FrancophonIA/ELRC3.0 huggingface dataset:
English: Excretion of the dose was slow and further excretion beyond 21 days would be expected based on the plasma half-life.
Slovenian: Izločanje odmerka je bilo počasno in glede na razpolovni čas v plazmi je pričakovati nadaljnje izločanje še po preteku 21 dni.
English: The liquid can also be administered through nasogastric or gastrostomy tubes.
Slovenian: Tekočino je mogoče dati tudi po nazogastrični ali gastrostomijski sondi.
English: In the vandetanib arm, a total of 73 (32%) patients progressed: 64 (28%) by response evaluation criteria in solid tumours (RECIST) progression and 9 (4%) by death in the absence of progression.
Slovenian: V kraku z vandetanibom se je napredovanje pojavilo pri skupaj 73 (32 %) bolnikov; pri 64 (28 %) so ugotovili napredovanje po RECIST (response evaluation criteria in solid tumours - merila za ocenjevanje odziva parenhimskih tumorjev) in 9 (4 %) bolnikov je umrlo, ne da bi se pojavilo napredovanje.
English: These usually go away when Caprelsa is stopped.
Slovenian: Ponavadi minejo po prenehanju uporabe zdravila Caprelsa.
English: The Patient Alert Card should include the following key elements:
Slovenian: Opozorilna izkaznica za bolnika mora vsebovati naslednje ključne elemente:
English: • Instructions on how to use the dosing and monitoring guide and the daily tracker for paediatric patients and caregivers.
Slovenian: • Navodila za uporabo vodnika za odmerjanje in spremljanje ter dnevnega sledilnika za pediatrične bolnike in njihove skrbnike.
English: A single dose pharmacokinetic study in volunteers indicated that hepatic impairment did not affect exposure to vandetanib.
Slovenian: Farmakokinetična študija enkratnega odmerka pri prostovoljcih kaže, da okvara jeter ne vpliva na izpostavljenost vandetanibu.
English: The benefit of vandetanib in patients with CTN less than 500 pg/ml has not been determined, therefore use in patients with CTN < 500 pg/ml should be carefully considered because of the treatment related risks of vandetanib.
Slovenian: Korist vandetaniba pri bolnikih s CTN, manjšim od 500 pg/ml, ni bila ugotovljena, zato je treba uporabo vandetaniba pri bolnikih s CTN < 500 pg/ml natančno pretehtati zaradi možnih, z zdravljenjem povezanih, tveganj uporabe vandetaniba.
English: Fourteen patients treated with vandetanib, and 3 with placebo had unresectable locally advanced disease only.
Slovenian: Štirinajst bolnikov, zdravljenih z vandetanibom, in 3 bolniki, zdravljeni s placebom, so imeli zgolj lokalno napredovalo neresektabilno bolezen.
English: If there is no appropriate alternative therapy, not recommended combinations with vandetanib may be made with additional ECG monitoring of the QTc interval, evaluation of electrolytes and further control at onset or worsening of diarrhoea.
Slovenian: Če ni drugega ustreznega alternativnega zdravljenja, je mogoče z vandetanibom uporabiti kombinacije, ki niso priporočljive ter ob tem dodatno spremljati interval QTc, določati elektrolite in nadalje nadzirati pojav ali poslabšanje driske.
English: Calcium hydrogen phosphate dihydrate Microcrystalline cellulose Crospovidone (type A) Povidone (K 29-32) Magnesium stearate
Slovenian: Jedro tablete kalcijev hidrogenfosfat dihidrat mikrokristalna celuloza krospovidon (vrsta A) povidon (K 29-32) magnezijev stearat
English: In consideration of the high intra-individual variability of the response to anticoagulation, and the possibility of interaction between vitamin K antagonists and chemotherapy, an increased frequency of the INR (International Normalised Ratio) monitoring is recommended, if it is decided to treat the patient with vitamin K antagonists.
Slovenian: Zaradi velike intraindividualne variabilnosti odziva na antikoagulantno zdravljenje in možnosti medsebojnih delovanj med antagonisti vitamina K in kemoterapijo, so v primeru zdravljenja z antagonisti vitamina K priporočljive pogostejše kontrole INR (internacionalnega normaliziranega razmerja).
English: For patients in whom Rearranged during Transfection (RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision (see important information in sections 4.4 and 5.1).
Slovenian: Pri bolnikih, za katere status mutacije RET ni znan ali pa je negativen (rearranged during transfection - prerazporejen med transfekcijo), je pred vsako posamezno odločitvijo glede zdravljenja treba upoštevati morebitno manjšo korist zdravljenja (glejte pomembne informacije v poglavjih 4.4 in 5.1).
English: • Changes in taste of foods (dysgeusia).
Slovenian: • spremenjen okus hrane (dizgevzija).
English: • Loss of hair from the head or body (alopecia).
Slovenian: • izguba las ali dlak (alopecija);
English: Pharmacokinetics in paediatric population
Slovenian: Farmakokinetika v pediatrični populaciji
English: • Dehydration.
Slovenian: • dehidracija;
English: Very common (affects more than 1 in 10 people):
Slovenian: Zelo pogosti (pojavijo se pri več kot 1 od 10 bolnikov):
English: • Frequent urination.
Slovenian: • pogosto uriniranje;
English: Silk Road Business Park Macclesfield, Cheshire SK10 2NA United Kingdom
Slovenian: Silk Road Business Park Macclesfield, Cheshire SK10 2NA Velika Britanija ali
English: Paediatric patients treated with Caprelsa and patients' caregivers must be given the dosing guide and be informed on the correct dose to be taken with the initial prescription and each subsequent dose adjustment.
Slovenian: Pediatričnim bolnikom, ki prejemajo zdravilo Caprelsa in osebam, ki zanje skrbijo, je treba izročiti vodnik za odmerjanje ter jih seznaniti s pravilnim odmerkom, ki ga je treba uporabljati, ko je zdravilo predpisano in ob vsaki nadaljnji prilagoditvi odmerka.
English: • Involuntary muscle contraction (convulsions).
Slovenian: • nehotni mišični krči (konvulzije);
English: If a patient presents with respiratory symptoms such as dyspnoea, cough and fever, vandetanib treatment should be interrupted and prompt investigation initiated.
Slovenian: Če ima bolnik dihalne simptome, npr. dispnejo, kašelj in vročino, je treba zdravljenje z vandetanibom prekiniti in bolnika takoj pregledati.
English: Temporary or permanent discontinuation of therapy may be necessary in patients with heart failure.
Slovenian: Pri bolnikih s srčnim popuščanjem bo morebiti potrebna začasna ali dokončna prekinitev zdravljenja.
English: There is a limited amount of data on the use of vandetanib during pregnancy.
Slovenian: Podatkov o uporabi vandetaniba med nosečnostjo je malo.
English: • Rapidly alternating muscular contraction and relaxation (clonus).
Slovenian: • hitro in izmenično krčenje ter sprostitev mišic (klonus);
English: Statistically significant advantages were seen for vandetanib for the secondary endpoints of response rate, disease control rate, and biochemical response.
Slovenian: Statistično značilne prednosti so bile za vandetanib opazne pri sekundarnih opazovanih dogodkih deleža odziva, deleža obvladanja bolezni in biokemičnega odziva.
English: • Heart rhythm changes (shown in an ECG).
Slovenian: • motnje srčnega ritma (pokažejo se na EKG).
English: If ILD is confirmed, vandetanib should be permanently discontinued and the patient treated appropriately.
Slovenian: Če je IBP potrjena, je treba zdravljenje z vandetanibom trajno prekiniti in bolnika ustrezno zdraviti.
English: - if you have a heart problem that you were born with called ‘congenital long QTc syndrome'.
Slovenian: če imate prirojeno srčno motnjo, imenovano "prirojeni sindrom dolgega QTc".
English: • Details of medicinal products where the co-administration of CAPRELSA is either contraindicated or not recommended;
Slovenian: • Podrobnosti glede zdravil s katerimi je sočasno dajanje zdravila CAPRELSA ali kontraindicirano ali pa ni priporočljivo.
English: In healthy male subjects, the exposure to vandetanib was reduced by 40% when given together with the potent CYP3A4 inducer, rifampicin.
Slovenian: Pri zdravih moških preiskovancih se je izpostavljenost vandetanibu zmanjšala za 40 %, če je bil uporabljen skupaj z močnim induktorjem CYP3A4 rifampicinom.
English: Summary of the safety profileThe most commonly reported adverse drug reactions have been diarrhoea, rash, nausea, hypertension, and headache.
Slovenian: Povzetek varnostnega profila Najpogosteje poročani neželeni učinki so bili driska, izpuščaj, navzea, hipertenzija in glavobol.
English: In the blinded comparison of vandetanib vs. placebo, only 2 patients known to be RET negative at all 6 exons received vandetanib and none demonstrated responses.
Slovenian: V slepljeni primerjavi vandetaniba s placebom sta zgolj 2 bolnika z negativnim RET v vseh 6 eksonih, prejela vandetanib in nobeden ni pokazal odziva.
English: It is important that you keep this dosing guide and show it to your caregiver.
Slovenian: Pomembno je, da ta vodnik za odmerjanje shranite in ga pokažete osebi, ki skrbi za vas.
English: Vandetanib had no effect on fertility in male rats.
Slovenian: Vandetanib ni vplival na plodnost podganjih samcev.
English: • Patients with a QTc interval over 480 msec.
Slovenian: • Bolniki z intervalom QTc, daljšim od 480 ms.
English: Pharmacotherapeutic Group: antineoplastic agent, protein kinase inhibitor, ATC Code: L01XE12
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, zaviralci proteinkinaze; oznaka ATC: L01XE12
English: Your doctor may need to prescribe or change your thyroid hormone treatment.
Slovenian: Zdravnik vam bo morda moral predpisati zdravljenje s ščitničnim hormonom ali vam takšno zdravljenje spremenil;
English: Of the patients enrolled in the study 10 patients on vandetanib and 4 on placebo (4% of all patients) had a World Health Organization performance status (WHO PS) score of ≥ 2 and 28 (12.1%) patients on vandetanib and 10 (10.1%) on placebo had cardiac impairment.
Slovenian: Med bolniki, vključenimi v študijo, je imelo 10 prejemnikov vandetaniba in 4 prejemniki placeba (4 % vseh bolnikov) oceno zmogljivostnega stanja po Svetovni zdravstveni organizaciji (WHO PS) ≥ 2; 28 (12,1 %) prejemnikov vandetaniba in 10 (10,1 %) prejemnikov placeba je imelo okvaro srca.
English: 37 Hollands Road Haverhill Suffolk, CB9 8PU United Kingdom
Slovenian: 37 Hollands Road Haverhill Suffolk, CB9 8PU Velika Britanija ali
English: CTN Response
Slovenian: ODZIV CTN
English: • Depression.
Slovenian: • depresija;
English: Only one supply per prescription is allowed.
Slovenian: Dovoljena je le ena izdaja zdravila na posamezni zdravniški recept.
English: Cardiac impairment was defined as patients with previous cardiovascular abnormality.
Slovenian: Okvara srca je bila opredeljena kot stanje bolnikov, ki so predhodno imeli neko kardiovaskularno nepravilnost.
English: Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Slovenian: Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Irska
English: The European Medicines Agency will review new information on the medicine at least every year and this leaflet will be updated as necessary.
Slovenian: Evropska agencija za zdravila bo vsaj enkrat letno ponovno pregledala nove podatke o tem zdravilu.
English: Caprelsa works by slowing down the growth of new blood vessels in tumours (cancers).
Slovenian: Zdravilo Caprelsa deluje tako, da upočasni rast novih žil v tumorjih (raku).
English: • Inflammation of the main air passages to the lungs.
Slovenian: • vnetje glavnih dihalnih poti v pljučih;
English: This is uncommon (affects less than 1 in 100 people) but can be life-threatening.
Slovenian: Ta učinek je občasen (pojavi se pri manj kot 1 od 100 bolnikov), a je lahko smrtno nevaren.
English: If you get side effects always tell your doctor.
Slovenian: Če se vam pojavijo neželeni učinki, morate to vedno povedati zdravniku.
English: For patients whose RET mutation status could be negative, a possible lower benefit should be taken into account before individual treatment decisions and the use of vandetanib should be carefully considered because of the treatment related risks.
Slovenian: Pri bolnikih, katerih status mutacije RET bi lahko bil negativen, je pred vsako odločitvijo glede zdravljenja in uporabe vandetaniba treba skrbno upoštevati morebitno manjšo korist zaradi z zdravljenjem povezanih tveganj.
English: Vandetanib is also a sub-micromolar inhibitor of vascular endothelial receptor-3 tyrosine kinase.
Slovenian: Vandetanib je tudi submikromolaren zaviralec tirozin-kinaznega endotelijskega receptorja 3.
English: A glucuronide conjugate was seen as a minor metabolite in excreta only.
Slovenian: Glukuronidni konjugat so kot manj pomembni presnovek našli samo v izločkih.
English: In repeat-dose toxicity studies of up to 9 months duration, effects included emesis, body weight loss and diarrhoea in dogs and physeal dysplasia in young dogs and rats with open growth plates.
Slovenian: Med učinki, zabeleženimi v do 9-mesečnih študijah toksičnosti ponavljajočih se odmerkov, so bili bruhanje, zmanjšanje telesne mase in driska pri psih ter fizalna displazija pri mladih psih in podganah z odprtimi rastnimi ploščicami.
English: • Vandetanib has demonstrated adverse effect on growing tissue that relies on vascularization such as teeth and growth plates in non-clinical studies;
Slovenian: • Predklinične študije so pokazale neželen učinek vandetaniba na rastoča tkiva, odvisna od vaskularizacije, npr. na zobe in rastne ploščice.
English: AstraZeneca UK Limited, Macclesfield, Cheshire, SK10 2NA, United Kingdom Or
Slovenian: Izdelovalec AstraZeneca UK Limited, Macclesfield, Cheshire, SK10 2NA, Velika Britanija ali
English: Vandetanib accumulates approximately 8-fold on multiple dosing with steady state achieved from approximately 2 months.
Slovenian: Vandetanib se med uporabo več odmerkov kopiči približno 8-kratno in stanje dinamičnega ravnovesja je doseženo po približno 2 mesecih.
English: • Patients who are on the increased dose (b in Table 1), should be recommenced at the starting dose (a in Table 1).
Slovenian: • Bolniki, ki prejemajo večji odmerek (b v preglednici 1), morajo zdravljenje znova začeti z začetnim odmerkom (a v preglednici 1).
English: • ondansetron (used to treat nausea and vomiting)
Slovenian: • ondansetron (uporablja se za zdravljenje občutka siljenja na bruhanje in bruhanja)
English: A post-hoc subgroup analysis of RET negative status based on absence of M918T mutation of the pivotal study 58 was performed.
Slovenian: V post-hoc podskupini je bila izvedena analiza negativnega statusa RET, ki je temeljila na odsotnosti mutacije M918T v ključni študiji 58.
English: In a repeat-dose toxicity study in rats, there was a decrease in the number of corpora lutea in the ovaries of rats given vandetanib for 1 month.
Slovenian: V študiji toksičnosti ponavljajočih se odmerkov pri podganah so ugotovili zmanjšanje števila rumenih telesc v jajčnikih podgan, ki so 1 mesec dobivale vandetanib.
English: Clinical data from MTC
Slovenian: Klinični podatki za MTC
English: If vandetanib is used during pregnancy or if the patient becomes pregnant while receiving vandetanib, she should be apprised of the potential for foetal abnormalities or loss of the pregnancy.
Slovenian: Če se vandetanib uporablja med nosečnostjo ali če bolnica med zdravljenjem s tem zdravilom zanosi, jo je treba opozoriti na možne nepravilnosti ploda oziroma prekinitev nosečnosti.
English: If you get side effects
Slovenian: Če se vam pojavijo neželeni učinki
English: • A type of rash that affects the hands and feet (hand foot syndrome).
Slovenian: • posebna vrsta izpuščaja, ki prizadene dlani in podplate (sindrom dlani in podplatov)
English: • Malnutrition.
Slovenian: • podhranjenost;
English: Your doctor or nurse should perform tests to check the levels of your blood potassium, calcium, magnesium, and thyroid-stimulating hormone (TSH) as well as the electrical activity of your heart with a test called an electrocardiogram (ECG).
Slovenian: Zdravnik ali medicinska sestra morata opraviti preiskave za kontrolo koncentracije kalija, kalcija, magnezija in tiroideo-stimulirajočega hormona (TSH) v krvi in za kontrolo električne aktivnosti srca s preiskavo, ki jo imenujemo elektrokardiogram (EKG).
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.
Slovenian: Petim bolnikom z zmerno okvaro ledvic izmed 6 (83 %), zdravljenih z vandetanibom, so zaradi neželenega učinka zmanjšali odmerek na 200 mg; 1 bolniku je nadalje bilo potrebno zmanjšati odmerek na 100 mg.
English: • The dosing and monitoring guide for paediatric patients and patient's caregivers;
Slovenian: • Vodnik za odmerjanje in spremljanje za pediatrične bolnike in njihove skrbnike;
English: Therefore, the concomitant use of ondansetron with vandetanib is not recommended.
Slovenian: Zato sočasna uporaba ondansetrona z vandetanibom ni priporočljiva.
English: There is limited data with 300 mg in patients with moderate renal impairment: the dose needed to be lowered to 200 mg in 5 out of 6 patients.
Slovenian: Podatkov o uporabi 300 mg pri bolnikih z zmerno okvaro ledvic je malo: pri 5 bolnikih od 6 je bilo potrebno odmerek zmanjšati na 200 mg.
English: There were no statistically significant differences observed for the exploratory endpoint of diarrhoea (reported as stool frequency).
Slovenian: Statistično značilnih razlik glede driske kot opazovanega dogodka ni bilo (poročano kot pogostnost odvajanja blata).
English: MARKETING AUTHORISATION HOLDER Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam,
English: Patients treated with Caprelsa must be given the patient alert card and be informed about the risks of Caprelsa (see also package leaflet).
Slovenian: Bolniki, zdravljeni z zdravilom Caprelsa, morajo dobiti opozorilno izkaznico in treba jih je seznaniti s tveganji za zdravilo Caprelsa (glejte tudi navodilo za uporabo).
English: Paediatric clinical trial data with vandetanib in MTC (see section 5.1) obtained during drug development is limited to 16 patients aged 9 years to 17 years with hereditary medullary thyroid carcinoma (Study IRUSZACT0098).
Slovenian: Podatki kliničnih preskušanj vandetaniba pri pediatričnih bolnikih z medularnim rakom ščitnice (glejte poglavje 5.1), pridobljeni med razvojem zdravila, so omejeni na 16 bolnikov, starih od 9 do 17 let, z dednim medularnim rakom ščitnice (študija IRUSZACT0098).
English: • The educational material, including: o Information about the risks associated with CAPRELSA: - QTc prolongation and Torsades de pointes - Posterior reversible encephalopathy syndrome (PRES); - Teeth and bone development abnormalities in pediatric patients - Medication errors in the pediatric population o The Physicians' dosing and monitoring guide for paediatric patients;
Slovenian: • Izobraževalno gradivo za zdravstvene delavce, ki vsebuje - Informacije o tveganjih, povezanih z zdravilom CAPRELSA o podaljšanje QTc intervala in Torsade de pointes o sindrom posteriorne reverzibilne encefalopatije (PRES) o razvojne nepravilnosti kosti in zob pri pediatričnih bolnikih o napake pri uporabi zdravila v pediatrični populaciji - Zdravnikov vodnik za odmerjanje in spremljanje pri pediatričnih bolnikih;
English: • Urgent desire to urinate.
Slovenian: • nujna potreba po uriniranju;
English: In healthy subjects, no clinically significant interaction was shown between vandetanib (a single dose of 300mg) and the potent CYP3A4 inhibitor, itraconazole (repeated doses of 200mg once daily).
Slovenian: Pri zdravih preiskovancih niso ugotovili klinično pomembnih medsebojnih delovanj med vandetanibom (enkratni odmerek 300 mg) in itrakonazolom (ponavljajoči se odmerki 200 mg enkrat na dan), ki je močan zaviralec CYP3A4.
English: The pharmacokinetics of vandetanib at the 300 mg dose in MTC patients are characterised by a volume of distribution of approximately 7450 l.
Slovenian: Za farmakokinetiko vandetaniba v odmerku 300 mg pri bolnikih z MTC je značilen volumen porazdelitve, ki je približno 7.450 l.
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.
Slovenian: Odmerki 100 mg/m2/dan v okviru indiciranega odmerjanja (funkcija telesne površine) pri pediatričnih bolnikih dosežejo podobno izpostavljenost kot jo pri odraslih doseže odmerjanje 300 mg na dan.
English: If ondansetron is administered with vandetanib, closer monitoring of serum electrolytes and ECGs and aggressive management of any abnormalities is required.
Slovenian: Če se ondansetron daje z vandetanibom, je zahtevano skrbno spremljanje serumskih elektrolitov in EKG ter vztrajna obravnava kakršnih koli nenormalnosti.
English: Individual patient management will be required by the physician, especially in paediatric patients with low BSA.
Slovenian: Zdravnik mora voditi vsakega bolnika posamezno; to še zlasti velja za pediatrične bolnike z majhno telesno površino.
English: If you get side effects, your doctor may tell you to take Caprelsa at a lower dose.
Slovenian: Če se vam pojavijo neželeni učinki, vam bo zdravnik morda naročil, da jemljite manjši odmerek zdravila Caprelsa.
English: Figure 1: Kaplan Meier plot of PFS
Slovenian: Kaplan-Meierjev prikaz PFS
English: • Patients who develop a single value of corrected ECG QTc interval of at least 500 msec should stop taking CAPRELSA.
Slovenian: • Bolniki, ki se jim na EKG pojavi ena sama vrednost korigiranega intervala QTc v vrednosti vsaj 500 ms, morajo prenehati z jemanjem zdravila CAPRELSA.
English: What Caprelsa is and what it is used for What you need to know before you take Caprelsa How to take Caprelsa
Slovenian: Kaj je zdravilo Caprelsa in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Caprelsa Kako jemati zdravilo Caprelsa Možni neželeni učinki
English: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk, CB9 8PU, United Kingdom Or
Slovenian: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk, CB9 8PU, Velika Britanija ali
English: PRES has also been observed in patients receiving vandetanib as monotherapy.
Slovenian: PRES so opažali tudi pri bolnikih, ki so prejemali vandetanib kot monoterapijo.
English: Based on height measurements at all visits, all children and adolescents in a paediatric study demonstrated linear growth while receiving vandetanib.
Slovenian: Meritve telesne višine na vseh obiskih so pokazale, da je bila v pediatrični študiji pri vseh otrocih in mladostnikih, ki so prejemali vandetanib, rast linearna.
English: • Sore mouth (stomatitis).
Slovenian: • vnetje ust (stomatitis);
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.
Slovenian: V študiji III. faze so, pri odmerku 300 mg na dan za MTC, opazili podaljšanje QTc večje od 500 ms pri 11 % bolnikov.
English: The concomitant use of vandetanib with ondansetron is not recommended (see section 4.5)
Slovenian: Sočasna uporaba vandetaniba z ondansetronom ni priporočljiva (glejte poglavje 4.5).
English: • The posology regimens according to patient's body surface area (BSA), including a visual representation of the two-week posology regimen per BSA;
Slovenian: • Sheme odmerjanja glede na bolnikovo telesno površino, vključno z vizualnim prikazom dvotedenske sheme odmerjanja glede na telesno površino.