FrancophonIA/ELRC3.0 huggingface dataset:
English: Approximately three-quarters of the events began during the first week of treatment, and in most patients the events resolved without dosing interruption.
Croatian: Približno tri četvrtine događaja počelo je u prvom tjednu liječenja, a u većine bolesnika ti su događaji nestali bez prekida primjene doze.
English: No dose adjustment for montelukast is recommended.
Croatian: Ne preporučuje se prilagodba doze za montelukast.
English: Other medicines and Orkambi
Croatian: Drugi lijekovi i Orkambi
English: • Increase of an enzyme in your blood (blood creatine phosphokinase)
Croatian: • povišenje jednog enzima u krvi (kreatin fosfokinaze u krvi)
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
English: However, increased liver enzymes in the blood have been seen more frequently in younger children than in adults.
Croatian: Međutim, povišene vrijednost enzima jetre u krvi češće su opažene u mlađe djece nego u odraslih.
English: Extension Week 96
Croatian: Nastavak, 96. tjedan
English: It may be better to avoid using Orkambi during pregnancy, if possible, and your doctor will help you decide what is best for you and your child.
Croatian: Možda je bolje da izbjegavate primjenu lijeka Orkambi za vrijeme trudnoće, ako je moguće, a liječnik će Vam pomoći da odlučite što je najbolje za
English: In some instances, these elevations have been associated with concomitant elevations in total serum bilirubin.
Croatian: U nekim slučajevima ta su povišenja povezana s istodobnim povišenjima ukupnog bilirubina u serumu.
English: If more than 6 hours have passed, the patient should be instructed to wait until the next scheduled dose.
Croatian: Ako je prošlo više od 6 sati, bolesniku se mora savjetovati da pričeka do sljedeće planirane doze.
English: • Ringing in the ears*
Croatian: • zvonjava u ušima*
English: Contents of the pack and other information What Orkambi contains
Croatian: Sadržaj pakiranja i druge informacije Što Orkambi sadrži
English: † From Trials 1, 2 and 3.
Croatian: † Iz ispitivanja 1, 2 i 3.
English: Following this period, the recommended daily dose should be continued (see section 4.5).
Croatian: Poslije tog razdoblja treba nastaviti s preporučenom dnevnom dozom (vidjeti dio 4.5).
English: Make sure that the mixture is consumed immediately and completely.
Croatian: Pazite da lijek uzme odmah i u cijelosti.
English: The Applicant should submit yearly analyses from December 2017 to 2020 and the final CSR by December 2021.
Croatian: Podnositelj mora podnositi godišnje analize od prosinca 2017. do 2020. godine, a konačno izvješće kliničkog ispitivanja do prosinca 2021. godine.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Orkambi in one or more subsets of the paediatric population in cystic fibrosis.
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Orkambi u jednoj ili više podskupina pedijatrijske populacije u cističnoj fibrozi.
English: What Orkambi is and what it is used for
Croatian: Što je Orkambi i za što se koristi
English: False Positive Urine Tests for THC
Croatian: Lažno pozitivni rezultati testova urina na THC
English: Although other risk factors were present in some cases (such as corticosteroid use and exposure to radiation), a possible risk attributable to ivacaftor cannot be excluded (see section 5.3).
Croatian: Iako su u nekim slučajevima bili prisutni drugi čimbenici rizika (kao što su primjena kortikosteroida i izloženost zračenju), mogući rizik koji se može pripisati ivakaftoru ne može se isključiti (vidjeti dio 5.3).
English: The safety profile in these paediatric patients is generally consistent with that in adult patients.
Croatian: Sigurnosni profil u tih pedijatrijskih bolesnika uglavnom se podudara s onim u odraslih bolesnika.
English: * Trial included key secondary and other secondary endpoints.
Croatian: * Ispitivanje je obuhvatilo ključne sekundarne i druge sekundarne mjere ishoda.
English: Each sachet is for single use only.
Croatian: Jedna vrećica je samo za jednokratnu uporabu.
English: 2 tablets in the morning 2 tablets in the evening
Croatian: 2 tablete ujutro 2 tablete navečer
English: Sodium laurilsulfate
Croatian: natrijev laurilsulfat
English: Hepatobiliary events
Croatian: Hepatobilijarni događaji
English: Pharmacotherapeutic group: Other respiratory system products; ATC code: R07AX30
Croatian: Farmakoterapijska skupina: drugi lijekovi za respiratorni sustav; ATK oznaka: R07AX30
English: The significance of these findings for humans is unknown.
Croatian: Nije poznat značaj ovih nalaza za ljude.
English: An alternative confirmatory method should be considered to verify results.
Croatian: Potrebno je razmotriti korištenje zamjenske potvrdne metode za provjeru rezultata.
English: Interim Analysis: December 2022
Croatian: Interim analiza: prosinac 2022.
English: Children under 2 years old
Croatian: Djeca mlađa od 2 godine
English: Patients from these trials were eligible to roll over into a blinded extension study.
Croatian: Bolesnici iz tih ispitivanja bili su pogodni za prijelaz u slijepi nastavak ispitivanja.
English: Check you have been given the right tablet (below).
Croatian: Provjerite jeste li dobili prave tablete (niže).
English: • Abnormal periods, including the absence or infrequent menses, or more frequent or heavier menstrual bleeding
Croatian: • poremećene menstruacije, uključujući izostanak ili rijetke menstruacije, ili češće ili obilnije menstrualno krvarenje
English: The clinical relevance of the magnitude of these changes in children 2 to 5 years with cystic fibrosis has not been clearly ascertained in longer-term treatment.
Croatian: Klinička važnost veličine ovih promjena u djece s cističnom fibrozom u dobi od 2 do 5 godina nije jasno potvrđena u dugotrajnijem liječenju.
English: Meals and snacks recommended in CF guidelines or meals recommended in standard nutritional guidelines contain adequate amounts of fat.
Croatian: Obroci i međuobroci preporučeni u smjernicama za osobe s cističnom fibrozom ili obroci koje preporučuju smjernice standardne prehrane sadrže dovoljnu količinu masti.
English: These results were not considered statistically significant within the framework of the testing hierarchy for the individual studies.
Croatian: Ti se rezultati nisu smatrali statistički značajnim unutar hijerarhije testiranja u pojedinačnim ispitivanjima.
English: Examples of other fat-containing foods are:
Croatian: Primjeri druge hrane koja sadrži masti:
English: The recommendations provided under “Clinical comment” in Table 3 are based on drug interaction studies, clinical relevance, or predicted interactions due to elimination pathways.
Croatian: Preporuke navedene pod naslovom "Klinička napomena" u tablici 3 temelje se na ispitivanjima interakcija, kliničkoj važnosti ili očekivanim interakcijama zbog puteva eliminacije.
English: These should not be relied upon as an effective method of birth control when given with Orkambi
Croatian: Na njih se ne smije oslanjati kao na učinkovitu metodu sprječavanja trudnoće kada se primjenjuju uz Orkambi.
English: Specific studies to evaluate the phototoxic potential of lumacaftor were not conducted; however, evaluation of the available non-clinical and clinical data suggests no phototoxic liability.
Croatian: Nisu provedena specifična ispitivanja kojima bi se procijenio fototoksični potencijal lumakaftora; međutim, procjena raspoloživih nekliničkih i kliničkih podataka ne ukazuje da je fototoksičnost vjerojatna.
English: If possible, have your medicine and this leaflet with you.
Croatian: Ako je moguće, imajte uz sebe svoj lijek i ovu uputu.
English: Anticoagulants: dabigatran
Croatian: Antikoagulansi: dabigatran
English: The worsening of liver function can be fatal.
Croatian: Pogoršanje funkcije jetre može dovesti do smrtnog ishoda.
English: Benzodiazepines: midazolam, triazolam ↔ LUM, IVA
Croatian: Benzodiazepini: midazolam, triazolam ↔ LUM, IVA
English: Results from Trial 3 are presented in Figure 1 and Table 6.
Croatian: Rezultati ispitivanja 3 prikazani su na slici 1 i u tablici 6.
English: The granules are supplied in sachets.
Croatian: Granule dolaze u vrećicama.
English: The information reported in Table 3 mostly derives from in vitro studies.
Croatian: Informacije navedene u tablici 3 većinom su dobivene u ispitivanjima in vitro.
English: Swallow the tablets whole.
Croatian: Tablete progutajte cijele.
English: Your child's doctor may request another test to verify results.
Croatian: Djetetov liječnik može zatražiti drugi test radi provjere rezultata.
English: The recommended dose for patients aged 2 years and over is indicated in the table below.
Croatian: Preporučena doza za bolesnike u dobi od 2 i više godina navedena je u tablici niže.
English: • Changes in the type of bacteria in mucus*
Croatian: • promjene u vrstama bakterija u sluzi*
English: 1 sachet every morning and 1 sachet in the evening every other day.
Croatian: 1 vrećica svakog jutra i 1 vrećica navečer svaki drugi dan
English: Patients with advanced liver disease
Croatian: Bolesnici s uznapredovalom bolešću jetre
English: • Cheese, whole milk, whole-milk dairy products
Croatian: • sir, punomasno mlijeko, mliječni proizvodi iz punomasnog mlijeka
English: In lumacaftor/ivacaftor-treated patients, approximately two-thirds of these reactions resolved, and the median duration was 10 days.
Croatian: U bolesnika liječenih lumakaftorom/ivakaftorom, približno dvije trećine tih reakcija nestale su uz medijan trajanja od 10 dana.
English: This extension trial was designed to evaluate the safety and efficacy of long-term treatment of lumacaftor/ivacaftor.
Croatian: Cilj ovog nastavka ispitivanja bio je procijeniti sigurnost i djelotvornost dugotrajnog liječenja lumakaftorom/ivakaftorom.
English: If a child experiences dizziness while taking Orkambi, it is advised that the child does not ride a bike or do anything else that needs their full attention, until their symptoms disappear.
Croatian: Ako dijete osjeti omaglicu za vrijeme uzimanja lijeka Orkambi, savjetuje se da dijete ne vozi bicikl i ne čini ništa što zahtijeva punu pozornost dok se simptomi ne povuku.
English: These menstrual events occurred more frequently in the subset of female patients who were taking hormonal contraceptives (25.0%) versus patients who were not taking hormonal contraceptives (3.5%) (see section 4.5).
Croatian: Ti menstrualni događaji bili su češći u podskupini bolesnica koje su uzimale hormonsku kontracepciju (25,0%) naspram onih koje je nisu uzimale (3,5%) (vidjeti dio 4.5).
English: Age, weight
Croatian: Dob, tjelesna težina
English: Extension Week 72
Croatian: Nastavak, 72. tjedan
English: * Based on clinical drug-drug interaction studies.
Croatian: *Na temelju kliničkih ispitivanja interakcija lijek-lijek.
English: If this is not possible, give it within the hour after mixing.
Croatian: Ako to nije moguće, dajte mu ga u roku od jednog sata nakon što ste ga pomiješali s hranom ili tekućinom.
English: • Inner ear disorder (feeling dizzy or spinning)*
Croatian: • poremećaj unutarnjeg uha (osjećaj omaglice ili vrtoglavica)*
English: Orkambi has to be taken in the morning and in the evening (12 hours apart) with food containing fat.
Croatian: Orkambi se uzima ujutro i navečer (s razmakom od 12 sati), s hranom koja sadrži masti.
English: Giving Orkambi granules to your child:
Croatian: Kako ćete davati Orkambi granule svom djetetu:
English: Always give your child this medicine exactly as your child's doctor has told you.
Croatian: Uvijek djetetu dajte ovaj lijek točno onako kako Vam je rekao djetetov liječnik.
English: For standard dosing recommendations see Table 1.
Croatian: Za standardne preporučene doze, vidjeti tablicu 1.
English: Your doctor may request another test to verify results.
Croatian: Liječnik može zatražiti drugi test radi provjere rezultata.
English: Orkambi tablets should not be used in children under the age of 6 years.
Croatian: Orkambi tablete ne smiju se primjenjivati u djece mlađe od 6 godina.
English: These serious side effects are uncommon (may affect up to 1 in 100 people).
Croatian: Te ozbiljne nuspojave javljaju se manje često (mogu se javiti u do 1 na 100 osoba).
English: Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego što Vaše dijete počne uzimati ovaj lijek jer sadrži Vama važne podatke.
English: If you plan to breast-feed, ask your doctor for advice before taking Orkambi.
Croatian: Ako planirate dojiti, upitajte liječnika za savjet prije nego što uzmete Orkambi.
English: * A total of 82% (421 of 516 eligible patients) completed 72 weeks of this study; 42% completed 96 weeks.
Croatian: *Ukupno 82% (421 od 516 pogodnih bolesnika) završilo je 72 tjedna u ovom ispitivanju; 42% je završilo 96 tjedana.
English: An alternative to these antibiotics, such as azithromycin, should be considered.
Croatian: Potrebno je razmotriti zamjenu za te antibiotike, kao što je azitromicin.
English: If you stop taking Orkambi You should keep taking the medicine as your doctor directs even if you feel well.
Croatian: Ako prestanete uzimati Orkambi Morate nastaviti uzimati lijek kako Vam je rekao liječnik čak i ako se osjećate dobro.
English: The recommended dose
Croatian: Preporučena doza
English: It is not known if Orkambi is safe and effective in children under 2 years of age.
Croatian: Nije poznato je li Orkambi siguran i djelotvoran u djece mlađe od 2 godine.
English: There are different strengths of Orkambi according to a child's age and weight.
Croatian: Postoje različite jačine lijeka Orkambi za djecu ovisno o njihovoj dobi i tjelesnoj težini.
English: Doses above 100 mg/kg/day resulted in survival and lactation indices that were 92% and 98% of control values, respectively, as well as reductions in pup body weights.
Croatian: Doze iznad 100 mg/kg na dan rezultirale su vrijednostima indeksa preživljenja i laktacije koje su iznosile 92% odnosno 98% kontrolnih vrijednosti, kao i smanjenjem tjelesne težine mladunčadi.
English: Effect on blood pressure
Croatian: Učinak na krvni tlak
English: Children under 6 years old
Croatian: Djeca mlađa od 6 godina
English: Oral hypoglycemics: repaglinide
Croatian: Oralni hipoglikemijski lijekovi: repaglinid
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.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala, reproduktivne i razvojne toksičnosti.
English: Your child may experience side effects, including those mentioned in section 4 below.
Croatian: U Vašeg se djeteta mogu javiti nuspojave, uključujući one spomenute niže u dijelu 4.
English: Patients should be instructed to swallow the tablets whole.
Croatian: Bolesnike se mora upozoriti da tablete progutaju cijele.
English: 6 to 11 years
Croatian: 6-11 godina
English: Lumacaftor/ivacaftor dosing was maintained or successfully resumed after interruption in all patients with transaminase elevations, except 1 patient who discontinued treatment permanently.
Croatian: Doziranje lumakaftora/ivakaftora održano je ili uspješno nastavljeno nakon prekida u svih bolesnika s povišenim transaminazama, osim u 1 bolesnika koji je trajno prekinuo liječenje.
English: Serious side effects for Orkambi include raised levels of liver enzymes in the blood, liver injury and worsening of pre-existing severe liver disease.
Croatian: Ozbiljne nuspojave lijeka Orkambi uključuju povišene razine jetrenih enzima u krvi, oštećenje jetre i pogoršanje već prisutne teške bolesti jetre.
English: Effects on sweat chloride
Croatian: Učinci na koncentraciju klorida u znoju
English: Results indicate no clinically relevant difference in pharmacokinetic parameters for lumacaftor or ivacaftor between males and females.
Croatian: Rezultati ne pokazuju klinički važnu razliku u farmakokinetičkim parametrima za lumakaftor ili ivakaftor između muškaraca i žena.
English: Usual dose: Take 2 tablets whole every 12 hours (morning and evening) with fat-containing food.
Croatian: Uobičajena doza: Uzimajte po 2 tablete (cijele) svakih 12 sati (ujutro i navečer) s hranom koja sadrži masti.
English: *** The event rate per patient-year was annualised to 48 weeks.
Croatian: *** Stopa događaja po bolesnik-godini na godišnjoj razini bila je iskazana na temelju 48 tjedana.
English: • Tear or cut sachet open along the line.
Croatian: • Poderite ili razrežite vrećicu duž oznake za otvaranje.
English: Patients should not chew, break, or dissolve the tablets.
Croatian: Bolesnici ne smiju žvakati, lomiti ili otapati tablete.
English: The potential relevance of these findings in humans is unknown.
Croatian: Nije poznata moguća važnost ovih nalaza za ljude.
English: In both trials, treatment with lumacaftor/ivacaftor resulted in a statistically significant improvement in ppFEV1 (Table 5).
Croatian: U oba ispitivanja liječenje lumakaftorom/ivakaftorom rezultiralo je statistički značajnim poboljšanjem vrijednosti ppFEV1 (tablica 5).
English: 1 sachet per day or less frequently
Croatian: 1 vrećica na dan ili rjeđe
English: OTHER Morning Evening
Croatian: DRUGO Ujutro Navečer
English: The event occurred within 5 days of the start of dosing and resolved following discontinuation of lumacaftor/ivacaftor (see section 4.4).
Croatian: Događaj je nastao unutar 5 dana od početka primjene i nestao je nakon prekida uzimanja lumakaftora/ivakaftora (vidjeti dio 4.4).
English: As a precautionary measure, it is preferable to avoid the use of lumacaftor/ivacaftor during pregnancy unless the clinical condition of the mother requires treatment with lumacaftor/ivacaftor.
Croatian: Kao mjera opreza, poželjno je izbjegavati primjenu lumakaftora/ivakaftora tijekom trudnoće osim ako kliničko stanje majke zahtijeva liječenje lumakaftorom/ivakaftorom.
English: Table 6: Long-term effect of Lumacaftor/Ivacaftor in Trial 3*
Croatian: Tablica 6: Dugoročni učinak lumakaftora/ivakaftora u ispitivanju 3*
English: 4 individual wallets with 14 sachets per wallet
Croatian: 4 pojedinačna ovitka s 14 vrećica po ovitku
English: For patients aged 6 to 11 years
Croatian: Za bolesnike u dobi od 6 do 11 godina
English: In healthy subjects, the half-life of ivacaftor when given with lumacaftor is approximately 9 hours.
Croatian: U zdravih ispitanika poluvijek ivakaftora primijenjenog s lumakaftorom iznosi približno 9 sati.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of genotoxicity and carcinogenic potential.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja genotoksičnosti i kancerogenosti.
English: In vitro studies suggest that lumacaftor has the potential to induce CYP2B6, CYP2C8, CYP2C9, and CYP2C19; however, inhibition of CYP2C8 and CYP2C9 has also been observed in vitro.
Croatian: In vitro ispitivanja ukazuju na to da lumakaftor ima sposobnost inducirati CYP2B6, CYP2C8, CYP2C9 i CYP2C19; međutim, in vitro je opažena i inhibicija CYP2C8 i CYP2C9.
English: Since the exposure of ivacaftor is very significantly reduced when dosed in combination with lumacaftor, lumacaftor/ivacaftor should not be used in these patients.
Croatian: Budući da je izloženost ivakaftoru vrlo značajno smanjena kada se primjenjuje u kombinaciji s lumakaftorom, lumakaftor/ivakaftor se ne smije primjenjivati u tih bolesnika.
English: Side effects in children
Croatian: Nuspojave u djece
English: Serious adverse reactions occurring in at least 0.5% of patients included hepatobiliary events, e.g., transaminase elevations, cholestatic hepatitis and hepatic encephalopathy.
Croatian: Ozbiljne nuspojave koje su se pojavile u najmanje 0,5% bolesnika uključile su hepatobilijarne događaje, npr. povišenja transaminaza, kolestatski hepatitis i hepatičku encefalopatiju.
English: Lumacaftor is not extensively metabolised in humans, with the majority of lumacaftor excreted unchanged in the faeces.
Croatian: Lumakaftor se ne metabolizira opsežno u ljudi, s tim da se većina lumakaftora izluči stolicom u nepromijenjenom obliku.
English: The treatment difference in this subgroup was comparable to that observed in patients with ppFEV1 ≥ 40.
Croatian: Terpijska razlika u ovoj podskupini bila je slična onoj opaženoj u bolesnika s vrijednošću ppFEV1 ≥ 40.
English: Give Orkambi to your child for as long as your child's doctor recommends.
Croatian: Orkambi nastavite davati djetetu onoliko dugo koliko je to preporučio djetetov liječnik.
English: • Cardiac glycosides (used for the treatment of mild to moderate congestive heart failure and an abnormal heart rhythm called atrial fibrillation) for example: digoxin
Croatian: • srčani glikozidi (primjenjuju se za liječenje blagog do umjerenog kongestivnog zatajenja srca i poremećenog srčanog ritma koji se zove fibrilacija atrija), primjerice: digoksin
English: Adverse events that occurred at an increased incidence of ≥ 5% in the supratherapeutic dose period compared with the therapeutic dose period were headache, generalised rash, and increased transaminase.
Croatian: Štetni događaji koji su nastajali povećanom incidencijom od ≥ 5% u razdoblju supraterapijske doze u usporedbi s razdobljem terapijske doze bili su glavobolja, generalizirani osip i povišene transaminaze.
English: ↓ fluconazole Due to induction by LUM; fluconazole is cleared primarily by renal excretion as unchanged drug; however, modest reduction in fluconazole exposure has been observed with strong inducers
Croatian: ↓ flukonazol zbog indukcije lumakaftorom; flukonazol se uklanja prvenstveno izlučivanjem putem bubrega kao neizmijenjeni lijek; međutim, uz primjenu jakih induktora opaženo je umjereno smanjenje izloženosti flukanazolu
English: Blister consisting of PolyChloroTriFluoroEthylene (PCTFE)/PolyVinyl Chloride (PVC) with a paper-backed aluminium foil lidding.
Croatian: Blister koji se sastoji od poliklorotrifluoroetilena (PCTFE) / polivinil klorida (PVC) zatvoren aluminijskom folijom s podlogom od papira.
English: If less than 6 hours have passed since the missed dose, the scheduled dose of Orkambi should be taken with fat-containing food.
Croatian: Ako je od propuštene doze prošlo manje od 6 sati, planiranu dozu lijeka Orkambi treba uzeti s hranom koja sadrži masti.
English: Blood pressure should be monitored periodically in all patients during treatment (see section 4.8).
Croatian: Tijekom liječenja, krvni tlak treba periodički pratiti u svih bolesnika (vidjeti dio 4.8).
English: Table 7: Summary of primary and key secondary outcomes in Trial 7 Placebo (n = 101)
Croatian: Tablica 7: Sažetak primarne i ključnih sekundarnih mjera ishoda u ispitivanju 7 Placebo (n = 101)
English: Lumacaftor is approximately 99% bound to plasma proteins, primarily to albumin.
Croatian: Približno 99% lumakaftora vezano je za proteine plazme, prvenstveno albumin.
English: • if you are allergic to lumacaftor, ivacaftor, or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na lumakaftor, ivakaftor ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Orkambi granules are packaged in a foil laminate [biaxially-oriented polyethylene terephthalate/polyethylene/foil/polyethylene (BOPET/PE/Foil/PE)] sachet.
Croatian: Orkambi granule pakirane su u vrećicu od laminirane folije [biaksijalno orijentirani polietilen tereftalat/polietilen/folija/polietilen (BOPET/PE/folija/PE)].