FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor may tell you to stop taking this medicine.
Slovenian: Zdravnik vam bo morda svetoval, da to zdravilo prenehate jemati.
English: The median delivered cumulative radioactive iodine activity before enrollment was approximately 14.8 GBq.
Slovenian: Mediana dovedena kumulativna radioaktivnost joda pred vključitvijo je bila približno 14,8 GBq.
English: - If you are going to have surgery, or if you had an operation recently.
Slovenian: - če je pri vas načrtovan kirurški poseg oz. ste pred kratkim imeli kirurški poseg.
English: Before initiating Nexavar, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Slovenian: Pred uvedbo zdravila Nexavar je treba to tveganje skrbno preučiti pri bolnikih z dejavniki tveganja, kot sta hipertenzija ali anamneza anevrizme.
English: Sorafenib should not be used during pregnancy unless clearly necessary, after careful consideration of the needs of the mother and the risk to the foetus.
Slovenian: Sorafeniba se ne sme uporabljati med nosečnostjo, razen če je to nujno potrebno, po skrbnem pretehtanju nujnosti zdravljenja za mater in tveganja za plod.
English: P-gp-substrates
Slovenian: P-gp substrati
English: Nexavar may reduce fertility in both men and women.
Slovenian: Zdravilo Nexavar lahko zmanjša plodnost tako pri moških kot ženskah.
English: The safety and efficacy of Nexavar in children and adolescents aged < 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Nexavar pri otrocih in mladostnikih, starih manj kot 18 let, nista bili dokazani.
English: Majority of patients had papillary carcinoma (56.8%), followed by follicular (25.4%) and poorly differentiated carcinoma (9.6%).
Slovenian: Večina bolnikov je imela papilarni karcinom (56,8 %), nato pa sta sledila folikularni (25,4 %) in slabo diferencirani karcinom (9,6 %).
English: - If you get chest pain or heart problems.
Slovenian: - če se pojavijo bolečine v prsnem košu ali težave s srcem.
English: The PFS analysis was conducted at 342 events in 769 patients.
Slovenian: Analiza PFS je bila pri 769 bolnikih izvedena po 342 dogodkih.
English: Secondary endpoints included overall survival (OS), tumour response rate and duration of response.
Slovenian: Sekundarni končni izid študije je vključeval celokupno preživetje (OS - Overall Survival), stopnjo odziva tumorja in trajanje odziva.
English: The effect of Nexavar may be decreased.
Slovenian: Učinek zdravila Nexavar se lahko zmanjša.
English: In vitro binding of sorafenib to human plasma proteins is 99.5 %.
Slovenian: In vitro se na humane plazemske beljakovine veže 99,5 % sorafeniba.
English: Because sorafenib could harm infant growth and development (see section 5.3), women must not breast-feed during sorafenib treatment.
Slovenian: Ker lahko sorafenib škoduje rasti in razvoju otroka (glejte poglavje 5.3), ženske med zdravljenjem s sorafenibom ne smejo dojiti.
English: No complete response (CR) according to RECIST was observed.
Slovenian: Popolnega odziva (CR, complete response) po kriterijih RECIST niso opazili.
English: An interim analysis (second interim analysis) for overall survival was conducted at 367 deaths in 903 patients.
Slovenian: Vmesna analiza (druga vmesna analiza) celokupnega preživetja je bila pri 903 bolnikih izvedena po 367 smrtnih dogodkih.
English: Blood pressure should be monitored regularly and treated, if required, in accordance with standard medical practice.
Slovenian: Krvni tlak je treba redno spremljati in ga, če je to potrebno, uravnavati v skladu s standardno klinično prakso.
English: This is equivalent to a daily dose of 800 mg or four tablets a day.
Slovenian: To ustreza dnevnemu odmerku 800 mg ali štirim tabletam na dan.
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: - če imate ali ste imeli anevrizmo (razširitev in oslabitev stene krvne žile) ali raztrganino v steni krvne žile.
English: There are no data on the use of sorafenib in pregnant women.
Slovenian: Podatkov o uporabi sorafeniba pri nosečnicah ni.
English: Environmental Risk Assessment information is available in the EPAR of this medicine (see section 6.6).
Slovenian: Ocena tveganja za okolje je na voljo v evropskem javnem poročilu o oceni zdravila (EPAR) (glejte poglavje 6.6).
English: Severe hypocalcaemia should be corrected to prevent complications such as QT-prolongation or torsade de pointes (see section QT prolongation).
Slovenian: Hudo hipokalciemijo je treba korigirati, da se preprečijo zapleti, kot so podaljšanje intervala QT ali torsade de pointes (glejte poglavje Podaljšanje intervala QT).
English: Baseline demographics and patient characteristics were well balanced for both treatment groups.
Slovenian: Demografske značilnosti in izhodiščne značilnosti bolnikov so bile za obe skupini bolnikov primerljive.
English: Environmental Risk assessment studies have shown that sorafenib tosylate has the potential to be persistent, bioaccumulative and toxic to the environment.
Slovenian: Študije ocene tveganja za okolje so pokazale, da je lahko sorafenibijev tosilat v okolju obstojen, bioakumulativen in strupen za okolje.
English: HR (95% CI)
Slovenian: RO (95-% IZ)
English: Age, MSKCC prognostic group, ECOG PS and prior therapy did not affect the treatment effect size.
Slovenian: Starost, prognoza po kriterijih MSKCC, ECOG PS in predhodno zdravljenje niso vplivali na terapevtski učinek.
English: If it is nearly time for the next dose, forget about the missed one and carry on as normal.
Slovenian: Če je že skoraj čas za naslednji odmerek, pozabljenega odmerka ne vzemite, temveč počakajte do naslednjega rednega odmerka.
English: The effect of sorafenib on PFS was consistent independent of geographic region, age above or below 60 years, gender, histological subtype, and presence or absence of bone metastasis.
Slovenian: Učinek sorafeniba na PFS je bil dosledno neodvisen od geografskega območja, starosti nad ali pod 60 leti, spola, histološkega podtipa in prisotnosti ali odsotnosti zasevkov v kosteh.
English: Similar effects were not induced in adult dogs.
Slovenian: Pri odraslih psih teh učinkov niso opazili.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder .
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
English: Other clinically relevant laboratory abnormalities observed in the study 5 are shown in table 2.
Slovenian: Druge klinično pomembne nenormalne vrednosti laboratorijskih preiskav, ki so jih opazili v študiji 5, so prikazane v preglednici 2.
English: Dogs showed tubular degeneration in the testes and oligospermia.
Slovenian: Pri psih so opazili tubulno degeneracijo testisov in oligospermijo.
English: Therefore, the decision to resume sorafenib therapy following a major surgical intervention should be based on clinical judgement of adequate wound healing.
Slovenian: Zato mora odločitev o ponovni uvedbi zdravljenja s sorafenibom po velikem kirurškem posegu temeljiti na klinični oceni ustreznosti celjenja ran.
English: In vitro studies of CYP enzyme induction
Slovenian: In vitro študije indukcije CYP encimov
English: Before initiating treatment, physicians are recommended to carefully evaluate the prognosis in the individual patient considering maximum lesion size (see section 5.1), symptoms related to the disease (see section 5.1) and progression rate.
Slovenian: Priporoča se, da zdravniki pred uvedbo zdravljenja skrbno pretehtajo napoved izida zdravljenja za vsakega posameznega bolnika; pri tem je treba upoštevati največjo velikost lezije (glejte poglavje 5.1), simptome, povezane z boleznijo (glejte poglavje 5.1) in stopnjo napredovanja bolezni.
English: PFS was evaluated by blinded independent radiological review using RECIST criteria.
Slovenian: PFS je bilo ovrednoteno s slepo neodvisno oceno radioloških posnetkov po kriterijih RECIST.
English: - If you get any bleeding problems, or are taking warfarin or phenprocoumon.
Slovenian: - če se pojavijo kakršne koli težave zaradi krvavitev ali če jemljete varfarin ali fenprokumon.
English: In animals, sorafenib and/or its metabolites were excreted in milk.
Slovenian: Pri živalih so se sorafenib in/ali njegovi presnovki izločali v mleko.
English: Elderly population No dose adjustment is required in the elderly (patients above 65 years of age).
Slovenian: Starejšim bolnikom (starim več kot 65 let) odmerka zdravila ni treba prilagajati.
English: Approximately half of the patients had an ECOG performance status of 0, and half of the patients were in the low risk MSKCC prognostic group.
Slovenian: Približno polovica bolnikov je imela oceno stanja zmogljivosti po ECOG 0 in polovica jih je bila po kriterijih MSKCC razvrščena v prognostično skupino z majhnim tveganjem.
English: Sorafenib has been shown to prolong the QT/QTc interval (see section 5.1), which may lead to an increased risk for ventricular arrhythmias.
Slovenian: Sorafenib podaljša interval QT/QTc (glejte poglavje 5.1), kar lahko zveča tveganje za pojav ventrikularnih aritmij.
English: Metastases were present in the lungs in 86%, lymph node in 51% and bone in 27% of the patients.
Slovenian: Zasevki so bili prisotni v pljučih pri 86 %, limfnih žlezah pri 51 % in v kosteh pri 27 % bolnikov.
English: Psychiatric disorders depression
Slovenian: Psihiatrične motnje depresija
English: - If you have diabetes.
Slovenian: - če imate sladkorno bolezen.
English: What Nexavar is and what it is used for
Slovenian: Kaj je zdravilo Nexavar in za kaj ga uporabljamo
English: - The active substance is sorafenib.
Slovenian: - Učinkovina je sorafenib.
English: You must not breast-feed your baby during Nexavar treatment, as this medicine may interfere with the growth and development of your baby.
Slovenian: Med zdravljenjem z zdravilom Nexavar ne smete dojiti, saj zdravilo lahko vpliva na rast in razvoj otroka.
English: If you intend to have a high fat meal, take the tablets at least 1 hour before or 2 hours after the meal.
Slovenian: Če nameravate zaužiti mastno hrano, vzemite tablete najmanj eno uro pred obrokom hrane ali dve uri po njem.
English: Eight metabolites of sorafenib have been identified, of which five have been detected in plasma.
Slovenian: Odkrili so osem presnovkov, pet od njih v plazmi.
English: CI=Confidence interval, HR=Hazard ratio (sorafenib over placebo) * statistically significant as the p-value was below the prespecified O'Brien Fleming stopping boundary of 0.0077 ** independent radiological review
Slovenian: IZ = interval zaupanja, RO = razmerje ogroženosti (sorafenib v primerjavi s placebom) * statistično značilno, ker je bila vrednost p pod vnaprej določeno vrednostjo O'Brien-Flemingove zgornje meje 0,0077 ** neodvisna ocena radioloških posnetkov
English: Overall Survival (OS) [median, weeks (95%
Slovenian: Celokupno preživetje [mediana, tedni (95-% IZ)] Čas do napredovanja [mediana, tedni
English: If you become pregnant while being treated with Nexavar, immediately tell your doctor who will decide if the treatment should be continued.
Slovenian: Če med zdravljenjem z zdravilom Nexavar zanosite, o tem takoj obvestite zdravnika, ki bo presodil, ali smete nadaljevati z zdravljenjem.
English: After improvement of non-haematological adverse reactions, the dose of Nexavar may be increased.
Slovenian: Po izboljšanju nehematoloških neželenih učinkov se lahko odmerek zdravila Nexavar zveča.
English: In healthy volunteers treated with a 5-day regimen of neomycin the average exposure to sorafenib decreased by 54%.
Slovenian: Pri zdravih prostovoljcih, ki so bili pet dni zdravljeni z neomicinom, se je povprečna izpostavljenost sorafenibu zmanjšala za 54 %.
English: Rash and hand foot skin reaction are usually CTC (Common Toxicity Criteria) Grade 1 and 2 and generally appear during the first six weeks of treatment with sorafenib.
Slovenian: Po CTC (Common Toxicitiy Criteria) so 1. in 2. stopnje in se ponavadi pojavijo v prvih šestih tednih zdravljenja s sorafenibom.
English: If you have missed a dose, take it as soon as you remember.
Slovenian: Če ste pozabili vzeti odmerek zdravila Nexavar, ga vzemite takoj ko se spomnite.
English: Furthermore, the sorafenib batch tested in the standard genotoxicity battery included 0.34 % PAPE.
Slovenian: Poleg tega je v skupini standardnih genotoksičnih študij sorafenib vključeval 0,34 % PAPE.
English: Administration of rifampicin for 5 days before administration of a single dose of sorafenib resulted in an average 37 % reduction of sorafenib AUC.
Slovenian: Uporaba rifampicina pet dni pred uporabo enkratnega odmerka sorafeniba zmanjša AUC sorafeniba za 37 %.
English: Nexavar can raise blood pressure, and your doctor will usually monitor your blood pressure and may give you a medicine to treat your high blood pressure.
Slovenian: Zdravilo Nexavar lahko zviša krvni tlak; zdravnik bo spremljal vrednosti krvnega tlaka in vam, če bo potrebno, predpisal zdravila za zdravljenje visokega krvnega tlaka.
English: The clinical significance of these findings is unknown (see section 4.4).
Slovenian: Klinični pomen teh ugotovitev ni znan (glejte poglavje 4.4).
English: The preclinical safety profile of sorafenib was assessed in mice, rats, dogs and rabbits.
Slovenian: Predklinični varnostni profil sorafeniba so ocenjevali pri miših, podganah, psih in kuncih.
English: EU/1/06/342/001
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/06/342/001
English: Adverse reactions reported in multiple clinical trials or through post-marketing use are listed below in table 1, by system organ class (in MedDRA) and frequency.
Slovenian: Neželeni učinki, ki so se pojavili v več kliničnih preskušanjih ali v obdobju trženja, so našteti v spodnji preglednici 1 po organskih sistemih (po klasifikaciji MedDRA) in pogostnosti.
English: If you forget to take Nexavar
Slovenian: Če ste pozabili vzeti zdravilo Nexavar
English: Nexavar can cause rashes and skin reactions, especially on the hands and feet.
Slovenian: Zdravilo Nexavar lahko povzroči kožne izpuščaje in kožne reakcije, še posebej na dlaneh in podplatih.
English: When administered with irinotecan, whose active metabolite SN-38 is further metabolised by the UGT1A1 pathway, there was a 67 - 120 % increase in the AUC of SN-38 and a 26 - 42 % increase in the AUC of irinotecan.
Slovenian: Med sočasno uporabo irinotekana, katerega aktivni presnovek SN-38 se nato presnovi prek UGT1A1, se AUC SN38 zveča za 67 do 120 %, AUC irinotekana pa za 26 do 42 %.
English: Nexavar treatment should be supervised by a physician experienced in the use of anticancer therapies.
Slovenian: Zdravljenje z zdravilom Nexavar mora nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje rakavih bolezni.
English: It is not known whether sorafenib is excreted in human milk.
Slovenian: Ni znano, ali se sorafenib izloča v materino mleko.
English: No data is available in patients requiring dialysis.
Slovenian: Podatkov o bolnikih, ki potrebujejo dializo, ni na voljo.
English: The safety and efficacy of sorafenib in the treatment of advanced renal cell carcinoma (RCC) were investigated in two clinical studies:
Slovenian: Varnost in učinkovitost sorafeniba pri zdravljenju napredovalega karcinoma ledvičnih celic so preučevali v dveh kliničnih študijah:
English: UGT1A1 and UGT1A9 substrates
Slovenian: Substrati UGT1A1 in UGT1A9
English: Swallow Nexavar tablets with a glass of water, either without food or with a low-fat or moderate fat meal.
Slovenian: Tablete Nexavar zaužijte z vodo (kozarec vode), brez hrane ali z malo oziroma zmerno mastnim obrokom hrane.
English: Your doctor will decide when to start with Nexavar again.
Slovenian: Zdravnik vam bo svetoval, kdaj boste zdravilo Nexavar lahko spet začeli jemati.
English: Your doctor will monitor your fluid and electrolyte balance.
Slovenian: Zdravnik bo spremljal ravnovesje tekočin in elektrolitov.
English: Monitoring of renal function should be considered.
Slovenian: Priporoča se spremljanje delovanja ledvic.
English: ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITION OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: A. PROIZVAJALCI, ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
English: The primary endpoints were overall survival and progression-free survival (PFS).
Slovenian: Primarna končna izida študije sta bila celokupno preživetje in preživetje brez napredovanja bolezni - angl. PFS (Progression-free Survival).
English: Only patients with clear cell renal carcinoma and low and intermediate risk MSKCC (Memorial Sloan Kettering Cancer Center) were included.
Slovenian: Vključeni so bili samo bolniki s svetloceličnim karcinomom ledvičnih celic in z majhnim ali zmernim tveganjem po kriterijih MSKCC (Memorial Sloan Kettering Cancer Center).
English: Repeat-dose toxicity studies revealed changes (degenerations and regenerations) in various organs at exposures below the anticipated clinical exposure (based on AUC comparisons).
Slovenian: V študijah toksičnosti pri ponavljajočih se odmerkih so odkrili spremembe (degeneracije in regeneracije) v različnih organih, kadar je bila izpostavljenost manjša od pričakovane klinične izpostavljenosti (glede na AUC).
English: It is recommended that sorafenib should be administered without food or with a low or moderate fat meal.
Slovenian: Sorafenib se priporoča jemati brez hrane ali z malo oziroma zmerno mastnim obrokom hrane.
English: They come in calendar packs of 112 tablets: four transparent blister packs of 28 tablets each.
Slovenian: Na voljo so v koledarskem pakiranju po 112 tablet; štirje prozorni pretisni omoti po 28 tablet.
English: Other medicines and Nexavar
Slovenian: Druga zdravila in zdravilo Nexavar
English: There are limited data from this study in patients with Child Pugh B liver impairment and only one patient with Child Pugh C had been included.
Slovenian: Iz te študije je na voljo le malo podatkov o bolnikih z okvaro jeter Child Pugh B, medtem ko je bil z okvaro jeter Child Pugh C vključen le en bolnik.
English: The median duration of response was 309 days (95% CI: 226,505 days) in sorafenib treated patients who experienced a PR.
Slovenian: Mediana trajanja odziva je bila 309 dni (95-% IZ: 226; 505 dni) pri bolnikih, ki so se zdravili s sorafenibom in so imeli PR.
English: In case of symptomatic hypoglycaemia, sorafenib should be temporarily interrupted.
Slovenian: Če se pojavi simptomatska hipoglikemija, je treba zdravljenje s sorafenibom začasno prekiniti.
English: Thus, also the risk for a clinically relevant in vivo inhibition of CYP2C9 by sorafenib may be expected to be low.
Slovenian: Zato se lahko pričakuje, da je tveganje za klinično pomembno in vivo zaviranje CYP2C9 s sorafenibom zelo majhno.
English: Ketoconazole, a potent inhibitor of CYP3A4, administered once daily for 7 days to healthy male volunteers did not alter the mean AUC of a single 50 mg dose of sorafenib.
Slovenian: Ketokonazol, močan zaviralec CYP3A4, ki so ga zdravi moški prostovoljci prejemali sedem dni enkrat na dan, ni vplival na povprečno AUC enkratnega 50-miligramskega odmerka sorafeniba.
English: RAF kinases are serine/threonine kinases, whereas c-KIT, FLT-3, VEGFR-2, VEGFR-3, and PDGFR-ß are receptor tyrosine kinases.
Slovenian: Kinaze RAF so serin/treonin-kinaze, medtem ko so c-KIT, FLT-3, VEGFR-2, VEGFR-3 in PDGFR-ß receptorji tirozin-kinaze.
English: Sorafenib is mainly eliminated via the liver, and exposure might be increased in this patient population.
Slovenian: Sorafenib se izloča v glavnem skozi jetra, zato se pri teh bolnikih izpostavljenost sorafenibu lahko zveča.
English: Table 1: All adverse reactions reported in patients in multiple clinical trials or through postmarketing use
Slovenian: Preglednica 1: Vsi neželeni učinki, o katerih so poročali pri bolnikih v različnih kliničnih preskušanjih in v obdobju trženja
English: What Nexavar is and what it is used for What you need to know before you take Nexavar How to take Nexavar
Slovenian: Kaj je zdravilo Nexavar in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Nexavar Kako jemati zdravilo Nexavar Možni neželeni učinki
English: In some cases this was not associated with apparent intra-abdominal tumour.
Slovenian: V nekaterih primerih gastrointestinalna perforacija ni bila povezana s prisotnim intraabdominalnim tumorjem.
English: After repeated dosing to young and growing dogs effects on bone and teeth were observed at exposures below the clinical exposure.
Slovenian: Po ponavljajočem se odmerjanju sorafeniba mladim psom v razvoju so opazili vpliv na kosti in zobe, kadar je bila izpostavljenost manjša od klinične izpostavljenosti.
English: Since sorafenib is mainly eliminated via the hepatic route exposure might be increased in patients with severe hepatic impairment (see sections 4.2 and 5.2).
Slovenian: Ker se sorafenib izloča predvsem skozi jetra, se lahko pri bolnikih s hudo okvaro jeter zveča izpostavljenost sorafenibu (glejte poglavji 4.2 in 5.2).
English: Therefore repeat evaluations of benefit and risk is recommended taking anti-tumour activity and tolerability into account.
Slovenian: Zato se priporoča redno ocenjevanje koristi in tveganj, pri čemer je treba upoševati protitumorsko aktivnost in prenašanje zdravila.
English: In an overall survival analysis conducted 9 months after the data cut-off for the final PFS analysis there was no statically significant difference in overall survival between the treatment groups (HR=0.884; 95% CI: 0.633, 1.236, one-sided p value of 0.236).
Slovenian: V analizi celokupnega preživetja, ki so jo izvedli 9 mesecev po prenehanju zbiranja podatkov za končno analizo PFS ni bilo statistično značilne razlike v celokupnem preživetju med zdravljenima skupinama (RO = 0,884; 95-% IZ: 0,633; 1,236, enostranska p-vrednost 0,236).
English: Neomycin
Slovenian: Neomicin
English: In the pre-specified stratification factors (ECOG status, presence or absence of macroscopic vascular invasion and/or extrahepatic tumour spread) of both Study 3 and 4, the HR consistently favoured sorafenib over placebo.
Slovenian: Pri vnaprej določenih stratifikacijskih faktorjih (stanje po ECOG, prisotnost ali odsotnost makroskopske žilne prizadetosti in/ali širjenje tumorja zunaj jeter) iz študij 3 in 4 je bilo razmerje ogroženosti vedno v prid sorafeniba v primerjavi s placebom.
English: When using sorafenib in these patients, periodic monitoring with on-treatment electrocardiograms and electrolytes (magnesium, potassium, calcium) should be considered.
Slovenian: Kadar se sorafenib uporablja pri teh bolnikih, je treba med zdravljenjem redno spremljati elektrokardiogram in vrednosti elektrolitov (magnezij, kalij, kalcij).
English: There were no reports of hypokalaemia CTCAE grade 4.
Slovenian: Poročil o hipokaliemiji 4. stopnje po CTCAE ni bilo.
English: In vitro, sorafenib has been shown to inhibit the transport protein p-glycoprotein (P-gp).
Slovenian: Pokazalo se je, da sorafenib in vitro zavira prenos beljakovine P-glikoprotein (P-gp).
English: The median duration of therapy in the double-blind period was 46 weeks (range 0.3-135) for patients receiving sorafenib and 28 weeks (range 1.7-132) for patients receiving placebo.
Slovenian: Mediana trajanja zdravljenja med dvojno slepim obdobjem je bila 46 tednov (razpon 0,3 - 135) za bolnike, ki so prejemali sorafenib, in 28 tednov (razpon 1,7-132) za bolnike, ki so prejemali placebo.
English: It works by slowing down the rate of growth of cancer cells and cutting off the blood supply that keeps cancer cells growing.
Slovenian: Deluje tako, da upočasni rast rakavih celic in prekine oskrbo s krvjo, ki je potrebna za rast rakavih celic.
English: Multiple dosing of sorafenib for 7 days resulted in a 2.5- to 7-fold accumulation compared to single dose administration.
Slovenian: Po sedemdnevnem večkratnem odmerjanju sorafeniba se je pojavilo 2,5 do 7-kratno kopičenje v primerjavi z enkratnim odmerkom.