FrancophonIA/ELRC3.0 huggingface dataset:
English: The majority of patients experienced maintenance and/or improvement in their disease-related symptoms, functioning, and health status.
Slovenian: Pri večini bolnikov je prišlo do ohranjanja stanja oziroma do izboljšanja z boleznijo povezanih simptomov,
English: AUCinf of sonidegib was 40%, 22% and 8% lower, respectively.
Slovenian: 40 %, 22 % oziroma za 8 % manjša.
English: • She must use 2 methods of recommended contraception (see the “Contraception” section below and section 4.6) while she is taking Odomzo, unless she commits to not having sexual intercourse (abstinence).
Slovenian: • mora v času zdravljenja z zdravilom Odomzo uporabljati 2 priporočeni kontracepcijski metodi (glejte spodaj poglavje "Kontracepcija" in poglavje 4.6), razen če se vnaprej v celoti odpove spolnim odnosom v tem času (pristane na spolno abstinenco),
English: The phase II pivotal study evaluated the safety of Odomzo in a total of 229 adult patients with locally advanced or metastatic BCC.
Slovenian: Povzetek varnostnih lastnosti V ključni študiji faze II so ocenjevali varnost zdravila Odomzo pri skupaj 229 odraslih bolnikih z lokalno napredovalim ali metastatskim bazalnoceličnim karcinomom.
English: Since sonidegib is not renally excreted, no change in systemic exposure is anticipated in patients with renal impairment.
Slovenian: Sonidegib se ne izloča skozi ledvice, zato pri bolnikih z okvaro ledvic ni pričakovati sprememb sistemske izpostavljenosti.
English: (serum Cr ≤ ULN)
Slovenian: (vrednost kreatinina v serumu ≤ZMN)
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če gre za zdravila, ki ste jih dobili brez zdravniškega recepta, ali zeliščna zdravila.
English: Additionally, amenorrhoea has been observed in clinical trials in women of childbearing potential (see section 4.8).
Slovenian: Poleg tega so v študijah pri ženskah v rodni dobi opažali amenorejo (glejte poglavje 4.8).
English: Sonidegib has not been studied in a dedicated pharmacokinetic study in patients with renal impairment.
Slovenian: Za proučevanje uporabe sonidegiba niso izvedli posebne farmakokinetične študije pri bolnikih z okvaro ledvic.
English: • National or other applicable specific arrangements for a prescription for Odomzo to be dispensed
Slovenian: • nacionalna ali druga ustrezna posebna navodila glede predpisovanja zdravila Odomzo bolnikom, ki ga morajo prejemati
English: This switches on signals that make the cancer cells grow out of control.
Slovenian: Zaradi teh sprememb se vključi signal, ki sproži nenadzorovano razmnoževanje rakavih celic.
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.
Slovenian: Bolniki z okvaro jeter Farmakokinetiko sonidegiba so proučevali pri osebah z blago okvaro jeter (Child-Pugh stopnje A; n=8), z zmerno okvaro jeter (Child-Pugh stopnje B; n=8) oziroma s hudo okvaro jeter (Child-Pugh stopnje C; n=9) in pri 8 zdravih osebah z normalnim delovanjem jeter.
English: • high level of creatinine (kidney function)
Slovenian: • zvišana vrednost kreatinina (delovanje ledvic),
English: Table 4 Efficacy overview per central review and local investigator assessment by FASa
Slovenian: Preglednica 4 Pregled učinkovitosti po oceni centralnih pregledovalcev in po oceni lokalnih raziskovalcev (po podatkih FASa)
English: • Capsule contents: crospovidone, lactose monohydrate, magnesium stearate, poloxamer (188), silica, colloidal anhydrous (colloidal silicon dioxide), sodium laurilsulfate (sodium lauryl sulfate).
Slovenian: • Vsebina kapsule: krospovidon, laktoza monohidrat, magnezijev stearat, poloksamer (188), silicijev dioksid, koloidni, brezvodni (koloidni silicijev dioksid), natrijev lavrilsulfat (natrijev lavrilsulfat).
English: In case of pregnancy occurring during treatment, Odomzo must be stopped immediately (see section 5.3).
Slovenian: Če bolnica zanosi v času zdravljenja, mora uporabo zdravila Odomzo takoj prekiniti (glejte poglavje 5.3).
English: Due to the risk of embryofoetal death or severe birth defects caused by sonidegib, women taking Odomzo must not be pregnant or become pregnant during treatment and for 20 months after ending treatment (see section 4.4).
Slovenian: Zaradi tveganja za smrt zarodka oziroma ploda ali hude prirojene napake, ki jih lahko povzroči sonidegib, ženske, ki jemljejo zdravilo Odomzo, ne smejo biti noseče oziroma ne smejo zanositi med zdravljenjem in še 20 mesecev po zaključku zdravljenja (glejte poglavje 4.4).
English: • Remind patients to return unused capsules at the end of the treatment (disposal will depend on local requirements)
Slovenian: • zahtevo po opozorilu bolnikov, naj po koncu zdravljenja vrnejo neuporabljene kapsule (zdravilo je treba odstranjevati v skladu z lokalnimi zahtevami)
English: Odomzo is used to treat adults with a type of skin cancer called basal cell carcinoma.
Slovenian: Zdravilo Odomzo uporabljamo za zdravljenje odraslih, ki imajo vrsto kožnega raka z imenom bazalnocelični karcinom.
English: If more than six hours have passed since the dose was due to be taken, skip the missed dose, then take the next dose at the scheduled time.
Slovenian: Če je od takrat, ko bi morali vzeti odmerek, minilo več kot 6 ur, izpustite pozabljeni odmerek in nadaljujte z naslednjim odmerkom po razporedu.
English: Aberrant Hh signalling has been linked to the pathogenesis of several types of cancer, including basal cell carcinoma (BCC).
Slovenian: Nenormalno signaliziranje Hh povezujejo s patogenezo več vrst raka, med katerimi je tudi bazalnocelični karcinom.
English: The following are recommended barrier methods
Slovenian: Priporočene pregradne metode
English: No patient taking HMG-CoA reductase inhibitors experienced grade 3/4 CK elevations, as opposed to 6 (9.0%) patients not taking HMG-CoA reductase inhibitors.
Slovenian: Med bolniki, ki so jemali zaviralce reduktaze HMG-CoA, ni pri nobenem prišlo do zvišanja vrednosti kreatin-kinaze do 3. oziroma 4. stopnje za razliko od 6 (9,0 %) bolnikov, ki niso jemali zaviralcev reduktaze HMG-CoA.
English: Further, sonidegib plasma concentrations above those achieved with the therapeutic doses were not associated with life-threatening arrhythmias or torsades de pointes.
Slovenian: Tudi koncentracije sonidegiba v plazmi, ki so presegale koncentracijo pri terapevtskih odmerkih, niso povzročale življenjsko nevarnih aritmij oziroma aritmije torsades de pointes.
English: • If renal function is not impaired and CK resolves to baseline, consider resuming treatment at 200 mg every other day.
Slovenian: • Če ledvična funkcija ni okvarjena, vrednost kreatin-kinaze pa se zniža na izhodiščno, razmislite o ponovni uvedbi zdravljenja z odmerjanjem 200 mg vsak drugi dan.
English: Tell your doctor before taking Odomzo if you have a history of muscle cramps or weakness or if you are taking other medicines.
Slovenian: Preden začnete jemati zdravilo Odomzo, zdravniku povejte, če ste že imeli kdaj mišične krče ali šibkost mišic ali če jemljete še druga zdravila.
English: • Safety advice for women of childbearing potential
Slovenian: • varnostne nasvete za ženske v rodni dobi
English: If you forget to take Odomzo If you forget to take a dose of Odomzo, take it as soon you realise.
Slovenian: Če pozabite vzeti odmerek zdravila Odomzo, ga vzemite takoj, ko to ugotovite.
English: Adverse drug reactions for the recommended dose from the phase II pivotal clinical study (Table 2) are listed by Medical Dictionary for Regulatory Activities (MedDRA) version 18 system organ class.
Slovenian: Neželeni učinki pri uporabi priporočenega odmerka iz ključne študije faze II (preglednica 2) so navedeni po organskih sistemih klasifikacije MedDRA različica 18.
English: If you stop taking Odomzo
Slovenian: Če ste prenehali jemati zdravilo Odomzo
English: The average steady state Ctrough for 200 mg was 830 ng/ml (range 200 to 2400 ng/ml) in cancer patients.
Slovenian: Pri bolnikih z rakom je bila pri odmerku 200 mg povprečna vrednost najnižje koncentracije (Ctrough) 830 ng/ml (od 200 do 2.400 ng/ml).
English: • A core text as agreed by the CHMP
Slovenian: • osnovno besedilo, ki ga je odobril Odbor za zdravila za uporabo v humani medicini (CHMP)
English: They must be instructed to report promptly any unexplained muscle pain, tenderness or weakness occurring during treatment with Odomzo or if symptoms persist after discontinuing treatment.
Slovenian: Bolnikom je treba naročiti, naj takoj sporočijo, če bi v času zdravljenja z zdravilom Odomzo opazili kakršnekoli nepojasnjene bolečine v mišicah oziroma občutljivost ali oslabelost mišic ali če bi ti simptomi vztrajali po prekinitvi zdravljenja.
English: CK levels should be checked prior to starting treatment and as clinically indicated thereafter, e.g. if muscle-related symptoms are reported.
Slovenian: Vrednost kreatin-kinaze je treba določiti pred začetkom zdravljenja, nato pa v skladu s kliničnimi indikacijami, na primer takrat, ko bolnik navaja z mišicami povezane simptome.
English: [Grade 3 (CK elevation >5 x ULN - 10 x ULN)] [Grade 4 (CK elevation >10 x ULN)]
Slovenian: [3. stopnja (zvišanje vrednosti kreatin-kinaze od >5-kratnika ZMN do 10-kratnika ZMN)] [4. stopnja (zvišanje vrednosti kreatin-kinaze na >10-kratnik ZMN)]
English: Following the administration of a single dose of Odomzo (100 mg to 3000 mg) without food in patients with cancer, the median time-to-peak concentration (Tmax) was 2 to 4 hours.
Slovenian: Pri bolnikih z rakom je po odmerjanju enkratnega odmerka zdravila Odomzo (od 100 mg do 3.000 mg) skupaj s hrano mediani čas do dosežene najvišje koncentracije (Tmax) znašal od 2 do 4 ure.
English: Embryofoetal death or severe birth defects
Slovenian: Smrt zarodka oziroma ploda ali hude prirojene napake
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).
Slovenian: V ključni študiji faze II ni bilo nobenega potrjenega primera rabdomiolize (kar je bilo opredeljeno z vrednostjo kreatin-kinaze, ki presega 10-kratnik vrednosti pred zdravljenjem oziroma izhodiščne vrednosti ali pa presega 10-kratnik ZMN, če izhodiščna vrednost ni znana, in z 1,5-kratnim zvišanjem vrednosti kreatinina v serumu v primerjavi z vrednostjo pred zdravljenjem oziroma z izhodiščno vrednostjo).
English: Agents that may increase sonidegib plasma concentration
Slovenian: Zdravila, ki lahko zvišajo koncentracijo sonidegiba v plazmi
English: You must follow the Odomzo Pregnancy Prevention Programme.
Slovenian: Upoštevati morate pogoje Programa preprečevanja nosečnosti pri uporabi zdravila Odomzo.
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).
Slovenian: Izogibati se je treba sočasni uporabi z močnimi induktorji CYP3A, med katere med drugim sodijo karbamazepin, fenobarbital, fenitoin, rifabutin, rifampin in šentjanževka (Hypericum perforatum).
English: Of the 230 patients randomised, 79 patients were assigned to Odomzo 200 mg. Of these 79 patients, 66 (83.5%) were laBCC patients (37 [46.8%] with aggressive histology and 29 [36.7%] with non-aggressive histology) and 13 (16.5%) were mBCC patients.
Slovenian: Med temi 79 bolniki jih je 66 (83,5 %) imelo lokalno napredovali bazalnocelični karcinom (od tega 37 [46,8 %] z agresivnim histološkim tipom in 29 [36,7 %] z neagresivnim histološkim tipom), 13 (16,5 %) pa jih je imelo metastatski bazalnocelični karcinom.
English: There was no evidence of clearance change with repeated dosing based on the population pharmacokinetic analysis and estimated accumulation at steady state was 19-fold irrespective of dose.
Slovenian: Po podatkih populacijske farmakokinetične analize se očistek po ponovnih odmerkih ni spreminjal, ocenjeno kopičenje v stanju dinamičnega ravnovesja pa je 19-kratno ne glede na višino odmerka.
English: Table 1 Recommended dose modifications and management for symptomatic CK elevations and muscle-related adverse events
Slovenian: Preglednica 1 Priporočene spremembe odmerkov in ukrepi v primerih simptomatskega zvišanja kreatin-kinaze in z mišicami povezanih neželenih učinkov
English: The elimination half-life (t1/2) of sonidegib estimated from population pharmacokinetic modeling was approximately 28 days.
Slovenian: Po oceni modeliranja populacijske farmakokinetike znaša razpolovni čas izločanja (t1/2) sonidegiba približno 28 dni.
English: In the phase II pivotal study muscle spasms were the most common “muscle-related” adverse events, and were reported in fewer patients in the Odomzo 200 mg group (54%) than in the Odomzo 800 mg group (69%).
Slovenian: V ključni študiji faze II so bili mišični spazmi najbolj pogost z mišicami povezan neželeni dogodek, navajalo pa ga je manj bolnikov iz skupine, v kateri so jemali odmerek 200 mg zdravila Odomzo, (54%) kot iz skupine z odmerkom 800 mg zdravila Odomzo (69%).
English: How long to take Odomzo
Slovenian: Kako dolgo je treba jemati zdravilo Odomzo
English: EU/1/15/1030/002 30 hard capsules
Slovenian: EU/1/15/1030/001 10 trdih kapsul EU/1/15/1030/002 30 trdih kapsul
English: In order to help healthcare providers and patients avoid embryonic and foetal exposure to Odomzo, the Marketing Authorisation Holder will provide educational materials (Odomzo Pregnancy Prevention Programme) to reinforce the potential risks associated with use of the medicinal product.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zdravstvenim delavcem in bolnikom priskrbeti izobraževalno gradivo, ki jim bo v pomoč pri preprečevanju izpostavljanja zarodka in ploda zdravilu Odomzo (v okviru Programa preprečevanja nosečnosti pri uporabi zdravila Odomzo) in v katerem so poudarjena možna tveganja, ki so lahko povezana z uporabo zdravila.
English: • medicines such as ketoconazole (not including shampoos and creams), itraconazole, posaconazole or voriconazole used to treat fungal infections
Slovenian: • zdravila kot so ketokonazol (razen v obliki šampona in kreme), itrakonazol, posakonazol ali vorikonazol, ki jih uporabljamo za zdravljenje glivičnih okužb,
English: For LaBCC, multiple punch biopsies were taken each time a response assessment was confounded by presence of lesion ulceration, cyst, and or scarring/fibrosis.
Slovenian: Pri lokalno napredovalem bazalnoceličnem karcinomu so izvedli več "punch" biopsij, kadar bi oceno odziva na leziji lahko motila prisotnost ulceracije, ciste in/ali brazgotinjenja ali fibroze na leziji.
English: • Odomzo exposes a teratogenic risk to the unborn child.
Slovenian: • uporaba zdravila Odomzo pomeni tveganje za teratogeno delovanje na nerojenega otroka,
English: Therefore, all patients should be monitored routinely while taking Odomzo, and cuSCC should be treated according to the standard of care.
Slovenian: Iz navedenih razlogov je treba v času zdravljenja z zdravilom Odomzo rutinsko spremljati vse bolnike, primere ploščatoceličnega karcinoma kože pa zdraviti v skladu z običajno prakso.
English: • you must keep using this contraception for 20 months after you have stopped taking Odomzo because traces of the medicine remain in the body for a long time.
Slovenian: • morate tako kontracepcijo uporabljati še 20 mesecev po tem, ko prenehate jemati zdravilo Odomzo,
English: Take the medicine and its packaging and leaflet with you.
Slovenian: S seboj vzemite zdravilo z ovojnino in navodilom za uporabo.
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.
Slovenian: Zdravilo Odomzo je indicirano za zdravljenje odraslih bolnikov z lokalno napredovalim bazalnoceličnim karcinomom, kadar bolniki niso primerni za kurativni kirurški poseg ali zdravljenje z obsevanjem.
English: Metabolism and nutrition disorders Decreased appetite
Slovenian: Presnovne in prehranske motnje zmanjšan apetit zelo pogosti dehidracija pogosti
English: Odomzo may cause severe birth defects, You must not become pregnant while taking this medicine (see “Pregnancy”, “Breast-feeding”, “Fertility” and “Contraception for women and men” in section 2 for more information).
Slovenian: V času jemanja tega zdravila ne smete zanositi (za več podatkov glejte "Nosečnost", "Dojenje", "Plodnost" in "Kontracepcija za ženske in moške" v poglavju 2).
English: • you must use 2 methods of contraception, one highly effective method and one barrier method (see the examples below) while you are taking Odomzo,
Slovenian: • morate v času jemanja zdravila Odomzo uporabljati 2 metodi kontracepcije, in sicer eno od zelo učinkovitih metod in eno od pregradnih metod (glejte primere spodaj),
English: b Using only negative histology to define CR among patients who have at least a PR from other modalities (MRI or photography) resulted in a CR rate of 21.2%.
Slovenian: b Če bi za opredelitev popolnega odziva zadoščal samo negativen histološki izvid pri tistih bolnikih, ki so imeli pri drugih preiskavah (pri slikanju z magnetno resonanco ali na fotografiji) ocenjen najmanj delni odziv, bi bila stopnja popolnega odziva 21,2 %.
English: • difficulty breathing or swallowing
Slovenian: • oteženo dihanje ali požiranje
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).
Slovenian: V preglednici 1 so navedena priporočila za prekinitev in/ali znižanje odmerjanja zdravila Odomzo in ukrepanje v primeru simptomatskega zvišanja vrednosti kreatin-kinaze in z mišicami povezanih neželenih učinkov (kot so mialgija, miopatija in/ali mišični spazmi).
English: • medicines such as ritonavir, saquinavir or zidovudine used to treat AIDS or HIV
Slovenian: • zdravila kot so ritonavir, sakvinavir ali zidovudin, ki jih uporabljamo za zdravljenje AIDS oziroma okužbe z virusom HIV,
English: Ranbaxy Pharmacie Generiques Tél:+33 1 41 44 44 50
Slovenian: Tél:+33 1 41 44 44 50
English: During your treatment with Odomzo, you should also tell your doctor or pharmacist if you are prescribed another medicine that you were not taking before.
Slovenian: Zdravnika ali farmacevta morate obvestiti tudi v primeru, da vam v času zdravljenja z zdravilom Odomzo dodatno predpišejo novo zdravilo, ki ga prej še niste jemali.
English: Clinically relevant laboratory abnormalities
Slovenian: Klinično pomembni patološki laboratorijski izvidi
English: Management of high-grade CK elevation using supportive therapy, including proper hydration, should be considered according to local standards of medical practice and treatment guidelines.
Slovenian: V primeru zvišanja kreatin-kinaze višje stopnje je treba razmisliti o uvedbi ukrepov podpornega zdravljenja v skladu z lokalnimi standardi zdravstvene prakse in smernicami zdravljenja, kar vključuje tudi skrb za ustrezno hidriranost bolnika.
English: The key efficacy results per central review and local investigator assessment are presented in Table 4.
Slovenian: V preglednici 4 so navedeni najbolj pomembni rezultati glede učinkovitosti po oceni centralnih pregledovalcev in po oceni lokalnih raziskovalcev.
English: Table 3 Laboratory abnormalities*
Slovenian: Preglednica 3 Patološki laboratorijski izvidi*
English: Persistent lack of menses during treatment with Odomzo should be assumed to indicate pregnancy until medical evaluation and confirmation.
Slovenian: Daljšo odsotnost menstruacije v času zdravljenja z zdravilom Odomzo je treba obravnavati kot znak nosečnosti, dokler ni s preiskavo dokazano drugače.
English: • If renal function is impaired, interrupt treatment and ensure that the patient is adequately hydrated and evaluate other secondary causes of renal impairment.
Slovenian: prekinite zdravljenje, poskrbite, da bo bolnik primerno hidriran, in ovrednotite druge možne vzroke za ledvično okvaro.
English: Iron oxide red (E172) Titanium dioxide (E171)
Slovenian: titanov dioksid (E171)
English: It is not known whether SCC can be related to treatment with Odomzo.
Slovenian: Ni znano, ali je ploščatocelični karcinom kože lahko povezan z zdravljenjem z zdravilom Odomzo.
English: • To return unused capsules at the end of the treatment (disposal will depend on local requirements)
Slovenian: • opozorilo, naj po koncu zdravljenja vrnejo neuporabljene kapsule (zdravilo je treba odstranjevati v skladu z lokalnimi zahtevami)
English: • Information for women of childbearing potential
Slovenian: • informacije za ženske v rodni dobi
English: Figures 1 shows the best change in target lesion size for each patient with laBCC at the dose of 200 mg per central review.
Slovenian: Na sliki 1 je prikazana največja sprememba velikosti opazovane lezije za vsakega od bolnikov z lokalno napredovalim bazalnoceličnim karcinomom pri uporabi odmerka 200 mg po oceni centralnih pregledovalcev.
English: • Printing ink: black iron oxide (E172), propylene glycol (E1520), shellac.
Slovenian: • Črnilo za tisk: črni železov oksid (E172), propilenglikol (E1520), šelak.
English: Re-introduce sonidegib at 200 mg every other day and follow the same monitoring recommendations.
Slovenian: Nato začnite zdravljenje s sonidegibom z odmerjanjem 200 mg vsak drugi dan in bolnika spremljate po enakih priporočilih kot prej.
English: The dose of sonidegib used prior to initiation of the strong inducer should be resumed if the strong inducer is discontinued.
Slovenian: V primeru prekinitve jemanja močnega induktorja je treba odmerek sonidegiba spet znižati na raven pred uvedbo močnega induktorja.
English: Treatment interruptions of up to 3 weeks were allowed based on individual tolerability.
Slovenian: Glede na individualno prenašanje zdravila so bolnikom dovolili prekinitev zdravljenja za največ 3 tedne.
English: Very common * Of the 79 patients receiving Odomzo 200 mg, 5 were women of childbearing age.
Slovenian: Preiskave zmanjšanje telesne mase zelo pogosti * Med 79 bolniki, ki so prejemali zdravilo Odomzo 200 mg, je bilo 5 žensk v rodni dobi.
English: The initial prescription and dispensing of Odomzo should occur within 7 days of a negative pregnancy test.
Slovenian: Prvo pakiranje zdravila Odomzo je treba bolnici predpisati in izdati v roku 7 dni po ugotovljenem negativnem izidu nosečnostnega testa.
English: Reproductive and developmental toxicity
Slovenian: Vpliv na sposobnost razmnoževanja in toksičen vpliv na razvoj
English: Agents that may increase muscle-related events
Slovenian: Zdravila, ki lahko povečajo razvoj z mišicami povezanih neželenih dogodkov
English: Longer duration of concomitant use of CYP3A4 strong inhibitors (e.g. more than 14 days) will lead to a larger fold change in sonidegib exposure based on simulation.
Slovenian: Po simulacijskih podatkih dolgotrajnejša sočasna uporaba (npr. več kot 14 dni) močnih zaviralcev oziroma induktorjev CYP3A4 povzroči še obsežnejše spremembe izpostavljenosti sonidegibu.
English: The most common grade 3/4 adverse drug reactions occurring in ≥2% of patients treated with Odomzo 200 mg were fatigue, weight decreased and muscle spasms.
Slovenian: Najbolj pogosti neželeni učinki 3. oziroma 4. stopnje, do katerih je prišlo pri najmanj 2 % bolnikov, ki so prejemali zdravilo Odomzo v odmerku 200 mg, so bili utrujenost, zmanjšanje telesne mase in mišični spazmi.
English: Unchanged sonidegib represented 36% of circulating radioactivity and the major circulating metabolite (45% of parent exposure) identified in plasma is the hydrolysis product of sonidegib and is pharmacologically inactive.
Slovenian: Najbolj pomemben presnovek v krvnem obtoku (45 % osnovne izpostavljenosti), ki so ga odkrili v plazmi, nastane s hidrolizo sonidegiba in je farmakološko neaktiven.
English: Patients with hepatic impairment No dose adjustment is necessary in patients with hepatic impairment (see section 5.2).
Slovenian: Bolniki z okvaro jeter Pri bolnikih z okvaro jeter prilagajanje odmerkov ni potrebno (glejte poglavje 5.2).