natgillin/translations-raw huggingface dataset:
In the phase 2 trial, dose reductions were recommended following adverse events; in addition in October 2013 new recommendations for prospective dose reduction in all CP-CML patients in the absence of adverse events were introduced in this trial with the aim of reducing the risk of vascular occlusive events.
Smanjivanje doze u bolesnika u kroničnoj fazi KML-a U ispitivanju faze 2, smanjenja doze preporučena su nakon pojave štetnih događaja; osim toga u listopadu 2013. u ovom ispitivanju uvedene su nove preporuke za prospektivno smanjenje doze za sve bolesnike u kroničnoj fazi KML-a bez štetnih događaja s ciljem smanjenja rizika za događaje vaskularne okluzije.
There were no effects on male rat fertility parameters.
Nije bilo nikakvih učinaka na parametre plodnosti u mužjaka štakora.
Elevation of AST or ALT ≥ 3 × ULN concurrent with an elevation of bilirubin > 2 × ULN and alkaline phosphatase < 2 × ULN
Porast vrijednosti AST-a ili ALTa ≥ 3 x GGN istodobno uz povišenje bilirubina > 2 x GGN i alkalne fosfataze < 2 x GGN
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),
Definiran kao omjer ≤0,1% BCR-ABL na ABL prijepise na međunarodnoj ljestvici (IS) (primjerice, ≤0,1% BCR-ABLIS; bolesnici moraju imati prijepis b2a2/b3a2 (p210)), u perifernoj krvi mjeren kvantitativno pomoću reakcije lančane polimeraze (qRT
For every BCR-ABL mutation detected in more than one CP-CML patient at entry, a MCyR was achieved following treatment with Iclusig.
Za svaku mutaciju BCR-ABL mutaciju uočenu na početku istraživanja u više od jednog bolesnika u kroničnoj fazi KML-a, MCyR je postignut nakon liječenja lijekom Iclusig.
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.
Potrebno je praćenje na pokazatelje pojave arterijske okluzije, a ako dođe do pojave slabljenja vida ili zamagljenja vida potrebno je obaviti oftalmološki pregled (uključujući fundoskopiju).
• bleeding in the brain
• krvarenje u mozgu
• heart problems, left sided chest pain, dysfunction of the left heart chamber
• problemi sa srcem, bol na lijevoj strani prsnog koša, poremećaj rada lijeve srčane komore
Patients were assigned to one of six cohorts based on disease phase (CP-CML; AP-CML; or BPCML/Ph+ ALL), resistance or intolerance (R/I) to dasatinib or nilotinib, and the presence of the T315I mutation.
Bolesnici su dodijeljeni u jednu od 6 kohorti na temelju faze bolesti (KML-kronična faza; KML-ubrzana faza; ili KML-blastična kriza/Ph+ ALL), rezistencija ili intolerancija (R/I) na dasatinib ili nilotinib i na prisutnost mutacije T315I.
Stop breast-feeding during treatment with Iclusig.
Prestanite dojiti tijekom liječenja lijekom Iclusig.
Patients should be monitored for signs or symptoms consistent with heart failure and they should be treated as clinically indicated, including interruption of Iclusig.
Potrebno je pratiti bolesnike zbog otkrivanja znakova i simptoma koji ukazuju na zatajenje srca i liječiti ih sukladno kliničkoj indikaciji, uključujući i prekid davanja Iclusiga.
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.
Ako se dijagnosticira, prekinite liječenje lijekom Iclusigom i nastavite liječenje tek nakon što se poremećaj povuče te ako je korist od nastavka liječenja veća od rizika od PRES-a.
Ponatinib is not a substrate for the human organic anion transporting polypeptides OATP1B1, OATP1B3 and the organic cation transporter OCT-1.
Ponatinib nije supstrat za polipeptide koji transportiraju humane organske anione OATP1B1, OATP1B3 i OCT-1 i transporter organskih kationa OCT-1.
• Iclusig discontinuation should be considered
• Potrebno je razmotriti prekid primjene lijeka Iclusig
A statistically significant increased incidence of squamous cell carcinoma of the clitoral gland was observed at that dose.
Pri toj dozi opažena je statistički značajno povećana incidencija karcinoma skvamoznih stanica klitoralne žlijezde.
A prior MCyR or better (MCyR, MMR, or CMR) to dasatinib or nilotinib was only achieved in 26% patients with CP-CML and a prior MaHR or better (MaHR, MCyR, MMR, or CMR) was only achieved in 21%, and 24% of AP-CML, and BP-CML/Ph+ALL patients, respectively.
Prethodni MCyR ili bolji (MCyR, MMR ili CMR) odgovor na dasatinib ili nilotinib postignut je samo u 26% bolesnika u kroničnoj fazi KML-a, a prethodni MaHR ili bolji (MaHR, MCyR, MMR ili CMR) postignut je samo u 21% odnosno u 24% bolesnika u ubrzanoj fazi KML odnosno blastičnoj fazi KML/Ph+ ALL.
If lipase elevations are accompanied by abdominal symptoms, Iclusig should be withheld and patients evaluated for evidence of pancreatitis (see section 4.2).
Ako je povišenje lipaza praćeno s abdominalnim simptomima, liječenje lijekom Iclusig se mora obustaviti, a bolesnika dodatno dijagnostički obraditi zbog suspektnog pankreatitisa (vidjeti dio 4.2).
*Reported using National Cancer Institute Common Terminology Criteria for Adverse Events version
*prema Zajedničkim kriterijima terminologije za nuspojave Nacionalnog instituta za karcinome,
The median dose intensity was 28 mg/day in CP-CML patients or, 63% of the expected 45 mg dose; median dose intensity was greater in advanced disease states (32 mg/day in the AP-CML patients and 44 mg/day in the BP CML/Ph+ ALL patients).
Medijan intenziteta doze iznosio je 28 mg/dan za bolesnike u CP-KML fazi ili 63% od očekivane doze od 45 mg; medijan intenziteta doze bio je veći u stanjima uznapredovale bolesti (32 mg/dan za bolesnike u AP-KML fazi i 44 mg/dan za bolesnike u fazi BP-KML/Ph+ ALL).
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.
Antileukemična aktivnost lijeka Iclusig također je procijenjena u ispitivanju faze 1 povišenja doze koja je uključivala 65 bolesnika s KML i Ph+ALL.
c MCyR combines both complete (No detectable Ph+ cells) and partial (1% to 35% Ph+ cells)
c MCyR kombinira i potpune (bez uočenih Ph+ stanica) i djelomične (1% do 35% Ph+ stanica)
• nosebleed, difficulty producing voice sounds, hypertension in the lungs
• krvarenje iz nosa, poteškoće u nastanku glasa, plućna hipertenzija
• Iclusig should be interrupted and hepatic function should be monitored
• Potrebno je prekinuti primjenu lijeka Iclusig i pratiti funkciju jetre
• blurred vision, dry eye, infection in the eye, visual disturbance
• zamagljen vid, suhe oči, infekcija oka, poremećaj vida
Severe Cutaneous Adverse Reactions (SCARs)
Teške kožne nuspojave (SCAR)
Iclusig should be discontinued *IULN = institution upper limit of normal Hepatic toxicity
Potrebno je prekinuti primjenu lijeka Iclusig *IGGN (engl. institution upper limit of normal) = gornja granica normalnih vrijednosti ustanove
cytogenetic responses.
citogenetske odgovore.
In 67% of CP-CML patients in the R/I cohort, no mutations were detected at study entry.
67% bolesnika u kroničnoj fazi KML-a u kohorti R/I nisu uočene mutacije prilikom uključivanja.
The trial enrolled 449 patients of which 444 were eligible for analysis: 267 CP-CML patients (R/I Cohort: n=203, T315I Cohort: n=64), 83 AP-CML patients (R/I Cohort: n=65, T315I Cohort: n=18), 62 BP-CML (R/I Cohort: n=38, T315I Cohort: n=24), and 32 Ph+ ALL patients (R/I Cohort: n=10, T315I Cohort: n=22).
Ispitivanje je uključivalo 449 bolesnika od kojih su 444 bili podobni za analizu: 267 bolesnika u kroničnoj fazi KML-a (R/I kohorta: n=203, T315I kohorta: N=64) 83 bolesnika u ubrzanoj fazi KML (R/I kohorta: n=65, T315I kohorta: n=18), 62 u blastičnoj fazi KML (R/I kohorta: n=38, T315I kohorta: n=24), i 32 bolesnika s Ph+ ALL (R/I kohorta: n=10, T315I kohorta: n=22).
Common blood bilirubin increased, blood alkaline phosphatase increased, gamma-glutamyltransferase increased
Često povišen bilirubin u krvi, povišena alkalna fosfataza u krvi, povišena gama-glutamil transferaza
Not known aneurysms and artery dissections
Nepoznato aneurizme i disekcije arterije
• or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall
• ili ste imali aneurizmu (proširenje i slabljenje stijenke krvne žile) ili rascjep stijenke krvne žile
Common pneumonia, sepsis, folliculitis, cellulitis
Često pneumonija, sepsa, folikulitis, celulitis
b CHR: WBC ≤ institutional ULN, ANC ≥ 1,000/mm3, platelets ≥ 100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤ 5%, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils < 5% in peripheral blood, No extramedullary involvement (including no hepatomegaly or splenomegaly).
b CHR: Leukociti ≤ GGN ustanove, ABN ≥1000/mm3, trombociti ≥100 000/mm3, bez blasta ili promijelocita u perifernoj krvi, blasta u koštanoj srži ≤5%, <5% mijelocita plus metamijelocita u perifernoj krvi, bazofila <5% u perifernoj krvi bez uključenosti organa i tkiva van koštane srži (bez hepatomegalije ili splenomegalije).
The primary efficacy endpoint in CP-CML was major cytogenetic response (MCyR), which included complete and partial cytogenetic responses (CCyR and PCyR).
Primarni ishod za bolesnike u kroničnoj fazi KML-a bio je značajni citogenetički odgovor (MCyR, engl. major cytogenetic response) koji je uključivao kompletni i parcijalni citogenetički odgovor (CCyR i PCyR, engl. complete and partial cytogenetic responses).
Of the CP-CML patients previously treated with one, two, three or four prior TKIs, 75% (12/16), 68% (66/97), 44% (63/142), and 58% (7/12)) achieved a MCyR while on Iclusig, respectively.
Od bolesnika u kroničnoj fazi KML-a koji su prethodno liječeni s jednim, dva, tri ili četiri TKI, 75% (12/16), 68% (66/97), 44% (63/142) odnosno
Fatal and serious heart failure or left ventricular dysfunction occurred in Iclusig-treated patients, including events related to prior vascular occlusive events.
Zatajenje srca sa smrtnim ishodom i ozbiljno zatajenje srca ili disfunkcija lijeve klijetke javili su se u bolesnika liječenih Iclusigom, uključujući i događaje povezane s ranijim događajima vaskularne okluzije.
No human data on the effect of ponatinib on fertility are available.
Nisu dostupni podaci o učinku ponatiniba na plodnost u ljudi.
≥ 12 month reduction at 30 mg 8 ≥ 18 month reduction at 30 mg 7 ≥ 24 month reduction at 30 mg 6 ≥ 36 month reduction at 30 mg 1 Any dose reduction to 15 mg ≥ 3 month reduction at 15 mg
≥ 3 mjeseca smanjenje na 30 mg ≥ 6 mjeseci smanjenje na 30 mg ≥ 12 mjeseci smanjenje na 30 mg ≥ 18 mjeseci smanjenje na 30 mg ≥ 24 mjeseca smanjenje na 30 mg 6 ≥ 36 mjeseci smanjenje na 30 mg
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.
Uz minimalno praćenje u razdoblju od 64 mjeseca, u 3,4% (9/267) bolesnika sa CP-KML bolest se transformirala na AP-KML ili BP-KML.
Iclusig should be discontinued
Iclusiga treba odmah prekinuti.
Iclusig should be interrupted and patients evaluated for serious or severe haemorrhage.
Potrebno je prekinuti davanje Iclusiga i izvršiti dijagnostičku obradu pacijenta zbog suspektne ozbiljne ili teške hemoragije.
Iclusig is available in plastic bottles, each containing one canister of a molecular sieve desiccant.
Iclusig je dostupan u plastičnim bocama, od kojih svaka sadrži jedan spremnik s molekularnim sitom kao sredstvom za sušenje.
For a dose of 30 mg or 15 mg once daily, 15 mg and 30 mg film-coated tablets are available.
Za dozu od 30 mg ili 15 mg jednom dnevno dostupne su filmom obložene tablete od 15 mg i 30 mg.
Serious venous thromboembolic adverse reactions occurred in 5% of patients (treatment-emergent frequencies) (see section 4.8).
Nuspojave ozbiljne venske tromboembolije javile su se u 5% bolesnika (učestalost nuspojava izazvanih liječenjem) (vidjeti dio 4.8).
• pain in skeletal system or neck
• bol u kostima ili vratu
Table 4 Adverse reactions observed in CML and Ph+ ALL patients - frequency reported by incidence of treatment emergent events System organ class
Tablica 4 Nuspojave uočene u KML i Ph+ ALL bolesnika - učestalost prijavljena prema incidenciji događaja izazvanih liječenjem
In CP-CML patients who achieved MCyR, the median time to MCyR was 2.8 months (range: 1.6 to 11.3 months) and in patients who achieved MMR, the median time to MMR was 5.5 months (range: 1.8 to 55.5 months).
Za bolesnike u kroničnoj fazi KML-a koji su postigli MCyR medijan vremena do postizanja MCyR iznosio je 2,8 mjeseci (raspon: 1,6 do 11,3 mjeseci), a u bolesnika koji su postigli MMR medijan vremena do postizanja MMR iznosio je 5,5 mjeseci (raspon: 1,8 do 55,5 mjeseci).
• a 15 mg film-coated tablet and a 30 mg film-coated tablet to allow for dose adjustments.
• filmom obložene tablete od 15 mg i filmom obložene tablete od 30 mg za prilagođavanje doze.
The recommended starting dose is 45 mg of ponatinib once daily.
Doziranje Preporučena početna doza iznosi 45 mg ponatiniba, jednom dnevno.
Women of childbearing potential/Contraception in males and females Women of childbearing age being treated with Iclusig should be advised not to become pregnant and men being treated with Iclusig should be advised not to father a child during treatment.
Ženama reproduktivne dobi koje se liječe lijekom Iclusig treba savjetovati da ne zatrudne, a muškarcima koji se liječe lijekom Iclusiga također treba savjetovati da ne začnu dijete tijekom liječenja.
• inability to develop or maintain an erection
• nesposobnost postizanja ili održavanja erekcije • zimica, bolest nalik gripi
Evidence for pre- and post-implantation loss of embryos was reported in female rats and ponatinib may therefore impair female fertility.
U ženki štakora prijavljeni su dokazi gubitka zametaka prije i poslije implantacije, te stoga ponatinib može smanjiti plodnost ženki.
If decreased vision or blurred vision occurs, an ophthalmic examination (including fundoscopy) should be performed.
Dođe li do slabljenja ili zamagljenja vida, potrebno je obaviti oftalmološki pregled (uključujući oftalmoskopiju).
The safety and efficacy of Iclusig in CML and Ph+ ALL patients who were resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy were evaluated in a single-arm, open-label, international, multicenter trial.
Klinička djelotvornost i sigurnost primjene Sigurnost i djelotvornost primjene ponatiniba u bolesnika s KML i Ph+ALL koji su bili rezistentni ili intolerantni na prethodna liječenja inhibitorima tirozin kinaze (TKI) procijenjeni su u otvorenom, međunarodnom, multicentričnom ispitivanju s jednom skupinom bolesnika.
Table 8 Efficacy of Iclusig in resistant or intolerant advanced phase CML patients Accelerated Phase CML
Tablica 8 Djelotvornost lijeka Iclusig u bolesnika u uznapredovaloj fazi KML koji su rezistentni ili ne podnose lijek Ubrzana faza KML
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.
U bolesnika liječenih Iclusigom javile su se arterijske okluzije, uključujući i infarkt miokarda sa smrtnim ishodom, moždani udar, arterijske okluzije mrežnice u nekim slučajevima povezane s trajnim pogoršanjem vida ili gubitkom vida, stenozu velikih arterija u mozgu, tešku perifernu vaskularnu bolest, stenozu bubrežne arterije (povezanu s pogoršanjem hipertenzije, graničnom ili refraktornom hipertenzijom), te potrebu za hitnim postupkom revaskularizacije.
Resistance in CP-CML was defined as failure to achieve either a complete haematological response (by 3 months), a minor cytogenetic response (by 6 months), or a major cytogenetic response (by 12 months) while on dasatinib or nilotinib.
Rezistencija bolesnika u kroničnoj fazi KML-a definirana je izostankom postizanja potpunog hematološkog odgovora (do 3 mjeseca), manjeg citogenetičkog odgovora (do 6 mjeseci) ili većeg citogenetičkog odgovora (do 12 mjeseci) za vrijeme liječenja dasatinibom ili nilotinibom.
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).
U ispitivanju faze 2 (s minimalnim razdobljem praćenja od 64 mjeseca), nuspojave venske tromboembolije zabilježene su u 6% bolesnika (učestalost nuspojava izazvanih liječenjem).
• diarrhoea, vomiting, nausea
• proljev, povraćanje, mučnina
The secondary efficacy endpoints in CP-CML were complete haematological response (CHR) and major molecular response (MMR).
Sekundarni ishodi za bolesnike u kroničnoj fazi KML-a bili su kompletni hematološki odgovor i veliki molekularni odgovor (MMR, engl. major molecular response).
Achieved MCyR at 45 mg (N=86)
Postignut MCyR pri 45 mg (N=86)
Bottles of Iclusig 15 mg contain either 30, 60 or 180 film-coated tablets.
Boca Iclusiga 15 mg sadrži 30, 60 ili 180 filmom obloženih tableta.
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),
Medijan vremena do MaHR za bolesnike u ubrzanoj fazi, blastičnoj fazi i Ph+ ALL bio je 0,7 mjeseci (raspon: 0,4 do 5,8 mjeseci), 1,0 mjeseci (raspon: 0,4 do 3,7 mjeseci) i 0,7 mjeseci (raspon: 0,4 do 5,5 mjeseci).
A MCyR at the 3-month landmark correlated strongly and statistically significantly with PFS and OS (p<0.0001 and p=0.0006, respectively).
MCyR na kontrolnoj točki od 3 mjeseca bio je u snažnoj i statistički značajnoj korelaciji s PFS-om i OS-om (p<0,0001
• an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).
• proširenje i slabljenje stijenke krvne žile ili rascjep stijenke krvne žile (aneurizme i disekcije arterije)
In the phase 2 trial, serious arterial occlusive adverse reactions occurred in 20% of patients (treatment-emergent frequencies).
U ispitivanju faze 2, ozbiljne nuspojave arterijske okluzije javile su se u 20% bolesnika (učestalost nuspojava izazvanih liječenjem).
Table 2 Dose modifications for pancreatitis and elevation of lipase/amylase Grade 2 pancreatitis and/or asymptomatic elevation of lipase/amylase
Tablica 2 Prilagodba doze u slučaju pankreatitisa i povišenja serumske lipaze/amilaze
6.6 Special precautions for disposal and other handling Disposal
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom
The incidence of severe bleeding events was higher in patients with AP-CML, BP-CML and Ph+ ALL.
Incidencija događaja teškog krvarenja bila je viša u bolesnika s AP-KML, BP-KML, i Ph+ ALL.
Of 43 CP-CML patients, 31 CP-CML patients achieved a MCyR with a median duration of follow-up of 55.5 months (range: 1.7 to 91.4 months).
Od 43 bolesnika u kroničnoj fazi KML-a, 31 je postigao MCyR s medijanom praćenja od 55,5 mjeseci (raspon: 1,7 do
Resistant or Intolerant R/I Cohort (N=203)
Rezistentan ili intolerantan R/I kohorta (N=203)
Very common rash, dry skin, pruritus
Vrlo često osip, suha koža, pruritus
At therapeutic serum concentrations, ponatinib did not inhibit OATP1B1 or OATP1B3, OCT1 or OCT2, organic anion transporters OAT1 or OAT3, or bile salt export pump (BSEP) in vitro.
Pri terapijskim koncentracijama u serumu ponatinib nije inhibirao OATP1B1 ili OATP1B3, OCT1 ili OCT2 transportere organskih aniona OATP1B1 ili OATP1B3, transportere organskih kationa OCT1
CP-CML patients who experienced a loss of response or development of a kinase domain mutation in the absence of a complete cytogenetic response or progression to AP-CML or BP-CML at any time on dasatinib or nilotinib were also considered resistant.
Bolesnici u kroničnoj fazi KML-a koji nisu odgovorili na liječenje ili su razvili mutacije u domeni BCR-ABL kinaze u odsutnosti potpunog citogenetičkog odgovora ili progresije bolesti u ubrzanu ili blastičnu fazu u bilo koje vrijeme liječenja dasatinibom ili nilotinibom također se smatraju rezistentnim.
The frequency of pancreatitis is greater in the first 2 months of use.
Učestalost pankreatitisa je veća u prva
Overall arterial occlusive adverse reactions have occurred in 25% of Iclusig-treated patients from the phase 2 trial, with serious adverse reactions occurring in 20% of patients.
U ispitivanju faze 2, nuspojave arterijske okluzije javile su se u ukupno 25% bolesnika liječenih Iclusigom, s ozbiljnim nuspojavama koje su se javile u 20% bolesnika.
The median duration of treatment with Iclusig was 32.2 months in CP-CML patients, 19.4 months in AP-CML patients, and 2.9 months in BP-CML/Ph+ ALL patients.
Medijan trajanja liječenja Iclusigom bio je 32,2 mjeseca za bolesnike u kroničnoj fazi (CP-KML), 19,4 mjeseca za bolesnike u ubrzanoj fazi (AP-KML) i 2,9 mjeseci za bolesnike u blastičnoj fazi (BP-KML) /Ph+ ALL.
Arterial occlusion and venous thromboembolism
Arterijska okluzija i venska tromboembolija
• obstruction of the blood vessels in the eye
• začepljenje krvnih žila u oku
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
In cynomolgus monkeys, systolic heart murmurs with no macroscopic or microscopic correlates were noted in individual animals treated with 5 and 45 mg/kg in the single dose toxicity study and at 1, 2.5
U makaki majmuna uočeni su sistolički šumovi srca bez makroskopkih ili mikroskopskih povezanosti s pojedinim životinjama liječenih s 5 i 45 mg/kg u studiji toksičnosti pojedinačne doze i u studiji toksičnosti ponovljene doze koja je trajala 4 tjedna i uključivala doze od 1, 2,5 i 5 mg/kg.
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).
Učestalost stupnja 3 ili 4 trombocitopenije, neutropenije i anemije bila je viša u bolesnika s AP-KML i BP-KML/Ph+ ALL nego u bolesnika s CP-KML (vidjeti Tablicu 5).
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).
Ozbiljne nuspojave arterijske kardiovaskularne, cerebrovaskularne i periferne vaskularne okluzije (učestalost nuspojava izazvanih liječenjem) javile su se u 10%, 7%, odnosno 9% bolesnika liječenih Iclusigom (vidjeti dio 4.8).
Discontinuation of ponatinib should be considered in patients who develop serious heart failure (see sections 4.2 and 4.8).
Potrebno je razmotriti prekid davanja ponatiniba u bolesnika kod kojih se razvije ozbiljno zatajenje srca (vidjeti dijelove 4.2 i 4.8).
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).
Učestalost tih događaja veća je u bolesnika s ubrzanom fazom KML (AP-KML) ili blastičnom fazom KML (BP-KML)/Ph+ ALL nego u kroničnoj fazi KML-a (CP-KML).
Table 10 Vascular occlusive first adverse events in CP-CML patients who achieved MCyR at 45 mg or 30 mg (data extraction 7 April 2014) Most recent dose at onset of first vascular occlusive Event 45 mg
Tablica 10 Prvi štetni događaji vaskularne okluzije u bolesnika u kroničnoj fazi KML-a koji su postigli MCyR pri dozi od 45 mg ili 30 mg (podatci od 7. travnja 2014.)