FrancophonIA/ELRC3.0 huggingface dataset:
English: Removal of unabsorbed bedaquiline may be aided by the administration of activated charcoal.
Croatian: Uklanjanje neapsorbiranog bedakilina može biti potpomognuto primjenom aktivnog ugljena.
English: Environmental risk assessment studies have shown that bedaquiline has the potential to be persistent, bioaccumulative and toxic to the environment (see section 6.6).
Croatian: Ispitivanja procjene rizika za okoliš pokazale su da je bedakilin potencijalno perzistentan, bioakumulativan i toksičan za okoliš (vidjeti dio 6.6).
English: The plasma protein binding of the N-monodesmethyl metabolite (M2) in humans is at least 99.8%.
Croatian: Vezanje N-monodezmetil metabolita (M2) u ljudi na proteine plazme je najmanje 99,8%.
English: • Interim IDMC recommendation when half of the patients reach W76: 4Q2020
Croatian: • Privremenu IDMC preporuku kada pola bolesnika dosegne Tjedan 76: 4. kvartal 2020.
English: The intracellular bactericidal activity of bedaquiline in primary peritoneal macrophages and in a macrophage-like cell line was greater than its extracellular activity.
Croatian: Unutarstanična baktericidna aktivnost bedakilina u primarnim peritonealnim makrofagima i u linijama stanica sličnih makrofagima bila je veća nego njegova izvanstanična aktivnost.
English: The MAH will evaluate additional efficacy and safety data of bedaquiline in different treatment regimen compared to a regimen that does not include bedaquiline (confirmatory phase III study) following an agreed protocol.
Croatian: Nositelj odobrenja će procijeniti dodatne podatke djelotvornosti i sigurnosti za bedakilin u različitim režimima doziranja u usporedbi s režimom koji ne uključuje bedakilin (potvrdno ispitivanje faze III) po dogovorenom protokolu.
English: The primary efficacy endpoint was the time to sputum culture conversion during treatment with SIRTURO (median 57 days, for 205 patients with sufficient data).
Croatian: Primarna mjera ishoda djelotvornosti bila je vrijeme do pretvorbe kulture sputuma tijekom liječenja lijekom SIRTURO (medijan 57 dana, za 205 bolesnika s dostatnim podacima).
English: The following are examples of medicines patients with multi-drug resistant tuberculosis may take and which may potentially interact with SIRTURO:
Croatian: U nastavku su kao primjer navedeni lijekovi koje mogu uzimati bolesnici s tuberkulozom otpornom na više lijekova i koji potencijalno mogu stupiti u interakciju s lijekom SIRTURO:
English: Monitor symptoms and laboratory tests (ALT, AST, alkaline phosphatase, and bilirubin) at baseline, monthly while on treatment, and as needed.
Croatian: Pratite simptome i laboratorijske pretrage (ALT, AST, alkalna fosfataza i bilirubin) na početku, mjesečno tijekom liječenja, te po potrebi.
English: Response rates at week 24 and week 120 (i.e. around 6 months after stopping all therapy) are presented in table 1.
Croatian: Stope odgovora u 24. tjednu i 120. tjednu (tj. oko 6 mjeseci nakon prekida svih lijekova) prikazane su u tablici 1.
English: If you take more SIRTURO than you should, talk to a doctor straight away.
Croatian: Ako uzmete više lijeka SIRTURO nego što ste trebali, odmah razgovarajte sa svojim liječnikom.
English: 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.
Croatian: Osnova za procjenu uzročne povezanosti između nuspojava i lijeka SIRTURO nije bila ograničena na ova ispitivanja, nego je također uključila pregled udruženih podataka o sigurnosti iz Faze I i Faze IIa.
English: During the trial, there was no evidence of antecedent significant QT prolongation or clinically significant dysrhythmia in any of the patients that died.
Croatian: Tijekom ispitivanja, nije bilo dokaza o prethodnom značajnom produljenju QT ili klinički značajnoj disritmiji niti u jednog bolesnika koji je umro.
English: • latent infection with Mycobacterium tuberculosis
Croatian: • latentne infekcije s Mycobacterium tuberculosis
English: The N-monodesmethyl metabolite (M2) is not thought to contribute significantly to clinical efficacy given its lower average exposure (23% to 31%) in humans and lower antimycobacterial activity (3- to 6-fold lower) compared to the parent compound.
Croatian: Za N-monodezmetil metabolit (M2) se ne smatra da značajno doprinosi kliničkoj djelotvornosti radi manje prosječne izloženosti (23% do 31%) u ljudi i niže antimikobakterijske aktivnosti (3 do 6 puta niže) u usporedbi s ishodišnim spojem.
English: Extent of resistance based on central laboratory drug susceptibility testing results was not available for 20 subjects in the mITT population (12 in the SIRTURO group and 8 in the placebo group).
Croatian: Opseg rezistencije temeljen na rezultatima osjetljivosti središnjeg laboratorija nije bio dostupan za 20 ispitanika u mITT populaciji (za 12 u SIRTURO skupini i za 8 placebo skupini).
English: 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.
Croatian: U ispitivanju interakcije bedakilina i ketokonazola, veći učinak na QTc bio je zabilježen nakon ponovljenog doziranja bedakilina i ketokonazola u kombinaciji, nego nakon ponovljenog doziranja pojedinačnih lijekova.
English: Bedaquiline specifically inhibits mycobacterial ATP (adenosine 5'-triphosphate) synthase, an essential enzyme for the generation of energy in Mycobacterium tuberculosis.
Croatian: Bedakilin specifično inhibira mikobakterijsku ATP (adenozin 5'-trifosfat) sintazu, esencijalni enzim za generiranje energije u Mycobacterium tuberculosis.
English: There are no safety data from bedaquiline multiple dose trials which utilised a dose higher than the indicated dose.
Croatian: Ne postoje podaci o sigurnosti iz ispitivanja bedakilina u višestrukim dozama u kojima je korištena doza viša od indicirane doze.
English: Bedaquiline prolongs the QTc interval.
Croatian: Bedakilin produljuje QTc interval.
English: Patients should be advised to take SIRTURO exactly as prescribed and to complete the full course of therapy.
Croatian: Bolesnicima treba savjetovati da uzimaju SIRTURO točno onako kako je propisano, te da uzimaju lijek tijekom cijelog ciklusa liječenja.
English: Caution is recommended when prescribing bedaquiline concomitantly with medicinal products with a known risk of QT prolongation.
Croatian: Preporučen je oprez kada se bedakilin propisuje istovremeno s lijekovima kod kojih je poznat rizik za produljenje QT.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with SIRTURO in one or more subsets of the paediatric population in the treatment of multi-drug resistant Mycobacterium tuberculosis (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka SIRTURO u jednoj ili više podskupina pedijatrijske populacije u liječenju multirezistentne Mycobacterium tuberculosis (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: CYP3A4 inducers
Croatian: CYP3A4 induktori
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak po pitanju reproduktivne toksičnosti (vidjeti dio 5.3).
English: There is limited information available on the potential for a pharmacodynamic interaction between bedaquiline and medicinal products that prolong the QT interval.
Croatian: Dostupni su ograničeni podaci o potencijalu za farmakodinamičku interakciju između bedakilina i lijekova koji produljuju QT interval.
English: Central laboratory drug susceptibility testing results became available for one additional placebo subject after the week 24 interim analysis.
Croatian: Rezultati ispitivanja osjetljivosti na lijek, provedenih u središnjem laboratoriju, postali su dostupni za još jednog dodatnog ispitanika koji je primao placebo, nakon privremene analize u 24. tjednu.
English: SIRTURO is indicated for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4.2, 4.4 and 5.1).
Croatian: SIRTURO je indiciran za primjenu kao dio odgovarajućeg kombiniranog režima liječenja multirezistentne plućne tuberkuloze (MDR-TBC) u odraslih bolesnika kada ne postoji mogućnost sastavljanja drugačijeg učinkovitog režima liječenja zbog rezistencije ili podnošljivosti (vidjeti dijelove 4.2, 4.4 i 5.1).
English: • QT interval as corrected by the Fridericia method (QTcF) > 450 ms (confirmed by repeat electrocardiogram);
Croatian: • QT intervalom korigiranim Fridericijevom metodom (QTcF) > 450 ms (potvrđen ponovljenim elektrokardiogramom);
English: 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).
Croatian: U ženki štakora, nije bilo učinka na parenje ili plodnost tijekom primjene bedakilina, međutim neki učinci uočeni su u mužjaka štakora (vidjeti dio 5.3).
English: Efflux-based mutations have been seen in preclinical and clinical isolates.
Croatian: Mutacije na temelju efluksa bile su zabilježene u pretkliničkim i kliničkim izolatima.
English: If you are not sure, talk to your doctor or pharmacist before taking SIRTURO.
Croatian: Ako niste sigurni, razgovarajte sa svojim liječnikom ili ljekarnikom prije uzimanja lijeka SIRTURO.
English: Medicine (name of the active substance)
Croatian: Lijek (naziv djelatne tvari)
English: The majority of isolates that are phenotypically resistant to bedaquiline are cross-resistant to clofazimine.
Croatian: Većina izolata koji su fenotipski rezistentni na bedakilin također su križno rezistentni na klofazimin.
English: Talk to your doctor, pharmacist or nurse before taking SIRTURO, if:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete SIRTURO:
English: Elderly population (≥ 65 years of age) There is limited clinical data (n = 2) on the use of SIRTURO in elderly patients.
Croatian: Starija populacija (≥ 65 godina starosti) Postoje ograničeni klinički podaci (n = 2) o primjeni lijeka SIRTURO u starijih bolesnika.
English: Extent of resistance based on central laboratory drug susceptibility testing results was not available for 32 subjects in the mITT population.
Croatian: Opseg rezistencije temeljen na rezultatima ispitivanja osjetljivosti na lijek, provedenih u središnjem laboratoriju, nije bio dostupan za 32 ispitanika u mITT populaciji.
English: There is no experience with the treatment of acute overdose with SIRTURO.
Croatian: Ne postoji iskustvo u liječenju akutnog predoziranja lijekom SIRTURO.
English: SIRTURO contains “lactose” (a type of sugar).
Croatian: SIRTURO sadrži “laktozu” (vrsta šećera).
English: These subjects were excluded from the subgroup analysis by extent of resistance of M tuberculosis strain.
Croatian: Ovi ispitanici bili su isključeni iz analize podskupina ovisno o opsegu rezistencije soja M. tuberculosis.
English: SIRTURO should be taken orally with food, as administration with food increases oral bioavailability by about 2-fold (see section 5.2).
Croatian: SIRTURO se mora uzeti peroralno s hranom, s obzirom da mu primjena s hranom povećava oralnu bioraspoloživost za otprilike 2 puta (vidjeti dio 5.2).
English: In the Phase IIb, open label study (C209), 6.9% (16/233) patients died.
Croatian: U otvorenom ispitivanju faze IIb (C209), 6,9% (16/233) bolesnika je umrlo.
English: 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.
Croatian: Neobložena, bijela do gotovo bijela okrugla bikonveksna tableta, promjera 11 mm, s utisnutim "T" iznad "207" na jednoj strani i "100" na drugoj strani.
English: Transaminases increased*
Croatian: Povišene transaminaze *
English: SIRTURO must always be taken together with other medicines for treating tuberculosis.
Croatian: SIRTURO se uvijek mora uzeti zajedno s drugim lijekovima za liječenje tuberkuloze.
English: 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.
Croatian: U ispitivanju kancerogenosti u štakora, bedakilin, pri visokim dozama od 20 mg/kg/dan u mužjaka i 10 mg/kg/dan u ženki, nije inducirao s liječenjem povezan porast incidencija tumora.
English: This is called multi-drug resistant pulmonary tuberculosis.
Croatian: Naziva se plućna tuberkuloza otporna na više lijekova.
English: 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.
Croatian: Eliminacija nepromijenjenog bedakilina putem mokraće bila je < 0,001% doze u kliničkim ispitivanjima, što upućuje na to da bubrežni klirens nepromijenjene djelatne tvari nije značajan.
English: Bedaquiline was associated with effects in target organs which included monocytic phagocytic system (MPS), skeletal muscle, liver, stomach, pancreas and heart muscle.
Croatian: Bedakilin je bio povezan s učincima na ciljne organe, a oni su uključivali monocitno-fagocitni sustav (MPS), poprečno-prugaste mišiće, jetru, želudac, gušteraču i srčani mišić.
English: Bedaquiline is a diarylquinoline.
Croatian: Bedakilin je diarilkinolin.
English: 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.
Croatian: Ako rezultati ispitivanja in vitro nisu dostupni, liječenje lijekom SIRTURO može se započeti u kombinaciji s najmanje četiri druga lijeka za koje je osjetljivost bolesnikovih izolata vjerojatna.
English: In vitro and in vivo genotoxicity tests indicated that bedaquiline did not have any mutagenic or clastogenic effects.
Croatian: In vitro i in vivo ispitivanja genotoksičnosti pokazala su da bedakilin nije imao mutagene ili klastogene učinke.
English: Mycobacterium xenopi, Mycobacterium novocastrense, Mycobacterium shimoidei and non-mycobacterial species are considered inherently resistant to bedaquiline.
Croatian: Za Mycobacterium xenopi, Mycobacterium novocastrense, Mycobacterium shimoidei i ne-mikobakterijske vrste smatra se da su prirođeno rezistentne na bedakilin.
English: An in vitro study indicated a potential for bedaquiline to inhibit BCRP at the concentrations achieved in the intestine after oral administration.
Croatian: In vitro ispitivanje pokazalo je potencijal bedakilina da inhibira BCRP pri koncentracijama postignutim u crijevima nakon peroralne primjene.
English: Body weight decreases in pups were noted in high dose groups during the lactation period after exposure to bedaquiline via milk and were not a consequence of in utero exposure.
Croatian: Smanjenja tjelesnih težina u mladunčadi primijećena su u skupinama visoke doze tijekom razdoblja dojenja, nakon izloženosti bedakilinu putem mlijeka što nije bila posljedica izloženosti u maternici.
English: Patients receiving SIRTURO alone with no other QT prolonging medicinal product developed a maximal mean QTcF increase over baseline of 23.7 ms with no QT duration in excess of 480 ms, whereas patients with at least 2 other QT prolonging medicinal products developed a maximal mean QTcF prolongation of 30.7 ms over baseline, resulting in a QTcF duration in excess of 500 ms in one patient.
Croatian: Bolesnici koji uzimaju SIRTURO samostalno bez drugih lijekova koji produljuju QT razvili su maksimalnu srednju vrijednost povišenja QTcF iznad početne vrijednosti od 23,7 ms bez QT trajanja s prekoračenjem od 480 ms, dok su bolesnici s barem 2 druga lijeka koji produljuju QT razvili maksimalnu srednju vrijednost produljenja QTcF od 30,7 ms iznad početne vrijednosti, dovodeći do QTcF trajanja s prekoračenjem od 500 ms u jednog bolesnika.
English: What SIRTURO contains
Croatian: Što SIRTURO sadrži
English: The corresponding plasma exposure (AUC) was 2-fold higher in rats compared to humans.
Croatian: Odgovarajuća izloženost u plazmi (AUC) bila je 2 puta viša u štakora u usporedbi s ljudima.
English: QT interval and concomitant clofazimine use
Croatian: QT interval i istodobna primjena klofazimina
English: White HDPE bottle with child-resistant polypropylene (PP) closure with aluminium induction seal liner containing 188 tablets.
Croatian: Bijela boca od HDPE-a, sa sigurnosnim zatvaračem za djecu od polipropilena (PP) i aluminijskim zaštitnim poklopcem, koja sadrži 188 tableta.
English: Treatment with SIRTURO should be initiated and monitored by a physician experienced in the management of multi-drug resistant Mycobacterium tuberculosis.
Croatian: Liječenje lijekom SIRTURO mora započeti i nadzirati liječnik koji ima iskustva u liječenju multirezistentne Mycobacterium tuberculosis.
English: Compared to the exposures (AUC) observed in subjects with MDR-TB in the bedaquiline phase II trials, the exposures (AUC) in rats at high doses were similar in males and 2-fold higher in females for bedaquiline, and 3-fold higher in males and 2-fold higher in females for M2.
Croatian: U usporedbi s izloženostima (AUC) uočenim u ispitanika s MDR-TBC u ispitivanjima faze II s bedakilinom, izloženosti (AUC) u štakora pri visokim dozama su bile slične u mužjaka i 2 puta više u ženki za bedakilin, te 3 puta više u mužjaka i 2 puta više u ženki za M2.
English: Purpose of the medicine rifampicin, rifapentine, rifabutin to treat some infections like tuberculosis (antimycobacterial)
Croatian: Svrha uzimanja lijeka rifampicin, rifapentin, rifabutin za liječenje nekih infekcija poput tuberkuloze (antimikobakterijski lijek)
English: Bedaquiline is bacteriostatic for many non-tuberculous mycobacterial species.
Croatian: Bedakilin je bakteriostatik za mnoge ne-tuberkulozne mikobakterijske vrste.
English: Of the 42 patients who were non-responders at week 24, confirmed culture conversion after week 24 (i.e., after bedaquiline dosing ended but the background regimen was continued) occurred in 9 patients (21.4%) and was maintained at week 120.
Croatian: Od 42 bolesnika koji nisu odgovorili u tjednu 24, potvrđena konverzija kulture nakon tjedna 24 (tj. nakon što je završilo doziranje bedakilina, ali je nastavljeno osnovno liječenje) javila se je u 9 bolesnika (21,4%) i bila je zadržana u 120. tjednu.
English: If syncope occurs, an electrocardiogram should be obtained to detect any QT prolongation.
Croatian: U slučaju pojave sinkope, mora se napraviti elektrokardiogram radi otkrivanja bilo kakve vrste QT produljenja.
English: After reaching Cmax, bedaquiline concentrations decline tri-exponentially.
Croatian: Nakon postizanja Cmax, koncentracije bedakilina opadaju tro-eksponencijalno.
English: Bedaquiline and M2 are not substrates or inhibitors of P-glycoprotein.
Croatian: Bedakilin i M2 nisu ni supstrati ni inhibitori P-glikoproteina.
English: efavirenz, etravirine, lopinavir/ritonavir to treat HIV infection (antiretroviral non-nucleoside reverse transcriptase inhibitors, antiretroviral protease inhibitors)
Croatian: efavirenz, etravirin, lopinavir/ritonavir za liječenje zaraze HIV-om (antiretrovirusni nenukleozidni inhibitori reverzne transkriptaze, antiretrovirusni inhibitori proteaze)
English: • Weeks 3-24: 200 mg (2 tablets of 100 mg) three times per week (with at least 48 hours between doses).
Croatian: • Tjedni 3-24: 200 mg (2 tablete od 100 mg) tri puta tjedno (s najmanje 48 sati između doza).
English: This low exposure was not considered to be clinically relevant as no clear relationship between exposure to bedaquiline and response has been observed in clinical trials.
Croatian: Ne smatra se da je ova niska izloženost klinički značajna, jer u kliničkim ispitivanjima nije uočena jasna povezanost između izloženosti bedakilinu i odgovora.
English: It is therefore not expected that mild or moderate renal impairment will have a clinically relevant effect on the exposure to bedaquiline.
Croatian: Stoga se ne očekuje da će blago ili umjereno oštećenje bubrega imati klinički značajan učinak na izloženost bedakilinu.
English: At both week 24 and week 120, responder rates were higher for patients on 3 or more active substances (in vitro) in their background regimen.
Croatian: I u 24. tjednu i u 120. tjednu, stope odgovora bile su više kod bolesnika koji su u osnovnom liječenju uzimali 3 ili više djelatnih tvari (in vitro).
English: Body weight decreases in pups were noted in high dose groups during the lactation period (see section 5.3).
Croatian: Smanjenja tjelesnih težina u mladunčadi zamijećena su u skupinama visokih doza za vrijeme dojenja (vidjeti dio 5.3).
English: Based on the preclinical studies, the bulk of the administered dose is eliminated in faeces.
Croatian: Na temelju pretkliničkih ispitivanja, velika količina primijenjene doze se eliminira putem fecesa.
English: In the rat, no adverse effects were observed in a pre- and post-natal development study at maternal plasma exposure (AUC) similar to humans and exposure in the offspring 3-fold higher than in adult humans.
Croatian: U štakora, nisu uočeni štetni učinci u pre- i postnatalnom razvojnom ispitivanju pri maternalnoj izloženosti u plazmi (AUC) koja je slična ljudskima, a izloženost u mladunčadi 3 puta viša nego u odraslih ljudi.
English: In patients with extensive drug resistance, where SIRTURO is considered necessary beyond 24 weeks to obtain a curative treatment, a longer duration of therapy may be considered only on a case by case basis and under close safety surveillance (see section 4.8).
Croatian: U bolesnika s ekstenzivnom rezistencijom na lijek, kada se smatra da je SIRTURO potrebno uzimati duže od 24 tjedna da bi se postigao kurativni učinak liječenja, duže trajanje liječenja može se uzeti u obzir samo od slučaja do slučaja te uz brižan nadzor sigurnosti (vidjeti dio 4.8).
English: 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.
Croatian: Ispitivanje C209 procijenilo je sigurnost, podnošljivost i djelotvornost 24-tjednog otvorenog liječenja lijekom SIRTURO kao dijela režima individualiziranog liječenja u 233 bolesnika čiji je razmaz sputuma bio pozitivan unutar 6 mjeseci prije probira.
English: It is recommended that SIRTURO is administered by directly observed therapy (DOT).
Croatian: Preporuča se da se primjena lijeka SIRTURO vrši u sklopu izravno nadziranog liječenja (DOT, engl. directly observed therapy).
English: Inherently resistant organisms Mycobacterium xenopi Mycobacterium novocastrense Mycobacterium shimoidei Non-mycobacterial species
Croatian: Prirođeno rezistentni mikroorganizmi Mycobacterium xenopi Mycobacterium novocastrense Mycobacterium shimoidei Ne-mikobakterijske vrste
English: Dizziness has been reported in some patients taking bedaquiline and should be considered when assessing a patient's ability to drive or operate machinery (see section 4.8).
Croatian: Omaglica je bila prijavljena u nekih bolesnika koji uzimaju bedakilin i treba se uzeti u obzir pri procjeni bolesnikove sposobnosti upravljanja vozilima ili rada sa strojevima (vidjeti dio 4.8).
English: Co-administration of bedaquiline and medicinal products that induce CYP3A4 may decrease bedaquiline plasma concentrations and reduce its therapeutic effect.
Croatian: Istovremena primjena bedakilina i lijekova koji induciraju CYP3A4 može smanjiti koncentracije bedakilina u plazmi i smanjiti njegov terapijski učinak.
English: A carton containing 4 push-through blister strips (containing 6 tablets per strip).
Croatian: Kutija sadrži 4 blister strip pakiranja kroz koja se protisnu tablete (strip sadrži 6 tableta).