FrancophonIA/ELRC3.0 huggingface dataset:
English: The median (range) tmax of ivacaftor is approximately 4.0 hours (2.0; 6.0) in the fed state.
Maltese: Il-medjan (medda) tat-tmax ta' ivacaftor hu ta' madwar 4.0 sigħat (2.0; 6.0) wara li wieħed ikun kiel.
English: ↓ carbamazepine, phenobarbital, phenytoin Due to induction of CYP3A by LUM
Maltese: ↓ carbamazepine, phenobarbital, phenytoin Minħabba linduzzjoni ta' CYP3A minn LUM
English: Infections and infestations very common Nasopharyngitis* common
Maltese: Infezzjonijiet u infestazzjonijiet komuni ħafna Nażofarinġite* komuni
English: STATEMENT OF ACTIVE SUBSTANCE Each sachet of granules contains 150 mg of lumacaftor and 188 mg of ivacaftor.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull qartas ta' granijiet fiha 150 mg ta' lumacaftor u 188 mg ta' ivacaftor.
English: Lumacaftor and ivacaftor work together to improve the function of the abnormal CFTR protein.
Maltese: Lumacaftor u ivacaftor jaħdmu flimkien biex itejbu l-funzjoni tal-proteina CFTR anormali.
English: Treatment with lumacaftor/ivacaftor resulted in no significant improvement in ppFEV1 relative to placebo in patients with CF heterozygous for the F508del mutation in the CFTR gene (treatment difference 0.60 [P = 0.5978]) and no meaningful improvements in BMI or weight (see section 4.4).
Maltese: Il-kura b'lumacaftor/ivacaftor ma rriżultat fl-ebda titjib sinifikanti fil-ppFEV1 meta mqabbel mal-plaċebo f'pazjenti b'CF heterozygous għall-mutazzjoni F508del fil-ġene CFTR (differenza fil-kura 0.60 [P=0.5978]) u l-ebda titjib sinifikanti fil-BMI jew filpiż (ara sezzjoni 4.4).
English: Respiratory, thoracic and mediastinal disorders very common Nasal congestion, dyspnoea, productive cough, sputum increased common
Maltese: Disturbi respiratorji, toraċiċi u medjastinali komuni ħafna Konġestjoni nażali, dispnea, sogħla produttiva, żieda fl-isputum komuni
English: The safety and efficacy of lumacaftor/ivacaftor in patients age 65 years or older have not been evaluated.
Maltese: Is-sigurtà u l-effikaċja ta' lumacaftor/ivacaftor f'pazjenti li jkollhom 65 sena jew aktar ma ġewx evalwati.
English: Pink, oval-shaped tablets (dimensions 14 × 7.6 × 4.9 mm) printed with “1V125” in black ink on one side.
Maltese: Pilloli ta' lewn roża, b'forma ovali (daqs 14 × 7.6 × 4.9 mm) stampati b'“1V125” b'linka sewda fuq naħa waħda.
English: ↔ LUM, IVA ↓ bupropion Due to induction of CYP2B6 by LUM
Maltese: ↓ bupropion Minħabba linduzzjoni ta' CYP2B6 minn LUM
English: • Anticonvulsant medicines (used for the treatment of fits [epileptic seizures]) for example: phenobarbital, carbamazepine, phenytoin
Maltese: • Mediċini kontra l-konvulżjonijiet (jintużaw għall-kura ta' aċċessjonijiet [aċċessjonijiet epilettiċi]) pereżempju: phenobarbital, carbamazepine, phenytoin
English: Following multiple oral doses of lumacaftor, the exposure of lumacaftor generally increased proportional to dose over the range of 50 mg to 1000 mg every 24 hours.
Maltese: Wara l-għoti ta' dożi multipli orali ta' lumacaftor, l-esponiment ta' lumacaftor ġeneralment żdied b'mod proporzjonali mad-doża fuq il-medda ta' 50 mg to 1000 mg kull 24 siegħa.
English: ↓ montelukast Due to the induction of CYP3A/2C8/2C9 by LUM
Maltese: ↓ montelukast Minħabba linduzzjoni ta' CYP3A/2C8/2C9 minn LUM
English: Placebo transitioned to Lumacaftor 400 mg q12h/ Ivacaftor 250 mg q12h (n = 176)**
Maltese: Fuq plaċebo li qalbu għal Lumacaftor 400 mg q12h/ Ivacaftor 250 mg q12h (n=176)**
English: The Phase 3 trials of lumacaftor/ivacaftor included 81 patients with ppFEV1 < 40 at baseline.
Maltese: Il-provi ta' Fażi 3 ta' lumacaftor/ivacaftor kienu jinkludu 81 pazjent b'ppFEV1 ta' <40 fil-linja bażi.
English: Due to the induction effect of lumacaftor on CYP3A, at steady-state, the net exposure of ivacaftor when co-administered with a CYP3A inhibitor is not expected to exceed that when given in the absence of lumacaftor at a dose of 150 mg every 12 hours, the approved dose of ivacaftor monotherapy.
Maltese: Minħabba leffett ta' induzzjoni ta' lumacaftor fuq CYP3A, fl-istat fiss, l-esponiment nett ta' ivacaftor meta jingħata flimkien ma' inibitur ta' CYP3A, mhux mistenni li jaqbeż dak ta' meta jingħata fl-assenza ta' lumacaftor f'doża ta' 150 mg kull 12-il siegħa, id-doża approvata ta' monoterapija ta' ivacaftor.
English: Table 7: Summary of primary and key secondary outcomes in Trial 7 Placebo (n = 101)
Maltese: Sommarju tar-riżultati primarji u r-riżultati sekondarji ewlenin fi Prova 7 Plaċebo
English: At Day 15, the treatment difference between lumacaftor 400 mg/ivacaftor 250 mg q12h and placebo for the mean absolute change (95% CI) in ppFEV1 from baseline was 2.51 percentage points in the pooled Trials 1 and 2 (P < 0.0001).
Maltese: F'Jum 15, id-differenza fil-kura bejn lumacaftor 400 mg/ivacaftor 250 mg q12h u plaċebo għall-bidla medja assoluta (95% CI) f'ppFEV1 mil-linja bażi kienet ta' 2.51 punti perċentwali fil-Provi miġbura 1 u 2 (P<0.
English: Therefore, co-administration with strong CYP3A inducers (e.g., rifampicin, St. John's wort [Hypericum perforatum]) is not recommended (see section 4.5).
Maltese: John's wort [Hypericum perforatum]), mhuwiex rakkomandat (ara sezzjoni 4.5).
English: Ear and labyrinth disorders common
Maltese: Disturbi fil-widnejn u fissistema labirintika komuni
English: Day 1: lumacaftor 200 mg + ivacaftor 250 mg Day 2: lumacaftor 100 mg + ivacaftor 125 mg
Maltese: Jum 2: lumacaftor 100 mg + ivacaftor 125 mg
English: Pink, oval-shaped tablets (dimensions 14 × 8.4 × 6.8 mm) printed with “2V125” in black ink on one side.
Maltese: Pilloli ta' lewn roża, b'forma ovali (daqs 14 × 8.4 × 6.8 mm) stampati b'“2V125” b'linka sewda fuq naħa waħda.
English: In a human pharmacokinetic study with lumacaftor alone, there was minimal elimination of lumacaftor and its metabolites in urine (only 8.6% of total radioactivity was recovered in the urine with 0.18% as unchanged parent).
Maltese: Fi studju farmakokinetiku fil-bnedmin b'lumacaftor waħdu, kien hemm eliminazzjoni minima ta' lumacaftor u l-metaboliti tiegħu fl-awrina (8.6% biss tar-radjuattività totali ġiet irkuprata fl-awrina, b'0.18% bħala l-kompost prinċipali mhux mibdul).
English: During the 24-week, placebo-controlled Phase 3 clinical study in 204 patients aged 6 to 11 years (Trial 7), the incidence of maximum transaminase (ALT or AST) levels > 8, > 5, and > 3 x ULN was 1.0%, 4.9%, and 12.6% in the lumacaftor/ivacaftor patients, and 2.0%, 3.0%, and 7.9% in the placebo-treated patients.
Maltese: Matul l-istudju kliniku ta' Fażi 3 li dam 24 ġimgħa, ikkontrollat bi plaċebo, li sar fuq 204 pazjent li kellhom minn 6 sa 11-il sena (Prova 7), l-inċidenza ta' livelli massimi ta' transaminases (ALT jew AST) ta' >8, >5, u >3 x ULN kienu ta' 1.0%, 4.9%, u 12.6% f'pazjenti li kienu fuq lumacaftor/ivacaftor, u 2.0%, 3.0%, u 7.9% f'pazjenti kkurati bi plaċebo.
English: Improvements in ppFEV1 were observed regardless of age, disease severity, sex and geographic region.
Maltese: Titjib f'ppFEV1 ġie osservat irrispettivament mill-età, is-severità tal-mard, is-sess tal-persuna u r-reġjun ġeografiku.
English: Orkambi 100 mg/125 mg granules in sachet:
Maltese: Orkambi 100 mg/125 mg granijiet f'qartas:
English: The worsening of liver function can be fatal.
Maltese: L-aggravament tal-funzjoni tal-fwied jista' jkun fatali.
English: PHARMACEUTICAL FORM AND CONTENTS 28 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 28 pillola miksija b'rita
English: PHARMACEUTICAL FORM Granules
Maltese: GĦAMLA FARMAĊEWTIKA
English: Note: P values in the table are nominal.
Maltese: Nota: Il-valuri P fit-tabella huma nominali.
English: 12 years and older Orkambi 200 mg/125 mg
Maltese: 12-il sena u aktar Orkambi 200 mg/125 mg
English: ↓ ibuprofen Due to induction of CYP3A/2C8/2C9 by LUM
Maltese: ↓ ibuprofen Minħabba linduzzjoni ta' CYP3A/2C8/2C9 minn LUM
English: Name and address of the manufacturer responsible for batch release Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate
Maltese: Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate
English: After oral administration of ivacaftor alone as 150 mg q12h in a fed state, the steady-state mean (± SD) for AUC0-12h and Cmax were 9.08 (3.20) µg∙hr/mL and 1.12 (0.319) µg/mL, respectively.
Maltese: Wara l-għoti orali ta' ivacaftor waħdu bħala 150 mg q12h wara li wieħed ikun kiel, il-medja fl-istat fiss (±SD) għall-AUC0-12h u s-Cmax kienet ta' 9.08 (3.20) g∙hr/mL u 1.
English: Table 3: Established and other potentially significant drug interactions - dose recommendations for use of lumacaftor/ivacaftor with other medicinal products
Maltese: Tabella 3: Interazzjonijiet stabbiliti tal-mediċina u interazzjonijiet oħrajn potenzjalment sinifikanti - rakkomandazzjonijiet dwar id-doża għall-użu ta' lumacaftor/ivacaftor ma' prodotti mediċinali oħrajn
English: 2 to 5 years and weighing less than 14 kg
Maltese: Sentejn sa 5 snin u jiżnu inqas minn 14-il kg
English: The steady-state exposure of ivacaftor is lower than that of Day 1 due to the CYP3A induction effect of lumacaftor (see section 4.5).
Maltese: Lesponiment ta' ivacaftor fl-istat fiss hu inqas minn dak ta' Jum 1 minħabba l-effett ta' induzzjoni ta' CYP3A ta' lumacaftor (ara sezzjoni 4.5).
English: PHARMACEUTICAL FORM AND CONTENTS 112 film-coated tablets (4 packs of 28 tablets).
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 112-il pillola miksija b'rita (4 pakketti ta' 28 pillola).
English: Orkambi 150 mg/188 mg granules in sachet Each sachet contains 150 mg of lumacaftor and 188 mg of ivacaftor.
Maltese: Orkambi 150 mg/188 mg granijiet f'qartas Kull qartas fih 150 mg ta' lumacaftor u 188 mg ta' ivacaftor.
English: The active substances are lumacaftor and ivacaftor.
Maltese: Is-sustanzi attivi huma lumacaftor u ivacaftor.
English: Package leaflet: Information for the patient Orkambi 100 mg/125 mg film-coated tablets Orkambi 200 mg/125 mg film-coated tablets lumacaftor/ivacaftor
Maltese: Informazzjoni għall-pazjent Orkambi 100 mg/125 mg pilloli miksija b'rita Orkambi 200 mg/125 mg pilloli miksija b'rita lumacaftor/ivacaftor
English: Lumacaftor/ivacaftor may decrease the exposure of fluconazole, which may reduce its efficacy.
Maltese: Lumacaftor/ivacaftor jista' jnaqqas l-esponiment ta' fluconazole, li jista' jnaqqas l-effikaċja tiegħu.
English: In the lumacaftor/ivacaftor patients, the treatment difference for absolute change in ppFEV1 from baseline through Week 24 was 2.4 (P = 0.0182).
Maltese: Fil-pazjenti li kienu fuq lumacaftor/ivacaftor, id-differenza tal-kura għall-bidla assoluta f'ppFEV1 mil-linja bażi sa Ġimgħa 24 kienet ta' 2.4 (P=0.0182).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - MULTIPACK - WITH BLUE BOX
Maltese: KARTUNA TA' BARRA - PAKKETT MULTIPLU BIL-KAXXA L-BLU
English: Abnormality of the lens of the eye (cataract) without any effect on vision has been noted in some children and adolescents treated with Orkambi and ivacaftor alone (one of the components of Orkambi).
Maltese: Anormalità tal-lenti tal-għajn (katarretti) mingħajr l-ebda effett fuq il-vista, ġiet osservata f'xi tfal u adolexxenti kkurati b'Orkambi u ivacaftor waħidhom (wieħed mill-komponenti ta' Orkambi).
English: During the 24-week, open-label Phase 3 clinical study (Trial 6) in 58 patients aged 6 to 11 years (mean baseline ppFEV1 was 91.4), the incidence of respiratory adverse reactions was 6.9% (4/58).
Maltese: Matul l-istudju kliniku ta' Fażi 3 li dam 24 ġimgħa, open-label, (Prova 6) li sar fi 58 pazjent li kellhom minn 6 sa 11-il sena (medja tal-ppFEV1 fil-linja bażi kienet ta' 91.4), l-inċidenza ta' reazzjonijiet avversi respiratorji kienet ta' 6.9% (4/58).
English: During the 24-week, placebo-controlled Phase 3 clinical study (Trial 7) in patients aged 6 to 11 years (mean baseline ppFEV1 was 89.8), the incidence of respiratory adverse reactions was 18.4% in lumacaftor/ivacaftor patients and 12.9% in placebo patients.
Maltese: Matul l-istudju kliniku ta' Fażi 3 li dam 24 ġimgħa, ikkontrollat bi plaċebo (Prova 7), f'pazjenti li kellhom minn 6 sa 11-il sena (medja tal-ppFEV1 fil-linja bażi kienet ta' 89.8), l-inċidenza ta' reazzjonijiet avversi respiratorji kienet ta' 18.4% f'pazjenti li kienu fuq lumacaftor/ivacaftor, u 12.9% f'pazjenti fuq il-plaċebo.
English: The exposures are similar between adults and the paediatric population based on population (PK) analyses as presented in Table 9.
Maltese: L-esponimenti huma simili bejn l-adulti u l-popolazzjoni pedjatrika bbażat fuq analiżijiet talpopolazzjoni (PK) kif ippreżentati f'Tabella 9 hawn taħt:
English: Two lumacaftor 100 mg/ivacaftor 125 mg tablets every 12 hours lumacaftor 400 mg/ ivacaftor 500 mg
Maltese: Żewġ pilloli ta' lumacaftor 100 mg/ivacaftor 125 mg kull 12-il siegħa lumacaftor 400 mg/ ivacaftor 500 mg
English: In this trial, 10 patients (homozygous for F508del-CFTR mutation) completed dosing with lumacaftor alone 400 mg q12h for 28 days followed by the addition of ivacaftor 250 mg q12h for an additional 28 days, and 25 patients (homozygous or heterozygous for F508del) completed dosing with placebo.
Maltese: F'din il-prova, 10 pazjenti (homozygous għall-mutazzjoni F508del-CFTR) temmew dożaġġ b'lumacaftor waħdu 400 mg q12h għal 28 jum segwit mill-inklużjoni ta' ivacaftor 250 mg q12h għal 28 jum addizzjonali, u 25 pazjent (homozygous jew heterozygous għal F508del) temmew dożaġġ bi plaċebo.
English: One lumacaftor 100 mg/ivacaftor 125 mg sachet every 12 hours lumacaftor 200 mg/ ivacaftor 250 mg
Maltese: Qartas wieħed ta' lumacaftor 100 mg/ivacaftor 125 mg kull 12-il siegħa lumacaftor 200 mg/ ivacaftor 250 mg
English: However, no ivacaftor-induced QT prolongation was observed in a dog telemetry study at single doses up to 60 mg/kg or in ECG measurements from repeat-dose studies of up to 1 year duration at the 60 mg/kg/day dose level in dogs (Cmax after 365 days = 36.2 to 47.6 μM).
Maltese: Madankollu, ma ġie osservat l-ebda titwil tal-QT ikkaġunat minn ivacaftor fi studju dwar it-telemetrija fil-klieb, f'dożi waħidhom sa 60 mg/kg, jew f'kejl permezz ta' ECG minn studji dwar dożi ripetuti li damu sa sena, fil-livell ta' doża ta' 60 mg/kg/kuljum fil-klieb (Cmax wara 365 jum = 36.2 sa 47.6 μM).
English: These results are presented in Table 7 below:
Maltese: Tabella 7:
English: Patients aged 12 to less than 18 years lumacaftor 400 mg/ivacaftor 250 mg every 12 hours
Maltese: Pazjenti li kellhom minn 12 sa inqas minn 18-il sena lumacaftor 400 mg/ivacaftor 250 mg kull 12-il siegħa
English: Clinical experience in patients with ppFEV1 <40 is limited and additional monitoring of these patients is recommended during initiation of therapy (see section 4.8).
Maltese: Esperjenza klinika f'pazjenti b'ppFEV1 ta' < 40 hi limitata u monitoraġġ addizzjonali ta' dawn il-pazjenti hu rakkomandat matul il-bidu tat-terapija(ara sezzjoni 4.8).
English: Clinical experience in patients with ppFEV1 < 40 is limited and additional monitoring of these patients is recommended during initiation of therapy (see section 4.8).
Maltese: Esperjenza klinika f'pazjenti b'ppFEV1 ta' <40 hi limitata u monitoraġġ addizzjonali ta' dawn il-pazjenti hu rakkomandat matul il-bidu tat-terapija(ara sezzjoni 4.8).
English: Two lumacaftor 200 mg/ivacaftor 125 mg tablets every 12 hours lumacaftor 800 mg/ ivacaftor 500 mg
Maltese: 12-il sena u aktar Żewġ pilloli ta' lumacaftor 200 mg/ivacaftor 125 mg kull 12-il siegħa lumacaftor 800 mg/ ivacaftor 500 mg
English: NAME OF THE MEDICINAL PRODUCT Orkambi 100 mg/125 mg tablets lumacaftor/ivacaftor
Maltese: Orkambi 100 mg/125 mg pilloli lumacaftor/ivacaftor
English: Absolute change in ppFEV1 at Week 24 (percentage points)
Maltese: Bidla assoluta f'ppFEV1 f'Ġimgħa 24 (punti perċentwali)
English: • Pack containing 28 film-coated tablets.
Maltese: • Pakkett li fih 28 pillola miksija b'rita.
English: NAME OF THE MEDICINAL PRODUCT Orkambi 150 mg/188 mg granules in sachet lumacaftor/ivacaftor
Maltese: Orkambi 150 mg/188 mg granijiet f'qartas lumacaftor/ivacaftor
English: Lumacaftor increases the amount of CFTR available and ivacaftor helps the abnormal protein to work more normally.
Maltese: Lumacaftor iżid l-ammont ta' CFTR disponibbli u ivacaftor jgħin lill-proteina abnormali biex taħdem b'mod aktar normali.
English: Three of the 48 patients who had faecal elastase-1 values < 100 µg/g at baseline achieved a level of ≥ 200 µg/g at Week 24.
Maltese: Tlieta mit-48 pazjent li kellhom valuri ta' elastase‑1 fekali < 100 µg/g fil-linja bażi laħqu livell ta' ≥ 200 µg/g f'Ġimgħa 24.
English: • Breast mass*
Maltese: • Sturdament*
English: In both trials, treatment with lumacaftor/ivacaftor resulted in a statistically significant improvement in ppFEV1 (Table 5).
Maltese: Fiż-żewġ provi, il-kura b'lumacaftor/ivacaftor irriżultat f'titjib statistikament sinifikanti f'ppFEV1 (Tabella 5).
English: Adverse reactions identified from the 24-week, placebo-controlled, Phase 3 studies (Trials 1 and 2) in patients aged 12 years and older and from a 24-week, placebo-controlled study in patients aged 6 to 11 years (Trial 7), who are homozygous for the F508del mutation in the CFTR gene are presented in Table 4 and are listed by system organ class, frequency, and adverse reactions.
Maltese: Reazzjonijiet avversi identifikati minn studji ta' 24 ġimgħa, ikkontrollati bi plaċebo, ta' Fażi 3 (Provi 1 u 2) f'pazjenti li kellhom 12-il sena u minn studju ta' 24 ġimgħa, ikkontrollat bi plaċebo, f'pazjenti li kellhom minn 6 sa 11-il sena (Prova 7), li kienu homozygous għall-mutazzjoni F508del fil-ġene CFTR huma ppreżentati f'Tabella 4 u huma elenkati skont is-sistema tal-klassifika tal-organi, il-frekwenza, u r-reazzjonijiet avversi.Reazzjonijiet avversi osservati b'ivacaftor waħdu huma wkoll ipprovduti f'Tabella 4.
English: Reproductive system and breast disorders common
Maltese: Disturbi fis-sistema riproduttiva u fis-sider komuni
English: • Multipacks containing 56 film-coated tablets (2 packs of 28 film-coated tablets).
Maltese: • Pakkett multipli li fihom 56 pillola miksija b'rita (2 pakketti ta' 28 pillola miksija b'rita).
English: During the 24-week, open-label Phase 3 clinical study in 58 patients aged 6 to 11 years (Trial 6), the incidence of maximum transaminase (ALT or AST) levels > 8, > 5, and > 3 x ULN was 5.3%, 8.8%, and 19.3%.
Maltese: Matul l-istudju kliniku ta' Fażi 3 li dam 24 ġimgħa, open-label, li sar fuq 58 pazjent li kellhom minn 6 sa 11-il sena (Prova 6), l-inċidenza ta' livelli massimi ta' transaminases (ALT jew AST) ta' >8, >5, u >3 x ULN kienet ta' 5.3%, 8.8%, u 19.3%.
English: During the 24-week, open-label Phase 3 clinical study in 58 patients aged 6 to 11 years (Trial 6), the incidence of maximum transaminase (ALT or AST) levels > 8, > 5, and >3 x ULN was 5.3%, 8.8%, and 19.3%.
Maltese: Matul l-istudju kliniku ta' Fażi 3 li dam 24 ġimgħa, open-label, li sar fuq 58 pazjent li kellhom minn 6 sa 11-il sena (Prova 6), l-inċidenza ta' livelli massimi ta' transaminases (ALT jew AST) ta' >8 , > 5, u > 3 x ULN kienet ta' 5.3%, 8.8%, u 19.3%.
English: Changes in sweat chloride in response to lumacaftor alone or in combination with ivacaftor were evaluated in a double-blind, placebo-controlled, Phase 2 clinical trial in patients with CF age 18 years and older.
Maltese: Bidliet tal-chloride fl-għaraq b'risposta għal lumacaftor waħdu jew flimkien ma' ivacaftor, ġew evalwati fi prova klinika ta' Fażi 2, double-blind, ikkontrollata bi plaċebo, f'pazjenti b'CF li kellhom 18-il sena u aktar.
English: Orkambi granules are indicated for the treatment of cystic fibrosis (CF) in children aged 2 years and older who are homozygous for the F508del mutation in the CFTR gene (see sections 4.2, 4.4 and 5.1).
Maltese: Il-granijiet ta' Orkambi huma indikati għall-kura ta' fibrożi ċistika (CF) fi tfal li jkollhom sentejn jew aktar u li jkunu homozygous għall-mutazzjoni F508del fil-ġene CFTR (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: Ivacaftor impaired fertility and reproductive performance indices in male and female rats.
Maltese: Ivacaftor indebbolixxa l-indiċijiet ta' prestazzjoni tal-fertilità u dawk riproduttivi f'firien irġiel u nisa.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwesustanza mhux attiva elenkata fissezzjoni 6.1.
English: At Week 24, the treatment difference between lumacaftor 400 mg/ivacaftor 250 mg q12h and placebo for the mean absolute change (95% CI) in ppFEV1 from baseline in the pooled Trials 1 and 2 were 3.39 percentage points (P = 0.0382) for patients with ppFEV1 < 40 and 2.47 percentage points (P < 0.0001) for patients with ppFEV1 ≥ 40.
Maltese: F'Ġimgħa 24, id-differenza fil-kura bejn lumacaftor 400 mg/ivacaftor 250 mg q12h u plaċebo għall-bidla medja assoluta (95% CI) f'ppFEV1 mil-linja bażi fil-Provi miġbura 1 u 2 kienet ta' 3.39 punti perċentwali (P=0.0382) għal pazjenti b'ppFEV1 ta' <40, u 2.47 punti perċentwali(P<0.0001) għal pazjenti b'ppFEV1 ta' ≥40.
English: Orkambi 100 mg/125 mg film-coated tablets Pack containing 112 film-coated tablets (4 packs of 28 film-coated tablets).
Maltese: Orkambi 100 mg/125 mg pilloli miksija b'rita Pakkett li fih 112-il pillola miksija b'rita (4 pakketti ta' 28 pillola miksija b'rita).
English: ↔ LUM, IVA ↑ or ↓ ranitidine
Maltese: Linja bażi u Punt Aħħari
English: NAME OF THE MEDICINAL PRODUCT Orkambi 100 mg/125 mg granules in sachet Orkambi 150 mg/188 mg granules in sachet
Maltese: Orkambi 100 mg/125 mg granijiet f'qartas Orkambi 150 mg/188 mg granijiet f'qartas
English: If possible, have your medicine and this leaflet with you.
Maltese: Jekk ikun possibbli, qis li jkollok il-mediċina u dan il-fuljett fuqek.
English: In patients who received placebo (mean baseline 114 mmHg systolic and 69 mmHg diastolic), the maximum increase from baseline in mean systolic and diastolic blood pressure was 0.9 mmHg and 0.9 mmHg, respectively.
Maltese: F'pazjenti li rċivew plaċebo (medja tal-pressjoni sistolika ta' 114 mmHg u tal-medja tal-pressjoni dijastolika ta' 69 mmHg fil-linja bażi), iż-żieda massima mil-linja bażi medja talpressjoni sistolika u tal-medja tal-pressjoni dijastolika tad-demm kienet ta' 0.9 mmHg u 0.9 mmHg, rispettivament.
English: Absolute change in BMI at Week 24 (kg/m
Maltese: Bidla assoluta filBMI f'Ġimgħa 24 (kg/m2)
English: • Mix entire content of sachet with 5 mL of age-appropriate soft food or liquid that is at or below room temperature.
Maltese: • Ħallat il-kontenut kollu tal-qartas ma' 5 mL ta' ikel artab jew likwidu li jkun adattat għall-età li qiegħed f'temperatura tal-kamra jew aktar baxxa.
English: Effects in repeated dose studies were observed only at exposures considered sufficiently in excess (> 25-, > 45-, and > 35-fold for mice, rats, and dogs, respectively) of the maximum human exposure of ivacaftor when administered as Orkambi, indicating little relevance to clinical use.
Maltese: L-effetti fi studji dwar dożi ripetuti dehru biss wara esponimenti meqjusa ferm aktar għolja millmassimu ta' esponiment fil-bniedem (> 25,> 45, u > 35 darba għal ġrieden, firien, u klieb, rispettivament) ta' ivacaftor meta mogħti bħala Orkambi, li juru ftit li xejn rilevanza għall-użu kliniku.Tagħrif mhux kliniku ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku fuq il-ġeni u riskju ta' kanċer, ma juri l-ebda periklu speċjali għall-bnedmin.
English: * Adverse reactions and frequencies observed in patients in clinical studies with ivacaftor monotherapy (a component of
Maltese: * Ir-reazzjonijiet avversi u l-frekwenzi osservati f'pazjenti fl-istudji kliniċi b'ivacaftor waħdu (komponent ta' Orkambi). † 1 pazjent minn 738 ‡
English: Hepatic impairment
Maltese: Anormalitajiet mestrwali
English: At Week-24, the treatment difference between lumacaftor 400 mg/ivacaftor 250 mg q12h and placebo for the mean absolute change (95% CI) in ppFEV1 from baseline in the pooled Trials 1 and 2 were 3.39 percentage points (P = 0.0382) for patients with ppFEV1 < 40 and 2.47 percentage points (P < 0.0001) for patients with ppFEV1 ≥ 40.
Maltese: F'Ġimgħa 24, id-differenza fil-kura bejn lumacaftor 400 mg/ivacaftor 250 mg q12h u plaċebo għall-bidla medja assoluta (95% CI) f'ppFEV1 mil-linja bażi fil-Provi miġbura 1 u 2 kienet ta' 3.39 punti perċentwali (P = 0.0382) għal pazjenti b'ppFEV1 ta' < 40, u 2.47 punti perċentwali(P < 0.0001) għal pazjenti b'ppFEV1 ta' ≥ 40.