natgillin/translations-raw huggingface dataset:
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.
MaHR za bolesnike s AP-KML (medijan trajanja liječenja: 19,4 mjeseci), BP-KML (medijan trajanja liječenja: 2,9 mjeseci), i Ph+ ALL (medijan trajanja liječenja: 2,7 mjeseci) procijenjen je na 12,9 mjeseci (raspon: 1,2 do 68,4 mjeseca), 6,0 mjeseci (raspon: 1,8 do 59,6 mjeseci) i 3,2 mjeseca (raspon: 1,8 do 12,8 mjeseci).
Arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions (treatment-emergent frequencies) occurred in 13%, 9%, and 11% of Iclusig-treated patients, respectively.
Nuspojave arterijske kardiovaskularne, cerebrovaskularne i periferne vaskularne okluzije (učestalost nuspojava izazvanih liječenjem) javile su se u 13%, 9%, odnosno 11% bolesnika liječenih Iclusigom.
Bottles of Iclusig 30 mg contain 30 film-coated tablets.
Boca Iclusiga 30 mg sadrži 30 filmom obloženih tableta.
CP-CML patients who received fewer prior TKIs attained higher cytogenetic, haematological, and molecular responses.
Bolesnici u kroničnoj fazi KML-a koji su prethodno primali manje TKI terapija postigli su bolji citogenetičke, hematološke i molekularne odgovore.
Common cardiac failure, myocardial infarction, cardiac failure congestive, coronary artery disease, angina pectoris, pericardial effusion, atrial fibrillation, ejection fraction decreased, acute coronary syndrome, atrial flutter
Često zatajenje srca, infarkt miokarda, kongestivno zatajenje srca, bolest koronarnih arterija, angina pectoris, efuzija perikarda, fibrilacija atrija, smanjena ejekcijska frakcija, akutni koronarni sindrom, undulacija atrija
If it is used during pregnancy, the patient must be informed of the potential risk to the foetus.
bolesnica mora biti obaviještena o potencijalnoj opasnosti za fetus.
60 tablets
30 tableta
Dose reduction to 30 mg only ≥ 3 month reduction at 30 mg
Bez smanjenja doze Smanjenje doze samo na 30 mg
• inflammation of hair follicles, swollen, red area of skin or underneath skin that feels hot and tender
• upala folikula kose, natečena, crvena područja na površini kože ili ispod kože, vruća i osjetljiva na dodir • smanjena aktivnost štitne žlijezde
• lung infection (may cause breathing difficulty)
• infekcija pluća (može izazvati otežano disanje)
Hepatic failure (including fatal outcome) has been observed.
Uočeno je zatajenje jetre (uključujući i ono sa smrtnim ishodom).
Table 6 Demographics and disease characteristics
Tablica 6 Demografske karakteristike te karakteristike bolesti Karakteristike bolesnika kod ulaska u ispitivanje
Uncommon cerebral artery stenosis, cerebral haemorrhage, haemorrhage intracranial, posterior reversible encephalopathy syndrome *
Manje često stenoza cerebralne arterije, cerebralna hemoragija, intrakranijska hemoragija, sindrom posteriorne reverzibilne encefalopatije *
Cardiovascular status should continue to be monitored and medical and supportive therapy for conditions that contribute to cardiovascular risk should be optimised during treatment with ponatinib.
Tijekom liječenja ponatinibom mora se nastaviti pratiti kardiovaskularno stanje i optimizirati medicinsko i suportivno liječenje za stanja koja doprinose kardiovaskularnom riziku.
Therefore, ponatinib may have the potential to increase plasma concentrations of co-administered substrates of P-gp (e.g., digoxin, dabigatran, colchicine, pravastatin) or BCRP (e.g., methotrexate, rosuvastatin, sulfasalazine) and may increase their therapeutic effect and adverse reactions.
kolhicina, pravastatina) ili BCRP (poput metotreksata, rosuvastatina, sulfasalazina) i može povećati njihov terapijski učinak i nuspojave.
For CP-CML patients overall (N=267), as well as for CP-CML R/I Cohort A patients (N=203) and T315I Cohort B patients (N=64), the median OS has not yet been reached.
kohorte A (N=203) te bolesnike T315I kohorte B (N=64), medijan ukupnog preživljenja još nije postignut.
Serious venous occlusive reactions (treatment-emergent frequencies) occurred in 5% of patients.
Ozbiljne nuspojave venske okluzije (učestalost nuspojava izazvanih liječenjem) javile su se u 5% bolesnika.
• Iclusig should be resumed at 30 mg after recovery to ≤ Grade 1 (< 3 × ULN), or recovery to pre-treatment grade Occurrence at 30 mg:
• Potrebno je nastaviti primjenu lijeka Iclusig s dozom od 30 mg nakon oporavka na ≤ stupanj 1 (< 3 x GGN) ili oporavka na stupanj prije liječenja Pojava uz 30 mg:
Iclusig 30 mg film-coated tablets are approximately 8 mm in diameter with "C7" on one side.
Iclusig 30 mg filmom obložene tablete su promjera oko 8 mm s oznakom "C7" na jednoj strani.
Venous thromboembolic reactions (treatment-emergent frequencies) occurred in 6% of patients.
Reakcije venske tromboembolije (učestalost nuspojava izazvanih liječenjem) javile su se u 6,0% bolesnika.
The incidence of thromboembolic events is higher in patients with Ph+ ALL or BP-CML than those with AP-CML or CP-CML.
Incidencija tromboembolijskih događaja viša je u bolesnika s Ph+ALL ili BP-KML u odnosu na one s AP-KML-om ili CP-KML-om.
Iclusig 45 mg film-coated tablets EU/1/13/839/003
Iclusig 45 mg filmom obložene tablete EU/1/13/839/003
Occurrence at 15 mg:
Pojava uz 15 mg:
Arterial occlusion adverse events were more frequent with increasing age and in patients with history of ischaemia, hypertension, diabetes, or hyperlipidaemia.
Štetni događaji arterijske okluzije bivali su češći s porastom godina i u bolesnika s anamnezom ishemije, hipertenzije, dijabetesa, ili hiperlipidemije.
Post-marketing cases of Posterior Reversible Encephalopathy Syndrome (PRES) have been reported in Iclusig-treated patients.
Nakon stavljanja lijeka u promet, u bolesnika liječenih lijekom Iclusig prijavljeni su slučajevi sindroma posteriorne reverzibilne encefalopatije (PRES).
• fluid in the thorax (may cause breathing difficulty)
• tekućina u prsnom košu (može uzrokovati otežano disanje)
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.
Također, provedene su post hoc analize radi procjene odnosa ishoda kratkoročnih citogenetičkih (MCyR) i molekularnih (MMR) odgovora prema dugoročnim ishodima preživljenja bez napredovanja bolesti
Occurrence at 30 mg:
Pojava uz 30 mg:
• a history of renal artery stenosis (narrowing of the blood vessels to one or both kidneys)
• anamnezu stenoze bubrežne arterije (suženje krvnih žila koje vode do jednog ili oba bubrega)
• upper airway infection (may cause breathing difficulty)
• infekcija gornjih dišnih putova (može izazvati otežano disanje)
*ULN = Upper Limit of Normal for the lab
Potrebno je prekinuti primjenu lijeka Iclusig *GGN = gornja granica normalnih vrijednosti laboratorija
Talk to your doctor or pharmacist before taking Iclusig if you have:
Obratite se svom liječniku ili ljekarniku prije nego uzmete Iclusig ako imate: • poremećaj jetre ili gušterače ili smanjenu funkciju bubrega.
Iclusig 15 mg film-coated tablets EU/1/13/839/001
Iclusig 15 mg filmom obložene tablete EU/1/13/839/001
Treatment-emergent hypertension (including hypertensive crisis) occurred in Iclusig-treated patients.
U bolesnika liječenih Iclusigom javila se hipertenzija izazvana liječenjem (uključujući hipertenzivnu krizu).
Iclusig 30 mg film-coated tablets EU/1/13/839/006
Iclusig 30 mg filmom obložene tablete EU/1/13/839/006
Common pancreatitis, blood amylase increased, gastrooesophageal reflux disease, stomatitis, dyspepsia, abdominal distension, abdominal discomfort, dry mouth, gastric haemorrhage
Često pankreatitis, povišena amilaza u krvi, gastroezofagealna refluksna bolest, stomatitis, dispepsija, distenzija abdomena, nelagoda u abdomenu, suha usta, krvarenje iz želuca
Severe skin reactions (such as Stevens-Johnson Syndrome) have been reported with some BCR-ABL Tyrosine Kinase Inhibitors.
U vezi s nekim inhibitorima BCR-ABL tirozin kinaze prijavljene su teške kožne nuspojave (poput Stevens-Johnsonova sindroma).
Other possible side effects that may occur with the following frequencies are:
• povećana sklonost krvarenju ili nastajanju modrica Druge moguće nuspojave koje se mogu pojaviti sa sljedećom učestalosti su:
In preclinical mutagenesis studies, 40 nM was determined as the concentration of ponatinib sufficient to inhibit viability of cells expressing all tested BCR-ABL mutants by > 50% (including T315I) and suppress the emergence of mutant clones.
50% vijabilnosti stanica koje eksprimiraju sve testirane mutacije BCR-ABL (uključujući T315I) i potiskivanje nadiranja mutantskih klonova.
Table 9 Efficacy of Iclusig in resistant or intolerant Ph+ ALL patients Overall (N=32)
Tablica 9 Djelotvornost lijeka Iclusig u bolesnika s Ph+ ALL koji su rezistentni ili ne podnose lijek
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.
Za većinu tih bolesnika (82/110 bolesnika; 75%) prijavljeno je da su kao zadnju dozu primali 15 mg, dok su 24/110 bolesnika (22%) primali 30 mg, a 4/110 (4%) 45 mg.
• had a prior heart attack or stroke
• anamnezu srčanog ili moždanog udara
Cytogenetic Response Major (MCyR) a
Značajni (MCyR) a
(95% CI) Major Molecular Response b
Značajni molekularni odgovor b %
Common dehydration, fluid retention, hypocalcaemia, hyperglycaemia, hyperuricaemia, hypophosphataemia, hypertriglyceridaemia, hypokalaemia, weight decreased, hyponatraemia
hiperglikemija, hiperuricemija, hipofosfatemija, hipertrigliceridemija, hipokalijemija, smanjenje tjelesne težine, hiponatremija
90 tablets
30 tableta 90 tableta
Table 11 Maintenance of response in CP-CML patients who achieved MCyR or MMR at 45 mg dose (data extraction 6 February 2017) Achieved MCyR at 45 mg (N=86)
MMR pri dozi od 45 mg (podatci od 06. veljače 2017.) Postignut MCyR pri 45 mg (N=86)
≥ 18 month day reduction at 15 mg ≥ 24 month reduction at 15 mg 32
≥ 3 mjeseca smanjenje na 15 mg ≥ 6 mjeseci smanjenje na 15 mg ≥ 12 mjeseci smanjenje na 15 mg 44 ≥ 18 mjeseci smanjenje na 15 mg 38 ≥ 24 mjeseci smanjenje na 15 mg 32 ≥ 36 mjeseci smanjenje na 15 mg
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
≥2% bolesnika u bilo kojoj skupini bolesti iz ispitivanja faze 2 (N=449):
• renal artery stenosis (narrowing of the blood vessels to one or both kidneys)
• stenoza bubrežne arterije (suženje krvnih žila koje vode do jednog ili oba bubrega)
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 (%)
Medijan vremena od postavljanja dijagnoze do prve doze, godine (raspon) Rezistentni na prethodnu TKI terapijua *, n(%) Prethodna TKI terapija- broj režima, n (%)
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).
U ispitivanju faze 2 (s najmanje 64 mjeseca praćenja), nuspojave arterijske okluzije javile su se u 25%
Iclusig 15 mg film-coated tablets Iclusig 30 mg film-coated tablets Iclusig 45 mg film-coated tablets ponatinib
Iclusig 15 mg filmom obložene tablete Iclusig 30 mg filmom obložene tablete Iclusig 45 mg filmom obložene tablete
Uncommon myocardial ischemia, cardiac discomfort, ischemic cardiomyopathy, arteriospasm coronary, left ventricular dysfunction,
Manje često ishemija miokarda, srčana nelagoda, ishemijska kardiomiopatija, spazam koronarne arterije, disfunkcija lijeve klijetke,
≥ 12 month reduction at 15 mg 44
Bilo koje smanjenje doze na 15 mg 52
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Kako čuvati Iclusig Lijek čuvajte izvan pogleda i dohvata djece.
The bottle contains one sealed plastic canister containing a molecular sieve desiccant.
Boca sadrži jedan plastični zatvoreni spremnik s molekularnim sitom kao sredstvom za sušenje.
INFORMATION IN BRAILLE Outer Carton:
16. PODACI NA BRAILLEOVOM PISMU
• skin rash, peeling of the skin, abnormal thickening of the skin, redness, bruising, skin pain,
• kožni osip, ljuštenje kože, nenormalna zadebljanja kože, crvenilo, nastanak modrica, bol po koži, promjene boje kože, gubitak kose
Serious side effects (common: may affect up to 1 in 10 people):
Ozbiljne nuspojave (često: mogu se javiti u do 1 na 10 osoba):
• increased blood level of bilirubin - the yellow breakdown substance of the blood pigment
• povišena razina bilirubina u krvi - žuti razgradni produkt krvnog pigmenta (simptomi uključuju:
Iclusig 45 mg
Kutija: Iclusig 45 mg
The bottle contains one sealed canister containing a molecular sieve desiccant.
Boca sadrži jedan zatvoreni spremnik s molekularnim sitom kao sredstvom za sušenje.
Uncommon poor peripheral circulation, splenic infarction, embolism venous, venous thrombosis, hypertensive crisis, renal artery stenosis
Manje često slaba periferna cirkulacija, infarkt slezene, venska embolija, venska tromboza, hipertenzivna kriza, stenoza bubrežne arterije
Common hypothyroidism
Često hipotiroidizam
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 sve bolesnike u ispitivanju faze 2, odnos jačina doze-sigurnost ukazao je na značajna povećanja štetnih događaja stupnja ≥ 3 (zatajenje srca, arterijska tromboza, hipertenzija, trombocitopenija,
Iclusig 30 mg
Kutija: Iclusig 30 mg
B to become active again, which can be fatal in some cases.
To je potrebno jer Iclusig može uzrokovati ponovnu aktivaciju hepatitisa B što u nekim slučajevima može rezultirati smrtnim ishodom.
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).
kardiovaskularni rizik, nuspojave liječenja ponatinibom, vrijeme do citogenetičkog odgovora i razine BCR-ABL transkripta (vidjeti dijelove 4.4 i 5.1).
In the phase 2 trial, 86 CP-CML patients achieved MCyR at a dose of 45 mg, 45 CP-CML patients achieved MCyR after a dose reduction to 30 mg, mostly for adverse events.
U ispitivanju faze 2, 86 bolesnika u kroničnoj fazi KML-a postiglo je MCyR pri dozi od 45 mg , 45
• heart attack (symptoms include: sudden feeling of increased heart rate, chest pain, breathlessness)
• srčani udar (simptomi uključuju: iznenadan osjećaj povećane brzine srčanih otkucaja, bol u prsnom košu, nedostatak zraka) • promjene koncentracija u krvi:
High density polyethylene (HDPE) bottles with screw-top closures, containing either 30, 60 or 180 film-coated tablets, together with one plastic canister containing a molecular sieve desiccant.
Boce od polietilena visoke gustoće (HDPE) s navojnim zatvaračima, sadrže 30, 60 ili 180 filmom obloženih tableta i jedan plastični spremnik s molekularnim sitom kao sredstvom za sušenje.
The clinical relevance of these findings on human fertility is unknown.
Klinički značaj ovih nalaza na ljudsku plodnost nije poznat.
Each film-coated tablet contains 80 mg of lactose monohydrate.
Svaka filmom obložena tableta sadrži 80 mg laktoze hidrata.
A break in treatment or a decrease in dose may be required when lipase is increased.
slučaju povišenih vrijednosti serumske lipaze, možda će biti potrebno napraviti stanku u liječenju ili smanjiti dozu.
High density polyethylene (HDPE) bottles with screw-top closures, containing either 30 or 90 film-coated tablets, together with one plastic canister containing a molecular sieve desiccant.
Boce od polietilena visoke gustoće (HDPE) s navojnim zatvaračima, sadrže 30 ili 90 filmom obloženih tableta i jedan plastični spremnik s molekularnim sitom kao sredstvom za sušenje.
In a study in rats, diffuse corneal edema with neutrophilic cell infiltration, and hyperplastic changes in the lenticular epithelium suggestive of a mild phototoxic reaction were observed in animals treated with 5 and 10 mg/kg ponatinib.
U studijama na štakorima kod doza od 5 i 10 mg/kg ponatiniba uočeni su difuzni edem rožnice s infiltracijom neutrofilnih stanica i hiperplastične promjene u epitelu leće što ukazuje na blage fototoksične reakcije.
High density polyethylene (HDPE) bottles with screw-top closures, containing 30 film-coated tablets, together with one plastic canister containing a molecular sieve desiccant.
Boce od polietilena visoke gustoće (HDPE) s navojnim zatvaračima, sadrže 30 filmom obloženih tableta i jedan plastični spremnik s molekularnim sitom kao sredstvom za sušenje.
At doses of 30 mg or greater plasma steady state trough concentrations of ponatinib typically exceed 21 ng/mL (40 nM).
Pri dozama od 30 mg ili većim u stanju dinamičke ravnoteže koncentracija ponatiniba obično prelazi
Ph+ cells) and partial (1% to 35% Ph+ cells) cytogenetic responses.
c MCyR kombinira i kompletne (bez uočenih Ph+ stanica) i parcijalne (1% do 35% Ph+ stanica) citogenetičke odgovore.
The clinical relevance of this finding for humans is not known.
Klinički značaj ovog nalaza za ljude nije poznat.
White, biconvex, round film-coated tablet that is approximately 8 mm in diameter, with "C7" debossed on one side.
Bijela, bikonveksna okrugla filmom obložena tableta, promjera oko 8 mm s oznakom "C7" utisnutom na jednoj strani.
The clinical relevance of these findings to human fertility is unknown.
Klinički značaj ovih nalaza za ljudsku plodnost nije poznat.
Based on the Kaplan-Meier estimates, 82% (95% CI: [74%-88%]) of CP-CML (median duration of treatment: 32.2 months) patients who achieved a MCyR are projected to maintain that response at 48 months and 61% (95% CI: [51%- 70%]) of CP-CML patients who achieved a MMR are projected to maintain that response at 36 months.
32,2 mjeseci) koji su postigli MCyR održati postignuti odgovor nakon 48 mjeseci i 61% (95% CI: [51% - 70%]) bolesnika u kroničnoj fazi KML-a koji su postigli MMR održati postignuti odgovor nakon 36 mjeseci.
Prior TKI therapy- number of regimens, n (%)
ECOG funkcionalni status, n (%)
• Contraceptive advice for men and women Women of childbearing age being treated with Iclusig should avoid becoming pregnant.
Ženama reproduktivne dobi koje se liječe lijekom Iclusig se ne preporučuje trudnoća.
• pain in bones, joints, pain in muscles, back, arms or legs, muscle spasms
• bolovi u kostima, zglobovima, bol u mišićima, leđima, rukama ili nogama, grčevi mišića • umor, nakupljanje tekućine u rukama i/ili nogama, vrućica, bol
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.
Zahvaljujući strukturi koja uključuje i trostruku vezu između atoma ugljika ponatinib ima visoki afinitet vezivanja za divlji tip BCR-ABL i mutirane ABL kinaze.
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.
Istovremena peroralna primjena 15 mg lijeka Iclusig s ketokonazolom (400 mg dnevno), snažnim CYP3A inhibitorom uzrokovala je skromni porast u sistemskoj izloženosti ponatinibu s vrijednostima
Iclusig 45 mg film-coated tablets
Iclusig 45 mg filmom obložene tablete
How to store Iclusig
Moguće nuspojave Kako čuvati Iclusig
Common pulmonary embolism, pleural effusion, epistaxis, dysphonia, pulmonary hypertension
Često plućna embolija, pleuralni izljev, epistaksa,
White, biconvex, round film-coated tablet that is approximately 9 mm in diameter, with “AP4” debossed on one side.
Bijela, bikonveksna okrugla filmom obložena tableta, promjera oko 9 mm s oznakom "AP4" utisnutom na jednoj strani.
Common pancytopenia, febrile neutropenia, white blood cell count decreased, lymphocyte count decreased
Često pancitopenija, febrilna neutropenija, smanjen broj leukocita, smanjen broj limfocita
Iclusig 15 mg
Kutija: Iclusig 15 mg
Iclusig 30 mg film-coated tablets
Iclusig 30 mg filmom obložene tablete
• Iclusig should be withheld and resumed at the same dose after recovery to ANC ≥ 1.5 x 109/L and platelet ≥ 75 x 109/L Recurrence at 45 mg:
• Potrebno je obustaviti primjenu lijeka Iclusig i nastaviti s istom dozom nakon oporavka ABN na ≥ 1,5 x 109/l te trombocita na ≥ 75 x 109/l
• Iclusig should be withheld and resumed at 15 mg after recovery to ANC ≥ 1.5 x 109/L and platelet ≥ 75 x 109/L
• Potrebno je obustaviti primjenu lijeka Iclusig i nastaviti s dozom od 15 mg nakon oporavka ABN na ≥ 1,5 x 109/l te trombocita na ≥ 75 x 109/l
Cohort (N=65)
R/I kohorta (N=65)
Iclusig is for oral use.
Lijek Iclusig uzima se peroralno.
Common rash pruritic, exfoliative rash, erythema, alopecia, skin exfoliation, night sweats, hyperhidrosis, petechia, ecchymosis, pain of skin, dermatitis exfoliative, hyperkeratosis, skin hyperpigmentation
hiperhidroza, petehije, ekhimoze, bolna koža, eksfolijativni dermatitis, hiperkeratoza, hiperpigmentacija kože
Iclusig is associated with pancreatitis.
Pankreatitis i serumska lipaza Liječenje lijekom Iclusig je povezano s pankreatitisom.
• Iclusig should be withheld and resumed at 30 mg after recovery to < Grade 2
• Potrebno je obustaviti primjenu lijeka Iclusig i nastaviti s dozom od 30 mg nakon oporavka na < stupanj 2 Pojava uz 30 mg:
Factors other than dose may also contribute to this risk of arterial occlusion.
Riziku arterijske okluzije mogu pridonijeti i drugi čimbenici osim doze.
Table 7 Efficacy of Iclusig in resistant or intolerant chronic phase CML patients Overall (N=267)
Tablica 7 Djelotvornost lijeka Iclusig u bolesnika u kroničnoj fazi KML-a koji su rezistentni ili intolerantni
• Iclusig should be interrupted and resumed at 15 mg after recovery to ≤ Grade 1, or recovery to pretreatment grade Occurrence at 15 mg:
• Potrebno je prekinuti primjenu lijeka Iclusig i nastaviti s dozom od 15 mg nakon oporavka na ≤ stupanj 1 ili oporavka na stupanj prije liječenja
Patients may require urgent clinical intervention for hypertension associated with confusion, headache, chest pain, or shortness of breath.
Za hipertenziju povezanu sa zbunjenošću, glavoboljom, boli u prsištu ili nedostatkom zraka bolesnicima može biti potrebna hitna klinička intervencija.
Retinal venous occlusions associated in some cases with permanent visual impairment or vision loss have occurred in Iclusig-treated patients.
U bolesnika liječenih Iclusigom bilo je pojava venske okluzije mrežnice, u nekim slučajevima povezane s trajnim oštećenjem ili gubitkom vida.
Iclusig 15 mg film-coated tablets
Iclusig 15 mg filmom obložene tablete
• Iclusig should be withheld and resumed at 15 mg after recovery to < Grade 2
• Potrebno je obustaviti primjenu lijeka Iclusig i nastaviti s dozom od 15 mg nakon oporavka na < stupanj 2 Pojava uz 15 mg: