natgillin/translations-raw huggingface dataset:
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Cyltezo has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way. 
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Cyltezo po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu Humira in da se po telesu enako porazdeli.
It is not intended to provide practical advice on how to use Cyltezo. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Cyltezo must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the 
Zdravilo Cyltezo se ne sme uporabljati pri bolnikih z aktivno tuberkulozo ali drugimi hudimi okužbami ali pri bolnikih z zmernim do hudim srčnim popuščanjem (stanjem, pri katerem srce ne zmore črpati
Cyltezo contains the active substance adalimumab and is a ‘biosimilar medicine'. 
Zdravilo Cyltezo vsebuje zdravilno učinkovino adalimumab in je „podobno biološko zdravilo“.
Treatment with Cyltezo must be started and supervised by a doctor who has experience in the treatment of the diseases for which Cyltezo is used. 
Zdravljenje z zdravilom Cyltezo lahko uvede in nadzira le zdravnik, ki ima izkušnje z zdravljenjem bolezni, za katere se zdravilo Cyltezo uporablja.
For the full list of side effects and restrictions with Cyltezo, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Cyltezo glejte navodilo za
In addition, a study in rheumatoid arthritis has shown that the effects of the medicine are equivalent to those of Humira in this condition. 
Poleg tega je študija revmatoidnega artritisa pokazala, da so učinki zdravila Cyltezo pri tej bolezni enakovredni učinkom zdravila Humira.
Doctors treating uveitis should also take advice from doctors who have experience of using Cyltezo. 
Zdravniki, ki zdravijo uveitis, se morajo posvetovati z zdravniki, ki imajo izkušnje z uporabo zdravila Cyltezo.
For practical information about using Cyltezo, patients should read the package leaflet or contact their 
Za praktične informacije o uporabi zdravila Cyltezo naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
• hidradenitis suppurativa (acne inversa), a long-term skin disease that causes lumps, abscesses (collections of pus) and scarring on the skin; 
• obolenja hidradenitis suppurativa (inverznih aken), tj. dolgotrajnega obolenja kože, ki povzroča zatrdline, abscese (gnojne tvorbe) in kožne brazgotine;
Laboratory studies comparing Cyltezo with Humira have shown that the active substance in Cyltezo is highly similar to that in Humira in terms of structure, purity and biological activity. 
Laboratorijske študije, v katerih so zdravilo Cyltezo primerjali z zdravilom Humira, so pokazale, da je zdravilna učinkovina zdravila Cyltezo po zgradbi, čistosti in biološkem delovanju zelo podobna zdravilni učinkovini v zdravilu Humira.
Studies have also shown that giving Cyltezo produces similar levels of the active substance in the body to giving Humira. 
Študije so pokazale tudi, da zdravilo Cyltezo vzpostavi podobne ravni zdravilne učinkovine v telesu kot zdravilo Humira.
Comparable benefit continued to be seen with longer term 
Primerljivo trajanje koristnega učinka zdravila so opazili tudi med 48-tedenskim dolgotrajnim zdravljenjem.
Cyltezo can only be obtained by prescription. 
Predpisovanje in izdaja zdravila Cyltezo je le na recept.
An alert card will also be 
Sočasno bodo bolniki prejeli
• psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints); 
• psoriatičnega artritisa (bolezni, ki povzroča nastajanje rdečih in luskastih zaplat na koži in vnetje
First 2 weeks: 
Prva 2 tedna:
Date of first authorisation: 5 March 2014 Date of latest renewal: 11 January 2019 
Datum prve odobritve: 5. marec 2014 Datum zadnjega podaljšanja: 11. januar 2019
Culture Conversion Status, n (%) 
Status konverzije kulture, n (%)
Table 1: Culture conversion Status 
Preglednica 1: status konverzije kulture
You may need to keep taking your other medicines for tuberculosis for longer than 6 months. 
Morda boste morali druga zdravila proti tuberkulozi jemati več kot 6 mesecev.
The following definitions applies for resistance categories used: 
Za kategorije odpornosti veljajo sledeče definicije:
The most common cause of death as reported by the investigator was tuberculosis (9 patients). 
Najpogostejši vzrok smrti, ki so ga poročali raziskovalci, je bila tuberkuloza (9 bolnikov).
A final evaluation was conducted at Week 120. 
Končno oceno so izvedli po koncu 120. tedna.
you may take SIRTURO on Monday, Wednesday and Friday every week from week 3 
Zdravilo SIRTURO lahko jemljete na primer ob ponedeljkih, sredah in petkih vsak teden od 3. tedna dalje.
Take the medicine pack with you. 
Škatlico z zdravilom vzemite s seboj.
The causes of death in the remaining patients varied. 
Vzroki smrti pri ostalih bolnikih so bili različni.
• make your treatment ineffective and your tuberculosis could get worse, and; 
• lahko postane zdravljenje neučinkovito, tuberkuloza pa se vam poslabša in
If this happens do not drive or operate machinery. 
Če pride do tega, ne vozite in ne upravljajte strojev.
* Patients who died during the trial or discontinued the trial were considered as non-responders. 
* Bolnike, ki so v času študije umrli ali pa so prekinili sodelovanje v študiji, so šteli kot neodzivne bolnike.
The clinical relevance is unknown. 
Klinična pomembnost ni znana.
• increase the chance that the bacteria will become resistant to the medicine. 
• povečujete možnost, da postanejo bakterije odporne na zdravilo.
The observed imbalance in deaths between the two treatment groups is unexplained. 
Opaženo neravnovesje števila smrti med obema skupinama ni pojasnjeno.
Consideration should be given to official guidance on the appropriate use of antibacterial agents. 
Pri tem je treba upoštevati uradne smernice o primerni uporabi antibakterijskih učinkovin.
The food is important to get the right levels of medicine in your body. 
Hrana je pomembna za doseganje prave koncentracije zdravila v telesu.
188 tablets 
188 tablet
• you have liver disease or you drink alcohol on a regular basis; 
• če imate bolezen jeter, ali če redno pijete alkohol
Data on longer treatment duration is very limited. 
Podatkov o daljšem trajanju zdravljenja je zelo malo.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
Zahteve glede predložitve rednega posodobljenega poročila o varnosti za to zdravilo so določene v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
The recommended dosage is: 
Priporočeno odmerjanje:
• increased liver enzymes (shown in blood tests) 
• zvišane koncentracije jetrnih encimov (kar pokaže krvna preiskava)
For additional information on deaths in the C209 trial, see section 5.1. 
Za dodatne informacije o smrtnih primerih v študiji C209 glejte poglavje 5.1.
This medicine may pose a risk to the environment. 
To zdravilo lahko predstavlja tveganje za okolje.
If you forget to take SIRTURO During the first 2 weeks 
Če ste pozabili vzeti zdravilo SIRTURO V prvih 2 tednih
This means your disease may not be treatable by SIRTURO or other medicines in the future. 
To pomeni, da vaše bolezni v prihodnje morda ne bo več mogoče zdraviti z zdravilom SIRTURO ali drugimi zdravili.
• you are allergic to bedaquiline or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na bedakilin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Main demographics were as follows: 63.1% were males, median age 34 years, 35% were Black, and 15% were HIV positive. 
Glavni demografski podatki so bili naslednji: 63,1% je bilo moških, mediana starost 34 let, 35% je bilo črne rase in 15% je bilo HIV pozitivnih.
• Take the missed dose of 200 mg as soon as possible. 
• Čim prej vzemite pozabljeni 200 mg odmerek.
Frequency categories are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100). 
Kategorije pogostnosti so določene kot sledi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10) in občasni (≥ 1/1.000 do
This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures 
Ker gre za pogojno dovoljenje za promet z zdravilom in ob upoštevanju člena 14(7) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet z zdravilom v določenem časovnem okviru izvesti naslednje ukrepe:
Lactose intolerance and lactase deficiency 
Intoleranca za laktozo in pomanjkanje laktaze
Antibiotics are medicines that kill bacteria that cause disease. 
Antibiotiki so zdravila, ki delujejo tako, da ubijejo bakterije, ki povzročajo bolezni.
These reports should aid the physician in selecting a combination of antibacterial medicinal products for treatment. 
Ta poročila naj bodo zdravniku v pomoč pri izbiranju kombinacije antibiotičnih zdravil za zdravljenje.
24 tablets 
24 tablet
• Annual updates on study progress in the frame of annual renewal submissions 
• Letne posodobitve napredka študije v okviru letnih vlog za podaljšanje dovoljenja za promet z zdravilom
S = susceptible R = resistant 
S = občutljivi (angl. susceptible) organizmi R = odporni organizmi
Patients infected with human immunodeficiency virus (HIV) 
Bolniki, okuženi z virusom humane imunske pomanjkljivosti (HIV)
• Clinically significant ventricular arrhythmia 
• klinično pomembna ventrikularna aritmija
The safety and efficacy of SIRTURO in children aged < 18 years have not yet been established. 
Varnost in učinkovitost zdravila SIRTURO pri otrocih, starih do 18 let, še nista bili dokazani.
Renal excretion of unchanged bedaquiline is insignificant (< 0.001%). 
Izločanje nespremenjenega bedakilina skozi ledvice ni pomembno (< 0,001%).
This can be seen in a blood test; 
To lahko pokaže krvni test.
Cavitation in one lung was seen in 58% of patients, and in both lungs in 16%. 
58% bolnikov je imelo kavitacijo v enem pljučnem krilu, 16% pa v obeh pljučnih krilih.
• Interim IDMC recommendation when half of the patients reach W76: 4Q2020 
• Vmesna IDMC priporočila, ko polovica bolnikov doseže 76. teden: 4.četrtletje 2020
Patients should be advised to take SIRTURO exactly as prescribed and to complete the full course of therapy. 
Bolnike je treba poučiti, da je treba zdravilo SIRTURO jemati natanko tako, kot je predpisano in da zaključijo celotno zdravljenje.
• Skip the missed dose and take the next dose as usual 
• Izpustite pozabljeni odmerek in vzemite naslednji odmerek kot običajno.
This long terminal elimination phase likely reflects slow release of bedaquiline and M2 from peripheral tissues. 
Tako dolga končna faza izločanja verjetno odraža počasno sproščanje bedakilina in presnovka M2 iz perifernih tkiv.
Environmental risk assessment studies have shown that bedaquiline has the potential to be persistent, bioaccumulative and toxic to the environment (see section 6.6). 
Študije ocene tveganja za okolje so pokazale, da bi bedakilin lahko bil obstojen, bioakumulativen in strupen za okolje (glejte poglavje 6.6).
A plastic bottle containing 188 tablets. 
Plastenka vsebuje 188 tablet.
Bedaquiline may have a minor influence on the ability to drive and use machines. 
Bedakilin lahko blago vpliv na sposobnost vožnje in upravljanja s stroji.
• feeling or being sick (nausea or vomiting). 
• občutek slabosti (navzea ali bruhanje).
The significance of phospholipidosis in humans is unknown. 
Pomen fosfolipidoze pri ljudeh ni znan.
Bedaquiline prolongs the QTc interval. 
Bedakilin podaljša interval QTc.
SIRTURO tablets should be swallowed whole with water. 
Tablete SIRTURO je treba pogoltniti cele z vodo.
Any unused medicine should be disposed of in accordance with local requirements. 
Neuporabljeno zdravilo zavrzite v skladu z lokalnimi predpisi.
• aching or tender muscles, not caused by exercise 
• bolečine ali občutljivost mišic, ki jih ne povzroči telesni napor
The intracellular bactericidal activity of bedaquiline in primary peritoneal macrophages and in a macrophage-like cell line was greater than its extracellular activity. 
Znotrajcelična baktericidna aktivnost bedakilina v primarnih peritonealnih makrofagih in v liniji makrofagom podobnih celic je bila večja od njegove zunajcelične aktivnosti.
This study included patients of all three resistance categories (MDRH&R-, pre-XDR- and XDR-TB). 
Študija je vključevala bolnike z vsemi tremi kategorijami odpornosti (MDRH&R, pre-XDR in XDR-TB).
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. 
Če bolnik izpusti odmerek v prvih dveh tednih zdravljenja, izpuščenega odmerka ne sme nadomeščati, ampak mora nadaljevati zdravljenje po običajnem razporedu.
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. 
Bolnike je treba spremljati med celotnim zdravljenjem, saj so se zvišanja koncentracij encimov so se pojavila pozno in koncentracije so se v obdobju 24 tednov postopno zviševale.
Clinical monitoring should be considered. 
Razmisliti je treba o kliničnem spremljanju bolnika.
Maximum plasma concentrations (Cmax) are typically achieved at about 5 hours post-dose. 
Normalno pride do najvišje koncentracije v plazmi (Cmax) približno 5 ur po odmerjanju.
Each tablet contains 145 mg of lactose (as monohydrate). 
Ena tableta vsebuje 145 mg laktoze (v obliki laktoze monohidrata).
• you have human immunodeficiency virus (HIV) infection. 
• če ste okuženi z virusom humane imunske pomanjkljivosti (HIV).
Response rates at week 24 and week 120 (i.e. around 6 months after stopping all therapy) are presented in table 1. 
Stopnja odgovora v 24. tednu in 120. tednu (približno 6 mesecev po prekinitvi vsega zdravljenja) je navedena v preglednici 1.
In the SIRTURO treatment group, the majority of these increases occurred throughout the 24 weeks of treatment and were reversible. 
V skupini z zdravilom SIRTURO je do večine teh zvišanj prišlo kadarkoli v 24-tedenskem obdobju zdravljenja, pri čemer so bila zvišanja reverzibilna.
Most of the observed changes occurred after prolonged daily dosing and subsequent increases in plasma and tissue concentrations of the active substance. 
Do večine sprememb, ki so jih opažali, je prišlo po dolgotrajnem vsakodnevnem odmerjanju in posledičnem zvišanju koncentracije učinkovine v plazmi in tkivih.
Tablets are packaged in aluminium/aluminium foil blisters. 
Tablete so pakirane v aluminij/aluminij pretisne omote.
It is not known whether bedaquiline or its metabolites are excreted in human milk. 
Ni znano, ali se bedakilin in njegovi presnovki izločajo v materino mleko.
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. 
Jasne povezave med smrtjo in konverzijo kulture sputuma, ponovitvijo bolezni, občutljivostjo na druga zdravila za zdravljenje tuberkuloze, statusom prisotnosti virusa humane imunske pomanjkljivosti ali resnostjo bolezni niso opazili.
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). 
Povprečni končni razpolovni čas izločanja bedakilina in njegovega aktivnega N-monodesmetilnega presnovka (M2) je približno 5 mesecev (v razponu od 2 do 8 mesecev).
• Take SIRTURO with food. 
• Zdravilo SIRTURO vzemite skupaj s hrano.
Skipping doses or not completing the full course of therapy may: 
Če izpuščate odmerke ali ne dokončate celotnega poteka zdravljenja:
SIRTURO treatment must be discontinued if the patient develops: 
Zdravljenje z zdravilom SIRTURO je treba prekiniti, če se pri bolniku pojavi:
Tablets packaged in: - aluminium/aluminium foil blisters: 3 years - white high density polyethylene (HDPE) bottles: 3 years 
Tablete, pakirane v: - aluminij/aluminij pretisne trakove: 3 leta - bele plastenke iz polietilena visoke gostote (HDPE): 3leta
Mechanisms of resistance 
Mehanizem rezistence
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake "Uporabno do".
After the end of SIRTURO treatment (i.e. after week 24), QTcF increases in the SIRTURO group gradually became less pronounced. 
Po zaključku zdravljenja z zdravilom SIRTURO (po koncu 24. tedna) je podaljšanje intervala QTcF v skupini z zdravilom SIRTURO postopoma postalo manj izrazito.
What SIRTURO is and what it is used for 
Kaj je zdravilo SIRTURO in za kaj ga uporabljamo
An electrocardiogram should be obtained before initiation of treatment and at least monthly after starting treatment with bedaquiline. 
Elektrokardiogram je potrebno posneti pred začetkom zdravljenja z bedakilinom in nato najmanj enkrat na mesec.
QT interval and concomitant clofazimine use 
Interval QT in sočasna uporaba klofazimina
• extra-pulmonary tuberculosis (e.g. central nervous system, bone) 
• ekstrapulmonalne tuberkuloze (na primer tuberkuloze centralnega živčevja, kosti)
Efflux-based mutations have been seen in preclinical and clinical isolates. 
Mutacije na osnovi izločanja so opazili v kliničnih in predkliničnih izolatih.
Any unused product or waste material should be disposed of in accordance with local requirements (see section 5.3). 
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi (glejte poglavje 5.3).
• Resume the three times a week schedule. 
• Nadaljujte z jemanjem zdravila trikrat na teden.
One of the ten deaths in the SIRTURO group (due to alcohol poisoning) occurred during the 24 week treatment period. 
Do ene izmed desetih smrti v skupini, ki je prejemala zdravilo SIRTURO (zastrupitev z alkoholom) je prišlo v 24-tedenskem obdobju zdravljenja.
SIRTURO has mainly been studied in patients with normal renal function. 
Uporabo zdravila SIRTURO so proučevali večinoma pri bolnikih z normalno ledvično funkcijo.
The total duration of treatment with SIRTURO is 24 weeks. 
Celotno zdravljenje z zdravilom SIRTURO traja 24 tednov.
It is therefore not expected that mild or moderate renal impairment will have a clinically relevant effect on the exposure to bedaquiline. 
Iz tega razloga ni pričakovati, da bi blaga ali zmerna okvara ledvic lahko klinično pomembno vplivala na izpostavljenost bedakilinu.
Isolates that are resistant to clofazimine can still be susceptible to bedaquiline. 
Izolati, ki so rezistentni na klofazimin, pa so še vedno lahko občutljivi za bedakilin.
Normal spermatogenesis and a normal amount of spermatozoa in the epidydimides were noted in these animals. 
Pri teh živalih so opažali normalno spermatogenezo in normalno količino semenčic v epididimisu.
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). 
Vrednost Cmax in površina pod krivuljo časovnega poteka koncentracije v plazmi (AUC) sta se povečevali sorazmerno do najvišjih proučevanih odmerkov (700 mg pri enkratnem odmerku in 400 mg enkrat na dan pri večkratnem odmerjanju).
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. 
Mehanizmi pridobljene rezistence, ki vplivajo na MIK bedakilina, vključujejo mutacije gena atpE, ki tarčno kodira sintazo ATP, in gena Rv0678, ki uravnava izražanje MmpS5-MmpL5 izlivne črpalke.
If you stop taking SIRTURO Do not stop taking SIRTURO without first talking to your doctor. 
Če ste prenehali jemati zdravilo SIRTURO Ne prenehajte uporabljati zdravila SIRTURO, ne da bi se prej posvetovali z zdravnikom.
6 cells/l (N = 22; see section 4.5). 
6/l (glejte poglavje 4.5).
The majority of isolates that are phenotypically resistant to bedaquiline are cross-resistant to clofazimine. 
Večina izolatovIzolati, ki so fenotipsko rezistentni na bedakilin, so navzkrižno rezistentni na klofazimin.
Those patients studied all had CD4+ cell counts greater than 250 x 10 
Pri vseh preučevanih bolnikih (n = 22) je bilo število celic CD4+ večje od 250 x 10
Relapse was defined in the trial as having a positive sputum culture after or during treatment following prior sputum culture conversion. 
V študiji je bila ponovitev bolezni opredeljena kot pozitiven izvid kulture sputuma po zdravljenju ali med zdravljenjem po predhodni konverziji kulture sputuma.
Resistance to bedaquiline 
Rezistenca na bedakilin
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. 
Študije toksičnega delovanja na živalih so izvajali z odmerjanjem bedakilina največ 3 mesece pri miših, največ 6 mesecev pri podganah in največ 9 mesecev pri psih.
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. 
In vitro bedakilin niti ne zavira pomembno delovanja nobenega od testiranih encimov CYP450 (CYP1A2, CYP2A6, CYP2C8/9/10, CYP2C19, CYP2D6, CYP2E1, CYP3A4, CYP3A4/5 in CYP4A) niti ne inducira delovanja CYP1A2, CYP2C9 ali CYP2C19.
The causes of death in the remaining SIRTURO subjects were alcohol poisoning, hepatitis/hepatic cirrhosis, septic shock/peritonitis, cerebrovascular accident and motor vehicle accident. 
Vzroki smrti ostalih bolnikov v skupini, ki je prejemala zdravilo SIRTURO so bili zastrupitev z alkoholom, hepatitis/ciroza jeter, septični šok/peritonitis, cerebrovaskularni dogodek in prometna nesreča.
Of the 163 patients who were responders at week 24, 139 patients (85.3%) were still responders at week 120. 
Od 163 bolnikov, ki so se odzvali na zdravljenje po 24. tednu, se jih je 139 (85,3%) odzvalo na zdravljenje tudi po 120. tednu.
SIRTURO is a type of antibiotic. 
Zdravilo SIRTURO je antibiotik.
In the Phase IIb, open label study (C209), 6.9% (16/233) patients died. 
V odprti študiji faze IIb (C209) je umrlo 6,9% (16/233) bolnikov.
There are no clinical data on the use of SIRTURO to treat: 
Ni kliničnih podatkov o uporabi zdravila SIRTURO za zdravljenje:
The primary efficacy endpoint was the time to sputum culture conversion during treatment with SIRTURO (median 57 days, for 205 patients with sufficient data). 
Primarni cilj opazovanja za oceno učinkovitosti je bil čas do konverzije kulture sputuma v času zdravljenja z zdravilom SIRTURO (mediana 57 dni za 205 bolnikov s podatki o učinkovitosti).
Minimal inhibitory concentration (MIC) breakpoints are as follows: Epidemiological Cut-Off (ECOFF) 
Mejne vrednosti minimalne inhibitorne koncentracije (MIK) so naslednje: epidemiološka mejna vrednost (ECOFFEpidemiological cut-off value)
SIRTURO must always be taken together with other medicines for treating tuberculosis. 
Zdravilo SIRTURO je treba vedno jemati skupaj z drugimi zdravili proti tuberkulozi.
Monitor symptoms and laboratory tests (ALT, AST, alkaline phosphatase, and bilirubin) at baseline, monthly while on treatment, and as needed. 
Potrebno je spremljanje simptomov in laboratorijsko testiranje (ALT, AST, alkalne fosfataze in bilirubina) pred začetkom zdravljenja, mesečno med zdravljenjem in po potrebi.