FrancophonIA/ELRC3.0 huggingface dataset:
English: Thus inhibition of CYP enzymes by vismodegib in vivo may be excluded.
Croatian: Stoga se može isključiti inhibitorno djelovanje vismodegiba na CYP enzime in vivo.
English: Effects of vismodegib on concomitant medicinal products
Croatian: Učinci vismodegiba na istodobno primijenjene lijekove
English: 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.
Croatian: Izloženost ženki štakora nakon primjene doze od 100 mg/kg odgovara 1,2 puta većoj vrijednosti AUC0-24h u stanju dinamičke ravnoteže od one koja se postiže u ljudi nakon primjene preporučene doze.
English: Effects of concomitant medicinal products on vismodegib
Croatian: Učinci istodobno primijenjenih lijekova na vismodegib
English: Erivedge or during the 2 months after his final dose.
Croatian: Erivedge ili unutar 2 mjeseca nakon uzimanja posljednje doze.
English: • The need to provide comprehensive advice and counselling to patients
Croatian: ● mora bolesnicima pružiti detaljne informacije i savjetovati ih
English: Do not use while pregnant or breast-feeding You must follow the Erivedge Pregnancy Prevention Programme
Croatian: Lijek se ne smije uzimati tijekom trudnoće i dojenja Morate se pridržavati Programa sprječavanja trudnoće pri primjeni lijeka Erivedge
English: • Keep the bottle tightly closed in order to protect from moisture.
Croatian: ● Bocu čuvati čvrsto zatvorenu radi zaštite od vlage.
English: • Capsule contents: microcrystalline cellulose, lactose monohydrate, sodium lauril sulfate, povidone (K29/32), sodium starch glycolate (Type A), talc and magnesium stearate.
Croatian: ● Sadržaj kapsule: mikrokristalična celuloza, laktoza hidrat, natrijev laurilsulfat, povidon (K29/32), natrijev škroboglikolat (vrste A), talk i magnezijev stearat.
English: If you forget to take Erivedge Do not take a double dose to make up for a forgotten dose, but resume with the next scheduled dose.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu nego nastavite uzimati lijek po uobičajenom rasporedu.
English: Pink coloured opaque body marked “150 mg” and a grey opaque cap marked “VISMO” with black ink.
Croatian: Neprozirno tijelo ružičaste boje s oznakom “150 mg” i neprozirna kapica sive boje s oznakom “VISMO” otisnutom crnom tintom.
English: 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.
Croatian: Međutim, ireverzibilna oštećenja zuba u rastu i prijevremeno zatvaranje epifizne ploče bedrene kosti primijećeno u istraživanjima toksičnosti na štakorima pri klinički značajnim razinama izloženosti predstavljalju rizik za postnatalni razvoj.
English: In a thorough QTc study in 60 healthy subjects, there was no effect of therapeutic doses of Erivedge on the QTc interval.
Croatian: Elektrofiziologija srca U temeljitom ispitivanju QTc-intervala u 60 zdravih ispitanika nije primijećen učinak terapijskih doza lijeka Erivedge na QTc-interval.
English: • Liver injury Serious skin reactions:
Croatian: ● ozbiljne kožne reakcije:
English: Do not take Erivedge if you are pregnant, think you may be pregnant, or are planning to become pregnant during the course of treatment or during the 24 months after your final dose of this medicine.
Croatian: Nemojte uzeti Erivedge ako ste trudni, mislite da biste mogli biti trudni ili namjeravate zatrudnjeti tijekom liječenja ili unutar 24 mjeseca nakon uzimanja posljednje doze ovog lijeka.
English: The majority of patients were male (57%); 8% had mBCC whereas 92% had laBCC.
Croatian: Većina ispitanika bili su muškarci (57%): 8% ih je imalo metastatski karcinom bazalnih stanica, a 92% lokalno uznapredovali karcinom bazalnih stanica.
English: A patient was considered a responder in the laBCC cohort if at least one of the following criteria was met and the patient did not experience progression: (1) ≥ 30 % reduction in lesion size [sum of the longest diameter (SLD)], from baseline in target lesions by radiography; (2) ≥ 30 % reduction in SLD from baseline in externally visible dimension of target lesions; (3) Complete resolution of ulceration in all target lesions.
Croatian: U kohorti oboljelih od lokalno uznapredovalog karcinoma bazalnih stanica smatralo se da je bolesnik odgovorio na liječenje ako je bio zadovoljen barem jedan od sljedećih kriterija i ako u bolesnika nije došlo do progresije bolesti: (1) radiografski utvrđeno smanjenje veličine lezije za ≥ 30% [zbroj najduljih promjera] u odnosu na početnu veličinu ciljnih lezija; (2) smanjenje zbroja najduljih promjera vidljivog vanjskog dijela ciljnih lezija za ≥ 30% u odnosu na početne vrijednosti; (3) potpuno povlačenje ulceracije u svim ciljnim lezijama.
English: • Safety advice for men
Croatian: ● savjete o sigurnosti primjene za muškarce
English: • The need for the patient to report immediately to the treating healthcare professional if his partner becomes pregnant whilst he is taking Erivedge or shortly after he has stopped taking Erivedge
Croatian: ● bolesnik mora odmah prijaviti zdravstvenome radniku ako je njegova partnerica zanijela dok on uzima Erivedge ili ubrzo nakon što je prestao uzimati Erivedge
English: • Brief background on Erivedge, its licensed indication and posology
Croatian: ● osnovne podatke o lijeku Erivedge, odobrenoj indikaciji i doziranju
English: The patient educational material for Erivedge should contain the following key elements:
Croatian: Edukacijski materijal za bolesnika za Erivedge mora sadržavati sljedeće ključne elemente:
English: LaBCC was defined as cutaneous lesions that were inappropriate for surgery (inoperable, or for whom surgery would result in substantial deformity) and for which radiotherapy was unsuccessful or contraindicated.
Croatian: Lokalno uznapredovali karcinom bazalnih stanica definirao se kao kožne lezije koje nisu bile pogodne za kirurško liječenje (inoperabilne ili kod kojih bi kirurški zahvat rezultirao znatnom deformacijom), a kod kojih je radioterapija je bila neuspješna ili kontraindicirana.
English: You must tell your doctor immediately during the course of treatment or during the 24 months after your final dose of this medicine if:
Croatian: Morate odmah obavijestiti svoga liječnika tijekom liječenja ili unutar 24 mjeseca nakon uzimanja posljednje doze ovoga lijeka:
English: In the same study there were no histopathological findings in male reproductive organs and no effects on male fertility endpoints, including percent motile sperm, observed at 100 mg/kg/day at the end of dosing or recovery phase (corresponding to 1.3-fold of the steady-state AUC0-24h at the recommended human dose).
Croatian: U istom ispitivanju, na kraju razdoblja doziranja i oporavka nije bilo histopatoloških nalaza na reproduktivnim organima mužjaka i nisu primijećeni učinci na mjere ishoda za plodnost mužjaka, uključujući postotak pokretljivih spermija, kada se primjenjivala doza od 100 mg/kg/dan (kojom se postizao AUC0-24h u stanju dinamičke ravnoteže 1,3 puta veći nego nakon primjene preporučene doze u ljudi).
English: Patients with severe renal impairment should be carefully monitored for adverse reactions.
Croatian: Bolesnike s teškim oštećenjem bubrežne funkcije potrebno je pažljivo pratiti kako bi se uočile eventualne nuspojave.
English: Very limited data is available in patients with severe renal impairment.
Croatian: Dostupni su vrlo ograničeni podaci o primjeni u bolesnika s teškim oštećenjem bubrežne funkcije.
English: • She must have a negative pregnancy test, conducted by a health care provider within 7 days before starting Erivedge treatment,
Croatian: ● mora imati negativan nalaz testa na trudnoću koji provodi zdravstveni djelatnik unutar 7 dana prije početka liječenja lijekom Erivedge,
English: 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).
Croatian: Budući da Erivedge može izazvati teška razvojna oštećenja, žene ne smiju dojiti tijekom liječenja ni 24 mjeseca nakon uzimanja posljednje doze lijeka (vidjeti dijelove 4.3 i 5.3).
English: In a clinical study in patients with hepatic impairment (degree of impairment based on subject's AST and total bilirubin levels) following multiple doses of vismodegib, it was shown that in patients with mild (NCI-ODWG criteria, n=8), moderate (NCI-ODWG criteria, n=6), and severe (NCI-ODWG criteria, n=3) hepatic impairment, the pharmacokinetic profile of vismodegib was comparable to that of subjects with normal hepatic function (n=9) (see section 4.2).
Croatian: Nakon primjene višestrukih doza vismodegiba u kliničkom ispitivanju u kojem su sudjelovali bolesnici s oštećenjem jetrene funkcije (stupanj oštećenja određivao se na temelju ispitanikovih razina ALT-a i ukupnog bilirubina) utvrđeno je da je farmakokinetički profil vismodegiba u bolesnika s blagim (prema NCI ODWG kriterijima, n=8), umjerenim (prema NCI-ODWG kriterijima, n=6) i teškim (prema NCI-ODWG kriterijima, n=3) oštećenjem jetrene funkcije bio usporediv s onim viđenim u ispitanika s normalnom jetrenom funkcijom (n=9) (vidjeti dio 4.2).
English: Of patients who had a confirmed response (partial or complete), the median Duration of Response was 23.0 months (95% CI: 20.4, 26.7) in the laBCC cohort and 13.9 months (95% CI: 9.2, NE) in the mBCC cohort.
Croatian: Kod bolesnika s potvrđenim odgovorom (djelomičnim ili potpunim), medijan trajanja odgovora iznosio je 23,0 mjeseci (95% CI: 20,4; 26,7) u kohorti s lokalno uznapredovalim karcinomom bazalnih stanica te 13,9 mjeseci (95% CI: 9,2; NP) u kohorti s metastatskim karcinomom bazalnih stanica.
English: Reversibility of fertility impairment is unknown.
Croatian: Nije poznato je li smanjenje plodnosti reverzibilno.
English: Seven cases of severe cutaneous adverse reactions (SCARs) have been reported in association with vismodegib cumulatively.
Croatian: Ukupno je prijavljeno sedam slučajeva teških kožnih reakcija povezanih s primjenom vismodegiba.
English: All reporting is based on ADRs of all grades using National Cancer Institute - Common Terminology Criteria for Adverse Events v 3.0 except where noted.
Croatian: Sve prijave temelje se na nuspojavama lijeka bilo kojeg stupnja prema verziji 3.0 Općih terminoloških kriterija za nuspojave Nacionalnog instituta za rak, osim ako nije drugačije navedeno.
English: Carcinogenic potential was identified in rats only and was limited to benign hair follicle tumors, including pilomatricomas and keratoacanthomas respectively at ≥ 0.1-fold and ≥0.6-fold of the steady-state AUC(0-24h) of the recommended human dose.
Croatian: Kancerogeni potencijal utvrđen je samo u štakora, a bio je ograničen na dobroćudne tumore folikula dlake, uključujući pilomatriksome i keratoakantome pri razini izloženosti od ≥ 0,1 puta odnosno ≥ 0,6 puta vrijednosti AUC(0-24h) u stanju dinamičke ravnoteže nakon primjene preporučene doze za ljude.
English: Decreased haematocrit or platelet count were observed in some dogs at clinically relevant exposures; however, there was no evidence of a primary effect on bone marrow in affected animals.
Croatian: U nekih je pasa kod klinički značajnih razina izloženosti primijećena smanjena vrijednost hematokrita ili smanjen broj trombocita; međutim, u tih životinja nije bilo dokaza primarnog učinka na koštanu srž.
English: Excipients Erivedge capsules contain lactose monohydrate.
Croatian: Erivedge kapsule sadrže laktozu hidrat.
English: What Erivedge is Erivedge is an anti-cancer medicine and contains the active substance vismodegib.
Croatian: Što je Erivedge Erivedge je lijek za liječenje raka koji sadrži djelatnu tvar vismodegib.
English: Any unused capsules at the end of treatment should immediately be disposed of by the patient in accordance with local requirements (if applicable, e.g. by returning the capsules to their pharmacist or physician).
Croatian: Nakon završetka liječenja bolesnik mora neiskorištene kapsule odmah zbrinuti sukladno lokalnim propisima (ako je primjenjivo, npr. vratiti kapsule svome ljekarniku ili liječniku).
English: Therefore, mild and moderate renal impairment is unlikely to have a clinically significant effect on the pharmacokinetics of vismodegib.
Croatian: Stoga nije vjerojatno da će blago i umjereno oštećenje bubrežne funkcije imati klinički značajnog utjecaja na farmakokinetiku vismodegiba.
English: • Do not use this medicine after the expiry date, which is stated on the bottle and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci i kutiji iza oznake ‘Rok valjanosti'.
English: Additionally, amenorrhoea has been observed in clinical trials in WCBP (see section 4.8).
Croatian: Osim toga, u kliničkim ispitivanjima u kojima su sudjelovale žene generativne dobi primijećena je amenoreja (vidjeti dio 4.8).
English: In animal species, vismodegib has been shown to cause severe irreversible changes in growing teeth (degeneration/necrosis of odontoblasts, formation of fluid-filled cysts in the dental pulp, ossification of the root canal, and haemorrhage) and closure of the epiphyseal growth plate.
Croatian: U životinjskih vrsta vismodegib uzrokuje teške ireverzibilne promjene zuba u razvoju (degeneracija/nekroza odontoblasta, nastanak cista ispunjenih tekućinom u zubnoj pulpi, okoštavanje korijenskog kanala i krvarenje) te zatvaranje epifizne ploče rasta.
English: • Distribution of the product
Croatian: ● distribuciju lijeka
English: • Widespread rash, fever, and enlarged lymph nodes (DRESS-syndrome or drug hypersensitivity syndrome).
Croatian: ● proširen osip, vrućica i povećani limfni čvorovi (DRESS ili sindrom preosjetljivosti na lijek)
English: • That the patient should tell the healthcare professional about any adverse event
Croatian: ● napomenu da bolesnik mora obavijestiti zdravstvenoga radnika o bilo kojoj nuspojavi
English: Drug induced liver injury*****
Croatian: oštećenje jetre uzrokovano lijekom*****
English: • To ensure that patients are capable of complying with the requirements for the safe use of Erivedge
Croatian: ● mora se pobrinuti da se bolesnici mogu pridržavati uvjeta za sigurnu primjenu lijeka
English: HCPs must educate the patients so they understand and acknowledge all the conditions of the Erivedge Pregnancy Prevention Programme.
Croatian: Zdravstveni radnici moraju educirati bolesnike kako bi oni razumjeli i prihvatili sve uvjete
English: In the dedicated 26-week vismodegib rat fertility study, vismodegib-related effects on female reproductive organs were observed at 100 mg/kg/day immediately after treatment discontinuation, including decreased implantations, increased percent preimplantation loss, and decreased number of dams with viable embryos.
Croatian: U posebnom 26-tjednom ispitivanju utjecaja vismodegiba na plodnost štakora, neposredno nakon prekida primjene doze od 100 mg/kg/dan primijećeni su učinci na reproduktivne organe ženki povezani s vismodegibom, uključujući smanjen broj implantacija, povećan postotak gubitka zametaka prije implantacije i smanjen broj ženki s vijabilnim zamecima.
English: However, results of a drug-drug interaction study conducted in cancer patients demonstrated that the systemic exposure of rosiglitazone (a CYP2C8 substrate) is not altered when co-administered with vismodegib.
Croatian: Međutim, rezultati ispitivanja interakcija lijekova provedenog u onkoloških bolesnika pokazali su da se sistemska izloženost roziglitazonu (supstratu CYP2C8) ne mijenja pri istodobnoj primjeni s vismodegibom.
English: • Information for women of childbearing potential
Croatian: ● informacije za žene generativne dobi
English: Vismodegib is slowly eliminated by a combination of metabolism and excretion of parent drug substance.
Croatian: Vismodegib se eliminira polako kombinacijom metabolizma i izlučivanja osnovnog spoja.
English: A WCBP must understand that:
Croatian: Žena generativne dobi mora znati da:
English: LaBCC patients had cutaneous lesions that were inappropriate for surgery (inoperable, multiply recurrent where curative resection deemed to be unlikely or for whom surgery would result in substantial deformity or morbidity) and for which radiotherapy was unsuccessful or contraindicated or inappropriate.
Croatian: Bolesnici s lokalno uznapredovalim karcinomom bazalnih stanica imali su kožne lezije koje nisu bile kirurški lječive (inoperabilne, višestruko recidivirajuće lezije kod kojih se kurativna resekcija ne smatra vjerojatnom ili kod kojih bi kirurški zahvat rezultirao znatnom deformacijom ili bolešću), a radioterapija je bila neuspješna, kontraindicirana ili neprihvatljiva.
English: • Capsule shell: iron oxide red (E172), iron oxide black (E172), titanium dioxide, gelatine,
Croatian: Ovojnica kapsule: crveni željezov oksid (E172), crni željezov oksid (E172), titanijev dioksid, želatina
English: The safety of Erivedge has been evaluated in clinical trials with 138 patients treated for advanced basal cell carcinoma (aBCC), which includes both metastatic BCC (mBCC) and locally advanced BCC (laBCC).
Croatian: Sigurnost lijeka Erivedge procijenjena je u kliničkim ispitivanjima u kojima je sudjelovalo 138 bolesnika liječenih zbog uznapredovalog karcinoma bazalnih stanica, koji uključuje i metastatski karcinom bazalnih stanica i lokalno uznapredovali karcinom bazalnih stanica.
English: This medicine contains less than 1 mmol sodium (23 mg) per capsule, i.e. essentially ‘sodium free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po kapsuli, tj. zanemarive količine natrija.
English: • The need to use condoms when having sex with a female partner
Croatian: ● bolesnici moraju koristiti prezervative pri spolnom odnosu s partnericom
English: This is because it is unknown whether Erivedge can pass into your milk and cause harm to your baby.
Croatian: Naime, nije poznato može li se Erivedge izlučivati u majčino mlijeko i tako naškoditi Vašem djetetu.
English: PHARMACEUTICAL FORM AND CONTENTS 28 capsules
Croatian: 28 kapsula
English: Results of a drug-drug interaction study conducted in cancer patients demonstrated that the systemic exposure of ethinyl estradiol and norethindrone is not altered when co-administered with vismodegib.
Croatian: Rezultati ispitivanja interakcija lijekova provedenog u onkoloških bolesnika pokazali su da se sistemska izloženost etinilestradiolu i noretindronu ne mijenja kod istodobne primjene s vismodegibom.
English: • The need to refer the patient to a specialist physician
Croatian: ● bolesnicu uputiti liječniku specijalistu
English: Therefore, all patients should be monitored routinely while taking Erivedge, and cuSCC should be treated according to the standard of care.
Croatian: Stoga je tijekom liječenja lijekom Erivedge sve bolesnike potrebno rutinski pratiti, a planocelularni karcinom kože liječiti sukladno zdravstvenim standardima.
English: • you think your contraception has failed for any reason,
Croatian: ● ako mislite da je zaštita od trudnoće iz bilo kojega razloga zakazala,
English: • Bones stop growing (epiphyses premature fusion)
Croatian: Nepoznato ● prestanak rasta kostiju (preuranjeno spajanje epifiza)
English: In the dedicated 26-week vismodegib rat fertility study, significantly increased absolute weights of seminal vesicles and reduced absolute weights of prostate were observed.
Croatian: U posebnom 26-tjednom ispitivanju utjecaja vismodegiba na plodnost štakora, primijećeno je značajno povećanje apsolutne težine sjemenih vrećica i smanjenje apsolutne težine prostate.
English: Problems with growing teeth and bones were seen in animal studies with this medicine.
Croatian: U ispitivanjima ovog lijeka na životinjama primijećene su tegobe sa zubima i kostima u razvoju.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. zanemarive količine natrija.
English: Complete response was achieved in 4.8% patients in the mBCC cohort and 33.4% in the laBCC cohort.
Croatian: Potpun odgovor postiglo je 4,8% bolesnika u kohorti s metastatskim karcinomom bazalnih stanica i 33,4% bolesnika u kohorti s lokalno uznapredovalim karcinomom bazalnih stanica.
English: Patients were treated with oral daily dosing of Erivedge at 150 mg.
Croatian: Bolesnici su liječeni lijekom Erivedge u peroralnoj dozi od 150 mg na dan.
English: • Not to give Erivedge to any other person
Croatian: ● upozorenje da bolesnik ne smije dati Erivedge drugoj osobi
English: Do this during treatment and for 2 months after your final dose of this medicine.
Croatian: Pridržavajte se toga tijekom liječenja i 2 mjeseca nakon uzimanja posljednje doze ovoga lijeka.
English: NE = not estimable * Efficacy-evaluable patient population is defined as all enrolled patients who received any amount of Erivedge and for whom the independent pathologist's interpretation of archival tissue or baseline biopsy was consistent with BCC.
Croatian: NP = ne može se procijeniti * Populaciju bolesnika u kojih je bilo moguće procijeniti djelotvornost čine svi uključeni bolesnici koji su primili bilo koju količinu lijeka Erivedge i u kojih je interpretacija pohranjenih uzoraka tkiva ili biopsije na početku liječenja od strane neovisnog patologa bila sukladna nalazu karcinoma bazalnih stanica.
English: Hedgehog pathway inhibitors (see section 5.1) such as vismodegib, have been demonstrated to be embryotoxic and/or teratogenic in multiple animal species and can cause severe malformations, including craniofacial anomalies, midline defects and limb defects (see section 5.3).
Croatian: Pokazalo se da su inhibitori signalnog puta Hedgehog (vidjeti dio 5.1), poput vismodegiba, embriotoksični i/ili teratogeni u brojnih životinjskih vrsta te mogu uzrokovati teške malformacije, uključujući kraniofacijalne anomalije, oštećenja središnje linije i oštećenja ekstremiteta (vidjeti dio 5.3).
English: Partial response was achieved in 32.1% patients in the mBCC cohort and 35.1% in the laBCC cohort.
Croatian: Djelomičan odgovor postiglo je 32,1% bolesnika u kohorti s metastatskim karcinomom bazalnih stanica i 35,1% bolesnika u kohorti s lokalno uznapredovalim karcinomom bazalnih stanica.
English: Patients with Gorlin syndrome who had at least one aBCC lesion and met inclusion criteria were eligible to participate in the study.
Croatian: U ispitivanju su mogli sudjelovati bolesnici s Gorlinovim sindromom koji su imali barem jednu leziju uznapredovalog karcinoma bazalnih stanica i koji su zadovoljavali kriterije za uključivanje.
English: Erivedge is unlikely to affect your ability to drive, use any tools or machines.
Croatian: Nije vjerojatno da bi Erivedge mogao utjecati na sposobnost upravljanja vozilima, rukovanja alatima ili rada sa strojevima.
English: WCBP must be able to comply with effective contraceptive measures.
Croatian: Žena generativne dobi mora biti u stanju pridržavati se djelotvornih mjera kontracepcije.
English: • if you are pregnant, think you may be pregnant, or are planning to become pregnant during the course of treatment or during the 24 months after your final dose of this medicine.
Croatian: ● ako ste trudni, mislite da biste mogli biti trudni ili planirate zatrudnjeti tijekom liječenja ili unutar 24 mjeseca nakon uzimanja posljednje doze ovog lijeka.
English: • Your doctor should check your skin regularly for a type of cancer called “cutaneous squamous cell carcinoma' (SCC).
Croatian: Liječnik bi Vam trebao redovito pregledavati kožu za slučaj da se razvije jedna vrsta raka koji se naziva „karcinom kože pločastih stanica“.
English: 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
Croatian: Prijenos signala signalnim putom Hedgehog preko transmembranskog proteina Smoothened (SMO) dovodi do aktivacije transkripcijskih čimbenika onkogena eksprimiranih u gliomima (GLI) i njihova premještanja u jezgru te indukcije ciljnih gena signalnog puta Hedgehog.
English: Vismodegib binds to and inhibits the SMO protein thereby blocking Hedgehog signal transduction.
Croatian: Vismodegib se veže za protein SMO i inhibira ga, blokirajući tako prijenos signala signalnim putom Hedgehog.