FrancophonIA/ELRC3.0 huggingface dataset:
English: PRES has also been observed in patients receiving vandetanib as monotherapy.
Danish: PRES er også blevet observeret hos patienter, der fik vandetanib som monoterapi.
English: RPLS is uncommon (affects less than 1 in 100 people).
Danish: RPLS er ikke almindeligt (ses hos mindre end 1 ud af 100 personer).
English: In healthy subjects, the AUC(0-t) and Cmax for digoxin (P-gp substrate) were increased by 23% and 29% respectively, when given together due to P-gp inhibition by vandetanib.
Danish: Hos raske forsøgspersoner blev AUC(0-t) og Cmax for digoxin (P-glykoprotein, P-gp-substrat) øget med henholdsvis 23 % og 29 % ved samtidig administration af vandetanib på grund af P-gp-hæmning af vandetanib.
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).
Danish: Til bestemmelse af status for RETmutation vil det være at foretrække, at vævsprøver udtages på tidspunktet for indledning af behandlingen snarere end på diagnosetidspunktet (se pkt.
English: This suggests that vandetanib slows but does not prevent wound healing.
Danish: Dette tyder på, at vandetanib forsinker sårheling, men ikke forhindrer den.
English: Rash and other skin reactions including photosensitivity reactions and palmar-plantar erythrodysaesthesia syndrome have been observed in patients who have received vandetanib.
Danish: Udslæt og andre hudreaktioner, inklusive lysfølsomhedsreaktioner og palmoplantar erytrodysæstesisyndrom, er blevet observeret hos patienter, som har fået vandetanib.
English: Other medicines and Caprelsa
Danish: Brug af anden medicin sammen med Caprelsa
English: It is expected that these would be uncommon adverse reactions in patients receiving vandetanib for MTC.
Danish: Disse forventes at være ikke almindelige bivirkninger hos patienter, der får vandetanib for MTC.
English: CYP3A4, and vandetanib-N-oxide by flavin-containing monooxygenase enzymes (FM01 and FMO3).
Danish: N-desmetyl-vandetanib dannes primært via CYP3A4, og vandetanib-N-oxid af de flavinholdige monooxygenase-enzymer FM01 og FMO3.
English: Vandetanib treatment must not be started in patients whose ECG QTc interval is greater than 480 msec. Vandetanib should not be given to patients who have a history of Torsades de pointes.
Danish: Behandling med vandetanib må ikke startes hos patienter, hvis EKG QTc-interval er større end 480 ms. Vandetanib bør ikke gives til patienter, som har en anamnese med torsades de pointes.
English: • If it is less than 12 hours until your next dose: Skip the missed dose.
Danish: • Hvis der er mindre end 12 timer til den næste dosis: Spring den glemte tablet over.
English: • The Patient Alert Card.
Danish: • Patientinformationskort.
English: ECG QTc interval prolonged
Danish: Forlænget EKG QTc-interval
English: The following adverse reactions have been identified in clinical studies with patients receiving vandetanib as treatment for MTC.
Danish: Følgende bivirkninger er blevet identificeret under kliniske studier med patienter, der fik vandetanib som behandling mod MTC.
English: Pharmacokinetics in paediatric population
Danish: Farmakokinetik i den pædiatriske population
English: RET mutation status was obtained at the time of diagnosis in a majority of patients and could have changed since.
Danish: PFS HR (95 %) konfidensinterval *RET-mutationsstatus stammer fra diagnosetidspunktet hos de fleste patienter og kan have ændret sig siden.
English: Events such as Torsades de pointes, Stevens-Johnson syndrome, erythema multiforme, interstitial lung disease (sometimes fatal) and PRES (RPLS) have occurred in patients treated with vandetanib monotherapy.
Danish: Bivirkninger såsom torsades de pointes, Stevens-Johnsons syndrom, erythema multiforme, interstitiel lungesygdom og PRES (RPLS) er forekommet hos patienter, som blev behandlet med vandetanib som monoterapi.
English: 116/231 81.6 months 0.99
Danish: 116/231 81,6 måneder 0.99 0,72, 1,38 0,9750
English: Very common (affects more than 1 in 10 people):
Danish: Meget almindelig (ses hos flere end 1 ud af 10 personer):
English: Rearranged during transfection (RET) status
Danish: RET-status (status for omlejret under transfektion)
English: Therefore, an appropriate clinical (e.g. ECG) and/or laboratory monitoring is recommended for patients receiving concomitant digoxin and vandetanib, and such patients may require a lower dose of digoxin.
Danish: Af denne grund anbefales passende klinisk (f.eks. EKG) og/eller laboratoriemæssig monitorering hos patienter, der får digoxin og vandetanib samtidig, og en lavere digoxindosis kan være nødvendig hos disse patienter (for vandetanibmonitorering, se pkt.
English: There is limited data in patients with hepatic impairment (serum bilirubin greater than 1.5 times upper limit of normal (see sections 4.2 and 4.4).
Danish: Der foreligger begrænsede data for patienter med nedsat leverfunktion (serumbilirubin større end 1,5 gange den øvre grænse for normalområdet (se pkt.
English: Torsades de pointes and ventricular tachycardia have been uncommonly reported in patients administered vandetanib 300 mg daily.
Danish: Torsades de pointes og ventrikulær takykardi er rapporteret som ikke almindelige bivirkninger hos patienter, der fik indgivet vandetanib 300 mg dagligt.
English: - if you are taking any of the following medicines: arsenic, cisapride (used to treat heartburn), erythromycin intravenous and moxifloxacin (used to treat infection), toremifene (used to treat breast cancer), mizolastine (used to treat allergies), Class IA and III antiarrhythmics (used to control heart rhythm).
Danish: - hvis du tager et af følgende lægemidler: Arsen, cisaprid (mod halsbrand), erythromycin som injektion i en vene og moxifloxacin (mod infektion), toremifen (til behandling af brystkræft), mizolastin (mod allergi), klasse IA- og III-antiarytmika (midler til kontrol af hjerterytmen).
English: Increase of serum ALT and AST, weight decreased blood creatinine increased
Danish: Forhøjet serumALAT og -ASAT, vægttab, forhøjet kreatinin i blodet
English: Start dose (mg)a
Danish: Startdosis (mg)
English: QTc prolongation and Torsades de Pointes
Danish: QTc-forlængelse og torsades de pointes
English: • Severe high blood pressure.
Danish: • Højt blodtryk.
English: If ondansetron is administered with vandetanib, closer monitoring of serum electrolytes and ECGs and aggressive management of any abnormalities is required.
Danish: Hvis ondansetron administreres sammen med vandetanib, skal serumelektrolytter og EKG nøje overvåges, og vedholdende behandling af eventuelle anormaliteter er påkrævet.
English: • Frequent urination.
Danish: • Hyppig vandladningstrang.
English: • cisapride (used to treat heart burn), pimozide (used to treat uncontrolled repeated movements of the body and verbal outbursts) and halofantrine and lumefantrine (used to treat malaria)
Danish: • cisaprid (mod halsbrand), pimozid (mod gentagne, ufrivillige bevægelser og verbale udbrud) og halofantrin og lumefantrin (mod malaria)
English: A patient was considered to have a RET mutation if either an M918T mutation by the ARMS assay, or a RET mutation in any exons sequenced was present in the tumour.
Danish: Patienten ansås for at have en RET-mutation, hvis der i tumoren forekom enten en M918T-mutation ifølge ARMS-metoden eller en RET-mutation i et af de sekventerede exoner.
English: There are no data on the use of vandetanib in breast-feeding women.
Danish: Der foreligger ingen data vedrørende anvendelsen af vandetanib hos ammende kvinder.
English: • Combinations not recommended: Methadone, haloperidol, amisulpride, chlorpromazine, sulpiride, zuclopenthixol, halofantrine, pentamidine and lumefantrine.
Danish: • Ikke anbefalede kombinationer: Methadon, haloperidol, amisulprid, chlorpromazin, sulpirid, zuclopenthixol, halofantrin, pentamidin og lumefantrin.
English: In vivo vandetanib administration reduced tumour cell-induced angiogenesis, tumour vessel permeability, tumour microvessel density, and inhibited tumour growth of a range of human xenograft tumour models in athymic mice.
Danish: In vivo-indgivelse af vandetanib reducerede tumorcelle-induceret angiogenese, permeabiliteten af tumorkar, og densiteten af tumormikrokar, samt hæmmede tumorvækst i en række humane xenografttumormodeller i athymiske mus.
English: • Flu.
Danish: • Influenza.
English: Heart failure, acute heart failure, rate and rhythm disorders, cardiac conduction disorders, ventricular arrhythmia and cardiac arrest
Danish: Hjerteinsufficiens, akut hjerteinsufficiens, frekvens- og rytmeforstyrrelser, ledningsforstyrrelser i hjertet, ventrikulær arytmi og hjertestop
English: A 2-year carcinogenicity study in rats was impaired by low survival in the high dose female group and limited exposure of the animals to vandetanib; however, no carcinogenic effects were observed in the remaining animals.
Danish: Et 2-årigt karcinogenicitetsstudie med rotter var svækket af lav overlevelse i gruppen af hundyr, der fik en høj dosis, samt af dyrenes begrænsede eksponering for vandetanib.
English: Ocular events such as blurred vision are common in patients who received vandetanib for MTC.
Danish: Okulære bivirkninger såsom sløret syn er almindelige hos patienter, som får vandetanib for MTC.
English: Clinical data suggest that no change in starting dose is required in patients with mild renal impairment.
Danish: Kliniske data tyder på, at en ændring af startdosis til patienter med let nedsat nyrefunktion ikke er nødvendig.
English: The Physicians' dosing and monitoring guide for paediatric patients should contain the following key elements:
Danish: Medicineringsfejl hos den pædiatriske population Lægens doserings- og overvågningsguide for pædiatriske patienter skal indeholde følgende hovedelementer:
English: A pharmacokinetic study in volunteers with mild, moderate and severe renal impairment shows that exposure to vandetanib after single dose is increased up to 1.5, 1.6 and 2-fold respectively in patients with mild, moderate (creatinine clearance ≥ 30 to < 50 ml/min) and severe (clearance below 30 ml/min) renal impairment at baseline (see section 5.2).
Danish: Nedsat nyrefunktion hos voksne patienter med MTC Et farmakokinetisk studie med frivillige forsøgspersoner med let, moderat eller svært nedsat nyrefunktion viser, at eksponering for en enkelt dosis vandetanib øges med op til faktor 1,5, 1,6 og 2 af niveauet hos patienter med let, moderat (kreatinin clearance ≥ 30 til < 50 ml/min) eller svært (clearance < 30 ml/min) nedsat nyrefunktion ved baseline (se pkt.
English: Posterior reversible encephalopathy syndrome, PRES (Reversible posterior leukoencephalopathy syndrome-RPLS)
Danish: Posteriort reversibelt encefalopatisyndrom, PRES (= reversibelt posteriort leukoencefalopati-syndrom, RPLS)
English: • Inflammation of the pancreas (pancreatitis).
Danish: • Betændelse i bugspytkirtlen (pancreatitis).
English: 100 every other day
Danish: 100 hver anden dag
English: • Stones or calcium deposits in the urinary tract (nephrolithiasis).
Danish: • Sten eller calciumaflejringer i urinrøret (nyresten).
English: Dosing can be resumed at a reduced dose thereafter when fully recovered from adverse reactions
Danish: Behandlingen kan genoptages med en lavere dosis, når patienten er kommet sig fuldstændigt over bivirkningerne.
English: • Blistering of skin (bullous dermatitis).
Danish: • Betændelse i huden med blærer (bulløs dermatitis).
English: Increased haemoglobin,serum amylase increased
Danish: Øget hæmoglobin, forhøjet serumamylase
English: Appendicitis, staphylococcal infection, diverticulitis, cellulitis, abdominal wall abscess
Danish: Appendicitis, stafylokokinfektion, diverticulitis, cellulitis, absces i abdominalvæggen
English: Nasopharyngitis bronchitis, upper respiratory tract infections, urinary tract infections
Danish: Nasopharyngitis, bronkitis, øvre luftvejsinfektioner, urinvejsinfektioner
English: Do not take a double dose (two doses at the same time) to make up for a forgotten tablet.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte tablet.
English: • Fainting, dizziness or heart rhythm changes.
Danish: • Besvimelsesanfald, svimmelhed eller ændringer i hjerterytmen.
English: Chromaturia, anuria
Danish: Kromaturi, anuri
English: Vandetanib is not recommended for use in patients with severe renal impairment since there is limited data in patients with severe renal impairment, and safety and efficacy have not been established.
Danish: Vandetanib anbefales ikke til patienter med svært nedsat nyrefunktion, da der er begrænsede data fra patienter med svært nedsat nyrefunktion, og sikkerhed og effekt er ikke blevet klarlagt.
English: Fertility In rats, vandetanib had no effect on male fertility but impaired female fertility (see section 5.3).
Danish: Hos rotter havde vandetanib ingen virkning på fertiliteten hos hanner, men det nedsatte fertiliteten hos hunner (se pkt.
English: • Increased levels of red cells in your blood.
Danish: • Forøget antal røde blodlegemer i blodet.
English: • Signs or symptoms of the safety concerns and when to seek attention from a HCP;
Danish: • Tegn og symptomer på bivirkninger og hvornår lægen skal kontaktes;
English: • Upper respiratory tract infections.
Danish: • Øvre luftvejsinfektioner.
English: Dosing can be resumed at a reduced dose after return of the ECG QTc interval to pre-treatment status has been confirmed and correction of possible electrolyte imbalance has been made;
Danish: Behandlingen kan genoptages med reduceret dosis, når et EKG har bekræftet, at QTc-intervallet er vendt tilbage til niveauet før behandling, og efter afhjælpning af eventuelle forstyrrelser i elektrolytbalancen;
English: • If a further event of CTCAE grade 3 or higher toxicity or prolongation of the ECG QTc interval occurs, dosing with vandetanib should be permanently stopped.
Danish: • Hvis der forekommer et yderligere tilfælde af CTCAE-grad 3 eller højere toksicitet eller forlænget QTc-interval i EKG, skal vandetanib seponeres permanent.
English: Vandetanib had no effect on fertility in male rats.
Danish: Vandetanib påvirkede ikke fertiliteten hos hanrotter.
English: • Loss of heart function.
Danish: • Nedsat hjertefunktion.
English: The administration of vandetanib with substances known to prolong the ECG QTc interval is contraindicated or not recommended (see section 4.3 and 4.5).
Danish: Administration af vandetanib sammen med stoffer, der vides at forlænge QTc-interval på EKG'et, er kontraindiceret eller frarådes (se pkt.
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.
Danish: De resterende 158 patienter (68 %) blev censureret i analysen af PFS. I placebogruppen havde i alt 51 patienter (51 %) progredieret sygdom; 46 (46 %) ved RECISTprogression, og 5 (5 %) ved dødsfald uden progression.
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.
Danish: Bivirkninger i forbindelse med overdosering skal behandles symptomatisk; specielt svær diarré skal behandles på behørig vis. I tilfælde af overdosering skal yderligere doser afbrydes, og der træffes de nødvendige forholdsregler til at sikre, at der ikke er opstået en uønsket hændelse, dvs. EKG inden for 24 timer, for at fastslå QTc-forlængelse.
English: Vision blurred, corneal structural change (including corneal deposits and corneal opacity)
Danish: Sløret syn i cornea (inklusive aflejringer i cornea og pletter i cornea)
English: • Sore mouth (stomatitis).
Danish: • Mundbetændelse (stomatitis).
English: • Increased pressure in the eye (glaucoma).
Danish: • Øget tryk i øjet (grøn stær).
English: Caprelsa is a treatment for adults and children aged 5 years and above with: Medullary thyroid cancer that cannot be removed by surgery or has spread to other parts of the body.
Danish: Medullær thyreoideacancer, som ikke kan fjernes med kirurgi, eller som har bredt sig til andre dele af kroppen.
English: • Numbness or tingling of the skin.
Danish: • Følelsesløshed eller prikkende fornemmelse i huden.
English: In healthy subjects, the Cmax for vandetanib was decreased by 15% while the AUC(0-t) for vandetanib was not affected when given together with omeprazole.
Danish: Ved samtidig administration af omeprazol blev Cmax for vandetanib reduceret med 15 % hos raske forsøgspersoner, mens AUC (0-t) for vandetanib ikke var påvirket.
English: Vandetanib is not recommended for use in adult and paediatric patients with hepatic impairment (serum bilirubin greater than 1.5 times upper limit of reference range (ULRR), this criterion does not apply to patients with Gilbert's Disease and alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) greater than 2.5 times ULRR, or greater than 5.0 times ULRR if judged by the physician to be related to liver metastases), since there is limited data in patients with hepatic impairment, and safety and efficacy have not been established (see section 4.4).
Danish: Dette kriterium gælder ikke for patienter med Gilberts sygdom og alaninaminotransferase (ALAT), aspartataminotransferase (ASAT) eller alkalisk fosfatase (ALP) > 2,5 gange ULRR eller > 5,0 gange ULRR, hvis det af lægen skønnes at være relateret til levermetastaser), eftersom der kun foreligger begrænsede data for patienter med nedsat leverfunktion, og sikkerhed og virkning ikke er blevet klarlagt (se pkt.
English: Table 1: Dosing nomogram for Paediatric Patients with MTC BSA (m2)
Danish: Tabel 1: Doseringsnomogram til pædiatriske patienter med MTC
English: • Bacterial infection.
Danish: • Bakterieinfektion.
English: 300 daily
Danish: 300 dagligt
English: • Concomitant use of vandetanib with the following medicinal products known to also prolong the QTc interval and/or induce Torsades de pointes: Arsenic, cisapride, erythromycin intravenous (IV), toremifene, mizolastine, moxifloxacin, Class IA and III antiarrhythmics (see section 4.5).
Danish: • Samtidig brug af vandetanib og følgende lægemidler, der ligeledes er kendt for at forlænge QTc-intervallet og/eller inducere torsades de pointes: arsenik, cisaprid, erythromycin intravenøst (i.v.
English: This syndrome should be considered in any patient presenting with seizures, headache, visual disturbances, confusion or altered mental function.
Danish: Dette syndrom bør tages i betragtning hos enhver patient, der indfinder sig med krampeanfald, hovedpine, synsforstyrrelser, konfusion eller ændret mental status.
English: • Malnutrition.
Danish: • Fejlernæring.
English: • PRES should be considered in any patient presenting with seizures, headache, visual disturbances, confusion or altered mental function.
Danish: • PRES bør tages i betragtning hos patienter, der indfinder sig med krampeanfald, hovedpine, synsforstyrrelser, konfusion eller ændret mental status.
English: crospovidone (type A), povidone (K29-32), magnesium stearate, hypromellose, macrogol and titanium dioxide (E171).
Danish: • De øvrige indholdsstoffer er calciumhydrogenphosphatdihydrat, mikrokrystallinsk cellulose, crospovidon (type A), povidon (K29-32), magnesiumstearat, hypromellose, macrogol og titandioxid (E171).
English: Breast-feeding is contraindicated while receiving vandetanib therapy.
Danish: Amning er kontraindiceret under behandling med vandetanib.
English: • Heart rate and rhythm disorders.
Danish: • Forstyrrelser af hjertets hastighed og rytme.
English: Tel: +44 (0)845 372 7101
Danish: Sanofi Tel: +44 (0)845 372 7101
English: Vandetanib is not recommended for use in patients with hepatic impairment (serum bilirubin greater than 1.5 times upper limit of normal), since there is limited data in patients with hepatic impairment, and safety and efficacy have not been established.
Danish: Vandetanib anbefales ikke til patienter med nedsat leverfunktion (serumbilirubin > 1,5 gange den øverste grænse for normalområdet), eftersom der foreligger begrænsede data for patienter med nedsat leverfunktion, og sikkerhed og virkning ikke er klarlagt.
English: Colitis, dry mouth, stomatitis, dysphagia, constipation, gastritis, gastrointestinal haemorrhage
Danish: Colitis, tør mund, stomatitis, synkebesvær, obstipation, gastrit, gastrointestinal blødning
English: In addition, the possibility of QTc prolongation and Torsades de pointes should be considered.
Danish: QTc-forlængelse og torsades de pointes tages i betragtning.
English: Cataract, accommodation disorders
Danish: Katarakt, akkomodationsforstyrrel ser
English: • Involuntary muscle contraction (convulsions).
Danish: • Ufrivillige muskelsammentrækninger (kramper).
English: Genzyme Europe B.V., Paasheuvelweg 25
Danish: Genzyme Europe B.V.
English: Upon improvement, treatment should be resumed at a reduced dose (see sections 4.2 and 4.8).
Danish: Når der er opnået bedring, kan behandlingen genoptages ved en reduceret dosis (se pkt.
English: 200 daily
Danish: 200 dagligt
English: A single dose pharmacokinetic study in volunteers indicated that exposure to vandetanib is enhanced (up to 1.5, 1.6 and 2-fold) in mild, moderate and severe renal impaired subjects respectively compared to subjects with normal renal function (see sections 4.2, 4.4 and 4.5).
Danish: Et enkeltdosis farmakokinetisk studie med frivillige forsøgspersoner indikerede, at eksponering for vandetanib forøges (op til 1,5, 1,6 og 2 gange) hos forsøgspersoner med hhv. mild, moderat og svær nyreinsufficiens i forhold til forsøgspersoner med normal nyrefunktion (se pkt.
English: • Bacterial skin infection.
Danish: • Bakterieinfektion i huden.
English: • Increased levels of calcium in your blood.
Danish: • Øget niveau af calcium i blodet.
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.
Danish: Hos patienter, der muligvis har negativ status for RET-mutation, bør der tages højde for, at der kan være færre fordele ved behandlingen, før der træffes afgørelser om behandling af den enkelte patient.
English: • Inflammation of the lining of the stomach (gastritis).
Danish: • Betændelse i maveslimhinden (gastrit).
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).
Danish: 5.1) fra udviklingen af lægemidlet er begrænset til 16 patienter i alderen 9-17 år med hereditær medullær thyreoideacancer (studie IRUSZACT0098).
English: Pharmacokinetic data from volunteers, suggests that no change in starting dose is required in patients with mild, moderate or severe hepatic impairment (see section 5.2).
Danish: Farmakokinetiske data fra frivillige tyder på, at der ikke kræves nogen ændring i startdosis til patienter med let, moderat eller svært nedsat leverfunktion (se pkt.
English: CTN Response
Danish: CTN-RESPONS
English: Abdominal pain, diarrhoea, nausea, vomiting, dyspepsia
Danish: Mave-tarmkanalen Abdominalsmerter, diarré, kvalme, opkastning, dyspepsi
English: N
Danish: a
English: Package leaflet: Information for the patient Caprelsa 100 mg film-coated tablets Caprelsa 300 mg film-coated tablets vandetanib
Danish: Indlægsseddel: Information til patienten Caprelsa 100 mg filmovertrukne tabletter Caprelsa 300 mg filmovertrukne tabletter vandetanib
English: Malnutrition
Danish: Fejlernæring
English: Median PFS HR 95% CI p-value
Danish: N Median PFS HR 95 % CI p-værdi Vandetanib 300 mg 73/231
English: • No change in starting dose is recommended in paediatric patients with mild renal impairment
Danish: • Ændring af startdosis er ikke nødvendig hos pædiatriske patienter med let nedsat nyrefunktion
English: • Seeing flashes of light (photopsia).
Danish: • Lysglimt for øjnene (fotopsi).
English: The pharmacokinetics of vandetanib at the 300 mg dose in MTC patients are characterised by a clearance of approximately 13.2 l/h.
Danish: Vandetanibs farmakokinetik ved en dosis på 300 mg hos MTC-patienter er karakteriseret ved en clearance på ca. 13,2 l/t og en plasmahalveringstid på ca.19 dage.