FrancophonIA/ELRC3.0 huggingface dataset:
English: *Indicates statistical significance confirmed in the hierarchical testing procedure.
Maltese: *Jindika sinifikanza statistika kkonfermata fil-proċedura ta' ttestjar ġerarkiku.
English: Symkevi is available in the following pack size: Pack size of 28 tablets (4 blister cards, each with 7 tablets).
Maltese: Daqs tal-pakkett ta' 28 pillola (4 folji, kull waħda b'7 pilloli).
English: When co-administered with moderate CYP3A inhibitors (e.g., fluconazole, erythromycin), the dose should be adjusted according to Table 1 (see sections 4.4 and 4.5).
Maltese: Meta jingħata flimkien ma' inibituri moderati ta' CYP3A (eż. fluconazole, erythromycin), id-doża għandha tiġi aġġustata skont Tabella 1 (ara sezzjonijiet 4.4 u 4.5).
English: • Blocked nose (sinus congestion)
Maltese: • Imnieħer imblukkat (konġestjoni tas-sinus)
English: Tezacaftor had no effects on fertility and reproductive performance indices in male and female rats at doses up to 100 mg/kg/day.
Maltese: Tezacaftor ma kellu l-ebda effetti fuq l-indiċijiet tal-fertilità u prestazzjoni riproduttiva f'firien irġiel u nisa f'dożi sa 100 mg/kg/jum.
English: Number of pulmonary exacerbations from baseline through Week 24
Maltese: Numru ta' aggravamenti pulmonari mil-linja bażi sa Ġimgħa 24
English: Patients had a ppFEV1 at screening between 40 to 90%.
Maltese: Il-pazjenti kellhom ppFEV1 bejn 40 u 90% waqt l-iscreening.
English: The effect of the CYP3A4*22 heterozygous genotype on tezacaftor and ivacaftor exposure is consistent with the effect of co-administration of a weak CYP3A4 inhibitor, which is not clinically relevant.
Maltese: L-effett tal-ġenotip eterożigotiku ta' CYP3A4*22 fuq l-esponiment ta' tezacaftor u ivacaftor huwa konsisenti mal-effett tal-għoti flimkien ta' inibitur dgħajjef ta' CYP3A4, li mhuwiex klinikament relevanti.
English: Symkevi contains two active substances, tezacaftor and ivacaftor.
Maltese: Symkevi fih żewġ sustanzi attivi, tezacaftor u ivacaftor.
English: *Nominal p-value, based on hierarchical testing procedure.
Maltese: *Valur p nominali, ibbażat fuq proċedura ta' ttestjar ġerarkiku.
English: At steady-state, the accumulation ratio is approximately 2.3 for tezacaftor and 3.0 for ivacaftor.
Maltese: Fl-istat fiss, il-proporzjon ta' akkumulazzjoni huwa madwar 2.3 għal tezacaftor u 3.0 għal ivacaftor.
English: In vitro data suggested that tezacaftor is metabolized mainly by CYP3A4 and CYP3A5.
Maltese: Dejta in vitro tissuġġerixxi li tezacaftor jiġi metabolizzat primarjament minn CYP3A4 u CYP3A5.
English: Patients had a percent predicted forced expiratory volume in one second (ppFEV1) at screening between 40 to 90%.
Maltese: Il-pazjenti kellhom perċentwali ta' volum espiratorju sfurzat f'sekonda waħda mbassar (ppFEV1, percent predicted forced expiratory volume in one second) bejn 40 u 90% waqt l-iscreening.
English: Symkevi 100 mg/150 mg tablets tezacaftor/ivacaftor
Maltese: Symkevi 100 mg/150 mg pilloli tezacaftor/ivacaftor
English: Number of subjects with events (n)/N Number of events (estimated event rate per year†) Rate ratio (RR) (95% CI) P value
Maltese: Proporzjon ta' rata (RR, Rate ratio) (95% CI) Valur P
English: Findings of cataracts were observed in juvenile rats dosed from postnatal Day 7 through 35 at ivacaftor exposure levels of 0.25 times the MRHD based on systemic exposure of ivacaftor and its metabolites when administered as tezacaftor/ivacaftor.
Maltese: Sejbiet ta' katarretti ġew osservati f'firien ġuvenili li ngħataw doża minn Jum 7 wara t-twelid sa Jum 35 fuq livelli ta' esponiment ta' ivacaftor 0.25 darbiet tal-MRHD (maximum recommended human dose) ibbażat fuq esponiment sistematiku għal ivacaftor u l-metaboliti tiegħu meta jingħata bħala tezacaftor/ivacaftor.
English: In population pharmacokinetic analysis, data from 147 patients on tezacaftor or tezacaftor in combination with ivacaftor in Phase 2/3 clinical studies indicated that mild renal impairment (estimated glomerular filtration rate, estimated by the modification of diet in renal disease method, 60 to ≤89 mL/min/1.73 m2) did not affect the clearance of tezacaftor significantly.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni, dejta minn 147 pazjent fuq tezacaftor jew fuq tezacaftor flimkien ma' ivacaftor fi provi kliniċi ta' Fażi 2/3 indikat li indeboliment ħafif tal-kliewi (rata stmata ta' filtrazzjoni glomerulari, stmata bil-metodu tal-modifika tad-dieta f'mard tal-kliewi, 60 sa ≤89 mL/min/1.73 m2) ma affettwax it-tneħħija ta' tezacaftor b'mod sinifikanti.
English: The treatment difference of 0.06 kg/m2 for mean change in BMI from baseline to Week 24 (95% CI: -0.08, 0.19) was not statistically significant (P=0.4127).
Maltese: Id-differenza fil-kura ta' 0.06 kg/m2 għal bidla medja fil-BMI mil-linja bażi sa Ġimgħa 24 (95% CI: -0.08, 0.19) ma kinitx statistikament sinifikanti (P=0.4127).
English: These include glimepiride and glipizide.
Maltese: Dawn jinkludu glimepiride u glipizide.
English: During the placebo-controlled Phase 3 studies (up to 24 weeks), the incidence of maximum transaminase (ALT or AST) >8, >5, or >3 x ULN were similar between Symkevi in combination with ivacaftor- and placebo-treated patients; 0.2%, 1.0%, and 3.4% in Symkevi in combination with ivacaftor-treated patients, and 0.4%, 1.0%, and 3.4% in placebo-treated patients.
Maltese: Waqt l-istudji ta' Fażi 3 ikkontrollati minn plaċebo (sa 24 ġimgħa), l-inċidenza ta' transaminases massimi (ALT jew AST) >8, >5, jew >3 x ULN kienet simili bejn pazjenti kkurati b'Symkevi flimkien ma' ivacaftor u pazjenti kkurati bi plaċebo; 0.2%, 1.0%, u 3.4% f'pazjenti kkurati b'Symkevi flimkien ma' ivacaftor; u 0.4%, 1.0%, u 3.4% f'pazjenti kkurati bi plaċebo.
English: Race had no clinically meaningful effect on the PK of ivacaftor in white (n=379) and non-white (n=29) patients based on a population PK analysis.
Maltese: Ir-razza ma kellha l-ebda effett klinikament sinifikanti fuq il-PK ta' ivacaftor f'pazjenti bojod (n=379) u pazjenti mhux bojod (n=29) abbażi ta' analiżi PK tal-popolazzjoni.
English: • The active substances are tezacaftor and ivacaftor.
Maltese: • Is-sustanzi attivi huma tezacaftor u ivacaftor.
English: Following multiple doses of tezacaftor and ivacaftor for 10 days, subjects with moderately impaired hepatic function (Child-Pugh Class B, score 7 to 9) had an approximately 36% increase in AUC and a 10% increase in Cmax for tezacaftor, and a 50% increase in ivacaftor AUC compared with healthy subjects matched for demographics.
Maltese: Wara l-għoti ta' dożi multipli ta' tezacaftor u ivacaftor għal 10 ijiem, individwi b'indeboliment moderat tal-fwied (Child-Pugh Klassi B, punteġġ 7 sa 9) kellhom żieda ta' madwar 36% fl-AUC u 10% żieda filCmax għal tezacaftor, u 50% żieda fl-AUC ta' ivacaftor meta mqabbel ma' individwi f'saħħithom meta mqabbla mad-demografija.
English: • Antibiotic medicines (used for the treatment of bacterial infections).
Maltese: • Mediċini antibijotiċi (użati għall-kura ta' infezzjonijiet batterjali).
English: EU/1/18/1306/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1306/001
English: If possible, take your medicine and this leaflet with you.
Maltese: Jekk ikun possibbli, qis li tieħu l-mediċina u dan il-fuljett miegħek.
English: Gender The pharmacokinetic parameters of tezacaftor and ivacaftor are similar in males and females.
Maltese: Il-parametri farmakokinetiċi ta' tezacaftor u ivacaftor huma simili fl-irġiel u n-nisa.
English: Table 4: Adverse reactions in patients treated with ivacaftor monotherapy MedDRA System Organ Class
Maltese: Tabella 4: Reazzjonijiet avversi f'pazjenti kkurati b'monoterapija ta' ivacaftor Sistema tal-Klassifika tal
English: The mean absolute change (SE) from baseline in ppFEV1 was 11.7 (1.2) percentage points in the Symkevi in combination with ivacaftor group, 7.6 (1.2) percentage points in the ivacaftor group and -0.4 (1.2) percentage points in the placebo group in Study 2.
Maltese: Il-bidla assoluta medja (SE) mil-linja bażi f'ppFEV1 kienet 11.7 (1.2) punti perċentwali fil-grupp ta' Symkevi flimkien ma' ivacaftor, 7.6 (1.2) punti perċentwali fil-grupp ta' ivacaftor, u -0.4
English: The mean absolute change (SE) from baseline in BMI z-value was -0.01(0.05) kg/m2 in the Symkevi in combination with ivacaftor group and 0.00 (0.05) kg/m2 in the placebo group in Study 1.
Maltese: 01(0.05) kg/m2 fil-grupp ta' Symkevi flimkien ma' ivacaftor, u 0.00 (0.05) kg/m2 fil-grupp tal-plaċebo fi Studju 1.
English: The pharmacokinetic parameters of tezacaftor in combination with ivacaftor in the elderly patients (65 to 72 years) are comparable to those in younger adults.
Maltese: Ilparametri farmakokinetiċi ta' tezacaftor flimkien ma' ivacaftor f'pazjenti anzjani (65 sa 72 sena) huma komparabbli ma' dawk f'adulti iżgħar.
English: The most common adverse reactions experienced by patients aged 12 years and older who received Symkevi in combination with ivacaftor in the pooled, placebo-controlled, Phase 3 studies were headache (14% versus 11% on placebo) and nasopharyngitis (12% versus 10% on placebo).
Maltese: Ir-reazzjonijiet avversi l-aktar komuni li kellhom pazjenti ta' 12-il sena jew aktar li rċivew Symkevi flimkien ma' ivacaftor fl-istudji miġbura ta' Fażi 3, ikkontrollati bi plaċebo, kienu wġigħ ta' ras (14% kontra 11% bil-plaċebo) u nażofarinġite (12% kontra 10% bil-plaċebo).
English: Symkevi 100 mg, 150 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Symkevi 100 mg, 150 mg
English: Ivacaftor may inhibit CYP2C9; therefore, monitoring of the international normalized ratio (INR) is recommended during co-administration of warfarin with Symkevi given in combination with ivacaftor.
Maltese: Ivacaftor jista' jinibixxi CYP2C9; għalhekk, monitoraġġ tal-proporzjon normalizzat internazzjonali (INR, international normalized ratio) huwa rakkomandat waqt l-għoti flimkien ta' warfarin ma' Symkevi meta jingħata flimkien ma' ivacaftor.
English: Pulmonary exacerbations requiring IV antibiotic therapy were lower in the treatment group compared to placebo (RR: 0.53 [95% CI: 0.34, 0.82]; nominal P=0.0042).
Maltese: L-aggravamenti pulmonari li kienu jeħtieġu terapija antibijotika ġol-vini kienu aktar baxxi fil-grupp ta' trattament meta mqabbel mal-plaċebo (RR: 0.53 [95% CI: 0.34, 0.82]; nominali P=0.0042).
English: The treatment difference between Symkevi (in combination with ivacaftor) and placebo for the primary endpoint of mean absolute change (95% CI) in ppFEV1 from baseline through Week 24 was 4.0 percentage points (95% CI: 3.1, 4.8; P<0.0001).
Maltese: Id-differenza fil-kura bejn Symkevi (flimkien ma' ivacaftor) u plaċebo għall-punt aħħari primarju tal-bidla assoluta medja (95% CI) f'ppFEV1 mil-linja bażi sa Ġimgħa 24 kienet ta' 4.0 punti perċentwali (95% CI: 3.1, 4.8; P<0.0001).
English: As presented in Table 8, the pharmacokinetic parameters of tezacaftor and ivacaftor in adolescents (12 to 17 years) are comparable to those in adults when given in combination.
Maltese: Kif ippreżentat f'Tabella 8, il-parametri farmakokinetiċi ta' tezacaftor u ivacaftor f'adolexxenti (12 sa 17-il sena) huma komparabbli ma' dawk f'adulti meta jingħataw flimkien.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles missodium'.
English: A total of 244 patients aged 12 years and older (mean age 34.8 years) who were heterozygous for the F508del mutation and a second mutation associated with residual CFTR activity were randomized to and received sequences of treatment that included Symkevi in combination with ivacaftor, ivacaftor, and placebo.
Maltese: Total ta' 244 pazjent li kellhom 12-il sena jew aktar (età medja ta' 34.8 snin) li kienu eterożigotiċi għall-mutazzjoni F508del u mutazzjoni oħra assoċjata ma' attività CFTR residwa, intgħażlu b'mod każwali u rċivew sekwenzi ta' kura li inkludew Symkevi flimkien ma' ivacaftor, ivacaftor, u plaċebo.
English: M1-TEZ has similar potency to that of tezacaftor and is considered pharmacologically active.
Maltese: M1-TEZ għandu potenza simili għal dik ta' tezacaftor u huwa kkunsidrat li hu farmakoloġikament attiv.
English: A total of 504 patients aged 12 years and older (mean age 26.3 years) who were homozygous for the F508del mutation in the CFTR gene were randomized (1:1 randomization: 248 Symkevi in combination with ivacaftor, 256 placebo).
Maltese: Total ta' 504 pazjent li kellhom 12-il sena jew aktar (età medja ta' 26.3 snin) li kienu omożigotiċi għall-mutazzjoni F508del fil-ġene CFTR, intgħażlu b'mod każwali (1:1 għażla b'mod każwali: 248 Symkevi flimkien ma' ivacaftor, 256 plaċebo).
English: After steady-state dosing of tezacaftor in combination with ivacaftor in CF patients, the mean (SD) terminal half-lives of tezacaftor and ivacaftor were approximately 156 (52.7) and 9.3 (1.7) hours, respectively.
Maltese: Wara dożaġġ fl-istat fiss ta' tezacaftor flimkien ma' ivacaftor f'pazjenti b'CF, il-half-lives terminali medji (SD) ta' tezacaftor u ivacaftor kienu ta' madwar 156 (52.7) u 9.3 (1.7) sigħat, rispettivament.
English: Dizziness has been reported in patients receiving Symkevi in combination with ivacaftor, as well as ivacaftor monotherapy (see section 4.8).
Maltese: Sturdament ġie rrappurtat f'pazjenti li kienu qed jirċievu Symkevi flimkien ma' ivacaftor, kif ukoll monoterapija ta' ivacaftor (ara sezzjoni 4.8).
English: In Study 1 (patients homozygous for the F508del mutation), the treatment difference between Symkevi in combination with 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; nominal P<0.0001*).
Maltese: Fi Studju 1 (pazjenti omożigotiċi għall-mutazzjoni F508del), id-differenza fil-kura bejn Symkevi flimkien ma' ivacaftor u plaċebo fil-bidla assoluta medja mil-linja bażi fil-chloride tal-għaraq sa Ġimgħa 24 kienet -10.1 mmol/L (95% CI: -11.4, -8.8; nominali P<0.0001*).
English: The impact of severe hepatic impairment (Child-Pugh Class C, score 10 to 15) on the pharmacokinetics of tezacaftor and ivacaftor has not been studied.
Maltese: L-effett ta' indeboliment sever tal-fwied (Child-Pugh Klassi Ċ, punteġġ 10 sa 15) fuq il-farmakokinetika ta' tezacaftor u ivacaftor ma ġiex studjat.
English: How to take Symkevi
Maltese: Tiħux Symkevi:
English: Primary ppFEV1 Baseline value
Maltese: Primarja ppFEV1
English: NA NA
Maltese: t½
English: The mean treatment difference between ivacaftor and placebo-treated patients was 4.4 percentage points (95% CI: 0.9,
Maltese: Id-differenza fil-kura medja bejn pazjenti kkurati b'ivacaftor u dawk ikkurati bi plaċebo kienet ta' 4.4 punti perċentwali (95% CI: 0.9, 7.9).
English: Co-administration with itraconazole, a strong CYP3A inhibitor, increased tezacaftor exposure (measured as AUC) by 4-fold and increased ivacaftor AUC by 15.6-fold.
Maltese: L-għoti flimkien ma' itraconazole, inibitur qawwi ta' CYP3A, żied l-esponiment għal tezacaftor (imkejjel bħala AUC) b'4 darbiet u żied l-AUC ta' ivacaftor bi 15.6 darbiet.
English: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000
Maltese: Ir-reazzjonijiet avversi huma elenkati skont is-sistema talklassifika tal-organi MedDRA u l-frekwenza: 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) u rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Ivacaftor is also metabolized extensively in humans.
Maltese: Ivacaftor ukoll jiġi metabolizzat b'mod estensiv fil-bnedmin.
English: Other medicines and Symkevi
Maltese: Mediċini oħra u Symkevi
English: ppFEV1 Baseline value
Maltese: ppFEV1 Valur fil-linja bażi
English: In a combination regimen with ivacaftor 150 mg tablets The recommended dose is one Symkevi (tezacaftor 100 mg/ivacaftor 150 mg) tablet taken in the morning and one ivacaftor 150 mg tablet taken in the evening, approximately 12 hours apart with fat-containing food (see Method of administration).
Maltese: Id-doża rakkomandata hija pillola Symkevi waħda (tezacaftor 100 mg/ivacaftor 150 mg) filgħodu u pillola waħda ivacaftor ta' 150 mg filgħaxija, madwar 12-il siegħa bejniethom ma' ikel li jkun fih ixxaħam (ara Metodu ta' kif għandu jingħata).
English: There were 16 patients with ppFEV1 <40 at baseline receiving Symkevi, 13 receiving ivacaftor and 15 receiving placebo in Study 2.
Maltese: Kien hemm 16-il pazjent b'ppFEV1 <40 fil-linja bażi li kienu qed jirċievu Symkevi, 13 kienu qed jirċievu ivacaftor u 15 kienu qed jirċievu plaċebo fi Studju 2.
English: Symkevi and ivacaftor are not expected to modify the efficacy of hormonal contraceptives.
Maltese: Symkevi u ivacaftor mhumiex mistennija li jimmodifikaw l-effikaċja ta' kontraċettivi ormonali.
English: Following oral administration of 14C-tezacaftor, the majority of the dose (72%) was excreted in the faeces (unchanged or as the M2-TEZ metabolite) and about 14% was recovered in urine (mostly as M2-TEZ metabolite), resulting in a mean overall recovery of 86% up to 21 days after the dose.
Maltese: Wara għoti orali ta' 14C-tezacaftor, il-maġġoranza tad-doża (72%) ġiet eliminata fl-ippurgar (mhux mibdula jew bħala l-metabolit M2-TEZ) u madwar 14% ġiet irkuprata fl-awrina (l-iżjed bħala lmetabolit M2-TEZ), li jirriżulta f'irkurpru globali medju ta' 86% sa 21 jum wara d-doża.
English: Symkevi is usually taken with ivacaftor.
Maltese: Symkevi normalment jittieħed ma' ivacaftor.
English: ppFEV1: percent predicted forced expiratory volume in 1 second; SD: Standard Deviation; LS mean: least squares mean; CI: confidence interval; NA: not applicable; IVA: ivacaftor; CFQ-R: Cystic Fibrosis Questionnaire-Revised.
Maltese: ppFEV1: perċentwali ta' volum espiratorju sfurzat f'sekonda waħda mbassar; SD: Devjazzjoni Standard; medja LS: medja tal-inqas kwadri ġeomteriċi; CI: intervall ta' kunfidenza;
English: Study in patients with CF who were heterozygous for the F508del mutation and a second mutation associated with residual CFTR activity (Study 2)
Maltese: Studju f'pazjenti b'CF li kienu eterożigotiċi għall-mutazzjoni F508del u mutazzjoni oħra assoċjata ma' attività CFTR residwa (Studju 2)
English: Absolute change from baseline through Week 24 (points)**
Maltese: Bidla assoluta mil-linja bażi sa Ġimgħa 24 (punti)**
English: Co-administration with (oral) midazolam, a sensitive CYP3A substrate, did not affect midazolam exposure.
Maltese: L-għoti flimkien ma' midazolam (orali), substrat sensittiv ta' CYP3A, ma affettwax l-esponiment għal midazolam.
English: BMI Baseline value
Maltese: BMI Valur fil-linja bażi
English: The No Observed Adverse Effect Level (NOAEL) for fertility findings provides an exposure level of approximately 5 times the systemic exposure of ivacaftor and its metabolites when administered as tezacaftor/ivacaftor in adult humans at the maximum recommended human dose (MRHD).
Maltese: Il-Livell tal-Ebda Effett Avvers Osservat (NOAEL, No Observed Adverse Effect Level) għas-sejbiet tal-fertilità jipprovdi livell ta' esponiment ta' 5 darbiet aktar l-esponiment sistemiku għal ivacaftor u l-metaboliti tiegħu meta jingħata bħala tezacaftor/ivacaftor fil-bnedmin adulti fid-doża massima rakkomandata tal-bniedem (MRHD, maximum recommended human dose).
English: • Cardiac glycosides (used for the treatment of some heart conditions).
Maltese: • Glycosides kardijaċi (użati għall-kura ta' xi kundizzjonijiet tal-qalb).
English: Relative change from baseline through Week 24
Maltese: Bidla relattiva mil-linja bażi sa Ġimgħa 24
English: Rhinitis common
Maltese: • Riħ komuni
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 ma' inibizzjoni dgħajfa ta' P-gp minn ivacaftor.
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 volume of distribution of tezacaftor and ivacaftor was 271 (157) L and 206 (82.9) L, 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) għall-volum apparenti tad-distribuzzjoni ta' tezacaftor u ivacaftor kienet ta' 271 (157) L u 206 (82.9) L, rispettivament.
English: In a human pharmacokinetic study with tezacaftor alone, there was minimal elimination of tezacaftor and its metabolites in urine (only 13.7% of total radioactivity was recovered in the urine with 0.79% as unchanged medicinal product).
Maltese: Fi studju farmakokinetiku fil-bnedmin b'tezacaftor waħdu, kien hemm eliminazzjoni minima ta' tezacaftor u lmetaboliti tiegħu fl-awrina (13.7% biss tar-radjuattività totali ġiet irkuprata fl-awrina, b'0.79% bħala lprodott mediċinali mhux mibdul).
English: Patients who received placebo in both Study 1 and Study 2 demonstrated improvements in ppFEV1 when treated with Symkevi in combination with ivacaftor in Study 3 [Study 1: within-group change=4.2 (0.5) percentage points, Study 2: within-group change=4.9 (0.6) percentage points].
Maltese: Pazjenti li rċivew plaċebo kemm fi Studju 1 kif ukoll fi Studju 2 urew titjib f'ppFEV1 meta kkurati b'Symkevi flimkien ma' ivacaftor fi Studju 3 [Studju 1: bidla fil-grupp innifsu=4.2 (0.5) punti perċentwali, Studju 2: bidla fil-grupp innifsu=4.9 (0.6) punti perċentwali].
English: Symkevi 100 mg tezacaftor/150 mg ivacaftor film-coated tablets are yellow, oval-shaped tablets stamped with “V100” on one side and plain on the other.
Maltese: Symkevi 100 mg tezacaftor/150 mg ivacaftor pilloli miksija b'rita huma pilloli sofor, b'forma ovali stampati b'“V100” fuq naħa u xejn fuq in-naħa l-oħra.
English: M1-IVA and M6-IVA are the two major metabolites of ivacaftor in humans.
Maltese: M1-IVA u M6-IVA huma ż-żewġ metaboliti maġġuri ta' ivacaftor fil-bnedmin.
English: Ivacaftor 1.28 (0.440) 9.3 (1.7) *AUC0-24h for tezacaftor and AUC0-12h for ivacaftor
Maltese: *AUC0-24h għal tezacaftor u AUC0-12h għal ivacaftor
English: When used concomitantly with digoxin or other substrates of P-gp with a narrow therapeutic index, such as ciclosporin, everolimus, sirolimus, and tacrolimus, caution and appropriate monitoring should be used.
Maltese: Meta jintuża fl-istess ħin ma' digoxin jew substrati oħra ta' P-gp b'indiċi terapewtiku dejjaq, bħal ciclosporin, everolimus, sirolimus, u tacrolimus, għandha tingħata attenzjoni u għandu jkun hemm monitoraġġ xieraq.
English: The mean treatment difference between Symkevi and placebo-treated patients for absolute change in ppFEV1 through Week 24 in this subgroup was 3.5 percentage points (95% CI: 1.0, 6.1).
Maltese: Id-differenza fil-kura medja bejn pazjenti kkurati b'Symkevi u dawk ikkurati bi plaċebo għal bidla assoluta f'ppFEV1 sa Ġimgħa 24 f'dan is-sottogrupp kienet ta' 3.5 punti perċentwali (95% CI: 1.0, 6.1).
English: Examples of moderate CYP3A inhibitors include:
Maltese: Eżempji ta' inibituri moderati ta' CYP3A jinkludu:
English: Symkevi works on a protein called CFTR (cystic fibrosis transmembrane conductance regulator), which is damaged in some people with CF (who have a mutation in the CFTR gene).
Maltese: Symkevi jaħdem fuq proteina li tissejjaħ CFTR (cystic fibrosis transmembrane conductance regulator),
English: Sinus congestion, Pharyngeal erythema common
Maltese: Konġestjoni tas-sinus, Eritema farinġeali komuni
English: Improvements in ppFEV1 were observed regardless of age, disease severity, sex, mutation class, 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-severità tal-marda, is-sess tal-persuna, il-klassi ta' mutazzjoni, il-kolonizzazzjoni b'Pseudomonas, l-użu fl-istess ħin ta' mediċini għal CF skont l-istandard tal-kura, u r-reġjun ġeografiku.