FrancophonIA/ELRC3.0 huggingface dataset:
English: When dose interruption is required, consider resuming Odomzo at the same dose after resolution of the adverse reaction to ≤ grade 1.
Croatian: Kada je potreban privremeni prekid doziranja, valja razmotriti nastavak liječenja Odomzom u istoj dozi nakon ublažavanja nuspojave do ≤ stupnja 1.
English: • Capsule shell: gelatin, red iron oxide (E172), titanium dioxide (E171).
Croatian: • ovojnica kapsule: želatina, crveni željezov oksid (E172), titanijev dioksid (E171).
English: • The active substance is sonidegib (as phosphate).
Croatian: • Djelatna tvar je sonidegib (kao sonidegibfosfat).
English: If you have questions about how long to take Odomzo, talk to your doctor or pharmacist.
Croatian: Ako imate pitanja o tome koliko dugo uzimati Odomzo, obratite se svom liječniku ili ljekarniku.
English: • Safety advice for women of childbearing potential
Croatian: • Sigurnosne savjete za žene reproduktivnog potencijala
English: Odomzo capsules contain lactose monohydrate.
Croatian: Odomzo kapsule sadrže laktozu hidrat.
English: No dose adjustment is necessary in patients with hepatic impairment.
Croatian: Nije potrebna prilagodba doze u bolesnika s oštećenjem jetre.
English: Odomzo is contraindicated in woman of childbearing potential who do not comply with the Odomzo Pregnancy Prevention Programme (see section 4.3).
Croatian: Odomzo je kontraindiciran u žena reproduktivne dobi koje se ne pridržavaju Programa sprječavanja trudnoće uz Odomzo (vidjeti dio 4.3).
English: Criteria defining a woman of childbearing potential
Croatian: Kriteriji za definiranje žene reproduktivne dobi
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.
Croatian: Sekundarni ishodi uključivali su trajanje odgovora, vrijeme do odgovora tumora i preživljenje bez progresije (PFS, engl. progression free survival ) prema mRECIST-u u bolesnika s luKBS-om i prema RECIST-u 1.1 u bolesnika s mKBS-om kako je utvrđeno centralnim ocjenjivanjem.
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.
Croatian: Populacijskom farmakokinetičkom analizom nije pronađen značajan utjecaj bubrežne funkcije (klirens kreatinina >27 ml/min) na prividni klirens (CL/F) sonidegiba, što ukazuje na to da prilagodba doze nije potrebna u bolesnika s oštećenjem bubrega.
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.
Croatian: Od tih 79 bolesnika, 66 (83,5%) bili su bolesnici s luKBS-om (37 [46,8%] s agresivnom histologijom i 29 [36,7%] s neagresivnom histologijom), 13 (16,5%) su bili bolesnici s mKBS-om.
English: Grade 1 [CK elevation >ULN - 2.5 x ULN]
Croatian: Stupanj 1 [povišenje CPK > GGN - 2,5 x GGN]
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.
Croatian: Rezultati iz kliničkog ispitivanja pokazali su promjenu u izloženosti sonidegibu (smanjenje AUC-a za 32% i Cmax za 38% ) nakon istodobne primjene jednokratne doze lijeka Odomzo 200 mg s esomeprazolom (inhibitor protonske pumpe) od 40 mg dnevno tijekom 6 dana u zdravih ispitanika.
English: Table 1 Recommended dose modifications and management for symptomatic CK elevations and muscle-related adverse events
Croatian: Tablica 1 Preporučene prilagodbe doze i zbrinjavanje simptomatskih povišenja CPK i štetnih događaja povezanih s mišićima
English: The majority of patients who had grade 2 or higher CK elevations developed muscle symptoms prior to the CK elevations.
Croatian: U većine bolesnika koji su imali povišenja CPK stupnja 2 ili višeg razvili su se mišićni simptomi prije povišenja CPK.
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.
Croatian: Događaji povezani s mišićima uključujući povišenje CPK Mišićna toksičnost klinički je najrelevantnija nuspojava prijavljena u bolesnika koji su primali terapiju sonidegibom i vjeruje se da je učinak razreda inhibitora signalnog puta Hedgehog (Hh).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 200 mg sonidegib (as phosphate).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tvrda kapsula sadrži 200 mg sonidegiba (u obliku sonidegibfosfata).
English: Prescribing and dispensing restrictions for women of childbearing potential
Croatian: Ograničenja propisivanja i izdavanja lijeka ženama reproduktivne dobi
English: Capsule content
Croatian: Tvrde kapsule
English: One death occurred while on treatment or within 30 days of the last dose taken in either metastatic BCC or locally advanced BCC patients taking Odomzo 200 mg.
Croatian: Došlo je do jednog smrtnog slučaja za vrijeme liječenja ili unutar 30 dana od posljednje uzete doze u bolesnika s ili metastatskim ili lokalno uznapredovalim karcinomom bazalnih stanica koji su uzimali Odomzo 200 mg.
English: Among adverse drug reactions reported (Table 2), the frequency was greater in patients taking Odomzo 800 mg than in patients taking Odomzo 200 mg except for musculoskeletal pain, diarrhoea, abdominal pain, headache and pruritus.
Croatian: Među prijavljenim nuspojavama (Tablica 2), učestalost je bila veća u bolesnika koji su uzimali Odomzo 800 mg nego u bolesnika koji su uzimali Odomzo 200 mg, osim kad je riječ o mišićno-koštanoj boli, proljevu, boli u abdomenu, glavobolji i pruritusu.
English: • Odomzo exposes a teratogenic risk to the unborn child.
Croatian: • Odomzo izlaže nerođeno dijete teratogenom riziku.
English: Very common * Of the 79 patients receiving Odomzo 200 mg, 5 were women of childbearing age.
Croatian: Pretrage smanjena tjelesna težina vrlo često * Od 79 bolesnika koji su primali Odomzo 200 mg, 5 su bile žene reproduktivne dobi.
English: During treatment and during the 20 months after your treatment has finished, tell your doctor straight away if:
Croatian: Tijekom liječenja i tijekom 20 mjeseci nakon završetka liječenja, odmah se obratite svom liječniku ako: • mislite da Vaša kontracepcija nije djelovala iz bilo kojeg razloga
English: • Printing ink: black iron oxide (E172), propylene glycol (E1520), shellac.
Croatian: • tinta za označavanje: crni željezov dioksid (E172), propilenglikol (E1520), šelak.
English: It is unknown whether sonidegib is excreted in human milk.
Croatian: Nije poznato izlučuje li se sonidegib u majčino mlijeko.
English: Tumour response was independent of Odomzo dose or plasma concentration in the dose range of 200 mg to 800 mg.
Croatian: Odomza ili koncentraciji u plazmi u rasponu doze od 200 mg do 800 mg.
English: Patients with advanced BCC have an increased risk of developing cuSCC.
Croatian: Bolesnici s uznapredovalim karcinomom bazalnih stanica imaju povećani rizik od razvoja karcinoma pločastih stanica kože.
English: Myopathy [muscular fatigue and muscular weakness]
Croatian: [umor mišića i slabost mišića]
English: • high levels of the following enzymes: creatine phosphokinase (muscle function), lipase and/or amylase
Croatian: • visoke razine sljedećih enzima: kreatin fosfokinaza (mišićna funkcija), lipaza i/ili amilaza (funkcija gušterače), alanin aminotransferaza (ALT) i/ili aspartat aminotransferaza (AST) (jetrena funkcija)
English: Read the specific instructions given to you by your doctor, particularly on the effects of Odomzo on unborn babies.
Croatian: Pročitajte posebne upute koje Vam je dao liječnik, osobito o učincima
English: • abnormal hair growth
Croatian: • poremećeni rast kose
English: A moderate meal taken 1 hour after the administration of Odomzo 200 mg provided similar exposures compared to the fasted state.
Croatian: Umjereni obrok uzet 1 sat nakon primjene Odomza 200 mg rezultirao je sličnim izloženostima u usporedbi sa stanjem kad je lijek uzet natašte.
English: Upon resolution, resume treatment at the same dose level and measure CK monthly thereafter.
Croatian: Nakon povratka na početno stanje, ponovno nastaviti liječenje istom dozom i mjeriti CPK svaki mjesec nakon toga.
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.
Croatian: U usporedbi sa stanjem kada je lijek uzet natašte, Cmax i AUC Odomza 800 mg povećali su se 7,8 odnosno 7,4 puta, kada je doza dana uz obrok s visokim udjelom masnoća.
English: The dose of sonidegib used prior to initiation of the strong inducer should be resumed if the strong inducer is discontinued.
Croatian: Ako se prekine primjena snažnog induktora, treba nastaviti s dozom sonidegiba koja se primjenjivala prije početka primjene snažnog induktora.
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.
Croatian: U većine bolesnika liječenih Odomzom 200 mg dnevno koji su imali povišenja CPK stupnja 2 ili višeg, razvili su se mišićni simptomi prije povišenja CPK.
English: Iron oxide red (E172) Titanium dioxide (E171)
Croatian: titanijev dioksid (E171)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1030/001 10 hard capsules
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1030/001 10 tvrdih kapsula
English: • dark urine, decreased urine output or no urine output.
Croatian: • tamna mokraća, smanjeno izlučivanje mokraće ili prestanak izlučivanja mokraće.
English: Women taking Odomzo must not be pregnant or become pregnant during treatment and for 20 months after ending treatment.
Croatian: Odomzo ne smiju biti trudne niti zatrudnjeti tijekom liječenja te 20 mjeseci nakon završetka liječenja.
English: You should not donate semen during your treatment and for 6 months after your treatment has finished.
Croatian: Ne smijete donirati sjeme tijekom liječenja te 6 mjeseci nakon što završite liječenje.
English: Odomzo 200 mg capsules are pink and opaque.
Croatian: Kako Odomzo izgleda i sadržaj pakiranja Odomzo 200 mg kapsule su ružičaste i neprozirne.
English: • Healthcare professional educational material
Croatian: • Edukacijske materijale za zdravstvene djelatnike
English: • Any male condom (with spermicide, if available)
Croatian: • Bilo koji kondom za muškarce (sa spermicidom, ako je dostupan) • Dijafragma (sa spermicidom, ako je dostupna)
English: It is unknown whether sonidegib is contained in semen.
Croatian: Nije poznato je li sonidegib prisutan u sjemenu.
English: • Continue treatment at the same dose and monitor CK levels weekly until resolution to baseline level and then monthly thereafter.
Croatian: • Nastaviti liječenje istom dozom i pratiti razine CPK svaki tjedan dok se ne vrate na početnu razinu, a nakon toga svaki mjesec.
English: • medicines such as carbamazepine, phenytoin or phenobarbital used to treat acute seizures
Croatian: • lijekove kao što su karbamazepin, fenitoin ili fenobarbital koji se koriste za liječenje akutnih epileptičkih napadaja
English: Patients with hepatic impairment No dose adjustment is necessary in patients with hepatic impairment (see section 5.2).
Croatian: Nije potrebna prilagodba doze u bolesnika s oštećenjem jetre (vidjeti dio 5.2).
English: Do not breast-feed during your treatment or during the 20 months after your treatment has finished.
Croatian: Nemojte dojiti tijekom liječenja ili tijekom 20 mjeseci nakon završetka liječenja.
English: Odomzo may cause severe birth defects.
Croatian: Odomzo može uzrokovati teške urođene anomalije.
English: • Monitor CK and serum creatinine levels weekly until resolution to baseline.
Croatian: • Pratiti razine CPK i kreatinina u serumu svaki tjedan do povratka na početne razine.
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.
Croatian: U zdravih ispitanika istodobna primjena jednokratne doze od 800 mg sonidegiba s ketokonazolom (200 mg dvaput na dan tijekom 14 dana), snažnim CYP3A inhibitorom, rezultirala je povećanjem AUC-a sonidegiba od 2,25 puta i Cmax od 1,49 puta, u usporedbi s primjenom samog sonidegiba.
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.
Croatian: • morate nastaviti koristiti tu kontracepciju 20 mjeseci nakon što ste prestali uzimati
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).
Croatian: Najčešće prijavljena odstupanja u nalazima laboratorijskih pretraga stupnja 3/4 s incidencijom od ≥ 5% koja su se javila u bolesnika liječenih Odomzom 200 mg bila su povišena lipaza i povišeni CPK u krvi
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.
Croatian: Najčešće nuspojave stupnja 3/4 koje su se javile u ≥ 2% bolesnika liječenih Odomzom 200 mg bile su umor, smanjena tjelesna težina i mišićni spazmi.
English: Agents that may decrease sonidegib plasma concentration
Croatian: Tvari koje mogu smanjiti koncentraciju sonidegiba u plazmi
English: • medicines such as ritonavir, saquinavir or zidovudine used to treat AIDS or HIV
Croatian: • lijekove kao što su ritonavir, sakvinavir ili zidovudin koji se koriste za liječenje AIDS-a ili HIV-a
English: The MAH shall distribute a Direct Healthcare Professional Communication letter at launch of the product, which should contain the following:
Croatian: Nositelj odobrenja dužan je prilikom stavljanja lijeka u promet distribuirati Pismo zdravstvenim djelatnicima koje bi trebalo sadržavati sljedeće:
English: • If renal function is impaired, interrupt treatment and ensure that the patient is adequately hydrated and evaluate other secondary causes of renal impairment.
Croatian: prekinuti liječenje i osigurati dostatnu hidraciju bolesnika, te procijeniti ostale sekundarne uzroke oštećenja funkcije bubrega.
English: Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
Croatian: Unutar svake klasifikacije organskog sustava, nuspojave su rangirane po učestalosti, počevši od najučestalijih.
English: Odomzo contains lactose
Croatian: Odomzo sadrži laktozu
English: How Odomzo works
Croatian: Kako Odomzo djeluje
English: • weight loss.
Croatian: • bol • smanjenje tjelesne težine.
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.
Croatian: Neprozirna ružičasta tvrda kapsula koja sadrži bijeli do gotovo bijeli prašak s granulama, s oznakom „NVR“
English: Figure 1 Best change from baseline in the target lesions of laBCC patients per central review assessment by FAS
Croatian: Slika 1 Najbolja promjena od početne vrijednosti u ciljnim lezijama bolesnika s luKBS-om prema centralnoj ocjeni prema FAS-u
English: Agents that may increase sonidegib plasma concentration
Croatian: Tvari koje mogu povećati koncentraciju sonidegiba u plazmi
English: • Not to give Odomzo to any other person as well as information on the disposal of unwanted medication and the need to keep Odomzo capsules out of sight and reach of children
Croatian: • Informaciju da se Odomzo ne smije davati nikome drugome, kao i informaciju o odlaganju neželjenog lijeka te potrebi da se kapsule
English: In healthy subjects, co-administration of a single dose of 800 mg sonidegib with rifampicin (600 mg daily for 14 days), a strong CYP3A inducer, resulted in 72% and 54% decreases in sonidegib AUC and Cmax respectively, compared with when sonidegib was given alone.
Croatian: U zdravih ispitanika istodobna primjena jednokratne doze od 800 mg sonidegiba s rifampicinom (600 mg dnevno tijekom 14 dana), snažnim induktorom CYP3A, rezultirala je smanjenjem AUC-a sonidegiba od 72% i Cmax od 54%, u usporedbi s primjenom samog sonidegiba.
English: Compared to the fasted state, the Cmax and AUC of Odomzo 200 mg was increased 2.8- and 3.5-fold, respectively, when the dose was given with a light meal.
Croatian: U usporedbi sa stanjem kada je lijek uzet natašte, Cmax i AUC Odomza 200 mg povećali su se 2,8 odnosno 3,5 puta, kada je doza dana uz lagani obrok.
English: Severity of CK elevation
Croatian: Težina povišenja CPK
English: • severe itching of the skin, with a red rash or raised bumps.
Croatian: • oticanje lica, usana, jezika ili grla • teški svrbež kože, s crvenim osipom ili izdignutim kvržicama.
English: Odomzo 200 mg hard capsules sonidegib
Croatian: Odomzo 200 mg tvrde kapsule sonidegib
English: • Monitor muscle symptoms for changes until resolution to baseline.
Croatian: • Pratiti promjene mišićnih simptoma do povratka na početno stanje.
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.
Croatian: Slika 1 pokazuje najbolju promjenu u veličini ciljne lezije za svakog bolesnika s luKBS-om pri dozi od
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).
Croatian: U tih bolesnika povećanja laboratorijskih vrijednosti CPK do težine stupnja 2 ili višeg imala su medijan vremena do nastupa od 12,9 tjedana (raspon 2 do 39 tjedana) nakon početka terapije
English: • She must not become pregnant while taking Odomzo and for 20 months after her final dose.
Croatian: • ne smije zatrudnjeti dok uzima Odomzo te 20 mjeseci nakon posljednje doze.
English: Clinically relevant laboratory abnormalities
Croatian: Klinički relevantna odstupanja u nalazima laboratorijskih pretraga
English: If you take more Odomzo than you should, or if someone else accidentally takes your medicine, talk to a doctor or go to a hospital straight away.
Croatian: Ako uzmete više Odomza nego što se trebali, ili ako netko drugi slučajno uzme
English: Strong CYP3A inhibitors include, but are not limited to, ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole and nefazodone.
Croatian: ritonavir, sakvinavir, telitromicin, ketokonazol, itrakonazol, vorikonazol, posakonazol i nefazodon.
English: • upset stomach or indigestion
Croatian: • nadražen želudac ili probavne smetnje • zatvor
English: Dose modifications for creatine phosphokinase (CK) elevations and muscle-related adverse events Temporary dose interruption and/or dose reduction of Odomzo therapy may be required for CK elevations and muscle-related adverse events.
Croatian: Zbog povišenja CPK i štetnih događaja povezanih s mišićima može biti potreban privremeni prekid doziranja i/ili smanjenje doze Odomza.
English: 20 months after their final dose
Croatian: Odomzo te 6 mjeseci nakon zadnje doze.
English: How to take Odomzo
Croatian: Kako uzimati Odomzo
English: Substances that are BCRP substrates with narrow therapeutic range (e.g. methotrexate, mitoxantrone, irinotecan, topotecan) should be avoided.
Croatian: metotreksat, mitoksantron, irinotekan, topotekan) treba izbjegavati.
English: 6.2 Incompatibilities
Croatian: šelak 6.2 Inkompatibilnosti
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,
Croatian: • morate koristiti 2 metode kontracepcije, jednu visoko učinkovitu metodu i jednu metodu barijere
English: NAME OF THE MARKETING AUTHORISATION HOLDER Sun Pharmaceutical Industries Europe B.V.
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Sun Pharmaceutical Industries Europe B.V.
English: • Information for patients on the teratogenic risks associated with Odomzo and the need to avoid foetal exposure
Croatian: • Informacije za bolesnike o teratogenim rizicima povezanima s Odomzom i o potrebi da se izbjegava izloženost fetusa
English: • an intra-uterine device (“the coil” or IUD)
Croatian: • unutarmaternični uložak („spirala“)
English: For women of childbearing potential Odomzo is contraindicated in women of childbearing potential who do not comply with the Odomzo Pregnancy Prevention Programme.
Croatian: Odomzo je kontraindiciran u žena reproduktivne dobi koje se ne pridržavaju Programa za sprječavanje trudnoće uz Odomzo.
English: - You should not donate blood while on treatment with Odomzo and for 20 months after ending your treatment.
Croatian: Ne smijete darivati krv dok se liječite Odomzom te 20 mjeseci nakon završetka liječenja.
English: Odomzo is for oral use.
Croatian: Odomzo je namijenjen za peroralnu primjenu.
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).
Croatian: ako je dostupan) kada imaju spolne odnose sa ženskom partnericom dok uzimaju Odomzo te 6 mjeseci nakon završetka liječenja (vidjeti dijelove 4.6 i 5.3).
English: • Healthcare professional reminder card
Croatian: • Karticu-podsjetnik za zdravstvene djelatnike
English: • A requirement to inform patients of the teratogenic risks associated with Odomzo and the need to avoid foetal exposure
Croatian: • Zahtjev za informiranjem bolesnika o teratogenim rizicima povezanima s Odomzom i o potrebi da se izbjegava izloženost fetusa
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).
Croatian: Zbog potencijala za ozbiljne nuspojave, kao što su ozbiljni poremećaji u razvoju dojene novorođenčadi/dojenčadi uzrokovani sonidegibom, žene ne smiju dojiti dok uzimaju
English: (NE)
Croatian: (NP)
English: Fertility preservation strategies should be discussed with women of childbearing potential prior to starting treatment with Odomzo.
Croatian: Prije početka liječenja Odomzom sa ženama reproduktivnog potencijala treba razgovarati o strategijama očuvanja plodnosti.
English: • diarrhoea or heartburn
Croatian: • proljev ili žgaravica
English: The healthcare professional's reminder card should contain the following key elements:
Croatian: Kartica-podsjetnik za zdravstvene djelatnike treba sadržavati sljedeće ključne elemente:
English: • a diaphragm (with spermicide, if available).
Croatian: • kondom (sa spermicidom, ako je dostupan) • dijafragma (sa spermicidom, ako je dostupna).
English: • Interrupt treatment and monitor CK levels weekly until resolution to baseline level.
Croatian: • Prekinuti liječenje i pratiti razine CPK svaki tjedan do povratka na početnu razinu.
English: • does not have a XY genotype, Turner's syndrome or uterine agenesis,
Croatian: • nema XY genotip, Turnerov sindrom ili agenezu maternice, • postane amenoroična nakon terapije za rak, uključujući liječenje Odomzom.
English: Monitor muscle symptoms for changes until resolution to baseline.
Croatian: Pratiti promjene mišićnih simptoma do povratka na početno stanje.
English: Table 2 Adverse drug reactions observed in the phase II pivotal study Primary system organ class Preferred term
Croatian: Tablica 2 Nuspojave zabilježene u ključnom ispitivanju faze II
English: Table 3 Laboratory abnormalities*
Croatian: Tablica 3 Odstupanja u nalazima laboratorijskih pretraga*