FrancophonIA/ELRC3.0 huggingface dataset:
English: Isolates that are resistant to clofazimine can still be susceptible to bedaquiline.
Danish: Isolater, der er resistente over for clofazimin, kan stadig være følsomme for bedaquilin.
English: SIRTURO contains “lactose” (a type of sugar).
Danish: SIRTURO indeholder lactose (sukkerart).
English: 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.
Danish: 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.
English: In a population pharmacokinetic analysis of tuberculosis patients treated with SIRTURO no clinically relevant difference in exposure between men and women were observed.
Danish: I en populationsfarmakokinetisk analyse af tuberkulosepatienter, der blev behandlet med SIRTURO, sås ingen klinisk relevant forskel mellem eksponering hos mænd og kvinder.
English: 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.
Danish: 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.
English: • Hypokalemia
Danish: • hypokaliæmi.
English: 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).
Danish: 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.
English: Urinary excretion of bedaquiline is negligible.
Danish: Udskillelse af bedaquilin i urinen er ubetydelig.
English: 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.
Danish: 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.
English: 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.
Danish: Den lave eksponering ansås ikke for klinisk relevant, da kliniske studier ikke har vist et entydigt forhold mellem eksponering for bedaquilin og respons.
English: What you need to know before you take SIRTURO
Danish: Det skal du vide, før du begynder at tage SIRTURO
English: 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).
Danish: 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.
English: Bedaquiline and M2 are not substrates or inhibitors of P-glycoprotein.
Danish: Bedaquilin og M2 er ikke substrater for eller hæmmere af P-glykoprotein.
English: Co-administration of bedaquiline and medicinal products that induce CYP3A4 may decrease bedaquiline plasma concentrations and reduce its therapeutic effect.
Danish: Samtidig administration af bedaquilin og lægemidler, der inducerer CYP3A4, kan nedsætte bedaquilins plasmakoncentration og reducere stoffets terapeutiske virkning.
English: an herbal product to relieve anxiety ciprofloxacin, erythromycin, clarithromycin to treat bacterial infections (antibacterials)
Danish: et naturlægemiddel mod angst ciprofloxacin, erythromycin, clarithromycin til at behandle bakterielle infektioner (antibiotika)
English: The intracellular bactericidal activity of bedaquiline in primary peritoneal macrophages and in a macrophage-like cell line was greater than its extracellular activity.
Danish: Bedaquilin udviste større intracellulær baktericid aktivitet i primære peritoneale makrofager og i en makrofaglignende cellelinje end ekstracellulær aktivitet.
English: If you are not sure, talk to your doctor or pharmacist before taking SIRTURO.
Danish: Hvis du er i tvivl, så spørg din læge eller på apoteket, før du tager SIRTURO.
English: Mortality
Danish: Mortalitet
English: Any unused product or waste material should be disposed of in accordance with local requirements (see section 5.3).
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer (se pkt.
English: These lead to 2- to 8-fold increases in bedaquiline MICs, resulting in bedaquiline MICs ranging from 0.25 to 0.5 mg/l.
Danish: 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.
English: If syncope occurs, an electrocardiogram should be obtained to detect any QT prolongation.
Danish: I tilfælde af synkope skal der optages EKG med henblik på påvisning af eventuel QT-forlængelse.
English: Overall responder at Week 24 Patients with MDRH&R-TB Patients infected with a pre-XDR-TB Overall nonresponder* at Week 24
Danish: Samlet antal respondere i uge 24 Patienter med MDRH&R-TB Patienter inficeret med præ-XDR-TB Samlet antal nonrespondere* i uge 24
English: 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).
Danish: 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.
English: 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.
Danish: 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).
English: 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%).
Danish: 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 %).
English: • A history of or ongoing hypothyroidism;
Danish: • anamnestisk eller aktuel hypotyroidisme
English: 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).
Danish: 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).
English: Of note, no change in bedaquiline dosing is recommended in case of co-treatment with lopinavir/ritonavir or other ritonavir-boosted HIV protease inhibitors.
Danish: 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.
English: Bedaquiline and M2 were not substrates of P-gp in vitro.
Danish: Bedaquilin og M2 var ikke substrater for P-gp in vitro.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: SIRTURO 100 mg tablets
Danish: SIRTURO 100 mg tabletter
English: • Take 400 mg (4 tablets of 100 mg) once a day.
Danish: • Tag 400 mg (4 tabletter a 100 mg) en gang dagligt.
English: 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).
Danish: 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.
English: 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.
Danish: I en populationsfarmakokinetisk analyse af tuberkulosepatienter (i alderen 18-68 år), der blev behandlet med SIRTURO, påvirkedes bedaquilins farmakokinetik ikke af alder.
English: Purpose of the medicine rifampicin, rifapentine, rifabutin to treat some infections like tuberculosis (antimycobacterial)
Danish: Medicinens formål rifampicin, rifapentin, rifabutin mod visse infektioner såsom tuberkulose (antibiotika med virkning på mykobakterier)
English: • A personal or family history of congenital QT prolongation;
Danish: • kongenit QT-forlængelse i personlig eller familiær anamnese
English: 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.
Danish: 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.
English: Concentrations of bedaquiline in milk were 6- to12-fold higher that the maximum concentration observed in maternal plasma.
Danish: Koncentrationen af bedaquilin i mælk var 6-12 gange højere end den maksimale koncentration observeret i moderdyrets plasma.
English: Exposure to bedaquiline was lower in multi-drug resistant tuberculosis-infected patients than in healthy subjects.
Danish: Eksponeringen for bedaquilin var lavere hos patienter inficeret med multiresistent tuberkulosis end hos raske forsøgspersoner.
English: There are no clinical data on the safety and efficacy of bedaquiline when co-administered with antiretroviral agents.
Danish: Der foreligger ingen data om klinisk sikkerhed og virkning af bedaquilin ved samtidig administration af antiretrovirale midler.
English: 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).
Danish: I kliniske studier sås forhøjede aminotransferaser eller aminotransferasestigning ledsaget af totalbilirubin ≥ 2x ULN under administration af SIRTURO sammen med baggrundsregimet (se pkt.
English: Co-administration of single-dose bedaquiline and multiple-dose nevirapine did not result in clinically relevant changes in the exposure to bedaquiline.
Danish: Samtidig administration af en enkelt dosis bedaquilin og gentagne doser nevirapin førte ikke til klinisk relevante ændringer i eksponeringen for bedaquilin.
English: A more pronounced effect on bedaquiline plasma exposures may be observed during prolonged co-administration with lopinavir/ritonavir.
Danish: Der vil muligvis kunne observeres en mere udtalt påvirkning af eksponeringen for bedaquilin i plasma ved længerevarende samtidig administration af lopinavir/ritonavir.
English: CYP3A4 was the major CYP isoenzyme involved in vitro in the metabolism of bedaquiline and the formation of the N-monodesmethyl metabolite (M2).
Danish: CYP3A4 var det væsentligste CYP-isoenzym, der indgik in vitro i metabolismen af bedaquilin og dannelse af metabolitten N-monodesmethyl (M2).
English: Body weight decreases in pups were noted in high dose groups during the lactation period (see section 5.3).
Danish: Der sås fald i legemsvægt hos afkommet under diegivningen i højdosis grupper (se pkt.
English: Increased transaminases
Danish: Forhøjede aminotransferaser
English: At week 120, sputum culture conversion was seen in 148/205 (72.2%) patients.
Danish: I uge 120 sås der konvertering af ekspektoratdyrkning hos 148/205 patienter (72,2 %).
English: 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.
Danish: 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.
English: QT interval prolonging medicinal products
Danish: Lægemidler der forlænger QT-intervallet
English: • Heart failure;
Danish: • hjerteinsufficiens
English: Store SIRTURO in the original container or package in order to protect it from light.
Danish: Opbevar SIRTURO i den originale beholder eller pakning for at beskytte det mod lys.
English: Bedaquiline had no effects on fertility when evaluated in female rats.
Danish: Bedaquilin påvirkede ikke fertiliteten ved evaluering i hunrotter.
English: 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).
Danish: 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.
English: • Take the missed dose of 200 mg as soon as possible.
Danish: • Tag den glemte dosis på 200 mg, så snart du kommer i tanke om den.
English: SIRTURO should be used with caution in patients with moderate hepatic impairment (see section 5.2).
Danish: SIRTURO bør anvendes med forsigtighed hos patienter med moderat nedsat leverfunktion (se pkt.
English: CYP3A4 is the major CYP isoenzyme involved in vitro in the metabolism of bedaquiline and the formation of the N-monodesmethyl metabolite (M2).
Danish: CYP3A4 er det væsentligste CYPisoenzym, der indgår in vitro i metabolismen af bedaquilin og dannelse af metabolitten N-monodesmethyl (M2).
English: 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.
Danish: 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.
English: Increases in plasma exposure to bedaquiline would be expected when it is coadministered with other ritonavir-boosted HIV protease inhibitors.
Danish: Der må forventes øget eksponering for bedaquilin i plasma, når lægemidlet administreres samtidig med andre ritonavir-boostede hiv-proteasehæmmere.
English: These subjects were excluded from the subgroup analysis by extent of resistance of M tuberculosis strain.
Danish: Disse forsøgspersoner blev udelukket fra delgruppeanalysen af grad af resistens for M tuberculosis-stamme.
English: Adverse drug reactions to SIRTURO reported from controlled trials in 102 patients treated with SIRTURO are presented in the table below.
Danish: I tabellen nedenfor vises bivirkninger af SIRTURO indberettet fra kontrollerede studier med 102 patienter, der blev behandlet med SIRTURO.
English: 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).
Danish: 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.
English: Other medicines may affect SIRTURO.
Danish: Brug af anden medicin sammen med SIRTURO Andre lægemidler kan påvirke SIRTURO.
English: 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.
Danish: 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.
English: A more pronounced effect on bedaquiline may be observed during prolonged co-administration of ketoconazole or other inhibitors of CYP3A4.
Danish: Der vil måske kunne ses en mere udtalt virkning på bedaquilin under længerevarende samtidig administration af ketoconazol eller andre CYP3A4-hæmmere.
English: SIRTURO 100 mg tablets bedaquiline
Danish: SIRTURO 100 mg tabletter bedaquilin
English: As bedaquiline is highly bound to plasma proteins, it is unlikely that it will be significantly removed from plasma by haemodialysis or peritoneal dialysis.
Danish: 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.
English: 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.
Danish: 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.
English: • Take 200 mg (2 tablets of 100 mg) once a day for 3 days of each week only.
Danish: • Tag 200 mg (2 tabletter a 100 mg) en gang dagligt, men kun 3 dage om ugen.
English: 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.
Danish: 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.
English: Talk to your doctor, pharmacist or nurse before taking SIRTURO, if:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager SIRTURO:
English: 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.
Danish: 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.
English: In the event that co-administration of such medicinal products with bedaquiline is necessary, clinical monitoring, including frequent electrocardiogram assessment, is recommended.
Danish: Hvis samtidig administration af sådanne lægemidler og bedaquilin skønnes nødvendig, anbefales klinisk monitorering, inklusive hyppig EKG-vurdering.
English: Bedaquiline has not been studied in patients with severe hepatic impairment (see section 4.2).
Danish: Bedaquilin er ikke undersøgt hos patienter med svært nedsat leverfunktion (se pkt.
English: How to take SIRTURO
Danish: Sådan skal du tage SIRTURO
English: (antimycobacterial) carbamazepine, phenytoin to treat epileptic fits (anticonvulsants) St. John's wort (Hypericum perforatum)
Danish: (antibiotika med virkning på mykobakterier) carbamazepin, phenytoin til at behandle epileptiske anfald (antiepileptika) perikon (Hypericum perforatum)
English: 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)].
Danish: Kortvarig samtidig administration af bedaquilin og ketoconazol (potent CYP3A4-hæmmer) til raske forsøgspersoner øgede eksponeringen (AUC) for bedaquilin med 22 % [90 % CI (12; 32)].
English: At week 24, sputum culture conversion was seen in 163/205 (79.5%) patients.
Danish: I uge 24 sås dyrkningskonvertering for ekspektoratdyrkningsprøver hos 163/205 (79,5 %).
English: • The active substance is bedaquiline.
Danish: • Aktivt stof: bedaquilin.
English: An additive or synergistic effect on QT prolongation of bedaquiline when co-administered with other medicinal products that prolong the QT interval cannot be excluded and frequent monitoring is recommended (see section 4.4).
Danish: Det kan ikke udelukkes, at der kan forekomme additiv eller synergistisk påvirkning af QT-forlængelsen fremkaldt af bedaquilin ved samtidig administration af andre lægemidler, der forlænger QT-intervallet, og hyppig monitorering anbefales (se pkt.
English: During the investigational phase in Stage 2 of study C208, increased aminotransferases were reported in 7/79 (8.9%) patients in the SIRTURO treatment group compared to 1/81 (1.2%) in the placebo treatment group.
Danish: Under forskningsfasens trin 2 i studie C208 blev der rapporteret om forhøjede aminotransferaser hos 7/79 (8,9 %) patienter i SIRTURO-gruppen sammenlignet med 1/81 (1,2 %) i placebogruppen.