FrancophonIA/ELRC3.0 huggingface dataset:
English: Posaconazole plasma concentrations following administration of posaconazole may increase over time in some patients (see section 5.2).
Croatian: U nekih se bolesnika koncentracije posakonazola u plazmi nakon primjene posakonazola mogu s vremenom povećavati (vidjeti dio 5.2).
English: Repeat dose administration of oral posaconazole oral suspension (400 mg twice daily for 16 days) increased the Cmax and AUC of sirolimus (2 mg single dose) an average of 6.7-fold and 8.9-fold (range 3.1 to 17.5-fold), respectively, in healthy subjects.
Croatian: Primjenom višestrukih doza posakonazol oralne suspenzije (400 mg dva puta na dan tijekom 16 dana) u zdravih se ispitanika Cmax sirolimusa (primijenjenog u jednokratnoj dozi od 2 mg) povećao za prosječno 6,7 puta, a AUC za prosječno 8,9 puta (raspon od 3,1 do 17,5 puta).
English: Clinical success rate at Day 14 Clinical success rate 4 weeks after end of treatment
Croatian: Tablica 4. Postotak kliničkog uspjeha u liječenju kandidijaze usta i ždrijela Mjera ishoda
English: Hydrochloric acid [for pH adjustment] Sodium hydroxide [for pH adjustment] Water for injections
Croatian: 6.1 Popis pomoćnih tvari natrijev sulfobutileter β-ciklodekstrin (SBECD) dinatrijev edetat kloridna kiselina [za podešavanje pH] natrijev hidroksid [za podešavanje pH] voda za injekcije
English: • heart rhythm problems
Croatian: • tegobe sa srčanim ritmom,
English: Each vial contains 300 mg of posaconazole.
Croatian: Jedna bočica sadrži 300 mg posakonazola.
English: Fusarium spp.
Croatian: Vrste roda Fusarium
English: • nausea or vomit (feeling or being sick), diarrhoea
Croatian: • mučnina ili povraćanje, proljev
English: Echocardiography revealed no indication of cardiac decompensation in a repeat dose safety pharmacology study in rats at a systemic exposure 2.2-fold greater than that achieved therapeutically.
Croatian: U farmakološkom ispitivanju sigurnosti ponovljenih doza u štakora, ehokardiografijom nisu utvrđeni znakovi dekompenzacije srca pri sustavnoj izloženosti 2,2 puta većoj od one koja se postiže tijekom liječenja.
English: Investigations Uncommon:
Croatian: Pretrage Manje često:
English: The tablet formulation was investigated in AML and MDS patients and those after HSCT with or at risk for Graft versus Host Disease (GvHD) only.
Croatian: Formulacija u tableti ispitana je samo u bolesnika s akutnom mijeloičnom leukemijom (AML) ili mijelodisplastičnim sindromom (MDS) te u bolesnika nakon transplantacije hematopoetskih matičnih stanica (HSCT) s reakcijom presatka protiv primatelja (engl. graft versus host disease, GVHD) ili rizikom od njena nastanka.
English: Echocardiography revealed no indication of cardiac decompensation in a repeat dose safety pharmacology study in rats at a systemic exposure 2.1-fold greater than that achieved therapeutically.
Croatian: U farmakološkom ispitivanju sigurnosti ponovljenih doza u štakora, ehokardiografijom nisu utvrđeni znakovi dekompenzacije srca pri sustavnoj izloženosti 2,1 puta većoj od one koja se postiže tijekom liječenja.
English: Posaconazole plasma concentrations following administration of posaconazole tablets may increase over time in some patients.
Croatian: Nakon primjene posakonazol tableta u nekih bolesnika mogu se tijekom vremena povećati koncentracije posakonazola u plazmi.
English: - The active substance in Noxafil is posaconazole.
Croatian: - Djelatna tvar u lijeku Noxafil je posakonazol.
English: • feeling weak, dizzy, tired or sleepy
Croatian: • slabost, omaglica, umor ili pospanost
English: • pneumonia - signs include feeling short of breath and producing discoloured phlegm
Croatian: • upala pluća - znakovi uključuju nedostatak zraka i promjenu boje iskašljaja
English: oedema, pain, chills, malaise, chest discomfort, drug intolerance, feeling jittery, mucosal inflammation
Croatian: edem, bol, zimica, opća slabost, nelagoda u prsištu, nepodnošenje lijeka, osjećaj treme, upala sluznica
English: The length of treatment may depend on the type of infection that you have or the length of time your immune system is not working properly and may be individually adapted for you by your doctor.
Croatian: Vam imunološki sustav ne radi pravilno, a liječnik ga može individualno prilagoditi Vašim potrebama.
English: Q1 Q2 Q3 Q4
Croatian: Q3
English: Gender The pharmacokinetics of posaconazole are comparable in men and women.
Croatian: Spol Farmakokinetika posakonazola u žena usporediva je s onom u muškaraca.
English: Repeat dose administration of fosamprenavir (700 mg twice daily x 10 days) decreased the Cmax and AUC of posaconazole oral suspension (200 mg once daily on the st day, 200 mg twice daily on the 2
Croatian: Primjena višekratnih doza fosamprenavira (700 mg dvaput na dan tijekom 10 dana) s oralnom suspenzijom posakonazola (200 mg jedanput na dan prvog dana, 200 mg dvaput na dan drugog dana, a zatim 400 mg dvaput na dan sljedećih 8 dana) snizila je Cmax posakonazola za 21%, a AUC za 23%.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Noxafil.
Croatian: Ako se nešto od gore navedenog odnosi na Vas (ili niste sigurni), obratite se svom liječniku ili ljekarniku prije nego uzmete Noxafil.
English: - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (GVHD) and who are at high risk of developing invasive fungal infections.
Croatian: Noxafil koncentrat za otopinu za infuziju indiciran je i za profilaksu invazivnih gljivičnih infekcija u sljedećih bolesnika: - u bolesnika s akutnom mijeloičnom leukemijom (AML) ili mijelodisplastičnim sindromima (MDS) koji primaju kemoterapiju za postizanje remisije bolesti za koju se očekuje da će izazvati dugotrajnu neutropeniju i u kojih postoji velik rizik za razvoj invazivnih gljivičnih infekcija; - u primatelja transplantiranih hematopoetskih matičnih stanica (HSCT) koji primaju visoke doze imunosupresiva zbog reakcije presatka protiv primatelja (engl. graft-versus-host disease, GVHD) i u kojih postoji velik rizik za razvoj invazivnih gljivičnih infekcija.
English: Respiratory, thoracic and mediastinal disorders Uncommon:
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Manje često:
English: Sixteen patients 8-17 years of age were treated with posaconazole oral suspension 800 mg/day in a study for invasive fungal infections.
Croatian: U ispitivanju liječenja invazivnih gljivičnih infekcija 16 bolesnika u dobi od 8-17 godina liječeno je posakonazol oralnom suspenzijom u dozi od 800 mg na dan.
English: Glycerol
Croatian: GVHD
English: If you are concerned that you may have taken too much, contact your doctor or healthcare professional immediately.
Croatian: Ako uzmete više lijeka Noxafil nego što ste trebali Ako mislite da ste uzeli previše lijeka Noxafil, odmah se obratite liječniku ili drugom zdravstvenom radniku.
English: • low potassium levels - shown up in blood tests
Croatian: • niske razine kalija - vide se na krvnim pretragama
English: August 2021
Croatian: kolovoz 2021.
English: Vascular occlusive events occurred in 44 of these 131 patients.
Croatian: Događaji vaskularne okluzije javili su se u 44 od tih 131 bolesnika.
English: 93055 Regensburg Germany
Croatian: 93055 Regensburg
English: The safety and efficacy of Iclusig in patients less than 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost u bolesnika mlađih od 18 godina još nije ustanovljena.
English: 4879 AC Etten-Leur Netherlands
Croatian: 4879 AC Etten-Leur Nizozemska
English: 1105 BP Amsterdam Netherlands
Croatian: 1105 BP Amsterdam Nizozemska
English: What you need to know before you take Iclusig Do not take Iclusig
Croatian: Što morate znati prije nego počnete uzimati Iclusig
English: • if you are allergic to ponatinib or any of the other ingredients of this medicine (listed in section
Croatian: • ako ste alergični na ponatinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Date of latest renewal: 8 February 2018
Croatian: Datum posljednje obnove odobrenja: 8. veljače 2018.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovog lijeka.
English: Tell your doctor straight away if you experience any of these symptoms during your treatment with ponatinib, because it could be serious.
Croatian: Odmah obavijestite svog liječnika ukoliko primijetite bilo koji od ovih simptoma tijekom liječenja ponatinibom jer stanje može biti ozbiljno.
English: Efficacy results are summarized in Table 7, Table 8, and Table 9.
Croatian: Rezultati djelotvornosti sažeti su u Tablici 7, Tablici 8 i Tablici 9.
English: Most patients who had an event of hepatotoxicity had their first event during the first year of treatment.
Croatian: U većine bolesnika koji su imali događaj hepatotoksičnosti prvi je događaj zabilježen tijekom prve godine liječenja.
English: Baseline demographic characteristics are described in Table 6 below.
Croatian: Početne demografske karakteristike opisane su u Tablici 6 u nastavku.
English: * Spontaneous reports from post-marketing experience
Croatian: * Spontane prijave iz iskustva nakon stavljanja lijeka u promet
English: • recurrence (reactivation) of Hepatitis B infection when you have had hepatitis B in the past (a liver infection).
Croatian: • ponovna pojava (ponovna aktivacija) infekcije virusom hepatitisa B ako ste u prošlosti imali hepatitis B (infekciju jetre)
English: Iclusig has minor influence on the ability to drive and use machines.
Croatian: Iclusig ima mali utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: When adjusted for exposure, the incidence of first arterial occlusive events was greatest in the first two years of follow-up and declined with decreasing daily dose intensity (following recommendation for prospective dose reduction).
Croatian: Nakon korekcije za izloženost, incidencija prvih događaja arterijske okluzije bila je najveća u prve dvije godine praćenja i opadala je sa smanjenjem intenziteta dnevne doze (nakon preporuke za prospektivno smanjenjem doze).
English: All patients (N=449)
Croatian: Svi bolesnici (N=449)
English: • headache, confusion, seizures, and loss of vision, which may be symptoms of a brain condition known as posterior reversible encephalopathy syndrome (PRES).
Croatian: • glavobolja, smetenost, napadaji i gubitak vida, što mogu biti simptomi stanja mozga poznatog kao sindrom posteriorne reverzibilne encefalopatije (PRES).
English: Discontinuing ponatinib should be considered if a complete haematologic response has not occurred by 3 months (90 days).
Croatian: Potrebno je razmotriti prekid davanja ponatiniba ako se potpuni hematološki odgovor ne javi za 3 mjeseca (90 dana).
English: See sections 4.2 for the assessment of cardiovascular status prior to start of therapy and 4.4 for situations where an alternative treatment may be considered.
Croatian: Prije početka liječenja vidjeti dio 4.2 za ocjenu kardiovaskularnog stanja i 4.4 za situacije u kojima treba razmotriti alternativno liječenje.
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures: Description
Croatian: Nositelj odobrenja dužan je, unutar navedenog vremenskog okvira, provesti niže navedene mjere: Opis
English: Iclusig should be continued at the same dose
Croatian: Potrebno je nastaviti s lijekom Iclusig pri istoj dozi
English: Gastrointestinal haemorrhage and subdural hematoma were the most commonly reported grade 3/4 bleeding events.
Croatian: Gastrointestinalna hemoragija i subduralni hematom bili su najčešće prijavljeni događaji krvarenja stupnja 3/4.
English: See section 2 “Iclusig contains lactose”.
Croatian: Vidjeti dio 2 „Iclusig sadrži laktozu“.
English: Inform your doctor immediately if you experience these symptoms.
Croatian: Odmah obavijestite svog liječnika ako osjetite takve simptome.
English: Iclusig has been evaluated in safety pharmacology, repeat-dose toxicity, genotoxicity, reproductive toxicity, phototoxicity and carcinogenicity studies.
Croatian: Iclusig je ocijenjen u studijama sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, reproduktivne toksičnosti, fototoksičnosti i kancerogenosti.
English: With a minimum follow-up of 48 months, and approximately 2 years after the recommendation for prospective dose reduction, there were 110 CP-CML patients ongoing.
Croatian: S minimalnim razdobljem praćenja od 48 mjeseci i približno 2 godine nakon preporuke za prospektivno smanjenje doze, bilo je uključeno 110 bolesnika s kroničnom fazom KML-a.
English: The median time to onset of the first cardiovascular, cerebrovascular, and peripheral vascular arterial occlusive events was 351, 611, and 605 days, respectively.
Croatian: Medijan vremena za pojavu prvih događaja kardiovaskularne, cerebrovaskularne i periferne arterijske vaskularne okluzije iznosio je 351, 611, odnosno 605 dana.
English: • you have a liver disorder.
Croatian: • ako imate poremećaj jetre.
English: Table 11 shows these data for patients who achieved MCyR and MMR at 45 mg; similar data are available for patients who achieved MCyR and MMR at 30 mg.
Croatian: Tablica 11 pokazuje te podatke za bolesnike koji su postigli MCyR i MMR pri 45 mg; slični su podatci dostupni za bolesnike koji su postigli MCyR i MMR pri 30 mg.
English: Patients should be tested for HBV infection before initiating treatment with Iclusig.
Croatian: Bolesnike je potrebno testirati na infekciju HBV-om prije početka liječenja Iclusig.
English: No venous occlusive events were fatal.
Croatian: Niti jedan događaj venske okluzije nije imao smrtni ishod.
English: • blood clot in the main arteries carrying blood to the head or neck (carotid artery)
Croatian: • krvni ugrušak u glavnim arterijama koje dovode krv u glavu ili vrat (karotidna arterija)
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors, ATC code: L01XE24
Croatian: Farmakoterapijska skupina: antineoplastici, inhibitori protein kinaze, ATK oznaka: L01XE24
English: Iclusig is used to treat adults with the following leukaemia types who are no longer benefiting from treatment with other medicines, or have a certain genetic difference known as a T315I mutation:
Croatian: Iclusig se koristi za liječenje odraslih bolesnika sa sljedećim tipovima leukemije koji više nemaju koristi od liječenja drugim lijekovima ili imaju određenu genetsku razliku poznatu kao mutacija
English: Incyte Biosciences Distribution B.V. Paasheuvelweg 25
Croatian: Incyte Biosciences Distribution B.V.
English: At doses of 15 mg or greater, 32 of 34 patients (94%) demonstrated a ≥ 50% reduction of CRK-like (CRKL) phosphorylation, a biomarker of BCR-ABL inhibition, in peripheral blood mononuclear cells.
Croatian: Pri dozama od 15 mg ili većim, 32 od 34 bolesnika (94%) pokazala su redukciju od ≥ 50% fosforilacije CRK-like (CRKL), biomarkera za inhibiciju BCR-ABL u mononuklearnim stanicama periferne krvi.
English: Additionally, after approximately 2 years of follow-up, all patients who were still taking a 45 mg daily dose were recommended to undergo a dose reduction, even in the absence of adverse events, in response to the continued occurrence of vascular occlusive events in the clinical trial.
Croatian: Uz to, nakon približno 2 godine praćenja svim bolesnicima koji su još uvijek uzimali dnevne doze od 45 mg preporučeno je smanjenje doze, čak i pri nepostojanju nuspojava, kao reakcija na nastavak pojave vaskularnih okluzivnih događaja u kliničkom ispitivanju.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Outer Carton:
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO
English: Patients should be warned to immediately report suspected skin reactions, especially if associated with blistering, peeling, mucosal involvement or systemic symptoms.
Croatian: Bolesnike je potrebno upozoriti da odmah prijave sve suspektne kožne reakcije, posebno ako su povezane s nastankom mjehurića, ljuštenjem kože, zahvaćanjem sluznice ili sistemskim simptomima.
English: PRES is a neurological disorder that can present with signs and symptoms such as seizure, headache, decreased alertness, altered mental functioning, vision loss, and other visual and neurological disturbances.
Croatian: PRES je neurološki poremećaj koji se može očitovati znakovima i simptomima kao što su napadaj, glavobolja, smanjena pozornost, promijenjeno mentalno funkcioniranje, gubitak vida i drugi poremećaji vida i neurološki poremećaji.
English: Check serum lipase every 2 weeks for the first 2 months and then periodically thereafter.
Croatian: Serumsku lipazu treba kontrolirati svaka 2 tjedna tijekom prva 2 mjeseca, a zatim periodično.
English: In a patient suspected of developing an arterial occlusive event or a venous thromboembolism, Iclusig should be immediately interrupted.
Croatian: U bolesnika kod kojih se sumnja na razvoj arterijskog okluzivnog događaja ili venske tromboembolije, primjena Iclusiga se mora odmah prekinuti.
English: Most of the patients with grade 3 or 4 platelet count decreased, anaemia or neutropenia, developed it within the first 3 months of treatment.
Croatian: U većine bolesnika sa smanjenjem trombocita stupnja 3 ili 4, anemijom ili neutropenijom stanje je nastalo unutar prva tri mjeseca liječenja.
English: Do not crush or dissolve the tablets.
Croatian: Nemojte drobiti ili otapati tablete.
English: Data from the phase 2 trial are available on the maintenance of response (MCyR and MMR) in all CPCML patients who underwent dose reduction for any reason.
Croatian: Dostupni su podatci iz ispitivanja faze 2 o održavanju odgovora (MCyR i MMR) u svih bolesnika u kroničnoj fazi KML-a kojima je iz bilo kojeg razloga smanjena doza.
English: Iclusig has not been studied at doses above 30 mg in patients with hepatic impairment (Childs-Pugh Classes A, B & C).
Croatian: Iclusig nije ispitivan u dozama iznad 30 mg u bolesnika s oštećenjem funkcije jetre (Child-Pugh stadiji A, B i C).
English: Database cutoff date 06 February 2017.
Croatian: Zaključni datum baze podataka 06. veljače 2017.
English: At the time of updated reporting with minimum follow-up for all ongoing patients of 64 months, the median durations of MCyR and MMR had not yet been reached.
Croatian: U vrijeme podnošenja ažuriranog izvješća s praćenjem svih uključenih bolesnika tijekom najmanje 64 mjeseca, medijan trajanja MCyR i MMR još nije bio dosegnut.
English: At the time of reporting, 25 CP-CML patients were in MCyR (median duration of MCyR had not been reached).
Croatian: U vrijeme izvještavanja 25 bolesnika u kroničnoj fazi KML-a bili su u MCyR (medijan trajanja MCyR nije dosegnut).
English: Intrinsic factors affecting ponatinib pharmacokinetics No specific studies have been performed to evaluate the effects of gender, age, race, and body weight on ponatinib pharmacokinetics.
Croatian: Intrinzični faktori koji djeluju na farmakokinetiku ponatiniba Nisu provedena ispitivanja za ocjenu utjecaja spola, dobi, rase i tjelesne težine na farmakokinetiku ponatiniba.
English: The 0.8 mg/kg/day dose in females resulted in a plasma exposure level generally lower or equivalent to the human exposure at the range of dose from 15 mg to 45 mg daily.
Croatian: Doza od 0,8 mg/kg/dan u ženki rezultirala je razinom plazmatske izloženosti općenito nižom ili jednakom izloženosti u ljudi pri rasponu dnevne doze od 15 mg do 45 mg.
English: • swollen, or red area of skin that feels hot and tender (cellulitis)
Croatian: • natečena ili crvena područja kože koja su vruća i osjetljiva na dodir (celulitis)
English: Compared to healthy volunteers with normal liver function, no major differences in ponatinib PK were observed in patients with varying degrees of hepatic impairment.
Croatian: U usporedbi sa zdravim dobrovoljcima s normalnom funkcijom jetre, nisu uočene veće razlike u farmakokinetičkim parametrima ponatiniba u bolesnika s različitim stupnjevima oštećenja jetre.
English: The risk of arterial occlusive events is likely to be dose-related.
Croatian: Rizik od događaja arterijske okluzije je vjerojatno povezan s dozom.
English: Of the CP-CML patients with no mutation detected at entry, 49% (66/136) achieved a MCyR.
Croatian: Od ukupnog broja bolesnika u kroničnoj fazi KML-a bez mutacija prilikom uključivanja, 49% (66/136) postiglo je MCyR.
English: In vitro data showed no difference in plasma protein binding in plasma samples of healthy subjects and hepatically impaired (mild, moderate and severe) subjects.
Croatian: Podaci in vitro nisu pokazali razliku u vezivanju proteina plazme između uzoraka plazme zdravih ispitanika i onih s oštećenjem jetre (blagim, umjerenim ili teškim).
English: CP -CML patients who achieved MCyR or MMR response within the first year of treatment had statistically significantly improved progression-free (PFS) and overall survival (OS) compared to those patients who did not meet the treatment milestones.
Croatian: Bolesnici u kroničnoj fazi KML-a koji su postigli MCyR ili MMR odgovor tijekom prve godine liječenja imali su statistički značajno poboljšano preživljenje bez napredovanja bolesti (PFS) i ukupno preživljenje (OS) u usporedbi s bolesnicima koji nisu postigli ciljeve liječenja.
English: amylase alkaline phosphatase gamma-glutamyltransferase
Croatian: amilaze alkalne fosfataze gama-glutamiltrasnferaze
English: In a fertility study in male and female rats, female fertility parameters were reduced at dose levels corresponding to human clinical exposures.
Croatian: U studiji plodnosti u mužjaka i ženki štakora, parametri plodnosti u ženki smanjeni su pri razinama doza koje odgovaraju kliničkim izloženostima u ljudi.
English: • ever had or might now have a hepatitis B infection.
Croatian: • ili ste ikada imali infekciju virusom hepatitisa B.
English: • uncomfortable pressure, fullness, squeezing or pain in the centre of the chest (Angina pectoris) and chest pain not in connection with the heart
Croatian: • neugodan pritisak, osjećaj punoće, stezanje ili bol u sredini prsnog koša (angina pectoris) i bol u prsnom košu koja nije povezana sa srcem
English: Your doctor may reduce your dose or tell you to temporarily stop taking Iclusig if:
Croatian: Vaš liječnik može smanjiti Vašu dozu ili Vam reći da privremeno prekinete uzimati Iclusig: • ako je postignut odgovarajući odgovor na liječenje.
English: Ponatinib is highly bound (> 99%) to plasma proteins in vitro.
Croatian: Ponatinib se izrazito veže na proteine plazme (> 99%) u in vitro uvjetima.
English: Dose interruption or discontinuation may be required as described in Table 3.
Croatian: Hepatotoksičnost Može biti potreban prekid ili obustava liječenja kako je objašnjeno u Tablici 3.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Iclusig in children from birth to less than 1 year in CML and Ph+ ALL.
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Iclusig u djece od rođenja do manje od godine dana s KML i Ph+ALL.
English: In rats, treatment with ponatinib has shown effects on female fertility and male fertility was not affected (see section 5.3).
Croatian: U štakora je liječenje ponatinibom pokazalo učinak na plodnost u ženki, no nije bilo učinka na plodnost u mužjaka (vidjeti dio 5.3).
English: Before initiating Iclusig, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Croatian: Prije početka primjene lijeka Iclusig potrebno je pažljivo razmotriti ovaj rizik u bolesnika s čimbenicima rizika kao što su hipertenzija ili aneurizma u anamnezi.
English: Formal studies of ponatinib with anti-clotting medicinal products have not been conducted.
Croatian: Službena ispitivanja ponatiniba s lijekovima protiv zgrušavanja nisu provedena.