FrancophonIA/ELRC3.0 huggingface dataset:
English: The majority of vemurafenib-related material (94%) was recovered in faeces, and <1% in urine.
Slovenian: Večina snovi povezane z vemurafenibom (94 %) se je izločila z blatom in < 1 % z urinom.
English: However, exposures in the embryofoetal development studies were below the clinical exposure based on AUC comparison, it is therefore difficult to define to what extent these results can be extrapolated to humans.
Slovenian: Izpostavljenosti v študijah razvoja zarodkov in plodov so bile pod klinično izpostavljenostjo (glede na primerjavo AUC), zaradi tega je težko določiti, do kakšne mere se lahko ti rezultati ekstrapolirajo na ljudi.
English: ● If you have any further questions, ask your doctor.
Slovenian: • Če imate dodatna vprašanja, se posvetujte z zdravnikom.
English: Pack-size: 56 x 1 film-coated tablets (7 blisters of 8 x 1 tablet)
Slovenian: Velikost pakiranja: 56 x 1 filmsko obložena tableta (7 pretisnih omotov po 8 x 1 tableto).
English: ● Decreased white blood cells (neutropenia).
Slovenian: • zmanjšano število belih krvničk (nevtropenija).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu.
English: Patients with mild hepatic impairment due to liver metastases without hyperbilirubinaemia may be monitored according to the general recommendations.
Slovenian: Bolnike, ki imajo zaradi metastaz v jetrih blago jetrno okvaro in nimajo hiperbilirubinemije, se lahko nadzoruje v skladu s splošnimi priporočili.
English: Sun protection
Slovenian: Zaščita pred soncem
English: ● If you are taking Zelboraf, you may become more sensitive to sunlight and get sunburns that can be severe.
Slovenian: • Če jemljete zdravilo Zelboraf, se lahko poveča občutljivost kože za sončno svetlobo in lahko dobite sončne opekline, ki so lahko hude.
English: Patients should be closely monitored when re-starting vemurafenib after an episode of pancreatitis.
Slovenian: Bolnike je treba skrbno spremljati, ko po epizodi pankreatitisa ponovno uvedemo vemurafenib.
English: INFORMATION IN BRAILLE zelboraf
Slovenian: PODATKI V BRAILLOVI PISAVI
English: The population pharmacokinetic analysis indicated a 17% greater apparent clearance (CL/F) and a 48% greater apparent volume of distribution (V/F) in males than in females.
Slovenian: Populacijska farmakokinetična analiza je pokazala, da je pri moških navidezni očistek (CL/F) 17 % večji in navidezni volumen porazdelitve (V/F) 48 % večji v primerjavi z ženskami.
English: Do not use any more Zelboraf until you have spoken to a doctor.
Slovenian: Ne vzemite zdravila Zelboraf, dokler se ne posvetujete z zdravnikom.
English: It is currently unknown whether vemurafenib at a plasma level of 100 µM observed in patients at steady state (approximately 50 µg/ml) may decrease plasma concentrations of concomitantly administered CYP2B6 substrates, such as bupropion.
Slovenian: Zaenkrat še ni znano, ali lahko vemurafenib pri 100 µM koncentraciji v plazmi, ki je bila opažena pri bolnikih v stanju dinamičnega ravnovesja (približno 50 µg/ml), zmanjša plazemske koncentracije sočasno dajanih substratov CYP2B6, kot je bupropion.
English: It was designed to detect the predominant BRAF V600E mutation with high sensitivity (down to 5% V600E sequence in a background of wild type sequence from FFPE-derived DNA).
Slovenian: Načrtovan je bil z namenom, da prevladujoče BRAF V600E mutacije zazna z visoko občutljivostjo (tudi do 5 % V600E zaporedja, pri tem ko je v ozadju divji tip zaporedja DNK, pridobljene iz FFPE).
English: Management of QTc prolongation may require specific monitoring measures (see section 4.4).
Slovenian: Obvladovanje podaljšanja intervala QTc lahko zahteva posebne ukrepe za spremljanje bolnika (glejte poglavje 4.4).
English: ● A medicine called ipilimumab, another medicine for the treatment of melanoma.
Slovenian: • zdravilo ipilimumab, drugo zdravilo za zdravljenje melanoma.
English: The study included two simultaneously enrolling cohorts:
Slovenian: V študiji so bolnike sočasno vključevali v dve skupini:
English: The in vivo relevance of this finding is unknown, but a risk for a clinically relevant effect on concomitantly administered CYP2C8 substrates cannot be excluded.
Slovenian: Kaj ta ugotovitev pomeni pri in vivo pogojih, ni znano, tveganja za klinično pomemben učinek na sočasno uporabljene učinkovine, ki so substrati CYP2C8, pa ni mogoče izključiti.
English: ● Additionally, your doctor needs to inspect your head, your neck, your mouth, your lymph glands and you will undergo CT scans regularly.
Slovenian: • Vaš zdravnik vam mora pregledati glavo, vrat, usta, bezgavke in redno opravljati slikanje z računalniško tomografijo (CT).
English: This test has CE marking and is used to assess the BRAF mutation status of DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumour tissue.
Slovenian: Ta test ima oznako CE in se uporablja za določevanje stanja mutacije BRAF pri DNK, izolirane iz tumorskega tkiva, fiksiranega s formalinom in vloženega v parafin (FFPE).
English: A decision must be made whether to discontinue breast-feeding or to discontinue vemurafenib therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem zdravljenja z vemurafenibom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Food (high fat meal) increases the relative bioavailability of a single 960 mg dose of vemurafenib.
Slovenian: Hrana (obrok, bogat z maščobami) poveča relativno biološko uporabnost enkratnega 960-mg odmerka vemurafeniba.
English: The effects of vemurafenib on medicinal products that are substrates of BCRP are unknown.
Slovenian: Učinki vemurafeniba na zdravila, ki so substrati BCRP, niso znani.
English: Vemurafenib exhibits high inter-patient variability.
Slovenian: Vemurafenib med bolniki izkazuje veliko variabilnost.
English: Treatment with vemurafenib should continue until disease progression or the development of unacceptable toxicity (see tables 1 and 2 below).
Slovenian: Zdravljenje z vemurafenibom moramo nadaljevati do napredovanja bolezni ali pojava nesprejemljive toksičnosti (glejte preglednici 1 in 2 spodaj).
English: Patients should be made aware of the potential fatigue or eye problems that could be a reason for not driving.
Slovenian: Bolnikom je treba povedati, da se lahko pojavita utrujenost in težave z očmi, kar sta lahko razloga, da ne vozijo.
English: These lesions are usually removed by surgery and patients continue their treatment.
Slovenian: Takšne lezije običajno odstranijo z operacijo, bolnik pa nadaljuje z zdravljenjem.
English: All patients should be advised to avoid sun exposure while taking vemurafenib.
Slovenian: Vsem bolnikom je treba naročiti, naj se med jemanjem vemurafeniba ne izpostavljajo soncu.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitor, ATC code: L01XE15
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, inhibitorji proteinske kinaze, oznaka ATC: L01XE15
English: Checks of your skin before, during and after treatment
Slovenian: Pregledi kože pred zdravljenjem, med zdravljenjem in po njem
English: In the human mass balance study with vemurafenib administered orally, on average 95% of the dose was recovered within 18 days.
Slovenian: V študiji masnega ravnovesja pri človeku z vemurafenibom, dajanim peroralno, se je povprečno 95 % odmerka izločilo v 18 dneh.
English: * Includes acute kidney injury, renal impairment, and laboratory changes consistent with acute kidney injury.
Slovenian: * Vključuje akutno poškodbo ledvic, ledvično okvaro in laboratorijske spremembe, ki ustrezajo akutni poškodbi ledvic.
English: ● Swelling usually in the legs (peripheral oedema)
Slovenian: • otekanje, po navadi v nogah (periferni edemi),
English: CuSCC usually occurred early in the course of treatment with a median time to the first appearance of 7 to 8 weeks.
Slovenian: Ploščatocelični karcinom kože se je po navadi pojavil zgodaj med zdravljenjem; mediana časa do prvega pojava je bila od 7 do 8 tednov.
English: Non-clinical and clinical studies with retrospective sequencing analyses have shown that the test also detects the less common BRAF V600D mutations and V600K mutations with lower sensitivity.
Slovenian: Neklinične in klinične študije z retrospektivnim določanjem zaporedja, so pokazale, da test zazna tudi manj pogoste BRAF V600D mutacije in V600K mutacije z nižjo občutljivostjo.
English: Non-censored results at time of cross-over: March 31 2011: HR (95% CI) = 0.47 (0.35, 0.62); October 3 2011: HR (95% CI) = 0.67 (0.54, 0.84); February 1 2012: HR (95% CI) = 0.76 (0.63, 0.93); December 20 2012: HR (95% CI) = 0.79 (0.66, 0.95)
Slovenian: Rezultati, ki niso bili krnjeni v času prehoda na vemurafenib: 31. marec 2011: razmerje ogroženosti (95-% interval zaupanja) = 0,47 (0,35; 0,62); 3. oktober 2011: razmerje ogroženosti (95-% interval zaupanja) = 0,67 (0,54; 0,84); 1. februar 2012: razmerje ogroženosti (95-% interval zaupanja) = 0,76 (0,63; 0,93); 20. december 2012: razmerje ogroženosti (95-% interval zaupanja) = 0,79 (0,66; 0,95).
English: At steady state, the mean vemurafenib exposure in plasma is stable during the 24-hour interval as indicated by the mean ratio of 1.13 between the plasma concentrations before and 2-4 hours after the morning dose.
Slovenian: V stanju dinamičnega ravnovesja je povprečna izpostavljenost vemurafenibu v plazmi stabilna v 24urnem intervalu, kot kaže povprečna vrednost razmerja 1,13 med koncentracijami v plazmi pred jutranjim odmerkom in 2 do 4 ure po jutranjem odmerku.
English: BRAFV600G BRAFV600M BRAFV600A
Slovenian: V600M BRAFV600A
English: Posology adjustments resulting in a dose below 480 mg twice daily are not recommended.
Slovenian: Zmanjšanje odmerka pod 480 mg dvakrat na dan ni priporočljivo.
English: After cessation of vemurafenib treatment, a washout of 8 days might be necessary to avoid an interaction with a subsequent treatment.
Slovenian: Po končanem zdravljenju z vemurafenibom bo morda potreben 8-dnevni premor, da se izognemo interakcijam z nadaljnjim zdravljenjem.
English: QT prolongation may lead to an increased risk of ventricular arrhythmias including Torsade de Pointes.
Slovenian: Podaljšanje intervala QT lahko poveča tveganje za ventrikularne aritmije, vključno s t. i. Torsade de Pointes.
English: The efficacy of vemurafenib has been evaluated in 336 patients from a phase III clinical trial (NO25026) and 278 patients from two phase II clinical trials (NP22657 and MO25743).
Slovenian: Učinkovitost vemurafeniba so ocenili pri 336 bolnikih v kliničnem preskušanju faze III (NO25026) in 278 bolnikih v dveh kliničnih preskušanjih faze II (NP22657 in MO25743).
English: Median overall survival was 15.9 months (95% CI: 11.6, 18.3).
Slovenian: Mediana celokupnega preživetja je bila 15,9 meseca (95-% interval zaupanja: 11,6; 18,3).
English: In cellular anti-proliferation assays the inhibitory concentration 50 (IC50) against V600 mutated cell lines (V600E, V600R, V600D and V600K mutated cell lines) ranged from 0.016 to 1.131 µM whereas the IC50 against BRAF wild type cell lines were 12.06 and 14.32 µM, respectively.
Slovenian: Pri testih proliferacije celic je bila inhibitorna koncentracija 50 (IC50) pri V600 mutiranih celičnih linijah (V600E, V600R, V600D in V600K mutiranih celičnih linijah) med 0,016 in 1,131 µM, medtem ko je bila IC50 pri BRAF divjem tipu celičnih linij med 12,06 in 14,32 µM.
English: Photosensitivity
Slovenian: Fotosenzibilnost
English: Zelboraf may decrease the efficacy of some oral contraceptives.
Slovenian: Zdravilo Zelboraf lahko zmanjša učinkovitost nekaterih peroralnih kontraceptivov.
English: ● Use an appropriate method of contraception during your treatment and for at least 6 months after the end of your treatment.
Slovenian: • Med zdravljenjem in do najmanj 6 mesecev po končanem zdravljenju morate uporabljati ustrezno kontracepcijsko zaščito.
English: In majority of the cases, vemurafenib was maintained and the event of sarcoidosis either resolved or persisted.
Slovenian: V večini primerov so zdravljenje z vemurafenibom nadaljevali, sarkoidoza pa je izzvenela ali vztrajala.
English: Concomitant administration of CYP2C8 substrates with a narrow therapeutic window should be made with caution since vemurafenib may increase their concentrations.
Slovenian: Pri sočasnem dajanju substratov CYP2C8 z ozkim terapevtskim oknom je potrebna previdnost, ker vemurafenib lahko poveča njihove koncentracije.
English: ● Inflammatory disease mainly affecting the skin, lung and eye (sarcoidosis)
Slovenian: • vnetna bolezen, ki v glavnem prizadene kožo, pljuča in oči (sarkoidoza),
English: ● If you notice any changes in your skin while taking this medicine, please talk to your doctor as soon as possible.
Slovenian: • Če med jemanjem tega zdravila opazite kakršne koli spremembe na koži, se morate čim prej posvetovati z zdravnikom.
English: ● A medicine used to prevent blood clots called warfarin
Slovenian: • zdravilo za preprečevanje krvnih strdkov, imenovano varfarin;
English: The majority of patients was male (61%), Caucasian (99%), and had stage M1c disease (61%).
Slovenian: Večina bolnikov je bila moških (61 %), belcev (99 %) in je imela stadij bolezni M1c (61 %).
English: Effect of other medicinal products on vemurafenib
Slovenian: Vplivi drugih zdravil na vemurafenib
English: At the pre-specified interim analysis with a December 30, 2010 data cut-off, significant improvements in the co-primary endpoints of OS (p<0.0001) and PFS (p<0.0001) (unstratified log-rank test) were observed.
Slovenian: Pri vnaprej določeni vmesni analizi s podatki, zbranimi do 30. decembra 2010 so opazili značilno izboljšanje v primarno opazovanih dogodkih celokupnega preživetja (p < 0,0001) in preživetja brez napredovanja bolezni (p < 0,0001) (nestratificirani log-rank test).
English: No specific studies with vemurafenib have been conducted in animals to evaluate the effect on fertility.
Slovenian: Pri živalih niso izvedli posebnih študij z vemurafenibom za oceno vpliva na plodnost.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Roche Registration GmbH.
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Roche Registration GmbH.
English: Figure 1: Kaplan-Meier curves of overall survival - previously untreated patients (December 20, 2012 cut-off)
Slovenian: Slika 1: Kaplan-Meierjevi krivulji celokupnega preživetja - predhodno nezdravljeni bolniki, podatki, zbrani do 20. decembra 2012
English: Vemurafenib should not be used in patients with wild type BRAF malignant melanoma.
Slovenian: Vemurafeniba se ne sme uporabljati pri bolnikih z malignim melanomom, ki ima divji tip BRAF.
English: The majority of the excised lesions reviewed by an independent central dermatopathology laboratory were classified as SCCkeratoacanthoma subtype or with mixed-keratoacanthoma features (52%).
Slovenian: Večina izrezanih sprememb, ki jih je pregledal neodvisen centralni histopatološki laboratorij, je bilo opredeljenih kot ploščatocelični karcinom keratoakantomske podvrste ali z mešanimi keratoakantomskimi značilnostmi (52 %).
English: They are available in aluminium perforated unit dose blisters in packs of 56 x 1 tablets.
Slovenian: Na voljo so v aluminijskem perforiranem pretisnem omotu za enkratni odmerek, v škatli s 56 x 1 tableto.
English: It is recommended that all patients receive a dermatologic evaluation prior to initiation of therapy and be monitored routinely while on therapy.
Slovenian: Priporočljivo je, da vsi bolniki pred uvedbo zdravljenja opravijo dermatološki pregled in da so med zdravljenjem deležni rednih kontrol.
English: The safety and efficacy of vemurafenib in children less than 18 years old have not been established.
Slovenian: Varnost in učinkovitost vemurafeniba pri otrocih, mlajših od 18 let, nista bili dokazani.
English: Liver enzymes (transaminases and alkaline phosphatase) and bilirubin should be measured before initiation of treatment and monitored monthly during treatment, or as clinically indicated.
Slovenian: Pred uvedbo zdravljenja je treba izmeriti jetrne encime (transaminaze in alkalno fosfatazo) ter bilirubin in jih spremljati mesečno med zdravljenjem oz. kot je klinično indicirano.
English: In addition ECG monitoring every month during the first three months is recommended.
Slovenian: Prav tako je vsak mesec, prve 3 mesece zdravljenja priporočljivo opraviti EKG pregled.
English: Zelboraf is an anticancer medicine that contains the active substance vemurafenib.
Slovenian: Zdravilo Zelboraf je zdravilo za zdravljenje raka, ki vsebuje učinkovino vemurafenib.
English: In the majority of cases, patients received radiotherapy regimens greater than or equal to 2 Gy/day (hypofractionated regimens).
Slovenian: V večini primerov so bolniki prejeli protokole obsevanja z 2 Gy/dan ali več (hipofrakcionirane protokole).
English: Based on mechanism of action, vemurafenib may cause progression of cancers associated with RAS mutations (see section 4.8).
Slovenian: Glede na mehanizem delovanja lahko vemurafenib povzroči napredovanje rakov, povezanih z mutacijo RAS (glejte poglavje 4.8).
English: In a phase III clinical trial (MO25515, N= 3219), a higher incidence of potentiation of radiation toxicity was reported when vemurafenib patients received radiation prior to and during vemurafenib therapy (9.1%) compared to those patients who received radiation and vemurafenib concomitantly (5.2 %) or to those whose radiation treatment was prior to vemurafenib (1.5%).
Slovenian: V kliničnem preskušanju faze III (MO25515, n = 3219) so poročali o večji incidenci povečanja toksičnosti obsevanja, ko so bolniki prejemali obsevanje pred in med zdravljenjem z vemurafenibom (9,1 %), v primerjavi s tistimi, ki so obsevanje in vemurafenib prejemali sočasno (5,2 %) ali tistimi, ki so obsevanje prejemali pred vemurafenibom (1,5 %).
English: The majority of patients were male (61.6%), and Caucasian (92.5%), and the median age was 54 years (range 26 to 83 years), similarly distributed between the two cohorts.
Slovenian: Večina bolnikov je bila moških (61,6 %) in belcev (92,5 %), mediana starost je bila 54 let (v razponu od 26 do 83 let), po starosti so bili bolniki enakomerno porazdeljeni med obe skupini.
English: Severe hypersensitivity reactions may include Stevens-Johnson syndrome, generalised rash, erythema or hypotension.
Slovenian: Hude preobčutljivostne reakcije lahko vključujejo Stevens-Johnsonov sindrom, generaliziran izpuščaj, eritem ali hipotenzijo.
English: It is important to keep taking Zelboraf for as long as your doctor prescribes it for you.
Slovenian: Pomembno je, da zdravilo Zelboraf jemljete toliko časa, kot vam je predpisal zdravnik.
English: Results from the phase II study (MO25743) in patients with brain metastases
Slovenian: Rezultati študije faze II (MO25743) pri bolnikih z zasevki v možganih
English: Zelboraf is not recommended for children and adolescents.
Slovenian: Jemanje zdravila Zelboraf ni priporočljivo pri otrocih in mladostnikih.
English: The safety of vemurafenib in children and adolescents has not been established.
Slovenian: Varnost vemurafeniba pri otrocih in mladostnikih ni bila dokazana.
English: In the phase II study, AUC0-8h and Cmax at day 1 were 22.1 ± 12.7 µg⋅h/mL and 4.1 ± 2.3 µg/mL.
Slovenian: V študiji faze II sta bili AUC0-8h in Cmax na dan 1 22,1 ± 12,7 µg⋅h/ml in 4,1 ± 2,3 µg/ml.
English: Serum creatinine should be measured before initiation of treatment and monitored during treatment as clinically indicated (see sections 4.2 and 4.8).
Slovenian: Serumski kreatinin je treba izmeriti pred začetkom zdravljenja in ga med zdravljenjem spremljati, kot je klinično indicirano (glejte poglavji 4.2 in 4.8).
English: Patients were randomised to treatment with vemurafenib (960 mg twice daily) or dacarbazine (1000 mg/m2 on day 1 every 3 weeks).
Slovenian: Bolnike so randomizirali na zdravljenje z vemurafenibom (960 mg dvakrat na dan) ali z dakarbazinom (1000 mg/m2 1. dan vsake 3 tedne).
English: Amongst these patients, 3 had a PR, 3 had SD, 2 had PD and one was not evaluable.
Slovenian: Med temi bolniki so 3 dosegli delni odziv, 3 so imeli stabilno bolezen, pri 2 je bolezen napredovala, pri enem bolniku pa ocena ni bila mogoča.
English: PFS - brain only Median (months)e
Slovenian: PFS - le v možganih mediana (meseci)e
English: Consistent intake of vemurafenib on an empty stomach may lead to significantly lower steady state exposure than consistent intake of vemurafenib with or a short time after a meal.
Slovenian: Redno jemanje vemurafeniba na prazen želodec lahko povzroči signifikantno nižjo izpostavljenost v stanju dinamičnega ravnovesja kot redno jemanje vemurafeniba z obrokom ali kmalu po njem.
English: There are no data regarding the use of vemurafenib in pregnant women.
Slovenian: Podatkov o uporabi vemurafeniba pri nosečnicah ni.
English: The effects of P-gp and BCRP inhibitors that are not also strong CYP3A4 inhibitors are unknown.
Slovenian: Vplivi zaviralcev P-gp in BCRP, ki niso tudi močni zaviralci CYP3A4, niso znani.
English: ● If it is less than 4 hours before your next dose, skip the missed dose.
Slovenian: • Če je do naslednjega odmerka manj kot 4 ure, pozabljeni odmerek izpustite.
English: In the phase III study, ninety-four (28%) of 336 patients with unresectable or metastatic melanoma treated with vemurafenib were ≥ 65 years.
Slovenian: V študiji faze III je bilo 94 bolnikov (28 %) od 336 z neresektabilnim ali metastatskim melanomom, zdravljenih z vemurafenibom, starih 65 let ali več.
English: • To grade 4
Slovenian: • do stopnje 4
English: Therefore an effect of vemurafenib on the foetus cannot be excluded.
Slovenian: Tako vpliv vemurafeniba na zarodek ne more biti izključen.
English: Re-initiation of treatment should occur once the QTc decreases below 500 ms and at a lower dose as described in table 2.
Slovenian: Zdravljenje se sme znova začeti, ko se interval QTc skrajša pod 500 ms; uporabiti je treba manjši odmerek, tako kot je opisano v preglednici 2.
English: - Cohort 2 with previously treated patients (N = 56): Patients who had been previously treated for their brain metastases and had progressed following this treatment.
Slovenian: - 2. skupina: predhodno zdravljeni bolniki (n = 56) - bolniki, katerih zasevke v možganih so že zdravili in jim je bolezen po tem zdravljenju napredovala.
English: ● Difficulty breathing
Slovenian: • težko dihanje,
English: Most cases were cutaneous in nature but some cases involving visceral organs had fatal outcomes (see sections 4.5 and 4.8).
Slovenian: Večina primerov je bila po naravi kožnih, a nekaj primerov, ki je vključevalo visceralne organe, je imelo smrtni izid (glejte poglavji 4.5 in 4.8).
English: Initiation of treatment with vemurafenib is not recommended in patients with QTc>500 milliseconds (ms).
Slovenian: Zdravljenja z vemurafenibom ni priporočljivo uvesti pri bolnikih, ki imajo interval QTc > 500 milisekund (ms).
English: The preclinical safety profile of vemurafenib was assessed in rats, dogs, and rabbits.
Slovenian: Predklinični varnostni profil vemurafeniba so ocenili pri podganah, psih in kuncih.
English: Variability in exposure may also occur due to differences in gastro-intestinal fluid content, volumes, pH, motility and transition time and bile composition.
Slovenian: Variabilnost v izpostavljenosti se lahko pojavi tudi zaradi razlik v vsebini gastrointestinalne tekočine, volumnu, pH, gibljivosti in času prehoda gastrointestinalnega trakta ter sestavi žolča.
English: Worsening of radiation treatment side effects can occur in patients who are treated with radiation before, during, or after Zelboraf treatment.
Slovenian: Neželeni učinki zdravljenja z obsevanjem se lahko poslabšajo pri bolnikih, zdravljenih z obsevanjem pred, med ali po zdravljenju z zdravilom Zelboraf.
English: Symptoms of allergic reactions may include swelling of the face, lips or tongue, difficulty breathing, rash, or fainting sensation.
Slovenian: Simptomi alergijske reakcije lahko vključujejo oteklost obraza, ust ali jezika, težko dihanje, kožni izpuščaj ali omedlevico.