FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of single-dose bedaquiline and multiple-dose nevirapine did not result in clinically relevant changes in the exposure to bedaquiline.
Croatian: Istovremena primjena jedne doze bedakilina i višestrukih doza nevirapina nije rezultirala klinički značajnim promjenama u izloženosti bedakilinu.
English: How to store SIRTURO
Croatian: Kako čuvati SIRTURO
English: • Take 400 mg (4 tablets of 100 mg) once a day.
Croatian: • Uzmite 400 mg (4 tablete od 100 mg) jedanput na dan.
English: A more pronounced effect on bedaquiline may be observed during prolonged co-administration of ketoconazole or other inhibitors of CYP3A4.
Croatian: Izraženiji učinak na bedakilin može se uočiti tijekom produžene istovremene primjene ketokonazola ili ostalih inhibitora CYP3A4.
English: Follow-up monitoring of electrolytes should be performed if QT prolongation is detected (see sections 4.5 and 4.8).
Croatian: U slučaju QT produljenja, mora se vršiti praćenje i nadzor elektrolita (vidjeti dijelove 4.5 i 4.8).
English: • Take 200 mg (2 tablets of 100 mg) once a day for 3 days of each week only.
Croatian: • Uzmite 200 mg (2 tablete od 100 mg) jedanput na dan samo 3 dana u svakom tjednu.
English: Bedaquiline has not been studied in patients with severe hepatic impairment (see section 4.2).
Croatian: Bedakilin nije bio ispitan u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.2).
English: No human data on the effect of bedaquiline on fertility are available.
Croatian: Nema dostupnih podataka o djelovanju bedakilina na plodnost u ljudi.
English: Since bedaquiline is highly protein-bound, dialysis is not likely to significantly remove bedaquiline from plasma.
Croatian: Budući da se bedakilin u velikoj mjeri veže na proteine, nije vjerojatno da će se dijalizom bedakilin značajno ukloniti iz plazme.
English: Concentrations of bedaquiline in milk were 6- to12-fold higher that the maximum concentration observed in maternal plasma.
Croatian: Koncentracije bedakilina u mlijeku bile su 6 do 12 puta više nego maksimalne koncentracije uočene u majčinoj plazmi.
English: In an open label Phase IIb trial, mean increases in QTcF were larger in the 17 subjects who were using concomitant clofazimine at week 24 (mean change from reference of 31.9 ms) than in subjects who were not using concomitant clofazimine at week 24 (mean change from reference of 12.3 ms) (see section 4.4).
Croatian: U otvorenom ispitivanju Faze IIb, srednje vrijednosti povišenja QTcF u tjednu 24 bile su veće kod 17 ispitanika koji su istodobno uzimali klofazimin, (promjena srednje vrijednosti od 31,9 ms u odnosu na referentnu), u odnosu na ispitanike koji istodobno nisu uzimali klofazimin u tjednu 24 (promjena srednje vrijednosti od 12,3 ms u odnosu na referentnu) (vidjeti dio 4.4).
English: (antimycobacterial) carbamazepine, phenytoin to treat epileptic fits (anticonvulsants) St. John's wort (Hypericum perforatum)
Croatian: (antimikobakterijski lijek) karbamazepin, fenitoin za liječenje epileptičkih napadaja (antikonvulzivi) gospina trava (Hypericum perforatum)
English: Of note, no change in bedaquiline dosing is recommended in case of co-treatment with lopinavir/ritonavir or other ritonavir-boosted HIV protease inhibitors.
Croatian: Važno je napomenuti da se promjena doziranja bedakilina u slučaju istovremenog liječenja s lopinavirom/ritonavirom ili s drugim inhibitorima proteaze HIV-a pojačanih ritonavirom ne preporučuje.
English: Bedaquiline has activity against Mycobacterium tuberculosis with a minimal inhibitory concentration (MIC) for drug-sensitive as well as drug-resistant strains (multi-drug resistant including preextensively drug resistant strains, extensively drug resistant strains) in the range of ≤ 0.008-0.12 mg/l.
Croatian: Bedakilin djeluje na Mycobacterium tuberculosis s minimalnom inhibitornom koncentracijom (MIC) u rasponu od ≤ 0,008-0,12 mg/l za sojeve osjetljive na lijek kao i za sojeve rezistentne na lijek (multirezistentne uključujući pred-ekstenzivno rezistentne sojeve, ekstenzivno rezistentne sojeve).
English: A more pronounced effect on bedaquiline plasma exposures may be observed during prolonged co-administration with lopinavir/ritonavir.
Croatian: Izraženiji učinak na izloženosti bedakilinu u plazmi može se uočiti tijekom produljene istovremene primjene s lopinavirom/ritonavirom.
English: Discontinued but converted
Croatian: Prekinuli ali s konverzijom 66
English: The short-term co-administration of bedaquiline and ketoconazole (potent CYP3A4 inhibitor) in healthy subjects increased the exposure (AUC) to bedaquiline by 22% [90% CI (12; 32)].
Croatian: Kratkotrajna istovremena primjena bedakilina i ketokonazola (potentni inhibitor CYP3A4) u zdravih ispitanika povisila je izloženost (AUC) bedakilinu za 22% [90% CI (12; 32)].
English: How much to take You take SIRTURO for a 24 week course.
Croatian: Koliko lijeka uzeti Lijek SIRTURO uzimate tijekom 24 tjedna.
English: Paediatric patients The pharmacokinetics of SIRTURO in paediatric patients have not been evaluated.
Croatian: Pedijatrijski bolesnici Farmakokinetika lijeka SIRTURO nije procijenjena u pedijatrijskih bolesnika.
English: • A personal or family history of congenital QT prolongation;
Croatian: • urođenim produljenjem QT intervala u osobnoj ili obiteljskoj anamnezi;
English: Bedaquiline is metabolised by CYP3A4.
Croatian: Bedakilin se metabolizira putem CYP3A4.
English: The most frequent adverse drug reactions (> 10.0% of patients) during treatment with SIRTURO in the controlled trials were nausea (35.3% in the SIRTURO group vs 25.7% in the placebo group), arthralgia (29.4% vs 20.0%), headache (23.5% vs 11.4%), vomiting (20.6% vs 22.9%) and dizziness (12.7% vs 11.4%).
Croatian: u kontroliranim ispitivanjima tijekom liječenja lijekom SIRTURO bile su mučnina (35,3% u SIRTURO skupini naspram 25,7% u placebo skupini), artralgija (29,4% naspram 20,0%), glavobolja (23,5% naspram 11,4%), povraćanje (20,6% naspram 22,9%) i omaglica (12,7% naspram 11,4%).
English: • infections due to mycobacterial species other than Mycobacterium tuberculosis
Croatian: • infekcija uzrokovanih mikobakterijskim vrstama koje nisu Mycobacterium tuberculosis
English: Any unused medicine should be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: Co-administration of bedaquiline and moderate or strong CYP3A4 inducers used systemically should, therefore, be avoided (see section 4.5).
Croatian: Istovremena primjena bedakilina i umjerenih ili snažnih CYP3A4 induktora primijenjenih sistemski stoga se mora izbjegavati (vidjeti dio 4.5).
English: Myalgia * Terms represented by ‘transaminases increased' included AST increased, ALT increased, hepatic enzyme increased,
Croatian: Mijalgija * Pojmovi obuhvaćeni pojmom ‘povišene transaminaze' uključili su povišen AST, povišen ALT, povišene jetrene enzime, abnormalnu funkciju jetre i povišene transaminaze (vidjeti odjeljak ispod).
English: In the MPS of all species, pigment-laden and/or foamy macrophages were also seen in various tissues, consistent with phospholipidosis.
Croatian: U MPS svih vrsta, sukladno fosfolipidozi, u različitim tkivima uočeni su makrofagi ispunjeni pigmentom i/ili pjenušavi makrofagi.
English: In an interaction study of single-dose bedaquiline and multiple-dose lopinavir/ritonavir, exposure (AUC) to bedaquiline was increased by 22% [90% CI (11; 34)].
Croatian: U ispitivanju interakcije jedne doze bedakilina i višestrukih doza lopinavira/ritonavira, izloženost (AUC) bedakilinu bila je povišena za 22% [90% CI (11; 34)].
English: If co-administration is required, more frequent electrocardiogram monitoring and monitoring of transaminases is recommended (see section 4.4).
Croatian: Ako je istovremena primjena potrebna, preporučeno je češće praćenje elektrokardiograma i transaminaza (vidjeti dio 4.4).
English: Overall responder at Week 24 Patients with MDRH&R-TB Patients infected with a pre-XDR-TB Overall nonresponder* at Week 24
Croatian: Sveukupno su odgovorili na liječenje u Tjednu 24 Bolesnici s MDRH&R-TB 39 Bolesnici inficirani s pre-XDR-TB Sveukupno nisu odgovorili na liječenje* u tjednu 24
English: During the investigational phase in Stage 2 of study C208, increased aminotransferases were reported in 7/79 (8.9%) patients in the SIRTURO treatment group compared to 1/81 (1.2%) in the placebo treatment group.
Croatian: Tijekom faze ispitivanja u stupnju 2 ispitivanja C208, povišene aminotransferaze bile su prijavljene u 7/79 (8,9%) bolesnika u skupini liječenoj lijekom SIRTURO u usporedbi s 1/81 (1,2%) u skupini liječenoj placebom.
English: Mortality
Croatian: Smrtnost
English: In the event that co-administration of such medicinal products with bedaquiline is necessary, clinical monitoring, including frequent electrocardiogram assessment, is recommended.
Croatian: U slučaju da je istovremena primjena takvih lijekova s bedakilinom neophodna, preporučeno je kliničko praćenje, uključujući čestu procjenu elektrokardiograma.
English: • Weeks 1-2: 400 mg (4 tablets of 100 mg) once daily
Croatian: • Tjedni 1-2: 400 mg (4 tablete od 100 mg) jedanput dnevno
English: In animals, bedaquiline and its active N-monodesmethyl metabolite (M2) are extensively distributed to most tissues, however, brain uptake was low.
Croatian: N- monodezmetil metabolit (M2) ekstenzivno se distribuiraju u većinu tkiva, međutim, prelazak u mozak je nizak.
English: CYP3A4 is the major CYP isoenzyme involved in vitro in the metabolism of bedaquiline and the formation of the N-monodesmethyl metabolite (M2).
Croatian: CYP3A4 je glavni CYP izoenzim uključen u in vitro metabolizam bedakilina i u nastanak N-monodezmetil metabolita (M2).
English: In study C208 (stage 1 and 2), aminotransferase elevations of at least 3 x ULN developed more frequently in the SIRTURO treatment group (11/102 [10.8%] versus 6/105 [5.7%]) in the placebo treatment group.
Croatian: U ispitivanju C208 (stadij 1 i 2), povišenja aminotransferaza od najmanje 3 x GGN razvila su se češće u skupini liječenoj lijekom SIRTURO, 11/102 (10,8%) naspram 6/105 (5,7%) u skupini liječenoj placebom.
English: In an interaction study of single-dose bedaquiline and once daily rifampicin (strong inducer) in healthy subjects, the exposure (AUC) to bedaquiline was reduced by 52% [90% CI (-57; -46)].
Croatian: U ispitivanju interakcije jedne doze bedakilina i rifampicina (snažni induktor) primijenjenog jedanput dnevno u zdravih ispitanika, izloženost (AUC) bedakilinu bila je smanjena za 52% [90% CI (-57; -46)].
English: SIRTURO contains lactose.
Croatian: SIRTURO sadrži laktozu.
English: • you have a decreased thyroid gland function.
Croatian: • ako Vam je smanjena funkcija štitne žlijezde.
English: In the randomised phase IIb study (C208, stage 2) a higher rate of deaths was seen in the SIRTURO treatment group (12.7%; 10/79 patients) compared to the placebo treatment group (3.7%; 3/81 patients).
Croatian: U randomiziranom ispitivanju faze IIb (C208, stupanj 2) viša stopa smrti uočena je u skupini liječenoj lijekom SIRTURO (12,7%; 10/79 bolesnika) u usporedbi s placebo skupinom (3,7%; 3/81 bolesnika).
English: SIRTURO should be used with caution in patients with moderate hepatic impairment (see section 5.2).
Croatian: SIRTURO se mora uzimati s oprezom u bolesnika s umjerenim oštećenjem jetre (vidjeti dio 5.2).
English: In the event that co-administration of clofazimine with bedaquiline is necessary, clinical monitoring, including frequent electrocardiogram assessment, is recommended (see section 4.5).
Croatian: U slučaju da je neophodna istovremena primjena klofazimina s bedakilinom, preporučeno je kliničko praćenje, uključujući čestu procjenu elektrokardiograma (vidjeti dio 4.5).
English: SIRTURO with alcohol You should not drink alcohol while taking SIRTURO.
Croatian: Ne smijete piti alkohol za vrijeme uzimanja lijeka SIRTURO.
English: Conversion rates at week 24 were highest (87.1%; 81/93) in patients with MDRH&R-TB, 77.3% (34/44) in pre-XDR-TB patients and lowest (54.1%; 20/37) in XDR-TB patients.
Croatian: Stope konverzije u 24. tjednu bile su najveće (87,1%; 81/93) u bolesnika s MDRH&R-TB,, 77,3% (34/44) u bolesnika s pre-XDR-TB i najmanje (54,1%; 20/37) u bolesnika s XDR-TB.
English: Multi-drug resistant Mycobacterium tuberculosis (MDRH&R-TB): isolate resistant to at least isoniazid and rifampicin, but susceptible to fluoroquinolones and second line injectable agents.
Croatian: Multirezistentna Mycobacterium tuberculosis (MDRH&R-TB): izolati rezistentni barem na izoniazid i rifampicin, ali osjetljivi na fluorokinolone i drugu liniju lijekova koji se primjenjuju injekcijom.
English: Conversion rates at week 120 were highest (73.1%; 68/93) in patients with MDRH&R-TB, 70.5% (31/44) in pre-XDR-TB patients and lowest (62.2%; 23/37) in XDR-TB patients.
Croatian: Stope konverzije u 120. tjednu bile su najviše (73,1%; 68/93) u bolesnika s MDRH&R-TB, 70,5% (31/44) u bolesnika s pre-XDR-TB i najniže (62,2%; 23/37) u XDR-TB bolesnika.
English: General measures to support basic vital functions including monitoring of vital signs and electrocardiogram (QT interval) monitoring should be taken in case of deliberate or accidental overdose.
Croatian: U slučaju namjernog ili slučajnog predoziranja treba poduzeti općenite potporne mjere vitalnih funkcija uključujući praćenje vitalnih znakova i praćenja elektrokardiograma (QT interval).
English: An electrocardiogram should be obtained before initiation of treatment and at least monthly after starting treatment with bedaquiline.
Croatian: Prije početka liječenja te barem jednom mjesečno nakon početka liječenja bedakilinom, mora se napraviti elektrokardiogram.
English: Three of 24 male rats treated with high bedaquiline doses failed to produce offspring in the fertility study.
Croatian: U ispitivanju plodnosti tri od 24 mužjaka štakora liječenih s visokim dozama bedakilina nisu mogla dobiti mladunčad.
English: If co-administration is required, more frequent electrocardiogram monitoring and monitoring of transaminases is recommended.
Croatian: Ako je istovremena primjena potrebna, preporučuje se češće praćenje elektrokardiograma te praćenja transaminaza.
English: Urinary excretion of bedaquiline is negligible.
Croatian: Izlučivanje bedakilina mokraćom je neznatno.
English: Electrocardiogram QT prolonged
Croatian: QT produljenje na elektrokardiogramu
English: SIRTURO contains lactose monohydrate
Croatian: SIRTURO sadrži laktozu hidrat
English: • A history of or ongoing bradyarrhythmia;
Croatian: • postojeća ili bradiaritmija u prošlosti;
English: No dose adjustment is necessary for SIRTURO in patients with mild or moderate hepatic impairment (see section 5.2).
Croatian: Za SIRTURO nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem jetre (vidjeti dio 5.2).
English: Pre-extensively drug resistant tuberculosis (pre-XDR-TB): isolate resistant to isoniazid, rifampicin, and either any fluoroquinolone or at least one second line injectable agent (but not to both a fluoroquinolone and a second line injectable agent).
Croatian: Tuberkuloza koja je pred-ektenzivno rezistentna na lijekove (pre-XDR-TB): izolati rezistentni na izoniazid, rifampicin i ili na bilo koji fluorokinolon ili na barem jedan lijek iz druge linije koji se primjenjuje injekcijom (ali ne na oboje i fluorokinolon i lijek iz druge linije koji se primjenjuje injekcijom).
English: SIRTURO 100 mg tablets bedaquiline
Croatian: SIRTURO 100 mg tablete bedakilin
English: Cardiovascular
Croatian: Kardiovaskularne
English: Walterovo náměstí 329/1 CZ158 00 Praha 5 - Jinonice Tel: +420 227 012 227
Croatian: CZ-158 00 Praha 5 - Jinonice Tel: +420 227 012 227
English: No dose adjustment is deemed necessary in patients with mild or moderate hepatic impairment.
Croatian: Smatra se da nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem jetre.
English: CYP3A4 was the major CYP isoenzyme involved in vitro in the metabolism of bedaquiline and the formation of the N-monodesmethyl metabolite (M2).
Croatian: In vitro, CYP3A4 je bio glavni CYP izoenzim uključen u metabolizam bedakilina i nastanak Nmonodezmetil metabolita (M2).
English: Refer to the Summary of Product Characteristics of the medicinal products used in combination with SIRTURO for their respective adverse reactions.
Croatian: Pogledajte Sažetak opisa svojstava lijekova koji se primjenjuje u kombinaciji s lijekom SIRTURO radi njihovih pojedinačnih nuspojava.
English: The safety and efficacy of SIRTURO in children aged < 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka SIRTURO u djece u dobi
English: The impact of high baseline bedaquiline MICs, the presence of Rv0678 based mutations at baseline, and/or increased post-baseline bedaquiline MICs on microbiologic outcomes is unclear because of the low incidence of such cases in the Phase II trials.
Croatian: Zbog niske učestalosti takvih slučajeva u ispitivanjima faze II nije jasan utjecaj visokih početnih vrijednosti MIC-ova bedakilina, prisutnosti mutacija u Rv0678 genu na početku ispitivanja i/ili povećanih MIC-ova bedakilina nakon početne vrijednosti na mikrobiološke ishode.
English: Extensively drug resistant tuberculosis (XDR-TB): isolate resistant to isoniazid, rifampicin, any fluoroquinolone, and at least one second line injectable agent.
Croatian: Tuberkuloza koja je ekstenzivno rezistentna na lijekove (XDR-TB): izolati rezistentni na izoniazid, rifampicin i bilo koji fluorokinolon i na barem jedan lijek iz druge linije koji se primjenjuje injekcijom.
English: Bedaquiline must only be used in an appropriate combination regimen for MDR-TB treatment as recommended by official guidelines, such as from WHO, to prevent development of resistance to bedaquiline.
Croatian: Sukladno službenim smjernicama, poput smjernica Svjetske zdravstvene organizacije, bedakilin se mora koristiti isključivo u odgovarajućem kombiniranom režimu liječenja multirezistentne plućne tuberkuloze (MDR-TBC) kako bi se spriječio razvoj rezistencije na bedakilin.
English: There is limited clinical data (n = 2) on the use of SIRTURO in tuberculosis patients aged 65 years and older.
Croatian: Klinički podaci o primjeni lijeka SIRTURO u bolesnika s tuberkulozom starosti 65 godina i više su ograničeni (n = 2).
English: QT interval prolonging medicinal products
Croatian: Lijekovi koji produljuju QT interval
English: Cases of intentional or accidental acute overdose with bedaquiline were not reported during clinical trials.
Croatian: Tijekom kliničkih ispitivanja s bedakilinom nisu bili prijavljeni slučajevi namjernog ili slučajnog akutnog predoziranja.
English: Store SIRTURO in the original container or package in order to protect it from light.
Croatian: SIRTURO čuvajte u originalnom spremniku ili pakiranju radi zaštite od svjetlosti.
English: 133-fold increases in bedaquiline MIC, resulting in MICs ranging from 0.25 to 4 mg/l.
Croatian: Ciljane mutacije razvijene u pretkliničkim ispitivanjima dovele su do od 8 do 133 puta većeg povećanja MIC-ova bedakilina, što je rezultiralo MIC-ovima u rasponu od 0,25 do 4 mg/l.
English: If you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
Croatian: Ako imate bolest nepodnošenja nekih šećera, prije nego što počnete uzimati ovaj lijek posavjetujete se sa svojim liječnikom.
English: Bedaquiline exposure may be reduced during co-administration with inducers of CYP3A4.
Croatian: Izloženost bedakilinu može biti smanjena tijekom istovremene primjene s induktorima CYP3A4.
English: Patients with MDRH&R-TB Patients infected with pre-XDR-TB Overall non-responder* at Week 120
Croatian: Bolesnici s MDRH&R-TB 39 Bolesnici inficirani s pre-XDR-TB
English: No dose adjustment is required in patients with mild or moderate renal impairment.
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem bubrega.
English: Susceptibility testing breakpoints
Croatian: Granične koncentracije ispitivanja osjetljivosti
English: Bedaquiline exposure may be increased during co-administration with inhibitors of CYP3A4.
Croatian: Izloženost bedakilinu može biti povećana tijekom istovremene primjene s inhibitorima CYP3A4.
English: Slovenská republika Johnson & Johnson s.r.o.
Croatian: Johnson & Johnson România SRL Str.
English: No relevant bedaquiline-related effects on developmental toxicity parameters were observed in rats and rabbits.
Croatian: U štakora i kunića nisu uočeni značajni učinci povezani s bedakilinom na parametre razvojne toksičnosti.
English: • The other ingredients are: colloidal anhydrous silica, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose, polysorbate 20.
Croatian: laktoza hidrat, magnezijev stearat, kukuruzni škrob, mikrokristalična celuloza, polisorbat 20.
English: Hepatic safety
Croatian: Jetrena sigurnost
English: If you forget to take SIRTURO During the first 2 weeks
Croatian: Ako ste zaboravili uzeti SIRTURO
English: SIRTURO contains the active substance bedaquiline.
Croatian: SIRTURO sadrži djelatnu tvar bedakilin.
English: QT prolongation (i.e., gatifloxacin, moxifloxacin and sparfloxacin).
Croatian: • istodobnom primjenom fluorokinolonskih antibiotika koji imaju potencijal za značajno produljenje QT intervala (npr., gatifloksacin, moksifloksacin i sparfloksacin).
English: Store in the original container or package in order to protect from light.
Croatian: Čuvati u originalnom spremniku ili pakiranju radi zaštite od svjetlosti.
English: Consideration should be given to WHO guidelines when selecting the appropriate combination regimen.
Croatian: Pri odabiru odgovarajućeg kombiniranog režima liječenja potrebno je razmotriti smjernice Svjetske zdravstvene organizacije.
English: Microcrystalline cellulose Croscarmellose sodium Silica, colloidal anhydrous Magnesium stearate
Croatian: 6.1 Popis pomoćnih tvari laktoza hidrat kukuruzni škrob hipromeloza polisorbat 20 celuloza, mikrokristalična karmelozanatrij, umrežena silicijev dioksid, koloidni, bezvodni magnezijev stearat
English: No dose-adjustment of isoniazid or pyrazinamide is required during co-administration with bedaquiline.
Croatian: Tijekom istovremene primjene s bedakilinom nije potrebna prilagodba doze izoniazida ili pirazinamida.
English: Due to the possibility of a reduction of the therapeutic effect of bedaquiline due to a decrease in systemic exposure, co-administration of bedaquiline and moderate or strong CYP3A4 inducers (e.g. efavirenz, etravirine, rifamycins including rifampicin, rifapentine and rifabutin, carbamazepine, phenytoin, St. John's wort (Hypericum perforatum)) used systemically should be avoided.
Croatian: efavirenz, etravirin, rifamicini uključujući rifampicin, rifapentin i rifabutin, karbamazepin, fenitoin, gospina trava (Hypericum perforatum) koji se primjenjuju sistemski.
English: Hepatic impairment
Croatian: • osjećaj omaglice
English: Driving and using machines You may feel dizzy after taking SIRTURO.
Croatian: Možete osjećati omaglicu nakon uzimanja lijeka SIRTURO.
English: Bedaquiline and M2 were not substrates of P-gp in vitro.
Croatian: Bedakilin i M2 nisu bili supstrati
English: d.o.o.
Croatian: IRL - Co.
English: Refer to the Summary of Product Characteristics of the medicinal products used in combination with SIRTURO for their specific dosing recommendations.
Croatian: Za specifične preporuke vezane uz doziranje tih lijekova, pogledajte Sažetak opisa svojstava lijeka koji se primjenjuje u kombinaciji s lijekom SIRTURO.
English: An improvement is usually seen within 16 weeks of treatment.
Croatian: Poboljšanje se obično može uočiti unutar 16 tjedana liječenja.
English: The dose to be used depends on the disease to be treated.
Croatian: Doza koja će se primijeniti ovisi o bolesti koja se liječi.
English: This summary was last updated in 11-2015.
Croatian: Ovaj je sažetak posljednji put ažuriran u studenom 2015.
English: Cosentyx secukinumab
Croatian: Cosentyx sekukinumab