FrancophonIA/ELRC3.0 huggingface dataset:
English: Take the missed dose with fat-containing food if less than 6 hours have passed since the time you missed the dose.
Slovenian: Vzemite izpuščeni odmerek z mastno hrano, če je preteklo manj kot 6 ur od takrat, ko ste izpustili odmerek.
English: Lumacaftor increases the amount of CFTR available and ivacaftor helps the abnormal protein to work more normally.
Slovenian: Lumakaftor zvečuje količino CFTR, ki je na voljo, ivakaftor pa pomaga nenormalni beljakovini bolj normalno delovati.
English: At maternally toxic doses in rats, ivacaftor produced reductions in foetal body weight; an increase in the incidence of variations in cervical ribs, hypoplastic ribs, and wavy ribs; and sternal irregularities, including fusions.
Slovenian: Pri podganah je ivakaftor v odmerkih, toksičnih za mater, povzročil zmanjšanje telesne mase plodov; zvečanje pogostnosti variacij cervikalnih reber, hipoplastičnih reber in valovite deformacije reber; in nepravilnosti prsnice, vključno s fuzijami.
English: The event rate per year, annualised to 48 weeks, was 0.70 in the lumacaftor/ivacaftor group and 1.14 in the placebo group.
Slovenian: Pogostnost dogodkov na leto, preračunana na 48 tednov, je bila 0,70 v skupini z lumakaftorjem/ivakaftorjem in 1,14 v skupini s placebom.
English: The safety and efficacy of lumacaftor/ivacaftor in patients age 65 years or older have not been evaluated.
Slovenian: Starejši Varnosti in učinkovitosti lumakaftorja/ivakaftorja pri bolnikih, starih 65 let ali več, niso ocenjevali.
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).
Slovenian: V farmakokinetični študiji na ljudeh samo z lumakaftorjem so ugotovili minimalno odstranjevanje lumakaftorja in njegovih presnovkov v urinu (samo 8,6 % celotne radioaktivnosti so prestregli v urinu, od tega je bilo 0,18 % v obliki nespremenjene izhodne snovi).
English: Table 7: Summary of primary and key secondary outcomes in Trial 7
Slovenian: Preglednica 7: Povzetek primarnih in ključnih sekundarnih ciljev v preskušanju 7
English: Patients with advanced liver disease
Slovenian: Bolniki z napredovalo boleznijo jeter
English: You may experience side effects, including those mentioned in section 4 below.
Slovenian: Mogoče boste dobili neželene učinke, vključno s tistimi, ki so omenjeni v poglavju 4 v nadaljevanju.
English: • Moderate liver problems: the dose may be reduced to two tablets in the morning and one tablet in the evening.
Slovenian: • Zmerne težave z jetri: odmerek se lahko zmanjša na dve tableti zjutraj in eno tableto zvečer.
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 %) po presnovnem preoblikovanju izloči v blatu.
English: Giving Orkambi granules to your child:
Slovenian: Dajanje zrnc zdravila Orkambi otroku:
English: • Increase of an enzyme in your blood (blood creatine phosphokinase)
Slovenian: • zvišanje encima (kreatin-fosfokinaze) v vaši krvi,
English: Swallow the tablets whole.
Slovenian: Tablete pogoltnite cele.
English: Therefore, concomitant use of lumacaftor/ivacaftor with CYP3A substrates may decrease the exposure of these substrates (see section 4.4).
Slovenian: Zato lahko sočasna uporaba lumakaftorja/ivakaftorja s substrati CYP3A zmanjša izpostavljenost tem substratom (glejte poglavje 4.4).
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).
Slovenian: Kliničnih izkušenj pri bolnikih s ppFEV1 < 40 je malo in med uvajanjem zdravljenja priporočajo dodatno spremljanje teh bolnikov (glejte poglavje 4.8).
English: Following resolution of transaminase elevations, the benefits and risks of resuming dosing should be considered (see sections 4.2, 4.8, and 5.2).
Slovenian: Potem ko zvišanja transaminaz izzvenijo, je treba pretehtati koristi in tveganja ponovnega odmerjanja (glejte poglavja 4.2, 4.8 in 5.2).
English: Taking Orkambi with fat-containing food is important to get the right levels of medicine in the body.
Slovenian: Jemanje zdravila Orkambi z mastno hrano je pomembno za doseganje ustreznih koncentracij zdravila v telesu.
English: Especially tell your doctor if you take any of the following medicines:
Slovenian: Zdravniku še posebno povejte, če jemljete katero od naslednjih zdravil:
English: The impact of mild hepatic impairment (Child-Pugh Class A, score 5 to 6) on pharmacokinetics of lumacaftor given in combination with ivacaftor has not been studied, but the increase in exposure is expected to be less than 50%.
Slovenian: Vpliva blage okvare jeter (razred A po Child-Pughovi lestvici, rezultat 5 do 6) na farmakokinetiko lumakaftorja, dajanega v kombinaciji z ivakaftorjem, niso raziskovali, vendar se pričakuje, da je zvečanje izpostavljenosti manj kot 50 %.
English: Do not chew, break, or dissolve the tablets.
Slovenian: Tablet ne žvečite, ne drobite in ne raztapljajte.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of lumacaftor/ivacaftor in pregnant women.
Slovenian: Podatkov o uporabi lumakaftorja/ivakaftorja pri nosečnicah ni oziroma so omejeni (manj kot 300 izpostavljenih nosečnosti).
English: Increased blood pressure
Slovenian: Zvišan krvni tlak
English: In healthy subjects, the half-life of ivacaftor when given with lumacaftor is approximately 9 hours.
Slovenian: Pri zdravih osebah je bil razpolovni čas ivakaftorja, če so ga dajali z lumakaftorjem, približno 9 ur.
English: Due to potential induction or inhibition of P-gp
Slovenian: Zaradi možne indukcije ali zaviranja P-gp
English: Important information about the contents of Orkambi This medicine contains less than 1 mmol sodium (23 mg) per dose, so it is essentially ‘sodium-free'.
Slovenian: Pomembne informacije o vsebini zdravila Orkambi To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: Proportion of patients with ≥5% relative change in ppFEV1 at Week 24
Slovenian: Delež bolnikov z ≥ 5 % relativno spremembo ppFEV1 v
English: Tell your child's doctor straight away if your child has any of these symptoms, which may be a sign of liver problems:
Slovenian: Obvestite otrokovega zdravnika, če ima vaš otrok katerega od teh simptomov, ki bi bil lahko znak težav z jetri:
English: Especially tell the doctor if your child takes any of the following medicines:
Slovenian: Še zlasti pa povejte zdravniku, če otrok jemlje katero od naslednjih zdravil:
English: CYP2B6 and CYP2C substrates
Slovenian: Substrati CYP2B6 in CYP2C
English: An alternative to these antibiotics, such as azithromycin, should be considered.
Slovenian: Razmisliti je treba o uporabi drugih antibiotikov, na primer azitromicina.
English: Table 8: Summary of secondary outcomes in Trial 8
Slovenian: Preglednica 8: Povzetek sekundarnih izidov v preskušanju 8 Sekundarna končna stanja*
English: Blood creatine phosphokinase increased uncommon Blood pressure increased
Slovenian: pogosti zvišana kreatin-fosfokinaza v krvi občasni zvišan krvni tlak
English: Therefore, after weighing the risks and benefits of treatment, Orkambi should be used with caution at a reduced dose (see sections 4.4, 4.8, and 5.2).
Slovenian: Zato je treba po presoji tveganja in koristi zdravljenja zdravilo Orkambi previdno uporabljati v zmanjšanem odmerku (glejte poglavja 4.4, 4.8 in 5.2).
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.
Slovenian: Zaradi indukcijskega učinka lumakaftorja na CYP3A v stanju dinamičnega ravnovesja ni pričakovati, da bi neto izpostavljenost ivakaftorju, kadar ga dajemo sočasno z zaviralcem CYP3A, presegla tisto pri dajanju brez lumakaftorja v odmerku 150 mg vsakih 12 ur, kar je odobreni odmerek monoterapije z ivakaftorjem.
English: There are different strengths of Orkambi tablet for different age groups.
Slovenian: Za različne starostne skupine so na voljo različne jakosti tablet zdravila Orkambi.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Instructions for use
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Navodilo za uporabo
English: If you forget to take Orkambi
Slovenian: Če ste pozabili vzeti zdravilo Orkambi
English: • Severe liver problems: the dose may be reduced to one sachet per day, or less often.
Slovenian: • Resne težave z jetri: odmerek se lahko zmanjša na eno vrečico na dan ali še redkeje.
English: ↓ citalopram, escitalopram, sertraline
Slovenian: ↓ citalopram, escitalopram, sertralin
English: The exposures of ivacaftor and the anticonvulsant may be significantly decreased, which may reduce the efficacy of both active substances.
Slovenian: Izpostavljenost ivakaftorju in antikonvulzivu se lahko znatno zmanjša, kar lahko zmanjša učinkovitost obeh učinkovin.
English: This medicine contains less than 1 mmole sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: Seven patients who received lumacaftor/ivacaftor had liver-related serious adverse events with elevated transaminases, including 3 with concurrent elevation in total bilirubin.
Slovenian: Sedem bolnikov, ki so prejemali lumakaftor/ivakaftor, je imelo z jetri povezane resne neželene učinke z zvišanimi transaminazami, vključno s tremi, ki so imeli sočasno zvišanje celotnega bilirubina.
English: If you take more Orkambi than you should
Slovenian: Če ste vzeli večji odmerek zdravila Orkambi, kot bi smeli
English: Ivacaftor was not teratogenic when dosed orally to pregnant rats and rabbits during the organogenesis stage of foetal development at doses approximately 7 times (ivacaftor and metabolite exposure) and 46 times the ivacaftor exposure in humans at the therapeutic lumacaftor/ivacaftor dose, respectively.
Slovenian: Ivakaftor ni bil teratogen, kadar so ga peroralno dajali brejim samicam podgan in kuncev med stadijem organogeneze fetalnega razvoja v odmerkih, ki so približno 7-krat (izpostavljenost ivakaftorju in presnovkom) oziroma 46-krat presegli izpostavljenost ivakaftorju pri ljudeh ob terapevtskem odmerku lumakaftorja/ivakaftorja.
English: Findings of cataracts were observed in juvenile rats dosed with ivacaftor at 0.32 times the maximum recommended human dose based on systemic exposure of ivacaftor and its metabolites when co-administered with lumacaftor as Orkambi.
Slovenian: Katarakte so ugotovili pri mladih podganah, ki so prejemale 0,32-kratnik največjega priporočenega odmerka za človeka na podlagi sistemske izpostavljenosti ivakaftorju in njegovim presnovkom, ko so ga dajali sočasno z lumakaftorjem v obliki zdravila Orkambi.
English: A double dose should not be taken to make up for the forgotten dose.
Slovenian: Bolnik ne sme vzeti dvojnega odmerka, da bi nadomestil pozabljeni odmerek.
English: Very common may affect more than 1 in 10 people:
Slovenian: Zelo pogosti se lahko pojavijo pri več kot 1 od 10 bolnikov:
English: While taking Orkambi, you may notice that your breathing is easier, that you do not get ill as often, and/or that it is easier to gain weight.
Slovenian: Med jemanjem zdravila Orkambi boste mogoče opazili, da lažje dihate, da ne zbolite tako pogosto in/ali da lažje pridobite telesno maso.
English: Almac Pharma Services Limited Seagoe Industrial Estate Craigavon
Slovenian: Almac Pharma Services Limited Seagoe Industrial Estate
English: Name and address of the manufacturer responsible for batch release Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serij Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate
English: • Anti-inflammatory medicines (used for the treatment of inflammation) for example: ibuprofen
Slovenian: • protivnetna zdravila (uporabljajo se za zdravljenje vnetja), na primer: ibuprofen;
English: Adverse reactions observed with ivacaftor alone are also provided in Table 4.
Slovenian: Neželeni učinki, ki so jih ugotovili pri ivakaftorju samem, so tudi navedeni v preglednici 4.
English: • This medicine has been prescribed for your child only.
Slovenian: • Zdravilo je bilo predpisano le vašemu otroku in ga ne smete dajati drugim.
English: Co-administration of Orkambi with medicinal products that inhibit BCRP may increase plasma lumacaftor concentration.
Slovenian: Sočasno dajanje zdravila Orkambi z zdravili, ki zavirajo BRCP, lahko zviša koncentracijo lumakaftorja v plazmi.
English: The safety and efficacy of Orkambi in patients aged 65 years or older have not been evaluated.
Slovenian: Varnosti in učinkovitosti zdravila Orkambi pri bolnikih, starih 65 let ali več, niso ocenjevali.
English: • Yellowing of the skin or the white part of the eyes
Slovenian: • porumenitev kože ali očesnih beločnic,
English: In vitro and in vivo data indicate that lumacaftor is mainly metabolised via oxidation and glucuronidation.
Slovenian: Podatki in vitro in in vivo kažejo, da se lumakaftor v glavnem presnavlja z oksidacijo in glukuronidacijo.
English: Clinical comment erythromycin
Slovenian: Klinični komentar eritromicin
English: Trial 8 evaluated 60 patients aged 2 to 5 years at screening (mean age at baseline 3.7 years).
Slovenian: V preskušanju 8 so ocenjevali 60 bolnikov, ki so bili ob presejanju stari 2 do 5 let (povprečna starost v izhodišču 3,7 let).
English: Two patients in the lumacaftor/ivacaftor group and two patients in the placebo group discontinued treatment permanently due to transaminase elevations.
Slovenian: Dva bolnika v skupini, ki je prejemala lumakaftor/ivakaftor, in dva bolnika v skupini s placebom sta trajno prenehala z zdravljenjem zaradi zvišanja transaminaz.
English: Cataracts were not observed in foetuses derived from rat dams treated during the organogenesis stage of foetal development, in rat pups exposed to a certain extent through milk ingestion prior to weaning, or in repeated dose toxicity studies with ivacaftor.
Slovenian: Katarakt niso ugotovili pri plodovih podganjih samic, ki so zdravilo prejemale med stadijem organogeneze fetalnega razvoja, pri podganjih mladičih, ki so bili v določeni meri pred odstavitvijo od prsi izpostavljeni preko materinega mleka, ali v študijah toksičnosti ponavljajočih se odmerkov ivakaftorja.
English: *Side effects seen for ivacaftor alone.
Slovenian: *Neželeni učinki, ki so jih opazili pri ivakaftorju samem.
English: Table 1: Recommended dose of Orkambi in patients aged 6 years and older Age
Slovenian: Preglednica 1: Priporočeni odmerek zdravila Orkambi za bolnike, stare 6 let ali več Starost
English: Lumacaftor is not extensively metabolised in humans, with the majority of lumacaftor excreted unchanged in the faeces.
Slovenian: Lumakaftor se pri ljudeh ne presnavlja izdatno, večinoma se nespremenjen izloči v blatu.
English: Ivacaftor may cause dizziness (see section 4.8).
Slovenian: Ivakaftor lahko povzroča omotico (glejte poglavje 4.8).
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from lumacaftor/ivacaftor therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom lumakaftor/ivakaftor, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: No dose adjustment
Slovenian: brez prilagoditve odmerka
English: Lumacaftor had no effects on fertility and reproductive performance indices in male and female rats.
Slovenian: Lumakaftor ni vplival na indekse plodnosti in reproduktivne uspešnosti pri samcih in samicah podgan.
English: The event occurred within 5 days of the start of dosing and resolved following discontinuation of lumacaftor/ivacaftor (see section 4.4).
Slovenian: Do dogodka je prišlo v 5 dneh po začetku odmerjanja, po ukinitvi lumakaftorja/ivakaftorja pa se je razrešil (glejte poglavje 4.4).
English: The percentage of patients with heart rate values < 50 bpm on treatment was 11% for patients who received lumacaftor/ivacaftor, compared to 4.9% for patients who received placebo.
Slovenian: Odstotni delež bolnikov z vrednostmi srčne frekvence < 50 bpm med zdravljenjem je bil 11 % pri bolnikih, zdravljenih z lumakaftorjem/ivakaftorjem, v primerjavi s 4,9 % pri bolnikih, ki so prejemali placebo.
English: No specific antidote is available for overdose with lumacaftor/ivacaftor.
Slovenian: Specifičen antidot za prevelik odmerek lumakaftorja/ivakaftorja ni na voljo.
English: The safety data from 1029 patients aged 12 years and older who were homozygous for the F508del mutation in the CFTR gene treated with lumacaftor/ivacaftor for up to an additional 96 weeks in the long-term safety and efficacy rollover study (Trial 3) were similar to the 24-week, placebo-controlled studies (see section 5.1).
Slovenian: Varnostni podatki pri 1029 bolnikih, starih 12 let ali starejših, ki so bili homozigotni za mutacijo F508del na genu CFTR, zdravljenih z lumakaftorjem/ivakaftorjem največ dodatnih 96 tednov v dolgoročni obnovitveni študiji varnosti in učinkovitosti (preskušanje 3), so bili podobni kot v 24-tedenskih, s placebom kontroliranih študijah (glejte poglavje 5.1).
English: Orkambi should not be used in patients other than those who have two copies of the F508del mutation in their CFTR gene.
Slovenian: Zdravilo Orkambi se sme uporabljati samo pri bolnikih, ki imajo dve kopiji mutacije F508del na svojem genu CFTR.
English: You can help by reporting any side effects your child may get.
Slovenian: Tudi sami lahko k temu prispevate tako, da poročate o katerem koli neželenem učinku zdravila, ki bi se utegnil pojaviti pri vašem otroku.
English: • Severe liver problems: the dose may be reduced to one tablet every 12 hours.
Slovenian: • Resne težave z jetri: odmerek se lahko zmanjša na eno tableto na 12 ur.
English: Among different age paediatric cohorts, in the 2 to 5 years old patients, transaminase elevations have been observed more frequently than in the 6 to 11 years old (see section 4.8).
Slovenian: Med pediatričnimi kohortami različnih starosti so zvišanja transaminaz pogosteje ugotavljali pri bolnikih, starih 2 do 5 let, kot pri bolnikih, starih 6 do 11 let (glejte poglavje 4.8).
English: The exposure of ivacaftor will be decreased, which may reduce the efficacy of lumacaftor/ivacaftor.
Slovenian: Izpostavljenost ivakaftorju se bo zmanjšala, kar lahko zmanjša učinkovitost lumakaftorja/ivakaftorja.
English: • Benzodiazepines (used for the treatment of anxiety or sleeplessness [insomnia], agitation, etc.) for example: midazolam, triazolam
Slovenian: • benzodiazepini (uporabljajo se za zdravljenje tesnobe (anksioznosti) ali nespečnosti [insomnije], vznemirjenosti itn.), na primer: midazolam, triazolam;
English: Table 4: Adverse reactions in lumacaftor/ivacaftor-treated patients and in patients treated with ivacaftor alone
Slovenian: Preglednica 4: Neželeni učinki pri bolnikih, zdravljenih z lumakaftorjem/ivakaftorjem, in pri bolnikih, zdravljenih samo z ivakaftorjem
English: St. John's wort (Hypericum perforatum)
Slovenian: šentjanževka (Hypericum perforatum);
English: Three patients discontinued lumacaftor/ivacaftor treatment permanently due to transaminase elevations.
Slovenian: Trije bolniki so se trajno prenehali zdraviti z lumakaftorjem/ivakaftorjem zaradi zvišanih transaminaz.
English: • Anti-allergic medicines (used for the treatment of allergies and/or asthma) for example: montelukast, fexofenadine
Slovenian: • zdravila proti alergijam (uporabljajo se za zdravljenje alergij in/ali astme), na primer: montelukast, feksofenadin;
English: Potential for lumacaftor/ivacaftor to interact with transporters In vitro experiments show that lumacaftor is a substrate for Breast Cancer Resistance Protein (BCRP).
Slovenian: Potencial lumakaftorja/ivakaftorja za medesebojno delovanje s prenašalci Poskusi in vitro kažejo, da je lumakaftor substrat beljakovine odpornosti pri raku dojke (Breast Cancer Resistance Protein - BCRP).
English: If you forget to give your child Orkambi
Slovenian: Če ste pozabili otroku dati zdravilo Orkambi
English: ** For patients rolled over from Trials 1 and 2 (placebo-to-lumacaftor/ivacaftor group) total exposure was up to 96 weeks.
Slovenian: ** Pri bolnikih, ki so nadaljevali iz preskušanj 1 in 2 (skupina, ki je prejemala najprej placebo, nato lumakaftor/ivakaftor), je trajala skupna izpostavljenost do 96 tednov.
English: The serum concentration of digoxin should be monitored and the dose should be titrated to obtain the desired clinical effect.
Slovenian: Treba je spremljati koncentracijo digoksina v serumu in titrirati odmerek, da bomo dosegli želeni klinični učinek.
English: In addition, the mean absolute change in sweat chloride from Week 24 at Week 26 following the 2-week washout period (to evaluate off-drug response) was an increase of 33.0 mmol/L (95% CI: 28.9, 37.1; nominal P < 0.0001), representing a return to baseline after treatment washout.
Slovenian: Poleg tega je bila povprečna absolutna sprememba kloridov v znoju od 24. tedna v 26. tednu po dvotedenskem obdobju spiranja (za ocenjevanje odziva brez prejemanja zdravila) zvečanje za 33,0 mmol/l (95 % IZ: 28,9, 37,1; nominalna P < 0,0001), ki predstavlja povratek na izhodišče po spiranju zdravila.
English: Patients treated with lumacaftor/ivacaftor in Trial 1 or Trial 2 showed an effect that was maintained with respect to baseline after an additional 96 weeks through Trial 3.
Slovenian: Bolniki, zdravljeni z lumakaftorjem/ivakaftorjem v preskušanju 1 ali preskušanju 2, so pokazali učinek, ki je glede na izhodišče trajal še dodatnih 96 tednov do konca preskušanja 3.
English: • Abdominal pain (stomach ache)
Slovenian: • abdominalna bolečina (bolečina v trebuhu)*,
English: Give the missed dose with fat-containing food if less than 6 hours have passed since the time your child missed the dose.
Slovenian: Dajte mu izpuščeni odmerek z mastno hrano, če je preteklo manj kot 6 ur od takrat, ko bi otrok moral dobiti odmerek.
English: The exposure of ivacaftor when given in combination with lumacaftor increased approximately 3-fold when given with fat-containing food in healthy volunteers.
Slovenian: Izpostavljenost ivakaftorju, ko so ga dajali skupaj z lumakaftorjem, se je zvečala za približno trikrat, če so ju dajali z mastno hrano zdravim prostovoljcem.
English: The efficacy of lumacaftor/ivacaftor in patients with CF who are homozygous for the F508del mutation in the CFTR gene was evaluated in two randomised, double-blind, placebo-controlled clinical trials of 1108 clinically stable patients with CF, in which 737 patients were randomised to and dosed with lumacaftor/ivacaftor.
Slovenian: Učinkovitost lumakaftorja/ivakaftorja pri bolnikih s CF, ki so homozigotni za mutacijo F508del na genu CFTR, so ovrednotili v dveh randomiziranih, dvojno slepih, s placebom kontroliranih kliničnih preskušanjih 1108 klinično stabilnih bolnikov s CF, v katerih je bilo 737 bolnikov randomiziranih na lumakaftor/ivakaftor, ki so ga nato prejemali.
English: Lumacaftor is a strong inducer of CYP3A.
Slovenian: Lumakaftor je močan induktor CYP3A.
English: warfarin
Slovenian: varfarin
English: The combined effect of lumacaftor and ivacaftor is increased quantity and function of F508del-CFTR at the cell surface, resulting in increased chloride ion transport.
Slovenian: Kombinirani učinek lumakaftorja in ivakaftorja je zvečana količina in funkcionalnost F508del-CFTR na celični površini, kar povzroči zvečan transport kloridnih ionov.
English: Appropriate clinical monitoring should be employed, as is reasonable, when co-administered with lumacaftor/ivacaftor.
Slovenian: Uporabiti je treba ustrezno klinično spremljanje, kot je primerno, kadar se uporablja sočasno z lumakaftorjem/ivakaftorjem.