FrancophonIA/ELRC3.0 huggingface dataset:
English: In the event of an overdose, further doses must be interrupted, and appropriate measures taken to assure that an adverse event has not occurred, i.e. ECG within 24 hours to determine QTc prolongation.
Slovenian: V primeru prevelikega odmerjanja je treba nadaljnjo uporabo zdravila prekiniti in ustrezno ukrepati za zagotovitev, da se ni pojavil kakšen neželeni učinek, tj. EKG v 24 urah za ugotovitev podaljšanja QTc.
English: Table 3: Summary of other efficacy findings in study 58 ORRa
Slovenian: Povzetek drugih izsledkov o učinkovitosti v študiji 58
English: • Failure of the lungs to function properly.
Slovenian: • nezmožnost ustreznega delovanja pljuč;
English: Most patients (81.3%) had undergone partial or total thyroidectomy prior to study entry.
Slovenian: Pri večini bolnikov (81,3 %) je bila pred vstopom v študijo opravljena delna ali popolna odstranitev ščitnice.
English: Frequent ECG monitoring of the QTc interval should be continued.
Slovenian: Nadaljevati je treba pogosto spremljanje intervala QTc.
English: These findings occurred at clinically-relevant plasma concentrations, were largely reversible within 4 weeks of cessation of dosing and were attributable to inhibition of vascular endothelial growth factor receptor (VEGFR) or EGFR.
Slovenian: Te spremembe so se pojavile pri klinično pomembnih koncentracijah v plazmi, bile so v veliki meri reverzibilne v 4 tednih po prenehanju uporabe zdravila in so jih pripisali zavrtju receptorja žilnega endotelijskega rastnega dejavnika (VEGFR) ali EGFR.
English: ECGs and blood tests should also be obtained as clinically indicated during this period and afterwards.
Slovenian: Prav tako je treba med tem obdobjem in pozneje posneti EKG in opraviti preiskave krvi kot je klinično indicirano.
English: A randomised, double-blind, placebo-controlled study (Study 58) was conducted to demonstrate safety and efficacy of vandetanib 300 mg versus placebo.
Slovenian: Opravljena je bila randomizirana, dvojno slepa, s placebom kontrolirana študija (študija 58) varnosti in učinkovitosti 300 mg vandetaniba v primerjavi s placebom.
English: Table 4: Summary of efficacy findings in a segment of patients according to RET mutation status
Slovenian: Povzetek ugotovitev glede učinkovitosti pri delu bolnikov glede na status mutacije RET
English: Due to the increased thrombotic risk in patients with cancer, the use of anticoagulation is frequent.
Slovenian: Zaradi večjega tveganja za trombozo je uporaba antikoagulantov pri bolnikih z rakom pogosta.
English: Survival status and the median final overall survival (81.6 months in the vandetanib arm and 80.4 months in the placebo arm) were similar across both treatment arms.
Slovenian: Stanje preživetja in mediano končno celokupno preživetje (81,6 meseca v skupini z vandetanibom in 80,4 meseca v skupini s placebom) sta bila v obeh terapevtskih skupinah podobna.
English: Patients should not take a double dose (two doses at the same time) to make up for a forgotten dose.
Slovenian: Bolnik ne sme vzeti dvojnega odmerka (dveh odmerkov hkrati), če je pozabil vzeti prejšnji odmerek.
English: Their frequency is presented in Table 2, adverse reactions using Council for International Organizations of Medical Sciences (CIOMS III), listed by MedDRA System Organ Class (SOC) and at the preferred term level and then by frequency classification.
Slovenian: Njihova pogostnost je prikazana v Preglednici 2, neželeni učinki zdravila z uporabo CIOMS III (Council for International Organizations of Medical Sciences) ter navajanja po organskih sistemih (SOC - System Organ Class) po MedDRA na ravni prednostnega termina in nato po razvrstitvi pogostnosti.
English: Dosing for paediatric patients should be on the basis of BSA in mg/m2.
Slovenian: Odmerjanje pri pediatričnih bolnikih mora temeljiti na telesni površini v mg/m2.
English: Biliary excretion of unchanged vandetanib is one of the excretion pathways for vandetanib.
Slovenian: Biliarno izločanje nespremenjenega vandetaniba je ena od poti izločanja vandetaniba.
English: When establishing RET mutation status, tissue samples should be obtained if possible at the time of initiation of treatment rather than at the time of diagnosis (see sections 4.1 and 5.1).
Slovenian: Če je mogoče, je treba za določitev statusa mutacije RET pridobiti tkivne vzorce ob uvedbi zdravljenja in ne ob času postavitve diagnoze (glejte poglavji 4.1 in 5.1).
English: For patients who have difficulty swallowing, vandetanib tablets may be dispersed in half a glass of non-carbonated drinking water.
Slovenian: Bolniki, ki imajo težave s požiranjem, lahko tablete vandetaniba raztopijo v pol kozarca negazirane pitne vode.
English: Vandetanib may be administered until disease progression or until the benefits of treatment continuation do no longer outweigh its risk, thereby considering the severity of adverse events (see sections 4.8) in relation to the degree of clinical stabilization of the tumour status.
Slovenian: Vandetanib se lahko uporablja do napredovanja bolezni ali do tedaj, ko koristi nadaljnjega zdravljenja ne odtehtajo več njegovih tveganj; pri tem je treba upoštevati izrazitost neželenih dogodkov (glejte poglavje 4.8) v primerjavi s stopnjo klinične stabilizacije stanja tumorja.
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.
Slovenian: V kraku s placebom se je napredovanje pojavilo pri skupaj 51 (51 %) bolnikov; pri 46 (46 %) so ugotovili napredovanje po RECIST in 5 (5 %) bolnikov je umrlo, ne da bi se pojavilo napredovanje.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist straight away.
Slovenian: Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, takoj obvestite svojega zdravnika ali farmacevta.
English: Patients with no M918T mutation and other mutations not tested or negative (n=79)*
Slovenian: Bolniki brez mutacije M918T in brez preskušanja za druge mutacije ali pa so te negativne (n = 79)*
English: M918T mutation is the most frequent mutation observed in patients with sporadic MTC; however it cannot be ruled out that some patients tested RET negative for M918T mutation might be positive for mutation on other exons.
Slovenian: Mutacija M918T je najpogostejša mutacija, opažena pri bolnikih s sporadničnim MTC; kljub temu se ne more izključiti možnosti, da so nekateri bolniki, preskušani za mutacijo RET, negativni za mutacijo M918T, lahko pozitivni za mutacijo na drugih eksonih.
English: The MAH shall ensure that in each Member State where CAPRELSA is marketed, all healthcare professionals (HCPs) and patients / caregivers who are expected to prescribe, dispense and use CAPRELSA have access to/are provided with an educational package containing:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer se zdravilo CAPRELSA trži, vsi zdravstveni delavci in bolniki/skrbniki, za katere se pričakuje, da bodo predpisovali, izdajali in uporabljali zdravilo Caprelsa, prejeli paket izobraževalnih gradiv, ki vsebuje:
English: If you forget to take Caprelsa
Slovenian: Če ste pozabili vzeti zdravilo Caprelsa
English: PVC/ PVDC/Alu blisters, sealed with aluminium foil, each containing 30 film-coated tablets.
Slovenian: Pretisni omoti iz PVC/PVDC/Alu, zapečateni z aluminijasto folijo; en pretisni omot vsebuje 30 filmsko obloženih tablet.
English: The precise mechanism of action of vandetanib in locally advanced or metastatic MTC is unknown.
Slovenian: Jasen mehanizem delovanja vandetaniba pri lokalno napredovalem ali metastatskem MTC ni znan.
English: N-desmethyl-vandetanib and vandetanib-N-oxide circulate at concentrations of approximately 11% and 1.4% of those of vandetanib.
Slovenian: N-desmetil-vandetanib in vandetanib-N-oksid krožita v koncentracijah, ki so približno 11 % in 1,4 % koncentracije vandetaniba.
English: The safety and efficacy of Caprelsa in children below 5 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila Caprelsa pri otrocih, mlajših od 5 let nista bili dokazani.
English: Long term safety data in paediatric patients are not available.
Slovenian: Dolgoročnih podatkov o varnosti pri pediatričnih bolnikih ni na voljo.
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.
Slovenian: • Če bi lahko zanosili, morate med jemanjem zdravila Caprelsa in še vsaj štiri mesece po zadnjem odmerku zdravila Caprelsa uporabljati učinkovito kontracepcijo.
English: Additional monitoring of QTc, electrolytes and renal function are required especially in case of diarrhoea, increase in diarrhoea/dehydration, electrolyte imbalance and/or impaired renal function.
Slovenian: Dodatno spremljanje intervala QTc, elektrolitov in delovanja ledvic je zahtevano zlasti v primeru driske, pogostejšega pojavljanja driske/dehidracije, elektrolitskega neravnovesja in/ali okvare delovanja ledvic.
English: Your doctor may also prescribe other medicines to help control your side effects.
Slovenian: Predpiše vam lahko tudi druga zdravila za pomoč pri obvladovanju neželenih učinkov.
English: • Inflammation of the diverticula (small bulging pouches that can form in your digestive system).
Slovenian: • vnetje divertikula (majhna, izbokla vrečica, ki lahko nastane v vaših prebavilih);
English: There is no experience with Caprelsa in patients 5-8 years of age in this study.
Slovenian: V tej študiji ni bilo izkušenj z zdravilom Caprelsa pri bolnikih, starih od 5 do 8 let.
English: • Signs or symptoms of the safety concerns and when to seek attention from a HCP;
Slovenian: • Znake in simptome varnostnih tveganj in kdaj je treba poiskati zdravniško pomoč.
English: In order to confirm the efficacy and safety of Caprelsa in RET-negative patients, the MAH should submit:
Slovenian: Za potrditev učinkovitosti in varnosti zdravila Caprelsa pri bolnikih, negativnih za RET, mora imetnik dovoljenja za promet predložiti:
English: Diarrhoea is a disease related symptom as well as a known undesirable effect of vandetanib.
Slovenian: Driska je z boleznijo povezan simptom, kakor tudi znan neželeni učinek vandetaniba.
English: • vitamin K antagonists and dabigatran often referred to as ‘blood thinners'
Slovenian: • antagoniste vitamina K in dabigatran, ki jih pogosto imenujejo 'zdravila za redčenje krvi'
English: Twenty-eight of the 231 patients (12.1%) on vandetanib and 3 of the 99 (3.0%) on placebo discontinued treatment because of an adverse event.
Slovenian: Osemindvajset od 231 (12,1 %) prejemnikov vandetaniba in 3 od 99 (3,0 %) prejemnikov placeba je zdravljenje prekinilo zaradi neželenega dogodka.
English: Starting vandetanib dose was 100mg/m2/day for all patients except for one who started at 150mg/m2/day.
Slovenian: Začetni odmerek vandetaniba je bil 100 mg/m2/dan pri vseh bolnikih razen pri enem, ki je zdravljenje začel s 150 mg/m2/dan.
English: Do not take a double dose (two doses at the same time) to make up for a forgotten tablet.
Slovenian: Ne vzemite dvojnega odmerka (dveh odmerkov hkrati), če ste pozabili vzeti prejšnjo tableto.
English: • 1, 3 and 6 weeks after starting Caprelsa
Slovenian: • 1, 3 in 6 tednov po začetku zdravljenja z zdravilom Caprelsa,
English: There was no statistically significant difference in final OS (HR 0.99, 95.002% CI 0.72, 1.38, p=0.9750).
Slovenian: Končno celokupno preživetje se ni statistično značilno razlikovalo (HR 0,99, 95,002 % IZ 0,72, 1,38, p = 0,9750).
English: In addition, vandetanib inhibits epidermal growth factor (EGF)-stimulated EGF receptor tyrosine kinase in tumour cells and endothelial cells.
Slovenian: Poleg tega vandetanib zavira z epidermalnim rastnim dejavnikom (EGF) stimulirani EGF receptor tirozin-kinazo v tumorskih celicah in endotelijskih celicah.
English: The analysis was performed using a log rank test with treatment as the only factor.
Slovenian: Analiza je bila izvedena s testom log-rang in zdravljenjem kot edinim faktorjem.
English: Adverse reactions associated with overdose may be prolonged due to the long half-life of vandetanib (see section 5.2).
Slovenian: Trajanje neželenih učinkov povezanih s prevelikim odmerjanjem je lahko podaljšano zaradi dolgega razpolovnega časa vandetaniba (glejte poglavje 5.2).
English: Effects noted in other studies included inhibition of human ether-à-go-go related gene (hERG) current and prolongation of QTc interval in dogs.
Slovenian: Med učinki, ugotovljenimi v drugih študijah, sta bila zavrtje toka hERG (humanega ether-a-go-go povezanega gena) in podaljšanje intervala QTc pri psih.
English: An ECG, and levels of serum potassium, calcium and magnesium and thyroid stimulating hormone (TSH) should be obtained at baseline, at 1, 3, 6 and 12 weeks after starting treatment and every 3 months for at least a year thereafter.
Slovenian: Snemanje EKG in meritve serumskih ravni kalija, kalcija in magnezija ter tiroideo-stimulirajočega hormona (TSH) je treba opraviti izhodiščno, nato 1, 3, 6 in 12 tednov po začetku zdravljenja ter vsake 3 mesece vsaj eno leto potem.
English: Reduction in dose may be necessary (see section 4.8).
Slovenian: Morda bo potrebno zmanjšanje odmerka (glejte poglavje 4.8).
English: Intent-to-treat (ITT) analysis includes patients who received open-label vandetanib before progression according to the central read.
Slovenian: Analiza »znamenom-zdravljenja« (ITT - "Intent to treat")) vključuje bolnike, ki so odprto ("open-label") prejemali vandetanib pred napredovanjem v skladu s centralnim odčitkom.
English: Serum potassium, serum magnesium and serum calcium should be kept within normal range to reduce the risk of ECG QTc prolongation.
Slovenian: Vrednosti kalija, magnezija in kalcija v serumu je treba vzdrževati v normalnem območju, da bi zmanjšali tveganje za podaljšanje intervala QTc.
English: Vandetanib is not a substrate of multidrug resistance protein 2 (MRP2), p-glycoprotein (P-gp) or breast cancer resistance protein (BCRP).
Slovenian: Vandetanib ni substrat beljakovine MRP2 (multidrug resistance protein 2), P-glikoproteina (P-gp) ali BCRP (breast cancer resistance protein).
English: For a further supply, a new prescription is required.
Slovenian: Za nadaljno izdajo zdravila je zahtevan nov zdravniški recept.
English: • Lack of urine.
Slovenian: • pomanjkanje urina;
English: As regards other P-gp substrates such as dabigatran, a clinical monitoring is recommended in case of combination with vandetanib.
Slovenian: Kar zadeva druge substrate P-gp kot je dabigatran, je priporočljivo klinično spremljanje v primeru uporabe skupaj z vandetanibom.
English: Keep in mind Caprelsa may make you feel tired, weak, or cause blurred vision.
Slovenian: Zavedajte se, da lahko zdravilo Caprelsa povzroči utrujenost, šibkost ali zamegljen vid.
English: These may be common (affecting less than 1 in 10 people) or uncommon (affects less than 1 in 100 people) depending on the type of skin reaction.
Slovenian: Lahko so pogoste (pojavijo se pri manj kot 1 od 10 bolnikov) ali občasne (pojavijo se pri manj kot 1 od 100 bolnikov), odvisno od vrste kožne reakcije.
English: At 12 months, the proportion of patients alive and progression-free was 192 (83%) for patients randomised to vandetanib and 63 (63%) for patients randomised to placebo.
Slovenian: Po 12 mesecih je bil delež bolnikov, ki so bili živi in brez napredovanja, 192 (83 %) med bolniki, randomiziranimi na vandetanib, in 63 (63 %) med bolniki, randomiziranimi na placebo.
English: QTc and serum electrolytes should be monitored more frequently.
Slovenian: Treba je bolj pogosto spremljati interval QTc in elektrolite v serumu.
English: Effect of other medicinal products on vandetanib
Slovenian: Vpliv drugih zdravil na vandetanib
English: Other medicines and Caprelsa
Slovenian: Druga zdravila in zdravilo Caprelsa
English: Treatment should be initiated and supervised by a physician experienced in treatment of MTC and in the use of anticancer medicinal products and experienced in the assessment of electrocardiogram (ECG).
Slovenian: Zdravljenje mora uvesti in nadzirati zdravnik, ki ima izkušnje z zdravljenjem MTC in z uporabo zdravil za zdravljenje rakavih bolezni ter izkušnje glede ocene elektrokardiograma (EKG).
English: • Loss of body fluid (dehydration).
Slovenian: • izguba telesnih tekočin (dehidracija);
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).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (gleje Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: The result of the primary analysis of PFS showed a statistically significant improvement in PFS for patients randomised to vandetanib compared to placebo (Hazard Ratio (HR) = 0.46; 95% Confidence Interval (CI) = 0.31-0.69; p=0.0001).
Slovenian: Rezultat primarne analize PFS je pokazal statistično značilno izboljšanje PFS pri bolnikih, randomiziranih na vandetanib, v primerjavi s placebom (razmerje ogroženosti (HR - hazard ratio)) = 0,46, 95 % interval zaupanja (IZ) = 0,31-0,69, p = 0,0001).
English: • Abnormal sensation of the skin.
Slovenian: • nenormalen občutek kože;
English: Results should be interpreted with caution due to the high percentage of patients in the placebo arm switching to openlabel vandetanib (79.0% [79/100] of patients).
Slovenian: Rezultate je treba tolmačiti previdno, ker je velik delež bolnikov v skupini s placebom prešel na odprto uporabo vandetaniba (79,0 % [79/100] bolnikov).
English: What you need to know before you take Caprelsa
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Caprelsa
English: If you are not sure, talk to your doctor.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom.
English: • Toxins in the blood as a complication of infection.
Slovenian: • strupene snovi v krvi kot zaplet okužbe;
English: • As instructed by your doctor or pharmacist
Slovenian: • Po navodilu zdravnika ali farmacevta.
English: • Blurred vision, including mild changes in the eye which can lead to blurred vision (corneal opacity).
Slovenian: • zamegljen vid, vključno z blagimi očesnimi spremembami, ki lahko povzročijo zamegljen vid
English: Recommended dosing regimens and dose modifications are presented in Table 1.
Slovenian: Priporočene odmerne sheme in prilagoditve odmerka prikazuje preglednica 1.
English: The starting dose could be reduced to 200 mg in patients with moderate renal impairment; safety and efficacy have however not been established with 200 mg (see section 4.4).
Slovenian: Bolnikom z zmerno okvaro ledvic je možno zmanjšati začetni odmerek na 200 mg, vendar varnost in učinkovitost nista bili dokazani z uporabo 200 mg (glejte poglavje 4.4).
English: Caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.
Slovenian: Zdravilo Caprelsa je indicirano za zdravljenje agresivnega in simptomatskega medularnega raka ščitnice (medullary thyroid cancer, MTC) pri bolnikih z neresektabilno lokalno napredovalo ali metastatsko boleznijo.
English: Characteristics of the patients at study entry were the following: mean age 14.2 years (range 9-17 years), 50% female, 50% male, 93.8% White, 26.7% Hispanic and 6.3% were Black.
Slovenian: 14,2 leta (razpon: od 9 do 17 let), 50 % deklet, 50 % fantov, 93,8 % belcev, 26,7 % hispanov in 6,3 % črncev.
English: • carbamazepine and phenobarbital (used to control seizures)
Slovenian: • karbamazepin in fenobarbital (uporabljata se za obvladovanje napadov krčev)
English: Effect of vandetanib on other medicinal products
Slovenian: Vpliv vandetaniba na druga zdravila
English: However, long term safety data in paediatric patients are not available.
Slovenian: Vendar pa dolgoročnih podatkov o varnosti pri pediatričnih bolnikih ni.
English: Upon objective disease progression based on the investigator's assessment, patients were discontinued from blinded study treatment and given the option to receive open-label vandetanib.
Slovenian: Po objektivnem napredovanju bolezni, na podlagi raziskovalčeve ocene, so bolniki končali slepljeno zdravljenje v študiji in ponudili so jim možnost, da odprto prejemajo vandetanib.
English: Either symptomatic disease or progressive disease alone is not enough to prompt the need of treatment with vandetanib.
Slovenian: Prisotnost zgolj simptomatske bolezni ali zgolj progresivne bolezni ni zadosten razlog za takojšnje zdravljenje z vandetanibom.
English: Vandetanib also inhibits both wild type and the majority of mutated, activated forms of RET, and significantly inhibits the proliferation of MTC cell lines in vitro.
Slovenian: Vandetanib zavira tudi divji tip in večino mutiranih, aktiviranih oblik RET ter pomembno zavre proliferacijo celičnih linij MTC in vitro.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCA, ODGOVORNA ZA SPROŠČANJE SERIJ
English: Not reached (predicted 30.5 months)
Slovenian: ni dosežena (predvidena
English: Fourteen of the 28 patients (50%) who stopped vandetanib for an adverse event discontinued without a dose reduction.
Slovenian: Štirinajst od 28 bolnikov (50 %), ki so nehali prejemati vandetanib zaradi neželenega dogodka, je zdravljenje prekinilo brez zmanjšanja odmerka.
English: 100 every other day
Slovenian: 100 vsak drugi dan
English: Effects on reproduction in paediatric patients treated with vandetanib are not known.
Slovenian: Vplivi na reprodukcijo pri pediatričnih bolnikih, zdravljenih z vandetanibom, niso znani.
English: The amount of Caprelsa given will depend on your child's body weight and height.
Slovenian: Uporabljena količina zdravila Caprelsa bo odvisna od bolnikove telesne mase in telesne višine.
English: All prescribers of Caprelsa must be familiar with the Physician Information and Management Guidelines.
Slovenian: Vsi zdravniki, ki predpisujejo zdravilo Caprelsa, morajo biti seznanjeni z Informacijami za zdravnika in Smernicami za vodenje.
English: • itraconazole, ketoconazole, ritonavir, clarithromycin, rifampicin and moxifloxacin (medicines used to treat infections)
Slovenian: • itrakonazol, ketokonazol, ritonavir, klaritromicin, rifampicin in moksifloksacin (zdravila, ki se uporabljajo za zdravljenje okužb)
English: The concomitant use of vandetanib with strong CYP3A4 inducers (such as rifampicin, St John's Wort, carbamazepine, phenobarbital) should be avoided (see section 4.5).
Slovenian: Sočasni uporabi vandetaniba z močnimi induktorji CYP3A4 (kot so rifampicin, šentjanževka, karbamazepin, fenobarbital) se je treba izogibati (glejte poglavje 4.5).
English: At various exposure durations, median haemoglobin levels in patients treated with vandetanib were increased by 0.5-1.5 g/dl compared to baseline.
Slovenian: Pri različnih obdobjih izpostavljenosti so bile mediane vrednosti hemoglobina pri bolnikih, zdravljenih z vandetanibom, povečane za 0,5-1,5 g/dl v primerjavi z izhodiščem.
English: Results of a pharmacodynamic and pharmacokinetic interaction study indicated that co-administration with ondansetron in healthy patients appeared to have little effect on the pharmacokinetics of vandetanib, but had a small additive effect on the prolongation of the QTc interval of approximately 10 ms.
Slovenian: Rezultati študij farmakodinamičnih in farmakokinetičnih medsebojnih delovanj kažejo, da sočasno dajanje z ondansetronom zdravim osebam, po vsem sodeč, le malo vpliva na farmakokinetiko vandetaniba, ima pa majhen aditiven učinek na podaljšanje intervala QTc za približno 10 ms.
English: Administration of vandetanib with potent CYP3A4 inducers should be avoided.
Slovenian: Uporabi vandetaniba z močnimi induktorji CYP3A4 se je treba izogibati.
English: • Not to stop taking CAPRELSA, or change the dose, without consulting the prescriber;
Slovenian: • Opozorilo, naj bolnik ne neha jemati zdravila CAPRELSA in naj ne spremeni njegovega odmerka, ne da bi se posvetoval z zdravnikom, ki je predpisal zdravilo.
English: • The active substance is vandetanib.
Slovenian: • Učinkovina je vandetanib.