FrancophonIA/ELRC3.0 huggingface dataset:
English: • Details of medicinal products where the co-administration of CAPRELSA is either contraindicated or not recommended;
Danish: • Nærmere angivelse af lægemidler, for hvilke samtidig administration af Caprelsa enten er kontraindiceret eller ikke kan anbefales;
English: This schedule should apply to the period after dose reduction due to QTc prolongation and after dose interruption for more than two weeks.
Danish: Denne plan bør følges i perioden efter dosisreduktion pga. QTcforlængelse og efter afbrydelse af behandlingen i mere end to uger.
English: - The re-evaluation of treatment efficacy in RET-negative patients based on the re-analysis of archived tumour samples from the pivotal study D4200C00058.
Danish: - Reevaluering af behandlingseffektiviten hos RET-negative patienter baseret på en reevaluering af arkiverede tumorprøver fra det pivotale studie D4200C00058.
English: Your doctor will discuss with you the benefits and risks of taking Caprelsa during this time.
Danish: Din læge vil diskutere fordele og risici ved at tage Caprelsa på dette tidspunkt.
English: 100 every other day 100 daily 100 daily
Danish: 100 hver anden dag 100 dagligt 100 dagligt
English: OVERALL SURVIVAL N Median OS HRc
Danish: SAMLET OVERLEVELSE N Median OS HR
English: Prior to launch of CAPRELSA in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Før Caprelsa lanceres i de enkelte medlemslande, skal indehaveren af markedsføringstilladelsen (MAH) blive enig med den relevante nationale myndighed om indholdet og udformningen af uddannelsesprogrammet, herunder kommunikationsmedier, distributionsmetoder og eventuelle andre aspekter af programmet.
English: • Take half a glass of still (non-carbonated) water.
Danish: • Tag et halvt glas postevand (uden brus).
English: • 1, 3 and 6 weeks after starting Caprelsa
Danish: • 1, 3 og 6 uger efter start med Caprelsa
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.
Danish: Overlevelsesstatus og den gennemsnitlige endelige OS (81,6 måneder i vandetanib armen og 80,4 måneder i placebo armen) var ens på tværs af begge behandlingsarme.
English: Film-coating Hypromellose Macrogol (300) Titanium dioxide (E171)
Danish: Filmovertræk Hypromellose Macrogol (300) Titandioxid (E171)
English: QTc and serum electrolytes should be monitored more frequently.
Danish: QTc og serumelektrolytter skal overvåges hyppigere.
English: The secondary endpoints were evaluation of overall objective response rate (ORR), disease control rate (DCR) defined as, partial response (PR) or complete response (CR) or stable disease (SD) lasting at least 24 weeks, duration of response (DOR), time to worsening of pain based on Brief Pain Inventory (BPI) worst pain scale, and overall survival (OS).
Danish: De sekundære effektmål var at evaluere den samlede objektive responsrate (ORR), sygdomskontrol(raten) (DCR) defineret som partielt respons (PR) eller komplet respons (CR) eller stabil sygdom (SD), der varede mindst 24 uger, varighed af respons (DOR), tid til smerteforværring baseret på Brief Pain Inventory (BPI) højeste smerteskala, og samlet overlevelse (OS).
English: However, RET status could not be tested in a large proportion of patients (mainly because of unavailable results for direct sequencing of DNA) and response rate was somewhat lower in the patients with unknown RET status compared with RET mutation positive status: 51.8% vs. 35.9 % respectively.
Danish: Det var dog ikke muligt at bestemme RET-status hos en større andel af patienterne (hovedsageligt fordi der ikke forelå resultater af direkte DNA-sekventering), og responsraten var noget lavere hos patienter med ukendt RET-status sammenlignet med patienter, som var positive for RET-mutation: henholdsvis 51,8 % og 35,9 %.
English: It is important that you keep this Alert Card and show it to your partner or caregivers.
Danish: Det er vigtigt, at du gemmer dette patientinformationskort og viser det til din partner eller omsorgsperson.
English: The European Medicines Agency will review new information on the medicine at least every year and this leaflet will be updated as necessary.
Danish: Det Europæiske Lægemiddelagentur vil mindst en gang om året vurdere nye oplysninger om lægemidlet, og denne indlægsseddel vil om nødvendigt blive ajourført.
English: Women of childbearing potential must use effective contraception during therapy and for at least four months following the last dose.
Danish: Fertile kvinder skal anvende sikker kontraception under behandlingen og i mindst fire måneder efter den sidste dosis.
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.
Danish: Deres hyppighed angives i tabel 2, bivirkninger, vha. Council for International Organizations of Medical Sciences (CIOMS III) opført efter MedDRAsystemorganklassen (SOC) og ved det foretrukne terminologiske niveau og derefter efter hyppighedsklassificeringen.
English: Individual patient management will be required by the physician, especially in paediatric patients with low BSA.
Danish: Lægen skal vurdere behandling individuelt, især hos pædiatriske patienter med lavt BSA
English: Rate of change in biomarker levels such as of calcitonin (CTN) and/or carcinoembryonic antigen (CEA) as well as the rate of change of tumour volume during watchful waiting might help to identify not only patients in need for treatment but also the optimal moment to commence treatment with vandetanib.
Danish: Hastigheden for ændringer i niveauet af biomarkører såsom calcitonin (CTN) og/eller karcinoembryonalt antigen (CEA) samt hastigheden for forandringer i tumorvolumen under observation (watchful waiting) kan hjælpe med til at identificere ikke blot patienter med behov for behandlingen, men også det optimale tidspunkt for indledning af behandling med vandetanib.
English: Reduction in dose may be necessary (see section 4.8).
Danish: Det kan være nødvendigt at reducere dosis (se pkt.
English: Effect of vandetanib on other medicinal products
Danish: Vandetanibs virkning på andre lægemidler
English: Bullous dermatitis
Danish: Bulløs dermatitis
English: Table 4: Summary of efficacy findings in a segment of patients according to RET mutation status
Danish: Tabel 4: Oversigt over effektfund hos et segment af patienterne opstillet efter status for RETmutation
English: You must not breast-feed during treatment with Caprelsa for the safety of your baby.
Danish: Du må ikke amme under behandling med Caprelsa af hensyn til barnets sikkerhed.
English: There was no statistically significant difference in final OS (HR 0.99, 95.002% CI 0.72, 1.38, p=0.9750).
Danish: Der var ingen statistisk signifikant forskel i den endelige OS (HR 0,99, 95,002 % CI 0,72, 1,38, p = 0,9750).
English: Appetite decreased, Hypocalcaemia
Danish: Nedsat appetit, hypokalcæmi
English: • The reduced dose as specified in Table 1 could be used in paediatric patients with moderate renal impairment.
Danish: • Den reducerede dosis, som er specificeret i tabel 1, kan anvendes til pædiatriske patienter med moderat nedsat nyrefunktion.
English: These usually go away when Caprelsa is stopped.
Danish: Disse tegn forsvinder sædvanligvis, når der ophøres med Caprelsa.
English: Frequent ECG monitoring of the QTc interval should be continued.
Danish: Hyppig EKG-monitorering af QTc-intervallet bør fortsættes.
English: No studies to establish the effects of vandetanib on ability to drive and use machines have been conducted.
Danish: Der er ikke udført studier for at fastslå vandetanibs indvirkning på evnen til at føre motorkøretøj og betjene maskiner.
English: For patients who have difficulty swallowing, vandetanib tablets may be dispersed in half a glass of non-carbonated drinking water.
Danish: For patienter med synkebesvær kan vandetanib-tabletterne opløses i et halvt glas ikke-kulsyreholdigt drikkevand.
English: A randomised, double-blind, placebo-controlled study (Study 58) was conducted to demonstrate safety and efficacy of vandetanib 300 mg versus placebo.
Danish: Der blev udført et randomiseret, dobbeltblindet, placebokontrolleret studie (studie 58) for at påvise sikkerhed og effektivitet af vandetanib 300 mg versus placebo.
English: Patients / caregivers
Danish: Patienter/omsorgspersoner
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammende, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager Caprelsa.
English: Not reached (predicted 30.5 months)
Danish: Ikke nået (prædikteret
English: • If it is 12 hours or more until your next dose: Take the missed tablet as soon as you remember.
Danish: • Hvis der er 12 timer eller mere til din næste dosis: Tag den glemte tablet, så snart du kommer i tanke om det.
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).
Danish: Resultaterne skal fortolkes med forsigtighed på grund af den høje procentdel af patienter, som skiftede fra placebo armen til open-label vandetanib (79,0 % [79/100] af patienterne).
English: Talk to your doctor or pharmacist before taking Caprelsa:
Danish: Kontakt lægen eller apotekspersonalet, før du tager Caprelsa:
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.
Danish: Påvirkninger bemærket i andre studier omfattede hæmning af human ether-à-go-go related gene (hERG)- strømmen og forlængelse af QTc-interval hos hunde.
English: Administration of vandetanib with potent CYP3A4 inducers should be avoided.
Danish: Administration af vandetanib sammen med potente CYP3A4-induktorer bør undgås.
English: If a patient presents with respiratory symptoms such as dyspnoea, cough and fever, vandetanib treatment should be interrupted and prompt investigation initiated.
Danish: Hvis en patient udviser symptomer fra luftvejene som f.eks. dyspnø, hoste og feber, skal behandlingen med vandetanib afbrydes, og en øjeblikkelig undersøgelse initieres.
English: • carbamazepine and phenobarbital (used to control seizures)
Danish: • carbamazepin og phenobarbital (til kontrol af epileptiske anfald)
English: There is a limited amount of data on the use of vandetanib during pregnancy.
Danish: Der foreligger begrænsede data vedrørende anvendelsen af vandetanib under graviditet.
English: Serum potassium, serum magnesium and serum calcium should be kept within normal range to reduce the risk of ECG QTc prolongation.
Danish: Serumkalium, serummagnesium og serumcalcium bør holdes inden for normalområdet for at reducere risikoen for QTc-forlængelse i EKG.
English: • Rapidly alternating muscular contraction and relaxation (clonus).
Danish: • Hurtigt skiftevis sammentrækning og afslapning af muskler (klonus).
English: Vandetanib is not a substrate of multidrug resistance protein 2 (MRP2), p-glycoprotein (P-gp) or breast cancer resistance protein (BCRP).
Danish: Vandetanib er ikke et substrat af multidrug-resistensprotein 2 (MRP2), p-glykoprotein (Pgp) eller brystcancerresistensprotein (BCRP).
English: As regards other P-gp substrates such as dabigatran, a clinical monitoring is recommended in case of combination with vandetanib.
Danish: Med hensyn til andre P-gp-substrater såsom dabigatran, anbefales klinisk monitorering ved administration sammen med vandetanib.
English: Biochemical response with vandetanib as compared to placebo as measured by CTN and CEA was also assessed as secondary endpoints.
Danish: Biokemisk respons med vandetanib i sammenligning med placebo målt ud fra CTN og CEA blev ligeledes vurderet som sekundære effektmål.
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.
Danish: Aktuelt blev 79 patienter identificeret i kraft af fravær af en M918T-mutation, og ingen identificeret RET-mutation ved nogen af de øvrige 6 testede exoner, men hos 71 af disse patienter var sekventeringen af de 6 exoner ufuldstændig.
English: Either symptomatic disease or progressive disease alone is not enough to prompt the need of treatment with vandetanib.
Danish: Symptomatisk sygdom eller progredierende sygdom alene er ikke nok til at foranledige behandling med vandetanib.
English: The amount of Caprelsa given will depend on your child's body weight and height.
Danish: Antallet afhænger af barnets vægt og højde.
English: In rats, effects on teeth, kidney and skin were noted.
Danish: Hos rotter blev der bemærket påvirkning af tænder, nyrer og hud.
English: • The posology regimens according to patient's body surface area (BSA), including a visual representation of the two-week posology regimen per BSA;
Danish: • Doseringsplan i henhold til patientens legemsoverfladeareal (BSA), som omfatter visuel visning af to ugers doseringsplanen i henhold til BSA;
English: Clinical efficacy in adults
Danish: Klinisk virkning hos voksne
English: Vandetanib has shown no carcinogenic potential effect in a 6 month carcinogenicity study in rasH2 transgenic mice.
Danish: Vandetanib har ikke vist karcinogenicitetspotentiale i et 6 måneders karcinogenicitetsstudie med rasH2 transgene mus.
English: Based on height measurements at all visits, all children and adolescents in a paediatric study demonstrated linear growth while receiving vandetanib.
Danish: Baseret på måling af højde ved alle besøg blev der i pædiatriske studier påvist lineær vækst hos alle børn og unge, mens de fik vandetanib.
English: Vandetanib has shown no mutagenic or clastogenic potential.
Danish: Vandetanib har ikke vist noget mutagent eller klastogent potentiale.
English: Patients with no M918T mutation and other mutations not tested or negative (n=79)*
Danish: Patienter uden M918T-mutationandre mutationer blev ikke undersøgt eller var negative (n=79)*
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.
Danish: Disse resultater viste sig ved klinisk relevante plasmakoncentrationer, var overvejende reversible inden for 4 ugers ophør med dosering og kunne henføres til hæmning af vaskulær endotelvækstfaktor-receptor (VEGFR) eller EGFR.
English: Caprelsa works by slowing down the growth of new blood vessels in tumours (cancers).
Danish: Caprelsa virker ved at hæmme væksten af nye blodkar i tumorer (cancer).
English: Biliary excretion of unchanged vandetanib is one of the excretion pathways for vandetanib.
Danish: Biliær udskillelse af ikke-omdannet vandetanib er en af udskillelsesvejene for vandetanib.
English: Results according to RET status (positive, unknown and RET M918T mutation negative definition) are presented in Table 4.
Danish: Resultaterne opstillet efter RET-status (defineret som positiv, ukendt og negativ RET-M918Tmutation) fremgår af tabel 4.
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.
Danish: Ved 12 måneder var andelen af patienter, der var i live og progressionsfri 192 (83 %) for patienter randomiseret til vandetanib, og 63 (63 %) for patienter randomiseret til placebo.
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.
Danish: M918T-mutation er den hyppigst observerede mutation hos patienter med sporadisk MTC; dog kan det ikke udelukkes, at nogle af de patienter, der var testet RET-negative for M918T-mutation, kunne have positiv status for mutation på andre exoner.
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:
Danish: I alle medlemslande, hvor Caprelsa markedsføres, skal MAH sikre, at alt sundhedspersonale og patienter/omsorgspersoner, som forventes at ordinere, udlevere eller anvende Caprelsa, forsynes med en uddannelsespakke indeholdende:
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.
Danish: Der vil være behov for yderligere monitorering af QTc, elektrolytter og nyrefunktion især i tilfælde af diarré, tiltagende diarré/dehydrering, elektrolytubalance og/eller nedsat nyrefunktion.
English: There were no statistically significant differences observed for the exploratory endpoint of diarrhoea (reported as stool frequency).
Danish: Der blev ikke observeret nogen statistisk signifikante forskelle for de eksplorative effektmål for diarré (rapporteret som afføringshyppighed).
English: A glucuronide conjugate was seen as a minor metabolite in excreta only.
Danish: Et glukuronidkonjugat blev udelukkende observeret som en mindre væsentlig metabolit i ekskreter.
English: It may not be reversible on stopping vandetanib.
Danish: Dette er muligvis ikke reversibelt ved ophør med vandetanib.
English: Caprelsa has uncommonly been associated with life-threatening changes in heart rhythm.
Danish: Caprelsa er i sjældne tilfælde forbundet med livstruende ændringer i hjerterytmen.
English: The Patient Alert Card should include the following key elements:
Danish: Patientinformationskortet skal indeholde følgende hovedelementer:
English: • Not to stop taking CAPRELSA, or change the dose, without consulting the prescriber;
Danish: • Ikke at stoppe behandlingen med Caprelsa og ikke ændre dosis uden først at have talt med lægen;
English: For more severe skin reactions (such as Stevens-Johnson syndrome), referral of the patient to seek urgent medical advice is recommended.
Danish: For alvorligere hudreaktioner (som f.eks. Stevens-Johnsons syndrom) skal patienten straks søge lægehjælp.
English: • The need to counsel patients about the risk of prolonged QTc and PRES and inform them of what symptoms and signs to be aware of and the actions to take;
Danish: • Behovet for at rådgive patienter om risikoen for forlænget QTc-interval og PRES og oplyse dem om symptomer, som de bør være opmærksomme på, og hvad de skal gøre i så fald;
English: Clinical efficacy in paediatric patients:
Danish: Klinisk virkning hos pædiatriske patienter:
English: If you forget to take Caprelsa
Danish: Hvis du har glemt at tage Caprelsa
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).
Danish: I studie 58 blev tests for RET-mutation udført ved hjælp af ARMS-teknologien (Amplification Refractory Mutation System) baseret på polymerasekædereaktion (PCR) for M918T-mutationen, og direkte DNA-sekventering for mutationer i exon 10, 11, 13, 14, 15 og 16 (stedet for M918T-mutation) hos alle enkeltpatienter med tilgængeligt DNA (297/298).
English: An increase in the frequency and severity of some adverse reactions, like rash, diarrhoea and hypertension was observed at multiple doses at and above 300 mg in healthy volunteer studies and in patients.
Danish: En forøgelse af frekvensen og sværhedsgraden af visse bivirkninger som f.eks. udslæt, diarré og hypertension blev observeret ved gentagne doser på 300 mg og derover, ved studier med raske frivillige og hos patienter.
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.
Danish: Ved en dosis på 300 mg pr. dag ved MTC blev der observeret bekræftet EKG QTc-forlængelse til over 500 ms. hos 11 % af patienterne i et fase III-studie.
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.
Danish: Der bør indhentes et EKG, samt værdier for serumkalium, calcium, magnesium og thyreoideastimulerende hormon (TSH) ved baseline og 1, 3, 6 og 12 uger efter behandlingsstart samt hver 3. måned i mindst et år derefter.
English: N-desmethyl-vandetanib and vandetanib-N-oxide circulate at concentrations of approximately 11% and 1.4% of those of vandetanib.
Danish: N-desmetyl-vandetanib og vandetanib-N-oxid cirkulerer med koncentrationer på ca. 11 % og 1,4 % af koncentrationen af vandetanib.
English: Vandetanib has not been studied in patients with ventricular arrhythmias or recent myocardial infarction.
Danish: Vandetanib er ikke blevet undersøgt hos patienter med ventrikulær arytmi eller nyligt myokardieinfarkt.
English: If you get side effects, your doctor may tell you to take Caprelsa at a lower dose.
Danish: Hvis du får bivirkninger, vil din læge muligvis fortælle dig, at du skal tage Caprelsa ved en lavere dosis.
English: • If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
Danish: • Hvis du har eller har haft et aneurisme (udvidelse og svækkelse af en blodårevæg) eller en rift i en blodårevæg
English: months n-vandetanib 231 196 169 140 40 1 0 n-placebo 100 71 57 45 13 0 0 ____ vandetanib 300 mg, ------ placebo, y-axis=PFS, x-axis=time in months, n-vandetanib=number of patients at risk-vandetanib, n-placebo=number of patients at risk-placebo HR = 0.46, 95%CI (0.31-0.69), p = 0.0001
Danish: måneder n-vandetanib 231 196 169 140 40 1 0 n-placebo 100 71 57 45 13 0 0 ____ vandetanib 300 mg, ------ placebo, y-akse=PFS, x-akse=tid i måneder, n-vandetanib=antal patienter med risiko i vandetanibgruppen, n-placebo=antal patienter med risiko i placebogruppen
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.
Danish: Ved forskellige eksponeringsvarigheder blev medianhæmoglobinniveauerne hos patienter i behandling med vandetanib forhøjet med 0,5-1,5 g/dl i forhold til baseline.
English: Caprelsa is indicated in adults, children and adolescents aged 5 years and older.
Danish: Caprelsa er indiceret til voksne, børn og unge fra 5 år og derover.
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.
Danish: Ved objektiv sygdomsprogression baseret på investigatorens vurdering blev patienterne seponeret fra blindet studiebehandling og fik mulighed for at modtage åben behandling med vandetanib.
English: The appropriate interval between discontinuation of vandetanib and subsequent elective surgery required to avoid the risks of impaired wound healing has not been determined.
Danish: Det passende nødvendige interval mellem seponering af vandetanib og efterfølgende elektiv kirurgi for at undgå risikoen for nedsat sårheling er ikke blevet fastlagt.
English: The precise mechanism of action of vandetanib in locally advanced or metastatic MTC is unknown.
Danish: Vandetanibs nøjagtige virkningsmekanisme ved lokalt fremskreden eller metastatisk MTC kendes ikke.
English: • Abnormal color of urine.
Danish: • Unormalt farvet urin.