natgillin/translations-raw huggingface dataset:
Noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see section 5.1): - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. 
Zdravilo Noxafil gastrorezistentne tablete je indicirano za zdravljenje naslednjih glivnih okužb pri odraslih (glejte poglavje 5.1): - invazivne aspergiloze pri bolnikih z okužbo, odporno na amfotericin B ali itrakonazol, ter pri bolnikih, ki ne prenašajo teh zdravil, - fuzarioze pri bolnikih z okužbo, odporno na amfotericin B, ter pri bolnikih, ki ne prenašajo amfotericina B, - kromoblastomikoze in micetoma pri bolnikih z okužbo, odporno na itrakonazol, ter pri bolnikih,
Noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients: - 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 and who are at high risk of developing invasive fungal infections. 
Zdravilo Noxafil peroralna suspenzija je indicirano tudi za profilakso invazivnih glivnih okužb pri: - bolnikih, ki prejemajo kemoterapijo za doseganje remisije akutne mieloične levkemije (AML) ali mielodisplastičnih sindromov (MDS) in pri katerih se zato pričakuje dolgotrajnejša nevtropenija ter imajo veliko tveganje za invazivne glivne okužbe, - prejemnikih presajenih hematopoetskih matičnih celic (HSCT), ki zaradi preprečevanja reakcije presadka proti gostitelju prejemajo visokoodmerno imunosupresivno zdravljenje in pri katerih obstaja veliko tveganje za invazivne glivne okužbe.
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. 
V farmakološki študiji varnosti ponavljajočih se odmerkov ehokardiografija pri podganah ni pokazala znakov srčne dekompenzacije pri sistemski izpostavljenosti, ki je bila 2,1-krat večja od terapevtsko dosežene.
What Noxafil contains 
Kaj vsebuje zdravilo Noxafil
Effects of posaconazole on other medicinal products Posaconazole is a potent inhibitor of CYP3A4. 
Posakonazol je močan zaviralec CYP3A4.
Do not breast-feed while taking Noxafil. 
Med jemanjem zdravila Noxafil ne dojite.
Hydrochloric acid [for pH adjustment] Sodium hydroxide [for pH adjustment] Water for injections 
6.1 Seznam pomožnih snovi natrijev sulfobutileter betaciklodekstrin (SBECD) dinatrijev edetat klorovodikova kislina [za prilagoditev pH] natrijev hidroksid [za prilagoditev pH] voda za injekcije
Multiple, time-matched ECGs collected over a 12 hour period were obtained before and during administration of posaconazole oral suspension (400 mg twice daily with high fat meals) from 173 healthy male and female volunteers aged 18 to 85 years. 
173 zdravim prostovoljcem in prostovoljkam, starim od 18 do 85 let, so v 12-urnem obdobju posneli več časovno usklajenih EKG, in sicer pred in med uporabo peroralne suspenzije posakonazola (400 mg dvakrat na dan, zaužite z zelo mastno hrano).
There were no neurologic, behavioural or developmental abnormalities in the dogs with this finding, and a similar brain finding was not seen with oral posaconazole administration to juvenile dogs (4 days to 9 months of age). 
Podobne spremembe niso ugotovili med peroralno uporabo posakonazola pri juvenilnih psih (starih od 4 dni do 9 mesecev).
No effects on electrocardiograms, including QT and QTc intervals, were seen in a repeat dose safety pharmacology study in monkeys at maximal plasma concentrations 8.5-fold greater than the concentrations obtained at therapeutic doses in humans. 
V farmakološki študiji varnosti ponavljajočih se odmerkov na opicah pri največjih koncentracijah v plazmi, ki so bile 8,5-krat večje od koncentracij, doseženih med uporabo terapevtskih odmerkov pri človeku, na elektrokardiogramih (vključno z intervaloma QT in QTc) niso opazili nobenih učinkov.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before using Noxafil. 
Če kaj od naštetega velja za vas (ali če ste negotovi), se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden začnete uporabljati zdravilo Noxafil.
Race There is insufficient data among different races with posaconazole tablets. 
Rasa O uporabi tablet posakonazola pri različnih rasah ni dovolj podatkov.
No effects on electrocardiograms, including QT and QTc intervals, were seen in a repeat dose safety pharmacology study in monkeys at systemic exposures 4.6-fold greater than the concentrations obtained at therapeutic doses in humans. 
V farmakološki študiji varnosti ponavljajočih se odmerkov na opicah pri sistemskih izpostavljenostih, ki so bile 4,6-krat večje od koncentracij, doseženih med uporabo terapevtskih odmerkov pri človeku, na elektrokardiogramih (vključno z intervaloma QT in QTc) niso opazili nobenih učinkov.
Tell your doctor, pharmacist or nurse straight away if you notice any of the following serious side effects - you may need urgent medical treatment: 
Če opazite katerega koli od naslednjih resnih neželenih učinkov, se takoj posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, kajti morda boste potrebovali nujno medicinsko pomoč:
Posaconazole plasma concentrations following administration of posaconazole may increase over time in some patients (see section 5.2). 
Pri nekaterih bolnikih se lahko koncentracija posakonazola v plazmi po njegovi uporabi sčasoma poveča (glejte poglavje 5.2).
Oral posaconazole suspension 800 mg/day in divided doses was evaluated for the treatment of invasive aspergillosis in patients with disease refractory to amphotericin B (including liposomal formulations) or itraconazole or in patients who were intolerant of these medicinal products in a noncomparative salvage therapy trial (Study 0041). 
V neprimerjalnem preskušanju (študija 0041) zadnje možnosti zdravljenja so za zdravljenje invazivne aspergiloze pri bolnikih z okužbo, odporno na amfotericin B (vključno z liposomskimi oblikami) ali itrakonazol, oziroma pri bolnikih, ki niso prenašali teh zdravil, ovrednotili peroralno suspenzijo posakonazola 800 mg/dan v deljenih odmerkih.
Pharmacotherapeutic group: Antimycotics for systemic use, triazole derivatives, ATC code: J02A C04. 
Oznaka ATC: J02A C04.
Liquid glucose 
Alkaloidi vinke
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Noxafil. 
Če kaj od naštetega velja za vas (ali če ste negotovi), se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden začnete jemati zdravilo Noxafil.
- The active substance in Noxafil is posaconazole. 
- Učinkovina v zdravilu Noxafil je posakonazol.
Oral posaconazole suspension 800 mg/day in divided doses was evaluated for the treatment of invasive aspergillosis in patients with disease refractory to amphotericin B (including liposomal formulations) or itraconazole or in patients who were intolerant of these medicinal products in a noncomparative salvage therapy trial. 
V neprimerjalnem preskušanju zadnje možnosti zdravljenja so za zdravljenje invazivne aspergiloze pri bolnikih z okužbo, odporno na amfotericin B (vključno z liposomskimi oblikami) ali itrakonazol, oziroma pri bolnikih, ki niso prenašali teh zdravil, ovrednotili peroralno suspenzijo posakonazola 800 mg/dan v deljenih odmerkih.
• nausea or vomit (feeling or being sick), diarrhoea 
• slabost v želodcu (siljenje na bruhanje) ali bruhanje, driska
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Noxafil. 
Če kaj od naštetega velja za vas (ali če ste negotovi), se posvetujte z zdravnikom ali farmacevtom, preden začnete jemati zdravilo Noxafil.
oedema, pain, chills, malaise, chest discomfort, drug intolerance, feeling jittery, infusion site pain, infusion site phlebitis, infusion site thrombosis, mucosal inflammation 
edemi, bolečine, mrzlica, splošno slabo počutje, nelagodje v prsnem košu, neprenašanje zdravila, občutek živčnosti, bolečine na mestu infundiranja, flebitis na mestu infundiranja, tromboza na mestu infundiranja, vnetje sluznice
What Noxafil contains The active substance is posaconazole. 
Zdravilo Noxafil vsebuje učinkovino posakonazol.
Proportion (%) of patients with proven/probable IFIs On-treatment period 
Odstotek (%) bolnikov z dokazanimi oziroma verjetnimi invazivnimi glivnimi okužbami Obdobje zdravljenja
Amikacin sulfate 
PRETISNI OMOTI
There is no paediatric experience with posaconazole tablets. 
Izkušenj s tabletami posakonazola pri pediatričnih bolnikih ni.
oedema, pain, chills, malaise, chest discomfort, drug intolerance, feeling jittery, mucosal inflammation 
edemi, bolečine, mrzlica, splošno slabo počutje, nelagodje v prsnem košu, neprenašanje zdravila, občutek živčnosti, vnetje sluznice
Ear and labyrinth disorder Rare: 
Motnje reprodukcije in dojk Občasni:
After administration of 
Po uporabi
Tablet core 
odmerna žlička
Do not breast-feed while using Noxafil. 
Med zdravljenjem z zdravilom Noxafil ne dojite.
Posaconazole plasma concentrations following administration of posaconazole tablets are generally higher than those obtained with posaconazole oral suspension. 
Koncentracije posakonazola v plazmi so po uporabi tablet običajno večje kot po uporabi peroralne suspenzije.
- 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. 
Zdravilo Noxafil koncentrat za raztopino za infundiranje je indicirano tudi za profilakso invazivnih glivnih okužb pri: - bolnikih, ki prejemajo kemoterapijo za doseganje remisije akutne mieloične levkemije (AML) ali mielodisplastičnih sindromov (MDS) in pri katerih se zato pričakuje dolgotrajnejša nevtropenija ter imajo veliko tveganje za invazivne glivne okužbe, - prejemnikih presajenih hematopoetskih matičnih celic (HSCT), ki zaradi preprečevanja reakcije presadka proti gostitelju (GVHD) prejemajo visokoodmerno imunosupresivno zdravljenje in pri katerih obstaja veliko tveganje za invazivne glivne okužbe.
(see Annex I: Summary of Product Characteristics, section 4.2). 
Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
How to store Noxafil 
Shranjevanje zdravila Noxafil
• if you are taking: terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, any medicines that contain “ergot alkaloids” such as ergotamine or dihydroergotamine, or a “statin” such as simvastatin, atorvastatin or lovastatin. 
ki vsebuje alkaloide ergot (na primer ergotamin ali dihidroergotamin) ali kakšen statin, na primer simvastatin, atorvastatin ali lovastatin.
August 2021 
avgust 2021
Vascular occlusive events occurred in 44 of these 131 patients. 
Vaskularni okluzivni dogodki so se pojavili pri 44 od teh 131 bolnikov.
• an appropriate response to the treatment is reached 
• je dosežen ustrezen odziv na zdravljenje;
Not known (frequency cannot be estimated from the available data): 
Neželeni učinki neznane pogostnosti (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
93055 Regensburg Germany 
93055 Regensburg Nemčija
Table 6 Demographics and disease characteristics 
Preglednica 6 Demografske značilnosti in značilnosti bolezni
No venous occlusive events were fatal. 
Venski okluzivni dogodki niso bili smrtni.
Persistent grade 2 (longer than 7 days) 
Perzistentna stopnja 2 (dlje kot 7 dni) Stopnja 3 ali višja stopnja
Baseline demographic characteristics are described in Table 6 below. 
Izhodiščne demografske značilnosti so opisane spodaj v preglednici 6.
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). 
Kategorije pogostnosti so zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10) in občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
*ULN = Upper Limit of Normal for the lab 
*ULN = zgornja meja normalnih vrednosti za laboratorij
Efficacy results are summarized in Table 7, Table 8, and Table 9. 
Rezultati učinkovitosti so povzeti v preglednici 7, 8 in 9.
All patients (N=449) 
Vsi bolniki (N = 449)
• recurrence (reactivation) of Hepatitis B infection when you have had hepatitis B in the past (a liver infection). 
• ponovitev (reaktivacija) okužbe s hepatitisom B, če ste imeli hepatitis B v preteklosti (okužba jeter)
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). 
Ob prilagoditvi izpostavljenosti je bil pojav prvih arterijskih okluzivnih dogodkov največji v prvih dveh letih spremljanja in se je zmanjšal z zmanjšanjem jakosti dnevnega odmerka (po priporočilu za zmanjšanje prihodnjega odmerka).
Most patients who had an event of hepatotoxicity had their first event during the first year of treatment. 
Pri večini bolnikov, pri katerih se je pojavila hepatotoksičnost, se je stanje prvič pojavilo v prvem letu zdravljenja.
Iclusig has minor influence on the ability to drive and use machines. 
Zdravilo Iclusig ima blag vpliv na sposobnost vožnje in upravljanja strojev.
Tell your doctor straight away if you experience any of these symptoms during your treatment with ponatinib, because it could be serious. 
Nemudoma obvestite zdravnika, če se med zdravljenjem s ponatinibom pri vas pojavi kateri koli od teh simptomov, ker je stanje lahko resno.
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. 
Pred začetkom zdravljenja glejte poglavji 4.2 za oceno kardiovaskularnega statusa in 4.4 za situacije, v katerih je treba razmisliti o alternativnem zdravljenju.
If diagnosed, interrupt Iclusig treatment and resume treatment only once the event is resolved and if the benefit of continued treatment outweighs the risk of PRES. 
Če je diagnosticiran, prekinite zdravljenje z zdravilom Iclusig in z zdravljenjem nadaljujte šele, ko dogodek izzveni in če koristi nadaljnjega zdravljenja prevladajo nad tveganjem za PRES.
• if you are allergic to ponatinib or any of the other ingredients of this medicine (listed in section 
• če ste alergični na ponatinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
• the number of white blood cells called neutrophils is reduced. 
• se število belih krvnih celic, imenovanih nevtrofilci, zmanjša;
SPECIAL STORAGE CONDITIONS Store in the original container in order to protect from light. 
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v originalnem vsebniku za zagotovitev zaščite pred svetlobo.
Most of the patients with grade 3 or 4 platelet count decreased, anaemia or neutropenia, developed it within the first 3 months of treatment. 
Pri večini bolnikov s 3. ali 4. stopnjo znižanega števila trombocitov, anemijo ali nevtropenijo, se je stanje razvilo v obdobju prvih 3 mesecev zdravljenja.
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. 
V preglednici 11 so prikazani ti podatki za bolnike, ki so dosegli MCyR in MMR pri 45 mg; podobni podatki so na voljo za bolnike, ki so dosegli MCyR in MMR pri 30 mg.
Hepatic failure (including fatal outcome) has been observed. 
Opazili so jetrno odpoved (vključno s smrtnim izidom).
Haupt Pharma - AMAREG GmbH Donaustaufer Strasse 378 93055 Regensburg Germany 
Haupt Pharma - AMAREG GmbH Donaustaufer Strasse 378 93055 Regensburg Nemčija
* Spontaneous reports from post-marketing experience 
* Spontana poročila po prihodu zdravila na trg
Before initiating Iclusig, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm. 
Pred uvedbo zdravila Iclusig je treba to tveganje skrbno preučiti pri bolnikih z dejavniki tveganja, kot sta hipertenzija ali anamneza anevrizme.
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. 
Podatki iz preskušanja 2. faze so na voljo za vzdrževanje odgovora (MCyR in MMR) pri vseh bolnikih s CP-KML, pri katerih je bil odmerek zmanjšan zaradi katerega koli razloga.
Figure 1- Kaplan-Meier estimates for overall survival in the CP-CML population (Treated Population) 
Slika 1 - Ocena po lestvici Kaplan-Meier za celokupno preživetje populacije bolnikov s CP-KML (zdravljene populacije)
Also, post-hoc analyses to assess the relationship of shorter-term cytogenetic (MCyR) and molecular (MMR) response outcomes with longer-term outcomes of PFS and OS, maintenance of response (MCyR and MMR) after dose reductions, and PFS and OS by Arterial Occlusive Event status were conducted. 
Tudi post-hoc analize za oceno kratkoročnega citogenetskega (MCyR-major cytogenetic response) in molekularnega (MMR-major molecular response) odgovora z dolgoročnejšimi rezultati PFS in OS, vzdrževanje odgovora (MCyR in MMR) po zmanjšanju odmerka, in PFS ter OS so bile izvedene s statusom arterijskih okluzivnih dogodkov.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 1 July 2013 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 1. julij 2013 Datum zadnjega podaljšanja: 8. februarja 2018
Of the CP-CML patients with no mutation detected at entry, 49% (66/136) achieved a MCyR. 
Od bolnikov s CP-KML brez odkritij mutacij ob vstopu jih je 49 % (66/136) doseglo MCyR.
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. 
Dodatno je bilo po približno 2 letih spremljanja vsem bolnikom, ki so prejemali dnevni odmerek 45 mg, priporočeno zmanjšanje odmerka, tudi če se neželeni učinki niso pojavili, kot odziv na nadaljevanje pojava vaskularnih okluzivnih dogodkov v kliničnem preskušanju.
At the time of reporting, all ongoing patients had a minimum follow-up of 64 months. 
V času poročanja so vse trenutne bolnike spremljali vsaj 64 mesecev.
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. 
Po enkratnem peroralnem odmerku s [14C] označenega ponatiniba se je približno 87 % radioaktivnega odmerka pojavilo v blatu in približno 5 % v urinu.
Cytogenetic Response Major (MCyR) a 
Citogenetski odgovor Bistven (MCyR) a
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. 
Pri bolnikih s CP-KML, ki so dosegli MCyR ali MMR v prvem letu zdravljenja, se je statistično značilno izboljšalo stanje brez napredovanja bolezni (PFS) in celokupno preživetje (OS) v primerjavi z bolniki, ki niso dosegli mejnikov zdravljenja.
Age Median, years (range) Gender, n (%) Male Race, n (%) Asian Black/African American White Other ECOG Performance Status, n (%) ECOG=0 or 1 Disease history Median time from diagnosis to first dose, years (range) Resistant to Prior TKI Therapy a *, n (%) 
Starost Mediana, leta (razpon) Spol, n (%) Moški Rasa, n (%) Azijci Črnci/afriški Američani Belci Drugo Status zmogljivosti po ECOG, n (%) ECOG = 0 ali 1 Zgodovina bolezni Mediana časa od diagnoze do prvega odmerka, leta (razpon) Odpornost na predhodno zdravljenje s TKIa*, n (%) Predhodno zdravljenje s TKI - število režimov, n (%)
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 celotno skupino bolnikov s CP-KML je ocenjena verjetnost preživetja pri 2, 3, 4 in 5 letih 86,0 %, 81,2 %, 76,9 % in 73,3 %, kar je prikazano na sliki 1.
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 odmerkih 15 mg ali več se je pri 32 od 34 bolnikov (94 %) pokazalo ≥ 50 % zmanjšanje fosforilacije encima CRK-like (CRKL), biomarkerja zaviranja BCR-ABL, v periferni krvi mononuklearnih celic.
Table 5 Incidence of clinically relevant grade 3/4* laboratory abnormalities in ≥ 2% of patients in any disease group from the Phase 2 Trial (N=449): minimum follow-up of 64 month for all ongoing patients Laboratory test 
stopnje* pri ≥ 2 % bolnikov v vsaki skupini bolezni iz preskušanja 2. faze (N=449): najmanj 64 mesecev spremljanja za vse bolnike Laboratorijski test
The anti-leukaemic activity of Iclusig was also evaluated in a phase 1 dose escalation study that included 65 CML and Ph+ ALL patients; the study is completed. 
Protilevkemična aktivnost zdravila Iclusig je bila ocenjena tudi v študiji 1. faze s povečevanjem odmerka, v katero je bilo vključenih 65 bolnikov s KML in Ph+ ALL; študija je zaključena.
• The active substance is ponatinib. 
• Učinkovina je ponatinib.
• blood clot in the main arteries carrying blood to the head or neck (carotid artery) 
• krvni strdek v glavni arteriji, ki dovaja kri v glavo ali vrat (karotidna arterija)
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). 
Potencial zdravila Iclusig za podaljšanje intervala QT so ocenili pri 39 bolnikih z levkemijo, pri čemer niso opazili pomembnega podaljšanja intervala QT (glejte poglavje 5.1).
(95% CI) Major Molecular Response b 
(95-% IZ) Bistven molekularni odgovor b
Iclusig has been evaluated in safety pharmacology, repeat-dose toxicity, genotoxicity, reproductive toxicity, phototoxicity and carcinogenicity studies. 
Zdravilo Iclusig so ocenili v študijah farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, vpliva na sposobnost razmnoževanja, fototoksičnosti in karcinogenosti.
• narrowing of the blood vessels, poor blood circulation, sudden increase in blood pressure 
• zoženje krvnih žil, slab krvni obtok, nenadno zvišanje krvnega tlaka
In rats, treatment with ponatinib has shown effects on female fertility and male fertility was not affected (see section 5.3). 
Pri podganah je zdravljenje s ponatinibom pokazalo učinke na plodnost pri samicah, pri samcih pa vpliva na plodnost ni bilo (glej poglavje 5.3).
Discontinuation due to myelosuppression was infrequent (thrombocytopenia 4%, neutropenia and anaemia < 1% each). 
Ukinitev zdravljenja zaradi mielosupresije je bila redka (trombocitopenija 4 %, nevtropenija in anemija po < 1 %).
Hypertension may contribute to risk of arterial thrombotic events, including renal artery stenosis. 
Hipertenzija lahko prispeva k tveganju arterijskih trombotičnih dogodkov, vključno s stenozo ledvične arterije.