FrancophonIA/ELRC3.0 huggingface dataset:
English: It is a medicine used for long-term treatment of cystic fibrosis (CF) in children aged 2 years and older who have a specific change (called F508del mutation) affecting the gene for a protein called cystic fibrosis transmembrane conductance regulator (CFTR), which plays an important role in regulating the flow of mucus in the lungs.
Slovenian: To je zdravilo, ki se uporablja za dolgoročno zdravljenje cistične fibroze (CF) pri otrocih, starih 2 leti ali več, ki imajo določeno spremembo (imenuje se mutacija F508del), ki vpliva na gen za beljakovino, ki se imenuje regulator transmembranske prevodnosti pri cistični fibrozi (CFTR), ki ima pomembno vlogo pri uravnavanju toka sluzi v pljučih.
English: Final Report: December 2025
Slovenian: december 2025.
English: Trial in patients with CF who are heterozygous for the F508del mutation in the CFTR gene Trial 4 was a multicentre, double-blind, randomised, placebo-controlled, Phase 2 trial in 125 patients with CF aged 18 years and older who had a ppFEV1 of 40 to 90, inclusive, and have the F508del mutation on one allele plus a second allele with a mutation predicted to result in the lack of CFTR production or a CFTR that is not responsive to ivacaftor in vitro.
Slovenian: Preskušanje pri bolnikih s CF, ki so heterozigotni za mutacijo F508del na genu CFTR Preskušanje 4 je bilo multicentrično, dvojno slepo, randomizirano preskušanje 2. faze, kontrolirano s placebom, pri 125 bolnikih s CF, starih 18 let ali več, ki so imeli ppFEV1 40 - 90 vključno in mutacijo F508del na enem alelu plus drugi alel z mutacijo, za katero je bilo napovedano, da bo preprečila nastajanje CFTR ali povzročila nastajanje CFTR, ki se in vitro ne odziva na ivakaftor.
English: Other efficacy variables included relative change from baseline in ppFEV1, absolute change from baseline in BMI, absolute change from baseline in CFQ-R Respiratory Domain the proportion of patients achieving ≥ 5% relative change from baseline in ppFEV1 at Week 24, and the number of pulmonary exacerbations (including those requiring hospitalisation or IV antibiotic therapy) through Week 24.
Slovenian: Druge učinkovitostne spremenljivke so vključevale relativno spremembo ppFEV1 od izhodišča, absolutno spremembo ITM od izhodišča, absolutno spremembo CFQ-R respiracijske domene od izhodišča, delež bolnikov, ki so dosegli ≥ 5 % relativno spremembo ppFEV1 od izhodišča v 24. tednu, in število pljučnih poslabšanj (vključno s tistimi, pri katerih je bila potrebna hospitalizacija ali i.v.
English: Talk to your child's doctor before taking Orkambi if you have been told your child has liver or kidney disease as the doctor may need to adjust the dose of Orkambi.
Slovenian: Posvetujte se z otrokovim zdravnikom, preden začnete otroku dajati zdravilo Orkambi, če so vam povedali, da ima vaš otrok bolezen jeter ali ledvic, ker bo zdravnik mogoče moral prilagoditi odmerek zdravila Orkambi.
English: Ivacaftor impaired fertility and reproductive performance indices in male and female rats at 200 mg/kg/day (yielding exposures approximately 11 and 7 times, respectively, those obtained with the maximum recommended human dose of the ivacaftor component of Orkambi based on summed AUCs of ivacaftor and its metabolites extrapolated from Day 90 exposures at 150 mg/kg/day in the 6-month repeat-dose toxicity study and gestation Day 17 exposures in the pilot embryofoetal development study in this species) when dams were dosed prior to and during early pregnancy.
Slovenian: Ivakaftor je zmanjšal indekse plodnosti in reproduktivne uspešnosti pri samcih in samicah podgan v odmerku 200 mg/kg/dan (ki je povzročil izpostavljenosti, ki so približno 11-krat oziroma 7-krat presegle tiste, ki so bile dosežene z največjim priporočenim odmerkom ivakaftorja (učinkovina zdravila Orkambi) za človeka na podlagi seštetih AUC ivakaftorja in njegovih presnovkov, ekstrapoliranih iz izpostavljenosti 90. dne pri odmerku 150 mg/kg/dan v 6-mesečni študiji toksičnosti ponavljajočih se odmerkov, in izpostavljenosti 17. dne brejosti v pilotski študiji embriofetalnega razvoja pri tej živalski vrsti), ko so samice prejemale zdravilo pred in med zgodnjo brejostjo.
English: Your doctor may request another test to verify results.
Slovenian: Zdravnik bo mogoče preveril rezultate z dodatno preiskavo.
English: After oral administration of ivacaftor 250 mg every 12 hours in combination with lumacaftor, the typical apparent volumes of distribution for the central and peripheral compartments [coefficient of variation as a percentage (CV)] were estimated to be 95.0 L (53.9%) and 201 L (26.6%), respectively.
Slovenian: Po peroralnem dajanju ivakaftorja v odmerku 250 mg na 12 ur skupaj z lumakaftorjem sta bila tipična navidezna volumna porazdelitve v centralnem oziroma perifernem razdelku (CV) ocenjena na 95,0 l (53,9 %) oziroma 201 l (26,6 %).
English: • H2 Antagonist medicines (used to reduce stomach acid) for example: ranitidine
Slovenian: • antagonisti receptorjev H2 (uporabljajo se za zmanjševanje nastajanja želodčne kisline), na primer: ranitidin;
English: After oral administration of 400 mg every 12 hours in patients with CF in a fed state, the typical apparent volumes of distribution for the central and peripheral compartments (CV) were estimated to be 23.5 L (48.7%) and 33.3 L (30.5%), respectively.
Slovenian: Po peroralnem dajanju 400 mg na 12 ur bolnikom s CF po obroku hrane sta bila tipična navidezna volumna porazdelitve v centralnem oziroma perifernem razdelku [koeficient variacije kot odstotni delež (CV)] ocenjena na 23,5 l (48,7 %) oziroma 33,3 l (30,5 %).
English: From Week 4, the change in mean heart rate at pre-dose ranged from 1 to 2 bpm below baseline among patients treated with lumacaftor/ivacaftor.
Slovenian: Od 4. tedna naprej je bila sprememba srednje srčne frekvence pred odmerjanjem pri bolnikih, zdravljenih z lumakaftorjem/ivakaftorjem, od 1 do 2 bpm pod izhodiščem.
English: Antifungals: itraconazole*, ketoconazole, posaconazole, voriconazole
Slovenian: itrakonazol*, ketokonazol, posakonazol, vorikonazol
English: LS Means (95% CI)
Slovenian: (95 % IZ)
English: An alternative to erythromycin, such as azithromycin, should be considered.
Slovenian: Razmisliti je treba o uporabi drugega antibiotika, na primer azitromicina.
English: Number of events requiring hospitalization per patientyear (95% CI) (rate per 48
Slovenian: Število dogodkov, zaradi katerih je bila potrebna hospitalizacija, na bolnika leto (95 % IZ) (pogostnost na 48 tednov)
English: • Irregular periods (menses) or pain with menses
Slovenian: • neredno mesečno perilo (menstruacija) ali bolečina pri mesečnem perilu,
English: The other ingredients are: cellulose, microcrystalline; croscarmellose sodium; hypromellose acetate succinate; povidone (K30); and sodium laurilsulfate.
Slovenian: Druge sestavine zdravila so: mikrokristalna celuloza; premreženi natrijev karmelozat; hipromeloza acetat sukcinat; povidon (K30); in natrijev lavrilsulfat.
English: Trial 7 evaluated subjects with lung clearance index (LCI2.5) ≥ 7.5 at the initial screening visit (mean LCI2.5 10.28 at baseline [range: 6.55 to 16.38]) and ppFEV1 ≥ 70 at screening (mean ppFEV1 89.8 at baseline [range: 48.6 to 119.6]).
Slovenian: V preskušanju 7 so ocenjevali osebe z indeksom pljučnega očistka (LCI2,5) ≥ 7,5 pri začetnem presejalnem pregledu (povprečni LCI2,5 10,28 v izhodišču [razpon: 6,55 do 16,38]) in ppFEV1 ≥ 70 ob presejanju (povprečni ppFEV1 89,8 ob presejanju [razpon: 48,6 do 119,6]).
English: Primary Endpoint Absolute change in lung clearance index (LCI2.5) from baseline through Week 24
Slovenian: Primarni cilj preskušanja Absolutna sprememba indeksa pljučnega očistka (LCI2,5) od izhodišča do konca
English: In Trial 8 in patients homozygous for F508del-CFTR mutation aged 2 to 5 years, the mean absolute within-group change in sweat chloride from baseline at Week 24 was -31.7 mmol/L (95% CI: -35.7, -27.6).
Slovenian: V preskušanju 8 pri bolnikih, homozigotnih za mutacijo F508del-CFTR, starih 2 do 5 let, je bila povprečna absolutna sprememba kloridov v znoju znotraj skupine od izhodišča v 24. tednu -31,7 mmol/l (95 % IZ: -35,7, -27,6).
English: • Increase in blood pressure
Slovenian: • porast krvnega tlaka,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1059/001 112 film-coated tablets (4 packs of 28 tablets) EU/1/15/1059/002 56 film-coated tablets (2 packs of 28 tablets)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1059/001 112 filmsko obloženih tablet (4 pakiranja po 28 tablet) EU/1/15/1059/002 56 filmsko obloženih tablet (2 pakiranji po 28 tablet)
English: The exposure (AUC) of lumacaftor is approximately 2-fold higher in healthy adult volunteers compared to exposure in patients with CF.
Slovenian: Izpostavljenost (AUC) lumakaftorju je približno dvakrat večja pri zdravih odraslih prostovoljcih kot pri bolnikih s CF. Izpostavljenost ivakaftorju je pri zdravih odraslih prostovoljcih in bolnikih s CF
English: Mean ivacaftor (SD) AUCss (μg/mL*h)
Slovenian: Povprečna (SD) AUCss ivakaftorja (μg/ml*h)
English: Orkambi granules are indicated for the treatment of cystic fibrosis (CF) in children aged 2 years and older who are homozygous for the F508del mutation in the CFTR gene (see sections 4.2, 4.4 and 5.1).
Slovenian: Zrnca zdravila Orkambi so indicirana za zdravljenje cistične fibroze (CF) pri otrocih, starih 2 leti ali več, ki so homozigotni za mutacijo F508del na genu CFTR (glejte poglavja 4.2, 4.4 in 5.1).
English: EU/1/15/1059/007
Slovenian: EU/1/15/1059/006 EU/1/15/1059/007
English: The primary efficacy endpoint in both studies was the absolute change from baseline in ppFEV1 at week 24.
Slovenian: Primarni učinkovitostni cilj v obeh študijah je bila absolutna sprememba ppFEV1 od izhodišča v 24. tednu.
English: Ivacaftor is a weak inhibitor of CYP3A when given as monotherapy.
Slovenian: Ivakaftor je šibek zaviralec CYP3A, kadar ga dajemo kot monoterapijo.
English: There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC - an active component in cannabis) in patients receiving Orkambi.
Slovenian: Pri bolnikih, ki so jemali zdravilo Orkambi, so poročali o lažno pozitivnih urinskih presejalnih testih za tetrahidrokanabinol (THC - aktivna sestavina kanabisa).
English: Your child's doctor may monitor your child's blood pressure during treatment with Orkambi.
Slovenian: Mogoče bo zdravnik otroku med zdravljenjem z zdravilom Orkambi spremljal krvni tlak.
English: 12 years and older
Slovenian: 12 let ali več
English: Table 1: Recommended dose of Orkambi in patients aged 2 years and older
Slovenian: Preglednica 3: Priporočeni odmerek zdravila Orkambi za bolnike, stare 2 leti ali več
English: • Avocados, hummus, soy-based products (tofu)
Slovenian: • avokado, humus, izdelki iz soje (tofu); • prehranske ploščice ali pijače.
English: Orkambi should be taken with fat-containing food.
Slovenian: Zdravilo Orkambi je treba jemati z mastno hrano.
English: PHARMACEUTICAL FORM AND CONTENTS granules
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA
English: Vascular disorders uncommon Hypertension
Slovenian: Žilne bolezni občasni hipertenzija
English: Therefore, co-administration with strong CYP3A inducers (e.g., rifampicin, St. John's wort [Hypericum perforatum]) is not recommended (see section 4.5).
Slovenian: Zato sočasno dajanje z močnimi induktorji CYP3A (npr. rifampicinom ali šentjanževko [Hypericum perforatum]) ni priporočljivo (glejte poglavje 4.5).
English: Description of selected adverse reactions for paediatric patients aged 2 to 11 years Hepatobiliary events
Slovenian: Opis izbranih neželenih učinkov pri pediatričnih bolnikih, starih 2 do 11 let Dogodki, povezani z jetri in žolčevodom
English: During the 24-week, placebo-controlled, Phase 3 studies, a maximum decrease in mean heart rate of 6 beats per minute (bpm) from baseline was observed on Day 1 and Day 15 around 4 to 6 hours after dosing.
Slovenian: Med 24-tedenskimi študijami 3. faze, kontroliranimi s placebom, so 1. in 15. dne okrog 4 do 6 ur po odmerjanju ugotovili največje zmanjšanje srednje srčne frekvence za 6 utripov na minuto (beats per minute, bpm) od izhodišča.
English: Safety data were evaluated in 60 patients aged 2 to 5 years, 161 patients aged 6 to 11 years (Trials 6, 7 and 8) and in 194 patients aged 12 to 17 years with CF who are homozygous for the F508del mutation and who received lumacaftor/ivacaftor in clinical studies.
Slovenian: Varnostne podatke so ocenili pri 60 bolnikih, starih 2 do 5 let, 161 bolnikih, starih 6 do 11 let (preskušanja 6, 7 in 8), in pri 194 bolnikih, starih 12 do 17 let, s CF, ki so bili homozigotni za mutacijo F508del in ki so prejemali lumakaftor/ivakaftor v kliničnih študijah.
English: Abnormalities in liver function, including advanced liver disease, can be present in patients with CF.
Slovenian: Pri bolnikih s CF so lahko prisotne nenormalnosti funkcije jeter, vključno z napredovalo boleznijo jeter.
English: Lumacaftor and ivacaftor work together to improve the function of the abnormal CFTR protein.
Slovenian: Lumakaftor in ivakaftor skupaj izboljšata funkcijo nenormalne beljakovine CFTR.
English: The active substances are lumacaftor and ivacaftor.
Slovenian: Učinkovini sta lumakaftor in ivakaftor.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala, toksičnega vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: In patients who received placebo (mean baseline 114 mmHg systolic and 69 mmHg diastolic), the maximum increase from baseline in mean systolic and diastolic blood pressure was 0.9 mmHg and 0.9 mmHg, respectively.
Slovenian: Pri bolnikih, ki so prejemali placebo (srednji izhodiščni sistolični tlak 114 mm Hg in srednji izhodiščni diastolični tlak 69 mm Hg), je bil največji porast srednjega sistoličnega in diastoličnega krvnega tlaka od izhodišča 0,9 mm Hg oziroma 0,9 mm Hg.
English: INFORMATION IN BRAILLE Orkambi 150 mg, 188 mg
Slovenian: Orkambi 150 mg, 188 mg
English: Interim Analysis: December 2022
Slovenian: december 2022.
English: During Trials 1 and 2, the incidence of maximum transaminase (ALT or AST) levels > 8, > 5, and > 3 x ULN was 0.8%, 2.0%, and 5.2%; and 0.5%, 1.9%, and 5.1% in lumacaftor/ivacaftor- and placebo-treated patients, respectively.
Slovenian: Med preskušanjima 1 in 2 je bila incidenca najvišjih ravni transaminaz (ALT ali AST) > 8, > 5 oziroma > 3 x ULN 0,8 %, 2,0 % oziroma 5,2 %; in 0,5 %, 1,9 % oziroma 5,1 % pri bolnikih, ki so prejemali lumakaftor/ivakaftor oziroma placebo.
English: • Dark urine
Slovenian: • temen urin;
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON FOR MULTIPACK NO BLUE BOX
Slovenian: PODATKI NA ZUNANJI OVOJNINI NOTRANJA ŠKATLA ZA SKUPNO PAKIRANJE BREZ »MODREGA OKENCA«
English: Trial 8: Safety and tolerability study in pediatric patients with CF aged 2 to 5 years homozygous for the F508del mutation in the CFTR gene
Slovenian: Preskušanje 8: Študija varnosti in prenašanja pri pediatričnih bolnikih s CF, starih 2 do 5 let, homozigotnih za mutacijo F508del na genu CFTR
English: The treatment difference (LS mean) in sweat chloride for the average absolute change at Day 15 and at Week 4 as compared to placebo was -20.8 mmol/L (95% CI: -23.4, -18.2; nominal P < 0.0001).
Slovenian: Razlika zaradi zdravljenja (povprečje najmanjših kvadratov) kloridov v znoju za povprečno absolutno spremembo v 15. dnevu in v 4. tednu v primerjavi s placebom je bila -20,8 mmol/l (95 % IZ: -23,4; -18,2; nominalna P < 0,0001).
English: Your doctor may monitor your blood pressure during treatment with Orkambi.
Slovenian: Mogoče vam bo zdravnik med zdravljenjem z zdravilom Orkambi spremljal krvni tlak.
English: Key secondary endpoints included average absolute change from baseline in sweat chloride at Day 15 and Week 4 and at Week 24 (see Pharmacodynamic effects), absolute change from baseline in BMI at Week 24, absolute change from baseline in CFQ-R Respiratory Domain through Week 24.
Slovenian: Ključni sekundarni cilji študije so vključevali povprečno absolutno spremembo kloridov v znoju od izhodišča do 15. dne in v 4. tednu in v 24. tednu (glejte Farmakodinamični učinki), absolutno spremembo ITM od izhodišča do 24. tedna in absolutno spremembo respiratorne domene CFQ-R od izhodišča do 24. tedna.
English: Lumacaftor is a strong inducer of CYP3A and ivacaftor is a weak inhibitor of CYP3A when given as monotherapy.
Slovenian: Lumakaftor je močan induktor CYP3A, ivakaftor pa šibek zaviralec CYP3A, kadar ju dajemo kot monoterapijo.
English: • Stuffy or runny nose
Slovenian: • kongestija nosu,
English: Patients with CF who have a gating (Class III) mutation in the CFTR gene Lumacaftor/ivacaftor has not been studied in patients with CF who have a gating (Class III) mutation in the CFTR gene on one allele, with or without the F508del mutation on the other allele.
Slovenian: Bolniki s CF, ki imajo mutacijo spreminjanja prehodnosti (skupina III) na genu CFTR Lumakaftorja/ivakaftorja niso proučevali pri bolnikih s CF, ki imajo mutacijo spreminjanja prehodnosti (skupina III) na genu CFTR na enem alelu in bodisi mutacijo F508del na drugem alelu, bodisi te mutacije na drugem alelu nimajo.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - MULTIPACK - WITH BLUE BOX
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA - SKUPNO PAKIRANJE - Z MODRIM OKENCEM
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Vertex Pharmaceuticals (Ireland) Limited
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Vertex Pharmaceuticals (Ireland) Limited
English: • Immunosuppressants (used after an organ transplantation) for example: ciclosporin, everolimus, sirolimus, tacrolimus
Slovenian: • zdravila za zaviranje imunske odzivnosti (uporabljajo se po presaditvi organa), na primer: ciklosporin, everolimus, sirolimus, takrolimus;
English: No serious respiratory events, dose reductions or discontinuations were seen in patients who were initiated at the half dose (see section 4.4).
Slovenian: Pri bolnikih, ki so jim uvedli polovični odmerek, ni bilo resnih respiracijskih dogodkov, zmanjšanj odmerkov ali prekinitev zdravljenja (glejte poglavje 4.4).
English: Adverse reactions identified from the 24-week, placebo-controlled, Phase 3 studies (Trials 1 and 2) in patients aged 12 years and older and from a 24-week, placebo-controlled study in patients aged 6 to 11 years (Trial 7), who are homozygous for the F508del mutation in the CFTR gene are presented in Table 4 and are listed by system organ class, frequency, and adverse reactions.
Slovenian: Neželeni učinki, ugotovljeni v 24-tedenskih, s placebom kontroliranih študijah faze 3 (preskušanji 1 in 2) pri bolnikih, starih 12 let ali več, in v 24-tedenski, s placebom kontrolirani študiji pri bolnikih, starih 6 do 11 let (preskušanje 7), ki so bili homozigotni za mutacijo F508del na genu CFTR, so navedeni v preglednici 4 po organskih sistemih, pogostnosti in neželenih učinkih.
English: Changes in sweat chloride in response to lumacaftor alone or in combination with ivacaftor were evaluated in a double-blind, placebo-controlled, Phase 2 clinical trial in patients with CF age 18 years and older.
Slovenian: Spremembe kloridov v znoju v odziv na lumakaftor sam ali v kombinaciji z ivakaftorjem so ovrednotili v dvojno slepem kliničnem preskušanju 2. faze, kontroliranem s placebom, pri bolnikih s CF, starih 18 let ali več.
English: Co-administration of lumacaftor/ivacaftor with itraconazole, a strong CYP3A inhibitor, did not impact the exposure of lumacaftor, but increased ivacaftor exposure by 4.3-fold.
Slovenian: Sočasno dajanje lumakaftorja/ivakaftorja z itrakonazolom, ki je močan zaviralec CYP3A, ni vplivalo na izpostavljenost lumakaftorju, je pa zvečalo izpostavljenost ivakaftorju za 4,3-krat.
English: Skin and subcutaneous tissue disorders common
Slovenian: Bolezni kože in podkožja pogosti izpuščaj
English: Dizziness has been reported in patients receiving ivacaftor, a component of Orkambi, which could influence the ability to drive or use machines.
Slovenian: Pri bolnikih, ki so jemali ivakaftor, ki je ena od sestavin zdravila Orkambi, so poročali o omotici, ki bi lahko vplivala na sposobnost uporabe zdravil ali strojev.
English: Patients who had 2 or more abnormal liver function tests (ALT, AST, AP, GGT ≥ 3 times the ULN), or ALT or AST > 5 times ULN, or total bilirubin > 2 times ULN were excluded.
Slovenian: 2 ali več nenormalnih testov funkcije jeter (ALT, AST, AP, GGT ≥ 3-kratnika ULN), ali ALT ali AST > 5-kratnika ULN, ali celotni bilirubin > 2-kratnika ULN, so bili izključeni.
English: It is unknown whether lumacaftor and/or ivacaftor and metabolites are excreted in human milk.
Slovenian: Ni znano, ali se lumakaftor in/ali ivakaftor in presnovki izločajo v materino mleko.
English: • Pack containing 28 film-coated tablets.
Slovenian: • pakiranje, ki vsebuje 28 filmsko obloženih tablet;
English: No dose adjustment is necessary when CYP3A inhibitors are initiated in patients currently taking lumacaftor/ivacaftor.
Slovenian: Prilagajanje odmerka ni potrebno, kadar uvajamo zaviralce CYP3A bolnikom, ki trenutno jemljejo lumakaftor/ivakaftor.
English: Patients received either lumacaftor/ivacaftor (n = 62) or placebo (n = 63) in addition to their prescribed CF therapies.
Slovenian: Bolniki so poleg svojih predpisanih terapij CF prejemali bodisi lumakaftor/ivakaftor (n = 62) ali placebo (n = 63).
English: Patients received either lumacaftor 200 mg/ivacaftor 250 mg every 12 hours (n = 103) or placebo (n = 101) in addition to their prescribed CF therapies.
Slovenian: Bolniki so prejemali poleg svojih predpisanih terapij CF bodisi lumakaftor 200 mg/ivakaftor 250 mg vsakih 12 ur (n = 103) ali placebo (n = 101).
English: Marketing Authorisation Holder Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper Dublin 2, D02 EK84
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper
English: There was negligible urinary excretion of ivacaftor as unchanged drug.
Slovenian: V urinu se je v obliki nespremenjenega zdravila izločila zanemarljiva količina ivakaftorja.
English: Ivacaftor did not cause developmental defects in the offspring of pregnant rats dosed orally from pregnancy through parturition and weaning at 100 mg/kg/day.
Slovenian: Peri- in postnatalni razvoj Ivakaftor ni povzročil razvojnih okvar pri potomstvu brejih podgan, ki so peroralno prejemale ves čas brejosti, kotitve in odstavljanja od prsi odmerek po 100 mg/kg/dan.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Vertex Pharmaceuticals (Ireland) Limited
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Vertex Pharmaceuticals (Ireland) Limited
English: Age, weight
Slovenian: Starost, telesna masa
English: Patients may start taking Orkambi on any day of the week.
Slovenian: Bolniki lahko začnejo jemati zdravilo Orkambi kateri koli dan v tednu.
English: Give Orkambi to your child for as long as your child's doctor recommends.
Slovenian: Če ste prenehali otroku dajati zdravilo Orkambi Otroku dajajte zdravilo toliko časa, dokler to priporoča otrokov zdravnik.
English: Potential for other medicinal products to affect lumacaftor/ivacaftor Inhibitors of CYP3A
Slovenian: Možnost, da bodo druga zdravila vplivala na lumakaftor/ivakaftor Zaviralci CYP3A
English: Pack size of 56 sachets (contains 4 individual wallets with 14 sachets per wallet).
Slovenian: Velikost pakiranja 56 vrečic (vsebuje 4 posamezne zloženke s po 14 vrečicami na zloženko).