FrancophonIA/ELRC3.0 huggingface dataset:
English: Carcinogenesis and mutagenesis No studies have been conducted to evaluate carcinogenicity or mutagenicity of aflibercept.
Danish: Karcinogenese og mutagenese Der er ikke gennemført studier til evaluering af karcinogenicitet eller mutagenicitet af aflibercept.
English: PlGF is also linked to pathological neovascularisation and recruitment of inflammatory cells into tumours.
Danish: PlGF er også forbundet med patologisk neovaskularisering og rekruttering af inflammatoriske celler til tumorer.
English: The treatment cycles on both arms were repeated every 2 weeks.
Danish: Behandlingen i begge arme blev gentaget hver 2. uge.
English: • Allergic reactions: Common (may affect up to 1 in 10 people) - these may happen within a few minutes after your infusion.
Danish: • Allergiske reaktioner: Almindeligt (kan påvirke op til 1 ud af 10 personer) - disse kan forekomme inden for få minutter efter din infusion.
English: Women of childbearing potential and fertile males should use effective contraception during and up to a minimum of 6 months after the last dose of treatment.
Danish: Kvinder i den fertile alder og fertile mænd skal benytte effektiv prævention under og i mindst 6 måneder efter den sidste behandling.
English: No metabolism studies have been conducted with aflibercept since it is a protein.
Danish: Der er ikke gennemført metabolismestudier med aflibercept, da det er et protein.
English: Grades ≥3
Danish: Grad ≥3
English: Before initiating ZALTRAP, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Danish: Inden indledning af behandling med ZALTRAP bør denne risiko overvejes nøje for patienter med risikofaktorer såsom hypertension eller tidligere aneurisme.
English: If you are unsure, ask your doctor, pharmacist or nurse if there are any reasons why you cannot use these medicines.
Danish: Hvis du er i tvivl, spørg lægen, apotekspersonalet eller sygeplejersken, om der er nogen grund til, at du ikke kan bruge disse lægemidler.
English: Your doctor will stop this medicine for at least 4 weeks before planned surgery and until the wound is fully healed.
Danish: Lægen vil stoppe med at give dette lægemiddel i mindst 4 uger før planlagte operationer og indtil såret er helet fuldstændig.
English: • blood clot in very small blood vessels (also called ‘thrombotic microangiopathy').
Danish: • blodprop i meget små blodkar (også kaldet ‘trombotisk mikroangiopati').
English: • Posterior reversible encephalopathy syndrome (PRES) (also known as reversible posterior leukoencephalopathy syndrome (RPLS))
Danish: • Posterior reversibelt encefalopatisyndrom (PRES) (også kaldet reversibelt posterior leukoencefalopati-syndrom (RPLS))
English: • Hypertension that is not adequately controlled with anti-hypertensive therapy or occurrence of hypertensive crisis or hypertensive encephalopathy
Danish: • Hypertension, som ikke er tilstrækkeligt kontrolleret med antihypertensiv behandling, eller ved forekomst af hypertensiv krise eller hypertensiv encefalopati
English: Patients with NYHA class III or IV congestive heart failure should not be treated with ZALTRAP.
Danish: Patienter med NYHA klasse III eller IV kongestiv hjerteinsufficiens bør ikke behandles med ZALTRAP.
English: • inflammation inside the nose and upper part of the throat
Danish: • betændelse inden i næsen og den øverste del af svælget
English: Aflibercept is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15 % of the total molecular mass, resulting in a total molecular weight of 115 kDa.
Danish: Aflibercept er et dimert glycoprotein med en proteinmolekylvægt på 97 kilodalton (kDa) og indeholder glycosylering, der udgør ekstra 15 % af den totale molekylære masse, hvilket giver en samlet molekylvægt på 115 kDa.
English: As angiogenesis is critical to foetal development, the inhibition of angiogenesis following administration of ZALTRAP may result in adverse effects on pregnancy.
Danish: Da angiogenese er kritisk for den føtale udvikling, kan hæmningen af angiogenesen efter administration af ZALTRAP medføre uønskede virkninger på graviditeten.
English: If the patient becomes pregnant while taking ZALTRAP, she should be informed of the potential hazard to the foetus.
Danish: Hvis patienten bliver gravid, mens hun får ZALTRAP, bør hun informeres om den mulige risiko for fosteret.
English: Frequency Category
Danish: Frekvenskategori
English: Stratified Cochran-Mantel-Haenszel test p-value a
Danish: Stratificeret Cochran-Mantel-Haenszel test p-værdi a
English: The side effects listed below were seen when ZALTRAP was given together with chemotherapy.
Danish: De bivirkninger, der er nævnt nedenfor, er set, når ZALTRAP blev givet sammen med kemoterapi.
English: Talk to your doctor for advice if you plan to have or father a child.
Danish: Spørg lægen til råds, hvis du planlægger at få børn.
English: Gender was the most significant covariate for explaining the interindividual variability of free aflibercept clearance and volume with a 15.5 % higher clearance and a 20.6 % higher volume of distribution in males than in females.
Danish: Køn var den mest signifikante variabel til at forklare interindividuel variation af clearance og volumen af fri aflibercept med en 15,5 % højere clearance og en 20,6 % højere fordelingsvolumen hos mænd end hos kvinder.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products or solvents except those mentioned in section 6.6.
Danish: Da der ikke foreligger studier over eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler eller opløsningsmidler med undtagelse af dem, der er nævnt i pkt.
English: ZALTRAP should be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.
Danish: ZALTRAP bør kun administreres under supervision af en læge, som har erfaring i anvendelse af antineoplastiske lægemidler.
English: • you have ever had any allergies - serious allergic reactions can happen during treatment with ZALTRAP (see section 4).
Danish: • du har haft nogen form for allergi - alvorlige allergiske reaktioner kan forekommer under behandling med ZALTRAP (se punkt 4).
English: Inform your doctor about your dental treatment and tell your dentist that you are being treated with ZALTRAP.
Danish: Oplys din læge om din tandlægebehandling og fortæl din tandlæge, at du er i behandling med ZALTRAP.
English: However, results from a repeat dose toxicity study suggest there is a potential for aflibercept to impair reproductive function and fertility.
Danish: Men resultater fra et toksicitetsstudie med gentagen dosering tyder på, at der er mulighed for, at aflibercept kan hæmme reproduktionsfunktion og fertilitet.
English: No specific studies with aflibercept have been conducted in animals to evaluate the effect on fertility.
Danish: Der er ikke gennemført specifikke studier med aflibercept på dyr til vurdering af indvirkningen på fertiliteten.
English: While being treated with ZALTRAP, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Danish: Mens du behandles med ZALTRAP, skal du opretholde en god tandhygiejne (inklusiv regelmæssig tandbørstning) og få foretaget rutinemæssige tandlægeeftersyn.
English: Linear clearance observed in the dose range of 2 to 9 mg/kg is likely due to non saturable biological mechanisms of elimination such as protein catabolism.
Danish: Lineær clearance observeret i dosisområdet på 2 til 9 mg/kg skyldes sandsynligvis biologiske eliminationsmekanismer, som ikke kan mættes, så som proteinkatabolisme.
English: This is because it is not known if the medicine passes into breast milk.
Danish: Dette skyldes, at det er ukendt om lægemidlet udskilles i modermælken.
English: • The diluted solution should be inspected visually for particulate matter and discolouration prior to administration.
Danish: • Den fortyndede opløsning skal inspiceres visuelt for partikler og misfarvning, før administration.
English: Neutropenia and neutropenic complications
Danish: Neutropeni og neutropeniske komplikationer
English: EU/1/12/814/001 EU/1/12/814/002
Danish: EU/1/12/814/001 EU/1/12/814/002 EU/1/12/814/003
English: Zaltrap may reduce the number of white cells in your blood and your doctor will monitor your white blood cell count and may give you additional medicines to increase it.
Danish: Zaltrap kan reducere antallet af hvide blodlegemer i dit blod og din læge vil overvåge antallet af hvide blodlegemer og kan give dig yderligere medicin for at forhøje det.
English: Most aflibercept-related findings were noted from the lowest dose tested corresponding to plasma exposures close to those in patients at the therapeutic dose.
Danish: De fleste aflibercept-relaterede fund blev noteret fra den laveste testede dosis svarende til plasmaeksponeringer tæt på den i patienterne ved den terapeutiske dosis.
English: In these mild and moderate hepatic impairment patients, there was no effect on clearance of aflibercept.
Danish: Hos disse patienter med mildt og moderat nedsat leverfunktion var der ingen indvirkning på clearance af aflibercept.
English: If blood pressure is not controlled, it may cause stroke, heart and kidney problems.
Danish: Hvis blodtrykket ikke bringes under kontrol, kan det medføre slagtilfælde, hjerte- og nyreproblemer.
English: ZALTRAP will be given to you by a doctor or a nurse that is experienced in the use of ‘chemotherapy'.
Danish: ZALTRAP vil blive indgivet af en læge eller en sygeplejerske med erfaring i brugen af ‘kemoterapi'.
English: If your white blood cells are low, your doctor may need to delay your treatment.
Danish: Hvis dit antal af hvide blodlegemer er for lavt, kan lægen blive nødt til at udsætte din behandling.
English: This is because ZALTRAP may increase the risk of developing holes in the gut wall.
Danish: Dette skyldes, at ZALTRAP kan øge risikoen for at få huller i tarmvæggen.
English: Weight had an effect on free aflibercept clearance and volume of distribution resulting with a 29 % increase in aflibercept exposure in patients weighing ≥ 100 kg.
Danish: Vægt havde en indvirkning på clearance af frit aflibercept og resulterende distributionsvolumen med en 29 % forøgelse af aflibercept-eksponering hos patienter, der vejede ≥100 kg.
English: Practical information for handling and administration of ZALTRAP for doctors, nurses and pharmacists when using this medicine is provided with this leaflet.
Danish: Praktiske oplysninger vedrørende håndtering og administration af ZALTRAP for læger, sygeplejersker og apotekspersonale ved brug af denne medicin findes i denne indlægsseddel.
English: • haemorrhoids, bleeding or pain in the back passage
Danish: • hæmorroider, blødning eller smerter i endetarmen
English: Free aflibercept is primarily cleared by binding to endogenous VEGF to form a stable, inactive complex.
Danish: Frit aflibercept udskilles primært ved binding til endogent VEGF, hvorved der dannes et stabilt, inaktivt kompleks.
English: ZALTRAP treatment should be continued until disease progression or unacceptable toxicity occurs.
Danish: ZALTRAP-behandlingen skal fortsætte indtil sygdomsprogression eller uacceptabel toksicitet.
English: Therapeutic use of G-CSF at first occurrence of grade ≥ 3 neutropenia and secondary prophylaxis may be considered in patients who may be at increased risk for neutropenia complications.
Danish: Terapeutisk anvendelse af G-CSF ved første forekomst af grad ≥3 neutropeni samt sekundær profylakse kan overvejes hos patienter med øget risiko for neutropeniske komplikationer.
English: Zaltrap may increase blood pressure (see section 4) and your doctor will need to monitor your blood pressure and may adjust your blood pressure medicines or your dose of ZALTRAP.
Danish: Zaltrap kan øge blodtrykket (se punkt 4) og din læge skal overvåge dit blodtryk og kan justere din blodtryksmedicin eller din dosis af ZALTRAP.
English: Aflibercept administration resulted in a delay in wound healing in rabbits.
Danish: Administration af aflibercept resulterede i en forsinket sårheling hos kaniner.
English: • you have kidney problems (protein in the urine), since your doctor will monitor your kidney function and may need to adjust your dose of ZALTRAP.
Danish: • du har nyreproblemer (protein i urinen), da lægen vil overvåge din nyrefunktion og evt. justere din dosis af ZALTRAP.
English: In the event of hypertension on aflibercept treatment, blood pressure should be controlled with appropriate anti-hypertensive therapy and blood pressure should be monitored regularly.
Danish: I tilfælde af hypertension ved aflibercept-behandling bør blodtrykket bringes under kontrol med egnet antihypertensiv behandling, og blodtrykket bør monitoreres regelmæssigt.
English: Neutropenic infection/sepsis (1)
Danish: Neutropenisk infektion/sepsis (1)
English: Patients with ECOG performance status ≥ 2 or having significant co-morbidities may be at greater risk for a poor clinical outcome and should be carefully monitored for early clinical deterioration.
Danish: Patienter med ECOG-performancestatus ≥2 eller med signifikant komorbiditet kan have større risiko for et dårligt klinisk resultat og bør overvåges nøje for tidlig klinisk forværring.
English: The pharmacokinetic properties described below have to a large extent been derived from a population pharmacokinetic analysis with data from 1,507 patients with various types of advanced malignancies.
Danish: De farmakokinetisie egenskaber, der er beskrevet nedenfor, er i vidt omfang udledt fra en populationsfarmakokinetisk analyse med data fra 1.507 patienter med forskellige typer fremskredne maligniteter.
English: • change of the voice, e.g. developing a hoarse voice
Danish: • ændring af stemmen, f.eks. udvikling af hæshed
English: There are very limited data in patients with severe renal impairment; therefore, these patients should be treated with caution.
Danish: Der er meget begrænsede data for patienter med svært nedsat nyrefunktion; derfor skal disse patienter behandles med forsigtighed.
English: Irinotecan dose should be reduced by 15-20 %.
Danish: Irinotecan-dosis bør reduceres med 15-20 %.
English: Observed effects included decreases in maternal body weights, an increased number of foetal resorptions, and an increased incidence of external, visceral, and skeletal foetal malformations.
Danish: Observerede virkninger omfattede nedsat kropsvægt hos moderdyret, et øget antal fosterresorptioner og en øget forekomst af eksterne, viscerale og skeletale fostermisdannelser.
English: Vascular endothelial growth factor A and B (VEGF-A, VEGF-B), and placental growth factor (PlGF) are members of the VEGF family of angiogenic factors that can act as potent mitogenic, chemotactic, and vascular permeability factors for endothelial cells.
Danish: Vaskulær endotelial vækstfaktor A og B (VEGF-A, VEGF-B) og placental vækstfaktor (PlGF) er medlemmer af VEGF-familien af angiogene faktorer, der kan virke som potente mitogene, kemotaktiske og vaskulære permeabilitetsfaktorer for endoteliale celler.
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX44
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, andre antineoplastiske stoffer ATC-kode: L01XX44
English: Caution should be exercised when Zaltrap and intravenous bisphosphonates are administered concurrently or sequentially.
Danish: Der skal udvises forsigtighed, når ZALTRAP og intravenøse bisfosfonater administreres samtidigt eller sekventielt.
English: Aflibercept, also known as VEGF TRAP in the scientific literature, is a recombinant fusion protein consisting of VEGF-binding portions from the extracellular domains of human VEGF receptors 1 and 2 fused to the Fc portion of the human IgG1.
Danish: Aflibercept, også kaldet VEGF TRAP i den videnskabelige litteratur, er et rekombinant fusionsprotein bestående af de VEGF-bindende dele fra de ekstracellulære områder af humane VEGF-receptorer 1 og 2 bundet til Fc-delen af det humane IgG1.
English: • polyethylene lined PVC
Danish: • polyethylen-belagt PVC
English: A limited number of patients having moderate/severe renal impairment at baseline (N = 49) were treated with ZALTRAP.
Danish: Et begrænset antal patienter med moderat/svært nedsat nyrefunktion ved baseline (N=49) blev behandlet med ZALTRAP.
English: Talk to your doctor straight away, if you notice any of the side effects above.
Danish: Tal omgående med lægen, hvis du bemærker nogen af ovenstående virkninger.
English: Do not re-enter the vial after the initial puncture.
Danish: Hætteglasset må ikke punkteres påny efter den første punktur.
English: • ZALTRAP is a single-use vial.
Danish: • ZALTRAP er et hætteglas til engangsbrug.
English: Careful monitoring is recommended in order to rapidly detect and treat signs and symptoms of diarrhoea and dehydration and to minimize potential risk (see section 4.8).
Danish: Nøje overvågning anbefales for hurtigt at kunne opdage og behandle tegn og symptomer på diarré og dehydrering samt for at minimere den potentielle risiko (se pkt.
English: The most commonly observed adverse reactions at these doses were similar to those observed at the therapeutic dose.
Danish: De hyppigst observerede bivirkninger ved disse doser svarede til det, der blev observeret ved den terapeutiske dosis.
English: • you have any bleeding problems or if you notice any bleeding after treatment (see section 4) or if you feel extreme tiredness, weakness, dizziness, or have changes in the colour of your stool.
Danish: • du har blødningsproblemer, eller hvis du opdager en blødning efter en behandling (se punkt 4), eller hvis du føler dig ekstremt træt, svag, svimmel eller har ændringer i farven på din afføring.
English: Patients with Grade 3 DVT should be treated with anticoagulation as clinically indicated, and aflibercept therapy should be continued.
Danish: Patienter med grad 3 DVT bør behandles med antikoagulantia efter klinisk indikation, og aflibercept-behandlingen bør fortsættes.
English: • an increase in protein in the urine, an increase in cholesterol in the blood, and swelling from excess fluid (oedema) (also called ‘nephrotic syndrome')
Danish: • en stigning i protein i urinen, en stigning i kolesterol i blodet og hævelse pga. overskydende væske (ødem) (også kaldet ‘nefrotisk syndrom')
English: • drop in the number of white blood cells (leucopenia)
Danish: • fald i antallet af hvide blodlegemer (leukopeni)
English: Aflibercept binds to human VEGF-A (equilibrium dissociation constant KD of 0.5 pM for VEGF-A165 and 0.36 pM for VEGF-A121), to human PlGF (KD of 39 pM for PlGF-2), and to human VEGF-B (KD of 1.92 pM) to form a stable, inert complex which has no detectable biological activity.
Danish: Aflibercept bindes til humant VEGF-A (ligevægtsdissociationskonstant KD på 0,5 pM for VEGF-A165 og 0,36 pM for VEGF-A121), til humant PlGF (KD på 39 pM for PlGF-2), og til humant VEGF-B (KD på 1,92 pM) og danner et stabilt, inert kompleks, der ikke har nogen detekterbar biologisk aktivitet.
English: VEGF-A acts via two receptor tyrosine kinases, VEGFR-1 and VEGFR-2, present on the surface of endothelial cells.
Danish: VEGF-A virker via to receptortyrosinkinaser, VEGFR-1 og VEGFR-2, som er til stede på overfladen af endotelceller.
English: Stratified log-rank test p-value Overall Response Rate (CR+PR) (95 % CI) (%)
Danish: Stratificeret Log-Rank test p-værdi Samlet respons-rate (CR+PR) (95 % CI) (%)
English: Signs may include dizziness especially when going from sitting to standing.
Danish: Symptomerne kan omfatte svimmelhed, især når du rejser dig fra siddende stilling.
English: Administration of aflibercept to mice bearing xenotransplant or allotransplant tumours inhibited the growth of various cancer types.
Danish: Administration af aflibercept til mus, der var bærere af xenotransplantat- eller allotransplantattumorer, hæmmede væksten af forskellige cancertyper.
English: At doses greater than 2 mg/kg, free aflibercept clearance was approximately 1.0L/day with a terminal half-life of 6 days.
Danish: Ved doser på over 2 mg/kg, var clearance af frit aflibercept cirka 1,0 L/dag med en halveringstid på 6 dage.
English: At the recommended dose regimen of 4 mg/kg every two weeks, concentration of free aflibercept were near steady-state levels by the second cycle of treatment with essentially no accumulation (accumulation ratio of 1.2 at steady-state compared to the first administration).
Danish: Ved det anbefalede dosis-regime på 4 mg/kg hver anden uge var koncentrationen af frit aflibercept nær steady-state-niveauer i den anden cyklus af behandlingen med essentielt ingen akkumulering (akkumulationsratio på 1,2 ved steady-state sammenlignet med den første administration).
English: Diarrhoea (1) Stomatitis
Danish: Diarré (1) Stomatitis
English: Your doctor will do blood tests regularly to check your white blood cell counts throughout your treatment.
Danish: Lægen vil jævnligt udtage blodprøver for at kontrollere dit antal hvide blodlegemer under hele din behandling.
English: A dental examination and appropriate preventive dentistry should be considered prior to starting the treatment with Zaltrap.
Danish: En tandlægeundersøgelse og passende forebyggende tandbehandling skal overvejes før behandlingen med ZALTRAP opstartes.
English: Store in the original package in order to protect from light.
Danish: Opbevares i den originale emballage for at beskytte produktet mod lys.
English: • you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction and especially if you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders).
Danish: • du har problemer med din mund eller dine tænder, så som dårlig tandhygiejne, sygdom i gummerne eller har en planlagt tandudtrækning, særligt hvis du tidligere er blevet behandlet med et bisfosfonat (anvendes til at forebygge knoglesygdomme).
English: Febrile neutropenia or neutropenic sepsis
Danish: Febril neutropeni eller neutropenisk sepsis
English: • you have had a tooth removed or any form of surgery in the last 4 weeks, or you are going to have an operation or a dental or medical procedure, or you have a wound after surgery that has not healed.
Danish: • du har fået trukket en tand ud eller foretaget andre typer operationer i de seneste 4 uger, eller du skal have foretaget en operation eller et indgreb foretaget af en tandlæge eller læge, eller hvis du har et operationssår, som endnu ikke er læget.
English: If hypertension cannot be adequately controlled, treatment with aflibercept should not be initiated.
Danish: Hvis hypertensionen ikke kan kontrolleres i tilstrækkelig grad, bør behandling med aflibercept ikke initieres.
English: Patients with thromboembolic events of Grade 3 or lower need to be closely monitored.
Danish: Patienter med tromboemboli af grad 3 eller derunder skal monitoreres omhyggeligt.
English: There are no data available for patients with severe hepatic impairment (total bilirubin > 3 x ULN and any AST).
Danish: Der er ingen tilgængelige data for patienter med svært nedsat leverfunktin (total bilirubin >3 x ULN og evt. ASAT).
English: Animal toxicology and pharmacology
Danish: Dyretoksikologi og farmakologi
English: Results by prior bevacizumab exposure are summarised in Table 3.
Danish: Resultater efter forudgående bevacizumab eksponering er opsummeret i tabel 3.
English: ZALTRAP is to be administered only as an intravenous infusion over 1 hour.
Danish: ZALTRAP skal administreres udelukkende som intravenøs infusion over 1 time.
English: If recurrence after irinotecan and 5-FU dose reductions, reduction of ZALTRAP dose to 2 mg/kg could be considered.
Danish: Ved recidiv efter dosisreduktion af irinotecan og 5-FU kan reduktion af ZALTRAP-dosis til 2 mg/kg overvejes.