FrancophonIA/ELRC3.0 huggingface dataset:
English: The toxicity of sonidegib as observed in studies C2301 and X2104 in adults was in line with the already known treatment related toxicity reported in adult patients with basal cell carcinoma.
Croatian: Toksičnost sonidegiba u odraslih u ispitivanjima C2301 i X2104 bila je u skladu s već poznatom toksičnosti povezanom s liječenjem koja je zabilježena u odraslih bolesnika s karcinomom bazalnih stanica.
English: Reproductive system and breast disorders Amenorrhoea*
Croatian: Poremećaji reproduktivnog sustava i dojki amenoreja*
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.
Croatian: Tijekom liječenja Odomzom također morate obavijestiti liječnika ili ljekarnika ako Vam se propiše neki drugi lijek koji niste ranije uzimali.
English: EU/1/15/1030/002 30 hard capsules
Croatian: EU/1/15/1030/002 30 tvrdih kapsula
English: The effect of renal impairment on the systemic exposure of sonidegib has not been studied.
Croatian: Učinak oštećenja bubrega na sistemsku izloženost sonidegiba nije bio ispitivan.
English: Odomzo must be taken at least two hours after a meal and at least one hour before the following meal.
Croatian: Odomzo se mora uzeti najmanje dva sata nakon obroka i najmanje jedan sat prije sljedećeg obroka.
English: Concomitant treatment with strong CYP inducers (e.g. rifampicin, carbamazepine or phenytoin) should be avoided, as a risk for decreased plasma concentrations and decreased efficacy of sonidegib cannot be excluded (see also section 4.5).
Croatian: Istodobno liječenje snažnim CYP induktorima (npr. rifampicin, karbamazepin ili fenitoin) treba izbjegavati, budući da se ne može isključiti rizik smanjenih koncentracija u plazmi i smanjenja djelotvornosti sonidegiba (vidjeti također dio 4.5).
English: Additionally, amenorrhoea has been observed in clinical trials in women of childbearing potential (see section 4.8).
Croatian: Nadalje, u kliničkim ispitivanjima zabilježena je amenoreja u žena reproduktivnog potencijala (vidjeti dio 4.8).
English: Progressive Disease
Croatian: Progresivna bolest
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.
Croatian: Za luKBS-a, višestruki uzorci „punch“ biopsija uzeti su svaki put kad su procjene odgovora bile zbunjujuće zbog prisutnosti ulceracije, ciste i/ili ožiljka/fibroze na leziji.
English: Sonidegib binding to Smo will inhibit Hh signalling and consequently block signal transduction.
Croatian: Sonidegib će vezanjem za Smo inhibirati Hh signalizaciju i posljedično blokirati signal transdukcije.
English: • a medicine called penicillamine used to treat rheumatoid arthritis
Croatian: • lijek koji se zove penicilamin koji se koristi za liječenje reumatoidnog artritisa
English: • Brief background on Odomzo, its licensed indication and posology
Croatian: • Kratki pregled osnovnih podataka o Odomzu, njegovu odobrenu indikaciju i doziranje
English: Grade 3 or 4 without renal impairment
Croatian: Stupanj 3 ili 4 bez oštećenja bubrega
English: Do not open, chew or crush the capsule.
Croatian: Nemojte otvarati, žvakati ili drobiti kapsulu.
English: The MAH shall continuously ensure that all physicians who are expected to prescribe Odomzo are provided with the following:
Croatian: Nositelj odobrenja dužan se neprekidno brinuti da svi liječnici od kojih se očekuje da će propisivati Odomzo dobiju sljedeće:
English: AUClast was 35% lower in mild hepatic impairment, 14% higher in moderate hepatic impairment and 23% lower in severe hepatic impairment.
Croatian: AUClast bio je 35% niži kod blagog oštećenja jetre, 14% viši kod umjerenog oštećenja jetre i 23% niži kod teškog oštećenja jetre.
English: Unused capsules should be returned at the end of treatment.
Croatian: Neiskorištene kapsule treba vratiti na kraju liječenja.
English: • Remind patients to return unused capsules at the end of the treatment (disposal will depend on local requirements)
Croatian: • Podsjetiti bolesnike da vrate neiskorištene kapsule na kraju liječenja (odlaganje će ovisiti o lokalnim zahtjevima)
English: Other medicines and Odomzo
Croatian: Drugi lijekovi i Odomzo
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.
Croatian: Dulje trajanje istodobne primjene snažnih inhibitora CYP3A4 (npr. više od 14 dana) dovest će do veće promjene izloženosti sonidegibu temeljeno na simulaciji.
English: Sonidegib is an orally bioavailable inhibitor of the Hh signalling pathway.
Croatian: Sonidegib je oralno bioraspoloživ inhibitor Hh signalnog puta.
English: You must keep doing this for 6 months after your treatment has finished.
Croatian: Morate to nastaviti činiti tijekom 6 mjeseci nakon završetka liječenja.
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.
Croatian: Sonidegib je pokazao povećanja AUC-a i Cmax proporcionalna dozi u rasponu doze od 100 mg do 400 mg, ali manje nego o dozi proporcionalna povećanja iznad 400 mg.
English: Since sonidegib is not renally excreted, no change in systemic exposure is anticipated in patients with renal impairment.
Croatian: Budući da se sonidegib ne izlučuje putem bubrega, ne očekuje se nikakva promjena sistemske izloženosti u bolesnika s oštećenjem bubrega.
English: Before starting Odomzo treatment, ask your doctor if you are able to become pregnant, even if your periods have stopped (menopause).
Croatian: Prije nego što počnete liječenje Odomzom, upitajte svog liječnika možete li zatrudnjeti, čak i ako više nemate menstruaciju (menopauza).
English: Odomzo has no or negligible influence on the ability to drive and use machines.
Croatian: Odomzo ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
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.
Croatian: Ti učinci zabilježeni pri klinički relevantnim izloženostima uključuju zatvaranje ploča rasta kosti, učinke na rastuće zube, učinke na muški i ženski reproduktivni sustav, atrofiju folikula kose s alopecijom, gastrointestinalnu toksičnost sa smanjenjem tjelesne težine i učinke na limfne čvorove.
English: Dose modifications* and management recommendations
Croatian: Prilagodbe doze* i preporuke za zbrinjavanje
English: A woman of childbearing potential is defined in the Odomzo Pregnancy Prevention Programme as a sexually mature female who
Croatian: Žena reproduktivne dobi definira se u Programu za sprječavanje trudnoće uz Odomzo kao spolno zrela ženska osoba koja
English: Odomzo may cause your baby to have severe birth defects or lead to the death of your unborn baby.
Croatian: Odomzo može Vašem djetetu uzrokovati teške urođene anomalije ili dovesti do smrti Vašeg nerođenog djeteta.
English: There are no data on the use of sonidegib in pregnant women.
Croatian: Nema podataka o primjeni sonidegiba u trudnica.
English: Based on a population pharmacokinetic analysis of 351 patients who received oral doses of Odomzo in the dose range of 100 mg to 3000 mg, the apparent steady-state volume of distribution (Vss/F) was 9170 litres.
Croatian: Na temelju populacijske farmakokinetičke analize 351 bolesnika koji su primili peroralne doze Odomza u rasponu doza od 100 mg do 3000 mg, prividni volumen distribucije u stanju dinamičke ravnoteže (Vss/F) bio je 9170 litara.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Odomzo in all subsets of the paediatric population in basal cell carcinoma (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka Odomzo u svim podskupinama pedijatrijske populacije za karcinom bazalnih stanica (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: • muscle cramps, muscle pain, pain in the bones, ligaments and tendons
Croatian: • grčevi mišića, mišićna bol, bol u kostima, ligamentima i tetivama
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.
Croatian: Nuspojave za preporučenu dozu iz ključnog kliničkog ispitivanja faze II (Tablica 2) navedene su prema klasifikaciji organskih sustava iz Medicinskog rječnika za regulatorne poslove (MedDRA), verzija 18.
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).
Croatian: Zbog dugog poluvijeka sonidegiba, očekuje se da će do punog učinka prekida doziranja ili prilagodbe doze sonidegiba na nekoliko štetnih događaja općenito doći nakon nekoliko tjedana (vidjeti dio 5.2).
English: Each hard capsule contains 38.6 mg lactose monohydrate.
Croatian: Jedna tvrda kapsula sadrži 38,6 mg laktoze hidrata.
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).
Croatian: Common Terminology Criteria for Adverse Events, CTCAE) v4.03, koje je razvio Nacionalni institut za rak (SAD).
English: Frequency all grades 200 mg
Croatian: Učestalost svih stupnjeva 200 mg
English: Women of childbearing potential must be able to comply with effective contraceptive measures.
Croatian: Žene u reproduktivnoj dobi moraju biti sposobne pridržavati se učinkovitih mjera kontracepcije.
English: Sonidegib is also a breast cancer resistance protein (BCRP) inhibitor (IC50 ~1.5µM).
Croatian: Sonidegib je također inhibitor proteina koji uzrokuje rezistenciju raka dojke na lijekove (engl. breast cancer resistance protein, BCRP) (IC50 ~1,5µM).
English: Blood donation
Croatian: Darivanje krvi
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.
Croatian: Zbog preklapajućih toksičnosti, bolesnici koji uzimaju Odomzo, a uzimaju i lijekove za koje je poznato da povećavaju rizik od toksičnosti povezane s mišićima mogu biti izloženi povećanom riziku od razvoja štetnih događaja povezanih s mišićima.
English: Agents that may increase muscle-related events
Croatian: Tvari koje mogu povećati broj događaja povezanih s mišićima
English: • a medicine called nefazodone used to treat depression
Croatian: • lijek koji se zove nefazodon koji se koristi za liječenje depresije
English: In particular tell your doctor or pharmacist if you are taking any of the following:
Croatian: Posebno obavijestite svog liječnika ili ljekarnika ako uzimate bilo što od sljedećeg:
English: If you stop taking Odomzo
Croatian: Ako prestanete uzimati Odomzo
English: If you are not sure, talk to your doctor or pharmacist before taking Odomzo.
Croatian: Ako niste sigurni, obratite se svom liječniku ili ljekarniku prije nego uzmete Odomzo.
English: If symptoms persist despite alternate-day dosing, consider discontinuing treatment.
Croatian: Ako simptomi ustraju usprkos doziranju svakog drugog dana, razmotriti trajni prekid liječenja.
English: • Patient Brochure
Croatian: • Brošuru za bolesnike
English: - If you are male, you should not donate semen at any time during treatment and for 6 months after the final dose.
Croatian: - Ako ste muškarac, ne smijete donirati sjeme u bilo kojem trenutku tijekom liječenja te 6 mjeseci nakon zadnje doze.
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).
Croatian: Ne smijete zatrudnjeti dok uzimate ovaj lijek (vidjeti „Trudnoća“, „Dojenje“, „Plodnost“ i „Kontracepcija za žene i muškarce“ u dijelu 2 za više informacija).
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.
Croatian: Odrasli bolesnici (≥ 18 godina) s luKBS-om ili mKBS-om koji nisu bili kandidati za radioterapiju, kirurški zahvat ili druge lokalne terapije, bili su randomizirani na primanje Odomza u dozi od 200 mg ili 800 mg dnevno do progresije bolesti ili do pojave neprihvatljive toksičnosti.
English: Blood tests during treatment with Odomzo
Croatian: Krvne pretrage tijekom liječenja Odomzom
English: In the phase II pivotal study, muscle spasms, myalgia, myopathy and cases of CK elevations were observed.
Croatian: U ključnom ispitivanju faze II opaženi su mišićni spazmi, mialgija, miopatija i slučajevi povišenja CPK.
English: They must use two methods of recommended contraception, including one highly effective method and a barrier method, during Odomzo therapy and for 20 months after the final dose.
Croatian: Moraju koristiti dvije metode preporučene kontracepcije, uključujući jednu visoko učinkovitu metodu i metodu barijere, tijekom terapije Odomzom te 20 mjeseci nakon zadnje doze.
English: Steady state was reached approximately 4 months after starting sonidegib.
Croatian: Stanje dinamičke ravnoteže postignuto je otprilike 4 mjeseca nakon početka terapije sonidegibom.
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.
Croatian: Medijan dobi svih bolesnika koji su primali Odomzo 200 mg bio je 67 godina (59,5% imalo je > 65 godina), 60,8% bili su muškarci, a 89,9% bijelci.
English: • a herbal medicine called St. John's wort (also known as Hypericum perforatum) used to treat depression.
Croatian: • biljni lijek koji se zove gospina trava (poznato i kao Hypericum perforatum) a koristi za liječenje depresije.
English: If clinically notable elevation of CK is detected, renal function should be assessed (see section 4.2).
Croatian: Ako se otkriju klinički značajna povišenja CPK, potrebno je procijeniti bubrežnu funkciju (vidjeti dio 4.2).
English: to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: Uz to, odgovarajuća kategorija učestalosti za svaku nuspojavu temelji se na sljedećoj konvenciji (CIOMS III): vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: CK levels should be checked prior to starting treatment and as clinically indicated thereafter, e.g. if muscle-related symptoms are reported.
Croatian: Razine CPK potrebno je provjeriti prije početka liječenja te nakon toga prema kliničkoj indikaciji, npr. ako su prijavljeni simptomi povezani s mišićima.
English: • A core text as agreed by the CHMP
Croatian: • Osnovni tekst koji je usuglašen s CHMP-om
English: Dose modification or interruption guidelines should be followed (see section 4.2).
Croatian: Potrebno je slijediti smjernice za prilagodbu doze ili prekid doziranja (vidjeti dio 4.2).
English: The initial prescription and dispensing of Odomzo should occur within 7 days of a negative pregnancy test.
Croatian: Prvo propisivanje i izdavanje Odomza treba provesti unutar 7 dana od negativnog testa na trudnoću.
English: Sonidegib and its metabolites are eliminated primarily by the hepatic route with 93.4% of the administered dose recovered in the faeces and 1.95% recovered in urine.
Croatian: Sonidegib i njegovi metaboliti eliminiraju se prvenstveno putem jetre pri čemu se 93,4% primijenjene doze izluči u stolici, a 1,95% u mokraći.
English: If a strong CYP3A4 inducer must be used concomitantly with sonidegib, consideration should be given to increasing the daily dose of sonidegib to 400-800 mg.
Croatian: Ako se snažni induktor CYP3A4 mora primjenjivati istodobno sa sonidegibom, treba razmotriti povećanje dnevne doze sonidegiba na 400-800 mg.
English: Therefore, all patients should be monitored routinely while taking Odomzo, and cuSCC should be treated according to the standard of care.
Croatian: Stoga sve bolesnike treba rutinski pratiti dok uzimaju Odomzo, a karcinom pločastih stanica kože treba liječiti u skladu sa standardnom skrbi.
English: This is because Odomzo may cause harm or death to your unborn baby (see section “Pregnancy”).
Croatian: To je zato što Odomzo može naškoditi Vašem nerođenom djetetu ili uzrokovati njegovu smrt (vidjeti dio „Trudnoća“).
English: Time to deterioration in the pre-specified PRO scales (corresponding to >10-point worsenings without subsequent improvement) essentially mirrored the estimated PFS.
Croatian: Patient Reported Outcomes) ljestvicama (koja odgovaraju pogoršanjima od >10 bodova bez naknadnog poboljšanja) zapravo je odražavalo procijenjeni PFS.
English: • He will tell his healthcare provider if his female partner becomes pregnant while he is taking Odomzo or during the 6 months after his final dose.
Croatian: • mora reći svom zdravstvenom djelatniku ako njegova partnerica zatrudni dok on uzima Odomzo ili tijekom 6 mjeseci nakon zadnje doze.
English: You should return unused capsules at the end of your treatment.
Croatian: Neiskorištene kapsule trebate vratiti na kraju Vašeg liječenja.
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%).
Croatian: Većina bolesnika (luKBS 74%, mKBS 92%) prethodno je bila podvrgnuta terapijama koje su uključivale kirurški zahvat (luKBS 73%, mKBS 85%), radioterapiju (luKBS 18%, mKBS 54%) i antineoplastične terapije (luKBS 23%, mKBS 23%).
English: It is not known whether Odomzo can pass into your breast milk and cause harm to your baby.
Croatian: Nije poznato može li Odomzo prijeći u majčino mlijeko i naškoditi Vašem djetetu.
English: Tell your doctor or pharmacist straight away if you notice any of the following:
Croatian: Odmah se obratite svom liječniku ili ljekarniku ako primijetite bilo što od sljedećeg:
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.
Croatian: Medijan trajanja izloženosti sonidegibu tijekom ispitivanja X2104 bio je 97 dana (raspon od 34 do 511 dana) za odrasle bolesnike te 55 dana (raspon od 2 do 289 dana) za pedijatrijske bolesnike.
English: Specific instructions (the Odomzo Pregnancy Prevention Programme) given to you by your doctor contain information particularly on the effects of Odomzo on unborn babies.
Croatian: Posebne upute (Program sprječavanja trudnoće uz Odomzo) koje ste dobili od Vašeg liječnika sadrže informacije osobito o učincima
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.
Croatian: Muškarci Dok uzimate Odomzo uvijek koristite kondom (sa spermicidom, ako je dostupan) kada imate spolne odnose sa ženskom partnericom, čak i ako ste se podvrgli vazektomiji.
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.
Croatian: Od tih bolesnika, 7 (58,3%) je imalo mišićne simptome najviše stupnja 1, dok su 43 (64,1%) bolesnika koji nisu uzimali inhibitore HMG-CoA reduktaze imali simptome najviše stupnja 3.
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.
Croatian: Ako je prošlo više od šest sati od vremena kada ste trebali uzeti dozu, preskočite propuštenu dozu, a zatim uzmite sljedeću dozu u planirano vrijeme.
English: Grade 2 without renal impairment
Croatian: Stupanj 2 bez oštećenja bubrega
English: As part of the Odomzo Pregnancy Prevention Programme, all patients will receive a:
Croatian: U sklopu Programa za sprječavanje trudnoće uz Odomzo bolesnici će dobiti:
English: Teratogenic effects included vertebral, distal limb and digit malformations, severe craniofacial malformations and other severe midline defects.
Croatian: Teratogeni učinci uključivali su malformacije kralježaka, distalnih ekstremiteta i prstiju, teške kraniofacijalne malformacije i druge teške anomalije središnje linije.
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.
Croatian: Nijedan bolesnik koji je uzimao inhibitore HMG-CoA reduktaze nije imao povišenja CPK stupnja 3/4, za razliku od 6 (9,0%) bolesnika koji nisu uzimali inhibitore HMG-CoA
English: This is because it is not known whether Odomzo can pass into your breast milk and cause harm to your baby (see section “Breast-feeding”).
Croatian: To je zato što nije poznato može li Odomzo prijeći u Vaše mlijeko i naškoditi Vašem djetetu (vidjeti dio „Dojenje“).
English: Additional information on the above points can be found in the sections “Pregnancy”, “Breast-feeding”, “Fertility” and “Contraception for women and men”.
Croatian: Dodatne informacije o gore navedenome mogu se pronaći u dijelovima „Trudnoća“, „Dojenje“, „Plodnost“ i
English: • She must have a negative pregnancy test, conducted by a healthcare professional within 7 days before starting Odomzo treatment.
Croatian: • mora imati negativan test na trudnoću, koji je obavio zdravstveni djelatnik unutar 7 dana prije početka liječenja Odomzom.
English: The phase II pivotal study evaluated the safety of Odomzo in a total of 229 adult patients with locally advanced or metastatic BCC.
Croatian: Ključno ispitivanje faze II procjenjivalo je sigurnost Odomza u ukupno 229 odraslih bolesnika s lokalno uznapredovalim ili metastatskim karcinomom bazalnih stanica.
English: You must follow the Odomzo Pregnancy Prevention Programme.
Croatian: Morate slijediti Program sprječavanja trudnoće uz Odomzo.
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).
Croatian: U ključnom ispitivanju faze II, 12 (15,2%) bolesnika liječenih Odomzom 200 mg uzelo je istodobno inhibitore HMG-CoA reduktaze (9 je uzelo pravastatin, 3 je uzelo inhibitore HMG-CoA reduktaze koji nisu bili pravastatin, a uključivali su rosuvastatin i simvastatin).
English: [Grade 3 (CK elevation >5 x ULN - 10 x ULN)] [Grade 4 (CK elevation >10 x ULN)]
Croatian: [Stupanj 3 (povišenje CPK > 5 x GGN - 10 x GGN)] [Stupanj 4 (povišenje CPK > 10 x GGN)]
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%).
Croatian: U ključnom ispitivanju faze II mišićni spazmi bili su najčešći štetni događaji „povezani s mišićima“, a bili su prijavljeni u manje bolesnika u skupini koja je primala Odomzo 200 mg (54%) nego u onoj koja je primala Odomzo 800 mg (69%).
English: • To return unused capsules at the end of the treatment (disposal will depend on local requirements)
Croatian: • Da vrate neiskorištene kapsule na kraju liječenja (odlaganje će ovisiti o lokalnim zahtjevima)
English: The average steady state Ctrough for 200 mg was 830 ng/ml (range 200 to 2400 ng/ml) in cancer patients.
Croatian: Prosječni Cnajniži u stanju dinamičke ravnoteže za 200 mg bio je 830 ng/ml (raspon 200 do 2400 ng/ml) u bolesnika s rakom.