FrancophonIA/ELRC3.0 huggingface dataset:
English: This population pharmacokinetic analysis revealed no clinically meaningful differences in clearance or systemic exposure (AUC) of free aflibercept in patients with moderate and mild renal impairment at the 4 mg/kg dose of ZALTRAP as compared to the overall population studied.
Danish: Denne populationsfarmakokinetiske analyse afslørede ingen klinisk betydningsfulde forskelle i clearance eller systemisk eksponering (AUC) for frit aflibercept hos patienter med moderat og let nedsat nyrefunktion ved 4 mg/kg dosis ZALTRAP sammenlignet med den samlede undersøgte population.
English: ZALTRAP should be used only if the potential benefit justifies the potential risk during pregnancy.
Danish: ZALTRAP bør kun anvendes under graviditet, hvis den potentielle fordel opvejer den potentielle risiko.
English: ZALTRAP in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy is indicated in adults with metastatic colorectal cancer (MCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen.
Danish: ZALTRAP i kombination med irinotecan/5-fluoruracil/folinsyre (FOLFIRI) kemoterapi er indiceret til voksne med metastaserende kolorektalcancer (mCRC), som er resistent overfor eller er progredieret efter et oxaliplatinholdigt regime.
English: No conclusion can be drawn for patients with severe renal impairment due to very limited data available.
Danish: Der kan ikke udledes nogen konklusion for patienter med svært nedsat nyrefunktion på grund af yderst begrænsede tilgængelige data.
English: Patients with a dipstick of ≥ 2+ for protein or a UPCR > 1 or a protein/creatinine ratio (PCR)> 100 mg/mmol should undergo a 24-hour urine collection.
Danish: Hos patienter med ≥2+ for protein på en urinstick eller UPCR >1 eller en protein/kreatinin ratio (PCR) >100 mg/mmol bør en døgnurinopsamling udføres.
English: Use only after dilution.
Danish: Må kun anvendes efter fortynding.
English: By blocking the growth of blood vessels, ZALTRAP helps to stop or slow down the growth of the tumour.
Danish: Ved at blokere væksten af blodkar medvirker ZALTRAP til at stoppe eller forsinke tumorens vækst.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis den ikke anvendes med det samme er brugeren ansvarlig for holdbarheden og for de forhold, som den opbevares under, hvilket normalt ikke vil være mere end 24 timer ved 2 °C til 8 °C, medmindre fortynding har fundet sted under kontrollerede og validerede aseptiske forhold.
English: In the event of recurrence, despite appropriate anticoagulation, aflibercept treatment should be discontinued.
Danish: I tilfælde af recidiv trods passende antikoagulationsbehandling bør aflibercept seponeres.
English: More than one vial could be needed for the preparation of the infusion solution.
Danish: Det kan være nødvendigt at bruge mere end et hætteglas til klargøring af infusionsopløsningen.
English: Caution should be exercised when handling ZALTRAP, taking into account the use of containment devices, personal protective equipment (e.g. gloves), and preparation procedures.
Danish: Der skal udvises forsigtighed ved håndtering af ZALTRAP, idet der tages hensyn til brugen af indkapslingsanordninger, personligt beskyttelsesudstyr (f.eks. handsker) og klargøringsprocedurer.
English: Severe diarrhoea
Danish: Svær diarré
English: ZALTRAP should be temporarily suspended for at least 4 weeks prior to elective surgery (see section
Danish: ZALTRAP bør midlertidigt seponeres i mindst 4 uger forud for elektiv kirurgi (se pkt.
English: Population pharmacokinetics analysis and inter study comparisons did not reveal any pharmacokinetic drug-drug interaction between aflibercept and the FOLFIRI regimen.
Danish: Populationsfarmakokinetisk analyse og sammenligning mellem studier viste ingen farmakokinetisk lægemiddelinteraktion mellem aflibercept og FOLFIRI-regimet.
English: Your doctor may give you medicines to stop or treat diarrhoea and being sick (vomiting).
Danish: Din læge kan give dig medicin, der kan stoppe eller behandle diarré og kvalme (opkastning).
English: Proteinuria (1),(3)
Danish: Proteinuri (1),(3)
English: • Inspect the ZALTRAP vial visually prior to use.
Danish: • Inspicer hætteglasset med ZALTRAP visuelt før brug.
English: ZALTRAP should be temporarily suspended until hypertension is controlled.
Danish: ZALTRAP bør seponeres midlertidigt, indtil hypertensionen er under kontrol.
English: ZALTRAP contains the active substance aflibercept, a protein that works by blocking the growth of new blood vessels within the tumour.
Danish: ZALTRAP indeholder det aktive stof aflibercept, et protein der virker ved at blokere væksten af nye blodkar i tumoren.
English: Aflibercept has been shown to be embryotoxic and teratogenic when administered intravenously to pregnant rabbits every 3 days during the organogenesis period (gestation days 6 to18) at doses approximately 1 to 15 times the human dose of 4 mg/kg every 2 weeks.
Danish: Aflibercept har vist sig at være embryotoksisk og teratogent ved intravenøs administration i drægtige kaniner hver 3. dag under organogenesen (drægtighedsdag 6 til 18) i doser på cirka 1 til 15 gange den humane dosis på 4 mg/kg hver 2. uge.
English: If severe diarrhoea persists with both dose reductions, FOLFIRI should be discontinued.
Danish: Hvis svær diarré vedvarer efter de 2 dosisreduktioner, skal FOLFIRI seponeres.
English: Exploratory biomarker analyses were undertaken in the VELOUR trial including analyses of RAS mutational status in 482 of 1,226 patients (n = 240 aflibercept; 242 placebo).
Danish: Eksplorative biomarkøranalyser blev gennemført i VELOUR-studiet, herunder RAS-analyser af mutationsstatus hos 482 af 1.226 patienter (n=240 aflibercept; 242 placebo).
English: The efficacy and safety of ZALTRAP were evaluated in a randomised, double-blind, placebo-controlled study in patients with metastatic colorectal cancer who had previously been treated with an oxaliplatin-based treatment with or without prior bevacizumab.
Danish: ZALTRAPS virkning og sikkerhed blev evalueret i et randomiseret, dobbelt-blindet, placebokontrolleret studie hos patienter med metastaserende kolorektalcancer, som tidligere var blevet behandlet med en oxaliplatin-baseret behandling med eller uden forudgående bevacizumab.
English: The incidence of diarrhoea, dizziness, asthenia, weight decrease, and dehydration was increased by ≥5% in elderly compared to younger patients.
Danish: Forekomsten af diarré, svimmelhed, asteni, vægttab og dehydrering var øget med ≥5 % hos ældre sammenlignet med yngre patienter.
English: Information about storage and the time to use ZALTRAP, after it has been diluted and is ready to use, is described in the ‘Practical information for healthcare professionals on preparation and handling of ZALTRAP 25 mg / ml concentrate for solution for infusion' at the end of this leaflet.
Danish: Oplysninger om opbevarings- og anvendelsestid for ZALTRAP, efter at det er fortyndet og klar til brug, er beskrevet i ‘Praktiske oplysninger for sundhedspersonale vedrørende klargøring og håndtering af ZALTRAP 25 mg/ml koncentrat til infusionsvæske, opløsning' i slutningen af denne indlægsseddel.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before you are given ZALTRAP and during your treatment if:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apoteket eller sundhedspersonalet, før du bruger ZALTRAP og under behandlingen, hvis:
English: Stratified on ECOG performance status (0 versus 1 versus 2) and prior bevacizumab (yes versus no).
Danish: Stratificeret på ECOG performance status (0 versus 1 versus 2) og tidligere bevacizumab (ja versus nej).
English: VTE include deep venous thrombosis and pulmonary embolism.
Danish: VTE omfatter dyb venetrombose og lungeemboli.
English: Elderly people should be closely monitored for the development of diarrhoea and potential dehydration (see section 4.4).
Danish: Ældre bør monitoreres nøje for udvikling af diarré og potentiel dehydrering (se pkt.
English: Post-hoc analyses excluding patients who progressed during or within 6 months of adjuvant therapy for patients with or without prior bevacizumab treatment are summarised in Table 4.
Danish: Post hoc analyser for patienter med eller uden forudgående behandling med bevacizumab, eksklusive patienter, som progredierede under eller indenfor 6 måneder efter adjuverende behandling, er opsummeret i tabel 4.
English: The concentration of the final ZALTRAP solution for intravenous infusion should be kept within the range of 0.6 mg / ml to 8 mg / ml of aflibercept.
Danish: Koncentrationen af den endelige ZALTRAP-opløsning til intravenøs infusion skal holdes inden for området 0,6 mg/ml til 8 mg/ml for aflibercept.
English: • inflammation inside the mouth
Danish: • betændelse inde i munden
English: 19.8 (16.4 to 23.2)
Danish: 19,8 (16,4 til 23,2)
English: Consistent with target-mediated drug disposition, free aflibercept exhibits a faster (non-linear) clearance at doses below 2 mg/kg, likely due to the high affinity binding of aflibercept to endogenous VEGF.
Danish: I overensstemmelse med målmedieret lægemiddeldisposition udviser frit aflibercept en hurtigere (ikke-lineær) clearance ved doser under 2 mg/kg, sandsynligvis på grund af højaffinitetsbinding af aflibercept til endogent VEGF.
English: EU/1/12/814/001 1 vial (100 mg/4 ml) EU/1/12/814/002 3 vials (100 mg/4 ml) EU/1/12/814/003 1 vial (200 mg/8 ml)
Danish: EU/1/12/814/001 1 hætteglas (100 mg/4 ml) EU/1/12/814/002 3 hætteglas (100 mg/4 ml) EU/1/12/814/003 1 hætteglas (200 mg/8 ml)
English: If you experience any of these symptoms, talk to your doctor immediatley since your doctor may want to treat your symptoms and stop your treatment with ZALTRAP.
Danish: Hvis du oplever nogen af disse symptomer, skal du tale med din læge med det samme, da din læge muligvis vil behandle dine symptomer og stoppe din behandling med ZALTRAP.
English: Table 3 - OS and PFS by prior bevacizumab exposure a
Danish: Tabel 3 - OS og PFS ved forudgående bevacizumab eksponering a
English: Caution should be used when retreating patients with prior hypersensitivity reactions as recurrent hypersensitivity reactions have been observed in some patients despite prophylaxis, including corticosteroids.
Danish: Der skal udvises forsigtighed ved genbehandling af patienter med tidligere overfølsomhedsreaktioner da der er observeret recidiverende overfølsomhedsreaktioner hos visse patienter trods profylakse, inklusive kortikosteroider.
English: Aflibercept acts as a soluble decoy receptor that binds to VEGF-A, with higher affinity than its native receptors, as well as the related ligands PlGF and VEGF-B. By acting as a ligand trap, aflibercept prevents binding of endogenous ligands to their cognate receptors and thereby blocks receptor mediated signaling.
Danish: Aflibercept virker som en opløselig lokke-receptor, der bindes til VEGF-A, med højere affinitet end dets naturlige receptorer, samt de relaterede ligander PlGF og VEGF-B. Ved at fungere som en ligandfælde hindrer aflibercept binding af endogene ligander til deres sammenhørende receptorer og blokerer derved receptormedieret signalering.
English: A numerically lower treatment effect on OS with the ZALTRAP/FOLFIRI regimen was reported for patients with prior bevacizumab as compared to patients without prior bevacizumab exposure, with no evidence of heterogeneity in treatment effect (non significant interaction test).
Danish: En numerisk lavere behandlingseffekt på OS for ZALTRAP/FOLFIRI-regimet blev rapporteret for patienter med forudgående eksponering for bevacizumab sammenlignet med patienter uden forudgående eksponering for bevacizumab, uden tegn på heterogenitet i behandlingseffekt (ikke-signifikant interaktionstest).
English: Overall efficacy results for the ZALTRAP/FOLFIRI regimen versus the placebo/FOLFIRI regimen are summarised in Figure 1 and Table 2.
Danish: Samlede effektresultater for ZALTRAP/FOLFIRI-regimet versus placebo/FOLFIRI-regimet er opsummeret i Figur 1 og Tabel 2.
English: • you have high blood pressure.
Danish: du har forhøjet blodtryk.
English: Treatment with anti-diarrhoeal medicinal products and rehydration can be used as needed.
Danish: Behandling med antidiarrépræparater og rehydrering kan benyttes efter behov.
English: 3.9 (3.02 to 4.30)
Danish: 3,9 (3,02 til 4,30)
English: Diluted solutions of ZALTRAP should be administered using infusion sets containing a 0.2 micron polyethersulfone filter.
Danish: Fortyndede opløsninger af ZALTRAP bør administreres ved hjælp af infusionssæt indeholdende et 0,2 mikrometer polyethersulfonfilter.
English: Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors, including sample handling, timing of sample collection, concomitant medicinal products, and underlying disease.
Danish: Desuden kan den observerede forekomst af antistofpositivitet i en analyse være påvirket af flere faktorer, inklusive prøvehåndtering, tidspunktet for prøveudtagningen, samtidig medicinering og bagvedliggende sygdomme.
English: Further increases in the aflibercept dose resulted in dose-related increases in circulating free aflibercept concentrations but only small further increases in the VEGF-bound aflibercept concentration.
Danish: Yderligere forhøjelser af aflibercept-dosis resulterede i dosis-relaterede forhøjelser i koncentrationen af cirkulerende frit aflibercept, men kun små yderligere forhøjelser i koncentrationen af VEGF-bundet aflibercept.
English: Elderly patients ≥65 years had an increased risk of diarrhoea, dizziness, asthenia, weight loss and dehydration.
Danish: Ældre ≥65 år havde en øget risiko for diarré, svimmelhed, asteni, vægttab og dehydrering.
English: Your doctor may need to treat you with other medicines and/or fluids given intravenously.
Danish: Din læge kan blive nødt til at behandle dig med anden medicin og/eller give dig væske intravenøst.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ZALTRAP therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med ZALTRAP seponeres/undlades, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: High molecular weight proteins are not cleared by the renal route, therefore renal elimination of aflibercept is expected to be minimal.
Danish: Proteiner med høj molekylvægt udskilles ikke via nyrerne, derfor forventes udskillelse via nyrerne af aflibercept at være minimal.
English: Women of childbearing potential / Contraception in males and females Women of childbearing potential should be advised to avoid becoming pregnant while on ZALTRAP, and should be informed of the potential hazard to the foetus.
Danish: Kvinder i den fertile alder/prævention hos mænd og kvinder Kvinder i den fertile alder skal tilrådes at undgå at blive gravide, mens de får ZALTRAP, og skal informeres om de potentielle risici for fosteret.
English: Ophthalmic / intravitreal use due to hyperosmotic properties of ZALTRAP (see section 4.4).
Danish: Oftalmisk/intravitreal brug på grund af ZALTRAPs hyperosmotiske egenskaber (se pkt.
English: Skin hyperpigmentation
Danish: Hyperpigmentering af huden
English: How ZALTRAP is given
Danish: Sådan gives ZALTRAP
English: Do not use ZALTRAP if you notice particles or discolouration of the medicine in the vial or infusion bag.
Danish: Brug ikke ZALTRAP, hvis der kan ses partikler i eller misfarvning af medicinen i hætteglasset eller infusionsposen.
English: Aflibercept blocks the activation of VEGF receptors and the proliferation of endothelial cells, thereby inhibiting the growth of new vessels that supply tumours with oxygen and nutrients.
Danish: Aflibercept blokerer aktiveringen af VEGF-receptorer og proliferationen af endotelialceller og hæmmer derved væksten af nye kar, der forsyner tumorer med oxygen og næringsstoffer.
English: One patient treated with the ZALTRAP/FOLFIRI regimen presenting with proteinuria and hypertension was diagnosed with thrombotic microangiopathy (TMA).
Danish: En patient behandlet med ZALTRAP/FOLFIRI-regimet, som henvendte sig med proteinuri og hypertension, fik diagnosticeret trombotisk mikroangiopati (TMA).
English: No dose adjustments of ZALTRAP is required in the elderly people.
Danish: Dosisjustering af ZALTRAP hos ældre er ikke nødvendig.
English: If you also have previously received or are receiving intravenous bisphosphonates dental treatment or dental surgery, (e.g. tooth extractions), should be avoided.
Danish: Hvis du også tidligere har fået eller får intravenøse bisfosfonater, skal tandlægebehandling eller operative tandindgreb, (for eksempel tandudtrækninger) undgås.
English: These were comparable between groups, and the difference between groups did not exceed ≥ 2 % incidence for the ZALTRAP/FOLFIRI regimen.
Danish: Disse var sammenlignelige i de 2 grupper, og forskellen mellem grupperne oversteg ikke ≥2 %.
English: • Nephrotic syndrome or thrombotic microangiopathy (TMA)
Danish: • Nefrotisk syndrom eller trombotisk mikroangiopati (TMA)
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 information om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu.
English: If you develop such a connection or passageway during treatment, your doctor will stop your treatment with ZALTRAP.
Danish: Hvis du udvikler en sådan forbindelse eller passage under behandlingen, vil lægen stoppe behandlingen med ZALTRAP.
English: There was no observed impact on the pharmacokinetic profile of aflibercept in patients who were positive in the immunogenicity assays.
Danish: Der blev ikke observeret en påvirkning af den farmakokinetiske profil af aflibercept hos patienter, der havde positive immunogenicitetsanalyser.
English: There are very limited data available for patients with severe renal impairment treated with aflibercept.
Danish: Der er yderst begrænsede tilgængelige data for patienter med svær nyreinsufficiens behandlet med aflibercept.
English: Precautions to be taken before handling or administering the medicinal product For instructions on dilution of the medicinal product before administration, and on infusion sets for administration, see section 6.6.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet For instruktioner om fortynding af lægemidlet før administration og om infusionssæt til brug ved administration, se pkt.
English: Irinotecan dose should be reduced by 15-20 % in subsequent cycles.
Danish: Irinotecan-dosis bør reduceres med 15-20 % i efterfølgende cykler.
English: • Dilute it to the required administration volume with sodium chloride 9 mg/ml (0.9%) solution or 5 % glucose solution for infusion.
Danish: • Fortynd det nødvendige administrationsvolumen med 9 mg/ml (0,9 %) natriumchlorid- eller 5 % glucoseinfusionvæske, opløsning.
English: Contact your doctor and dentist immediately during and after treatment with ZALTRAP if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.
Danish: Kontakt straks din læge og tandlæge under og efter behandling med ZALTRAP, hvis du oplever problemer med din mund eller tænder såsom løse tænder, smerter eller hævelse, sår der ikke vil hele eller udflåd, da dette kan være tegn på osteonekrose af kæben.
English: Of the 1,226 patients randomised in the study, the median age was 61 years, 58.6 % were male, 97.8 % had a baseline ECOG performance status (PS) of 0 or 1, and 2.2 % had a baseline ECOG performance status (PS) of 2.
Danish: Af de 1226 patienter, der blev randomiseret i studiet, var gennemsnitsalderen 61 år, 58,6 % var mænd, 97,8 % havde en baseline ECOG performancestatus (PS) på 0 eller 1, og 2,2 % havde en baseline ECOG performancestatus (PS) på 2.
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er bivirkningerne listet efter faldende alvorlighed.
English: In preclinical tumour models, biologically active doses of aflibercept correlated with those necessary to produce circulating concentrations of free aflibercept in excess of VEGF-bound aflibercept.
Danish: I prækliniske tumormodeller, var biologisk aktive doser af aflibercept korreleret til dem, der er nødvendige for at producere cirkulerende koncentrationer af frit aflibercept der overstiger VEGFbundet aflibercept.
English: • liver problem with an increase in liver enzymes.
Danish: • leverproblem med en forøgelse af leverenzymer.
English: Talk to your doctor before being given this medicine if you are breast-feeding.
Danish: Tal med lægen, før du får denne medicin, hvis du ammer.
English: • Diarrhoea and dehydration: Very common (may affect more than 1 in 10 people) for diarrhoea and Common (may affect up to 1 in 10 people) for dehydration - severe diarrhoea and being sick (vomiting) can cause you to lose too much body fluid (called ‘dehydration') and body salts (electrolytes).
Danish: • Diarré og dehydrering: Meget almindeligt (kan påvirke mere end 1 ud af 10 personer) for diarré og Almindeligt (kan påvirke op til 1 ud af 10 personer) for dehydrering - svær diarré og kvalme (opkastning) kan betyde, at du mister for megen kropsvæske (kaldes ‘dehydrering') og kropssalte (elektrolytter).
English: Administration of ZALTRAP/FOLFIRI should be delayed until neutrophil count is 1.5 x 10
Danish: Administration af ZALTRAP/FOLFIRI bør udsættes, indtil neutrofiltallet er 1,5 x 10
English: You may be advised to have a dental check-up before you start treatment with ZALTRAP.
Danish: Du kan blive anbefalet at få et tandlægeeftersyn inden du påbegynder behandling med ZALTRAP.
English: 9/L or platelet count is
Danish: 9/l eller trombocyttallet er
English: Weekly/every two weeks intravenous administration of aflibercept to cynomolgus monkeys for up to 6 months resulted in changes in the bone (effects on growth plate and the axial and appendicular skeleton), nasal cavity, kidney, ovary, and adrenal gland.
Danish: Ugentlig/hver anden uge intravenøs administration af aflibercept til cynomolgusaber i op til 6 måneder medførte forandringer i knogle (indvirkninger på vækstpladen og det aksiale og appendikulære skelet), næsehulen, nyrer, ovarier og binyrer.
English: Off-label intravitreal use
Danish: Intravitreal anvendelse uden for indikation
English: If any discolouration or particulate matter is observed, the reconstituted solution should be discarded.
Danish: Hvis der observeres nogen misfarvning eller partikler, skal den rekonstituerede opløsning kasseres.
English: Given the similar ADA assay results in patients treated with placebo or ZALTRAP, the actual incidence of immunogenicity with ZALTRAP based on these assays is likely to be overestimated.
Danish: Da ADA-analyseresultaterne hos patienter behandlet med placebo eller ZALTRAP er sammenlignelige, er det sandsynligt, at den faktiske forekomst af immunogenicitet ved ZALTRAP baseret på disse analyser er overvurderet.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Danish: LÆGEMIDLETS NAVN STYRKE OG/ELLER ADMINISTRATIONSVEJ(E)
English: The signs of a blood clot may vary depending on where it appears (e.g. lungs, leg, heart or brain) but may include symptoms such as chest pain, coughing, being short of breath or having difficulty breathing.
Danish: Tegnene på en blodprop kan variere afhængig af hvor den opstår (f.eks. lunger, ben, hjerte eller hjerne) men kan omfatte symptomer så som smerter i brystet, hoste, stakåndethed eller vejrtrækningsbesvær.
English: • you are 65 years of age or older and experience diarrhoea, dizziness, weakness, weight loss, or severe loss of body fluids (called ‘dehydration').
Danish: • du er 65 år eller ældre og oplever diarré, svimmelhed, svaghed, vægttab eller alvorligt tab af kropsvæsker (kaldet ‘dehydrering').