FrancophonIA/ELRC3.0 huggingface dataset:
English: See also section 4 “Possible side effects”.
Croatian: Također pogledajte dio 4 “Moguće nuspojave”.
English: Tell your doctor straight away if you notice any of the following side effects - you may need urgent medical treatment:
Croatian: Odmah se obratite svom liječniku ako primijetite bilo koje od sljedećih nuspojava - možda će Vam biti potrebna hitna medicinska pomoć:
English: It may help shrink tumours associated with this type of cancer.
Croatian: Može pomoći smanjiti tumore povezane s ovom vrstom raka.
English: Dose reductions are recommended for events that, if persistent, could become serious or intolerable.
Croatian: Smanjenje doze se preporučuje u događajima koji, ako potraju, mogu postati ozbiljni ili nepodnošljivi.
English: The median time to first dose reduction was 43 days, and to first dose interruption was 33 days.
Croatian: Medijan vremena do prvog smanjenja doze iznosio je 43 dana, a do prvog prekida doze 33 dana.
English: Component of a 28 day pack, can't be sold separately.
Croatian: Sastojci pakiranja za 28 dana ne mogu se prodavati odvojeno.
English: For an additional 115 subjects the RET mutational status could not be determined or was unclear.
Croatian: Kod preostalih 115 ispitanika RET mutacijski status se nije mogao odrediti ili nije bio dovoljno jasan.
English: In case of such combination, INR values should be monitored.
Croatian: U slučaju takve kombinacije, potrebno je pratiti INR vrijednosti.
English: To remove the capsules for your dose:
Croatian: Da biste izvadili kapsule za svoju dozu:
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Croatian: Molimo obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli bilo koje druge lijekove, uključujući lijekove koje ste nabavili bez recepta.
English: No specific dosing recommendations can be made.
Croatian: Nije moguće dati specifične preporuke o doziranju.
English: You should continue to take this medicine until your doctor decides to stop your treatment.
Croatian: Morate uzimati ovaj lijek dok Vaš liječnik ne odluči prekinuti Vaše liječenje.
English: The capsules should be swallowed whole and not opened.
Croatian: Kapsule se mora progutati cijele i neotvorene.
English: The clinical significance of these potential interactions is unknown.
Croatian: Nije poznat klinički značaj ovih mogućih interakcija.
English: Depending on the dose you were prescribed, the number of capsules to take are as follows:
Croatian: Ovisno o dozi koja vam je propisana, broj kapsula koje trebate uzeti je sljedeći:
English: COMETRIQ is not recommended for children or adolescents.
Croatian: COMETRIQ se ne preporučuje za djecu i adolescente.
English: Your doctor may also prescribe other medicines to help control your side effects.
Croatian: Liječnik Vam također može propisati druge lijekove koji će pomoći kontrolirati nuspojave.
English: Not Known (unknown frequency)
Croatian: Nepoznato (učestalost nije poznata)
English: The capsule contains an off-white to white powder.
Croatian: Kapsula sadrži gotovo bijeli do bijeli prašak.
English: Do not store above 25°C.
Croatian: Ne čuvati na temperaturi iznad 25ºC.
English: 30 September
Croatian: 30 rujna 2020
English: Evaluations in juvenile rats (comparable to a <2 year old pediatric population) have not been performed.
Croatian: Ispitivanja na mladim štakorima (koji su usporedivi s pedijatrijskom populacijom starosti <2 godine) nisu provedena.
English: (1/55)c a Response = CR + PR b Disease Control Rate = SD+ ORR c Includes patients who were evaluable for response
Croatian: (1/55)c a Odgovor = CR + PR b Stopa kontrole bolesti = SD+ ORR c Uključuje bolesnike koji su bili podobni za odgovor
English: Two dose reductions were required in 41% of patients.
Croatian: U 41% bolesnika bila su potrebna dva smanjenja doze.
English: The clinical relevance of the observed neoplastic lesions in rats is uncertain, but likely to be low.
Croatian: Klinički značaj uočenih neoplastičnih lezija u štakora nije izvjestan, ali je vjerojatno nizak.
English: COMETRIQ should be taken once a day.
Croatian: COMETRIQ se mora uzimati jednom dnevno.
English: T. Narbuto 5,
Croatian: Narbuto 5,
English: Median Overall Survival
Croatian: Medijan ukupnog preživljenja
English: No specific dose adjustment for the use of cabozantinib in older people (≥ 65 years) is recommended.
Croatian: Nije preporučena specifična prilagodba doze prilikom uporabe kabozantiniba u starijih osoba (≥ 65 godina).
English: There are no data on human fertility.
Croatian: Nema podataka o učinku na ljudsku plodnost.
English: Date of first authorisation: 21 March 2014 Date of latest renewal: 28 March 2019
Croatian: Datum posljednje obnove odobrenja: 28. ožujka 2019.
English: Do not take COMETRIQ - if you are allergic to cabozantinib or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati COMETRIQ - ako ste alergični na kabozantinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: This could mean that your doctor needs to change the dose(s) that you take.
Croatian: Vaš liječnik bi prema tome trebao promijeniti dozu(e) koju uzimate.
English: Push capsule through foil
Croatian: Gurnite kapsulu kroz foliju
English: Your doctor will determine if you need your dose adjusted, particularly during the first eight weeks of therapy with COMETRIQ.
Croatian: Vaš liječnik će odlučiti je li potrebno prilagoditi Vašu dozu, naročito tijekom prvih osam tjedana terapije lijekom COMETRIQ.
English: PVC/PE/PCTFE-Al blisters with foil backing, sealed into a secondary heat-sealed card packaging.
Croatian: PVC/PE/PCTFE-Al blisteri s pokrovnom folijom, toplinom zalijepljeni u sekundarno kartično pakiranje.
English: Based on the populationpharmacokinetic (PK) model, the volume of distribution (V/F) is approximately 349 L (SE: ± 2.73%).
Croatian: Na osnovu populacijsko-farmakokinetičkog (PK) modela, volumen distribucije (V/F) iznosi otprilike 349 L (SE: ± 2,73%).
English: Studies in animals have shown embryo-foetal and teratogenic effects (see section 5.3).
Croatian: Ispitivanja na životinjama su pokazala embriofetalne i teratogene učinke (vidjeti dio 5.3).
English: Next generation sequencing of RET exons 10, 11, and 13-16 will be performed, which covers the vast majority of known RET mutations.
Croatian: Provest će se sekvenciranje nove generacije RET egzona 10, 11 i 13-16, koje pokriva veliku većinu poznatih mutacija RET-a.
English: Both men and women should be advised to seek advice and consider fertility preservation before treatment.
Croatian: Muškarce i žene mora se savjetovati da potraže savjet i razmisle o očuvanju plodnosti prije liječenja.
English: Talk to your doctor or pharmacist before taking COMETRIQ if you:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete COMETRIQ ako:
English: Keep in mind that treatment with COMETRIQ may make you feel tired or weak.
Croatian: Imajte na umu da se od lijeka COMETRIQ možete osjećati umorno ili slabo.
English: If you take COMETRIQ whilst using oral contraceptives, the oral contraceptives may be ineffective.
Croatian: Ako uzimate COMETRIQ tijekom korištenja oralnih kontraceptiva, može se dogoditi da oralni kontraceptivi ne budu učinkoviti.
English: It should be expected that a majority of patients treated with COMETRIQ will require one or more dose adjustments (reduction and/or interruption) due to toxicity.
Croatian: Mora se očekivati da će u većine bolesnika koji se liječe lijekom COMETRIQ biti potrebno jedno ili više prilagođavanja doze (smanjenje i/ili prekid) zbog toksičnosti.
English: PK assessments will be required for all subjects (both dose groups).
Croatian: Farmakokinetičke procjene će biti nužne za sve ispitanike (za obje dozne skupine).
English: • Decreased appetite, weight loss, altered sense of taste
Croatian: • Smanjen apetit, gubitak težine, izmijenjen osjet okusa
English: Take all capsules in one row each day without food (patients should fast for at least 2 hours before through 1 hour after taking the capsules).
Croatian: Uzimajte sve kapsule odjednom svakodnevno bez hrane (bolesnici moraju biti natašte najmanje 2 sata prije uzimanja i 1 sat nakon uzimanja kapsula).
English: • Hair colour changes (lightening), hair loss
Croatian: • Promjene boje kose (posvjetljivanje), gubitak kose
English: As most events can occur early in the course of treatment, the physician should evaluate the patient closely during the first eight weeks of treatment to determine if dose modifications are warranted.
Croatian: Obzirom da se većina događaja može razviti u ranoj fazi liječenja, liječnik mora pažljivo pratiti bolesnika tijekom prvih osam tjedana liječenja kako bi odredio jesu li potrebne prilagodbe doze.
English: If you have taken more COMETRIQ than you have been instructed to, talk to a doctor or go to the hospital with the capsules and this leaflet straight away.
Croatian: Ako ste uzeli više lijeka COMETRIQ nego što ste trebali, obratite se liječniku ili odmah otiđite u bolnicu i ponesite kapsule i ovu uputu.
English: There is no information on the precise food-effect when taken 1 hour after administration of cabozantinib.
Croatian: Ne postoje podaci o preciznom učinku hrane uzete 1 sat nakon primjene kabozantiniba.
English: If you take more COMETRIQ than you should
Croatian: Ako uzmete više lijeka COMETRIQ nego što ste trebali
English: However, a trend in increased rate of SAEs has been observed in subjects aged 75 years and older.
Croatian: Međutim, primijećen je povećan broj ozbiljnih nuspojava u osoba u dobi od 75 ili više godina.
English: Avoid consuming grapefruit-containing products for as long as you are using this medicine, as it may increase the levels of COMETRIQ in your blood.
Croatian: Izbjegavajte konzumiranje proizvoda koji sadrže grejp cijelo vrijeme tijekom korištenja ovog lijeka, jer on može povećati razinu lijeka COMETRIQ u krvi.
English: Patients should be advised regarding oral hygiene practice.
Croatian: Bolesnike se mora savjetovati o održavanju oralne higijene.
English: More information on the blister cards including how many capsules you will take and how many capsules there are in total in each blister card are described below in section 6.
Croatian: Više informacija o blister karticama, uključujući i koliko kapsula trebate uzeti te koliko ima ukupno kapsula u svakoj blister kartici, je opisano ispod, u dijelu 6.
English: Female partners of male patients taking cabozantinib must also avoid pregnancy.
Croatian: Ženske partnerice muških bolesnika koji primaju kabozantinib također moraju izbjegavati trudnoću.
English: Table 2: Summary of key efficacy findings
Croatian: Tablica 2: Sažetak ključnih nalaza o djelotvornosti
English: Catalent UK Packaging Limited Lancaster Way, Wingates Industrial Park, Westboughton, Bolton, Lancashire, BL5 3XX, United Kingdom
Croatian: Catalent UK Packaging Limited Lancaster Way, Wingates Industrial Park, Westhoughton, Bolton, Lancashire, BL5 3XX, Ujedinjeno Kraljevstvo
English: • Stopping menstruation, vaginal bleeding
Croatian: • Izostanak menstruacije, vaginalno krvarenje
English: Metabolic clinical laboratory parameters should be monitored at least weekly or as deemed clinically appropriate to assess any possible changing trends.
Croatian: Metaboličke kliničke laboratorijske parametre mora se pratiti barem jednom tjedno ili kako se klinički smatra potrebnim za procjenju bilo kojih mogućih promjena.
English: Each day, take all the capsules across the row.
Croatian: Svaki dan uzmite sve kapsule iz jednog reda.
English: The carcinogenic potential of cabozantinib has been evaluated in two species: rasH2 transgenic mice and Sprague-Dawley rats.
Croatian: Kancerogeni potencijal kabozantiniba procijenjen je u dvije vrste: u rasH2 transgeničnih miševa i Sprague-Dawley štakora.
English: Record date of first dose.
Croatian: Zabilježite datum uzimanja prve doze.
English: • Vomiting or coughing up blood, which may be bright red or look like coffee grounds.
Croatian: • Povraćanje ili iskašljavanje krvi, koja može biti svijetlocrvena ili izgledati kao talog kave.
English: There is no specific treatment for cabozantinib overdose and possible symptoms of overdose have not been established.
Croatian: Ne postoji posebno liječenje za predoziranje kabozantinibom, a mogući simptomi predoziranja nisu utvrđeni.
English: Frequencies are based on all grades and defined as: very common (≥1/10), common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100), not known (cannot be estimated from the available data).
Croatian: Učestalost se temelji na svim stupnjevima i definira se kao: vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10); manje često (≥ 1/1000 do < 1/100), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Duration of Response; Median (95% CI)
Croatian: Trajanje odgovora; Medijan (95% CI)
English: These may be signs of a gastrointestinal perforation, a hole that develops in your stomach or intestine that could be life-threatening.
Croatian: Ovo mogu biti znakovi gastrointestinalne perforacije, puknuća koje se razvija u Vašem želucu ili crijevima, a koja može biti opasno po život.
English: The effects of COMETRIQ in people younger than 18 years old are not known.
Croatian: Nisu poznati učinci lijeka COMETRIQ na osobe mlađe od 18 godina.
English: • Increase in the level of bilirubin in your blood (which may result in jaundice/yellow skin or eyes)
Croatian: • Povećana razina bilirubina u krvi (što može dovesti do pojave žutice/žutila kože ili žutih očiju)
English: This effect was not associated with a change in cardiac wave form morphology or new rhythms.
Croatian: Ovaj učinak nije bio povezan s promjenom oblika srčane krivulje ili promjenom ritma.
English: • Changes in test results that measure blood clotting or blood cells
Croatian: • Promjene u rezultatima nalaza koji mjere zgrušavanje krvi ili krvne stanice
English: Common (1/100 to <1/10)
Croatian: Često (1/100 do<1/10)
English: Fertility studies in rats have shown reduced male and female fertility.
Croatian: Ispitivanja plodnosti u štakora su pokazala smanjenju plodnost kod mužjaka i ženki.
English: • Loss of attention, loss of consciousness, changes in speech, delirium, abnormal dreams
Croatian: • Gubitak pažnje, gubitak svijesti, promjene u govoru, delirij, abnormalni snovi
English: You should also tell your dentist that you are taking COMETRIQ.
Croatian: Također morate obavijestiti svog stomatologa ako uzimate COMETRIQ.
English: • Loss of taste
Croatian: • Gubitak osjeta okusa
English: Results will be used to evaluate the exposure to cabozantinib at the 60 and 140 mg dose levels and to further characterize the population PK models and exposure response relationships of cabozantinib and possible metabolites in this population.
Croatian: Rezultati će se koristiti za procjenu ekspozicije kabozantiniba pri dozama od 60 i 140 mg, kao i za daljnje karakteriziranje farmakokinetičkih modela populacije i veze odgovora ekspozicije između kabozantiniba i potencijalnih metabolita u ovoj populaciji.
English: Swallow the capsules one at a time with water.
Croatian: Progutajte kapsule s vodom, jednu po jednu.
English: The effect of cabozantinib on the pharmacokinetics of contraceptive steroids has not been investigated.
Croatian: Učinak kabozantiniba na farmakokinetiku kontracepcijskih steroida nije ispitan.
English: If you experience serious side effects, your doctor may decide to change your dose or stop treatment earlier than originally planned.
Croatian: Ako Vam se jave ozbiljne nuspojave, Vaš liječnik može odlučiti promijeniti dozu ili prekinuti liječenje ranije nego što je prethodno predviđeno.
English: All patients should be monitored for hypertension and treated as needed with standard anti-hypertensive therapy.
Croatian: Sve bolesnike mora se kontrolirati na hipertenziju i liječiti po potrebi standardnom antihipertenzivnom terapijom.
English: The primary objective was to compare progression-free survival (PFS) in patients receiving cabozantinib versus patients receiving placebo.
Croatian: Primarni cilj ispitivanja bio je usporediti preživljenje bez progresije bolesti (PFS) u bolesnika koji primaju kabozantinib s bolesnicima koji primaju placebo.
English: Cabozantinib was metabolized in vivo.
Croatian: Kabozantinib se metabolizirao in vivo.
English: This is because COMETRIQ can affect the way some other medicines work.
Croatian: To je bitno zato što COMETRIQ može utjecati na način djelovanja nekih drugih lijekova.
English: If there are still 12 hours or more before your next dose is due then take the missed dose as soon as you remember.
Croatian: Ako ima još 12 ili više sati do iduće doze, uzmite propuštenu dozu čim se sjetite.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with cabozantinib in one or more subsets of the paediatric population in the treatment of malignant solid tumours (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka kabozantinib u jednoj ili više podskupina pedijatrijske populacije u liječenju malignih solidnih tumora (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Patients were treated until disease progression or unacceptable toxicity.
Croatian: Bolesnici su liječeni dok se nije javila progresija bolesti ili neprihvatljiva toksičnost.
English: These patients (n=16) showed significant prolongation of PFS (HR of 0.15) and an objective response rate of 31%.
Croatian: Ovi bolesnici (n=16) su pokazali značajno produženje PFS-a (HR od 0,15) te stopu objektivnog odgovora od 31%.
English: 65 quai Georges Gorse 92100 Boulogne-Billancourt France
Croatian: 65 quai Georges Gorse 92100 Boulogne-Billancourt Francuska
English: Cabozantinib is highly protein bound in vitro in human plasma (≥ 99.7%).
Croatian: Kabozantinib se in vitro izrazito veže za proteine u ljudskoj plazmi (≥ 99,7%).
English: Other medicines and COMETRIQ
Croatian: Drugi lijekovi i COMETRIQ
English: The safety and efficacy of cabozantinib in children aged <18 years have not yet been established.
Croatian: Sigurnost i djelotvornost kabozantiniba u djece mlađe od 18 godina nije utvrđena.
English: • Decrease in the levels of protein in your blood
Croatian: • Smanjenja razina proteina u krvi
English: • Loss of coordination in your muscles, damage to skeletal muscles
Croatian: • Gubitak koordinacije mišića, oštećenje skeletnih mišića
English: There is limited data in patients with cardiac impairment.
Croatian: Postoje ograničeni podaci o bolesnicima s oštećenjem srčane funkcije.
English: 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:
Croatian: 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:
English: In addition, samples will be evaluated for mutations in RAS gene hotspots (HRAS, KRAS, and NRAS genes).
Croatian: Pored toga, uzorci će biti ispitani na mutacije vrućih točaka RAS gena (HRAS, KRAS i NRAS geni).
English: • Changes in blood tests used to monitor general health and the liver, low levels of electrolytes (like magnesium, calcium or potassium)
Croatian: • Promjene krvnih nalaza kojima se prati opće zdravstveno stanje i stanje jetre, niske razine elektrolita (kao što su magnezij, kalcij ili kalij)
English: COMETRIQ capsules are packaged in blister cards organised by prescribed dose.
Croatian: COMETRIQ kapsule su zapakirane u blister kartice uređene prema propisanoj dozi.
English: Each row of the blister card contains the daily dose.
Croatian: Svaki red u blister kartici sadrži dnevnu dozu.
English: If a patient misses a dose, the missed dose should not be taken if it is less than 12 hours before the next dose.
Croatian: U slučaju da bolesnik propusti uzeti dozu, propuštenu dozu ne smije uzeti ako do sljedeće doze ima manje od 12 sati.
English: COMETRIQ may slow or stop the growth of medullary thyroid cancer.
Croatian: COMETRIQ može usporiti ili zaustaviti rast medularnog raka štitnjače.
English: Perforations, fistulas, and intra-abdominal abscesses
Croatian: Perforacije, fistule i intraabdominalni apscesi
English: 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.
Croatian: 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.
English: As unchanged contraceptive effect may not be guaranteed, an additional contraceptive method, such as a barrier method, is recommended.
Croatian: Budući da nije sigurno da se kontracepcijski učinak neće promijeniti, preporučuje se korištenje dodatne metode kontracepcije, kao što su mehanička sredstva kontracepcije.
English: What COMETRIQ is and what it is used for 2.
Croatian: Što je COMETRIQ i za što se koristi 2.
English: No data are available to determine a difference in PK based on race.
Croatian: Nisu dostupni podaci pomoću kojih bi se odredila razlika u farmakokinetici na osnovu rase.
English: You may need treatment for them, or your doctor may decide to change your dose of COMETRIQ, or stop treatment altogether.
Croatian: Možda ćete ih morati liječiti, ili će Vaš liječnik promijeniti dozu lijeka COMETRIQ ili pak potpuno prestati s liječenjem.
English: A neutralizing antibody to CYP2C9 showed a minimal effect on cabozantinib metabolite formation (ie, a <20% reduction).
Croatian: Neutralizirajuće antitijelo CYP2C9 pokazalo je minimalni učinak na formaciju metabolita kabozantiniba (tj. smanjenje <20%).
English: No cabozantinib-treated subjects had a QTcF >500 ms.
Croatian: Nitko od bolesnika koji su primali kabozantinib nije imao QTcF >500 ms.
English: Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor, ATC code: L01XE26.
Croatian: Farmakoterapijska skupina: antineoplastička sredstva, inhibitor protein kinaze, ATK oznaka: L01XE26
English: Blister cards containing:
Croatian: Blister kartice sadrže:
English: 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.
Croatian: Posavjetujte se s Vašim liječnikom PRIJE uzimanja lijeka COMETRIQ ako Vi ili Vaš partner razmišljate ili planirate imati dijete nakon završetka liječenja.
English: To help you remember your doses, write the date when you took your first dose in the space next to the capsules.
Croatian: Kako biste si olakšali pamćenje doza, pored kapsula zapišite datum kad ste uzeli prvu dozu.
English: 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).
Croatian: 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).
English: 4.0 months
Croatian: 4,0 mjeseci
English: Cabozantinib has shown no mutagenic or clastogenic potential in a standard battery of genotoxicity assays.
Croatian: Kabozantinib nije pokazao mutageni ili klastogeni potencijal u standardnom skupu testova genotoksičnosti.
English: Cabozantinib has a minor influence on the ability to drive and use machines.
Croatian: Kabozantinib malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Dose interruptions are recommended for management of CTCAE grade 3 or greater toxicities or intolerable grade 2 toxicities.
Croatian: Prekid uzimanja doza se preporučuje u slučaju zbrinjavanja toksičnosti stupnja 3 ili većeg po CTCAEu ili nepodnošljivih toksičnosti stupnja 2.
English: Patients should therefore be closely monitored during the first eight weeks of therapy (see section 4.4).
Croatian: Stoga se mora pažljivo pratiti bolesnike tijekom prvih osam tjedana terapije (vidjeti dio 4.4).