FrancophonIA/ELRC3.0 huggingface dataset:
English: Repeat-dose toxicity studies involving the co-administration of lumacaftor and ivacaftor revealed no special hazard for humans in terms of potential for additive and/or synergistic toxicities.
Croatian: Ispitivanja toksičnosti ponovljene doze koja su uključivala istodobnu primjenu lumakaftora i ivakaftora nisu otkrila posebnu opasnost za ljude u smislu moguće aditivne i/ili sinergističke toksičnosti.
English: In order to evaluate off drug effects, patients had a safety follow-up visit following a 2-week washout period.
Croatian: Da bi se procijenili učinci prestanka uzimanja lijeka, bolesnici su imali kontrolni pregled u sklopu praćenja sigurnosti nakon 2-tjednog razdoblja ispiranja lijeka iz organizma.
English: The exposure (AUC) of lumacaftor is approximately 2-fold higher in healthy adult volunteers compared to exposure in patients with CF.
Croatian: Izloženost (AUC) lumakaftoru približno je 2 puta viša u zdravih odraslih dobrovoljaca u usporedbi s izloženošću u bolesnika s cističnom fibrozom.
English: Tell your child's doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
Croatian: Obavijestite djetetovog liječnika ili ljekarnika ako Vaše dijete uzima, nedavno je uzelo ili bi moglo uzeti bilo koje druge lijekove.
English: A fat-containing meal or snack should be consumed just before or just after dosing (see section 5.2).
Croatian: Obrok ili međuobrok koji sadrži masti treba konzumirati neposredno prije ili odmah poslije primjene doze (vidjeti dio 5.2).
English: If possible, have your child's medicine and this leaflet with you.
Croatian: Ako je moguće, imajte uz sebe djetetov lijek i ovu uputu.
English: Respiratory events such as shortness of breath or chest tightness were seen in patients when starting Orkambi, especially in patients who have poor lung function.
Croatian: Respiratorni događaji, kao što su nedostatak zraka ili stezanje u prsnom košu, opaženi su u bolesnika kada su počeli uzimati Orkambi, a osobito u bolesnika sa slabom plućnom funkcijom.
English: People with the mutation will produce an abnormal CFTR protein.
Croatian: U osoba s ovom mutacijom stvara se abnormalni protein CFTR.
English: An alternative to erythromycin, such as azithromycin, should be considered.
Croatian: Potrebno je razmotriti zamjenu za eritromicin, kao što je azitromicin.
English: Mean improvement in ppFEV1 was rapid in onset (Day 15) and sustained throughout the 24-week treatment period.
Croatian: Srednja vrijednost poboljšanja vrijednosti ppFEV1 nastupila je brzo (15. dan) i zadržala se tijekom 24-tjednog razdoblja liječenja.
English: Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
Croatian: Ovojnica poli(vinilni alkohol) titanijev dioksid (E171) makrogol 3350
English: Ivacaftor is not an inhibitor of OAT1 and OAT3.
Croatian: Ivakaftor nije inhibitor prijenosnika OAT1 i OAT3.
English: Therefore, concomitant use of lumacaftor/ivacaftor may alter (i.e., either increase or decrease) the exposure of CYP2C8 and CYP2C9 substrates, decrease the exposure of CYP2C19 substrates, and substantially decrease the exposure of CYP2B6 substrates.
Croatian: Stoga istodobna primjena lumakaftora/ivakaftora može promijeniti (tj. ili povećati ili smanjiti) izloženost supstratima CYP2C8 i CYP2C9, smanjiti izloženost supstratima CYP2C19 i znatno smanjiti izloženost supstratima CYP2B6.
English: Note: ↑ = increase, ↓ = decrease, ↔ = no change; LUM = lumacaftor; IVA = ivacaftor.
Croatian: Napomena: ↑ = povećanje, ↓ = smanjenje, ↔ = bez promjene; LUM = lumakaftor; IVA = ivakaftor.
English: Because an association with liver injury cannot be excluded, assessments of liver function tests (ALT, AST and bilirubin) are recommended before initiating lumacaftor/ivacaftor, every 3 months during the first year of treatment, and annually thereafter.
Croatian: Budući da se povezanost s oštećenjem jetre ne može isključiti, prije nego što se započne liječenje lumakaftorom/ivakaftorom preporučuju se procjene testova jetrene funkcije (ALT, AST i bilirubin), i to svaka 3 mjeseca tijekom prve godine liječenja, a nakon toga jednom godišnje.
English: 14 sachets
Croatian: 14 vrećica
English: You may experience side effects, including those mentioned in section 4 below.
Croatian: Mogu Vam se javiti nuspojave, uključujući one spomenute niže u dijelu 4.
English: Do not chew, break, or dissolve the tablets.
Croatian: Nemojte žvakati, lomiti ni otapati tablete.
English: The small amount of F508del-CFTR that reaches the cell surface has low channel-open probability (defective channel gating).
Croatian: F508del-CFTR-a koja dospije na površinu stanice ima malu vjerojatnost otvaranja kanala (nepravilna regulacija kanala).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 November 2015
Croatian: Datum prvog odobrenja: 19. studenoga 2015.
English: Talk to your doctor or pharmacist before taking Orkambi.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Orkambi.
English: Majority of patients discontinued for reasons other than safety.
Croatian: U većine bolesnika razlog prekida nije bila sigurnost primjene.
English: If the patient's genotype is unknown, an accurate and validated genotyping method should be performed to confirm the presence of the F508del mutation on both alleles of the CFTR gene.
Croatian: Ako genotip bolesnika nije poznat, mora se napraviti genotipizaciju pomoću točne i validirane metode kako bi se potvrdilo postojanje mutacije F508del na oba alela gena CFTR.
English: The post-dose decline was resolved by Week 16.
Croatian: To smanjenje koje je nastajalo nakon primjene doze povuklo se do 16. tjedna.
English: For patients with moderate hepatic impairment (Child-Pugh Class B), a dose reduction is recommended.
Croatian: Bolesnicima s umjerenim oštećenjem funkcije jetre (Child-Pugh stadij B) preporučuje se smanjenje doze.
English: Patients took the study drug with fat-containing food for 24 weeks in addition to their prescribed CF therapies (e.g., bronchodilators, inhaled antibiotics, dornase alfa, and hypertonic saline).
Croatian: Bolesnici su uzimali ispitivani lijek s hranom koja sadrži masti kroz 24 tjedna, uz svoje propisane terapije za cističnu fibrozu (npr. bronhodilatatore, inhalacijske antibiotike, alfa dornazu i hipertoničnu otopinu natrijevog klorida).
English: Established and other potentially significant drug interactions Table 3 provides the established or predicted effect of lumacaftor/ivacaftor on other medicinal products or the effect of other medicinal products on lumacaftor/ivacaftor.
Croatian: Ustanovljene i druge potencijalno značajne interakcije lijekova Tablica 3 prikazuje ustanovljen ili predviđen učinak lumakaftora/ivakaftora na druge lijekove ili učinak drugih lijekova na lumakaftor/ivakaftor.
English: The effect of gender on lumacaftor pharmacokinetics was evaluated using a population pharmacokinetics analysis of data from clinical studies of lumacaftor given in combination with ivacaftor.
Croatian: Učinak spola na farmakokinetiku lumakaftora procijenjen je na temelju populacijske farmakokinetičke analize podataka dobivenih iz kliničkih ispitivanja lumakaftora kada je primjenjivan u kombinaciji s ivakaftorom.
English: Lumacaftor/ivacaftor should be used with caution in patients with advanced liver disease and only if the benefits are expected to outweigh the risks.
Croatian: Lumakaftor/ivakaftor se mora primjenjivati oprezno u bolesnika s uznapredovalom bolešću jetre, te samo ako se očekuje da će koristi primjene biti veće od rizika.
English: Animal studies with lumacaftor and ivacaftor do not indicate direct or indirect harmful effects with respect to developmental and reproductive toxicity, whereas effects were noted with ivacaftor only at maternally toxic doses (see section 5.3).
Croatian: Ispitivanja lumakaftora i ivakaftora na životinjama ne ukazuju na izravne ili neizravne štetne učinke s obzirom na razvojnu i reproduktivnu toksičnost, dok su učinci zabilježeni samo za ivakaftor kod doza toksičnih za majku (vidjeti dio 5.3).
English: Pooled (Trial 1 and Trial 2)
Croatian: Objedinjeno (ispitivanja 1 i 2)
English: Final Report: December 2025
Croatian: Konačno izvješće u prosincu 2025.
English: Examples of meals or snacks that contain fat are those prepared with butter or oils or those containing eggs.
Croatian: Primjeri obroka ili međuobroka koji sadrže masti jesu oni pripremljeni s maslacem ili uljem ili oni koji sadrže jaja.
English: • Anticoagulants (used to prevent blood clots from forming or growing larger in blood and blood vessels) for example: warfarin, dabigatran
Croatian: • antikoagulansi (primjenjuju se za sprječavanje stvaranja i povećavanja krvnih ugrušaka u krvi i krvnim žilama), primjerice: varfarin, dabigatran
English: Anti-inflammatories: ibuprofen
Croatian: Protuupalni lijekovi: ibuprofen
English: Check your child has been given the right dose (below).
Croatian: Provjerite uzima li Vaše dijete odgovarajuću dozu (niže).
English: Description of selected adverse reactions for patients aged 6 to 11 years Hepatobiliary events
Croatian: Opis odabranih nuspojava za bolesnike u dobi od 6 do 11 godina Hepatobilijarni događaji
English: A fat-containing meal or snack should be consumed just before or just after taking Orkambi.
Croatian: Obrok ili međuobrok koji sadrži masti treba konzumirati neposredno prije ili odmah poslije primjene lijeka Orkambi.
English: The safety and efficacy of Orkambi in children aged less than 2 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Orkambi u djece mlađe od 2 godine nisu još ustanovljene.
English: Ivacaftor, which is one of the active components of Orkambi, has a minor influence on the ability to drive or use machines.
Croatian: Ivakaftor koji je jedna od djelatnih tvari lijeka Orkambi, ima manji utjecaj na sposobnost upravljanja vozilima ili strojevima.
English: Other forms of this medicine (granules in a sachet) are more suitable for children under 6 years of age, ask your doctor or pharmacist.
Croatian: Za djecu mlađu od 6 godina pogodniji su drugi oblici ovog lijeka (granule u vrećici); upitajte liječnika ili ljekarnika.
English: Abnormality of the lens of the eye (cataract) without any effect on vision has been noted in some children and adolescents treated with Orkambi and ivacaftor alone (one of the components of Orkambi).
Croatian: Poremećaj očnih leća (katarakta) bez ikakvog utjecaja na vid, opažen je u neke djece i adolescenata liječenih lijekom Orkambi i samo ivakaftorom (jednom od komponenti lijeka Orkambi).
English: In the event of significant elevation of ALT or AST, with or without elevated bilirubin (either ALT or AST > 5 x the upper limit of normal [ULN], or ALT or AST > 3 x ULN with bilirubin > 2 x ULN), dosing with lumacaftor/ivacaftor should be discontinued and laboratory tests closely followed until the abnormalities resolve.
Croatian: U slučaju značajnih povišenja ALT-a ili AST-a, bez obzira na to je li bilirubin povišen ili ne (ili ALT ili AST > 5 x iznad gornje granice normale [GGN], ili ALT ili AST > 3 x GGN s bilirubinom > 2 x GGN), primjenu lumakaftora/ivakaftora potrebno je prekinuti, a laboratorijske testove pažljivo pratiti sve dok se poremećene vrijednosti ne riješe.
English: The recommended dose for patients aged 6 years and over is two tablets in the morning, and two tablets in the evening (12 hours apart).
Croatian: Preporučena doza za bolesnike u dobi od 6 i više godina iznosi dvije tablete ujutro i dvije tablete navečer (s razmakom od 12 sati).
English: Respiratory events (e.g., chest discomfort, dyspnoea, and respiration abnormal) were more common during initiation of lumacaftor/ivacaftor therapy.
Croatian: Respiratorni događaji (npr. nelagoda u prsištu, dispneja i poremećeno disanje) bili su češći za vrijeme započinjanja terapije lumakaftorom/ivakaftorom.
English: Lumacaftor and ivacaftor are not inhibitors of OATP1B1, OATP1B3, and organic cation transporter (OCT) 1 and 2.
Croatian: Lumakaftor i ivakaftor nisu inhibitori prijenosnika OATP1B1, OATP1B3 i prijenosnika organskih kationa (engl. organic cation transporter - OCT) 1 i 2.
English: Therefore, concomitant use of lumacaftor/ivacaftor with P-gp substrates (e.g., digoxin) may alter the exposure of these substrates.
Croatian: Stoga istodobna primjena lumakaftora/ivakaftora sa supstratima P-gp-a (npr. digoksin) može promijeniti izloženost ovim supstratima.
English: Use all 7 days' doses before starting a new wallet.
Croatian: Kroz usta Ujutro Navečer Primijenite doze za svih 7 dana prije nego što načnete novi ovitak.
English: Following oral administration of lumacaftor, the majority of lumacaftor (51%) is excreted unchanged in the faeces.
Croatian: Nakon peroralne primjene, veći dio lumakaftora (51%) eliminira se stolicom u nepromijenjenom obliku.
English: Ivacaftor is approximately 99% bound to plasma proteins, primarily to alpha 1-acid glycoprotein and albumin.
Croatian: Približno 99% ivakaftora vezano je za proteine plazme, prvenstveno za alfa 1-kiseli glikoprotein i albumin.
English: Blood creatine phosphokinase increased uncommon Blood pressure increased
Croatian: često povišena kreatin fosfokinaza u krvi manje često povišen krvni tlak
English: Orkambi should only be prescribed by physicians with experience in the treatment of CF.
Croatian: Orkambi smiju propisivati samo liječnici s iskustvom u liječenju cistične fibroze.
English: Antibiotics: clarithromycin, telithromycin
Croatian: Antibiotici: klaritromicin,
English: The CFTR protein is a chloride channel present at the surface of epithelial cells in multiple organs.
Croatian: Protein CFTR je kloridni kanal prisutan na površini epitelnih stanica mnogih organa.
English: The safety and efficacy of lumacaftor/ivacaftor in patients age 65 years or older have not been evaluated.
Croatian: Sigurnost i djelotvornost lumakaftora/ivakaftora u bolesnika u dobi od 65 i više godina nisu procijenjene.
English: Concomitant medicinal products of most clinical relevance Anti-allergics: montelukast
Croatian: Lijekovi od najvećeg kliničkog značaja koji se primjenjuju istodobno Antialergici: montelukast
English: The incidence of these events was more common in patients with lower pre-treatment FEV1.
Croatian: Incidencija ovih događaja bila je češća u bolesnika s nižom vrijednošću FEV1 prije liječenja.
English: Following oral administration of ivacaftor alone, the majority of ivacaftor (87.8%) is eliminated in the faeces after metabolic conversion.
Croatian: Nakon peroralne primjene samo ivakaftora, većina ivakaftora (87,8%) eliminira se stolicom poslije metaboličke konverzije.
English: Table 3: Established and other potentially significant drug interactions - dose recommendations for use of lumacaftor/ivacaftor with other medicinal products
Croatian: Tablica 3: Ustanovljene i druge potencijalno značajne interakcije lijekova - preporuke doza kad se lumakaftor/ivakaftor primjenjuje s drugim lijekovima
English: Interaction with CYP2B6 and CYP2C substrates has not been investigated in vivo.
Croatian: Interakcija sa supstratima CYP2B6 i CYP2C nije ispitana in vivo.
English: Co-administration of Orkambi with medicinal products that inhibit BCRP may increase plasma lumacaftor concentration.
Croatian: Istodobna primjena lijeka Orkambi s lijekovima koji inhibiraju BCRP može povećati koncentraciju lumakaftora u plazmi.
English: * In each study, a hierarchical testing procedure was performed within each active treatment arm for primary and secondary endpoints vs. placebo; at each step, P ≤ 0.0250 and all previous tests also meeting this level of significance was required for statistical significance.
Croatian: *U svakom ispitivanju, unutar svake aktivne terapijske skupine proveden je postupak hijerarhijskog testiranja za primarne i sekundarne mjere ishoda naspram placebu; za statističku značajnost u svakom je koraku trebalo postići vrijednost P ≤ 0,0250, a svi prethodni testovi morali su ispunjavati tu razinu značajnosti.
English: The majority of events were mild or moderate in severity, non-serious and did not result in treatment discontinuation (see section 4.4).
Croatian: Događaji su većinom bili blage do umjerene težine, nisu bili ozbiljni i nisu za posljedicu imali prekid liječenja (vidjeti dio 4.4).
English: Infections and infestations very common Nasopharyngitis* common
Croatian: Infekcije i infestacije vrlo često nazofaringitis*
English: No patients had total bilirubin levels > 2 x ULN.
Croatian: Nijedan bolesnik nije imao razine ukupnog bilirubina > 2 x GGN.
English: H2 blockers: ranitidine
Croatian: H2 blokatori:
English: Orkambi contains two active substances, lumacaftor and ivacaftor.
Croatian: Orkambi sadrži dvije djelatne tvari, lumakaftor i ivakaftor.
English: 2 to 5 years and weighing less than 14 kg
Croatian: 2-5 godina i tjelesne težine manje od 14 kg
English: Patients received either lumacaftor/ivacaftor (n = 62) or placebo (n = 63) in addition to their prescribed CF therapies.
Croatian: Bolesnici su primali lumakaftor/ivakaftor (n = 62) ili placebo (n = 63) osim svoje propisane terapije za cističnu fibrozu.
English: In vitro studies indicated that lumacaftor has the potential to both inhibit and induce P-gp.
Croatian: In vitro ispitivanja pokazala su da lumakaftor ima sposobnost i inhibirati i inducirati P-gp.
English: Lumacaftor inhibits the organic anion transporter (OAT) 1 and 3.
Croatian: Lumakaftor inhibira prijenosnik organskih aniona (engl. organic anion transporter - OAT) 1 i 3.
English: The event rate per year, annualised to 48 weeks, was 0.70 in the lumacaftor/ivacaftor group and 1.14 in the placebo group.
Croatian: Stopa događaja na godinu, iskazana na godišnjoj razini kao 48 tjedana, bila je 0,70 u skupini koja je primala lumakaftor/ivakaftor, a 1,14 u skupini koja je primala placebo.
English: Orkambi should be taken with fat-containing food.
Croatian: Orkambi treba uzimati s hranom koja sadrži masti.
English: Description of selected adverse reactions for paediatric patients aged 2 to 11 years Hepatobiliary events
Croatian: Opis odabranih nuspojava za pedijatrijske bolesnike u dobi od 2 do 11 godina Hepatobilijarni događaji
English: Number of pulmonary exacerbations through Week 24
Croatian: Broj plućnih egzacerbacija do 24. tjedna
English: If you stop giving your child Orkambi
Croatian: Ako prestanete djetetu davati Orkambi
English: Effects in repeated dose studies were observed only at exposures considered sufficiently in excess (> 25-, > 45-, and > 35-fold for mice, rats, and dogs, respectively) of the maximum human exposure of ivacaftor when administered as Orkambi, indicating little relevance to clinical use.
Croatian: U ispitivanjima ponovljene doze učinci su opaženi samo pri izloženostima koje su se smatrale dovoljno većima (> 25 puta za miševe, > 45 puta za štakore i > 35 puta za pse) od najveće izloženosti u ljudi za ivakaftor kada se primjenjuje kao Orkambi, što ukazuje na njihov mali značaj za kliničku primjenu.
English: If you experience dizziness, you should not drive or use machines until these symptoms disappear.
Croatian: Ako osjetite omaglicu, ne upravljajte vozilima i strojevima dok ti simptomi traju.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of lumacaftor/ivacaftor in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni lumakaftora/ivakaftora u trudnica ograničeni (manje od 300 trudnoća).
English: Available pharmacokinetic data in animals have shown excretion of both lumacaftor and ivacaftor into the milk of lactating female rats.
Croatian: Dostupni farmakokinetički podaci u životinja pokazali su da se i lumakaftor i ivakaftor izlučuju u mlijeko ženke štakora u laktaciji.
English: Absolute change from baseline in faecal elastase-1 (FE-1) levels (µg/g)**
Croatian: Apsolutna promjena od početne vrijednosti razine fekalne elastaze-1 (FE-1) (µg/g)
English: Transaminase elevations have been observed more frequently in paediatric patients than in adult patients (see section 4.8).
Croatian: Povišenje transaminaza češće je bilo opaženo u pedijatrijskih bolesnika nego u odraslih bolesnika (vidjeti dio 4.8).
English: Seven patients who received lumacaftor/ivacaftor had liver-related serious adverse events with elevated transaminases, including 3 with concurrent elevation in total bilirubin.
Croatian: Sedam bolesnika koji su primali lumakaftor/ivakaftor imali su s jetrom povezane ozbiljne štetne događaje s povišenim transaminazama, uključujući 3 s istodobnim povišenjem ukupnog bilirubina.
English: CYP2B6 and CYP2C substrates
Croatian: Supstrati CYP2B6 i CYP2C
English: • Contraceptive medicines (used for the prevention of pregnancy): oral, injectable, and implantable contraceptives as well as contraceptive skin patches; that may include ethinyl estradiol, norethindrone, and other progestogens.
Croatian: • kontracepcijski lijekovi (primjenjuju se za sprječavanje trudnoće), primjerice: oralni, injekcijski i implantati te kontracepcijski flasteri za kožu; oni mogu sadržavati etinilestradiol, noretindron i druge progestogene.
English: Once mixed, the product has been shown to be stable for one hour, and therefore should be ingested during this period.
Croatian: Pokazalo se da je lijek nakon miješanja s hranom ili tekućinom stabilan jedan sat i stoga mješavinu treba uzeti u tom roku.
English: Therefore, Orkambi should not be used in children under the age of 2 years.
Croatian: Stoga se Orkambi ne smije primjenjivati u djece mlađe od 2 godine.
English: • Moderate liver problems: the dose may be reduced to two tablets in the morning and one tablet in the evening.
Croatian: • Umjerene jetrene tegobe: doza se može smanjiti na dvije tablete ujutro i jednu tabletu navečer.
English: Transaminase elevations have been observed more frequently in paediatric patients than in adult patients.
Croatian: Povišenje transaminaza češće je bilo opaženo u pedijatrijskih bolesnika nego u odraslih bolesnika.
English: At Week 24, 16% of children had a reduction in sweat chloride below 60 mmol/L, and none below 30 mmol/L.
Croatian: U 24. tjednu, koncentracija klorida u znoju snizila se na vrijednosti ispod 60 mmol/L u 16% djece, ali ni u jednog djeteta nije bila niža od 30 mmol/L.
English: Following discontinuation of lumacaftor/ivacaftor, liver function tests returned to baseline or improved substantially in all patients (see section 4.4).
Croatian: Nakon prekida primjene lumakaftora/ivakaftora, testovi jetrene funkcije vratili su se na početne vrijednosti ili su se bitno poboljšali u svih bolesnika (vidjeti dio 4.4).
English: Findings of cataracts were observed in juvenile rats dosed with ivacaftor at 0.32 times the maximum recommended human dose based on systemic exposure of ivacaftor and its metabolites when co-administered with lumacaftor as Orkambi.
Croatian: Nalazi katarakte opaženi su u mladih štakora koji su primali ivakaftor u dozi 0,32 puta većoj od najveće preporučene doze u ljudi na temelju sistemske izloženosti ivakaftoru i njegovim metabolitima, kada se primjenjivao s lumakaftorom kao Orkambi.
English: If you forget to take Orkambi
Croatian: Ako ste zaboravili uzeti Orkambi
English: Additionally, in vitro studies suggest that ivacaftor may inhibit CYP2C9.
Croatian: Osim toga, in vitro ispitivanja ukazuju na to da ivakaftor može inhibirati CYP2C9.
English: Co-administration of Orkambi with medicinal products that are substrates for OAT1/3 and BCRP transport may increase plasma concentrations of such medicinal products.
Croatian: Istodobna primjena lijeka Orkambi s lijekovima koji su supstrati za prijenos putem OAT1/3 i BCRP-a može povisiti koncentracije tih lijekova u plazmi.
English: However, no ivacaftor-induced QT prolongation was observed in a dog telemetry study at single doses up to 60 mg/kg or in ECG measurements from repeat-dose studies of up to 1 year duration at the 60 mg/kg/day dose level in dogs (Cmax after 365 days = 36.2 to 47.6 μM).
Croatian: Međutim, u telemetrijskom ispitivanju u pasa nije opaženo da je ivakaftor izazvao produženje QT intervala kod primjene jednokratnih doza do 60 mg/kg ili u mjerenjima EKG-a u ispitivanjima ponovljene doze u pasa u trajanju do 1 godine pri razini doze od 60 mg/kg na dan (Cmax nakon 365 dana = 36,2 do 47,6 μM).