natgillin/translations-raw huggingface dataset:
b CHR: WBC ≤ institutional ULN, ANC ≥1000/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).
- gamma-glutamyltransferase
amilaze alkalne fosfataze gama-glutamiltrasnferaze
Very common side effects (affects more than 1 per 10 users):
Vrlo česte nuspojave (javljaju se u više od 1 na 10 korisnika):
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 (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
Common peripheral arterial occlusive disease, peripheral ischaemia, peripheral artery stenosis, intermittent claudication, deep vein thrombosis, hot flush, flushing
Često periferna okluzivna arterijska bolest, periferna ishemija, stenoza perifernih arterija, intermitentna klaudikacija, duboka venska tromboza, navale vrućine, naleti crvenila
Ponatinib did not adversely affect important developmental parameters in the juvenile toxicity study.
U ispitivanjima toksičnosti u mladih štakora ponatinib nije štetno djelovao na važne parametre razvoja.
• pain in bones, joints, back, arms or legs, muscle spasms
• bolovi u kostima, zglobovima, leđima, rukama ili nogama, grčevi mišića
Dose reduction in CP-CML patients
Smanjivanje doze u bolesnika u kroničnoj fazi KML
Common cerebrovascular accident, cerebral infarction, neuropathy peripheral, lethargy, migraine, hyperaesthesia, hypoaesthesia, paraesthesia, transient ischaemic attack
Često cerebrovaskularni incident, moždani infarkt, periferna neuropatija, letargija, migrena, hiperestezija, hipoestezija, parestezija, tranzitorna ishemijska ataka
Handling:
Rukovanje:
• upper airway infection
• infekcija gornjih dišnih putova
Caution is recommended in when administering Iclusig to patients with estimated creatinine clearance of < 50 mL/min or end-stage renal disease (see section 4.2).
Preporučuje se oprez prilikom primjene lijeka Iclusig bolesnicima s klirensom kreatinina < 50 ml/min ili bolesnicima u terminalnoj fazi bubrežnog zatajenja (vidjeti dio 4.2).
Overall arterial and venous occlusive adverse reactions have occurred in 23% of Iclusig-treated patients from the phase 2 trial, with serious adverse reactions occurring in 18% of patients.
U ispitivanju faze 2, nuspojave arterijske i venske okluzije javile su se u ukupno 23% bolesnika liječenih Iclusigom, s ozbiljnim nuspojavama koje su se javile u 18% bolesnika.
Iclusig has not been studied in patients with renal impairment.
Iclusig nije ispitivan kod bolesnika s oštećenjem funkcije bubrega.
Common pulmonary embolism, pleural effusion, epistaxis, dysphonia, pulmonary hypertension
Često plućna embolija, pleuralni izljev, epistaksa, disfonija, plućna hipertenzija
Arterial and venous thrombosis and occlusions, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures have occurred in Iclusig-treated patients.
U bolesnika liječenih Iclusigom javile su se arterijske i venske tromboze i okluzije, uključujući i infarkt miokarda sa smrtnom posljedicom, moždani udar, stenozu velikih arterija u mozgu, tešku perifernu vaskularnu bolest, te potrebu za hitnim postupkom revaskularizacije.
The median time to MaHR in patients with AP-CML, BP-CML, and Ph+ ALL was 21 days (range: 12 to 176 days), 29 days (range: 12 to 113 days), and 20 days (range: 11 to 168 days), respectively.
Medijan vremena do MaHR za bolesnike u ubrzanoj fazi, blastičnoj fazi i Ph+ ALL bio je 21 dan (raspon: 12 do 176 dana), 29 dana (raspon: 12 do 113 dana) i 20 dana (raspon: 11 do 168 dana).
High density polyethylene (HDPE) bottles with screw-top closures, containing either 60 or 180 film-coated tablets, together with one plastic canister containing molecular sieve desiccant.
Boce od polietilena visoke gustoće (HDPE) s navojnim zatvaračima, sadrže 60 ili 180 filmom obloženih tableta i jedan plastični spremnik s molekularnim sitom kao sredstvom za sušenje.
Common dehydration, fluid retention, hypocalcaemia, hyperglycaemia, hyperuricaemia, hypophosphataemia, hypertriglyceridaemia, hypokalaemia, weight decreased
Često dehidracija, retencija tekućine, hipokalcijemija, hiperglikemija, hiperuricemija, hipofosfatemija, hipertrigliceridemija, hipokalijemija, smanjenje tjelesne težine
Iclusig 45 mg film-coated tablets are approximately 9 mm in diameter with "AP4" on one side.
Iclusig 45 mg filmom obložene tablete su promjera oko 9 mm s oznakom "AP4" na jednoj strani.
No specific studies have been performed to evaluate the effects of gender, age, race, and body weight on ponatinib pharmacokinetics.
Intrinzični faktori koji djeluju na farmakokinetiku ponatiniba Nisu provedena ispitivanja za ocjenu utjecaja spola, dobi, rase i tjelesne težine na farmakokinetiku ponatiniba.
Common pancreatitis, blood amylase increased, gastrooesophageal reflux disease, stomatitis, dyspepsia, abdominal distension, abdominal discomfort, dry mouth
Često pankreatitis, povišena amilaza u krvi, gastroezofagealna refluksna bolest, stomatitis, dispepsija, distenzija abdomena, nelagoda u abdomenu, suha usta
Substances that may increase ponatinib serum concentrations
Tvari koje mogu povećati serumske koncentracije ponatiniba
Calcium decreased
Snižen kalcij
• the number of blood platelets is reduced.
• ako je smanjen broj krvnih pločica (trombocita).
Very common fatigue, asthenia, oedema peripheral, pyrexia, pain
Vrlo često umor, astenija, periferni edem, pireksija, bol
Iclusig 15 mg film-coated tablets are approximately 6 mm in diameter with "A5" on one side.
Iclusig 15 mg filmom obložene tablete su promjera oko 6 mm s oznakom "A5" na jednoj strani.
Common cardiac failure, myocardial infarction, cardiac failure congestive, coronary artery disease, angina pectoris, pericardial effusion, atrial fibrillation, ejection fraction decreased
Često zatajenje srca, infarkt miokarda, kongestivno zatajenje srca, bolest koronarnih arterija, angina pectoris, efuzija perikarda, fibrilacija atrija, smanjena ejekcijska frakcija
Duration of use
Trajanje primjene
Amylase increased
Povišena amilaza
Substances that may decrease ponatinib serum concentrations
Tvari koje mogu smanjiti serumske koncentracije ponatiniba
Each film-coated tablet contains 40 mg of lactose monohydrate.
Svaka filmom obložena tableta sadrži 40 mg laktoze hidrata.
• heart failure (symptoms include: weakness, fatigue, swollen legs)
• zatajenje srca (simptomi uključuju: slabost, umor, oticanje nogu)
Very common abdominal pain, diarrhoea, vomiting, constipation, nausea, lipase increased
Vrlo često bol u abdomenu, proljev, povraćanje, konstipacija, mučnina, povišena lipaza
• a history of blood clots in your blood vessels
• anamnezu krvnih ugrušaka u krvnim žilama
Based on the Kaplan-Meier estimates, 87% (95% CI: [78%-92%]) of CP-CML patients (median duration of treatment: 866 days) who achieved a MCyR and 66% (95% CI: [55%- 75%]) of CP-CML patients who achieved a MMR are projected to maintain that response at 24 months.
Temeljem Kaplan-Meierovih analiza predviđa se da će 87% (95% CI: [78%-92%]) bolesnika u kroničnoj fazi KML (medijan trajanja liječenja: 866 dana) koji su postigli MCyR i 66% (95% CI: [55%- 75%]) bolesnika u kroničnoj fazi KML koji su postigli MMR održati postignuti odgovor nakon 24 mjeseca.
Uncommon poor peripheral circulation, splenic infarction, embolism venous, venous thrombosis
Manje često slaba periferna cirkulacija, infarkt slezene, venska embolija, venska tromboza
In the phase 2 trial, serious arterial and venous occlusive adverse reactions occurred in 18% of patients (treatment-emergent frequencies).
U ispitivanju faze 2, ozbiljne nuspojave arterijske i venske okluzije javile su se u 18% bolesnika (učestalost nuspojava izazvanih liječenjem).
Very common upper respiratory tract infection
Vrlo često infekcije gornjeg dišnog sustava
Dose modifications or interruption of dosing should be considered for the management of haematological and non-haematological toxicities.
Za zbrinjavanje hematoloških i nehematoloških toksičnosti potrebno je razmotriti promjenu doze ili prekid doziranja.
• increased blood levels of liver and pancreatic enzymes:
• povišene razine enzima jetre i gušterače u krvi:
R/I Cohort (N=38)
R/I kohorta (N=38)
cells) and partial (1% to 35% Ph+ cells) cytogenetic responses.
Ph+ ne mogu se uočiti) i parcijalne (1% do 35% Ph+ stanica) citogenetičke odgovore.
Co-administration of a single 45 mg dose of Iclusig in the presence of rifampin (600 mg daily), a strong CYP3A inducer, to 19 healthy volunteers, decreased the AUC0-∞ and Cmax of ponatinib by 62% and 42%, respectively, when compared to administration of ponatinib alone.
Istovremena primjena jednokratne doze lijeka Iclusig od 45 mg s rifampicinom (600 mg dnevno), snažnim CYP3A induktorom, u 19 zdravih dobrovoljaca, uzrokovala je sniženje AUC0-∞ i Cmax ponatiniba za 62% odnosno 42% u usporedbi s onima kad se ponatinib primjenjivao sam.
In the phase 2 trial, arterial and venous occlusive adverse reactions have occurred in 23% of patients (treatment-emergent frequencies).
U ispitivanju faze 2, nuspojave arterijske i venske okluzije javile su se u 23% bolesnika (učestalost nuspojava izazvanih liječenjem).
• indinavir, nelfinavir, ritonavir, saquinavir: medicines to treat HIV infection.
• indinavir, nelfinavir, ritonavir, sakvinavir: lijekovi za liječenje HIV infekcija.
At the time of updated reporting with minimum follow-up for all ongoing patients of 27 months, the median duration of MaHR for AP-CML (median duration of treatment: 590 days), BP-CML (median duration of treatment: 89 days), and Ph+ ALL (median duration of treatment: 81 days) patients was estimated as 13.1 months (range: 1.2 to 35.8+ months), 6.1 months (range: 1.8 to 31.8+ months), and 3.3 months (range: 1.8 to 13.0 months), respectively.
MaHR za bolesnike s AP-KML (medijan trajanja liječenja: 590 dana), BP-KML (medijan trajanja liječenja: 89 dana), i Ph+ ALL (medijan trajanja liječenja: 81 dan) procijenjen je na 13,1 mjesec (raspon: 1,2 do 35,8+ mjeseci), 6,1 mjesec (raspon: 1,8 do 31,8+ mjeseci) i 3,3 mjeseca (raspon: 1,8 do 13,0 mjeseci).
Uncommon myocardial ischemia, acute coronary syndrome, cardiac discomfort, ischemic cardiomyopathy, arteriospasm coronary, left ventricular dysfunction, atrial flutter
Manje često ishemija miokarda, akutni koronarni sindrom, srčana nelagoda, ishemijska kardiomiopatija, spazam koronarne arterije, disfunkcija lijeve klijetke, undulacija atrija
Common rash pruritic, exfoliative rash, erythema, alopecia, pruritis, skin exfoliation, night sweats, hyperhidrosis, petechia, ecchymosis, pain of skin, dermatitis exfoliative
Često pruritički osip, eksfolijativni osip, eritem, alopecija, pruritus, eksfolijacija kože, noćno znojenje, hiperhidroza, petehije, ekhimoze, bolna koža, eksfolijativni dermatitis
c MCyR combines both complete (No detectable 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.
R/I Cohort (N=65)
R/I kohorta (N=65)
Uncommon cerebral artery stenosis
Manje često stenoza cerebralne arterije
Arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions (treatmentemergent frequencies) occurred in 9.6%, 7.3%, and 6.9% of Iclusig-treated patients, respectively.
Nuspojave arterijske kardiovaskularne, cerebrovaskularne i periferne vaskularne okluzije (učestalost nuspojava izazvanih liječenjem) javile su se u 9,6%, 7,3%, odnosno 6,9% bolesnika liječenih Iclusigom.
• liver tests Liver function tests will be performed periodically, as indicated by your doctor.
Kontrole jetrene funkcije treba obavljati povremeno u skladu s uputama liječnika.
Pancreatitis Recommended modifications for pancreatic adverse reactions are summarized in Table 2.
Pankreatitis Preporučene izmjene doze u slučaju nuspojava na gušterači sažete su Tablici 2.
Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor, ATC code: L01XE24
Farmakoterapijska skupina: antineoplastična tvar, inhibitor protein kinaze, ATK oznaka: L01XE24 Ponatinib je snažni opći BCR-ABL inhibitor.
Lactose monohydrate Microcrystalline cellulose Sodium starch glycolate Colloidal anhydrous silica Magnesium stearate
Jezgra tablete laktoza hidrat celuloza, mikrokristalična natrijev škroboglikolat silicijev dioksid, koloidni, bezvodni magnezijev stearat
Caution should be exercised and a reduction of the starting dose of Iclusig to 30 mg should be considered with concurrent use of strong CYP3A inhibitors such as clarithromycin, indinavir, itraconazole,
Treba biti oprezan i razmotriti smanjenje početne doze lijeka Iclusig na 30 mg kod istovremene primjene s jakim inhibitorima CYP3A kao što su klaritromicin, indinavir, itrakonazol, ketokonazol, nefazodon, nelfinavir, ritonavir, sakvinavir, telitromicin, troleandomicin, vorikonazol i sok grejpfruta.
• a history of bleeding issues
• anamnezu problema s krvarenjem
The secondary efficacy endpoints in AP-CML and BP-CML/Ph+ ALL were MCyR and MMR.
Sekundarni ishodi za bolesnike u ubrzanoj fazi KML i blastičnoj fazi KML/Ph+ ALL bili su MCyR i MMR.
approximately 87% of the radioactive dose is recovered in the faeces and approximately 5% in the urine.
Nakon pojedinačne doze [14C]-označenog ponatiniba, približno 87% radioaktivne doze odstranjuje se fecesom, a približno 5% mokraćom.
Ponatinib elicited tumour shrinkage and prolonged survival in mice bearing tumours expressing native or T315I mutant BCR-ABL.
Ponatinib je izazvao smanjenje tumora i produljeno preživljavanje miševa s T315I BCR-ABL mutacijom ili bez nje.
The primary efficacy endpoint in AP-CML and BP-CML/Ph+ ALL was major haematological response (MaHR), defined as either a complete haematological response (CHR) or no evidence of leukaemia (NEL).
Primarni ishod za bolesnike u ubrzanoj fazi KML i blastičnoj fazi KML/Ph+ALL bio je značajan hematološki odgovor (MaHR) definiran bilo kao kompletni hematološki odgovor (CHR, engl. complete haematological response) ili nema dokaza leukemije.
Neutropenia (ANC decreased)
Neutropenija (smanjeni ABN)
A benefit -risk consideration should guide a decision to restart Iclusig therapy (see sections 4.2 and 4.8).
Odluka za ponovno uvođenje terapije Iclusigom mora biti vođena razmatranjem omjera koristi i rizika (vidjeti dio 4.2 i 4.8).
A break in treatment or a decrease in dose may be required when lipase is increased.
U slučaju povišenih vrijednosti serumske lipaze, možda će biti potrebno napraviti stanku u liječenju ili smanjiti dozu.
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 .
The bottle contains one sealed plastic canister containing molecular sieve desiccant.
Boca sadrži jedan plastični zatvoreni spremnik s molekularnim sitom kao sredstvom za sušenje.
• diarrhoea, vomiting, constipation, nausea
• proljev, povraćanje, zatvor, mučnina
Table 8 Efficacy of Iclusig in resistant or intolerant Ph+ ALL patients Overall (N=32)
Tablica 8 Djelotvornost lijeka Iclusig u bolesnika s bolesnika s Ph+ ALL koji su rezistentni ili ne podnose lijek
Very common headache, dizziness
Vrlo često glavobolja, omaglica
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.
Serious side effects (common: affects 1 to 10 users in 100):
Ozbiljne nuspojave (često: javljaju se u 1 do 10 korisnika na 100)
Important adverse reactions
Važne nuspojave
Patients with and without cardiovascular risk factors, including patients age 50 years or younger, experienced these events.
Ti su se štetni događaji javili u bolesnika sa i bez kardiovaskularnih čimbenika rizika, uključujući bolesnike u dobi od 50 godina ili mlađe.
The bottle contains one sealed canister containing molecular sieve desiccant.
Boca sadrži jedan zatvoreni spremnik s molekularnim sitom kao sredstvom za sušenje.
Leukopenia (WBC decreased)
Leukopenija (snižen broj Lkc)
Serious arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions (treatment-emergent frequencies) occurred in 6.7%, 5.6%, and 5.1% of Iclusig treated patients, respectively.
Ozbiljne nuspojave arterijske kardiovaskularne, cerebrovaskularne i periferne vaskularne okluzije (učestalost nuspojava izazvanih liječenjem) javile su se u 6,7%, 5,6%, odnosno 5,1 % bolesnika liječenih Iclusigom.
White, biconvex, round film-coated tablet that is approximately 6 mm in diameter, with "A5" debossed on one side.
Bijela, bikonveksna okrugla filmom obložena tableta, promjera oko 6 mm s oznakom "A5" utisnutom na jednoj strani.
Iclusig 15 mg film-coated tablets Iclusig 45 mg film-coated tablets
Iclusig 15 mg filmom obložene tablete Iclusig 45 mg filmom obložene tablete ponatinib
• had a prior heart attack or stroke
• preboljeli srčani ili moždani udar
(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% CI) a Primarni ishod za kohorte s AP-KML i BP-KML/Ph+ ALL bio je MaHR što kombinira kompletni hematološki odgovori i bez dokaza leukemije.
(95% CI) Major Molecular Response b
(95% CI) Značajan citogenetski odgovorc
Haupt Pharma - AMAREG GmbH Donaustaufer Strasse 378 D-93055 Regensburg Germany
Haupt Pharma - AMAREG GmbH Donaustaufer Strasse 378
Very common bone pain, arthralgia, myalgia, pain in extremity, back pain, muscle spasms
Vrlo često bol u kostima, artralgije, mijalgije, bol u udovima, bol u leđima, spazmi mišića
Vascular occlusion
Vaskularna okluzija
Serious venous occlusive reactions (treatment-emergent frequencies) occurred in 4.5% of patients.
Ozbiljne nuspojave venske okluzije (učestalost nuspojava izazvanih liječenjem) javile su se u 4,5% bolesnika.
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.
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 prsima ili nedostatkom zraka bolesnicima može biti potrebna hitna klinička intervencija.
Substances that may have their serum concentrations altered by ponatinib
Tvari čija se koncentracija u serumu mijenja pod utjecajem ponatiniba
Do not swallow the desiccant canister.
Nemojte progutati spremnik sa sredstvom za sušenje.
Common pancytopenia, febrile neutropenia, white blood cell count decreased
Često pancitopenija, febrilna neutropenija, smanjen broj leukocita
ANC ≥ 1.5 x 109/L and platelet ≥ 75 x 109/L
≥ 75 x 109/l
Venous occlusive reactions (treatment-emergent frequencies) occurred in 5.0% of patients.
Nuspojave venske okluzije (učestalost nuspojava izazvanih liječenjem) javile su se u 5,0 % bolesnika.
• Withhold Iclusig and resume at 30 mg after recovery to
• Obustavite terapiju lijekom Iclusig i nastavite s 30 mg nakon oporavka na < stupanj 2
MARKETING AUTHORISATION NUMBER(S) EU/1/13/839/001
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/839/001
• hot flush, flushing
• navale vrućine, naleti crvenila
(95% CI) Major Cytogenetic Responsec
(95% CI) Značajan citogenetički odgovorc
NAME OF THE MEDICINAL PRODUCT Iclusig 15 mg film-coated tablets
NAZIV LIJEKA Iclusig 15 mg filmom obložene tablete
Very common anaemia, platelet count decreased, neutrophil count decreased
Vrlo često anemija, smanjenje broja trombocita, smanjenje broja neutrofila
- pancreas inflammation.
- upala gušterače.
Phosphorus decreased
Snižen fosfor
Common side effects (affects 1 to 10 users in 100):
Česte nuspojave (javljaju se u 1 do 10 korisnika na 100)
Treatment-emergent hypertension occurred in Iclusig-treated patients.
U bolesnika liječenih Iclusigom javila se hipertenzija izazvana liječenjem.
Ponatinib is a potent pan BCR-ABL inhibitor with structural elements, including a carbon-carbon triplebond, 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.
• chills, flu-like illness
• zimica, bolest nalik gripi
NAME OF THE MEDICINAL PRODUCT Iclusig 45 mg film-coated tablets
NAZIV LIJEKA Iclusig 45 mg filmom obložene tablete
T315I Cohort (N=64)
T315I kohorta (N=64)
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 15 mg of ponatinib (as hydrochloride).
KVALITATIVNI I KVANTITATIVNI SASTAV Svaka filmom obložena tableta sadrži 15 mg ponatiniba (u obliku ponatinibklorida).
Close clinical surveillance is recommended when ponatinib is administered with these medicinal products.
Preporučuje se pomno praćenje bolesnika koji uz ponatinib primaju i navedene lijekove.
Sodium decreased
Snižen natrij
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 45 mg of ponatinib (as hydrochloride).
KVALITATIVNI I KVANTITATIVNI SASTAV Svaka filmom obložena tableta sadrži 45 mg ponatiniba (u obliku ponatinibklorida).
Haematologic support such as platelet transfusion and haematopoietic growth factors can be used during treatment if clinically indicated.
Ukoliko je to klinički indicirano, mogu se primjenjivati suportivne mjere liječenja kao što su transfuzije trombocita i hematopoetskih čimbenika rasta.
Uncommon side effects (affects 1 to 10 users in 1,000):
Manje česte nuspojave (javljaju se u 1 do 10 korisnika na 1000)
• Withhold Iclusig and resume at 15 mg after recovery to
• Obustavite terapiju lijekom Iclusig i nastavite s 15 mg nakon oporavka na < stupanj 2
Table 6 Efficacy of Iclusig in resistant or intolerant chronic phase CML patients Overall (N=267)
Tablica 6 Djelotvornost lijeka Iclusig u bolesnika u kroničnoj fazi KML koji su rezistentni ili intolerantni
Ponatinib is not displaced by concomitant administration of ibuprofen, nifedipine, propranolol, salicylic acid, or warfarin.
Istovremena primjena ibuprofena, nifedipina, propranolola, salicilatne kiseline, ili varfarina ne istiskuje ponatinib iz veze s proteinima plazme.
T315I Cohort (N=18)
T315I kohorta (N=18)
Common vision blurred, dry eye, periorbital oedema, eyelid oedema
Često zamagljeni vid, suhe oči, periorbitalni edem, edem očnog kapka