FrancophonIA/ELRC3.0 huggingface dataset:
English: Pazopanib is an orally administered, potent multi-target tyrosine kinase inhibitor (TKI) of vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3, platelet-derived growth factor (PDGFR) -α and -β, and stem cell factor receptor (c-KIT), with IC50 values of 10, 30, 47, 71, 84 and 74 nM, respectively.
Slovenian: Je močan multitarčni zaviralec tirozin kinaznih (TKI - tyrosine kinase inhibitor) receptorjev za žilni endotelijski rastni faktor (VEGFR - Vascular Endothelial Growth Factor Receptors)-1, -2 in -3, trombocitni rastni faktor (PDGFR - platelet-derived growth factor)-α in -β, ter receptorje za faktor matičnih celic (stem cell factor receptor; (c-KIT).
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.
Slovenian: Pogosti neželeni učinki (lahko se pojavijo pri največ 1 od 10 bolnikov): - prebavne težave, napihnjenost, nabiranje plinov v črevesu, - krvavitev iz nosu, - suha usta ali razjede v ustih, - okužbe, - nenormalna zaspanost, - motnje spanja, - bolečina v prsih, kratka sapa, bolečine v nogah in oteklost nog/stopal.
English: Administration of pazopanib to patients with mild or moderate hepatic impairment should be undertaken with caution and close monitoring of tolerability.
Slovenian: Pri bolnikih z blago ali zmerno okvaro jeter je treba pazopanib uporabiti previdno in skrbno nadzirati prenašanje.
English: Administration of pazopanib to patients with mild or moderate hepatic impairment should be undertaken with caution and close monitoring.
Slovenian: Pri bolnikih z blago do zmerno okvaro jeter je treba pazopanib uporabljati previdno in ob natančnem spremljanju.
English: Seek medical help immediately if you get any of these symptoms.
Slovenian: Če se pri vas pojavi kateri od teh simptomov, takoj poiščite zdravniško pomoč.
English: 30 film-coated tablets 90 film-coated tablets
Slovenian: filmsko obložena tableta 30 filmsko obloženih tablet 90 filmsko obloženih tablet
English: Take it at least two hours after a meal, or one hour before a meal.
Slovenian: Zdravilo Votrient vzemite vsaj dve uri po jedi ali eno uro pred jedjo.
English: Each Votrient 200 mg film-coated tablet contains 200 mg pazopanib.
Slovenian: Ena Votrient 200 mg filmsko obložena tableta vsebuje 200 mg pazopaniba.
English: 150 mg/m resulted in an approximately 20% increase in systemic exposure to SN-38.
Slovenian: Sočasna uporaba 400 mg pazopaniba enkrat na dan z 250 mg/m cetuksimaba in 150 mg/m irinotekana je povečala sistemsko izpostavljenost presnovku SN-38 za približno 20 %.
English: Rare side effects (may affect up to 1 in 1,000 people): - inflammation of the lung (pneumonitis)
Slovenian: Redki neželeni učinki (lahko se pojavijo pri največ 1 od 1.000 bolnikov):
English: Not all pack sizes or tablet strengths may be available in your country.
Slovenian: Na trgu morda ni vseh navedenih pakiranj ali jakosti zdravila.
English: PRES/RPLS has been reported in association with pazopanib.
Slovenian: V povezavi s pazopanibom je bil opisan PRES/RPLS.
English: - Tell your doctor if you have high blood pressure.
Slovenian: - Če imate visok krvni tlak, o tem obvestite svojega zdravnika.
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.
Slovenian: V izhodišču so bile metastaze pri večini bolnikov prisotne v pljučih (74 %) in/ali bezgavkah (54 %).
English: - Avoid driving or using machines if you feel dizzy, tired or weak, or if your energy levels are low.
Slovenian: - Če ste omotični, utrujeni, oslabeli ali brez energije, ne smete upravljati z vozili ali stroji.
English: x axis; Months, y axis; Proportion Progression Free, Pazopanib --- (N = 290) Median 9.2 months; Placebo ------- (N = 145) Median 4.2 months; Hazard Ratio = 0.46, 95% CI (0.34, 0.62), P <0.0000001
Slovenian: os x: meseci, os y: delež brez napredovanja, Pazopanib --- (n = 290) mediana 9,2 meseca, Placebo -------(n = 145) mediana 4,2 meseca, Razmerje tveganj = 0,46, 95 % IZ (0,34; 0,62), P < 0,0000001
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.
Slovenian: Opravili so primerjave farmakokinetičnih parametrov pazopaniba Cmax (razpon povprečij od 27,5 do 58,1 µg/ml) in AUC(0-24) (razpon povprečij od 48,7 do 1040 µg*h/ml) po uporabi 800 mg pazopaniba samega in po uporabi 400 mg pazopaniba s 400 mg ketokonazola (povprečna Cmax 59,2 µg/ml, povprečna AUC(0-24) 1300 µg*h/ml).
English: Each Votrient 400 mg film-coated tablet contains 400 mg pazopanib.
Slovenian: Ena Votrient 400 mg filmsko obložena tableta vsebuje 400 mg pazopaniba.
English: The maximally tolerated pazopanib dose (MTD) in patients with moderate hepatic impairment (defined as an elevation of bilirubin >1.5 x to 3 x ULN regardless of the ALT values) was 200 mg once daily.
Slovenian: Pri bolnikih z zmerno okvaro jeter (opredeljeno kot zvišanje bilirubina na > 1,5- do 3-kratno ZMN ne glede na vrednost ALT) je bil največji tolerirani odmerek (MTD - maximally tolerated dose) pazopaniba 200 mg enkrat na dan.
English: Pazopanib has been shown to be embryotoxic and teratogenic when administered to rats and rabbits at exposures more than 300-fold lower than the human exposure (based on AUC).
Slovenian: Pri podganah in kuncih je pazopanib pri izpostavljenosti, ki je bila več kot 300-krat manjša od izpostavljenosti človeka (na osnovi AUC), deloval embriotoksično in teratogeno.
English: The clinical status of the patient and the adverse event profile of pazopanib should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills.
Slovenian: Pri presojanju bolnikove sposobnosti za opravila, ki zahtevajo presojo motorične ali kognitivne funkcije, je treba upoštevati tako klinično stanje bolnika kot profil neželenih učinkov pazopaniba.
English: Mild
Slovenian: Zmerna
English: Votrient 400 mg film-coated tablets are capsule-shaped, white with “GS UHL” marked on one side.
Slovenian: Votrient 400 mg filmsko obložene tablete Bele filmsko obložene tablete v obliki kapsule z oznako GS UHL na eni strani.
English: Transaminase elevation of >8 x ULN
Slovenian: Zvišanje vrednosti aminotransferaz na > 8-kratno ZMN
English: x axis; Months, y axis; Proportion Progression Free, Pazopanib --- (N = 155) Median 11.1 months; Placebo -------- (N = 78) Median 2.8 months; Hazard Ratio = 0.40, 95% CI (0.27, 0.60), P <0.0000001
Slovenian: os x: meseci, os y: delež brez napredovanja, Pazopanib --- (n = 155) mediana 11,1 meseca, Placebo-------(n = 78) mediana 2,8 meseca, Razmerje tveganj = 0,40, 95 % IZ (0,27; 0,60), P < 0,0000001
English: The film-coated tablets should be taken whole with water and not broken or crushed (see section 5.2).
Slovenian: Ne sme jih razpolavljati ali zdrobiti (glejte poglavje 5.2).
English: Administration of 1500 mg lapatinib (a substrate for and weak inhibitor of CYP3A4 and P-gp and a potent inhibitor of BCRP) with 800 mg pazopanib resulted in an approximately 50% to 60% increase in mean pazopanib AUC(0-24) and Cmax compared to administration of 800 mg pazopanib alone.
Slovenian: Pri uporabi lapatiniba (ki je substrat in šibek zaviralec CYP3A4 in P-gp ter močen zaviralec BCRP) v odmerku 1500 mg skupaj s pazopanibom v odmerku 800 mg, sta se srednji vrednosti AUC(0-24) in Cmax pazopaniba povečali za približno od 50 % do 60 % v primerjavi z uporabo pazopaniba samega v odmerku 800 mg. Zavrtje P-gp in/ali BCRP z lapatinibom je verjetno pripomoglo k večji izpostavljenosti pazopanibu.
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).
Slovenian: V kliničnih študijah, v katerih so preučevali pazopanib v monoterapiji, v kombinaciji z bevacizumabom oziroma v kombinaciji s topotekanom, je bila opisana TMA (glejte poglavje 4.8).
English: - Use a reliable method of contraception while you're taking Votrient, and at least for 2 weeks after, to prevent pregnancy.
Slovenian: - Med zdravljenjem in še najmanj 2 tedna po zaključku zdravljenja z zdravilom Votrient morate uporabljati zanesljivo metodo kontracepcije in tako preprečiti zanositev.
English: 30 film-coated tablets 60 film-coated tablets
Slovenian: filmsko obložena tableta 30 filmsko obloženih tablet 60 filmsko obloženih tablet
English: Blood pressure should be well controlled prior to initiating pazopanib.
Slovenian: Pred uvedbo zdravljenja s pazopanibom mora biti vrednost krvnega tlaka dobro nadzorovana.
English: 800 mg pazopanib once daily is the recommended dose in patients with mild abnormalities of serum liver tests (see section 4.2).
Slovenian: Za bolnike z blagimi nepravilnostmi serumskih jetrnih testov je priporočeni odmerek 800 mg pazopaniba enkrat na dan (glejte poglavje 4.2).
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).
Slovenian: faze (VEG102616, n = 225) in randomizirane, odprte študije neinferiornosti III. faze z vzporednimi skupinami (VEG108844, n = 557) (glejte poglavje 5.1).
English: Therefore, pazopanib should be administered at least 1 hour before or 2 hours after a meal.
Slovenian: Bolnik mora pazopanib jemati vsaj eno uro pred ali dve uri po jedi.
English: Dose modification
Slovenian: Prilagoditev odmerka
English: Take it at least two hours after a meal or one hour before a meal (see section 3).
Slovenian: Zdravilo Votrient morate vzeti vsaj dve uri po jedi ali eno uro pred jedjo (glejte poglavje 3).
English: - if you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
Slovenian: (nenormalna povezava med dvema deloma črevesa), - če imate težave s ščitnico, - če imate ali ste imeli anevrizmo (razširitev in oslabitev stene krvne žile) ali raztrganino v steni krvne žile.
English: In clinical studies with pazopanib, events of QT prolongation and torsade de pointes have occurred (see section 4.8).
Slovenian: V kliničnih študijah s pazopanibom so poročali o pojavu podaljšanja intervala QT in tahikardiji torsade de pointes (glejte poglavje 4.8).
English: Pharmacogenomics
Slovenian: Farmakogenomika
English: Baseline laboratory measurement of thyroid function is recommended and patients with hypothyroidism should be treated as per standard medical practice prior to the start of pazopanib treatment.
Slovenian: Bolnike s hipotiroidizmom je treba pred uvedbo zdravljenja s pazopanibom zdraviti v skladu z ustaljeno prakso.
English: See Table 1 for dose modification guidance for patients with baseline values of total bilirubin 1.5 x ULN and AST and ALT 2 x ULN:
Slovenian: Glejte preglednico 1 za smernice za prilagoditev odmerka pri bolnikih, ki imajo izhodiščne vrednosti celokupnega bilirubina  1,5-kratno ZMN ter vrednosti AST in ALT  2-kratno vrednost ZMN: Preglednica 1 Prilagoditev odmerka v primeru medikamentozno povzročenih hepatotoksičnih učinkov
English: Combination with strong P-gp or BCRP inhibitors should be avoided, or selection of an alternate concomitant medicinal product with no or minimal potential to inhibit P-gp or BCRP is recommended.
Slovenian: Priporočljivo je izbrati alternativno sočasno zdravilo, ki ne zavira ali ima minimalen vpliv na zaviranje P-gp ali BCRP.
English: Grapefruit juice should be avoided during treatment with pazopanib (see section 4.5).
Slovenian: Med zdravljenjem s pazopanibom bolnik ne sme uživati soka grenivke (glejte poglavje 4.5).
English: Heart conditions
Slovenian: Težave s srcem
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).
Slovenian: Glede na manjšo izpostavljenost in majhno jetrno rezervo pri bolnikih s hudo okvaro jeter (opredeljeno kot celokupni bilirubin > 3-kratna ZMN ne glede na vrednost ALT) uporaba pazopaniba ni priporočljiva (glejte poglavje 4.2).
English: These include: - clarithromycin, ketoconazole, itraconazole, rifamicin, telithromycin, voriconazzole (used to treat infection).
Slovenian: Takšna zdravila so: - klaritromicin, ketokonazol, itrakonazol, rifampicin, telitromicin in vorikonazol (uporabljamo jih za zdravljenje okužb), - atazanavir, indinavir, nelfinavir, ritonavir, sakvinavir (uporabljamo jih za zdravljenje okužbe z virusom HIV), - nefazodon (uporabljamo ga za zdravljenje depresije), - simvastatin in morda tudi drugi statini (uporabljajo se za zdravljenje zvišanega holesterola), - zdravila, ki zmanjšujejo želodčno kislino.
English: x axis; Months, y axis; Proportion Progression Free, Pazopanib --- (N = 135) Median 7.4 months; Placebo -------- (N = 67) Median 4.2 months; Hazard Ratio = 0.54, 95% CI (0.35, 0.84), P <0.001
Slovenian: os x: meseci, os y: delež brez napredovanja, Pazopanib --- (n = 135) mediana 7,4 meseca, Placebo--(n = 67) mediana 4,2 meseca, Razmerje tveganj = 0,54, 95 % IZ (0,35; 0,84), P < 0,001
English: Uncommon Menorrhagia Vaginal haemorrhage 3 (<1%) Metrorrhagia
Slovenian: Motnje reprodukcije in dojk občasni menoragija krvavitev iz nožnice 3 (< 1 %) metroragija
English: Upper gastrointestinal haemorrhage
Slovenian: Perforacije in fistula v gastrointestinalnem traktu
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
Slovenian: - visok krvni tlak, - driska, - siljenje na bruhanje ali bruhanje, - bolečina v želodcu, - izguba apetita, - hujšanje, - motnje čuta za okušanje ali izguba okusa, - vneta usta, - glavobol, - tumorska bolečina, - pomanjkanje energije, občutek šibkosti ali utrujenosti, - spremembe barve las, - neobičajno izpadanje ali redčenje las,
English: Pazopanib is not recommended in patients with severe hepatic impairment (total bilirubin >3 x ULN regardless of the ALT value) (see sections 4.2 and 5.2).
Slovenian: Pri bolnikih s hudo okvaro jeter (celokupni bilirubin > 3-kratna ZMN ne glede na vrednost ALT) uporaba pazopaniba ni priporočljiva (glejte poglavji 4.2 in 5.2).
English: Cases of hepatic failure (including fatalities) have been reported during use of pazopanib.
Slovenian: Med uporabo pazopaniba so poročali o primerih odpovedi jeter (vključno s smrtnimi izidi).
English: Thrombotic microangiopathy (TMA)
Slovenian: Trombotična mikroangiopatija
English: % (95% CI)
Slovenian: % (95 % interval zaupanja)
English: What Votrient looks like and contents of the pack Votrient 200 mg film-coated tablets are capsule-shaped, pink with “GS JT” marked on one side.
Slovenian: Votrient 200 mg filmsko obložene tablete Rožnate filmsko obložene tablete v obliki kapsule z oznako GS JT na eni strani.
English: Pneumothorax
Slovenian: Pnevmotoraks
English: 200 mg OD
Slovenian: 200 mg 1x na dan
English: It cannot be excluded that pazopanib will affect the pharmacokinetics of other statins (e.g. atorvastatin, fluvastatin, pravastatin, rosuvastatin).
Slovenian: Poleg tega je treba pazopanib skupaj z drugimi statini uporabljati previdno, ker ni dovolj podatkov za oceno njihovega vpliva na raven ALT. Ni mogoče izključiti, da bo pazopanib vplival na farmakokinetiko drugih statinov (npr. atrovastatin, fluvastatin, pravastatin, rosuvastatin).
English: The median steady-state Cmax and AUC(0-24) values after administration of 200 mg pazopanib once daily in patients with moderate hepatic impairment were approximately 44% and 39%, of the corresponding median values after administration of 800 mg once daily in patients with normal hepatic function, respectively (see Table 7).
Slovenian: V stanju dinamičnega ravnovesja, po uporabi 200 mg pazopaniba enkrat na dan pri bolnikih z zmerno okvaro jeter, je bila mediana Cmax približno 44 %, mediana AUC(0-24) pa 39 % ustrezne mediane Cmax oz. AUC(0-24) po uporabi 800 mg pazopaniba enkrat na dan pri bolnikih z normalnim delovanjem jeter (glejte preglednico 7).
English: The following terms have been combined: a Abdominal pain, abdominal pain upper and gastrointestinal pain b Oedema, oedema peripheral and eyelid oedema c
Slovenian: Bolečine v trebuhu, bolečine v zgornjem delu trebuha in bolečine v prebavilih b Edemi, periferni edemi in edem vek c
English: Don't take Votrient with food, as it affects the way the medicine is absorbed.
Slovenian: Hrana vpliva na absorpcijo zdravila iz prebavil.
English: The median steady-state Cmax and AUC(0-24) values after administration of 200 mg pazopanib once daily in patients with severe hepatic impairment were approximately 18% and 15%, of the corresponding median values after administration of 800 mg once daily in patients with normal hepatic function.
Slovenian: V stanju dinamičnega ravnovesja po uporabi 200 mg pazopaniba enkrat na dan pri bolnikih s hudo okvaro jeter je bila mediana Cmax približno 18 %, mediana AUC(0-24) pa 15 % ustrezne mediane Cmax oz. AUC(0-24) po uporabi 800 mg pazopaniba enkrat na dan pri bolnikih z normalnim delovanjem jeter.
English: Cough
Slovenian: Huda
English: Table 2 Treatment-related adverse reactions reported in RCC studies (n = 1149) or during post-marketing period
Slovenian: (n = 1149) ali med obdobjem trženja
English: Cerebrovascular accident
Slovenian: Možganska kap
English: Your blood pressure will be checked before you take Votrient and while you are taking it.
Slovenian: Pred začetkom zdravljenja z zdravilom Votrient bo zdravnik preveril vrednost krvnega tlaka in ga nato med zdravljenjem redno spremljal.
English: In clinical studies with pazopanib in advanced soft tissue sarcoma, events of pneumothorax have occurred (see section 4.8).
Slovenian: V kliničnih študijah pazopaniba pri napredovalem sarkomu mehkih tkiv so se pojavili primeri pnevmotoraksa (glejte poglavje 4.8).
English: BOTTLE LABEL - 200 mg film-coated tablets
Slovenian: NALEPKA NA STEKLENICI - 200 mg filmsko obložene tablete
English: Figure 1 Kaplan-Meier curve for progression-free survival by independent assessment for the overall population (treatment-naïve and cytokine pre-treated populations) (VEG105192)
Slovenian: Slika 1 Kaplan-Meierjeva krivulja časa preživetja brez napredovanja bolezni na osnovi neodvisne presoje za celotno populacijo (predhodno še nezdravljeni bolniki in bolniki, ki so se predhodno že zdravili s citokini) (VEG105192)
English: Votrient 400 mg film-coated tablets
Slovenian: Votrient 400 mg filmsko obložene tablete
English: In clinical studies with pazopanib, events of GI perforation or fistula have occurred (see section 4.8).
Slovenian: V kliničnih študijah s pazopanibom so poročali o pojavu perforacij ali fistule v gastrointestinalnem traktu (glejte poglavje 4.8).
English: Your doctor may need to reduce your dose if you get side effects.
Slovenian: V primeru pojava neželenih učinkov bo zdravnik morda moral odmerek zmanjšati.
English: BOTTLE LABEL - 400 mg film-coated tablets
Slovenian: NALEPKA NA STEKLENICI - 400 mg filmsko obložene tablete
English: Votrient 200 mg film-coated tablets Votrient 400 mg film-coated tablets
Slovenian: Votrient 200 mg filmsko obložene tablete Votrient 400 mg filmsko obložene tablete
English: Votrient 200 mg film-coated tablets
Slovenian: Votrient 200 mg filmsko obložene tablete
English: Pazopanib has not been studied in patients who had a history of haemoptysis, cerebral haemorrhage or clinically significant gastrointestinal (GI) haemorrhage in the past 6 months.
Slovenian: Pri bolnikih z anamnezo izkašljevanja krvi, cerebralne krvavitve ali klinično pomembne gastrointestinalne krvavitve v zadnjih 6 mesecih, uporaba pazopaniba ni raziskana.
English: Wound healing
Slovenian: Celjenje ran
English: Pazopanib is eliminated slowly with a mean half-life of 30.9 hours after administration of the recommended dose of 800 mg.
Slovenian: Pri uporabi priporočenega 800 mg odmerka je srednji razpolovni čas 30,9 ure.
English: Tell your doctor if any of these apply to you.
Slovenian: Če se kar koli od navedenega nanaša na vas, o tem obvestite svojega zdravnika.
English: Arterial thrombotic events
Slovenian: Arterijska tromboza
English: Pazopanib is not recommended in patients with severe hepatic impairment (defined as total bilirubin >3 x ULN regardless of the ALT value).
Slovenian: Pri bolnikih s hudo okvaro jeter (opredeljeno kot celokupni bilirubin > 3-kratna ZMN ne glede na vrednost ALT) uporaba pazopaniba ni priporočljiva.
English: Cardiac dysfunction/heart failure, heart attack
Slovenian: Srčno popuščanje, srćna kap
English: Thrombotic microangiopathy (including thrombotic thrombocytopenic purpura and haemolytic uraemic syndrome)†
Slovenian: Bolezni krvi in limfatičnega sistema pogosti trombocitopenija nevtropenija levkopenija občasni policitemija redki trombotična mikroangiopatija (vključno s trombotično trombocitopenično purpuro in hemolitičnouremičnim sindromom)†
English: Baseline and periodic evaluation of LVEF is recommended in patients at risk of cardiac dysfunction.
Slovenian: Bolnikom, ki imajo tveganje za moteno delovanje srca, je priporočljivo kontrolirati LVEF izhodiščno in redno pozneje.
English: Figure 2 Kaplan-Meier curve for progression-free survival by independent assessment for the treatment-naïve population (VEG105192)
Slovenian: Slika 2 Kaplan-Meierjeva krivulja časa preživetja brez napredovanja bolezni na osnovi neodvisne presoje za predhodno še nezdravljene bolnike (VEG105192)
English: Thrombocytopenia
Slovenian: Pazopanib Placebo
English: In vitro studies suggest that pazopanib is a substrate for P-gp and BCRP.
Slovenian: In vitro študije kažejo, da je pazopanib substrat za P-glikoprotein (P-gp) in protein, odporen za raka dojke (BCRP - breast cancer resistant protein).
English: 800 mg pazopanib once daily is the recommended dose in patients with mild abnormalities in serum liver tests (defined either as normal bilirubin and any degree of alanine aminotransferase (ALT) elevation or as an elevation of bilirubin (>35% direct) up to 1.5 x upper limit of normal (ULN) regardless of the ALT value).
Slovenian: Za bolnike z blagimi nepravilnostmi serumskih jetrnih testov (opredeljenimi bodisi kot normalen bilirubin in kakršno koli zvišanje alanin-aminotransferaze (ALT) bodisi kot zvišanje bilirubina (> 35 % direktnega) do 1,5-kratne zgornje normalne meje (ZMN) ne glede na vrednost ALT) je priporočeni odmerek 800 mg pazopaniba enkrat na dan. Za bolnike z zmerno okvaro jeter (opredeljeno kot zvišanje bilirubina na > 1,5- do 3-kratno ZMN ne glede na vrednost ALT) je priporočljiv manjši odmerek pazopaniba 200 mg enkrat na dan (glejte poglavje 5.2).
English: Renal impairment is unlikely to have a clinically relevant effect on pazopanib pharmacokinetics given the low renal excretion of pazopanib and metabolites (see section 5.2).
Slovenian: Pazopanib in njegovi presnovki se le v majhnem obsegu izločajo preko ledvic, zato je verjetnost, da bi okvara ledvic klinično pomembno vplivala na farmakokinetiko pazopaniba, majhna (glejte poglavje 5.2).
English: In clinical studies with pazopanib haemorrhagic events have been reported (see section 4.8).
Slovenian: V kliničnih študijah s pazopanibom so poročali o pojavu hemoragičnih dogodkov (glejte poglavje 4.8).