FrancophonIA/ELRC3.0 huggingface dataset:
English: In vivo vandetanib administration reduced tumour cell-induced angiogenesis, tumour vessel permeability, tumour microvessel density, and inhibited tumour growth of a range of human xenograft tumour models in athymic mice.
Slovenian: In vivo je uporaba vandetaniba zmanjšala tumorsko celično inducirano angiogenezo, permeabilnost tumorskih žil, gostoto tumorskega mikrožilja ter zavrla rast tumorjev v celi vrsti modelov ksenotransplantatov človeških tumorjev pri atimičnih miših.
English: • Loss of appetite (anorexia).
Slovenian: • izguba apetita (neješčnost);
English: The dosing and monitoring guide for patients and patient's caregivers should contain the following key elements:
Slovenian: Vodnik za odmerjanje in spremljanje za bolnike in njihove skrbnike, mora vsebovati naslednje ključne elemente:
English: Other side effects include:
Slovenian: Med drugimi neželenimi učinki so
English: Routine anti-diarrhoeal agents are recommended for the treatment of diarrhoea.
Slovenian: Za zdravljenje driske je priporočljivo uporabljati običajne antidiaroike.
English: • Inability to control your bowel movements.
Slovenian: • nezmožnost nadzirati iztrebljanje;
English: • How CAPRELSA dose is calculated;
Slovenian: • Kako se izračuna odmerek zdravila Caprelsa;
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.
Slovenian: Kaj je zdravilo Caprelsa in za kaj ga uporabljamo Zdravilo Caprelsa se uporablja za zdravljenje odraslih in otrok, starih 5 let in starejših, z: Medularnim rakom ščitnice, ki ga ni mogoče odstraniti z operacijo ali se je razširil v druge dele telesa.
English: If QTc increases markedly but stays below 500 msec, cardiologist advice should be sought.
Slovenian: Če se interval QTc znatno podaljša, a ostaja manjši od 500 ms, je treba poiskati nasvet kardiologa.
English: • Numbness or tingling of the skin.
Slovenian: • odrevenelost ali zbadanje v koži;
English: • Inability to heal properly.
Slovenian: • nezmožnost ustreznega celjenja;
English: An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).
Slovenian: Pogostnost: neznana razširitev in oslabitev stene krvne žile ali raztrganina v steni krvne žile (anevrizme in disekcije arterij).
English: • The other ingredients are calcium hydrogen phosphate dihydrate, microcrystalline cellulose,
Slovenian: • Pomožne snovi so kalcijev hidrogenfosfat dihidrat, mikrokristalna celuloza, krospovidon
English: Breast-feeding is contraindicated while receiving vandetanib therapy.
Slovenian: Dojenje je med zdravljenjem z vandetanibom kontraindicirano.
English: Clinical data suggest that no change in starting dose is required in patients with mild renal impairment.
Slovenian: Klinični podatki kažejo, da bolnikom z blago okvaro ledvic začetnega odmerka ni potrebno spreminjati.
English: CYP3A4, and vandetanib-N-oxide by flavin-containing monooxygenase enzymes (FM01 and FMO3).
Slovenian: N-desmetil-vandetanib nastane predvsem z delovanjem CYP3A4, vandetanib-N-oksid pa z delovanjem flavin vsebujočih monooksigenaznih encimov (FMO1 in FMO3).
English: Vandetanib at a dose of 300 mg is associated with a substantial and concentration dependent prolongation in QTc (mean 28 msec, median 35 msec).
Slovenian: Podaljšanje intervala QTc in Torsades de Pointes Vandetanib v odmerku 300 mg je povezan z znatnim, od koncentracije odvisnim podaljšanjem intervala QTc (v povprečju za 28 ms, mediana 35 ms).
English: A Phase I/II single-center open-label, single-arm study (Study IRUSZACT0098) assessed the activity of vandetanib in 16 patients with unresectable locally advanced or metastatic hereditary MTC.
Slovenian: faze z eno samo skupino (študija IRUSZACT0098) je ocenila aktivnost vandetaniba pri 16 bolnikih z inoperabilnim, lokalno napredovalim ali metastatskim dednim medularnim rakom ščitnice.
English: Fertility In rats, vandetanib had no effect on male fertility but impaired female fertility (see section 5.3).
Slovenian: Pri podganah, vandetanib ni vplival na plodnost samcev, poslabšal pa je plodnost samic (glejte poglavje 5.3).
English: Vandetanib inhibits EGFR-dependent cell proliferation and cell survival in vitro.
Slovenian: Vandetanib in vitro zavira od EGFR odvisno proliferacijo celic in preživetje celic.
English: Ocular events such as blurred vision are common in patients who received vandetanib for MTC.
Slovenian: Očesni učinki, npr. zamegljen vid, so pri bolnikih, ki so prejemali vandetanib zaradi MTC, pogosti.
English: Elevation of systolic and diastolic blood pressure was observed in rats and dogs.
Slovenian: Pri podganah in psih so opazili zvišanje sistoličnega in diastoličnega krvnega tlaka.
English: In healthy subjects, the AUC(0-t) and Cmax for digoxin (P-gp substrate) were increased by 23% and 29% respectively, when given together due to P-gp inhibition by vandetanib.
Slovenian: Pri zdravih preiskovancih se je AUC(0-t) digoksina (ki je substrat P-glikoproteina (P-gp)) povečala za 23 % in njegova Cmax za 29 %, če je bil uporabljen skupaj z vandetanibom (ki zavira P-gp).
English: Posterior reversible encephalopathy syndrome, PRES (Reversible posterior leukoencephalopathy syndrome-RPLS)
Slovenian: Sindrom posteriorne reverzibilne encefalopatije, PRES (Posterior reversible encephalopathy syndrome) (Sindrom reverzibilne posteriorne levkoencefalopatije - Reversible posterior leukoencephalopathy syndrome, RPLS)
English: A 2-year carcinogenicity study in rats was impaired by low survival in the high dose female group and limited exposure of the animals to vandetanib; however, no carcinogenic effects were observed in the remaining animals.
Slovenian: Dveletna študija kancerogenosti pri podganah je bila okrnjena zaradi majhnega preživetja v skupini samic z velikim odmerkom in omejene izpostavljenosti živali vandetanibu.
English: Vandetanib 300 mg Placebo
Slovenian: 300 mg vandetaniba placebo
English: Patients without RET mutation may have a decreased benefit from vandetanib treatment and the benefit/risk balance for this group of patients may therefore differ from that of the group with RET mutations.
Slovenian: Status mutacije RET (Rearranged during transfection) Pri bolnikih brez mutacije RET je lahko korist zdravljenja z vandetanibom manjša in razmerje korist/tveganje se za to skupino bolnikov lahko razlikuje od tistega za skupino bolnikov z mutacijo RET.
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.
Slovenian: Odmerjanje je mogoče znova uvesti v manjšem odmerku, ko je potrjeno, da je interval QTc spet takšen kot pred zdravljenjem in, da je morebitno elektrolitsko neravnovesje popravljeno.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/749/001
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/749/001
English: • Congenital long QTc syndrome.
Slovenian: • Sindrom prirojenega podaljšanja QTc.
English: • If a further event of CTCAE grade 3 or higher toxicity or prolongation of the ECG QTc interval occurs, dosing with vandetanib should be permanently stopped.
Slovenian: • Če se pojavi še en toksični učinek 3. stopnje ali več po CTCAE ali podaljšanje intervala QTc na EKG, je treba zdravljenje z vandetanibom za stalno končati.
English: • Stones or calcium deposits in the urinary tract (nephrolithiasis).
Slovenian: • kamni ali odlaganje kalcijevih soli v sečilih (nefrolitiaza);
English: Sanofi S.p.A Tel: +39 02 39394275
Slovenian: Malta Sanofi S.p.ATel: +39 02 39394275
English: Vandetanib also showed evidence of phototoxic potential in an in vitro cytotoxicity assay.
Slovenian: Vandetanib je znake fototoksičnega potenciala pokazal tudi v določanju citotoksičnosti in vitro.
English: • Pneumonia that happens when you breathe in foreign matter into your lungs.
Slovenian: • pljučnica zaradi vdihnjenja tujka v pljuča;
English: Therefore, an appropriate clinical (e.g. ECG) and/or laboratory monitoring is recommended for patients receiving concomitant digoxin and vandetanib, and such patients may require a lower dose of digoxin.
Slovenian: Bolnike, ki sočasno prejemajo digoksin in vandetanib, je zato priporočljivo ustrezno klinično (npr. EKG) in/ali laboratorijsko spremljati; takšni bolniki lahko potrebujejo nižji odmerek digoksina.
English: • The Patient Alert Card.
Slovenian: • Opozorilna kartica za bolnika.
English: • Fainting, dizziness or heart rhythm changes.
Slovenian: • omedlevica, omotica ali motnje srčnega ritma.
English: How to take Caprelsa
Slovenian: Kako jemati zdravilo Caprelsa
English: • Severe high blood pressure.
Slovenian: • visok krvni tlak.
English: Children Caprelsa should not be given to children below 5 years of age.
Slovenian: Otroci Zdravila Caprelsa ne smejo jemati otroci, mlajši od 5 let.
English: Vandetanib 300 mg 73/231
Slovenian: n mediana PFS HR 95% IZ p-vrednost vandetanib 300 mg 73/231
English: QTc prolongation and Torsades de Pointes
Slovenian: Podaljšanje QTc intervala in Torsade de pointes
English: • Disorder of the cornea of the eye (keratopathy).
Slovenian: • bolezen očesne roženice (keratopatija);
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.
Slovenian: Vandetaniba ni priporočljivo uporabljati pri bolnikih z okvaro jeter (bilirubin v serumu večji od 1,5kratnika zgornje normalne meje), ker je podatkov o bolnikih z okvaro jeter malo in varnost ter učinkovitost nista bili dokazani.
English: • Upset stomach (dyspepsia).
Slovenian: • razdražen želodec (dispepsija);
English: CEA Response
Slovenian: ODZIV CEA
English: To make sure there is no medicine left, refill the glass halfway with water and drink it.
Slovenian: Da boste popili zares vso zdravilo, kozarec še enkrat napolnite z vodo, tokrat do polovice, in vodo popijte.
English: Vandetanib and/or its metabolites is excreted into milk in rats and found in plasma of pups following dosing to lactating rats (see section 5.3).
Slovenian: Podatkov o uporabi vandetaniba pri doječih ženskah ni. Vandetanib in/ali njegovi presnovki se izločajo v mleko podgan in so jih, po uporabi pri doječih podganah, ugotovili v plazmi mladičev (glejte poglavje 5.3).
English: Your doctor may tell you to stop taking Caprelsa or take Caprelsa at a lower dose.
Slovenian: Zdravnik vam bo morda naročil, da prenehate z jemanjem zdravila Caprelsa ali, da jemljete manjši odmerek zdravila Caprelsa;
English: The prescriber must discuss the risks of Caprelsa therapy with the patient.
Slovenian: Zdravniki se morajo pogovoriti z bolnikom o tveganjih zdravljenja z zdravilom Caprelsa in bolniku zagotoviti Opozorilno kartico za bolnika.
English: • A type of diarrhoea (colitis).
Slovenian: • posebna vrsta driske (kolitis);
English: The HCPs educational materials should include the following key elements:
Slovenian: Izobraževalno gradivo za zdravstvene delavce mora vsebovati naslednje ključne elemente:
English: Heart failure, acute heart failure, rate and rhythm disorders, cardiac conduction disorders, ventricular arrhythmia and cardiac arrest
Slovenian: srčno popuščanje, akutno srčno popuščanje, motnje utripa in ritma, prevodne motnje srca, prekatna aritmija in srčna odpoved
English: There is limited clinical data with vandetanib in patients with MTC aged over 75.
Slovenian: Kliničnih podatkov o vandetanibu pri bolnikih z MTC, starejših od 75 let, je malo.
English: EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: POGOJNEGA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: • Seizures, headache, confusion or finding it difficult to concentrate.
Slovenian: • napadi krčev, glavobol, zmedenost ali težave z zbranostjo.
English: There is limited clinical experience with vandetanib in patients with unresectable locally advanced disease and without metastasis.
Slovenian: Klinične izkušnje glede uporabe vandetaniba pri bolnikih z neresektabilno lokalno napredovalo boleznijo in brez prisotne metastatske bolezni, so omejene.
English: This syndrome should be considered in any patient presenting with seizures, headache, visual disturbances, confusion or altered mental function.
Slovenian: Na ta sindrom je treba pomisliti pri bolniku, ki se mu pojavijo krči, glavobol, motnje vida, zmedenost ali motnje zavesti.
English: • The need for an ECG, and serum levels of potassium, calcium and magnesium and thyroid stimulating hormone (TSH) and the times and situations when it should be performed;
Slovenian: • Potreba po izvedbi preiskave EKG, določitvi serumskih ravni kalija, kalcija in magnezija ter tiroideo-stimulirajočega hormona.
English: • The reduced dose as specified in Table 1 could be used in paediatric patients with moderate renal impairment.
Slovenian: • je mogoče pri pediatričnih bolnikih z zmerno okvaro ledvic uporabiti manjši odmerek, naveden v preglednici 1.
English: • Abnormal color of urine.
Slovenian: • nenormalna obarvanost urina;
English: Genzyme Europe B.V., Paasheuvelweg 25
Slovenian: Genzyme Europe B.V.
English: Food effect Exposure to vandetanib is not affected by food.
Slovenian: Hrana ne vpliva na izpostavljenost vandetanibu.
English: Interstitial Lung Disease (ILD) has been observed in patients receiving vandetanib and some cases have been fatal.
Slovenian: Pri bolnikih, ki so prejemali vandetanib, so opažali intersticijsko bolezen pljuč (IBP); nekaj primerov je bilo smrtnih.
English: • Concomitant use of vandetanib with the following medicinal products known to also prolong the QTc interval and/or induce Torsades de pointes: Arsenic, cisapride, erythromycin intravenous (IV), toremifene, mizolastine, moxifloxacin, Class IA and III antiarrhythmics (see section 4.5).
Slovenian: • Sočasna uporaba vandetaniba z naslednjimi zdravili, ki prav tako podaljšajo interval QTc in / ali sprožijo Torsades de pointes: arzen, cisaprid, eritromicin intravensko (i.v.
English: ECG QTc interval prolonged
Slovenian: Zdravila, ki podaljšajo interval QTc
English: Vandetanib exposure in children between 5-8 years old with glioma-related indications was comparable to MTC patients aged 9-18 years.
Slovenian: Pri otrocih, starih od 5 do 8 let z indikacijami, povezanimi z gliomom, je bila izpostavljenost vandetanibu podobna kot pri bolnikih z medularnim rakom ščitnice, starih od 9 do 18 let.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/749/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/11/749/002
English: ECG QTc prolongation appears to be dose-dependent.
Slovenian: Kaže, da je podaljšanje intervala QTc odvisno od odmerka.
English: Insomnia, Depression
Slovenian: Psihiatrične motnje nespečnost, depresija anksioznost
English: If severe diarrhoea (CTCAE grade 3-4) develops, vandetanib should be stopped until diarrhoea improves.
Slovenian: - 4. stopnje po CTCAE), je treba zdravljenje z vandetanibom prekiniti, dokler se driska ne izboljša.
English: 95% CI
Slovenian: 95% IZ p-vrednost
English: 300 daily
Slovenian: 300 na dan
English: A single dose pharmacokinetic study in volunteers indicated that exposure to vandetanib is enhanced (up to 1.5, 1.6 and 2-fold) in mild, moderate and severe renal impaired subjects respectively compared to subjects with normal renal function (see sections 4.2, 4.4 and 4.5).
Slovenian: Farmakokinetična študija enkratnega odmerka pri prostovoljcih kaže, da je lahko izpostavljenost večja pri osebah z blago, zmerno in hudo okvaro ledvic (do 1,5, 1,6 in 2-krat) v primerjavi z osebami z normalnim delovanjem ledvic (glejte poglavja 4.2, 4.4 in 4.5).
English: Neither the Cmax nor the AUC(0-t) for vandetanib was affected when given together with ranitidine.
Slovenian: Ne Cmax ne AUC(0-t) vandetaniba se nista spremenila, če je bil uporabljen sočasno z ranitidinom.
English: Dose increase (mg)b when tolerated well after 8 weeks at starting dose
Slovenian: Preglednica 1: Nomogram za odmerjanje pri pediatričnih bolnikih z MTC Telesna površina (m2) Začetni odmerek (mg)a Povečanje odmerka (mg)b v primeru dobrega prenašanja po 8 tednih uporabe začetnega odmerka
English: • Before starting Caprelsa
Slovenian: • pred začetkom jemanja zdravila Caprelsa,
English: The Physicians' dosing and monitoring guide for paediatric patients should contain the following key elements:
Slovenian: Napake pri uporabi zdravila v pediatrični populaciji Zdravnikov vodnik za odmerjanje in spremljanje pediatričnih bolnikov mora vsebovati naslednje ključne elemente:
English: In mice, vandetanib was shown to delay but not prevent wound healing.
Slovenian: Pri miših je vandetanib upočasnil celjenje ran, ni pa ga preprečil.
English: • Upper respiratory tract infections.
Slovenian: • okužbe zgornjih dihalnih poti;
English: Biochemical response with vandetanib as compared to placebo as measured by CTN and CEA was also assessed as secondary endpoints.
Slovenian: Kot sekundarna opazovana dogodka sta bila izmerjena tudi biokemični odziv CTN in CEA z vandetanibom in placebom.
English: Caprelsa 300 mg tablets
Slovenian: Caprelsa 300 mg tablete
English: • Pneumonia.
Slovenian: • pljučnica;
English: Vandetanib has not been studied in patients with ventricular arrhythmias or recent myocardial infarction.
Slovenian: Vandetanib ni raziskan pri bolnikih s prekatnimi motnjami srčnega ritma ali nedavnim srčnim infarktom.
English: 200 daily
Slovenian: 200 na dan
English: Caprelsa 100 mg tablets
Slovenian: Caprelsa 100 mg tablete
English: • Inflammation of a follicle, especially a hair follicle.
Slovenian: • vnetje mešičkov, zlasti lasnih mešičkov;
English: What Caprelsa contains
Slovenian: Kaj vsebuje zdravilo Caprelsa
English: The pharmacokinetics of vandetanib at the 300 mg dose in MTC patients are characterised by a clearance of approximately 13.2 l/h.
Slovenian: Za farmakokinetiko vandetaniba v odmerku 300 mg pri bolnikih z MTC sta značilna očistek, ki je približno 13,2 l/h, in plazemski razpolovni čas, ki je približno 19 dni.
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).
Slovenian: V primeru toksičnih učinkov 3. stopnje ali več po CTCAE (common terminology criteria for adverse events) ali podaljšanja intervala QTc, je treba odmerjanje vandetaniba vsaj začasno končati in ga znova uvesti v zmanjšanem odmerku, ko toksični učinki izginejo ali se izboljšajo na 1. stopnjo po CTCAE (glejte poglavje 4.4).
English: INFORMATION IN BRAILLE Caprelsa 100 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Caprelsa 100 mg
English: • Inflammation of the appendix (appendicitis).
Slovenian: • vnetje slepiča (apendicitis);
English: Vandetanib has shown no carcinogenic potential effect in a 6 month carcinogenicity study in rasH2 transgenic mice.
Slovenian: V 6-mesečni študiji kancerogenosti pri transgenih miših rasH2 vandenatib ni pokazal učinka kancerogenega potenciala.
English: As expected from its pharmacological actions, vandetanib has shown significant effects on all stages of female reproduction in rats (see section 5.3).
Slovenian: Vandetanib je močno vplival na vse stopnje reprodukcije pri podganjih samicah, kot je pričakovano glede na njegovo farmakološko delovanje (glejte poglavje 5.3).
English: • Increased pressure in the eye (glaucoma).
Slovenian: • povečan pritisk v očesu (glavkom);
English: Torsades de pointes and ventricular tachycardia have been uncommonly reported in patients administered vandetanib 300 mg daily.
Slovenian: Občasno so poročali o Torsades de pointes in prekatni tahikardiji pri bolnikih, ki so prejemali 300 mg vandetaniba na dan.
English: INFORMATION IN BRAILLE Caprelsa 300 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Caprelsa 300 mg
English: • Loss of heart function.
Slovenian: • poslabšano delovanje srca;
English: • Inflammation of the lining of the stomach (gastritis).
Slovenian: • vnetje želodčne sluznice (gastritis);
English: • Tiredness.
Slovenian: • driska.
English: OVERALL SURVIVAL N Median OS HRc
Slovenian: n Mediano celokupno preživetje
English: • Inflammation of the lung tissue.
Slovenian: • vnetje pljučnega tkiva;
English: 30.5 months with 95% confidence interval 25.5 to 36.5 months.
Slovenian: Toda na podlagi statističnega modeliranja podatkov, zbranih do 43. percentila, je predvideno mediano PFS 30,5 meseca (95 % interval zaupanja: 25,5 do 36,5 mesecev).
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).
Slovenian: Farmakokinetični podatki pri prostovoljcih kažejo, da bolnikom z blago, zmerno ali hudo okvaro jeter, začetnega odmerka ni potrebno spreminjati (glejte poglavje 5.2).
English: Vandetanib inhibits VEGF-stimulated endothelial cell migration, proliferation, survival and new blood vessel formation in in vitro models of angiogenesis.
Slovenian: Vandetanib v modelih angiogeneze in vitro zavre z VEGF stimulirano migracijo, proliferacijo in preživetje endotelijskih celic ter tvorbo novih žil.
English: • An irritation of the eyes (conjunctivitis).
Slovenian: • draženje oči (konjunktivitis);
English: • Coughing up of blood.
Slovenian: • izkašljevanje krvi;
English: In healthy subjects, the Cmax for vandetanib was decreased by 15% while the AUC(0-t) for vandetanib was not affected when given together with omeprazole.
Slovenian: Pri zdravih preiskovancih se je med sočasno uporabo z omeprazolom Cmax vandetaniba zmanjšala za 15 %, AUC(0-t) vandetaniba pa se ni spremenila.
English: • Bacterial infection.
Slovenian: • bakerijska okužba;
English: It is expected that these would be uncommon adverse reactions in patients receiving vandetanib for MTC.
Slovenian: Pričakovati je mogoče, da bodo ti neželeni učinki pri bolnikih, ki prejemajo vandetanib zaradi MTC, občasni.
English: N Response rate ORb
Slovenian: CELOTNI DELEŽ ODZIVAa n delež odziva ORb
English: Visual impairment, halo vision, photopsia, glaucoma, conjunctivitis, dry eye, keratopathy
Slovenian: okvara vida, vid z odsevi ("halo-vid"), fotopsija, glavkom, konjunktivitis, suho oko, keratopatija katarakta, motnje akomodacije
English: • Heart rate and rhythm disorders.
Slovenian: • motnje srčnega utripa in ritma;
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).
Slovenian: Farmakokinetični podatki pri prostovoljcih kažejo, da bolnikom z blago, zmerno ali hudo okvaro jeter, začetnega odmerka ni potrebno spreminjati (glejte poglavji 4.2 in 5.2).
English: • Increased levels of glucose in your blood.
Slovenian: • povečanje koncentracije glukoze v vaši krvi;
English: A value > 1 favors vandetanib.
Slovenian: Vrednost > 1 je v korist vandetaniba.
English: Patients who develop a single value of a QTc interval of ≥500 msec should stop taking vandetanib.
Slovenian: Bolniki, ki se jim na EKG pojavi posamezna vrednost intervala QTc, ki je ≥ 500 ms, morajo prenehati z jemanjem vandetaniba.
English: • No change in starting dose is recommended in paediatric patients with mild renal impairment
Slovenian: • začetnega odmerka ni treba spremeniti pediatričnim bolnikom z blago okvaro ledvic.
English: • Drowsiness.
Slovenian: • dremavost;
English: * 13.4% vandetanib patients had QTc (Bazett's) ≥ 500 ms compared with 1.0% placebo patients.
Slovenian: zmanjšanje telesne mase, povečanje kreatinina v krvi povečanje serumske amilaze * 13,4 % bolnikov, ki so prejemali vandetanib, je imelo interval QTc (Bazett) ≥ 500 ms v primerjavi z 1,0 % bolnikov, ki so prejemali placebo.
English: Caprelsa 100 mg tablets Each film-coated tablet contains 100 mg of vandetanib.
Slovenian: Caprelsa 100 mg tablete Ena filmsko obložena tableta vsebuje 100 mg vandetaniba.
English: Talk to your doctor or pharmacist before taking Caprelsa:
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Caprelsa se posvetujte z zdravnikom ali farmacevtom: