FrancophonIA/ELRC3.0 huggingface dataset:
English: Approximately half of all patients had 3 or more organs involved in their disease and most patients had the lung (74%), and/or lymph nodes (54%) as a metastatic location for disease at baseline.
Croatian: Približno je polovica svih bolesnika imala 3 ili više organa zahvaćenih bolešću, te su kod većine bolesnika pluća (74%) i/ili limfni čvorovi (54%) bili sijela metastaza na početku ispitivanja.
English: Signs and symptoms of stroke may include: - numbness or weakness on one side of your body - difficulty talking - headache - dizziness
Croatian: Znakovi i simptomi mogu uključivati: - utrnulost ili slabost jedne strane Vašeg tijela - otežan govor - glavobolju - omaglicu
English: Breast-feeding should be discontinued during treatment with pazopanib.
Croatian: Treba prekinuti dojenje tijekom liječenja pazopanibom.
English: Deep vein thrombosis (DVT) and pulmonary embolism Votrient may cause blood clots in your veins, especially in your legs (deep vein thrombosis or DVT), which may also travel to your lungs (pulmonary embolism).
Croatian: Votrient može uzrokovati krvne ugruške u Vašim venama, pogotovo u nogama (duboka venska tromboza ili DVT), koji mogu otići u Vaša pluća (plućna embolija).
English: Some medicines may affect how Votrient works or make it more likely that you'll have side effects.
Croatian: Neki lijekovi mogu utjecati na to kako Votrient djeluje ili mogu povećati mogućnost pojave nuspojava.
English: Adverse drug reactions, all grades, which were reported in RCC and STS subjects or during the post-marketing period are listed below by MedDRA body system organ class, frequency and grade of severity.
Croatian: Nuspojave svih stupnjeva, koje su prijavljene u ispitanika s RCC-om i STS-om ili nakon stavljanja lijeka u promet, su niže navedene prema MedDRA klasifikaciji organskih sustava, učestalosti i stupnju težine.
English: Venous thromboembolic events
Croatian: Venski tromboembolijski događaji
English: The median overall survival (OS) data at the protocol-specified final survival analysis were 22.9 months and 20.5 months [HR = 0.91 (95% CI: 0.71, 1.16; p = 0.224)] for patients randomised to the pazopanib and placebo arms, respectively.
Croatian: Medijan sveukupnog preživljenja (OS) prema protokolu definirane završne analize preživljenja bio je 22,9 mjeseci odnosno 20,5 mjeseci [HR = 0,91 (95% CI: 0,71; 1,16; p = 0,224)] za bolesnike randomizirane u skupinu s pazopanibom odnosno skupinu s placebom.
English: A synthetic intermediate in manufacture of pazopanib, which is also present in the final drug substance in low amounts, was not mutagenic in the Ames assay but genotoxic in the mouse lymphoma assay and in vivo mouse micronucleus assay.
Croatian: Sintetički međuproizvod u proizvodnji pazopaniba, kojeg u malim količinama nalazimo i u završnom lijeku, u Amesovom testu nije bio mutagen, ali je bio genotoksičan u testu mišjeg limfoma i in vivo testu mikronukleusa miša.
English: Therefore, pazopanib should be administered at least two hours after food or at least one hour before food (see section 4.2).
Croatian: Stoga, pazopanib treba uzimati barem dva sata nakon obroka ili barem jedan sat prije obroka (vidjeti dio 4.2).
English: Pazopanib is for oral use.
Croatian: Pazopanib je za peroralnu primjenu.
English: Decreases in LVEF in subjects who had post-baseline and follow-up LVEF measurement were detected in 11% (15/140) in the pazopanib arm, compared with 3% (1/39) in the placebo arm.
Croatian: Smanjenje LVEF-a, u ispitanika kojima je LVEF mjeren nakon početka ispitivanja te u periodu praćenja, zabilježeno je u 11% (15/140) bolesnika u skupini na pazopanibu, u usporedbi s 3% (1/39) onih u placebo skupini.
English: Very common side effects that may show up in your blood or urine tests: - increase in liver enzymes - decrease in albumin in the blood - protein in the urine - decrease in the number of blood platelets (cells that help blood to clot) - decrease in the number of white blood cells
Croatian: Vrlo česte nuspojave koje se mogu pokazati u pretragama krvi ili urina: - povišenje jetrenih enzima - sniženje razine albumina u krvi - proteini u urinu - sniženje broja trombocita (stanica koje pomažu u zgrušavanju krvi) - sniženje broja bijelih krvnih stanica
English: Therefore, inhibitors and inducers of CYP3A4 may alter the metabolism of pazopanib.
Croatian: Stoga, inhibitori ili induktori CYP3A4 mogu utjecati na metabolizam pazopaniba.
English: CYP3A4, P-gp, BCRP inhibitors Pazopanib is a substrate for CYP3A4, P-gp and BCRP.
Croatian: Inhibitori CYP3A4, P-gp-a, BCRP-a Pazopanib je supstrat za CYP3A4, P-gp i BCRP.
English: These were reported as adverse events less frequently by investigators than as indicated by laboratory value tables.
Croatian: Ispitivači su rjeđe prijavili kao nuspojavu nego što je navedeno u tablicama laboratorijskih vrijednosti.
English: If a patient receiving concomitant simvastatin develops ALT elevations, follow guidelines for pazopanib posology and discontinue simvastatin (see section 4.4).
Croatian: Ukoliko bolesnik koji istodobno uzima simvastatin razvije porast vrijednosti ALT-a, slijedite smjernice za doziranje pazopaniba i ukinite simvastatin (vidjeti dio 4.4).
English: Very common Tumour pain
Croatian: vrlo često tumorska bol
English: Selection of alternative concomitant medicinal products with no or minimal potential to inhibit CYP3A4, P-gp or BCRP should be considered.
Croatian: Potrebno je razmotriti mogućnost istovremenih alternativnih terapija lijekovima koji ne inhibiraju ili imaju minimalni potencijal za inhibiciju CYP3A4, P-gp-a ili BCRP-a.
English: Thrombotic microangiopathy (TMA)
Croatian: Trombotička mikroangiopatija (TMA)
English: Common Gingival infection 4 (1%)
Croatian: Infekcije i infestacije često infekcija gingive 4 (1%)
English: They are supplied in bottles of 30 or 90 tablets.
Croatian: Pakirane su u boce s 30 ili 90 tableta.
English: Continue on pazopanib with weekly monitoring of liver function until transaminases return to Grade 1 or baseline.
Croatian: Nastaviti liječenje pazopanibom uz tjedno praćenje funkcije jetre sve dok se vrijednosti transaminaza ne vrate na 1. stupanj ili na početnu vrijednost.
English: Upon oral administration of a single pazopanib 800 mg dose to patients with solid tumours, maximum plasma concentration (Cmax) of approximately 19 ± 13 µg/ml was obtained after median 3.5 hours (range 1.0-11.9 hours) and an AUC0-∞ of approximately 650 ± 500 µg.h/ml was obtained.
Croatian: Nakon peroralne primjene jedne doze pazopaniba od 800 mg u bolesnika sa solidnim tumorima, nakon medijana od 3,5 sati (raspon 1,0 do 11,9 sati) postignuta je maksimalna koncentracija u plazmi (Cmax) od približno 19 ± 13 µg/ml i AUC0-∞ od približno 650 ± 500 µg.h/ml.
English: If you take too many tablets, contact a doctor or pharmacist for advice.
Croatian: Ako uzmete previše tableta, obratite se liječniku ili ljekarniku.
English: Votrient is indicated in adults for the first-line treatment of advanced renal cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease.
Croatian: Votrient je indiciran za odrasle kao prva linija liječenja uznapredovalog karcinoma bubrega (RCC; engl. renal cell carcinoma), te za bolesnike koji su već primili terapiju citokinima zbog uznapredovale bolesti.
English: HR = hazard ratio; PFS = progression-free survival;
Croatian: HR = omjer hazarda; PFS = preživljenje bez progresije;
English: Grapefruit juice contains an inhibitor of CYP3A4 and may also increase plasma concentrations of pazopanib.
Croatian: Sok grejpa sadrži inhibitor CYP3A4 i također može povećati koncentracije pazopaniba u plazmi.
English: 800 mg OD 52.0
Croatian: 800 mg JD 52,0
English: Not known (frequency cannot be estimated from the available data): - an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall
Croatian: Nepoznato (ne može se procijeniti iz dostupnih podatka): - proširenje i slabljenje stijenke krvne žile ili rascjep stijenke krvne žile (aneurizme i disekcije arterije)
English: Symptoms of infections may include: - fever - flu-like symptoms such as cough, tiredness and body aches that do not go away - shortness of breath and/or wheezing - pain while urinating - cuts, scrapes or wounds that are red, warm, swollen or painful Seek medical help immediately if you get any of these symptoms.
Croatian: Simptomi infekcija mogu uključivati: - vrućicu - simptome nalik gripi kao što su kašalj, umor i bolovi u tijelu koji ne prolaze - nedostatak zraka i/ili piskanje - bol prilikom mokrenja - posjekotine, ogrebotine ili rane koje su crvene, tople, otečene ili bolne Odmah potražite liječničku pomoć u slučaju pojave bilo kojega od navedenih simptoma.
English: Therefore, activity of pazopanib is mainly dependent on parent pazopanib exposure.
Croatian: Stoga, aktivnost pazopaniba uglavnom ovisi o izloženosti nepromijenjenom pazopanibu.
English: Do not drink grapefruit juice while you are being treated with Votrient as this may increase the chance of side effects.
Croatian: Za vrijeme terapije lijekom Votrient nemojte piti sok od grejpa jer može povećati mogućnost pojave nuspojava.
English: Votrient can affect how well your heart pumps or can increase the likelihood of having a heart attack.
Croatian: Vaše srce pumpa ili može povećati vjerojatnost srčanog udara.
English: Cardiac dysfunction/Heart failure
Croatian: Disfunkcija srca/zatajenje srca
English: Patients developing PRES/RPLS should permanently discontinue treatment with pazopanib.
Croatian: Bolesnici u kojih se razvije PRES/RPLS trajno trebaju prekinuti terapiju pazopanibom.
English: Take it at least two hours after a meal or one hour before a meal (see section 3).
Croatian: Uzmite ga najmanje dva sata nakon obroka ili jedan sat prije obroka (pogledajte dio 3).
English: TMA has been reported in clinical studies of pazopanib as monotherapy, in combination with bevacizumab, and in combination with topotecan (see section 4.8).
Croatian: Slučajevi TMA-e zabilježeni su u kliničkim ispitivanjima pazopaniba kao monoterapije, u kombinaciji s bevacizumabom i u kombinaciji s topotekanom (vidjeti dio 4.8).
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (Vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
English: In vitro studies suggest that pazopanib is a substrate for P-gp and BCRP.
Croatian: Ispitivanja in vitro ukazuju da je pazopanib supstrat za P-gp i BCRP.
English: Concomitant use of pazopanib and simvastatin increases the incidence of ALT elevations.
Croatian: Istodobna primjena pazopaniba i simvastatina povećava incidenciju porasta vrijednosti ALT-a.
English: Fatal perforation events have occurred.
Croatian: Zabilježeni su slučajevi perforacije sa smrtnim ishodom.
English: - if you have had heart failure or a heart attack.
Croatian: - ako ste doživjeli zatajenje srca ili srčani udar. - ako ste doživjeli kolaps pluća.
English: Pazopanib doses up to 2000 mg have been evaluated in clinical studies.
Croatian: U kliničkim ispitivanjima procjenjivale su se doze pazopaniba do 2000 mg.
English: Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with pazopanib (see section 4.6).
Croatian: Ženama u reproduktivnoj dobi treba se savjetovati da izbjegavaju trudnoću tijekom liječenja pazopanibom (vidjeti dio 4.6).
English: In a pharmacogenetic meta-analysis of data from 31 clinical studies of pazopanib administered either as monotherapy or in combination with other agents, ALT >5 x ULN (NCI CTC Grade 3) occurred in 19% of HLA-B*57:01 allele carriers and in 10% of non-carriers.
Croatian: U farmakogenetičkoj meta-analizi podataka iz 31 kliničkog ispitivanja pazopaniba primjenjenog ili u monoterapiji ili u kombinaciji s drugim lijekovima, ALT >5 x GGN (NCI CTC stupnja 3) pojavio se u 19% ispitanika nositelja alela HLA-B*57:01 i 10% ispitanika koji nisu nositelji tog alela.
English: In the three smallest of these 20 subgroups, the point estimate of the hazard ratio exceeded 1.25; i.e. in subjects with no prior nephrectomy (n=186, HR=1.403, 95% CI (0.955, 2.061)), baseline LDH >1.5 x ULN (n=68, HR=1.72, 95% CI (0.943, 3.139)), and MSKCC: poor risk (n=119, HR=1.472, 95% CI (0.937, 2.313)).
Croatian: U tri najmanje podskupine od njih 20, procjena omjera hazarda bila je viša od 1,25; tj. u ispitanika bez ranije nefrektomije (n=186, HR=1,403, 95% CI (0,955; 2,061)), početne vrijednosti LDH >1,5 x iznad gornje granice normale (n=68, HR=1,72, 95% CI (0,943; 3,139)) i MSKCC: nizak rizik (n=119, HR=1,472, 95% CI (0,937;
English: The most common adverse reactions (experienced by at least 10% of the patients) of any grade in the RCC and STS trials included: diarrhoea, hair colour change, skin hypopigmentation, exfoliative rash, hypertension, nausea, headache, fatigue, anorexia, vomiting, dysgeusia, stomatitis, weight decreased, pain, elevated alanine aminotransferase and elevated aspartate aminotransferase.
Croatian: Najčešće nuspojave (koje je doživjelo najmanje 10% bolesnika) bilo kojeg stupnja u ispitivanjima RCC-a i STS-a uključivale su: proljev, promjenu boje kose, hipopigmentaciju kože, osip s ljuštenjem, hipertenziju, mučninu, glavobolju, slabost, anoreksiju, povraćanje, disgeuziju, stomatitis, smanjenje tjelesne težine, bol, povišene razine alanin aminotransferaze te povišene razine aspartat aminotransferaze.
English: Magnesium stearate Microcrystalline cellulose Povidone (K30) Sodium starch glycolate
Croatian: Jezgra tablete magnezijev stearat celuloza, mikrokristalična povidon (K30) natrijev škroboglikolat
English: Pazopanib should be used with caution in patients who are at increased risk of thrombotic events or who have had a history of thrombotic events.
Croatian: Pazopanib treba koristiti s posebnim oprezom u bolesnika u kojih postoji povećan rizik od trombotičkih događaja ili onih koji imaju trombotičke događaje u anamnezi.
English: Administration of pazopanib with a high-fat or low-fat meal results in an approximately 2-fold increase in AUC and Cmax.
Croatian: Uzimanje pazopaniba s obrocima s puno ili malo masti rezultiralo je približno dvostrukim povećanjem AUC i Cmax.
English: 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.
Croatian: 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.
English: 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).
Croatian: 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).
English: 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).
Croatian: 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).
English: 200 mg OD 22.2
Croatian: 200 mg JD 22,2
English: Cases of hyperglycaemia have been observed during concomitant treatment with ketoconazole.
Croatian: Tijekom istodobnog liječenja ketokonazolom zabilježeni su slučajevi hiperglikemije.
English: 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).
Croatian: 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).
English: The majority of these cases were Palmar-plantar erythrodysaesthesia syndrome d Venous thromboembolic events - includes Deep vein thrombosis, Pulmonary embolism and Thrombosis terms e
Croatian: U većini slučajeva radilo se o palmarno-plantarnoj eritrodisesteziji d Venski tromboembolijski događaji - uključuje duboku vensku trombozu, plućnu emboliju i trombozu e
English: Table 4 Overall efficacy results in RCC by independent assessment (VEG105192)
Croatian: Tablica 4 Sveukupni rezultat djelotvornosti u RCC-u prema neovisnoj procjeni (VEG105192)
English: Other important serious adverse reactions identified in STS studies included venous thromboembolic events, left ventricular dysfunction and pneumothorax.
Croatian: Druge važne ozbiljne nuspojave zabilježene u ispitivanjima STS-a uključuju venske tromboembolijske događaje, disfunkciju lijeve klijetke i pneumotoraks.
English: Symptoms include: - passing blood in the stools or passing black stools - passing blood in the urine - stomach pain - coughing or vomiting up blood
Croatian: Simptomi uključuju: - krvave stolice ili crne stolice - krv u urinu - bol u želucu - iskašljavanje ili povraćanje krvi
English: Baseline and periodic urinanalysis during treatment is recommended and patients should be monitored for worsening proteinuria.
Croatian: Preporučuje se početna analiza urina, te povremene analize urina tijekom terapije kojima će se pratiti eventualno pogoršanje proteinurije.
English: Fertility may be affected by treatment with Votrient.
Croatian: Liječenje lijekom Votrient može utjecati na plodnost.
English: 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).
Croatian: 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).
English: Transaminase elevations >3 x ULN concurrently with bilirubin elevations >2 x ULN
Croatian: Porast vrijednosti transaminaza na >3 x GGN istodobno s porastom vrijednosti bilirubina na >2 x GGN
English: Transaminase elevation of >8 x ULN
Croatian: Porast vrijednosti transaminaza na >8 x GGN
English: 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.
Croatian: 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.
English: HDPE bottles with polypropylene child resistant closures containing either 30 or 60 tablets.
Croatian: HDPE boce s polipropilenskim sigurnosnim zatvaračima za djecu koje sadrže 30 ili 60 tableta.
English: In clinical studies with pazopanib, venous thromboembolic events including venous thrombosis and fatal pulmonary embolus have occurred.
Croatian: U kliničkim ispitivanjima pazopaniba zabilježeni su venski tromboembolijski događaji uključujući vensku trombozu i fatalnu plućnu emboliju.
English: In clinical studies with pazopanib, events of cardiac dysfunction such as congestive heart failure and decreased LVEF have occurred (see section 4.8).
Croatian: U kliničkim ispitivanjima pazopaniba zabilježeni su slučajevi disfunkcije srca kao što su kongestivno zatajenje srca i smanjenje LVEF-a (vidjeti dio 4.8).
English: Investigated dose
Croatian: Ispitivana doza
English: Hypothyroidism 83 (7%)
Croatian: Endokrini poremećaji često hipotireoidizam 83 (7%)
English: Your blood pressure will be checked before you take Votrient and while you are taking it.
Croatian: Vaš krvni tlak kontrolirat će se prije nego što počnete s uzimanjem te tijekom korištenja lijeka Votrient.
English: HDPE bottles with polypropylene child resistant closures containing either 30 or 90 tablets.
Croatian: HDPE boce s polipropilenskim sigurnosnim zatvaračima za djecu koje sadrže 30 ili 90 tableta.
English: 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.
Croatian: 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.
English: Table 6 Overall efficacy results in STS by independent assessment (VEG110727)
Croatian: Tablica 6 Sveukupni rezultati djelotvornosti za STS na temelju nezavisne procjene (VEG110727)
English: Fatal events that were considered possibly related to pazopanib included gastrointestinal haemorrhage, pulmonary haemorrhage/haemoptysis, abnormal hepatic function, intestinal perforation and ischaemic stroke.
Croatian: 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.
English: Pazopanib should be used with caution in patients with significant risk of haemorrhage.
Croatian: Pazopanib se treba koristiti s posebnim oprezom u bolesnika sa značajnim rizikom za krvarenje.
English: Grade 4 n (%)
Croatian: Stupanj 4 n (%)
English: Pre-clinical studies in animals have shown reproductive toxicity (see section 5.3).
Croatian: Neklinička ispitivanja na životinjama su pokazala reproduktivnu toksičnost (vidjeti dio 5.3).
English: Co-administration of pazopanib with a CYP3A4, P-gp, and BCRP inhibitor, such as lapatinib, will result in an increase in plasma pazopanib concentrations.
Croatian: Istovremena primjena pazopaniba s inhibitorima CYP3A4, P-gp-a i BCRP-a, poput lapatiniba, rezultirat će povećanjem koncentracije pazopaniba u plazmi.