FrancophonIA/ELRC3.0 huggingface dataset:
English: • Abnormality of the eye lens (cataract) without any effect on vision has been noted in some children and adolescents treated with Kalydeco (alone or in combination with tezacaftor/ivacaftor).
Maltese: • Anormalità tal-lenti tal-għajn (katarretti) mingħajr ebda effett fuq il-vista ġiet osservata f'xi tfal u adolexxenti kkurati b'Kalydeco (waħdu jew flimkien ma' tezacaftor/ivacaftor).
English: Each tablet contains 150 mg of ivacaftor.
Maltese: Kull pillola fiha 150 mg ta' ivacaftor.
English: Ivacaftor 150 mg tablet
Maltese: Pillola ta' ivacaftor 150 mg
English: During the 48-week placebo-controlled studies 1 and 2 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 f'pazjenti li kellhom 6 snin u aktar, linċidenza 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,
English: In vitro studies showed that ivacaftor is not a substrate for OATP1B1 or OATP1B3.
Maltese: Il-potenzjal li ivacaftor ikollu interazzjoni ma' trasportaturi Studji in vitro wrew li ivacaftor mhuwiex substrat ta' OATP1B1 jew OATP1B3.
English: Package leaflet: Information for the patient Kalydeco 25 mg granules in sachet
Maltese: INFORMAZZJONI BIL-BRAILLE Kalydeco 25 mg granijiet
English: In the event of significant elevations of transaminases (e.g., patients with ALT or AST > 5 x the upper limit of normal (ULN), or ALT or AST > 3 x ULN with bilirubin > 2 x ULN), dosing should be interrupted and laboratory tests closely followed until the abnormalities resolve.
Maltese: Fil-każ ta' żidiet sinifikanti fit-transaminases (eż., pazjenti b'ALT jew AST ta' >5 darbiet aktar tal-ogħla limitu tan-normal (ULN, upper limit of normal); jew ALT jew AST ta' >3 darbiet aktar mill-ULN b'bilirubina ta' >2 darbiet aktar mill-ULN), id-dożaġġ għandu jitwaqqaf u t-testijiet tal-laboratorju għandhom ikunu segwiti millqrib sakemm jissolvew l-anormalitajiet.
English: Table 4: Effect of ivacaftor for efficacy variables in the overall population and for specific CFTR mutations Absolute change in percent predicted FEV1
Maltese: Tabella 4: L-effett ta' ivacaftor għal varjabbli ta' effikaċja fil-popolazzjoni globali u għal mutazzjonijiet CFTR speċifiċi Bidla assoluta f'perċentwali ta' FEV1 imbassar
English: Kalydeco tablets are also indicated for the treatment of adults aged 18 years and older with cystic fibrosis (CF) who have an R117H mutation in the CFTR gene (see sections 4.4 and 5.1).
Maltese: Il-pilloli Kalydeco huma indikati wkoll għall-kura ta' adulti li jkollhom 18-il sena u aktar b'fibrożi ċistika (CF), li jkollhom mutazzjoni R117H fil-ġene CFTR (ara sezzjonijiet 4.4 u 5.1).
English: The No-Observed-Adverse-Effect-Level (NOAEL) for fertility findings provides an exposure level of approximately 4 times the systemic exposure of ivacaftor and its metabolites when administered as ivacaftor monotherapy in adult humans at the maximum recommended human dose (MRHD).
Maltese: esponiment sistemiku ta' madwar 4 darbiet aktar tal-esponiment ta' ivacaftor u l-metaboliti tiegħu meta mogħti bħala monoterapija b'ivacaftor fil-bnedmin adulti fid-doża massima rakkomandata għallbniedem (MRHD, maximum recommended human dose).
English: In study 5, part 1 in patients who had a non-G551D gating mutation in the CFTR gene, treatment with ivacaftor led to a rapid (15 days) and substantial mean change from baseline in sweat chloride of -49 mmol/L (95% CI -57, -41) through 8 weeks of treatment.
Maltese: Fi studju 5, parti 1 f'pazjenti li kellhom mutazzjoni non-G551D gating fil-ġene CFTR, il-kura b'ivacaftor wasslet għal bidla mgħaġġla (15-il jum) u bidla medja sostanzjali mil-linja bażi talchloride fl-għaraq ta' -49 mmol/L (95% CI -57, -41) sa 8 ġimgħat ta' kura.
English: How to store Kalydeco
Maltese: X'fih Kalydeco
English: Study 5: study in patients with CF with non-G551D gating mutations Study 5 was a Phase 3, two-part, randomised, double-blind, placebo-controlled, crossover study (part 1) followed by a 16-week open-label extension period (part 2) to evaluate the efficacy and safety of ivacaftor in patients with CF aged 6 years and older who have a G970R or non-G551D gating mutation in the CFTR gene (G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P or G1349D).
Maltese: Studju 5: studju f'pazjenti b'CF b'mutazzjonijiet non-G551D gating Studju 5 kien studju ta' fażi 3, li kien fih żewġ partijiet, li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollat bi plaċebo, crossover (parti 1) segwit minn perjodu open-label ta' estensjoni li dam 16-il ġimgħa (parti 2) biex jevalwa l-effikaċja u s-sigurtà ta' ivacaftor f'pazjenti b'CF li kellhom 6 snin u aktar, li kellhom mutazzjoni G970R jew non-G551D gating fil-ġene CFTR (G178R,
English: Efficacy was not demonstrated in patients aged 6 to 11 years with CF who have an R117H mutation while only two adolescent patients were enrolled in study 6 (see section 5.1).
Maltese: L-effikaċja ma ntwerietx f'pazjenti li kellhom minn 6 sa 11-il sena b'CF li kellhom mutazzjoni R117H, filwaqt li żewġ pazjenti adolexxenti biss ġew irreġistrati fi studju 6 (ara sezzjoni 5.1).
English: The treatment difference between ivacaftor and placebo for the mean absolute change (95% CI) in percent predicted FEV1 from baseline through week 24 in patients 12 to 17 years of age in study 1 was 11.9 percentage points (5.9, 17.9).
Maltese: Id-differenza fil-kura bejn ivacaftor u plaċebo għall-bidla assoluta medja (95% CI) f'perċentwali talFEV1 imbassar mil-linja bażi sa ġimgħa 24 f'pazjenti li kellhom minn 12 sa 17-il sena fi studju 1 kienet ta' 11.9 punti perċentwali (5.9, 17.9).
English: In a subgroup analysis in patients 6 to 11 years of age (8 patients on placebo and 9 patients on ivacaftor), the placebo group showed an improvement in mean percent predicted FEV1 from 94.0% at baseline to 98.4% post-baseline; the ivacaftor group showed a slight decline in mean FEV1 from 97.5% at baseline to 96.2% overall post-baseline.
Maltese: F'analiżi tas-sottogrupp f'pazjenti li kellhom minn 6 sa 11-il sena (8 pazjenti fuq plaċebo u 9 pazjenti fuq ivacaftor), il-grupp tal-plaċebo wera titjib fil-medja tal-perċentwali tal-FEV1 imbassar minn 94.0% fil-linja bażi għal 98.4% wara l-linja bażi; il-grupp ta' ivacaftor wera tnaqqis żgħir fil-medja tal-FEV1 minn 97.5% fil-linja bażi għal 96.2% b'mod ġenerali wara l-linja bażi.
English: In vitro studies showed that ivacaftor is not a substrate for P-gp.
Maltese: Studji in vitro wrew li ivacaftor mhuwiex substrat ta' P-gp.
English: The treatment difference between ivacaftor and placebo for the mean absolute change (95% CI) in percent predicted FEV1 from baseline through week 24 in patients with baseline predicted FEV1 greater than 90% in study 2 was 6.9 percentage points (-3.8, 17.6).
Maltese: Id-differenza fil-kura bejn ivacaftor u plaċebo għall-bidla assoluta medja (95% CI) f'perċentwali tal-FEV1 imbassar mil-linja bażi sa ġimgħa 24 f'pazjenti b'FEV1 imbassar ta' aktar minn 90% fi studju 2 kienet ta' 6.9 punti perċentwali (-3.8; 17.6).
English: The impact of severe hepatic impairment (Child Pugh Class C, score 10 to15) on the pharmacokinetics of ivacaftor have not been studied.
Maltese: L-impatt ta' indeboliment sever tal-fwied (Child-Pugh Klassi C, punteġġ 10 sa 15) fuq ilfarmakokinetika ta' ivacaftor ma ġiex studjat.
English: Granules in sachet
Maltese: U L-UŻU
English: Similar results to part 1 were seen in part 2 of the study.
Maltese: Riżultati simili għal parti 1 ġew osservati f'parti 2 tal-istudju.
English: There were no additional improvements in study 4 (week 48 through week 144).
Maltese: Ma kien hemm l-ebda titjib addizzjonali fi studju 4 (ġimgħa 48 sa ġimgħa 144).
English: Each sachet contains 25 mg of ivacaftor.
Maltese: Kull qartas fih 25 mg ta' ivacaftor.
English: Based on clinical (percent predicted FEV1) and pharmacodynamic (sweat chloride) responses to ivacaftor, efficacy in patients with the G970R mutation could not be established.
Maltese: Ibbażat fuq ir-risponsi kliniċi (perċentwali tal-FEV1 imbassar) u farmakodinamiċi (chloride fl-għaraq) għal ivacaftor, leffikaċja f'pazjenti bil-mutazzjoni G970R ma setgħetx tiġi stabbilita.
English: In patients with a confirmed R117H-7T genetic variant, the treatment difference between ivacaftor and placebo was 0.2% (95% CI -8.1, 8.5).
Maltese: F'pazjenti b'varjant ġenetiku ta' R117H-7T ikkonfermat iddifferenza fil-kura bejn ivacaftor u l-plaċebo kienet ta' 0.2% (95% CI -8.1, 8.5).
English: Shellac
Maltese: Talc
English: For patients randomised to the placebo/ivacaftor treatment sequence in part 1 there was a further mean (SD) change of 3.3% (9.3%) in percent predicted FEV1 after the additional 16 weeks of treatment with ivacaftor.
Maltese: Għal pazjenti li ntgħażlu b'mod każwali għas-sekwenza ta' kura bi plaċebo/ivacaftor f'parti 1, kien hemm bidla medja (SD) addizzjonali ta' 3.3% (9.3%) f'perċentwali ta' FEV1 imbassar wara s-16-il ġimgħa addizzjonali ta' kura b'ivacaftor.
English: Secondary and exploratory efficacy endpoints evaluated were absolute change from baseline in sweat chloride through 24 weeks of treatment, absolute change from baseline in weight, body mass index (BMI) and stature (supported by weight, BMI and stature z-scores) at 24 weeks of treatment, and measures of pancreatic function such as Faecal Elastase-1.
Maltese: Il-punti aħħarin taleffikaċja sekondarji u esploratorji evalwati kienu l-bidla assoluta mil-linja bażi fil-chloride fl-għaraq sa 24 ġimgħa ta' kura, il-bidla assoluta mil-linja bażi fil-piż, l- indiċi tal-massa tal-ġisem (BMI), u listatura (appoġġjata mill-punteġġi z tal-piż, BMI u tal-istatura) wara 24 ġimgħa ta' kura, u l-kejl talfunzjoni tal-frixa bħal Elastase-1 fl-Ippurgar.
English: The safety data of ivacaftor monotherapy were evaluated in 11 patients between 6 months to less than 12 months of age, 19 patients between 12 months to less than 24 months of age, 34 patients between 2 to less than 6 years of age, 61 patients between 6 to less than 12 years of age and 94 patients between 12 to less than 18 years of age.
Maltese: Id-dejta dwar is-sigurtà ta' ivacaftor ġiet evalwata fi 11-il pazjent li kellhom bejn 6 xhur sa inqas minn 12-il xahar, f'19-il pazjent li kellhom bejn 12-il xahar sa inqas minn 24 xahar, f'34 pazjent li kellhom bejn sentejn sa inqas minn 6 snin, 61 pazjent li kellhom bejn 6 sa inqas minn 12-il sena, u 94 pazjent li kellhom bejn 12 sa inqas minn 18-il sena.
English: Only patients with CF who had a G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R gating (class III) or G970R mutation in at least one allele of the CFTR gene were included in studies 1, 2, 5 and 7 (see section 5.1).
Maltese: Pazjenti biss b'CF li kellhom mutazzjoni gating G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N jew S549R (klassi III) jew mutazzjoni G970R f'mill-inqas allele wieħed tal-ġene CFTR ġew inklużi fi studji 1, 2, 5 u 7 (ara sezzjoni 5.1).
English: Tablet film coat
Maltese: Pillola waħda ta' tezacaftor
English: Kalydeco 25 mg granules
Maltese: Kalydeco 25 mg granijiet f'qartas
English: Table 3 reflects the adverse reactions observed with ivacaftor monotherapy in clinical trials (placebocontrolled and uncontrolled studies) in which the length of exposure to ivacaftor ranged from 16 weeks to 144 weeks.
Maltese: Tabella 3 tirrifletti r-reazzjonijiet avversi osservati b'monoterapija b'ivacaftor fiprovi 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: Very limited data are available for elderly patients treated with ivacaftor (administered as monotherapy or in a combination regimen with tezacaftor/ivacaftor).
Maltese: Hemm dejta limitata ħafna disponibbli għal pazjenti anzjani kkurati b'ivacaftor (mogħti bħala monoterapija jew f'kors ikkombinat flimkien ma' tezacaftor/ivacaftor).
English: Ivacaftor (as monotherapy or in a combination regimen with tezacaftor/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 (bħala monoterapija jew f'kors ikkombinat flimkien ma' tezacaftor/ivacaftor) ġie studjat ma' kontraċettiv orali li fih oestrogen/progesterone u nstab li ma kellu l-ebda effett sinifikanti fuq lesponimenti tal-kontraċettiv orali.
English: Granules in sachet 14 sachets
Maltese: 12-il xahar sa inqas minn 24 xahar
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTER - 56-TABLET PACK
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TA' BARRA GĦALL-FOLJA - PAKKETT TA' 56 PILLOLA
English: Sinus congestion common
Maltese: Konġestjoni tas-sinus komuni
English: Due to its high intrinsic permeability and low likelihood of being excreted intact, co-administration of BCRP inhibitors is not expected to alter exposure of ivacaftor and M1-IVA, while any potential changes in M6-IVA exposures are not expected to be clinically relevant.
Maltese: Minħabba l-permeabbiltà intrinsika għolja tiegħu u l-probabbiltà baxxa li jiġi eliminat intatt, l-għoti flimkien ma' inibituri ta' BCRP mhuwiex mistenni li jibdel l-esponiment ta' ivacaftor u M1-IVA, filwaqt li kwalunkwe bidliet potenzjali fl-esponimenti għal M6-IVA mhumiex mistennija li jkunu klinikament rilevanti.
English: Each sachet contains 75 mg of ivacaftor.
Maltese: Kull qartas fih 75 mg ta' ivacaftor.
English: Mon. Tue. Wed. Thu. Fri. Sat. Sun.
Maltese: Ikel ieħor li fih ix-xaħam hu:
English: Kalydeco monotherapy in adults, adolescents, and children aged 6 years and older and weighing 25 kg or more
Maltese: Monoterapija b'Kalydeco f'adulti, adolexxenti, u tfal li għandhom 6 snin u aktar u li jiżnu 25 kg jew aktar
English: Treatment with ivacaftor resulted in a mean absolute change in percent predicted FEV1 through week 24 of 4.5 percentage points in the ivacaftor group versus -0.46 percentage points in the placebo group.
Maltese: Il-kura b'ivacaftor irriżultat f'bidla assoluta medja fil-perċentwali talFEV1 imbassar sa ġimgħa 24 ta' 4.5 punti perċentwali fil-grupp ta' ivacaftor kontra -0.46 punti perċentwali fil-grupp tal-plaċebo.
English: The exact mechanism leading ivacaftor to potentiate the gating activity of normal and some mutant CFTR forms in this system has not been completely elucidated.
Maltese: Il-mekkaniżmu eżatt li jwassal biex ivacaftor isaħħaħ l-attività gating ta' forom normali u xi forom mutanti ta' CFTR f'din is-sistema, ma ġiex spjegat kompletament.
English: Kalydeco 50 mg granules
Maltese: Kalydeco 50 mg granijiet f'qartas
English: Kalydeco 25 mg granules ivacaftor
Maltese: Kalydeco 25 mg granijiet f'qartas ivacaftor
English: Kalydeco contains the active ingredient ivacaftor.
Maltese: X'fih Kalydeco • Is-sustanza attiva hi ivacaftor.
English: Do not use this medicine after the expiry date which is stated on the package after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-pakkett wara EXP.
English: The mean (SD) overall change in percent predicted FEV1 from baseline at week 24 (exploratory endpoint) was 1.8 (17.81).
Maltese: Il-medja (SD) globali tal-bidla f'perċentwali ta' FEV1 imbassar mil-linja bażi f'ġimgħa 24 (punt aħħari esploratorju) kienet ta' 1.8 (17.81).
English: Kalydeco dosing recommendations are provided in Table 1.
Maltese: Rakkomandazzjoni dwar id-dożaġġ ta' Kalydeco huma pprovduti f'Tabella 1.
English: The primary endpoint of safety was evaluated through week 24 (see section 4.8).
Maltese: Il-punt aħħari primarju tas-sigurtà ġie evalwat sa ġimgħa 24 (ara sezzjoni 4.8).
English: In study 4, patients who completed treatment in studies 1 and 2 with placebo were switched to ivacaftor while patients on ivacaftor continued to receive it for a minimum of 96 weeks, i.e., the length of treatment with ivacaftor was at least 96 weeks for patients in the placebo/ivacaftor group and at least 144 weeks for patients in the ivacaftor/ivacaftor group.
Maltese: Fi Studju 4, pazjenti li lestew il-kura fi studji 1 u 2 bil-plaċebo nqalbu għal ivacaftor, filwaqt li pazjenti fuq ivacaftor komplew jirċevuh għal minimu ta' 96 ġimgħa, i.e., it-tul tal-kura b'ivacaftor kien mill-inqas 96 ġimgħa għal pazjenti fil-grupp tal-plaċebo/ivacaftor u mill-inqas 144 ġimgħa għal pazjenti fil-grupp ta' ivacaftor/ivacaftor.
English: The treatment difference between ivacaftor and placebo for the mean relative change (95% CI) in percent predicted FEV1 from baseline through week 24 was 17.1% (13.9, 20.2) in study 1 and 15.8% (8.4, 23.2) in study 2.
Maltese: Id-differenza fil-kura bejn ivacaftor u plaċebo għall-bidla relattiva medja (95% CI) f'perċentwali tal-FEV1 imbassar mil-linja bażi sa ġimgħa 24 kienet ta' 17.1% (13.9, 20.2) fi studju 1 u 15.
English: In children aged 6 to less than 12 years, the incidence of patients experiencing transaminase elevations (ALT or AST) > 3 x ULN was 15.0% (6/40) in ivacaftor-treated patients and 14.6% (6/41) in patients who received placebo.
Maltese: 0% (6/40) f'pazjenti kkurati b'ivacaftor u 14.6% (6/41) f'pazjenti li rċivew plaċebo.
English: BATCH NUMBER
Maltese: Linja Bażi
English: The effect of ivacaftor in the overall population of study 5 (including the secondary endpoints absolute change in BMI at 8 weeks of treatment and absolute change in the respiratory domain score of the CFQ-R through 8 weeks of treatment) and by individual mutation (absolute change in sweat chloride and in percent predicted FEV1 at week 8) is shown in Table 4.
Maltese: L-effett ta' ivacaftor fil-popolazzjoni globali ta' studju 5 (li jinkludi l-bidla assoluta tal-punti aħħarin sekondarji f'BMI wara 8 ġimgħat ta' kura u l-bidla assoluta fil-punteġġ tad-dominju respiratorju talCFQ-R wara 8 ġimgħat ta' kura) u skont il-mutazzjoni individwali (bidla assoluta tal-chloride flgħaraq u f'perċentwali tal-FEV1 imbassar f'ġimgħa 8) qed jintwera f'Tabella 4.
English: During the 24-week open-label Phase 3 clinical study of ivacaftor monotherapy in 34 patients aged 2 to less than 6 years (study 7), the incidence of patients experiencing transaminase elevations (ALT or AST) > 3 x ULN was 14.7% (5/34).
Maltese: Matul l-istudju kliniku fuq il-monoterapija b'ivacaftor open-label ta' Fażi 3 li dam 24 ġimgħa li sar f'34 pazjent, li kellhom minn sentejn sa inqas minn 6 snin (studju 7), l-inċidenza ta' pazjenti li kellhom żidiet fil-livell ta' transaminases (ALT jew AST) >3 x ULN kienet ta' 14.7% (5/34).
English: The mean absolute change from baseline through week 24 in percent predicted FEV1 (primary efficacy endpoint) was 2.57 percentage points in the ivacaftor group and 0.46 percentage points in the placebo group.
Maltese: Il-bidla assoluta medja mil-linja bażi sa ġimgħa 24 fil-perċentwali tal-FEV1 imbassar (punt aħħari tal-effikaċja primarja) kienet ta' 2.57 punti perċentwali fil-grupp ta' ivacaftor u 0.46 punti perċentwali fil-grupp tal-plaċebo.
English: The phase of the poly-T variant identified with the R117H mutation should be determined in accordance with local clinical recommendations.
Maltese: Il-fażi tal-varjant poly-T identifikata bil-mutazzjoni R117H għandha tiġi stabbilita skont irrakkomandazzjonijiet kliniċi lokali.
English: The effect of ivacaftor in the overall population of study 5 (including the secondary endpoints absolute change in BMI at 8 weeks of treatment and absolute change in the respiratory domain score of the CFQ-R through 8 weeks of treatment) and by individual mutation (absolute change in sweat chloride and in percent predicted FEV1 at week 8) is shown in Table 5.
Maltese: L-effett ta' ivacaftor fil-popolazzjoni globali ta' studju 5 (li jinkludi l-bidla assoluta tal-punti aħħarin sekondarji f'BMI wara 8 ġimgħat ta' kura u l-bidla assoluta fil-punteġġ tad-dominju respiratorju talCFQ-R wara 8 ġimgħat ta' kura) u skont il-mutazzjoni individwali (bidla assoluta tal-chloride flgħaraq u f'perċentwali tal-FEV1 imbassar f'ġimgħa 8) qed jintwera f'Tabella 5.
English: 6 months to less than 12 months (7 kg to < 14 kg)
Maltese: 6 xhur sa inqas minn 12il xahar (7 kg sa <14 kg)
English: At baseline, mean predicted FEV1 was 84.2% (range: 44.0% to 133.8%) and mean age was 9 years (range: 6 to 12 years); 8 (30.8%) patients in the placebo group and 4 (15.4%) patients in the ivacaftor group had an FEV1 less than 70% predicted at baseline.
Maltese: 2% (medda: 44.0% sa 133.8%) u l-età medja kienet ta' 9 snin (medda: 6 sa 12-il sena); 8 (30.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTER CARD - 28-TABLET PACK
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TA' BARRA GĦALL‑KARD BIL-FOLJI - PAKKETT TA' 28 PILLOLA
English: For patients in the ivacaftor/ivacaftor group from study 1, the annualised rate of pulmonary exacerbations was 0.57 events/year across day 1 to week 48 when patients were on ivacaftor.
Maltese: Għall-pazjenti fil-grupp ta' ivacaftor/ivacaftor minn studju 1, ir-rata annwalizzata ta' aggravamenti pulmonari kienet ta' 0.57 avvenimenti/sena minnjum 1 sa ġimgħa 48 meta l-pazjenti kienu fuq ivacaftor.
English: Administration of Kalydeco may increase systemic exposure of medicinal products that are sensitive substrates of P-gp, which may increase or prolong their therapeutic effect and adverse reactions.
Maltese: L-għoti ta' Kalydeco jista' jżid lesponiment sistemiku ta' prodotti mediċinali li huma substrati sensittivi ta' P-gp, u dan jista' jżid jew itawwal l-effett terapewtiku u r-reazzjonijiet avversi tagħhom.
English: Each sachet of granules should be mixed with 5 mL of age-appropriate soft food or liquid and completely and immediately consumed.
Maltese: Kull qartas ta' granijiet għandu jitħallat ma' 5 mL ta' ikel artab jew likwidu li jkun adattat għall-età, u jiġi kkunsmat kompletament u immedjatament.
English: CI: confidence interval; NA: not analysed due to low incidence of events a Treatment difference = effect of ivacaftor - effect of placebo b CFQ-R: Cystic Fibrosis Questionnaire-Revised is a disease-specific, health-related quality-of-life measure for CF. c Study 1 data were pooled from CFQ-R for adults/adolescents and CFQ-R for children 12 to 13 years of age; Study 2 data were obtained from CFQ-R for children 6 to 11 years of age.
Maltese: Kwestjonarju dwar il-Fibrożi Ċistika - Rivedut, kejl speċifiku għall-marda tal-kwalità tal-ħajja assoċjata mas saħħa, użat għal CF. ċ Dejta minn Studju 1 inġabret minn CFQ-R għal adulti/adolexxenti u CFQ-R għal tfal minn 12 sa 13-il sena; dejta minn
English: Vestibular disorder common
Maltese: Disturb vestibulari komuni Konġestjoni fil-widnejn mhux komuni
English: Tablet core
Maltese: Tabella 1.
English: The exposure of ivacaftor increased approximately 2.5- to 4-fold when given with food containing fat.
Maltese: L-esponiment ta' ivacaftor żdied b'madwar minn 2.5 sa 4 darbiet meta ngħata ma' ikel li kien fih ix-xaħam.
English: Rhinitis common
Maltese: Ir-Renju Unit
English: When the mean (SD) absolute change in percent predicted FEV1 is compared from study 4 baseline for patients in the ivacaftor/ivacaftor group (n = 72) who rolled over from study 1, the mean (SD) absolute change in percent predicted FEV1 was 0.0% (9.05), while for patients in the ivacaftor/ivacaftor group (n = 25) who rolled over from study 2 this figure was 0.6% (9.1).
Maltese: Meta l-medja (SD) tal-bidla assoluta f'perċentwali tal-FEV1 imbassar titqabbel mil-linja bażi ta' studju 4 għall-pazjenti fil-grupp ta' ivacaftor/ivacaftor (n=72) li nqalbu minn studju 1, il-medja (SD) ta' bidla assoluta f'perċentwali tal-FEV1 imbassar kienet ta' 0.0% (9.05), filwaqt li għall-pazjenti filgrupp ta' ivacaftor/ivacaftor (n=25) li nqalbu minn studju 2, din il-figura kienet ta' 0.6% (9.1).
English: Patients in study 7 were aged 2 to less than 6 years (mean age 3 years).
Maltese: Il-pazjenti fi studju 7 kellhom minn sentejn sa inqas minn 6 snin (età medja ta' 3 snin).
English: Study 7: study in paediatric patients with CF aged 2 to less than 6 years with G551D or another gating mutation
Maltese: Studju 7: studju f'pazjenti pedjatriċi b'CF li kellhom minn sentejn sa inqas minn 6 snin, b'mutazzjoni G551D jew mutazzjoni oħra gating