FrancophonIA/ELRC3.0 huggingface dataset:
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).
Maltese: IIb (C208, stadju 2) ġiet osservata rata ogħla ta' imwiet fil-grupp ta' trattament b'SIRTURO (12.7%;10/79 pazjent) meta mqabbla mal-grupp ta' trattament bi plaċebo (3.7%; 3/81 pazjent).
English: Concentrations of bedaquiline in milk were 6- to12-fold higher that the maximum concentration observed in maternal plasma.
Maltese: Il-konċentrazzjonijiet ta' bedaquiline fil-ħalib kien minn 6 sa 12-il darba aktar mill-konċentrazzjoni massima osservata fil-plażma materna.
English: When bedaquiline is co-administered with other medicinal products that prolong the QTc interval (including delamanid and levofloxacin), an additive or synergistic effect on QT prolongation cannot be excluded (see section 4.5).
Maltese: Meta bedaquiline jiġi mogħti ma' prodotti mediċinali oħra li jtawwlu l-intervall ta' QTc (inklużi delamanid u levofloxacin), effett addittiv jew sinerġistiku fuq it-titwil ta' QT ma jistax jiġi eskluż (ara sezzjoni 4.5).
English: Patients received SIRTURO (n = 79) or placebo (n = 81) for 24 weeks, both in combination with a preferred 5-drug background regimen (BR) consisting of ethionamide, kanamycin, pyrazinamide, ofloxacin, and cycloserine/terizidone.
Maltese: Il-pazjenti irċevew jew SIRTURO (n = 79) jew il-plaċebo (n = 81) għal 24 ġimgħa it-tnejn f'kombinazzjoni, ma'programm ta' kura fl-isfond ta' 5 mediċini (BR) li jikkonsistu minn ethionamide, kanamycin, pyrazinamide, ofloxacin, u cycloserine/terizidone.
English: The primary outcome parameter was the time to sputum culture conversion (i.e. the interval between the first SIRTURO intake and the first of two consecutive negative liquid cultures from sputum collected at least 25 days apart) during treatment with SIRTURO or placebo (median time to conversion was 83 days for the SIRTURO group, 125 days for the placebo group (hazard ratio, 95% CI: 2.44 [1.57; 3.80]), p < 0.0001).
Maltese: Il-parametru prinċipali kien il-ħin tal-konverżjoni tal-kultura tal-isputum (i.e. l-intervall f'jiem bejn l-ewwel teħid ta' SIRTURO u l-ewwel minn żewġ kulturi likwidi konsekuttivi li rriżultaw fin-negattiv minn sputum miġbur tal-anqas f'intervall ta' 25 jum) waqt il-kura b'SIRTURO jew plaċebo (iż-żmien medjan ta' konverżjoni kienet ta' 83 jum għall-grupp ta' SIRTURO, 125 jum għall-grupp ta' plaċebo (proporzjon ta' periklu, 95 %CI: 2.44 [1.57; 3.80]), p < 0.0001).
English: ul.
Maltese: IIa.
English: Commonly susceptible species Mycobacterium tuberculosis
Maltese: Speċijiet komunament suxxetibbli Mycobacterium tuberculosis
English: For patients with full characterisation of resistance status, 76% (84/111) were infected with an MDRH&R-TB strain and 24% (27/111) with a pre-XDR-TB strain.
Maltese: Għal pazjent li kellhom iżolati bil-karatteristiċi kollha tal-istat ta' reżistenza. 76 % (84/111) kienu infettati b'razza ta' MDRH&R-TB u 24% (27/111) b'razza ta' preXDR-TB.
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.
Maltese: Fl-istudju C208 (stadju 1 u 2), żidiet fl-aminotransferase ta' mill-inqas 3x il-livell normali ta' fuq (ULN) żviluppaw aktar ta' spiss fil-grupp ta' kura b'SIRTURO (11/102 [10.8%] kontra 6/105 [5.7%]) milli fil-grupp ta' kura għall-plaċebo.
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.
Maltese: Ir-rati ta' konverżjoni f'ġimgħa 120 kienu l-ogħla (73.1%; 68/93) f'pazjenti b'MDRH&R-TB, 70.5% (31/44) f'pazjenti bi pre-XDR-TB u l-inqas (62.2%; 23/37) f'pazjenti b'XDR-TB.
English: In the SIRTURO group, no or only minor differences in time to culture conversion and culture conversion rates were observed between patients with pre-XDR-TB and patients with MDRH&R-TB.
Maltese: Fil-grupp ta' SIRTURO, ma kien hemm l-ebda differenza jew differenza minuri biss fiż-żmien għal konverżjoni ta' kultura u rati ta' konverżjoni ta' kultura kienu osservati f'pazjenti bi pre-XDR-TB u pazjenti b'MDRH&R-TB.
English: In a placebo-controlled clinical study in patients with multi-drug resistant Mycobacterium tuberculosis, no major impact of co-administration of bedaquiline on the pharmacokinetics of ethambutol, kanamycin, pyrazinamide, ofloxacin or cycloserine was observed.
Maltese: Fi studju kliniku bil-plaċebo bħala kontroll f'pazjenti b' Mycobacterium tuberculosis reżistenti għal diversi mediċini, ma ġie osservat l-ebda impatt maġġuri ta' bedaquiline fuq il-farmakokinetiċi ta' ethambutol, kanamycin, pyrazinamide, ofloxacin jew cycloserine.
English: Cmax and the area under the plasma concentration-time curve (AUC) increased proportionally up to the highest doses studied (700 mg single-dose and once daily 400 mg multiple doses).
Maltese: Cmax u ż-żona ta' taħt il-kurva tal-konċentrazzjoni tal-plażma mal-ħin (AUC) żdiedet proporzjonalment sal-ogħla dożi studjati (700 mg doża waħda u waħda kuljum ta' 400 mg f'dożi multipli).
English: Minimal inhibitory concentration (MIC) breakpoints are as follows: Epidemiological Cut-Off (ECOFF)
Maltese: Il-punti ta' riferiment a ta' konċentrazzjoni impeditorja minima (MIC) huma kif ġejjin: Riferiment Epidemjoloġiku
English: Electrocardiogram QT prolonged
Maltese: Elettrokardjogramma b'QT mtawwla
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)].
Maltese: L-għoti konġunt ta' bedaquiline u ketoconazole (impeditur ta' CYP3A4 qawwi) għal żmien qasir f'individwi b'saħħithom żied l-esponiment (AUC) għal bedaquiline bi 22% [90% CI (12; 32)].
English: • There must be at least 48 hours in between each time you take SIRTURO.
Maltese: • Għandu jkun hemm tal-anqas 48 siegħa bejn kull darba li tieħu SIRTURO.
English: Bedaquiline has not been studied in patients with severe hepatic impairment (see section 4.2).
Maltese: Bedaquiline ma ġiex studjat f'pazjenti b'indeboliment tal-fwied sever (ara sezzjoni 4.2).
English: In vitro and in vivo genotoxicity tests indicated that bedaquiline did not have any mutagenic or clastogenic effects.
Maltese: Testijiet ta' ġenotossiċità in vitro u in vivo indikaw li bedaquiline ma għandux effetti mutageniċi jew klastoġeniċi.
English: Cavitation in one lung was seen in 58% of patients, and in both lungs in 16%.
Maltese: Toqba f'wieħed mill-pulmuni ġiet osservata f'58 % tal-pazjenti, toqba fiżżewġ pulmuni kienet osservata f'16%.
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.
Maltese: Matul l-istadju ta' stħarriġ f'Fażi 2 ta' studju C208, livelli ogħla ta' aminotransferases ġew rapportati f'7/79 (8.9 %) tal-pazjenti fil-grupp ta' kura ta' SIRTURO meta mqabbla ma' 1/81 (1.2%) fil-grupp ta' kura tal-plaċebo.
English: UAB "JOHNSON & JOHNSON" Konstitucijos pr. 21C LT-08130 Vilnius Tel: +370 5 278 68 88
Maltese: LT-08130 Vilnius Tel: +370 5 278 68 88
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).
Maltese: Rapporti ta' stima tar-riskju ambjentali wrew li bedaquiline għandu l-potenzjal li jkun persistenti, bijoakkumulattiv u tossiku għall-ambjent (ara sezzjoni 6.6).
English: • latent infection with Mycobacterium tuberculosis
Maltese: • infezzjoni li ma tidhirx b'Mycobacterium tuberculosis
English: • Weeks 3-24: 200 mg (2 tablets of 100 mg) three times per week (with at least 48 hours between doses).
Maltese: • Ġimgħat 3-24: 200 mg (2 pilloli ta' 100 mg) tliet darbiet kull ġimgħa (b'tal-anqas 48 siegħa bejn id-dożi).
English: There are only limited clinical data on the efficacy of bedaquiline in HIV-infected patients not receiving antiretroviral (ARV) therapy.
Maltese: Hemm biss tagħrif kliniku ristrett dwar l-effikaċja ta' bedaquiline f'pazjenti infettati b'HIV li ma jkunux qed jirċievu terapija antiretrovirali (ARV - antiretroviral).
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.
Maltese: L-eliminazzjoni awrinarja ta' bedaquiline mhux mibdul kien ta' < 0.001% tad-doża fl-istudji kliniċi, li jindika li t-tneħħija mill-kliewi tas-sustanza attiva mhux mibdula huwa insinjifikanti.
English: In a population pharmacokinetic analysis of tuberculosis patients (age range 18 years to 68 years) treated with SIRTURO age was not found to influence the pharmacokinetics of bedaquiline.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni ta' pazjenti b'tuberkolosi (firxa ta' etajiet bejn 18-il sena sa 68 sena) ikkurati b'SIRTURO l-età ma nstabitx li kienet ser tinfluwenza l-farmakokinetiċi ta' bedaquiline.
English: 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.
Maltese: Ir-rekwiżiti għas-sottomissjoni tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornamenti sussegwenti ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
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.
Maltese: Bedaquiline jaġixxi kontra Mycobacterium tuberculosis b'konċentrazzjoni impeditorja minima (MIC) għal razez li huma sensittivi għall-mediċina kif ukoll razez reżistenti għal mediċini (reżistenti għal diversi mediċini li jinkludu razez reżistenti estensivament minn qabel għal mediċina, mediċini li jinkludu razez reżistenti estensivament għal mediċina) fil-firxa ta' ≤ 0.008-0.12 mg/l.
English: Increased transaminases
Maltese: Żieda fi transaminases
English: 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.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni ta' pazjenti bit-tuberkolosi kurati b'SIRTURO 200 mg tliet darbiet f'ġimgħa, it-tneħħija ta' kreatinina (firxa: 40 sa 227 ml/min) ma nstabitx li kienet tinfluwenza l-parametri farmakokinetiċi ta' bedaquiline.
English: Overall responder at Week 24 Patients with MDRH&R-TB Patients infected with a pre-XDR-TB Overall nonresponder* at Week 24
Maltese: Pazjenti b' MDRH&R-TB Pazjenti infettati bi pre-XDR-TB Persuni li globalment* ma rrispoondewx sa Ġimgħa 24
English: In the controlled Phase IIb study (C208), mean increases from baseline values in QTcF were observed from the first on-treatment assessment onwards (9.9 ms at week 1 for SIRTURO and 3.5 ms for placebo).
Maltese: IIb (C208), żidiet medji mill-valuri fil-linja bażi fi QTcF kienu osservati mill-ewwel analiżi ta' trattament 'il quddiem (9.9 ms f'ġimgħa 1 għal SIRTURO u 3.5 ms għallplacebo).
English: White HDPE bottle with child-resistant polypropylene (PP) closure with aluminium induction seal liner containing 188 tablets.
Maltese: Flixkun abjad ta' HDPE b'għatu tal-polypropylene (PP) reżistenti għal ftuħ mit-tfal b'inforra talaluminju siġillata b'induzzjoni li fih 188 pillola.
English: This long terminal elimination phase likely reflects slow release of bedaquiline and M2 from peripheral tissues.
Maltese: Din il-fażi ta' eliminazzjoni twila x'aktarx tirrifletti tnixxija bil-mod ta' bedaquiline u M2 mit-tessuti periferali.
English: Co-administration of bedaquiline and moderate or strong CYP3A4 inhibitors may increase the systemic exposure to bedaquiline, which could potentially increase the risk of adverse reactions (see section 4.5).
Maltese: L-għoti fl-istess waqt ta' bedaquiline u impedituri moderati jew qawwija ta' CYP3A4 jista' jżid l-esponiment sistemiku ta' bedaquiline, li potenzjalment jista' jżid ir-riskju ta' reazzjonijiet avversi (ara sezzjoni 4.5).
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).
Maltese: SIRTURO hu indikat għall-użu bħala parti minn terapija ta' kombinazzjoni għal tuberkolosi pulmonari reżistenti għal diversi mediċini (MDR-TB) f'pazjenti adulti meta programm ta' kura effettiva ma jistax jiġi kompost għal raġunijiet ta' reżistenza jew tollerabilitijiet (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: It is recommended that SIRTURO is administered by directly observed therapy (DOT).
Maltese: Huwa rakkomandat li SIRTURO jingħata b'terapija amministrata direttament (DOT).
English: Failure to convert Relapse
Maltese: Nuqqas ta' konverżjoni Irkadar
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).
Maltese: Il-firxa ta' reżistenza bażata fuq riżultati ta' testijiet dwar is-suxxetibilità ta' mediċina li saru f'laboratorju ċentrali ma kinux disponibbli għal 20 individwu fil-popolazzjoni mITT (12 fil-grupp ta' SIRTURO u 8 fil-grupp tal-plaċebo).
English: The recommended dosage is:
Maltese: Id-doża rakkomandata hija:
English: The pharmacokinetic properties of bedaquiline have been evaluated in adult healthy subjects and in adult multi-drug resistant tuberculosis-infected patients.
Maltese: Il-proprjetajiet farmakokinetiċi ta' bedaquiline ġew evalwati f'individwi adulti b'saħħithom u f'pazjenti adulti infettati b'tuberkolosi reżistenti għal diversi mediċini.
English: The elimination of bedaquiline has not been fully characterised in vivo.
Maltese: L-eliminazzjoni ta' bedaquiline ma ġiex ikkaraterizzat b'mod sħiħ in vivo.
English: Increases in transaminases or aminotransferase elevations accompanied by total bilirubin ≥ 2x ULN were seen in clinical trials during administration of SIRTURO with the background regimen (see section 4.8).
Maltese: Ġew osservati żidiet fi transaminases jew żidiet f'aminotransferase akkumpanjati minn bilirubin totali ≥ 2x limitu normali ta' fuq (ULN) fi provi kliniċi waqt l-għoti ta' SIRTURO bil-programm ta' kura fl-isfond (ara sezzjoni 4.8).
English: QT prolongation (i.e., gatifloxacin, moxifloxacin and sparfloxacin).
Maltese: • L-għoti fl-istess waqt ta' antibijotiċi ta' fluoroquinolone li għandhom potenzjal ta' titwil sinifikanti tal-QT (i.e., gatifloxacin, moxifloxacin u sparfloxacin).
English: It is therefore not expected that mild or moderate renal impairment will have a clinically relevant effect on the exposure to bedaquiline.
Maltese: Għalhekk mhux mistenni li indeboliment ħafif jew moderat ser ikollu effett klinikament rilevanti fuq l-esponiment ta' bedaquiline.
English: Resistance to bedaquiline
Maltese: Reżistenza għal bedaquiline
English: Adverse drug reactions to SIRTURO reported from controlled trials in 102 patients treated with SIRTURO are presented in the table below.
Maltese: Reazzjonijet avversi għall-mediċina għal SIRTURO rapportati minn provi kkontrollati f'102 pazjenti kkurati b'SIRTURO huma preżentati fit-tabella hawn taħt.
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.
Maltese: Fi studju ta' karċinoġeniċità fil-firien, bedaquiline, fid-dożi għoljin ta' 20 mg/kg/jum fl-irġiel u 10 mg/kg/jum fin-nisa, ma qanqal ebda żieda fl-inċidenza ta' tumuri marbuta mat-trattament.
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)].
Maltese: Fi studju ta' interazzjoni b'doża waħda kuljum ta' bedaquiline u doża waħda kuljum ta' rifampicin (sensibilizzatur qawwi) f'individwi b'saħħithom, l-esponiment (AUC) għal bedaquiline tnaqqas bi 52% [90% CI (-57; -46)].
English: Monitor symptoms and laboratory tests (ALT, AST, alkaline phosphatase, and bilirubin) at baseline, monthly while on treatment, and as needed.
Maltese: Issorvelja s-sintomi u t-testijiet tal-laboratorju (ALT, AST, alkaline phosphatase, u bilirubin) fil-linja bażi, kull xahar wara t-trattament, u kif meħtieġ.
English: Method of administration
Maltese: Mekkaniżmi ta' reżistenza
English: • infections due to mycobacterial species other than Mycobacterium tuberculosis
Maltese: • infezzjonijiet dovuti għal speċji mikobatteriċi li mhumiex Mycobacterium tuberculosis
English: These lead to 2- to 8-fold increases in bedaquiline MICs, resulting in bedaquiline MICs ranging from 0.25 to 0.5 mg/l.
Maltese: Dawn wasslu għal żidiet għal darbtejn sa 8 darbiet l-MIC ta' bedaquiline li rriżulta fl-MIC ta' bedaquiline jvarja minn 0.25 sa 0.50 mg/l.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fissezzjoni 6.1
English: Extensively drug resistant tuberculosis (XDR-TB): isolate resistant to isoniazid, rifampicin, any fluoroquinolone, and at least one second line injectable agent.
Maltese: Tuberkulosi reżistenti b'mod estensiv għal mediċini (XDR-TB): iżolat reżistenti għal isoniazid, rifampicin, xi fluoroquinolone, u tal-anqas sustanza injetabbli tat-tieni linja ta' preferenza.
English: This medicine may pose a risk to the environment.
Maltese: Din il-mediċina tista' tkun ta' riskju għall-ambjent.
English: The plasma bedaquiline exposure (AUC) in rats and dogs was similar to that observed in humans.
Maltese: L-esponiment ta' bedaquiline fil-plażma (AUC) fil-firien u l-klieb kien simili għal dak osservat fil-bniedem.
English: No structural abnormalities in the testes and epididymides were seen after up to 6-months of bedaquiline treatment.
Maltese: Ma ġew osservati l-ebda abnormalità fit-testikoli u l-epididimide sa perijodu ta' 6 xhur ta' kura bi bedaquiline.
English: SIRTURO has mainly been studied in patients with normal renal function.
Maltese: SIRTURO ġie studjat prinċipalment f'pazjenti b'funzjoni tal-kliewi normali.
English: Cardiovascular
Maltese: Artralġja
English: • A personal or family history of congenital QT prolongation;
Maltese: • Storja personali jew familjari ta' titwil konġenitali ta' QT;
English: Twenty-four of these 24-week responders (14.7%) were considered non-responders at week 120, of which 19 patients had prematurely discontinued the trial while being culture converted and 5 patients had experienced relapse.
Maltese: Erbgħaugħoxrin minn fost dawk li rrispondew wara 24 ġimgħa (14.7%) kienu kkonsidrati bħala li ma rrispondewx f'ġimgħa 120, li minnhom 19-il pazjent kienu waqfu minn qabel il-prova waqt li kienu qed jiġu konvertiti f'kultura u 5 pazjenti kienu esperjenzaw irkadar.
English: The intracellular bactericidal activity of bedaquiline in primary peritoneal macrophages and in a macrophage-like cell line was greater than its extracellular activity.
Maltese: L-attività intraċellulari batteriċida ta' bedaquiline f'makrofaġi peritoneali primarji u f'razza ċellulari bħal ta' makrofaġi kienet akbar mill-attività ekstraċellulari.
English: The mean terminal elimination half-life of both bedaquiline and the active N-monodesmethyl metabolite (M2) is about 5 months (ranging from 2 to 8 months).
Maltese: Il-half-life ta' eliminazzjoni terminali medja ta' bedaquiline u l-metabolit attiv Nmonodesmethyl (M2) huwa ta' madwar 5 xhur (li tvarja minn 2 sa 8 xhur).
English: • abnormal reading on the electrocardiogram called “QT prolongation”.
Maltese: • reġistrazzjoni abnormali tal-elettrokardjogramma li tissejjaħ ‘titwil ta' QT”.
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.
Maltese: Pazjenti li rċevew SIRTURO waħdu u l-ebda prodott mediċinali ieħor li ttawwal il-QT żviluppaw QTcF medju massimu ogħla fuq il-linja bażi ta' 23.7 ms mingħajr ebda tul żejjed minn 480 ms, filwaqt li pazjenti b'tal-anqas 2 prodotti mediċinali oħra li jtawwlu l-QT żviluppaw QTcF medju massimu ta' 30.7 ms fuq il-linja bażi, li rriżulta f'aktar minn 500 ms f'pazjent wieħed.
English: Bedaquiline was associated with effects in target organs which included monocytic phagocytic system (MPS), skeletal muscle, liver, stomach, pancreas and heart muscle.
Maltese: Bedaquiline kien assoċjat ma' effetti f'organi bersalljati li kienu jinkludu s-sistema fagoċitika monoċitika (MPS), il-muskoli skeletriċi, il-fwied, l-istonku, il-frixa u lmuskolu tal-qalb.
English: 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
Maltese: Peress li din hi Awtorizzazzjoni għat-Tqegħid fis-Suq kondizzjonali u skont l-Artikolu 14(7) tar-Regolament (KE) 726/2004, l-MAH għandu jtemm, fiż-żmien stipulat, il-miżuri li ġejjin:
English: Bedaquiline was a weak OCT1, OATP1B1 and OATP1B3 substrate in vitro, while M2 was not.
Maltese: Bedaquiline kien sottostrat dgħajjef in vitro ta' OCT 1, OATP1B1 u OATP1B3, filwaqt li M2 ma kienx.
English: There is limited clinical data (n = 2) on the use of SIRTURO in tuberculosis patients aged 65 years and older.
Maltese: Hemm tagħrif kliniku ristrett (n = 2) dwar l-użu ta' SIRTURO f'pazjenti b'tuberkolosi li għandhom 65 sena u aktar.
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.
Maltese: Il-metabolit Nmonodesmethyl (M2) mhux maħsub li jikkontribwixxi b'mod sinifikanti għall-effikaċja klinika minħabba l-esponiment medju aktar baxx (23% sa 31%) fil-bniedem u l-attività antimikobatterika aktar baxxa (minn 3 sa 6 darbiet aktar baxxa) meta mqabbla mal-kompost ewlieni.
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.
Maltese: Pillola mhux miksija, bajda għal kważi bajda mżaqqa fuq żewġ naħat, 11-il mm f'dijametru, b'"T" intaljata fuq "207" fuq naħa waħda u "100" fuq in-naħa l-oħra.
English: In the Phase IIb, open label study (C209), where patients with no treatment options received other QTprolonging medicinal products used to treat tuberculosis, including clofazimine, concurrent use with SIRTURO resulted in additive QT prolongation, proportional to the number of QT prolonging medicinal products in the treatment regimen.
Maltese: IIb, bit-tikketta tingħaraf (C209), fejn pazjenti mingħajr għażliet ta' kura rċevew prodotti mediċinali oħra li jtawwlu l-QT użati fil-kura tat-tuberkolosi, li jinkludu clofazimine, l-użu fl-istess waqt ta' SIRTURO rriżulta f'titwil addittiv ta' QT, b'mod proporzjonali għall-għadd ta' prodotti mediċinali li jtawwlu l-QT fil-programm ta' kura.