FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy of Symkevi in combination with ivacaftor 150 mg tablet in patients with CF was demonstrated in two Phase 3, double-blind, controlled studies (Study 1 and Study 2), and one Phase 3, open-label extension study (Study 3).
Slovenian: Učinkovitost zdravila Symkevi v kombinaciji s 150 mg tabletami ivakaftorja pri bolnikih s CF so dokazali v dveh dvojno slepih kontroliranih študijah 3. faze (študija 1 in študija 2) in eni odprti podaljšani študiji 3. faze (študija 3).
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.
Slovenian: Ivakaftor je bil povezan z rahlim zmanjšanjem mase semenskih mešičkov, zmanjšanjem indeksa celotne plodnosti in števila brejosti pri samicah, ki so se parile s samci, ki so prejemali zdravilo, in s pomembnim zmanjšanjem števila rumenih telesc in ugnezditvenih mest s posledičnim zmanjšanjem povprečne velikosti legla in povprečnega števila za življenje sposobnih zarodkov na leglo pri samicah, ki so prejemale zdravilo.
English: These include phenobarbital, carbamazepine and phenytoin.
Slovenian: Vključujejo fenobarbital, karbamazepin in fenitoin;
English: AUCτ,ss (mcg∙h/mL)
Slovenian: Ivakaftor povprečje (SD) AUCτ,ss (µg∙h/ml)
English: No data are available for CYP3A4*22 homozygous genotype patients.
Slovenian: Za bolnike s homozigotnim genotipom CYP3A4*22 podatki niso na voljo.
English: No dose adjustment specific to this patient population is required (see section 5.2).
Slovenian: Prilagoditev odmerkov, ki bi bila značilna za to skupino bolnikov, ni potrebna (glejte poglavje 5.2).
English: Symkevi is not to be used in children under the age of 12 years.
Slovenian: Zdravilo Symkevi se pri otrocih, mlajših od 12 let, ne sme uporabljati.
English: The mean (SD) elimination half-lives for M1-TEZ, M2-TEZ and M5-TEZ were similar to that of the parent compound.
Slovenian: Povprečni (SD) razpolovni čas izločanja M1-TEZ, M2-TEZ in M5-TEZ je bil podoben kot pri izhodni spojini.
English: Both Symkevi and ivacaftor tablets should be taken with fat-containing food, such as food recommended in standard nutritional guidelines (see section 5.2).
Slovenian: Tako tablete zdravila Symkevi kot tablete ivakaftorja je treba jemati z mastno hrano, na primer tisto, ki jo priporočajo standardne prehranske smernice (glejte poglavje 5.2).
English: Laboratory abnormalities
Slovenian: Laboratorijske nenormalnosti
English: The pharmacokinetics of tezacaftor/ivacaftor in children below 12 years of age has not been investigated.
Slovenian: Farmakokinetike tezakaftorja/ivakaftorja pri otrocih, mlajših od 12 let, niso raziskovali.
English: Therefore, co-administration with strong CYP3A inducers is not recommended (see section 4.5).
Slovenian: Zato sočasna uporaba z močnimi induktorji CYP3A ni priporočljiva (glejte poglavje 4.5).
English: Medicinal products affected by tezacaftor and ivacaftor CYP2C9 substrates
Slovenian: Zdravila, na katera vplivata tezakaftor in ivakaftor Substrati CYP2C9
English: Adolescents aged 12 years and older Adolescents were included together with adults in the trials.
Slovenian: Mladostniki so bili v preskušanjih vključeni skupaj z odraslimi.
English: Co-administration of ciprofloxacin did not affect the exposure of ivacaftor or tezacaftor.
Slovenian: Sočasno dajanje ciprofloksacina ni vplivalo na izpostavljenost ivakaftorju ali tezakaftorju.
English: Co-administration of ivacaftor with rifampicin, a strong CYP3A inducer, significantly decreased ivacaftor exposure [area under the curve (AUC)] by 89%.
Slovenian: Sočasna uporaba ivakaftorja z rifampicinom, ki je močan induktor CYP3A, je pomembno zmanjšala izpostavljenost ivakaftorju [površina pod krivuljo (area under the curve - AUC)] za 89 %.
English: CF is an inherited condition in which the lungs and the digestive system can become clogged with thick, sticky mucus.
Slovenian: CF je podedovana bolezen, pri kateri se lahko pljuča in prebavila mašijo z gosto, lepljivo sluzjo.
English: Symkevi taken with ivacaftor is for long-term treatment of patients aged 12 and over who have CF with certain genetic mutations that result in reduced amount and/or function of the CFTR protein.
Slovenian: Zdravilo Symkevi skupaj z ivakaftorjem je namenjeno za dolgoročno zdravljenje bolnikov, starih 12 let ali več, ki imajo CF z nekaterimi genetskimi mutacijami, ki povzročijo zmanjšano količino in/ali delovanje beljakovine CFTR.
English: Ivacaftor is approximately 99% bound to plasma proteins, primarily to alpha 1-acid glycoprotein and albumin.
Slovenian: Ivakaftor je približno 99-odstotno vezan na plazemske beljakovine, predvsem na alfa 1-kisli glikoprotein in albumin.
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).
Slovenian: Zdravilo Symkevi deluje na beljakovino, ki se imenuje regulator transmembranske prevodnosti pri cistični fibrozi (cystic fibrosis transmembrane conductance regulator - CFTR), ki je pri nekaterih ljudeh s CF okvarjen (ti imajo mutacijo v genu CFTR).
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.
Slovenian: Tega niso opazili pri plodovih iz podganjih samic, ki so od 7. do 17. dne brejosti prejemale ivakaftor, pri podganjih mladičih, ki so bili izpostavljeni ivakaftorju s tem, da so se do 20. poporodnega dne hranili z mlekom, pri 7 dni starih podganah, niti pri 3,5 do 5 mesecev starih psih, ki so prejemali ivakaftor.
English: There was negligible urinary excretion of ivacaftor as unchanged drug.
Slovenian: Izločanje ivakaftorja z urinom v obliki nespremenjenega zdravila je bilo zanemarljivo.
English: In a human pharmacokinetic study with ivacaftor alone, there was minimal elimination of ivacaftor and its metabolites in urine (only 6.6% of total radioactivity was recovered in the urine).
Slovenian: V študiji farmakokinetike ivakaftorja samega pri ljudeh so se ivakaftor in njegovi presnovki minimalno izločali v urinu (v urinu so prestregli samo 6,6 % celotne radioaktivnosti).
English: Adults and adolescents aged 12 years and older
Slovenian: Mladostniki, stari 12 let ali več
English: Ivacaftor causes the protein to work better while tezacaftor increases the amount of protein at the cell surface.
Slovenian: Ivakaftor povzroči, da beljakovina bolje deluje, tezakaftor pa zveča količino beljakovine na celični površini.
English: M6-IVA is not considered pharmacologically active.
Slovenian: Za M6-IVA velja, da ni farmakološko aktiven.
English: Following oral administration of a single dose of 100 mg 14C-tezacaftor to healthy male subjects, M1-TEZ, M2-TEZ, and M5-TEZ were the three major circulating metabolites of tezacaftor in humans, contributing to 15%, 31%, and 33% of total radioactivity, respectively.
Slovenian: Po peroralnem dajanju enkratnega odmerka 100 mg 14C-tezakaftorja zdravim moškim preiskovancem so bili trije glavni presnovki tezakaftorja, ki so pri ljudeh krožili v krvi, M1-TEZ, M2-TEZ in M5-TEZ, ki so prispevali 15 %, 31 % oziroma 33 % celotne radioaktivnosti.
English: Symkevi taken with ivacaftor helps your breathing by improving your lung function.
Slovenian: Zdravilo Symkevi skupaj z ivakaftorjem vam pomaga dihati, tako da izboljša delovanje vaših pljuč.
English: Do not make changes unless your doctor tells you.
Slovenian: Ne spreminjajte odmerka ali časa jemanja, če vam tega ne naroči zdravnik.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of tezacaftor or ivacaftor in pregnant women.
Slovenian: Podatkov o uporabi tezakaftorja ali ivakaftorja pri nosečnicah ni oziroma so omejeni (manj kot 300 izpostavljenih nosečnosti).
English: Symkevi in combination with ivacaftor has not been studied in patients with moderate or severe renal impairment (creatinine clearance ≤30 mL/min) or in patients with end-stage renal disease.
Slovenian: Zdravila Symkevi v kombinaciji z ivakaftorjem pri bolnikih z zmerno ali težko okvaro ledvic (očistek kreatinina ≤ 30 ml/min) ali pri bolnikih z boleznijo ledvic v končnem stadiju niso raziskali.
English: Symkevi in combination with ivacaftor was associated with a lower event rate per year of severe pulmonary exacerbations requiring hospitalization or IV antibiotic therapy (0.29) compared to placebo (0.54).
Slovenian: Zdravilo Symkevi v kombinaciji z ivakaftorjem je bilo povezano z manjšo pogostnostjo dogodkov težkih pljučnih eksacerbacij, pri katerih je bil potreben sprejem v bolnišnico ali intravensko antibiotično zdravljenje (0,29), na leto v primerjavi s placebom (0,54).
English: Medicinal products affecting the pharmacokinetics of tezacaftor and ivacaftor CYP3A inducers
Slovenian: Zdravila, ki vplivajo na farmakokinetiko tezakaftorja in ivakaftorja Induktorji CYP3A
English: What Symkevi looks like and contents of the pack
Slovenian: Izgled zdravila Symkevi in vsebina pakiranja
English: Table 5: Primary and key secondary efficacy analyses, full analysis set (Study 1) Analysis
Slovenian: Preglednica 5: Analize primarne in ključnih sekundarnih učinkovitosti, celotna skupina bolnikov za analizo (študija 1)
English: Concomitant use of CYP3A inducers may result in reduced exposures and thus reduced efficacy of Symkevi and ivacaftor.
Slovenian: Sočasna uporaba induktorjev CYP3A lahko povzroči zmanjšanje izpostavljenosti in s tem zmanjšanje učinkovitosti zdravila Symkevi in ivakaftorja.
English: Table 6: Primary and key secondary efficacy analyses, full analysis set (Study 2) Analysis
Slovenian: Preglednica 6: Analize primarne in ključnih sekundarnih učinkovitosti, celotna skupina bolnikov za analizo (študija 2)
English: Placebo N=161
Slovenian: N=161
English: Gender The pharmacokinetic parameters of tezacaftor and ivacaftor are similar in males and females.
Slovenian: Farmakokinetični parametri tezakaftorja in ivakaftorja so pri moških in ženskah podobni.
English: Pulmonary exacerbations
Slovenian: Pljučne eksacerbacije
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.
Slovenian: Po 10-dnevnem dajanju večkratnih odmerkov tezakaftorja in ivakaftorja se je pri osebah z zmerno okvarjeno funkcijo jeter (razred B po Child-Pughovi lestvici, rezultat 7 do 9) AUC tezakaftorja zvečala približno za 36 % in Cmax tezakaftorja za 10 %, AUC ivakaftorja pa se je v primerjavi z zdravimi preiskovanci s primerljivimi demografskimi podatki zvečala za 50 %.
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).
Slovenian: V študiji farmakokinetike tezakaftorja samega pri ljudeh so se tezakaftor in njegovi presnovki minimalno izločali v urinu (v urinu so prestregli samo 13,7 % celotne radioaktivnosti, od tega je bilo 0,79 % nespremenjenega zdravila).
English: Mean improvement in ppFEV1 was observed at the first assessment on Day 15 and sustained throughout the 8-week treatment period.
Slovenian: Povprečno izboljšanje ppFEV1 so ugotovili pri prvem ocenjevanju 15. dne in je trajalo ves čas 8-tedenskega obdobja zdravljenja.
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.
Slovenian: Po peroralnem dajanju 14C-tezakaftorja se je večina odmerka (72 %) izločila v blatu (nespremenjen ali kot presnovek M2-TEZ), okrog 14 % odmerka pa so prestregli v urinu (večinoma kot presnovek M2-TEZ).
English: The AUC of tezacaftor did not change when given with fat-containing food relative to fasted conditions.
Slovenian: AUC tezakaftorja se ni spremenil glede na stanje na tešče, če so ga dali z obrokom mastne hrane.
English: No dose-adjustment of tezacaftor and ivacaftor is considered necessary.
Slovenian: Prilagajanje odmerka tezakaftorja in ivakaftorja se ne šteje kot potrebno.
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.
Slovenian: Tezakaftor lajša celično procesiranje in transport normalnih ali številnih mutantnih oblik CFTR (tudi F508del-CFTR), s čimer se zveča količina beljakovine CFTR, ki prispe na površino celice, s tem pa se zveča transport kloridov in vitro.
English: The median (range) tmax of ivacaftor was approximately 6 hours (3 to 10 hours) in the fed state.
Slovenian: Mediani (razpon) tmax ivakaftorja po obroku hrane je bil približno 6 ur (3 do 10 ur).
English: Table 7: Mean (SD) pharmacokinetic parameters of tezacaftor and ivacaftor at steady state in patients with CF
Slovenian: Preglednica 7: Povprečni (SD) farmakokinetični parametri tezakaftorja in ivakaftorja v stanju dinamičnega ravnovesja pri bolnikih s CF
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.
Slovenian: Preiskave bakterije v izmečku zelo pogosti Podatki o varnosti iz vmesne analize varnosti, opravljene na 867 bolnikih v dolgoročni obnovitveni študiji varnosti in učinkovitosti (študija 3), v katero je bilo vključenih 326 bolnikov z ≥ 48 tednov kumulativnega zdravljenja z zdravilom Symkevi, ki so ga dajali skupaj z ivakaftorjem, so se skladali s podatki o varnosti iz študij 3. faze, kontroliranih s placebom.
English: If you stop taking Symkevi
Slovenian: Če ste prenehali jemati zdravilo Symkevi
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.
Slovenian: Izboljšanje ppFEV1 so ugotovili ne glede na starost, spol, izhodiščni ppFEV1, kolonizacijo z bakterijo Pseudomonas, sočasno uporabo standardnih zdravil za CF in zemljepisno območje.
English: ** Linear Mixed Effects model with treatment, period, and study baseline ppFEV1 as fixed effects and subject as a random effect.
Slovenian: **Linearni model mešanih učinkov za ponovljene ukrepe, pri čemer so zdravljenje, čas in izhodiščni ppFEV1 študije nespremenljivi učinki in preiskovanec naključen učinek.
English: Physiologically based pharmacokinetic modeling suggested co-administration with fluconazole, a moderate CYP3A inhibitor, may increase tezacaftor exposure (AUC) by approximately 2-fold.
Slovenian: Farmakokinetično modeliranje na podlagi fiziologije je pokazalo, da sočasna uporaba s flukonazolom, ki je zmeren zaviralec CYP3A, lahko zveča izpostavljenost tezakaftorju (AUC) za približno 2-krat.
English: Symkevi in combination with ivacaftor should not be prescribed in patients with CF who are heterozygous for the F508del mutation and have a second CFTR mutation not listed in section 4.1.
Slovenian: Zdravila Symkevi v kombinaciji z ivakaftorjem ni dovoljeno predpisovati bolnikom s CF, ki so heterozigotni za mutacijo F508del in imajo drugo mutacijo CFTR, ki ni navedena v poglavju 4.1.
English: • Anticoagulant medicines (used to prevent blood clots).
Slovenian: • antikoagulanti (uporabljajo se za preprečevanje krvnih strdkov).
English: Clinical trials of Symkevi in combination with ivacaftor did not include patients over 75 years of age.
Slovenian: V klinična preskušanja zdravila Symkevi v kombinaciji z ivakaftorjem bolniki, starejši od 75 let, niso bili vključeni.
English: • In the evening, take one ivacaftor 150 mg tablet.
Slovenian: • Zvečer vzemite eno tableto ivakaftorja 150 mg.
English: S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T.
Slovenian: S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G in 3849+10kbC→T.
English: Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper Dublin 2, D02 EK84
Slovenian: 28-32 Pembroke Street Upper Dublin 2, D02 EK84 Irska
English: Following oral administration of ivacaftor alone, the majority of ivacaftor (87.8%) is eliminated in the faeces after metabolic conversion.
Slovenian: Po peroralnem dajanju ivakaftorja samega se večina ivakaftorja (87,8 %) izloči v blatu.
English: If you forget to take Symkevi
Slovenian: Če ste pozabili vzeti zdravilo Symkevi
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.
Slovenian: Sočasna uporaba z itrakonazolom, ki je močan zaviralec CYP3A, je zvečala izpostavljenost tezakaftorju (merjeno kot AUC) za štirikrat in zvečala AUC ivakaftorja za 15,6-krat.
English: • Changes in the type of bacteria in mucus
Slovenian: • izpuščaj, • spremembe vrst bakterij v sluzi.
English: The mean ppFEV1 at baseline was 62.3% (range: 34.6% to 93.5%).
Slovenian: Povprečni ppFEV1 v izhodišču je bil 62,3 % (razpon: 34,6 % do
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.
Slovenian: Izboljšanje ppFEV1 so ugotavljali ne glede na starost, izraženost bolezni, spol, razred mutacije, kolonizacijo z bakterijo Pseudomonas, sočasno uporabo standardnih zdravil za CF in zemljepisno območje.
English: Number of pulmonary exacerbations from baseline through Week 24
Slovenian: Število pljučnih eksacerbacij od izhodišča do vključno 24. tedna število oseb z dogodki
English: Tell your doctor right away if you have any symptoms of liver problems.
Slovenian: Nemudoma povejte zdravniku, če imate kakšne simptome težav z jetri, ki so navedeni v poglavju 4.
English: Take both Symkevi and ivacaftor tablets with food that contains fat.
Slovenian: Tako tablete zdravila Symkevi kot tablete ivakaftorja jemljite skupaj z obrokom, ki vsebuje maščobe.
English: M1-IVA has approximately one-sixth the potency of ivacaftor and is considered pharmacologically active.
Slovenian: M1-IVA ima približno šestino jakosti ivakaftorja in velja za farmakološko aktivnega.
English: Pulmonary exacerbations requiring hospitalizations were similar between treatment groups (RR: 0.78 [95% CI: 0.44, 1.36]; P=0.3801).
Slovenian: Pogostnost pljučnih eksacerbacij, pri katerih je bil potreben sprejem v bolnišnico, je bila pri obeh zdravljenih skupinah podobna (RR: 0,78 [95 % IZ: 0,44; 1,36]; P = 0,3801).
English: Mean (SD) tezacaftor and ivacaftor exposure by age group Age group
Slovenian: Povprečna (SD) izpostavljenost tezakaftorju in ivakaftorju po starostnih skupinah Starostna skupina
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).
Slovenian: Raven brez ugotovljenih neželenih učinkov (No Observed Adverse Effect Level - NOAEL) za rezultate plodnosti je dala raven izpostavljenosti, ki je bila petkratnik sistemske izpostavljenosti ivakaftorju in njegovim presnovkom, kadar so ga dajali kot tezakaftor/ivakaftor odraslim ljudem v največjem priporočenem odmerku za ljudi (maximum recommended human doseMRHD).
English: Increased liver enzymes in the blood have been seen in patients with CF receiving Symkevi.
Slovenian: Zvišane jetrne encime v krvi so ugotavljali pri bolnikih s CF, ki so prejemali zdravilo Symkevi.
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.
Slovenian: Ne pričakujemo, da bodo sočasni zaviralci OATP1B1, P-gp ali BCRP pomembno vplivali na izpostavljenost tezakaftorju zaradi svoje velike intrinzične permeabilnosti in majhne verjetnosti izločanja v nespremenjeni obliki.
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.
Slovenian: nominalna P < 0,0001± ppFEV1: odstotek napovedanega forsiranega ekspiracijskega volumna v 1 sekundi; SD: standardna deviacija; IZ: interval zaupanja; ITM: indeks telesne mase; CFQ-R: vprašalnik o cistični fibrozi-revidiran.
English: Do not chew, crush or break the tablets before swallowing.
Slovenian: Pred požiranjem tablet ne žvečite, zdrobite ali prelomite.
English: The NOAEL for viability and growth in the offspring provides an exposure level of approximately 4 times the systemic exposure of ivacaftor and its metabolites when administered as tezacaftor/ivacaftor in adult humans at the MRHD.
Slovenian: NOAEL za sposobnost preživetja in rast pri potomstvu je dala raven izpostavljenosti, ki je bila približno štirikratnik sistemske izpostavljenosti ivakaftorju in njegovim presnovkom, kadar so ga dajali kot tezakaftor/ivakaftor odraslim ljudem v MRHD.
English: CYP3A, digoxin and other P-gp Substrates
Slovenian: CYP3A, digoksin in drugi substrati P-gp Substrati CYP3A
English: These include warfarin.
Slovenian: Vključujejo varfarin;
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.
Slovenian: Ivakaftor lahko zavira CYP2C9; zato je med sočasnim dajanjem varfarina z zdravilom Symkevi, dajanega v kombinaciji z ivakaftorjem, priporočljivo spremljanje mednarodnega normaliziranega razmerja (international normalized ratio - INR).
English: In Study 2 treatment with Symkevi in combination with ivacaftor resulted in a statistically significant improvement in ppFEV1 (Table 6).
Slovenian: V študiji 2 je zdravljenje z zdravilom Symkevi v kombinaciji z ivakaftorjem povzročilo statistično značilno izboljšanje ppFEV1 (preglednica 6).
English: Elevated transaminases are common in patients with CF, and have been observed in some patients treated with Symkevi in combination with ivacaftor, as well as with ivacaftor monotherapy.
Slovenian: Zvišane transaminaze so pri bolnikih s CF pogoste in so jih ugotovili pri nekaterih bolnikih, zdravljenih z zdravilom Symkevi v kombinaciji z ivakaftorjem, pa tudi pri monoterapiji z ivakaftorjem.
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).
Slovenian: Kadar ju uporabljate skupaj z zmernimi zaviralci CYP3A (npr. flukonazolom ali eritromicinom), je treba odmerek prilagoditi v skladu s preglednico 1 (glejte poglavji 4.4 in 4.5).
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.
Slovenian: Celotna skupina 244 bolnikov, starih 12 let ali več (povprečna starost 34,8 leta), ki so bili heterozigotni za mutacijo F508del in drugo mutacijo, povezano z rezidualno aktivnostjo CFTR, je bila randomizirana in je prejela zaporedja zdravljenja, ki so vključevala zdravilo Symkevi v kombinaciji z ivakaftorjem, ivakaftor in placebo.
English: Placebo N=256
Slovenian: N=256