FrancophonIA/ELRC3.0 huggingface dataset:
English: Other rare serious side effects (which may affect up to 1 in 1,000 people) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (a serious skin condition).
Maltese: Effetti sekondarji serji rari oħra (li jistgħu jaffettwaw sa persuna 1 minn kull 1,000) jinkludu nuqqas tal-mudullun milli jipproduċi ċelloli tad-demm, disturb tan-nervituri, lupus u kundizzjonijiet simili għallupus (meta s-sistema immuni tattakka t-tessuti tal-pazjent innifsu, b'hekk tikkawża infjammazzjoni u ħsara fl-organi), u s-sindrome ta' Stevens-Johnson (kundizzjoni serja tal-ġilda).
English: This is a summary of the European public assessment report (EPAR) for Cyltezo.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Cyltezo.
English: The active substance in Cyltezo, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF).
Maltese: Is-sustanza attiva f'Cyltezo, adalimumab, hija antikorp monoklonali (tip ta' proteina) li tfassal biex jagħraf u jeħel ma' sustanza fil-ġisem imsejħa fattur ta' nekrożi tumorali (TNF, tumour necrosis factor).
English: Laboratory studies comparing Cyltezo with Humira have shown that the active substance in Cyltezo is highly similar to that in Humira in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li jqabblu Cyltezo ma' Humira wrew li s-sustanza attiva f'Cyltezo hija simili ħafna għal dik f'Humira f'termini ta' struttura, purità u attività bijoloġika.
English: For more information on
Maltese: infjammazzjoni;
English: In addition, a study involving 645 patients with moderate or severe rheumatoid arthritis who were also taking methotrexate confirmed that Cyltezo and Humira have similar effectiveness.
Maltese: Barra minn hekk, studju li involva 645 pazjent b'artrite rewmatojde moderata jew severa li kienu qed jieħdu wkoll methotrexate kkonfermaw li Cyltezo u Humira għandhom effettività simili.
English: The most common side effects with adalimumab (seen in more than 1 patient in 10) are infections (including in the nose, throat and sinuses), injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain.
Maltese: L-effetti sekondarji l-aktar komuni b'adalimumab (li dehru f'aktar minn pazjent 1 minn kull 10) huma infezzjonijiet (inkluż dawk fl-imnieħer, fil-griżmejn u fis-sinus), reazzjonijiet fis-sit tal-injezzjoni (ħmura, ħakk, fsada, uġigħ jew nefħa), uġigħ ta' ras u uġigħ fil-muskoli u fl-għadam.
English: What are the risks associated with Cyltezo?
Maltese: X'inhuma r-riskji assoċjati ma' Cyltezo?
English: • axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when X-ray does not show disease but there are clear signs of inflammation;
Maltese: • spondiloartrite assjali (infjammazzjoni tas-sinsla tad-dahar li tikkawża wġigħ fid-dahar), inkluż spondilite ankilożanti u fejn ir-raġġi X ma jurux mard iżda jkun hemm sinjali ċari ta'
English: This means that Cyltezo is highly similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU).
Maltese: Dan ifisser li Cyltezo huwa simili għal mediċina bijoloġika (magħrufa wkoll bħala l-‘mediċina ta' referenza') li diġà hija awtorizzata flUnjoni Ewropea (UE).
English: For the full list of side effects and restrictions with Cyltezo, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Cyltezo, ara l-fuljett ta' tagħrif.
English: • ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);
Maltese: • kollite ulċerattiva (marda li tikkawża infjammazzjoni u ulċeri fir-rita tal-imsaren);
English: These packs will include information on the safety of the medicine.
Maltese: Għal aktar informazzjoni dwar il-mediċini bijosimili, ara hawn.
English: Studies have also shown that giving Cyltezo produces similar levels of the active substance in the body to giving Humira.
Maltese: L-istudji wrew ukoll li l-għoti ta' Cyltezo jipproduċi livelli simili tas-sustanza attiva fil-ġisem bħall-għoti ta' Humira.
English: All these data were considered sufficient to conclude that Cyltezo will behave in the same way as Humira in terms of effectiveness and safety in its approved uses.
Maltese: Din id-data kollha ġiet meqjusa biżżejjed sabiex jiġi konkluż li Cyltezoser jaġixxi bl-istess mod bħal Humira f'termini ta' effettività u sigurtà fl-użu approvat tiegħu.
English: Like other medicines of its class, Cyltezo may affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab.
Maltese: Bħal mediċini oħra tal-klassi tiegħu, Cyltezo jista' jaffettwa l-abbiltà tas-sistema immuni li tiġġieled linfezzjonijiet u l-kanċer, u kien hemm xi każijiet ta' infezzjonijiet serji u kanċers tad-demm f'pazjenti li kienu qed jużaw adalimumab.
English: In addition, a study in rheumatoid arthritis has shown that the effects of the medicine are equivalent to those of Humira in this condition.
Maltese: Barra minn hekk, studju fl-artrite rewmatojde wera li l-effetti tal-mediċina huma ekwivalenti għal dawk ta' Humira f'din il-kondizzjoni.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Cyltezo has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċiediet li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Cyltezo wera li għandu struttura, purità u attività bijoloġika simili ħafna għal Humira u jiġi distribwit bl-istess mod fil-ġisem.
English: By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.
Maltese: Meta jeħel mat-TNF, adalimumab jimblokka l-attività tiegħu, u b'hekk inaqqas l-infjammazzjoni u sintomi oħra tal-mard.
English: The company that markets Cyltezo must provide educational packs for doctors who prescribe the medicine.
Maltese: Dawn il-pakketti ser jinkludu informazzjoni dwar is-sigurtà tal-mediċina.
English: Because Cyltezo is a biosimilar medicine, the studies on effectiveness and safety of adalimumab carried out with Humira do not all need to be repeated for Cyltezo.
Maltese: Peress li Cyltezo huwa mediċina bijosimili, l-istudji dwar l-effettività u s-sigurtà ta' adalimumab li saru b'Humira m'għandhomx bżonn jiġu ripetuti kollha għal Cyltezo.
English: For further information, see the package leaflet.
Maltese: Ser tingħata wkoll kard ta' twissija lill-pazjenti.
English: What benefits of Cyltezo have been shown in studies?
Maltese: Għaliex ġie approvat Cyltezo?
English: It may harm them,
Maltese: Generu sesswali
English: Culture Conversion Status, n (%)
Maltese: Stat ta' Konverżjoni ta' Kultura, n (%)
English: 188 tablets
Maltese: 188 pillola
English: Table 1: Culture conversion Status
Maltese: Tabella 1: Stat ta' Konverżjoni ta' Kultura
English: 6 cells/l (N = 22; see section 4.5).
Maltese: 6 celluli/l (N = 22; ara sezzjoni 4.5).
English: Bedaquiline is a diarylquinoline.
Maltese: Bedaquiline huwa diarylquinoline.
English: System Organ Class (SOC) Frequency Category
Maltese: Sistema tal-Klassifika tal-Organi (SOC)
English: • Final analysis - Clinical Study Report 4Q 2023
Maltese: • Analiżi finali - Rapport talIstudju Kliniku 4K 2023.
English: • The active substance is bedaquiline.
Maltese: • Is-sustanza attiva hi bedaquiline.
English: Microcrystalline cellulose Croscarmellose sodium Silica, colloidal anhydrous Magnesium stearate
Maltese: Microcrystalline cellulose Croscarmellose sodium Silica, kollojdali anidru Magnesium stearate
English: Placebo/BR
Maltese: Plaċebo/BR
English: • extra-pulmonary tuberculosis (e.g. central nervous system, bone)
Maltese: • tuberkolosi ekstrapulmonari (eż. is-sistema nervuża ċentrali, għadam)
English: • A history of Torsade de Pointes;
Maltese: • Storja ta' Torsade de Pointes;
English: Medicine (name of the active substance)
Maltese: Medicina (isem tassustanza attiva)
English: Patients infected with human immunodeficiency virus (HIV)
Maltese: Pazjenti infettati bil-virus ta' immunodefiċjenza umana (HIV)
English: • The other ingredients are: colloidal anhydrous silica, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose, polysorbate 20.
Maltese: • Is-sustanzi l-oħra huma: colloidal anhydrous silica, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose, polysorbate 20.
English: A final evaluation was conducted at Week 120.
Maltese: Evalwazzjoni finali saret f'Ġimgħa 120.
English: A plastic bottle containing 188 tablets.
Maltese: Flixkun tal-plastik li fih 188 pillola.
English: SIRTURO contains “lactose” (a type of sugar).
Maltese: SIRTURO fih “lactose” (tip ta' zokkor).
English: S = susceptible R = resistant
Maltese: S = suxxetibbli R = reżistenti
English: Lactose intolerance and lactase deficiency
Maltese: Intolleranza għal lactose u defiċjenza ta' lactase
English: SIRTURO is a type of antibiotic.
Maltese: SIRTURO huwa tip ta' antibijotiku.
English: 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.
Maltese: In vitro, bedaquiline ma jimpedixxix b'mod sinifikanti l-attività ta' xi wieħed mill-enzimi ta' CYP450 ittestjati (CYP1A2, CYP2A6, CYP2C8/9/10, CYP2C19, CYP2D6, CYP2E1, CYP3A4, CYP3A4/5 u CYP4A) u ma jinduċix l-attivitajiet ta' CYP1A2, CYP2C9, jew CYP2C19.
English: • QT interval as corrected by the Fridericia method (QTcF) > 450 ms (confirmed by repeat electrocardiogram);
Maltese: • Intervall ta' QT kif ikkoreġut bil-metodu Fridericia (QTcF) > 450 ms (ikkonfermat b'ripetizzjoni ta' elettrokardjogramma);
English: • you have human immunodeficiency virus (HIV) infection.
Maltese: • għandek infezzjoni minn virus ta' immunodefiċjenza umana (HIV).
English: SIRTURO contains lactose monohydrate
Maltese: SIRTURO fih lactose monohydrate
English: Inherently resistant organisms Mycobacterium xenopi Mycobacterium novocastrense Mycobacterium shimoidei Non-mycobacterial species
Maltese: Organiżmi reżistenti inerenti Mycobacterium xenopi Mycobacterium novocastrense Mycobacterium shimoidei Speċi mhux mikobatteriċi
English: Bedaquiline and M2 did not inhibit the transporters P-gp, OATP1B1, OATP1B3, BCRP, OAT1, OAT3, OCT1, OCT2, MATE1 and MATE2 at clinically relevant concentrations in vitro.
Maltese: Bedaquiline ma kienx sottostrat ta' MRP2 u BCRP in vitro, Bedaquiline u M2 ma impedixxux it-trasportaturi P-gp, OATP1B1, OATP1B3, BCRP, OAT1, OAT3, OCT1, OCT2, MATE1 u MATE2 f'konċentrazzjonijiet klinikament rilevanti in vitro.
English: Bedaquiline is metabolised by CYP3A4.
Maltese: Bedaquiline jiġi metabolizzat b'CYP3A4.
English: There were no documented cases of Torsade de Pointes in the safety database (see section 4.4).
Maltese: Ma kien hemm l-ebda każ dokumentat ta' Torsade de Pointes fid-database tas-sigurtà (ara sezzjoni 4.4).
English: SIRTURO 100 mg tablets
Maltese: SIRTURO 100 mg pilloli
English: From week 3 to week 24:
Maltese: Minn ġimgħa 3 sa ġimgħa 24:
English: • Clinically significant ventricular arrhythmia
Maltese: • Arritimija ventrikulari klinikament sinifikanti
English: Take the medicine pack with you.
Maltese: Ħu pakkett tal-mediċina miegħek.
English: This study included patients of all three resistance categories (MDRH&R-, pre-XDR- and XDR-TB).
Maltese: Dan lis-studju inkluda pazjenti reżistenti ghal kull 3 tipi ta' kategoriji (MDRH&R-, pre-XDR- and XDR-TB).
English: Mortality
Maltese: Mortalità
English: Frequency categories are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Maltese: Il-kategoriji ta' frekwenza huma mfissra bħala: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100).
English: SIRTURO 100 mg tablets bedaquiline
Maltese: SIRTURO 100 mg pilloli bedaquiline
English: Renal excretion of unchanged bedaquiline is insignificant (< 0.001%).
Maltese: L-eliminazzjoni millkliewi ta' bedaquiline mhux mibdul hi insinifikanti (< 0.001%).
English: SIRTURO contains the active substance bedaquiline.
Maltese: SIRTURO fih is-sustanza attiva bedaquiline.
English: Bedaquiline and M2 were not substrates of P-gp in vitro.
Maltese: Bedaquiline u M2 ma kinux sottostrati ta' P-gp in vitro.
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%).
Maltese: 0% ta' pazjenti) waqt il-kura b'SIRTURO fil-provi kliniċi kkontrollati kienu dardir (35.3% fil-grupp ta' SIRTURO kontra 25.7% fil-grupp tal-plaċebo), artralġja (29.4% kontra 20.0%), uġigħ ta' ras (23.5% vs 11.4%), remettar (20.6% kontra 22.9%) u stordament (12.7% kontra 11.4%).
English: • A QTcF interval of > 500 ms (confirmed by repeat electrocardiogram).
Maltese: • Intervall ta' QTcF ta' > 500 ms (ikkonfermat b'ripetizzjoni tal-elettrokardjogramma).
English: Tablets packaged in: - aluminium/aluminium foil blisters: 3 years - white high density polyethylene (HDPE) bottles: 3 years
Maltese: Pilloli ppakkjati: - f'folji tal-fojl tal-aluminju/aluminju: 3 snin - fi fliexken bojod tal-polyethylene b'densità għolja (HDPE - high density polyethylene): 3 snin
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)].
Maltese: Fi studju ta' interazzjoni b'doża waħda ta' bedaquiline u doża multipli ta' lopinavir/ritonavir, l-esponiment (AUC) għal bedaquiline żdied bi 22% [90% CI (11; 34)].
English: Overall responder at Week 120
Maltese: Rispons globali sa Ġimgħa 120
English: Pharmacotherapeutic group: Antimycobacterials, drugs for treatment of tuberculosis, ATC code: J04AK05
Maltese: Kategorija farmakoterapewtika: Antimikobatteriċi, mediċini għall-kura tat-tuberkolosi, Kodiċi ATC:
English: (antimycobacterial) carbamazepine, phenytoin to treat epileptic fits (anticonvulsants) St. John's wort (Hypericum perforatum)
Maltese: (antimikobatterjali) carbamazepine, phenytoin sabiex jiġu trattati aċċessjonijiet epilettiċi (antikonvulsanti)
English: Each tablet contains bedaquiline fumarate equivalent to 100 mg bedaquiline.
Maltese: Kull pillola fiha bedaquiline fumarate ekwivalenti għal 100 mg bedaquiline.
English: Bedaquiline specifically inhibits mycobacterial ATP (adenosine 5'-triphosphate) synthase, an essential enzyme for the generation of energy in Mycobacterium tuberculosis.
Maltese: Bedaquiline jimpedixxi speċifikament l-ATP (adenosine 5'-triphosphate) synthase tal-majkobatterja, enzima essenzjali għall-ġenerazzjoni ta' enerġija f' Mycobacterium tuberculosis.
English: The plasma protein binding of the N-monodesmethyl metabolite (M2) in humans is at least 99.8%.
Maltese: Ir-rabta mal-proteini fil-plażma tal-metabolit N-monodesmethyl (M2) fil-bniedem hi talanqas 99.8%.
English: • Hypokalemia
Maltese: • Ipokalemija
English: • Weeks 1-2: 400 mg (4 tablets of 100 mg) once daily
Maltese: • Ġimgħat 1-2: 400 mg (4 pilloli ta' 100 mg) darba kuljum
English: At week 120, sputum culture conversion was seen in 148/205 (72.2%) patients.
Maltese: Fil-ġimgħa 120, il-konverżjoni ta' kultura ta' sputum ġiet osservata f'148/205 (72.2%) pazjenti.
English: SIRTURO contains lactose.
Maltese: SIRTURO fih lactose.
English: There is limited information available on the potential for a pharmacodynamic interaction between bedaquiline and medicinal products that prolong the QT interval.
Maltese: Hemm informazzjoni limitata disponibbli dwar il-potenzjal għal interazzjoni farmakodinamika bejn bedaquiline u prodotti mediċinali li jtawwlu l-intervall ta' QT.
English: Walterovo náměstí 329/1 CZ158 00 Praha 5 - Jinonice Tel: +420 227 012 227
Maltese: CZ-158 00 Praha 5 - Jinonice Tel: +420 227 012 227
English: Mycobacterium xenopi, Mycobacterium novocastrense, Mycobacterium shimoidei and non-mycobacterial species are considered inherently resistant to bedaquiline.
Maltese: Mycobacterium xenopi, Mycobacterium novocastrense, Mycobacterium shimoidei u speċi mhux mikobatteriċi huma kkonsidrati reżistenti b'mod inerenti għal bedaquiline.
English: • Take 400 mg (4 tablets of 100 mg) once a day.
Maltese: • Ħu 400 mg (4 pilloli ta' 100 mg) darba kuljum.
English: A Phase IIb, placebo-controlled, double-blind, randomised trial (C208) evaluated the antibacterial activity, safety, and tolerability of SIRTURO in newly diagnosed patients with sputum smear-positive pulmonary MDRH&R- and pre-XDR-TB.
Maltese: IIb, ikkontrollata bi plaċebo, u double-blind, (C208) evalwat l-attività antibatterika, is-sigurtà, u t-tollerabilità ta' SIRTURO f'pazjenti li jkunu għadhom kif ġew dijanjozzati b'MDRH&R- u pre-XDR-TB minn msiħ pulmonari pożittiv minn sputum.
English: • you have a personal or family history of a heart problem called “congenital long QT syndrome”;
Maltese: • inti għandek storja personali jew familjari ta' problemi tal-qalb li tissejjaħ “sindromu konġenitali ta' QT twila”;
English: Do not take SIRTURO if:
Maltese: Tiħux SIRTURO:
English: Date of first authorisation: 5 March 2014 Date of latest renewal: 11 January 2019
Maltese: Data tal-aħħar tiġdid: 11 ta' Jannar 2019
English: Bedaquiline and M2 are not substrates or inhibitors of P-glycoprotein.
Maltese: Bedaquiline u M2 mhumiex sottostrati jew impedituri ta' P-glycoprotein.
English: CYP3A4 is the major CYP isoenzyme involved in vitro in the metabolism of bedaquiline and the formation of the N-monodesmethyl metabolite (M2).
Maltese: CYP3A4 huwa l-isoenzim prinċipali involut in vitro fil-metaboliżmu ta' bedaquiline u l-formazzjoni tal-metabolit N-monodesmethyl (M2).
English: Bedaquiline is also bactericidal against dormant (non-replicating) tubercle bacilli.
Maltese: Bedaquiline huwa wkoll batteriċida kontra baċilli tuberkli rieqda (mhux li qed jirreplikaw).
English: At week 24, sputum culture conversion was seen in 163/205 (79.5%) patients.
Maltese: Fil-ġimgħa 24, il-konverżjoni ta' kultura ta' sputum ġiet osservata f'163/205 (79.5%) pazjent.
English: Hepatic safety
Maltese: Sigurtà epatika
English: A single-dose study of SIRTURO in 8 subjects with moderate hepatic impairment (Child-Pugh B) demonstrated exposure to bedaquiline and M2 (AUC672h) was 19% lower compared to healthy subjects.
Maltese: Studju ta-għoti ta' doża waħda ta' SIRTURO fi 8 individwi b'indeboliment tal-fwied moderat (ChildPugh B), l-esponiment għal bedaquiline u M2 (AUC672h) kien ta' 19% inqas meta mqabbel ma' individwi b'saħħithom.
English: In the MPS of all species, pigment-laden and/or foamy macrophages were also seen in various tissues, consistent with phospholipidosis.
Maltese: Fl-MPS ta' kull speċi, ġew osservati pigments u/jew makrofaġi bil-fowm f'tessuti diversi, konsistenti ma' fosfolipidosi.
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.
Maltese: Rati ta' konverżjoni f'ġimgħa 24 kienu l-ogħla (87.1%; 81/93) f'pazjenti b'MDRH&R-TB, 77.3% (34/44) fi pre-XDR-TB u l-inqas (54.1%; 20/37) ) f'pazjenti b'XDR-TB.
English: Transaminases increased*
Maltese: Żieda fit-transaminases*
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.
Maltese: Minħabba l-possibilità ta' tnaqqis fl-effett terapewtiku ta' bedaquiline minħabba tnaqqis fl-esponiment sistemiku, l-għoti konġunt ta' bedaquiline u indutturi moderati jew qawwija ta' CYP3A4 (eż. efavirenz, etravirine, rifamycins li jinkludi rifampicin, rifapentine u rifabutine, carbamazepine, phenytoin, St.
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.
Maltese: Fi studju ta' interazzjoni bejn bedaquiline u ketoconazole, effett akbar fuq il-QTc kien osservat wara dożi ripetuti bi bedaquiline u ketoconazole f'kombinazzjoni milli wara dożi ripetuti bil-prodotti mediċinali individwali.
English: Follow-up monitoring of electrolytes should be performed if QT prolongation is detected (see sections 4.5 and 4.8).
Maltese: Monitoraġġ ta' elettroliti għandu jsir jekk it-titwil tal-QT jiġi osservat (ara sezzjonijiet 4.5 u 4.8).
English: Due to the potential risk of adverse reactions due to an increase in systemic exposure, prolonged co-administration of bedaquiline and moderate or strong CYP3A4 inhibitors (e.g. ciprofloxacin, erythromycin, fluconazole, clarithromycin, ketoconazole, ritonavir) used systemically for more than 14 consecutive days should be avoided.
Maltese: Minħabba r-riskju potenzjali ta' reazzjonijiet avversi dovuti għal żieda flesponiment sistemiku, it-teħid prolongat ta' bedaquiline u impedituri moderati jew qawwija ta' CYP3A4 (eż. ciprofloxacin, erythromycin, fluconazole, clarithromycin, ketoconazole, ritonavir) użati sistemikament għal aktar minn 14-il jum għandu jiġi evitat.
English: Each tablet contains 145 mg of lactose (as monohydrate).
Maltese: Eċċipjent b'effett magħruf Kull pillola fiha 145 mg ta' lactose (bħala monoidrat).
English: Other medicines and SIRTURO
Maltese: Mediċini oħra u SIRTURO
English: Clinical Breakpoints
Maltese: Punti ta' riferiment kliniku
English: Patients with MDRH&R-TB Patients infected with pre-XDR-TB Overall non-responder* at Week 120
Maltese: MDRH&R-TB Pazjenti infettati bi pre-XDR-TB Persuni li globalment* ma rrispondewx sa Ġimgħa 120
English: efavirenz, etravirine, lopinavir/ritonavir to treat HIV infection (antiretroviral non-nucleoside reverse transcriptase inhibitors, antiretroviral protease inhibitors)
Maltese: (antimikobatterjali) ketoconazole, fluconazole sabiex jiġu kkurati infezzjonijiet tal-moffa (antifungali) efavirenz, etravirine, lopinavir/ritonavir sabiex jiġu kkurati infezzjonijiet ta' HIV(impedituri mhux nukleosidi ta' reverse transcriptase antiretrovirali, impedituri ta' protease antiretrovirali)
English: Main demographics were as follows: 63.1% were males, median age 34 years, 35% were Black, and 15% were HIV positive.
Maltese: Id-demografiji ewlenin kienu kif ġej: 63.1% kienu rġiel, età medjana ta' 34 sena, 35% kienu Suwed, u 15% kienu pożittivi għal virus ta' immunodefiċjenza umana.
English: In the mouse model for TB infection, bedaquiline has demonstrated bactericidal and sterilizing activities.
Maltese: F'mudell tal-ġurdien għal infezzjoni bit-TB, bedaquiline wera attivitajiet batteriċida u sterilizzanti.
English: 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.
Maltese: Meta disponibbli, il-laboratorju mikrobijoloġiku kliniku għandu jipprovdi lit-tabib bir-riżultati ta' testijiet ta' suxxetibilità in vitro għal prodotti mediċinali antimikrobijali użati fi sptarijiet residenti bħala rapporti perjodiċi li jiddiskrivu l-profil ta' suxxetibilità ta' patoġeni nosokomijali u dawk akwiżiti mill-komunità.