FrancophonIA/ELRC3.0 huggingface dataset:
English: Take Kalydeco for as long as your doctor recommends.
Slovenian: Jemljite zdravilo Kalydeco, dokler vam to priporoča zdravnik.
English: # Causes a splicing defect resulting in little-to-no CFTR protein at the cell surface
Slovenian: # Povzroči cepitveni defekt, ta pa povzroči, da je na celični površini malo ali nič beljakovine CFTR.
English: Therefore, use in transplanted patients is not recommended.
Slovenian: Zato uporaba zdravila pri bolnikih s presajenimi organi ni priporočljiva.
English: If your child feels dizzy, it is advised that your child does not ride his/her bike or do anything else that needs his/her full attention.
Slovenian: Če otrok postane omotičen, je priporočljivo, da se ne vozi s kolesom in da se ne ukvarja s kakršnokoli aktivnostjo, za katero mora biti popolnoma zbran.
English: Some medicines can affect how Kalydeco works, or make side effects more likely.
Slovenian: Nekatera zdravila lahko vplivajo na to, kako zdravilo Kalydeco deluje, ali zvečajo verjetnost neželenih učinkov.
English: For all patients with a history of transaminase elevations, more frequent monitoring of liver function tests should be considered.
Slovenian: Pri vseh bolnikih z anamnezo zvišanja transaminaz pride v poštev pogostejše spremljanje testov funkcije jeter.
English: Your doctor will do some blood tests to check your liver before and during treatment, particularly during the first year and especially if your blood tests showed high liver enzymes in the past.
Slovenian: Zdravnik bo pred in med zdravljenjem naredil nekaj krvnih preiskav za preskus vaših jeter, posebno v prvem letu zdravljenja in posebno, če so preiskave krvi pri vas kdaj prej pokazale visoke jetrne encime.
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.
Slovenian: V primeru pomembnih zvišanj transaminaz (npr. bolniki z ALT ali AST > 5 x zgornja meja normalnih vrednosti (upper limit of normal-ULN) ali ALT ali AST > 3 x ULN z bilirubinom > 2 x ULN) je treba prekiniti odmerjanje in skrbno spremljati laboratorijske teste, dokler abnormalnosti ne izzvenijo.
English: Ivacaftor and its metabolites are substrates of BCRP in vitro.
Slovenian: Ivakaftor in njegovi presnovki so substrati BCRP in vitro.
English: The granules are packed in a Biaxially Oriented Polyethylene Terephthalate/Polyethylene/Foil/Polyethylene (BOPET/PE/Foil/PE) sachet.
Slovenian: Zrnca so pakirana v vrečico iz biaksialno usmerjenega polietilen tereftalata/polietilena/folije/polietilena (BOPET/PE/folija/PE).
English: Following multiple oral dose administrations of ivacaftor, the exposure of ivacaftor generally increased with dose from 25 mg every 12 hours to 450 mg every 12 hours.
Slovenian: Po večkratnih aplikacijah peroralnega odmerka ivakaftorja se je izpostavljenost ivakaftorju na splošno zvečala z odmerkom od 25 mg vsakih 12 ur do 450 mg vsakih 12 ur.
English: Sixty-two percent (24/39) of them carried the F508del-CFTR mutation in the second allele.
Slovenian: Dvainšestdeset odstotkov od njih (24/39) je imelo mutacijo F508del CFTR na drugem alelu.
English: All 5 patients had maximum ALT or AST levels > 8 x ULN, which returned to baseline levels following interruption of dosing with ivacaftor granules.
Slovenian: Vseh 5 bolnikov je imelo najvišje ravni ALT ali AST > 8 x ULN, ki so se vrnile na izhodiščno raven po prekinitvi odmerjanja z zrnci ivakaftorja.
English: Your doctor may need to adjust your dose.
Slovenian: Mogoče vam bo moral zdravnik prilagoditi odmerek.
English: Your doctor will decide whether to recommend that you stop breast-feeding or for you to stop ivacaftor therapy.
Slovenian: Zdravnik se bo odločil, ali vam bo priporočil, da prenehate dojiti ali da se prenehate zdraviti z ivakaftorjem.
English: Kalydeco has minor influence on the ability to drive or use machines.
Slovenian: Zdravilo Kalydeco ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: When used concomitantly with digoxin or other substrates of P-gp with a narrow therapeutic index, such as ciclosporin, everolimus, sirolimus or tacrolimus, caution and appropriate monitoring should be used.
Slovenian: Kadar ga uporabljamo sočasno z digoksinom ali drugimi substrati P-gp z ozkim terapevtskim indeksom, na primer s ciklosporinom, everolimusom, sirolimusom ali takrolimusom, sta potrebna previdnost in primerno spremljanje.
English: Ivacaftor helps certain abnormal CFTR proteins open more often to improve chloride movement in and out of the cell.
Slovenian: Ivakaftor pomaga nekaterim nenormalnim beljakovinam CFTR, da se pogosteje odpirajo, s čimer se izboljša gibanje klorida v celico in iz nje.
English: Kalydeco monotherapy in adults, adolescents, and children aged 6 years and older and weighing 25 kg or more
Slovenian: Monoterapija z zdravilom Kalydeco pri odraslih, mladostnikih in otrocih, starih 6 let ali več in s telesno maso 25 kg ali več
English: The granules are supplied in sachets.
Slovenian: Zrnca so na voljo v vrečicah.
English: In vitro studies showed that ivacaftor is not a substrate for P-gp.
Slovenian: Študije in vitro so pokazale, da ivakaftor ni substrat za P-gp.
English: Data on percent predicted FEV1 (exploratory endpoint) were available for 3 patients in the ivacaftor 50 mg group and 17 patients in the 75 mg dosing group.
Slovenian: Podatki o odstotkih napovedanega FEV1 (eksploratorno končno stanje) so bili na voljo za 3 bolnike v skupini z ivakaftorjem 50 mg in 17 bolnikov v skupini, ki je prejemala po 75 mg.
English: Therefore, use of Kalydeco monotherapy in these patients is not recommended.
Slovenian: Zato uporaba monoterapije z zdravilom Kalydeco pri teh bolnikih ni priporočljiva.
English: Other forms of this medicine (granules in sachet) are more suitable for children under 6 years of age; ask your doctor or pharmacist.
Slovenian: Za otroke, mlajše od 6 let, so primernejše druge oblike tega zdravila (zrnca v vrečici); posvetujte se s svojim zdravnikom ali farmacevtom.
English: Ivacaftor acts at the level of the cystic fibrosis transmembrane conductance regulator (CFTR), a protein that forms a channel at the cell surface that allows the movement of particles such as chloride in and out of the cell.
Slovenian: Ivakaftor deluje na ravni ojačevalca regulatorja transmembranske prevodnosti pri cistični fibrozi (CFTR-cystic fibrosis transmembrane conductance regulator), beljakovine, ki oblikuje kanalček pri površini celice, ki omogoča gibanje delcev, na primer klorida, v celico in iz nje.
English: Results shown as mean (minimum, maximum) change from baseline for ivacaftor-treated patients at week 8*:
Slovenian: Rezultati so prikazani kot povprečna (minimum, maksimum) sprememba od izhodišča pri bolnikih, zdravljenih z ivakaftorjem, v 8. tednu*:
English: • Ear pain, ear discomfort
Slovenian: • bolečine v ušesih, nelagodje v ušesih
English: CYP2C9 substrates
Slovenian: Substrati CYP2C9
English: Due to mutations in the CFTR gene (see below), chloride movement is reduced in those with cystic fibrosis (CF).
Slovenian: Zaradi mutacij v genu CFTR (glejte v nadaljevanju) se pri bolnikih s cistično fibrozo (CF) gibanje klorida zmanjša.
English: Efficacy was not demonstrated in patients aged 6 to 11 years with CF who have an R117H mutation while only two adolescent patients were enrolled in study 6 (see section 5.1).
Slovenian: Učinkovitosti niso dokazali pri bolnikih, starih 6 do 11 let, s CF, ki imajo mutacijo R117H, medtem ko sta bila vključena v študijo 6 samo dva bolnika mladostnika (glejte poglavje 5.1).
English: • Upper respiratory tract infection (the common cold), including sore throat and nasal congestion
Slovenian: • okužba zgornjih dihal (prehlad), vključno z vnetim žrelom in zamašenim nosom
English: Other medicines and Kalydeco
Slovenian: Druga zdravila in zdravilo Kalydeco
English: Twenty-six patients out of the 34 enrolled (76.5%) had a CFTR genotype G551D/F508del with only 2 patients with a non-G551D mutation (S549N).
Slovenian: Šestindvajset bolnikov od vključenih 34 (76,5 %) je imelo genotip CFTR G551D/F508del, samo 2 bolnika sta imela ne-G551D mutacijo (S549N).
English: † Reflects results from the one patient with the G551S mutation with data at the 8-week time point.
Slovenian: † Zrcali rezultate pri enem bolniku z mutacijo G551S s podatki, pridobljenimi v časovni točki 8 tednov.
English: Tell your child's doctor right away if your child has any of these symptoms, which may be a sign of liver problems:
Slovenian: Takoj povejte otrokovemu zdravniku, če ima vaš otrok katerega od teh simptomov, ki utegnejo biti znak težav z jetri:
English: Side effects seen in children and adolescents are similar to those observed in adults.
Slovenian: Dodatni neželeni učinki pri otrocih in mladostnikih Neželeni učinki, ki jih vidimo pri otrocih in mladostnikih, so podobni tistim, ki jih opazujemo pri odraslih.
English: Whenever possible the phase of the poly-T variant identified with the R117H mutation should be determined as this may be informative in considering treatment of patients with an R117H mutation (see section 4.2).
Slovenian: Fazo variante poli-T, identificirane z mutacijo R117H, je treba določiti, kadar koli je to mogoče, ker je to lahko povedno pri odločanju o zdravljenju bolnikov z mutacijo R117H (glejte poglavje 4.2).
English: These medications included dornase alfa (73.1% versus 65.1%), salbutamol (53.8% versus 42.2%), tobramycin (44.9% versus 33.7%) and salmeterol/fluticasone (41.0% versus 27.7%).
Slovenian: Ta zdravila so vključevala dornazo alfa (73,1 % proti 65,1 %), salbutamol (53,8 % proti 42,2 %), tobramicin (44,9 % proti 33,7 %) in salmeterol/flutikazon (41,0 % proti 27,7 %).
English: Peak LFT (ALT or AST) elevations were generally higher in paediatric patients than in older patients.
Slovenian: Najvišje vrednosti jetrnih funkcijskih testov (ALT ali AST) so bile na splošno višje pri pediatričnih bolnikih kot pri starejših bolnikih.
English: Bacteria in sputum very common
Slovenian: Preiskave bakterije v sputumu zelo pogosti
English: Your child must keep using all other medicines, unless your child's doctor tells him/her to stop using any.
Slovenian: Vaš otrok mora še naprej jemati vsa druga zdravila, razen če mu/ji otrokov zdravnik naroči, naj preneha jemati katero od zdravil.
English: Tell your child's doctor or pharmacist if your child is using, has recently used or might use any other medicines.
Slovenian: Obvestite otrokovega zdravnika ali farmacevta, če vaš otrok uporablja, je pred kratkim uporabljal ali pa bo morda začel uporabljati katero koli drugo zdravilo.
English: M1 has approximately one-sixth the potency of ivacaftor and is considered pharmacologically active.
Slovenian: M1 ima približno šestino jakosti ivakaftorja in ga imamo za farmakološko aktivnega.
English: Median (min, max)
Slovenian: (min, maks)
English: The pharmacokinetics of ivacaftor are similar between healthy adult volunteers and patients with CF.
Slovenian: Farmakokinetika ivakaftorja pri zdravih odraslih prostovoljcih in bolnikih s CF je podobna.
English: • Cardiac glycosides such as digoxin, used for the treatment of mild to moderate congestive heart failure and an abnormal heart rhythm called atrial fibrillation
Slovenian: • srčni glikozidi, na primer digoksin, ki se uporabljajo za zdravljenje blagega do zmernega kongestivnega popuščanja srca in nenormalnega srčnega ritma, ki se imenuje atrijska fibrilacija;
English: Your child's doctor will do some blood tests to check your child's liver before and during treatment, particularly during the first year and especially if blood tests showed high liver enzymes in the past.
Slovenian: Otrokov zdravnik bo pred in med zdravljenjem naredil nekaj krvnih preiskav za preskus otrokovih jeter, posebno v prvem letu zdravljenja in posebno, če so krvne preiskave v preteklosti pokazale visoke jetrne encime.
English: As a precautionary measure, it is preferable avoid the use of Kalydeco during pregnancy.
Slovenian: Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Kalydeco bolje izogibati.
English: Exposure to ivacaftor may be reduced by the concomitant use of CYP3A inducers, potentially resulting in the loss of ivacaftor efficacy.
Slovenian: Izpostavljenost ivakaftorju se lahko zmanjša s sočasno uporabo induktorjev CYP3A, kar lahko povzroči izgubo učinkovitosti ivakaftorja.
English: Following resolution of transaminase elevations, the benefits and risks of resuming treatment should be considered (see section 4.8).
Slovenian: Ko zvišanje transaminaz izzveni, je treba pretehtati koristi in tveganja ponovne uvedbe zdravljenja (glejte poglavje 4.8).
English: Do not give this medicine in combination with tezacaftor/ivacaftor to children under 12 years of age as it is not known if they are safe and effective for them.
Slovenian: Ne dajajte tega zdravila v kombinaciji s tezakaftorjem/ivakaftorjem otrokom, mlajšim od 12 let, ker ni znano, ali je pri njih varno in učinkovito.
English: • Meats, oily fish
Slovenian: • meso, mastne ribe
English: Patients receiving Kalydeco in combination with tezacaftor/ivacaftor should be told not to take more than one dose of either tablet at the same time.
Slovenian: Bolnikom, ki jemljejo zdravilo Kalydeco v kombinaciji s tezakaftorjem/ivakaftorjem, je treba naročiti, naj ne jemljejo sočasno več kot enega odmerka niti ene niti druge tablete.
English: Clinical studies of ivacaftor in combination regimen with tezacaftor did not include patients over 75 years of age.
Slovenian: V klinične študije ivakaftorja v kombinirani shemi s tezakaftorjem niso bili vključeni bolniki, starejši od 75 let.
English: For patients with moderate hepatic impairment (Child-Pugh Class B), the dose should be reduced (see Table 2).
Slovenian: Pri bolnikih z zmerno okvaro jeter (razred B po Child-Pughovi lestvici) je treba odmerek zmanjšati (glejte preglednico 2).
English: Based on clinical (percent predicted FEV1) and pharmacodynamic (sweat chloride) responses to ivacaftor, efficacy in patients with the G970R mutation could not be established.
Slovenian: Na podlagi kliničnih (napovedani FEV1 v odstotkih) in farmakodinamičnih (kloridi v znoju) odzivov na ivakaftor učinkovitosti pri bolnikih z mutacijo G970R niso mogli dokazati.
English: 56 sachets
Slovenian: 56 vrečic
English: Take the missed dose if less than 6 hours have passed since the time you missed the dose.
Slovenian: Vzemite izpuščeni odmerek, če je preteklo manj kot 6 ur od takrat, ko ste izpustili odmerek.
English: There were no additional improvements in study 4 (week 48 through week 144).
Slovenian: V študiji 4 (od 48. tedna do 144. tedna) ni bilo dodatnih izboljšanj.
English: Interactions with medicinal products
Slovenian: Medsebojno delovanje zdravil
English: Kalydeco dosing recommendations are provided in Table 1.
Slovenian: Priporočila za odmerjanje zdravila Kalydeco so navedena v preglednici 1.
English: The pharmacokinetic parameters of ivacaftor in combination with tezacaftor in the elderly patients (65-72 years) are comparable to those in younger adults.
Slovenian: Farmakokinetični parametri ivakaftorja v kombinaciji s tezakaftorjem pri starejših bolnikih (65-72 let) so primerljivi s tistimi pri mlajših odraslih.
English: Each film-coated tablet contains 167.2 mg of lactose (as monohydrate)
Slovenian: Ena filmsko obložena tableta vsebuje 167,2 mg laktoze (v obliki monohidrata).
English: In part 1 of study 5, the mean FEV1 percent predicted at baseline in placebo-treated patients was 79.3% while in ivacaftor-treated patients this value was 76.4%.
Slovenian: V prvem delu študije 5 je bil povprečni FEV1 v odstotkih, napovedan v izhodišču pri bolnikih, ki so prejemali placebo, 79,3 %, medtem ko je bila pri bolnikih, ki so se zdravili z ivakaftorjem, ta vrednost 76,4 %.
English: • Nipple changes or pain
Slovenian: • spremembe prsne bradavice ali bolečina v njej
English: Film-coated tablet (tablet)
Slovenian: FARMACEVTSKA OBLIKA filmsko obložena tableta (tableta)
English: What Kalydeco is and what it is used for
Slovenian: Kaj je zdravilo Kalydeco in za kaj ga uporabljamo
English: This finding has not been observed in foetuses 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 podganjih samic, ki so ivakaftor prejemale na 7. do 17. dan gestacije, pri podganjih mladičih, izpostavljenim ivakaftorju prek mleka, zaužitega do 20. dneva po rojstvu, pri 7 tednov starih podganah niti pri 3,5 do 5 mesecev starih psih, ki so jim dajali ivakaftor.
English: If you have liver problems, either moderate or severe, your doctor may need to reduce the dose of your tablets, because your liver will not clear the medicine as fast as in people who have normal liver function.
Slovenian: Če imate težave z delovanjem jeter, bodisi zmerne ali hude, vam bo zdravnik mogoče moral zmanjšati odmerek vaših tablet, ker vaša jetra ne bodo očistila zdravila tako hitro kot pri ljudeh z normalnim delovanjem jeter.
English: See leaflet for further information.
Slovenian: Za nadaljnje podatke glejte navodilo za uporabo.
English: No ivacaftor-treated patients experienced a transaminase elevation > 3 x ULN associated with elevated total bilirubin > 1.5 x ULN.
Slovenian: Noben bolnik, zdravljen z ivakaftorjem, ni imel zvišanja transaminaz > 3 x ULN, povezanega z zvišanim celotnim bilirubinom > 1,5 x ULN.
English: In ivacaftor-treated patients, most transaminase elevations up to 5 x ULN resolved without treatment interruption.
Slovenian: Pri bolnikih, zdravljenih z ivakaftorjem, so zvišanja transaminaz do 5 x ULN večinoma izzvenela brez prekinitve zdravljenja.
English: Do not use this medicine after the expiry date which is stated on the package after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: In part B of study 8, the primary endpoint of safety was evaluated through 24 weeks (see section 4.8).
Slovenian: Primarni cilj študije glede varnosti v delu B študije 8 so ocenjevali v obdobju 24 tednov (glejte poglavje 4.8).
English: Ivacaftor may inhibit CYP2C9.
Slovenian: Ivakaftor lahko zavira CYP2C9.
English: • Anticoagulant medicines such as warfarin, used to prevent blood clots from forming or growing larger in blood and blood vessels
Slovenian: • zdravila proti strjevanju krvi, na primer varfarin, ki se uporabljajo za preprečevanje nastajanja ali rasti krvnih strdkov v krvi in krvnih žilah;
English: • Changes in the type of bacteria in mucus
Slovenian: • sprememba vrste bakterij v sluzi
English: The use of inhaled hypertonic saline was not permitted.
Slovenian: Uporaba inhalacije hipertonične raztopine kuhinjske soli ni bila dovoljena.
English: Treatment differencea
Slovenian: Razlika zaradi zdravljenjaa
English: For patients in the placebo/ivacaftor group baseline percent predicted FEV1 is that of study 4 while for patients in the ivacaftor/ivacaftor group the baseline value is that of studies 1 and 2.
Slovenian: Za bolnike v skupini placebo/ivakaftor je izhodiščni napovedani FEV1 tisti iz študije 4, medtem ko je za bolnike v skupini ivakaftor/ivakaftor izhodiščna vrednost tista iz študij 1 in 2.
English: Additional adverse reactions observed with ivacaftor in combination with tezacaftor/ivacaftor are also provided in Table 3.
Slovenian: Dodatni neželeni učinki, ki so jih ugotavljali pri ivakaftorju v kombinaciji s tezakaftorjem/ivakaftorjem, so tudi navedeni v preglednici 3.
English: The safety and efficacy of Kalydeco in children aged less than 6 months have not been established.
Slovenian: Varnost in učinkovitost zdravila Kalydeco pri otrocih, mlajših od 6 mesecev, nista bili dokazani.
English: Transaminase elevations occurred in 12.8% of ivacaftor-treated patients versus 11.5% of placebo-treated patients.
Slovenian: Zvišanje transaminaz se je pojavilo pri 12,8 % bolnikov, zdravljenih z ivakaftorjem, in pri 11,5 % bolnikov, ki so prejemali placebo.
English: This shows that patients in the ivacaftor/ivacaftor group maintained the improvement seen at week 48 of the initial study (day 0 through week 48) in percent predicted FEV1 through week 144.
Slovenian: To kaže, da so bolniki v skupini ivakaftor/ivakaftor ohranjali izboljšanje, ugotovljeno v 48. tednu začetne študije (od dneva 0 do 48. tedna) v odstotkih napovedanega FEV1 do 144. tedna.
English: There was negligible urinary excretion of ivacaftor as unchanged parent (less than 0.01% following a single oral dose of 500 mg).
Slovenian: V obliki nespremenjene izhodne snovi se je ivakaftor izločal v urinu v zanemarljivi količini (manj kot 0,01 % po enkratnem peroralnem odmerku 500 mg).
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: Change from prior study baseline after 48 weeks of placebo treatment.
Slovenian: Sprememba od izhodišča prejšnje študije po 48 tednih dajanja placeba.
English: CI: confidence interval; NA: not analysed due to low incidence of events a Treatment difference = effect of ivacaftor - effect of placebo b CFQ-R: Cystic Fibrosis Questionnaire-Revised is a disease-specific, health-related quality-of-life measure for CF. c Study 1 data were pooled from CFQ-R for adults/adolescents and CFQ-R for children 12 to 13 years of age; Study 2 data were obtained from CFQ-R for children 6 to 11 years of age.
Slovenian: IZ: interval zaupanja; NA: ni analizirano zaradi majhne pogostnosti dogodkov a razlika zaradi zdravljenja = učinek ivakaftorja - učinek placeba b CFQ-R: Vprašalnik za cistično fibrozo - revidirani je za bolezen specifično, z zdravjem povezano merilo kakovosti življenja za CF. c Podatki študije 1 so bili združeni iz CFQ-R za odrasle/mladostnike in CFQ-R za otroke, stare 12 do 13 let; podatki študije 2 so bili pridobljeni iz CFQ-R za otroke, stare 6 do 11 let.
English: Ivacaftor was administered orally every 12 hours with fat-containing food in addition to their prescribed CF therapies.
Slovenian: Ivakaftor so jim dajali peroralno vsakih 12 ur z obrokom hrane, ki vsebuje maščobe, poleg njihovih predpisanih terapij CF.
English: Table 6: Effect of ivacaftor on growth parameters in patients aged 6 months to less than 24 months with baseline and week 24 values
Slovenian: Preglednica 6: Učinek ivakaftorja na parametre rasti pri bolnikih, starih 6 mesecev do manj kot 24 mesecev, z vrednostmi v izhodišču in 24. tednu
English: The safety data of ivacaftor in combination with tezacaftor/ivacaftor was evaluated in 98 patients between 12 to less than 18 years of age.
Slovenian: Varnostne podatke ivakaftorja v kombinaciji s tezakaftorjem/ivakaftorjem so ovrednotili pri 98 bolnikih, starih med 12 in manj kot 18 let.
English: • Mix the entire content of a sachet with 5 mL of age-appropriate soft food or liquid.
Slovenian: • Zmešajte vso vsebino vrečice s 5 ml za starost primerne mehke hrane ali tekočine.
English: The exposure of ivacaftor increased approximately 2.5- to 4-fold when given with food containing fat.
Slovenian: Izpostavljenost ivakaftorju se je zvečala približno 2,5- do 4-krat, če so ga bolniki jemali skupaj z obrokom, ki vsebuje maščobe.
English: Dosing intervals should be modified according to clinical response and tolerability (see sections 4.4 and 5.2).
Slovenian: Časovne presledke med posameznimi odmerki je treba spreminjati glede na klinični odziv in prenašanje (glejte poglavji 4.4 in 5.2).
English: Co-administration of ivacaftor with grapefruit juice, which contains one or more components that moderately inhibit CYP3A, may increase exposure to ivacaftor.
Slovenian: Sočasna uporaba ivakaftorja s sokom grenivke, ki vsebuje eno ali več sestavin, ki zmerno zavirajo CYP3A, lahko zveča izpostavljenost ivakaftorju.
English: Mean absolute change from baseline in CFQ-Rb respiratory domain score (points)c
Slovenian: Povprečna absolutna sprememba od izhodišča na lestvici respiracijske domene CFQ-Rb (točke)c