natgillin/translations-raw huggingface dataset:
• you need to continue contraception for 24 months after your final dose of this medicine because Erivedge may remain in your body for up to 24 months after your final dose.
• kontracepcijo morate še naprej uporabljati 24 mesecev po zadnjem odmerku tega zdravila, ker lahko zdravilo Erivedge ostane v telesu še do 24 mesecev po zadnjem odmerku.
• The need to use condoms when having sex with a female partner
• potrebo po uporabi kondoma pri spolnem odnosu z žensko partnerko
In a thorough QTc study in 60 healthy subjects, there was no effect of therapeutic doses of Erivedge on the QTc interval.
V natančni študiji QTc pri 60 zdravih preiskovancih zdravilo Erivedge v terapevtskih odmerkih ni vplivalo na interval QTc.
• Information on the methodology, agreed with the National Competent Authority, to collect information on the use of Erivedge and the compliance with the pregnancy pharmacovigilance programme and its effectiveness.
• Informacije o metodologiji, dogovorjeni s pristojnim nacionalnim organom glede zbiranja informacij o uporabi zdravila Erivedge in preverjanja skladnosti s farmakovigilančnim programom preprečevanja nosečnosti in njegove učinkovitosti.
• rifampicin - used for bacterial infections,
• rifampicin - uporablja se za zdravljenje bakterijskih okužb,
Specific instructions (the Erivedge Pregnancy Prevention Programme), given to you by your doctor contain information particularly on the effects of Erivedge on unborn babies.
Posebna navodila (Program preprečevanja nosečnosti med uporabo zdravila Erivedge), ki vam jih bo dal vaš zdravnik, vsebujejo podatke zlasti o učinkih zdravila Erivedge na nerojenega otroka.
• you need to change contraception.
• morate zamenjati kontracepcijo.
95 % CI for overall response
Odzivni bolniki 95-% interval zaupanja za celotni odziv
• Obligations of the health care professional in relation to the prescribing of Erivedge
• obveze za zdravstvene delavce v povezavi s predpisovanjem zdravila Erivedge
**54 % of laBCC patients had no histopathologic evidence of BCC at 24 weeks.
**54 % bolnikov z lokalno napredovalim bazalnoceličnim karcinomom ni imelo histopatoloških znakov bazalnoceličnega karcinoma po 24 tednih.
In the mBCC cohort, tumour response was assessed according to the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.0.
V kohorti z metastatskim bazalnoceličnim karcinomom so odziv tumorja ocenjevali po merilih RECIST (Response Evaluation Criteria in Solid Tumours), verzija 1.0.
• sulfasalazine - used for certain inflammatory disorders, and especially,
• sulfasalazin - uporablja se za nekatere vnetne bolezni, in še posebej
• loss of monthly periods in women of childbearing age,
• izostanek menstruacij pri ženskah v rodni dobi,
Amongst these women, amenorrhoea was observed in 3 patients (30 %).
Med temi ženskami so amenorejo zabeležili pri 3 bolnicah (30 %).
Hedgehog pathway signalling through the Smoothened transmembrane protein (SMO) leads to the activation and nuclear localisation of Glioma-Associated Oncogene (GLI) transcription factors and induction of
Signaliziranje po poti Hedgehog preko SMO (smoothened transmembrane protein) povzroči aktiviranje in jedrno lokalizacijo transkripcijskih faktorjev GLI (Glioma Associated Oncogene) in indukcijo ciljnih genov
The preclinical safety profile of Erivedge was assessed in mice, rats, and dogs.
Predklinične varnostne značilnosti zdravila Erivedge so ocenili pri miših, podganah in psih.
Metastatic BCC was defined as histologically confirmed distant metastasis.
Metastatski bazalnocelični karcinom so opredelili kot histološko potrjeno oddaljeno metastazo.
If you take more Erivedge than you should If you take more Erivedge than you should, talk to your doctor.
Če ste vzeli večji odmerek zdravila Erivedge, kot bi smeli Če ste vzeli večji odmerek zdravila Erivedge, kot bi smeli, se posvetujte z zdravnikom.
Absorption is saturable as evidenced by the lack of dose proportional increase in exposure after a single dose of 270 mg and
Absorpcija je saturabilna; to se kaže z odsotnostjo odmerku sorazmernega povečanja izpostavljenosti po enkratnih odmerkih 270 mg in 540 mg zdravila Erivedge.
Therefore, all patients should be monitored routinely while taking Erivedge, and cuSCC should be treated according to the standard of care.
Zato je treba vse bolnike med zdravljenjem z zdravilom Erivedge rutinsko kontrolirati, ploščatocelični karcinom kože pa zdraviti v skladu s standardnim zdravljenjem.
Mild and moderate renal impairment is not expected to impact the elimination of vismodegib and no dose adjustment is needed.
Ni pričakovati, da bi blaga ali zmerna ledvična okvara vplivala na izločanje vismodegiba, in odmerka ni treba prilagoditi.
• To ensure that patients are capable of complying with the requirements for the safe use of Erivedge
• zagotoviti, da so bolniki sposobni slediti zahtevam glede varne uporabe zdravila Erivedge
This also includes non-prescription medicines, vitamins and herbal medicines.
To vključuje tudi zdravila, ki ste jih kupili brez recepta, vitamine in zeliščna zdravila.
• Your doctor should check your skin regularly for a type of cancer called “cutaneous squamous cell carcinoma' (SCC).
• Vaš zdravnik mora redno pregledovati vašo kožo za vrsto raka, imenovano "ploščatocelični karcinom kože".
The findings of premature fusion of the epiphyses indicate a potential risk for short stature and tooth deformities to infants and children (see section 5.3).
Izsledki o prezgodnjem zraščanju epifiz kažejo na mogoče tveganje za nizko rast in deformacije zob pri dojenčkih in otrocih (glejte poglavje 5.3).
Therefore, mild and moderate renal impairment is unlikely to have a clinically significant effect on the pharmacokinetics of vismodegib.
Zato ni verjetno, da bi imela blaga in zmerna ledvična okvara klinično pomemben učinek na farmakokinetiko vismodegiba.
Erivedge has been administered at doses 3.6 times higher than the recommended 150 mg daily dose.
Zdravilo Erivedge so dajali v odmerkih, ki so bili 3,6-krat večji od priporočenega 150-mg dnevnega odmerka.
Erivedge contains a type of sugar called lactose.
Zdravilo Erivedge vsebuje vrsto sladkorja, ki se imenuje laktoza.
Erivedge is for oral use.The capsules must be swallowed whole with water, with or without food (see section 5.2).
Kapsule je treba zaužiti cele z vodo, s hrano ali brez nje (glejte poglavje 5.2).
• carbamazepine, phenytoin - used for epilepsy,
• karbamazepin, fenitoin - uporabljata se za zdravljenje epilepsije,
Erivedge has no or negligible influence on the ability to drive and use machines.
Zdravilo Erivedge nima vpliva ali ima zanemarljiv vpliv na sposobnost za vožnjo in upravljanje strojev.
• topotecan - used for certain types of cancer,
• topotekan - uporablja se pri nekaterih tipih rakov,
Vismodegib concentrations are strongly correlated with AAG levels, showing parallel fluctuations of AAG and total vismodegib over time and consistently low unbound vismodegib levels.
Koncentracija vismodegiba močno korelira s koncentracijo AAG ter kaže vzporedno fluktuacijo AAG in celotnega vismodegiba skozi čas in skladno s tem nizko koncentracijo nevezanega vismodegiba.
• Coadministration of St John's wort (Hypericum perforatum) (see section 4.5).
• Sočasna uporaba šentjanževke (Hypericum perforatum) (glejte poglavje 4.5).
The single dose mean (CV %) absolute bioavailability of Erivedge is 31.8 (14.5) %.
Povprečna (koeficient variacije - KV %) absolutna biološka uporabnost enkratnega odmerka zdravila Erivedge je 31,8 (14,5) %.
The pivotal trial, ERIVANCE BCC (SHH4476g), was an international, single-arm, multi-centre, 2-cohort study.
Ključno preskušanje ERIVANCE BCC (SHH4476g) je bila mednarodna, multicentrična študija z enim krakom in 2 kohortama.
• That the patient should tell the healthcare professional about any adverse event
• Da mora bolnik obvestiti zdravstvene delavce o katerem koli neželenem učinku
Since the number of subjects who were not Caucasian comprised only < 3% of the total population (6 Black, 219 Caucasian), race was not evaluated as a covariate in the population pharmacokinetic analysis.
Število bolnikov, ki niso bili belci, je znašalo manj kot 3 % celotne populacije (6 črnopoltih, 219 belcev), rase niso ocenjevali kot kovariante v populacijski farmakokinetični analizi.
• if you are able to become pregnant but are unable or unwilling to follow the necessary pregnancy prevention measures that are listed in the Erivedge Pregnancy Prevention Programme,
• bi lahko zanosili, pa ne morete ali nočete uporabljati potrebnih ukrepov za preprečitev nosečnosti, ki so navedeni v Programu preprečevanja nosečnosti med uporabo zdravila Erivedge;
In order to assist health care providers and patients to avoid embryonic and foetal exposure to Erivedge the Marketing Authorisation Holder will provide educational materials (Erivedge Pregnancy Prevention Programme) to reinforce the potential risks associated with the use of Erivedge.
Da bi zdravstvenim delavcem in bolnikom pomagal preprečiti izpostavljenost zarodka in ploda zdravilu Erivedge, bo imetnik dovoljenja za promet z zdravilom priskrbel izobraževalna gradiva (Program preprečevanja nosečnosti med uporabo zdravila Erivedge), v katerih bo poudaril mogoča tveganja, povezana z uporabo zdravila Erivedge.
Basal cell carcinoma develops when DNA in normal skin cells becomes damaged and the body cannot repair the damage.
Kako deluje zdravilo Erivedge Bazalnocelični karcinom nastane, ko se DNK v normalnih kožnih celicah okvari in telo ne more okvare popraviti.
• Hormonal depot injection,
• kontracepcijsko depo injekcijo,
Due to the long drug elimination half-life, these events may occur or progress after drug discontinuation.
Zaradi dolgega razpolovnega časa izločanja se lahko ta neželena učinka pojavita ali napredujeta tudi po prenehanju jemanja zdravila.
Some medicines may affect how Erivedge works, or make it more likely that you will have side effects.
Nekatera zdravila lahko vplivajo na delovanje zdravila Erivedge ali povečajo verjetnost, da se pojavijo neželeni učinki.
Other medicines and Erivedge
Druga zdravila in zdravilo Erivedge
If the patient has developed any of these reactions with the use of vismodegib, treatment with vismodegib must not be restarted in this patient at any time.
Če se je pri bolniku med uporabo vismodegiba pojavil kateri koli od teh neželenih učinkov, se pri njem zdravljenja z vismodegibom ne sme več ponovno uvesti.
In general, the tolerability of Erivedge in repeat-dose toxicity studies in rats and dogs was limited by nonspecific manifestations of toxicity including decreased body weight gain and food consumption.
Na splošno so prenašanje zdravila Erivedge v študijah toksičnosti s ponavljajočimi se odmerki pri podganah in psih omejile nespecifične manifestacije toksičnosti, vključno z zmanjšanim pridobivanjem telesne mase in manjšim uživanjem hrane.
In an embryo-foetal development study in which pregnant rats were administered vismodegib daily during organogenesis, vismodegib crossed the placenta and was severely toxic to the conceptus.
V študiji embrio-fetalnega razvoja, v kateri so brejim podganam med obdobjem organogeneze dajali vismodegib vsak dan, je vismodegib prehajal skozi placento in je bil izredno toksičen za konceptus.
The volume of distribution for vismodegib is low, ranging from 16.4 to 26.6 L. In vitro binding of vismodegib to human plasma proteins is high (97 %) at clinically relevant concentrations.
Volumen porazdelitve vismodegiba je majhen in sega od 16,4 do 26,6 l. Vezava vismodegiba na človeške plazemske beljakovine je in vitro ob klinično pomembnih koncentracijah velika (97-%).
• Women who are pregnant or breast-feeding (see sections 4.4 and 4.6).
• Nosečnice in doječe ženske (glejte poglavji 4.4 in 4.6).
• Description of the pregnancy prevention programme and categorisation of patients based on sex and childbearing potential
• opis programa preprečevanja nosečnosti in kategorizacijo bolnikov glede na spol in rodno dobo
Effects on post-natal development
Vplivi na postnatalni razvoj
If you stop taking Erivedge
Če ste prenehali jemati zdravilo Erivedge
Concomitant treatment with strong CYP inducers (e.g. rifampicin, carbamazepine or phenytoin) should be avoided, as a risk for decreased plasma concentrations and decreased efficacy of vismodegib cannot be excluded (see also section 4.5).
Treba se je izogibati sočasnemu zdravljenju z močnimi induktorji CYP (npr. rifampicinu, karbamazepinu ali fenitoinu), saj ni mogoče izključiti tveganja za znižane plazemske koncentracije in zmanjšano učinkovitost vismodegiba (glejte tudi poglavje 4.5).
Fertility impairment in human males is not expected (see Section 5.3).
Okvara plodnosti pri moških ni pričakovana (glejte poglavje 5.3).
• a change in the way things taste or the complete loss of taste,
• spremenjeno okušanje ali popolna izguba okusa, • zaprtje,
Repeat-dose toxicity
Toksičnost ponavljajočih se odmerkov
As shown in the waterfall plots in figures 1 and 2, which chart maximum reduction in target lesion(s) size for each patient, the majority of patients in both cohorts experienced tumour shrinkage as assessed by the IRF.
Kot kažeta stolpičasta diagrama na slikah 1 in 2, ki prikazujeta največje zmanjšanje ciljne lezije/ciljnih lezij za vsakega bolnika, so se tumorji po oceni IRF zmanjšali pri večini bolnikov v obeh skupinah.
Talk to your doctor or pharmacist before taking Erivedge if you have questions on the information in this section:
Preden boste vzeli zdravilo Erivedge, se posvetujte z zdravnikom ali farmacevtom, če imate vprašanja o informacijah v tem odstavku:
METHOD AND ROUTE(S) OF ADMINISTRATION Do not crush, open or chew the capsule Read the package leaflet before use Oral use
POSTOPEK IN POT(I) UPORABE ZDRAVILA Kapsul ne drobite, odpirajte ali žvečite Pred uporabo preberite priloženo navodilo peroralna uporaba
• Emergency contact phone numbers
• Kontaktne telefonske številke v primeru nujnega stanja.
Benefit of continued treatment should be regularly assessed, with the optimal duration of therapy varying for each individual patient.
Optimalno trajanje zdravljenja je različno za vsakega posameznega bolnika.
• Local contact details for reporting of any suspected pregnancy
• lokalni kontaktni podatki za poročanje ob katerem koli sumu na nosečnost
Persistent lack of menses during treatment with Erivedge should be assumed to indicate pregnancy until medical evaluation and confirmation.
Odsotnost menstruacij med zdravljenjem z zdravilom Erivedge je treba šteti za indikacijo nosečnosti do kliničnega ovrednotenja in potrditve.
• has spread to areas nearby (called “locally advanced” basal cell carcinoma) and your doctor decides that treatment with surgery or radiation is inappropriate.
• razširil v okoliške predele (takšen rak imenujemo "lokalno napredovali" bazalnocelični karcinom), zdravnik pa presodi, da zdravljenje z operacijo ali obsevanjem ni primerno.
******Cases of SCAR (including SJS/TEN, DRESS and AGEP) have been reported in patients during post-marketing use.
******O primerih hudih kožnih neželenih učinkov (vključno s SJS/TEN, DRESS in AGEP) so pri bolnikih poročali po prihodu zdravila na trg.
Population pharmacokinetic analyses suggest that age did not have a clinically significant impact on steady-state concentration of vismodegib.
Populacijske farmakokinetične analize kažejo, da starost ni klinično pomembno vplivala na koncentracijo vismodegiba v stanju dinamičnega ravnovesja.
It may also lead to the death of the unborn baby.
Povzroči lahko tudi, da še nerojeni otrok umre.
The extent to which vismodegib is excreted in breast milk is not known.
Ni znano, v kolikšni meri se vismodegib izloča v materino mleko.
Due to its potential to cause serious developmental defects women must not breast-feed while taking Erivedge and for 24 months after the final dose (see sections 4.3 and 5.3).
Ker lahko povzroči resne razvojne napake, ženske ne smejo dojiti med jemanjem zdravila Erivedge in še 24 mesecev po zadnjem odmerku tega zdravila (glejte poglavji 4.3 in 5.3).
• Periodic Safety Update Reports The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of
• Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
In clinical trials with aBCC, approximately 40 % of patients were of geriatric age (≥ 65 years).
V kliničnih preskušanjih napredovalega bazalnoceličnega karcinoma je bilo približno 40 % bolnikov geriatrične starosti (≥ 65 let).
Problems with growing teeth and bones were seen in animal studies with this medicine.
V študijah s tem zdravilom na živalih so opažali težave z rastjo zob in kosti.
As part of the Erivedge Pregnancy Prevention Programme, all patients will receive a:
V okviru Programa preprečevanja nosečnosti med uporabo zdravila Erivedge bodo vsi bolniki prejeli: knjižico za bolnika,
Prior to launch in each Member State, the Marketing Authorisation Holder (MAH) shall agree the following with the National Competent Authority:
Imetnik dovoljenja za promet se mora v vsaki državi članici pred prihodom zdravila na trg s pristojnim nacionalnim organom dogovoriti sledeče:
• She must be able to comply with effective contraceptive measures,
• mora biti sposobna zadostiti vsem zahtevam glede učinkovite kontracepcije;
Before starting the treatment, ask your doctor if you are able to become pregnant.
Pred začetkom zdravljenja se z zdravnikom posvetujte o tem, ali je mogoče, da zanosite.
The use of Erivedge in children and adolescents under the age of 18 years is not recommended.
Zdravila Erivedge ni priporočljivo uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
In vitro binding to AAG is saturable at clinically relevant concentrations.
Vezava na AAG je in vitro pri klinično pomembnih koncentracijah saturabilna.
In addition, in the vismodegib general toxicity studies up to 26-week in sexually mature rats and dogs, no effects on male reproductive organs were observed.
Poleg tega v študijah splošne toksičnosti vismodegiba na spolno zrelih psih in podganah do 26. tedna niso opazili učinkov na reproduktivne organe samcev.
• has spread to other parts of the body (called “metastatic” basal cell carcinoma)
• razširil v druge dele telesa (takšen rak imenujemo "metastatski" bazalnocelični karcinom),
Each hard capsule contains 71.5 mg lactose monohydrate per capsule.
Ena trda kapsula vsebuje 71,5 mg laktoze monohidrata na kapsulo.
If you are not sure, talk to your doctor or pharmacist before taking Erivedge.
Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom, preden boste vzeli zdravilo Erivedge.
Treatment interruptions of up to 4 weeks were allowed based on individual tolerability.
Glede na posameznikovo prenašanje zdravila so dovoljevali prekinitve zdravljenja do 4 tednov.
• The need for adequate contraceptive measures
• potreba po ustrezni kontracepcijski zaščiti
Do not use while pregnant or breast-feeding You must follow the Erivedge Pregnancy Prevention Programme
Ne uporabljajte med nosečnostjo in dojenjem Upoštevati morate Program preprečevanja nosečnosti med uporabo zdravila Erivedge
However, irreversible defects in growing teeth and premature closure of the femoral epiphyseal plate, observed in rat toxicity studies at clinically relevant exposures, represent risks to post-natal development.
Vendar pa ireverzibilne okvare v rasti zob in prezgodnje zaprtje stegnenične epifizne plošče, ki so jih v študijah toksičnosti na podganah opažali pri klinično pomembnih izpostavljenostih, pomenijo tveganje za postnatalni razvoj.
The exposure in female rats at 100 mg/kg corresponds to 1.2-fold of the steady-state AUC0-24h at the recommended human dose.
Izpostavljenost pri podganjih samicah pri odmerkih 100 mg/kg ustreza 1,2-kratniku površine pod krivuljo AUC0-24h v stanju dinamičnega ravnovesja pri priporočenem odmerku za človeka.
Vismodegib and associated metabolic products are eliminated primarily by the hepatic route.
Vismodegib in z njim povezani presnovki se odstranijo predvsem po jetrni poti.
Erivedge may cause severe birth defects.
Zdravilo Erivedge lahko povzroči hude prirojene napake.
• ezetimibe and statins , such as atorvastatin, fluvastatin, pravastatin, rosuvastatin, simvastatin used for high cholesterol,
• ezetimib in statine, kot so atorvastatin, fluvastatin, pravastatin, rosuvastatin, simvastatin uporabljajo se za zdravljenje zvišanega holesterola,
After a single oral dose, vismodegib has a terminal half-life of ca. 12 days.
Po enkratnem peroralnem odmerku ima vismodegib končni razpolovni čas približno 12 dni.
• locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy (see section 5.1).
• s simptomatskim metastatskim bazalnoceličnim karcinomom, • z lokalno napredovalim bazalnoceličnim karcinomom, neprimernim za operacijo ali radioterapijo (glejte poglavje 5.1).
HCPs must educate the patients so they understand and acknowledge all the conditions of the Erivedge Pregnancy Prevention Programme.
Zdravstveni delavci morajo bolnike poučiti tako, da razumejo in sprejmejo vse zahteve Programa za preprečevanje nosečnosti med uporabo zdravila Erivedge.
Some women taking Erivedge have stopped having periods.
Nekatere ženske, ki so jemale zdravilo Erivedge, niso imele več menstruacij.
PD = progressive disease, SD = stable disease, PR = partial response.
NB = napredovanje bolezni, SB = stabilna bolezen, DO = delni odziv.
• Do not store above 30 °C.
• Shranjujte pri temperaturi do 30 °C.
Thus inhibition of CYP enzymes by vismodegib in vivo may be excluded.
Tako lahko zaviranje encimov CYP s strani vismodegiba in vivo izključimo.
Posology The recommended dose is one 150 mg capsule taken once daily.
Odmerjanje Priporočeni odmerek je ena 150 mg kapsula enkrat na dan.
In the laBCC cohort, tumour response was assessed based on visual assessment of external tumour and ulceration, tumour imaging (where appropriate), and tumour biopsy.
V kohorti z lokalno napredovalim bazalnoceličnim karcinomom so odziv tumorja ocenjevali na podlagi vizualne ocene zunanjega tumorja in ulceracij, slikanja tumorja (kjer je bilo to ustrezno) in biopsije tumorja.
• Red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis).
• rdeč, luskast, razširjen izpuščaj s podkožnimi bulicami in mehurji, ki ga spremlja zvišana telesna temperatura ob začetku zdravljenja (akutna generalizirana eksantemska pustuloza).
• lack of energy or weakness (asthenia),
• pomanjkanje energije ali šibkost (astenija),
Erivedge is a highly permeable compound with low aqueous solubility (BCS Class 2).
Zdravilo Erivedge je zelo permeabilna spojina z majhno vodotopnostjo (razred 2 po biofarmacevtskem klasifikacijskem sistemu).
After continuous once-daily dosing, the pharmacokinetics of vismodegib appears to be nonlinear due to saturable absorption and saturable protein binding.
Po neprekinjeni uporabi enkrat na dan je farmakokinetika vismodegiba nelinearna zaradi saturabilne absorpcije in saturabilne vezave na beljakovine.
• you must take precautions so that you do not become pregnant while taking Erivedge
• morate upoštevati previdnostne ukrepe, da med jemanjem zdravila Erivedge ne boste zanosili.
In addition, in the vismodegib general 26-week toxicity study, decreased number of corpora lutea was observed at 100 mg/kg/day; the effect was not reversed by the end of an 8 week recovery period.
Poleg tega so v 26-tedenski študiji splošne toksičnosti vismodegiba pri odmerkih 100 mg/kg/dan opazili zmanjšano število rumenih telesc; učinek se do konca 8-tedenskega okrevanja ni izkazal kot reverzibilen.
What you need to know before you take Erivedge
Kaj morate vedeti, preden boste vzeli zdravilo Erivedge 3.
Metastatic BCC was defined as BCC that had spread beyond the skin to other parts of the body, including the lymph nodes, lung, bones and/or internal organs.
Metastatski bazalnocelični karcinom je bil opredeljen kot bazalnocelični karcinom, ki se je razširil iz kože v druge dele telesa, vključno z bezgavkami, pljuči, kostmi in/ali notranjimi organi.