FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Tijekom ispitivanja 1 i 2, incidencija maksimalnih razina transaminaza (ALT ili AST) > 8, > 5 i > 3 x GGN bila je 0,8%, 2,0% i 5,2% u bolesnika liječenih lumakaftorom/ivakaftorom, odnosno 0,5%, 1,9% i 5,1% u bolesnika liječenih placebom.
English: There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC - an active component in cannabis) in patients receiving Orkambi.
Croatian: U bolesnika koji primaju Orkambi zabilježeni su lažno pozitivni rezultati probirnih testova urina na tetrahidrokanabinol (THC - djelatna tvar u kanabisu).
English: † For patients rolled over from Trials 1 and 2 (lumacaftor/ivacaftor-to-lumacaftor/ivacaftor group) total exposure was up to 120 weeks.
Croatian: † U bolesnika koji su nastavili iz ispitivanja 1 i 2 (skupina koja je primala lumakaftor/ivakaftor i nastavila primati lumakaftor/ivakaftor) ukupna izloženost bila je do 120 tjedana.
English: Menstruation irregular, dysmenorrhoea, metrorrhagia, breast mass* uncommon Menorrhagia, amenorrhoea, polymenorrhoea, breast inflammation*, gynaecomastia*, nipple disorder*, nipple pain*, oligomenorrhoea
Croatian: Poremećaji reproduktivnog sustava i dojki često neredovita menstruacija, dismenoreja, metroragija, kvržica u dojci* manje često menoragija, amenoreja, polimenoreja, upala dojki*, ginekomastija*, poremećaj bradavica*, bol u bradavicama*, oligomenoreja
English: The typical apparent clearance, CL/F (CV), of lumacaftor was estimated to be 2.38 L/hr (29.4%) for patients with CF.
Croatian: U bolesnika s cističnom fibrozom, tipični prividni klirens CL/F (CV) lumakaftora procijenjen je na 2,38 L/h (29,4%).
English: In vitro and in vivo data indicate that ivacaftor is primarily metabolised by CYP3A.
Croatian: Podaci dobiveni in vitro i in vivo pokazuju da se metabolizam ivakaftora prvenstveno odvija putem enzima CYP3A.
English: Gastrointestinal disorders very common Abdominal pain*, abdominal pain upper, diarrhoea, nausea common
Croatian: Poremećaji probavnog sustava vrlo često bol u abdomenu*, bol u gornjem dijelu abdomena, proljev, mučnina često flatulencija, povraćanje
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Vertex Pharmaceuticals (Ireland) Limited
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Vertex Pharmaceuticals (Ireland) Limited
English: After oral administration of lumacaftor 400 mg q12h/ivacaftor 250 mg q12h in a fed state, the steady-state mean (± SD) for AUC0-12h and Cmax were 198 (64.8) µg∙hr/mL and 25.0 (7.96) µg/mL for lumacaftor, respectively, and 3.66 (2.25) µg∙hr/mL and 0.602 (0.304) µg/mL for ivacaftor, respectively.
Croatian: Nakon peroralne primjene lumakaftora 400 mg svakih 12 sati/ivakaftora 250 mg svakih 12 sati u stanju sitosti, srednje vrijednosti (±SD) u stanju dinamičke ravnoteže za AUC0-12h i Cmax bile su 198 (64,8) µg∙h/mL odnosno 25,0 (7,96) µg/mL za lumakaftor, a 3,66 (2,25) µg∙h/mL odnosno 0,602 (0,304) µg/mL za ivakaftor.
English: Taking Orkambi with fat-containing food is important to get the right levels of medicine in the body.
Croatian: Važno je da se Orkambi uzima s hranom koja sadrži masti kako bi se postigle potrebne koncentracije lijeka u tijelu.
English: An increase in blood pressure has been seen in some patients treated with Orkambi.
Croatian: U nekih bolesnika liječenih lijekom Orkambi opaženo je povišenje krvnog tlaka.
English: In patients treated with lumacaftor/ivacaftor (mean baseline 114 mmHg systolic and 69 mmHg diastolic), the maximum increase from baseline in mean systolic and diastolic blood pressure was 3.1 mmHg and 1.8 mmHg, respectively.
Croatian: U bolesnika liječenih lumakaftorom/ivakaftorom (srednja početna vrijednost sistoličkog tlaka bila je 114 mmHg, a dijastoličkog 69 mmHg), maksimalno povećanje srednje vrijednosti sistoličkog tlaka u odnosu na početnu vrijednost iznosilo je 3,1 mmHg, a dijastoličkog 1,8 mmHg.
English: Patients with CF who are heterozygous for the F508del mutation in the CFTR gene Lumacaftor/ivacaftor is not effective in patients with CF who have the F508del mutation on one allele plus a second allele with a mutation predicted to result in a lack of CFTR production or that is not responsive to ivacaftor in vitro (see section 5.1).
Croatian: Bolesnici s cističnom fibrozom koji su heterozigoti za mutaciju F508del gena CFTR Lumakaftor/ivakaftor nije djelotvoran u bolesnika s cističnom fibrozom koji na jednom alelu imaju mutaciju F508del, a na drugom alelu mutaciju za koju se predviđa da će za posljedicu imati nedostatnu proizvodnju CFTR-a ili CFTR koji nije osjetljiv na ivakaftor in vitro (vidjeti dio 5.1).
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.
Croatian: Ključne sekundarne mjere ishoda uključivale su prosječnu apsolutnu promjenu koncentracije klorida u znoju od početka do 15. dana i 4. tjedna te 24. tjedna (vidjeti Farmakodinamički učinci), apsolutnu promjenu indeksa tjelesne mase (ITM) od početka do 24. tjedna, te apsolutnu promjenu rezultata u respiratornoj domeni CFQ-R od početka do 24. tjedna.
English: ↑ or ↓ digoxin Due to potential induction or inhibition of P-gp
Croatian: ↑ ili ↓ digoksin zbog moguće indukcije ili inhibicije P-gp-a
English: Ivacaftor impaired fertility and reproductive performance indices in male and female rats.
Croatian: Ivakaftor je štetno utjecao na indekse plodnosti i reproduktivne sposobnosti u mužjaka i ženki štakora.
English: Therefore, co-administration of lumacaftor/ivacaftor is not recommended with strong CYP3A inducers (see sections 4.2 and 4.4).
Croatian: Stoga se ne preporučuje istodobna primjena lumakaftora/ivakaftora i jakih induktora CYP3A (vidjeti dijelove 4.2 i 4.4).
English: # of events (rate per 48 wks)
Croatian: Broj događaja (stopa u 48 tjedana)
English: No serious respiratory events, dose reductions or discontinuations were seen in patients who were initiated at the half dose (see section 4.4).
Croatian: U bolesnika koji su liječenje započeli polovicom doze nisu opaženi ozbiljni respiratorni događaji, nije bilo sniženja doze ni prekida liječenja (vidjeti dio 4.4).
English: * Adverse reactions and frequencies observed in patients in clinical studies with ivacaftor monotherapy (a component of
Croatian: *Nuspojave i učestalosti opažene u bolesnika iz kliničkih ispitivanja monoterapije ivakaftorom (komponenta lijeka Orkambi).
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]).
Croatian: ≥ 7,5 na početnom probirnom pregledu (srednja vrijednost LCI2.5 na početku 10,28 [raspon: od 6,55 do 16,38]) i ppFEV1 ≥ 70 na probiru (srednja vrijednost ppFEV1 na početku 89,8 [raspon: od 48,6 do 119,6]).
English: • Cough with sputum
Croatian: • kašalj s iskašljajem
English: Therefore, lumacaftor/ivacaftor should be administered with fat-containing food.
Croatian: Stoga se lumakaftor/ivakaftor mora primjenjivati s hranom koja sadrži masti.
English: Percent predicted FEV1 was also evaluated as a clinically meaningful other secondary endpoint.
Croatian: Kao klinički značajna druga sekundarna mjera ishoda procijenjen je i postotak predviđenog FEV1.
English: Brilliant blue FCF aluminium lake (E133) Indigo carmine aluminium lake (E132)
Croatian: talk carmine (E120) brilliant blue FCF aluminium lake (E133)
English: • If you have any further questions, ask your child's doctor or pharmacist.
Croatian: • Ako imate dodatnih pitanja, obratite se djetetovom liječniku ili ljekarniku.
English: Nervous system disorders very common Headache, dizziness* uncommon Hepatic encephalopathy†
Croatian: Krvožilni poremećaji manje često hipertenzija Poremećaji živčanog sustava vrlo često glavobolja, omaglica* manje često hepatička encefalopatija†
English: The international normalised ratio (INR) should be monitored when warfarin co-administration with lumacaftor/ivacaftor is required.
Croatian: Kada je potrebna istodobna primjena varfarina s lumakaftorom/ivakaftorom, mora se nadzirati međunarodni normalizirani omjer (INR).
English: In the pooled analysis, the rate ratio of exacerbations through week 24 in subjects treated with lumacaftor/ivacaftor (lumacaftor 400 mg/ivacaftor 250 mg q12h; n = 369) was 0.61 (P < 0.0001), representing a reduction of 39% relative to placebo.
Croatian: U objedinjenoj analizi, stopa omjera egzacerbacija do 24. tjedna u ispitanika liječenih lumakaftorom/ivakaftorom (lumakaftor 400 mg/ivakaftor 250 mg svakih 12 sati; n = 369) bila je 0,61 (P < 0,0001), što je predstavljalo smanjenje od 39% u odnosu na placebo.
English: ↓ bupropion Due to induction of CYP2B6 by LUM
Croatian: ↓ bupropion zbog indukcije CYP2B6 lumakaftorom
English: Table 8: Mean (SD) lumacaftor and ivacaftor exposure by age group
Croatian: Tablica 8: Srednja vrijednost (SD) izloženosti lumakaftoru i ivakaftoru po dobnoj skupini
English: ↓ carbamazepine, phenobarbital, phenytoin Due to induction of CYP3A by LUM
Croatian: ↓ karbamazepin, fenobarbital, fenitoin zbog indukcije CYP3A lumakaftorom
English: The exposure of ivacaftor is similar between healthy adult volunteers and patients with CF. After twice-daily dosing, steady-state plasma concentrations of lumacaftor and ivacaftor in healthy subjects were generally reached after approximately 7 days of treatment, with an accumulation ratio of approximately 1.9 for lumacaftor.
Croatian: Nakon doziranja dvaput na dan, koncentracije lumakaftora i ivakaftora u plazmi u stanju dinamičke ravnoteže postignute su u zdravih ispitanika u većini slučajeva nakon približno 7 dana liječenja, uz omjer nakupljanja lumakaftora od približno 1,9.
English: ↓ esomeprazole, lansoprazole, omeprazole Due to induction of CYP3A/2C19 by LUM
Croatian: ↓ esomeprazol, lansoprazol, omeprazol zbog indukcije CYP3A/2C19 lumakaftorom
English: • Redness inside the ear*
Croatian: • crvenilo unutrašnjosti uha*
English: During the 24-week, open-label Phase 3 clinical study (Trial 6) in 58 patients aged 6 to 11 years (mean baseline ppFEV1 was 91.4), the incidence of respiratory adverse reactions was 6.9% (4/58).
Croatian: Tijekom 24-tjednog, otvorenog kliničkog ispitivanja faze 3 (ispitivanje 6) u 58 bolesnika u dobi od 6 do 11 godina (srednja vrijednost početnog ppFEV1 bila je 91,4), incidencija respiratornih nuspojava bila je 6,9% (4/58).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1059/001 112 film-coated tablets EU/1/15/1059/002 56 film-coated tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1059/001 112 filmom obloženih tableta EU/1/15/1059/002 56 filmom obloženih tableta
English: Treatment with lumacaftor/ivacaftor resulted in no significant improvement in ppFEV1 relative to placebo in patients with CF heterozygous for the F508del mutation in the CFTR gene (treatment difference 0.60 [P = 0.5978]) and no meaningful improvements in BMI or weight (see section 4.4).
Croatian: Liječenje lumakaftorom/ivakaftorom nije rezultiralo značajnim poboljšanjem vrijednosti ppFEV1 u odnosu na placebo u bolesnika s cističnom fibrozom koji su heterozigoti za mutaciju F508del gena CFTR (terapijska razlika 0,60 [P = 0,5978]) ni značajnim poboljšanjim indeksa tjelesne mase ili težine
English: Trial 3 was a Phase 3, parallel-group, multicentre, rollover extension study in patients with CF that included patients aged 12 years and older from Trial 1 and Trial 2.
Croatian: Ispitivanje 3 bilo je multicentrični nastavak ispitivanja faze III s prijelazom ispitanika (engl. rollover) iz ispitivanja 1 i ispitivanja 2, provedeno na usporednim skupinama bolesnika s cističnom fibrozom u dobi od 12 i više godina.
English: • Sinus congestion*
Croatian: • začepljenost sinusa*
English: Table 9: Mean (SD) lumacaftor and ivacaftor exposure by age group
Croatian: Tablica 9: Srednja vrijednost (SD) izloženosti lumakaftoru i ivakaftoru po dobnoj skupini
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).
Croatian: Terapijska razlika (srednja vrijednost dobivena LS metodom) između liječenja i placeba u prosječnoj apsolutnoj promjeni koncentracije klorida u znoju 15. dana i u 4. tjednu iznosila je -20,8 mmol/L (95% CI: -23,4, -18,2; nominalni P < 0,0001).
English: During a 24-week, open label, Phase 3b clinical study (Trial 5) in 46 patients aged 12 years and older with advanced lung disease (ppFEV1 < 40) [mean ppFEV1 29.1 at baseline (range: 18.3 to 42.0)], the incidence of respiratory events was 65.2%.
Croatian: Tijekom otvorenog kliničkog ispitivanja faze 3b (ispitivanje 5) u trajanju od 24 tjedna, provedenog u 46 bolesnika u dobi od 12 i više godina s uznapredovalom bolesti pluća (ppFEV1 < 40) [srednja vrijednost ppFEV1 bila je na početku 29,1 (raspon: od 18,3 do 42,0)], incidencija respiratornih događaja iznosila je 65,2%.
English: A higher dose of these systemic corticosteroids may be required to obtain the desired clinical effect.
Croatian: Može biti potrebna viša doza ovih sistemskih kortikosteroida da bi se postigao željeni klinički učinak.
English: Pharmacokinetic studies have not been performed with lumacaftor/ivacaftor in patients with renal impairment.
Croatian: Ispitivanja farmakokinetike lumakaftora/ivakaftora nisu provedena u bolesnika s oštećenjem funkcije bubrega.
English: The typical CL/F (CV) of ivacaftor when given in combination with lumacaftor was estimated to be 25.1 L/hr (40.5%) for patients with CF.
Croatian: U bolesnika s cističnom fibrozom, tipični prividni klirens CL/F (CV) ivakaftora primijenjenog u kombinaciji s lumakaftorom procijenjen je na 25,1 L/h (40,5%).
English: Uncommon may affect up to 1 in 100 people:
Croatian: Manje česte - mogu se javiti u do 1 na 100 osoba:
English: Severe hepatic impairment (Child-Pugh Class C)
Croatian: Teško oštećenje funkcije jetre (Child-Pugh stadij C)
English: Patients aged 12 to less than 18 years lumacaftor 400 mg/ivacaftor 250 mg every 12 hours
Croatian: Bolesnici u dobi od 12 do manje od 18 godina lumakaftor 400 mg/ivakaftor 250 mg svakih 12 sati
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.
Croatian: Tijekom 24-tjednih, placebom kontroliranih ispitivanja faze 3, oko 4 do 6 sati nakon doziranja na 1. dan i 15. dan bilo je opaženo maksimalno sniženje srednje vrijednosti frekvencije srca od 6 otkucaja po minuti u odnosu na početnu vrijednost.
English: • Tablet coating: polyvinyl alcohol; titanium dioxide (E171); macrogol 3350; talc; carmine (E120);
Croatian: • ovojnica tablete: poli(vinilni alkohol); titanijev dioksid (E171); makrogol 3350; talk; boja carmine (E120); boja brilliant blue FCF aluminium lake (E133); boja indigo carmine aluminium lake (E132)
English: The primary efficacy endpoint in both studies was the absolute change from baseline in ppFEV1 at Week 24.
Croatian: Primarna mjera ishoda djelotvornosti u oba ispitivanja bila je apsolutna promjena vrijednosti ppFEV1 u 24. tjednu liječenja u odnosu na početnu vrijednost.
English: • Pack containing 28 film-coated tablets.
Croatian: • Pakiranje od 28 filmom obloženih tableta.
English: Primary Endpoint Absolute change in lung clearance index (LCI2.5) from baseline through Week 24
Croatian: Primarna mjera ishoda Apsolutna promjena indeksa klirensa iz pluća (LCI2.5) od početka ispitivanja do 24. tjedna
English: • Hold sachet of granules with cut line on top.
Croatian: • Držite vrećicu s granulama tako da oznaka duž koje se vrećica otvara bude gore.
English: Table 2: Dose adjustment recommendations for patients with hepatic impairment Hepatic impairment Dose adjustment
Croatian: Tablica 2: Preporuke za prilagodbu doze bolesnicima s oštećenjem funkcije jetre Oštećenje funkcije jetre
English: Investigations very common Bacteria in sputum* common
Croatian: Pretrage vrlo često bakterije u iskašljaju*
English: The treatment difference between the combination of lumacaftor 400 mg/ivacaftor 250 mg q12h and placebo evaluated as mean change in sweat chloride from baseline to Day 56 was statistically significant at -11 mmol/L (95% CI: -18, -4).
Croatian: Terapijska razlika između primjene kombinacije lumakaftora 400 mg/ivakaftora 250 mg svakih 12 sati i placeba, procijenjena kao srednja vrijednost promjene u koncentraciji klorida u znoju od početka ispitivanja do 56. dana, bila je statistički značajna na -11 mmol/L (95% CI: -18, -4).
English: The primary efficacy endpoint was absolute change in LCI2.5 from baseline through Week 24.
Croatian: Primarna mjera ishoda djelotvornosti bila je apsolutna promjena LCI2.5 od početka do 24. tjedna.
English: • Tablet core: cellulose, microcrystalline; croscarmellose sodium; hypromellose acetate succinate;
Croatian: • jezgra tablete: celuloza, mikrokristalična; karmelozanatrij, umrežena;
English: • H2 Antagonist medicines (used to reduce stomach acid) for example: ranitidine
Croatian: • antagonisti H2 receptora (primjenjuju se za smanjenje proizvodnje želučane kiseline), primjerice:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON FOR MULTIPACK NO BLUE BOX
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA U VIŠESTRUKOM PAKIRANJU BEZ PLAVOG OKVIRA
English: PHARMACEUTICAL FORM AND CONTENTS 112 film-coated tablets (4 packs of 28 tablets) 56 film-coated tablets (2 packs of 28 tablets)
Croatian: OBLIK I SADRŽAJ 112 filmom obloženih tableta (4 pakiranja po 28 tableta) 56 filmom obloženih tableta (2 pakiranja po 28 tableta)
English: The treatment difference between lumacaftor 400 mg q12h alone and placebo evaluated as mean absolute change in ppFEV1 was -4.6 percentage points (95% CI: -9.6, 0.4) from baseline to Day 28, 4.2 percentage points (95% CI: -1.3, 9.7) from baseline to Day 56, and 7.7 percentage points (95% CI: 2.6, 12.8; statistically significant) from Day 28 to Day 56 (following the addition of ivacaftor to lumacaftor monotherapy).
Croatian: Terapijska razlika između samo lumakaftora u dozi od 400 mg svakih 12 sati i placeba, procijenjena kao srednja vrijednost apsolutne promjene u vrijednosti ppFEV1 iznosila je od početka ispitivanja do 28. dana -4,6 postotnih bodova (95% CI: -9,6, 0,4), od početka ispitivanja do 56. dana 4,2 postotna boda (95% CI: -1,3, 9,7) i od 28. do 56. dana (poslije dodavanja ivakaftora monoterapiji lumakaftorom) 7,7 postotnih bodova (95% CI: 2,6, 12,8; statistički značajno).
English: The exposures are similar between adults and the paediatric population based on population (PK) analyses as presented in Table 9.
Croatian: Na temelju populacijskih (farmakokinetičkih) analiza, izloženost u odraslih i pedijatrijske populacije je slična, kao što je prikazano u tablici 9 niže:
English: Moderate hepatic impairment (Child-Pugh Class B)
Croatian: Umjereno oštećenje funkcije jetre (Child-Pugh stadij B)
English: No dose adjustment of lumacaftor/ivacaftor is recommended when co-administered with fluconazole.
Croatian: Ne preporučuje se prilagodba doze lumakaftora/ivakaftora kada se primjenjuje istodobno s flukonazolom.
English: According to their weight at screening, patients were administered granules mixed with food every 12 hours, at a dose of lumacaftor 100 mg/ivacaftor 125 mg granules for patients weighing less than14 kg (n = 19) or lumacaftor 150 mg/ivacaftor 188 mg for patients weighing 14 kg or greater (n = 41), for 24 weeks in addition to their prescribed CF therapies.
Croatian: Prema tjelesnoj težini na probiru, bolesnicima su davane granule pomiješane s hranom svakih 12 sati tako da su bolesnici tjelesne težine manje od 14 kg (n = 19) dobivali dozu od 100 mg lumakaftora/125 mg ivakaftora, a bolesnici tjelesne težine 14 kg ili veće (n = 41) dozu od 150 mg lumakaftora/188 mg ivakaftora tijekom 24 tjedna uz svoju propisanu terapiju za cističnu fibrozu.
English: No dose adjustment of lumacaftor/ivacaftor is recommended when these antifungals are initiated in patients currently taking lumacaftor/ivacaftor.
Croatian: Ne preporučuje se prilagodba doze lumakaftora/ivakaftora kada se s primjenom tih antimikotika započinje u bolesnika koji već uzimaju lumakaftor/ivakaftor.
English: Orkambi 150 mg/188 mg granules in sachet are white to off-white granules.
Croatian: Orkambi 150 mg/188 mg granule u vrećici bijele su do gotovo bijele granule.
English: Patients experiencing dizziness while taking Orkambi should be advised not to drive or use machines until symptoms abate.
Croatian: Orkambi mora se savjetovati da ne upravljaju vozilima i strojevima dok ti simptomi traju.
English: During the 24-week, open-label Phase 3 clinical study in 60 patients aged 2 through 5 years (Trial 8), the incidence of maximum transaminase (ALT or AST) levels > 8, > 5, and > 3 x ULN was 8.3% (5/60), 11.7% (7/60), and 15.0% (9/60).
Croatian: Tijekom 24-tjednog otvorenog kliničkog ispitivanja faze 3 u 60 bolesnika u dobi od 2 do 5 godina (ispitivanje 8), incidencija maksimalnih razina transaminaza (ALT ili AST) > 8, > 5 i > 3 x GGN bila je 8,3% (5/60), 11,7% (7/60) odnosno 15,0% (9/60).
English: • Proton pump inhibitor medicines (used to treat acid reflux disease and ulcers): omeprazole, esomeprazole, lansoprazole
Croatian: • inhibitori protonske pumpe (primjenjuju se za liječenje refluksne bolesti i vrijeda), primjerice omeprazol, esomeprazol, lansoprazol
English: No dose adjustment of lumacaftor/ivacaftor is recommended when co-administered with erythromycin.
Croatian: Ne preporučuje se prilagodba doze lumakaftora/ivakaftora kada se primjenjuje istodobno s eritromicinom.
English: During the 24-week, placebo-controlled Phase 3 clinical study in 204 patients aged 6 to 11 years (Trial 7), the incidence of maximum transaminase (ALT or AST) levels > 8, > 5, and > 3 x ULN was 1.0%, 4.9%, and 12.6% in the lumacaftor/ivacaftor patients, and 2.0%, 3.0%, and 7.9% in the placebo-treated patients.
Croatian: Tijekom 24-tjednog placebom kontroliranog kliničkog ispitivanja faze 3 u 204 bolesnika u dobi od 6 do 11 godina (ispitivanje 7), incidencija maksimalnih razina transaminaza (ALT ili AST) > 8, > 5 i > 3 x GGN bila je 1,0%, 4,9% odnosno 12,6% u bolesnika liječenih lumakaftorom/ivakaftorom te 2,0%, 3,0% odnosno 7,9% u bolesnika koji su primali placebo.
English: What you need to know before you take Orkambi Do not take Orkambi
Croatian: Što morate znati prije nego počnete uzimati Orkambi
English: Trial 1 evaluated 549 patients with CF who were aged 12 years and older (mean age 25.1 years) with percent predicted FEV1 (ppFEV1) at screening between 40-90 (mean ppFEV1 60.7 at baseline [range: 31.1 to 94.0]).
Croatian: U ispitivanju 1 procijenjeno je 549 bolesnika s cističnom fibrozom u dobi od 12 i više godina (srednja vrijednost dobi 25,1 godina) s postotkom predviđenog FEV1 (ppFEV1) na probiru između 40 i 90 (srednja vrijednost ppFEV1 na početku ispitivanja bila je 60,7 [raspon: od 31,1 do 94,0]).
English: It is unknown if lumacaftor or ivacaftor are found in human milk.
Croatian: Nije poznato izlučuje li se lumakaftor ili ivakaftor u majčino mlijeko.
English: Absolute change in BMI at Week 24 (kg/m
Croatian: Apsolutna promjena indeksa tjelesne mase u 24. tjednu (kg/m2)
English: Orkambi should not be used in patients other than those who have two copies of the F508del mutation in their CFTR gene.
Croatian: Orkambi se ne smije primjenjivati u bolesnika koji u genu CFTR nemaju dvije kopije mutacije
English: Patients aged 6 to 11 years lumacaftor 200 mg/ivacaftor 250 mg every 12 hours
Croatian: Bolesnici u dobi od 6 do 11 godina lumakaftor 200 mg/ivakaftor 250 mg svakih 12 sati
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1059/003 28 film-coated tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1059/003 28 filmom obloženih tableta