natgillin/translations-raw huggingface dataset:
Common side effects that may show up in your blood or urine tests: - underactive thyroid gland - abnormal liver function - increase in bilirubin (a substance produced by the liver) - increase in lipase (an enzyme involved in digestion - increase in creatinine (a substance produced in muscles) - changes in the levels of other different chemicals / enzymes in the blood.
Česte nuspojave koje se mogu pokazati u pretragama krvi ili urina: - nedovoljno aktivna štitnjača - poremećaj funkcije jetre - povišenje razine bilirubina (tvari koju proizvodi jetra) - povišenje razine lipaze (enzima koji sudjeluje u probavi) - povišenje razine kreatinina (tvari koja se proizvodi u mišićima) - promjene razina drugih različitih spojeva / enzima u krvi.
Pooled data from the pivotal RCC study (VEG105192, n=290), the extension study (VEG107769, n=71), the supportive Phase II study (VEG102616, n=225) and the randomised, open-label, parallel group Phase III non-inferiority study (VEG108844, n=557) were evaluated in the overall evaluation of safety and tolerability of pazopanib (total n=1149) in subjects with RCC (see section 5.1).
Združeni podaci iz ključnog ispitivanja RCC-a (VEG105192, n=290), produžetka ispitivanja (VEG107769, n=71) i pratećeg ispitivanja faze II (VEG102616, n=225), kao i randomiziranog, otvorenog ispitivanja neinferiornosti faze III s paralelnim skupinama (VEG108844, n=557) procijenjeni su u sveukupnoj procjeni sigurnosti i podnošljivosti pazopaniba (ukupno n=1149) u ispitanika s RCC-om (vidjeti dio 5.1).
The European Medicines Agency has deferred the obligation to submit the results of studies with Votrient in one or more subsets of the paediatric population in the treatment of rhabdomyosarcoma, non-rhabdomyosarcoma soft tissue sarcoma and Ewing sarcoma family of tumours (see section 4.2 for information on paediatric use).
Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Votrient u jednoj ili više podskupina pedijatrijske populacije za liječenje rabdomiosarkoma, sarkoma mekih tkiva koji nisu rabdomiosarkom i tumora iz porodice Ewingovih sarkoma (vidjeti dio 4.2. za informacije o pedijatrijskoj primjeni).
200 mg OD 22.2
200 mg JD 22,2
Cases of hyperglycaemia have been observed during concomitant treatment with ketoconazole.
Tijekom istodobnog liječenja ketokonazolom zabilježeni su slučajevi hiperglikemije.
The European Medicines Agency has waived the obligation to submit the results of studies with Votrient in all subsets of the paediatric population in treatment of kidney and renal pelvis carcinoma (excluding nephroblastoma, nephroblastomatosis, clear cell sarcoma, mesoblastic nephroma, renal medullary carcinoma and rhabdoid tumour of the kidney) (see section 4.2 for information on paediatric use).
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Votrient u svim podskupinama pedijatrijske populacije s karcinomom bubrega i karcinomom bubrežne nakapnice (isključujući nefroblastom, nefroblastomatozu, karcinom svijetlih stanica, mezoblastični nefrom, medularni karcinom bubrega i rabdoidni tumor bubrega) (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
The majority of these cases were Palmar-plantar erythrodysaesthesia syndrome d Venous thromboembolic events - includes Deep vein thrombosis, Pulmonary embolism and Thrombosis terms e
U većini slučajeva radilo se o palmarno-plantarnoj eritrodisesteziji d Venski tromboembolijski događaji - uključuje duboku vensku trombozu, plućnu emboliju i trombozu e
Table 4 Overall efficacy results in RCC by independent assessment (VEG105192)
Tablica 4 Sveukupni rezultat djelotvornosti u RCC-u prema neovisnoj procjeni (VEG105192)
Other important serious adverse reactions identified in STS studies included venous thromboembolic events, left ventricular dysfunction and pneumothorax.
Druge važne ozbiljne nuspojave zabilježene u ispitivanjima STS-a uključuju venske tromboembolijske događaje, disfunkciju lijeve klijetke i pneumotoraks.
Symptoms include: - passing blood in the stools or passing black stools - passing blood in the urine - stomach pain - coughing or vomiting up blood
Simptomi uključuju: - krvave stolice ili crne stolice - krv u urinu - bol u želucu - iskašljavanje ili povraćanje krvi
Baseline and periodic urinanalysis during treatment is recommended and patients should be monitored for worsening proteinuria.
Preporučuje se početna analiza urina, te povremene analize urina tijekom terapije kojima će se pratiti eventualno pogoršanje proteinurije.
Fertility may be affected by treatment with Votrient.
Liječenje lijekom Votrient može utjecati na plodnost.
A similar proportion of patients in each arm were treatment-naïve and cytokine pre-treated (53% and 47% in pazopanib arm, 54% and 46% in placebo arm).
Sličan udio bolesnika u svakom kraku ispitivanja nije bio prethodno liječen ili je prethodno primao terapiju citokinima (53% i 47% u kraku s pazopanibom, 54% i 46% u kraku s placebom).
Transaminase elevations >3 x ULN concurrently with bilirubin elevations >2 x ULN
Porast vrijednosti transaminaza na >3 x GGN istodobno s porastom vrijednosti bilirubina na >2 x GGN
Transaminase elevation of >8 x ULN
Porast vrijednosti transaminaza na >8 x GGN
Concomitant administration of pazopanib with esomeprazole decreases the bioavailability of pazopanib by approximately 40% (AUC and Cmax), and co-administration of pazopanib with medicines that increase gastric pH should be avoided.
Istodobna primjena pazopaniba i esomeprazola smanjuje bioraspoloživost pazopaniba za približno 40% (AUC i Cmax) te treba izbjegavati istodobnu primjenu pazopaniba i lijekova koji povisuju želučani pH.
HDPE bottles with polypropylene child resistant closures containing either 30 or 60 tablets.
HDPE boce s polipropilenskim sigurnosnim zatvaračima za djecu koje sadrže 30 ili 60 tableta.
In clinical studies with pazopanib, venous thromboembolic events including venous thrombosis and fatal pulmonary embolus have occurred.
U kliničkim ispitivanjima pazopaniba zabilježeni su venski tromboembolijski događaji uključujući vensku trombozu i fatalnu plućnu emboliju.
In clinical studies with pazopanib, events of cardiac dysfunction such as congestive heart failure and decreased LVEF have occurred (see section 4.8).
U kliničkim ispitivanjima pazopaniba zabilježeni su slučajevi disfunkcije srca kao što su kongestivno zatajenje srca i smanjenje LVEF-a (vidjeti dio 4.8).
Investigated dose
Ispitivana doza
Hypothyroidism 83 (7%)
Endokrini poremećaji često hipotireoidizam 83 (7%)
Your blood pressure will be checked before you take Votrient and while you are taking it.
Vaš krvni tlak kontrolirat će se prije nego što počnete s uzimanjem te tijekom korištenja lijeka Votrient.
HDPE bottles with polypropylene child resistant closures containing either 30 or 90 tablets.
HDPE boce s polipropilenskim sigurnosnim zatvaračima za djecu koje sadrže 30 ili 90 tableta.
Pharmacokinetic parameter comparisons of pazopanib Cmax (range of means 27.5 to 58.1 µg/ml) and AUC(0-24) (range of means 48.7 to 1040 µg*h/ml) after administration of pazopanib 800 mg alone and after administration of pazopanib 400 mg plus ketoconazole 400 mg (mean Cmax 59.2 µg/ml, mean AUC(0-24)1300 µg*h/ml) indicated that, in the presence of a strong CYP3A4 and P-gp inhibitor a dose reduction to pazopanib 400 mg once daily will, in the majority of patients, result in systemic exposure similar to that observed after administration of 800 mg pazopanib once daily alone.
Usporedba farmakokinetičkih parametara za Cmax pazopaniba (raspon srednjih vrijednosti 27,5 do 58,1 µg/ml) i AUC(0-24) (raspon srednjih vrijednosti 48,7 do 1040 µg*h/ml) nakon primjene samo pazopaniba 800 mg i nakon primjene 400 mg pazopaniba plus 400 mg ketokonazola (srednja vrijednost Cmax 59,2 µg/ml, srednja vrijednost AUC(0-24) 1300 µg*h/ml) ukazuju da će u prisustvu jakog CYP3A4 i P-gp inhibitora smanjenje doze pazopaniba na 400 mg jednom dnevno, u većine bolesnika, rezultirati u sistemskoj izloženosti sličnoj onoj zabilježenoj nakon primjene samog pazopaniba u dozi od 800 mg jednom na dan.
Table 6 Overall efficacy results in STS by independent assessment (VEG110727)
Tablica 6 Sveukupni rezultati djelotvornosti za STS na temelju nezavisne procjene (VEG110727)
Fatal events that were considered possibly related to pazopanib included gastrointestinal haemorrhage, pulmonary haemorrhage/haemoptysis, abnormal hepatic function, intestinal perforation and ischaemic stroke.
Događaji s fatalnim ishodom za koje se smatralo da bi mogli biti povezani s pazopanibom uključivali su gastrointestinalno krvarenje, plućno krvarenje/hemoptizu, poremećaj funkcije jetre, perforaciju crijeva i ishemijski moždani udar.
Pazopanib should be used with caution in patients with significant risk of haemorrhage.
Pazopanib se treba koristiti s posebnim oprezom u bolesnika sa značajnim rizikom za krvarenje.
Grade 4 n (%)
Stupanj 4 n (%)
Pre-clinical studies in animals have shown reproductive toxicity (see section 5.3).
Neklinička ispitivanja na životinjama su pokazala reproduktivnu toksičnost (vidjeti dio 5.3).
Co-administration of pazopanib with a CYP3A4, P-gp, and BCRP inhibitor, such as lapatinib, will result in an increase in plasma pazopanib concentrations.
Istovremena primjena pazopaniba s inhibitorima CYP3A4, P-gp-a i BCRP-a, poput lapatiniba, rezultirat će povećanjem koncentracije pazopaniba u plazmi.
Results from in vitro studies demonstrated that metabolism of pazopanib is mediated primarily by CYP3A4, with minor contributions from CYP1A2 and CYP2C8.
Rezultati ispitivanja in vitro pokazali su da je metabolizam pazopaniba primarno posredovan CYP3A4, s manjim doprinosima od CYP1A2 i CYP2C8.
Perforation and fistula
Proboj i fistula
The majority of patients had either favourable (39%) or intermediate (54%), MSKCC (Memorial Sloan Kettering Cancer Centre) / Motzer prognostic factors.
Kod većine su bolesnika MSKCC (Memorial Sloan Kettering Cancer Centre) / Motzer prognostički faktori bili povoljni (39%) ili osrednji (54%).
Effects of other medicinal products on pazopanib
Učinci drugih lijekova na pazopanib
In the RCC studies of pazopanib, overall no clinically significant differences in safety of pazopanib were observed between subjects aged at least 65 years and younger subjects.
U ispitivanjima pazopaniba u bolesnika s karcinomom bubrega nije uočena ukupna klinički značajna razlika u sigurnosti pazopaniba u ispitanika starijih od 65 godina te mlađih ispitanika.
Posterior reversible encephalopathy / reversible posterior leukoencephalopathy syndrome†
rijetko posteriorni reverzibilni encefalopatski sindrom / sindrom reverzibilne posteriorne leukoencefalopatije†
Uncommon side effects (may affect up to 1 in 100 people): - stroke - temporary fall in blood supply to the brain (transient ischaemic attack) - interruption of blood supply to part of the heart or heart attack (myocardial infarction) - partial interruption of blood supply to part of the heart (myocardial ischaemia) - blood clots accompanied by a decrease in red blood cells and cells involved in clotting
Manje česte nuspojave (mogu se javiti kod manje od 1 na 100 ljudi): - moždani udar - privremeno smanjenje dotoka krvi u mozak (prolazni napadaj nalik moždanom udaru) - prekid opskrbe krvlju jednog dijela srca ili srčani udar (infarkt miokarda) - djelomični prekid opskrbe krvlju jednog dijela srca (ishemija miokarda) - krvni ugrušci praćeni smanjenim brojem crvenih krvnih stanica i stanica uključenih u zgrušavanje krvi (trombotička mikroangiopatija, TMA).
Signs that your liver may not be working properly may include: - yellowing of your skin or the whites of your eyes (jaundice) - dark urine - tiredness - nausea - vomiting - loss of appetite - pain on the right side of your stomach area (abdomen) - bruising easily
Znakovi da Vaša jetra možda ne radi ispravno mogu uključivati: - pojavu žutila kože ili bjeloočnica (žutica) - taman urin - umor - mučninu - povraćanje - gubitak apetita - bol u desnoj strani trbuha (abdomena) - lako stvaranje modrica
Pazopanib should be used with caution in patients at risk for GI perforation or fistula.
Pazopanib se treba koristiti s posebnim oprezom u bolesnika s rizikom razvijanja GI perforacije ili fistule.
Pulmonary haemorrhage
Upala pluća
Therefore, pazopanib should be administered at least 1 hour before or 2 hours after a meal.
Stoga se pazopanib treba davati barem 1 sat prije ili 2 sata nakon obroka.
* - treatment-naïve and cytokine pre-treated populations
* - populacija bez ranije terapije i populacija liječena citokinima
Similar proportions of patients in each arm had prior nephrectomy (89% and 88% in the pazopanib and placebo arms, respectively) and/or prior radiotherapy (22% and 15% in the pazopanib and placebo arms, respectively.
Sličan udio bolesnika u svakom kraku ispitivanja je imao raniju nefrektomiju (89% u kraku s pazopanibom i 88% u placebo kraku) i/ili raniju radioterapiju (22% u kraku s pazopanibom i 15% s placebom).
Dose modification (decrease or increase) should be in 200 mg decrements or increments in a stepwise fashion based on individual tolerability in order to manage adverse reactions.
Kako bi se kontrolirale nuspojave, prilagodbu doze (smanjenje ili povećanje) treba raditi postupno, smanjivati ili povećavati po 200 mg prema individualnoj podnošljivosti.
Grade 3 fatigue (dose-limiting toxicity) and Grade 3 hypertension were each observed in 1 of 3 patients dosed at 2000 mg and 1000 mg daily, respectively.
Umor 3. stupnja (toksičnost koja ograničava dozu) primijećen je u 1 od 3 bolesnika koji su primali dozu od 2000 mg na dan, a hipertenzija 3. stupnja u 1 od 3 bolesnika koji su primali dozu od 1000 mg na dan.
- heart becomes less effective at pumping blood around the body (cardiac dysfunction) - slow heart beat - bleeding in the mouth, rectum or lung - dizziness - blurred vision - hot flushes - swelling caused by fluid of face, hands, ankles, feet or eyelids - tingling, weakness or numbness of the hands, arms, legs or feet - skin disorders, redness, itching, dry skin - nail disorders - burning, prickling, itching or tingling skin sensation - sensation of coldness, with shivering - excessive sweating - dehydration - muscle, joint, tendon or chest pain, muscle spasms - hoarseness - shortness of breath - cough - coughing up blood - hiccups - collapsed lung with air trapped in the space between the lung and chest, often causing shortness of breath (pneumothorax)
- srce postaje manje učinkovito u pumpanju krvi po tijelu (disfunkcija srca) - usporeni otkucaji srca - krvarenje u ustima, iz rektuma ili u plućima - omaglica - zamućen vid - navale vrućine - oticanje izazvano nakupljanjem tekućine u licu, rukama, gležnjevima, stopalima ili očnim kapcima - trnci, slabost ili utrnulost šaka, ruku, nogu ili stopala - poremećaji kože, crvenilo, svrbež, suha koža - poremećaji noktiju - osjećaj peckanja, bockanja, svrbeži ili trnaca - osjet hladnoće uz drhtavicu - pojačano znojenje - dehidracija - bol u mišićima, zglobovima, tetivama ili prsnom košu, grčenje mišića - promuklost - nedostatak zraka - kašalj - iskašljavanje krvi - štucanje - stanje kada pluća kolabiraju, a zrak ostane zaglavljen u prostoru između pluća i prsa, često uzrokujući nedostatak zraka (pneumotoraks)
Votrient can cause severe bleeding in the digestive system (such as stomach, oesophagus, rectum or intestine), or the lungs, kidneys, mouth, vagina and brain, although this is uncommon.
Votrient može, iako je to manje česta nuspojava, uzrokovati teško krvarenje u probavnom sustavu (poput želuca, jednjaka, rektuma ili crijeva) ili u plućima, bubrezima, ustima, vagini i mozgu.
Votrient 400 mg film-coated tablets are capsule-shaped, white with “GS UHL” marked on one side.
Votrient 400 mg filmom obložene tablete su oblika kapsule, bijele s oznakom „GS UHL“ na jednoj strani.
The safe use of pazopanib during breast-feeding has not been established.
Nije utvrđena sigurna primjena pazopaniba tijekom dojenja.
Signs and symptoms may include: - bruising easily - high blood pressure - fever - confusion - drowsiness - seizures (fits) - decrease in urine output
Znakovi i simptomi mogu uključivati: - lako stvaranje modrica - visoki krvni tlak - vrućicu - smetenost - omamljenost - napadaje - smanjeno izlučivanje urina
CYP3A4 inducers such as rifampin may decrease plasma pazopanib concentrations.
Induktori CYP3A4, poput rifampicina, mogu smanjiti koncentraciju pazopaniba u plazmi.
Patients on pazopanib treatment should be observed closely for signs and symptoms of pneumothorax.
Bolesnike koji se liječe pazopanibom treba pomno nadzirati radi uočavanja znakova i simptoma pneumotoraksa.
Reversal of effects of TMA has been observed after treatment was discontinued.
Nakon prekidanja terapije zabilježen je obrat učinaka TMA-e.
In clinical studies with pazopanib, myocardial infarction, myocardial ischaemia, ischaemic stroke and transient ischaemic attack were observed (see section 4.8).
U kliničkim ispitivanjima pazopaniba zabilježeni su slučajevi infarkta miokarda, ishemije miokarda, ishemijskog moždanog udara i tranzitorne ishemijske atake (vidjeti dio 4.8).
Signs and symptoms may include: - sharp chest pain - shortness of breath - rapid breathing - leg pain - swelling of your arms and hands or legs and feet
Znakovi i simptomi mogu uključivati: - oštru bol u prsnom košu - nedostatak zraka - ubrzano disanje - bol u nozi - oticanje Vaših ruku i šaka ili nogu i stopala
Care should be taken when pazopanib is co-administered with substrates of UGT1A1.
Potreban je oprez kada se pazopanib primjenjuje istodobno sa supstratima UGT1A1.
Signs and symptoms include: - irregular or fast heartbeat - rapid fluttering of your heart - fainting - chest pain or pressure - pain in your arms, back, neck or jaw - shortness of breath - leg swelling
Znakovi i simptomi uključuju: - nepravilne ili brze otkucaje srca - brzo lepršanje srčanih pretklijetki - nesvjesticu - bol ili pritisak u prsnom košu - bol u Vašim rukama, leđima, vratu ili čeljusti - nedostatak zraka - oticanje nogu
Adipocytic sarcoma (all subtypes), all rhabdomyosarcoma that were not alveolar or pleomorphic, chondrosarcoma, osteosarcoma, Ewing tumours/primitive neuroectodermal tumours (PNET), GIST, dermofibromatosis sarcoma protuberans, inflammatory myofibroblastic sarcoma, malignant mesothelioma and mixed mesodermal tumours of the uterus.
Adipocitni sarkom (svi podtipovi), svi rabdomiosarkomi koji nisu alveolarni ili pleomofni, hondrosarkom, osteosarkom, Ewingovi tumori/primitivni neuroektodermalni tumori (PNET), GIST, sarkom dermofibromatosis protuberans, upalni miofibroblastični sarkom, maligni mezoteliom i miješani mezodermalni tumori maternice.
In vitro studies suggested that the oxidative metabolism of pazopanib in human liver microsomes is mediated primarily by CYP3A4, with minor contributions from CYP1A2 and CYP2C8.
Ispitivanja in vitro ukazuju da je oksidativni metabolizam pazopaniba u mikrosomima ljudske jetre primarno posredovan putem CYP3A4, uz manji doprinos CYP1A2 i CYP2C8.
Fibroblastic (adult fibrosarcoma, myxofibrosarcoma, sclerosing epithelioid fibrosarcoma, malignant solitary fibrous tumours), so-called fibrohistiocytic (pleomorphic malignant fibrous histiocytoma [MFH], giant cell MFH, inflammatory MFH), leiomyosarcoma, malignant glomus tumours, skeletal muscles (pleomorphic and alveolar rhabdomyosarcoma), vascular (epithelioid hemangioendothelioma, angiosarcoma), uncertain differentiation (synovial, epithelioid, alveolar soft part, clear cell, desmoplastic small round cell, extra-renal rhabdoid, malignant mesenchymoma, PEComa, intimal sarcoma), malignant peripheral nerve sheath tumours, undifferentiated soft tissue sarcomas not otherwise specified (NOS) and other types of sarcoma (not listed as ineligible).
Fibroblastični (fibrosarkom odraslih, miksofibrosarkom, sklerozirajući epiteloidni fibrosarkom, maligni solitarni fibrozni tumori), takozvani fibrohistiocitni (pleomorfni maligni fibrozni histiocitom [MFH], MFH velikih stanica, inflamatorni MFH), leiomiosarkom, maligni glomus tumor, skeletni mišići (pleomorfni i alveolarni rabdomiosarkom), krvožilni (epiteloidni hemangioendoteliom, angiosarkom), nesigurne diferencijacije (sinovijalni, epiteloidni, alveolari mekotkivni, svijetlih stanica, dezmoplastičnih okruglih malih stanica, ekstrarenalni rabdoidni, maligni mezenhimom, PECom, sarkom intime), maligni tumori ovojnice perifernih živaca, nediferencirani sarkomi mekih tkiva koji nisu drugačije specificirani (NOS) i drugi tipovi sarkoma (nisu navedeni kao nepogodni).
Co-administration of pazopanib with potent P-gp or BCRP inducers may alter the exposure and distribution of pazopanib, including distribution into the CNS.
Istovremena primjena pazopaniba s potentnim induktorima P-gp-a ili BCRP-a može utjecati na izloženost i distribuciju pazopaniba, uključujući i distribuciju u SŽS.
Grade 3 n (%)
Stupanj 3 n (%)
Concomitant administration of pazopanib with uridine diphosphate glucuronosyl transferase 1A1 (UGT1A1) substrates (e.g. irinotecan) should be undertaken with caution since pazopanib is an inhibitor of UGT1A1 (see section 4.5).
Obzirom da je pazopanib inhibitor uridin-difosfat-glukuronozil-transferaze (UGT1A1), potreban je poseban oprez pri istovremenom davanju supstrata UGT1A1 (npr. irinotekana) (vidjeti dio 4.5).
Fatal events have been observed.
Zabilježeni su slučajevi sa smrtnim ishodom.
Pneumothorax
Pneumotoraks
Signs and symptoms of a hypertensive crisis may include: - severe chest pain - severe headache - blurred vision - confusion - nausea - vomiting - severe anxiety - shortness of breath - seizures (fits) - fainting
Znakovi i simptomi hipertenzivne krize mogu uključivati: - jaku bol u prsnom košu - jaku glavobolju - zamagljen vid - smetenost - mučninu - povraćanje - tešku tjeskobu - nedostatak zraka - napadaje - nesvjesticu
Concomitant treatment with strong inhibitors of CYP3A4, P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) should be avoided due to risk of increased exposure to pazopanib (see section 4.5).
Zbog rizika od povećane izloženosti pazopanibu, treba se izbjegavati istovremena terapija s jakim inhibitorima CYP3A4, P-glikoproteina (P-gp) ili BCRP proteina (od engl. breast cancer resistance protein) (vidjeti dio 4.5).
Figure 4 Kaplan-Meier Curve for progression-free survival by independent assessment for the overall population (VEG108844)
Slika 4 Kaplan-Meier krivulja za preživljenje bez progresije bolesti prema neovisnoj procjeni za sveukupnu populaciju (VEG108844)
Table 7 Median steady-state pazopanib pharmacokinetics measured in subjects with hepatic impairment.
Tablica 7 Medijan farmakokinetičkih parametara za pazopanib u stanju dinamičke ravnoteže u ispitanika s oštećenjem funkcije jetre.
Animal studies indicate that male and female fertility may be affected by treatment with pazopanib (see section 5.3).
Ispitivanja na životinjama su pokazala da terapija pazopanibom može utjecati na mušku i žensku plodnost (vidjeti dio 5.3).
There was no consistent increase in AUC or Cmax at pazopanib doses above 800 mg.
Pri dozama pazopaniba iznad 800 mg nije bilo konzistentnog povećanja AUC ili Cmax.
Cases of hepatic failure (including fatalities) have been reported during use of pazopanib.
Prijavljeni su slučajevi zatajenja jetre (uključujući one s fatalnim ishodom) tijekom primjene pazopaniba.
In clinical studies with pazopanib, increase in serum transaminases (ALT, aspartate aminotransferase [AST]) and bilirubin were observed (see section 4.8).
U kliničkim ispitivanjima pazopaniba primijećen je porast transaminaza u serumu (ALT, aspartat aminotransferaza [AST]), te bilirubina (vidjeti dio 4.8).
Pazopanib is an inhibitor of the uridine diphosphoglucuronosyl-transferase 1A1 (UGT1A1) enzyme in vitro.
In vitro, pazopanib je inhibitor enzima uridindifosfoglukuronil-transferaze 1A1 (UGT1A1).
Common Hypothyroidism 18 (5%)
Endokrini poremećaji često hipotiroidizam 18 (5%) 0