natgillin/translations-raw huggingface dataset:
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.
It is recommended that SIRTURO is administered by directly observed therapy (DOT).
Priporočeno je odmerjanje zdravila SIRTURO v okviru neposredno nadzorovanega zdravljenja (DOT - directly observed therapy).
If in vitro testing results are unavailable, treatment may be initiated with SIRTURO in combination with at least four medicinal products to which the patient's isolate is likely to be susceptible.
Če rezultatov in vitro testiranja ni, se zdravljenje z zdravilom SIRTURO lahko uvede v kombinaciji z vsaj štirimi zdravili, na katere je bolnikov izolat verjetno občutljiv.
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.
Če je le mogoče, naj klinični mikrobiološki laboratorij zdravniku priskrbi rezultate in vitro testov občutljivosti za protimikrobna zdravila, ki jih uporabljajo v tej bolnišnici, in sicer v obliki periodičnih poročil z opisom profila občutljivosti patogenov, ki povzročajo bolnišnične okužbe in okužbe, pridobljene v domačem okolju (angl. community-acquired).
SIRTURO should be taken orally with food, as administration with food increases oral bioavailability by about 2-fold (see section 5.2).
Zdravilo SIRTURO je treba jemati peroralno skupaj s hrano, saj jemanje s hrano poveča njegovo biološko uporabnost za približno dvakrat (glejte poglavje 5.2).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze, malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
• A personal or family history of congenital QT prolongation;
• z osebno ali družinsko anamnezo prirojenega podaljšanja intervala QT
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.
Zaradi možnih neželenih učinkov na dojenega otroka se je treba odločiti, ali naj mati prekine dojenje ali prekine oziroma sploh ne začne zdravljenja z zdravilom SIRTURO, pri čemer je treba upoštevati koristi dojenja za otroka in prednosti zdravljenja za mater.
• A QTcF interval of > 500 ms (confirmed by repeat electrocardiogram).
• trajanje intervala QTcF > 500 ms (potrjeno s ponovljenim elektrokardiogramom).
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.
Dajanje katerekoli ravni odmerka bedakilina podganjim samicam ni vplivalo na spolno dozorevanje, vedenjski razvoj, parjenje, plodnost ali sposobnost razmnoževanja pri živalih generacije F1.
In animals, bedaquiline and its active N-monodesmethyl metabolite (M2) are extensively distributed to most tissues, however, brain uptake was low.
Pri živalih se bedakilin in njegov aktivni N-monodesmetilni presnovek (M2) obsežno porazdelita v večino tkiv razen v možgane, kjer je njun privzem majhen.
A carton containing 4 push-through blister strips (containing 6 tablets per strip).
Škatla vsebuje 4 pretisne trakove (vsak pretisni trak vsebuje 6 tablet).
What you need to know before you take SIRTURO
Kaj morate vedeti, preden boste vzeli zdravilo SIRTURO
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).
Pri nekaterih bolnikih, ki so prejemali bedakilin so poročali o omotici, kar je treba upoštevati pri oceni bolnikove sposobnosti za vožnjo in upravljanja s stroji (glejte poglavje 4.8).
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.
Po ugotovitvah analize populacijske farmakokinetike pri bolnikih, ki imajo tuberkulozo in jemljejo zdravilo SIRTURO 200 mg trikrat na teden, očistek kreatinina (v obsegu od 40 do 227 ml/min) ni vplival na farmakokinetične parametre bedakilina.
Study C209 evaluated the safety, tolerability, and efficacy of 24 weeks treatment with open-label SIRTURO as part of an individualized treatment regimen in 233 patients who were sputum smear positive within 6 months prior to screening.
Odprta študija C209 je ocenjevala varnost, prenašanje in učinkovitost 24-tedenskega zdravljenja z zdravilom SIRTURO v sklopu individualizirane sheme zdravljenja pri 233 bolnikih, ki so imeli v obdobju 6 mesecev pred začetnim obiskom (screening) pozitiven izvid razmaza sputuma.
If you have missed a dose and you are not sure what to do, talk to your doctor or pharmacist.
Če ste pozabili vzeti odmerek in niste prepričani, kako morate ravnati, se posvetujte z zdravnikom ali farmacevtom.
Urinary excretion of bedaquiline is negligible.
Izločanje bedakilina z urinom je zanemarljivo.
Other medicines and SIRTURO
Druga zdravila in zdravilo SIRTURO
The basis of assessment of causality between the adverse drug reactions and SIRTURO was not restricted to these trials, but also on review of the pooled Phase I and Phase IIa safety data.
Ocena vzročne povezave med neželenim učinkom in zdravilom SIRTURO pa ni bila omejena le na podatke iz navedenih študij, ampak je temeljila tudi na pregledu združenih podatkov o varnosti v študijah faze I in II.
Pharmacotherapeutic group: Antimycobacterials, drugs for treatment of tuberculosis, ATC code: J04AK05
Farmakoterapevtska skupina: Učinkovine za zdravljenje infekcij z mikobakterijami, Zdravila z delovanjem na bakterijo Mycobacterium tuberculosis, oznaka ATC: J04AK05
• QT interval as corrected by the Fridericia method (QTcF) > 450 ms (confirmed by repeat electrocardiogram);
• z intervalom QT po metodi s korekcijo Fridericia (QTcF) > 450 ms (potrjeno s ponovljenim elektrokardiogramom)
There are limited data on the use of SIRTURO in pregnant women.
Podatki o uporabi zdravila SIRTURO pri nosečnicah so omejeni.
Three of 24 male rats treated with high bedaquiline doses failed to produce offspring in the fertility study.
Trije od 24 podganjih samcev, ki so jim v študiji plodnosti dajali visoke odmerke bedakilina, niso mogli zaploditi potomcev.
The elimination of bedaquiline has not been fully characterised in vivo.
In vivo izločanje bedakilina ni bilo povsem pojasnjeno.
If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking SIRTURO.
Če karkoli od navedenega velja za vas (ali če o tem niste prepričani), se pogovorite z zdravnikom, s farmacevtom ali z medicinsko sestro, preden vzamete zdravilo SIRTURO.
In a rat carcinogenicity study, bedaquiline, at the high doses of 20 mg/kg/day in males and 10 mg/kg/day in females, did not induce any treatment-related increases in tumour incidences.
V študiji karcinogenosti pri podganah, bedakilin pri visokih odmerkih 20 mg/kg/dan pri samcih in 10 mg/kg/dan pri samicah ni zvečal z zdravljenjem povezane pojavnosti tumorjev.
Do not take SIRTURO if:
Ne jemljite zdravila SIRTURO:
What SIRTURO is and what it is used for What you need to know before you take SIRTURO How to take SIRTURO
Kaj je zdravilo SIRTURO in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo SIRTURO Kako jemati zdravilo SIRTURO Možni neželeni učinki
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.
Navedena manjša izpostavljenost ne velja za klinično pomembno, saj v kliničnih študijah niso opažali jasne povezave med izpostavljenostjo bedakilinu in odzivom pri bolnikih.
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).
Zdravilo SIRTURO je indicirano za uporabo kot del ustrezne kombinirane sheme zdravljenja pljučne tuberkuloze, odporne proti več zdravilom (MDR-TB - multidrug-resistant tuberculosis), pri odraslih bolnikih, kadar se učinkovite sheme zdravljenja zaradi odpornosti ali prenosljivosti ne da drugače sestaviti (glejte poglavja 4.2, 4.4 in 5.1).
All but one patients who died of tuberculosis had not converted or had relapsed.
Pri vseh bolnikih, z izjemo enega bolnika, ki so umrli zaradi tuberkuloze, ni prišlo do konverzije ali pa je prišlo do ponovitve bolezni.
There were no documented cases of Torsade de Pointes in the safety database (see section 4.4).
V podatkovni bazi o varnosti zdravila ni bilo dokumentiranih primerov pojava torsade de pointes (glejte poglavje 4.4).
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.
Če bolnik izpusti odmerek od tretjega tedna dalje, mora izpuščeni odmerek 200 mg vzeti takoj, ko je to mogoče in nato nadaljevati z jemanjem zdravila trikrat na teden.