FrancophonIA/ELRC3.0 huggingface dataset:
English: • Abnormalities in your liver or pancreas (shown in blood tests).
Croatian: • poremećaji jetre ili gušterače (pokažu se pretragama krvi).
English: Vandetanib inhibits EGFR-dependent cell proliferation and cell survival in vitro.
Croatian: Vandetanib in vitro inhibira o EGFR-u ovisnu proliferaciju i preživljavanje stanica.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: • Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1. • Urođeni sindrom dugog QTc-intervala.
English: Summary of the safety profileThe most commonly reported adverse drug reactions have been diarrhoea, rash, nausea, hypertension, and headache.
Croatian: Najčešće prijavljene nuspojave lijeka bile su proljev, osip, mučnina, hipertenzija i glavobolja.
English: Vandetanib inhibits VEGF-stimulated endothelial cell migration, proliferation, survival and new blood vessel formation in in vitro models of angiogenesis.
Croatian: Vandetanib u in vitro modelima angiogeneze inhibira VEGF-om stimuliranu migraciju, proliferaciju i opstanak endotelnih stanica te stvaranje novih krvnih žila.
English: Dosing can be resumed at a reduced dose after return of the QTc interval to pretreatment status has been confirmed and correction of possible electrolyte imbalance has been made.
Croatian: Primjena lijeka može se nastaviti u nižoj dozi nakon potvrde da se QTc-interval vratio na vrijednosti prije liječenja i korekcije eventualne neravnoteže elektrolita.
English: • The dosing and monitoring guide for paediatric patients and patient's caregivers;
Croatian: • vodič za doziranje i terapijsko praćenje za pedijatrijske bolesnike i njegovatelje bolesnika
English: Vandetanib accumulates approximately 8-fold on multiple dosing with steady state achieved from approximately 2 months.
Croatian: Vandetanib se nakon višekratnog doziranja kumulira približno osmerostruko, a stanje dinamičke ravnoteže postiže se nakon otprilike dva mjeseca.
English: • Skin rash or acne.
Croatian: • kožni osip ili akne.
English: • Coughing up of blood.
Croatian: • iskašljavanje krvi.
English: If it is less than 12 hours to the next dose, the patient should not take the missed dose.
Croatian: 12 sati, bolesnik ne smije uzeti propuštenu dozu.
English: • Contact details of the CAPRELSA prescriber.
Croatian: • podatke za kontaktiranje liječnika propisivača lijeka CAPRELSA
English: For more severe skin reactions (such as Stevens-Johnson syndrome), referral of the patient to seek urgent medical advice is recommended.
Croatian: U slučaju težih kožnih reakcija (poput Stevens-Johnsonovog sindroma)
English: There is a limited amount of data on the use of vandetanib during pregnancy.
Croatian: Podaci o primjeni vandetaniba tijekom trudnoće su ograničeni.
English: 200 daily
Croatian: 200 dnevno
English: Actually 79 patients were identified by absence of an M918T mutation and no RET mutation identified at any of the other 6 exons tested but in 71 of such patients sequencing of the 6 exons was incomplete.
Croatian: U stvarnosti je pronađeno 79 bolesnika u kojih nije postojala mutacija M918T niti RET mutacija na bilo kojem od ostalih 6 ispitanih eksona;
English: Biochemical response with vandetanib as compared to placebo as measured by CTN and CEA was also assessed as secondary endpoints.
Croatian: Kao sekundarni ishod ocijenjeni su i biokemijski odgovori na vandetanib odnosno placebo, mjereni vrijednostima CTN i CEA.
English: Talk to your doctor or pharmacist before taking Caprelsa:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete lijek Caprelsa: • ako ste osjetljivi na sunčevu svjetlost.
English: Posterior reversible encephalopathy syndrome, PRES (Reversible posterior leukoencephalopathy syndrome-RPLS)
Croatian: Posterior reversible encephalopathy syndrome, PRES); [Sindrom reverzibilne posteriorne leukoencefalopatije (engl.
English: Tel: +44 (0)845 372 7101
Croatian: Sanofi Tel: +44 (0)845 372 7101
English: Insomnia, Depression
Croatian: Psihijatrijski poremećaji nesanica, depresija anksioznost
English: Cataract, accommodation disorders
Croatian: keratopatija katarakta, poremećaji akomodacije
English: Pharmacokinetic data from volunteers, suggests that no change in starting dose is required in patients with mild, moderate or severe hepatic impairment (see section 5.2).
Croatian: Farmakokinetički podaci prikupljeni u dobrovoljaca ukazuju na to da nije potrebno mijenjati početnu dozu u bolesnika s blagim, umjerenim ili teškim oštećenjem jetre (vidjeti dio 5.2).
English: • Increased pressure in the eye (glaucoma).
Croatian: • povišen očni tlak (glaukom).
English: • The summary of Product Characteristics (SmPC);
Croatian: • sažetak opisa svojstava lijeka (SPC)
English: • Before starting Caprelsa
Croatian: • prije početka liječenja lijekom Caprelsa
English: In mice, vandetanib was shown to delay but not prevent wound healing.
Croatian: U miševa je vandetanib produljio, ali ne i spriječio, zacjeljivanje rana.
English: • Upper respiratory tract infections.
Croatian: • infekcije gornjih dišnih puteva.
English: Dosing can be resumed at a reduced dose after return of the ECG QTc interval to pre-treatment status has been confirmed and correction of possible electrolyte imbalance has been made;
Croatian: Primjena lijeka može se nastaviti u nižoj dozi nakon potvrde da se QTc-interval na EKG-u vratio na vrijednosti prije liječenja i korekcije eventualne neravnoteže elektrolita.
English: In Study 58, RET mutation testing was performed by using the polymerase chain reaction (PCR) based Amplification Refractory Mutation System (ARMS) assay for the M918T mutation, and direct sequencing of DNA for mutations in exons 10, 11, 13, 14, 15 and 16 (site of M918T mutation) on all sporadic patients where DNA was available (297/298).
Croatian: M918T, te izravnim sekvenciranjem DNK za mutacije na eksonima 10, 11, 13, 14, 15 i 16 (mjesto mutacije M918T).
English: Vandetanib is not recommended for use in patients with hepatic impairment (serum bilirubin greater than 1.5 times upper limit of normal), since there is limited data in patients with hepatic impairment, and safety and efficacy have not been established.
Croatian: Ne preporučuje se primjena vandetaniba u bolesnika s oštećenjem jetrene funkcije (vrijednosti bilirubina u serumu više od 1,5 puta iznad gornje granice normale), jer su podaci o primjeni u takvih bolesnika ograničeni, a sigurnost primjene i djelotvornost nisu ustanovljene.
English: In the placebo arm, a total of 51 (51%) of patients had progressed: 46 (46%) by RECIST progression and 5 (5%) by death in the absence of progression.
Croatian: 46 bolesnika (46%) progresija je utvrđena prema RECIST-u, a 5 bolesnika (5%) je umrlo, a da nije došlo do progresije.
English: Biliary excretion of unchanged vandetanib is one of the excretion pathways for vandetanib.
Croatian: Jedan od putova eliminacije vandetaniba je izlučivanje nepromijenjenog vandetaniba putem žuči.
English: Dosing at 100mg/m2/day of the indicated posology (function of BSA) in paediatrics delivers similar exposure to that achieved in adults at 300 mg daily.
Croatian: (funkcija površine tijela) u pedijatriji donosi sličnu izloženost onoj postignutoj u odraslih s 300 mg dnevno.
English: As expected from its pharmacological actions, vandetanib has shown significant effects on all stages of female reproduction in rats (see section 5.3).
Croatian: Vandetanib je pokazao značajne učinke na sve stupnjeve reprodukcije kod ženki štakora, što je očekivano s obzirom na njegovo farmakološko djelovanje (vidjeti dio 5.3).
English: Prolongation of ECG QTc interval(*) (**)
Croatian: Srčani poremećaji produljenje QTc intervala na EKG-u (*)
English: To make sure there is no medicine left, refill the glass halfway with water and drink it.
Croatian: Kako biste zaista popili sav lijek, čašu još jednom dopola napunite vodom i popijte.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF CAPRELSA 100 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA CAPRELSE 100 mg
English: Pharmacokinetic data from volunteers, suggests that no change in starting dose is required in patients with mild, moderate or severe hepatic impairment (see sections 4.2 and 5.2).
Croatian: Farmakokinetički podaci prikupljeni u dobrovoljaca ukazuju na to da nije potrebno mijenjati početnu dozu u bolesnika s blagim, umjerenim ili teškim oštećenjem jetre (vidjeti dijelove 4.2 i 5.2).
English: • Painful urination.
Croatian: • bolno mokrenje.
English: • Gallstones (cholelithiasis).
Croatian: • žučni kamenci (kolelitijaza).
English: At a dose of 300 mg per day in MTC, ECG QTc prolongation to above 500 msec was observed in a phase III study in 11% of patients.
Croatian: Produljenje QTc-intervala na više od 500 ms opaženo je u 11% bolesnika u fazi III kliničkog ispitivanja pri primjeni doze od 300 mg na dan u liječenju medularnog karcinoma štitnjače.
English: A value > 1 favors vandetanib.
Croatian: Vrijednost > 1 ide u korist vandetaniba.
English: • CAPRELSA treatment must not be started in patients: o Whose ECG QTc interval is greater than 480 msec; o Who have congenital long QTc syndrome; o Who have a history of Torsades de pointes unless all risk factors that contributed to Torsades de pointes have been corrected;
Croatian: o koji na EKG-u imaju QTc-interval dulji od 480 ms o koji imaju urođeni sindrom dugog QTc-intervala o koji u anamnezi imaju torsades de pointes, osim ukoliko su svi rizični faktori koji su pridonijeli nastupu torsades de pointes uklonjeni.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF CAPRELSA 300 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA CAPRELSE 300 mg
English: Film-coating Hypromellose Macrogol (300) Titanium dioxide (E171)
Croatian: titanijev dioksid (E171)
English: There is limited clinical data with vandetanib in patients with MTC aged over 75.
Croatian: Klinički podaci o primjeni vandetaniba u bolesnika s medularnim karcinomom štitnjače starijih od 75 godina su ograničeni.
English: ECG QTc interval prolonged
Croatian: QTc-interval dulji od
English: It may not be reversible on stopping vandetanib.
Croatian: Zatajenje srca možda se neće povući s prestankom primjene vandetaniba.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF CAPRELSA 100 mg
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER CAPRELSE 100 mg
English: • Heart failure.
Croatian: • zatajenje srca.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF CAPRELSA 300 mg
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER CAPRELSE 300 mg
English: • How CAPRELSA is used / administered;
Croatian: • kako se lijek CAPRELSA koristi/primjenjuje;
English: Palmar-plantar erythrodysaesthiesia syndrome, alopecia
Croatian: poremećaji noktiju sindrom palmarnoplantarne eritrodizestezije, alopecija bulozni dermatitis
English: The median PFS for patients randomised to vandetanib has not been reached; however, based on statistical modelling of data observed up to the 43rd percentile, the median PFS is predicted to be
Croatian: Medijan PFS-a za bolesnike na terapiji vandetanibom nije postignut; međutim, na temelju statističkog modeliranja podataka opaženih do 43. percentile, predviđa se da je medijan PFS-a 30,5 mjeseci, uz 95%-tni interval pouzdanosti od 25,5 do 36,5 mjeseci.
English: In the event of common terminology criteria for adverse events (CTCAE) grade 3 or higher toxicity or prolongation of the ECG QTc interval, dosing with vandetanib should be at least temporarily stopped and resumed at a reduced dose when toxicity has resolved or improved to CTCAE grade 1 (see section 4.4).
Croatian: Criteria for Adverse Events, CTCAE), toksičnosti ili produljenja QTc-intervala na EKG-u, primjenu vandetaniba treba barem privremeno prekinuti te nastaviti u sniženoj dozi nakon što se toksični učinci povuku ili umanje do CTCAE stupnja 1 (vidjeti dio 4.4).
English: • Inflammation of the lung tissue.
Croatian: • upala plućnog tkiva.
English: Not reached (predicted 30.5 months)
Croatian: 30,5 mjeseci)
English: • Protein or blood in your urine (shown in a urine test).
Croatian: • bjelančevine ili krv u mokraći (pokažu se pretragama mokraće).
English: Common (affects less than 1 in 10 people)
Croatian: Često (javljaju se u manje od 1 na 10 osoba)
English: • Heart rate and rhythm disorders.
Croatian: • poremećaji brzine i ritma otkucaja srca.
English: Vitamin K antagonists
Croatian: • antagoniste vitamina
English: • Increased levels of glucose in your blood.
Croatian: • povišena razina glukoze u krvi.
English: Care should be taken with sun exposure by wearing protective clothing and/or sunscreen due to the potential risk of phototoxicity reactions associated with vandetanib treatment.
Croatian: Zbog mogućeg rizika od reakcija fototoksičnosti povezanih s liječenjem vandetanibom potreban je oprez kod izlaganja suncu uz nošenje zaštitne odjeće i/ili nanošenje sredstva za sunčanje.
English: The following adverse reactions have been identified in clinical studies with patients receiving vandetanib as treatment for MTC.
Croatian: Sljedeće su nuspojave utvrđene u kliničkim ispitivanjima u bolesnika koji su primali vandetanib za liječenje medularnog karcinoma štitnjače.
English: Table 1: Dosing nomogram for Paediatric Patients with MTC BSA (m2)
Croatian: Tablica 1: Nomogram doziranja za pedijatrijske bolesnike s medularnim karcinomom štitnjače
English: • Weakness (asthenia).
Croatian: • slabost (astenija).
English: 100 daily
Croatian: 100 dnevno
English: There are no data on the use of vandetanib in breast-feeding women.
Croatian: Nema podataka o primjeni vandetaniba u dojilja.
English: Hypokalaemia, hypercalcaemia, hyperglycemia, dehydration, hyponatremia
Croatian: Poremećaji metabolizma i prehrane smanjen tek, hipokalcijemija hipokalijemija, hiperkalcijemija, hiperglikemija, dehidracija, hiponatrijemija malnutricija
English: Food effect Exposure to vandetanib is not affected by food.
Croatian: Djelovanje hrane Hrana ne mijenja izloženost vandetanibu.
English: • vitamin K antagonists and dabigatran often referred to as ‘blood thinners'
Croatian: K i dabigatran, koji se često nazivaju „lijekovi za razrjeđivanje krvi“
English: Caprelsa 300 mg tablets
Croatian: Caprelsa 300 mg tablete
English: Disease control rate = response rate + stable disease at 24 weeks.
Croatian: Stopa kontrolirane bolesti = stopa odgovora +
English: Colitis, dry mouth, stomatitis, dysphagia, constipation, gastritis, gastrointestinal haemorrhage
Croatian: dispepsija kolitis, suha usta, stomatitis, disfagija, konstipacija, gastritis, gastrointestinalno krvarenje pankreatitis, peritonitis, ileus, perforacija crijeva, inkontinencija stolice
English: • A type of diarrhoea (colitis).
Croatian: • vrsta proljeva (kolitis).
English: Package leaflet: Information for the patient Caprelsa 100 mg film-coated tablets Caprelsa 300 mg film-coated tablets vandetanib
Croatian: Uputa o lijeku: Informacija za bolesnika Caprelsa 100 mg filmom obložene tablete Caprelsa 300 mg filmom obložene tablete vandetanib
English: Rash and other skin reactions including photosensitivity reactions and palmar-plantar erythrodysaesthesia syndrome have been observed in patients who have received vandetanib.
Croatian: U bolesnika liječenih vandetanibom zabilježeni su osip i druge kožne reakcije, uključujući reakcije fotoosjetljivosti te sindrom palmarno-plantarne eritrodizestezije.
English: Caprelsa 100 mg tablets Each film-coated tablet contains 100 mg of vandetanib.
Croatian: Caprelsa 100 mg tablete Jedna filmom obložena tableta sadrži 100 mg vandetaniba.
English: • Combinations not recommended: Methadone, haloperidol, amisulpride, chlorpromazine, sulpiride, zuclopenthixol, halofantrine, pentamidine and lumefantrine.
Croatian: • Kombinacije koje se ne preporučuju: metadon, haloperidol, amisulprid, klorpromazin, sulpirid,
English: - Keep this leaflet and the patient alert card. You may need to read it again.
Croatian: Sačuvajte ovu uputu i Karticu s upozorenjima za bolesnika.
English: • An irritation of the eyes (conjunctivitis).
Croatian: • nadraženost očiju (konjunktivitis).
English: • Increased levels of calcium in your blood.
Croatian: • povišena razina kalcija u krvi.
English: The primary efficacy outcome was ORR according to RECIST v 1.0.
Croatian: Primarni je ishod djelotvornosti bila stopa objektivnog odgovora (engl. objective response rate, ORR) prema mjerilima za ocjenu odgovora u solidnim tumorima (engl. response evaluation criteria in solid tumours, RECIST) v 1.0.
English: 37 Hollands Road Haverhill Suffolk, CB9 8PU United Kingdom
Croatian: Suffolk, CB9 8PU Ujedinjeno Kraljevstvo
English: Caprelsa 100 mg tablets
Croatian: Caprelsa 100 mg tablete
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/749/002
Croatian: EU/1/11/749/001 EU/1/11/749/002
English: • The Patient Alert Card.
Croatian: • uputu o lijeku • karticu s upozorenjima za bolesnika
English: • Pneumonia.
Croatian: • upala pluća.
English: • In the event of CTCAE grade 3 or higher toxicity or prolongation of the ECG QTc interval, dosing with vandetanib should be at least temporarily stopped and resumed at a reduced dose when toxicity has resolved or improved to CTCAE grade 1.
Croatian: • U slučaju pojave,toksičnosti ili produljenja QTc intervala na EKG- u CTCAE stupnja 3 ili višeg, primjenu vandetaniba treba barem privremeno prekinuti te nastaviti u sniženoj dozi nakon što se toksični učinci povuku ili umanje do CTCAE stupnja 1. • Bolesnici koji su na početnoj dozi (a u Tablici 1) trebaju početi iznova sa sniženom dozom (c u
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2.)
English: • Urgent desire to urinate.
Croatian: • hitan nagon za mokrenjem.
English: Impaired healing
Croatian: Nuspojave lijeka
English: Uncommon (affects less than 1 in 100 people)
Croatian: Manje često (javljaju se u manje od 1 na 100 osoba)
English: Caprelsa 300 mg tablets Each film-coated tablet contains 300 mg of vandetanib.
Croatian: Caprelsa 300 mg tablete Jedna filmom obložena tableta sadrži 300 mg vandetaniba.
English: Endocrine disorders
Croatian: Endokrini poremećaji hipotiroidizam
English: Appendicitis, staphylococcal infection, diverticulitis, cellulitis, abdominal wall abscess
Croatian: gljivična infekcija, pijelonefritis apendicitis, stafilokokna infekcija, divertikulitis, celulitis, apsces trbušne stijenke
English: It is expected that these would be uncommon adverse reactions in patients receiving vandetanib for MTC.
Croatian: Očekuje se da bi to mogle biti manje česte nuspojave u bolesnika koji primaju vandetanib za liječenje medularnog karcinoma štitnjače.
English: The pharmacokinetics of vandetanib at the 300 mg dose in MTC patients are characterised by a clearance of approximately 13.2 l/h.
Croatian: Farmakokinetiku vandetaniba pri dozi od 300 mg u bolesnika s medularnim karcinomom štitnjače obilježava klirens od oko 13,2 l/h i vrijeme polueliminacije u plazmi od približno 19 dana.
English: • Inflammation of the lining of the stomach (gastritis).
Croatian: • upala želučane sluznice (gastritis).
English: In rats, embryofoetal toxicity was evident as foetal loss, delayed foetal development, heart vessel abnormalities and precocious ossification of some skull bones.
Croatian: U štakora se embriofetalna toksičnost očitovala gubitkom ploda, kašnjenjem u razvoju ploda,
English: Heart failure, acute heart failure, rate and rhythm disorders, cardiac conduction disorders, ventricular arrhythmia and cardiac arrest
Croatian: poremećaji srčane provodljivosti, ventrikularna aritmija i zastoj srca
English: • Inflammation of the appendix (appendicitis).
Croatian: • upala slijepog crijeva (apendicitis).
English: Hypertensive crisis, ischaemic cerebrovascular conditions
Croatian: Krvožilni poremećaji hipertenzija hipertenzivna kriza, ishemijske cerebrovaskularne bolesti aneurizme i disekcije arterije
English: N-desmethyl-vandetanib is primarily produced by
Croatian: Početna doza vandetaniba bila je
English: Dose adjustments in adult patients with MTC
Croatian: Prilagodbe doze u odraslih bolesnika s medularnim karcinomom štitnjače
English: A post-hoc subgroup analysis of RET negative status based on absence of M918T mutation of the pivotal study 58 was performed.
Croatian: Ispitivanja 58, utvrđenim na temelju nepostojanja mutacije M918T.
English: Convulsion, clonus, brain oedema
Croatian: poremećaji ravnoteže, disgeuzija konvulzije, klonus, edem mozga
English: • Feeling unsteady.
Croatian: • osjećaj nestabilnosti.
English: • Decreased levels of calcium in your blood.
Croatian: • smanjena razina kalcija u krvi.
English: • Fungal infection.
Croatian: • gljivična infekcija.
English: Pneumonia, sepsis, influenza, cystitis, sinusitis, laryngitis, folliculitis, furuncle, fungal infection, pyelonephritis
Croatian: Infekcije i infestacije nazofaringitis, bronhitis, infekcije gornjih dišnih putova, infekcije mokraćnih puteva pneumonija, sepsa, gripa, cistitis, sinusitis, laringitis, folikulitis, furunkule,
English: • Inability to control your bowel movements.
Croatian: • nemogućnost kontrole stolice.
English: Vandetanib also inhibited the growth of MTC xenograft tumours in vivo.
Croatian: Vandetanib je inhibirao i rast ksenotransplantata medularnog karcinoma štitnjače in vivo.
English: Dose adjustments in paediatric patients with MTC
Croatian: Prilagodbe doze u pedijatrijskih bolesnika s medularnim karcinomom štitnjače
English: • Inflammation of the voice box (larynx).
Croatian: • upala ždrijela (larinksa).
English: • Swelling of the brain.
Croatian: • oticanje mozga.
English: Interstitial Lung Disease (ILD) has been observed in patients receiving vandetanib and some cases have been fatal.
Croatian: U bolesnika koji primaju vandetanib zabilježena je intersticijska bolest pluća, koja je u nekim slučajevima završila smrću.
English: Five out of 6 patients (83%) with moderate renal failure who were treated with vandetanib had a dose reduction to 200 mg for adverse reaction; 1 patient required a further reduction to 100 mg.
Croatian: U 5 od 6 bolesnika (83%) s umjerenim zatajenjem bubrega koji su liječeni vandetanibom, doza je zbog nuspojave smanjena na
English: • If you may become pregnant you must use effective contraception when you are taking Caprelsa and for at least four months after the last dose of Caprelsa.
Croatian: • Ako možete zatrudnjeti, morate koristiti učinkovitu kontracepciju tijekom uzimanja lijeka
English: Posology for MTC in adult patients
Croatian: Doziranje za medularni karcinom štitnjače u odraslih bolesnika
English: Caprelsa is a treatment for adults and children aged 5 years and above with: Medullary thyroid cancer that cannot be removed by surgery or has spread to other parts of the body.
Croatian: medularnim karcinomom štitnjače koji se ne može odstraniti operacijom ili se proširio na druge dijelove tijela.
English: Increase of serum ALT and AST, weight decreased blood creatinine increased
Croatian: Pretrage produljenje QTc intervala na EKG-u povišene vrijednosti ALT-a i AST-a u serumu, smanjenje tjelesne težine, povišene vrijednosti kreatinina u krvi povišene vrijednosti hemoglobina, povišene vrijednosti amilaza u serumu
English: France sanofi-aventis France
Croatian: Ελλάδα sanofi-aventis AEBE
English: • Boil.
Croatian: • bol.
English: The Caprelsa 300 mg tablet is an oval-shaped, biconvex, white film-coated tablet with ‘Z300' impressed on one side.
Croatian: Caprelsa 300 mg tableta je ovalna, bikonveksna, bijela filmom obložena tableta, s utisnutom oznakom ‘Z300' na jednoj strani.
English: QTc and serum electrolytes should be monitored more frequently.
Croatian: QTc-interval i razinu elektrolita u serumu.
English: Medicinal products known to prolong QTc interval Vandetanib has been shown to prolong the ECG QTc interval; Torsades de pointes have been uncommonly reported.
Croatian: Pokazalo se da vandetanib produljuje QTc-interval, a manje često su prijavljeni slučajevi torsades de pointes.
English: • Inflammation of the pancreas (pancreatitis).
Croatian: • upala gušterače (pankreatitis).