FrancophonIA/ELRC3.0 huggingface dataset:
English: This is uncommon (affects less than 1 in 100 people) but can be life-threatening.
Danish: Dette er ikke almindeligt (ses hos mindre end 1 ud af 100 personer), men kan være livstruende.
English: These may be signs of a condition called RPLS (Reversible Posterior Leukoencephalopathy Syndrome).
Danish: Dette kan være tegn på en tilstand kaldet RPLS (reversibelt posteriort leukoencefalopati-syndrom).
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.
Danish: Pædiatriske patienter, der behandles med Caprelsa, og deres omsorgspersoner skal have udleveret en doseringsvejledning og oplyses om den korrekte startdosis og alle efterfølgende dosisjusteringer.
English: Tell your doctor or pharmacist if you are taking any of the following medicines:
Danish: Fortæl det til lægen eller apotekspersonalet, hvis du tager et eller flere af følgende midler:
English: If ILD is confirmed, vandetanib should be permanently discontinued and the patient treated appropriately.
Danish: Hvis ILD bekræftes, bør behandlingen med vandetanib seponeres permanent, og patienten behandles på passende vis.
English: Before initiating vandetanib, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Danish: Inden indledning af behandling med <produktnavn> bør denne risiko overvejes nøje for patienter med risikofaktorer såsom hypertension eller tidligere aneurisme.
English: Intent-to-treat (ITT) analysis includes patients who received open-label vandetanib before progression according to the central read.
Danish: Intent-to-treat (ITT)-analyse inkluderer patienter, som fik åben behandling med vandetanib før progression i henhold til den centrale aflæsning.
English: E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
Danish: E. SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE
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).
Danish: Behandlingen skal iværksættes og overvåges af en læge med erfaring i behandling af MTC og anvendelse af cancermedicin og erfaring med vurdering af elektrokardiogram (EKG).
English: While you are taking Caprelsa, protect yourself when you go outside by always using sunscreen and wearing clothes to avoid exposure to the sun.
Danish: Mens du tager Caprelsa, skal du beskytte dig selv, når du går udenfor, ved altid at benytte solcreme og bære tøj for at undgå eksponering for solen.
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.
Danish: Fordelen ved vandetanib til patienter med CTN mindre end 500 pg/ml er ikke blevet klarlagt, derfor bør brug til patienter med CTN <500 pg/ml omhyggeligt overvejes på grund af de behandlingsrelaterede risici ved vandetanib.
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.
Danish: Hvis vandetanib anvendes under graviditeten, eller hvis patienten bliver gravid, mens hun får vandetanib, skal hun underrettes om den potentielle risiko for misdannelser af fosteret eller den potentielle risiko for abort.
English: ECG QTc prolongation appears to be dose-dependent.
Danish: EKG QTcforlængelse synes at være dosisafhængig.
English: Patients treated with Caprelsa must be given the patient alert card and be informed about the risks of Caprelsa (see also package leaflet).
Danish: Patienter, som får Caprelsa, skal have udleveret et patientinformationskort og oplyses om risiciene ved Caprelsa (se også indlægssedlen).
English: Calcium hydrogen phosphate dihydrate Microcrystalline cellulose Crospovidone (type A) Povidone (K 29-32) Magnesium stearate
Danish: Calciumhydrogenphosphatdihydrat Mikrokrystallinsk cellulose Crospovidon (type A) Povidon (K 29-32) Magnesiumstearat
English: If severe diarrhoea (CTCAE grade 3-4) develops, vandetanib should be stopped until diarrhoea improves.
Danish: Hvis der udvikles svær diarré (CTCAE-grad 3-4), bør indtagelse af vandetanib ophøre, indtil diarréen forbedres.
English: • Inflammation of the diverticula (small bulging pouches that can form in your digestive system).
Danish: • Betændelse i divertikler (små udposninger, der kan dannes i fordøjelsessystemet).
English: Starting vandetanib dose was 100mg/m2/day for all patients except for one who started at 150mg/m2/day.
Danish: Startdosis af vandetanib var 100 mg/m2/dag for alle patienter med undtagelse af en patient, som indledte behandlingen med 150 mg/m2/dag.
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.
Danish: Resultaterne af et farmakodynamisk og farmakokinetisk interaktionsstudie indikerede, at samtidig indgift af ondansetron til raske patienter viste sig at have ringe virkning på farmakokinetikken af vandetanib, men havde en lille additiv effekt på forlængelsen af QTc-intervallet på ca. 10 ms.
English: Vandetanib is an inhibitor of the organic cation 2 (OCT2) transporter.
Danish: Vandetanib er en hæmmer af den organiske kationtransporter 2 (OCT2).
English: • An irritation of the eyes (conjunctivitis).
Danish: • En irritation af øjnene (øjenkatar).
English: • CAPRELSA prolongs the QTc interval and can cause Torsades de pointes and sudden death
Danish: • Caprelsa forlænger QTc-intervallet og kan forårsage torsades de pointes og pludselig død;
English: The patient will be provided with the Patient Alert Card with each prescription.
Danish: Patienten vil få udleveret et patientinformationskort ved hver medicinudlevering.
English: - the clinical study report of study D4200C00104, an observational study including a retrospective arm to evaluate the Benefit/Risk of vandetanib (Caprelsa) 300 mg in RET mutation negative and RET mutation positive patients with symptomatic, aggressive, sporadic, unresectable, locally advanced/metastatic thyroid cancer (MTC).
Danish: - Den kliniske studierapport for studie D4200C00104, en observationsevaluering inklusive en retrospectiv arm til evaluering af benefit/risk for vandetanib (Caprelsa) 300 mg i RET mutation negative og RET mutation positive patienter med symptomatisk, aggressiv, sporadisk, inoperabel, lokal fremskreden/metastatisk thyreoideacancer (MTC).
English: • Inflammation of the main air passages to the lungs.
Danish: • Betændelse i hovedluftvejene til lungerne.
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.
Danish: Af patienterne inkluderet i studiet havde 10 patienter på vandetanib og 4 på placebo (4 % af alle patienter) en World Health Organization Performance status (WHO PS) score på ≥ 2, og 28 (12,1 %) patienter på vandetanib og 10 (10,1 %) på placebo havde påvirkning af hjertet.
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.
Danish: Hvis der ikke findes anden passende behandling, kan de ikke anbefalede kombinationer med vandetanib foretages med yderligere EKG-overvågning af QTc-intervallet, evaluering af elektrolytter og yderligere kontrol ved debut/forværring af diarré.
English: Fourteen patients treated with vandetanib, and 3 with placebo had unresectable locally advanced disease only.
Danish: 14 patienter, der blev behandlet med vandetanib, og 3 med placebo havde kun inoperabel lokalt fremskreden sygdom.
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.
Danish: Vandetanib hæmmer også både vildtype og størstedelen af muterede, aktiverede former af RET, og hæmmer markant væksten af MTC-cellelinjer in vitro.
English: The risk of Torsades may be increased in patients with electrolyte imbalance (see section 4.8).
Danish: Risikoen for torsades kan være øget hos patienter med elektrolytubalance (se pkt.
English: • Abnormal sensation of the skin.
Danish: • Unormal fornemmelse i huden.
English: * 13.4% vandetanib patients had QTc (Bazett's) ≥ 500 ms compared with 1.0% placebo patients.
Danish: * 13,4 % patienter på vandetanib havde QTc (Bazetts formel) ≥ 500 ms sammenlignet med 1,0 % af patienterne på placebo.
English: Frequencies of occurrence of undesirable effects are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Danish: Hyppighed for forekomsten af bivirkninger er defineret som: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden
English: Considering the data available in adult patients with renal impairment:
Danish: Ud fra de foreliggende data for voksne patienter med nedsat nyrefunktion:
English: Caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.
Danish: Caprelsa er indiceret til behandling af aggressiv og symptomatisk medullær thyreoideacancer (MTC) hos patienter med inoperabel lokalt fremskreden eller metastatisk sygdom.
English: • The summary of Product Characteristics (SmPC);
Danish: • Produktresumé (SmPC);
English: Other side effects include:
Danish: Andre bivirkninger omfatter
English: Hypertensive crisis, ischaemic cerebrovascular conditions
Danish: Hypertensiv krise, iskæmiske cerebrovaskulære tilstande
English: Caprelsa comes in blister packs of 30 tablets.
Danish: Caprelsa leveres i blisterpakninger med 30 tabletter.
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.
Danish: I vandetanib gruppen havde i alt 73 patienter (32 %) progredieret sygdom; 64 (28 %) ved progression efter respons evaluerings kriterier i faste tumorer (RECIST) og 9 (4 %) ved dødsfald uden progression.
English: Hypertension, including hypertensive crisis, has been observed in patients treated with vandetanib.
Danish: Hypertension, herunder hypertensiv krise, er blevet observeret hos patienter behandlet med vandetanib.
English: • Patients who are on the increased dose (b in Table 1), should be recommenced at the starting dose (a in Table 1).
Danish: • Patienter, som tager den øgede dosis (b i tabel 1), bør genoptage behandlingen med startdosis (a i tabel 1).
English: Effect of other medicinal products on vandetanib
Danish: Andre lægemidlers virkning på vandetanib
English: • Seizures, headache, confusion or finding it difficult to concentrate.
Danish: • Anfald, hovedpine, forvirring eller koncentrationsbesvær.
English: • Caprelsa may be taken with or without food.
Danish: • Caprelsa kan tages i forbindelse med et måltid eller mellem måltiderne.
English: PRES is a syndrome of subcortical vasogenic oedema diagnosed by a MRI of the brain, has been observed infrequently with vandetanib treatment in combination with chemotherapy.
Danish: PRES er et syndrom med subkortikalt vasogent ødem, der diagnosticeres ved MR-skanning af hjernen, og som er blevet observeret sjældent i forbindelse med vandetanib-behandling i kombination med kemoterapi.
English: The half-life of vandetanib (19 days) renders this prolongation in QTc interval particularly problematic (see section 4.8).
Danish: Halveringstiden for vandetanib (19 dage) gør forlængelsen af QTc-intervallet særligt problematisk (se pkt.
English: Dose reduction (mg) c
Danish: Dosisreduktion (mg)
English: Vandetanib accumulates approximately 8-fold on multiple dosing with steady state achieved from approximately 2 months.
Danish: Vandetanib akkumuleres ca. ottefoldigt ved multiple doser med, steady-state opnået fra ca. 2 måneder.
English: The analysis was performed using a log rank test with treatment as the only factor.
Danish: Analysen var udført vha. en log-rank test med behandling som den eneste faktor.
English: Statistically significant advantages were seen for vandetanib for the secondary endpoints of response rate, disease control rate, and biochemical response.
Danish: Der sås statistisk signifikante fordele ved vandetanib, hvad angår de sekundære effektmål responsrate, sygdomskontrol og biokemisk respons.
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).
Danish: Resultatet af den primære analyse af PFS viste en statistisk signifikant forbedring i PFS for patienter randomiseret til vandetanib sammenlignet med placebo (Hazard Ratio (HR) = 0,46; 95 % Konfidensinterval (CI) = 0,31-0,69; p=0,0001).
English: Food effect Exposure to vandetanib is not affected by food.
Danish: Virkning af fødeindtagelse Eksponering for vandetanib påvirkes ikke af føde.
English: AstraZeneca UK Limited, Macclesfield, Cheshire, SK10 2NA, United Kingdom Or
Danish: AstraZeneca UK Limited, Macclesfield, Cheshire, SK10 2NA, Storbritannien eller
English: Mechanism of action and pharmacodynamic effects Vandetanib is a potent inhibitor of vascular endothelial growth factor receptor-2 (VEGFR-2 also known as kinase insert domain containing receptor [KDR]), epidermal growth factor receptor (EGFR) and RET tyrosine kinases.
Danish: Virkningsmekanisme og farmakodynamisk virkning Vandetanib er en potent hæmmer af vaskulær endotelvækstfaktor-receptor 2 (VEGFR-2 også kaldet tyrosinkinaser af typen kinase insert domain receptor [KDR]), epidermal vækstfaktorreceptor (EGFR) og RET tyrosinkinaser.
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).
Danish: Der blev ikke påvist nogen klinisk signifikant interaktion hos raske forsøgspersoner mellem vandetanib (en enkelt dosis på 300 mg) og den potente CYP3A4-hæmmer, itraconazol (gentagne doser på 200 mg én gang dagligt).
English: Alanine aminotransferase elevations
Danish: Forhøjet alaninaminotransferase
English: All prescribers of Caprelsa must be familiar with the Physician Information and Management Guidelines.
Danish: Alle læger, der ordinerer Caprelsa, skal være bekendt med informationen til lægen og retningslinjerne for anvendelse.
English: • How CAPRELSA dose for infants and adolescents is calculated;
Danish: • Hvordan Caprelsa-dosis beregnes hos børn og unge;
English: Your doctor may need to prescribe or change your thyroid hormone treatment.
Danish: Lægen får måske brug for at ordinere behandling med thyreoideahormon eller ændre din behandling.
English: • Lack of urine.
Danish: • Manglende urindannelse.
English: • pentamidine (used to treat infection)
Danish: • pentamidin (mod infektion)
English: Summary of the safety profileThe most commonly reported adverse drug reactions have been diarrhoea, rash, nausea, hypertension, and headache.
Danish: Sammenfatning af sikkerhedsprofilen De mest hyppigt indberettede bivirkninger er diarré, udslæt, kvalme, hypertension og hovedpine.
English: Vandetanib binds to human serum albumin and alpha-1-acid-glycoprotein with in vitro protein binding being approximately 90%.
Danish: Vandetanib binder sig til humant serumalbumin og alfa-1-syre-glykoprotein med in vitroproteinbinding på ca. 90 %.
English: • The active substance is vandetanib.
Danish: • Aktivt stof: vandetanib.
English: • 12 weeks after starting Caprelsa
Danish: • 12 uger efter start med Caprelsa
English: • Congenital long QTc syndrome.
Danish: • Medfødt langt QTc-syndrom.
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.
Danish: Disse kan være almindelige (ses hos mindre end 1 ud af 10 personer) eller ualmindelige (ses hos mindre end 1 ud af 100 personer) afhængigt af typen af hudreaktion.
English: As expected from its pharmacological actions, vandetanib has shown significant effects on all stages of female reproduction in rats (see section 5.3).
Danish: Som forventet ud fra dets farmakologiske virkninger har vandetanib udvist markante virkninger på alle stadier af reproduktionsevnen hos hunrotter (se pkt.
English: The safety findings in this study are consistent with the safety profile of vandetanib in adult patients with MTC.
Danish: Sikkerhedsfundene i dette studie svarer til vandetanibs sikkerhedsprofil hos voksne patienter med MTC.
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.
Danish: 28 ud af de 231 patienter (12,1 %) på vandetanib og 3 ud af de 99 (3,0 %) på placebo seponerede behandlingen på grund af en bivirkning.
English: The prescriber must discuss the risks of Caprelsa therapy with the patient.
Danish: Sundhedspersonale skal drøfte risici ved behandling med Caprelsa med patienten.
English: Diarrhoea is a disease related symptom as well as a known undesirable effect of vandetanib.
Danish: Diarré er både et sygdomsrelateret symptom og en kendt bivirkning ved vandetanib.
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).
Danish: Din læge eller sygeplejerske skal undersøge dit blods indhold af kalium, calcium, magnesium og thyreoideastimulerende hormon (TSH) samt kontrollere dit hjertes elektriske aktivitet med en test kaldet et elektrokardiogram (EKG).
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;
Danish: • Nødvendigheden af at tage EKG og kontrollere serumværdier af kalium, calcium og magnesium samt thyroidea-stimulerende hormon (TSH), og de tider og situationer, hvor det bør udføres;
English: Fourteen of the 28 patients (50%) who stopped vandetanib for an adverse event discontinued without a dose reduction.
Danish: 14 ud af de 28 patienter (50 %), som stoppede med vandetanib på grund af en bivirkning, blev seponeret uden en dosisreduktion.
English: The liquid can also be administered through nasogastric or gastrostomy tubes.
Danish: Væsken kan også indgives gennem en nasogastrisk sonde eller en gastrostomisonde.
English: Therefore, the concomitant use of ondansetron with vandetanib is not recommended.
Danish: Samtidig brug af ondansetron og vandetanib anbefales derfor ikke.
English: Silk Road Business Park Macclesfield, Cheshire SK10 2NA United Kingdom
Danish: Silk Road Business Park Macclesfield, Cheshire SK10 2NA Storbritannien eller
English: • What CAPRELSA is, what it treats, how it is administered;
Danish: • Hvad Caprelsa er, hvad det anvendes til og, hvordan det administreres;
English: • Dehydration.
Danish: • Dehydrering.
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.
Danish: Patientkarakteristika ved inklusion i studiet var følgende: gennemsnitsalder 14,2 år (interval 9-17 år), 50 % piger, 50 % drenge, 93,8 % kaukasiere, 26,7 % latinamerikanere og 6,3 % af afrikansk afstamning.
English: • Vandetanib is not recommended in paediatric patients with severe renal impairment
Danish: • Vandetanib anbefales ikke til pædiatriske patienter med svært nedsat nyrefunktion
English: • CAPRELSA treatment must not be started in patients: o Whose ECG QTc interval is greater than 480 msec; o Who have congenital long QTc syndrome; o Who have a history of Torsades de pointes unless all risk factors that contributed to Torsades de pointes have been corrected;
Danish: • Caprelsa-behandling må ikke indledes hos patienter: o som har QTc-interval over 480 ms på EKG; o som har kongenit langt QTc-syndrom; o som har torsades de pointes i anamnesen, med mindre alle risikofaktorer, der bidrog til torsades de pointes, er korrigeret;
English: Caution should be used when administering vandetanib to patients with brain metastases, as intracranial haemorrhage has been reported.
Danish: Forsigtighed tilrådes ved administration af vandetanib til patienter med hjernemetastaser, da der er rapporteret intrakranielle blødninger.
English: In addition, vandetanib inhibits epidermal growth factor (EGF)-stimulated EGF receptor tyrosine kinase in tumour cells and endothelial cells.
Danish: Derudover hæmmer vandetanib epidermal vækstfaktor (EGF)-stimuleret EGF-receptor-tyrosinkinase i tumorceller og endotelceller.
English: Your doctor may recommend you take Caprelsa at a lower dose or stop taking Caprelsa.
Danish: Din læge vil muligvis anbefale, at du tager Caprelsa i en lavere dosis eller holder op med at tage Caprelsa.
English: Table 2: Adverse reactions and system organ class System Organ
Danish: Tabel 2: Bivirkninger og systemorganklasse Systemorganklasse Meget almindelig Almindelig
English: • Loss of appetite (anorexia).
Danish: • Appetitløshed (anoreksi).
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.
Danish: I et toksicitetsstudie med gentagne doser hos rotter var der et fald i antallet af corpora lutea i æggestokkene hos rotter, som fik vandetanib i 1 måned.
English: • How CAPRELSA dose is calculated;
Danish: • Hvordan Caprelsa-dosis beregnes;
English: There is limited clinical data with vandetanib in patients with MTC aged over 75.
Danish: Der er begrænsede kliniske data for vandetanib fra patienter over 75 år med MTC.
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.
Danish: Hos 5 ud af 6 patienter (83 %) med moderat nyresvigt, som blev behandlet med vandetanib, blev dosis reduceret til 200 mg pga. bivirkning; hos 1 patient var der behov for yderligere dosisreduktion til 100 mg.
English: Dosing for paediatric patients should be on the basis of BSA in mg/m2.
Danish: Dosering til pædiatriske patienter bør baseres på mg/m2 legemsoverfladeareal (BSA).
English: This is because Caprelsa can affect the way some medicines work and some medicines can have an effect on Caprelsa.
Danish: Caprelsa kan påvirke virkningen af anden medicin, og/eller anden medicin kan påvirke virkningen af Caprelsa.
English: Interstitial Lung Disease (ILD) has been observed in patients receiving vandetanib and some cases have been fatal.
Danish: Interstitiel lungesygdom (ILD) er blevet observeret hos patienter, der fik vandetanib, og visse tilfælde var dødelige.
English: Vandetanib is also a sub-micromolar inhibitor of vascular endothelial receptor-3 tyrosine kinase.
Danish: Vandetanib er også en sub-mikromolær hæmmer af vaskulær endotel-receptor3 tyrosinkinase.
English: Pharmacotherapeutic Group: antineoplastic agent, protein kinase inhibitor, ATC Code: L01XE12
Danish: Farmakoterapeutisk gruppe: proteinkinasehæmmere, antineoplastiske stoffer, ATC-kode: L01XE12