FrancophonIA/ELRC3.0 huggingface dataset:
English: not known not known not known
Slovenian: ni znano ni znano ni znano
English: The safety and efficacy of pazopanib in children aged 2 to 18 years of age have not yet been established.
Slovenian: Varnost in učinkovitost pazopaniba pri otrocih, starih 2 do 18 let, še nista bili dokazani.
English: Combination with other systemic anti-cancer therapies
Slovenian: Kombinacija z drugimi sistemskimi zdravili proti raku
English: The risks of these problems may be higher for people with an existing heart problem, or who are taking other medicines.
Slovenian: Tveganje za pojav takšnih težav je lahko večje pri ljudeh, ki že imajo težave s srcem ali pa jemljejo še druga zdravila.
English: Swallow the tablets whole with water, one after the other.
Slovenian: Tablete pogoltnite cele skupaj z vodo, eno po eno.
English: It works by preventing the activity of proteins that are involved in the growth and spread of cancer cells.
Slovenian: Zdravilo deluje tako, da prepreči aktivnost proteinov, ki so udeleženi pri rasti in širjenju rakavih celic.
English: Talk to your doctor about this.
Slovenian: O tem se pogovorite s svojim zdravnikom.
English: This can result in a very fast heartbeat causing a sudden loss of consciousness.
Slovenian: To lahko povzroči zelo hitro bitje srca in posledično nenadno izgubo zavesti.
English: Clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some elderly patients cannot be ruled out.
Slovenian: Klinične izkušnje ne kažejo na razlike v odzivu pri starostnikih in mlajših bolnikih, vendar pa večje občutljivosti posameznih starostnikov ni mogoče izključiti.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjšanjem tveganja).
English: Do not take Votrient - if you are allergic to pazopanib or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Votrient - če ste alergični na pazopanib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Tell your doctor if you notice any change in your vision.
Slovenian: Obvestite zdravnika, če opazite kakršnokoli spremembo vida.
English: Pregnancy/ Contraception in males and females
Slovenian: Nosečnost/Kontracepcija pri moških in ženskah
English: Votrient with food and drink
Slovenian: Zdravilo Votrient skupaj s hrano in pijačo
English: Patients should be monitored for hypertension early after starting treatment (no longer than one week after starting pazopanib) and frequently thereafter to ensure blood pressure control.
Slovenian: Bolnike je treba nadzirati glede pojava hipertenzije zgodaj po začetku zdravljenja (ne pozneje kot en teden po uvedbi pazopaniba), pozneje pa pogosto, da bi zagotovili urejenost krvnega tlaka.
English: These may harm organs such as the brain and kidneys.
Slovenian: To lahko povzroči poškodbo organov, na primer možganov in ledvic.
English: What Votrient is and what it is used for
Slovenian: Kaj je zdravilo Votrient in za kaj ga uporabljamo
English: 99% of patients (243/246) enrolled in the STS Phase III study, including the 15 subjects, received anthracycline.
Slovenian: 99 % bolnikov (243/246) vključenih v študijo III. faze pri STS, vključno s temi 15 preiskovanci, je prejemalo antracikline.
English: A treatment decision should be made based on the assessment of individual patient's benefit/risk.
Slovenian: Odločitev o uvedbi zdravljenja je treba sprejeti na osnovi ocene razmerja med koristjo in tveganjem pri vsakem posameznem bolniku.
English: In the majority of the cases, isolated increases in ALT and AST have been reported, without concomitant elevations of alkaline phosphatase or bilirubin.
Slovenian: V večini primerov so poročali o posameznih primerih zvišanja vrednosti ALT in AST, brez sočasnega zvišanja vrednosti alkalne fosfataze ali bilirubina.
English: Cases of serious infections (with or without neutropenia), in some cases with fatal outcome, have been reported.
Slovenian: Opisani so primeri hudih okužb (z nevtropenijo ali brez nje), v nekaterih primerih s smrtnim izidom.
English: Categories have been assigned based on absolute frequencies in the clinical trial data.
Slovenian: Kategorije pogostnosti so bile določene na osnovi absolutne pogostnosti iz kliničnih študij.
English: Your doctor will decide whether Votrient is suitable for you.
Slovenian: Zdravnik bo presodil, če je zdravljenje z zdravilom Votrient primerno za vas.
English: Please consult your doctor or nurse for advice.
Slovenian: Za nasvet se posvetujte s svojim zdravnikom ali medicinsko sestro.
English: All patients had clear cell histology or predominantly clear cell histology.
Slovenian: Vsi bolniki so imeli čisto celično histologijo ali pretežno čisto celično histologijo.
English: The following convention has been utilised for the classification of frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available data).
Slovenian: Pogostnost je navedena v skladu z naslednjim dogovorom: zelo pogosti ( 1/10); pogosti ( 1/100 do < 1/10); občasni ( 1/1.000 do < 1/100); redki ( 1/10.000 do < 1/1.000); zelo redki (< 1/10.000) in neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
English: If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Slovenian: Če vložitev PSUR in posodobitev RMP sovpadata, se lahko predložita sočasno.
English: Pazopanib has not been studied in patients who have had an event within the previous 6 months.
Slovenian: Pazopanib ni raziskan pri bolnikih, ki so imeli dogodek v preteklih 6 mesecih.
English: Possible side effects (including possible serious side effects under the relevant frequency category).
Slovenian: Možni neželeni učinki (vključno z možnimi resnimi neželenimi učinki v ustrezni skupini glede na pogostnost):
English: - certain forms of soft-tissue sarcoma, which is a type of cancer that affects the supportive tissues of the body.
Slovenian: - določenih vrst sarkoma mehkih tkiv; to je vrsta raka, ki prizadene podporna tkiva telesa.
English: The dose of pazopanib should not exceed 800 mg.
Slovenian: Odmerek pazopaniba ne sme preseči 800 mg.
English: Before initiating pazopanib, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Slovenian: Pred uvedbo pazopaniba je treba to tveganje skrbno preučiti pri bolnikih z dejavniki tveganja, kot sta hipertenzija ali anamneza anevrizme.
English: The effect of Votrient during pregnancy is not known.
Slovenian: Učinek zdravila Votrient med nosečnostjo ni znan.
English: Patients should avoid driving or using machines if they feel dizzy, tired or weak.
Slovenian: Bolniki naj ne vozijo in ne upravljajo s stroji, če so omotični, utrujeni ali šibki.
English: While observed in both RCC and STS studies, the incidence was higher in the STS population (5%) than in the RCC population (2%).
Slovenian: Te dogodke so opažali tako v študijah RCC kot STS, vendar je bila incidenca v populaciji s STS večja (5 %) kot v populaciji z RCC (2 %).
English: Votrient can also affect how some other medicines work.
Slovenian: Tudi zdravilo Votrient lahko vpliva na delovanje nekaterih drugih zdravil.
English: Based on the rodent-specific pathogenesis and mechanism for these findings, they are not considered to represent an increased carcinogenic risk for patients taking pazopanib.
Slovenian: Glede na specifično patogenezo pri glodalcih in mehanizem nastanka teh sprememb, se smatra, da ne prestavljajo povečanega kancerogenega tveganja za bolnike, ki jemljejo pazopanib.
English: The recommendations for how PPIs and H2-receptor antagonists are co-administered are based on physiological considerations.
Slovenian: Priporočila glede hkratne uporabe PPI in antagonistov receptorjev H2 temeljijo na fizioloških razmislekih.
English: For example, you could take it two hours after breakfast or one hour before lunch.
Slovenian: Na primer, zdravilo lahko vzamete dve uri po zajtrku ali eno uro pred kosilom.
English: QT prolongation and torsade de pointes
Slovenian: Podaljšanje intervala QT in torsade de pointes
English: The preclinical safety profile of pazopanib was assessed in mice, rats, rabbits and monkeys.
Slovenian: Profil varnosti pazopaniba je bil predklinično ovrednoten pri miših, podganah, kuncih in opicah.
English: There are no adequate data from the use of pazopanib in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi pazopaniba pri nosečnicah.
English: Stop taking Votrient and seek medical help immediately if you get any of these symptoms, or if you get headache accompanied with any of these symptoms.
Slovenian: Nehajte jemati zdravilo Votrient in nemudoma poiščite zdravniško pomoč, če se vam pojavi kateri koli od teh simptomov, ali če se vam pojavi glavobol, ki ga spremlja kateri od teh simptomov.
English: Extremadura, 3, 09400 Aranda De Duero, Burgos, Spain Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom
Slovenian: Extremadura 3, 09400 Aranda De Duero, Burgos, Španija Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Velika Britanija
English: Efficacy and safety has only been established in certain STS histological tumour subtypes (see section 5.1).
Slovenian: Učinkovitost in varnost sta bili ugotovljeni le pri določenih histoloških podvrstah STS (glejte poglavje 5.1).
English: The majority of patients had either favourable (39%) or intermediate (54%), MSKCC (Memorial Sloan Kettering Cancer Centre) / Motzer prognostic factors.
Slovenian: Večina bolnikov je imela bodisi ugoden (39 %) bodisi vmesen (54 %) MSKCC (Memorial Sloan Kettering Cancer Centre) ali Motzer-jev prognostični faktor.
English: This can result in blurry or impaired vision.
Slovenian: Posledica je lahko zamegljen vid ali okvara vida.
English: Post-marketing data on safety and tolerability across all pazopanib clinical studies and from spontaneous reports have also been evaluated.
Slovenian: Ocenjeni so bili tudi postmarketinški podatki o varnosti in prenosljivosti vključujoč vse klinične študije in spontana poročila.
English: Table 5 Overall efficacy results (VEG108844)
Slovenian: Preglednica 5 Rezultati celokupne učinkovitosti (VEG108844)
English: These could be signs of a blood clot in your body (thromboembolism).
Slovenian: To so lahko znaki krvnega strdka v telesu (trombembolije).
English: Permanently discontinue pazopanib.
Slovenian: Trajno ukinite uporabo pazopaniba.
English: Pazopanib is not indicated for use in combination with other agents.
Slovenian: Pazopanib ni indiciran za uporabo v kombinaciji z drugimi zdravili.
English: Demographic characteristics were similar between the treatment arms.
Slovenian: Demografske značilnosti med obema terapevtskima krakoma so bile podobne.
English: From the total of 435 patients in this study, 233 patients were treatment-naïve and 202 were second-line patients who had received one prior IL-2 or INF-based therapy.
Slovenian: Od skupno 435 bolnikov, ki so bili vključeni v to študijo, se 233 bolnikov predhodno še ni zdravilo, 202 bolnika pa sta se predhodno zdravila z IL-2 ali INF.
English: The use of VEGF pathway inhibitors in patients with or without hypertension may promote the formation of aneurysm and/or artery dissections.
Slovenian: Uporaba zaviralcev poti VEGF pri bolnikih s hipertenzijo ali brez nje lahko spodbudi nastanek anevrizem in/ali disekcij arterij.
English: Serum liver tests should be performed before initiation of treatment with pazopanib, at weeks 3, 5, 7 and 9, then at months 3 and 4, with additional tests as clinically indicated.
Slovenian: Serumske jetrne teste je treba izvesti pred uvedbo zdravljenja s pazopanibom, nato pa 3., 5., 7. in 9. teden ter 3. in 4. mesec zdravljenja in dodatno kadar je to klinično indicirano.
English: What you need to know before you take Votrient
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Votrient
English: Pazopanib should not be used in children younger than 2 years of age because of safety concerns with regard to organ growth and maturation (see sections 4.4 and 5.3).
Slovenian: Pazopaniba se ne sme uporabljati pri otrocih, mlajših od 2 let, ker obstajajo pomisleki glede varnosti, kar zadeva rast in dozorevanje organov (glejte poglavji 4.4 in 5.3).
English: In this dataset, 133/2235 (6%) of the patients carried the HLA-B*57:01 allele (see section 4.4).
Slovenian: V tem naboru podatkov je imelo 133/2235 (6 %) bolnikov prisoten alel HLA-B*57:01 (glejte poglavje 4.4).
English: Median (weeks)
Slovenian: Mediana (tedni)
English: Some patients however may have systemic pazopanib exposure greater than what has been observed after administration of 800 mg pazopanib alone.
Slovenian: A pri nekaterih bolnikih je lahko sistemska izpostavljenost pazopanibu večja, kot je bila zabeležena po uporabi 800 mg pazopaniba samega.
English: The OS results are subject to potential bias as 54% of patients in the placebo arm also received pazopanib in the extension part of this study following disease progression.
Slovenian: Rezultati celokupnega preživetja so lahko pristranski, ker je 54 % bolnikov iz skupine s placebom v podaljšanju te študije po napredovanju bolezni prav tako prejemalo pazopanib.
English: If you are going to have an operation
Slovenian: Če imate predviden kirurški poseg
English: Exposure at a 200 mg dose is markedly reduced, though highly variable, in these patients, with values considered insufficient to obtain a clinically relevant effect.
Slovenian: Izpostavljenost po odmerku 200 mg je pri teh bolnikih sicer zelo variabilna in bistveno nižja, dosežene vrednosti ocenjujejo kot nezadostne za doseganje klinično pomembnega učinka.
English: High blood pressure and Votrient
Slovenian: Visok krvni tlak in zdravilo Votrient
English: Ninety-eight percent (98%) of subjects received prior doxorubicin, 70% prior ifosfamide, and 65% of subjects had received at least three or more chemotherapeutic agents prior to study enrolment.
Slovenian: Osemindevetdeset odstotkov (98 %) preiskovancev je predhodno prejemalo doksorubicin, 70 % ifosfamid in 65 % preiskovancev je pred vključitvijo v študijo prejelo vsaj tri ali več kemoterapevtskih sredstev.
English: If the concomitant administration of an H2-receptor antagonist is medically necessary, pazopanib should be taken without food at least 2 hours before or at least 10 hours after a dose of an H2-receptor antagonist.
Slovenian: Če je sočasna uporaba antagonista receptorjev H2 medicinsko potrebna, je treba pazopanib vzeti brez hrane vsaj 2 uri pred ali vsaj 10 ur po odmerku antagonista receptorjev H2.
English: See section 4.4 for liver monitoring and dose modification for patients with drug-induced hepatotoxicity.
Slovenian: Glejte poglavje 4.4 za spremljanje jeter in prilagoditev odmerka pri bolnikih z medikamentozno povzročenimi hepatotoksičnimi učinki.
English: OS = overall survival * Overall survival for the respective STS histological subgroups (leiomyosarcoma, synovial sarcoma and “Other” STS) should be interpreted with caution due to the small number of subjects and wide confidence intervals
Slovenian: OS = celokupno preživetje * Celokupno preživetje za zadevne histološke podskupine STS (leiomiosarkom, sinovijski sarkom in "drugi" STS) je treba zaradi majhnega števila preiskovancev in širokih intervalov zaupanja tolmačiti previdno.
English: Table 3 Treatment-related adverse reactions reported in STS studies (n=382)
Slovenian: Preglednica 3: Z zdravljenjem povezani neželeni učinki, o katerih so poročali v študijah pri STS (n = 382)
English: PFS Overall ITT
Slovenian: PFS Celokupni ITT
English: Liver test values
Slovenian: Vrednosti jetrnih testov
English: Votrient is used in adults to treat: - kidney cancer that is advanced or has spread to other organs.
Slovenian: Zdravilo Votrient se uporablja pri odraslih za zdravljenje: - raka ledvic, ki je napredoval ali se je razširil v druge organe.
English: Other medicines and Votrient
Slovenian: Druga zdravila in zdravilo Votrient
English: If the concomitant use of a proton-pump inhibitor (PPI) is medically necessary, it is recommended that the dose of pazopanib be taken without food once daily in the evening concomitantly with the PPI.
Slovenian: Če je sočasna uporaba zaviralcev protonske črpalke (PPI - proton-pump inhibitor) medicinsko potrebna, je odmerek pazopaniba priporočljivo vzeti brez hrane, enkrat na dan zvečer, obenem s PPI.
English: If the clot breaks off, it may travel to your lungs and this may be life threatening or even fatal.
Slovenian: Če se strdek odtrga, lahko potuje v pljuča; to je lahko smrtno nevarno ali celo usodno.
English: Symptoms include shortness of breath or cough that will not go away.
Slovenian: Med simptomi sta težko dihanje ali kašelj, ki ne mine.
English: P value (one-sided)
Slovenian: P vrednost (enostranski test)
English: OS Overall ITT
Slovenian: OS Celokupni ITT
English: Results indicate that less than 4% of an orally administered pazopanib dose is excreted in the urine as pazopanib and metabolites.
Slovenian: Rezultati kažejo, da se manj kot 4 % peroralno uporabljenega odmerka pazopaniba izloči z urinom v obliki pazopaniba in presnovkov.
English: The majority of these cases describe mucositis f Frequency is based on laboratory value tables from VEG110727 (N=240).
Slovenian: Večina teh primerov opisuje mukozitis f Pogostnost temelji na preglednicah laboratorijskih vrednosti iz VEG110727 (n = 240).
English: Perforation and fistula
Slovenian: Perforacija in fistula
English: The four principle pazopanib metabolites account for only 6% of the exposure in plasma.
Slovenian: Štirje glavni presnovki pazopaniba predstavljajo le 6 % izpostavljenosti v plazmi.
English: Since vascular endothelial growth factor (VEGF) inhibitors may impair wound healing, treatment with pazopanib should be stopped at least 7 days prior to scheduled surgery.
Slovenian: Ker lahko zaviralci žilnega endotelnega rastnega faktorja (VEGF - vascular endothelial growth factor) vplivajo na celjenje ran, je treba zdravljenje s pazopanibom prekiniti vsaj 7 dni pred načrtovanim kirurškim posegom.
English: Votrient has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Votrient nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: When post-weaning rats were dosed from day 21 post partum to day 62 post partum, toxicological findings were similar to adult rats at comparable exposures.
Slovenian: Ko so podgane po prenehanju dojenja pazopanib prejemale od 21. do 62. postpartalnega dneva, so bile toksikološke ugotovitve podobne kot pri odraslih podganah pri primerljivih izpostavljenostih.
English: Renal cell carcinoma (RCC)
Slovenian: Karcinom ledvičnih celic (RCC)
English: VEG108844 achieved its primary endpoint of PFS and demonstrated that pazopanib was non-inferior to sunitinib, as the upper bound of the 95% CI for the hazard ratio was less than the protocol-specified non-inferiority margin of 1.25.
Slovenian: Študija VEG108844 je dosegla primarni opazovani dogodek preživetja brez napredovanja in je pokazala, da je pazopanib neinferioren sunitinibu, ker je bila zgornja meja 95 % IZ za razmerje ogroženosti manjša od v protokolu opredeljene meje neinferiornosti 1,25.
English: Four of the 15 subjects had full recovery (within 5% of baseline) and 5 had partial recovery (within the normal range, but >5% below baseline).
Slovenian: Štirje od 15 preiskovancev so povsem okrevali (vrednost znotraj 5 % od izhodiščne), 5 pa jih je okrevalo delno (vrednost znotraj normalnega območja, vendar > 5 % manj od izhodiščne).
English: Patients should be monitored until return to Grade 1 or baseline.
Slovenian: Bolnike je treba nadzirati, dokler se vrednosti ne vrnejo na stopnjo 1 ali izhodiščno vrednost.
English: The safety and pharmacokinetics of pazopanib in patients with moderate to severe heart failure or those with a below normal left ventricular ejection fraction (LVEF) have not been studied.
Slovenian: Varnost in farmakokinetika pazopaniba pri bolnikih z zmernim do hudim srčnim popuščanjem in bolnikih z iztisnim deležem levega prekata (LVEF - left ventricular ejection fraction), nižjim od normalnega, nista raziskani.
English: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG12 0DJ, United Kingdom.
Slovenian: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG12 0DJ, Velika Britanija
English: Votrient can raise your blood pressure.
Slovenian: Zdravilo Votrient lahko zviša krvni tlak.
English: However, the UGT1A1 genotype was not always predictive of the effect of pazopanib on SN-38 disposition.
Slovenian: Vendar genotip UGT1A1 ni bil vedno napovednik vpliva pazopaniba na odstranjevanje SN-38.
English: Prior anthracycline therapy may be a risk factor for cardiac dysfunction.
Slovenian: Predhodno zdravljenje z antraciklini je lahko dejavnik tveganja za moteno delovanje srca.
English: You may need extra tests to check that your heart and liver are working properly.
Slovenian: Zdravnik bo morda moral opraviti dodatne preiskave, s katerimi bo preveril delovanje srca in jeter.
English: Based on in vitro IC50 and in vivo plasma Cmax values, pazopanib metabolites GSK1268992 and GSK1268997 may contribute to the net inhibitory effect of pazopanib towards BCRP.
Slovenian: Glede na vrednosti IC50 in vitro in vrednosti Cmax v plazmi in vivo lahko presnovka pazopaniba GSK1268992 in GSK1268997 pripomoreta k neto zaviralnemu vplivu pazopaniba na BCRP.
English: Concomitant use of pazopanib and simvastatin increases the incidence of ALT elevations.
Slovenian: Sočasna uporaba pazopaniba in simvastatina poveča incidenco zvišanj ALT.
English: Male patients (including those who have had vasectomies) who have partners who are either pregnant or who could become pregnant (including those who use other methods of contraception) should use condoms during sexual intercourse while taking Votrient and for at least 2 weeks after the last dose.
Slovenian: Bolniki moškega spola (tudi tisti, ki so imeli vazektomijo), katerih partnerka je noseča ali lahko zanosi (kar vključuje tudi tiste partnerke, ki uporabljajo še druge metode kontracepcije), morajo v času jemanja zdravila Votrient in še najmanj 2 tedna po tem, ko vzamejo zadnji odmerek, pri spolnih odnosih uporabljati kondom.
English: Reproductive, fertility and teratogenic effects
Slovenian: Vpliv na sposobnost razmnoževanja, plodnost in teratogeni učinki
English: What Votrient is and what it is used for What you need to know before you take Votrient How to take Votrient
Slovenian: Kaj je zdravilo Votrient in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Votrient Kako jemati zdravilo Votrient Možni neželeni učinki
English: Blood pressure should be monitored and managed promptly using a combination of anti-hypertensive therapy and dose modification of pazopanib (interruption and re-initiation at a reduced dose based on clinical judgement) (see sections 4.2 and 4.8).
Slovenian: Krvni tlak je treba kontrolirati in ga takoj urejati s kombinacijo antihipertenzivnih zdravil in prilagoditvijo odmerka pazopaniba (prekinitev in ponovna uvedba v zmanjšanem odmerku po klinični presoji) (glejte poglavji 4.2 in 4.8).