natgillin/translations-raw huggingface dataset:
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. 
Po podatkih analize populacijske farmakokinetike pri bolnikih, ki imajo tuberkulozo in prejemajo zdravilo SIRTURO, je bila pri bolnikih črne rase izpostavljenost bedakilinu manjša kot pri bolnikih drugih rasnih kategorij.
an herbal product to relieve anxiety ciprofloxacin, erythromycin, clarithromycin to treat bacterial infections (antibacterials) 
rastlinsko zdravilo za zdravljenje anksioznosti ciprofloksacin, eritromicin, klaritromicin za zdravljenje bakterijskih okužb (antibiotiki)
The plasma protein binding of the N-monodesmethyl metabolite (M2) in humans is at least 99.8%. 
N-monodesmetilni presnovek (M2) se pri ljudeh veže na beljakovine v plazmi v najmanj 99,8%.
It is used in adults aged 18 years and over. 
Zdravilo je namenjeno odraslim, starim najmanj 18 let.
All of these toxicities except effects on MPS were monitored clinically. 
Vse navedene oblike toksičnega delovanja razen delovanja na monocitno-fagocitni sistem so klinično spremljali.
• The active substance is bedaquiline. 
• Zdravilna učinkovina je bedakilin.
At week 120, sputum culture conversion was seen in 148/205 (72.2%) patients. 
Po 120. tednu so opazili konverzijo kulture sputuma pri 148/205 (72,2%) bolnikih.
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. 
Pri klinično pomembnih koncentracijah bedakilin in M2 in vitro nista zavirala prenašalcev P-gp, OATP1B1, OATP1B3, BCRP, OAT1, OAT3, OCT1, OCT2, MATE1 in MATE2.
Other antituberculosis medicinal products 
Drugi tuberkulostatiki
Central laboratory drug susceptibility testing results became available for one additional placebo subject after the week 24 interim analysis. 
Za enega dodatnega preiskovanca iz skupine, ki je prejemala placebo, so bili rezultati testiranja občutljivosti v centralnem laboratoriju razpoložljivi po vmesni analizi po 24 tednih.
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. 
Neželene učinke zdravila SIRTURO so ugotavljali iz združenih podatkov kliničnih študij faze IIb (nadzorovanih in nenadzorovanih), v katere je bilo vključenih 335 bolnikov, ki so prejemali zdravilo SIRTURO v kombinaciji z zdravili osnovne sheme zdravljenja tuberkuloze.
The impact of high baseline bedaquiline MICs, the presence of Rv0678 based mutations at baseline, and/or increased post-baseline bedaquiline MICs on microbiologic outcomes is unclear because of the low incidence of such cases in the Phase II trials. 
Ni povsem jasno, kako na mikrobiološke izide vplivajo visoke izhodiščne vrednosti MIK bedakilina, prisotnost mutacij Rv0678 ob izhodišču in/ali zvišanje vrednosti MIK bedakilina po izhodišču, saj je bila incidenca takih primerov v študijah faze II nizka.
There is limited information available on the potential for a pharmacodynamic interaction between bedaquiline and medicinal products that prolong the QT interval. 
Podatki o možnih farmakodinamičnih interakcijah med bedakilinom in zdravili, ki podaljšujejo interval QT, so omejeni.
SIRTURO treatment initiation is not recommended in patients with the following, unless the benefits of bedaquiline are considered to outweigh the potential risks: 
Zdravljenje z zdravilom SIRTURO ni priporočeno (razen če koristi zdravljenja z bedakilinom ne odtehtajo morebitnih tveganj) pri bolnikih:
In vitro and in vivo genotoxicity tests indicated that bedaquiline did not have any mutagenic or clastogenic effects. 
Pri testih genotoksičnosti in vitro in in vivo se je pokazalo, da bedakilin ne deluje mutageno ali klastogeno.
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. 
Med bolniki z vsemi značilnostmi rezistence je bilo 76% (84/111) okuženih s sevom MDRH&R-TB, 24% (27/111) pa s sevom pre-XDR-TB.
Each tablet contains bedaquiline fumarate equivalent to 100 mg bedaquiline. 
Ena tableta vsebuje bedakilinijev fumarat v količini, ki ustreza 100 mg bedakilina.
ketoconazole, fluconazole to treat fungal infections (antifungals) 
ketokonazol, flukonazol za zdravljenje okužb z glivicami (antimikotiki)
Check with your doctor or pharmacist. 
Pogovorite se z zdravnikom ali farmacevtom.
These subjects were excluded from the subgroup analysis by extent of resistance of Mycobacterium tuberculosis strain. 
Ti posamezniki so bili izključeni iz analize podskupin po obsegu odpornosti sevov Mycobacterium tuberculosis.
Treatment with SIRTURO should be initiated and monitored by a physician experienced in the management of multi-drug resistant Mycobacterium tuberculosis. 
Zdravljenje z zdravilom SIRTURO mora uvesti in nadzorovati zdravnik z izkušnjami pri zdravljenju okužbe z bakterijo Mycobacterium tuberculosis, ki je odporna proti več zdravilom.
There are no clinical data on the safety and efficacy of bedaquiline when co-administered with antiretroviral agents. 
Ni kliničnih podatkov o varnosti in učinkovitosti bedakilina pri sočasni uporabi s protiretrovirusnimi učinkovinami.
In a population pharmacokinetic analysis of tuberculosis patients treated with SIRTURO no clinically relevant difference in exposure between men and women were observed. 
V analizi populacijske farmakokinetike pri bolnikih, ki imajo tuberkulozo in prejemajo zdravilo SIRTURO, niso opažali klinično pomembnih razlik v izpostavljenosti med moškimi in ženskami.
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). 
V 120-tedenski študiji C208, v kateri so zdravilo SIRTURO odmerjali 24 tednov v kombinaciji z osnovno shemo, je v skupini z zdravilom SIRTURO prišlo do več smrtnih primerov kot v skupini s placebom (glejte poglavje 5.1).
At week 24, sputum culture conversion was seen in 163/205 (79.5%) patients. 
Po 24 tednih zdravljenja so opazili konverzijo kulture sputuma pri 163/205 (79,5%) bolnikov.
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. 
Študija enkratnega odmerjanja zdravila SIRTURO pri 8 osebah z zmerno okvaro jeter (razreda Child-Pugh B) je pokazala, da je izpostavljenost bedakilinu in presnovku M2 (AUC672h) za 19% manjša kot pri zdravih osebah.
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. 
V odprti študiji faze IIb (C209) v kateri so bolniki, pri katerih ni bilo druge možnosti, za zdravljenje tuberkuloze prejeli tudi druge učinkovine, ki podaljšujejo interval QT (vključno s klofaziminom) je sočasna uporaba z zdravilom SIRTURO vodila v dodatno podaljšanje intervala QT, ki je bilo sorazmerno s številom učinkovin, ki podaljšujejo interval QT v shemi zdravljenja.
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. 
Zaradi možnosti povečanja tveganja za neželene učinke pri povečanju sistemske izpostavljenosti zdravilu se je treba izogibati dolgotrajnejši sočasni uporabi bedakilina in zmernih ali močnih zaviralcev CYP3A4 (npr. ciprofloksacin, eritromicin, flukonazol, klaritromicin, ketokonazol, ritonavir) s sistemskim vnosom, ki bi trajala več kot 14 zaporednih dni.
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). 
V prvih 24 tednih je največje povprečno podaljšanje intervala QTcF, glede na izhodiščno vrednost, v skupini s placebom znašalo 6,2 ms (tudi po 18 tednih) (glejte poglavje 4.4).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI TRAKU
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%). 
V nadzorovanih kliničnih študijah so bili v času zdravljenja z zdravilom SIRTURO najbolj pogosti neželeni učinki (pri > 10,0% bolnikov): navzea (35,3% v skupini z zdravilom SIRTURO v primerjavi s 25,7% v skupini s placebom), artralgija (29,4% v primerjavi z 20,0%), glavobol (23,5% v primerjavi z 11,4%), bruhanje (20,6% v primerjavi z 22,9%) in omotičnost (12,7% v primerjavi z 11,4%).
• abnormal reading on the electrocardiogram called “QT prolongation”. 
• nenormalnost na elektrokardiogramu (EKG), ki se imenuje "podaljšanje intervala QT".
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). 
Sočasna uporaba bedakilina in zmernih ali močnih zaviralcev encima CYP3A4 lahko poveča sistemsko izpostavljenost bedakilinu, kar bi lahko povečalo tveganje za neželene učinke (glejte poglavje 4.5).
SIRTURO with alcohol You should not drink alcohol while taking SIRTURO. 
Zdravilo SIRTURO skupaj z alkoholom V času jemanja zdravila SIRTURO ne smete uživati alkohola.
Adverse drug reactions are listed by system organ class (SOC) and frequency. 
Neželeni učinki so razvrščeni po organskih sistemih in pogostnosti.
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). 
Ni kliničnih podatkov o sočasni uporabi bedakilina in protiretrovirusnih zdravil pri bolnikih, ki so okuženi z virusom humane imunske pomanjkljivosti in bakterijo Mycobacterium tuberculosis odporno proti več zdravilom (glejte poglavje 4.4).
White HDPE bottle with child-resistant polypropylene (PP) closure with aluminium induction seal liner containing 188 tablets. 
Bela plastenka iz HDPE s polipropilensko (PP) za otroke varno zaporko in z indukcijsko zataljeno folijo s 188 tabletami.
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. 
Zaradi zmanjšanja sistemske izpostavljenosti zdravilu lahko pride do zmanjšanja terapevtskega učinka bedakilina, zato se je treba izogibati sočasni uporabi bedakilina in zmernih ali močnih induktorjev encima CYP3A4 (npr. efavirenz, etravirin, rifamicini (vključno z rifampicinom, rifapentinom in rifabutinom), karbamazepin, fenitoin, šentjanževka (Hypericum perforatum)) s sistemskim vnosom.
Furthermore, response rates in patients that completed the bedaquiline treatment period were comparable between different race categories in the clinical trials. 
Razen tega je bil v kliničnih študijah delež bolnikov z odzivom med bolniki, ki so zaključili obdobje zdravljenja z bedakilinom, med različnimi rasnimi kategorijami primerljiv.
CYP3A4 is the major CYP isoenzyme involved in vitro in the metabolism of bedaquiline and the formation of the N-monodesmethyl metabolite (M2). 
Encim CYP3A4 je najpomembnejši izoencim CYP, ki je vpleten v in vitro presnovo bedakilina in tvorbo N-monodesmetilnega presnovka (M2).
Purpose of the medicine rifampicin, rifapentine, rifabutin to treat some infections like tuberculosis (antimycobacterial) 
Zakaj se zdravilo uporablja rifampicin, rifapentin, rifabutin za zdravljenje okužb, kot je tuberkuloza (zdravila za zdravljenje okužb z mikobakterijami)
Elderly population (≥ 65 years of age) There is limited clinical data (n = 2) on the use of SIRTURO in elderly patients. 
Starejši bolniki (≥ 65 let) Kliničnih podatkov o uporabi zdravila SIRTURO pri starejših bolnikih je zelo malo (n = 2).
• Take 200 mg (2 tablets of 100 mg) once a day for 3 days of each week only. 
• jemljete 200 mg (2 tableti po 100 mg) enkrat na dan samo 3 dni v tednu.
Bedaquiline and M2 were not substrates of P-gp in vitro. 
Bedakilin in M2 in vitro nista bila substrata P-gp.
Bedaquiline and M2 are not substrates or inhibitors of P-glycoprotein. 
Bedakilin in presnovek M2 nista substrata ali zaviralca glikoproteina P.
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. 
V s placebom nadzorovani klinični študiji z bolniki, ki so imeli okužbo z bakterijo Mycobacterium tuberculosis odporno proti več zdravilom, niso opazili bistvenega vpliva sočasne uporabe bedakilina na farmakokinetiko etambutola, kanamicina, pirazinamida, ofloksacina ali cikloserina.
Therefore, the combination of bedaquiline and moderate or strong CYP3A4 inhibitors used systemically for more than 14 consecutive days should be avoided. 
Zato se je treba izogibati sočasni uporabi bedakilina in zmernih oziroma močnih zaviralcev encima CYP3A4 s sistemskim vnosom, ki bi trajala več kot 14 zaporednih dni.
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. 
Pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) ali s končno ledvično odpovedjo, zaradi katere je potrebno zdravljenje s hemodializo ali peritonealno dializo, lahko pride do zvišanja koncentracij bedakilina zaradi spremenjene absorpcije, porazdelitve in presnove učinkovine pri zmanjšani ledvični funkciji.
Based on the preclinical studies, the bulk of the administered dose is eliminated in faeces. 
Glede na rezultate predkliničnih študij se večina danega odmerka izloči z blatom.
Bedaquiline has not been studied in patients with severe hepatic impairment (see section 4.2). 
Uporabe bedakilina pri bolnikih s hudo okvaro jeter niso proučevali (glejte poglavje 4.2).
In female rats, there was no effect on mating or fertility with bedaquiline treatment, however some effects were observed in male rats (see section 5.3). 
Pri podganjih samicah uporaba bedakilina ni vplivala na parjenje in plodnost, pri podganjih samcih pa so opažali določene učinke (glejte poglavje 5.3).
There are no clinical data on the use of SIRTURO as part of combination regimens used to treat drug-susceptible Mycobacterium tuberculosis. 
Ni kliničnih podatkov o uporabi zdravila SIRTURO v kombinirani shemi zdravljenja okužbe z Mycobacterium tuberculosis, ki je občutljiva na zdravila.
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. 
V študiji medsebojnega delovanja bedakilina in ketokonazola so pri večkratnem odmerjanju kombinacije obeh zdravil opažali večji vpliv na interval QTc kot pri večkratnih odmerkih vsakega od zdravil posebej.
• infections due to mycobacterial species other than Mycobacterium tuberculosis 
• okužb z drugimi mikobakterijami (razen Mycobacterium tuberculosis)
There is no experience with the treatment of acute overdose with SIRTURO. 
Z zdravljenjem v primeru akutnega prevelikega odmerjanja zdravila SIRTURO ni na voljo nobenih izkušenj.
• Weeks 1-2: 400 mg (4 tablets of 100 mg) once daily 
• 1. in 2. teden: 400 mg (4 tablete po 100 mg) enkrat na dan
• you have a personal or family history of a heart problem called “congenital long QT syndrome”; 
• če imate sami ali ima kdo v vaši družini motnjo v delovanju srca, ki se imenuje "sindrom prirojenega podaljšanja intervala QT"
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). 
V odprti študiji faze IIb je bilo po 24 tednih zdravljenja povprečno podaljšanje intervala QTcF bolj izrazito pri 17 bolnikih, ki so sočasno uporabljali klofazimin, (s povprečno spremembo od referenčne vrednosti za 31,9 ms) kot pri bolnikih, ki niso sočasno uporabljali klofazimina (s povprečno spremembo od referenčne vrednosti za 12,3 ms) (glejte poglavje 4.4).
What SIRTURO looks like and contents of the pack Uncoated, white to almost white round biconvex tablet, 11 mm in diameter, with debossing of "T" over "207" on one side and "100" on the other side. 
Izgled zdravila SIRTURO in vsebina pakiranja Neobložena, bela do umazano bela okrogla bikonveksna tableta premera 11 mm z vtisnjeno oznako "T" preko oznake "207" na eni strani tablete in z oznako "100" na drugi strani.
Your doctor will decide which other medicines you should take with SIRTURO. 
Katera druga zdravila morate jemati skupaj z zdravilom SIRTURO, bo določil vaš zdravnik.
Within the concentration range achieved with the therapeutic dose, no pharmacokinetic/pharmacodynamic relationship was observed in patients. 
V okviru koncentracij, ki jih zdravilo doseže pri terapevtskem odmerjanju, pri bolnikih niso opažali odvisnosti med farmakokinetičnimi in farmakodinamičnimi lastnostmi zdravila.
Uncoated, white to almost white round biconvex tablet, 11 mm in diameter, with debossing of "T" over "207" on one side and "100" on the other side. 
Neobložena, bela do umazano bela okrogla bikonveksna tableta premera 11 mm z vtisnjeno oznako "T" preko oznake "207" na eni strani tablete in z oznako "100" na drugi strani.
Twenty-four of these 24-week responders (14.7%) were considered non-responders at week 120, of which 19 patients had prematurely discontinued the trial while being culture converted and 5 patients had experienced relapse. 
Štiriindvajset bolnikov (14,7%), ki se je odzvalo na zdravljenje po 24 tednih, so označili za neodzivne po 120. tednu zdravljenja; 19 bolnikov je zaradi konverzije kulture sputuma sodelovanje v študiji predčasno prekinilo, pri 5 bolnikih pa se je bolezen ponovila.
• Hypokalemia 
• s hipokaliemijo.
If the benefit outweighs the risk, SIRTURO may be used with caution when co-administered with lopinavir/ritonavir. 
Kadar korist odtehta tveganje, se zdravilo SIRTURO lahko sočasno uporablja s kombinacijo lopinavir/ritonavir, vendar je pri tem potrebna previdnost.
In the event that co-administration of such medicinal products with bedaquiline is necessary, clinical monitoring, including frequent electrocardiogram assessment, is recommended. 
Če je sočasna uporaba teh zdravil z bedakilinom potrebna, je priporočeno klinično spremljanje, vključno s pogostim spremljanjem električne aktivnosti srca (elektrokardiogram).
• Weeks 3-24: 200 mg (2 tablets of 100 mg) three times per week (with at least 48 hours between doses). 
• 3. do vključno 24. teden: 200 mg (2 tableti po 100 mg) trikrat na teden (med posameznimi odmerki mora biti najmanj 48 ur).
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). 
V nadzorovani študiji faze IIb (v študiji C208) so od prve ocene elektrokardiograma v času zdravljenja dalje opazili povprečno podaljšanje intervala QTcF (9,9 ms po 1 tednu zdravljenja za SIRTURO in 3,5 ms za placebo) glede na izhodiščne vrednosti.
QT interval prolonging medicinal products 
Zdravila, ki podaljšujejo interval QT
The inhibition of ATP synthase leads to bactericidal effects for both replicating and non-replicating tubercle bacilli. 
Zaviranje ATP-sintaze ima baktericiden učinek tako na tiste bacile tuberkuloze, ki so v fazi razmnoževanja, kot na tiste, ki niso.
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. 
Če koncentracija aspartat-aminotransferaze (AST) ali alanin-aminotransferaze (ALT) presega 5-kratnik zgornje meje normalnih koncentracij, je treba ponovno pregledati shemo zdravljenja in prekiniti jemanje zdravila SIRTURO in/ali katerega od osnovnih zdravil, če ta škodljivo vpliva na jetra.
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. 
V kliničnih študijah se je manj kot 0,001% odmerka bedakilina izločilo v nespremenjeni obliki z urinom, kar pomeni, da izločanje nespremenjene učinkovine preko ledvic ni pomembno.
During the trial, there was no evidence of antecedent significant QT prolongation or clinically significant dysrhythmia in any of the patients that died. 
Pri nobenem od umrlih bolnikov niso v času študije opazili znakov predhodnega pomembnega podaljšanja intervala QT ali klinično pomembnih motenj ritma.
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. 
Po podatkih analize populacijske farmakokinetike pri bolnikih, ki imajo tuberkulozo, so stari od 18 do 68 let in prejemajo zdravilo SIRTURO, starost ne vpliva na farmakokinetiko bedakilina.
An in vitro study indicated a potential for bedaquiline to inhibit BCRP at the concentrations achieved in the intestine after oral administration. 
In vitro študija je pokazala, da bi bedakilin v koncentracijah, doseženih v prebavilih po peroralnem jemanju, lahko zaviral BCRP.
This increase is likely due to ritonavir. 
Verjetno je vzrok ritonavir.
Administration of bedaquiline with food increased the relative bioavailability by about 2-fold compared to administration under fasted conditions. 
Odmerjanje bedakilina skupaj s hrano je povečalo njegovo biološko uporabnost približno za dvakrat v primerjavi z odmerjanjem zdravila na tešče.
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. 
V študiji C208 (1. in 2. stopnja) je do zvišanja koncentracije aminotransferaz na najmanj 3-kratnik zgornje meje normalnih vrednosti prišlo bolj pogosto v skupini z zdravilom SIRTURO (11/102 [10,8%] kot v skupini s placebom (6/105 [5,7%]).
SIRTURO is used to treat tuberculosis that affects the lungs when the disease has become resistant to other antibiotics. 
Zdravilo SIRTURO uporabljamo za zdravljenje tuberkuloze, ki prizadene pljuča in je odporna na druge antibiotike, kar imenujemo tuberkuloza, odporna proti več zdravilom.
The plasma bedaquiline exposure (AUC) in rats and dogs was similar to that observed in humans. 
Pri podganah in psih je bila izpostavljenost bedakilinu v plazmi (AUC) podobna kot pri ljudeh.
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. 
Pri zdravih prostovoljcih kratkotrajna sočasna uporaba bedakilina z izoniazidom oziroma s pirazinamidom ni povzročila klinično pomembnih sprememb izpostavljenosti (AUC) bedakilinu ali izoniazidu oziroma pirazinamidu.