FrancophonIA/ELRC3.0 huggingface dataset:
English: The concomitant use of vandetanib with strong CYP3A4 inducers (such as rifampicin, St John's Wort, carbamazepine, phenobarbital) should be avoided (see section 4.5).
Danish: Samtidig anvendelse af vandetanib med stærke CYP3A4-inducere (såsom rifampicin, perikon, carbamazepin, phenobarbital) bør undgås (se pkt.
English: • The dosing and monitoring guide for paediatric patients and patient's caregivers;
Danish: • Doserings- og overvågningsguide til pædiatriske patienter og deres omsorgspersoner;
English: • Patients who are on the starting dose (a in Table 1), should be recommenced at the reduced dose (c in Table 1).
Danish: • Patienter, som tager startdosis (a i tabel 1), bør genoptage behandlingen med den reducerede dosis (c i tabel 1).
English: The pharmacokinetic parameters of vandetanib in paediatrics MTC patients aged 9-17 years were similar to those in adults.
Danish: Vandetanibs farmakokinetiske parametre hos pædiatriske MTC-patienter i alderen 9-17 år var de samme som hos voksne.
English: This medicinal product has been authorized under a so-called “conditional approval” scheme.
Danish: Dette lægemiddel er godkendt under såkaldt ”betingede omstændigheder”.
English: Adverse reactions associated with overdose may be prolonged due to the long half-life of vandetanib (see section 5.2).
Danish: Bivirkninger, der forbindes med overdosering, kan forekomme over længere tid på grund af vandetanibs lange halveringstid (se pkt.
English: Therefore, the concomitant use of vandetanib with medicinal products known to also prolong the QTc interval and/or induce Torsades de pointes is either contraindicated or not recommended depending on existing alternative therapies.
Danish: Samtidig anvendelse af vandetanib og lægemidler, der vides også at forlænge QTc-intervallet og/eller inducere torsades de pointes er derfor enten kontraindiceret eller anbefales ikke, afhængigt af eksisterende behandlingsalternativer.
English: Palmar-plantar erythrodysaesthiesia syndrome, alopecia
Danish: Palmoplantar erytrodysæstesisyndr om, alopeci
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.
Danish: Ved den blindede sammenligning af vandetanib versus placebo var der kun 2 patienter med kendt negativ RET-status for alle 6 exoner, som fik vandetanib, og ingen af disse viste respons på behandlingen.
English: • Vandetanib has demonstrated adverse effect on growing tissue that relies on vascularization such as teeth and growth plates in non-clinical studies;
Danish: • Vandetanib har i non-kliniske studier vist negative virkninger på voksende væv, som er afhængig af vaskularisering, f.eks. tænder og vækstskiver;
English: Scheduled slit lamp examinations have revealed corneal opacities (vortex keratopathies) in treated patients; however, routine slit lamp examinations are not required for patients receiving vandetanib.
Danish: Planlagte undersøgelser med spaltelampe har afsløret macula corneae (vortex-keratopatier) hos behandlede patienter; rutinemæssige undersøgelser med spaltelampe er dog ikke påkrævet for patienter, der får vandetanib.
English: Figure 1: Kaplan Meier plot of PFS
Danish: Figur 1: Kaplan-Meier-kurver for PFS
English: A post-hoc subgroup analysis of RET negative status based on absence of M918T mutation of the pivotal study 58 was performed.
Danish: Der blev gennemført en post-hoc analyse af en subgruppe med negativ RET-status baseret på fravær af M918T-mutation i det pivotale studie 58.
English: Tell your doctor straight away if you notice any of the side effects above.
Danish: Fortæl det straks til din læge, hvis du oplever en eller flere af ovenstående bivirkninger.
English: • What are the side effects associated with CAPRELSA and which monitoring is requested;
Danish: • Bivirkningerne ved Caprelsa og, hvilken form for overvågning der er påkrævet;
English: • Sensitivity of the skin to sunlight.
Danish: • Hudfølsomhed over for sollys.
English: In an animal model of wound-healing, mice dosed with vandetanib had reduced skin-breaking strength compared with controls.
Danish: I en dyremodel for sårheling havde mus, som blev behandlet med doser af vandetanib, nedsat styrke i huden over for brud sammenlignet med kontrolmus.
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.
Danish: I toksicitetsstudier på op til 9 måneders varighed med gentagne doser, omfattede virkningerne opkastning, vægttab og diarré hos hunde, og epifysedysplasi hos unge hunde og rotter med åbne epifyseskiver.
English: In a female fertility study, there was a trend towards increased oestrus cycle irregularity, a slight reduction in pregnancy incidence and increase in implantation loss.
Danish: I et studie af fertiliteten hos hunrotter var der en tendens til øget uregelmæssighed af østrogencyklus, en let reduktion drægtighedsincidensen og et øget implantationstab.
English: The European Medicines Agency (EMA) will review new information on the product every year and this SmPC will be updated as necessary.
Danish: Det Europæiske Lægemiddelagentur vil hvert år vurdere nye oplysninger om lægemidlet og produktresuméet vil om nødvendigt blive ajourført.
English: Following oral dosing of 14C- vandetanib, unchanged vandetanib and metabolites vandetanib N-oxide and N-desmethyl vandetanib were detected in plasma, urine and feces.
Danish: Efter oral indgift af 14C-vandetanib blev der påvist ikke-omdannet vandetanib, samt metabolitterne vandetanib N-oxid og N-desmetyl-vandetanib i plasma, urin og afføring.
English: Tremor, lethargy, loss of consciousness, balance disorders, dysgeusia
Danish: Tremor, apati, tab af bevidsthed, balanceproblemer, dysgeusi
English: Neither the Cmax nor the AUC(0-t) for vandetanib was affected when given together with ranitidine.
Danish: Hverken Cmax eller AUC (0-t) for vandetanib var påvirket ved samtidig administration af ranitidin.
English: Caprelsa should not be given to children below 5 years of age.
Danish: Caprelsa må ikke anvendes til børn under 5 år.
English: A statistically significant advantage was seen for vandetanib for the secondary endpoint of time to worsening of pain (derived as a composite endpoint using the worst pain score from BPI and patient reported opioid analgesic use) (vandetanib 49%, placebo 57%, HR 0.61, 97.5%CI 0.43-0.87, p< 0.006: 8 vs. 3 months).
Danish: Der sås en statistisk signifikant fordel med vandetanib for det sekundære endepunkt tid til forværring af smerter (der fremkommer som et kombineret effektmål ved hjælp af scoren for værste smerte fra BPI og patientrapporteret brug af opioidanalgetika) (vandetanib 49 %, placebo 57 % HR 0,61, 97,5 % CI 0,43-0,87, p<0,006: 8 versus 3 måneder).
English: There is limited clinical experience with vandetanib in patients with unresectable locally advanced disease and without metastasis.
Danish: Der er begrænset klinisk erfaring med vandetanib hos patienter med inoperabel lokalt fremskreden sygdom og uden metastaser.
English: • Loss of body fluid (dehydration).
Danish: • Tab af kropsvæske (dehydrering).
English: • itraconazole, ketoconazole, ritonavir, clarithromycin, rifampicin and moxifloxacin (medicines used to treat infections)
Danish: • itraconazol, ketoconazol, ritonavir, clarithromycin, rifampicin og moxifloxacin (medicin til behandling af infektioner)
English: • Information about the risks of QTc prolongation and Torsades de pointes, and Posterior reversible encephalopathy syndrome (PRES);
Danish: • Information om risikoen for QTc-forlængelse og torsades de pointes og posteriort reversibelt encefalopatisyndrom (PRES);
English: In healthy male subjects, the exposure to vandetanib was reduced by 40% when given together with the potent CYP3A4 inducer, rifampicin.
Danish: Hos raske mandlige forsøgspersoner blev eksponeringen for vandetanib reduceret med 40 % ved administration af den potente CYP3A4-induktor rifampicin.
English: • The need to closely monitor teeth and bone abnormalities in the paediatric population;
Danish: • Nødvendigheden af tæt monitorering for tegn på tand- og knogleabnormiteter hos den pædiatriske population.
English: Following oral administration of vandetanib absorption is slow with peak plasma concentrations typically achieved at a median of 6 hours, range 4-10 hours, after dosing.
Danish: Efter oral indgift af vandetanib er absorptionen langsom, og maksimale plasmakoncentrationer opnås typisk mediant 6 timer efter indgift (i området mellem 4-10 timer efter indgift).
English: Vandetanib also showed evidence of phototoxic potential in an in vitro cytotoxicity assay.
Danish: Vandetanib viste også tegn på fototoksisk potentiale i en cytotoksisk in vitroanalyse.
English: 37 Hollands Road Haverhill Suffolk, CB9 8PU United Kingdom
Danish: 37 Hollands Road Haverhill Suffolk, CB9 8PU Storbritannien eller
English: In a rat pre- and post-natal development study, at doses producing maternal toxicity during gestation and/or lactation, vandetanib increased pre-birth loss and reduced post-natal pup growth.
Danish: I et præ-/postnatal udviklingsstudie hos rotter med doser, der forårsagede maternel toksicitet under drægtighed og/eller amning, øgede vandetanib tab før fødsel, og reducerede postnatal vækst hos ungerne.
English: A value <1 favors vandetanib.
Danish: En værdi > 1 begunstiger vandetanib.
English: Patients who develop a single value of a QTc interval of ≥500 msec should stop taking vandetanib.
Danish: Patienter, som udvikler en enkelt værdi for QTc-interval på ≥ 500 ms, bør holde op med at tage vandetanib.
English: The signs may include redness, pain, ulcers, blisters and shedding of the skin.
Danish: Tegnene kan også omfatte rødme, smerter, sår, blister og afskalning af huden.
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;
Danish: • Uddannelsesmateriale indeholdende: o Information om risiciene forbundet med Caprelsa: - QTc-forlængelse og torsades de pointes - Posteriort reversibelt encefalopatisyndrom (PRES) Abnormiteter i udviklingen af tænder og knogler hos den pædiatriske population Medicineringsfejl hos den pædiatriske population o Lægens doserings- og overvågningsguide for pædiatriske patienter;
English: Vandetanib exposure in children between 5-8 years old with glioma-related indications was comparable to MTC patients aged 9-18 years.
Danish: Eksponeringen for vandetanib hos børn i alderen 5-8 år ved gliom-relaterede indikationer var sammenlignelig med vandetanib-eksponering hos MTC-patienter i alderen 9-18 år.
English: Hypokalaemia, hypercalcaemia, hyperglycemia, dehydration, hyponatremia
Danish: Hypokaliæmi, hyperkalcæmi, hyperglykæmi, dehydrering, hyponatriæmi
English: Furthermore, the bradycardiac effect of digoxin may increase the risk of vandetanib QTc interval prolongation and Torsade de Pointes.
Danish: Derudover kan digoxins evne til at udløse bradykardi øge risikoen for vandetabibrelateret forlængelse af QTc-intervallet og torsades de pointes.
English: Vandetanib at a dose of 300 mg is associated with a substantial and concentration dependent prolongation in QTc (mean 28 msec, median 35 msec).
Danish: Vandetanib i en dosis på 300 mg associeres med en væsentlig og koncentrationsafhængig forlængelse af QTc-intervallet (middelværdi 28 ms, median 35 ms).
English: Appropriate clinical and/or laboratory monitoring is recommended for patients receiving concomitant metformin and vandetanib, and such patients may require a lower dose of metformin.
Danish: Passende klinisk og/eller laboratoriemæssig monitorering anbefales hos patienter, der får metformin og vandetanib samtidig, og en lavere metformindosis kan være nødvendig hos disse patienter.
English: A Phase I/II single-center open-label, single-arm study (Study IRUSZACT0098) assessed the activity of vandetanib in 16 patients with unresectable locally advanced or metastatic hereditary MTC.
Danish: Et åbent, enkeltcenter fase I/II-enkeltarmsstudie (studie IRUSZACT0098) undersøgte vandetanibs aktivitet hos 16 patienter med inoperabel lokalt fremskreden eller metastatisk hereditær MTC.
English: There is no experience in paediatric patients with hereditary MTC below 9 years of age (see section 5.1).
Danish: Der er ingen erfaring med pædiatriske patienter under 9 år med hereditær MTC (se pkt.
English: Patients without RET mutation may have a decreased benefit from vandetanib treatment and the benefit/risk balance for this group of patients may therefore differ from that of the group with RET mutations.
Danish: Patienter uden RET-mutation kan have begrænsede fordele af behandling med vandetanib, og der kan gælde et andet benefit/risk-forhold for denne patientpopulation end for gruppen med RET-mutationer.
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.
Danish: En dosis på 100 mg/m2/dag ifølge den angivne dosering (som funktion af BSA) hos pædiatriske patienter resulterer i samme eksponering som 300 mg dagligt til voksne.
English: • Dry eye.
Danish: • Tørre øjne.
English: • Clouding of the lens of the eye.
Danish: • Uklarheder i linsen i øjet.
English: • The role and use of the Patient Alert Card.
Danish: • Formål med/brug af patientinformationskort.
English: The safety and efficacy of Caprelsa in children below 5 years of age have not been established.
Danish: Caprelsas sikkerhed og virkning hos børn under 5 år er ikke klarlagt.
English: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk, CB9 8PU, United Kingdom Or
Danish: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk, CB9 8PU, Storbritannien eller
English: Alanine aminotransferase elevations occur commonly in patients treated with vandetanib.
Danish: Forhøjet alaninaminotransferase er almindeligt forekommende hos patienter behandlet med vandetanib.
English: In clinical studies, a small number of patients had surgery while receiving vandetanib and there were no reported wound healing complications.
Danish: I kliniske studier blev et lille antal patienter opereret, mens de fik vandetanib, og der blev ikke rapporteret om sårhelingskomplikationer.
English: Vandetanib and/or its metabolites is excreted into milk in rats and found in plasma of pups following dosing to lactating rats (see section 5.3).
Danish: Vandetanib og/eller dets metabolitter udskilles i mælken hos rotter og findes i plasma hos ungerne efter indgift til ammende rotter (se pkt.
English: A single dose pharmacokinetic study in volunteers indicated that hepatic impairment did not affect exposure to vandetanib.
Danish: Et enkeltdosis farmakokinetisk studie med frivillige indikerede, at nedsat leverfunktion ikke påvirkede eksponering for vandetanib.
English: However, long term safety data in paediatric patients are not available.
Danish: Der foreligger imidlertid ingen langtidsdata for sikkerheden hos pædiatriske patienter.
English: The pharmacokinetics of vandetanib at the 300 mg dose in MTC patients are characterised by a volume of distribution of approximately 7450 l.
Danish: Farmakokinetikken af vandetanib ved en dosis på 300 mg hos MTC-patienter er karakteriseret af et fordelingsvolumen på ca. 7450 l.
English: An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).
Danish: • En udvidelse og svækkelse af en blodårevæg eller en rift i en blodårevæg (aneurismer og arterielle dissektioner).
English: Posterior reversible encephalopathy syndrome (PRES) also known as reversible posterior leukoencephalopathy syndrome (RPLS)
Danish: Posteriort reversibelt encefalopatisyndrom (PRES) - også kendt som reversibelt posteriort leukoencefalopati-syndrom (RPLS)
English: Renal impairment in paediatric patients with MTC There is no experience with the use of vandetanib in paediatric patients with renal impairment.
Danish: Nedsat nyrefunktion hos pædiatriske patienter med MTC Der er ingen erfaring med brug af vandetanib til pædiatriske patienter med nedsat nyrefunktion.
English: Pneumonia, sepsis, influenza, cystitis, sinusitis, laryngitis, folliculitis, furuncle, fungal infection, pyelonephritis
Danish: Pneumoni, sepsis, influenza, cystitis, sinuitis, laryngitis, folliculitis, furunculus, svampeinfektion, pyelonephritis
English: Vandetanib inhibits EGFR-dependent cell proliferation and cell survival in vitro.
Danish: Vandetanib hæmmer EGFR-afhængig celledeling og celleoverlevelse in vitro.
English: Do not take Caprelsa: - if you are allergic to vandetanib or any of the other ingredients of this medicine (listed in Section 6).
Danish: - hvis du er allergisk over for vandetanib eller et af de øvrige indholdsstoffer i Caprelsa (angivet i punkt 6).
English: In healthy subjects with wild type for OCT2, the AUC(0-t) and Cmax for metformin (OCT2 substrate) were increased by 74% and 50%, respectively and CLR of metformin was decreased by 52% when given together with vandetanib.
Danish: Hos raske forsøgspersoner med OCT2-vildtype, blev AUC(0-t) og Cmax for metformin (OCT2-substrat) øget med henholdsvis 74 % og 50 %, og renal clearance af metformin blev reduceret med 52 % ved administration sammen med vandetanib.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Du kan finde yderligere oplysninger om Caprelsa på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu.
English: • Heart rhythm changes (shown in an ECG).
Danish: • Ændringer i hjerterytmen (ses ved et EKG).
English: • ondansetron (used to treat nausea and vomiting)
Danish: • ondansetron (mod kvalme og opkastning)
English: It is important that you keep this dosing guide and show it to your caregiver.
Danish: Det er vigtigt at gemme doseringsguiden og vise den til eventuelle omsorgspersoner.
English: Vandetanib was excreted into milk in rat and found in plasma of pups following dosing to lactating rats.
Danish: Vandetanib blev udskilt i mælken hos rotter og fundet i plasma hos unger efter indgift til ammende rotter.
English: N Response rate ORb
Danish: N Responsrate ORb
English: Photosensitivity reaction, rash and other skin rections (including acne, dry skin, dermatitis, pruritus), nail disorders
Danish: Lysfølsomhedsreak tion, udslæt og andre hudreaktioner (inklusive acne, tør hud, dermatitis, pruritis), neglelidelser
English: In healthy subjects, the exposure for midazolam (CYP3A4 substrate) was not affected when given together with a single dose of vandetanib at 800 mg.
Danish: Eksponeringen for midazolam (CYP3A4-substrat) hos raske forsøgspersoner blev ikke påvirket ved samtidig administration af en enkelt dosis vandetanib på 800 mg.
English: Vandetanib may be administered until disease progression or until the benefits of treatment continuation do no longer outweigh its risk, thereby considering the severity of adverse events (see sections 4.8) in relation to the degree of clinical stabilization of the tumour status.
Danish: Vandetanib administreres indtil sygdomsprogression eller indtil fordelene ved behandlingen ikke længere opvejer risiciene, idet der tages hensyn til bivirkningernes sværhedsgrad (se pkt.
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).
Danish: Hos patienter, hvis status for RET-mutationer (RET = rearranged during transfection, omlejret under transfektion) ikke er kendt eller er negativ, bør der tages højde for en mulig mindre fordel før individuel behandlingsbeslutning (se vigtig information i pkt.
English: • Severe diarrhoea.
Danish: • Svær diarré.
English: Infection and infestation disorders
Danish: Infektioner og parasitære sygdomme
English: Your doctor may tell you to stop taking Caprelsa or take Caprelsa at a lower dose.
Danish: Din læge vil muligvis fortælle dig, at du skal holde op med at tage Caprelsa eller tage Caprelsa ved en lavere dosis.
English: • Abnormalities in your liver or pancreas (shown in blood tests).
Danish: • Abnormiteter i lever eller bugspytkirtel (ses i blodprøver).
English: Long term safety data in paediatric patients are not available.
Danish: Der foreligger ingen langtidsdata for sikkerheden hos pædiatriske patienter.
English: Dosing can be resumed at a reduced dose after return of the QTc interval to pretreatment status has been confirmed and correction of possible electrolyte imbalance has been made.
Danish: Behandlingen kan genoptages med reduceret dosis, når tilbagevenden af QTcintervallet til status som før behandlingen, er blevet bekræftet og en eventuel elektrolytubalance er blevet korrigeret.
English: • Swelling caused by excess fluid (oedema).
Danish: • Hævelser, som skyldes overskydende væske (ødem).
English: Epistaxis, haemoptysis, pneumonitis
Danish: Epistaxis, hæmoptyse, pneumoni
English: In rats, embryofoetal toxicity was evident as foetal loss, delayed foetal development, heart vessel abnormalities and precocious ossification of some skull bones.
Danish: Hos rotter blev embryoføtal toksicitet påvist som fostertab, forsinket fosterudvikling, uregelmæssigheder i hjertekarrene, og for tidlig ossifikation af visse kranieknogler.
English: Disease Control Rate including best response or Stable Disease >24 weeks was 75.0%.
Danish: 75,0 % af patienterne opnåede sygdomskontrol, indbefattet bedst respons eller stabil sygdom >24 uger.
English: • Trouble sleeping (insomnia).
Danish: • Søvnbesvær (søvnmangel).
English: Vandetanib inhibits VEGF-stimulated endothelial cell migration, proliferation, survival and new blood vessel formation in in vitro models of angiogenesis.
Danish: Vandetanib hæmmer VEGF-stimuleret endotelcellemigration, -vækst, -overlevelse og dannelse af nye blodkar i in vitro-modeller for angiogenese.
English: MARKETING AUTHORISATION HOLDER Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
Danish: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Holland
English: Vandetanib also inhibited the growth of MTC xenograft tumours in vivo.
Danish: Vandetanib hæmmede også væksten af MTC-xenograft-tumorer in vivo.
English: Patient Alert Card
Danish: Patientinformationskort
English: CEA Response
Danish: CEA-RESPONS
English: Pancreatitis, peritonitis, ileus, intestinal perforation, faecal incontinence
Danish: Pankreatitis, peritonitis, ileus, intestinal perforation, fækal inkontinens
English: • Patients who develop a single value of corrected ECG QTc interval of at least 500 msec should stop taking CAPRELSA.
Danish: • Patienter, der i et enkelt tilfælde får korrigeret QTc-interval på EKG på mindst 500 ms, skal holde op med at tage Caprelsa.
English: Do not throw away medicines via wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: • Hole in your bowel.
Danish: • Bylder i bughulen.
English: In mice, vandetanib was shown to delay but not prevent wound healing.
Danish: Hos mus har vandetanib påvist at forsinke, men ikke forhindre sårheling.
English: The dosing and monitoring guide for patients and patient's caregivers should contain the following key elements:
Danish: Doserings- og overvågningsguiden til patienter og deres omsorgspersoner skal indeholde følgende hovedelementer:
English: Heart failure has been observed in patients who received vandetanib.
Danish: Der er blevet observeret hjerteinsufficiens hos patienter, der fik vandetanib.
English: • Instructions on how to use the dosing and monitoring guide and the daily tracker for paediatric patients and caregivers.
Danish: • Vejledning til brug af doserings- og overvågningsguiden og kalenderen til afkrydsning af den daglige dosis til pædiatriske patienter og deres omsorgspersoner.