacokinetic/pharmacodynamic relationship was observed in patients.
På grund af potentielle bivirkninger hos børn, der ammes, skal det besluttes, om amning skal ophøre eller behandling med SIRTURO seponeres, idet der tages højde for fordelene ved amning for barnet i for hold til de terapeutiske fordele for moderen. 
Because of the potential for adverse reactions in breastfed infants, a decision must be made whether to discontinue breast-feeding or to discontinue/abstain from SIRTURO therapy taking into account the benefit of breast-feeding for the infant and the benefit of therapy for the mother.
SIRTURO skal indtages per os i forbindelse med et måltid, da den orale biotilgængelighed omtrent fordobles ved administration sammen med føde (se pkt. 
SIRTURO should be taken orally with food, as administration with food increases oral bioavailability by about 2-fold (see section 5.2).
Den største gennemsnitlige øgning af baselineværdier af QTcF i placebo-gruppen i de første 24 uger var på 6,2 ms (ligeledes i uge 18) (se pkt. 
The largest mean increase from baseline values in QTcF in the placebo group during the first 24 weeks was 6.2 ms (also at week 18) (see section 4.4).
• latent infektion med Mycobacterium tuberculosis. 
• latent infection with Mycobacterium tuberculosis
Generelt følsomme arter Mycobacterium tuberculosis 
Commonly susceptible species Mycobacterium tuberculosis
Hvor meget skal du tage Du skal tage SIRTURO i 24 uger. 
How much to take You take SIRTURO for a 24 week course.
Hos rotter var koncentrationen af bedaquilin i mælk 6-12 gange højere end den maksimale koncentration observeret i moderdyrets plasma. 
In rats, concentrations of bedaquiline in milk were 6- to 12-fold higher than the maximum concentration observed in maternal plasma.
ketoconazol, fluconazol til at behandle svampeinfektioner (antimykotika) 
ketoconazole, fluconazole to treat fungal infections (antifungals)
Plasmaeksponering for bedaquilin (AUC) i rotter og hunde svarede til den observerede eksponering hos mennesker. 
The plasma bedaquiline exposure (AUC) in rats and dogs was similar to that observed in humans.
Isolater, der er resistente over for clofazimin, kan stadig være følsomme for bedaquilin. 
Isolates that are resistant to clofazimine can still be susceptible to bedaquiline.
SIRTURO indeholder lactose (sukkerart). 
SIRTURO contains “lactose” (a type of sugar).
Hos patienter med svært nedsat nyrefunktion (kreatininclearance < 30 ml/min) eller nyresygdom i terminalstadiet og behov for hæmodialyse eller peritonealdialyse kan koncentrationerne af bedaquilin stige på grund af ændringer i absorption af det aktive stof, fordeling og metabolisme som følge af renal dysfunktion. 
However, in patients with severe renal impairment (creatinine clearance < 30 ml/min) or end-stage renal disease requiring haemodialysis or peritoneal dialysis, bedaquiline concentrations may be increased due to alteration of active substance absorption, distribution, and metabolism secondary to renal dysfunction.
I en populationsfarmakokinetisk analyse af tuberkulosepatienter, der blev behandlet med SIRTURO, sås ingen klinisk relevant forskel mellem eksponering hos mænd og kvinder. 
In a population pharmacokinetic analysis of tuberculosis patients treated with SIRTURO no clinically relevant difference in exposure between men and women were observed.
Efavirenz er en moderat CYP3A4-induktor, og samtidig administration af bedaquilin kunne føre til reduceret eksponering for bedaquilin og dermed nedsat virkning, hvorfor dette ikke kan anbefales. 
Efavirenz is a moderate inducer of CYP3A4 activity and co-administration with bedaquiline may result in reduced bedaquiline exposure and loss of activity, and is, therefore, not recommended.
• hypokaliæmi. 
• Hypokalemia
I et studie med 44 raske forsøgspersoner, der fik en enkelt dosis på 800 mg SIRTURO, svarede bivirkningerne til dem, der blev observeret i kliniske studier ved den rekommanderede dosis (se pkt. 
In a study in 44 healthy subjects receiving a single 800 mg dose of SIRTURO, adverse reactions were consistent with those observed in clinical studies at the recommended dose (see section 4.8).
Udskillelse af bedaquilin i urinen er ubetydelig. 
Urinary excretion of bedaquiline is negligible.
I det åbne fase IIb-studie (C209), hvor patienter uden andre behandlingsmuligheder blev behandlet for tuberkulose med andre lægemidler, der forlænger QT-intervallet, herunder clofazimin, samtidig med SIRTURO, førte det til yderligere QT-forlængelse proportionalt med det antal QT-forlængende lægemidler, der indgik i behandlingsregimet. 
In the Phase IIb, open label study (C209), where patients with no treatment options received other QTprolonging medicinal products used to treat tuberculosis, including clofazimine, concurrent use with SIRTURO resulted in additive QT prolongation, proportional to the number of QT prolonging medicinal products in the treatment regimen.
Den lave eksponering ansås ikke for klinisk relevant, da kliniske studier ikke har vist et entydigt forhold mellem eksponering for bedaquilin og respons. 
This low exposure was not considered to be clinically relevant as no clear relationship between exposure to bedaquiline and response has been observed in clinical trials.
Det skal du vide, før du begynder at tage SIRTURO 
What you need to know before you take SIRTURO
Der er rapporteret om svimmelhed hos visse patienter ved administration af bedaquilin, og der skal tages højde for dette ved vurdering af en patients evne til at føre motorkøretøj eller betjene maskiner (se pkt. 
Dizziness has been reported in some patients taking bedaquiline and should be considered when assessing a patient's ability to drive or operate machinery (see section 4.8).
Bedaquilin og M2 er ikke substrater for eller hæmmere af P-glykoprotein. 
Bedaquiline and M2 are not substrates or inhibitors of P-glycoprotein.
Samtidig administration af bedaquilin og lægemidler, der inducerer CYP3A4, kan nedsætte bedaquilins plasmakoncentration og reducere stoffets terapeutiske virkning. 
Co-administration of bedaquiline and medicinal products that induce CYP3A4 may decrease bedaquiline plasma concentrations and reduce its therapeutic effect.
et naturlægemiddel mod angst ciprofloxacin, erythromycin, clarithromycin til at behandle bakterielle infektioner (antibiotika) 
an herbal product to relieve anxiety ciprofloxacin, erythromycin, clarithromycin to treat bacterial infections (antibacterials)