natgillin/translations-raw huggingface dataset:
alanine aminotransferase aspartate aminotransferase 
- alanin-aminotransferaze
The median time to MaHR in patients with AP-CML, BP-CML, and Ph+ ALL was 0.7 months (range: 0.4 to 5.8 months), 1.0 months (range: 0.4 to 3.7 months), and 0.7 months (range: 0.4 to 5.5 months), 
Mediana časa do MaHR pri bolnikih z AP-KML, BP-KML in Ph+ ALL je bila 0,7 meseca (razpon: 0,4 do 5,8 meseca), 1,0 meseca (razpon: 0,4 do 3,7 meseca) oz. 0,7 meseca (razpon: 0,4 do 5,5 meseca).
Alkaline phosphatase increased 
- alkalne fosfataze
Table 7 Efficacy of Iclusig in resistant or intolerant chronic phase CML patients Overall (N=267) 
Preglednica 7 Učinkovitost zdravila Iclusig pri bolnikih s kronično fazo KML, ki so na zdravljenje odporni ali ga ne prenašajo Skupaj (N = 267)
• you develop heart or blood vessel problems. 
• se pojavijo težave s srcem ali krvnimi žilami;
Database cutoff date 06 February 2017. 
Upoštevajo se podatki v podatkovni zbirki, vneseni do 6. februarja 2017.
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. 
Po najmanj 64 mesecih spremljanja so bile stopnje pojavnosti neželenih učinkov, zaradi katerih je bilo treba zdravljenje prekiniti, 20 % za CP-KML, 11 % za AP-KML, 15 % za BP-KML in 9 % za Ph+ ALL.
Arterial occlusion and venous thromboembolism 
Arterijska okluzija in venska trombembolija
What you need to know before you take Iclusig Do not take Iclusig 
Kaj morate vedeti, preden boste vzeli zdravilo Iclusig Ne jemljite zdravila Iclusig
• inflammation of hair follicles, swollen, red area of skin or underneath skin that feels hot and tender 
• vnetje lasnih foliklov, otekel ali rdeč predel kože ali območja pod njo, na katerem se pojavi občutek toplote in nežne kože
Defined as a ≤ 0.1% ratio of BCR-ABL to ABL transcripts on the International Scale (IS) (ie, ≤ 0.1% BCR-ABLIS; patients must have the b2a2/b3a2 (p210) transcript), 
Opredeljeno kot ≤ 0,1 % razmerje BCR-ABL glede na transkripte ABL na mednarodni lestvici (IS, International Scale) (tj. ≤ 0,1 % BCR-ABLIS; bolniki morajo imeti transkript b2a2/b3a2 (p210)), v periferni krvi, izmerjeno s pomočjo kvantitativne reakcije verižne polimerizacije reverzne transkriptaze (qRT PCR, quantitative reverse transcriptase polymerase chain reaction).
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”). 
Pri sočasni uporabi ponatiniba z zdravili proti strjevanju krvi je pri bolnikih, pri katerih obstaja tveganje za krvavitev, potrebna previdnost (glejte "Mielosupresija" in "Krvavitev").
No human data on the effect of ponatinib on fertility are available. 
Pri ljudeh ni podatkov o vplivu ponatiniba na plodnost.
Lactose monohydrate Microcrystalline cellulose Sodium starch glycolate Colloidal anhydrous silica Magnesium stearate 
Jedro tablete laktoza monohidrat mikrokristalna celuloza natrijev karboksimetilškrob brezvodni koloidni silicijev dioksid magnezijev stearat
• a 15 mg film-coated tablet and a 30 mg film-coated tablet to allow for dose adjustments. 
• 15 mg filmsko obložene tablete in 30 mg filmsko obložene tablete za prilagajanje odmerka.
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). 
Korelacija med PFS in OS z MCyR je bila statistično značilna na 12-mesečni kontrolni točki (p =< 0,0001 oziroma p = 0,0012).
Achieved MCyR at 45 mg (N=86) 
Dosežen MCyR pri 45 mg (N=86)
Serious venous thromboembolic adverse reactions occurred in 5% of patients (treatment-emergent frequencies) (see section 4.8). 
Resni venski trombembolični neželeni učinki so se pojavili pri 5 % bolnikov (pogostnosti v povezavi z zdravljenjem) (glejte poglavje 4.8).
Evidence for pre- and post-implantation loss of embryos was reported in female rats and ponatinib may therefore impair female fertility. 
Pri samicah podgan so poročali o izgubi zarodkov pred vgnezditvijo in po njej in zato lahko ponatinib zmanjša plodnost žensk.
In the phase 2 trial, serious arterial occlusive adverse reactions occurred in 20% of patients (treatment-emergent frequencies). 
V preskušanjih 2. faze so se resni arterijski okluzivni neželeni učinki pojavili pri 20 % bolnikov (pogostnosti v povezavi z zdravljenjem).
Dose reduction to 30 mg only ≥ 3 month reduction at 30 mg 
Brez zmanjšanja odmerka Zmanjšanje odmerka le na 30 mg 15
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, arthralgia) over the dose range of 15 to 45 mg once-daily. 
Za vse bolnike v preskušanju 2. faze razmerje med intenzivnostjo odmerjanja in varnostjo kaže, da v razponu odmerkov od 15 do 45 mg enkrat na dan obstaja značilno povečanje neželenih učinkov stopnje ≥ 3 (srčno popuščanje, arterijska tromboza, hipertenzija, trombocitopenija, pankreatitis, nevtropenija, izpuščaj, povečanje vrednosti ALT, povečanje vrednosti AST, povečanje vrednosti lipaze, mielosupresija, artralgija).
• bleeding in the brain 
• krvavitev v možganih
Bottles of Iclusig 15 mg contain either 30, 60 or 180 film-coated tablets. 
Plastenke zdravila Iclusig 15 mg vsebujejo 30, 60 ali 180 filmsko obloženih tablet.
With a minimum follow-up of 64 months, 3.4% (9/267) of CP-CML patients experienced transformation of their disease to AP-CML or BP-CML. 
Z najkrajšim časom spremljanja 64 mesecev, se je pri 3,4 % (9/267) bolnikih s CP-KML dosegel prehod bolezni na AP-KML ali BP-KML.
6.6 Special precautions for disposal and other handling Disposal 
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
• heart problems, left sided chest pain, dysfunction of the left heart chamber 
• težave s srcem, bolečine na levi strani prsnega koša, nepravilno delovanje levega srčnega prekata
Adverse reactions reported in all CML and Ph+ ALL patients are presented in Table 4. 
Neželeni učinki, o katerih so poročali za vse bolnike s KML in Ph+ ALL, so predstavljeni v preglednici 4.
amylase alkaline phosphatase gamma-glutamyltransferase 
- gama-glutamiltransferaze
Arterial occlusions, including fatal myocardial infarction, stroke, retinal arterial occlusions associated in some cases with permanent visual impairment or vision loss, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, renal artery stenosis (associated with worsening, labile or treatment-resistant hypertension), and the need for urgent revascularization procedures have occurred in Iclusig-treated patients. 
Pri bolnikih, zdravljenih z zdravilom Iclusig, so se pojavili arterijska okluzija, vključno s smrtnim miokardnim infarktom, možgansko kapjo, retinalna arterijska okluzija, v nekaterih primerih povezana s trajno okvaro vida ali slepoto, stenozo velikih arterijskih žil v možganih, hudo periferno žilno boleznijo, stenozo ledvične arterije (povezano s poslabšanjem hipertenzije, labilno hipertenzijo ali na zdravljenje odporno hipertenzijo) in potrebo po nujnem postopku revaskularizacije.
Table 8 Efficacy of Iclusig in resistant or intolerant advanced phase CML patients Accelerated Phase CML 
Preglednica 8 Učinkovitost zdravila Iclusig pri bolnikih s KML z napredovalo fazo, ki so na zdravljenje odporni ali ga ne prenašajo KML v pospešeni fazi
• you have a liver disorder. 
• imate motnje v delovanju jeter.
Co-administration of a single 15 mg oral dose of Iclusig in the presence of ketoconazole (400 mg daily), a strong CYP3A inhibitor, resulted in modest increases in ponatinib systemic exposure, with ponatinib AUC0-∞ and Cmax values that were 78% and 47% higher, respectively, than those seen when ponatinib was administered alone. 
Sočasna uporaba enega 15 mg peroralnega odmerka zdravila Iclusig v prisotnosti ketokonazola (400 mg na dan), močnega zaviralca CYP3A, je povzročila blago zvišanje sistemske izpostavljenosti ponatinibu, z vrednostima AUC0-∞ in Cmax, ki sta bili za 78 % oz. 47 % višji kot pri dajanju samega ponatiniba.
(95% CI) a Primary endpoint for AP-CML and BP-CML/Ph+ ALL Cohorts was MaHR, which combines complete haematological responses and no evidence of leukaemia. 
(95-% IZ) a Primarni opazovani dogodek za kohorti AP-KML in BP-KML/Ph+ ALL je bil MaHR, ki združuje celovit hematološki odgovor in odsotnost dokazov o levkemiji.
• chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation 
• s kronično mieloidno levkemijo (KML) v kronični fazi, pospešeni fazi ali blastni fazi, ki so odporni na dasatinib ali nilotinib; ki ne prenašajo dasatiniba ali nilotiniba in pri katerih nadaljnje zdravljenje z imatinibom ni klinično ustrezno; ali ki imajo mutacijo T315I
Iclusig is available in plastic bottles, each containing one canister of a molecular sieve desiccant. 
Zdravilo Iclusig je na voljo v plastenkah, od katerih vsaka vsebuje eno posodo s sušilnim sredstvom z molekulskim sitom.
The secondary efficacy endpoints in CP-CML were complete haematological response (CHR) and major molecular response (MMR). 
Sekundarni opazovani dogodek učinkovitosti pri bolnikih s CP-KML je bil celovit hematološki odgovor (CHR, complete haematological response) in bistven molekularni odgovor (MMR, major molecular response).
The incidence of severe bleeding events was higher in patients with AP-CML, BP-CML and Ph+ ALL. 
Incidenca težkih krvavitev je bila večja pri bolnikih z AP-KML, BP-KML in Ph+ ALL.
Occurrence at 30 mg: 
Pojav pri 30 mg:
Arterial occlusive adverse events were more frequent with increasing age and in patients with history of ischaemia, hypertension, diabetes, or hyperlipidaemia. 
Neželeni učinki arterijske okluzije so bili pogostejši pri starejših bolnikih in pri bolnikih z ishemijo, hipertenzijo, sladkorno boleznijo ali hiperlipidemijo v anamnezi.
Serious venous occlusive reactions (treatment-emergent frequencies) occurred in 5% of patients. 
Resne venske okluzivne reakcije (pogostnosti v povezavi z zdravljenjem) so se pojavile pri 5 % bolnikov.
• pain in bones, joints, pain in muscles, back, arms or legs, muscle spasms 
• bolečina v kosteh, sklepih, bolečina v mišicah, hrbtu, rokah ali nogah, mišični krči
Resistant or Intolerant R/I Cohort (N=203) 
Odporni ali ne prenašajo O/N kohorta (N = 203)
• Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. 
• z akutno limfoblastno levkemijo s prisotnim kromosomom Philadelphia (Ph+ ALL), ki so odporni na dasatinib; ki ne prenašajo dasatiniba in pri katerih nadaljnje zdravljenje z imatinibom ni klinično ustrezno; ali ki imajo mutacijo T315I.
In the phase 2 trial (with a minimum of 64 months follow-up), venous thromboembolic adverse reactions have occurred in 6% of patients (treatment-emergent frequencies). 
V preskušanju 2. faze (z najmanj 64 mesecev spremljanja), so se venski trombembolični neželeni učinki pojavili pri 6 % bolnikov (pogostnosti v povezavi z zdravljenjem).
• stroke (symptoms include: difficulty to speak or move, sleepiness, migraine, abnormal sensations) 
• možganska kap (simptomi vključujejo težave z govorom ali premikanjem, zaspanost, migreno,
QUALITATIVE AND QUANTITATIVE COMPOSITION Iclusig 15 mg film-coated tablets 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Iclusig 15 mg filmsko obložene tablete
Venous thromboembolic reactions (treatment-emergent frequencies) occurred in 6% of patients. 
Venski trombembolični dogodki (pogostnosti v povezavi z zdravljenjem) so se pojavili pri 6 % bolnikov.
In the phase 2 trial (with a minimum of 64 months follow-up), arterial occlusive adverse reactions have occurred in 25% of patients (treatment-emergent frequencies). 
V preskušanju 2. faze (z najmanj 64 mesecev spremljanja) so se arterijski okluzivni neželeni učinki pojavili pri 25 % bolnikov (pogostnosti v povezavi z zdravljenjem).
• sodium decrease in the blood 
• znižanje ravni natrija v krvi
• lung infection (may cause breathing difficulty) 
• okužba pljuč (lahko povzroči težave z dihanjem)
• renal artery stenosis (narrowing of the blood vessels to one or both kidneys) 
• stenoza ledvične arterije (zožitev krvnih žil do ene ali obeh ledvic)
Severe skin reactions (such as Stevens-Johnson Syndrome) have been reported with some BCR-ABL Tyrosine Kinase Inhibitors. 
Hudi neželeni učinki na koži (SCARs - severe cutaneous adverse reactions) Pri nekaterih zaviralcih tirozin-kinaze BCR-ABL so poročali o hudih učinkih na koži (kot je Stevens-Johnsonov sindrom).
• blurred vision, dry eye, infection in the eye, visual disturbance 
• zamegljen vid, suhe oči, vnetje oči, motnje vida
Iclusig should be continued at the same dose 
Nadaljevati je treba z enakim odmerkom zdravila Iclusig.
Unchanged ponatinib accounted for 24% and < 1% of the administered dose in faeces and urine, respectively, with the remainder of the dose comprising metabolites. 
V blatu je bilo 24 % nespremenjenega uporabljenega ponatiniba in v urinu < 1 %, preostali odmerek pa so predstavljali presnovki.
Treatment-emergent hypertension (including hypertensive crisis) occurred in Iclusig-treated patients. 
Pri bolnikih, zdravljenih z zdravilom Iclusig, se je pojavila z zdravljenjem povezana hipertenzija (vključno s hipertenzivno krizo).
The clinical relevance of this finding for humans is not known. 
Klinični pomen te ugotovitve za človeka ni znan.
The frequency of these events is greater in patients with accelerated phase CML (AP-CML) or blast phase CML (BP-CML)/Ph+ ALL than in chronic phase CML (CP-CML). 
Pogostnost teh dogodkov je večja pri bolnikih s KML v pospešeni fazi (AP-KML) ali KML v blastni fazi (BP-KML)/Ph+ ALL, kot pri bolnikih s KML v kronični fazi (CP-KML).
Arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions (treatment-emergent frequencies) occurred in 13%, 9%, and 11% of Iclusig-treated patients, respectively. 
Arterijski kardiovaskularni, cerebrovaskularni in periferni vaskularni okluzivni neželeni učinki (pogostnosti v povezavi z zdravljenjem) so se pojavili pri 13 %, 9 % oz. 11 % bolnikov, zdravljenih z zdravilom Iclusig.
The risk of arterial occlusive events is likely to be dose-related (see sections 4.2 and 5.1). 
Tveganje arterijskih okluzivnih dogodkov je verjetno povezano z odmerkom (glejte poglavji 4.2 in
Occurrence at 15 mg: 
Pojav pri 15 mg:
Post-marketing cases of Posterior Reversible Encephalopathy Syndrome (PRES) have been reported in Iclusig-treated patients. 
Pri bolnikih, zdravljenih z zdravilom Iclusig, so po prihodu zdravila na trg poročali o primerih sindroma posteriorne reverzibilne encefalopatije (PRES - Posterior Reversible Encephalopathy Syndrome).
Bottles of Iclusig 30 mg contain 30 film-coated tablets. 
Plastenke zdravila Iclusig 30 mg vsebujejo 30 filmsko obloženih tablet.
The frequency of Grade 3 or 4 thrombocytopenia, neutropenia, and anaemia was higher in patients with AP-CML and BPCML/Ph+ ALL than in patients with CP-CML (see Table 5). 
Pogostnost trombocitopenije, nevtropenije in anemije 3. ali 4. stopnje je bila pogostejša pri bolnikih z AP-KML in BP-KML/Ph+ ALL, kot pri bolnikih s CP-KML (glejte preglednico 5).
Iclusig 15 mg film-coated tablets Iclusig 30 mg film-coated tablets Iclusig 45 mg film-coated tablets ponatinib 
Iclusig 15 mg filmsko obložene tablete Iclusig 30 mg filmsko obložene tablete Iclusig 45 mg filmsko obložene tablete ponatinib
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. 
trombociti < 50 x 109/l), ki nista povezani z levkemijo, je povzeto v preglednici 1.
Ponatinib is a potent pan BCR-ABL inhibitor with structural elements, including a carbon-carbon triple-bond, that enable high affinity binding to native BCR-ABL and mutant forms of the ABL kinase. 
Ponatinib je močan zaviralec pan-BCR-ABL s strukturnimi elementi, vključno s trojno vezjo ogljik-ogljik, ki omogočajo visoko afiniteto vezave na nativni BCR-ABL in mutirane oblike kinaze ABL. Ponatinib zavira aktivnost tirozin-kinaze ABL in mutanta ABL T315I z vrednostmi IC50 0,4 oz. 2,0 nM.
Monitoring for evidence of arterial occlusion should be performed and if decreased vision or blurred vision occurs, an ophthalmic examination (including fundoscopy) should be performed. 
Spremljati je treba znake arterijske okluzije in, če se pojavi poslabšanje vida ali zamegljen vid, je treba opraviti oftalmološki pregled (vključno s fundoskopijo), Zdravljenje z zdravilom Iclusig takoj prekiniti, če se pojavi arterijska okluzija.
A majority of these ongoing patients (82/110 patients; 75%) were reported to be receiving 15 mg at the last dose, while 24/110 patients (22%) were receiving 30 mg, and 4/110 (4%) were receiving 45 mg. At the time of study closure initiation (minimum follow-up of 64 months, and more than 3 years after the recommendation for prospective dose reduction), 99 CP-CML patients were ongoing and 77 (78%) of these patients received 15 mg as their last dose on study. 
Večina teh bolnikov (82/110 bolnikov; 75 %) je prejemalo 15 mg pri zadnjem odmerku, medtem ko je 24/110 bolnikov (22 %) prejemalo 30 mg in 4/110 (4 %) 45 mg.
• upper airway infection (may cause breathing difficulty) 
• okužba zgornjih dihal (lahko povzroči težave z dihanjem)
The clinical relevance of these findings on human fertility is unknown. 
Klinična pomembnost teh ugotovitev za plodnost pri človeku ni znana.
• rash, dry skin, itching 
• izpuščaj, suha koža, srbenje
Serious arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions (treatment-emergent frequencies) occurred in 10%, 7%, and 9% of Iclusig treated patients, respectively (see section 4.8). 
Resni arterijski kardiovaskularni, cerebrovaskularni in periferni vaskularni okluzivni neželeni učinki (pogostnosti v povezavi z zdravljenjem) so se pojavili pri 10 %, 7 % oz. 9 % bolnikov, zdravljenih z zdravilom Iclusig (glejte poglavje 4.8).
The primary efficacy endpoint in CP-CML was major cytogenetic response (MCyR), which included complete and partial cytogenetic responses (CCyR and PCyR). 
Primarni opazovani dogodek učinkovitosti pri bolnikih s CP-KML je bil bistven citogenetski odgovor (MCyR, major cytogenetic response), ki je vključeval celovit (CCyR, complete cytogenetic response)
Reducing the dose of Iclusig to 15 mg should be considered for CP-CML patients who have achieved a major cytogenetic response taking the following factors into account in the individual patient assessment: cardiovascular risk, side effects of ponatinib therapy, time to cytogenetic response, and BCR-ABL transcript levels (see sections 4.4 and 5.1). 
Pri teh bolnikih je treba pri oceni koristi in tveganj za posameznika upoštevati naslednje dejavnike: kardiovaskularno tveganje, neželene učinke zdravljenja s ponatinibom, čas do citogenetskega odgovora in ravni transkriptov BCR-ABL (glejte poglavji 4.4 in 5.1).
The incidence of thromboembolic events is higher in patients with Ph+ ALL or BP-CML than those with AP-CML or CP-CML. 
Pojavnost trombemboličnih dogodkov je višja pri bolnikih s Ph + ALL ali BP-KML kot pri bolnikih z AP-KML ali CP-KML.
Iclusig 30 mg film-coated tablets are approximately 8 mm in diameter with "C7" on one side. 
Zdravilo Iclusig 30 mg filmsko obložene tablete imajo v premeru približno 8 mm in vtisnjeno oznako "C7" na eni strani.
Iclusig 45 mg film-coated tablets EU/1/13/839/003 
Iclusig 45 mg filmsko obložene tablete EU/1/13/839/003
Cohort (N=65) 
O/N kohorta (N = 65)
Discontinuation of ponatinib should be considered in patients who develop serious heart failure (see sections 4.2 and 4.8). 
Pri bolnikih, pri katerih se razvije resno srčno popuščanje, je treba razmisliti o ukinitvi ponatiniba (glejte poglavji 4.2 in 4.8).
The bottle contains one sealed plastic canister containing a molecular sieve desiccant. 
Plastenka vsebuje eno zaprto plastično posodo s sušilnim sredstvom, ki vsebuje molekulsko sito.
• a history of renal artery stenosis (narrowing of the blood vessels to one or both kidneys) 
• stenozo ledvične arterije v zdravstveni zgodovini (zožitev krvnih žil do ene ali obeh ledvic)
Table 9 Efficacy of Iclusig in resistant or intolerant Ph+ ALL patients Overall (N=32) 
Preglednica 9 Učinkovitost zdravila Iclusig pri bolnikih Ph+ ALL, ki so na zdravljenje odporni ali ga ne prenašajo
At the time of updated reporting with minimum follow-up for all ongoing patients of 64 months, the median duration of MaHR for AP-CML (median duration of treatment: 19.4 months) BP-CML (median duration of treatment: 2.9 months), and Ph+ ALL (median duration of treatment: 2.7 months) patients was estimated as 12.9 months (range: 1.2 to 68.4 months), 6.0 months (range: 1.8 to 59.6 months), and 3.2 months (range: 1.8 to 12.8 months), respectively. 
19,4 meseca) ocenjena na 12,9 mesecev (razpon: 1,2 do 68,4 meseca), za bolnike z BP-KML (mediana trajanja zdravljenja: 2,9 meseca) na 6,0 mesecev (razpon: 1,8 do 59,6 meseca) in za bolnike s Ph+ ALL (mediana trajanja zdravljenja: 2,7 meseca) na 3,2 meseca (razpon: 1,8 do 12,8 meseca).
Iclusig 15 mg film-coated tablets EU/1/13/839/001 
Iclusig 15 mg filmsko obložene tablete EU/1/13/839/001
Serious arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions (treatment-emergent frequencies) occurred in 10%, 7%, and 9% of Iclusig treated patients, respectively. 
Resni arterijski kardiovaskularni, cerebrovaskularni in periferni vaskularni okluzivni neželeni učinki (pogostnosti v povezavi z zdravljenjem) so se pojavili pri 10 %, 7 % oz. 9 % bolnikov, zdravljenih z zdravilom Iclusig.
Iclusig 30 mg film-coated tablets EU/1/13/839/006 
Iclusig 30 mg filmsko obložene tablete EU/1/13/839/006
• the number of blood platelets is reduced. 
• se število trombocitov zmanjša;
Iclusig should be discontinued *IULN = institution upper limit of normal Hepatic toxicity 
*IULN = zgornja meja normalnih vrednosti, specifična za ustanovo (institutional upper limit of normal)
Experts in liver disease and in the treatment of hepatitis B should be consulted before treatment is initiated in patients with positive hepatitis B serology (including those with active disease) and for patients who test positive for HBV infection during treatment. 
Bolnike je treba pred začetkom zdravljenja z zdravilom Iclusig testirati glede okužbe z virusom hepatitisa B. Pri bolnikih s pozitivno serologijo na hepatitis B (vključno z bolniki z aktivno boleznijo) in bolnikih, pri katerih se med zdravljenjem test glede okužbe z virusom hepatitisa B izkaže za pozitivnega, se je treba pred začetkom zdravljenja posvetovati s strokovnjaki za obolenja jeter in zdravljenje hepatitisa B. Pri prenašalcih virusa hepatitisa B, pri katerih je potrebno zdravljenje z zdravilom Iclusig, je treba med zdravljenjem in nekaj mesecev po njegovem zaključku skrbno spremljati pojav znakov in simptomov aktivne okužbe z virusom hepatitisa B (glej poglavje 4.8).
• sulfasalazine: a medicine to treat severe bowel and rheumatic joint inflammation. 
• sulfasalazin: zdravilo za zdravljenje hudega vnetja črevesja ali revmatičnega vnetja sklepov Zdravilo Iclusig skupaj s hrano in pijačo
• obstruction of the blood vessels in the eye 
• zapora krvnih žil v očesu
• Iclusig should be resumed at 30 mg after recovery to ≤ Grade 1 (< 3 × ULN), or recovery to pre-treatment grade Occurrence at 30 mg: 
• Z jemanjem zdravila Iclusig 30 mg je treba nadaljevati po vrnitvi na ≤ stopnje 1 (< 3 × ULN) ali vrnitvi na stopnjo pred zdravljenjem.
Retinal venous occlusions associated in some cases with permanent visual impairment or vision loss have occurred in Iclusig-treated patients. 
Pri nekaterih bolnikih zdravljenih z zdravilom Iclusig so se pojavile venske okluzije mrežnice, ki so v nekaterih primerih povezane s stalno izgubo vida ali slabovidnostjo.