natgillin/translations-raw huggingface dataset:
Table 2 Dose modifications for pancreatitis and elevation of lipase/amylase Grade 2 pancreatitis and/or asymptomatic elevation of lipase/amylase 
Tablica 2 Prilagodba doze u slučaju pankreatitisa i povišenja serumske lipaze/amilaze Pankreatitis 2. stupnja i/ili asimptomatsko povišenje lipaze/amilaze
An integrated population pharmacokinetic analysis completed for ponatinib suggests that age may be predictive of variability for ponatinib apparent oral clearance (CL/F). 
Integrirana populacijska farmakokinetska analiza provedena za ponatinib upućuje na to da dob može predskazivati varijabilnost za prividni peroralni klirens ponatiniba (CL/F).
Formal studies of ponatinib with anti-clotting medicinal products have not been conducted. 
Formalna ispitivanja ponatiniba s lijekovima protiv zgrušavanja nisu provedena.
AST increased 
Povišena AST
The carboxylic acid and the N-desmethyl metabolite comprise 58% and 2% of the circulating levels of ponatinib, respectively. 
Karboksilna kiselina i N-desmetil metabolit čine 58% odnosno 2% cirkulirajuće razine ponatiniba.
Ponatinib is metabolized to an inactive carboxylic acid by esterases and/or amidases, and metabolized by CYP3A4 to an N-desmethyl metabolite that is 4 times less active than ponatinib. 
Ponatinib se metabolizira u inaktivnu karboksilnu kiselinu putem esteraza i/ili amidaza i metabolizirati putem CYP3A4 u N-desmetil metabolit koji je 4 puta manje aktivan od ponatiniba.
If a dose reduction is considered, the following factors should be to taken into account in the individual benefit-risk assessment: cardiovascular risk, side effects of ponatinib therapy, time to cytogenetic response, and BCR-ABL transcript levels (see sections 4.4 and 5.1). 
Ako se razmatra smanjenje doze, u individualnoj procjeni koristi i rizika moraju se u obzir uzeti sljedeći čimbenici:kardiovaskularni rizik, nuspojave liječenja ponatinibom, vrijeme do citogenetičkog odgovora i razine BCR-ABL transkripta (vidjeti dijelove 4.4 i 5.1).
Vascular occlusion (see section 4.2 and 4.4). 
Vaskularna okluzija (vidjeti dio 4.2 i 4.4)
Caution should be exercised with concurrent use of Iclusig and moderate and strong CYP3A inhibitors and moderate and strong CYP3A inducers (see section 4.5). 
Potreban je oprez s istovremenom primjenom lijeka Iclusig i umjerenih i jakih inhibitora CYP3A te umjerenih i jakih induktora CYP3A (vidjeti dio 4.5).
• checks of the serum protein known as lipase A serum protein called lipase will be checked every 2 weeks for the first 2 months, then periodically. 
• provjera razine proteina zvanog serumska lipaza Serumska lipaza provjeravat će se svaka 2 tjedna tijekom prva 2 mjeseca i potom povremeno.
Inform your doctor immediately if pancreas inflammation occurs. 
Odmah obavijestite svog liječnika ako se pojavi upala gušterače.
Iclusig is associated with pancreatitis. 
Liječenje lijekom Iclusig je povezano s pankreatitisom.
At the time of updated reporting with minimum follow-up for all ongoing patients of 27 months, the median durations of MCyR and MMR had not yet been reached. 
U vrijeme podnošenja ažuriranog izvješća s praćenjem svih uključenih bolesnika tijekom najmanje 27 mjeseci, medijan trajanja MCyR i MMR još nije bio dosegnut.
The QT interval prolongation potential of Iclusig was assessed in 39 leukaemia patients who received 30 mg, 45 mg, or 60 mg Iclusig once daily. 
Učinak lijeka Iclusig na produljenje QT intervala procijenjen je u 39 bolesnika s leukemijom koji su primali 30 mg, 45 mg ili 60 mg lijeka Iclusig jednom dnevno.
Women of childbearing potential/Contraception in males and females Women of childbearing age being treated with Iclusig should be advised not to become pregnant and men being treated with Iclusig should be advised not to father a child during treatment. 
Žene reproduktivne dobi/Kontracepcija u muškaraca i žena Ženama reproduktivne dobi koje se liječe lijekom Iclusig treba savjetovati da ne zatrudne, a muškarcima koji se liječe lijekom Iclusiga također treba savjetovati da ne začnu dijete tijekom liječenja.
Therefore, ponatinib may have the potential to increase plasma concentrations of co-administered substrates of P-gp (e.g., digoxin, dabigatran, colchicine, pravastatin) or BCRP (e.g., methotrexate, rosuvastatin, sulfasalazine) and may increase their therapeutic effect and adverse reactions. 
Stoga ponatinib može smanjiti plazmatske koncentracije istovremeno primijenjenih supstrata P-gp (poput digoksina, dabigatrana, kolhicina, pravastatina) ili BCRP (poput metotreksata, rosuvastatina, sulfasalazina) i može povećati njihov terapijski učinak i nuspojave.
The Marketing Authorisation Holder shall ensure that in each Member State where ICLUSIG is marketed all physicians who are expected to prescribe ICLUSIG are provided with the Healthcare Professional 
Nositelj odobrenja mora osigurati da u svakoj državi članici u kojoj se ICLUSIG stavlja u promet, svi liječnici za koje se predviđa da će propisivati ICLUSIG dobiju brošuru za zdravstvene radnike.
• pravastatin, rosuvastatin: medicines to lower elevated cholesterol levels. 
• pravastatin, rosuvastatin: lijekovi za snižavanje povišenih razina kolesterola.
How to take Iclusig 
Kako uzimati Iclusig
Following single and multiple 45 mg doses of Iclusig, the terminal elimination half-life of ponatinib was 22 hours, and steady state conditions are typically achieved within 1 week of continuous dosing. 
Nakon pojedinačne i višestruke doze Iclusiga od 45 mg, terminalni poluvijek eliminacije ponatiniba iznosio je 22 sata, a stanje dinamičke ravnoteže se postiže unutar tjedan dana neprekidnog doziranja.
A complete blood count should be performed every 2 weeks for the first 3 months and then monthly or as clinically indicated. 
Kompletnu krvnu sliku treba kontrolirati svaka 2 tjedna tijekom prva 3 mjeseca liječenja te zatim jednom mjesečno ili kada je klinički indicirano.
• chest pain not in connection with the heart 
• bol u prsištu koja nije povezana sa srcem
In a patient suspected of developing an arterial or venous occlusive event, Iclusig should be immediately interrupted. 
U bolesnika kod kojih se sumnja na razvoj arterijskog ili venskog okluzijskog događaja, primjena Iclusig se mora odmah prekinuti.
In juvenile rats, mortality related to inflammatory effects was observed in animals treated with 3 mg/kg/day, and reductions in body weight gain were observed at doses of 0.75, 1.5 and 3 mg/kg/day during the pre weaning and early post weaning treatment phases. 
U mladih štakora, smrtnost povezana s upalnim učincima zabilježena je u životinja liječenih s 3 mg/kg/dan, a smanjenje u dobivanju na tjelesnoj težini zabilježeno je pri dozama 0,75; 1,5 i 3 mg/kg/dan tijekom faza liječenja u razdoblju prije prestanka sisanja i ranom razdoblju poslije prestanka sisanja.
Iclusig is indicated in adult patients with 
Iclusig je indiciran za liječenje odraslih bolesnika s:
For patients whose adverse reactions are resolved or attenuated in severity, Iclusig may be restarted and escalation of the dose back to the daily dose used prior to the adverse reaction may be considered, if clinically appropriate. 
Za bolesnike čije su se nuspojave povukle ili je njihova težina oslabila, Iclusig se može ponovno početi davati i može se razmotriti povećanje doze natrag na dnevnu dozu od prije nuspojave ako je to klinički opravdano.
• Recommendation to consider discontinuing ponatinib if a complete haematologic response has not occurred by 3 months (90 days). 
• Preporuka za razmatranje prekida davanja ponatiniba ako se potpuni hematološki odgovor ne javi za 3 mjeseca (90 dana).
• the number of white blood cells called neutrophils is reduced. 
• ako je smanjen broj bijelih krvnih stanica (leukocita) zvanih neutrofili.
Therefore, clinical medicinal product interactions are unlikely to occur as a result of ponatinib-mediated inhibition of substrates for these transporters. 
Stoga nisu vjerojatne kliničke interakcije lijekova koje će se javljati kao rezultat inhibicije supstrata ovih transportera ponatinibom.
Iclusig therapy should be prescribed by a doctor experienced in leukaemia treatment. 
Terapiju lijekom Iclusig treba propisati liječnik iskusan u liječenju leukemije.
Isolated reports of unintentional overdose with Iclusig were reported in clinical trials. 
Prijavljeni su izolirani slučajevi nenamjernog predoziranja lijekom Iclusig u kliničkim ispitivanjima.
Men receiving treatment with Iclusig are advised not to father a child during treatment. 
Muškarcima koji primaju Iclusig savjetuje se da ne začinju dijete tijekom liječenja.
• Information on important adverse reactions for which monitoring and/or dose adjustment are recommended as outlined in the SmPC: pancreatitis, increased amylase and lipase levels, myelosuppression, liver function test abnormalities, haemorrhage, cardiac failure/left ventricular dysfunction, vascular occlusive events and hypertension. 
• Informacije o važnim nuspojavama za koje se preporučuje praćenje i/ili prilagodba doze kako je navedeno u Sažetku opisa svojstava lijeka: pankreatitis, povišene razine amilaze i lipaze, mijelosupresija, poremećene vrijednosti testova jetrene funkcije, hemoragija, zatajenje srca/disfunkcija lijeve klijetke, događaji vaskularne okluzije i hipertenzija.
Patients aged 65 and over are more likely to be affected by side effects. 
Vjerojatnije je da će bolesnici od 65 godina i stariji biti zahvaćeni nuspojavama.
In addition, the pharmacokinetic-pharmacodynamic models show no exposure-effect relationship, with an estimated QTcF mean change of -6.4 ms (upper confidence interval -0.9 ms) at Cmax for the 60 mg group. 
Pored toga, farmakokinetički-farmakodinamički modeli nisu pokazali odnos izloženosti-učinka s procijenjenom prosječnom promjenom QTcF od -6,4 ms (gornji interval pouzdanosti -0,9 ms) pri Cmax za skupinu od 60 mg.
• nefazodone: a medicine to treat depression. 
• nefazodon: lijek za liječenje depresije.
In order to determine the optimal starting dose of Iclusig and characterise the safety and efficacy of Iclusig following dose reductions after achieving MCyR in patients with CP-CML, the MAH should conduct and submit the results of a doseranging study. 
Kako bi se odredila optimalna početna doza Iclusiga i okarakterizirala sigurnost i djelotvornost Iclusiga nakon smanjenja doze u bolesnika s kroničnom fazom KML koji su postigli MCyR, nositelj odobrenja će provesti ispitivanje raspona doze lijeka i podnijeti rezultate.
Within the range of clinically relevant doses evaluated in patients (15 mg to 60 mg), ponatinib exhibited dose proportional increases in both Cmax and AUC. 
Unutar raspona klinički relevantnih doza koje su ocijenjene u bolesnika (15 mg do 60 mg) ponatinib je iskazao proporcionalne poraste doze kod Cmax i AUC.
Dose adjustments to 30 mg once daily or 15 mg once daily were allowed for the management of treatment toxicity. 
Prilagodbe doze na 30 mg jednom dnevno ili 15 mg jednom dnevno bile su dozvoljene u slučaju toksičnosti.
Do not use this medicine after the expiry date which is stated on the bottle label and carton after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici bočice i kutiji iza „Rok valjanosti“.
In vitro, ponatinib is an inhibitor of P-gp and BCRP. 
U in vitro uvjetima ponatinib djeluje kao inhibitor P-gp i BCRP.
It is not known if Iclusig passes into breast milk. 
Nije poznato prelazi li Iclusig u majčino mlijeko.
Concomitant use of ponatinib with anti-clotting agents should be approached with caution in patients who may be at risk of bleeding events (see “Myelosuppression” and “Haemorrhage”). 
Istovremenoj primjeni ponatiniba sa lijekovima protiv zgrušavanja treba pristupiti oprezno u bolesnika kod kojih je moguć rizik od događaja krvarenja (vidjeti “Mijelosupresija” i “Hemoragija”).
The risk of vascular occlusive events is likely to be dose-related (see sections 4.2 and 5.1). 
Rizik od događaja vaskularne okluzije je vjerojatno povezan s dozom (vidjeti dijelove 4.2 i 5.1).
Multiple doses of 90 mg per day for 12 days in a patient resulted in pneumonia, systemic inflammatory response, atrial fibrillation, and asymptomatic, moderate pericardial effusion. 
Višestruke doze od 90 mg dnevno tijekom 12 dana rezultirale su pneumonijom, sistemnim upalnim odgovorom organizma, fibrilacijom atrija i asimptomatskom, umjerenom efuzijom perikarda.
• heart problems, including heart failure, irregular heartbeats, and QT prolongation 
• probleme sa srcem, uključujući zatajenje srca, nepravilan ritam srca, i produljenje QT
All patients received 45 mg Iclusig once daily. 
Svi bolesnici primali su 45 mg lijeka Iclusig jednom dnevno.
At the time of reporting, all ongoing patients had a minimum follow-up of 27 months. 
U vrijeme podnošenja izvješća svi uključeni bolesnici bili su praćeni tijekom najmanje 27 mjeseci.
At the time of reporting, 25 CP-CML patients were in MCyR (median duration of MCyR had not been reached). 
U vrijeme izvještavanja 25 bolesnika u kroničnoj fazi KML bili su u MCyR (medijan trajanja MCyR nije dosegnut).
The European Medicines Agency has deferred the obligation to submit the results of studies with Iclusig in paediatric patients from 1 year to less than 18 years in CML and Ph+ ALL (see section 4.2 for information on paediatric use). 
Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka Iclusig u pedijatrijskih bolesnika od godine dana do 18 godina s KML i Ph+ALL (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
(95% CI) Complete (CCyR) 
(95% CI) Kompletni (CCyR)
The most common serious adverse reactions >1% (treatment-emergent frequencies) were pancreatitis (5.6%), pyrexia (4.2%), abdominal pain (4.0%), myocardial infarction (3.6%), atrial fibrillation (3.3%), anaemia, (3.3%), platelet count decreased (3.1%), febrile neutropenia (2.9%), cardiac failure (2.0%), lipase increased (1.8%), dyspnea (1.6%), diarrhoea (1.6%), neutrophil count decreased (1.3%), pancytopenia (1.3%), and pericardial effusion (1.3%). 
Najčešće ozbiljne nuspojave (>1%) (učestalost nuspojava izazvanih liječenjem) bile su pankreatitis (5,6%), pireksija (4,2%), bol u abdomenu (4,0%), infarkt miokarda (3,6%), fibrilacija atrija (3,3%), anemija (3,3%), smanjenje broja trombocita (3,1%), febrilna neutropenija (2,9%), zatajenje srca (2,0%), porast lipaze (1,8%), dispneja (1,6%), proljev (1,6%), smanjenje broja neutrofila (1,3%), pancitopenija (1,3%) i efuzija perikarda (1,3%).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. 
Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi trebali uzimati ovaj lijek.
Dose modifications for neutropenia (ANC* < 1.0 x 109/L) and thrombocytopenia (platelet < 50 x 109/L) that are unrelated to leukaemia are summarized in Table 1. 
Prilagođavanje doze zbog neutropenije (ABN* < 1,0 x 109/l) i trombocitopenije (trombociti < 50 x 109/l) koje nisu povezane s leukemijom prikazane su u Tablici 1.
There is insufficient data available to make formal recommendations on dose reduction (in the absence of an adverse event) in patients with chronic phase (CP) CML patients who have achieved Major Cytogenetic Response. 
Nema dovoljno dostupnih podataka za formalnu preporuku smanjenja doze (u odsutstvu štetnih događaja) u bolesnika s kroničnom fazom KML koji su postigli veći citogenetički odgovor.
At doses of 30 mg or greater plasma steady state trough concentrations of ponatinib typically exceed 21 ng/mL (40 nM). 
Pri dozama od 30 mg ili većim u stanju dinamičke ravnoteže koncentracija ponatiniba obično prelazi 21 ng/ml (40 nM).
• digoxin: a medicine to treat heart weakness. 
• digoksin: lijek za liječenje slabosti srca.
Although renal excretion is not a major route of ponatinib elimination, the potential for moderate or severe renal impairment to affect hepatic elimination has not been determined (see section 4.2). 
Iako izlučivanje putem bubrega nije glavni put eliminacije ponatiniba, moguć utjecaj umjerenog ili teškog oštećenja bubrega na eliminaciju putem jetre nije utvrđen (vidjeti dio 4.2).
Iclusig treatment should be temporarily interrupted if hypertension is not medically controlled. 
Liječenje Iclusigom se mora privremeno prekinuti ako se hipertenzija ne kontrolira lijekovima.
For all patients in the phase 2 trial, the dose intensity-safety relationship indicated that there are significant increases in grade ≥ 3 adverse events (cardiac failure, arterial thrombosis, hypertension, thrombocytopenia, pancreatitis, neutropenia, rash, ALT increase, AST increase, lipase increase, myelosuppression) over the dose range of 15 to 45 mg once-daily. 
Za sve bolesnike u ispitivanju faze 2, odnos jačina doze-sigurnost ukazao je na značajna povećanja štetnih događaja stupnja ≥ 3 (zatajenje srca, arterijska tromboza, hipertenzija, trombocitopenija, pankreatitis, neutropenija, osip, povećanje ALT, povećanje AST, povećanje lipaze, mijelosupresija) u rasponu doze od 15 do 45 mg jednom dnevno.
All patients were administered 45 mg of Iclusig once-daily with the possibility of dose de-escalations and dose interruptions followed by dose resumption and re-escalation. 
Svi bolesnici primili su 45 mg lijeka Iclusig jednom dnevno s mogućnosti smanjenja doze i prekida doze, a potom ponovni nastavak doziranja i povišenje doze.
Grade 3 or 4 asymptomatic elevation of lipase/amylase (> 2.0 x IULN*) only 
Samo asimptomatsko povišenje lipaze/amilaze 3. ili 4. stupnja (> 2,0 x IGGN*)
Fatal and serious heart failure or left ventricular dysfunction occurred in Iclusig-treated patients, including events related to prior vascular occlusive events. 
Smrtonosno i ozbiljno zatajenje srca ili disfunkcija lijeve klijetke javili su se u bolesnika liječenih Iclusigom, uključujući i događaje povezane s ranijim događajima vaskularne okluzije.
Monitor patients for signs or symptoms consistent with heart failure and treat as clinically indicated, including interruption of Iclusig. 
Pratite bolesnike zbog otkrivanja znakova i simptoma koji ukazuju na zatajenje srca i liječite ih sukladno kliničkoj indikaciji, uključujući i prekid davanja Iclusiga.
• narrowing of the arteries in the brain 
• suženje arterija u mozgu
In the event of an overdose of Iclusig, the patient should be observed and appropriate supportive treatment given. 
U slučaju predoziranja lijekom Iclusig bolesnike treba nadzirati i primijeniti odgovarajuće potporne mjere liječenja.
Anaemia (Hgb decreased) 
Anemija (snižen Hgb)
Liver function abnormality 
Abnormalna jetrena funkcija
Multiple foetal soft tissue and skeletal alterations were also observed at maternal nontoxic dosages. 
Višestruke izmjene mekog tkiva i kostura fetusa također su uočene pri dozama koje nisu bile toksične za majku.
In a cell-based accelerated mutagenesis assay, no mutation in BCR-ABL was detected that could confer resistance to 40 nM ponatinib. 
U ubrzanom testu mutagenosti provedenom na stanicama nisu uočene BCR-ABL mutacije koje bi prouzrokovale rezistenciju na 40 nM ponatiniba.
Overall, the most common adverse reactions (≥20%) were platelet count decreased, rash, dry skin, and abdominal pain. 
Ukupno gledano najčešće nuspojave (≥20%) bile su pad broja trombocita, osip, suha koža i bol u abdomenu.
Consider discontinuing ponatinib if a complete haematologic response has not occurred by 3 months (90 days). 
Razmotrite prekid davanja ponatiniba ako se potpuni hematološki odgovor ne javi za 3 mjeseca (90 dana).
Ponatinib is mainly eliminated via faeces. 
Ponatinib se uglavnom uklanja fecesom.
Of the CP-CML patients with no mutation detected at entry, 46% (63/136) achieved a MCyR. 
Od ukupnog broja bolesnika u kroničnoj fazi KML bez mutacija prilikom uključivanja, 46% (63/136) postiglo je MCyR.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, silica (colloidal anhydrous), magnesium stearate, talc, macrogol 3000, polyvinyl alcohol, titanium dioxide (E171). 
• Drugi sastojci su laktoza hidrat, mikrokristalična celuloza, natrijev škroboglikolat, silicijev dioksid (koloidni bezvodni), magnezijev stearat, talk, makrogol 4000, poli(vinilni alkohol), titanijev dioksid (E171).
• narrowing of the blood vessels, poor blood circulation 
• suženje krvnih žila, slaba cirkulacija krvi
The QT interval prolongation potential of Iclusig was assessed in 39 leukaemia patients and no clinically significant QT prolongation was observed (see section 5.1). 
Utjecaj lijeka Inclusig na produljenje QT intervala ispitano je u 39 bolesnika s leukemijom te nije uočeno značajno produljenje QT intervala (vidjeti dio 5.1).
ARIAD Pharma Ltd. Riverbridge House Guildford Road Leatherhead Surrey KT22 9AD United Kingdom 
Riverbridge House Guildford Road Leatherhead Surrey KT22 9AD Velika Britanija
Haematological Response Rate Majora (MaHR) 
Stopa hematološkog odgovora Značajana (MaHR)
Consider discontinuation of ponatinib in patients who develop serious heart failure (see sections 4.2 and 4.8). 
Razmotrite prekid davanja ponatiniba u bolesnika kod kojih se razvije ozbiljno zatajenje srca (vidjeti dijelove 4.2 i 4.8).
• chronic myeloid leukaemia (CML): a blood cancer involving too many abnormal white blood cells in the blood and the bone marrow (where blood cells are formed). 
• kroničnom mijeloičnom leukemijom (KML): rakom krvi s previše nenormalnih bijelih krvnih stanica u krvi i koštanoj srži (u kojoj se stvaraju krvne stanice).
Ponatinib inhibits the activity of other clinically relevant kinases with IC50 values below 20 nM and has demonstrated cellular activity against RET, FLT3, and KIT and members of the FGFR, PDGFR, and VEGFR families of kinases. 
Ponatinib inhibira aktivnost drugih klinički značajnih kinaza s vrijednostima IC50 ispod 20 nM i dokazano smanjuje aktivnost RET, FLT3 i KIT te članova obitelji kinaza FGFR, PDGFR i VEGFR.
• increased blood sugar or uric acid levels in the blood, high blood fat values of triglycerides 
• povišene razine šećera ili mokraćne kiseline u krvi, visoke razine triglicerida u krvi
Patients with estimated creatinine clearance of ≥ 50 mL/min should be able to safely receive Iclusig with no dosage adjustment. 
Bolesnici s klirensom kreatinina ≥ 50 ml/min mogu primati Iclusig bez prilagodbe doze.
• a liver or pancreas disorder or reduced kidney function. 
• poremećaj jetre ili gušterače ili smanjenu funkciju bubrega
Therapy should be initiated by a physician experienced in the diagnosis and treatment of patients with leukaemia. 
Liječenje treba provesti liječnik s iskustvom u dijagnosticiranju i liječenju bolesnika s leukemijom.
Very common alanine aminotransferase increased, aspartate aminotransferase increased 
Vrlo često povišena alanin aminotransferaza, povišena aspartat aminotransferaza
Very common hypertension 
Vrlo često hipertenzija
The geometric mean (CV%) Cmax and AUC(0-τ) exposures achieved for ponatinib 45 mg daily at steady state were 77 ng/mL (50%) and 1296 ng•hr/mL (48%), respectively. 
Geometrijska sredina (CV%) Cmax i AUC(0-τ) izloženosti postignute za ponatinib 45 mg dnevno u stanju dinamičke ravnoteže je 77 ng/ml (50%) odnosno 1296 ng•hr/ml (48%).
• increased blood level of bilirubin - the yellow breakdown substance of the blood pigment 
• povišena razina bilirubina u krvi - žuti razgradni produkt krvnog pigmenta
Iclusig may result in elevation in ALT, AST, bilirubin, and alkaline phosphatase. 
Iclusig može uzrokovati porast vrijednosti ALT-a, AST-a, bilirubina i alkalne fosfataze.
PHARMACEUTICAL FORM AND CONTENTS 60 tablets 
OBLIK I SADRŽAJ 60 tableta
• dabigatran: a medicine to prevent the formation of blood clots. 
• dabigatran: lijek za sprječavanje nastanka krvnih ugrušaka.
- increased levels of the serum proteins lipase or amylase. 
- povišene razine proteina lipaza ili amilaza u serumu.