FrancophonIA/ELRC3.0 huggingface dataset:
English: The median duration of exposure to sonidegib during Study X2104 was 97 days (range 34 to 511 days) for adult patients and 55 days (range 2 to 289 days) for paediatric patients.
Slovenian: Povprečen čas izpostavljenosti sonidegibu med študijo X2104 je pri odraslih bolnikih znašal 97 dni (od 34 do 511 dni), pri pediatričnih bolnikih pa 55 dni (od 2 do 289 dni).
English: Other possible side effects If any of these side effects become severe, tell your doctor or pharmacist.
Slovenian: Drugi možni neželeni učinki Če katerikoli od teh neželenih učinkov postane zelo izražen, obvestite zdravnika ali farmacevta.
English: Due to the long half-life of sonidegib the full effect of a dose interruption or dose adjustment of sonidegib on several adverse events is expected to generally occur after a few weeks (see section 5.2).
Slovenian: Zaradi dolgega razpolovnega časa sonidegiba je celoten učinek prekinitve zdravljenja ali znižanja odmerka sonidegiba pri posameznih neželenih dogodkih večinoma mogoče pričakovati šele po nekaj tednih (glejte poglavje 5.2).
English: Management of severe or intolerable adverse reactions may require temporary dose interruption (with or without a subsequent dose reduction) or discontinuation.
Slovenian: Pri obvladovanju hudih ali neznosnih neželenih učinkov je včasih treba odmerjanje zdravila začasno prekiniti (in ga nato ponovno uvesti z enakim ali znižanim odmerkom) ali pa ga je treba dokončno ukiniti.
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX48
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, druga zdravila z delovanjem na novotvorbe, oznaka ATC: L01XX48 Mehanizem delovanja
English: You must not become pregnant while taking this medicine.
Slovenian: V času jemanja tega zdravila ne smete zanositi.
English: • has not undergone a hysterectomy or a bilateral oophorectomy, or who does not have medically-confirmed permanent premature ovarian failure,
Slovenian: • ji niso odstranili maternice ali obeh jajčnikov in nima medicinsko potrjene prezgodnje trajne odpovedi jajčnikov,
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.
Slovenian: Študija CLDE225X2104 je bila študija faze I/II sonedigiba pri pediatričnih bolnikih s ponavljajočim ali trdovratnim meduloblastomom ali z drugimi tumorji, potencialno odvisnimi od signalne poti Hedgehog (Hg), in pri odraslih bolnikih s ponavljajočim ali trdovratnim meduloblastomom.
English: • Patient educational material
Slovenian: • izobraževalno gradivo za bolnike
English: Patients should be closely monitored for muscle-related symptoms if Odomzo is used in combination with certain medicinal products that may increase the potential risk of developing muscle toxicity (e.g. CYP3A4 inhibitors, chloroquine, hydroxychloroquine, fibric acid derivatives, penicillamine, zidovudine, niacin and HMG-CoA reductase inhibitors) (see section 4.5).
Slovenian: Bolnike je treba skrbno spremljati glede pojavljanja z mišicami povezanih simptomov, če jemljejo zdravilo Odomzo v kombinaciji z določenimi zdravili, ki lahko povečajo tveganje za toksično delovanje na mišice (na primer z zaviralci CYP3A4, klorokinom, hidroksiklorokinom, derivati fibrične kisline, penicilaminom, zidovudinom, niacinom ali zaviralci reduktaze HMG-CoA) (glejte poglavje 4.5).
English: Sonidegib did not inhibit apical efflux transporters, P-gp or MRP2, hepatic uptake transporters OATP1B1 or OATP1B3, renal organic anion uptake transporters OAT1 and OAT3, or the organic cation uptake transporters OCT1 or OCT2 at clinically relevant concentrations.
Slovenian: Sonidegib v klinično ustreznih koncentracijah ni zaviral apikalnih izlivnih prenašalcev, P-gp ali MRP2, jetrnih privzemnih prenašalcev OATP1B1 in OATP1B3, ledvičnih privzemnih prenašalcev organskih anionov OAT1 in OAT3 ter privzemnih prenašalcev organskih kationov OCT1 in OCT2.
English: Problems with growing teeth and bones were seenwith this medicine.
Slovenian: Pri tem zdravilu so opazili težave z rastjo zob in kosti.
English: Before starting Odomzo treatment, ask your doctor if you are able to become pregnant, even if your periods have stopped (menopause).
Slovenian: Preden začnete zdravljenje z zdravilom Odomzo, se pri zdravniku pozanimajte, ali obstaja možnost, da zanosite, tudi če menstruacije nimate več (zaradi menopavze).
English: Other medicines and Odomzo
Slovenian: Druga zdravila in zdravilo Odomzo
English: Prescribing and dispensing restrictions for women of childbearing potential
Slovenian: Omejitve predpisovanja in izdajanja zdravila ženskam v rodni dobi
English: The median age of all patients receiving Odomzo 200 mg was 67 years (59.5% were >65 years of age), 60.8% were male and 89.9% Caucasian.
Slovenian: Mediana starosti vseh bolnikov, ki so prejemali zdravilo Odomzo v odmerku 200 mg, je bila 67 let (59,5 % jih je bilo starih več kot 65 let), 60,8 % med njimi jih je bilo moškega spola in 89,9 % je bilo belcev.
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.
Slovenian: Rezultati populacijske farmakokinetične analize ne kažejo, da starost (v testiranem obsegu 20-93 let, s povprečjem 61 let), telesna masa (v testiranem obsegu 42-181 kg, s povprečjem 77 kg), spol ali očistek kreatinina (v testiranem obsegu od 27,3-290 ml/min, s povprečjem 92,9 ml/min) lahko klinično pomembno vplivajo na sistemsko izpostavljenost sonidegibu.
English: The MAH shall continuously ensure that all physicians who are expected to prescribe Odomzo are provided with the following:
Slovenian: Imetnik dovoljenja za promet mora ves čas zagotavljati, da zdravniki, ki bodo predvidoma predpisovali zdravilo Odomzo, prejmejo naslednje gradivo:
English: Unused capsules should be returned at the end of treatment.
Slovenian: Neuporabljene kapsule morate po koncu zdravljenja vrniti.
English: It is not known whether Odomzo can pass into your breast milk and cause harm to your baby.
Slovenian: Ni znano, ali zdravilo Odomzo lahko prehaja v materino mleko in škoduje otroku.
English: Teratogenic effects included vertebral, distal limb and digit malformations, severe craniofacial malformations and other severe midline defects.
Slovenian: Med teratogenimi učinki so bili prirojene nepravilnosti hrbtenice, distalnih delov okončin in prstov, hude kraniofacialne malformacije in druge hude nepravilnosti zraščanja v srednji telesni liniji.
English: − Measures to ensure that all appropriate actions have been performed prior to Odomzo being prescribed and dispensed
Slovenian: − ukrepe za zagotovitev vseh potrebnih postopkov pred predpisovanjem in izdajo zdravila
English: Due to overlapping toxicities, patients taking Odomzo who are also taking medicinal products known to increase the risk of muscle-related toxicity may be at increased risk of developing muscle-related adverse events.
Slovenian: Zaradi prekrivajočega se toksičnega delovanja posameznih zdravil lahko pri bolnikih, ki jemljejo zdravilo Odomzo in sočasno uporabljajo zdravila, za katera je znano, da povečujejo tveganje za toksično delovanje na mišice, pride do povečanega tveganja za razvoj z mišicami povezanih neželenih dogodkov.
English: In the event of pregnancy, treatment must not be initiated.
Slovenian: Če je bolnica noseča, ne sme začeti z zdravljenjem.
English: Data from studies in rats and dogs indicate that male and female fertility may be irreversibly compromised by treatment with Odomzo (see section 5.3).
Slovenian: Podatki študij na podganah in psih kažejo, da bi zdravljenje z zdravilom Odomzo lahko ireverzibilno zmanjšalo plodnost pri moških in ženskah (glejte poglavje 5.3).
English: If you are not sure, talk to your doctor or pharmacist before taking Odomzo.
Slovenian: Če niste prepričani, se pogovorite z zdravnikom ali farmacevtom, preden začnete jemati zdravilo Odomzo.
English: If you vomit after you swallow the capsule, do not take any more capsules until your next scheduled dose.
Slovenian: Če bruhate po tem, ko ste zaužili kapsulo, ne jemljite dodatnih kapsul, ampak počakajte na naslednji odmerek po razporedu.
English: Best % change from baseline (target lesions)
Slovenian: največja odstotna sprememba od izhodišča (opazovana lezija)
English: It is unknown whether sonidegib is excreted in human milk.
Slovenian: Ni znano, ali se sonidegib izloča v materino mleko.
English: • The active substance is sonidegib (as phosphate).
Slovenian: • Zdravilna učinkovina je sonidegib (v obliki fosfata).
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.
Slovenian: Povprečen čas izpostavljenosti sonidegibu med študijo C2301 je pri odraslih bolnikih znašal 2,8 meseca (od 0,4 do 33,2 meseca), pri pediatričnih bolnikih pa 3,5 meseca (od 1,3 do 5,7 meseca).
English: Your doctor will perform blood tests before treatment, and possibly during treatment as well.
Slovenian: Krvne preiskave v času zdravljenja z zdravilom Odomzo Zdravnik vas mora napotiti na krvne preiskave pred začetkom zdravljenja in po možnosti tudi kasneje v času zdravljenja.
English: If concomitant use of a strong CYP3A inhibitor is required, the sonidegib dose should be reduced to 200 mg every other day.
Slovenian: Če je treba sočasno uporabljati močan zaviralec CYP3A, je treba odmerjanje sonidegiba znižati na 200 mg vsak drugi dan.
English: Foetotoxicity in rabbits was also seen at very low maternal exposure.
Slovenian: Pri kuncih so opažali fetotoksično delovanje že pri zelo nizki maternalni izpostavljenosti.
English: Patients were treated with Odomzo 200 mg daily (n=79) or with Odomzo 800 mg daily (n=150).
Slovenian: Bolniki so prejemali zdravilo Odomzo v odmerku 200 mg na dan (n=79) ali v odmerku 800 mg na dan (n=150).
English: Do not use while pregnant or breast-feeding.
Slovenian: Ne uporabljajte zdravila, če ste noseči ali dojite.
English: • becomes amenorrhoeic following cancer therapy, including treatment with Odomzo.
Slovenian: • je izgubila menstruacijo po zdravljenju raka, kar lahko vključuje zdravljenje z zdravilom Odomzo.
English: Of these patients, 7 (58.3%) had up to grade 1 muscle symptoms while 43 (64.1%) patients not taking HMG-CoA reductase inhibitors experienced up to grade 3 symptoms.
Slovenian: 7 (58,3 %) imelo mišične simptome največ 1. stopnje, medtem ko je 43 (64,1 %) bolnikov, ki niso jemali zaviralcev reduktaze HMG-CoA, navajalo simptome največ 3. stopnje.
English: Based on the mechanism of action, in animal studies, sonidegib has been shown to be teratogenic and foetotoxic.
Slovenian: V študijah na živalih se je pokazalo, da je sonidegib zaradi svojega mehanizma delovanja teratogen in fetotoksičen.
English: • medicines such as chloroquine and hydroxychloroquine used to treat parasitic infections as well as other diseases such as rheumatoid arthritis or lupus erythematosus
Slovenian: • zdravila kot sta klorokin in hidroklorokin, ki jih uporabljamo za zdravljenje okužb s paraziti, pa tudi drugih bolezni, kot sta revmatoidni artritis in eritematozni lupus,
English: These effects observed at clinically relevant exposures include closure of bone growth plates, effects on growing teeth, effects on the male and female reproductive tract, atrophy of the hair follicles with alopecia, gastrointestinal toxicity with body weight loss and effects on lymph nodes.
Slovenian: Med te učinke, ki so jih opažali pri izpostavljenostih, ki ustrezajo kliničnim, sodijo zaprtje rastne plošče v epifizi kosti, vpliv na izraščanje zob, vpliv na reproduktivni sistem pri samcih in samicah in atrofija lasnih mešičkov z alopecijo, toksično delovanje na prebavila z zmanjševanjem telesne mase in učinki na bezgavke.
English: Substances that are BCRP substrates with narrow therapeutic range (e.g. methotrexate, mitoxantrone, irinotecan, topotecan) should be avoided.
Slovenian: Uporabi snovi, ki imajo ozko terapevtsko okno in so substrati prenašalca BCRP (kot so metotreksat, mitoksantron, irinotekan in topotekan), se je treba izogibati.
English: Progression-free survival probability (%), (95% CI)
Slovenian: verjetnost za obdobje brez napredovanja bolezni (progression-free survival probability) (%), (95
English: These tests will check the health of your muscles by measuring the levels of an enzyme in your blood called creatine phosphokinase.
Slovenian: S temi preiskavami preverja stanje vaših mišic, in sicer je zato treba določiti raven encima kreatin-kinaze v krvi.
English: If any of the above apply to you or you are not sure, talk to your doctor or pharmacist before taking Odomzo.
Slovenian: Če jemljete katerokoli od zgoraj navedenih zdravil ali o tem niste prepričani, se posvetujte z zdravnikom ali farmacevtom, preden začnete jemati zdravilo Odomzo.
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
Slovenian: • zdravila kot so metotreksat, mitoksantron, irinotekan ali topotekan, ki jih uporabljamo za zdravljenje nekaterih vrst raka oziroma drugih bolezni, kot so hude težave s sklepi (revmatoidni artritis) in luskavica (psoriaza),
English: In the phase II pivotal trial, 12 (15.2%) patients treated with Odomzo 200 mg took concomitant HMG-CoA reductase inhibitors (9 took pravastatin, 3 took non-pravastatin HMG-CoA reductase inhibitors including rosuvastatin and simvastatin).
Slovenian: V ključni študiji faze II je 12 (15,2 %) bolnikov, ki so jemali zdravilo Odomzo 200 mg, sočasno jemalo še katerega od zaviralcev reduktaze HMG-CoA (9 jih je jemalo pravastatin, 3 pa so jemali katerega od drugih zaviralcev reduktaze HMG-CoA, kar vključuje rosuvastatin in simvastatin).
English: • Do not use this medicine after the expiry date which is stated on the pack and the blister after EXP.
Slovenian: • Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pakiranju in pretisnem omotu poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
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).
Slovenian: Rezultati s sonidegibom povezane toksičnosti, ugotovljene pri pediatričnih bolnikih, so bili podobni rezultatom pri odraslih, z izjemo zmanjšane pojavnosti toksičnosti mišic (npr. povišanje kreatinkinaze (CK) je v študiji X2104 pri pediatričnih bolnikih znašalo 16,7 % v primerjavi s 50 % pri odraslih) in ugotovljenih učinkov na postnatalni razvoj, zlasti pri daljši izpostavljenosti (ugotovljenih primerov motenj epifizne plošče prstnih členkov, subhondralne kondenzacije kolena v predelu rastne plošče, fizalnih motenj distalnega dela stegnenice, hondropatije in okrušenih zob).
English: Do not stop taking Odomzo without talking to your doctor first.
Slovenian: Ne prenehajte jemati zdravila Odomzo, ne da bi se prej posvetovali z zdravnikom.
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.
Slovenian: Študija CLDE225C2301 je bila odprta multicentrična študija faze II z enim krakom glede učinkovitosti in varnosti oralnih odmerkov sonidegiba pri bolnikih s Hh-aktiviranim recidivnim meduloblastomom.
English: Odomzo may cause your baby to have severe birth defects or lead to the death of your unborn baby.
Slovenian: Zdravilo Odomzo lahko povzroči hude prirojene napake pri vašem otroku ali pa celo povzroči smrt nerojenega otroka.
English: • medicines such as telithromycin, rifampicin or rifabutin used to treat bacterial infections
Slovenian: • zdravila kot so telitromicin, rifampin ali rifabutin, ki jih uporabljamo za zdravljenje bakterijskih okužb,
English: • She must have a negative pregnancy test monthly during treatment, even if she has become amenorrhoeic.
Slovenian: • mora imeti negativen izvid pri vsakem nosečnostnem testu, ki ga mora v času zdravljenja opravljati enkrat na mesec, tudi če je izgubila menstruacijo,
English: • thirst, not passing much urine, weight loss, dry flushed skin, irritability (possible symptoms of low level of fluids in the body, known as dehydration).
Slovenian: • žeja, zmanjšano izločanje urina, hujšanje, suha rdeča koža, razdražljivost (možni simptomi premajhe količine tekočine v telesu, čemur pravimo izsušenost ali dehidriranost)
English: If clinically notable elevation of CK is detected, renal function should be assessed (see section 4.2).
Slovenian: V primeru klinično opaznega zvišanja vrednosti kreatin-kinaze je treba oceniti ledvično funkcijo (glejte poglavje 4.2).
English: In clinical trials, treatment with Odomzo was continued until disease progression or until unacceptable toxicity.
Slovenian: V kliničnih študijah so z zdravljenjem z zdravilom Odomzo nadaljevali do napredovanja bolezni ali do pojava nesprejemljivih toksičnih učinkov.
English: Treatment should be continued as long as clinical benefit is observed or until unacceptable toxicity develops.
Slovenian: Z zdravljenjem naj bolnik nadaljuje, dokler mu to klinično koristi oziroma dokler ne pride do nesprejemljivih toksičnih učinkov.
English: Do not crush, open or chew the capsule.
Slovenian: Kapsule ne drobite, ne odpirajte in ne žvečite.
English: Opaque pink hard capsule containing white to almost white powder with granules, with “NVR” imprinted in black ink on the cap and “SONIDEGIB 200MG” imprinted in black ink on the body.
Slovenian: Neprozorna trda kapsula rožnate barve vsebuje bel do skoraj bel prašek z zrnci, na pokrovčku kapsule je s črnim barvilom natisnjena oznaka "NVR", na telesu kapsule pa je s črnim barvilom natisnjena oznaka "SONIDEGIB 200MG".
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.
Slovenian: Najbolj pogosti neželeni učinki zdravila, do katerih je prišlo pri najmanj 10 % bolnikov, ki so prejemali zdravilo Odomzo v odmerku 200 mg, so bili mišični spazmi, alopecija, motnje okušanja, utrujenost, navzea, mišičnoskeletna bolečina, diareja, zmanjšanje telesne mase, zmanjšan apetit, mialgija, bolečine v trebuhu, glavobol, bolečine, bruhanje in srbenje.
English: Sonidegib was highly bound to human plasma proteins (human serum albumin and alpha-1 acid glycoprotein) in vitro (>97%), and binding was not concentration-dependent from 1 ng/ml to 2500 ng/ml.
Slovenian: Sonidegib se je in vitro v veliki meri (>97 %) vezal na beljakovine v plazmi (na človeški serumski albumin in na alfa-1 kisli glikoprotein), pri čemer vezava ni bila odvisna od koncentracije v okviru od 1 ng/ml do
English: 30 x 1 hard capsule
Slovenian: 10 x 1 trda kapsula 30 x 1 trda kapsula
English: AUClast was 35% lower in mild hepatic impairment, 14% higher in moderate hepatic impairment and 23% lower in severe hepatic impairment.
Slovenian: AUClast (do zadnje merljive koncentracije) je bila pri blagi okvari jeter za 35 % manjša, pri zmerni okvari jeter za 14 % večja, pri hudi okvari jeter pa za 23 % manjša.
English: For most patients, muscle symptoms and CK elevations resolved with appropriate management.
Slovenian: Pri večini bolnikov so mišični simptomi in zvišanje vrednosti kreatinkinaze izzveneli ob ustreznem ukrepanju.
English: • Obligations of the health care professional in relation to the prescribing of Odomzo
Slovenian: • opis dolžnosti, ki jih imajo zdravstveni delavci v povezavi s predpisovanjem zdravila Odomzo
English: Co-administration of sonidegib with strong CYP3A inducers decreases sonidegib plasma concentration.
Slovenian: Sočasno odmerjanje sonidegiba z močnimi induktorji CYP3A zniža koncentracijo sonidegiba v plazmi.
English: • you need to change contraception
Slovenian: • morate zamenjati kontracepcijsko metodo.
English: A population pharmacokinetic analysis did not find significant influence of renal function (creatinine clearance >27 ml/min) on the apparent clearance (CL/F) of sonidegib suggesting that dose adjustment is not necessary in patients with renal impairment.
Slovenian: Rezultati populacijske farmakokinetične analize ne kažejo, da bi ledvična funkcija (pri očistku kreatinina >27 ml/min) lahko pomembno vplivala na navidezni očistek (CL/F) sonidegiba, kar pomeni, da pri bolnikih z okvaro ledvic prilagajanje odmerkov ni potrebno.
English: Women taking Odomzo must not be pregnant or become pregnant during treatment and for 20 months after ending treatment.
Slovenian: Ženske, ki jemljejo zdravilo Odomzo, ne smejo biti noseče oziroma ne smejo zanositi v času zdravljenja in še 20 mesecev po zaključku zdravljenja.
English: Each capsule contains 200 mg sonidegib.
Slovenian: Ena kapsula vsebuje 200 mg sonidegiba.
English: Sonidegib may pass into the semen.
Slovenian: Sonidegib lahko prehaja v spermo.
English: At exposures well above the clinical exposure, an additional target organ was the kidney.
Slovenian: Pri izpostavljenosti, ki precej presega klinično, so tarčni organ tudi ledvice.
English: - Your doctor will check your skin regularly for another type of cancer called cutaneous squamous cell carcinoma (SCC).
Slovenian: - Zdravnik bo redno pregledoval vašo kožo glede pojavljanja druge vrste kožnega raka, ki jo imenujemo ploščatocelični karcinom kože.
English: Terapia S.A.
Slovenian: România Terapia S.A.
English: • Capsule shell: gelatin, red iron oxide (E172), titanium dioxide (E171).
Slovenian: • Ovojnica kapsule: želatina, rdeči železov oksid (E172), titanov dioksid (E171).
English: * The above recommendations for dose modifications are based on the Common Terminology Criteria for Adverse Events (CTCAE) v4.03, developed by the National Cancer Institute (USA).
Slovenian: * Zgoraj navedena priporočila za spreminjanje odmerjanja temeljijo na dokumentu Skupni terminološki kriteriji za neželene dogodke (CTCAE-Common Terminology Criteria for Adverse Events),
English: • If symptoms re-occur, interrupt treatment until resolution to baseline.
Slovenian: • Če se simptomi ponovijo, ponovno prekinite zdravljenje do izboljšanja na izhodiščno raven.
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.
Slovenian: Pri ženskah v rodni dobi je treba ugotoviti status nosečnosti najprej v roku 7 dni pred začetkom zdravljenja z zdravilom Odomzo, nato pa enkrat na mesec v času zdravljenja, in sicer mora teste nosečnosti izvajati zdravstveni delavec.
English: Adult (≥18 years of age) patients with laBCC or mBCC who were not candidates for radiotherapy, surgery or other local therapies, were randomised to receive Odomzo at either 200 mg or 800 mg daily until disease progression or unacceptable toxicity.
Slovenian: Odrasle bolnike (stare najmanj 18 let), ki so imeli lokalno napredovali ali metastatski bazalnocelični karcinom in niso bili primerni za zdravljenje z obsevanjem ali kirurškim posegom oziroma za lokalno zdravljenje, so randomizirali tako, da so prejemali zdravilo Odomzo bodisi v odmerku 200 mg ali v odmerku 800 mg enkrat na dan do napredovanja bolezni ali do nesprejemljivega toksičnega delovanja.