FrancophonIA/ELRC3.0 huggingface dataset:
English: Exposure to tezacaftor is not expected to be affected significantly by concomitant inhibitors of OATP1B1, P-gp, or BCRP due to its high intrinsic permeability and low likelihood of being excreted intact.
Maltese: L-esponiment għal tezacaftor mhuwiex mistenni li jiġi affettwat b'mod sinifikanti minn inibituri konkomitanti ta' OATP1B1, P-gp, jew BCRP minħabba l-permeabbiltà intrinsika għolja tiegħu u l-probabbiltà baxxa li jiġi eliminat intatt.
English: Tezacaftor 100 mg/ivacaftor 150 mg tablet Ivacaftor 150 mg tablet
Maltese: Doża ta' Filgħodu Tezacaftor 100 mg/ ivacaftor 150 mg pillola
English: There were 23 patients with ppFEV1 <40 at baseline receiving Symkevi and 24 patients receiving placebo in Study 1.
Maltese: Kien hemm 23 pazjent b'ppFEV1 <40 fil-linja bażi li kienu qed jirċievu Symkevi u 24 pazjent li kienu qed jirċievu plaċebo fi Studju 1.
English: Average absolute change from baseline through Week 24 (percentage points)**
Maltese: Bidla assoluta medja millinja bażi sa Ġimgħa 24 (punti perċentwali)**
English: Long-term safety and efficacy rollover study (Study 3) An ongoing, Phase 3, open-label, multicenter, rollover, 96-week study to evaluate the safety and efficacy of long-term treatment with Symkevi in combination with ivacaftor is being conducted with patients from Studies 1 (n=459) and 2 (n=226).
Maltese: Studju rollover dwar is-sigurtà u effikaċja fit-tul (Studju 3) Studju open-label, rollover, multiċentriku ta' Fażi 3, ta' 96 ġimgħa u li għadu għaddej, biex jevalwa ssigurtà u l-effikaċja tal-kura fit-tul b'Symkevi flimkien ma' ivacaftor, qiegħed jitwettaq f'pazjenti minn Studji 1 (n=459) u 2 (n=226).
English: Physiologically based pharmacokinetic modeling suggested co-administration with fluconazole, a moderate CYP3A inhibitor, may increase tezacaftor exposure (AUC) by approximately 2-fold.
Maltese: Immudellar farmakokinetiku bbażat fuq il-fiżjoloġija ssuġġerixxa li l-għoti flimkien ma' fluconazole, inibitur moderat ta' CYP3A, jista' jżid l-esponiment għal tezacaftor (AUC) b'madwar id-doppju.
English: Absolute change from baseline to the average of Week 4 and Week 8 (points)**
Maltese: Bidla assoluta millinja bażi talistudju sal-medja ta' Ġimgħa 4 u Ġimgħa 8 (punti)**
English: Ivacaftor is a CFTR potentiator that potentiates the channel-open probability (or gating) of CFTR at the cell surface to increase chloride transport.
Maltese: Ivacaftor huwa potenzjatur ta' CFTR li jsaħħaħ il-probabbiltà ta' channel miftuħ (jew gating) ta' CFTR fil-wiċċ taċ-ċellula biex iżid it-trasport ta' chloride.
English: • Stomach (abdominal) ache
Maltese: • Uġigħ fl-istonku (addominali)
English: Nausea common
Maltese: Sturdament komuni
English: Table 1: Dosing recommendations for concomitant use with moderate CYP3A inhibitors Day 1 Day 2 Day 3 Day 4*
Maltese: Tabella 1: Rakkomandazzjonijiet dwar id-dożaġġ għall-użu fl-istess ħin ta' inibituri moderati ta' CYP3A
English: M2-TEZ is much less pharmacologically active than tezacaftor or M1-TEZ, and M5-TEZ is not considered pharmacologically active.
Maltese: M2-TEZ huwa ħafna inqas farmakoloġikament attiv minn tezacaftor jew M1-TEZ, u M5-TEZ mhuwiex ikkunsidrat farmakoloġikament attiv.
English: The evening dose of ivacaftor should not be taken (see sections 4.4 and 4.5).
Maltese: Id-doża ta' filgħaxija ta' ivacaftor m'għandhiex tittieħed (ara sezzjonijiet 4.4 u 4.5).
English: The dose of Symkevi and ivacaftor should be adjusted when co-administered with moderate CYP3A inhibitors (see Table 1 in section 4.2).
Maltese: Id-doża ta' Symkevi u ivacaftor għandha tiġi aġġustata meta tingħata flimkien ma' inibituri moderati ta' CYP3A (ara Tabella 1 f'sezzjoni 4.2).
English: Adolescent patients with CF who were homozygous for the F508del mutation in the CFTR gene The mean absolute change (SE) from baseline in ppFEV1 was 3.5 (0.6) percentage points in the Symkevi in combination with ivacaftor group and -0.4 (0.6) percentage points in the placebo group in Study 1.
Maltese: Pazjenti adolexxenti b'CF li kienu omożigotiċi għall-mutazzjoni F508del fil-ġene CFTR Il-bidla assoluta medja (SE) mil-linja bażi fil-ppFEV1 kienet 3.5 (0.6) punti perċentwali fil-grupp ta' Symkevi flimkien ma' ivacaftor, u -0.4
English: Table 7: Mean (SD) pharmacokinetic parameters of tezacaftor and ivacaftor at steady state in patients with CF
Maltese: Parametri farmakokinetiċi medji (SD) ta' tezacaftor u ivacaftor fl-istat fiss f'pazjenti b'CF
English: Administration of Symkevi in combination with ivacaftor 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' Symkevi flimkien ma' ivacaftor jista' jżid l-esponiment 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: No data are available for CYP3A4*22 homozygous genotype patients.
Maltese: M'hemm l-ebda data disponibbli dwar pazjenti bil-ġenotip omożigotiku ta' CYP3A4*22.
English: Under steady-state, for each of the metabolites, exposure to M1-TEZ, M2-TEZ and M5-TEZ is approximately 1.5-fold higher than for tezacaftor.
Maltese: Fl-istat fiss, għall kull wieħed mill-metaboliti, l-esponiment għal M1-TEZ, M2TEZ u M5-TEZ huwa madwar 1.5 darbiet ogħla milli għal tezacaftor.
English: Ivacaftor 150 mg tablet *Continue dosing with tezacaftor 100 mg/ivacaftor 150 mg or ivacaftor 150 mg tablets on alternate days.
Maltese: Ivacaftor 150 mg pillola Doża ta' Filgħaxija Ivacaftor 150 mg pillola *Kompli d-dożaġġ b'tezacaftor 100 mg/ivacaftor 150 mg jew ivacaftor 150 mg pilloli kull jumejn.
English: The median (range) tmax of ivacaftor was approximately 6 hours (3 to 10 hours) in the fed state.
Maltese: Il-medjan (medda) tattmax ta' ivacaftor kien ta' madwar 6 sigħat (3 sa 10 sigħat) wara li wieħed ikun kiel.
English: Table 3: Adverse reactions in patients treated with Symkevi in combination with ivacaftor MedDRA System Organ Class
Maltese: Tabella 3: Reazzjonijiet avversi f'pazjenti kkurati b'Symkevi flimkien ma' ivacaftor Sistema tal-Klassifika tal
English: After oral administration of tezacaftor 100 mg once daily in combination with ivacaftor 150 mg every 12 hours in patients with CF in the fed state, the mean (±SD) for apparent clearance values of tezacaftor and ivacaftor were 1.31 (0.41) and 15.7 (6.38) L/h, respectively.
Maltese: Wara l-għoti orali ta' tezacaftor 100 mg darba kuljum flimkien ma' ivacaftor 150 mg kull 12-il siegħa f'pazjenti b'CF wara li kienu kielu, il-medja (±SD) għal valuri ta' tneħħija apparenti ta' tezacaftor u ivacaftor kienet ta' 1.31 (0.41) u 15.7 (6.38) L/siegħa, rispettivament.
English: n/N Mean (SD) n/N Within-group change LS mean (95% CI) Treatment difference versus placebo LS mean (95% CI) P value
Maltese: n/N Medja (SD) n/N Bidla fil-grupp innifsu Medja LS (95% CI) Differenza fil-kura kontra medja LS tal-plaċebo (95% CI) valur P
English: Symkevi in combination with ivacaftor can make you dizzy.
Maltese: Symkevi flimkien ma' ivacaftor jista' jisturdik.
English: Study 2 was a randomized, double-blind, placebo-controlled, 2-period, 3-treatment, 8-week crossover study.
Maltese: Studju 2 kien studju crossover b'2 perjodi u 3 trattamenti, li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind u kkontrollat bi plaċebo, li dam 8 ġimgħat.
English: This finding has not been observed in fetuses derived from rat dams treated with ivacaftor on gestation Days 7 to 17, in rat pups exposed to ivacaftor through milk ingestion up to postnatal Day 20, in 7-week-old rats, nor in 3.5- to 5-month-old dogs treated with ivacaftor.
Maltese: Din is-sejba ma ġietx osservata f'feti miksuba minn firien nisa kkurati b'ivacaftor f'Jiem 7 sa 17 tal-ġestazzjoni, fi frieħ ta' firien esposti għal ivacaftor permezz ta' inġestjoni ta' ħalib sa Jum 20 wara t-twelid, f'firien ta' età ta' 7 ġimgħat, u lanqas fi klieb ta' età ta' 3.5 sa 5 xhur kkurati b'ivacaftor.
English: Subgroup analysis of patients with severe lung dysfunction (ppFEV1 <40) Study 1 and Study 2 included a total of 39 patients treated with Symkevi in combination with ivacaftor with ppFEV1 <40.
Maltese: Studju 1 u Studju 2 inkludew total ta' 39 pazjent ikkurati b'Symkevi flimkien ma' ivacaftor b'ppFEV1 <40.
English: The combination targets the abnormal CFTR protein by increasing the quantity and function of CFTR at the cell surface and subsequently increasing airway surface liquid height, and ciliary beat frequency in vitro in human bronchial epithelial (HBE) cells from homozygous F508del CF patients.
Maltese: Il-kombinazzjoni timmira l-proteina CFTR anormali billi żżid il-kwantità u lfunzjoni ta' CFTR fil-wiċċ taċ-ċellula u sussegwentement iżżid l-għoli tal-likwidu fil-wiċċ tal-passaġġ tan-nifs, u l-frekwenza tat-taħbit ċiljari in vitro f'ċelluli epiteljali tal-bronki tal-bniedem (HBE, human bronchial epithelial) minn pazjenti omożigotiċi F508del CF.
English: Table 5: Primary and key secondary efficacy analyses, full analysis set (Study 1) Analysis
Maltese: Analiżijiet ta' effikaċja primarji u sekondarji ewlenin, sett sħiħ ta' analiżi (Studju 1) Analizi
English: Co-administration with grapefruit juice, which contains one or more components that moderately inhibit CYP3A, may increase exposure of ivacaftor and tezacaftor; therefore, food or drink containing grapefruit or Seville oranges should be avoided during treatment (see section 4.2).
Maltese: L-għoti flimkien mal-meraq tal-grejpfrut, li fih komponent wieħed jew aktar li jinibixxu moderatament lil CYP3A, jista' jżid l-esponiment għal ivacaftor u tezacaftor; għalhekk, ikel jew xorb li fih il-grejpfrut jew larinġ ta' Seville għandu jiġi evitat matul it-trattament (ara sezzjoni 4.2).
English: The safety, efficacy and pharmacokinetics of Symkevi in combination with ivacaftor have been examined in a limited number of elderly patients.
Maltese: Is-sigurtà, l-effikaċja u l-farmakokinetika ta' Symkevi flimkien ma' ivacaftor ġew eżaminati f'numru limitat ta' pazjenti anzjani.
English: • In the morning, take one yellow Symkevi tablet.
Maltese: • Filgħodu, ħu pillola Symkevi safra waħda.
English: Dizziness common
Maltese: Rinite komuni
English: Adolescent patients with CF who were heterozygous for the F508del mutation and a second mutation associated with residual CFTR activity
Maltese: Pazjenti adolexxenti b'CF li kienu eterożigotiċi għall-mutazzjoni F508del u t-tieni mutazzjoni assoċjata ma' attività CFTR residwa
English: Patients in Studies 1 and 2 continued on their standard-of-care CF therapies during the studies (e.g., bronchodilators, inhaled antibiotics, dornase alfa, and hypertonic saline), and were eligible to roll over into a 96-week open-label extension study (Study 3).
Maltese: Il-pazjenti fi Studji 1 u 2 komplew it-terapiji ta' CF tagħhom skont l-istandard tal-kura waqt l-istudji (eż., bronkodilataturi, antibijotiċi li jinġibdu man-nifs, dornase alfa, u soluzzjoni mielħa ipertonika), u kienu eliġibbli li jaqilbu għal studju ta' estensjoni open-label ta' 96 ġimgħa (Studju 3).
English: The treatment difference between ivacaftor alone- and placebo-treated patients was 4.7 percentage points (95% CI: 3.7, 5.8; P<0.0001) and 2.1 percentage points (95% CI: 1.2, 2.9) between Symkevi in combination with ivacaftor- and ivacaftor alone-treated patients.
Maltese: Id-differenza fil-kura bejn pazjenti kkurati b'Symkevi flimkien ma' ivacaftor u pazjenti kkurati bi plaċebo għall-punt aħħari primarju tal-bidla assoluta medja f'ppFEV1 mil-linja bażi tal-istudju sal-medja ta' Ġimgħa 4 u Ġimgħa 8 kienet ta' 6.8 punti perċentwali (95% CI: 5.7, 7.8; P<0.0001). Id-differenza fil-kura bejn pazjenti kkurati b'ivacaftor waħdu u dawk ikkurati bi plaċebo kienet ta' 4.7 punti perċentwali (95% CI: 3.7, 5.8; P<0.0001) u 2.1 punti perċentwali (95% CI: 1.2 2.9) bejn pazjenti kkurati b'Symkevi flimkien ma' ivacaftor u dawk ikkurati b'ivacaftor waħdu.
English: Key pharmacokinetic parameters for tezacaftor and ivacaftor at steady-state are shown in Table 7.
Maltese: Il-parametri farmakokinetiċi ewlenin għal tezacaftor u ivacaftor fl-istat fiss huma murija f'Tabella 7.
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' żieda sinifikanti ta' transaminases (eż., pazjenti b'ALT jew AST ta' >5 x il-limitu ta' fuq tan-normal (ULN), jew ALT jew AST ta' >3 x ULN b'bilirubina ta' >2 x ULN), id-dożaġġ għandu jitwaqqaf u t-testijiet tal-laboratorju għandhom jiġu segwiti mill-qrib sakemm l-anormalitajiet jgħaddu.
English: Table 3 reflects adverse reaction observed with Symkevi in combination with ivacaftor in patients aged 12 years and older based on pooled data from three double-blind, placebo-controlled Phase 3 clinical studies.
Maltese: Tabella 3 tirrifletti r-reazzjonijiet avversi osservati b'Symkevi flimkien ma' ivacaftor f'pazjenti ta' 12il sena jew aktar ibbażati fuq dejta miġbura minn tliet studji kliniċi ta' Fażi 3, double-blind u kkontrollati bi plaċebo.
English: Patients with a history of colonization with organisms associated with a more rapid decline in pulmonary status such as Burkholderia cenocepacia, Burkholderia dolosa, or Mycobacterium abscessus, or who had two or more abnormal liver function tests at screening (ALT, AST, AP, GGT
Maltese: Pazjenti bi storja medika ta' kolonizzazzjoni b'organiżmi assoċjati ma' tnaqqis mgħaġġel fl-istat talpulmun bħal Burkholderia cenocepacia, Burkholderia dolosa, jew Mycobacterium abscessus, jew li kellhom tnejn jew aktar testijiet tal-funzjoni tal-fwied b'riżultat anormali fl-iscreening (ALT, AST, AP, GGT ≥3 x ULN jew bilirubina totali ≥2 x ULN) jew AST jew ALT ≥5 x ULN, ġew esklużi miż-żewġ studji.
English: Tablet film coat
Maltese: Valur fil-linja bażi
English: Symkevi in combination with ivacaftor has not been studied in patients with CF who have undergone organ transplantation.
Maltese: Symkevi flimkien ma' ivacaftor ma ġiex studjat f'pazjenti b'CF li kellhom trapjant tal-organi.
English: n/N Mean (SD) n/N Within-group change LS mean (95% CI) Treatment difference LS mean (95% CI) P value
Maltese: n/N Medja (SD) n/N Bidla fil-grupp innifsu Medja LS (95% CI) Differenza fil-kura Medja LS (95% CI) Valur P
English: Symkevi in combination with ivacaftor has been studied with an estrogen/progesterone oral contraceptive and was found to have no significant effect on the exposures of the hormonal contraceptive.
Maltese: Symkevi flimkien ma' ivacaftor ġie studjat ma' kontraċettiv orali li fih estrogen/progesterone u nstab li ma kellu l-ebda effett sinifikanti fuq l-esponimenti tal-kontraċettiv ormonali.
English: Breast mass common
Maltese: Massa fis-sider komuni
English: In Study 2 treatment with Symkevi in combination with ivacaftor resulted in a statistically significant improvement in ppFEV1 (Table 6).
Maltese: Fi Studju 2, il-kura b'Symkevi flimkien ma' ivacaftor irriżultat f'titjib statistikament sinifikanti filppFEV1 (Tabella 6).
English: See Table 6 for a summary of primary and key secondary outcomes.
Maltese: Ara Tabella 6 għal sommarju tar-riżultati primarji u r-riżultati sekondarji ewlenin.
English: • Anticonvulsant medicines (used for the treatment of epilepsy and epileptic seizures or fits).
Maltese: • Mediċini kontra l-konvulżjonijiet (użati għall-kura ta' epilessija u puplesiji epilettiċi jew aċċessjonijiet).
English: Clinical trials of Symkevi in combination with ivacaftor did not include patients over 75 years of age.
Maltese: Provi kliniċi ta' Symkevi flimkien ma' ivacaftor ma inkludewx pazjenti ta' aktar minn 75 sena.
English: Table 2: Dosing recommendations for patients with hepatic impairment Mild (Child-Pugh Class A)
Maltese: Tabella 2: Rakkomandazzjonijiet dwar id-dożaġġ għal pazjenti b'indeboliment tal-fwied Ħafif (Child-Pugħ Klassi A)
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 ta' inibituri ta' BCRP mhux mistenni li jibdel l-esponiment għal ivacaftor u M1-IVA, filwaqt li kull bidliet potenzjali fl-esponimenti għal M6-IVA mhux mistennija li jkunu klinikament rilevanti.
English: Each film-coated tablet contains 100 mg of tezacaftor and 150 mg of ivacaftor.
Maltese: Kull pillola miksija b'rita fiha 100 mg ta' tezacaftor u 150 mg ta' ivacaftor.
English: • Medicines for diabetes.
Maltese: • Mediċini għad-dijabete.
English: What you need to know before you take Symkevi 3.
Maltese: X'għandek tkun taf qabel ma tieħu Symkevi 3.
English: The mean treatment difference between Symkevi and placebo-treated patients for absolute change in ppFEV1 through the average of Week 4 and Week 8 was 4.4 percentage points (95% CI: 1.1, 7.8).
Maltese: Id-differenza fil-kura medja bejn pazjenti kkurati b'Symkevi u dawk ikkurati bi plaċebo għal bidla assoluta f'ppFEV1 sal-medja ta' Ġimgħa 4 u Ġimgħa 8 kienet ta' 4.4 punti perċentwali (95% CI: 1.1, 7.8).
English: Improvements in ppFEV1 were observed regardless of age, sex, baseline ppFEV1, colonization with Pseudomonas, concomitant use of standard-of-care medications for CF, and geographic region.
Maltese: Titjib f'ppFEV1 ġie osservat irrispettivament mill-età, is-sess tal-persuna, il-linja bażi ta' ppFEV1, il-kolonizzazzjoni b'Pseudomonas, l-użu fl-istess ħin ta' mediċini għal CF skont l-istandard tal-kura, u r-reġjun ġeografiku. Ara Tabella 5 għal sommarju tar-riżultati primarji u r-riżultati sekondarji ewlenin.
English: M1-IVA has approximately one-sixth the potency of ivacaftor and is considered pharmacologically active.
Maltese: M1-IVA għandu madwar wieħed minn sitta tal-potenza ta' ivacaftor u hu kkunsidrat li hu farmakoloġikament attiv.
English: Safety data from an interim safety analysis performed on 867 patients in a long-term safety and efficacy rollover study (Study 3), including 326 patients with ≥48 weeks of cumulative treatment with Symkevi given in combination with ivacaftor, were consistent with the safety data from the placebo-controlled Phase 3 studies.
Maltese: Id-dejta dwar is-sigurtà minn analiżi interim dwar is-sigurtà mwettqa fuq 867 pazjenti fi studju rollover dwar is-sigurtà u effikaċja fit-tul (Studju 3), li kienet tinkludi 326 pazjent bi ≥48 ġimgħa ta' kura kumulattiva b'Symkevi mogħti flimkien ma' ivacaftor, kienet konsistenti mad-dejta dwar is-sigurtà mill-istudji ta' Fażi 3 ikkontrollati bi plaċebo.
English: These include telithromycin,
Maltese: Dawn jinkludu telithromycin,
English: It is important to take this medicine regularly.
Maltese: Hu importanti li tieħu din ilmediċina regolari.
English: The dose of Symkevi and ivacaftor should be adjusted when used concomitantly with strong or moderate CYP3A inhibitors (see section 4.5 and Table 1 in section 4.2).
Maltese: Id-doża ta' Symkevi u ivacaftor għandha tiġi aġġustata meta tintuża fl-istess ħin ma' inibituri qawwija jew moderati ta' CYP3A (ara sezzjoni 4.5 u Tabella 1 f'sezzjoni 4.2).
English: Symkevi is indicated in a combination regimen with ivacaftor 150 mg tablets for the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: P67L, R117C, L206W,
Maltese: Symkevi huwa indikat f'kors ikkombinat ma' pilloli ivacaftor ta' 150 mg għall-kura ta' pazjenti b'fibrożi ċistika (CF) li għandhom 12-il sena u aktar u li jkunu omożigotiċi għall-mutazzjoni F508del jew eterożigotiċi għall-mutazzjoni F508del u li jkollhom waħda mill-mutazzjonijiet li ġejjin fil-ġene cystic fibrosis transmembrane conductance regulator (CFTR): P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, u 3849+10kbC→T.
English: CFQ-R respiratory domain score Baseline value
Maltese: .7 Effetti fuq il-ħila biex issuq u tħaddem magni
English: Exposures of tezacaftor (administered alone or in combination with ivacaftor) increase in an approximately dose-proportional manner with increasing doses from 10 mg to 300 mg once daily.
Maltese: L-esponimenti għal tezacaftor (mogħti waħdu jew flimkien ma' ivacaftor) jiżdiedu b'manjiera bejn wieħed u ieħor proporzjonali għad-doża b'dożi li jiżdiedu minn 10 mg għal 300 mg darba kuljum.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of tezacaftor or ivacaftor in pregnant women.
Maltese: M'hemmx dejta jew hemm dejta limitata (inqas minn 300 riżultat ta' tqala) mill-użu ta' tezacaftor jew ivacaftor f'nisa tqal.
English: These include ciclosporin,
Maltese: Dawn jinkludu ciclosporin, tacrolimus,
English: Package leaflet: Information for the patient Symkevi 100 mg/150 mg film-coated tablets tezacaftor/ivacaftor
Maltese: Informazzjoni għall-pazjent Symkevi 100 mg/150 mg pilloli miksija b'rita tezacaftor/ivacaftor
English: • Runny nose
Maltese: • Awrina skura
English: ppFEV1: percent predicted forced expiratory volume in 1 second; SD: Standard Deviation; LS mean: least squares mean; CI: confidence interval; BMI: body mass index; CFQ-R: Cystic Fibrosis Questionnaire-Revised.
Maltese: BMI: indiċi talmassa tal-ġisem; CFQ-R: Kwestjonarju dwar il-Fibrożi Ċistika-Rivedut ** Mudell tal-Effett Imħallat għal miżuri ripetuti bil-kura, viżta, interazzjoni ta' kura skont il-viżta, sess, grupp ta' età (<18, >=18-il sena) fl-iscreening, fil-valur fil-linja bażi, u fl-interazzjoni ta' valur skont il-viżta fil-linja bażi bħala effett fiss.
English: Tablet core
Maltese: Organi MedDRA
English: Do not use this medicine after the expiry date that 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: No ivacaftor 150 mg dose
Maltese: L-ebda doża ta' ivacaftor 150 mg
English: Ear congestion uncommon
Maltese: Batterji fl-isputum komuni ħafna
English: Abdominal pain, Diarrhoea very common
Maltese: Uġigħ addominali, Dijarea komuni ħafna
English: Placental transfer of tezacaftor was observed in pregnant rats.
Maltese: It-trasferiment mill-plaċenta ta' tezacaftor kien osservat f'firien tqal.
English: Tezacaftor facilitates the cellular processing and trafficking of normal or multiple mutant forms of CFTR (including F508del-CFTR) to increase the amount of CFTR protein delivered to the cell surface, resulting in increased chloride transport in vitro.
Maltese: Tezacaftor huwa korrettur selettiv ta' CFTR li jeħel mal-ewwel Dominju li Jkopri l-Membrana (MSD-1, Membrane Spanning Domain) ta' CFTR. Tezacaftor jiffaċilita l-ipproċessar ċellulari u t-traffikar ta' forom normali jew multipli mutanti ta' CFTR (inkluż F508del-CFTR) biex iżid l-ammont ta' proteina ta' CFTR li tasal fil-wiċċ taċ-ċellula, li jirriżulta f'żieda fit-trasport ta' chloride in vitro.
English: Exposure to tezacaftor and ivacaftor may be reduced by the concomitant use of CYP3A inducers, potentially resulting in reduced efficacy of Symkevi and ivacaftor.
Maltese: L-esponiment għal tezacaftor u ivacaftor jista' jitnaqqas bl-użu fl-istess ħin ta' indutturi ta' CYP3A, li potenzjalment jirriżulta fi tnaqqis fl-effikaċja ta' Symkevi u ivacaftor.
English: The exact mechanisms by which tezacaftor improves cellular processing and trafficking of F508del-CFTR and ivacaftor potentiates F508del-CFTR are not known.
Maltese: Il-mekkaniżmi preċiżi li bihom tezacaftor itejjeb l-ipproċessar u l-ittraffikar ċellulari ta' F508del-CFTR u li bihom ivacaftor iżid il-qawwa ta' F508del-CFTR mhumiex magħrufa.
English: Possible signs of liver problems
Maltese: Sinjali possibbli ta' problemi fil-fwied
English: Symkevi 100 mg/150 mg film-coated tablets
Maltese: Symkevi 100 mg/150 mg pilloli miksija b'rita
English: • In the evening, take one ivacaftor 150 mg tablet.
Maltese: • Filgħaxija, ħu ivacaftor 150 mg pillola waħda.