FrancophonIA/ELRC3.0 huggingface dataset:
English: Kalydeco in a combination regimen with tezacaftor/ivacaftor The efficacy and safety of Kalydeco in a combination regimen with tezacaftor/ivacaftor in patients with CF was assessed in two clinical studies; a 24 week, randomized, double-blind, placebo-controlled study with 504 patients aged 12 years and older who were homozygous for the F508del mutation; and a randomized, double-blind, placebo-controlled and ivacaftor controlled, 2 period, 3 treatment, 8-week crossover study with 244 patients aged 12 years and older who were heterozygous for the F508del mutation and a second mutation associated with residual CFTR activity.
Maltese: Kalydeco f'kors ikkombinat flimkien ma' tezacaftor/ivacaftor L-effikaċja u s-sigurtà ta' Kalydeco f'kors ikkombinat ma' tezacaftor/ivacaftor f'pazjenti b'CF ġew ivvalutati f'żewġ studji kliniċi; studju li dam 24 ġimgħa, li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind u kkontrollat bil-plaċebo b'504 pazjent li kellhom 12-il sena u aktar, li kienu omożigotiċi għall-mutazzjoni ta' F508del; u studju crossover, li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind u kkontrollat bil-plaċebo u b'ivacaftor fuq żewġ (2) perjodi, 3 trattamenti, 8 ġimgħat b'244 pazjent li kellhom 12-il sena jew aktar li kienu eterożigotiċi għall-mutazzjoni ta' F508del u ttieni mutazzjoni assoċjata mal-attività residwali ta' CFTR.
English: Co-administration with (oral) midazolam, a sensitive CYP3A substrate, increased midazolam exposure 1.5-fold, consistent with weak inhibition of CYP3A by ivacaftor.
Maltese: L-għoti flimkien (orali) ma' midazolam, substrat sensittiv għal CYP3A, żied l-esponiment għal midazolam b'1.5 darbiet, u dan hu konsistenti ma' inibizzjoni dgħajfa ta' CYP3A minn ivacaftor.
English: − Blister card pack containing 28 film-coated tablets
Maltese: KARD BIL-FOLJI - PAKKETT TA' 28 PILLOLA
English: • Kalydeco (alone or in combination with tezacaftor/ivacaftor) is not recommended if you have undergone an organ transplant.
Maltese: • Kalydeco (waħdu jew flimkien ma' tezacaftor/ivacaftor) mhuwiex rakkomandat jekk sarlek trapjant ta' organu.
English: Findings of cataracts were observed in juvenile rats dosed from postnatal day 7 through 35 at ivacaftor exposure levels of 0.22 times the MRHD based on systemic exposure of ivacaftor and its metabolites when administered as ivacaftor monotherapy.
Maltese: Sejbiet ta' katarretti ġew osservati f'firien ġuvenili li ngħataw doża minn jum 7 sa 35 wara t-twelid fillivelli ta' esponiment ta' ivacaftor ta' 0.22 darbiet tal-MRHD ibbażata fuq l-esponiment sistemiku ta' ivacaftor u l-metaboliti tiegħu meta mogħti bħala monoterapija b'ivacaftor.
English: The results for clinically relevant secondary endpoints are shown in Table 3.
Maltese: Ir-riżultati għal punti aħħarin sekondarji klinikament rilevanti qed jintwerew f'Tabella 3.
English: Kalydeco in a combination regimen with tezacaftor/ivacaftor in adults and adolescents aged 12 years and older
Maltese: Kalydeco f'kors ikkombinat flimkien ma' tezacaftor/ivacaftor f'adulti u adolexxenti li għandhom 12
English: Study 3: study in patients with CF with the F508del mutation in the CFTR gene Study 3 (part A) was a 16-week, 4:1 randomised, double-blind, placebo-controlled, parallel-group Phase 2 study of ivacaftor (150 mg every 12 hours) in 140 patients with CF age 12 years and older who were homozygous for the F508del mutation in the CFTR gene and who had FEV1 ≥ 40% predicted.
Maltese: Studju 3: studju f'pazjenti b'CF bil-mutazzjoni F508del fil-ġene CFTR Studju 3 (parti A) kien studju ta' Fażi 2, li dam 16-il ġimgħa, li fih il-parteċipanti ntgħażlu b'mod każwali fi proporzjoni ta' 4:1, double-blind, ikkontrollat bi plaċebo, tat-tip grupp parallel, li sar dwar ivacaftor (150 mg kull 12-il siegħa) f'140 pazjent b'CF li kellhom 12-il sena u aktar, li kienu omożigotiċi għall-mutazzjoni F508del fil-ġene CFTR u li kellhom FEV1 ≥40% ta' dak imbassar.
English: Hepatobiliary disorders
Maltese: Il-metaboliti maġġuri
English: 2- to 5-year-olds (≥ 14 kg to < 25 kg)
Maltese: (≥14 kg sa <25 kg)
English: The recommended dose of Kalydeco is one 150 mg tablet every 12 hours (in total 2 tablets: 300 mg per day).
Maltese: Id-doża rakkomandata ta' Kalydeco hi ta' pillola waħda ta' 150 mg kull 12-il siegħa (b'kollox 2 pilloli: 300 mg kuljum).
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis‑sodium'.
English: The pharmacokinetic profile, safety and efficacy of ivacaftor in 34 patients aged 2 to less than 6 years with CF who had a G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R mutation in the CFTR gene were assessed in a 24-week uncontrolled study with ivacaftor (patients weighing less than 14 kg received ivacaftor 50 mg and patients weighing 14 kg or more received ivacaftor 75 mg).
Maltese: Il-profil farmakokinetiku, is-sigurtà u l-effikaċja ta' ivacaftor f'34 pazjent b'CF li kellhom minn sentejn sa inqas minn 6 snin, li kellhom mutazzjoni G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N jew S549R fil-ġene CFTR ġew evalwati fi studju b'ivacaftor, mhux ikkontrollat, li dam 24 ġimgħa (pazjenti li jiżnu inqas minn 14 kg irċivew ivacaftor 50 mg, u pazjenti li jiżnu 14 kg jew aktar irċivew ivacaftor 75 mg).
English: In a human pharmacokinetic study, 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, kien hemm eliminazzjoni minima ta' ivacaftor u l-metaboliti tiegħu flawrina (6.6% biss tar-radjuattività totali ġiet irkuprata fl-awrina).
English: Patients continued on their prescribed standard-of-care CF therapies.
Maltese: Il-pazjenti komplew bit-terapiji tagħhom standard ta' kura preskritta għall-CF.
English: Sixty-two percent (24/39) of them carried the F508del-CFTR mutation in the second allele.
Maltese: Tnejn u sittin fil-mija (24/39) minnhom kellhom il-mutazzjoni F508del-CFTR fit-tieni allele.
English: In study 8 in patients with CF aged less than 24 months, the mean absolute change from baseline in sweat chloride was -67.9 mmol/L (95% CI -77.6, -58.2) at week 24.
Maltese: Fi studju 8 li sar f'pazjenti b'CF li kellhom inqas minn 24 xahar, il-bidla assoluta medja mil-linja bażi tal-chloride fl-għaraq kienet -67.9 mmol/L (95% CI -77.6, -58.2) f'ġimgħa 24.
English: Data on percent predicted FEV1 (exploratory endpoint) were available for 3 patients in the ivacaftor 50 mg group and 17 patients in the 75 mg dosing group.
Maltese: Dejta dwar il-perċentwali ta' FEV1 imbassar (punt aħħari esploratorju) kienet disponibbli għal 3 pazjenti fil-grupp ta' ivacaftor 50 mg, u għal 17-il pazjent filgrupp tad-dożaġġ ta' 75 mg.
English: Co-administration of ivacaftor with rifampicin, a strong CYP3A inducer, decreased ivacaftor exposure (AUC) by 89% and decreased hydroxymethyl ivacaftor (M1) to a lesser extent than ivacaftor.
Maltese: L-għoti flimkien ta' ivacaftor ma' rifampicin, induttur qawwi ta' CYP3A, naqqas l-esponiment għal ivacaftor (AUC) b'89% u naqqas hydroxymethyl ivacaftor (M1) bi grad inqas minn ivacaftor.
English: G1244E (5) G1349D (2) G178R (5) G551S (2) G970R# (4) S1251N (8) S1255P (2) S549N (6)
Maltese: G1244E (5) G1349D (2) G178R (5)
English: However, in patients with the G970R-CFTR mutation, the mean (SD) absolute change in sweat chloride at week 8 was -6.25 (6.55) mmol/L.
Maltese: Madankollu, f'pazjenti bilmutazzjoni G970R-CFTR, il-medja (SD) tal-bidla assoluta tal-chloride fl-għaraq f'ġimgħa 8 kienet ta' -6.25 (6.55) mmol/L.
English: Thirty-nine patients (mean age 23 years) with baseline FEV1 ≥ 40% predicted (mean FEV1 78% predicted [range: 43% to 119%]) were enrolled.
Maltese: Disgħa u tletin pazjent (età medja ta' 23 sena) b'linja bażi ta' FEV1 ≥ 40% ta' dak imbassar (medja ta' FEV1 78% imbassra [medda: 43% sa 119%]) ġew irreġistrati.
English: Tympanic membrane hyperaemia common
Maltese: Iperemija tal-membrana timpanika komuni
English: A single ivacaftor-treated patient (2.5%) in this age range had an elevation of ALT and AST > 8 x ULN.
Maltese: Pazjent wieħed ikkurat b'ivacaftor (2.5%) f'din il-medda ta' età, kellu żieda ta' ALT u AST ta' >8 x ULN.
English: In the cohort of patients aged 6 months to less than 12 months one patient (9.1%) had elevated ALT of > 3 to ≤5 x ULN.
Maltese: Fil-koort ta' pazjenti li kellhom 6 xhur sa inqas minn 12-il xahar pazjent wieħed (9.1%) kellu żieda fil-livell ta' ALT ta' > 3 sa ≤ 5 x ULN.
English: • Antibacterial agents such as telithromycin, clarithromycin, erythromycin, rifampicin and rifabutin, used for the treatment of bacterial infections
Maltese: • Aġenti antibatterjali bħal telithromycin, clarithromycin, erythromycin, rifampicin, u rifabutin, li jintużaw għal kura ta' infezzjonijiet batterjali
English: • Anticonvulsant medicines such as phenobarbital, carbamazepine and phenytoin, used for the treatment of epileptic seizures
Maltese: • Mediċini kontra l-konvulżjonijiet bħal phenobarbital, carbamazepine, u phenytoin, li jintużaw għal kura ta' puplesiji epilettiċi
English: Ivacaftor has been studied with an oestrogen/progesterone oral contraceptive and was found to have no significant effect on the exposures of the oral contraceptive.
Maltese: Ivacaftor ġie studjat ma' kontraċettiv orali li fih oestrogen/progesterone u nstab li ma kellu l-ebda effett sinifikanti fuq l-esponimenti tal-kontraċettiv orali.
English: Race had no clinically meaningful effect on the PK of ivacaftor in white (n = 379) and non-white (n = 29) patients based on a population PK analysis.
Maltese: Ir-razza ma kellha l-ebda effett klinikament sinifikanti fuq il-PK ta' ivacaftor f'pazjenti bojod (n=379) u mhux bojod (n=29) abbażi ta' analiżi tal-PK fil-popolazzjoni.
English: Ivacaftor granules (2 x 75 mg sachets) had similar bioavailability as the 150 mg tablet when given with fat-containing food to healthy adult subjects.
Maltese: Il-granijiet ta' ivacaftor (qratas ta' 2 x 75 mg) kellhom bijodisponibilità bħall-pillola ta' 150 mg meta ngħataw ma' ikel li kien fih ix-xaħam lil individwi adulti b'saħħithom.
English: A pre-planned subgroup analysis was conducted in patients 18 years and older (26 patients on placebo and 24 on ivacaftor).
Maltese: Analiżi ta' sottogrupp ippjanata minn qabel twettqet f'pazjenti li kellhom 18-il sena u aktar (26 pazjent fuq plaċebo u 24 fuq ivacaftor).
English: After oral administration of ivacaftor 150 mg every 12 hours in combination with tezacaftor 100 mg once daily in patients with CF in the fed state, the mean (± SD) for apparent volume of distribution of ivacaftor was 206 (82.9) L.
Maltese: Wara l-għoti orali ta' ivacaftor 150 mg kull 12-il siegħa flimkien ma' tezacaftor 100 mg darba kuljum f'pazjenti b'CF wara li jkunu kielu, il-medja (±SD) għall-volum apparenti tad-distribuzzjoni ta' ivacaftor kienet 206 (82.9) L.
English: The film-coated tablets are packed in a thermoform (PolyChloroTriFluoroEthylene [PCTFE]/foil) blister or a High-Density PolyEthylene (HDPE) bottle with a polypropylene child-resistant closure, foil-lined induction seal and molecular sieve desiccant.
Maltese: [PCTFE]/fojl) jew flixkun tal-PolyEthylene ta' Densità Għolja (HDPE) b'għatu tal-polypropylene reżistenti għat-tfal, foil-lined induction seal u passatur molekulari bħala desikkant.
English: For patients in the placebo/ivacaftor group from study 1, the annualised rate of pulmonary exacerbations was higher in the initial study when patients were on placebo (1.34 events/year) than during the subsequent study 4 when patients rolled over to ivacaftor (0.48 events/year across day 1 to week 48, and 0.67 events/year across weeks 48 to 96).
Maltese: Għall-pazjenti fil-grupp tal-plaċebo/ivacaftor minn studju 1, ir-rata annwalizzata ta' aggravamenti pulmonari kienet ogħla fl-istudju inizjali meta l-pazjenti kienu fuq il-plaċebo (1.34 avvenimenti/sena) milli matul l-istudju 4 sussegwenti meta l-pazjenti qalbu għal ivacaftor (0.48 avvenimenti/sena minn jum 1 sa ġimgħa 48, u 0.67 avvenimenti/sena minn ġimgħat 48 sa 96).
English: Table 2: Dosing recommendations for patients with hepatic impairment for Kalydeco monotherapy and in a combination regimen with tezacaftor/ivacaftor Kalydeco monotherapy Kalydeco in a combination regimen with tezacaftor/ivacaftor
Maltese: Tabella 2: Rakkomandazzjonijiet tad-dożaġġ għal pazjenti b'indeboliment epatiku għal monoterapija b'Kalydeco u f'kors ikkombinat flimkien ma' tezacaftor/ivacaftor Monoterapija b'Kalydeco
English: The results for clinically relevant secondary endpoints are shown in Table 4.
Maltese: Ir-riżultati għal punti aħħarin sekondarji klinikament rilevanti qed jintwerew f'Tabella 4.
English: Kalydeco tablets can also be used in combination with tezacaftor/ivacaftor tablets for the treatment of adults and adolescents aged 12 years and older with CF who have two F508del mutations in the CFTR gene (homozygous for the F508del mutation) or who have an F508del mutation and certain other second mutations (heterozygous for the F508del mutation).
Maltese: Pilloli Kalydeco jistgħu jintużaw ukoll flimkien ma' pilloli tezacaftor/ivacaftor għall-kura ta' adulti u adolexxenti li għandhom 12-il sena jew aktar b'CF li għandhom żewġ mutazzjonijiet F508del fil-ġene CFTR (omożigotiċi għall-mutazzjoni F508del) jew li għandhom mutazzjoni F508del u ċerti mutazzjonijet oħra (eterożigotiċi għall-mutazzjoni F508del).
English: Predicted ivacaftor exposure based on observed ivacaftor concentrations in Phase 2 and 3 studies as determined using population PK analysis is presented by age group in Table 7.
Maltese: L-esponiment imbassar ta' ivacaftor ibbażat fuq il-konċentrazzjonijiet osservati ta' ivacaftor fl-istudji ta' Fażi 2 u 3 kif determinat bl-użu ta' analiżi PK tal-popolazzjoni, qed jiġi ppreżentat skont il-grupp ta' età f'Tabella 7.
English: During the 48-week placebo-controlled studies 1 and 2 of ivacaftor monotherapy in patients aged 6 years and older, the incidence of maximum transaminase (ALT or AST) > 8, > 5 or > 3 x ULN was 3.7%, 3.7% and 8.3% in ivacaftor-treated patients and 1.0%, 1.9% and 8.7% in placebo-treated patients, respectively.
Maltese: Matul l-istudji ikkontrollati bi plaċebo 1 u 2, li damu 48 ġimgħa fuq il-monoterapija b'ivacaftor f'pazjenti li kellhom 6 snin u aktar, l-inċidenza ta' livelli massimi ta' transaminases (ALT jew AST) ta' >8, >5 jew >3 x ULN kienet ta' 3.7%, 3.7% u 8.3% f'pazjenti kkurati b'ivacaftor u 1.0%, 1.9% u 8.7% f'pazjenti kkurati bi plaċebo, rispettivament.
English: Co-administration of Kalydeco (as monotherapy or in a combination regimen with tezacaftor/ivacaftor) with strong CYP3A inducers, such as rifampicin, rifabutin, phenobarbital, carbamazepine, phenytoin and St. John's wort (Hypericum perforatum), is not recommended (see section 4.4).
Maltese: L-għoti flimkien ta' Kalydeco (bħala monoterapija jew f'kors ikkombinat flimkien ma' tezacaftor/ivacaftor) ma' indutturi qawwija ta' CYP3A bħal rifampicin, rifabutin, phenobarbital, carbamazepine, phenytoin u St.
English: At baseline, mean predicted FEV1 was 63.6% (range: 31.6% to 98.2%) and mean age was 26 years (range: 12 to 53 years).
Maltese: Fil-linja bażi, il-medja tal-FEV1 imbassar kienet ta' 63.6% (medda: 31.6% sa 98.2%) u l-età medja kienet ta' 26 sena (medda: 12 sa 53 sena).
English: All patients (N = 39) Results shown as mean (95% CI) change from baseline ivacaftor vs. placebo-treated patients:
Maltese: Riżultati murija bħala bidla medja (95% CI) mil-linja bażi ta' pazjenti kkurati b'ivacaftor vs. plaċebo:
English: Table 2 reflects the adverse reactions observed with ivacaftor in clinical trials (placebo-controlled and uncontrolled studies) in which the length of exposure to ivacaftor ranged from 16 weeks to 144 weeks.
Maltese: Tabella 2 tirrifletti r-reazzjonijiet avversi osservati b'ivacaftor fil-provi kliniċi (studji kkontrollati bi placebo u mhux ikkontrollati) li fihom it-tul tal-esponiment għal ivacaftor ivarja minn 16-il ġimgħa sa 144 ġimgħa.
English: Kalydeco 75 mg granules
Maltese: Kalydeco 75 mg granijiet f'qartas
English: Kalydeco 75 mg granules ivacaftor
Maltese: Kalydeco 75 mg granijiet f'qartas ivacaftor
English: When co-administered with moderate inhibitors of CYP3A, the Kalydeco dose should be reduced to 150 mg once daily (see sections 4.4 and 4.5).
Maltese: Meta jingħata flimkien ma' inibituri moderati ta' CYP3A, id-doża ta' Kalydeco għandha titnaqqas għal 150 mg darba kuljum (ara sezzjonijiet 4.4 u 4.5).
English: Cmin, ss (ng/mL) AUCτ,ss (ng*h/mL)
Maltese: Medja ta' Ivacaftor (SD) AUCτ,ss (ng*h/mL)
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu/.
English: Moderate transaminase (alanine transaminase [ALT] or aspartate transaminase [AST]) elevations are common in subjects with CF. Transaminase elevations have been observed in some patients treated with ivacaftor monotherapy.
Maltese: Żidiet moderati fil-livelli ta' transaminase (alanine transaminases [ALT] jew aspartate transaminases [AST]) huma komuni f'persuni b'CF.
English: Co-administration with fluconazole, a moderate inhibitor of CYP3A, increased ivacaftor exposure by 3-fold and increased M1 to a lesser extent than ivacaftor.
Maltese: L-għoti flimkien ma' fluconazole, inibitur moderat ta' CYP3A, żied l-esponiment għal ivacaftor bi 3 darbiet u żied M1 bi grad inqas minn ivacaftor.
English: Tezacaftor 100 mg/ ivacaftor 150 mg tablet Ivacaftor 150 mg tablet
Maltese: 100 mg/ivacaftor 150 mg darba kuljum
English: Study 1 and 2: studies in patients with CF with G551D gating mutations The efficacy of Kalydeco has been evaluated in two Phase 3 randomised, double-blind, placebo-controlled, multi-centre studies of clinically stable patients with CF who had the G551D mutation in the CFTR gene on at least 1 allele and had FEV1 ≥ 40% predicted.
Maltese: Studju 1 u 2: studji f'pazjenti b'CF b'mutazzjonijiet gating G551D L-effikaċja ta' Kalydeco ġiet evalwata f'żewġ studji ta' Fażi 3 li fihom il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollati bi plaċebo, multiċentriċi, ta' pazjenti klinikament stabbli b'CF li kellhom il-mutazzjoni G551D fil-ġene CFTR fuq mill-inqas allele wieħed u li kellhom FEV1 ≥40% ta'
English: Whenever possible the phase of the poly-T variant identified with the R117H mutation should be determined as this may be informative in considering treatment of patients with an R117H mutation (see section 4.2).
Maltese: Kull meta jkun possibbli, il-fażi tal-varjant poly-T identifikata bil-mutazzjoni R117H, għandha tiġi stabbilita għax dan jista' jkun informattiv fil-konsiderazzjoni talkura ta' pazjenti b'mutazzjoni R117H (ara sezzjoni 4.2).
English: Simulations for predicting the steady-state exposure of ivacaftor showed that by reducing the dosage from 150 mg q12h to 150 mg once daily, adults with moderate hepatic impairment would have comparable steady-state Cmin values as those obtained with a dose of 150 mg q12h in adults without hepatic impairment.
Maltese: Simulazzjonijiet għat-tbassir tal-esponiment fl-istat fiss ta' ivacaftor urew li bit-tnaqqis tad-dożaġġ minn 150 mg q12h għal 150 mg darba kuljum, adulti b'indeboliment moderat tal-fwied se jkollhom valuri komparabbli ta' Cmin fl-istat fiss bħal dawk miksuba b'doża ta' 150 mg q12h f'adulti mingħajr indeboliment tal-fwied.
English: Light blue, capsule-shaped film-coated tablets, printed with “V 150” in black ink on one side and plain on the other (16.5 mm x 8.4 mm in modified tablet shape).
Maltese: Pilloli miksija b'rita b'forma ta' kapsula, ta' lewn blu ċar, stampati b'“V 150” b'linka sewda fuq naħa waħda u xejn fuq in-naħa l-oħra (16.5 mm x 8.4 mm f'forma modifikata ta' pillola).
English: Part B of study 8 enrolled, 19 patients aged 12 months to less than 24 months (mean age 15.2 months at baseline), with 18 patients completing the 24-week treatment period, and 11 patients aged 6 months to less than 12 months (mean age 9.0 months at baseline) with all 11 patients completing the 24-week treatment period.
Maltese: Parti B ta' studju 8 irreġistrat 19-il pazjent li kellhom 12-il xahar sa inqas minn 24 xahar (età medja ta' 15.2 xhur fil-linja bażi), bi 18-il pazjent ilestu l-perjodu ta' trattament li dam 24 ġimgħa, u 11il pazjent li kellhom 6 xhur sa inqas minn 12-il xahar (età medja ta' 9.0 xhur fil-linja bażi) bil-11il pazjent kollha jlestu l-perjodu ta' trattament li dam 24 ġimgħa.
English: The apparent clearance (CL/F) of ivacaftor was similar for healthy subjects and patients with CF.
Maltese: It-tneħħija apparenti (CL/F) ta' ivacaftor kienet simili għal individwi b'saħħithom u pazjenti b'CF.
English: In study 7 in patients aged 2 to less than 6 years with a gating mutation on at least 1 allele of the CFTR gene administered either 50 mg or 75 mg of ivacaftor twice daily, the mean absolute change from baseline in sweat chloride was -47 mmol/L (95% CI -58, -36) at week 24.
Maltese: Fi studju 7 li sar f'pazjenti li kellhom minn sentejn sa inqas minn 6 snin, b'mutazzjoni gating f'millinqas allele wieħed tal-ġene CFTR li ngħataw jew 50 mg jew 75 mg ta' ivacaftor darbtejn kuljum (studju 6), il-bidla assoluta medja mil-linja bażi fil-chloride fl-għaraq kienet ta' -47 mmol/L (95% CI -58, -36) f'ġimgħa 24.
English: OTHER
Maltese: N
English: Mutation (n)
Maltese: (n)
English: When co-administered with moderate inhibitors of CYP3A, the dose of Kalydeco and tezacaftor/ivacaftor should be adjusted according to the recommendations in Table 1 (see section 4.4 and 4.5).
Maltese: Meta tittieħed flimkien ma' inibituri moderati ta' CYP3A, id-doża ta' Kalydeco u tezacaftor/ivacaftor għandha tkun aġġustata skont ir-rakkomandazzjonijiet fit-Tabella 1 (ara sezzjoni 4.4 u 4.5).
English: The mean (SD) overall (both ivacaftor dosing groups combined) absolute change from baseline in BMI at week 24 was 0.32 kg/m2 (0.54) and the mean (SD) overall change in BMI-for-age z-score was 0.37 (0.42).
Maltese: 32 kg/m2 (0.54) u l-medja (SD) globali tal-bidla fil-BMI għallpunteġġ z tal-età kienet ta' 0.
English: Only patients with CF who had a G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R gating (class III), G970R or R117H mutation in at least one allele of the CFTR gene were included in studies 1, 2, 5 and 6 (see section 5.1).
Maltese: Pazjenti biss b'CF li kellhom mutazzjoni gating G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R (klassi III), mutazzjoni G970R jew R117H f'mill-inqas allele wieħed tal-ġene CFTR ġew inklużi fi studji 1, 2, 5 u 6 (ara sezzjoni 5.1).
English: Administration of ivacaftor may increase systemic exposure of medicinal products that are sensitive substrates of CYP2C9, and/or P-gp, and/or CYP3A which may increase or prolong their therapeutic effect and adverse reactions.
Maltese: L-għoti ta' ivacaftor jista' jżid l-esponiment sistemiku ta' prodotti mediċinali li huma substrati sensittivi ta' CYP2C9, u/jew P-gp, u/jew CYP3A li jista' jżid jew itawwal l-effett terapewtiku u lavvenimenti avversi tagħhom.
English: • Dark urine
Maltese: • Awrina skura
English: Less evidence of a positive effect of ivacaftor has been shown for patients with an R117H-7T mutation associated with less severe disease (see section 5.1).
Maltese: Intweriet inqas evidenza ta' effett pożittiv ta' ivacaftor għal pazjenti b'mutazzjoni R117H-7T assoċjata ma' mard inqas sever (ara sezzjoni 5.1).
English: 4 individual wallets with 14 sachets per wallet
Maltese: 4 kartieri individwali b'14-il qartas f'kull kartiera
English: Tinnitus common
Maltese: ANNESS II
English: Following a single dose of 150 mg of ivacaftor, adult subjects with moderately impaired hepatic function (Child-Pugh Class B, score 7 to 9) had similar ivacaftor Cmax (mean [± SD] of 735 [331] ng/mL) but an approximately two-fold increase in ivacaftor AUC0-∞ (mean [± SD] of 16800 [6140] ng*hr/mL) compared with healthy subjects matched for demographics.
Maltese: 735 [331] ng/mL), iżda kellhom żieda ta' madwar id-doppju fl-AUC0-∞ ta' ivacaftor (medja [± SD] ta' 16800 [6140] ng*hr/mL) meta mqabbla ma' individwi b'saħħithom li tqabblu skont id-demografija.