natgillin/translations-raw huggingface dataset:
Patients were treated until disease progression or unacceptable toxicity.
Bolesnici su liječeni dok se nije javila progresija bolesti ili neprihvatljiva toksičnost.
These patients (n=16) showed significant prolongation of PFS (HR of 0.15) and an objective response rate of 31%.
Ovi bolesnici (n=16) su pokazali značajno produženje PFS-a (HR od 0,15) te stopu objektivnog odgovora od 31%.
65 quai Georges Gorse 92100 Boulogne-Billancourt France
65 quai Georges Gorse 92100 Boulogne-Billancourt Francuska
Cabozantinib is highly protein bound in vitro in human plasma (≥ 99.7%).
Kabozantinib se in vitro izrazito veže za proteine u ljudskoj plazmi (≥ 99,7%).
Other medicines and COMETRIQ
Drugi lijekovi i COMETRIQ
The safety and efficacy of cabozantinib in children aged <18 years have not yet been established.
Sigurnost i djelotvornost kabozantiniba u djece mlađe od 18 godina nije utvrđena.
• Decrease in the levels of protein in your blood
• Smanjenja razina proteina u krvi
• Loss of coordination in your muscles, damage to skeletal muscles
• Gubitak koordinacije mišića, oštećenje skeletnih mišića
There is limited data in patients with cardiac impairment.
Postoje ograničeni podaci o bolesnicima s oštećenjem srčane funkcije.
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:
Nuspojave koje nisu zabilježene u kliničkim ispitivanjima, ali su zapažene u životinja pri razinama ekspozicije sličnim razinama kliničke ekspozicije u ljudi i s mogućom važnošću za kliničku primjenu, bile su sljedeće:
In addition, samples will be evaluated for mutations in RAS gene hotspots (HRAS, KRAS, and NRAS genes).
Pored toga, uzorci će biti ispitani na mutacije vrućih točaka RAS gena (HRAS, KRAS i NRAS geni).
• Changes in blood tests used to monitor general health and the liver, low levels of electrolytes (like magnesium, calcium or potassium)
• Promjene krvnih nalaza kojima se prati opće zdravstveno stanje i stanje jetre, niske razine elektrolita (kao što su magnezij, kalcij ili kalij)
COMETRIQ capsules are packaged in blister cards organised by prescribed dose.
COMETRIQ kapsule su zapakirane u blister kartice uređene prema propisanoj dozi.
Each row of the blister card contains the daily dose.
Svaki red u blister kartici sadrži dnevnu dozu.
If a patient misses a dose, the missed dose should not be taken if it is less than 12 hours before the next dose.
U slučaju da bolesnik propusti uzeti dozu, propuštenu dozu ne smije uzeti ako do sljedeće doze ima manje od 12 sati.
COMETRIQ may slow or stop the growth of medullary thyroid cancer.
COMETRIQ može usporiti ili zaustaviti rast medularnog raka štitnjače.
Perforations, fistulas, and intra-abdominal abscesses
Perforacije, fistule i intraabdominalni apscesi
COMETRIQ is a medicine used to treat medullary thyroid cancer, a rare type of thyroid cancer, that cannot be removed by surgery or that has spread to other parts of the body.
COMETRIQ je lijek koji se koristi za liječenje medularnog raka štitnjače, rijetke vrste raka štitnjače koji se ne može ukloniti kirurškim zahvatom ili se proširio na druge dijelove tijela.
As unchanged contraceptive effect may not be guaranteed, an additional contraceptive method, such as a barrier method, is recommended.
Budući da nije sigurno da se kontracepcijski učinak neće promijeniti, preporučuje se korištenje dodatne metode kontracepcije, kao što su mehanička sredstva kontracepcije.
What COMETRIQ is and what it is used for 2.
Što je COMETRIQ i za što se koristi 2.
No data are available to determine a difference in PK based on race.
Nisu dostupni podaci pomoću kojih bi se odredila razlika u farmakokinetici na osnovu rase.
You may need treatment for them, or your doctor may decide to change your dose of COMETRIQ, or stop treatment altogether.
Možda ćete ih morati liječiti, ili će Vaš liječnik promijeniti dozu lijeka COMETRIQ ili pak potpuno prestati s liječenjem.
A neutralizing antibody to CYP2C9 showed a minimal effect on cabozantinib metabolite formation (ie, a <20% reduction).
Neutralizirajuće antitijelo CYP2C9 pokazalo je minimalni učinak na formaciju metabolita kabozantiniba (tj. smanjenje <20%).
No cabozantinib-treated subjects had a QTcF >500 ms.
Nitko od bolesnika koji su primali kabozantinib nije imao QTcF >500 ms.
Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor, ATC code: L01XE26.
Farmakoterapijska skupina: antineoplastička sredstva, inhibitor protein kinaze, ATK oznaka: L01XE26
Blister cards containing:
Blister kartice sadrže:
Talk to your doctor BEFORE taking COMETRIQ if you or your partner are considering or planning to have a baby after your treatment has finished.
Posavjetujte se s Vašim liječnikom PRIJE uzimanja lijeka COMETRIQ ako Vi ili Vaš partner razmišljate ili planirate imati dijete nakon završetka liječenja.
To help you remember your doses, write the date when you took your first dose in the space next to the capsules.
Kako biste si olakšali pamćenje doza, pored kapsula zapišite datum kad ste uzeli prvu dozu.
Because oral contraceptives might possibly not be considered as “effective methods of contraception,” they should be used together with another method, such as a barrier method (see section 4.5).
Budući da postoji mogućnost da oralni kontraceptivi ne predstavljaju „učinkovitu metodu kontracepcije“, moraju se koristiti uz dodatnu metodu, kao što su mehanička sredstva kontracepcije (vidjeti dio 4.5).
4.0 months
4,0 mjeseci
Cabozantinib has shown no mutagenic or clastogenic potential in a standard battery of genotoxicity assays.
Kabozantinib nije pokazao mutageni ili klastogeni potencijal u standardnom skupu testova genotoksičnosti.
Cabozantinib has a minor influence on the ability to drive and use machines.
Kabozantinib malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Dose interruptions are recommended for management of CTCAE grade 3 or greater toxicities or intolerable grade 2 toxicities.
Prekid uzimanja doza se preporučuje u slučaju zbrinjavanja toksičnosti stupnja 3 ili većeg po CTCAEu ili nepodnošljivih toksičnosti stupnja 2.
Patients should therefore be closely monitored during the first eight weeks of therapy (see section 4.4).
Stoga se mora pažljivo pratiti bolesnike tijekom prvih osam tjedana terapije (vidjeti dio 4.4).
Tell your doctor if you or your partner become pregnant or plan to become pregnant while you are being treated with COMETRIQ.
Obavijestite svog liječnika ako Vi ili Vaš partner zatrudnite ili ako planirate trudnoću tijekom liječenja lijekom COMETRIQ.
Cabozantinib should not be used during pregnancy unless the clinical condition of the woman requires treatment with cabozantinib.
Kabozantinib se mora izbjegavati tijekom trudnoće, osim ako kliničko stanje žene zahtijeva liječenje kabozantinibom.
What you need to know before you take COMETRIQ 3.
Što morate znati prije nego počnete uzimati COMETRIQ 3.
Adverse reactions such as fatigue and weakness have been associated with cabozantinib.
Nuspojave kao što su umor i slabost se povezuju s kabozantinibom.
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.
Pojava nekih ozbiljnih nuspojava (kao što je gastrointestinalna fistula) može zavisiti od kumulativne doze te se može javiti u kasnijoj fazi liječenja.
Embryo-foetal development studies were performed in rats and rabbits.
Provedena su ispitivanja embrio-fetalnog razvoja u štakora i kunića.
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.
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.
Also, some medicines can affect the way COMETRIQ works.
Isto tako, neki lijekovi mogu utjecati na način djelovanja lijeka COMETRIQ.
Management of suspected adverse drug reactions may require temporary interruption and/or dose reduction of COMETRIQ therapy.
Zbrinjavanje mogućih nuspojava na lijek može zahtijevati privremeni prekid i/ili smanjenje doze terapije lijekom COMETRIQ.
RPLS is uncommon (it affects less than 1 in 100 people).
RPLS nije čest (javlja se u manje od 1 na 100 osoba).
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.
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%.
Before initiating cabozantinib, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Prije početka primjene kabozantiniba potrebno je pažljivo razmotriti ovaj rizik u bolesnika s čimbenicima rizika kao što su hipertenzija ili aneurizma u anamnezi.
Because of high plasma protein binding levels of cabozantinib (section 5.2) a plasma protein displacement interaction with warfarin may be possible.
Zbog visokih razina vezanja kabozantiniba za proteine plazme (dio 5.2) pri istodobnoj primjeni s varfarinom moguće su interakcije istiskivanja sa proteina plazme.
Probability
Vjerojatnost
Therefore, caution should be recommended when driving or operating machines.
Stoga se mora savjetovati oprez prilikom upravljanja vozilima ili rada sa strojevima.
In vitro data demonstrate that cabozantinib is a substrate of MRP2.
In vitro podaci pokazuju da je kabozantinib supstrat MRP2.
If you or your partner could become pregnant, use adequate contraception during treatment and for at least 4 months after treatment has finished.
Ako postoji mogućnost da Vi ili Vaš partner zatrudnite, koristite odgovarajuću kontracepciju tijekom liječenja te najmanje 4 mjeseca nakon završetka liječenja.
COMETRIQ is indicated for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma.
COMETRIQ je indiciran za liječenje odraslih bolesnika s progresivnim, inoperabilnim lokalno uznapredovalim ili metastatskim medularnim karcinomom štitnjače.
• Hypertension (increase in blood pressure)
• Hipertenzija (povišen krvni tlak)
What COMETRIQ contains
Što COMETRIQ sadrži
• Anxiety, depression, confusion
• Tjeskoba, depresija, smetenost
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).
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).
It is not known whether cabozantinib and/or its metabolites are excreted in human milk.
Nije poznato izlučuje li se kabozantinib i/ili njegovi metaboliti u majčino mlijeko u ljudi.
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.
Morate također koristiti mehanička sredstva kontracepcije (npr. kondom ili dijafragmu) tijekom uzimanja lijeka COMETRIQ te najmanje 4 mjeseca nakon završetka liječenja.
If you forget to take COMETRIQ
Ako ste zaboravili uzeti COMETRIQ
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).
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).
Each blister card has enough capsules to last for seven days (one week).
Svaka blister kartica sadrži dovoljno kapsula za sedam dana (jedan tjedan).
Disease Control Rate b (95% CI) Calcitonin Responsea
Stopa kontrole bolesti b (95% CI) Odgovor kalcitoninaa
The decision to resume cabozantinib therapy after surgery should be based on clinical judgment of adequate wound healing.
Odluku o nastavku terapije kabozantinibom nakon operacije mora se donijeti na osnovu kliničke procjene o adekvatnom zacjeljivanju rane.
Ninety-two percent of patients on the cabozantinib arm had a prior thyroidectomy, and 89% were taking thyroid hormones prior to first dose.
92% bolesnika na kabozantinibu su prethodno imali tireoidektomiju, a 89% je uzimalo hormone štitnjače prije uzimanja prve doze kabozantiniba.
• Blood clots in the arteries
• Krvni ugrušci u arterijama
Cabozantinib was not carcinogenic in the rasH2 mouse model at a slightly higher exposure than the intended human therapeutic exposure.
Kabozantinib nije bio kancerogen u mišjem modelu rasH2 pri nešto većoj izloženosti od predviđene terapijske izloženosti u ljudi.
Treatment should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.
Liječenje mora trajati sve dok bolesnik ima kliničku korist od terapije ili do pojave neprihvatljive toksičnosti.
What COMETRIQ is and what it is used for
Što je COMETRIQ i za što se koristi
You should not eat anything for at least 2 hours before taking COMETRIQ and for 1 hour after taking the medicine.
Ne smijete ništa jesti najmanje 2 sata prije uzimanja lijeka COMETRIQ te 1 sat nakon uzimanja lijeka.
The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.
Europska agencija za lijekove će barem jednom godišnje procjenjivati sve nove informacije o ovom lijeku te će se ova uputa ažurirati prema potrebi.
Effect of other medicinal products on cabozantinib
Učinak drugih lijekova na kabozantinib
Tumor tissue samples initially will undergo histological evaluation, manual tumor enrichment, and DNA isolation.
Uzorci tumorskog tkiva će prvo biti podvrgnuti histološkom ispitivanju, ručnom obogaćivanju stanica tumora te izolaciji DNK.
Talk to your doctor about which methods of contraception are appropriate while you are taking COMETRIQ.
Posavjetujte se sa svojim liječnikom o odgovarajućim metodama kontracepcije tijekom uzimanja lijeka COMETRIQ.
In the case of persistent hypertension despite use of anti-hypertensives, the cabozantinib dose should be reduced.
U slučaju trajne hipertenzije unatoč primjeni antihipertenziva, mora se smanjiti dozu kabozantiniba.
Based on non-clinical safety findings, male and female fertility may be compromised by treatment with cabozantinib (see section 5.3).
Na temelju pretkliničkih podataka o sigurnosti primjene, plodnost u muškaraca i žena može biti ugrožena liječenjem kabozantinibom (vidjeti dio 5.3).
Patients should be instructed to not eat anything for at least 2 hours before through 1 hour after taking COMETRIQ.
Bolesnike se mora uputiti da ne jedu ništa najmanje 2 sata prije i 1 sat nakon uzimanja lijeka COMETRIQ.
Overall Response Ratea (95% CI)
Ukupna stopa odgovoraa (95% CI)
It is important for you to practice good mouth care during treatment with COMETRIQ.
Važno je održavati dobru higijenu usta tijekom liječenja lijekom COMETRIQ.
Selection of an alternative concomitant medicinal product with no or minimal potential to induce or inhibit CYP3A4 should be considered.
Mora se razmotriti odabir alternativnog lijeka koji se uzima istodobno, a koji je bez ili s minimalnom mogućnosti induciranja ili inhibiranja CYP3A4.
The plasma terminal half-life of cabozantinib in single dose studies in healthy volunteers is approximately 120 hours.
Terminalno poluvrijeme kabozantiniba u plazmi u ispitivanjima s jednom dozom u zdravih dobrovoljaca iznosi otprilike 120 sati.
• Hypotension (decrease in blood pressure)
• Hipotenzija (snižen krvni tlak)
Adverse reactions associated with overdose are to be treated symptomatically.
Nuspojave povezane s predoziranjem treba liječiti simptomatski.
These could be signs of bone damage in the jaw (osteonecrosis).
Ovo mogu biti znakovi oštećenja kosti u čeljusti (osteonekroza).
• A wound that does not heal.
• Rana koja ne cijeli.
• A tear or abnormal connection of the tissue in your digestive system; symptoms can include severe or persistent stomach ache
• Razdor ili abnormalno spajanje tkiva u probavnom sustavu; simptomi mogu uključivati tešku ili ustrajnu bol u želucu
Close monitoring of patients is therefore recommended during the first eight weeks of therapy (see section 4.2).
Stoga se preporučuje pažljivo praćenje bolesnika tijekom prvih osam tjedana terapije (vidjeti dio 4.2).
These may be signs of a condition called reversible posterior leukoencephalopathy syndrome (RPLS).
Ovo mogu biti simptomi stanja koje se naziva sindrom reverzibilne posteriorne leukoencefalopatije (RPLS).
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.
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.
When using cabozantinib, periodic monitoring with on-treatment ECGs and electrolytes (serum calcium, potassium, and magnesium) should be considered.
Prilikom primjene kabozantiniba, moraju se razmotriti povremene kontrole s praćenjem EKG-a i elektrolita (serumski kalcij, kalij i magnezij).
Figure 2: Kaplan-Meier curve of overall survival
Slika 2: Kaplan-Meierova krivulja ukupnog preživljenja
Psychiatric disorders anxiety, depression, confusional state abnormal dreams, delirium
Psihijatrijski poremećaji anksioznost, depresija, konfuzno stanje abnormalni snovi, delirij
A dose-comparison study (XL-184-401) (140 mg vs 60 mg) in 112 patients with hereditary or sporadic medullary thyroid cancer.
Ispitivanje usporedbe doza (XL-184-401) (140 mg u usporedbi sa 60 mg) u 112 bolesnika s nasljednim ili sporadičnim medularnim karcinomom štitnjače.
The median duration of objective responses was 14.6 months (95% CI: 11.1, 17.5) for subjects in the cabozantinib arm.
Medijan trajanja objektivnog terapijskog odgovora bio je 14,6 mjeseci (95% CI: 11,1; 17,5) za skupinu ispitanika u kojih je primjenjivan kabozantinib.
• Skin ulcers, cysts, red spots on the face or thighs
• Ulceracije na koži, ciste, crvene točkice na licu ili bedrima
Each blister card contains enough medicine for 7 days.
Svaka blister kartica sadrži količinu lijeka koja je dovoljna za 7 dana.
Cabozantinib should be discontinued if hypertension is severe and persistent despite anti-hypertensive therapy and dose reduction of cabozantinib.
Mora se prekinuti s primjenom kabozantiniba ako je hipertenzija teška i trajna unatoč primjeni antihipertenzivne terapije i smanjenju doze kabozantiniba.
• Pain in the arms, hands, legs or feet
• Bol u rukama, šakama, nogama ili stopalima
Take your next dose at the normal time.
Vašu iduću dozu uzmite u predviđeno vrijeme.
• Fungal infection that can be in the skin, mouth, or genitals
• Gljivična infekcija na koži, u ustima ili na spolnim organima
What you need to know before you take COMETRIQ
Što morate znati prije nego počnete uzimati COMETRIQ
Plasma-concentration time profiles show a second absorption peak approximately 24 hours after administration, which suggests that cabozantinib may undergo enterohepatic recirculation.
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.
• Atrial fibrillation (a fast and erratic heartbeat)
• Treperenje pretklijetki (brzi i nasumični otkucaji srca)
Samples will undergo thorough evaluation for RET and RAS mutations.
Uzorci će biti podvrgnuti temeljitom ispitivanju na postojanje mutacija RET-a i RAS-a.
Effect of cabozantinib on other medicinal products
Učinak kabozantiniba na druge lijekove
• Inflammation at the root of your hair, acne, blisters (on parts of your body other than the hands or feet)
• Upala korijena kose, akne, mjehurići (na drugim dijelovima tijela osim šaka ili stopala)
Cardiac disorders atrial fibrillation angina pectoris, supraventricular tachycardia myocardial infarction
Srčani poremećaji fibrilacija atrija angina pektoris, supraventikularna tahikardija infarkt miokarda
Therapy with COMETRIQ should be initiated by a physician experienced in the administration of anticancer medicinal products.
Terapiju lijekom COMETRIQ mora započeti liječnik koji ima iskustva s primjenom citotoksičnih lijekova.
Adverse reactions are listed in Table 1 according to MedDRA system organ class and frequency categories.
U tablici 1 navedene su nuspojave prema MedRA klasifikaciji organskih sustava i kategorijama učestalosti.
Dose reductions and dose interruptions occurred in 79% and 72%, respectively, of cabozantinib-treated patients in the pivotal clinical trial.
Smanjenje doze i prekidi doza su se javili u 79%, odnosno 72% bolesnika koji su liječeni kabozantinibom tijekom ključnog kliničkog ispitivanja.
OTHER SPECIAL WARNING(S), IF NECESSARY Dispensing instructions
DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Upute za uzimanje
26.6 months
26,6 mjeseci
The resulting DNA samples will be evaluated for quality by a PCR-based amplification test, and by Sanger sequencing for RET M918T.
Kvaliteta dobivenih uzorci DNK će se ispitivati testom amplifikacije zasnovanom na lančanoj reakciji polimeraze te Sanger sekvenciranjem na RET M918T.
Avoid becoming pregnant while being treated with COMETRIQ.
Izbjegavajte trudnoću tijekom uzimanja lijeka COMETRIQ.
• Lightening of skin, flakey skin, unusual pale skin
• Posvjetljivanje kože, ljuskava koža, neobično blijeda koža
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.
Kabozantinib je mala molekula koja inhibira višestruke receptore tirozinskih kinaza (RTK) povezane s rastom tumora i angiogenezom, patološkom pregradnjom kostiju te metastatskom progresijom raka.
• Blood clots in the veins and the lungs
• Krvni ugrušci u venama i plućima
Further genetic analysis showed that a small proportion of patients harboured somatic tumour mutations in HRAS, KRAS, or NRAS.
Daljnja genetska analiza pokazala je da je mali udio bolesnika posjedovao somatske mutacije tumora u HRAS-u, KRAS-u ili NRAS-u.
Your capsules will come in a blister card organised by prescribed dose.
Vaše kapsule dolaze u blister kartici raspoređene po propisanoj dozi.
• Weakness or reduced sensation or tingling in the limbs
• Slabost ili smanjen osjet ili trnci u udovima
Do not use this medicine after the expiry date which is stated on the blister card after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blister kartici iza oznake „Rok valjanosti“.
You should not take COMETRIQ with food.
Ne smijete uzimati COMETRIQ s hranom.
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.
S obzirom da postoji mogućnost da naškodi djetetu, majke moraju prekinuti dojenje tijekom liječenja kabozantinibom te najmanje 4 mjeseca nakon završetka terapije.