natgillin/translations-raw huggingface dataset:
There are no data on the use of sonidegib in pregnant women. 
Nema podataka o primjeni sonidegiba u trudnica.
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. 
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.
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). 
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).
• muscle cramps, muscle pain, pain in the bones, ligaments and tendons 
• grčevi mišića, mišićna bol, bol u kostima, ligamentima i tetivama
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. 
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.
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). 
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).
Each hard capsule contains 38.6 mg lactose monohydrate. 
Jedna tvrda kapsula sadrži 38,6 mg laktoze hidrata.
* 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). 
Common Terminology Criteria for Adverse Events, CTCAE) v4.03, koje je razvio Nacionalni institut za rak (SAD).
Frequency all grades 200 mg 
Učestalost svih stupnjeva 200 mg
Women of childbearing potential must be able to comply with effective contraceptive measures. 
Žene u reproduktivnoj dobi moraju biti sposobne pridržavati se učinkovitih mjera kontracepcije.
Sonidegib is also a breast cancer resistance protein (BCRP) inhibitor (IC50 ~1.5µM). 
Sonidegib je također inhibitor proteina koji uzrokuje rezistenciju raka dojke na lijekove (engl. breast cancer resistance protein, BCRP) (IC50 ~1,5µM).
Blood donation 
Darivanje krvi
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. 
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.
Agents that may increase muscle-related events 
Tvari koje mogu povećati broj događaja povezanih s mišićima
• a medicine called nefazodone used to treat depression 
• lijek koji se zove nefazodon koji se koristi za liječenje depresije
In particular tell your doctor or pharmacist if you are taking any of the following: 
Posebno obavijestite svog liječnika ili ljekarnika ako uzimate bilo što od sljedećeg:
If you stop taking Odomzo 
Ako prestanete uzimati Odomzo
If you are not sure, talk to your doctor or pharmacist before taking Odomzo. 
Ako niste sigurni, obratite se svom liječniku ili ljekarniku prije nego uzmete Odomzo.
If symptoms persist despite alternate-day dosing, consider discontinuing treatment. 
Ako simptomi ustraju usprkos doziranju svakog drugog dana, razmotriti trajni prekid liječenja.
• Patient Brochure 
• Brošuru za bolesnike
- If you are male, you should not donate semen at any time during treatment and for 6 months after the final dose. 
- Ako ste muškarac, ne smijete donirati sjeme u bilo kojem trenutku tijekom liječenja te 6 mjeseci nakon zadnje doze.
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). 
Ne smijete zatrudnjeti dok uzimate ovaj lijek (vidjeti „Trudnoća“, „Dojenje“, „Plodnost“ i „Kontracepcija za žene i muškarce“ u dijelu 2 za više informacija).
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. 
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.
Blood tests during treatment with Odomzo 
Krvne pretrage tijekom liječenja Odomzom
In the phase II pivotal study, muscle spasms, myalgia, myopathy and cases of CK elevations were observed. 
U ključnom ispitivanju faze II opaženi su mišićni spazmi, mialgija, miopatija i slučajevi povišenja CPK.
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. 
Moraju koristiti dvije metode preporučene kontracepcije, uključujući jednu visoko učinkovitu metodu i metodu barijere, tijekom terapije Odomzom te 20 mjeseci nakon zadnje doze.
Steady state was reached approximately 4 months after starting sonidegib. 
Stanje dinamičke ravnoteže postignuto je otprilike 4 mjeseca nakon početka terapije sonidegibom.
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. 
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.
• a herbal medicine called St. John's wort (also known as Hypericum perforatum) used to treat depression. 
• biljni lijek koji se zove gospina trava (poznato i kao Hypericum perforatum) a koristi za liječenje depresije.
If clinically notable elevation of CK is detected, renal function should be assessed (see section 4.2). 
Ako se otkriju klinički značajna povišenja CPK, potrebno je procijeniti bubrežnu funkciju (vidjeti dio 4.2).
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). 
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).
CK levels should be checked prior to starting treatment and as clinically indicated thereafter, e.g. if muscle-related symptoms are reported. 
Razine CPK potrebno je provjeriti prije početka liječenja te nakon toga prema kliničkoj indikaciji, npr. ako su prijavljeni simptomi povezani s mišićima.
• A core text as agreed by the CHMP 
• Osnovni tekst koji je usuglašen s CHMP-om
Dose modification or interruption guidelines should be followed (see section 4.2). 
Potrebno je slijediti smjernice za prilagodbu doze ili prekid doziranja (vidjeti dio 4.2).
The initial prescription and dispensing of Odomzo should occur within 7 days of a negative pregnancy test. 
Prvo propisivanje i izdavanje Odomza treba provesti unutar 7 dana od negativnog testa na trudnoću.
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. 
Sonidegib i njegovi metaboliti eliminiraju se prvenstveno putem jetre pri čemu se 93,4% primijenjene doze izluči u stolici, a 1,95% u mokraći.
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. 
Ako se snažni induktor CYP3A4 mora primjenjivati istodobno sa sonidegibom, treba razmotriti povećanje dnevne doze sonidegiba na 400-800 mg.
Therefore, all patients should be monitored routinely while taking Odomzo, and cuSCC should be treated according to the standard of care. 
Stoga sve bolesnike treba rutinski pratiti dok uzimaju Odomzo, a karcinom pločastih stanica kože treba liječiti u skladu sa standardnom skrbi.
This is because Odomzo may cause harm or death to your unborn baby (see section “Pregnancy”). 
To je zato što Odomzo može naškoditi Vašem nerođenom djetetu ili uzrokovati njegovu smrt (vidjeti dio „Trudnoća“).
Time to deterioration in the pre-specified PRO scales (corresponding to >10-point worsenings without subsequent improvement) essentially mirrored the estimated PFS. 
Patient Reported Outcomes) ljestvicama (koja odgovaraju pogoršanjima od >10 bodova bez naknadnog poboljšanja) zapravo je odražavalo procijenjeni PFS.
• 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. 
• mora reći svom zdravstvenom djelatniku ako njegova partnerica zatrudni dok on uzima Odomzo ili tijekom 6 mjeseci nakon zadnje doze.
You should return unused capsules at the end of your treatment. 
Neiskorištene kapsule trebate vratiti na kraju Vašeg liječenja.
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%). 
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%).
It is not known whether Odomzo can pass into your breast milk and cause harm to your baby. 
Nije poznato može li Odomzo prijeći u majčino mlijeko i naškoditi Vašem djetetu.
Tell your doctor or pharmacist straight away if you notice any of the following: 
Odmah se obratite svom liječniku ili ljekarniku ako primijetite bilo što od sljedećeg:
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. 
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.
Specific instructions (the Odomzo Pregnancy Prevention Programme) given to you by your doctor contain information particularly on the effects of Odomzo on unborn babies. 
Posebne upute (Program sprječavanja trudnoće uz Odomzo) koje ste dobili od Vašeg liječnika sadrže informacije osobito o učincima
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. 
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.
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. 
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.
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. 
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.
Grade 2 without renal impairment 
Stupanj 2 bez oštećenja bubrega
As part of the Odomzo Pregnancy Prevention Programme, all patients will receive a: 
U sklopu Programa za sprječavanje trudnoće uz Odomzo bolesnici će dobiti:
Teratogenic effects included vertebral, distal limb and digit malformations, severe craniofacial malformations and other severe midline defects. 
Teratogeni učinci uključivali su malformacije kralježaka, distalnih ekstremiteta i prstiju, teške kraniofacijalne malformacije i druge teške anomalije središnje linije.
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. 
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
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”). 
To je zato što nije poznato može li Odomzo prijeći u Vaše mlijeko i naškoditi Vašem djetetu (vidjeti dio „Dojenje“).
Additional information on the above points can be found in the sections “Pregnancy”, “Breast-feeding”, “Fertility” and “Contraception for women and men”. 
Dodatne informacije o gore navedenome mogu se pronaći u dijelovima „Trudnoća“, „Dojenje“, „Plodnost“ i
• She must have a negative pregnancy test, conducted by a healthcare professional within 7 days before starting Odomzo treatment. 
• mora imati negativan test na trudnoću, koji je obavio zdravstveni djelatnik unutar 7 dana prije početka liječenja Odomzom.
The phase II pivotal study evaluated the safety of Odomzo in a total of 229 adult patients with locally advanced or metastatic BCC. 
Ključno ispitivanje faze II procjenjivalo je sigurnost Odomza u ukupno 229 odraslih bolesnika s lokalno uznapredovalim ili metastatskim karcinomom bazalnih stanica.
You must follow the Odomzo Pregnancy Prevention Programme. 
Morate slijediti Program sprječavanja trudnoće uz Odomzo.
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). 
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).
[Grade 3 (CK elevation >5 x ULN - 10 x ULN)] [Grade 4 (CK elevation >10 x ULN)] 
[Stupanj 3 (povišenje CPK > 5 x GGN - 10 x GGN)] [Stupanj 4 (povišenje CPK > 10 x GGN)]
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%). 
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%).
• To return unused capsules at the end of the treatment (disposal will depend on local requirements) 
• Da vrate neiskorištene kapsule na kraju liječenja (odlaganje će ovisiti o lokalnim zahtjevima)
The average steady state Ctrough for 200 mg was 830 ng/ml (range 200 to 2400 ng/ml) in cancer patients. 
Prosječni Cnajniži u stanju dinamičke ravnoteže za 200 mg bio je 830 ng/ml (raspon 200 do 2400 ng/ml) u bolesnika s rakom.
The sonidegib-related toxicity reported in paediatric patients was similar to the results reported in adults, with the exceptions of a reduced incidence of muscle toxicity (e.g. CK elevations observed in 16.7% of paediatric patients compared with 50% of adults in study X2104) and the observation of post-natal development effect particularly with prolonged exposure (reported as cases of epiphyseal plate of phalanx disorder, knee subchondral condensation of area of growth plate, physeal distal femur disorder, chondropathy, and chipped tooth). 
Toksičnost povezana sa sonidegibom koja je zabilježena u pedijatrijskih bolesnika bila je slična rezultatima koji su zabilježeni u odraslih uz iznimku smanjenja incidencije mišićne toksičnosti (npr.povišenja CK zabilježena u 16,7 % pedijatrijske populacije u usporedbi s 50 % odraslih u ispitivanju X2104) i bilježenja učinka na razvoj nakon rođenja, posebice uz produljenu izloženost (zabilježeni slučajevi poremećaja epifizne ploče falange, kondenzacije subhondralne kosti koljena na području ploče rasta, poremećaja fizealnog distalnog femura, hondropatije i okrhnutih zubi).
Patient-reported outcomes were evaluated as an exploratory endpoint using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and its associated head and neck cancer specific module (H&N35). 
upitnik Europske organizacije za istraživanje i liječenje raka o kvaliteti života (EORTC QLQ-C30) i s njim povezan specifičan modul za rak glave i vrata (H&N35).
If concomitant use of a strong CYP3A inhibitor is required, the sonidegib dose should be reduced to 200 mg every other day. 
Ako je potrebna istodobna primjena snažnog CYP3A inhibitora, doza sonidegiba treba se smanjiti na 200 mg svaki drugi dan.
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). 
Žene reproduktivne dobi moraju koristiti dvije metode preporučene kontracepcije, uključujući jednu visoko učinkovitu metodu i metodu barijere dok uzimaju Odomzo i još 20 mjeseci nakon završetka liječenja (vidjeti dio 4.6).
Do not take Odomzo if you are pregnant, think you may be pregnant, or are planning to become pregnant during your treatment or during the 20 months after your treatment has finished. 
Odomzo ako ste trudni, mislite da biste mogli biti trudni ili planirate zatrudnjeti tijekom Vašeg liječenja ili tijekom 20 mjeseci nakon završetka liječenja.
Patients were treated with Odomzo 200 mg daily (n=79) or with Odomzo 800 mg daily (n=150). 
Bolesnici su bili liječeni Odomzom 200 mg na dan (n=79) ili Odomzom 800 mg na dan (n=150).
Sonidegib has not been studied in a dedicated pharmacokinetic study in patients with renal impairment. 
Sonidegib nije bio ispitivan u posebnom farmakokinetičkom ispitivanju u bolesnika s oštećenjem bubrega.
For most patients, muscle symptoms and CK elevations resolved with appropriate management. 
Za većinu bolesnika mišićni simptomi i povišenja CPK povukli su se nakon odgovarajućeg zbrinjavanja.
Aspartate amino transaminase (AST) increased 
vrlo često povišena aspartat aminotransaminaza (AST)
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. 
Cmax sonidegiba nakon jednokratne oralne doze od 800 mg bio je 20%, 21% i 60% niži u bolesnika s blagim, umjerenim odnosno teškim oštećenjem jetre, u usporedbi s onima s normalnom jetrenom funkcijom.
Sonidegib undergoes metabolism primarily by CYP3A4, and concomitant administration of strong inhibitors or inducers of CYP3A4 can increase or decrease sonidegib concentrations significantly. 
Metabolizam sonidegiba odvija se prvenstveno putem CYP3A4, a istodobna primjena snažnih inhibitora ili induktora CYP3A4 može značajno povećati ili smanjiti koncentracije sonidegiba.
If any of the above apply to you or you are not sure, talk to your doctor or pharmacist before taking Odomzo. 
Ako se bilo što od navedenog odnosi na Vas ili niste sigurni, obratite se svom liječniku ili ljekarniku prije nego uzmete Odomzo.
Aberrant Hh signalling has been linked to the pathogenesis of several types of cancer, including basal cell carcinoma (BCC). 
Aberantna Hh signalizacija povezana je s patogenezom nekoliko vrsta raka, uključujući karcinom bazalnih stanica.
It binds to Smoothened (Smo), a G protein-coupled receptor-like molecule that positively regulates the Hh pathway and eventually activates and releases glioma-associated oncogene (GLI) transcription factors which induces the transcription of Hh target genes involved in proliferation, differentiation and survival. 
Veže se na Smoothened (Smo), molekulu nalik receptoru povezanom s G proteinom koja pozitivno regulira Hh put, te posljedično aktivira i otpušta transkripcijske faktore onkogena povezanog s gliomom (GLI, engl. glioma-associated oncogene) koji inducira transkripciju
If vomiting occurs during the course of the treatment, then no re-dosing of the patient is allowed before the next scheduled dose. 
Ako dođe do povraćanja tijekom liječenja, nije dopušteno ponovno uzimanje doze prije sljedeće doze po rasporedu.
The pregnancy status of women of child-bearing potential must be established within 7 days prior to the initiation of Odomzo treatment and monthly during treatment by means of a test performed by a healthcare professional. 
Status trudnoće žena reproduktivne dobi mora se utvrditi unutar 7 dana prije početka liječenja Odomzom te svaki mjesec tijekom liječenja pomoću testa koji provodi zdravstveni djelatnik.
The most common adverse drug reactions occurring in ≥10% of patients treated with Odomzo 200 mg were muscle spasms, alopecia, dysgeusia, fatigue, nausea, musculoskeletal pain, diarrhoea, weight decreased, decreased appetite, myalgia, abdominal pain, headache, pain, vomiting and pruritus. 
Najčešće nuspojave koje su se javile u ≥ 10% bolesnika liječenih Odomzom 200 mg bile su mišićni spazmi, alopecija, disgeuzija, umor, mučnina, mišićno-koštana bol, proljev, smanjena tjelesna težina, smanjeni apetit, mialgija, bol u abdomenu, glavobolja, bol, povraćanje i pruritus.
Sonidegib was shown to be foetotoxic in rabbits, as evidenced by abortion and/or complete resorption of foetuses and teratogenic resulting in severe malformations at very low exposure. 
Pokazalo se da je sonidegib fetotoksičan u kunića, što je dokazano na temelju pobačaja i/ili kompletne resorpcije fetusa, te teratogen, što je rezultiralo teškim malformacijama pri vrlo niskoj izloženosti.
CK levels should be measured weekly for 2 months after re-administration of sonidegib and monthly thereafter. 
Razine CPK trebaju se mjeriti svaki tjedan tijekom 2 mjeseca nakon ponovnog uvođenja sonidegiba, te svaki mjesec nakon toga.
Response by digital clinical photograph was evaluated by World Health Organization (WHO) adapted criteria [partial response (PR): ≥50% decrease in the sum of the product of perpendicular diameters (SPD) of a lesion; complete response (CR): disappearance of all lesions; progressive disease: ≥25% increase in the SPD of lesions]. 
Tumorski odgovor na MR-u bio je procijenjen pomoću RECIST-a 1.1. Odgovor prema digitalnoj kliničkoj fotografiji bio je procijenjen prema prilagođenim kriterijima Svjetske zdravstvene organizacije (SZO) [djelomični odgovor (PR, engl. partial response): smanjenje od ≥ 50% u zbroju umnožaka najvećih okomitih promjera lezije (SPD, engl. sum of the product of perpendicular diameters); kompletan odgovor (CR, engl. complete response): nestanak svih lezija; progresivna bolest: povećanje od ≥ 25% u SPD-u lezija].
For sonidegib-treated male rats, exposure at approx. 2-fold the clinical exposure did not impact male fertility. 
Za mužjake štakore liječene sonidegibom, izloženost otprilike 2 puta veća od kliničke izloženosti nije utjecala na plodnost mužjaka.
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. 
Jedan bolesnik koji je primao Odomzo 200 mg imao je mišićne simptome i povišenja CPK iznad 10 x GGN i bile mu je potrebno intravenozno nadoknaditi tekućinu, u usporedbi sa 6 bolesnika koji su primali Odomzo 800 mg.
How long to take Odomzo 
Koliko dugo uzimati Odomzo