FrancophonIA/ELRC3.0 huggingface dataset:
English: Results from in vitro studies demonstrated that metabolism of pazopanib is mediated primarily by CYP3A4, with minor contributions from CYP1A2 and CYP2C8.
Croatian: Rezultati ispitivanja in vitro pokazali su da je metabolizam pazopaniba primarno posredovan CYP3A4, s manjim doprinosima od CYP1A2 i CYP2C8.
English: Perforation and fistula
Croatian: Proboj i fistula
English: The majority of patients had either favourable (39%) or intermediate (54%), MSKCC (Memorial Sloan Kettering Cancer Centre) / Motzer prognostic factors.
Croatian: Kod većine su bolesnika MSKCC (Memorial Sloan Kettering Cancer Centre) / Motzer prognostički faktori bili povoljni (39%) ili osrednji (54%).
English: Effects of other medicinal products on pazopanib
Croatian: Učinci drugih lijekova na pazopanib
English: 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.
Croatian: 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.
English: Posterior reversible encephalopathy / reversible posterior leukoencephalopathy syndrome†
Croatian: rijetko posteriorni reverzibilni encefalopatski sindrom / sindrom reverzibilne posteriorne leukoencefalopatije†
English: 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
Croatian: 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).
English: 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
Croatian: 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
English: Pazopanib should be used with caution in patients at risk for GI perforation or fistula.
Croatian: Pazopanib se treba koristiti s posebnim oprezom u bolesnika s rizikom razvijanja GI perforacije ili fistule.
English: Pulmonary haemorrhage
Croatian: Upala pluća
English: Therefore, pazopanib should be administered at least 1 hour before or 2 hours after a meal.
Croatian: Stoga se pazopanib treba davati barem 1 sat prije ili 2 sata nakon obroka.
English: * - treatment-naïve and cytokine pre-treated populations
Croatian: * - populacija bez ranije terapije i populacija liječena citokinima
English: 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.
Croatian: 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).
English: 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.
Croatian: Kako bi se kontrolirale nuspojave, prilagodbu doze (smanjenje ili povećanje) treba raditi postupno, smanjivati ili povećavati po 200 mg prema individualnoj podnošljivosti.
English: 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.
Croatian: 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.
English: - 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)
Croatian: - 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)
English: 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.
Croatian: 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.
English: Votrient 400 mg film-coated tablets are capsule-shaped, white with “GS UHL” marked on one side.
Croatian: Votrient 400 mg filmom obložene tablete su oblika kapsule, bijele s oznakom „GS UHL“ na jednoj strani.
English: The safe use of pazopanib during breast-feeding has not been established.
Croatian: Nije utvrđena sigurna primjena pazopaniba tijekom dojenja.
English: Signs and symptoms may include: - bruising easily - high blood pressure - fever - confusion - drowsiness - seizures (fits) - decrease in urine output
Croatian: Znakovi i simptomi mogu uključivati: - lako stvaranje modrica - visoki krvni tlak - vrućicu - smetenost - omamljenost - napadaje - smanjeno izlučivanje urina
English: CYP3A4 inducers such as rifampin may decrease plasma pazopanib concentrations.
Croatian: Induktori CYP3A4, poput rifampicina, mogu smanjiti koncentraciju pazopaniba u plazmi.
English: Patients on pazopanib treatment should be observed closely for signs and symptoms of pneumothorax.
Croatian: Bolesnike koji se liječe pazopanibom treba pomno nadzirati radi uočavanja znakova i simptoma pneumotoraksa.
English: Reversal of effects of TMA has been observed after treatment was discontinued.
Croatian: Nakon prekidanja terapije zabilježen je obrat učinaka TMA-e.
English: In clinical studies with pazopanib, myocardial infarction, myocardial ischaemia, ischaemic stroke and transient ischaemic attack were observed (see section 4.8).
Croatian: U kliničkim ispitivanjima pazopaniba zabilježeni su slučajevi infarkta miokarda, ishemije miokarda, ishemijskog moždanog udara i tranzitorne ishemijske atake (vidjeti dio 4.8).
English: 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
Croatian: 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
English: Care should be taken when pazopanib is co-administered with substrates of UGT1A1.
Croatian: Potreban je oprez kada se pazopanib primjenjuje istodobno sa supstratima UGT1A1.
English: 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
Croatian: 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
English: 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.
Croatian: 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.
English: 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.
Croatian: Ispitivanja in vitro ukazuju da je oksidativni metabolizam pazopaniba u mikrosomima ljudske jetre primarno posredovan putem CYP3A4, uz manji doprinos CYP1A2 i CYP2C8.
English: 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).
Croatian: 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).
English: Co-administration of pazopanib with potent P-gp or BCRP inducers may alter the exposure and distribution of pazopanib, including distribution into the CNS.
Croatian: Istovremena primjena pazopaniba s potentnim induktorima P-gp-a ili BCRP-a može utjecati na izloženost i distribuciju pazopaniba, uključujući i distribuciju u SŽS.
English: Grade 3 n (%)
Croatian: Stupanj 3 n (%)
English: 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).
Croatian: 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).
English: Fatal events have been observed.
Croatian: Zabilježeni su slučajevi sa smrtnim ishodom.
English: Pneumothorax
Croatian: Pneumotoraks
English: 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
Croatian: 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
English: 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).
Croatian: 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).
English: Figure 4 Kaplan-Meier Curve for progression-free survival by independent assessment for the overall population (VEG108844)
Croatian: Slika 4 Kaplan-Meier krivulja za preživljenje bez progresije bolesti prema neovisnoj procjeni za sveukupnu populaciju (VEG108844)
English: Table 7 Median steady-state pazopanib pharmacokinetics measured in subjects with hepatic impairment.
Croatian: Tablica 7 Medijan farmakokinetičkih parametara za pazopanib u stanju dinamičke ravnoteže u ispitanika s oštećenjem funkcije jetre.
English: Animal studies indicate that male and female fertility may be affected by treatment with pazopanib (see section 5.3).
Croatian: Ispitivanja na životinjama su pokazala da terapija pazopanibom može utjecati na mušku i žensku plodnost (vidjeti dio 5.3).
English: There was no consistent increase in AUC or Cmax at pazopanib doses above 800 mg.
Croatian: Pri dozama pazopaniba iznad 800 mg nije bilo konzistentnog povećanja AUC ili Cmax.
English: Cases of hepatic failure (including fatalities) have been reported during use of pazopanib.
Croatian: Prijavljeni su slučajevi zatajenja jetre (uključujući one s fatalnim ishodom) tijekom primjene pazopaniba.
English: In clinical studies with pazopanib, increase in serum transaminases (ALT, aspartate aminotransferase [AST]) and bilirubin were observed (see section 4.8).
Croatian: U kliničkim ispitivanjima pazopaniba primijećen je porast transaminaza u serumu (ALT, aspartat aminotransferaza [AST]), te bilirubina (vidjeti dio 4.8).
English: Pazopanib is an inhibitor of the uridine diphosphoglucuronosyl-transferase 1A1 (UGT1A1) enzyme in vitro.
Croatian: In vitro, pazopanib je inhibitor enzima uridindifosfoglukuronil-transferaze 1A1 (UGT1A1).
English: Common Hypothyroidism 18 (5%)
Croatian: Endokrini poremećaji često hipotiroidizam 18 (5%) 0
English: The most important serious adverse reactions identified in the RCC or STS studies were transient ischaemic attack, ischaemic stroke, myocardial ischaemia, myocardial and cerebral infarction, cardiac dysfunction, gastrointestinal perforation and fistula, QT prolongation, Torsade de Pointes and pulmonary, gastrointestinal and cerebral haemorrhage, all adverse reactions being reported in <1% of treated patients.
Croatian: Najvažnije ozbiljne nuspojave zabilježene u ispitivanjima RCC-a i STS-a bile su tranzitorna ishemijska ataka, ishemijski moždani udar, ishemija miokarda, infarkt miokarda i cerebralni infarkt, disfunkcija srca, perforacija i fistula u gastrointestinalnom traktu, produljenje QT intervala, torsade de pointes te plućno, gastrointestinalno i cerebralno krvarenje.
English: Tablet coating Hypromellose Iron oxide red (E172) Macrogol 400
Croatian: Ovojnica tablete hipromeloza željezov oksid, crveni (E172) makrogol 400 polisorbat 80 titanijev dioksid (E171)
English: Laboratory monitoring of thyroid function should be performed periodically and managed as per standard medical practice.
Croatian: Periodično se trebaju pratiti laboratorijski parametri funkcije štitnjače i u slučaju potrebe liječiti na uobičajen način.
English: Very common side effects (may affect more than 1 in 10 people): - high blood pressure - diarrhoea - feeling or being sick (nausea or vomiting) - stomach pain - loss of appetite - weight loss - taste disturbance or loss of taste - sore mouth - headache - tumour pain - lack of energy, feeling weak or tired - changes in hair colour - unusual hair loss or thinning - loss of skin pigment
Croatian: Vrlo česte nuspojave (mogu se javiti kod više od 1 na 10 ljudi): - visok krvni tlak - proljev - mučnina ili povraćanje - bol u trbuhu - gubitak apetita - gubitak tjelesne težine - poremećaj ili gubitak okusa - bolna usta - glavobolja - bol uzrokovana tumorom - gubitak energije, osjećaj slabosti ili umora - promjene boje kose
English: Grapefruit juice should be avoided during treatment with pazopanib (see section 4.5).
Croatian: Tijekom terapije pazopanibom treba izbjegavati sok od grejpa (vidjeti dio 4.5).
English: Administration of a pazopanib 400 mg crushed tablet increased AUC(0-72) by 46% and Cmax by approximately 2 fold and decreased tmax by approximately 2 hours compared to administration of the whole tablet.
Croatian: U usporedbi s primjenom cijele tablete, primjena 400 mg pazopaniba u obliku izmrvljene tablete povećala je AUC(0-72) za 46% i Cmax približno 2 puta i smanjilo tmax za približno 2 sata.
English: Concurrent administration of pazopanib (400 mg once daily) with the strong CYP3A4 and P-gp inhibitor ketoconazole (400 mg once daily) for 5 consecutive days resulted in a 66% and 45% increase in mean pazopanib AUC(0-24) and Cmax, respectively, relative to administration of pazopanib alone (400 mg once daily for 7 days).
Croatian: Istodobna primjena pazopaniba (400 mg jednom dnevno) s jakim CYP3A4 i P-gp inhibitorom ketokonazolom (400 mg jednom dnevno) tijekom 5 uzastopnih dana dovela je do 66% odnosno 45% povećanja srednje vrijednosti AUC(0-24) odnosno Cmax za pazopanib, u odnosu na primjenu samog pazopaniba (400 mg jednom dnevno tijekom 7 dana).
English: Administration of pazopanib to patients with mild or moderate hepatic impairment should be undertaken with caution and close monitoring of tolerability.
Croatian: U bolesnika s blagim ili umjerenim oštećenjem jetre pazopanib se treba primjenjivati s oprezom i uz pomno praćenje podnošljivosti.
English: No formal studies of the effect of pazopanib on wound healing have been conducted.
Croatian: Službena ispitivanja djelovanja pazopaniba na cijeljenje rana nisu provođena.
English: Pazopanib is not recommended in patients with severe hepatic impairment (defined as total bilirubin >3 x ULN regardless of the ALT value).
Croatian: Pazopanib se ne preporučuje bolesnicima s teškim oštećenjem jetre (definirano kao ukupni bilirubin >3 x GGN neovisno o vrijednosti ALT-a).
English: Figure 5 Kaplan-Meier Curve for Progression-Free Survival in STS by Independent Assessment for the Overall Population (VEG110727)
Croatian: Slika 5 Kaplan-Meier krivulja za preživljenje bez progresije (PFS) u STS-u temeljem nezavisne procjene za sveukupnu populaciju (VEG110727)
English: 800 mg OD
Croatian: 800 mg JD
English: Your doctor may need to reduce your dose if you get side effects.
Croatian: Ako osjetite nuspojave, liječnik će Vam možda morati smanjiti dozu.
English: Very common Hypertension Common Venous thromboembolic eventd Hot flush Flushing Uncommon Haemorrhage Not known Aneurysms and artery dissections
Croatian: Krvožilni poremećaji vrlo često hipertenzija često venski tromboembolijski događaj d navale vrućine crvenilo uz osjećaj vrućine manje često krvarenje nepoznato aneurizme i disekcije arterije nepoznato nepoznato nepoznato
English: Patients developing TMA should permanently discontinue treatment with pazopanib.
Croatian: Bolesnici u kojih se razvije TMA trebaju trajno prekinuti terapiju pazopanibom.
English: Based on the diminished exposure and limited hepatic reserve pazopanib is not recommended in patients with severe hepatic impairment (defined as total bilirubin >3 X ULN regardless of any level of ALT) (see section 4.2).
Croatian: Temeljno na smanjenoj izloženosti i ograničenoj rezervi jetre pazopanib se ne preporučuje u bolesnika s teškim oštećenjem funkcije jetre (definirano kao ukupni bilirubin >3 x GGN neovisno o vrijednostima ALT-a) (vidjeti dio 4.2).
English: Votrient can increase your likelihood of having a stroke.
Croatian: Votrient može povećati vjerojatnost moždanog udara.
English: Arterial thrombotic events
Croatian: Slučajevi arterijske tromboze
English: In clinical studies with pazopanib, proteinuria has been reported.
Croatian: U kliničkim ispitivanjima pazopaniba zabilježeni su slučajevi proteinurije.
English: Care should be taken when pazopanib is co-administered with other oral BCRP and P-gp substrates.
Croatian: Potreban je oprez pri istovremenoj primjeni pazopaniba i drugih peroralnih supstrata BCRP-a i P-gp-a.
English: Heart conditions
Croatian: Srčane bolesti
English: Common side effects (may affect up to 1 in 10 people): - indigestion, bloating, flatulence - nose bleed - dry mouth or mouth ulcers - infections - abnormal drowsiness - difficulty sleeping - chest pain, shortness of breath, leg pain, and swelling of the legs/feet.
Croatian: Česte nuspojave (mogu se javiti kod manje od 1 na 10 ljudi): - probavne smetnje, nadutost, vjetrovi - krvarenje iz nosa - suha usta ili ranice u ustima - infekcije - neuobičajena pospanost - otežano spavanje - bol u prsnom košu, nedostatak zraka, bol u nozi te oticanje nogu/stopala.
English: Abdominal pain, abdominal pain upper and abdominal pain lower b Oedema, oedema peripheral, eye oedema, localised oedema and face oedema c
Croatian: Bol u abdomenu, bol u gornjem dijelu abdomena i bol u donjem dijelu abdomena b Edem, periferni edem i edem očnog kapka c
English: A detrimental effect on such activities cannot be predicted from the pharmacology of pazopanib.
Croatian: Iz farmakologije pazopaniba ne mogu se predvidjeti štetni učinci na takve aktivnosti.
English: Interrupt pazopanib until transaminases return to Grade 1 or baseline.
Croatian: Privremeno prekinuti liječenje pazopanibom sve dok se vrijednosti transaminaza ne vrate na 1. stupanj ili na početnu vrijednost.
English: Pazopanib should be discontinued if the patient develops nephrotic syndrome.
Croatian: Liječenje pazopanibom se treba prekinuti u bolesnika koji razviju nefrotski sindrom.
English: In clinical studies with pazopanib in advanced soft tissue sarcoma, events of pneumothorax have occurred (see section 4.8).
Croatian: U kliničkim ispitivanjima pazopaniba kod uznapredovalog sarkoma mekih tkiva, pojavili su se slučajevi pneumotoraksa (vidjeti dio 4.8).
English: Blood pressure should be well controlled prior to initiating pazopanib.
Croatian: Prije započinjanja terapije pazopanibom krvni tlak treba biti dobro kontroliran.
English: These include: - clarithromycin, ketoconazole, itraconazole, rifamicin, telithromycin, voriconazzole (used to treat infection).
Croatian: To uključuje: - klaritromicin, ketokonazol, itrakonazol, rifamicin, telitromicin, vorikonazol (koriste se za liječenje infekcija). - atazanavir, indinavir, nelfinavir, ritonavir, sakvinavir (koriste se za liječenje HIV-a). - nefazodon (koristi se za liječenje depresije). - simvastatin i moguće drugi statini (koriste se za liječenje visoke razine kolesterola). - lijekove koji smanjuju kiselinu u želucu.
English: Each film-coated tablet contains 400 mg pazopanib (as hydrochloride).
Croatian: Jedna filmom obložena tableta sadrži 400 mg pazopaniba (u obliku pazopanibklorida).