FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor if you or your partner become pregnant or plan to become pregnant while you are being treated with COMETRIQ.
Croatian: Obavijestite svog liječnika ako Vi ili Vaš partner zatrudnite ili ako planirate trudnoću tijekom liječenja lijekom COMETRIQ.
English: Cabozantinib should not be used during pregnancy unless the clinical condition of the woman requires treatment with cabozantinib.
Croatian: Kabozantinib se mora izbjegavati tijekom trudnoće, osim ako kliničko stanje žene zahtijeva liječenje kabozantinibom.
English: What you need to know before you take COMETRIQ 3.
Croatian: Što morate znati prije nego počnete uzimati COMETRIQ 3.
English: Adverse reactions such as fatigue and weakness have been associated with cabozantinib.
Croatian: Nuspojave kao što su umor i slabost se povezuju s kabozantinibom.
English: The occurrence of some serious adverse reactions (like GI fistula) might be dependent on the cumulative dose and might present in a later stage of treatment.
Croatian: Pojava nekih ozbiljnih nuspojava (kao što je gastrointestinalna fistula) može zavisiti od kumulativne doze te se može javiti u kasnijoj fazi liječenja.
English: Embryo-foetal development studies were performed in rats and rabbits.
Croatian: Provedena su ispitivanja embrio-fetalnog razvoja u štakora i kunića.
English: Women taking COMETRIQ should not breast feed during treatment and for at least 4 months after treatment has finished, as cabozantinib and/or its metabolites may be excreted in breast milk and be harmful to your child.
Croatian: Žene koje uzimaju COMETRIQ ne smiju dojiti tijekom liječenja te najmanje 4 mjeseca nakon završetka liječenja, jer se kabozantinib i/ili njegovi metaboliti mogu izlučivati u majčinom mlijeku te naškoditi djetetu.
English: Also, some medicines can affect the way COMETRIQ works.
Croatian: Isto tako, neki lijekovi mogu utjecati na način djelovanja lijeka COMETRIQ.
English: Management of suspected adverse drug reactions may require temporary interruption and/or dose reduction of COMETRIQ therapy.
Croatian: Zbrinjavanje mogućih nuspojava na lijek može zahtijevati privremeni prekid i/ili smanjenje doze terapije lijekom COMETRIQ.
English: RPLS is uncommon (it affects less than 1 in 100 people).
Croatian: RPLS nije čest (javlja se u manje od 1 na 100 osoba).
English: The objective response rates measured in these subgroups were generally consistent with the PFS results, with the RET mutation positive, negative, and unknown subgroups showing tumour response rates of 32%, 22%, and 25%, respectively.
Croatian: Stope objektivnog odgovora izmjerene u ovim podskupinama su se pokazale većinom konzistentnim s PFS rezultatima, pri čemu su skupine pozitivne na mutaciju RET-a, negativne i nepoznate pokazale stopu odgovora tumora od 32%, odnosno 22%, odnosno 25%.
English: Before initiating cabozantinib, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Croatian: Prije početka primjene kabozantiniba potrebno je pažljivo razmotriti ovaj rizik u bolesnika s čimbenicima rizika kao što su hipertenzija ili aneurizma u anamnezi.
English: Because of high plasma protein binding levels of cabozantinib (section 5.2) a plasma protein displacement interaction with warfarin may be possible.
Croatian: Zbog visokih razina vezanja kabozantiniba za proteine plazme (dio 5.2) pri istodobnoj primjeni s varfarinom moguće su interakcije istiskivanja sa proteina plazme.
English: Probability
Croatian: Vjerojatnost
English: Therefore, caution should be recommended when driving or operating machines.
Croatian: Stoga se mora savjetovati oprez prilikom upravljanja vozilima ili rada sa strojevima.
English: In vitro data demonstrate that cabozantinib is a substrate of MRP2.
Croatian: In vitro podaci pokazuju da je kabozantinib supstrat MRP2.
English: If you or your partner could become pregnant, use adequate contraception during treatment and for at least 4 months after treatment has finished.
Croatian: Ako postoji mogućnost da Vi ili Vaš partner zatrudnite, koristite odgovarajuću kontracepciju tijekom liječenja te najmanje 4 mjeseca nakon završetka liječenja.
English: COMETRIQ is indicated for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma.
Croatian: COMETRIQ je indiciran za liječenje odraslih bolesnika s progresivnim, inoperabilnim lokalno uznapredovalim ili metastatskim medularnim karcinomom štitnjače.
English: • Hypertension (increase in blood pressure)
Croatian: • Hipertenzija (povišen krvni tlak)
English: What COMETRIQ contains
Croatian: Što COMETRIQ sadrži
English: • Anxiety, depression, confusion
Croatian: • Tjeskoba, depresija, smetenost
English: For patients in whom Rearranged during Transfection (RET) mutation status is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision (see important information in sections 4.4 and 5.1).
Croatian: Rearranged during Transfection) protoonkogena nepoznat ili negativan, mora se uzeti u obzir mogućnost smanjene koristi prije donošenja pojedinačne odluke o liječenju (vidjeti bitne informacije u dijelovima 4.4. i 5.1).
English: It is not known whether cabozantinib and/or its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuje li se kabozantinib i/ili njegovi metaboliti u majčino mlijeko u ljudi.
English: You should also use a barrier contraceptive (e.g. condom or diaphragm) whilst taking COMETRIQ and for at least 4 months after treatment has finished.
Croatian: Morate također koristiti mehanička sredstva kontracepcije (npr. kondom ili dijafragmu) tijekom uzimanja lijeka COMETRIQ te najmanje 4 mjeseca nakon završetka liječenja.
English: If you forget to take COMETRIQ
Croatian: Ako ste zaboravili uzeti COMETRIQ
English: Bile salt-sequestering agents such as cholestyramine and cholestagel may interact with cabozantinib and may impact absorption (or reabsorption) resulting in potentially decreased exposure (see section 5.2).
Croatian: Sekvestranti žučne kiseline poput kolestiramina i lijeka Cholestagel mogu ući u interakciju s kabozantinibom i utjecati na apsorpciju (ili reapsorpciju) te dovesti do mogućeg smanjenja izloženosti (vidjeti dio 5.2).
English: Each blister card has enough capsules to last for seven days (one week).
Croatian: Svaka blister kartica sadrži dovoljno kapsula za sedam dana (jedan tjedan).
English: Disease Control Rate b (95% CI) Calcitonin Responsea
Croatian: Stopa kontrole bolesti b (95% CI) Odgovor kalcitoninaa
English: The decision to resume cabozantinib therapy after surgery should be based on clinical judgment of adequate wound healing.
Croatian: Odluku o nastavku terapije kabozantinibom nakon operacije mora se donijeti na osnovu kliničke procjene o adekvatnom zacjeljivanju rane.
English: Ninety-two percent of patients on the cabozantinib arm had a prior thyroidectomy, and 89% were taking thyroid hormones prior to first dose.
Croatian: 92% bolesnika na kabozantinibu su prethodno imali tireoidektomiju, a 89% je uzimalo hormone štitnjače prije uzimanja prve doze kabozantiniba.
English: • Blood clots in the arteries
Croatian: • Krvni ugrušci u arterijama
English: Cabozantinib was not carcinogenic in the rasH2 mouse model at a slightly higher exposure than the intended human therapeutic exposure.
Croatian: Kabozantinib nije bio kancerogen u mišjem modelu rasH2 pri nešto većoj izloženosti od predviđene terapijske izloženosti u ljudi.
English: Treatment should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.
Croatian: Liječenje mora trajati sve dok bolesnik ima kliničku korist od terapije ili do pojave neprihvatljive toksičnosti.
English: What COMETRIQ is and what it is used for
Croatian: Što je COMETRIQ i za što se koristi
English: You should not eat anything for at least 2 hours before taking COMETRIQ and for 1 hour after taking the medicine.
Croatian: Ne smijete ništa jesti najmanje 2 sata prije uzimanja lijeka COMETRIQ te 1 sat nakon uzimanja lijeka.
English: The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.
Croatian: Europska agencija za lijekove će barem jednom godišnje procjenjivati sve nove informacije o ovom lijeku te će se ova uputa ažurirati prema potrebi.
English: Effect of other medicinal products on cabozantinib
Croatian: Učinak drugih lijekova na kabozantinib
English: Tumor tissue samples initially will undergo histological evaluation, manual tumor enrichment, and DNA isolation.
Croatian: Uzorci tumorskog tkiva će prvo biti podvrgnuti histološkom ispitivanju, ručnom obogaćivanju stanica tumora te izolaciji DNK.
English: Talk to your doctor about which methods of contraception are appropriate while you are taking COMETRIQ.
Croatian: Posavjetujte se sa svojim liječnikom o odgovarajućim metodama kontracepcije tijekom uzimanja lijeka COMETRIQ.
English: In the case of persistent hypertension despite use of anti-hypertensives, the cabozantinib dose should be reduced.
Croatian: U slučaju trajne hipertenzije unatoč primjeni antihipertenziva, mora se smanjiti dozu kabozantiniba.
English: Based on non-clinical safety findings, male and female fertility may be compromised by treatment with cabozantinib (see section 5.3).
Croatian: Na temelju pretkliničkih podataka o sigurnosti primjene, plodnost u muškaraca i žena može biti ugrožena liječenjem kabozantinibom (vidjeti dio 5.3).
English: Patients should be instructed to not eat anything for at least 2 hours before through 1 hour after taking COMETRIQ.
Croatian: Bolesnike se mora uputiti da ne jedu ništa najmanje 2 sata prije i 1 sat nakon uzimanja lijeka COMETRIQ.
English: Overall Response Ratea (95% CI)
Croatian: Ukupna stopa odgovoraa (95% CI)
English: It is important for you to practice good mouth care during treatment with COMETRIQ.
Croatian: Važno je održavati dobru higijenu usta tijekom liječenja lijekom COMETRIQ.
English: Selection of an alternative concomitant medicinal product with no or minimal potential to induce or inhibit CYP3A4 should be considered.
Croatian: Mora se razmotriti odabir alternativnog lijeka koji se uzima istodobno, a koji je bez ili s minimalnom mogućnosti induciranja ili inhibiranja CYP3A4.
English: The plasma terminal half-life of cabozantinib in single dose studies in healthy volunteers is approximately 120 hours.
Croatian: Terminalno poluvrijeme kabozantiniba u plazmi u ispitivanjima s jednom dozom u zdravih dobrovoljaca iznosi otprilike 120 sati.
English: • Hypotension (decrease in blood pressure)
Croatian: • Hipotenzija (snižen krvni tlak)
English: Adverse reactions associated with overdose are to be treated symptomatically.
Croatian: Nuspojave povezane s predoziranjem treba liječiti simptomatski.
English: These could be signs of bone damage in the jaw (osteonecrosis).
Croatian: Ovo mogu biti znakovi oštećenja kosti u čeljusti (osteonekroza).
English: • A wound that does not heal.
Croatian: • Rana koja ne cijeli.
English: • A tear or abnormal connection of the tissue in your digestive system; symptoms can include severe or persistent stomach ache
Croatian: • Razdor ili abnormalno spajanje tkiva u probavnom sustavu; simptomi mogu uključivati tešku ili ustrajnu bol u želucu
English: Close monitoring of patients is therefore recommended during the first eight weeks of therapy (see section 4.2).
Croatian: Stoga se preporučuje pažljivo praćenje bolesnika tijekom prvih osam tjedana terapije (vidjeti dio 4.2).
English: These may be signs of a condition called reversible posterior leukoencephalopathy syndrome (RPLS).
Croatian: Ovo mogu biti simptomi stanja koje se naziva sindrom reverzibilne posteriorne leukoencefalopatije (RPLS).
English: Cabozantinib is a substrate for CYP3A4 metabolism in vitro, as a neutralizing antibody to CYP3A4 inhibited formation of metabolite XL184 N-oxide by >80% in a NADPH-catalyzed human liver microsomal (HLM) incubation; in contrast, neutralizing antibodies to CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C19, CYP2D6 and CYP2E1 had no effect on cabozantinib metabolite formation.
Croatian: Kabozantinib je supstrat za metabolizam CYP3A4 in vitro; kao neutralizirajuće antitijelo CXP3A4 inhibirao je formaciju metabolita XL184 N-oksida za >80% u mikrosomalnoj inkubaciji ljudske jetre (HLM) kataliziranoj NADP-om; za razliku od toga, neutralizirajuća antitijela CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C19, CYP2D6 i CYP2E1 nisu imala učinak na formaciju metabolita kabozantiniba.
English: When using cabozantinib, periodic monitoring with on-treatment ECGs and electrolytes (serum calcium, potassium, and magnesium) should be considered.
Croatian: Prilikom primjene kabozantiniba, moraju se razmotriti povremene kontrole s praćenjem EKG-a i elektrolita (serumski kalcij, kalij i magnezij).
English: Figure 2: Kaplan-Meier curve of overall survival
Croatian: Slika 2: Kaplan-Meierova krivulja ukupnog preživljenja
English: Psychiatric disorders anxiety, depression, confusional state abnormal dreams, delirium
Croatian: Psihijatrijski poremećaji anksioznost, depresija, konfuzno stanje abnormalni snovi, delirij
English: A dose-comparison study (XL-184-401) (140 mg vs 60 mg) in 112 patients with hereditary or sporadic medullary thyroid cancer.
Croatian: Ispitivanje usporedbe doza (XL-184-401) (140 mg u usporedbi sa 60 mg) u 112 bolesnika s nasljednim ili sporadičnim medularnim karcinomom štitnjače.
English: The median duration of objective responses was 14.6 months (95% CI: 11.1, 17.5) for subjects in the cabozantinib arm.
Croatian: Medijan trajanja objektivnog terapijskog odgovora bio je 14,6 mjeseci (95% CI: 11,1; 17,5) za skupinu ispitanika u kojih je primjenjivan kabozantinib.
English: • Skin ulcers, cysts, red spots on the face or thighs
Croatian: • Ulceracije na koži, ciste, crvene točkice na licu ili bedrima
English: Each blister card contains enough medicine for 7 days.
Croatian: Svaka blister kartica sadrži količinu lijeka koja je dovoljna za 7 dana.
English: Cabozantinib should be discontinued if hypertension is severe and persistent despite anti-hypertensive therapy and dose reduction of cabozantinib.
Croatian: Mora se prekinuti s primjenom kabozantiniba ako je hipertenzija teška i trajna unatoč primjeni antihipertenzivne terapije i smanjenju doze kabozantiniba.
English: • Pain in the arms, hands, legs or feet
Croatian: • Bol u rukama, šakama, nogama ili stopalima
English: Take your next dose at the normal time.
Croatian: Vašu iduću dozu uzmite u predviđeno vrijeme.
English: • Fungal infection that can be in the skin, mouth, or genitals
Croatian: • Gljivična infekcija na koži, u ustima ili na spolnim organima
English: What you need to know before you take COMETRIQ
Croatian: Što morate znati prije nego počnete uzimati COMETRIQ
English: Plasma-concentration time profiles show a second absorption peak approximately 24 hours after administration, which suggests that cabozantinib may undergo enterohepatic recirculation.
Croatian: Profil ovisnosti koncentracije u plazmi o vremenu pokazuju drugu vršnu vrijednost apsorpcije otprilike 24 sata nakon primjene, što ukazuje na mogućnost da kabozantinib podliježe enterohepatičkoj recirkulaciji.
English: • Atrial fibrillation (a fast and erratic heartbeat)
Croatian: • Treperenje pretklijetki (brzi i nasumični otkucaji srca)
English: Samples will undergo thorough evaluation for RET and RAS mutations.
Croatian: Uzorci će biti podvrgnuti temeljitom ispitivanju na postojanje mutacija RET-a i RAS-a.
English: Effect of cabozantinib on other medicinal products
Croatian: Učinak kabozantiniba na druge lijekove
English: • Inflammation at the root of your hair, acne, blisters (on parts of your body other than the hands or feet)
Croatian: • Upala korijena kose, akne, mjehurići (na drugim dijelovima tijela osim šaka ili stopala)
English: Cardiac disorders atrial fibrillation angina pectoris, supraventricular tachycardia myocardial infarction
Croatian: Srčani poremećaji fibrilacija atrija angina pektoris, supraventikularna tahikardija infarkt miokarda
English: Therapy with COMETRIQ should be initiated by a physician experienced in the administration of anticancer medicinal products.
Croatian: Terapiju lijekom COMETRIQ mora započeti liječnik koji ima iskustva s primjenom citotoksičnih lijekova.
English: Adverse reactions are listed in Table 1 according to MedDRA system organ class and frequency categories.
Croatian: U tablici 1 navedene su nuspojave prema MedRA klasifikaciji organskih sustava i kategorijama učestalosti.
English: Dose reductions and dose interruptions occurred in 79% and 72%, respectively, of cabozantinib-treated patients in the pivotal clinical trial.
Croatian: Smanjenje doze i prekidi doza su se javili u 79%, odnosno 72% bolesnika koji su liječeni kabozantinibom tijekom ključnog kliničkog ispitivanja.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Dispensing instructions
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Upute za uzimanje
English: 26.6 months
Croatian: 26,6 mjeseci
English: The resulting DNA samples will be evaluated for quality by a PCR-based amplification test, and by Sanger sequencing for RET M918T.
Croatian: Kvaliteta dobivenih uzorci DNK će se ispitivati testom amplifikacije zasnovanom na lančanoj reakciji polimeraze te Sanger sekvenciranjem na RET M918T.
English: Avoid becoming pregnant while being treated with COMETRIQ.
Croatian: Izbjegavajte trudnoću tijekom uzimanja lijeka COMETRIQ.
English: • Lightening of skin, flakey skin, unusual pale skin
Croatian: • Posvjetljivanje kože, ljuskava koža, neobično blijeda koža
English: Cabozantinib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumour growth and angiogenesis, pathologic bone remodeling, and metastatic progression of cancer.
Croatian: Kabozantinib je mala molekula koja inhibira višestruke receptore tirozinskih kinaza (RTK) povezane s rastom tumora i angiogenezom, patološkom pregradnjom kostiju te metastatskom progresijom raka.
English: • Blood clots in the veins and the lungs
Croatian: • Krvni ugrušci u venama i plućima
English: Further genetic analysis showed that a small proportion of patients harboured somatic tumour mutations in HRAS, KRAS, or NRAS.
Croatian: Daljnja genetska analiza pokazala je da je mali udio bolesnika posjedovao somatske mutacije tumora u HRAS-u, KRAS-u ili NRAS-u.
English: Your capsules will come in a blister card organised by prescribed dose.
Croatian: Vaše kapsule dolaze u blister kartici raspoređene po propisanoj dozi.
English: • Weakness or reduced sensation or tingling in the limbs
Croatian: • Slabost ili smanjen osjet ili trnci u udovima
English: Do not use this medicine after the expiry date which is stated on the blister card after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blister kartici iza oznake „Rok valjanosti“.
English: You should not take COMETRIQ with food.
Croatian: Ne smijete uzimati COMETRIQ s hranom.
English: Because of the potential harm to the infant, mothers should discontinue breast-feeding during treatment with cabozantinib, and for at least 4 months after completing therapy.
Croatian: S obzirom da postoji mogućnost da naškodi djetetu, majke moraju prekinuti dojenje tijekom liječenja kabozantinibom te najmanje 4 mjeseca nakon završetka terapije.
English: Fresh tumour samples for tumour genetic analysis from the most recent metastatic site in patients enrolled in the dose-comparison study should be collected.
Croatian: Za genetsku analizu tumora se mora uzeti svježe uzorke tumora s najnovijeg mjesta pojave metastaza u bolesnika koji su uključeni u ispitivanje usporedbe doza.
English: COMETRIQ should not be taken with food.
Croatian: COMETRIQ se ne smije uzimati s hranom.
English: 11.2 months
Croatian: 11,2 mjeseca
English: A replacement sample will be requested if an original sample fails during the PCR quality or the Sanger sequencing tests.
Croatian: Zamjenski uzorak će se zatražiti ako originalni uzorak ne prođe testove kvalitete zasnovane na lančanoj reakciji polimeraze ili testove Sanger sekvenciranja.
English: Two non-conjugated metabolites (XL184-N-oxide and XL184 amide cleavage product), which possess <1% of the on-target kinase inhibition potency of parent cabozantinib, each represent <10% of total drug-related plasma exposure.
Croatian: Dva nekonjugirana metabolita (XL184-N-oksid i XL184 produkt cijepanja amida), koji posjeduju <1% sposobnost inhibicije ciljne kinaze ishodišnog kabozantiniba, pri čemu svaki predstavlja <10% ukupne ekspozicije vezane za lijek u plazmi.
English: Four metabolites were present in plasma at exposures (AUC) greater than 10% of parent: XL184-N-oxide, XL184 amide cleavage product, XL184 monohydroxy sulfate, and 6-desmethyl amide cleavage product sulfate.
Croatian: Četiri metabolita su bila prisutna pri ekspoziciji u plazmi (AUC) većoj od 10% u odnosu na ishodišnu tvar, a to su: XL184-N-oksid, XL184 produkt cijepanja amida, XL184 monohidroksi sulfat i 6-dezmetil produkt cijepanja amid sulfata.
English: Patients with cardiac impairment
Croatian: Bolesnici s oštećenjem srčane funkcije
English: 20 mg and 80 mg
Croatian: 20 mg i 80 mg
English: Protein binding was not altered in subjects with mild or moderately impaired renal or hepatic function.
Croatian: Vezivanje za proteine nije bilo izmijenjeno u ispitanika s blagim ili umjerenim oštećenjem funkcije bubrega ili jetre.
English: Mean clearance (CL/F) at steady-state in cancer patients was estimated to be 4.4 L/hr in a population PK analysis.
Croatian: Srednja vrijednost klirensa (CL/F) u stanju dinamičke ravnoteže u bolesnika s rakom je procijenjena na 4,4 L/h u analizi populacijske farmakokinetike.
English: Cabozantinib should be discontinued in patients with wound healing complications requiring medical intervention.
Croatian: Primjena kabozantiniba se mora prekinuti u bolesnika u kojih se jave komplikacije sa cijeljenjem rana koje zahtijevaju medicinsku intervenciju.
English: Table 1: Adverse reactions reported with cabozantinib
Croatian: Tablica 1: Nuspojave prijavljene kod primjene kabozantiniba
English: If you get side effects, your doctor may tell you to take COMETRIQ at a lower dose.
Croatian: Ako Vam se jave nuspojave, liječnik Vam može reći da smanjite dozu lijeka COMETRIQ.
English: 1495 - 190 Algés
Croatian: Miraflores P-1495 - 190 Algés
English: Cabozantinib should be used with caution in patients with a history of QT interval prolongation, patients who are taking antiarrhythmics, or patients with relevant pre-existing cardiac disease, bradycardia, or electrolyte disturbances.
Croatian: Kabozantinib se mora primjenjivati s oprezom u bolesnika s anamnezom produljenja QT intervala, u bolesnika koji uzimaju antiaritmike ili u bolesnika s relevantnom postojećom srčanom bolesti, bradikardijom ili poremećajima elektrolita.
English: Findings in uterus/ovaries and decreased haematopoiesis appeared to be transient, while effects on bone parameters and liver pigmentation were sustained.
Croatian: Promjene na maternici/jajnicima te smanjena hematopoeza su se pokazale prolaznim, dok su učinci na parametre kostiju i pigmentaciju jetre bili dugoročni.
English: • Swelling in the face and in other parts of the body
Croatian: • Oticanje lica i drugih dijelova tijela
English: Endocrine disorders hypothyroidism
Croatian: Endokrini poremećaji hipotireoza
English: Centralized, independent, blinded review of the imaging data was used in the assessment of PFS and ORR.
Croatian: U procjeni PFS-a i ORR-a korištena je centralizirana, neovisna, slijepa analiza slikovnih podataka.
English: Women of childbearing potential/Contraception in males and females Women of childbearing potential must be advised to avoid pregnancy while on cabozantinib.
Croatian: Žene reproduktivne dobi/Kontracepcija u muškaraca i žena Žene reproduktivne dobi moraju biti savjetovane da izbjegavaju trudnoću dok primaju kabozantinib.
English: Cabozantinib is a CYP3A4 substrate.
Croatian: Kabozantinib je supstrat CYP3A4.
English: Monitor for adverse events and adjust dose or use dosing interruption as needed (see section 4.2).
Croatian: Potrebno je pratiti nuspojave te prilagoditi dozu ili prekinuti primjenu lijeka po potrebi (vidjeti dio 4.2).