FrancophonIA/ELRC3.0 huggingface dataset:
English: Bradycardia with life-threatening consequences, urgent intervention indicated
Croatian: Bradikardija s po život opasnim posljedicama, indicirana hitna intervencija
English: • pain in arms and legs
Croatian: • bol u rukama i nogama
English: The most common sites of extra-thoracic metastasis included 69% brain (of whom 62% had received prior radiation to the brain), 39% bone, and 26% liver.
Croatian: Najčešća mjesta ekstratorakalnih metastaza uključuju 69 % mozak (od kojih je 62 % prethodno imalo zračenje mozga), 39 % kosti i 26 % jetru.
English: The mechanism of micronucleus induction was abnormal chromosome segregation (aneugenicity) and not a clastogenic effect on chromosomes.
Croatian: Mehanizam indukcije mikronukleusa bio je abnormalna segregacija kromosoma (aneugenost), a ne klastogeni učinak na kromosome.
English: Table 4: Efficacy results in ALTA (ITT population) Efficacy parameter
Croatian: Tablica 4: Rezultati djelotvornosti u ispitivanju ALTA (ITT populacija) Parametar djelotvornosti
English: Treatment with Alunbrig is not recommended in persons under 18 years of age.
Croatian: Liječenje lijekom Alunbrig se ne preporučuje u osoba mlađih od 18 godina.
English: Alunbrig may cause visual disturbances, dizziness or tiredness.
Croatian: Alunbrig može uzrokovati smetnje vida, omaglicu ili umor.
English: The median time to onset for CPK elevations was 27 days.
Croatian: Medijan vremena do pojave porasta razine CPK bio je 27 dana.
English: Alunbrig should not be used during pregnancy unless the clinical condition of the mother requires treatment.
Croatian: Alunbrig se ne smije koristiti tijekom trudnoće, osim ako kliničko stanje majke ne zahtijeva liječenje.
English: Other medicines and Alunbrig
Croatian: Drugi lijekovi i Alunbrig
English: • The tablets can be taken with or without food.
Croatian: • Tablete možete uzeti s hranom ili bez nje.
English: Brigatinib was moderately bound (91%) to human plasma proteins and binding was not concentration-dependent.
Croatian: Brigatinib se umjereno vezivao (91 %) za proteine u ljudskoj plazmi, a vezivanje nije ovisilo o koncentraciji.
English: Adverse reactions seen in animals at exposure levels similar to clinical exposure levels with possible relevance to clinical use were as follows: gastrointestinal system, bone marrow, eyes, testes, liver, kidney, bone, and heart.
Croatian: Nuspojave opažene u životinja pri razinama izloženosti sličnima kliničkim izloženostima s mogućom povezanosti s kliničkom uporabom bile su sljedeće: gastrointestinalni sustav, koštana srž, oči, testisi, jetra, bubrezi, kost i srce.
English: (27.7, NE)
Croatian: (27,7; NP)
English: The incidence of Grade 3-4 elevations of CPK was 13.6%.
Croatian: Incidencija porasta razina CPK 3.-4. stupnja bila je 13,6 %.
English: Do not stop taking Alunbrig before talking to your doctor.
Croatian: Ne smijete prestati uzimati Alunbrig prije savjetovanja sa liječnikom.
English: Grade 4 hypertension (life threatening consequences, urgent intervention indicated)
Croatian: Hipertenzija 4. stupnja (posljedice opasne po život, indicirana hitna intervencija)
English: Prior to launch of Alunbrig in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije stavljanja u promet lijeka Alunbrig u svakoj državi članici nositelj odobrenja će s nadležnim nacionalnim tijelom dogovoriti sadržaj i oblik edukacijskih materijala, uključujući oblik komunikacije, način distribucije i sve druge aspekte programa.
English: Alunbrig has minor influence on the ability to drive and use machines.
Croatian: Alunbrig malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: ALK-positive NSCLC status should be known prior to initiation of Alunbrig therapy.
Croatian: ALK pozitivni status NSCLC-a mora biti poznat prije početka liječenja lijekom Alunbrig.
English: Brigatinib can be administered with or without food.
Croatian: Brigatinib se može primjenjivati s hranom ili bez nje.
English: Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitors, ATC code: L01XE43
Croatian: Farmakoterapijska skupina: antineoplastici, inhibitori protein kinaze, ATK oznaka: L01XE43
English: Carcinogenicity studies have not been performed with brigatinib.
Croatian: Ispitivanja kancerogenosti s brigatinibom nisu provedena.
English: The major outcome measure was confirmed objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST v1.1) as evaluated by investigator.
Croatian: Glavna mjera ishoda bila je potvrđena stopa objektivnog odgovora (engl. objective response rate, ORR) prema Kriterijima za procjenu odgovora kod solidnih tumora (RECIST v1.1) prema procjeni ispitivača.
English: Unchanged brigatinib was the major circulating radioactive component (92%) along with AP26123 (3.5%), the primary metabolite also observed in vitro.
Croatian: Nepromijenjeni brigatinib bio je glavni cirkulirajući radioaktivni sastojak (92 %) zajedno sa AP26123 (3,5 %), primarnim metabolitom također opaženim in vitro.
English: The limited data on the safety and efficacy of Alunbrig in patients aged 65 years and older suggest that a dose adjustment is not required in elderly patients (see section 4.8).
Croatian: Ograničeni podaci o sigurnosti i djelotvornosti lijeka Alunbrig u bolesnika u dobi od 65 i više godina ukazuju na to da nije potrebna prilagodba doze u starijih bolesnika (vidjeti dio 4.8).
English: Macrogol Polyvinyl alcohol Titanium dioxide
Croatian: Poli(vinilni alkohol) Titanijev dioksid
English: Thirty percent of patients had resolution of all peripheral neuropathy adverse reactions.
Croatian: Kod trideset posto bolesnika povukle su se sve nuspojave periferne neuropatije.
English: 12-month survival probability (%)
Croatian: Vjerojatnost preživljenja 12 mjeseci
English: Patients should be advised to report any visual symptoms.
Croatian: Bolesnike treba savjetovati da prijave sve poremećaje vida.
English: Alunbrig is not recommended during pregnancy unless the benefit outweighs the risk to the baby.
Croatian: Alunbrig se ne preporučuje tijekom trudnoće osim ako je korist od liječenja veća od rizika za bebu.
English: Assessment for ALK-positive NSCLC should be performed by laboratories with demonstrated proficiency in the specific technology being utilised.
Croatian: Testiranje za ALK pozitivni NSCLC se mora provoditi u laboratoriju koji je dokazano stručan u korištenju odabrane tehnologije ispitivanja.
English: Unchanged brigatinib represented 41% and 86% of the total radioactivity in faeces and urine, respectively, the remainder being metabolites.
Croatian: Nepromijenjeni brigatinib predstavljao je 41 % i 86 % ukupne radioaktivnosti u fecesu, odnosno urinu, a ostatak su bili metaboliti.
English: Alunbrig should be permanently discontinued if patient is unable to tolerate the 60 mg once daily dose.
Croatian: Liječenje lijekom Alunbrig se mora trajno prekinuti ako bolesnik ne može tolerirati dozu od 60 mg jedanput dnevno.
English: The following medicines can affect or be affected by Alunbrig:
Croatian: Sljedeći lijekovi mogu utjecati na Alunbrig ili Alunbrig može utjecati na njih:
English: Eye disorders Very common Visual disturbancee Common
Croatian: Poremećaji oka Vrlo često Poremećaj vidae Često
English: At the beginning of your treatment with Alunbrig your doctor may prescribe a treatment initiation pack.
Croatian: Na početku Vašeg liječenja lijekom Alunbrig, liječnik vam može prepisati početno pakiranje.
English: Some patients experienced pneumonitis later in treatment with Alunbrig.
Croatian: Neki bolesnici su dobili pneumonitis kasnije tijekom liječenja lijekom Alunbrig.
English: There are no clinical data on the use of Alunbrig in pregnant women.
Croatian: Nema kliničkih podataka o primjeni Alunbriga u trudnica.
English: The MAH shall ensure that in each Member State where Alunbrig is marketed, all healthcare professionals and patients/carers who are expected to prescribe and use Alunbrig have access to/are provided with the following educational package:
Croatian: Nositelj odobrenja mora osigurati da u svakoj državi članici gdje je Alunbrig na tržištu svi zdravstveni radnici i bolesnici/skrbnici za koje se očekuje da će propisivati i primjenjivati Alunbrig dobiju sljedeći edukacijski paket:
English: Very common AST increased ALT increased
Croatian: Vrlo često Povišeni AST Povišeni ALT
English: The median time to onset for amylase elevations and lipase elevations was 17 days and 29 days, respectively.
Croatian: Medijan vremena za pojavu porasta razina amilaze i lipaze bio je 17 dana, odnosno 29 dana.
English: Do not use this medicine after the expiry date which is stated on either the bottle label or blister and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici bočice ili na blisteru i kutiji iza oznake „EXP“.
English: This effect was observed at approximately five fold the human exposure at the 180 mg once daily dose.
Croatian: Ovaj je učinak opažen na približno pet puta većoj izloženosti od one u ljudi pri dnevnoj dozi od 180 mg jedanput dnevno.
English: • symptoms such as numbness, tingling, prickling sensation, weakness or pain in hands or feet
Croatian: • simptomi kao što su utrnulost, bockanje, peckanje, slabost ili bol u šakama ili stopalima
English: Alunbrig is available as a treatment initiation pack.
Croatian: Alunbrig je dostupan kao početno pakiranje.
English: Modest accumulation was observed upon repeated dosing (geometric mean accumulation ratio: 1.9 to 2.4).
Croatian: Umjerena akumulacija lijeka zabilježena je nakon opetovane primjene (akumulacijski omjer geometrijskih sredina: 1,9 do 2,4).
English: In the event of an overdose, monitor the patient for adverse reactions (see section 4.8) and provide appropriate supportive care.
Croatian: U slučaju predoziranja, bolesnika je potrebno pažljivo nadzirati zbog nuspojava (vidjeti dio 4.8) i pružiti mu odgovarajuću suportivnu skrb.
English: (3.7, NE)
Croatian: (3,7; NP)
English: Baseline demographics and disease characteristics in ALTA were median age 54 years old (range 18 to 82; 23% 65 and over), 67% White and 31% Asian, 57% female, 36% ECOG PS 0 and 57% ECOG PS 1, 7% ECOG PS2, 60% never smoker, 35% former smoker, 5% current smoker, 98% Stage IV, 97% adenocarcinoma, and 74% prior chemotherapy.
Croatian: Početne demografske karakteristike te karakteristike bolesti u ispitivanju ALTA bile su medijan dobi od 54 godine (raspon od 18 do 82; 23 % u dobi od 65 i više), 67 % bijelaca i 31 % Azijata, 57 % žena, 36 % ECOG PS 0 i 57 % ECOG PS 1, 7 % ECOG PS2, 60 % nikada pušača, 35 % bivših pušača, 5 % trenutnih pušača, 98 % 4. stadij, 97 % adenokarcinom i 74 % prethodna kemoterapija.
English: However, caution should be exercised when driving or operating machines as patients may experience visual disturbance, dizziness, or fatigue while taking Alunbrig.
Croatian: Međutim, potreban je oprez prilikom vožnje ili upravljanja strojevima jer bolesnici mogu iskusiti smetnje vida, omaglicu ili umor dok uzimaju lijek Alunbrig.
English: • The active substance is brigatinib.
Croatian: • Djelatna tvar je brigatinib.
English: Increased age and shorter interval (less than 7 days) between the last dose of crizotinib and the first dose of Alunbrig were independently associated with an increased rate of these pulmonary adverse reactions.
Croatian: Starija dob i kraće razdoblje (kraće od 7 dana) između posljednje doze krizotiniba i prve doze lijeka Alunbrig bile su svaka za sebe povezane s povećanom stopom nuspojava na plućima.
English: After a single dose and at steady state, systemic exposure was dose proportional over the dose range of 60-240 mg once daily.
Croatian: Nakon jednokratne doze i u stanju dinamičke ravnoteže, sistemska izloženost bila je proporcionalna dozi u rasponu od 60240 mg jedanput dnevno.
English: • abnormal electrical activity of the heart (prolonged electrocardiogram QT interval)
Croatian: • poremećena električna aktivnost srca (produljeni QT interval u elektrokardiogramu)
English: Evidence of pneumonitis in any patient with worsening respiratory symptoms should be promptly investigated.
Croatian: Znakove pneumonitisa treba odmah istražiti u svih bolesnika s pogoršanim respiratornim simptomima.
English: Adverse reactions† all grades
Croatian: Nuspojave† svih stupnjeva
English: The effect of gemfibrozil on the pharmacokinetics of brigatinib is not clinically meaningful and the underlying mechanism for the decreased exposure of brigatinib is unknown.
Croatian: Učinak gemfibrozila na farmakokinetiku brigatiniba nije klinički značajan, a temeljni mehanizam smanjene izloženosti brigatinibu nije poznat.
English: (peripheral neuropathy)
Croatian: (periferna neuropatija)
English: In ALTA, 69% of patients experienced hyperglycaemia.
Croatian: U ispitivanju ALTA, 69 % bolesnika imalo je hiperglikemiju.
English: Treatment with Alunbrig should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Croatian: Liječenje lijekom Alunbrig mora započeti i nadzirati liječnik s iskustvom u primjeni lijekova za liječenje raka.
English: Outer Carton: PC:
Croatian: Vanjska kutija: PC:
English: Population pharmacokinetic analyses showed that race and gender had no impact on the pharmacokinetics of brigatinib.
Croatian: Populacijska farmakokinetička analiza pokazala je da rasa i spol nisu imali utjecaja na farmakokinetiku brigatiniba.
English: Interstitial lung disease (ILD)/pneumonitis
Croatian: Intersticijska bolest pluća (IBP)/pneumonitis
English: • If you vomit after taking Alunbrig, do not take any more tablets until your next scheduled dose.
Croatian: • Ako povratite nakon uzimanja lijeka Alunbrig, nemojte uzeti dodatne tablete prije sljedeće planirane doze.
English: Study 101: An open-label multicentre phase 1/2 dose escalation/expansion trial in patients with advanced malignancies.
Croatian: Ispitivanje 101: otvoreno multicentrično ispitivanje faze s 1/2 povišenja/proširenja doze u bolesnika s uznapredovalim zloćudnim bolestima.
English: The abnormal gene produces a protein known as a kinase that stimulates the growth of the cancer cells.
Croatian: Izmijenjeni gen proizvodi protein kinazu koji potiče rast stanica raka.
English: There is no specific antidote for overdose with Alunbrig.
Croatian: Nema specifičnog antidota za predoziranje lijekom Alunbrig.
English: • rifabutin, rifampicin: medicines to treat tuberculosis or certain other infections
Croatian: • rifabutin, rifampicin: lijekovi za liječenje tuberkuloze ili određenih drugih infekcija
English: • carbamazepine: a medicine to treat epilepsy, euphoric/depressive episodes and certain pain conditions
Croatian: • karbamazepin: lijek za liječenje epilepsije, euforičnih/depresivnih stanja i određenih bolnih stanja
English: Common Dry skin Photosensitivity reaction
Croatian: Suha koža Reakcija fotoosjetljivosti
English: • cold-like symptoms (upper respiratory tract infection)
Croatian: • simptomi slični prehladi (infekcija gornjih dišnih puteva)
English: The safety and efficacy of Alunbrig in patients less than 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka Alunbrig u bolesnika mlađih od 18 godina nisu još ustanovljene.
English: Eligibility criteria permitted enrolment of patients with a documented ALK rearrangement based on a validated test, ECOG Performance Status of 0-2, and prior chemotherapy.
Croatian: Uključni kriteriji dozvolili su uključenje bolesnika s dokumentiranim mutacijama preslagivanja ALKa temeljem validiranog testa, ECOG funkcionalnog statusa 0-2, i prethodno liječenih kemoterapijom.
English: The KM median PFS was 16.3 months (95% CI: 9.2, NE) and the 12-month probability of overall survival was 84.0% (95% CI: 62.8, 93.7).
Croatian: KM medijan PFSa bio je 16,3 mjeseca (95 % CI: 9,2; NP), a 12 -mjesečna vjerojatnost ukupnog preživljenja bila je 84,0 % (95 % CI: 62,8; 93,7).
English: In patients, at steady state, the plasma AUC of AP26123 was < 10% of brigatinib exposure.
Croatian: U bolesnika u stanju dinamičke ravnoteže, AUC AP26123 u plazmi iznosio je < 10 % izloženosti brigatinibu.
English: • The patient alert card shall contain the following key messages: o A warning message for health care professionals treating the patient at any time, including in conditions of emergency, that the patient is using Alunbrig o That Alunbrig treatment may increase the risk of early onset pulmonary events (including interstitial lung disease and pneumonitis) o Signs or symptoms of the safety concern and when to seek attention from a HCP o Contact details of the Alunbrig prescriber
Croatian: • Kartica s upozorenjima za bolesnika treba sadržavati sljedeće ključne poruke: o upozorenje za zdravstvene radnike koji u bilo kojem trenutku skrbe za bolesnika, uključujući i u hitnim stanjima, da bolesnik uzima Alunbrig o da liječenje lijekom Alunbrig može povećati rizik od plućnih događaja rano tijekom liječenja (uključujući intestricijsku bolest pluća i pneumonitis) o znakove ili simptome sigurnosnih rizika i kad potražiti liječničku pomoć o kontakt podatke liječnika koji je propisao Alunbrig
English: Brigatinib is a tyrosine kinase inhibitor that targets ALK, c-ros oncogene 1 (ROS1), and insulin-like growth factor 1 receptor (IGF-1R).
Croatian: Brigatinib je inhibitor tirozin kinaze koji cilja ALK, c-ros onkogen 1(ROS1) i receptor inzulinu sličnog faktora rasta 1 (IGF-1R).
English: The primary route of excretion of brigatinib is in faeces.
Croatian: Primarni put izlučivanja brigatiniba je putem fecesa.
English: The most common serious adverse reactions (≥ 2%) reported in patients treated with Alunbrig at the recommended dosing regimen other than events related to neoplasm progression were pneumonitis, pneumonia, and dyspnoea.
Croatian: Najčešće ozbiljne nuspojave (≥ 2 %) prijavljene u bolesnika liječenih lijekom Alunbrig u preporučenom režimu doziranja, osim događaja vezanih za progresiju neoplazme, bile su pneumonitis, upala pluća i dispneja.
English: Findings included embryo-lethality, reduced foetal growth, and skeletal variations.
Croatian: Nalazi su uključivali smrtnost embrija, smanjen rast fetusa i promjene kostura.
English: If you stop taking Alunbrig
Croatian: Ako prestanete uzimati Alunbrig
English: Given that brigatinib exhibits high solubility and high permeability, inhibition of P-gp and BCRP is not expected to result in a clinically meaningful change in the systemic exposure of brigatinib.
Croatian: Budući da brigatinib pokazuje visok stupanj topljivosti i visok stupanj permeabilnosti, ne očekuje se da će inhibicija Pgp-a i BCRP-a rezultirati klinički značajnom promjenom u sistemskoj izloženosti brigatinibu.
English: If Alunbrig is interrupted for 14 days or longer for reasons other than adverse reactions, treatment should be resumed at 90 mg once daily for 7 days before increasing to the previously tolerated dose.
Croatian: Ako se uzimanje lijeka Alunbrig prekine na 14 dana ili dulje zbog razloga koji nisu vezani uz nuspojave, liječenje treba nastaviti sa 90 mg jedanput dnevno tijekom 7 dana prije povećanja na prethodno podnošljivu dozu.
English: Safety pharmacology studies with brigatinib identified potential for pulmonary effects (altered respiration rate; 1-2 times the human Cmax), cardiovascular effects (altered heart rate and blood pressure; at 0.5 times the human Cmax), and renal effects (reduced renal function; at 1-2.5 times the human Cmax), but did not indicate any potential for QT prolongation or neurofunctional effects.
Croatian: Ispitivanja sigurnosne farmakologije brigatiniba identificirala su potencijal za učinke na pluća (promijenjena brzina disanja, kod 1 - 2 puta Cmax u ljudi), učinke na kardiovaskularni sustav (promijenjena srčana frekvencija i krvni tlak; kod 0,5 puta Cmax u ljudi) i učinke na bubrege (smanjena funkcija bubrega; kod 1 - 2,5 puta Cmax u ljudi), ali nisu ukazala na nikakav potencijal za produljenje QT intervala niti učinke na neurološku funkciju.
English: If Alunbrig is used during pregnancy, or if the patient becomes pregnant while taking this medicinal product, the patient should be apprised of the potential hazard to a foetus.
Croatian: Ako se Alunbrig koristi tijekom trudnoće ili bolesnica zatrudni dok uzima ovaj lijek, bolesnicu treba obavijestiti o potencijalnim opasnostima po fetus.
English: Patients should be closely monitored when Alunbrig is coadministered with substrates of these transporters with a narrow therapeutic index (e.g., digoxin, dabigatran, methotrexate).
Croatian: Bolesnike se treba pažljivo nadzirati kad se Alunbrig daje istodobno sa supstratima tih transportera s uskim terapijskim indeksom (npr. digoksin, dabigatran, metotreksat).
English: Adverse reactions reported in ALTA and Study 101 at the recommended dosing regimen are presented in Table 3 and are listed by system organ class, preferred term and frequency.
Croatian: Nuspojave prijavljene u ispitivanju ALTA i Ispitivanju 101 pri preporučenom režimu doziranja prikazane su u Tablici 3 i navedene prema klasifikaciji organskih sustava, preporučenim izrazima i učestalosti.
English: Figure 1: Investigator-Assessed Systemic Progression-Free Survival: ITT Population by Treatment Arm (ALTA)
Croatian: Slika 1: Preživljenje bez progresije prema procjeni ispitivača: ITT populacija po liječenoj skupni (ALTA)
English: Of these, 19 patients had an investigator-assessed confirmed objective response (76%; 95% CI: 55, 91) and the KM estimate median duration of response among the 19 responders was 26.1 months (95% CI: 7.9, 26.1).
Croatian: Među njima, 19 bolesnika imalo je potvrđenu stopu objektivnog odgovora prema procjeni ispitivača (76 %; 95 % CI: 55, 91) a medijan trajanja odgovora među tih 19 ispitanika s odgovorom prema KM procjeni bio je 26,1 mjesec (95 % CI: 7,9, 26,1).
English: Each pack consists of an outer carton with two inner cartons containing:
Croatian: Svako pakiranje se sastoji od vanjske kutije s dvije unutarnje kutije koje sadrže:
English: Your doctor may stop Alunbrig treatment and refer you to an ophthalmologist.
Croatian: Vaš liječnik može prekinuti liječenje lijekom Alunbrig i uputiti vas oftlamologu.
English: Alunbrig is available in plastic foil strips (blisters) packed in a carton with:
Croatian: Alunbrig je dostupan u plastičnim blisterima s pokrovnom folijom, pakiranima u kutiji:
English: Each bottle contains one canister of a desiccant and is packed in a carton with:
Croatian: Svaka bočica sadrži jedan spremnik sa sredstvom za sušenje, i pakirana je u kutiju:
English: In monkeys, findings included reduced size of testes along with microscopic evidence of hypospermatogenesis; these effects were reversible during the recovery period.
Croatian: nalazi su uključivali smanjenu veličinu testisa zajedno s mikroskopskim dokazom postojanja hipospermatogeneze; ti su učinci bili reverzibilni tijekom razdoblja oporavka.
English: In repeated dose toxicity studies, lung changes (foamy alveolar macrophages) were noted in monkeys at ≥ 0.2 times the human AUC; however, these were minimal and similar to those reported as background findings in naive monkeys, and there was no clinical evidence of respiratory distress in these monkeys.
Croatian: U ispitivanjima toksičnosti ponovljene doze, opažene su promjene na plućima (pjenasti alveolarni makrofagi) u majmuna pri izloženosti ≥ 0,2 puta AUC u ljudi; međutim, one su bile minimalne i slične onima prijavljenima kao osnovni nalaz u neliječenih majmuna pa nema kliničkih dokaza o respiratornom distresu u ovih majmuna.
English: A patient alert card
Croatian: Kartica sa upozorenjima za bolesnika
English: Clinical drug-drug interaction studies with CYP3A sensitive substrates have not been conducted.
Croatian: Klinička ispitivanja interakcija s osjetljivim supstratima CYP3A nisu provedena.
English: Takeda Pharmaceuticals Czech Republic s.r.o.
Croatian: Česká republika Takeda Pharmaceuticals Czech Republic s.r.o.