FrancophonIA/ELRC3.0 huggingface dataset:
English: INFORMATION IN BRAILLE Orkambi 200 mg, 125 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Orkambi 200 mg, 125 mg
English: Trials in patients with CF aged 6 to 11 years old who are homozygous for the F508del mutation in the CFTR gene
Croatian: Ispitivanja u bolesnika s cističnom fibrozom u dobi od 6 do 11 godina koji su homozigoti za mutaciju F508del gena CFTR
English: After oral administration of ivacaftor alone as 150 mg q12h in a fed state, the steady-state mean (± SD) for AUC0-12h and Cmax were 9.08 (3.20) µg∙hr/mL and 1.12 (0.319) µg/mL, respectively.
Croatian: Nakon peroralne primjene samo ivakaftora u dozi od 150 mg svakih 12 sati u stanju sitosti, srednje vrijednosti (±SD) u stanju dinamičke ravnoteže za AUC0-12h i Cmax bile su 9,08 (3,20) µg∙h/mL odnosno 1,12 (0,319) µg/mL.
English: Transaminase elevations uncommon Cholestatic hepatitis‡
Croatian: Poremećaji jetre i žuči često povišenja transaminaza manje često kolestatski hepatitis‡
English: Tell your doctor straight away if you have any of these symptoms, which may be a sign of liver problems:
Croatian: Ako imate neki od ovih simptoma, koji mogu biti znak poremećaja jetre, odmah o tome obavijestite liječnika:
English: rifapentine
Croatian: rifapentin
English: Concomitant use of lumacaftor/ivacaftor with these benzodiazepines is not recommended.
Croatian: Ne preporučuje se istodobna primjena lumakaftora/ivakaftora s ovim benzodiazepinima.
English: • Abdominal pain (stomach ache)
Croatian: • bol u trbuhu (bol u abdomenu)
English: PHARMACEUTICAL FORM Granules
Croatian: OBLIK Granule
English: You may start taking Orkambi on any day of the week.
Croatian: Možete početi uzimati Orkambi bilo koji dan u tjednu.
English: Trial 2 evaluated 559 patients aged 12 years and older (mean age 25.0 years) with ppFEV1 at screening between 40-90 (mean ppFEV1 60.5 at baseline [range: 31.3 to 99.8]).
Croatian: U ispitivanju 2 procijenjeno je 559 bolesnika u dobi od 12 i više godina (srednja vrijednost dobi 25,0 godina) u kojih je ppFEV1 na probiru iznosio između 40 i 90 (srednja vrijednost ppFEV1 na početku ispitivanja bila je 60,5 [raspon: od 31,3 do 99,8]).
English: There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving Orkambi.
Croatian: U bolesnika koji primaju Orkambi zabilježeni su lažno pozitivni rezultati probirnih testova urina na tetrahidrokanabinol (THC).
English: The treatment difference between lumacaftor 400 mg q12h alone and placebo evaluated as mean change in sweat chloride from baseline to Day 28 was statistically significant at -8.2 mmol/L (95% CI: -14, -2).
Croatian: Terapijska razlika između primjene samo lumakaftora u dozi od 400 mg svakih 12 sati i placeba, procijenjena kao srednja vrijednost promjene u koncentraciji klorida u znoju od početka ispitivanja do 28. dana, bila je statistički značajna na -8,2 mmol/L (95% CI: -14, -2).
English: For patients aged 2 to 5 years and ≥ 14 kg lumacaftor 300 mg + ivacaftor 376 mg
Croatian: Za bolesnike u dobi od 2 do 5 godina i ≥ 14 kg 300 mg lumakaftora + 376 mg ivakaftora
English: Orkambi 200 mg/125 mg film-coated tablets (tablets) are pink, oval-shaped tablets (dimensions 14 × 8.4 × 6.8 mm) printed with “2V125” in black ink on one side.
Croatian: Orkambi 200 mg/125 mg filmom obložene tablete (tablete) ružičaste su ovalne tablete (dimenzija 14 × 8,4 × 6,8 mm) s otisnutom oznakom “2V125” crnom tintom s jedne strane.
English: ↓ ethinyl estradiol, norethindrone, and other progestogens Due to induction of CYP3A/UGT by LUM
Croatian: ↓ etinilestradiol, noretindron i drugi progestogeni zbog indukcije CYP3A/UGT lumakaftorom
English: During the 24-week, placebo-controlled Phase 3 clinical study (Trial 7) in patients aged 6 to 11 years (mean baseline ppFEV1 was 89.8), the incidence of respiratory adverse reactions was 18.4% in lumacaftor/ivacaftor patients and 12.9% in placebo patients.
Croatian: Tijekom 24-tjednog, placebom kontroliranog kliničkog ispitivanja faze 3 (ispitivanje 7) u bolesnika u dobi od 6 do 11 godina (srednja vrijednost početnog ppFEV1 bila je 89,8), incidencija respiratornih nuspojava bila je 18,4% u bolesnika liječenih lumakaftorom/ivakaftorom i 12,9% u bolesnika koji su primali placebo.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I: Sažetak opisa svojstava lijeka, dio 4.2).
English: Absolute change from baseline in stature (cm)
Croatian: Apsolutna promjena od početne vrijednosti visine (cm)
English: The exposure of lumacaftor increased approximately 2.0-fold when given with fat-containing food relative to fasted conditions.
Croatian: Kada se lumakaftor davao uz hranu koja sadrži masti, izloženost lumakaftoru povećala se približno 2,0 puta u odnosu na stanja natašte.
English: Due to induction of CYP3A by these anticonvulsants
Croatian: ↔ LUM ↓ IVA zbog indukcije CYP3A ovim antikonvulzivima
English: No dose adjustment of lumacaftor/ivacaftor is recommended when clarithromycin or telithromycin are initiated in patients currently taking lumacaftor/ivacaftor.
Croatian: Ne preporučuje se prilagodba doze lumakaftora/ivakaftora kada se započinje s primjenom klaritromicina ili telitromicina u bolesnika koji već uzimaju lumakaftor/ivakaftor.
English: Placebo transitioned to Lumacaftor 400 mg q12h/ Ivacaftor 250 mg q12h (n = 176)**
Croatian: Prijelaz s placeba na lumakaftor 400 mg/ ivakaftor 250 mg svakih 12 sati (n = 176)**
English: Due to potential induction or inhibition of CYP2C9 by LUM
Croatian: ↑ ili ↓ varfarin zbog moguće indukcije ili inhibicije CYP2C9 lumakaftorom
English: LUM 200 mg/IVA 250 mg q12h (n = 103)
Croatian: LUM 200 mg/IVA 250 mg svakih 12 sati (n = 103)
English: Patients in both trials were randomised 1:1:1 to receive lumacaftor 600 mg once daily/ivacaftor 250 mg q12h, lumacaftor 400 mg q12h/ivacaftor 250 mg q12h, or placebo.
Croatian: U oba ispitivanja bolesnici su bili randomizirani u omjeru 1:1:1 u skupinu koja je primala lumakaftor 600 mg jedanput na dan/ivakaftor 250 mg svakih 12 sati, lumakaftor 400 mg svakih 12 sati/ivakaftor 250 mg svakih 12 sati ili placebo.
English: During the 24-week, open-label Phase 3 clinical study in 58 patients aged 6 to 11 years (Trial 6), the incidence of maximum transaminase (ALT or AST) levels > 8, > 5, and >3 x ULN was 5.3%, 8.8%, and 19.3%.
Croatian: Tijekom 24-tjednog, otvorenog kliničkog ispitivanja faze 3 u 58 bolesnika u dobi od 6 do 11 godina (ispitivanje 6), incidencija maksimalnih razina transaminaza (ALT ili AST) > 8, > 5 i > 3 x GGN bila je 5,3%, 8,8% odnosno 19,3%.
English: Lumacaftor/ivacaftor has not been studied in patients with CF who have undergone organ transplantation.
Croatian: Lumakaftor/ivakaftor nije ispitan u bolesnika s cističnom fibrozom kojima je presađen organ.
English: ↓ ibuprofen Due to induction of CYP3A/2C8/2C9 by LUM
Croatian: ↓ ibuprofen zbog indukcije CYP3A/2C8/2C9 lumakaftorom
English: For patients aged 2 to 5 years and ≥ 14 kg Day 1: lumacaftor 300 mg + ivacaftor 376 mg Day 2: lumacaftor 150 mg + ivacaftor 188 mg
Croatian: Za bolesnike u dobi od 2 do 5 godina i ≥ 14 kg 1. dan: 300 mg lumakaftora + 376 mg ivakaftora 2. dan: 150 mg lumakaftora + 188 mg ivakaftora
English: A higher dose of these proton pump inhibitors may be required to obtain the desired clinical effect.
Croatian: Može biti potrebna viša doza inhibitora protonske pumpe da bi se postigao željeni klinički učinak.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - SINGLE PACK
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA - JEDNO PAKIRANJE
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.
Croatian: Orkambi ako Vam je rečeno da Vaše dijete ima bolest jetre ili bubrega, jer će liječnik možda trebati prilagoditi dozu lijeka Orkambi.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Orkambi 150 mg/188 mg granules lumacaftor/ivacaftor
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Orkambi 150 mg/188 mg granule lumacaftorum/ivacaftorum
English: Lumacaftor/ivacaftor may decrease the exposures of these proton pump inhibitors, which may reduce their efficacy.
Croatian: Lumakaftor/ivakaftor može smanjiti izloženosti ovim inhibitorima protonske pumpe, što može oslabiti njihovu djelotvornost.
English: Due to inhibition of CYP3A by these antifungals
Croatian: ↔ LUM ↑ IVA zbog inhibicije CYP3A ovim antimikoticima
English: INFORMATION IN BRAILLE Orkambi 100 mg, 125 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Orkambi 100 mg, 125 mg
English: For patients aged 2 to 5 years and < 14 kg lumacaftor 200 mg + ivacaftor 250 mg
Croatian: Za bolesnike u dobi od 2 do 5 godina i < 14 kg 200 mg lumakaftora + 250 mg ivakaftora
English: * For the endpoints listed, absolute change from baseline is the mean absolute change from baseline at Week 24.
Croatian: Za navedene mjere ishoda, apsolutna promjena od početne vrijednosti je srednja vrijednost apsolutne promjene od početne vrijednosti do 24. tjedna.
English: The use of lumacaftor/ivacaftor in organ transplant patients has not been studied.
Croatian: Primjena lumakaftora/ivakaftora u bolesnika kojima je presađen organ nije ispitana.
English: ↓ montelukast Due to the induction of CYP3A/2C8/2C9 by LUM
Croatian: ↓ montelukast zbog indukcije CYP3A/2C8/2C9 lumakaftorom
English: • Mix the entire contents of a sachet with one teaspoon (5 mL) of age-appropriate soft food or liquid.
Croatian: • Pomiješajte cijeli sadržaj vrećice s 5 mL meke hrane ili tekućine primjerene djetetovoj dobi.
English: Absolute change in CFQ-R Respiratory Domain Score at Week 24 (points)
Croatian: Apsolutna promjena rezultata CFQ-R u respiratornoj domeni u 24. tjednu (bodovi)
English: Absolute change from baseline in BMI-for-age-z-score n = 57 95% CI: 0.14, 0.45; P = 0.0003
Croatian: Apsolutna promjena od početne vrijednosti z-rezultata za ITM za dob n = 57 95% CI: 0,14; 0,45; P = 0,0003
English: A transient decline in FEV1 has also been observed in some patients following initiation of lumacaftor/ivacaftor.
Croatian: U nekih je bolesnika nakon početka liječenja lumakaftorom/ivakaftorom opaženo i prolazno smanjenje FEV1.
English: Do not stop unless your child's doctor advises you to. You should keep giving the medicine as the doctor directs even if the child feels well.
Croatian: Nemojte prestati osim ako Vam tako nije savjetovao djetetov liječnik.
English: At Week 24, the treatment difference between lumacaftor 400 mg/ivacaftor 250 mg q12h and placebo for the mean absolute change (95% CI) in ppFEV1 from baseline in the pooled Trials 1 and 2 were 3.39 percentage points (P = 0.0382) for patients with ppFEV1 < 40 and 2.47 percentage points (P < 0.0001) for patients with ppFEV1 ≥ 40.
Croatian: U 24. tjednu, u objedinjenim ispitivanjima 1 i 2 terapijska razlika između lumakaftora 400 mg/ivakaftora 250 mg svakih 12 sati i placeba za srednju vrijednost apsolutne promjene (95% CI) u ppFEV1 u odnosu na početnu vrijednost iznosila je 3,39 postotnih bodova (P = 0,0382) u bolesnika s ppFEV1 < 40 i 2,47 postotnih bodova (P < 0,0001) u bolesnika s ppFEV1 ≥ 40.
English: Abnormalities in liver function, including advanced liver disease, can be present in patients with CF.
Croatian: U bolesnika s cističnom fibrozom mogu biti prisutni poremećaji funkcije jetre, uključujući uznapredovalu bolest jetre.
English: Orkambi 150 mg/188 mg granules in sachet: Each sachet contains 150 mg of lumacaftor and 188 mg of ivacaftor.
Croatian: Orkambi 150 mg/188 mg granule u vrećici Jedna vrećica sadrži 150 mg lumakaftora (lumacaftorum) i 188 mg ivakaftora (ivacaftorum).
English: Absolute change from baseline in weight-for-age z-score n = 57 95% CI: 0.15, 0.38; P < 0.0001
Croatian: Apsolutna promjena od početne vrijednosti z-rezultata za tjelesnu težinu za dob n = 57 95% CI: 0,15; 0,38; P < 0,0001
English: If Orkambi is interrupted for more than one week and then re-initiated while taking strong CYP3A inhibitors, the Orkambi dose should be reduced to one tablet daily (lumacaftor 100 mg/ivacaftor 125 mg for patients aged 6 to 11 years; lumacaftor 200 mg/ivacaftor 125 mg for patients aged 12 years and older) for the first week of treatment re-initiation.
Croatian: Ako se uzimanje lijeka Orkambi prekine na dulje od tjedan dana i zatim ponovno započne za vrijeme primjene jakih inhibitora CYP3A, dozu lijeka Orkambi treba smanjiti na jednu tabletu dnevno (100 mg lumakaftora/125 mg ivakaftora za bolesnike u dobi od 6 do 11 godina te 200 mg lumakaftora/125 mg ivakaftora za bolesnike u dobi od 12 i više godina) u prvom tjednu ponovno započete terapije.
English: Corticosteroids, systemic: methylprednisolone, prednisone
Croatian: Kortikosteroidi, sistemski: metilprednizolon, prednizon
English: NAME OF THE MEDICINAL PRODUCT Orkambi 100 mg/125 mg granules in sachet Orkambi 150 mg/188 mg granules in sachet
Croatian: Orkambi 100 mg/125 mg granule u vrećici Orkambi 150 mg/188 mg granule u vrećici
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.
Croatian: Kombinacija lumakaftor/ivakaftor nije ispitana u bolesnika s cističnom fibrozom koji na jednom alelu imaju mutaciju III. klase (engl. gating mutation) gena CFTR zbog koje dolazi do nepravilne regulacije kanala, s mutacijom ili bez mutacije F508del na drugom alelu.
English: If Orkambi is interrupted for more than one week and then re-initiated while taking strong CYP3A inhibitors, the Orkambi dose should be reduced to one sachet (lumacaftor 100 mg/ivacaftor 125 mg for patients aged 2 to 5 years and weighing less than 14 kg; lumacaftor 150 mg/ivacaftor 188 mg for patients aged 2 to 5 years and weighing 14 kg or greater) every other day for the first week of treatment re-initiation.
Croatian: Ako se uzimanje lijeka Orkambi prekine na dulje od tjedan dana i zatim ponovno započne za vrijeme primjene jakih inhibitora CYP3A, dozu lijeka Orkambi treba smanjiti na jednu vrećicu (100 mg lumakaftora/125 mg ivakaftora za bolesnike u dobi od 2 do 5 godina i tjelesne težine manje od 14 kg; 150 mg lumakaftora/188 mg ivakaftora za bolesnike u dobi od 2 do 5 godina i tjelesne težine 14 kg ili više) koja se uzima svaki drugi dan u prvom tjednu ponovno započete terapije.
English: Absolute change in CFQ-R Respiratory Domain Score through Week 24 (points)
Croatian: Apsolutna promjena u rezultatu respiratorne domene CFQ-R do 24. tjedna (bodovi)
English: Baseline ppFEV1‡ Absolute change from baseline ppFEV1 (percentage points)
Croatian: Početni ppFEV1‡ Apsolutna promjena ppFEV1 u odnosu na početnu vrijednost (postotni bodovi)
English: Patients aged 2 to 5 years and weighing 14 kg or greater lumacaftor 150 mg/ivacaftor 188 mg sachet every 12 hours
Croatian: Bolesnici u dobi od 2 do 5 godina i tjelesne težine 14 kg ili veće vrećica lumakaftora 150 mg/ivakaftora 188 mg svakih 12 sati
English: PHARMACEUTICAL FORM AND CONTENTS 112 film-coated tablets (4 packs of 28 tablets).
Croatian: OBLIK I SADRŽAJ 112 filmom obloženih tableta (4 pakiranja po 28 tableta)
English: Pink, oval-shaped tablets (dimensions 14 × 8.4 × 6.8 mm) printed with “2V125” in black ink on one side.
Croatian: Ružičaste, ovalne tablete (dimenzija 14 × 8,4 × 6,8 mm) s oznakom "2V125" otisnutom crnom tintom na jednoj strani.
English: Lumacaftor/ivacaftor may decrease the exposure of hormonal contraceptives, which may reduce their efficacy.
Croatian: Lumakaftor/ivakaftor može smanjiti izloženost hormonskim kontraceptivima, što može oslabiti njihovu djelotvornost.
English: Pink, oval-shaped tablets (dimensions 14 × 7.6 × 4.9 mm) printed with “1V125” in black ink on one side.
Croatian: Ružičaste, ovalne tablete (dimenzija 14 × 7,6 × 4,9 mm) s oznakom "1V125" otisnutom crnom tintom na jednoj strani.
English: Absolute change from baseline in stature-for-age z-score n = 57 95% CI: 0.02, 0.15; P = 0.0104
Croatian: Apsolutna promjena od početne vrijednosti z-rezultata za visinu za dob n = 57 95% CI: 0,02; 0,15; P = 0,0104
English: ↓ repaglinide Due to induction of CYP3A/2C8 by LUM
Croatian: ↓ repaglinid zbog indukcije CYP3A/2C8 lumakaftorom
English: Baseline BMI (kg/m2)‡ Absolute change from baseline in BMI (kg/m2)
Croatian: Početni ITM (kg/m2)‡ Apsolutna promjena vrijednosti ITM (kg/m2) u odnosu na početnu
English: Lumacaftor/ivacaftor may decrease the exposures of clarithromycin and telithromycin, which may reduce their efficacy.
Croatian: Lumakaftor/ivakaftor može smanjiti izloženost klaritromicinu i telitromicinu, što može oslabiti njihovu djelotvornost.
English: Concomitant use of lumacaftor/ivacaftor with these immunosuppressants is not recommended.
Croatian: Ne preporučuje se istodobna primjena lumakaftora/ivakaftora s ovim imunosupresivima.
English: The dose of lumacaftor/ivacaftor should be reduced to one tablet daily for the first week of treatment when initiating lumacaftor/ ivacaftor in patients currently taking clarithromycin or telithromycin.
Croatian: Dozu lumakaftora/ivakaftora treba smanjiti na jednu tabletu dnevno u prvom tjednu liječenja kada se započinje s primjenom lumakaftora/ivakaftora u bolesnika koji već uzimaju klaritromicin ili telitromicin.
English: • Redness in the throat*
Croatian: • crvenilo grla*
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.
Croatian: 200 mg/ivakaftor 250 mg svakih 12 sati (n = 103) ili placebo (n = 101).
English: Orkambi 100 mg/125 mg granules in sachet:
Croatian: Orkambi 100 mg/125 mg granule u vrećici:
English: Mild hepatic impairment (Child-Pugh Class A)
Croatian: Blago oštećenje funkcije jetre (Child-Pugh stadij A)
English: Ear pain*, ear discomfort*, tinnitus*, tympanic membrane hyperaemia*, vestibular disorder* uncommon Ear congestion*
Croatian: Poremećaji uha i labirinta često bol u uhu*, nelagoda u uhu*, tinitus*, hiperemija bubnjića*, vestibularni poremećaj* manje često kongestija uha*
English: Iron oxide black (E172) Propylene glycol Ammonium hydroxide
Croatian: indigo carmine aluminium lake (E132) Tinta za označivanje šelak željezov oksid, crni (E172) propilenglikol amonijev hidroksid
English: ↓ rifabutin Due to induction of CYP3A by LUM
Croatian: ↓ rifabutin zbog indukcije CYP3A lumakaftorom
English: Patients aged 2 to 5 years and weighing and less than 14 kg lumacaftor 100 mg/ivacaftor 125 mg sachet every 12 hours
Croatian: Bolesnici u dobi od 2 do 5 godina i tjelesne težine manje od 14 kg vrećica lumakaftora 100 mg/ivakaftora 125 mg svakih 12 sati
English: However, when initiating Orkambi in patients taking strong CYP3A inhibitors, the dose should be reduced to one sachet (lumacaftor 100 mg/ivacaftor 125 mg for patients aged 2 to 5 years and weighing less than 14 kg; lumacaftor 150 mg/ivacaftor 188 mg for patients aged 2 to 5 years and weighing 14 kg or greater) every other day for the first week of treatment to allow for the steady state induction effect of lumacaftor.
Croatian: Međutim, kada se s primjenom lijeka Orkambi započinje u bolesnika koji uzimaju jake inhibitore CYP3A, u prvom tjednu liječenja dozu treba smanjiti na jednu vrećicu (100 mg lumakaftora/125 mg ivakaftora za bolesnike u dobi od 2 do 5 godina i tjelesne težine manje od 14 kg; 150 mg lumakaftora/188 mg ivakaftora za bolesnike u dobi od 2 do 5 godina i tjelesne težine 14 kg ili više) koja se uzima svaki drugi dan, da bi se omogućio indukcijski učinak lumakaftora u stanju dinamičke ravnoteže.
English: Method of administration Orkambi is for oral use.
Croatian: Način primjene Orkambi se uzima kroz usta.
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).
Croatian: Orkambi granule indicirane su za liječenje cistične fibroze (CF) u djece u dobi od 2 i više godina koja su homozigoti za mutaciju F508del gena CFTR (engl.
English: However, when initiating Orkambi in patients taking strong CYP3A inhibitors, the dose should be reduced to one tablet daily (lumacaftor 100 mg/ivacaftor 125 mg for patients aged 6 to 11 years; lumacaftor 200 mg/ivacaftor 125 mg for patients aged 12 years and older) for the first week of treatment to allow for the steady state induction effect of lumacaftor.
Croatian: Međutim, kada se s primjenom lijeka Orkambi započinje u bolesnika koji uzimaju jake inhibitore CYP3A, u prvom tjednu liječenja dozu treba smanjiti na jednu tabletu dnevno (100 mg lumakaftora/125 mg ivakaftora za bolesnike u dobi od 6 do 11 godina i 200 mg lumakaftora/125 mg ivakaftora za bolesnike u dobi od 12 i više godina) uzimajući u obzir indukcijski učinak lumakaftora u stanju dinamičke ravnoteže.
English: The dose of lumacaftor/ivacaftor should be reduced to one sachet daily for the first week of treatment when initiating lumacaftor/ivacaftor in patients currently taking clarithromycin or telithromycin.
Croatian: Dozu lumakaftora/ivakaftora treba smanjiti na jednu vrećicu dnevno u prvom tjednu liječenja kada se započinje s primjenom lumakaftora/ivakaftora u bolesnika koji već uzimaju klaritromicin ili telitromicin.
English: Lumacaftor/ivacaftor may alter the exposure of digoxin.
Croatian: Lumakaftor/ivakaftor može promijeniti izloženost digoksinu.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING WALLET FOR SACHET
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU OVITAK ZA VREĆICU
English: Lumacaftor/ivacaftor may alter the exposure of dabigatran.
Croatian: Lumakaftor/ivakaftor može promijeniti izloženost dabigatranu.
English: Trials in patients with CF aged 12 years and above who are homozygous for the F508del mutation in the CFTR gene
Croatian: Ispitivanja u bolesnika s cističnom fibrozom u dobi od 12 i više godina koji su homozigoti za mutaciju F508del gena CFTR
English: Lumacaftor/ivacaftor may decrease the exposure of montelukast, which may reduce its efficacy.
Croatian: Lumakaftor/ivakaftor može smanjiti izloženost montelukastu, što može oslabiti njegovu djelotvornost.
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.
Croatian: Cystic Fibrosis Questionnaire - Revised) u odnosu na početni, udio bolesnika koji je postigao relativnu promjenu od ≥ 5% u odnosu na početnu u ppFEV1 u 24. tjednu i broj plućnih egzacerbacija (uključujući one kojima je bila potrebna hospitalizacija ili i.v. terapija antibioticima) do 24. tjedna.
English: Relative change from baseline ppFEV1 (%) Extension Week 72
Croatian: Relativna promjena ppFEV1 (%) u odnosu na početnu vrijednost Nastavak, 72. tjedan
English: • Ear pain, ear discomfort*
Croatian: • bol u uhu, nelagoda u uhu*
English: fexofenadine
Croatian: feksofenadin
English: Two lumacaftor 200 mg/ivacaftor 125 mg tablets every 12 hours lumacaftor 800 mg/ ivacaftor 500 mg
Croatian: 12 i više godina dvije tablete lumakaftor 200 mg/ ivakaftor 125 mg svakih 12 sati lumakaftor 800 mg/ ivakaftor 500 mg
English: Clinical comment erythromycin
Croatian: Klinička napomena feksofenadin
English: Inducers of CYP3A
Croatian: Induktori CYP3A
English: ketoconazole, voriconazole Due to induction of CYP3A by LUM
Croatian: ↓ itrakonazol, ketokonazol, vorikonazol zbog indukcije CYP3A lumakaftorom
English: Orkambi 100 mg/125 mg film-coated tablets 3 years
Croatian: Orkambi 100 mg/125 mg filmom obložene tablete 3 godine
English: Each sachet contains 100 mg of lumacaftor and 125 mg of ivacaftor.
Croatian: Jedna vrećica sadrži 100 mg lumakaftora i 125 mg ivakaftora.
English: • Nipple changes or pain*
Croatian: • promjene na bradavicama ili bolnost bradavica*.