FrancophonIA/ELRC3.0 huggingface dataset:
English: The sonidegib-related toxicity reported in paediatric patients was similar to the results reported in adults, with the exceptions of a reduced incidence of muscle toxicity (e.g. CK elevations observed in 16.7% of paediatric patients compared with 50% of adults in study X2104) and the observation of post-natal development effect particularly with prolonged exposure (reported as cases of epiphyseal plate of phalanx disorder, knee subchondral condensation of area of growth plate, physeal distal femur disorder, chondropathy, and chipped tooth).
Croatian: Toksičnost povezana sa sonidegibom koja je zabilježena u pedijatrijskih bolesnika bila je slična rezultatima koji su zabilježeni u odraslih uz iznimku smanjenja incidencije mišićne toksičnosti (npr.povišenja CK zabilježena u 16,7 % pedijatrijske populacije u usporedbi s 50 % odraslih u ispitivanju X2104) i bilježenja učinka na razvoj nakon rođenja, posebice uz produljenu izloženost (zabilježeni slučajevi poremećaja epifizne ploče falange, kondenzacije subhondralne kosti koljena na području ploče rasta, poremećaja fizealnog distalnog femura, hondropatije i okrhnutih zubi).
English: Patient-reported outcomes were evaluated as an exploratory endpoint using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and its associated head and neck cancer specific module (H&N35).
Croatian: upitnik Europske organizacije za istraživanje i liječenje raka o kvaliteti života (EORTC QLQ-C30) i s njim povezan specifičan modul za rak glave i vrata (H&N35).
English: If concomitant use of a strong CYP3A inhibitor is required, the sonidegib dose should be reduced to 200 mg every other day.
Croatian: Ako je potrebna istodobna primjena snažnog CYP3A inhibitora, doza sonidegiba treba se smanjiti na 200 mg svaki drugi dan.
English: Women of child-bearing potential must use two methods of recommended contraception, including one highly effective method and a barrier method, while taking Odomzo and for 20 months after ending treatment (see section 4.6).
Croatian: Žene reproduktivne dobi moraju koristiti dvije metode preporučene kontracepcije, uključujući jednu visoko učinkovitu metodu i metodu barijere dok uzimaju Odomzo i još 20 mjeseci nakon završetka liječenja (vidjeti dio 4.6).
English: Do not take Odomzo if you are pregnant, think you may be pregnant, or are planning to become pregnant during your treatment or during the 20 months after your treatment has finished.
Croatian: Odomzo ako ste trudni, mislite da biste mogli biti trudni ili planirate zatrudnjeti tijekom Vašeg liječenja ili tijekom 20 mjeseci nakon završetka liječenja.
English: Patients were treated with Odomzo 200 mg daily (n=79) or with Odomzo 800 mg daily (n=150).
Croatian: Bolesnici su bili liječeni Odomzom 200 mg na dan (n=79) ili Odomzom 800 mg na dan (n=150).
English: Sonidegib has not been studied in a dedicated pharmacokinetic study in patients with renal impairment.
Croatian: Sonidegib nije bio ispitivan u posebnom farmakokinetičkom ispitivanju u bolesnika s oštećenjem bubrega.
English: For most patients, muscle symptoms and CK elevations resolved with appropriate management.
Croatian: Za većinu bolesnika mišićni simptomi i povišenja CPK povukli su se nakon odgovarajućeg zbrinjavanja.
English: Aspartate amino transaminase (AST) increased
Croatian: vrlo često povišena aspartat aminotransaminaza (AST)
English: Cmax of sonidegib after a single oral 800 mg dose was 20%, 21% and 60% lower in mild, moderate and severe hepatic impairment, respectively, compared to normal hepatic function.
Croatian: Cmax sonidegiba nakon jednokratne oralne doze od 800 mg bio je 20%, 21% i 60% niži u bolesnika s blagim, umjerenim odnosno teškim oštećenjem jetre, u usporedbi s onima s normalnom jetrenom funkcijom.
English: Sonidegib undergoes metabolism primarily by CYP3A4, and concomitant administration of strong inhibitors or inducers of CYP3A4 can increase or decrease sonidegib concentrations significantly.
Croatian: Metabolizam sonidegiba odvija se prvenstveno putem CYP3A4, a istodobna primjena snažnih inhibitora ili induktora CYP3A4 može značajno povećati ili smanjiti koncentracije sonidegiba.
English: If any of the above apply to you or you are not sure, talk to your doctor or pharmacist before taking Odomzo.
Croatian: Ako se bilo što od navedenog odnosi na Vas ili niste sigurni, obratite se svom liječniku ili ljekarniku prije nego uzmete Odomzo.
English: Aberrant Hh signalling has been linked to the pathogenesis of several types of cancer, including basal cell carcinoma (BCC).
Croatian: Aberantna Hh signalizacija povezana je s patogenezom nekoliko vrsta raka, uključujući karcinom bazalnih stanica.
English: It binds to Smoothened (Smo), a G protein-coupled receptor-like molecule that positively regulates the Hh pathway and eventually activates and releases glioma-associated oncogene (GLI) transcription factors which induces the transcription of Hh target genes involved in proliferation, differentiation and survival.
Croatian: Veže se na Smoothened (Smo), molekulu nalik receptoru povezanom s G proteinom koja pozitivno regulira Hh put, te posljedično aktivira i otpušta transkripcijske faktore onkogena povezanog s gliomom (GLI, engl. glioma-associated oncogene) koji inducira transkripciju
English: If vomiting occurs during the course of the treatment, then no re-dosing of the patient is allowed before the next scheduled dose.
Croatian: Ako dođe do povraćanja tijekom liječenja, nije dopušteno ponovno uzimanje doze prije sljedeće doze po rasporedu.
English: The pregnancy status of women of child-bearing potential must be established within 7 days prior to the initiation of Odomzo treatment and monthly during treatment by means of a test performed by a healthcare professional.
Croatian: Status trudnoće žena reproduktivne dobi mora se utvrditi unutar 7 dana prije početka liječenja Odomzom te svaki mjesec tijekom liječenja pomoću testa koji provodi zdravstveni djelatnik.
English: The most common adverse drug reactions occurring in ≥10% of patients treated with Odomzo 200 mg were muscle spasms, alopecia, dysgeusia, fatigue, nausea, musculoskeletal pain, diarrhoea, weight decreased, decreased appetite, myalgia, abdominal pain, headache, pain, vomiting and pruritus.
Croatian: Najčešće nuspojave koje su se javile u ≥ 10% bolesnika liječenih Odomzom 200 mg bile su mišićni spazmi, alopecija, disgeuzija, umor, mučnina, mišićno-koštana bol, proljev, smanjena tjelesna težina, smanjeni apetit, mialgija, bol u abdomenu, glavobolja, bol, povraćanje i pruritus.
English: Sonidegib was shown to be foetotoxic in rabbits, as evidenced by abortion and/or complete resorption of foetuses and teratogenic resulting in severe malformations at very low exposure.
Croatian: Pokazalo se da je sonidegib fetotoksičan u kunića, što je dokazano na temelju pobačaja i/ili kompletne resorpcije fetusa, te teratogen, što je rezultiralo teškim malformacijama pri vrlo niskoj izloženosti.
English: CK levels should be measured weekly for 2 months after re-administration of sonidegib and monthly thereafter.
Croatian: Razine CPK trebaju se mjeriti svaki tjedan tijekom 2 mjeseca nakon ponovnog uvođenja sonidegiba, te svaki mjesec nakon toga.
English: Response by digital clinical photograph was evaluated by World Health Organization (WHO) adapted criteria [partial response (PR): ≥50% decrease in the sum of the product of perpendicular diameters (SPD) of a lesion; complete response (CR): disappearance of all lesions; progressive disease: ≥25% increase in the SPD of lesions].
Croatian: Tumorski odgovor na MR-u bio je procijenjen pomoću RECIST-a 1.1. Odgovor prema digitalnoj kliničkoj fotografiji bio je procijenjen prema prilagođenim kriterijima Svjetske zdravstvene organizacije (SZO) [djelomični odgovor (PR, engl. partial response): smanjenje od ≥ 50% u zbroju umnožaka najvećih okomitih promjera lezije (SPD, engl. sum of the product of perpendicular diameters); kompletan odgovor (CR, engl. complete response): nestanak svih lezija; progresivna bolest: povećanje od ≥ 25% u SPD-u lezija].
English: For sonidegib-treated male rats, exposure at approx. 2-fold the clinical exposure did not impact male fertility.
Croatian: Za mužjake štakore liječene sonidegibom, izloženost otprilike 2 puta veća od kliničke izloženosti nije utjecala na plodnost mužjaka.
English: One patient receiving Odomzo 200 mg experienced muscle symptoms and CK elevations above 10x ULN and required intravenous fluids, compared to 6 patients receiving Odomzo 800 mg.
Croatian: Jedan bolesnik koji je primao Odomzo 200 mg imao je mišićne simptome i povišenja CPK iznad 10 x GGN i bile mu je potrebno intravenozno nadoknaditi tekućinu, u usporedbi sa 6 bolesnika koji su primali Odomzo 800 mg.
English: How long to take Odomzo
Croatian: Koliko dugo uzimati Odomzo
English: Metabolism and nutrition disorders Decreased appetite
Croatian: Poremećaji metabolizma i prehrane smanjeni apetit vrlo često dehidracija često
English: Odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy.
Croatian: Odomzo je indiciran za liječenje odraslih bolesnika s lokalno uznapredovalim karcinomom bazalnih stanica koji nisu pogodni za kurativni kirurški zahvat ili radioterapiju.
English: • medicines such as chloroquine and hydroxychloroquine used to treat parasitic infections as well as other diseases such as rheumatoid arthritis or lupus erythematosus
Croatian: • lijekove kao što su klorokin i hidroksiklorokin koji se koriste za liječenje parazitskih infekcija kao i drugih bolesti kao što su reumatoidni artritis i lupus eritematozus
English: Do not take Odomzo:
Croatian: Nemojte uzimati Odomzo:
English: Tell your doctor or pharmacist immediately if your muscles hurt or you have unexplained muscle cramps or weakness during treatment with Odomzo.
Croatian: Odmah se obratite svom liječniku ili ljekarniku ako Vas bole mišići ili ako imate neobjašnjene mišićne grčeve ili slabost za vrijeme liječenja Odomzom.
English: • medicines such as ketoconazole (not including shampoos and creams), itraconazole, posaconazole or voriconazole used to treat fungal infections
Croatian: • lijekove kao što su ketokonazol (ne uključujući šampone i kreme), itrakonazol, posakonazol ili vorikonazol koji se koriste za liječenje gljivičnih infekcija
English: Study CLDE225X2104 was a Phase I/II study of sonidegib in paediatric patients with recurrent or refractory medulloblastoma or other tumours potentially dependent on the Hedgehog (Hh) signalling pathway and adult patients with recurrent or refractory medulloblastoma.
Croatian: Ispitivanje CLDE225X2104 bilo je ispitivanje sonidegiba faze I/II u pedijatrijskih bolesnika s recidivirajućim ili refraktornim meduloblastomom ili drugim tumorima koji mogu biti ovisni o signalnom putu hedgehog (Hh) i odraslih bolesnika s recidivirajućim ili refraktornim meduloblastomom.
English: In the phase II pivotal study, no reported cases of rhabdomyolysis were confirmed (defined as CK levels >10-fold above the pre-treatment or baseline level or >10x ULN if no baseline level reported plus a 1.5-fold increase in serum creatinine from the pre-treatment or baseline level).
Croatian: U ključnom ispitivanju faze II nije bilo potvrđenih prijavljenih slučajeva rabdomiolize (definirane kao razine CPK > 10 puta iznad razine prije liječenja ili početne razine u ispitivanju ili > 10 x GGN ako nije bila zabilježena početna razina plus povećanje od 1,5 puta kreatinina u serumu u odnosu na razinu prije liječenja ili početnu razinu u ispitivanju).
English: What Odomzo is
Croatian: Što je Odomzo
English: Persistent lack of menses during treatment with Odomzo should be assumed to indicate pregnancy until medical evaluation and confirmation.
Croatian: Za perzistentni izostanak menstruacije tijekom liječenja Odomzom treba se pretpostaviti da ukazuje na trudnoću dok se ne provede medicinska procjena i ne dobije potvrda.
English: Grade 3/4 increase in blood CK was reported in 8% of patients taking Odomzo 200 mg.
Croatian: Povišenje CPK u krvi stupnja 3/4 bilo je prijavljeno u 8% bolesnika koji su uzimali Odomzo 200 mg.
English: Odomzo may cause embryo-foetal death or severe birth defects when administered to pregnant women.
Croatian: Odomzo može uzrokovati embriofetalnu smrt ili teške urođene anomalije ako se primjenjuje u trudnica.
English: • Information for women of childbearing potential
Croatian: • Informacije za žene reproduktivnog potencijala
English: • Obligations of the health care professional in relation to the prescribing of Odomzo
Croatian: • Obveze zdravstvenih djelatnika u vezi s propisivanjem Odomza
English: - Your doctor will check your skin regularly for another type of cancer called cutaneous squamous cell carcinoma (SCC).
Croatian: - Liječnik će Vam redovito provjeravati kožu zbog druge vrste raka koja se naziva karcinom pločastih stanica kože.
English: • She must not take Odomzo if she is pregnant or plans to become pregnant.
Croatian: Odomzo ako je trudna ili planira zatrudnjeti.
English: 30 x 1 hard capsule
Croatian: 10 x 1 tvrda kapsula 30 x 1 tvrda kapsula
English: In the phase II pivotal study, 2 (14.3%) out of 14 women of either child-bearing potential or of child-bearing age sterilised by tubal ligation developed amenorrhoea while on treatment with Odomzo 200 mg or 800 mg once daily.
Croatian: U ključnom ispitivanju faze II, u 2 (14,3%) od 14 žena ili reproduktivnog potencijala ili reproduktivne dobi steriliziranih podvezivanjem jajovoda razvila se amenoreja tijekom liječenja Odomzom 200 mg ili 800 mg jedanput na dan.
English: Odomzo is used to treat adults with a type of skin cancer called basal cell carcinoma.
Croatian: Odomzo se koristi za liječenje odraslih osoba s vrstom raka kože koji se zove karcinom bazalnih stanica.
English: Local investigator laBCC
Croatian: Lokalni ispitivač luKBS
English: Table 4 Efficacy overview per central review and local investigator assessment by FASa
Croatian: Tablica 4 Pregled djelotvornosti prema centralnom ocjenjivanju i procjeni lokalnog ispitivača po
English: The median duration of exposure to sonidegib during Study C2301 was 2.8 months (range 0.4 to 33.2 months) for adult patients and 3.5 months (range 1.3 to 5.7 months) for paediatric patients.
Croatian: Medijan trajanja izloženosti sonidegibu tijekom ispitivanja C2301 bio je 2,8 mjeseci (raspon od 0,4 do 33,2 mjeseca) za odrasle bolesnike te 3,5 mjeseci (raspon od 1,3 do 5,7 mjeseci) za pedijatrijske bolesnike.
English: • Adverse event reporting
Croatian: • Prijavljivanje štetnih događaja
English: Tell your doctor before taking Odomzo if you have a history of muscle cramps or weakness or if you are taking other medicines.
Croatian: Obratite se svom liječniku prije nego uzmete Odomzo ako ste ranije imali mišićne grčeve ili slabost ili ako uzimate druge lijekove.
English: Women of childbearing potential who do not comply with the Odomzo Pregnancy Prevention Programme (see sections 4.4 and 4.6).
Croatian: Žene reproduktivne dobi koje se ne pridržavaju Programa za sprječavanje trudnoće uz Odomzo (vidjeti dijelove 4.4 i 4.6).
English: Table 1 summarises recommendations for dose interruption and/or dose reduction of Odomzo therapy in the management of symptomatic CK elevations and muscle-related adverse events (such as myalgia, myopathy, and/or spasm).
Croatian: Tablici 1 naveden je sažetak preporuka za prekid doziranja i/ili smanjenje doze Odomza kod zbrinjavanja simptomatskih povišenja CPK i štetnih događaja povezanih s mišićima (kao što su mialgija, miopatija i/ili spazam).
English: • medicines such as methotrexate, mitoxantrone, irinotecan, or topotecan used to treat certain types of cancers or other diseases such as severe joint problems (rheumatoid arthritis) and psoriasis
Croatian: • lijekove kao što su metotreksat, mitoksantron, irinotekan ili topotekan koji se koriste za liječenje određenih vrsta raka ili drugih bolesti kao što su teške tegobe sa zglobovima (reumatoidni artritis) i psorijaza
English: • medicines such as statins and fibric acid derivatives used to treat high cholesterol and lipids
Croatian: • lijekove kao što su statini i derivati fibratne kiseline koji se koriste za liječenje visokog kolesterola i masnoća
English: • Patient educational material
Croatian: • Edukacijske materijale za bolesnike
English: The sonidegib plasma concentration-QTc analysis showed that the upper bound of one-sided 95% confidence interval for QTc increase was below 5 msec at steady-state Cmax for 800 mg daily doses, which provide 2.3-fold plasma exposure compared with the recommended 200 mg dose.
Croatian: Analiza odnosa koncentracije sonidegiba u plazmi i QTc intervala pokazala je da je gornja granica jednostranog 95% intervala pouzdanosti za produljenje QTc intervala bila ispod 5 msec pri Cmax u stanju dinamičke ravnoteže za dnevne doze od 800 mg, što pruža 2,3 puta veću izloženost u plazmi u usporedbi s preporučenom dozom od 200 mg.
English: moderate (Child-Pugh class B; n=8) or severe (Child-Pugh class C; n=9) hepatic impairment and in 8 healthy subjects with normal hepatic function.
Croatian: Farmakokinetika sonidegiba ispitivana je u ispitanika s blagim (Child-Pugh stadij A; n=8), umjerenim (Child-Pugh stadij B; n=8) ili teškim (Child-Pugh stadij C; n=9) oštećenjem jetre te u 8 zdravih ispitanika s normalnom jetrenom funkcijom.
English: The Cmax and AUCinf of sonidegib in Japanese healthy subjects were 1.56 and 1.68-fold higher, respectively, than those seen in Western healthy subjects for a single dose of 200 mg.
Croatian: Cmax i AUCinf sonidegiba u japanskih zdravih ispitanika bili su 1,56 odnosno 1,68 puta viši od onih opaženih u zdravih ispitanika sa Zapada za jednokratnu dozu od 200 mg.
English: For patients with laBCC, the Independent Review Committee (IRC) Composite Overall Response was integrated from centrally evaluated MRI scans, digital clinical photographs and histopathology according to mRECIST.
Croatian: Independent Review Committee) bio je sastavljen od centralno procijenjenih MR snimki, digitalnih kliničkih fotografija i histopatologije prema mRECIST-u.
English: • severe muscle cramps, muscle pain or muscle weakness.
Croatian: • jaki grčevi mišića, mišićna bol ili mišićna slabost.
English: Population pharmacokinetic analyses showed that there are no clinically relevant effects of age (range tested from 20-93 years, mean 61 years), body weight (range tested 42-181 kg, mean 77 kg), gender, or creatinine clearance (range tested 27.3-290 ml/min, mean 92.9 ml/min) on the systemic exposure of sonidegib.
Croatian: Učinak dobi, tjelesne težine i spola Populacijske farmakokinetičke analize pokazale su da nema klinički relevantnih učinaka dobi (ispitan raspon od 20-93 godine, srednja vrijednost 61 godina), tjelesne težine (ispitan raspon od 42-181 kg, srednja vrijednost 77 kg), spola ili klirensa kreatinina (ispitan raspon od 27,3-290 ml/min, srednja vrijednost
English: • medicines such as telithromycin, rifampicin or rifabutin used to treat bacterial infections
Croatian: • lijekove kao što su telitromicin, rifampicin ili rifabutin koji se koriste za liječenje bakterijskih infekcija
English: What Odomzo is used for
Croatian: Za što se Odomzo koristi
English: In dose escalation studies, Odomzo was administered at doses up to 3000 mg orally once daily.
Croatian: Odomzo se primjenjivao u dozama do 3000 mg peroralno jedanput na dan.
English: Muscle-related adverse events
Croatian: Štetni događaji povezani s mišićima
English: If the same adverse drug reaction occurs following the switch to alternate daily dosing and does not improve, consider discontinuing treatment with Odomzo.
Croatian: Ako se ista nuspojava na lijek pojavi nakon prebacivanja na doziranje svaki drugi dan i ne dođe do njezina poboljšanja, potrebno je razmotriti trajni prekid liječenja Odomzom.
English: Co-administration of sonidegib with strong CYP3A inducers decreases sonidegib plasma concentration.
Croatian: Istodobna primjena sonidegiba sa snažnim induktorima CYP3A smanjuje koncentraciju sonidegiba u plazmi.
English: INFORMATION IN BRAILLE Odomzo 200 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Odomzo 200 mg
English: Amenorrhoea
Croatian: Amenoreja
English: • Capsule contents: crospovidone, lactose monohydrate, magnesium stearate, poloxamer (188), silica, colloidal anhydrous (colloidal silicon dioxide), sodium laurilsulfate (sodium lauryl sulfate).
Croatian: • sadržaj kapsule: krospovidon, laktoza hidrat, magnezijev stearat, poloksamer (188), silicijev dioksid, koloidni bezvodni, natrijev laurilsulfat.
English: A population pharmacokinetic analysis found that mild or moderate renal impairment did not have a significant effect on the apparent clearance (CL/F) of sonidegib, suggesting that dose adjustment is not necessary in patients with renal impairment (see section 5.2).
Croatian: Populacijskom farmakokinetičkom analizom pronađeno je da blago ili umjereno oštećenje bubrega nije imalo značajan učinak na prividni klirens (CL/F) sonidegiba, što upućuje na to da prilagodba doze nije potrebna u bolesnika s oštećenjem bubrega (vidjeti dio 5.2).
English: The primary efficacy endpoint of the study was objective response rate according to modified Response Evaluation Criteria in Solid Tumours (mRECIST) in patients with laBCC and RECIST 1.1 in patients with mBCC as determined by central review.
Croatian: Primarni ishod djelotvornosti u ispitivanju bio je stopa objektivnog odgovora prema modificiranim Kriterijima za ocjenu odgovora kod solidnih tumora (mRECIST, engl. modified Response Evaluation Criteria in Solid Tumours) u bolesnika s luKBS-om i prema RECIST 1.1 u bolesnika s mKBS-om kako je utvrđeno centralnim ocjenjivanjem.
English: • pain in the belly
Croatian: • bol u trbuhu
English: Tell your doctor straight away if your partner becomes pregnant while you are taking Odomzo and for 6 months after your treatment has finished.
Croatian: Odmah se obratite liječniku ako Vaša partnerica zatrudni dok uzimate Odomzo te tijekom 6 mjeseci nakon završetka liječenja.
English: Study CLDE225C2301 was a Phase II, multi-centre, open-label, single-arm study of the efficacy and safety of oral sonidegib in patients with Hh-activated relapsed medulloblastoma.
Croatian: Ispitivanje CLDE225C2301 bilo je multicentrično, otvoreno ispitivanje faze II s jednom skupinom kojim se procjenjivala djelotvornost i sigurnost sonidegiba koji se primjenjuje kroz usta u bolesnika s Hh-aktiviranim recidivirajućim meduloblastomom.
English: (serum Cr ≤ ULN)
Croatian: (serumski Cr ≤ GGN)
English: Patients who present with amenorrhoea during treatment with Odomzo should continue monthly pregnancy testing while on treatment.
Croatian: Bolesnice u kojih dođe do amenoreje tijekom liječenja Odomzom trebaju nastaviti s mjesečnim testiranjem na trudnoću tijekom liječenja.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1030/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1030/001
English: • If renal function is not impaired and CK resolves to baseline, consider resuming treatment at 200 mg every other day.
Croatian: • Ako bubrežna funkcija nije oštećena, a CPK se vrati na početnu razinu, razmotriti nastavak liječenja s 200 mg svaki drugi dan.
English: To avoid potential foetal exposure during pregnancy, male patients, even those who have had a vasectomy, must always use a condom (with spermicide, if available) when having sex with a female partner while taking Odomzo and for 6 months after the final dose.
Croatian: Da bi se izbjegla potencijalna izloženost fetusa tijekom trudnoće, muški bolesnici, čak i oni koji su se podvrgli vazektomiji, moraju uvijek koristiti kondom (sa spermicidom, ako je dostupan) za vrijeme spolnih odnosa sa ženskom partnericom dok uzimaju
English: Concomitant use of strong CYP3A inducers should be avoided; this includes, but is not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin and St John's Wort (Hypericum perforatum).
Croatian: Istodobnu primjenu snažnih CYP3A induktora treba izbjegavati; to uključuje, između ostaloga, karbamazepin, fenobarbital, fenitoin, rifabutin, rifampicin i gospinu travu (Hypericum perforatum).
English: Each capsule contains 200 mg sonidegib.
Croatian: Jedna kapsula sadrži 200 mg sonidegiba.