FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: Ženske v rodni dobi morajo v času zdravljenja z zdravilom Odomzo in še 20 mesecev po zaključku zdravljenja uporabljati dve od priporočenih metod kontracepcije, in sicer eno od zelo učinkovitih metod in eno od pregradnih metod kontracepcije (glejte poglavje 4.6).
English: The secondary endpoints included duration of response, time to tumour response and progression free survival (PFS) according to mRECIST in patients with laBCC and RECIST 1.1 in patients with mBCC as determined by central review.
Slovenian: Med sekundarnimi cilji opazovanja so bili trajanje odziva, čas do tumorskega odziva in preživetje brez napredovanja bolezni po kriterijih mRECIST pri bolnikih z lokalno napredovalim bazalnoceličnim karcinomom in po kriterijih RECIST 1.1 pri bolnikih z metastatskim bazalnoceličnim karcinomom, kar so določali centralni pregledovalci.
English: • pain in the belly
Slovenian: • bolečine v trebuhu
English: 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 ending treatment (see sections 4.6 and 5.3).
Slovenian: Moški bolnik mora v času zdravljenja z zdravilom Odomzo in še 6 mesecev po zaključku zdravljenja pri spolnih odnosih z žensko vsakokrat uporabiti kondom (s spermicidom, če je na voljo), tudi če je moški vazektomiran (glejte poglavji 4.6 in 5.3).
English: • If CK and serum creatinine levels return to baseline consider resuming treatment at 200 mg every other day and measure CK levels weekly for 2 months and monthly thereafter; otherwise discontinue treatment permanently.
Slovenian: • Če se vrednost kreatin-kinaze in kreatinina v serumu znižata na izhodiščno raven, razmislite o ponovni uvedbi zdravljenja z odmerjanjem 200 mg vsak drugi dan in pri tem prva 2 meseca določajte vrednost kreatin-kinaze enkrat na teden, kasneje pa enkrat na mesec.
English: Sonidegib undergoes metabolism primarily by CYP3A4, and concomitant administration of strong inhibitors or inducers of CYP3A4 can increase or decrease sonidegib concentrations significantly.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Sonidegib se primarno presnavlja s CYP3A4, zato sočasno odmerjanje močnih zaviralcev ali induktorjev CYP3A4 lahko bistveno zviša oziroma zniža koncentracijo sonidegiba.
English: If vomiting occurs during the course of the treatment, then no re-dosing of the patient is allowed before the next scheduled dose.
Slovenian: Če v času zdravljenja pride do bruhanja, bolnik ne sme vzeti nadomestnega odmerka, ampak mora počakati na naslednji odmerek po razporedu.
English: Do not open, chew or crush the capsule.
Slovenian: Kapsule ne odpirajte, ne grizite in ne drobite.
English: When dose interruption is required, consider resuming Odomzo at the same dose after resolution of the adverse reaction to ≤ grade 1.
Slovenian: Kadar je treba odmerjanje zdravila začasno prekiniti, lahko razmislimo o ponovni uvedbi zdravila Odomzo v enakem odmerku, vendar po zmanjšanju izraženosti neželenega učinka do stopnje 1 ali manj.
English: • you stop using contraception
Slovenian: • vam izostanejo menstruacije • prenehate uporabljati kontracepcijo,
English: A phase II, randomised double-blind study of two dose levels (200 mg or 800 mg once daily) of Odomzo was conducted in 230 patients with either locally advanced basal cell carcinoma (laBCC) (n=194) or metastatic basal cell carcinoma (mBCC) (n=36).
Slovenian: (200 mg oziroma 800 mg enkrat na dan), so izvajali pri 230 bolnikih, ki so imeli bodisi lokalno napredovali bazalnocelični karcinom (n=194) ali metastatski bazalnocelični karcinom (n=36).
English: A moderate meal taken 1 hour after the administration of Odomzo 200 mg provided similar exposures compared to the fasted state.
Slovenian: Pri zaužitju zmernega obroka 1 uro po odmerjanju 200 mg zdravila Odomzo je prišlo do približno enake izpostavljenosti zdravilu kot pri odmerjanju na tešče.
English: A woman of childbearing potential is defined in the Odomzo Pregnancy Prevention Programme as a sexually mature female who
Slovenian: V Programu preprečevanja nosečnosti pri uporabi zdravila Odomzo je ženska v rodni dobi opredeljena kot spolno zrela ženska, ki:
English: While you are taking Odomzo, always use a condom (with spermicide, if available) when you have sex with a female partner, even if you have had a vasectomy.
Slovenian: V času zdravljenje z zdravilom Odomzo pri spolnih odnosih z žensko vedno uporabljajte kondom (s spermicidom, če je na voljo), tudi če ste vazektomirani.
English: Patients should be monitored closely for adverse events and given appropriate supportive measures in all cases of overdose.
Slovenian: Pri vseh primerih prevelikega odmerjanja je treba bolnike skrbno opazovati glede pojavljanja neželenih dogodkov in uvesti ustrezne podporne ukrepe.
English: Because of the potential for serious adverse drug reactions, such as serious developmental defects in breast-fed newborns/infants from sonidegib, women must not breast-feed while taking Odomzo or for 20 months after ending treatment (see section 5.3).
Slovenian: Ker bi pri dojenih novorojencih/otrocih zaradi sonidegiba lahko prišlo do resnih neželenih učinkov, kot so resne razvojne nepravilnosti, ženske ne smejo dojiti v času zdravljenja z zdravilom Odomzo in še 20 mesecev po zaključku zdravljenja (glejte poglavje 5.3).
English: The size of the capsule is “Size #00” (dimensions 23.3 x 8.53 mm).
Slovenian: Kapsula, ki meri 23,3 x 8,53 mm, ustreza velikosti "00".
English: Muscle-related adverse events
Slovenian: Z mišicami povezani neželeni dogodki
English: If you have questions about how long to take Odomzo, talk to your doctor or pharmacist.
Slovenian: Če imate kakršnakoli vprašanja o tem, kako dolgo boste jemali zdravilo Odomzo, se posvetujte z zdravnikom ali farmacevtom.
English: Grade 1 [CK elevation >ULN - 2.5 x ULN]
Slovenian: 1. stopnja [zvišanje vrednosti kreatin-kinaze od >ZMN do 2,5-kratnika ZMN]
English: You must keep doing this for 6 months after your treatment has finished.
Slovenian: Kondom uporabljajte še 6 mesecev po zaključku zdravljenja.
English: In these patients, increases in laboratory values of CK to grade 2 and higher severity had a median time to onset of 12.9 weeks (range 2 to 39 weeks) after initiating Odomzo therapy and a median time to resolution (to normalisation or grade 1) of 12 days (95% CI 8 to 14 days).
Slovenian: 12,9 tednih (od 2 do 39 tednih) od začetka zdravljenja z zdravilom Odomzo, do umiritve teh simptomov ( do normalizacije ali do 1. stopnje izraženosti) pa je prišlo po mediano 12 dneh (95-odstotni IZ: od 8 do 14 dni).
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.
Slovenian: Primarni cilj opazovanja učinkovitosti zdravila v študiji je bila objektivna stopnja učinkovitosti, ki so jo pri bolnikih z lokalno napredovalim bazalnoceličnim karcinomom ocenjevali centralni pregledovalci po modificiranih kriterijih za vrednotenje odziva pri solidnih tumorjih (mRECIST-modified Response Evaluation Criteria in Solid Tumors), pri bolnikih z metastatskim bazalnoceličnim karcinomom pa po različici RECIST 1.1.
English: • Monitor muscle symptoms for changes until resolution to baseline.
Slovenian: • Spremljajte mišične simptome in njihove spremembe, dokler ne pride do izboljšanja na izhodiščno raven.
English: It is unknown whether sonidegib is contained in semen.
Slovenian: Moški Ni znano, ali je sonidegib prisoten v spermi.
English: Keep taking Odomzo for as long as your doctor tells you.
Slovenian: Zdravilo Odomzo jemljite tako dolgo, kot vam priporoča zdravnik.
English: 10 x 1 hard capsule in PCTFE/PVC/Alu perforated unit-dose blisters.
Slovenian: 10 x 1 trda kapsula v perforiranem pretisnem omotu z razdelki za posamezni odmerek iz poliklorotrifluoroetilena (PCTFE)/polivinilklorida (PVC)/aluminija.
English: • Check renal function (serum creatinine) regularly and ensure that patient is adequately hydrated.
Slovenian: • Redno pregledujte delovanje ledvic (vrednost kreatinina v serumu) in skrbite,
English: The median duration of treatment was 11.0 months for patients treated with Odomzo at the recommended dose of 200 mg (range 1.3 to 41.3 months).
Slovenian: Pri bolnikih, ki so prejemali zdravilo Odomzo v priporočenem odmerku 200 mg, je bila mediana trajanja zdravljenja 11,0 meseca (od 1,3 do
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.
Slovenian: Response) predstavljala skupno oceno na podlagi centralno ovrednotenih magnetnoresonančnih (MR) posnetkov, digitalnih kliničnih fotografij in histopatoloških izvidov po kriterijih mRECIST.
English: Sonidegib is also a breast cancer resistance protein (BCRP) inhibitor (IC50 ~1.5µM).
Slovenian: (angl. breast cancer resistance protein, BCRP) s srednjo inhibitorno koncentracijo (IC50)
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.
Slovenian: Da ne bi prišlo do izpostavljenosti ploda v času nosečnosti, morajo moški bolniki v času zdravljenja z zdravilom Odomzo in še 6 mesecev po zaključku zdravljenja pri spolnih odnosih z žensko vsakokrat uporabiti kondom (s spermicidom, če je na voljo), tudi če so vazektomirani.
English: United Kingdom Ranbaxy UK Ltd Tel: +44 (0) 208 848 8688
Slovenian: Tel: +44 (0) 208 848 8688
English: • a herbal medicine called St. John's wort (also known as Hypericum perforatum) used to treat depression.
Slovenian: • zdravilo, ki ga imenujemo penicilamin in ga uporabljamo za zdravljenje revmatoidnega artritisa, • zdravilo rastlinskega izvora z imenom šentjanževka (imenujemo jo tudi Hypericum perforatum), ki ga uporabljamo za zdravljenje depresije.
English: Aspartate amino transaminase (AST) increased
Slovenian: zelo pogosti zvišana vrednost aspartat-aminotransferaze (AST)
English: Odomzo has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Odomzo nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the following with the National Competent Authority:
Slovenian: Imetnik dovoljenja za promet z zdravilom se mora v vsaki državi članici pred uvedbo zdravila na trg s pristojnim nacionalnim organom za zdravila dogovoriti: • o nacionalno specifičnem delu Neposrednega obvestila za zdravstvene delavce (DHPC),
English: • Healthcare professional educational material
Slovenian: • informacije o zdravilu • izobraževalno gradivo za zdravstvene delavce
English: The majority of patients who had grade 2 or higher CK elevations developed muscle symptoms prior to the CK elevations.
Slovenian: Pri večini bolnikov, pri katerih je prišlo do zvišanja vrednosti kreatin-kinaze 2. ali višje stopnje, je do mišičnih simptomov prišlo že pred zvišanjem vrednosti kreatin-kinaze.
English: • A requirement to inform patients of the teratogenic risks associated with Odomzo and the need to avoid foetal exposure
Slovenian: • zahtevo po obveščanju bolnikov o teratogenem tveganju, ki je povezano z zdravilom Odomzo, in o potrebi po izogibanju izpostavljenosti ploda zdravilu
English: • Vasectomy
Slovenian: • vazektomija
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.
Slovenian: Med bolniki, ki so prejemali zdravilo Odomzo v odmerku 200 mg, je pri enem bolniku prišlo do mišičnih simptomov in zvišanja vrednosti kreatin-kinaze nad 10-kratnik ZMN, pri čemer je bolnik potreboval intravensko nadomeščanje tekočin, medtem ko je med bolniki, ki so prejemali zdravilo Odomzo v odmerku
English: Patients should be instructed not to donate blood while taking Odomzo and for at least 20 months after ending treatment.
Slovenian: Bolnikom je treba naročiti, naj ne darujejo krvi v času zdravljenja z zdravilom Odomzo in še najmanj 20 mesecev po zaključku zdravljenja.
English: The majority of patients treated with Odomzo 200 mg daily who had grade 2 or higher CK elevations developed muscle symptoms prior to the CK elevations.
Slovenian: Pri večini bolnikov, ki so prejemali zdravilo Odomzo v odmerku 200 mg na dan in pri katerih je prišlo do zvišanja vrednosti kreatin-kinaze 2. ali višje stopnje, je do mišičnih simptomov prišlo že pred zvišanjem vrednosti kreatin-kinaze.
English: Grade 2, 3 or 4 with renal impairment (serum Cr > ULN)
Slovenian: 2., 3. ali 4. stopnja s sočasno okvaro ledvic
English: If a dose is missed, it should be taken as soon as this is realised, unless more than six hours have passed since it was scheduled to be taken; in this case, the patient should wait and take the next scheduled dose.
Slovenian: Če bolnik pozabi vzeti odmerek, naj ga vzame čimprej po tem, ko to opazi, razen če je od časa, ko bi moral vzeti odmerek, minilo že več kot 6 ur.
English: These medicines should be used with caution or may need to be avoided during your treatment with Odomzo.
Slovenian: V času zdravljenja z zdravilom Odomzo je pri uporabi navedenih zdravil potrebna previdnost ali pa se jim je treba izogibati.
English: However, results of a drug-drug interaction study in cancer patients demonstrate that the systemic exposure of bupropion (a CYP2B6 substrate) and warfarin (a CYP2C9 substrate) is not altered when co-administered with sonidegib.
Slovenian: Sonidegib je in vitro kompetitivni zaviralec CYP2B6 oziroma CYP2C9, vendar rezultati študije medsebojnega delovanja posameznih zdravil pri bolnikih z rakom kažejo, da ni prišlo do sprememb sistemske izpostavljenosti bupropionu (ki je substrat CYP2B6) oziroma varfarinu (ki je substrat CYP2C9), če so ju odmerjali sočasno s sonidegibom.
English: Sonidegib exhibited dose-proportional increases in AUC and Cmax over the dose range from 100 mg to 400 mg, but less than dose-proportional increases above 400 mg.
Slovenian: V okviru odmerjanja od 100 mg do 400 mg sta se vrednosti AUC in Cmax sonidegiba povečevali sorazmerno z odmerkom, pri odmerkih nad 400 mg pa je bilo njuno povečevanje manjše od sorazmernega.
English: However, one reported case in a patient treated with Odomzo 800 mg in a non-pivotal study was confirmed.
Slovenian: Za razliko od te študije pa so v študiji, ki ni bila ključna, poročali o enem potrjenem primeru pri bolniku, ki je prejemal zdravilo Odomzo v odmerku 800 mg. Amenoreja
English: The majority of patients (laBCC 74%, mBCC 92%) had undergone prior therapies including surgery (laBCC 73%, mBCC 85%), radiotherapy (laBCC 18%, mBCC 54%) and antineoplastic therapies (laBCC 23%, mBCC 23%).
Slovenian: Pri večini bolnikov (74 % tistih z lokalno napredovalim bazalnoceličnim karcinomom in 92 % tistih z metastatskim bazalnoceličnim karcinomom) so karcinom zdravili že prej, kar vključuje kirurški poseg (73 % tistih z lokalno napredovalim bazalnoceličnim karcinomom in 85 % tistih z metastatskim bazalnoceličnim karcinomom), obsevanje (18 % tistih z lokalno napredovalim bazalnoceličnim karcinomom in 54 % tistih z metastatskim bazalnoceličnim karcinomom) in zdravljenje s citostatiki (23 % tistih z lokalno napredovalim bazalnoceličnim karcinomom in 23 % tistih z metastatskim bazalnoceličnim karcinomom).
English: Of the 230 patients, 16 had a diagnosis of Gorlin Syndrome (15 laBCC and 1 mBCC).
Slovenian: 16 imelo diagnozo Gorlinovega sindroma (15 z lokalno napredovalim in 1 z metastatskim bazalnoceličnim karcinomom).
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.
Slovenian: Pri bolnikih z blago, zmerno oziroma hudo okvaro jeter je bila po enkratnem peroralnem odmerku 800 mg Cmax sonidegiba za 20 %, 21 % oziroma 60 % nižja kot pri osebah z normalnim delovanjem jeter.
English: • Information for patients of the teratogenic risks associated with Odomzo and the need to avoid foetal exposure
Slovenian: • informacijo za bolnike o teratogenem tveganju, ki je povezano z zdravilom Odomzo, in potrebi po izogibanju izpostavljenosti ploda zdravilu
English: • Monitor CK and serum creatinine levels weekly until resolution to baseline.
Slovenian: • Vrednost kreatin-kinaze in kreatinina v serumu določajte enkrat na teden do znižanja na izhodiščno vrednost.
English: Muscle toxicity is the most clinically relevant side effect reported in patients receiving sonidegib therapy and is believed to be a class effect of inhibitors of the Hedgehog (Hh) signalling pathway.
Slovenian: Z mišicami povezani dogodki, vključno z zvišanjem vrednosti kreatin-kinaze Toksično delovanje na mišice je klinično najbolj pomemben neželeni učinek, o katerem so poročali pri bolnikih, ki so prejemali sonidegib, pri čemer gre verjetno za učinke, ki so specifični za skupino zaviralcev signalne kaskade Hedgehog (Hh).
English: The healthcare professional educational material for Odomzo should contain the following key elements:
Slovenian: Izobraževalno gradivo za zdravstvene delavce za zdravilo Odomzo mora vsebovati naslednje ključne elemente:
English: Odomzo may cause severe birth defects.
Slovenian: Zdravilo Odomzo lahko povzroča hude prirojene nepravilnosti.
English: Compared to the fasted state, the Cmax and AUC of Odomzo 800 mg was increased 7.8- and 7.4-fold, respectively when the dose was given with a high-fat meal.
Slovenian: Pri odmerjanju zdravila Odomzo 800 mg skupaj z obrokom z veliko maščob je bila Cmax 7,8-krat višja, AUC pa 7,4-krat večja kot pri odmerjanju zdravila na tešče.
English: Men should not father a child or donate semen while taking Odomzo and for at least 6 months after ending treatment.
Slovenian: Moški ne smejo zaploditi otroka ali darovati sperme v času, ko jemljejo zdravilo Odomzo in še najmanj 6 mesecev po zaključku zdravljenja.
English: Myopathy [muscular fatigue and muscular weakness]
Slovenian: [utrujenost in šibkost mišic] Motnje reprodukcije in dojk amenoreja*
English: Dose modifications* and management recommendations
Slovenian: Stopnja zvišanja vrednosti kreatin-kinaze Priporočila za spremembo odmerka* in druge ukrepe
English: Iron oxide black (E172) Propylene glycol (E1520) Shellac
Slovenian: propilenglikol (E1520) šelak
English: They must not be chewed or crushed.
Slovenian: Kapsule je treba pogoltniti cele, ne sme se jih zgristi ali zdrobiti.
English: The most commonly reported grade 3/4 laboratory abnormalities with an incidence of ≥5% occurring in patients treated with Odomzo 200 mg were lipase increase and blood CK increase (Table 3).
Slovenian: Med patološkimi laboratorijskimi izvidi 3. oziroma 4. stopnje s pogostnostjo najmanj 5 % pri bolnikih, ki so prejemali zdravilo Odomzo v odmerku 200 mg, so najbolj pogosto poročali o zvišani vrednosti lipaze in zvišani vrednosti kreatin-kinaze v krvi (preglednica 3).
English: • Brief background on Odomzo, its licensed indication and posology
Slovenian: • kratek pregled osnovnih podatkov o zdravilu Odomzo, odobreno indikacijo in odmerjanje zdravila
English: • Inform patients that they should not donate blood during treatment with Odomzo and for at least
Slovenian: • opozorilo, da bolniki ne smejo darovati krvi v času zdravljenja z zdravilom Odomzo in še najmanj
English: [CK elevation >2.5 x ULN - 5 x ULN]
Slovenian: [zvišanje vrednosti kreatin-kinaze od >2,5-kratnika ZMN do 5-kratnika ZMN]
English: Table 2 Adverse drug reactions observed in the phase II pivotal study Primary system organ class Preferred term
Slovenian: Preglednica 2 Neželeni učinki, ki so jih opažali v ključni študiji faze II
English: Odomzo is for oral use.
Slovenian: Zdravilo Odomzo je namenjeno peroralni uporabi.
English: If the same adverse drug reaction occurs following the switch to alternate daily dosing and does not improve, consider discontinuing treatment with Odomzo.
Slovenian: Če se po prehodu na odmerjanje zdravila vsak drugi dan isti neželeni učinek ponovi oziroma ne pride do izboljšanja,
English: NAME OF THE MARKETING AUTHORISATION HOLDER Sun Pharmaceutical Industries Europe B.V.
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Sun Pharmaceutical Industries Europe B.V.
English: Talk to your doctor if you plan to have children in the future.
Slovenian: Če bi radi imeli otroke v prihodnje, se posvetujte z zdravnikom.
English: Haematological parameters Haemoglobin decreased
Slovenian: Hematološki parametri znižana vrednost hemoglobina zelo pogosti znižano število limfocitov zelo pogosti
English: Patients who present with amenorrhoea during treatment with Odomzo should continue monthly pregnancy testing while on treatment.
Slovenian: Bolnice, ki med zdravljenjem z zdravilom Odomzo izgubijo menstruacijo, morajo še naprej enkrat mesečno opravljati teste nosečnosti, dokler jemljejo zdravilo.
English: Results from a clinical study demonstrated a change in sonidegib exposure (32% and 38% decrease in AUC and Cmax) after co-administration of a single dose of Odomzo 200 mg with esomeprazole (a proton pump inhibitor) at 40 mg daily for 6 days in healthy subjects.
Slovenian: Rezultati klinične študije so pokazali, da se je pri zdravih osebah pri sočasni uporabi enkratnega odmerka 200 mg zdravila Odomzo skupaj z esomeprazolom (zaviralcem protonske črpalke) v odmerku 40 mg na dan 6 dni spremenila izpostavljenost sonidegibu (prišlo je do zmanjšanja AUC za 32 % in do znižanja Cmax za
English: Additional precautions
Slovenian: Druga opozorila
English: Some other medicines can also affect how Odomzo works, or make it more likely that you will have side effects.
Slovenian: To je potrebno zato, ker zdravilo Odomzo lahko vpliva na delovanje nekaterih zdravil, druga zdravila pa lahko vplivajo na delovanje zdravila Odomzo ali pa povečajo možnost za neželene učinke.
English: Odomzo 200 mg hard capsules sonidegib
Slovenian: Odomzo 200 mg trde kapsule sonidegib
English: Sonidegib binding to Smo will inhibit Hh signalling and consequently block signal transduction.
Slovenian: Hh in tako blokira prenos signala.
English: Strong CYP3A inhibitors include, but are not limited to, ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole and nefazodone.
Slovenian: telitromicin, ketokonazol, itrakonazol, vorikonazol, posakonazol in nefazodon.
English: Women of childbearing potential who do not comply with the Odomzo Pregnancy Prevention Programme (see sections 4.4 and 4.6).
Slovenian: Za ženske v rodni dobi, ki niso vključene v Program preprečevanja nosečnosti pri uporabi zdravila Odomzo, je uporaba zdravila Odomzo kontraindicirana (glejte poglavje 4.3).
English: No dose adjustment is necessary in patients with hepatic impairment.
Slovenian: Pri bolnikih z okvaro jeter prilagajanje odmerkov ni potrebno.
English: The MAH shall distribute a Direct Healthcare Professional Communication letter at launch of the product, which should contain the following:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora ob uvedbi zdravila na trg zdravstvenim delavcem posredovati DHPC, ki mora vsebovati naslednje:
English: In healthy subjects, co-administration of a single 800 mg dose of sonidegib with ketoconazole (200 mg twice daily for 14 days), a strong CYP3A inhibitor, resulted in a 2.25-fold and a 1.49-fold increase in sonidegib AUC and Cmax, respectively, compared with sonidegib alone.
Slovenian: ki je močan zaviralec CYP3A, osebe pa so ga prejemale 14 dni 200 mg dvakrat na dan, povzročilo 2,25-kratno povečanje AUC in 1,49-kratno zvišanje Cmax sonidegiba v primerjavi z vrednostmi pri odmerjanju samo sonidegiba.