FrancophonIA/ELRC3.0 huggingface dataset:
English: * Patients who died during the trial or discontinued the trial were considered as non-responders.
Croatian: * Za bolesnike koji su umrli tijekom ispitivanja ili su prekinuli ispitivanje, smatra se da nisu odgovorili na liječenje.
English: SIRTURO is a type of antibiotic.
Croatian: SIRTURO je jedna vrsta antibiotika.
English: • There must be at least 48 hours in between each time you take SIRTURO.
Croatian: • Mora proteći najmanje 48 sati između svakog uzimanja lijeka SIRTURO.
English: • Take SIRTURO with food.
Croatian: • SIRTURO uzmite s hranom.
English: • increase the chance that the bacteria will become resistant to the medicine.
Croatian: • može se povećati mogućnost da bakterija postane otporna na lijek.
English: The observed imbalance in deaths between the two treatment groups is unexplained.
Croatian: Uočena neravnoteža u smrti između dvije liječene skupine je neobjašnjena.
English: A plastic bottle containing 188 tablets.
Croatian: Plastična boca sadrži 188 tableta.
English: Date of first authorisation: 5 March 2014 Date of latest renewal: 11 January 2019
Croatian: Datum posljednje obnove odobrenja: 11. siječnja 2019.
English: Failure to convert Relapse
Croatian: Neuspjeh konverzije Relaps
English: The clinical relevance is unknown.
Croatian: Klinički značaj nije poznat.
English: This increase is likely due to ritonavir.
Croatian: Ovo povišenje vjerojatno je radi ritonavira.
English: • Skip the missed dose and take the next dose as usual
Croatian: • Preskočite propuštenu dozu i uzmite slijedeću dozu kao i obično
English: • you are allergic to bedaquiline or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na bedakilin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: 6 cells/l (N = 22; see section 4.5).
Croatian: 6 stanica/l (N = 22; vidjeti dio 4.5).
English: Antibiotics are medicines that kill bacteria that cause disease.
Croatian: Antibiotici su lijekovi koji uništavaju bakterije koje uzrokuju bolest.
English: Do not take SIRTURO if this applies to you.
Croatian: Nemojte uzimati SIRTURO ako se ovo odnosi na Vas.
English: • A history of Torsade de Pointes;
Croatian: • Torsade de pointes u prošlosti;
English: Frequency categories are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Croatian: Kategorije učestalosti definirane su na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10) i manje često (≥ 1/1000 do < 1/100).
English: • Annual updates on study progress in the frame of annual renewal submissions
Croatian: • Godišnje dopune podatka o napretku ispitivanja u okviru podnošenja godišnje obnove odobrenja
English: • Take the missed dose of 200 mg as soon as possible.
Croatian: • Uzmite propuštenu dozu od 200 mg što je prije moguće.
English: This medicine may pose a risk to the environment.
Croatian: Ovaj lijek može predstavljati rizik za okoliš.
English: • increased liver enzymes (shown in blood tests)
Croatian: • povišeni jetreni enzimi (što se vidi iz krvnih nalaza)
English: Main demographics were as follows: 63.1% were males, median age 34 years, 35% were Black, and 15% were HIV positive.
Croatian: Glavni demografski podaci su sljedeći: 63,1% su bili muškarci, medijan dobi 34 godine, 35% su bili crne rase, a 15% ih je bilo pozitivno na HIV.
English: For additional information on deaths in the C209 trial, see section 5.1.
Croatian: Za dodatne informacije vezano uz smrti u ispitivanju C209, vidjeti dio 5.1.
English: SIRTURO treatment must be discontinued if the patient develops:
Croatian: Liječenje lijekom SIRTURO mora se prekinuti ako bolesnik razvije:
English: Cavitation in one lung was seen in 58% of patients, and in both lungs in 16%.
Croatian: Kavitacija na jednom plućnom krilu zabilježena je u 58% bolesnika, a na oba plućna krila u 16%.
English: • Final analysis - Clinical Study Report 4Q 2023
Croatian: • Finalnu analizu - Izvješće kliničkog ispitivanja 4. kvartal 2023.
English: This means your disease may not be treatable by SIRTURO or other medicines in the future.
Croatian: To znači da Vam se u budućnosti bolest možda neće moći liječiti lijekom SIRTURO ili drugim lijekovima.
English: These reports should aid the physician in selecting a combination of antibacterial medicinal products for treatment.
Croatian: Ovi izvještaji moraju pomoći liječniku pri odabiru kombinacije antibakterijskih lijekova za liječenje.
English: • you have human immunodeficiency virus (HIV) infection.
Croatian: • ako imate infekciju virusom humane imunodeficijencije (HIV).
English: There were no documented cases of Torsade de Pointes in the safety database (see section 4.4).
Croatian: Ne postoje dokumentirani slučajevi Torsade de pointes u bazi podataka o sigurnosti (vidjeti dio 4.4).
English: The significance of phospholipidosis in humans is unknown.
Croatian: Značaj fosfolipidoze u ljudi nije poznat.
English: There are no data to support a lowered bedaquiline dose in such circumstances.
Croatian: Ne postoje podaci koji bi podržali sniženu dozu bedakilina u ovim okolnostima.
English: If a dose is missed during the first two weeks of treatment, patients should not make up the missed dose, but should continue the usual dosing schedule.
Croatian: Ako se doza propusti uzeti tijekom prva dva tjedna liječenja, bolesnici ne moraju nadoknaditi propuštenu dozu već moraju nastaviti s uobičajenim rasporedom doziranja.
English: Check with your doctor or pharmacist.
Croatian: Provjerite sa svojim liječnikom ili ljekarnikom.
English: • extra-pulmonary tuberculosis (e.g. central nervous system, bone)
Croatian: • izvanplućne tuberkuloze (npr. središnjeg živčanog sustava, kostiju)
English: SIRTURO is used to treat tuberculosis that affects the lungs when the disease has become resistant to other antibiotics.
Croatian: SIRTURO se koristi za liječenje tuberkuloze koja pogađa pluća, kada bolest postane otporna na druge antibiotike.
English: • Clinically significant ventricular arrhythmia
Croatian: • klinički značajnu ventrikularnu aritmiju
English: This long terminal elimination phase likely reflects slow release of bedaquiline and M2 from peripheral tissues.
Croatian: Ova duga faza terminalne eliminacije vjerojatno oslikava polagano otpuštanje bedakilina i M2 iz perifernih tkiva.
English: One death in the SIRTURO group and one death in the placebo group were reported after the week 120 window.
Croatian: Jedna smrt u SIRTURO skupini i jedna smrt u placebo skupini bile su prijavljene nakon tjedna 120.
English: Patients should be monitored throughout the treatment course, since the increases in liver enzymes were slow to appear and increased gradually during the 24 weeks.
Croatian: Bolesnike se tijekom trajanja liječenja mora pratiti budući da su se porasti jetrenih enzima pojavljivali sporo i povećavali postupno tijekom 24 tjedna.
English: The plasma protein binding of bedaquiline is > 99.9% in all species tested, including human.
Croatian: Vezanje bedakilina na proteine plazme je > 99,9% u svih ispitivanih vrsta, uključujući ljude.
English: Maximum plasma concentrations (Cmax) are typically achieved at about 5 hours post-dose.
Croatian: Maksimalne koncentracije u plazmi (Cmax) u pravilu se postižu oko 5 sati nakon uzimanja doze.
English: • aching or tender muscles, not caused by exercise
Croatian: • bolni ili osjetljivi mišići, što nije uzrokovano vježbom
English: Those patients studied all had CD4+ cell counts greater than 250 x 10
Croatian: Svi bolesnici u ispitivanju imali su broj CD4+ stanica veći od 250 x 10
English: If you have missed a dose and you are not sure what to do, talk to your doctor or pharmacist.
Croatian: Ako ste propustili dozu i niste sigurni što trebate učiniti, razgovarajte sa svojim liječnikom ili ljekarnikom.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Croatian: U obzir se moraju uzeti službene smjernice o prikladnoj primjeni antibakterijskih lijekova.
English: What SIRTURO is and what it is used for
Croatian: Što je SIRTURO i za što se koristi
English: Tell your doctor right away if you faint.
Croatian: Odmah recite liječniku ako se onesvjestite.
English: Relapse was defined in the trial as having a positive sputum culture after or during treatment following prior sputum culture conversion.
Croatian: Relaps je bio definiran u ispitivanju kao pozitivna kultura sputuma nakon ili tijekom liječenja nakon ranije konverzije kulture sputuma.
English: If AST or ALT exceeds 5 times the upper limit of normal then the regimen should be reviewed and SIRTURO and/or any hepatotoxic background medicinal product should be discontinued.
Croatian: Ako AST ili ALT premaše za 5 puta premaše gornju granicu normale, tada se režim mora preispitati, a SIRTURO i/ili bilo koji hepatotoksični osnovni lijek mora se prestati uzimati.
English: Renal excretion of unchanged bedaquiline is insignificant (< 0.001%).
Croatian: Izlučivanje nepromijenjenog bedakilina putem bubrega nije značajno (< 0,001%).
English: Very common (may affect more than 1 in 10 people):
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 ljudi):
English: • you have had an abnormal heart reading (ECG) or heart failure;
Croatian: • ako ste imali nepravilan srčani zapis (EKG) ili zatajenje srca;
English: Patients infected with human immunodeficiency virus (HIV)
Croatian: Bolesnici s infekcijom virusom humane imunodeficijencije (HIV)
English: Normal spermatogenesis and a normal amount of spermatozoa in the epidydimides were noted in these animals.
Croatian: U ovih životinja primijećena je normalna spermatogeneza i normalna količina spermatozoa u epididimisima.
English: One of the ten deaths in the SIRTURO group (due to alcohol poisoning) occurred during the 24 week treatment period.
Croatian: Jedan od deset smrtnih slučajeva u SIRTURO skupini (zbog trovanja alkoholom) dogodio se tijekom 24-tjednog razdoblja liječenja.
English: System Organ Class (SOC) Frequency Category
Croatian: Klasifikacija organskih sustava (SOC)
English: Therefore, bedaquiline should be taken with food to enhance its oral bioavailability.
Croatian: Stoga se bedakilin mora uzimati s hranom kako bi se poboljšala njegova oralna bioraspoloživost.
English: If you stop taking SIRTURO Do not stop taking SIRTURO without first talking to your doctor.
Croatian: Ako prestanete uzimati SIRTURO Nemojte prestati uzimati SIRTURO bez da prethodno razgovarate sa svojim liječnikom.
English: SIRTURO tablets should be swallowed whole with water.
Croatian: Tablete SIRTURO moraju se progutati cijele s vodom.
English: Other medicines and SIRTURO
Croatian: Drugi lijekovi i SIRTURO
English: The imbalance in deaths is unexplained; no evidence has been found for a causal relationship with SIRTURO treatment.
Croatian: Neuravnoteženost u smrtnim slučajevima je neobjašnjena; nema dokaza uzročne povezanosti s liječenjem lijekom SIRTURO.
English: If a dose is missed from week three onwards, patients should take the missed dose of 200 mg as soon as possible and then resume the three times a week regimen.
Croatian: Ako se doza propusti uzeti od trećeg tjedna nadalje, bolesnici moraju uzeti propuštenu dozu od 200 mg što je prije moguće, a nakon toga trebaju nastaviti sa režimom uzimanja tri puta tjedno.
English: SIRTURO was administered as 400 mg once daily for the first 2 weeks, and as 200 mg 3 times/week for the following 22 weeks.
Croatian: SIRTURO je bio primijenjen kao 400 mg jedanput dnevno prva 2 tjedna, i 200 mg 3 puta tjedno iduća 22 tjedna.
English: The total duration of treatment with SIRTURO is 24 weeks.
Croatian: Ukupno trajanje liječenja lijekom SIRTURO je 24 tjedna.
English: Most of the observed changes occurred after prolonged daily dosing and subsequent increases in plasma and tissue concentrations of the active substance.
Croatian: Većina uočenih promjena pojavila se nakon produljenog dnevnog doziranja i posljedičnih povišenja koncentracija djelatne tvari u plazmi i tkivu.
English: Minimal inhibitory concentration (MIC) breakpoints are as follows: Epidemiological Cut-Off (ECOFF)
Croatian: Granične vrijednosti minimalne inhibitorne koncentracije (MIK) su sljedeće: Epidemiološki “Cut-Off” (ECOFF)
English: In the SIRTURO group, all of the five deaths due to tuberculosis occurred in patients whose sputum culture status at last visit was ‘not converted'.
Croatian: U skupini liječenoj lijekom SIRTURO, svih pet smrti zbog tuberkuloze dogodile su se u bolesnika čiji je status kulture sputuma na zadnjoj viziti bio ‘bez konverzije'.
English: Bedaquiline had no effects on fertility when evaluated in female rats.
Croatian: Bedakilin nije imao učinaka na plodnost kada je procijenjen u ženki štakora.
English: Tablets are packaged in aluminium/aluminium foil blisters.
Croatian: Tablete su pakirane u blistere od aluminij/aluminij folije.
English: Treatment with the other agents in the regimen should continue after completion of treatment with SIRTURO.
Croatian: Liječenje drugim lijekovima u režimu mora se nastaviti nakon završetka liječenja lijekom SIRTURO.
English: Pharmacotherapeutic group: Antimycobacterials, drugs for treatment of tuberculosis, ATC code: J04AK05
Croatian: Farmakoterapijska skupina: Antimikobakterijski lijekovi, lijekovi za liječenje tuberkuloze, ATK oznaka: J04AK05
English: After the end of SIRTURO treatment (i.e. after week 24), QTcF increases in the SIRTURO group gradually became less pronounced.
Croatian: Nakon završetka liječenja lijekom SIRTURO (tj. nakon tjedna 24), QTcF povišenja u SIRTURO skupini s vremenom su postajala manje naglašena.
English: Animal toxicology studies have been conducted with bedaquiline administration up to 3 months in mice, up to 6 months in rats, and up to 9 months in dogs.
Croatian: Ispitivanja toksičnosti u životinja bila su provedena s primjenom bedakilina do 3 mjeseca u miševa, do 6 mjeseci u štakora i do 9 mjeseci u pasa.
English: Other medicines may affect SIRTURO.
Croatian: Drugi lijekovi mogu imati utjecaj na SIRTURO.
English: • Heart failure;
Croatian: • zatajenjem srca;
English: No structural abnormalities in the testes and epididymides were seen after up to 6-months of bedaquiline treatment.
Croatian: Nisu uočene strukturalne nepravilnosti u testisima i epididimisima do 6 mjeseci nakon liječenja bedakilinom.
English: There was no effect of maternal treatment with bedaquiline at any dose level on sexual maturation, behavioural development, mating performance, fertility or reproductive capacity of the F1 generation animals.
Croatian: Nije bilo učinaka liječenja majke bedakilinom pri bilo kojoj dozi na spolno sazrijevanje, bihevioralni razvoj, sposobnost parenja, plodnost ili reproduktivni kapacitet F1 generacije životinja.
English: • you have a personal or family history of a heart problem called “congenital long QT syndrome”;
Croatian: • ako u osobnoj ili obiteljskoj povijesti bolesti postoji problem sa srcem koji se zove “urođeni sindrom dugog QT-a”;
English: The mean terminal elimination half-life of both bedaquiline and the active N-monodesmethyl metabolite (M2) is about 5 months (ranging from 2 to 8 months).
Croatian: Srednja vrijednost terminalnog poluvremena eliminacije i bedakilina i aktivnog N-monodezmetil metabolita (M2) je otprilike 5 mjeseci (u rasponu od 2 do 8 mjeseci).
English: Cmax and the area under the plasma concentration-time curve (AUC) increased proportionally up to the highest doses studied (700 mg single-dose and once daily 400 mg multiple doses).
Croatian: Cmax i površina ispod krivulje koncentracija-vrijeme (AUC) povisili su se proporcionalno do najviših ispitivanih doza (700 mg pojedinačna doza i višestruke doze od 400 mg jednom na dan).
English: • Hypokalemia
Croatian: • hipokalijemijom
English: What SIRTURO is and what it is used for What you need to know before you take SIRTURO How to take SIRTURO
Croatian: Što je SIRTURO i za što se koristi Što morate znati prije nego počnete uzimati SIRTURO Kako uzimati SIRTURO
English: In the SIRTURO treatment group, the majority of these increases occurred throughout the 24 weeks of treatment and were reversible.
Croatian: U skupini liječenoj lijekom SIRTURO, većina ovih povišenja pojavila su se tijekom 24 tjedna liječenja i bila su reverzibilna.
English: Tablets packaged in: - aluminium/aluminium foil blisters: 3 years - white high density polyethylene (HDPE) bottles: 3 years
Croatian: Tablete zapakirane u: - Blistere od aluminij/aluminij folije: 3 godine - bijele boce od polietilena visoke gustoće (HDPE): 3 godine
English: It is not known whether bedaquiline or its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se bedakilin ili njegovi metaboliti u majčino mlijeko u ljudi.
English: The elimination of bedaquiline has not been fully characterised in vivo.
Croatian: Eliminacija bedakilina nije u potpunosti bila okarakterizirana in vivo.
English: 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.
Croatian: Nije se mogao primijetiti zamjetan obrazac između smrti i pretvorbe kulture sputuma, relapsa, osjetljivosti na druge lijekove koji se uzimaju za liječenje tuberkuloze, statusa virusa humane imunodeficijencije ili težine bolesti.
English: If you take more SIRTURO than you should
Croatian: Ako uzmete više lijeka SIRTURO nego što ste trebali
English: Common (may affect up to 1 in 10 people):
Croatian: Često (mogu se javiti u do 1 na 10 ljudi):
English: Each tablet contains 145 mg of lactose (as monohydrate).
Croatian: Jedna tableta sadrži 145 mg laktoze (u obliku hidrata).
English: Do not take SIRTURO if:
Croatian: Nemojte uzimati SIRTURO:
English: Other hepatotoxic medicinal products and alcohol should be avoided while on SIRTURO, especially in patients with diminished hepatic reserve.
Croatian: Drugi hepatotoksični lijekovi i alkohol moraju se izbjegavati tijekom uzimanja lijeka SIRTURO, a posebno u bolesnika smanjene jetrene rezerve.
English: SIRTURO has not been studied in patients with severe hepatic impairment and is not recommended in this population.
Croatian: SIRTURO nije ispitan u bolesnika s teškim oštećenjem jetre i ne preporučuje se toj populaciji.
English: If the benefit outweighs the risk, SIRTURO may be used with caution when co-administered with lopinavir/ritonavir.
Croatian: Ako korist premašuje rizik, SIRTURO se može primjenjivati uz oprez kada se primjenjuje istodobno s lopinavirom/ritonavirom.
English: The other nine deaths among those treated with SIRTURO occurred after completion of treatment with this agent (range 86 911 days post SIRTURO; median 344 days).
Croatian: Preostalih devet smrtnih slučajeva među onima koji su liječeni lijekom SIRTURO dogodilo se nakon završetka liječenja tim lijekom (raspon 86-911 dana nakon lijeka SIRTURO; medijan 344 dana).
English: In the mouse model for TB infection, bedaquiline has demonstrated bactericidal and sterilizing activities.
Croatian: U mišjem modelu za TBC infekciju, bedakilin je pokazao baktericidnu i sterilizirajuću aktivnost.
English: When available, the clinical microbiology laboratory should provide the physician with the results of in vitro susceptibility test results for antimicrobial medicinal products used in resident hospitals as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens.
Croatian: Kada je dostupan, klinički mikrobiološki laboratorij liječniku mora osigurati rezultate in vitro osjetljivosti na antimikrobne lijekove koji se koriste u bolnicama kao periodičke izvještaje koji opisuju profil osjetljivosti bolnički i izvanbolnički stečenih patogena.
English: Bedaquiline may have a minor influence on the ability to drive and use machines.
Croatian: Bedakilin može malo utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: The causes of death in the remaining SIRTURO subjects were alcohol poisoning, hepatitis/hepatic cirrhosis, septic shock/peritonitis, cerebrovascular accident and motor vehicle accident.
Croatian: Uzroci smrti preostalih SIRTURO ispitanika bile su trovanje alkoholom, hepatitis/ciroza jetre, septički šok/peritonitis, cerebrovaskularni događaj i nesreća u motornom vozilu.
English: What you need to know before you take SIRTURO
Croatian: Što morate znati prije nego počnete uzimati SIRTURO
English: Resistance to bedaquiline
Croatian: Rezistencija na bedakilin
English: See section 4.5, QT interval and concomitant clofazimine use, for further information regarding patients using clofazimine concomitantly.
Croatian: Vidjeti dio 4.5, QT interval i istovremena primjena klofazimina za daljnje informacije o bolesnicima koji uzimaju klofazimin istovremeno.
English: This study included patients of all three resistance categories (MDRH&R-, pre-XDR- and XDR-TB).
Croatian: U ovo ispitivanje uključeni su bolesnici sve tri kategorije rezistencije (MDRH&R-, pre-XDR- i XDR-TB).
English: Nausea, vomiting
Croatian: Mučnina, povraćanje
English: All but one patients who died of tuberculosis had not converted or had relapsed.
Croatian: Kod svih bolesnika koji su umrli od tuberkuloze osim kod jednog, nije bilo konverzije ili su imali relaps.
English: In vitro, bedaquiline does not significantly inhibit the activity of any of the CYP450 enzymes tested (CYP1A2, CYP2A6, CYP2C8/9/10, CYP2C19, CYP2D6, CYP2E1, CYP3A4, CYP3A4/5 and CYP4A) and does not induce CYP1A2, CYP2C9 or CYP2C19 activities.
Croatian: In vitro, bedakilin ne inhibira značajno aktivnost bilo kojeg od ispitanih CYP450 enzima (CYP1A2, CYP2A6, CYP2C8/9/10, CYP2C19, CYP2D6, CYP2E1, CYP3A4, CYP3A4/5 i CYP4A) i ne inducira aktivnosti CYP1A2, CYP2C9 ili CYP2C19.
English: After the 24-week investigational period, the background regimen was continued to complete 18 to 24 months of total multi-drug resistant Mycobacterium tuberculosis treatment.
Croatian: Nakon 24-tjednog razdoblja ispitivanja, osnovno liječenje je nastavljeno 18 do 24 mjeseca radi završetka ukupnog liječenja multirezistentne Mycobacterium tuberculosis.
English: As a precautionary measure, avoid the use of SIRTURO during pregnancy unless the benefit of therapy is considered to outweigh the risks.
Croatian: Kao mjeru opreza, izbjegavajte primjenu lijeka SIRTURO tijekom trudnoće osim ako se smatra da korist liječenja nadvladava rizike.
English: SIRTURO treatment initiation is not recommended in patients with the following, unless the benefits of bedaquiline are considered to outweigh the potential risks:
Croatian: Započinjanje liječenja lijekom SIRTURO nije preporučeno u bolesnika sa sljedećim stanjima, osim ako se ne smatra da korist bedakilina prevladava nad potencijalnim rizikom:
English: Acquired resistance mechanisms that affect bedaquiline MICs include mutations in the atpE gene, which codes for the ATP synthase target, and in the Rv0678 gene, which regulates the expression of the MmpS5-MmpL5 efflux pump.
Croatian: Mehanizmi stečene rezistencije koja utječe na MIC-ove bedakilina uključuju mutacije u atpE genu, koji ciljno kodira ATP sintazu, i u Rv0678 genu, koji regulira ekspresiju MmpS5-MmpL5 efluksne pumpe.
English: SIRTURO has mainly been studied in patients with normal renal function.
Croatian: SIRTURO je većinom ispitivan u bolesnika s normalnom funkcijom bubrega.
English: 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.
Croatian: Zbog mogućnosti za nuspojave u dojenčadi, potrebno je odlučiti treba li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom SIRTURO, uzimajući u obzir korist dojenja za dijete i korist liječenja za majku.
English: Of the 163 patients who were responders at week 24, 139 patients (85.3%) were still responders at week 120.
Croatian: Od 163 bolesnika koji su odgovorili na liječenje u 24. tjednu, 139 bolesnika (85,3%) još uvijek je odgovaralo u 120. tjednu.
English: • A QTcF interval of > 500 ms (confirmed by repeat electrocardiogram).
Croatian: • QTcF interval od > 500 ms (potvrđen ponovljenim elektrokardiogramom).