natgillin/translations-raw huggingface dataset:
What Zelboraf is and what it is used for
Kaj je zdravilo Zelboraf in za kaj ga uporabljamo
Grade 1 or Grade 2 (tolerable)
Stopnja 1 ali stopnja 2 (prenosljivo)
● use a lip balm and a broad spectrum sunscreen (minimum of Sun Protection Factor (SPF) 30, re-applied every 2 to 3 hours).
• uporabite mazilo za ustnice in sredstvo za sončenje z visoko zaščito (vsaj zaščitni faktor SPF 30; sredstvo znova nanesite vsake 2 do 3 ure).
● Tell your doctor if you have had a different type of cancer than melanoma, as Zelboraf may cause progression of certain types of cancers.
• Zdravniku povejte, če ste imeli drugo vrsto raka, kot je melanom, ker lahko zdravilo Zelboraf povzroči napredovanje nekaterih vrst raka.
This may affect the activity of Zelboraf.
Te lahko vplivajo na aktivnost zdravila Zelboraf.
If you are taking any of these medicines (or if you are not sure), please talk to your doctor before taking Zelboraf.
Če jemljete katero koli od teh zdravil (ali ste negotovi), se posvetujte z zdravnikom, preden boste vzeli zdravilo Zelboraf.
Treatment with vemurafenib should be initiated and supervised by a qualified physician experienced in the use of anticancer medicinal products.
Zdravljenje z vemurafenibom mora uvesti in nadzorovati usposobljen zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
No new safety signals were observed in a clinical study with six adolescent patients.
V klinični študiji s šestimi adolescenti niso opazili novih varnostnih signalov.
What you need to know before you take Zelboraf
Kaj morate vedeti, preden boste vzeli zdravilo Zelboraf
Temporarily interrupt treatment until QTc decreases below 500 ms.
Zdravljenje začasno prekinite dokler se interval QTc ne zniža pod 500 ms.
The combination of this medicine with Zelboraf is not recommended due to increased toxicity to the liver.
Sočasno jemanje tega zdravila z zdravilom Zelboraf ni priporočljivo zaradi povečane toksičnosti za jetra.
However, the parent compound was the predominant component (95%) in plasma.
Kljub temu je bila prevladujoča sestavina (95 %) v plazmi matična spojina.
● Tell your doctor if you observe any unusual thickening of the palms of your hands accompanied by tightening of the fingers inward or any unusual thickening of the soles of your feet which may be painful.
• Zdravniku povejte, če opazite kakršno koli neobičajno zadebelitev dlani, ki jo spremlja zategovanje prstov proti dlani, ali kakršno koli neobičajno zadebelitev podplatov, ki je lahko boleča.
● The active substance is vemurafenib.
• Učinkovina je vemurafenib.
Table 2: Dose modification schedule based on prolongation of the QT interval QTc value
Preglednica 2: Shema prilagajanja odmerka glede na podaljšanje intervala QT Vrednost intervala QTc
Unexplained abdominal pain should be promptly investigated (including measurement of serum amylase and lipase).
Nepojasnjeno bolečino v trebuhu je treba nemudoma preiskati (vključno z določitvijo serumske amilaze in lipaze).
● Swallow the tablets whole with a glass of water.
• Tablete morate zaužiti cele in s kozarcem vode.
The maximum tolerated dose could not be determined.
Največjega prenosljivega odmerka ni bilo mogoče določiti.
It is currently unknown whether vemurafenib is a substrate also to other transport proteins.
Trenutno ni znano, ali je vemurafenib tudi substrat drugih prenašalnih beljakovin.
● Do not take Zelboraf regularly on an empty stomach.
• Izogibajte se stalnemu jemanju zdravila Zelboraf na prazen želodec.
Grenzach-Wyhlen Germany
Grenzach-Wyhlen Nemčija
● Usually, this lesion appears on sun-damaged skin, remains local and can be cured by surgical removal.
• Po navadi se ta sprememba pojavi na koži, poškodovani od sonca, ostane lokalno omejena in jo je mogoče ozdraviti s kirurško odstranitvijo.
Other medicines and Zelboraf
Druga zdravila in zdravilo Zelboraf
Abnormal findings should be managed according to clinical practices.
Nenormalne spremembe je treba obravnavati v skladu s klinično prakso.
● Change in liver laboratory tests results or liver injury, including severe liver injury where liver is injured to the extent that it is not able to fully perform its function
• spremembe v izvidih jetrnih testov ali poškodba jeter, vključno s hudo poškodbo, ko jetra ne morejo v celoti opravljati svoje funkcije,
Very rare < 1/10,000
Zelo redki: < 1/10.000
Based on the criteria for drug induced liver injury developed by an international expert working group of clinicians and scientists, liver injury was defined as any one of the following laboratory abnormalities:
V skladu z merili za poškodbo jeter, povzročeno z zdravili, ki jih je razvila mednarodna strokovna delovna skupina, sestavljena iz zdravnikov in znanstvenikov, je bila poškodba jeter opredeljena kot ena od spodnjih laboratorijskih nenormalnosti:
● Take 4 tablets in the morning.
• Vzemite 4 tablete zjutraj, potem vzemite 4 tablete zvečer.
The effects of Zelboraf in people younger than 18 years old are not known.
Učinki zdravila Zelboraf pri otrocih, mlajših od 18 let, niso znani.
● Swelling of the face, lips or tongue
• oteklost obraza, ustnic ali jezika,
● Changes in electrical activity of the heart (QT prolongation)
• spremembe v električni aktivnosti srca (podaljšanje QT),
● It is not known whether the ingredients in Zelboraf pass into human milk.
• Ni znano, ali sestavine zdravila Zelboraf prehajajo v materino mleko.
● Allergic reactions that may include swelling of the face and difficulty breathing
• alergijske reakcije, ki lahko vključujejo otekel obraz in težko dihanje,
The tablets are to be swallowed whole with water.
Tablete je treba zaužiti cele, z vodo.
● Tell your doctor if you have a heart disorder, such as an alteration of the electrical activity of your heart called “QT prolongation”.
• Zdravniku morate povedati, če imate motnjo delovanja srca, kot je spremenjena električna aktivnost srca, imenovana "podaljšanje intervala QT".
(y) As of December 30, 2010, a total of 549 patients were evaluable for PFS and 439 patients were evaluable for overall response rate.
Do 30. decembra 2010 so skupno 549 bolnikom ocenili preživetje brez napredovanja bolezni in 439 bolnikom celokupni odziv.
Forty-nine percent of patients failed ≥ 2 prior therapies.
Pri 49 % bolnikov je bilo neuspešnih 2 ali več predhodnih zdravljenj.
PHARMACEUTICAL FORM AND CONTENTS 56 x 1 film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA 56 x 1 filmsko obložena tableta
● If you experience side effects, your doctor may decide to carry on your treatment but lower your dose.
• Če se pojavijo neželeni učinki, se bo vaš zdravnik morda vseeno odločil za nadaljevanje zdravljenja, vendar bo zmanjšal odmerek.
See monitoring measures in section 4.4.
Za ukrepe spremljanja glejte poglavje 4.4.
Biliary excretion appears to be another important elimination pathway.
Zdi se, da je tudi izločanje z žolčem pomembna pot izločanja.
● Tell your doctor if you have kidney or liver problems.
• Zdravniku morate povedati, če imate težave z ledvicami ali jetri.
Carcinogenicity studies have not been conducted with vemurafenib.
Študij kancerogenosti z vemurafenibom niso izvedli.
Results from the phase II study (NP22657) in patients who failed at least one prior therapy
Rezultati študije faze II (NP22657) pri bolnikih, pri katerih je bilo neuspešno vsaj eno predhodno zdravljenje
Hazard Ratio 95% Confidence Interval
95-% interval zaupanja
● Zelboraf is not recommended for use during pregnancy unless your doctor considers that the benefit for the mother outweighs the risk for the baby.
• Zdravila Zelboraf ni priporočljivo uporabljati med nosečnostjo, razen če zdravnik meni, da je korist zdravljenja za mater pomembnejša od morebitnega tveganja za otroka.
● Sunburn, being more sensitive to sunlight
• sončne opekline, večja občutljivost za sončno svetlobo,
Results from the phase I study (NO25390) in paediatric patients
Rezultati iz študije faze I (NO25390) pri pediatričnih bolnikih
• ≥ 3x ULN ALT with simultaneous elevation of bilirubin concentration > 2x ULN
• ≥ 3 x ULN ALT s hkratnim zvišanjem koncentracije bilirubina > 2 x ULN.
Mutations in the BRAF gene result in constitutive activation of BRAF proteins, which can cause cell proliferation without associated growth factors.
Mutacije v genu BRAF povzročijo konstitutivno aktivacijo beljakovine BRAF, kar lahko spodbudi proliferacijo celic brez pridruženih rastnih faktorjev.
Do not chew or crush the tablets.
Tablet ne žvečite ali drobite.
Serum creatinine elevations were mostly mild (>1-1.5x ULN) to moderate (>1.5-3x ULN) and observed to be reversible in nature (see table 4).
Zvišanja serumskega kreatinina so bila večinoma blaga (> 1-1,5x ULN) do zmerna (> 1,5-3x ULN); ugotovili so, da so po naravi reverzibilna (glejte preglednico 4).
● Regularly during your treatment and up to 6 months after your treatment, your doctor needs to check your skin for a type of cancer called “cutaneous squamous cell carcinoma”.
• Zdravnik vam mora med zdravljenjem in še 6 mesecev po zdravljenju redno pregledovati kožo zaradi vrste raka, imenovanega "ploščatocelični karcinom kože".
The median number of brain target lesions at baseline was 2 (range 1 to 5), in both cohorts.
Mediana števila ciljnih lezij v možganih v izhodišču je bila v obeh skupinah 2 (razpon od 1 do 5).
Table 4: Creatinine changes from baseline in the phase III study
Preglednica 4: Spremembe kreatinina glede na izhodišče v študiji faze III
The majority of vemurafenib-related material (94%) was recovered in faeces, and <1% in urine.
Večina snovi povezane z vemurafenibom (94 %) se je izločila z blatom in < 1 % z urinom.
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.
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.
● If you have any further questions, ask your doctor.
• Če imate dodatna vprašanja, se posvetujte z zdravnikom.
Pack-size: 56 x 1 film-coated tablets (7 blisters of 8 x 1 tablet)
Velikost pakiranja: 56 x 1 filmsko obložena tableta (7 pretisnih omotov po 8 x 1 tableto).
● Decreased white blood cells (neutropenia).
• zmanjšano število belih krvničk (nevtropenija).
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu.
Patients with mild hepatic impairment due to liver metastases without hyperbilirubinaemia may be monitored according to the general recommendations.
Bolnike, ki imajo zaradi metastaz v jetrih blago jetrno okvaro in nimajo hiperbilirubinemije, se lahko nadzoruje v skladu s splošnimi priporočili.
Sun protection
Zaščita pred soncem
● If you are taking Zelboraf, you may become more sensitive to sunlight and get sunburns that can be severe.
• Če jemljete zdravilo Zelboraf, se lahko poveča občutljivost kože za sončno svetlobo in lahko dobite sončne opekline, ki so lahko hude.
Patients should be closely monitored when re-starting vemurafenib after an episode of pancreatitis.
Bolnike je treba skrbno spremljati, ko po epizodi pankreatitisa ponovno uvedemo vemurafenib.
INFORMATION IN BRAILLE zelboraf
PODATKI V BRAILLOVI PISAVI
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.
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.
Do not use any more Zelboraf until you have spoken to a doctor.
Ne vzemite zdravila Zelboraf, dokler se ne posvetujete z zdravnikom.
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.
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.
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).
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).
Management of QTc prolongation may require specific monitoring measures (see section 4.4).
Obvladovanje podaljšanja intervala QTc lahko zahteva posebne ukrepe za spremljanje bolnika (glejte poglavje 4.4).
● A medicine called ipilimumab, another medicine for the treatment of melanoma.
• zdravilo ipilimumab, drugo zdravilo za zdravljenje melanoma.
The study included two simultaneously enrolling cohorts:
V študiji so bolnike sočasno vključevali v dve skupini:
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.
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.
● Additionally, your doctor needs to inspect your head, your neck, your mouth, your lymph glands and you will undergo CT scans regularly.
• Vaš zdravnik vam mora pregledati glavo, vrat, usta, bezgavke in redno opravljati slikanje z računalniško tomografijo (CT).
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.
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).
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.
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.
Food (high fat meal) increases the relative bioavailability of a single 960 mg dose of vemurafenib.
Hrana (obrok, bogat z maščobami) poveča relativno biološko uporabnost enkratnega 960-mg odmerka vemurafeniba.
The effects of vemurafenib on medicinal products that are substrates of BCRP are unknown.
Učinki vemurafeniba na zdravila, ki so substrati BCRP, niso znani.
Vemurafenib exhibits high inter-patient variability.
Vemurafenib med bolniki izkazuje veliko variabilnost.
Treatment with vemurafenib should continue until disease progression or the development of unacceptable toxicity (see tables 1 and 2 below).
Zdravljenje z vemurafenibom moramo nadaljevati do napredovanja bolezni ali pojava nesprejemljive toksičnosti (glejte preglednici 1 in 2 spodaj).
Patients should be made aware of the potential fatigue or eye problems that could be a reason for not driving.
Bolnikom je treba povedati, da se lahko pojavita utrujenost in težave z očmi, kar sta lahko razloga, da ne vozijo.
These lesions are usually removed by surgery and patients continue their treatment.
Takšne lezije običajno odstranijo z operacijo, bolnik pa nadaljuje z zdravljenjem.
All patients should be advised to avoid sun exposure while taking vemurafenib.
Vsem bolnikom je treba naročiti, naj se med jemanjem vemurafeniba ne izpostavljajo soncu.
Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitor, ATC code: L01XE15
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, inhibitorji proteinske kinaze, oznaka ATC: L01XE15
Checks of your skin before, during and after treatment
Pregledi kože pred zdravljenjem, med zdravljenjem in po njem
In the human mass balance study with vemurafenib administered orally, on average 95% of the dose was recovered within 18 days.
V študiji masnega ravnovesja pri človeku z vemurafenibom, dajanim peroralno, se je povprečno 95 % odmerka izločilo v 18 dneh.
* Includes acute kidney injury, renal impairment, and laboratory changes consistent with acute kidney injury.
* Vključuje akutno poškodbo ledvic, ledvično okvaro in laboratorijske spremembe, ki ustrezajo akutni poškodbi ledvic.
● Swelling usually in the legs (peripheral oedema)
• otekanje, po navadi v nogah (periferni edemi),
CuSCC usually occurred early in the course of treatment with a median time to the first appearance of 7 to 8 weeks.
Ploščatocelični karcinom kože se je po navadi pojavil zgodaj med zdravljenjem; mediana časa do prvega pojava je bila od 7 do 8 tednov.
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.
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.
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)
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).
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.
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.
BRAFV600G BRAFV600M BRAFV600A
V600M BRAFV600A
Posology adjustments resulting in a dose below 480 mg twice daily are not recommended.
Zmanjšanje odmerka pod 480 mg dvakrat na dan ni priporočljivo.
After cessation of vemurafenib treatment, a washout of 8 days might be necessary to avoid an interaction with a subsequent treatment.
Po končanem zdravljenju z vemurafenibom bo morda potreben 8-dnevni premor, da se izognemo interakcijam z nadaljnjim zdravljenjem.
QT prolongation may lead to an increased risk of ventricular arrhythmias including Torsade de Pointes.
Podaljšanje intervala QT lahko poveča tveganje za ventrikularne aritmije, vključno s t. i. Torsade de Pointes.
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).
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).
Median overall survival was 15.9 months (95% CI: 11.6, 18.3).
Mediana celokupnega preživetja je bila 15,9 meseca (95-% interval zaupanja: 11,6; 18,3).
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.
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.
Photosensitivity
Fotosenzibilnost
Zelboraf may decrease the efficacy of some oral contraceptives.
Zdravilo Zelboraf lahko zmanjša učinkovitost nekaterih peroralnih kontraceptivov.
● Use an appropriate method of contraception during your treatment and for at least 6 months after the end of your treatment.
• Med zdravljenjem in do najmanj 6 mesecev po končanem zdravljenju morate uporabljati ustrezno kontracepcijsko zaščito.
In majority of the cases, vemurafenib was maintained and the event of sarcoidosis either resolved or persisted.
V večini primerov so zdravljenje z vemurafenibom nadaljevali, sarkoidoza pa je izzvenela ali vztrajala.
Concomitant administration of CYP2C8 substrates with a narrow therapeutic window should be made with caution since vemurafenib may increase their concentrations.
Pri sočasnem dajanju substratov CYP2C8 z ozkim terapevtskim oknom je potrebna previdnost, ker vemurafenib lahko poveča njihove koncentracije.
● Inflammatory disease mainly affecting the skin, lung and eye (sarcoidosis)
• vnetna bolezen, ki v glavnem prizadene kožo, pljuča in oči (sarkoidoza),
● If you notice any changes in your skin while taking this medicine, please talk to your doctor as soon as possible.
• Če med jemanjem tega zdravila opazite kakršne koli spremembe na koži, se morate čim prej posvetovati z zdravnikom.
● A medicine used to prevent blood clots called warfarin
• zdravilo za preprečevanje krvnih strdkov, imenovano varfarin;
The majority of patients was male (61%), Caucasian (99%), and had stage M1c disease (61%).
Večina bolnikov je bila moških (61 %), belcev (99 %) in je imela stadij bolezni M1c (61 %).
Effect of other medicinal products on vemurafenib
Vplivi drugih zdravil na vemurafenib
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.
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).
No specific studies with vemurafenib have been conducted in animals to evaluate the effect on fertility.
Pri živalih niso izvedli posebnih študij z vemurafenibom za oceno vpliva na plodnost.
NAME OF THE MARKETING AUTHORISATION HOLDER Roche Registration GmbH.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Roche Registration GmbH.
Figure 1: Kaplan-Meier curves of overall survival - previously untreated patients (December 20, 2012 cut-off)
Slika 1: Kaplan-Meierjevi krivulji celokupnega preživetja - predhodno nezdravljeni bolniki, podatki, zbrani do 20. decembra 2012
Vemurafenib should not be used in patients with wild type BRAF malignant melanoma.
Vemurafeniba se ne sme uporabljati pri bolnikih z malignim melanomom, ki ima divji tip BRAF.
The majority of the excised lesions reviewed by an independent central dermatopathology laboratory were classified as SCCkeratoacanthoma subtype or with mixed-keratoacanthoma features (52%).
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 %).
They are available in aluminium perforated unit dose blisters in packs of 56 x 1 tablets.
Na voljo so v aluminijskem perforiranem pretisnem omotu za enkratni odmerek, v škatli s 56 x 1 tableto.
It is recommended that all patients receive a dermatologic evaluation prior to initiation of therapy and be monitored routinely while on therapy.
Priporočljivo je, da vsi bolniki pred uvedbo zdravljenja opravijo dermatološki pregled in da so med zdravljenjem deležni rednih kontrol.
The safety and efficacy of vemurafenib in children less than 18 years old have not been established.
Varnost in učinkovitost vemurafeniba pri otrocih, mlajših od 18 let, nista bili dokazani.