FrancophonIA/ELRC3.0 huggingface dataset:
English: A categorical outlier analysis of ECG data demonstrated new QTc >500 msec in 12 patients (1.3%).
Croatian: Kategorička analiza ekstremnih vrijednosti podataka s EKG-a pokazala je novi QTc >500 msek u 12 bolesnika (1,3%).
English: Periodic monitoring with ECGs and periodic monitoring of electrolytes (e.g. potassium) is recommended in these patients.
Croatian: Preporučuje se periodičko praćenje EKG-om i periodičko praćenje elektrolita (npr. kalija) u tih bolesnika.
English: Vision problems
Croatian: Problemi s vidom
English: Event-free probability estimate at 9 months d
Croatian: Procjena vjerojatnosti izostanka događaja nakon 9 mjeseci d
English: Lipase and/or amylase elevations
Croatian: Povišenja lipaze i/ili amilaze
English: The median duration of follow-up was 16.5 months (from randomisation to data cut-off date).
Croatian: Medijan trajanja praćenja bio je 16,5 mjeseci (od randomizacije do isključnog datuma).
English: Main biotransformation pathways identified in healthy subjects included mono-oxygenation, O-dealkylation, and N-formylation.
Croatian: Glavni putevi biotransformacije identificirani u zdravih ispitanika uključivali su monooksigenaciju, O-dealkilaciju i N-formilaciju.
English: INTERMEDIATE CARTON OF PACK (WITHOUT BLUE BOX) CONTAINING 50 HARD CAPSULES
Croatian: SREDNJA KUTIJA PAKIRANJA (BEZ PLAVOG OKVIRA) KOJE SADRŽI 50 TVRDIH KAPSULA
English: One hundred and eighty-nine (189) patients were randomised to ceritinib and one hundred eightyseven (187) were randomised to chemotherapy.
Croatian: Sto osamdeset i devet (189) bolesnika bilo je randomizirano na ceritinib, a sto osamdeset i sedam (187) bilo je randomizirano na kemoterapiju.
English: The median duration of follow-up was 19.7 months (from randomisation to cut-off date).
Croatian: Medijan trajanja praćenja bio je 19,7 mjeseci (od randomizacije do isključnog datuma).
English: In the ceritinib arm, 115 patients were treated with 750 mg once daily fasted.
Croatian: U ceritinib skupini bilo je liječeno 115 bolesnika s 750 mg jedanput dnevno natašte.
English: For patients who develop a concurrent medical condition and are unable to take Zykadia with food please refer to section 4.5.
Croatian: Za bolesnike koji razviju istodobno medicinsko stanje te nisu u mogućnosti uzeti Zykadiu uz hranu, molimo pogledajte dio 4.5.
English: 1% of patients required permanent discontinuation of treatment in clinical studies with ceritinib (see sections 4.2 and 4.4).
Croatian: 1% bolesnika zahtijevalo je trajni prekid liječenja u kliničkim ispitivanjima s ceritinibom (vidjeti dijelove 4.2 i 4.4).
English: PVC/PCTFE (polyvinylchloride/polychlorotrifluoroethylene) - Aluminium blisters containing 10 hard capsules.
Croatian: PVC/PCTFE (polivinilklorid/poliklorotrifluoroetilen) - aluminijski blisteri koji sadrže 10 tvrdih kapsula.
English: Gastrointestinal events were managed primarily with concomitant medicinal products including anti-emetic/anti-diarrhoeal medicinal products.
Croatian: Gastrointestinalni događaji su se zbrinjavali u prvom redu istodobnom primjenom drugih lijekova uključujući antiemetike/antidijaroike.
English: Patients with symptomatic CNS (central nervous system) metastases who were neurologically unstable or had required increasing doses of steroids within the 2 weeks prior to screening to manage CNS symptoms, were excluded from the study.
Croatian: Bolesnici sa simptomatskim metastazama u SŽS-u (središnjem živčanom sustavu) koji su bili neurološki nestabilni ili su im bile potrebne sve veće doze steroida unutar 2 tjedna prije probira radi kontroliranja simptoma SŽS-a bili su isključeni iz ispitivanja.
English: If long-term concomitant treatment with a strong CYP3A inhibitor is necessary and the patient tolerates the reduced dose well, the dose may be increased again with careful monitoring for safety, to avoid potential under-treatment.
Croatian: Ako je dugoročno istodobno liječenje snažnim CYP3A inhibitorom nužno, a bolesnik dobro podnosi smanjenu dozu, doza se može ponovo povećati uz pažljivo motrenje radi sigurnosti, kako bi se izbjeglo potencijalno nedostatno davanje terapije.
English: Zykadia should be discontinued in patients unable to tolerate 150 mg daily taken with food.
Croatian: Liječenje Zykadiom mora se prekinuti u bolesnika koji ne podnose 150 mg dnevno uzeto uz hranu.
English: CARTON OF UNIT PACK CONTAINING 40 OR 90 HARD CAPSULES
Croatian: KUTIJA JEDINIČNOG PAKIRANJA KOJA SADRŽI 40 ILI 90 TVRDIH KAPSULA
English: Based on in vitro data, ceritinib does not inhibit apical efflux transporter MRP2, hepatic uptake transporters OATP1B1 or OATP1B3, renal organic anion uptake transporters OAT1 and OAT3, or the organic cation uptake transporters OCT1 or OCT2 at clinically relevant concentrations.
Croatian: Na temelju in vitro podataka, ceritinib ne inhibira apikalni efluksni transporter MRP2, transportere unosa u jetru OATP1B1 ili OATP1B3, bubrežne transportere za unos organskih aniona OAT1 i OAT3, ili transportere za unos organskih kationa OCT1 ili OCT2 pri klinički relevantnim koncentracijama.
English: Ceritinib was demonstrated to be effective against EML4-ALK activity in a NSCLC cell line (H2228), resulting in inhibition of cell proliferation in vitro and regression of tumours in H2228-derived xenografts in mouse and rat.
Croatian: Ceritinib se pokazao djelotvornim protiv aktivnosti EML4-ALK-a u staničnoj liniji NSCLC-a (H2228), što rezultira inhibicijom proliferacije stanica in vitro i regresijom tumora u ksenograftima izvedenima iz H2228 u miševa i štakora.
English: In rats, ceritinib crosses the intact blood brain barrier with a brain-to-blood exposure (AUCinf) ratio of about 15%.
Croatian: U štakora ceritinib prelazi neoštećenu krvno-moždanu barijeru s omjerom izloženosti mozga i krvi (AUCinf) od oko 15%.
English: PVC/PCTFE (polyvinylchloride/polychlorotrifluoroethylene) - Aluminium blister containing 21 film-coated tablets.
Croatian: PVC/PCTFE (polivinilklorid/poliklorotrifluoroetilen) - aluminijski blister koji sadrži 21 filmom obloženu tabletu.
English: Ceritinib has been classified in vivo as a weak CYP2C9 inhibitor.
Croatian: Ceritinib je in vivo klasificiran kao slab CYP2C9 inhibitor.
English: The bioavailability of ceritinib is increased in the presence of food.
Croatian: Bioraspoloživost ceritiniba povećava se u prisutnosti hrane.
English: 150 (3 packs of 50) hard capsules.
Croatian: 150 (3 pakiranja od 50) tvrdih kapsula.
English: The capsules are provided in blisters and are available in packs containing 40, 90 or 150 (3 packs of 50) capsules.
Croatian: Kapsule se isporučuju u blisterima i dostupne su u pakiranjima koja sadrže 40, 90 ili 150 (3 pakiranja od 50) kapsula.
English: Following a single oral administration of radioactive ceritinib dose at 750 mg fasted, ceritinib was the main circulating component in human plasma.
Croatian: Nakon jednokratne peroralne primjene doze radioaktivnog ceritiniba od 750 mg natašte, ceritinib je bio glavna cirkulirajuća komponenta u ljudskoj plazmi.
English: A grade 3 event of diarrhoea was reported in one patient (1.1%).
Croatian: Događaj proljeva stupnja 3 bio je prijavljen u jednog bolesnika (1,1%).
English: The tablets are provided in blisters and are available in a pack containing 84 tablets (4 blisters of 21 tablets).
Croatian: Tablete se isporučuju u blisterima i dostupne su u pakiranju koje sadrži 84 tablete (4 blistera po 21 tableta).
English: Binding of ceritinib to human plasma proteins in vitro is approximately 97% in a concentration independent manner, from 50 ng/ml to 10,000 ng/ml.
Croatian: Vezanje ceritiniba za proteine u ljudskoj plazmi in vitro otprilike iznosi 97% i to neovisno o koncentraciji, od 50 ng/ml do 10 000 ng/ml.
English: Patients who completed 4 cycles of chemotherapy (induction) without progressive disease subsequently received pemetrexed (500 mg/m2) as single-agent maintenance therapy every 21 days.
Croatian: Bolesnici koji su dovršili 4 ciklusa kemoterapije (indukcija) bez progresivne bolesti naknadno su primali pemetreksed (500 mg/m2) kao monoterapiju održavanja svakih 21 dan.
English: Safety pharmacology studies indicate that ceritinib is unlikely to interfere with vital functions of the respiratory and central nervous systems.
Croatian: Sigurnosna farmakološka ispitivanja upućuju na to da je mala vjerojatnost da će ceritinib ometati vitalne funkcije dišnog i središnjeg živčanog sustava.
English: if you have problems with your heart, including reduced heart rate, or if the results of an electrocardiogram (ECG) have shown that you have an abnormality of the electrical activity of your heart known as “prolonged QT interval”.
Croatian: ako imate probleme sa srcem, uključujući sniženu srčanu frekvenciju, ili ako su rezultati elektrokardiograma (EKG) pokazali da imate poremećaj električne aktivnosti srca koji se naziva „produljeni QT interval“. ako imate šećernu bolest (visoku razinu šećera u krvi).
English: One hundred fifteen (115) patients were randomised to Zykadia and one hundred sixteen (116) were randomised to chemotherapy (either pemetrexed or docetaxel).
Croatian: Sto petnaest (115) bolesnika bilo je randomizirano na Zykadiu, a sto šesnaest (116) je bilo randomizirano na kemoterapiju (ili pemetreksed ili docetaksel).
English: The majority of patients were Caucasian (66.3%) or Asian (28.8%).
Croatian: Većina bolesnika bili su bijelci (66,3%) ili Azijati (28,8%).
English: Acid reducing agents (e.g., proton pump inhibitors, H2-receptor antagonists, antacids) can alter the solubility of ceritinib and reduce its bioavailability.
Croatian: Tvari koje smanjuju kiselost (npr. inhibitori protonske pumpe, antagonisti H2-receptora, antacidi) mogu promijeniti topivost ceritiniba i smanjiti njegovu bioraspoloživost.
English: 59.5% of patients with brain metastasis at baseline received no prior radiotherapy to the brain.
Croatian: 59,5% bolesnika s metastazama na mozgu na početku nije prethodno primalo radioterapiju za mozak.
English: Daily oral dosing of ceritinib results in achievement of steady-state by approximately 15 days and remains stable afterwards, with a geometric mean accumulation ratio of 6.2 after 3 weeks of daily dosing.
Croatian: Svakodnevna peroralna doza ceritiniba rezultira postizanjem stanja dinamičke ravnoteže nakon približno 15 dana i ostaje stabilna nakon toga, uz geometrijsku srednju vrijednost omjera akumulacije od 6,2 nakon 3 tjedna svakodnevnog doziranja.
English: Caution should be used in patients with severe renal impairment, as there is no experience with ceritinib in this population (see section 5.2).
Croatian: Potreban je oprez u bolesnika s teškim oštećenjem bubrega, budući da nema iskustva s ceritinibom u ovoj populaciji (vidjeti dio 5.2).
English: What you need to know before you take Zykadia
Croatian: Što morate znati prije nego počnete uzimati Zykadiu
English: Only 1.3% of the administered oral dose is recovered in the urine.
Croatian: Samo 1,3% primijenjene peroralne doze izlučuje se mokraćom.
English: One hundred and five (105) patients out of the 145 patients (72.4%) that discontinued treatment in the chemotherapy arm received subsequent ALK inhibitor as first antineoplastic therapy.
Croatian: Sto pet (105) bolesnika od 145 bolesnika (72,4%) koji su prekinuli liječenje u kemoterapijskoj skupini primalo je naknadno ALK inhibitor kao prvu antineoplastičnu terapiju.
English: The potential for Zykadia to cause infertility in male and female patients is unknown (see section 5.3).
Croatian: Potencijal Zykadie da uzrokuje neplodnost u muških ili ženskih bolesnika nije poznat (vidjeti dio 5.3).
English: An in vivo telemetry study in monkeys showed a modest QT prolongation in 1 of 4 animals after receiving the highest dose of ceritinib.
Croatian: In vivo telemetrijsko ispitivanje u majmuna pokazalo je skromno produljenje QT intervala u 1 od 4 životinje nakon primanja najviše doze ceritiniba.
English: 93.3% had adenocarcinoma and 96.9% had either never been or were former smokers.
Croatian: 93,3% imalo je adenokarcinom, a 96,9% nikada nije pušilo ili su bili bivši pušači.
English: These include medicines that treat fungal infections (antifungals such as ketoconazole, itraconazole, voriconazole, posaconazole) and medicines that treat certain types of bacterial infection (antibiotics such as telithromycin).
Croatian: Oni uključuju lijekove koji liječe gljivične infekcije (antimikotike kao što su ketokonazol, itrakonazol, vorikonazol, posakonazol) i lijekove koji liječe određene vrste bakterijskih infekcija (antibiotike kao što je telitromicin).
English: Limited information is available in ALK-positive NSCLC patients with non-adenocarcinoma histology.
Croatian: Dostupne su ograničene informacije u bolesnika s ALK-pozitivnim NSCLC-om s histologijom ne-adenokarcinoma.
English: Low level of phosphate in the blood (this would be detected during blood tests) High level of enzymes called lipase and/or amylase in the blood (this would be detected during blood tests)
Croatian: Niska razina fosfata u krvi (to se otkriva tijekom krvnih pretraga) Visoka razina enzima u krvi koji se zovu lipaza i/ili amilaza (to se otkriva tijekom krvnih pretraga)
English: Your doctor should perform blood tests before you start treatment, every 2 weeks during the first three months of treatment and monthly therafter.
Croatian: Liječnik bi Vam trebao obaviti krvne pretrage prije nego što započnete liječenje, svaka 2 tjedna tijekom prva tri mjeseca liječenja te mjesečno nakon toga.
English: If you stop taking Zykadia
Croatian: Ako prestanete uzimati Zykadiu
English: Reproductive toxicology studies (i.e. embryo-foetal development studies) in pregnant rats and rabbits indicated no foetotoxicity or teratogenicity after dosing with ceritinib during organogenesis; however, maternal plasma exposure was less than that observed at the recommended human dose.
Croatian: Ispitivanja reproduktivne toksikologije (tj. ispitivanja embrio-fetalnog razvoja) u skotnih štakora i kunića nisu ukazala ni na kakvu fetotoksičnost ili teratogenost nakon doziranja s ceritinibom tijekom organogeneze; međutim, izloženost majčinske plazme bila je manja od izloženosti uočene pri preporučenoj dozi u ljudi.
English: Pack containing 84 film-coated tablets (4 blisters per pack).
Croatian: Pakiranje sadrži 84 filmom obloženih tableta (4 blistera po pakiranju).
English: It is unknown whether ceritinib/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se ceritinib/metaboliti u majčino mlijeko.
English: NE = not estimable
Croatian: NP = ne može se procijeniti
English: 8.3 (3.5, NE)
Croatian: 8,3 (3,5; NP)
English: In the majority of NSCLC cases, EML4 is the translocation partner for ALK; this generates an EML4-ALK fusion protein containing the protein kinase domain of ALK fused to the N-terminal part of EML4.
Croatian: U većini slučajeva NSCLC-a, EML4 je translokacijski partner za ALK; to stvara fuzijski protein EML4-ALK koji sadrži domenu protein kinaze u ALK-u fuzioniranu s N-terminalnim dijelom EML4.
English: Patient reported outcome questionnaires were collected using the EORTC QLQ C30/LC13, LCSS and EQ-5D-5L.
Croatian: Upitnici o ishodima na temelju procjene bolesnika prikupljeni su koristeći EORTC QLQ C30/LC13, LCSS i EQ-5D-5L.
English: CYP2A6 and CYP2E1 substrates
Croatian: CYP2A6 i CYP2E1 supstrati
English: Across seven clinical studies, 168 out of 925 patients (18.2%) treated with Zykadia were aged 65 years or older.
Croatian: U sedam kliničkih ispitivanja, 168 od 925 bolesnika (18,2%) liječenih Zykadiom bilo je u dobi od 65 godina ili starije.
English: Talk to your doctor or pharmacist before taking Zykadia: if you have problems with your liver.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Zykadiu: ako imate probleme s jetrom. ako imate probleme s plućima ili probleme s disanjem.
English: Cases of hepatotoxicity occurred in 1.1% of patients receiving ceritinib in clinical studies.
Croatian: Slučajevi hepatotoksičnosti javili su se u 1,1% bolesnika koji su primali ceritinib u kliničkim ispitivanjima.
English: In vitro data show that the IC50 for the inhibitory effect of ceritinib on the hERG potassium channel was 0.4 micromolar.
Croatian: In vitro podaci pokazuju da je IC50 za inhibitorni učinak ceritiniba na kalijev kanal hERG bio 0,4 μmol/L.
English: 64.5% of the study population were Caucasian, 29.4% Asian, 0.4% Black and 2.6% other races.
Croatian: 64,5% ispitivane populacije bili su bijelci, 29,4%, Azijati, 0,4% crnci, a 2,6% ostalih rasa.
English: Zykadia is for oral use.
Croatian: Zykadia je namijenjena za peroralnu primjenu.
English: In vitro studies suggest that ceritinib is a substrate for P-glycoprotein (P-gp), but not of breast cancer resistance protein (BCRP) or multi-resistance protein 2 (MRP2).
Croatian: In vitro ispitivanja ukazuju na to da je ceritinib supstrat za P-glikoprotein (P-gp), ali ne za protein koji uzrokuje rezistenciju raka dojke na lijekove (engl. breast cancer resistance protein, BCRP) ili protein višestruke rezistencije na lijekove 2 (MRP2).
English: All except one patient received prior chemotherapy (including a platinum doublet) for advanced disease; 11.3% of the patients in the ceritinib arm and 12.1% of the patients in the chemotherapy arm were treated with two prior chemotherapy regimen for advanced disease.
Croatian: Svi osim jednog bolesnika primali su prethodno kemoterapiju (uključujući dvojnu terapiju na temelju platine) za uznapredovalu bolest; 11,3% bolesnika u ceritinib skupini i 12,1% bolesnika u kemoterapijskoj skupini liječilo se s dva prethodna kemoterapijska režima za uznapredovalu bolest.
English: No signs of mutagenicity or clastogenicity were observed in other in vitro and in vivo genotoxicity studies with ceritinib.
Croatian: Nisu uočeni nikakvi znakovi mutagenosti ili klastogenosti u drugim in vitro i in vivo ispitivanjima genotoksičnosti s ceritinibom.
English: If concomitant use of a strong CYP3A inhibitor is unavoidable, reduce the dose by approximately one third (dose not clinically verified), rounded to the nearest multiple of the 150 mg dosage strength.
Croatian: Ako je istodobna primjena snažnog CYP3A inhibitora neizbježna, dozu treba smanjiti za otprilike jednu trećinu (doza koja nije klinički provjerena), zaokruženo na najbliži višekratnik jačine doze od 150 mg.
English: Monitoring of the QT interval is indicated in the event of combinations of such medicinal products (see sections 4.2 and
Croatian: Praćenje QT intervala je indicirano u slučaju kombinacije takvih lijekova (vidjeti dijelove 4.2 i 4.4).
English: The drug-drug interaction study was designed to observe the impact of proton pump inhibitor in the worst scenario, but in clinical use the impact of proton pump inhibitor on ceritinib exposure appears to be less pronounced.
Croatian: Ispitivanje interakcije među lijekovima bilo je dizajnirano da uoči učinak inhibitora protonske pumpe u najlošijem scenariju, ali izgleda da je u kliničkoj primjeni učinak inhibitora protonske pumpe na izloženost ceritinibu slabije izražen.
English: Ceritinib has been classified in vivo as a strong CYP3A4 inhibitor and has the potential to interact with medicinal products that are metabolised by CYP3A, which may lead to increased serum concentrations of the other product.
Croatian: Ceritinib je in vivo klasificiran kao snažan CYP3A4 inhibitor te ima potencijal ući u interakciju s lijekovima koji se metaboliziraju putem CYP3A, što može dovesti do povećane koncentracije drugog lijeka u serumu.
English: Abnormal liver function test (hepatic function abnormal, hyperbilirubinaemia)
Croatian: Poremećeni test jetrene funkcije (abnormalna jetrena funkcija, hiperbilirubinemija)
English: Caution is advised with concomitant use of proton pump inhibitors, as exposure of ceritinib may be reduced.
Croatian: Savjetuje se oprez kod istodobne primjene inhibitora protonske pumpe, jer se izloženost ceritinibu može smanjiti.
English: Ceritinib 750 mg 115 87 68 40 31 18 12 9 Chemotherapy
Croatian: Ceritinib 750 mg 115 87 68 40 31 18 12 9 Kemoterapija
English: The primary route of excretion of ceritinib and its metabolites is in the faeces.
Croatian: Primarni put izlučivanja ceritiniba i njegovih metabolita je stolicom.
English: If ceritinib is administered with medicinal products that inhibit P-gp, an increase in ceritinib concentration is likely.
Croatian: Ako se ceritinib primjenjuje s lijekovima koji inhibiraju P-gp, vjerojatno je povećanje koncentracije ceritiniba.
English: Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first.
Croatian: Unutar svakog organskog sustava nuspojave su razvrstane po učestalosti, pri čemu su najučestalije navedene prve.
English: QTc prolongation has been observed in clinical studies in patients treated with ceritinib (see sections 4.8 and 5.2), which may lead to an increased risk for ventricular tachyarrhythmias (e.g. torsade de pointes) or sudden death.
Croatian: Produljenje QTc intervala uočeno je u kliničkim ispitivanjima u bolesnika liječenih ceritinibom (vidjeti dijelove 4.8 i 5.2), što može dovesti do povećanog rizika od ventrikularnih tahiaritmija (npr. torsade de pointes) ili iznenadne smrti.
English: Hepatotoxicity events were managed with dose interruptions or reductions in 40.6% of patients.
Croatian: Hepatotoksični događaji su se zbrinjavali prekidima doziranja ili smanjenjima doze u 40,6% bolesnika.
English: 26.2 (22.8, NE)
Croatian: 26,2 (22,8, NP)
English: Alveolar foamy macrophages (confirmed phospholipidosis) were seen in the lungs of rats, but not in monkeys, and the lymph nodes of rats and monkeys had macrophage aggregates.
Croatian: Alveolarni pjenasti makrofagi (potvrđena fosfolipidoza) uočeni su u plućima štakora, ali ne u majmuna, a limfni čvorovi štakora i majmuna imali su nakupine makrofaga.
English: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation >5 times upper limit of normal (ULN) with concurrent total bilirubin ≤2 times ULN
Croatian: Povišenje alanin aminotransferaze (ALT) ili aspartat aminotransferaze (AST) >5 puta iznad gornje granice normale (GGN) uz istodobni ukupni bilirubin ≤2 puta GGN
English: The median duration of exposure to Zykadia 750 mg fasted was 44.9 weeks (range: 0.1 to 200.1 weeks).
Croatian: Medijan trajanja izloženosti Zykadii od 750 mg natašte bio je 44,9 tjedana (raspon: 0,1 do 200,1 tjedana).
English: Table 6 ALK-positive advanced NSCLC - overview of efficacy results from Studies X2101 and A2201
Croatian: Tablica 6 ALK-pozitivan uznapredovali NSCLC - pregled rezultata djelotvornosti iz Ispitivanja X2101 i A2201
English: The potential for QT interval prolongation of ceritinib was assessed in seven clinical studies with Zykadia.
Croatian: Potencijal ceritiniba da produlji QT interval bio je ocijenjen u sedam kliničkih ispitivanja sa Zykadiom.
English: Peak plasma levels (Cmax) of ceritinib are achieved approximately 4 to 6 hours after a single oral administration in patients.
Croatian: Vršne razine ceritiniba u plazmi (Cmax) postižu se otprilike 4 do 6 sati nakon jednokratne peroralne primjene u bolesnika.
English: Abnormal results of blood tests to check kidney function (high level of creatinine) Heartburn (potential sign of a disorder of the digestive tract) Reduction in the number of red blood cells, known as anaemia
Croatian: Poremećeni rezultati krvnih pretraga za provjeru bubrežne funkcije (visoka razina kreatinina) Žgaravica (potencijalni znak poremećaja probavnog sustava) Smanjenje broja crvenih krvnih stanica, poznato kao anemija
English: Evaluate concomitant medicinal products known to cause bradycardia, as well as anti-hypertensive medicinal products.
Croatian: Ocijeniti istodobno primijenjene lijekove za koje je poznato da uzrokuju bradikardiju, kao i antihipertenzive.
English: Caution should be exercised when driving or using machines during treatment as patients may experience fatigue or vision disorders.
Croatian: Potreban je oprez kod upravljanja vozilima ili rada sa strojevima tijekom liječenja budući da bolesnici mogu osjetiti umor ili poremećaje vida.