FrancophonIA/ELRC3.0 huggingface dataset:
English: Ivacaftor is a potentiator of the CFTR protein, i.e., in vitro ivacaftor increases CFTR channel gating to enhance chloride transport in specified gating mutations (as listed in section 4.1) with reduced channel-open probability compared to normal CFTR.
Maltese: Ivacaftor hu potenzjatur tal-proteina CFTR, i.e. in vitro ivacaftor iżid is-CFTR channel gating biex itejjeb it-trasport tal-chloride f'mutazzjonijiet gating speċifikati (kif elenkati f'sezzjoni 4.1) bi probabbiltà mnaqqsa ta' channel miftuħ meta mqabbla ma' CFTR normali.
English: One patient (0.2%) on therapy and 2 patients (0.4%) on placebo permanently discontinued treatment for elevated transaminases.
Maltese: Pazjent wieħed (0.2%) fuq terapija u żewġ (2) pazjenti (0.4%) fuq il-plaċebo waqqfu l-kura b'mod permanenti minħabba livelli għolja ta' transaminases.
English: Moderate (Child-Pugh Class B)
Maltese: (Child-Pugh Klassi B)
English: In vitro responses seen in single channel patch clamp experiments using membrane patches from rodent cells expressing mutant CFTR forms do not necessarily correspond to in vivo pharmacodynamic response (e.g., sweat chloride) or clinical benefit.
Maltese: Risponsi in vitro li ġew osservati f'esperimenti waħidhom bl-użu ta' channel patch clamp fejn jintużaw membrani minn ċelluli tal-ġrieden li jesprimu forom mutanti ta' CFTR, mhux neċessarjament jikkorrispondu għal rispons farmakodinamiku in vivo (eż., chloride fl-għaraq) jew benefiċċju kliniku.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas totali ta' lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din ilmediċina.
English: In a human pharmacokinetic study with ivacaftor monotherapy, 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 filbnedmin fuq monoterapija b'ivacaftor, kien hemm eliminazzjoni minima ta' ivacaftor u l-metaboliti tiegħu fl-awrina (6.6% biss tar-radjuattività totali ġiet irkuprata fl-awrina).
English: Kalydeco 150 mg tablets ivacaftor
Maltese: Kalydeco 150 mg pilloli ivacaftor
English: * Values based on data from a single patient; standard deviation not reported.
Maltese: * Valuri bbażati fuq data minn pazjent wieħed; devjazzjoni standard mhix irrapportata.
English: * Statistical testing was not performed due to small numbers for individual mutations.
Maltese: * L-ittestjar statistiku ma twettaqx minħabba n-numru żgħir ta' mutazzjonijiet individwali. †
English: Refer to the Summary of Product Characteristics of tezacaftor/ivacaftor for additional data.
Maltese: Irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott għal tezacaftor/ivacaftor għal informazzjoni addizzjonali.
English: The estimated treatment difference for ivacaftor versus placebo was 2.1 percentage points (95% CI -1.1, 5.4).
Maltese: Id-differenza stmata fil-kura għal ivacaftor kontra l-plaċebo kienet ta' 2.1 punti perċentwali (95% CI -1.1, 5.4).
English: Ivacaftor was associated with slight decreases of the seminal vesicle weights, a decrease of overall fertility index and number of pregnancies in females mated with treated males and significant reductions in number of corpora lutea and implantation sites with subsequent reductions in the average litter size and average number of viable embryos per litter in treated females.
Maltese: Ivacaftor kien assoċjat ma' tnaqqis żgħir fil-piżijiet tal-vexxikuli seminali, ma' tnaqqis fl-indiċi globali tal-fertilità u fin-numru ta' tqaliet fin-nisa mgħammra ma' rġiel ikkurati, u tnaqqis sinifikanti finnumru ta' corpora lutea u siti ta' impjantazzjoni bi tnaqqis sussegwenti fid-daqs medju tal-boton u finnumru medju tal-embrijuni vijabbli għal kull boton fin-nisa kkurati.
English: Absolute change in sweat chloride (mmol/L)
Maltese: Bidla assoluta tal-chloride fl-għaraq (mmol/L)
English: Ivacaftor is extensively metabolised in humans.
Maltese: Ivacaftor jiġi metabolizzat b'mod estensiv fil-bnedmin.
English: Nausea *
Maltese: Dardir *
English: Currently available data are described in sections 4.4, 4.8 and 5.1, but no recommendation on a posology can be made.
Maltese: Data disponibbli hija deskritta fis-sezzjonijiet 4.4, 4.8 u 5.1, iżda ma' tista' ssir l-ebda rakkomandazzjoni dwar pożoloġija.
English: During the 24-week, open-label, Phase 3 clinical study of ivacaftor in patients aged less than 24 months (study 8), the incidence of patients experiencing transaminase elevations (ALT or AST) > 3, > 5, and > 8 x ULN in the cohort of patients aged 12 months to less than 24 months was 27.8% (5/18), 11.1% (2/18) and 11.1% (2/18), respectively.
Maltese: Matul l-istudju kliniku open-label ta' Fażi 3 ta' ivacaftor li dam 24 ġimgħa li sar f'pazjenti li kellhom inqas minn 24 xahar (Studju 8), l-inċidenza ta' pazjenti li kellhom żidiet fil-livell ta' transaminases (ALT jew AST) > 3, > 5, u > 8 x ULN fil-koort ta' pazjenti li kellhom 12-il xahar sa inqas minn 24 xahar kienet ta' 27.8% (5/18), 11.1% (2/18) u 11.1% (2/18), rispettivament.
English: Following oral administration in healthy volunteers, the majority of ivacaftor (87.8%) was eliminated in the faeces after metabolic conversion.
Maltese: Wara l-għoti mill-ħalq f'voluntiera b'saħħithom, il-maġġoranza ta' ivacaftor (87.8%) ġiet eliminata flippurgar wara konverżjoni metabolika.
English: • Cardiac glycosides such as digoxin, used for the treatment of mild to moderate congestive heart failure and an abnormal heart rhythm called atrial fibrillation
Maltese: • Glycosides kardijaċi, bħal digoxin, li jintużaw għal kura ta' insuffiċjenza konġestiva tal-qalb minn ħafifa sa moderata u ritmu mhux normali tal-qalb, imsejjaħ fibrillazzjoni atrijali
English: d Hazard ratio for time to first pulmonary exacerbation e In subjects under 20 years of age (CDC growth charts)
Maltese: d Proporzjon ta' periklu għall-ewwel aggravament pulmonari e F'individwi ta' taħt l-20 sena (charts tat-tkabbir CDC)
English: During the placebo controlled Phase 3 studies (up to 24 weeks) of ivacaftor in a combination regimen with tezacaftor/ivacaftor, the incidence of maximum transaminase (ALT or AST) > 8, > 5, or > 3 x ULN were similar between tezacaftor/ivacaftor in combination with ivacaftor and placebo-treated patients; 0.2%, 1.0%, and 3.4% in tezacaftor/ivacaftor in combination with ivacaftor-treated patients, and 0.4%, 1.0%, and 3.4% in placebo-treated patients.
Maltese: Matul l-istudji kkontrollati bil-plaċebo ta' Fażi 3 (sa 24 ġimgħa) ta' ivacaftor f'kors ikkombinat flimkien ma' tezacaftor/ivacaftor, l-inċidenza ta' transaminases massima (ALT jew AST) >8, >5, jew >3 darbiet aktar l-ULN kienet simili bejn tezacaftor/ivacaftor flimkien ma' pazjenti kkurati b'ivacaftor u l-plaċebo; 0.2%, 1.0%, u 3.4% f'pazjenti kkurati b'tezacaftor/ivacaftor ikkombinat ma' ivacaftor, u 0.4%, 1.0%, u 3.4% f'pazjenti kkurati bil-plaċebo.
English: The most common adverse reactions experienced by patients aged 6 years and older who received ivacaftor in the pooled 48-week placebo-controlled Phase 3 studies that occurred with an incidence of at least 3% and up to 9% higher than in the placebo arm were headache (23.9%), oropharyngeal pain (22.0%), upper respiratory tract infection (22.0%), nasal congestion (20.2%), abdominal pain (15.6%), nasopharyngitis (14.7%), diarrhoea (12.8%), dizziness (9.2%), rash (12.8%) and bacteria in sputum (12.8%).
Maltese: L-iktar reazzjonijiet avversi komuni li kellhom pazjenti fl-età ta' 6 snin jew iktar li rċivew ivacaftor flistudji miġbura ta' Fażi 3, li damu 48 ġimgħa, ikkontrollati bi plaċebo, li seħħew b'inċidenza ta' millinqas 3% u sa 9% ogħla milli fil-parti tal-istudju dwar il-plaċebo, kienu wġigħ ta' ras (23.9%), uġigħ orofarinġeali (22.0%), infezzjoni fin-naħa ta' fuq tal-apparat respiratorju (22.0%), konġestjoni nażali (20.2%), uġigħ addominali (15.
English: The frequency of adverse reactions is defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Maltese: Il-frekwenza tar-reazzjonijiet avversi hi definita kif ġej: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Weight-for-age z-score Length-for-age z-score Weight-for-length z-score 28
Maltese: Bidla medja mil-linja bażi f'punteġġi z
English: In studies 1 and 2 in patients with the G551D mutation in one allele of the CFTR gene, ivacaftor led to rapid (15 days), substantial (the mean change in sweat chloride from baseline through week 24 was -48 mmol/L [95% CI -51, -45] and -54 mmol/L [95% CI -62, -47], respectively) and sustained (through 48 weeks) reductions in sweat chloride concentration.
Maltese: Fi studji 1 u 2 f'pazjenti bil-mutazzjoni G551D f'allele wieħed tal-ġene CFTR, ivacaftor wassal għal tnaqqis mgħaġġel (15-il jum), sostanzjali (il-medja tal-bidla fil-chloride fl-għaraq mil-linja bażi sa ġimgħa 24 kienet ta' -48 mmol/L [95% CI -51, -45] u -54 mmol/L [95% CI -62, -47], rispettivament), u tnaqqis sostnut (sa 48 ġimgħa) fil-konċentrazzjoni ta' chloride fl-għaraq.
English: The mean (SD) Faecal Elastase-1 value at baseline (n = 27) was 28 µg/g (95).
Maltese: Il-medja (SD) tal-valur ta' Elastase-1 fl-Ippurgar fil-linja bażi (n=27) kienet ta' 28 µg/L (95).
English: When co-administered with strong inhibitors of CYP3A, the Kalydeco dose should be reduced to one sachet (ivacaftor 25 mg for patients 5 kg to < 7 kg; ivacaftor 50 mg for patients 7 kg to < 14 kg; ivacaftor 75 mg for patients 14 kg to < 25 kg) twice a week (see sections 4.4 and 4.5).
Maltese: Meta jingħata flimkien ma' inibituri qawwija ta' CYP3A, id-doża ta' Kalydeco għandha titnaqqas għal qartas wieħed (ivacaftor 25 mg għal pazjenti li jiżnu bejn 5 kg sa < 7 kg; ivacaftor 50 mg għal pazjenti li jiżnu 7 kg sa < 14 kg; ivacaftor 75 mg għal pazjenti li jiżnu 14 kg sa < 25 kg) darbtejn fil-ġimgħa (ara sezzjonijiet 4.4 u 4.5).
English: Kalydeco is available in the following pack sizes:
Maltese: Kalydeco hu disponibbli fid-daqsijiet tal-pakkett li ġejjin:
English: For patients with moderate hepatic impairment (Child-Pugh Class B), a reduced dose of one sachet (ivacaftor 25 mg for patients 5 kg to < 7 kg; ivacaftor 50 mg for patients 7 kg to < 14 kg; ivacaftor 75 mg for patients 14 kg to < 25 kg) once daily is recommended.
Maltese: Għal pazjenti b'indeboliment moderat tal-fwied (Child-Pugh Klassi B), doża mnaqqsa ta' qartas wieħed (ivacaftor 25 mg għal pazjenti li jiżnu bejn 5 kg sa < 7 kg; ivacaftor 50 mg għal pazjenti li jiżnu 7 kg sa < 14 kg; ivacaftor 75 mg għal pazjenti li jiżnu 14 kg sa < 25 kg) darba kuljum hi rakkomandata.
English: The pharmacokinetic parameters of ivacaftor in combination with tezacaftor in the elderly patients (65-72 years) are comparable to those in younger adults.
Maltese: Il-parametri farmakokinetiċi ta' ivacaftor flimkien ma' tezacaftor filpazjenti anzjani (65-72 sena) huma komparabbli għal dawk fl-adulti żgħażagħ.
English: In patients aged 6 months to less than 24 months, with both baseline and week 24 values available, sixteen patients were pancreatic insufficient at baseline (defined as Faecal Elastase-1 < 200 µg/g) with mean (SD) Faecal Elastase-1 values at baseline and week 24 of 19.8 µg/g (23) and 248.2 µg/g (135.6), respectively (mean [SD] absolute change 228.4 µg/g [136.5]).
Maltese: F'pazjenti li kellhom 6 xhur sa inqas minn 24 xahar, li kellhom kemm il-valuri fil-linja bażi u kemm dawk ta' ġimgħa 24 disponibbli, sittax-il pazjent kellhom insuffiċjenza fil-frixa fil-linja bażi (definita bħala Elastase-1 fl-Ippurgar <200 µg/g) b'valuri medji (SD) ta' Elastase-1 fl-Ippurgar fil-linja bażi u f'ġimgħa 24 ta' 19.8 µg/g (23) u 248.2 µg/g (135.6), rispettivament (bidla assoluta medja [SD] ta' 228.4 µg/g [136.5]).
English: In patients aged 2 to less than 6 years the most common adverse reactions were nasal congestion (26.5%), upper respiratory tract infection (23.5%), transaminase elevations (14.7%), rash (11.8%), and bacteria in sputum (11.8%).
Maltese: 5%), infezzjoni fin-naħa ta' fuq tal-apparat respiratorju (23.5%), żidiet fittransaminases (14.7%), raxx (11.8%), u batterji fl-isputum (11.8%).
English: Ivacaftor has not been studied in patients with CF who have undergone organ transplantation.
Maltese: Ivacaftor ma ġiex studjat f'pazjenti b'CF li kellhom trapjant tal-organi.
English: How to store Kalydeco 6.
Maltese: Kif taħżen Kalydeco 6.
English: Table 2: Adverse reactions in ivacaftor-treated patients aged 6 months and older System organ class
Maltese: Tabella 2: Reazzjonijiet avversi f'pazjenti kkurati b'ivacaftor li kellhom 6 xhur u aktar Sistema tal-klassifika talorgani
English: Medicinal products affecting the pharmacokinetics of ivacaftor
Maltese: Prodotti mediċinali li jaffettwaw il-farmakokinetika ta' ivacaftor
English: Other medicines and Kalydeco
Maltese: Mediċini oħra u Kalydeco
English: Kalydeco tablets are also indicated in a combination regimen with tezacaftor 100 mg/ivacaftor 150 mg tablets for the treatment of adults and adolescents aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the CFTR gene: P67L, R117C, L206W, R352Q, A455E,
Maltese: Il-pilloli Kalydeco huma indikati wkoll f'kors ikkombinat ma' pilloli tezacaftor 100 mg/ivacaftor 150 mg għall-kura ta' adulti u adolexxenti li għandhom 12-il sena u aktar b'fibrożi ċistika (CF) u li jkunu omożigotiċi għall-mutazzjoni F508del jew eterożigotiċi għall-mutazzjoni F508del u li jkollhom waħda mill-mutazjonijiet li ġejjin fil-ġene CFTR: P67L, R117C, L206W, R352Q, A455E, D579G,
English: Twenty-six patients out of the 34 enrolled (76.5%) had a CFTR genotype G551D/F508del with only 2 patients with a non-G551D mutation (S549N).
Maltese: Sitta u għoxrin pazjent mill-34 li kienu rreġistrati (76.5%) kellhom ġenotip CFTR G551D/F508del, b'2 pazjenti biss li kellhom mutazzjoni non-G551D (S549N).
English: The mean (±SD) CL/F for a single 150 mg dose was 17.3 (8.4) L/hr in healthy subjects.
Maltese: Il-medja (±SD) CL/F għal doża waħda ta' 150 mg kienet ta' 17.3 (8.4) L/siegħa f'individwi b'saħħithom.
English: Co-administration with digoxin, a sensitive P-gp substrate, increased digoxin exposure by 1.3-fold, consistent with weak inhibition of P-gp by ivacaftor.
Maltese: L-għoti flimkien ma' digoxin, substrat sensittiv ta' P-gp, żied l-esponiment għal digoxin b'1.3 darbiet, u dan hu konsistenti mal-inibizzjoni dgħajfa ta' P-gp minn ivacaftor.
English: After oral administration of a single 150 mg dose to healthy volunteers in a fed state, the mean (± SD) for AUC and Cmax were 10600 (5260) ng*hr/mL and 768 (233) ng/mL, respectively.
Maltese: Wara l-għoti mill-ħalq ta' dożi waħidhom ta' 150 mg lil voluntiera b'saħħithom wara li kienu kielu, il-medja (±SD) għall-AUC u s-Cmax kienu ta' 10600 (5260) ng*hr/mL u 768 (233) ng/mL, rispettivament.
English: Each film-coated tablet contains 167.2 mg of lactose (as monohydrate)
Maltese: Kull qartas fih 73.2 mg ta' lactose (bħala monohydrate).
English: The pharmacokinetic parameters of ivacaftor in combination with tezacaftor in adolescent patients (12 to 17 year-olds) are comparable to those in adults (see Table 8).
Maltese: Il-parametri farmakokinetiċi ta' ivacaftor flimkien ma' tezacaftor fil-pazjenti adolexxenti (li jkollhom minn 12 sa 17-il sena) huma komparabbli għal dawk fl-adulti (ara Tabella 8).
English: • Talk to your doctor if you have liver problems, or have previously had them.
Maltese: • Kellem lit-tabib tiegħek jekk għandek problemi tal-kliewi, jew kellek problemi tal-kliewi fil passat.
English: The safety profile is generally consistent among paediatric patients aged 6 months and older and adult patients.
Maltese: Il-profil tas-sigurtà hu ġeneralment konsistenti fost pazjenti pedjatriċi li għandhom 6 xhur u aktar u f'pazjenti adulti.
English: CYP3A substrates
Maltese: CYP3A
English: G1244E (5) G1349D (2) G178R (5) G551S (2) G970R# (4) S1251N (8) S1255P (2) S549N (6) S549R (4)
Maltese: S1251N (8) S1255P (2) S549N (6) S549R (4)
English: The estimated treatment difference for ivacaftor versus placebo was 1.7 percentage points (95% CI -0.6, 4.1); this difference was not statistically significant (P = 0.15).
Maltese: Id-differenza stmata fil-kura għal ivacaftor kontra l-plaċebo kienet ta' 1.7 punti perċentwali (95% CI -0.6, 4.1); din id-differenza ma kinitx statistikament sinifikanti (P=0.15).
English: Vertex
Maltese: Treddigħ
English: Following multiple oral dose administrations of ivacaftor, the exposure of ivacaftor generally increased with dose from 25 mg every 12 hours to 450 mg every 12 hours.
Maltese: Wara l-għoti ta' dożi multipli orali ta' ivacaftor, l-esponiment għal ivacaftor ġeneralment żdied ma' doża minn 25 mg kull 12-il siegħa sa 450 mg kull 12-il siegħa.
English: Mean absolute change from baseline in BMI (kg/m2)
Maltese: Bidla assoluta medja mil-linja bażi fil-BMI (kg/m2)
English: Breast mass common
Maltese: Ġinekomastija mhux komuni
English: Medicinal products affected by ivacaftor
Maltese: Prodotti mediċinali affettwati minn ivacaftor
English: • Meats, oily fish
Maltese: • Laħmijiet, ħut żejtni
English: 2- to 5-year-olds (< 14 kg)
Maltese: Tfal minn 2 sa 5 snin (<14 kg)
English: The confirmed R117H poly-T variant was 5T in 38 patients and 7T in 16 patients.
Maltese: Il-varjant kkonfermat ta' R117H poly-T kien 5T fi 38 pazjent u 7T f'16il pazjent.
English: S549R (4)
Maltese: G551S (2)
English: Effect on liver function tests
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Kalydeco monotherapy
Maltese: Monoterapija b'Kalydeco
English: 6 months to less than 12 months (5 kg to < 7 kg) *
Maltese: (5 kg sa <7 kg) *
English: When they rolled over into study 4, the rate of annualised pulmonary exacerbations was 0.91 events/year across day 1 to week 48 and 0.77 events/year across weeks 48 to 96.
Maltese: Meta qalbu għal studju 4, ir-rata annwalizzata ta' aggravamenti pulmonari kienet ta' 0.91 avvenimenti/sena minn jum 1 sa ġimgħa 48 u 0.77 avvenimenti/sena minn ġimgħat 48 sa 96.
English: Children and adolescents
Maltese: Adolexxenti minn
English: Gynaecomastia uncommon
Maltese: Sturdament komuni ħafna
English: Infants aged at least 6 months, toddlers, children, adolescents and adults should be dosed according to Table 1.
Maltese: Trabi li għandhom mill-inqas 6 xhur, trabi li għadhom kemm telqu jimxu, tfal, adolexxenti u adulti għandhom jiġu ddożati skont Tabella 1.
English: Kalydeco 25 mg granules in sachet Kalydeco 50 mg granules in sachet Kalydeco 75 mg granules in sachet
Maltese: Kalydeco 25 mg granijiet f'qartas Kalydeco 50 mg granijiet f'qartas Kalydeco 75 mg granijiet f'qartas ivacaftor
English: Ivacaftor had an effect on fertility in rats (see section 5.3).
Maltese: Ivacaftor kellu effett fuq il-fertilità fil-firien (ara sezzjoni 5.3).
English: The treatment difference between ivacaftor and placebo for the mean absolute change (95% CI) in percent predicted FEV1 from baseline through week 24 was 10.6 percentage points (8.6, 12.6) in study 1 and 12.5 percentage points (6.6, 18.3) in study 2.
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 kienet ta' 10.6 punti perċentwali (8.6, 12.6) fi studju 1 u 12.5 punti perċentwali (6.6, 18.3) fi studju 2.
English: Placebo Study 2
Maltese: Ivacaftor Plaċebo Studju 2
English: tezacaftor 100 mg qd / ivacaftor 150 mg q12h
Maltese: ivacaftor 150 mg q12h
English: Absolute change from baseline in percent predicted FEV1 (percentage points) N
Maltese: Bidla assoluta f'perċentwali ta' FEV1 imbassar (punti perċentwali)
English: Ivacaftor acts at the level of the cystic fibrosis transmembrane conductance regulator (CFTR), a protein that forms a channel at the cell surface that allows the movement of particles such as chloride in and out of the cell.
Maltese: Ivacaftor jaġixxi fil-livell tas-cystic fibrosis transmembrane conductance regulator (CFTR), proteina li tifforma kanal fil-wiċċ taċ-ċellula li jippermetti l-moviment ta' partiċelli bħal chloride fi u 'l barra miċ-ċellula.
English: The mean (SD) overall change in stature-for-age z-score was -0.01 (0.33).
Maltese: Il-medja (SD) globali tal-bidla fl-istatura għall-punteġġ z għall-età kienet ta' -0.01 (0.33).
English: In part 1 of study 5, the mean FEV1 percent predicted at baseline in placebo-treated patients was 79.3% while in ivacaftor-treated patients this value was 76.4%.
Maltese: F'parti 1 ta' studju 5, il-medja f'perċentwali tal-FEV1 imbassar fil-linja bażi f'pazjenti kkurati bi plaċebo kienet ta' 79.3%, filwaqt li f'pazjenti kkurati b'ivacaftor, dan il-valur kien ta' 76.4%.
English: Ivacaftor in a combination regimen with tezacaftor/ivacaftor In patients homozygous for the F508del mutation, the treatment difference between ivacaftor in combination with tezacaftor/ivacaftor and placebo in mean absolute change from baseline in sweat chloride through week 24, was -10.1 mmol/L (95% CI: -11.4, -8.8).
Maltese: Ivacaftor f'kors ikkombinat flimkien ma' tezacaftor/ivacaftor F'pazjenti omożigotiċi għall-mutazzjoni F508del, id-differenza fil-kura bejn ivacaftor flimkien ma' tezacaftor/ivacaftor u plaċebo fil-bidla assoluta medja minn linja bażi fi chloride tal-għaraq sa ġimgħa 24 kienet -10.1 mmol/L (95% CI: -11.4, -8.8).
English: Tertiary endpoints included efficacy measures such as Faecal Elastase-1 and growth parameters.
Maltese: Il-punti aħħarin terzjarji kienu jinkludu kejl ta' effikaċja bħal Elastase-1 fl-Ippurgar (Faecal Elastase-1) u parametri tat-tkabbir.
English: Table 8: Mean (SD) of ivacaftor exposure when used in combination with tezacaftor, by age group
Maltese: Tabella 8: Il-medja (SD) tal-esponiment ta' ivacaftor meta jintuża flimkien ma' tezacaftor, skont il-grupp ta' età
English: Co-administration of Kalydeco 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 ma' indutturi qawwija ta' CYP3A bħal rifampicin, rifabutin, phenobarbital, carbamazepine, phenytoin u St.
English: Mix the entire content of a sachet with 5 mL of age-appropriate soft food or liquid that is at or below room temperature and consume it completely.
Maltese: Ħallat il-kontenut kollu ta' qartas ma' 5 mL ta' ikel artab jew likwidu li jkunu adattati għall-età li jkun fit-temperatura tal-kamra jew taħt it-temperatura tal-kamra, u kkunsmah kompletament.
English: The median (range) tmax is approximately 4.0 (3.0; 6.0) hours in the fed state.
Maltese: Il-medjan (medda) tat-tmax hu ta' madwar 4.0 (3.0; 6.0) sigħat wara li wieħed ikun kiel.