FrancophonIA/ELRC3.0 huggingface dataset:
English: Anticonvulsants: carbamazepine, phenobarbital, phenytoin
Maltese: Mediċini kontra lkonvulżjoni: carbamazepine, phenobarbital, phenytoin
English: Anti-mycobacterials: rifabutin, rifampicin*, rifapentine
Maltese: Antimikobatterjali: rifabutin, rifampicin*,
English: Consume it completely.
Maltese: Ikkonsmah kompletament.
English: People with the mutation will produce an abnormal CFTR protein.
Maltese: Nies bil-mutazzjoni se jipproduċu proteina CFTR anormali.
English: Mean (SD)
Maltese: (SD)
English: Number of pulmonary exacerbations through Week 24
Maltese: Numru ta' aggravamenti pulmonari sa Ġimgħa 24
English: Corticosteroids, systemic: methylprednisolone, prednisone
Maltese: Kortikosterojdi sistemiċi: methylprednisolone, prednisone
English: Lumacaftor and ivacaftor
Maltese: Lumacaftor u ivacaftor
English: Hormonal contraceptives: ethinyl estradiol, norethindrone, and other progestogens
Maltese: Kontraċettivi ormonali: ethinyl estradiol, norethindrone, u progestogens oħrajn
English: Lumacaftor and ivacaftor are not inhibitors of OATP1B1, OATP1B3, and organic cation transporter (OCT) 1 and 2.
Maltese: Lumacaftor u ivacaftor mhumiex inibituri ta' OATP1B1, OATP1B3, u tat-trasportatur ketajoniku organiku (OCT) 1 u 2.
English: • Printing ink: shellac; iron oxide black (E172); propylene glycol; and ammonium hydroxide.
Maltese: • Linka tal-istampar: shellac; iron oxide black (E172); propylene glycol; u ammonium hydroxide
English: Respiratory Domain Score (points)‡
Maltese: Respiratorju (punti)‡
English: Orkambi granules are packaged in a foil laminate [biaxially-oriented polyethylene terephthalate/polyethylene/foil/polyethylene (BOPET/PE/Foil/PE)] sachet.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Il-granijiet ta' Orkambi huma ppakkjati f'qartas illaminat bil-fojl [polyethylene terephthalate orjentat biassjalment/polyethylene/fojl/polyethylene (BOPET/PE/Fojl/PE)].
English: 14 sachets
Maltese: 14-il qartas
English: INFORMATION IN BRAILLE Orkambi 150 mg, 188 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Orkambi 150 mg, 188 mg
English: Cellulose, microcrystalline Croscarmellose sodium Hypromellose acetate succinate Povidone (K30) Sodium laurilsulfate Magnesium stearate
Maltese: Qalba tal-pillola Cellulose, microcrystalline Croscarmellose sodium Hypromellose acetate succinate Povidone (K30) Sodium laurilsulfate Magnesium stearate
English: Age, weight
Maltese: Età, piż
English: Lumacaftor is approximately 99% bound to plasma proteins, primarily to albumin.
Maltese: Lumacaftor jeħel madwar 99% mal-proteini tal-plażma, primarjament mal-albumina.
English: Pooled (Trial 1 and Trial 2)
Maltese: Miġbura (Prova 1 u Prova 2)
English: Mean ivacaftor (SD) AUCss (μg/mL*h)
Maltese: Medja ta' ivacaftor (SD) AUCss (μg/mL*h)
English: Mean lumacaftor (SD) AUCss (μg/mL*h)
Maltese: Medja ta' lumacaftor (SD) AUCss (μg/mL*h)
English: Proton pump inhibitors: esomeprazole, lansoprazole, omeprazole
Maltese: esomeprazole, lansoprazole, omeprazole
English: Benzodiazepines: midazolam, triazolam ↔ LUM, IVA
Maltese: midazolam, triazolam ↔ LUM, IVA
English: Interim Analysis: December 2022
Maltese: Diċembru 2022
English: • Antibiotic medicines (used for the treatment of bacterial infections) for example: telithromycin, clarithromycin, rifampicin, rifabutin, rifapentine, erythromycin
Maltese: • Mediċini antibijotiċi (jintużaw għall-kura ta' infezzjonijiet batterjali) pereżempju: telithromycin, clarithromycin, rifampicin, rifabutin, rifapentine, erythromycin
English: † 1 patient out of 738 ‡ 2 patients out of 738
Maltese: 2 pazjenti minn 738
English: Immunosuppressants: ciclosporin, everolimus, sirolimus, tacrolimus (used after organ transplant)
Maltese: Immunosoppressanti: ciclosporin, everolimus, sirolimus, tacrolimus (użati wara trapjant ta' organu)
English: Brilliant blue FCF aluminium lake (E133) Indigo carmine aluminium lake (E132)
Maltese: Brilliant blue FCF aluminium lake (E133)
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D barcode 2D li jkollu l­identifikatur uniku inkluż.
English: CYP2B6 and CYP2C substrates
Maltese: Substrati ta' CYP2B6 u CYP2C
English: Hypromellose acetate succinate
Maltese: Hypromellose acetate succinate Povidone (K30)
English: Ivacaftor is approximately 99% bound to plasma proteins, primarily to alpha 1-acid glycoprotein and albumin.
Maltese: Ivacaftor jeħel madwar 99% mal-proteini tal-plażma, primarjament ma' alpha 1-acid glycoprotein u mal-albumina.
English: Results from Trial 3 are presented in Figure 1 and Table 6.
Maltese: Ir-riżultati minn Prova 3 huma ppreżentati f'Figura 1 u Tabella 6.
English: Placebo (n = 371)
Maltese: Plaċebo (n=371)
English: Active substance name Effect
Maltese: Isem tas-sustanza attiva Effett
English: Inducers of CYP3A
Maltese: Indutturi ta' CYP3A
English: • Risk Management Plan (RMP)
Maltese: • Pjan tal-Ġestjoni tar-Riskju(RMP)
English: (μg/mL*h)
Maltese: (FE‑1) (µg/g)**
English: During Trials 1 and 2, the incidence of maximum transaminase (ALT or AST) levels > 8, > 5, and > 3 x ULN was 0.8%, 2.0%, and 5.2%; and 0.5%, 1.9%, and 5.1% in lumacaftor/ivacaftor- and placebo-treated patients, respectively.
Maltese: Matul Provi 1 u 2, l-inċidenza ta' livelli massimi ta' transaminases (ALT jew AST) ta' > 8, > 5, u > 3 x ULN kienet 0.8%, 2.0%, u 5.2%; u 0.5%, 1.9%, u 5.1% fil-pazjenti kkurati b'lumacaftor/ivacaftor u bi plaċebo, rispettivament.
English: • Antifungal medicines (used for the treatment of fungal infections) for example: fluconazole, ketoconazole, itraconazole, posaconazole, voriconazole
Maltese: • Mediċini antifungali (jintużaw għall-kura ta' infezzjonijiet fungali) pereżempju: fluconazole, ketoconazole, itraconazole, posaconazole, voriconazole
English: • Antidepressant medicines (used for the treatment of depression) for example: citalopram, escitalopram, sertraline, bupropion
Maltese: • Mediċini kontra d-depressjoni (jintużaw għall-kura ta' depressjoni) pereżempju: citalopram, escitalopram, sertraline, bupropion
English: For standard dosing recommendations see Table 1.
Maltese: Għar-rakkomandazzjonijiet tad-dożaġġ standard ara Tabella 1.
English: Baseline CFQ-R
Maltese: CFQ-R fil-Linja bażi
English: Lumacaftor/ivacaftor may alter the exposure of digoxin.
Maltese: Lumacaftor/ivacaftor jista' jibdel l-esponiment ta' digoxin.
English: Patients with a history of colonisation with organisms such as Burkholderia cenocepacia, Burkholderia dolosa, or Mycobacterium abscessus or who had 3 or more abnormal liver function tests (ALT, AST, AP, GGT ≥ 3 times the ULN or total bilirubin ≥ 2 times the ULN) were excluded.
Maltese: Pazjenti bi storja medika ta' kolonizzazzjoni b'organiżmi bħal Burkholderia cenocepacia, Burkholderia dolosa, jew Mycobacterium abscessus jew li kellhom 3 jew aktar testijiet tal-funzjoni tal-fwied b'riżultat anormali (ALT, AST, AP, GGT ta' ≥3 darbiet tal-ULN jew bilirubina totali ta' ≥ darbtejn tal-ULN), ġew esklużi.
English: Changes in FEV1
Maltese: Bidliet fl-FEV1
English: • Immunosuppressants (used after an organ transplantation) for example: ciclosporin, everolimus, sirolimus, tacrolimus
Maltese: • Immunosoppressanti (jintużaw wara trapjant ta' organu) pereżempju: ciclosporin, everolimus, sirolimus, tacrolimus
English: CLINICAL PARTICULARS
Maltese: Kumment kliniku
English: Ivacaftor produced concentration-dependent inhibitory effect on hERG (human ether-à-go-go related gene) tail currents, with an IC15 of 5.5 µM, compared to the Cmax (1.5 µM) for ivacaftor at the therapeutic dose for lumacaftor/ivacaftor.
Maltese: Ivacaftor ipproduċa effett inibitorju li jiddependi fuq il-konċentrazzjoni fuq hERG (human ether-à-go-go related gene) tail currents, b'IC15 ta' 5.5 µM, meta mqabbel mas-Cmax (1.5 µM) għal ivacaftor fid-doża terapewtika għal lumacaftor/ivacaftor.
English: Table 8: Mean (SD) lumacaftor and ivacaftor exposure by age group
Maltese: Tabella 8: Medja (SD) tal-esponiment ta' lumacaftor u ivacaftor skont il-grupp ta' età
English: Substrates of CYP3A
Maltese: Substrati ta' CYP3A
English: • Tablet coating: polyvinyl alcohol; titanium dioxide (E171); macrogol 3350; talc; carmine (E120);
Maltese: • Kisja tal-pillola: polyvinyl alcohol; titanium dioxide (E171); macrogol 3350; talc; carmine (E120); brilliant blue FCF aluminum lake (E133); u indigo carmine aluminum lake (E132)
English: Placebo (n = 184)
Maltese: Plaċebo (n=184)
English: Moderate hepatic impairment (Child-Pugh Class B)
Maltese: Indeboliment moderat tal-fwied (Child-Pugh Klassi B)
English: The Applicant should submit yearly analyses from December 2017 to 2020 and the final CSR by December 2021.
Maltese: L-Applikant għandu jissottometti analiżijiet kull sena minn Diċembru 2017 sa 2020, u s-CSR finali sa Diċembru 2021.
English: Table 9: Mean (SD) lumacaftor and ivacaftor exposure by age group
Maltese: Tabella 9: Medja (SD) tal-esponiment ta' lumacaftor u ivacaftor skont il-grupp ta' età
English: In a human pharmacokinetic study with ivacaftor alone, there was minimal elimination of ivacaftor and its metabolites in urine (only 6.6% of total radioactivity was recovered in the urine).
Maltese: Fi studju farmakokinetiku fil-bnedmin b'ivacaftor waħdu, kien hemm eliminazzjoni minima ta' ivacaftor u l-metaboliti tiegħu fl-awrina (6.6% biss tarradjuattività totali ġiet irkuprata fl-awrina).
English: In vitro studies suggest that lumacaftor has the potential to induce CYP2B6, CYP2C8, CYP2C9, and CYP2C19; however, inhibition of CYP2C8 and CYP2C9 has also been observed in vitro.
Maltese: Interazzjoni ma' substrati ta' CYP2B6 u CYP2C ma ġietx investigata in vivo.Studji in vitro jissuġġerixxu li lumacaftor għandu l-potenzjal li jinduċi CYP2B6, CYP2C8, CYP2C9 u CYP2C19; madankollu, l-inibizzjoni ta' CYP2C8 u CYP2C9 ġiet osservata wkoll in vitro.
English: Ivacaftor may cause dizziness (see section 4.8).
Maltese: Ivacaftor jista' jikkawża sturdament (ara sezzjoni 4.8).
English: Antidepressants: citalopram, escitalopram, sertraline
Maltese: citalopram, escitalopram, sertraline
English: • Increase of an enzyme in your blood (blood creatine phosphokinase)
Maltese: • Żieda ta' enzima fid-demm (creatine phosphokinase fid-demm)
English: *Side effects seen for ivacaftor alone.
Maltese: *Effetti sekondarji li ġew osservati għal ivacaftor biss.
English: No patients had total bilirubin levels > 2 x ULN.
Maltese: Ħadd mill-pazjenti ma kellu livelli ta' bilirubina totali ta' >2 x ULN.
English: Final Report: December 2025
Maltese: Diċembru 2025
English: Potential for lumacaftor/ivacaftor to interact with transporters In vitro experiments show that lumacaftor is a substrate for Breast Cancer Resistance Protein (BCRP).
Maltese: Potenzjal għal lumacaftor/ivacaftor li jinteraġixxi mat-trasportaturi Esperimenti in vitro juru li lumacaftor hu substrat għall-Proteina ta' Reżistenza għall-Kanċer tas-Sider (BCRP).
English: Severe hepatic impairment (Child-Pugh Class C)
Maltese: Indeboliment sever talfwied (Child-Pugh Klassi C)
English: As such, risks to the suckling child cannot be excluded.
Maltese: Għaldaqstant, ir-riskju gћat-tarbija li tkun qed terda' ma jistax jiġi eskluż.
English: Table 6: Long-term effect of Lumacaftor/Ivacaftor in Trial 3*
Maltese: Tabella 6: Effett fit-tul tal-Lumacaftor/Ivacaftor fi Prova 3*
English: NAME OF THE MARKETING AUTHORISATION HOLDER Vertex Pharmaceuticals (Ireland) Limited
Maltese: Vertex Pharmaceuticals (Ireland) Limited
English: Due to induction of CYP3A by St. John's wort
Maltese: Minħabba linduzzjoni ta' CYP3A minn St.John' s wort
English: • Avocados, hummus, soy-based products (tofu)
Maltese: • Avokado, ħummus, prodott ibbażati fuq is-sojja (tofu)
English: • Sinus congestion*
Maltese: • Konġestjoni tas-sinus*
English: • Cardiac glycosides (used for the treatment of mild to moderate congestive heart failure and an abnormal heart rhythm called atrial fibrillation) for example: digoxin
Maltese: • Glycosides kardijaċi (jintużaw għall-kura ta' insuffiċjenza konġestiva tal-qalb minn ħafifa sa moderata u ritmu mhux normali tal-qalb imsejjaħ fibrillazzjoni atrijali) pereżempju: digoxin
English: Placebo (n = 187)
Maltese: Plaċebo (n=187)
English: Following oral administration of ivacaftor alone, the majority of ivacaftor (87.8%) is eliminated in the faeces after metabolic conversion.
Maltese: Wara l-għoti orali ta' ivacaftor waħdu, il-maġġoranza ta' ivacaftor (87.8%) tiġi eliminata fl-ippurgar wara konverżjoni metabolika.
English: Co-administration of lumacaftor/ivacaftor with rifampicin, a strong CYP3A inducer, had minimal effect on the exposure of lumacaftor, but decreased ivacaftor exposure (AUC) by 57%.
Maltese: L-għoti flimkien ta' lumacaftor/ivacaftor ma' rifampicin, induttur qawwi ta' CYP3A, kellu impatt minimu fuq l-esponiment ta' lumacaftor, iżda żied l-esponiment ta' ivacaftor (AUC) b'57%.
English: Concomitant medicinal product class:
Maltese: Kategorija farmakoterapewtika:
English: The treatment difference between lumacaftor 400 mg q12h alone and placebo evaluated as mean absolute change in ppFEV1 was -4.6 percentage points (95% CI: -9.6, 0.4) from baseline to Day 28, 4.2 percentage points (95% CI: -1.3, 9.7) from baseline to Day 56, and 7.7 percentage points (95% CI: 2.6, 12.8; statistically significant) from Day 28 to Day 56 (following the addition of ivacaftor to lumacaftor monotherapy).
Maltese: Id-differenza fil-kura bejn lumacaftor 400 mg q12h waħdu u plaċebo evalwati bħala l-bidla assoluta medja fil-ppFEV1 kienet ta' -4.6 punti perċentwali (95% CI: -9.6, 0.4) mil-linja bażi sa Jum 28, 4.2 punti perċentwali (95% CI: -1.3, 9.7) mil-linja bażi sa Jum 56, 7.7 punti perċentwali (95% CI: 2.6, 12.8; statistikament sinifikanti) minn Jum 28 sa Jum 56 (wara ż-żieda ta' ivacaftor malmonoterapija b'lumacaftor).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1059/001 112 film-coated tablets (4 packs of 28 tablets) EU/1/15/1059/002 56 film-coated tablets (2 packs of 28 tablets)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1059/001 112-il pillola miksija b'rita (4 pakketti ta' 28 pillola) EU/1/15/1059/002 56 pillola miksija b'rita (2 pakketti ta' 28 pillola)
English: During Trials 1 and 2, the incidence of combined menstrual abnormality events (amenorrhoea, dysmenorrhoea, menorrhagia, menstruation irregular, metrorrhagia, oligomenorrhoea, and polymenorrhoea) was 9.9 % in lumacaftor/ivacaftor-treated female patients and 1.7% in placebo-treated females.
Maltese: Matul Provi 1 u 2, l-inċidenza ta' avvenimenti kombinati ta' anormalità mestrwali (amenorrea, dismenorrea, menorraġija, mestrwazzjoni irregolari, metrorraġija, oligomenorrea, u polimenorrea) kienet ta' 9.9% fil-pazjenti nisa kkurati b'lumacaftor/ivacaftor u 1.7% f'nisa ikkurati bi plaċebo.
English: • Corticosteroid medicines (used to treat inflammation): methylprednisolone, prednisone
Maltese: • Mediċini kortikosterojdi (jintużaw għall-kura ta' infjammazzjoni): methylprednisolone, prednisone
English: Table 8: Summary of secondary outcomes in Trial 8
Maltese: Tabella 8: Sommarju tar-riżultati sekondarji ewlenin fi Prova 8 Punti aħħarin sekondarji*
English: Patients aged 12 to 17 years were included in Trials 1 and 2.
Maltese: Pazjenti li kellhom minn 12 sa 17-il sena ġew inklużi fi Provi 1 u 2.
English: Lumacaftor/ivacaftor may decrease the exposures of methylprednisolone and prednisone, which may reduce their efficacy.
Maltese: Lumacaftor/ivacaftor jista' jnaqqas lesponimenti ta' methylprednisolone u prednisone, li jista' jnaqqas l-effikaċja tagħhom.
English: Note: ↑ = increase, ↓ = decrease, ↔ = no change; LUM = lumacaftor; IVA = ivacaftor.
Maltese: Nota: ↑ = żieda, ↓ = tnaqqis, ↔ = l-ebda bidla; LUM = lumacaftor;
English: No data are available (see section 5.1).
Maltese: M'hemm l-ebda data disponibbli (ara sezzjoni 5.1).
English: Orkambi contains two active substances, lumacaftor and ivacaftor.
Maltese: Orkambi fih żewġ sustanzi attivi, lumacaftor u ivacaftor.
English: Baseline ppFEV1‡ Absolute change from baseline ppFEV1 (percentage points)
Maltese: Bidla assoluta mil-linja bażi ppFEV1 (punti perċentwali)
English: • Benzodiazepines (used for the treatment of anxiety or sleeplessness [insomnia], agitation, etc.) for example: midazolam, triazolam
Maltese: • Benzodiazepines (jintużaw għall-kura ta' ansjetà jew nuqqas ta' rqad [insomnja], aġitazzjoni, eċċ.) pereżempju: midazolam, triazolam
English: • Oral hypoglycaemics (used for the management of type 2 diabetes): repaglinide
Maltese: • Ipogliċemiċi orali (jintużaw għall-immaniġġjar ta' dijabete ta' tip 2): repaglinide
English: ↓ esomeprazole, lansoprazole, omeprazole Due to induction of CYP3A/2C19 by LUM
Maltese: ↓ esomeprazole, lansoprazole, omeprazole Minħabba linduzzjoni ta' CYP3A/2C19 minn LUM
English: Baseline ppFEV1‡
Maltese: Epatite kolestatika‡
English: The information reported in Table 3 mostly derives from in vitro studies.
Maltese: L-informazzjoni rrappurtata f'Tabella 3 hi miksuba l-aktar minn studji in vitro.
English: Anti-inflammatories: ibuprofen
Maltese: Ibuprofen
English: INFORMATION IN BRAILLE Orkambi 200 mg, 125 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Orkambi 200 mg, 125 mg
English: Absolute change in CFQ-R Respiratory Domain Score (points)
Maltese: Bidla assoluta fil-Punteġġ tad-Dominju Respiratorju CFQ-R (punti)
English: The typical apparent clearance, CL/F (CV), of lumacaftor was estimated to be 2.38 L/hr (29.4%) for patients with CF.
Maltese: It-tneħħija apparenti tipika, CL/F (CV), ta' lumacaftor kienet stmata li hi ta' 2.38 L/siegħa (29.4%) għal pazjenti b'CF.
English: INFORMATION IN BRAILLE Orkambi 100 mg, 125 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Orkambi 100 mg, 125 mg
English: * A total of 82% (421 of 516 eligible patients) completed 72 weeks of this study; 42% completed 96 weeks.
Maltese: *Total ta' 82% (421 minn 516-il-pazjent eliġibbli) temmew 72 Ġimgħa ta' dan l-istudju; 42% temmew 96 Ġimgħa.
English: • Loss of appetite
Maltese: • Relf ta' aptit
English: One lumacaftor 150 mg/ivacaftor 188 mg sachet every 12 hours lumacaftor 300 mg/ ivacaftor 376 mg
Maltese: Qartas wieħed ta' lumacaftor 150 mg/ivacaftor 188 mg kull 12-il siegħa lumacaftor 300 mg/ ivacaftor 376 mg
English: Potential for other medicinal products to affect lumacaftor/ivacaftor Inhibitors of CYP3A
Maltese: Potenzjal għal prodotti mediċinali oħrajn li jaffettwaw lumacaftor/ivacaftor Inibituri ta' CYP3A
English: Table 5: Summary of primary and key secondary outcomes in Trial 1 and Trial 2*
Maltese: Sommarju tar-riżultati primarji u r-riżultati sekondarji ewlenin fi Prova 1 u Prova 2*
English: In Trial 8 in patients homozygous for F508del-CFTR mutation aged 2 to 5 years, the mean absolute within-group change in sweat chloride from baseline at Week 24 was -31.7 mmol/L (95% CI: -35.7, -27.6).
Maltese: Fi Prova 8 f'pazjenti homozygous għall-mutazzjoni F508del-CFTR li għandhom bejn sentejn u 5 snin, il-medja tal-bidla assoluta fil-grupp innifsu ta' chloride fl-għaraq millinja bażi f'Ġimgħa 24 kienet -31.7 mmol/L (95% CI: -35.7, -27.6).
English: Menstruation irregular, dysmenorrhoea, metrorrhagia, breast mass* uncommon Menorrhagia, amenorrhoea, polymenorrhoea, breast inflammation*, gynaecomastia*, nipple disorder*, nipple pain*, oligomenorrhoea
Maltese: Menorraġija, amenorrea, polimenorrea, infjammazzjoni tas-sider*, ġinekomastija*, disturb fil-beżżula*, uġigħ fil-beżżula*, oligomenorrea
English: The post-dose decline was resolved by Week 16.
Maltese: It-tnaqqis ta' wara d-doża għadda sa Ġimgħa 16.
English: Following multiple doses of lumacaftor/ivacaftor for 10 days, subjects with moderately impaired hepatic function (Child-Pugh Class B, score 7 to 9) had higher exposures (AUC0-12hr by approximately 50% and Cmax by approximately 30%) compared with healthy subjects matched for demographics.
Maltese: Wara dożi multipli ta' lumacaftor/ivacaftor għal 10 ijiem, individwi b'funzjoni tal-fwied indebolita moderatament (Child-Pugh Klassi B, punteġġ minn 7 sa 9) kellhom esponimenti ogħla (AUC0-12hr b'madwar 50% u Cmax b'madwar 30%) meta mqabbla ma' individwi b'saħħithom li ġew imqabbla għad-demografija.
English: † For patients rolled over from Trials 1 and 2 (lumacaftor/ivacaftor-to-lumacaftor/ivacaftor group) total exposure was up to 120 weeks.
Maltese: Għal pazjenti li komplew minn Provi 1 u 2 (il-grupp ta' lumacaftor/ivacaftor għal lumacaftor/ivacaftor), l-esponiment totali kien sa 120 Ġimgħa.
English: H2 blockers: ranitidine
Maltese: Imblokkaturi ta' H2:
English: Additional adverse reactions from Trial 6 are included in Table 4.
Maltese: Reazzjonijiet avversi addizzjonali minn Prova 6 huma inklużi f'Tabella 4.
English: The incidence of transaminase-related adverse reactions was 5.1% and 4.6% in lumacaftor/ivacaftor-treated patients and those who received placebo, respectively.
Maltese: L-inċidenza ta' reazzjonijiet avversi relatati ma' transaminases kienet ta' 5.1% u 4.6% f'pazjenti kkurati b'lumacaftor/ivacaftor u f'dawk li rċivew plaċebo, rispettivament.
English: Potential for lumacaftor/ivacaftor to affect other medicinal products CYP3A substrates
Maltese: Il-potenzjal għal lumacaftor/ivacaftor li jaffettwa prodotti mediċinali oħrajn Substrati ta' CYP3A
English: A decline in ppFEV1 at initiation of therapy was observed during serial post dose spirometry assessments.
Maltese: Tnaqqis fil-ppFEV1 fil-bidu tat-terapija ġie osservat matul diversi evalwazzjonijiet tal-ispirometrija wara d-doża.
English: Absolute change from baseline in weight-for-age z-score n = 57 95% CI: 0.15, 0.38; P < 0.0001
Maltese: Bidla assoluta mil-linja bażi fil-punteġġ piż għal età z n = 57 95% CI: 0.15, 0.38; P < 0.0001
English: For patients aged 6 to 11 years 2 tablets of 100 mg/125 mg in the morning + 1 tablet of 100 mg/125 mg in the evening (12 hours later)
Maltese: Għal pazjenti li għandhom minn 6 sa 11-il sena 2 pilloli ta' 100 mg/125 mg filgħodu + 1 pillola ta' 100 mg/125 mg filgħaxija (12il siegħa wara)
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Vertex Pharmaceuticals (Ireland) Limited
Maltese: FIS-SUQ Vertex Pharmaceuticals (Ireland) Limited
English: Patients in both trials were randomised 1:1:1 to receive lumacaftor 600 mg once daily/ivacaftor 250 mg q12h, lumacaftor 400 mg q12h/ivacaftor 250 mg q12h, or placebo.
Maltese: Il-pazjenti fiżżewġ provi ntgħażlu b'mod każwali fi proporzjon ta' 1:1:1 biex jirċievu lumacaftor 600 mg darba kuljum/ivacaftor 250 mg q12h, lumacaftor 400 mg q12h/ivacaftor 250 mg q12h, jew plaċebo.
English: Respiration abnormal, oropharyngeal pain, sinus congestion*, rhinorrhoea, pharyngeal erythema*
Maltese: Respirazzjoni anormali, uġigħ orofarinġeali, konġestjoni tas-sinus *, rinorrea,eritema talfarinġi*
English: Absolute change from baseline in BMI-for-age-z-score n = 57 95% CI: 0.14, 0.45; P = 0.0003
Maltese: Bidla assoluta mil-linja bażi fil-punteġġ BMI għal età z n = 57 95% CI: 0.14, 0.45; P = 0.0003
English: The CFTR protein is a chloride channel present at the surface of epithelial cells in multiple organs.
Maltese: Il-proteina CFTR hu kanal tal-chloride preżenti fuq il-wiċċ ta' ċelluli epiteljali f'organi multipli.
English: • Contraceptive medicines (used for the prevention of pregnancy): oral, injectable, and implantable contraceptives as well as contraceptive skin patches; that may include ethinyl estradiol, norethindrone, and other progestogens.
Maltese: • Mediċini kontraċettivi (jintużaw għall-prevenzjoni tat-tqala): kontraċettivi orali, injettabli, u li jistgħu jiġu impjantati kif ukoll patches kontraċettivi tal-ġilda; li jistgħu jinkludu ethinyl estradiol, norethindrone, u progestogens oħrajn.
English: ↓ fluconazole Due to induction by LUM; fluconazole is cleared primarily by renal excretion as unchanged drug; however, modest reduction in fluconazole exposure has been observed with strong inducers
Maltese: ↓ fluconazole Minħabba linduzzjoni minn LUM; fluconazole jitneħħa primarjament permezz ta' tneħħija mill-kliewi bħala mediċina mhux mibdula; madankollu, tnaqqis modest flesponiment ta' fluconazole ġie osservat ma' indutturi qawwija
English: In vitro and in vivo data indicate that lumacaftor is mainly metabolised via oxidation and glucuronidation.
Maltese: Dejta in vitro u in vivo tindika li lumacaftor jiġi metabolizzat primarjament permezz ta' ossidazzjoni u glukuronidazzjoni.