natgillin/translations-raw huggingface dataset:
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).
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).
All patients (N=449)
Svi bolesnici (N=449)
• headache, confusion, seizures, and loss of vision, which may be symptoms of a brain condition known as posterior reversible encephalopathy syndrome (PRES).
• glavobolja, smetenost, napadaji i gubitak vida, što mogu biti simptomi stanja mozga poznatog kao sindrom posteriorne reverzibilne encefalopatije (PRES).
Discontinuing ponatinib should be considered if a complete haematologic response has not occurred by 3 months (90 days).
Potrebno je razmotriti prekid davanja ponatiniba ako se potpuni hematološki odgovor ne javi za 3 mjeseca (90 dana).
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.
Prije početka liječenja vidjeti dio 4.2 za ocjenu kardiovaskularnog stanja i 4.4 za situacije u kojima treba razmotriti alternativno liječenje.
• Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures: Description
Nositelj odobrenja dužan je, unutar navedenog vremenskog okvira, provesti niže navedene mjere: Opis
Iclusig should be continued at the same dose
Potrebno je nastaviti s lijekom Iclusig pri istoj dozi
Gastrointestinal haemorrhage and subdural hematoma were the most commonly reported grade 3/4 bleeding events.
Gastrointestinalna hemoragija i subduralni hematom bili su najčešće prijavljeni događaji krvarenja stupnja 3/4.
See section 2 “Iclusig contains lactose”.
Vidjeti dio 2 „Iclusig sadrži laktozu“.
Inform your doctor immediately if you experience these symptoms.
Odmah obavijestite svog liječnika ako osjetite takve simptome.
Iclusig has been evaluated in safety pharmacology, repeat-dose toxicity, genotoxicity, reproductive toxicity, phototoxicity and carcinogenicity studies.
Iclusig je ocijenjen u studijama sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, reproduktivne toksičnosti, fototoksičnosti i kancerogenosti.
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.
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.
The median time to onset of the first cardiovascular, cerebrovascular, and peripheral vascular arterial occlusive events was 351, 611, and 605 days, respectively.
Medijan vremena za pojavu prvih događaja kardiovaskularne, cerebrovaskularne i periferne arterijske vaskularne okluzije iznosio je 351, 611, odnosno 605 dana.
• you have a liver disorder.
• ako imate poremećaj jetre.
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.
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.
Patients should be tested for HBV infection before initiating treatment with Iclusig.
Bolesnike je potrebno testirati na infekciju HBV-om prije početka liječenja Iclusig.
No venous occlusive events were fatal.
Niti jedan događaj venske okluzije nije imao smrtni ishod.
• blood clot in the main arteries carrying blood to the head or neck (carotid artery)
• krvni ugrušak u glavnim arterijama koje dovode krv u glavu ili vrat (karotidna arterija)
Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors, ATC code: L01XE24
Farmakoterapijska skupina: antineoplastici, inhibitori protein kinaze, ATK oznaka: L01XE24
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:
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
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.
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.
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.
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.
OTHER SPECIAL WARNING(S), IF NECESSARY Outer Carton:
DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO
Patients should be warned to immediately report suspected skin reactions, especially if associated with blistering, peeling, mucosal involvement or systemic symptoms.
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.
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.
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.
Check serum lipase every 2 weeks for the first 2 months and then periodically thereafter.
Serumsku lipazu treba kontrolirati svaka 2 tjedna tijekom prva 2 mjeseca, a zatim periodično.
In a patient suspected of developing an arterial occlusive event or a venous thromboembolism, Iclusig should be immediately interrupted.
U bolesnika kod kojih se sumnja na razvoj arterijskog okluzivnog događaja ili venske tromboembolije, primjena Iclusiga se mora odmah prekinuti.
Most of the patients with grade 3 or 4 platelet count decreased, anaemia or neutropenia, developed it within the first 3 months of treatment.
U većine bolesnika sa smanjenjem trombocita stupnja 3 ili 4, anemijom ili neutropenijom stanje je nastalo unutar prva tri mjeseca liječenja.
Do not crush or dissolve the tablets.
Nemojte drobiti ili otapati tablete.
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.
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.
Iclusig has not been studied at doses above 30 mg in patients with hepatic impairment (Childs-Pugh Classes A, B & C).
Iclusig nije ispitivan u dozama iznad 30 mg u bolesnika s oštećenjem funkcije jetre (Child-Pugh stadiji A, B i C).
Database cutoff date 06 February 2017.
Zaključni datum baze podataka 06. veljače 2017.
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.
U vrijeme podnošenja ažuriranog izvješća s praćenjem svih uključenih bolesnika tijekom najmanje 64 mjeseca, medijan trajanja MCyR i MMR još nije bio dosegnut.
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-a bili su u MCyR (medijan trajanja MCyR nije dosegnut).
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.
Intrinzični faktori koji djeluju na farmakokinetiku ponatiniba Nisu provedena ispitivanja za ocjenu utjecaja spola, dobi, rase i tjelesne težine na farmakokinetiku ponatiniba.
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.
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.
• swollen, or red area of skin that feels hot and tender (cellulitis)
• natečena ili crvena područja kože koja su vruća i osjetljiva na dodir (celulitis)
Compared to healthy volunteers with normal liver function, no major differences in ponatinib PK were observed in patients with varying degrees of hepatic impairment.
U usporedbi sa zdravim dobrovoljcima s normalnom funkcijom jetre, nisu uočene veće razlike u farmakokinetičkim parametrima ponatiniba u bolesnika s različitim stupnjevima oštećenja jetre.
The risk of arterial occlusive events is likely to be dose-related.
Rizik od događaja arterijske okluzije je vjerojatno povezan s dozom.
Of the CP-CML patients with no mutation detected at entry, 49% (66/136) achieved a MCyR.
Od ukupnog broja bolesnika u kroničnoj fazi KML-a bez mutacija prilikom uključivanja, 49% (66/136) postiglo je MCyR.
In vitro data showed no difference in plasma protein binding in plasma samples of healthy subjects and hepatically impaired (mild, moderate and severe) subjects.
Podaci in vitro nisu pokazali razliku u vezivanju proteina plazme između uzoraka plazme zdravih ispitanika i onih s oštećenjem jetre (blagim, umjerenim ili teškim).
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.
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.
amylase alkaline phosphatase gamma-glutamyltransferase
amilaze alkalne fosfataze gama-glutamiltrasnferaze
In a fertility study in male and female rats, female fertility parameters were reduced at dose levels corresponding to human clinical exposures.
U studiji plodnosti u mužjaka i ženki štakora, parametri plodnosti u ženki smanjeni su pri razinama doza koje odgovaraju kliničkim izloženostima u ljudi.
• ever had or might now have a hepatitis B infection.
• ili ste ikada imali infekciju virusom hepatitisa B.
• uncomfortable pressure, fullness, squeezing or pain in the centre of the chest (Angina pectoris) and chest pain not in connection with the heart
• neugodan pritisak, osjećaj punoće, stezanje ili bol u sredini prsnog koša (angina pectoris) i bol u prsnom košu koja nije povezana sa srcem
Your doctor may reduce your dose or tell you to temporarily stop taking Iclusig if:
Vaš liječnik može smanjiti Vašu dozu ili Vam reći da privremeno prekinete uzimati Iclusig: • ako je postignut odgovarajući odgovor na liječenje.
Ponatinib is highly bound (> 99%) to plasma proteins in vitro.
Ponatinib se izrazito veže na proteine plazme (> 99%) u in vitro uvjetima.
Dose interruption or discontinuation may be required as described in Table 3.
Hepatotoksičnost Može biti potreban prekid ili obustava liječenja kako je objašnjeno u Tablici 3.
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.
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.
In rats, treatment with ponatinib has shown effects on female fertility and male fertility was not affected (see section 5.3).
U štakora je liječenje ponatinibom pokazalo učinak na plodnost u ženki, no nije bilo učinka na plodnost u mužjaka (vidjeti dio 5.3).
Before initiating Iclusig, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Prije početka primjene lijeka Iclusig potrebno je pažljivo razmotriti ovaj rizik u bolesnika s čimbenicima rizika kao što su hipertenzija ili aneurizma u anamnezi.
Formal studies of ponatinib with anti-clotting medicinal products have not been conducted.
Službena ispitivanja ponatiniba s lijekovima protiv zgrušavanja nisu provedena.
• problems of the blood vessels in the heart muscle
• problemi krvnih žila u srčanom mišiću
A brain condition called posterior reversible encephalopathy syndrome (PRES) has been reported in patients treated with ponatinib.
Stanje mozga pod nazivom sindrom posteriorne reverzibilne encefalopatije (PRES) prijavljeno je u bolesnika koji su liječeni ponatinibom.
Frequency categories are very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from the available data).
(≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
Following a single oral dose of [14C]-labeled ponatinib, approximately 87% of the radioactive dose is recovered in the faeces and approximately 5% in the urine.
Nakon pojedinačne doze [14C]-označenog ponatiniba, približno 87% radioaktivne doze odstranjuje se fecesom, a približno 5% mokraćom.
Carriers of HBV who require treatment with Iclusig should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy (see section 4.8).
Nositelje virusa HBV kojima je potrebno liječenje Iclusig potrebno je pozorno nadzirati radi utvrđivanja eventualnih znakova i simptoma aktivne infekcije HBV-om tijekom terapije te nekoliko mjeseci nakon završetka terapije (vidjeti dio 4.8).
In a two-year carcinogenicity study in male and female rats, oral administration of ponatinib at 0.05, 0.1 and 0.2 mg/kg/day in males and at 0.2 and 0.4 mg/kg/day in females did not result in any tumorigenic effects.
U dvogodišnjoj studiji kancerogenosti u mužjaka i ženki štakora, peroralna primjena ponatiniba u dozama od 0,05, 0,1 i 0,2 mg/kg/dan u mužjaka i dozama od 0,2 i 0,4 mg/kg/dan u ženki nije izazvala tumorogene učinke.
• narrowing of the blood vessels, poor blood circulation, sudden increase in blood pressure
• suženje krvnih žila, slaba cirkulacija krvi, nagli porast krvnog tlaka
Hypertension may contribute to risk of arterial occlusive events.
Hipertenzija može doprinijeti riziku za arterijski okluzivni događaj.
Discontinuation due to myelosuppression was infrequent (thrombocytopenia 4%, neutropenia and anaemia < 1% each).
Prekidi terapije zbog mijelosupresije nisu bili česti (trombocitopenija 4%, neutropenija i anemija <1%
Management of toxicities
Zbrinjavanje toksičnosti
For the overall CP-CML disease group, the probability of survival at 2, 3, 4, and 5 years is estimated as 86.0%, 81.2%, 76.9%, and 73.3%, respectively, as shown in Figure 1.
Za sve bolesnike u skupini bolesti kronične faze KML-a, vjerojatnost preživljenja u 2., 3., 4. i 5. godini procijenjena je na 86,0%, 81,2%, 76,9% odnosno 73,3%, kao što je prikazano na Slici 1.
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 oznake „Rok valjanosti“.
Symptoms may include sudden onset of severe headache, confusion, seizures, and vision changes.
Simptomi mogu uključivati iznenadnu pojavu jake glavobolje, smetenost, napadaje i promjene vida.
• changes in blood levels: decreased number of red blood cells (symptoms include: weakness, dizziness, fatigue) decreased number of blood platelets (symptoms include: increased tendency to bleed or bruise) decreased number of white blood cells called neutrophilis (symptoms include: increase tendency of infection) increased level of the serum protein known as lipase
smanjeni broj crvenih krvnih stanica (simptomi uključuju: slabost, omaglicu, umor) smanjeni broj trombocita (simptomi uključuju: povećanu sklonost krvarenju i nastajanju modrica) smanjeni broj bijelih krvnih stanica zvanih neutrofili (simptomi uključuju: povećanu sklonost infekcijama) povišena razina serumskog proteina zvanog lipaza
Posterior Reversible Encephalopathy Syndrome
Sindrom posteriorne reverzibilne encefalopatije
With once-daily dosing, plasma exposures of ponatinib are increased by approximately 1.5-fold between first dose and steady state conditions.
Pri doziranju jednom dnevno izloženost ponatinibu u plazmi povećava se za približno 1,5 puta između prve doze i stanja dinamičke ravnoteže.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, silica (colloidal anhydrous), magnesium stearate, talc, macrogol 4000, 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).
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.
Figure 1- Kaplan-Meier estimates for overall survival in the CP-CML population (Treated Population)
Slika 1 - Procjene ukupnog preživljenja po Kaplan-Meieru u populaciji s kroničnom fazom KML-a
The probability of all patients with CP CML maintaining MCyR and MMR did not change further when the analysis was extended out to 5 years.
Vjerojatnost održavanja MCyR-a i MMR-a u svih bolesnika u kroničnoj fazi KMLa nije se dodatno promijenila kad je analiza produljena na 5 godina.
SPECIAL STORAGE CONDITIONS Store in the original container in order to protect from light.
POSEBNE MJERE ČUVANJA Čuvati u originalnom spremniku radi zaštite od svjetlosti.
Hypertension may contribute to risk of arterial thrombotic events, including renal artery stenosis.
Hipertenzija može doprinijeti riziku za arterijski trombotski događaj, uključujući stenozu bubrežne arterije.
Co-administration of strong CYP3A4 inducers such as carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, and St. John's Wort with ponatinib should be avoided, and alternatives to the CYP3A4 inducer should be sought, unless the benefit outweighs the possible risk of ponatinib underexposure.
Istovremenu primjenu snažnih CYP3A4 induktora kao što su karbamazepin, fenobarbital, fenitoin, rifabutin, rifampicin, i gospina trava s ponatinibom treba izbjegavati, te potražiti alternative CYP3A4 induktoru, osim ako su koristi veće od mogućeg rizika smanjene izloženosti ponatinibu.
At the time of reporting, all ongoing patients had a minimum follow-up of 64 months.
U vrijeme podnošenja izvješća svi uključeni bolesnici bili su praćeni tijekom najmanje 64 mjeseca.
Patients with hepatic impairment may receive the recommended starting dose.
Oštećenje funkcije jetre Bolesnici s oštećenjem jetre mogu primiti preporučenu početnu dozu.
BCR-ABL mutation detected at entry, n (%)b None a* of 427 patients reporting prior TKI therapy with dasatinib or nilotinib b Of the patients with one or more BCR-ABL kinase domain mutations detected at entry, 37 unique mutations were detected.
BCR-ABL mutacija otkrivena pri ulasku u ispitivanje, n (%)b Nema a* od 427 bolesnika koji su prijavili prethodnu TKI terapiju dasatinibom ili nilotinibom b Među bolesnicima u kojih je pri uključivanju u ispitivanje uočena jedna ili više mutacija u domeni BCR-ABL kinaze, uočeno je 37 jedinstvenih mutacija.
The risk of arterial occlusive events is likely to be dose-related (see sections 4.2 and 5.1).
Rizik od događaja arterijske okluzije je vjerojatno povezan s dozom (vidjeti dijelove 4.2 i 5.1).
The most common serious adverse reactions >2% (treatment-emergent frequencies) were pneumonia (7.3%), pancreatitis (5.8%), abdominal pain (4.7%), atrial fibrillation (4.5%), pyrexia (4.5%), myocardial infarction (4.0%), peripheral arterial occlusive disease (3.8%), anaemia (3.8%), angina pectoris (3.3%), platelet count decreased (3.1%), febrile neutropenia (2.9%), hypertension (2.9%), coronary artery disease (2.7%), cardiac failure congestive (2.4%), cerebrovascular accident (2.4%), sepsis (2.4%), cellulitis (2.2%), acute kidney injury (2.0%), urinary tract infection (2.0%) and lipase increased (2.0%).
(7,3%), pankreatitis (5,8%), bol u abdomenu (4,7%), fibrilacija atrija (4,5%), pireksija (4,5%), infarkt miokarda (4,0%), periferna arterijska okluzivna bolest (3,8%), anemija (3,8%), angina pectoris (3,3%), smanjenje broja trombocita (3,1%), febrilna neutropenija (2,9%), hipertenzija (2,9%), bolest koronarnih arterija (2,7%), kongestivno zatajenje srca (2,4%), cerebrovaskularni incident (2,4%),
In patients with moderate or severe hepatic impairment, ponatinib Cmax and AUC0-∞ were lower and ponatinib plasma elimination half-life was longer in patients with mild, moderate, and severe hepatic impairment but not clinically significantly different than in healthy volunteers with normal hepatic function.
U bolesnika s umjerenim ili teškim oštećenjem jetre, Cmax i AUC0-∞ ponatiniba bili su sniženi, a poluvijek eliminacije ponatiniba iz plazme u bolesnika s blagim, umjerenim i teškim oštećenjem jetre bio je dulji, ali ne klinički značajno različit od onog u zdravih dobrovoljaca s normalnom funkcijom jetre.
Statistical significance was achieved in the correlation of PFS and OS with a MCyR at the 12-month landmark (p=<0.0001 and p=0.0012, respectively).
Statistički značajna korelacija PFS-a i OS-a s MCyR postignuta je na kontrolnoj točki od 12 mjeseci (p=<0,0001 odnosno p=0,0012).
Arterial occlusion
Arterijska okluzija
Monitoring for evidence of thromboembolism should be performed.
Potrebno je praćenje na pokazatelje pojave tromboembolije.
• troubling skin rashes involving blisters or peeling and spread across the body, and involving tiredness.
• problematični osipi na koži koji uključuju mjehuriće ili ljuštenje i šire se tijelom, a popraćeni su i umorom.
After a minimum follow-up of 64 months, the rates of adverse reactions resulting in discontinuation were 20% in CP-CML, 11% in AP-CML, 15% in BP-CML and 9% in Ph+ ALL.
Nakon minimalnog praćenja od 64 mjeseca, stope nuspojava koje su rezultirale prekidom liječenja iznosile su 20% u CP-KML, 11% u AP-KML, 15% u BP-KML i 9% u Ph+ALL.
• sodium decrease in the blood
• smanjenje natrija u krvi
In the event of significant worsening, labile or treatment-resistant hypertension, treatment should be interrupted and evaluation for renal artery stenosis should be considered.
U slučaju značajnog pogoršanja hipertenzije ili granične ili refraktorne hipertenzije potrebno je prekinuti liječenje i razmotriti dijagnostičku obradu zbog suspektne stenoze bubrežne arterije.