FrancophonIA/ELRC3.0 huggingface dataset:
English: Another study compared Zebinix taken on its own with another epilepsy medicine, carbamazepine, in 815 newly diagnosed adults.
Danish: I en anden undersøgelse blev Zebinix taget alene sammenlignet med et andet epilepsilægemiddel, carbamazepin, hos 815 nydiagnosticerede voksne.
English: Zebinix is an epilepsy medicine used to treat adults with partial-onset seizures (epileptic fits) with or without secondary generalisation.
Danish: Zebinix er et epilepsilægemiddel, som anvendes til behandling af voksne med partielle anfald (epileptiske anfald) med eller uden sekundær generalisering.
English: What is Zebinix and what is it used for?
Danish: Hvad er Zebinix, og hvad anvendes det til?
English: For adults and children weighing 60 kg or more, treatment is started at a dose of 400 mg once a day, before increasing it to the standard dose of 800 mg once a day after one or two weeks.
Danish: Hos voksne og børn på 60 kg eller derover indledes behandlingen med en dosis på 400 mg en gang dagligt, inden denne øges til standarddosis på 800 mg en gang dagligt efter en eller to uger.
English: Zebinix can only be obtained with a prescription.
Danish: Zebinix udleveres kun på recept.
English: Zebinix contains the active substance eslicarbazepine acetate.
Danish: Zebinix indeholder det aktive stof eslicarbazepinacetat.
English: The active substance in Zebinix, eslicarbazepine acetate, is converted into eslicarbazepine in the body.
Danish: Det aktive stof i Zebinix, eslicarbazepinacetat, omdannes i kroppen til eslicarbazepin.
English: Looking at the results of the three studies taken together, Zebinix 800 mg and 1,200 mg were more effective than placebo at reducing the number of seizures, when used as add-on to other epilepsy medicines.
Danish: Resultaterne af de tre undersøgelser taget under et viser, at Zebinix 800 mg og 1 200 mg var mere effektivt end placebo til at reducere antallet af anfald, når det blev givet som tillægsbehandling til andre epilepsilægemidler.
English: Why is Zebinix authorised?
Danish: Hvorfor er Zebinix godkendt?
English: What are the risks associated with Zebinix?
Danish: Hvilke risici er der forbundet med Zebinix?
English: For the full list of side effects and restrictions with Zebinix, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Zebinix fremgår af indlægssedlen.
English: Zebinix can also be used in adolescents and children above 6 years of age, in combination with existing therapies, to treat partial-onset seizures with or without secondary generalisation.
Danish: Zebinix kan også anvendes i kombination med eksisterende behandlinger til at behandle unge og børn over seks år for partielle anfald med eller uden sekundær generalisering.
English: Three main studies compared Zebinix with placebo (a dummy treatment) in 1,050 adults with partialonset seizures that were not controlled by other medicines.
Danish: Virkningen af Zebinix blev sammenlignet med placebo (en virkningsløs behandling) i tre hovedundersøgelser, der omfattede 1 050 voksne med partielle anfald, som ikke var kontrolleret med andre lægemidler.
English: Zebinix was effective, although slightly less than carbamazepine, at reducing seizures after 6 months of treatment: 71% of patients who took Zebinix and did not prematurely withdraw from the study (276 out of 388 patients) were seizure-free after 6 months compared with 76% of patients taking carbamazepine (300 out of 397 patients).
Danish: 71 % af de patienter, der tog Zebinix, og som ikke forlod undersøgelsen før tiden (276 ud af 388 patienter), var anfaldsfrie efter seks måneder sammenlignet med 76 % af de patienter, der tog carbamazepin (300 ud af 397 patienter).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zebinix have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Zebinix.
English: Zebinix (eslicarbazepine acetate)
Danish: Zebinix (efiskcarbazepitacetat)
English: How does Zebinix work?
Danish: Hvordan virker Zebinix?
English: How is Zebinix used?
Danish: Hvordan anvendes Zebinix?
English: What benefit of Zebinix have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Zebinix?
English: This information supplements the sections 3 and 5 for the user.
Danish: Disse oplysninger supplerer punkt 3 og 5 for brugeren.
English: How much and how often you will receive treatment
Danish: Hvor meget og hvor tit du vil modtage af behandlingen
English: These effects were fully reversible within 8-18 weeks after the last injection.
Danish: Disse virkninger var fuldt reversible inden for 8-18 uger efter den sidste injektion.
English: This is considered as one treatment cycle.
Danish: Dette betragtes som en behandlingscyklus.
English: • for at least 6 months after the last dose of treatment.
Danish: • i mindst 6 måneder efter den sidste dosis af behandlingen.
English: These animals also lost normal menstrual cycling.
Danish: Disse dyr mistede også den normale menstruationscyklus.
English: Date of first authorisation: 01 February 2013 Date of latest renewal: 21 September 2017
Danish: Dato for første markedsføringstilladelse: 01 februar 2013 Dato for seneste fornyelse: 21 september 2017
English: Your doctor should monitor you carefully.
Danish: Din læge bør overvåge dig nøje.
English: • You will usually be given an infusion once every 2 weeks.
Danish: • Du vil sædvanligvis få en infusion en gang hver 2. uge.
English: As determined per IVRS
Danish: Som bestemt ved IVRS
English: You may need to read it again, or provide it to future healthcare providers.
Danish: Du kan få brug for at læse den igen, eller give den videre til fremtidigt sundhedspersonale.
English: Sometimes, depending on where this happens, you may get an unusual discharge at that place.
Danish: Sommetider, afhængigt af hvor det sker, kan du få et usædvanligt udflåd på det pågældende sted.
English: This can lead to death.
Danish: Dette kan være dødeligt.
English: • in your eye, since it may severely damage it.
Danish: • i dit øje, da det kan forårsage alvorlig skade.
English: From a microbiological point of view, the solution for infusion should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt bør infusionsopløsningen anvendes med det samme.
English: • your level of everyday activities is limited or worsens on treatment.
Danish: • dit aktivitetsniveau i hverdagen er begrænset eller forværres ved behandling.
English: Your doctor will decide the correct dose for you.
Danish: Din læge vil bestemme den korrekte dosis for dig.
English: You should take your temperature often during treatment with this medicine.
Danish: Du bør tage din temperatur ofte under behandling med denne medicin.
English: • during treatment with ZALTRAP and
Danish: • under behandling med ZALTRAP og
English: • changes in the colour of the skin.
Danish: • forandringer i hudens farve.
English: Hypertension may exacerbate underlying cardiovascular disease.
Danish: Hypertension kan forværre underliggende kardiovaskulær sygdom.
English: • your number of white blood cells is too low.
Danish: • dit antal af hvide blodlegemer er for lavt.
English: Overall objective response rate by IRC
Danish: Samlet objektiv respons-rate ved IRC
English: This medicine is not for children or adolescents under the age of 18 years because the safety and benefit of using ZALTRAP in children and adolescents have not been shown.
Danish: Dette lægemiddel er ikke til børn eller unge under 18 år, da sikkerheden og fordelene ved anvendelse af ZALTRAP til børn og unge ikke er blevet påvist.
English: Please also read the package leaflets for the other medicines (‘chemotherapy') that are part of your treatment, to see if they are suitable for you.
Danish: Læs indlægssedlen for de andre lægemidler (‘kemoterapi'), der er en del af din behandling, for at se om de er egnede for dig.
English: Race No effect of race was identified in the population analysis.
Danish: Race Ingen effekt af race blev identificeret i populationsanalysen.
English: • Your doctor will decide how often you will be given the medicine and if you need a change in the dose.
Danish: • Din læge vil beslutte, hvor tit du skal have medicinen, og om du behøver ændringer af dosis.
English: They may also prescribe a medicine called ‘G-CSF' to help prevent complications if your white blood cell count is too low.
Danish: De kan også ordinere et lægemiddel til dig, som kaldes ‘G-CSF', for at hjælpe med til at forebygge komplikationer, hvis dit antal af hvide blodlegemer er for lavt.
English: Treatment will continue as long as your doctor thinks the treatment is of benefit to you, and the side effects are acceptable.
Danish: Behandlingen vil fortsætte så længe din læge mener, at behandlingen er gavnlig for dig og bivirkningerne er acceptable.
English: It is therefore also important to tell your doctor, pharmacist or nurse if you have other heart problems since high blood pressure could make these worse.
Danish: Det er derfor også vigtigt at fortælle det til lægen, apoteket eller sundhedspersonalet hvis du har andre hjerteproblemer, da højt blodtryk kan forværre disse.
English: There was no margin of exposure to patients in relation to these effects.
Danish: Der var ingen eksponeringsmargin til patienter i relation til disse påvirkninger.
English: The use of granulocyte colony-stimulating factor (G-CSF) may be considered.
Danish: Anvendelse af granulocytkoloni-stimulerende faktor (GCSF) kan overvejes.
English: • The recommended dose is 4 mg for each kilogram of your body weight.
Danish: • Den anbefalede dosis er 4 mg for hvert kilo af din kropsvægt.
English: Invasive dental procedures are also an identified risk factor.
Danish: Operative tandindgreb er også en kendt risikofaktor.
English: The tumour needs nutrients and oxygen from blood in order to grow.
Danish: Tumoren behøver næringsstoffer og ilt fra blodet for at vokse.
English: Your doctor will temporarily stop the treatment before and after surgery.
Danish: Din læge vil midlertidigt stoppe behandlingen før og efter operationen.
English: The medicine must be diluted before it is given.
Danish: Medicinen skal fortyndes, før den gives.
English: Immunogenicity data are highly dependent on the sensitivity and specificity of the assay.
Danish: Immunogenicitetsdata er stærkt afhængige af analysens sensitivitet og specificitet.
English: A risk to the breast-fed child cannot be excluded.
Danish: En risiko for det diende barn kan ikke udelukkes.
English: Distribution The volume of distribution of free aflibercept at steady-state is approximately 8 litres.
Danish: Fordeling Distributionsvolumen af frit aflibercept ved steady-state er cirka 8 liter.
English: ZALTRAP has no or negligible influence on the ability to drive and use machines.
Danish: ZALTRAP har ingen eller ubetydelig indflydelse på evnen til at føre bil eller betjene maskiner.
English: Unopened vial 3 years
Danish: Uåbnede hætteglas 3 år
English: • The drip (infusion) lasts for about 1 hour.
Danish: • Droppet (infusionen) varer cirka 1 time.
English: Table 4 - Post-hoc analyses excluding adjuvant patients a,b
Danish: Table 4 - Post-hoc analyser eksklusive adjuverende patienter a,b
English: Any unused concentrate should be discarded.
Danish: Alt ikke anvendt koncentrat skal bortkastes.
English: The treatment cycle is repeated every 2 weeks.
Danish: Behandlingscyklussen gentages hver 2. uge.
English: The concentrate solution must be clear and without particles.
Danish: Den koncentrerede opløsning skal være klar og uden partikler.
English: You may need to go to the hospital for treatment.
Danish: Du skal muligvis behandles på hospital.
English: You should not use ZALTRAP during pregnancy unless you and your doctor decide that the benefit for you is greater than any possible risk to you or your unborn baby.
Danish: Du bør ikke bruge ZALTRAP under graviditet, medmindre du og din læge beslutter at fordelene for dig er større end de potentielle risici for dig og dit ufødte barn.
English: • you experience signs of a blood clot (see section 4).
Danish: • du oplever tegn på en blodprop (se punkt 4).
English: It is important that you read the entire content of this procedure prior to the preparation of infusion solution.
Danish: Det er vigtigt, at du gennemlæser hele indholdet af denne vejledning inden klargøringen af infusionsopløsningen.
English: There are no data from the use of aflibercept in pregnant women.
Danish: Der er ingen data fra anvendelse af aflibercept til gravide kvinder.
English: No studies have been conducted to assess the impact of ZALTRAP on milk production, its presence in breast milk or its effects on the breast-fed child.
Danish: Der er ikke gennemført studier til vurdering af virkningen af ZALRAP på produktionen af mælk, dets tilstedeværelse i mælk eller dets indvirkning på det diende barn.
English: PFS (based on tumour assessment by the IRC): Significance threshold is set to 0.0001
Danish: PFS (baseret på tumorvurdering ved IRC): Signifikanstærskel er sat til 0,0001
English: Talk to your doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment:
Danish: Tal omgående med lægen, hvis du bemærker nogen af følgende alvorlige bivirkninger - du kan behøve akut medicinsk behandling:
English: Patients were treated until disease progression or unacceptable toxicity.
Danish: Patienterne blev behandlet indtil sygdomsprogression eller uacceptabel toksicitet.
English: You may have side effects that affect your sight, concentration or ability to react.
Danish: Du kan få bivirkninger, der påvirker dit syn, din koncentrations- eller reaktionsevne.
English: The primary efficacy endpoint was overall survival.
Danish: Det primære effekt-endemål var samlet overlevelse.
English: Elderly (≥ 65 years of age) may be more likely to experience adverse reactions.
Danish: Ældre (≥65 år) kan være mere tilbøjelige til at opleve bivirkninger.
English: This may include swelling of the feet or whole body and may be related to kidney disease.
Danish: Dette kan omfatte hævelse af fødderne eller hele kroppen og kan være relateret til nyresygdom.
English: What ZALTRAP is used for
Danish: Hvad ZALTRAP anvendes til
English: During treatment, your doctor will perform a number of tests to monitor the function of your body and how the medicine is working.
Danish: Under behandlingen vil lægen foretage en række prøver for at overvåge dine kropsfunktioner og se, hvordan medicinen virker.
English: Cases of overdose should be managed by appropriate supportive measures particularly with regard to monitoring and treatment of hypertension and proteinuria.
Danish: Tilfælde af overdosering skal behandles ved passende understøttende foranstaltninger, specielt med hensyn til monitorering og behandling af hypertension og proteinuri.
English: Baseline and periodic evaluations of left ventricular function should be considered while the patient is receiving Zaltrap.
Danish: Baseline og periodiske evalueringer af venstre ventrikelfunktion bør overvejes, mens patienten modtager Zaltrap.
English: This medicine may harm your unborn baby since it may stop new blood vessels from forming.
Danish: Dette lægemiddel kan skade det ufødte barn da det kan hindre dannelsen af nye blodkar.
English: Tests may include blood and urine tests, x-ray or other scanning techniques and/or other tests.
Danish: Prøverne kan omfatte blod- og urinprøver, røntgen eller andre former for scanning og/eller andre prøver.
English: ZALTRAP must not be injected into the eye, since it may severely damage it.
Danish: ZALTRAP må ikke injiceres i øjet, da det kan forårsage alvorlig skade.
English: These differences do not affect exposure due to weight-based dosing and no dose modifications based on gender are required.
Danish: Disse forskelle påvirker ikke eksponeringen på grund af vægtbaseret dosering og der er ikke behov for dosismodifikationer på baggrund af køn.
English: Your doctor will decide the appropriate doses for these other chemotherapy medicines.
Danish: Din læge vil beslutte den nøjagtige dosis af disse andre kemoterapipræparater.
English: Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity with ZALTRAP.
Danish: Immunogenicitet Som ved alle terapeutiske proteiner er der en mulighed for immunogenicitet ved ZALTRAP.
English: Aflibercept is expected to degrade to small peptides and individual amino acids.
Danish: Aflibercept forventes at nedbrydes til små peptider og individuelle aminosyrer.
English: If this happens, do not drive or use any tools or machines.
Danish: Hvis dette sker for dig, bør du ikke køre bil eller andet motorkøretøj eller bruge værktøjer eller maskiner.
English: As with other large proteins, both free and bound aflibercept, are expected to be cleared, more slowly, by other biological mechanisms, such as proteolytic catabolism.
Danish: Som ved andre store proteiner forventes både frit og bundet aflibercept at blive udskilt langsommere af andre biologiske mekanismer, så som proteolytisk katabolisme.
English: ZALTRAP is a hyperosmotic solution, which is not formulated for compatibility with the intraocular environment.
Danish: ZALTRAP er en hyperosmotisk opløsning, der ikke er formuleret med henblik på kompatibilitet med det intraokulære miljø.
English: Table 2 - Main efficacy endpoints a
Danish: Tabel 2 - Hoved-effektendepunkter a
English: This is because ZALTRAP may increase the risk of bleeding.
Danish: Dette skyldes at ZALTRAP kan øge risikoen for blødning.
English: There is no specific antidote to ZALTRAP overdose.
Danish: Der findes ingen specifik antidot mod ZALTRAP-overdosering.
English: Filters made of polyvinylidene fluoride (PVDF) or nylon must not be used.
Danish: Filtre fremstillet af polyvinylidenfluorid (PVDF) eller nylon må ikke anvendes.
English: Paediatric population The safety in paediatric patients has not been established.
Danish: Pædiatrisk population Sikkerheden hos pædiatriske patienter er ikke klarlagt.
English: Excessive activation of these receptors by VEGF-A can result in pathological neovascularisation and excessive vascular permeability.
Danish: Overdreven aktivering af disse receptorer af VEGF-A kan resultere i patologisk neovaskularisering og overdreven vaskulær permeabilitet.
English: PlGF and VEGF-B bind only to VEGFR-1, which is also present on the surface of leucocytes.
Danish: PlGF og VEGF-B binder sig kun til VEGFR-1, som også er til stede på overfladen af leukocytter.
English: Frequencies are based on all grades and defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Danish: Frekvenser er baseret på alle grader og defineres som: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000) meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: These data are exploratory and the statistical interaction test was non-significant (lack of evidence for heterogeneity in treatment effect between the RAS wild-type and RAS mutant subgroups).
Danish: Disse data er eksplorative, og testen for statistisk interaktion var ikke signifikant (mangel på bevis for heterogenitet i behandlingseffekt mellem RAS-vildtype og RAS-muterede subgrupper).
English: There is no information on the safety of aflibercept given at doses exceeding 7 mg/kg every 2 weeks or 9 mg/kg every 3 weeks.
Danish: Der foreligger ikke nogen oplysninger om sikkerheden af aflibercept givet i doser over 7 mg/kg hver 2. uge eller 9 mg/kg hver 3. uge.
English: • Compromised wound healing requiring medical intervention
Danish: • Kompromitteret sårheling, der kræver intervention
English: The infusion should be temporarily suspended until the reaction resolves.
Danish: Infusionen skal seponeres midlertidigt, indtil reaktionen er ophørt.
English: If you wear dentures you should make sure these fit properly.
Danish: Hvis du bruger proteser, skal du sikre at disse er korrekt tilpassede.
English: It is unknown whether aflibercept is excreted in human milk.
Danish: Det vides ikke, om aflibercept udskilles i human mælk.
English: There is no relevant use of ZALTRAP in the paediatric population for the indication of metastatic colorectal cancer.
Danish: Der er ingen relevant anvendelse af ZALTRAP til den pædiatriske population til indikationen metastaserende kolorektalcancer.
English: Men and women who can father or have children should use effective contraception:
Danish: Mænd og kvinder, der kan få børn, bør benytte effektive præventionsmidler:
English: Your doctor should check your blood pressure throughout your treatment.
Danish: Din læge skal kontrollere dit blodtryk gennem hele behandlingen.
English: • Based on the required dose for the patient, withdraw the necessary volume of ZALTRAP concentrate from the vial.
Danish: • På grundlag af den påkrævede dosis til patienten trækkes det nødvendige volumen ZALTRAPkoncentrat ud af hætteglasset.
English: Intensity of the adverse reactions is graded according to NCI CTC version 3.0 (grade ≥ 3 = G ≥ 3).
Danish: Bivirkningernes sværhedsgrad er gradueret efter NCI CTC version 3.0 (grad ≥3 = G≥3).
English: • feeling tired or weak
Danish: • følelse af træthed eller svækkelse
English: Figure 1 - Overall survival (months) - Kaplan-Meier curves by treatment group - ITT population
Danish: Figur 1 - Samlet overlevelse (måneder) - Kaplan-Meier kurver efter behandlingsgruppeITT-population
English: • DEHP free PVC containing trioctyl-trimellitate (TOTM)
Danish: • DEHP-frit PVC indeholdende trioctyl-trimellitat (TOTM)
English: Your doctor may need to treat the allergic reaction or stop your treatment with ZALTRAP.
Danish: Din læge kan blive nødt til at behandle den allergiske reaktion eller stoppe behandlingen med ZALTRAP.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C and for 8 hours at 25°C.
Danish: Den kemiske og fysiske stabilitet under brug er påvist i 24 timer ved 2 °C til 8 °C og i 8 timer ved 25 °C.
English: Aflibercept increased blood pressure in normotensive rodents.
Danish: Aflibercept forhøjede blodtrykket hos normotensive gnavere.
English: If you are a woman that could become pregnant you should use effective contraception (see “Contraception” section below for details on male and female contraception).
Danish: Hvis du er kvinde i den fødedygtige alder, bør du anvende effektiv prævention (se afsnit om Prævention nedefor for detaljer om prævention for mænd og kvinder).
English: Demographics were well balanced between the treatment arms (age, race, ECOG performance status, and prior bevacizumab status).
Danish: Demografien var velafbalanceret mellem behandlingsarmene (alder, race, ECOG performancestatus og tidligere bevacizumab-status).
English: Diarrhoea and dehydration
Danish: Diarré og dehydrering
English: • kidney problem with an increase in creatinine (a marker of kidney function)
Danish: • nyreproblem med en forøgelse af kreatinin (en markør for nyrefunktion)
English: For these reasons, comparison of the incidence of antibodies to ZALTRAP with the incidence of antibodies to other products may be misleading.
Danish: Af disse grunde kan sammenligning af forekomsten af antistoffer over for ZALTRAP med forekomsten af antistoffer over for andre produkter være misvisende.
English: ZALTRAP/FOLFIRI should be discontinued and appropriate medical therapy should be administered.
Danish: ZALTRAP/FOLFIRI bør seponeres og passende medicinsk behandling administreres.
English: If patients are experiencing symptoms that affect their vision or concentration, or their ability to react, they should be advised not to drive or use machines (see section 4.8).
Danish: Hvis patienterne oplever symptomer, der påvirker deres syn, koncentration eller reaktionsevne, bør de tilrådes ikke at føre motorkøretøj eller betjene maskiner (se pkt.