natgillin/translations-raw huggingface dataset:
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)
Bedaquilin udviste større intracellulær baktericid aktivitet i primære peritoneale makrofager og i en makrofaglignende cellelinje end ekstracellulær aktivitet.
The intracellular bactericidal activity of bedaquiline in primary peritoneal macrophages and in a macrophage-like cell line was greater than its extracellular activity.
Hvis du er i tvivl, så spørg din læge eller på apoteket, før du tager SIRTURO.
If you are not sure, talk to your doctor or pharmacist before taking SIRTURO.
Mortalitet
Mortality
Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer (se pkt.
Any unused product or waste material should be disposed of in accordance with local requirements (see section 5.3).
Disse medførte 2- til 8-fold-stigninger i bedaquilins MIC-værdi, hvilket medførte MIC-værdier for bedaquilin på mellem 0,25 og 0,5 mg/l.
These lead to 2- to 8-fold increases in bedaquiline MICs, resulting in bedaquiline MICs ranging from 0.25 to 0.5 mg/l.
I tilfælde af synkope skal der optages EKG med henblik på påvisning af eventuel QT-forlængelse.
If syncope occurs, an electrocardiogram should be obtained to detect any QT prolongation.
Samlet antal respondere i uge 24 Patienter med MDRH&R-TB Patienter inficeret med præ-XDR-TB Samlet antal nonrespondere* i uge 24
Overall responder at Week 24 Patients with MDRH&R-TB Patients infected with a pre-XDR-TB Overall nonresponder* at Week 24
I et åbent fase IIb-studie var de gennemsnitlige stigninger i QTcF større hos de 17 forsøgspersoner, der samtidig fik clofazimin i uge 24 (gennemsnitlig ændring fra en referenceværdi på 31,9 ms) end hos forsøgspersoner, der ikke samtidig fik clofazimin i uge 24 (gennemsnitlig ændring fra referenceværdi på 12,3 ms) (se pkt.
In an open label Phase IIb trial, mean increases in QTcF were larger in the 17 subjects who were using concomitant clofazimine at week 24 (mean change from reference of 31.9 ms) than in subjects who were not using concomitant clofazimine at week 24 (mean change from reference of 12.3 ms) (see section 4.4).
I en populationsfarmakokinetisk analyse af tuberkulosepatienter, der blev behandlet med SIRTURO 200 mg tre gange ugentligt, påvirkedes bedaquilins farmakokinetiske parametre ikke af kreatininclearance (i området 40 til 227 ml/min).
In a population pharmacokinetic analysis of tuberculosis patients treated with SIRTURO 200 mg three times a week, creatinine clearance (range: 40 to 227 ml/min) was not found to influence the pharmacokinetic parameters of bedaquiline.
De hyppigste bivirkninger (hos > 10,0 % af patienterne) under behandling med SIRTURO i de kontrollerede studier var kvalme (35,3 % i SIRTURO-gruppen vs. 25,7 % i placebogruppen), artralgi (29,4 % vs. 20,0 %), hovedpine (23,5 % vs. 11,4 %), opkastning (20,6 % vs. 22,9 %) og svimmelhed (12,7 % vs. 11,4 %).
The most frequent adverse drug reactions (> 10.0% of patients) during treatment with SIRTURO in the controlled trials were nausea (35.3% in the SIRTURO group vs 25.7% in the placebo group), arthralgia (29.4% vs 20.0%), headache (23.5% vs 11.4%), vomiting (20.6% vs 22.9%) and dizziness (12.7% vs 11.4%).
• anamnestisk eller aktuel hypotyroidisme
• A history of or ongoing hypothyroidism;
I det kontrollerede fase IIb-studie (C208) blev der observeret gennemsnitlig øgning af baselineværdier af QTcF fra og med den første vurdering efter behandlingen (9,9 ms i uge 1 for SIRTURO og 3,5 ms for placebo).
In the controlled Phase IIb study (C208), mean increases from baseline values in QTcF were observed from the first on-treatment assessment onwards (9.9 ms at week 1 for SIRTURO and 3.5 ms for placebo).
Bemærk, at det ikke er tilrådeligt at ændre doseringen af bedaquilin i tilfælde af samtidig behandling med lopinavir/ritonavir eller andre ritonavir-boostede hiv-proteasehæmmere.
Of note, no change in bedaquiline dosing is recommended in case of co-treatment with lopinavir/ritonavir or other ritonavir-boosted HIV protease inhibitors.
Bedaquilin og M2 var ikke substrater for P-gp in vitro.
Bedaquiline and M2 were not substrates of P-gp in vitro.
På grund af den potentielle risiko for bivirkninger ved stigning i systemisk eksponering bør langvarig samtidig administration af bedaquilin og moderate eller stærke CYP3A4-hæmmere (f.eks. ciprofloxacin, erythromycin, fluconazol, clarithromycin, ketoconazol, ritonavir) til systemisk brug ikke finde sted i længere tid end 14 dage i træk.
Due to the potential risk of adverse reactions due to an increase in systemic exposure, prolonged co-administration of bedaquiline and moderate or strong CYP3A4 inhibitors (e.g. ciprofloxacin, erythromycin, fluconazole, clarithromycin, ketoconazole, ritonavir) used systemically for more than 14 consecutive days should be avoided.
I et placebokontrolleret klinisk studie med patienter med multiresistent Mycobacterium tuberculosis påvirkede samtidig administration af bedaquilin ikke i væsentlig grad de farmakokinetiske egenskaber af ethambutol, kanamycin, pyrazinamid, ofloxacin eller cycloserin.
In a placebo-controlled clinical study in patients with multi-drug resistant Mycobacterium tuberculosis, no major impact of co-administration of bedaquiline on the pharmacokinetics of ethambutol, kanamycin, pyrazinamide, ofloxacin or cycloserine was observed.
Korttids samtidig administration af bedaquilin med isoniazid/pyrazinamid til raske forsøgspersoner førte ikke til klinisk relevante ændringer i eksponeringen (AUC) for bedaquilin, isoniazid eller pyrazinamid.
The short-term co-administration of bedaquiline with isoniazid/pyrazinamide in healthy subjects did not result in clinically relevant changes in the exposure (AUC) to bedaquiline, isoniazid or pyrazinamide.
SIRTURO 100 mg tabletter
SIRTURO 100 mg tablets
• Tag 400 mg (4 tabletter a 100 mg) en gang dagligt.
• Take 400 mg (4 tablets of 100 mg) once a day.
SIRTURO er indiceret til anvendelse som led i en passende kombinationsbehandling af multiresistent lungetuberkulose (MDR-TB) hos voksne patienter, når det ikke er muligt at sammensætte et andet virksomt behandlingsregime på grund af forhold vedrørende resistens eller tolerabilitet (se pkt.
SIRTURO is indicated for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4.2, 4.4 and 5.1).
I en populationsfarmakokinetisk analyse af tuberkulosepatienter (i alderen 18-68 år), der blev behandlet med SIRTURO, påvirkedes bedaquilins farmakokinetik ikke af alder.
In a population pharmacokinetic analysis of tuberculosis patients (age range 18 years to 68 years) treated with SIRTURO age was not found to influence the pharmacokinetics of bedaquiline.
Medicinens formål rifampicin, rifapentin, rifabutin mod visse infektioner såsom tuberkulose (antibiotika med virkning på mykobakterier)
Purpose of the medicine rifampicin, rifapentine, rifabutin to treat some infections like tuberculosis (antimycobacterial)
• kongenit QT-forlængelse i personlig eller familiær anamnese
• A personal or family history of congenital QT prolongation;
På grund af potentiel reduktion af bedaquilins terapeutiske virkning ved et fald i systemisk eksponering bør det undgås samtidigt at administrere bedaquilin og moderate eller potente CYP3A4induktorer (f.eks. efavirenz, etravirin, rifamyciner inklusive rifampicin, rifapentin og rifabutin, carbamazepin, phenytoin, perikon (Hypericum perforatum)) til systemisk brug.
Due to the possibility of a reduction of the therapeutic effect of bedaquiline due to a decrease in systemic exposure, co-administration of bedaquiline and moderate or strong CYP3A4 inducers (e.g. efavirenz, etravirine, rifamycins including rifampicin, rifapentine and rifabutin, carbamazepine, phenytoin, St. John's wort (Hypericum perforatum)) used systemically should be avoided.
Koncentrationen af bedaquilin i mælk var 6-12 gange højere end den maksimale koncentration observeret i moderdyrets plasma.
Concentrations of bedaquiline in milk were 6- to12-fold higher that the maximum concentration observed in maternal plasma.
Eksponeringen for bedaquilin var lavere hos patienter inficeret med multiresistent tuberkulosis end hos raske forsøgspersoner.
Exposure to bedaquiline was lower in multi-drug resistant tuberculosis-infected patients than in healthy subjects.
Der foreligger ingen data om klinisk sikkerhed og virkning af bedaquilin ved samtidig administration af antiretrovirale midler.
There are no clinical data on the safety and efficacy of bedaquiline when co-administered with antiretroviral agents.
I kliniske studier sås forhøjede aminotransferaser eller aminotransferasestigning ledsaget af totalbilirubin ≥ 2x ULN under administration af SIRTURO sammen med baggrundsregimet (se pkt.
Increases in transaminases or aminotransferase elevations accompanied by total bilirubin ≥ 2x ULN were seen in clinical trials during administration of SIRTURO with the background regimen (see section 4.8).
Samtidig administration af en enkelt dosis bedaquilin og gentagne doser nevirapin førte ikke til klinisk relevante ændringer i eksponeringen for bedaquilin.
Co-administration of single-dose bedaquiline and multiple-dose nevirapine did not result in clinically relevant changes in the exposure to bedaquiline.
Der vil muligvis kunne observeres en mere udtalt påvirkning af eksponeringen for bedaquilin i plasma ved længerevarende samtidig administration af lopinavir/ritonavir.
A more pronounced effect on bedaquiline plasma exposures may be observed during prolonged co-administration with lopinavir/ritonavir.
CYP3A4 var det væsentligste CYP-isoenzym, der indgik in vitro i metabolismen af bedaquilin og dannelse af metabolitten N-monodesmethyl (M2).
CYP3A4 was the major CYP isoenzyme involved in vitro in the metabolism of bedaquiline and the formation of the N-monodesmethyl metabolite (M2).
Der sås fald i legemsvægt hos afkommet under diegivningen i højdosis grupper (se pkt.
Body weight decreases in pups were noted in high dose groups during the lactation period (see section 5.3).
Forhøjede aminotransferaser
Increased transaminases
I uge 120 sås der konvertering af ekspektoratdyrkning hos 148/205 patienter (72,2 %).
At week 120, sputum culture conversion was seen in 148/205 (72.2%) patients.
I studie C208 (trin 1 og 2) udvikledes der hyppigere forhøjede aminotransferaser på mindst 3xULN i SIRTURO-gruppen (11/102 [10,8 %] versus 6/105 [5,7 %]) i placebogruppen.
In study C208 (stage 1 and 2), aminotransferase elevations of at least 3 x ULN developed more frequently in the SIRTURO treatment group (11/102 [10.8%] versus 6/105 [5.7%]) in the placebo treatment group.
Lægemidler der forlænger QT-intervallet
QT interval prolonging medicinal products
• hjerteinsufficiens
• Heart failure;
Opbevar SIRTURO i den originale beholder eller pakning for at beskytte det mod lys.
Store SIRTURO in the original container or package in order to protect it from light.
Bedaquilin påvirkede ikke fertiliteten ved evaluering i hunrotter.
Bedaquiline had no effects on fertility when evaluated in female rats.
Samtidig administration af bedaquilin og moderate eller stærke CYP3A4-hæmmere kan øge systemisk eksponering for bedaquilin, hvilket potentielt kan øge risikoen for bivirkninger (se pkt.
Co-administration of bedaquiline and moderate or strong CYP3A4 inhibitors may increase the systemic exposure to bedaquiline, which could potentially increase the risk of adverse reactions (see section 4.5).
• Tag den glemte dosis på 200 mg, så snart du kommer i tanke om den.
• Take the missed dose of 200 mg as soon as possible.
SIRTURO bør anvendes med forsigtighed hos patienter med moderat nedsat leverfunktion (se pkt.
SIRTURO should be used with caution in patients with moderate hepatic impairment (see section 5.2).
CYP3A4 er det væsentligste CYPisoenzym, der indgår in vitro i metabolismen af bedaquilin og dannelse af metabolitten N-monodesmethyl (M2).
CYP3A4 is the major CYP isoenzyme involved in vitro in the metabolism of bedaquiline and the formation of the N-monodesmethyl metabolite (M2).
I et studie med administration af en enkelt dosis SIRTURO til 8 forsøgspersoner med moderat nedsat leverfunktion (Child-Pugh-klasse B) blev det påvist, at eksponeringen for bedaquilin og M2 (AUC672h) var 19 % lavere end hos raske forsøgspersoner.
A single-dose study of SIRTURO in 8 subjects with moderate hepatic impairment (Child-Pugh B) demonstrated exposure to bedaquiline and M2 (AUC672h) was 19% lower compared to healthy subjects.
Der må forventes øget eksponering for bedaquilin i plasma, når lægemidlet administreres samtidig med andre ritonavir-boostede hiv-proteasehæmmere.
Increases in plasma exposure to bedaquiline would be expected when it is coadministered with other ritonavir-boosted HIV protease inhibitors.
Disse forsøgspersoner blev udelukket fra delgruppeanalysen af grad af resistens for M tuberculosis-stamme.
These subjects were excluded from the subgroup analysis by extent of resistance of M tuberculosis strain.
I tabellen nedenfor vises bivirkninger af SIRTURO indberettet fra kontrollerede studier med 102 patienter, der blev behandlet med SIRTURO.
Adverse drug reactions to SIRTURO reported from controlled trials in 102 patients treated with SIRTURO are presented in the table below.
Der foreligger ingen kliniske data om samtidig administration af bedaquilin og antiretrovirale midler til patienter, der samtidig er inficeret med human immundefekt virus og multiresistent Mycobacterium tuberculosis (se pkt.
Clinical data on co-administration of bedaquiline and antiretroviral agents in patients co-infected with human immunodeficiency virus and multi-drug resistant Mycobacterium tuberculosis are not available (see section 4.4).
Brug af anden medicin sammen med SIRTURO Andre lægemidler kan påvirke SIRTURO.
Other medicines may affect SIRTURO.
For at forebygge udvikling af resistens over for bedaquilin må bedaquilin kun bruges i et egnet kombinationsregime til behandling af MDR-TB som anbefalet i officielle retningslinjer, som for eksempel fra WHO.
Bedaquiline must only be used in an appropriate combination regimen for MDR-TB treatment as recommended by official guidelines, such as from WHO, to prevent development of resistance to bedaquiline.
Der vil måske kunne ses en mere udtalt virkning på bedaquilin under længerevarende samtidig administration af ketoconazol eller andre CYP3A4-hæmmere.
A more pronounced effect on bedaquiline may be observed during prolonged co-administration of ketoconazole or other inhibitors of CYP3A4.
SIRTURO 100 mg tabletter bedaquilin
SIRTURO 100 mg tablets bedaquiline
Eftersom bedaquilin binder til plasmaproteiner med høj affinitet, er det usandsynligt, at det kan fjernes fra plasma i et væsentligt omfang ved hæmodialyse eller peritonealdialyse.
As bedaquiline is highly bound to plasma proteins, it is unlikely that it will be significantly removed from plasma by haemodialysis or peritoneal dialysis.
Konverteringsraterne i uge 24 var højest (87,1 %; 81/93) hos patienter med MDRH&R-TB, 77,3 % (34/44) hos præ-XDR-TBpatienter og lavest (54,1 %; 20/37) hos XDR-TB-patienter.
Conversion rates at week 24 were highest (87.1%; 81/93) in patients with MDRH&R-TB, 77.3% (34/44) in pre-XDR-TB patients and lowest (54.1%; 20/37) in XDR-TB patients.
• Tag 200 mg (2 tabletter a 100 mg) en gang dagligt, men kun 3 dage om ugen.
• Take 200 mg (2 tablets of 100 mg) once a day for 3 days of each week only.
Multiresistent Mycobacterium tuberculosis (MDRH&R-TB): isolat, der er resistent over for mindst isoniazid og rifampicin, men følsomme over for fluorquinoloner og injicerbare lægemidler til andenlinjebehandling.
Multi-drug resistant Mycobacterium tuberculosis (MDRH&R-TB): isolate resistant to at least isoniazid and rifampicin, but susceptible to fluoroquinolones and second line injectable agents.
Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager SIRTURO:
Talk to your doctor, pharmacist or nurse before taking SIRTURO, if:
Konverteringsraterne i uge 120 var højest (73,1 %; 68/93) hos patienter med MDRH&R-TB, 70,5 % (31/44) hos præ-XDR-TB-patienter og lavest (62,2 %; 23/37) hos XDR-TB-patienter.
Conversion rates at week 120 were highest (73.1%; 68/93) in patients with MDRH&R-TB, 70.5% (31/44) in pre-XDR-TB patients and lowest (62.2%; 23/37) in XDR-TB patients.
Hvis samtidig administration af sådanne lægemidler og bedaquilin skønnes nødvendig, anbefales klinisk monitorering, inklusive hyppig EKG-vurdering.
In the event that co-administration of such medicinal products with bedaquiline is necessary, clinical monitoring, including frequent electrocardiogram assessment, is recommended.
Bedaquilin er ikke undersøgt hos patienter med svært nedsat leverfunktion (se pkt.
Bedaquiline has not been studied in patients with severe hepatic impairment (see section 4.2).
Sådan skal du tage SIRTURO
How to take SIRTURO
(antibiotika med virkning på mykobakterier) carbamazepin, phenytoin til at behandle epileptiske anfald (antiepileptika) perikon (Hypericum perforatum)
(antimycobacterial) carbamazepine, phenytoin to treat epileptic fits (anticonvulsants) St. John's wort (Hypericum perforatum)
Kortvarig samtidig administration af bedaquilin og ketoconazol (potent CYP3A4-hæmmer) til raske forsøgspersoner øgede eksponeringen (AUC) for bedaquilin med 22 % [90 % CI (12; 32)].
The short-term co-administration of bedaquiline and ketoconazole (potent CYP3A4 inhibitor) in healthy subjects increased the exposure (AUC) to bedaquiline by 22% [90% CI (12; 32)].
I uge 24 sås dyrkningskonvertering for ekspektoratdyrkningsprøver hos 163/205 (79,5 %).
At week 24, sputum culture conversion was seen in 163/205 (79.5%) patients.
• Aktivt stof: bedaquilin.
• The active substance is bedaquiline.