FrancophonIA/ELRC3.0 huggingface dataset:
English: • Any male condom (with spermicide, if available),
Croatian: ● bilo koji prezervativ za muškarce (po mogućnosti sa spermicidom),
English: Additionally, safety was assessed in a post approval study that included 1215 aBCC patients evaluable for safety and treated with 150 mg.
Croatian: Osim toga, sigurnost je ocijenjena i u ispitivanju nakon dobivanja odobrenja koje je uključilo 1215 bolesnika s uznapredovalim karcinomom bazalnih stanica koji su liječeni dozom od 150 mg i u kojih je bilo moguće ocijeniti sigurnost primjene.
English: How to take Erivedge
Croatian: Kako čuvati Erivedge
English: • muscle, tendon, ligament, bone pain,
Croatian: ● bol u mišićima, tetivama, ligamentima ili kostima,
English: This is because Erivedge may harm or cause the death of your unborn baby.
Croatian: Naime, Erivedge može naškoditi nerođenu djetetu ili prouzročiti njegovu smrt.
English: It is not known if SCC is related to treatment with Erivedge.
Croatian: Nije poznato je li karcinom kože pločastih stanica povezan s liječenjem lijekom Erivedge.
English: Table 1 ADRs occurring in patients treated with Erivedge MedDRA SOC Very common
Croatian: Tablica 1 Nuspojave koje se javljaju u bolesnika liječenih lijekom Erivedge MedDRA organski sustav
English: **54 % of laBCC patients had no histopathologic evidence of BCC at 24 weeks.
Croatian: **U 54% bolesnika s lokalno uznapredovalim karcinomom bazalnih stanica u 24. tjednu nisu pronađeni histopatološki dokazi karcinoma bazalnih stanica
English: The MAH shall distribute a Direct Healthcare Professional Communication letter at launch of the product, which should contain the following:
Croatian: Nositelj odobrenja će prilikom stavljanja lijeka u promet distribuirati pismo za zdravstvene radnike koje mora sadržavati sljedeće:
English: Among patients in the efficacy-evaluable population with measurable and histologically confirmed disease, 68.5% and 36.9% responded to treatment in the laBCC and mBCC cohorts, respectively, by RECIST v1.1.
Croatian: Među bolesnicima u populaciji s mjerljivom i histološki potvrđenom bolešću u kojoj se mogla ocijeniti djelotvornost, prema verziji 1.1 RECIST kriterija na liječenje je odgovorilo 68,5% bolesnika s lokalno uznapredovalim karcinomom bazalnih stanica i 36,9% bolesnika s metastatskim karcinomom bazalnih stanica.
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA
English: What Erivedge is used for
Croatian: Za što se koristi Erivedge
English: To avoid potential foetal exposure during pregnancy, male patients must always use a condom (with spermicide, if available), even after a vasectomy, when having sex with a female partner while taking Erivedge and for 2 months after the final dose.
Croatian: Da bi se izbjegla moguća izloženost ploda lijeku za vrijeme trudnoće, bolesnici moraju tijekom liječenja lijekom Erivedge i 2 mjeseca nakon uzimanja posljednje doze lijeka koristiti prezervativ (po mogućnosti sa spermicidom) uvijek kada imaju spolni odnos s partnericom, čak i ako su se prije toga podvrgnuli vazektomiji.
English: The median age of the efficacy evaluable population was 62 years (46 % were at least 65 years old), 61 % male and 100 % White.
Croatian: Medijan dobi populacije u kojoj se mogla ocijeniti djelotvornost iznosio je 62 godine (46% bolesnika imalo je najmanje 65 godina).
English: For health care providers (HCP)
Croatian: Za zdravstvene djelatnike
English: • Methodology to collect information on the use of Erivedge and the compliance with the pregnancy pharmacovigilance programme and its effectiveness
Croatian: ● metode za prikupljanje podataka o primjeni lijeka Erivedge i o pridržavanju programa praćenja nuspojava vezanih uz trudnoću te njegovoj učinkovitosti
English: ADRs are presented in table 1 below by system organ class (SOC) and absolute frequency.
Croatian: Nuspojave lijeka prikazane su u nastavku u Tablici 1 prema klasifikaciji organskih sustava i apsolutnoj učestalosti.
English: • The healthcare professional should report confirmed pregnancies to the MAH
Croatian: ● zdravstveni radnik mora potvrđene trudnoće prijaviti nositelju odobrenja
English: Human female fertility may be compromised by treatment with Erivedge (see section 5.3).
Croatian: Liječenje lijekom Erivedge može dovesti do smanjenja plodnosti u žena (vidjeti dio 5.3).
English: In the laBCC cohort, tumour response was assessed based on visual assessment of external tumour and ulceration, tumour imaging (where appropriate), and tumour biopsy.
Croatian: U kohorti bolesnika oboljelih od lokalno uznapredovalog karcinoma bazalnih stanica tumorski je odgovor procijenjen na temelju vizualne procjene vidljivog dijela tumora i ulceracije, slikovnog prikaza (po potrebi) i biopsije tumora.
English: • Pregnancy reporting form
Croatian: ● obrazac za prijavu trudnoće
English: • The need to provide patients with the patient educational material and patient reminder cards
Croatian: Erivedge ● mora bolesnicima dati edukacijski materijal i karticu-podsjetnik za bolesnika
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU
English: Always use a condom (with spermicide, if available) even after a vasectomy, when you have sex with a female partner.
Croatian: Uvijek koristite prezervativ (po mogućnosti sa spermicidom) kada imate spolni odnos s partnericom, čak i ako ste se prethodno podvrgnuli vazektomiji.
English: • becomes amenorrhoeic following cancer therapy, including treatment with Erivedge.
Croatian: ● u koje nakon antitumorskog liječenja, uključujući liječenje lijekom Erivedge, nastupi amenoreja.
English: • Description of the patient reminder card
Croatian: ● opis kartice s podsjetnikom za bolesnika
English: The healthcare professional's reminder card should contain the following key elements
Croatian: Podsjetnik za zdravstvene radnike mora sadržavati sljedeće ključne elemente
English: • Information on the disposal of unwanted medication
Croatian: ● informacije o odlaganju lijeka koji bolesniku više ne treba
English: For men
Croatian: Za muškarce
English: • symptomatic metastatic basal cell carcinoma
Croatian: ● simptomatskim metastatskim karcinomom bazalnih stanica
English: • The need to contact the healthcare professional immediately if a pregnancy is suspected during treatment or in the 24 months following treatment
Croatian: ● bolesnice moraju odmah obavijestiti zdravstvenoga radnika ako posumnjaju na trudnoću tijekom liječenja ili unutar 24 mjeseca po njegovu završetku
English: • The need to tell patients to report immediately to the treating healthcare professional if pregnancy is suspected in a female patient, or in a female partner of a male patient
Croatian: ● bolesnike je potrebno upozoriti da nadležnome zdravstvenom radniku odmah prijave sumnju na trudnoću u bolesnica ženskoga spola ili partnerica bolesnika muškoga spola
English: Figure 1 SHH4476g Metastatic BCC Cohort
Croatian: Slika 1 SHH4476g Kohorta bolesnika s metastatskim karcinomom bazalnih stanica
English: The patient reminder card should contain the following key elements:
Croatian: Kartica podsjetnik za bolesnika mora sadržavati sljedeće ključne elemente:
English: In the mBCC cohort, tumour response was assessed according to the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.0.
Croatian: Kriterija za procjenu odgovora kod solidnih tumora (RECIST kriteriji).
English: According to investigator assessment, the median time to maximum tumour reduction occurred in 6.7 and 5.5 months for laBCC and mBCC patients respectively.
Croatian: Prema procjeni ispitivača, medijan vremena do maksimalnog smanjenja veličine tumora iznosio je 6,7 mjeseci u bolesnika s lokalno uznapredovalim karcinomom bazalnih stanica i 5,5 mjeseci u bolesnika s metastatskim karcinomom bazalnih stanica.
English: Patients with advanced BCC have an increased risk of developing cuSCC.
Croatian: U bolesnika s uznapredovalim karcinomom bazalnih stanica postoji povećan rizik od razvoja planocelularnog karcinoma kože.
English: • Safety advice for women of childbearing potential
Croatian: ● savjete o sigurnosti primjene za žene generativne dobi
English: What Erivedge looks like and contents of the pack The capsules have a pink opaque coloured body marked “150 mg” and a grey cap marked "VISMO” in black edible ink.
Croatian: Kapsule imaju neprozirno tijelo ružičaste boje s oznakom “150 mg” i sivu kapicu s oznakom “VISMO” otisnutom jestivom crnom tintom.
English: How Erivedge works
Croatian: Kako djeluje Erivedge
English: METHOD AND ROUTE(S) OF ADMINISTRATION Do not crush, open or chew the capsule Read the package leaflet before use Oral use
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Kapsule nemojte drobiti, otvarati ni žvakati
English: • The active substance is vismodegib.
Croatian: Djelatna tvar je vismodegib.
English: In four open label phase 1 and 2 clinical trials patients were treated with at least one dose of Erivedge monotherapy at doses ≥ 150 mg. Doses > 150 mg did not result in higher plasma concentrations in clinical trials and patients on doses > 150 mg have been included in the analysis.
Croatian: U kliničkim ispitivanjima doze > 150 mg nisu rezultirale višom koncentracijom lijeka u plazmi, a bolesnici koji su primali doze > 150 mg uključeni su u analizu.
English: • Keep this medicine out of the sight and reach of children.
Croatian: Lijek čuvajte izvan pogleda i dohvata djece.
English: • 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
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: No dose adjustment is required in patients with mild, moderate or severe hepatic impairment defined based on National Cancer Institute Organ Dysfunction Working Group (NCI-ODWG)- criteria for hepatic impairment:
Croatian: Oštećenje jetrene funkcije Nije potrebno prilagođavati dozu u bolesnika s blagim, umjerenim ili teškim oštećenjem jetrene funkcije definiranim prema kriterijima za oštećenje jetrene funkcije Radne skupine za disfunkciju organa Nacionalnog instituta za rak (engl.
English: The major elimination pathways of vismodegib involve hepatic metabolism and biliary/intestinal secretion.
Croatian: Glavni putovi eliminacije vismodegiba uključuju jetreni metabolizam i izlučivanje kroz žuč/crijeva.
English: • moderate: 1.5 x ULN < TB < 3 x ULN, AST any
Croatian: ● umjereno: 1,5 x GGN < UB < 3 x GGN, uz bilo koju vrijednost AST-a
English: In vitro binding to AAG is saturable at clinically relevant concentrations.
Croatian: Pri klinički značajnim koncentracijama in vitro vezivanje za AAG je saturabilno.
English: • mild:total bilirubin (TB) ≤ upper limit of normal (ULN), aspartate aminotransferase
Croatian: ● blago: ukupan bilirubin (UB) ≤ gornja granica normale (GGN), aspartat aminotransferaza (AST) > GGN ili GGN<UB≤ 1,5 x GGN, uz bilo koju vrijednost AST-a
English: • severe: 3 x ULN < TB < 10 x ULN, AST any
Croatian: ● teško: 3 x GGN < UB < 10 x GGN, uz bilo koju vrijednost AST-a
English: • A requirement to inform patients of the teratogenic risks associated with Erivedge and the need to avoid foetal exposure
Croatian: ● zahtjev da bolesnike treba informirati o teratogenim rizicima povezanima s lijekom Erivedge te o potrebi da se izbjegne izloženost ploda
English: Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and Acute Generalised Exanthematous Pustulosis (AGEP)******
Croatian: (TEN), reakcija na lijek praćena eozinofilijom i sistemskim simptomima (DRESS) i akutna generalizirana egzantematozna pustuloza (AGEP)******
English: Figure 2 SHH4476g Locally Advanced BCC Cohort
Croatian: SHH4476g Kohorta bolesnika s lokalno uznapredovalim karcinomom bazalnih stanica
English: Male patients must always use a condom (with spermicide, if available), even after a vasectomy, when having sex with a female partner while taking Erivedge and for 2 months after the final dose (see section 4.6).
Croatian: Bolesnici moraju tijekom liječenja lijekom Erivedge i 2 mjeseca nakon uzimanja posljednje doze lijeka koristiti prezervativ (po mogućnosti sa spermicidom) uvijek kada imaju spolni odnos s partnericom, čak i ako su se prije toga podvrgnuli vazektomiji (vidjeti dio 4.6).
English: • She must tell her healthcare provider if any of the following occur during treatment and for 24 months after her final dose:
Croatian: ● mora obavijestiti zdravstvenog djelatnika ako se tijekom liječenja ili unutar 24 mjeseca nakon uzimanja posljednje doze dogodi nešto od sljedećeg:
English: • Printing ink: shellac glaze and iron oxide black (E172).
Croatian: Tinta za označivanje: šelak glazura i crni željezov oksid (E172).
English: • Women of childbearing potential who do not comply with the Erivedge Pregnancy Prevention
Croatian: Žene generativne dobi koje se ne pridržavaju Programa sprječavanja trudnoće pri primjeni lijeka
English: Female patients must use two methods of recommended contraception including one highly effective method and a barrier method during Erivedge therapy and for 24 months after the final dose (see section 4.6).
Croatian: Bolesnice moraju tijekom liječenja lijekom Erivedge i 24 mjeseca nakon uzimanja posljednje doze lijeka primjenjivati dvije metode preporučene kontracepcije, jednu metodu visoke učinkovitosti i jednu metodu barijere (vidjeti dio 4.6).
English: Under clinically relevant conditions (steady state), the PK of vismodegib is not affected by food.
Croatian: U klinički značajnim uvjetima (stanje dinamičke ravnoteže) hrana ne utječe na farmakokinetiku vismodegiba, pa se Erivedge može uzimati neovisno o obrocima.
English: • The need for adequate contraceptive measures (even if the woman has amenorrhoea) during treatment and for 24 months after Erivedge treatment
Croatian: ● bolesnica mora primjenjivati odgovarajuće kontracepcijske mjere (čak i ako ima amenoreju) tijekom liječenja lijekom Erivedge i 24 mjeseca po njegovu završetku
English: • Erivedge exposes a teratogenic risk to the unborn child if he engages in unprotected sexual activity with a pregnant woman,
Croatian: ● ako se upusti u nezaštićen spolni odnos s trudnicom, Erivedge može biti teratogen za nerođeno dijete,
English: Median Duration of Response (months) (95 % CI)
Croatian: Medijan trajanja odgovora (mjeseci)
English: At least one case of Stevens-Johnson syndrome/Toxic epidermal necrolysis (SJS/TEN), 2 cases of Drug reaction with eosinophilia and systemic symptoms (DRESS) and one case of acute generalised exanthematous pustulosis (AGEP) are causally related to the treatment, based on clinical and pathological features, and the compatible temporal relationship.
Croatian: S obzirom na njihove kliničke i patološke značajke te kompatibilnu vremensku povezanost, najmanje jedan slučaj Stevens-Johnsonova sindroma/toksične epidermalne nekrolize (SJS/TEN), 2 slučaja reakcije na lijek praćene eozinofilijom i sistemskim simptomima (DRESS) te jedan slučaj akutne generalizirane egzantematozne pustuloze (AGEP) uzročno su povezani s liječenjem.
English: Nervous system disorder
Croatian: Oštećenje bubrežne funkcije
English: Metabolism and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane smanjen apetit dehidracija
English: • The need for the patient to report a suspected pregnancy immediately to the treating healthcare professional
Croatian: ● bolesnica mora sumnju na trudnoću odmah prijaviti nadležnome zdravstvenom radniku
English: • The need for monthly pregnancy tests even if the patient has amenorrhoea
Croatian: ● bolesnice moraju svaki mjesec raditi test na trudnoću, čak i ako imaju amenoreju
English: It may lead to the death of a baby before it is born or shortly after being born.
Croatian: Erivedge može izazvati teške prirođene mane i prouzročiti smrt djeteta prije njegova rođenja ili ubrzo po rođenju.
English: Each hard capsule contains 150 mg of vismodegib.
Croatian: Jedna tvrda kapsula sadrži 150 mg vismodegiba.
English: Within each frequency grouping, ADRs are presented in the order of decreasing seriousness.
Croatian: Unutar iste skupine učestalosti nuspojave na lijek su prikazane od najozbiljnijih prema manje ozbiljnima.
English: † Unevaluable/missing data included 1 mBCC and 4 laBCC patients.
Croatian: † Podaci koji se ne mogu procijeniti/podaci koji nedostaju obuhvaćaju 1 bolesnika s metastatskim karcinomom bazalnih stanica i 4 bolesnika s lokalno uznapredovalim karcinomom bazalnih stanica.
English: Erivedge is contraindicated in WCBP who do not comply with the Erivedge Pregnancy Prevention Programme.
Croatian: Erivedge je kontraindiciran u žena generativne dobi koje se ne pridržavaju Programa sprječavanja trudnoće pri primjeni lijeka Erivedge.
English: Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Germany
Croatian: Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Njemačka
English: No increases in plasma vismodegib levels or toxicity were observed during these clinical trials.
Croatian: U tim kliničkim ispitivanjima nisu primijećene povišene koncentracije vismodegiba u plazmi, kao ni povećanje toksičnosti.
English: NAME OF THE MEDICINAL PRODUCT Erivedge 150 mg hard capsules
Croatian: NAZIV LIJEKA Erivedge 150 mg tvrde kapsule
English: Severe cutaneous adverse reactions (SCARs) including cases of Stevens-Johnson syndrome/Toxic epidermal necrolysis (SJS/TEN), Drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP), which can be life-threatening, have been reported during post-marketing use (see section 4.8).
Croatian: Nakon stavljanja lijeka na tržište zabilježene su teške kožne nuspojave, uključujući slučajeve Stevens-Johnsonova sindroma/toksične epidermalne nekrolize (SJS/TEN), reakcije na lijek praćene eozinofilijom i sistemskim simptomima (engl. drug reaction with eosinophilia and systemic symptoms, DRESS) te akutne generalizirane egzantematozne pustuloze (AGEP), koji mogu biti opasni po život
English: Vismodegib is predominant in plasma, with concentrations representing greater than 98 %
Croatian: Vismodegib se uglavnom nalazi u plazmi i to u koncentracijama koje čine više od 98% ukupnih koncentracija u cirkulaciji (uključujući povezane metabolite).
English: • 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.
Croatian: ● informacije o metodama za prikupljanje podataka o primjeni lijeka Erivedge i o pridržavanju programa praćenja nuspojava vezanih uz trudnoću te njegovoj učinkovitosti, dogovorenima s nacionalnim nadležnim tijelom.
English: Precocious puberty****
Croatian: Endokrini poremećaji prijevremeni pubertet****
English: In a WCBP, a medically supervised pregnancy test, conducted by a heath care provider, should be performed within 7 days prior to initiating treatment and monthly during treatment.
Croatian: U žene generativne dobi zdravstveni djelatnik mora provesti test na trudnoću 7 dana prije početka liječenja i svakog mjeseca tijekom liječenja.
English: • The need for adequate contraceptive measures during treatment and for 24 months after Erivedge treatment
Croatian: ● potreba za primjenom odgovarajuće kontracepcije tijekom liječenja lijekom Erivedge i 24 mjeseca po njegovu završetku
English: For the metastatic cohort, the majority of patients had prior therapies, including surgery (91%), radiotherapy (62%) and systemic therapy (16%).
Croatian: U kohorti bolesnika oboljelih od metastatskog karcinoma bazalnih stanica, većina je bolesnika prethodno bila liječena, uključujući kirurški zahvat (91%), radioterapiju (62%) i sustavno liječenje (16%).
English: Clinically significant PK interactions between vismodegib and CYP450 substrates are not expected.
Croatian: Ne očekuju se klinički značajne farmakokinetičke interakcije između vismodegiba i supstrata CYP450.
English: • Pregnancy test within a maximum of 7 days prior to treatment initiation, and monthly medically supervised pregnancy tests during treatment
Croatian: ● bolesnica mora napraviti test na trudnoću unutar najviše 7 dana prije početka liječenja te jednom mjesečno tijekom liječenja, pod liječničkim nadzorom
English: You should not donate semen at any time during treatment and for 2 months after your final dose of this medicine.
Croatian: Ne smijete darivati spermu ni u kojem trenutku tijekom liječenja ni tijekom 2 mjeseca nakon uzimanja posljednje doze ovoga lijeka.
English: The extent to which vismodegib is excreted in breast milk is not known.
Croatian: Nije poznato u kojoj se mjeri vismodegib izlučuje u majčino mlijeko.
English: Prior to study enrolment, diagnosis of BCC was confirmed by histology.
Croatian: Prije uključivanja u ispitivanje histološki je potvrđena dijagnoza karcinoma bazalnih stanica.
English: • The need for adequate contraceptive measures
Croatian: ● bolesnice moraju primjenjivati odgovarajuće kontracepcijske mjere
English: and moderate (BSA-indexed CrCl 30 to 50 mL/min, n=16) renal impairment, mild and moderate impaired renal function had no clinically significant effect on the pharmacokinetics of vismodegib (see section 4.2).
Croatian: Na temelju populacijske farmakokinetičke analize provedene u bolesnika s blagim (klirens kreatinina [ClCr] indeksiran prema površini tijela: 50-80 ml/min, n=58) i umjerenim (ClCr indeksiran prema površini tijela: 30-50 ml/min, n=16) oštećenjem bubrežne funkcije, utvrđeno je da blago i umjereno oštećenje bubrežne funkcije nije imalo klinički značajnog utjecaja na farmakokinetiku vismodegiba (vidjeti dio 4.2).
English: For the locally advanced cohort, the majority of patients had prior therapies, including surgery (85%), radiotherapy (28%) and systemic therapy (7%).
Croatian: U kohorti bolesnika oboljelih od lokalno uznapredovalog karcinoma bazalnih stanica, većina je bolesnika prethodno bila liječena, uključujući kirurški zahvat (85%), radioterapiju (28%) i sustavno liječenje (7%).
English: For the laBCC cohort (n = 63), 94 % of patients had prior therapies including surgery (89 %), radiotherapy (27 %), and systemic/topical therapies (11 %).
Croatian: U kohorti bolesnika oboljelih od lokalno uznapredovalog karcinoma bazalnih stanica (n = 63) prethodno je liječeno 94% bolesnika: kirurškim zahvatom (89%), radioterapijom (27%) i sustavnim/topikalnim liječenjem (11%).
English: Tell your doctor in case you notice any changes in your skin.• Never give this medicine to anyone else.
Croatian: Obavijestite svog liječnika ako primijetite bilo kakve promjene na koži.
English: • rash,
Croatian: ● osip,
English: • If you are male, you should not donate semen at any time during treatment and for 2 months after the final dose.
Croatian: Ako ste muškarac, ne smijete darovati spermu bilo kada tijekom liječenja i unutar 2 mjeseca nakon posljednje doze.
English: NAME OF THE MEDICINAL PRODUCT Erivedge 150 mg hard capsules vismodegib
Croatian: NAZIV LIJEKA Erivedge 150 mg tvrde kapsule vismodegib
English: • She must not become pregnant while taking Erivedge and for 24 months after her final dose,
Croatian: ● ne smije zatrudnjeti tijekom liječenja lijekom Erivedge niti 24 mjeseca nakon uzimanja posljednje doze,
English: • if you are breast-feeding or plan to breast-feed during the course of treatment or during the 24 months after your final dose of this medicine.
Croatian: ● ako dojite ili namjeravate dojiti tijekom liječenja ili unutar 24 mjeseca nakon uzimanja posljednje doze ovog lijeka.
English: Clinically significant PK interactions between vismodegib and P-gp inhibitors are not expected.
Croatian: Ne očekuju se klinički značajne farmakokinetičke interakcije između vismodegiba i inhibitora P-gp-a.
English: Clinically significant PK interactions between vismodegib and CYP450 inhibitors are not expected.
Croatian: Ne očekuju se klinički značajne farmakokinetičke interakcije između vismodegiba i inhibitora CYP450.