FrancophonIA/ELRC3.0 huggingface dataset:
English: In one main study involving 96 patients, treatment with Enzepi led to the absorption of 84% of the fats consumed by patient over 72 hours compared with 85% absorption with the already authorised medicine.
Danish: I en hovedundersøgelse, hvori deltog 96 patienter, medførte behandling med Enzepi en absorption på 84 % af de fedtstoffer, som patienten indtog over 72 timer, sammenholdt med 85 % for det allerede godkendte lægemiddel.
English: In terms of safety, Enzepi's side effects are comparable to other marketed products.
Danish: For så vidt angår sikkerheden, er bivirkningerne ved Enzepi sammenlignelige med andre markedsførte produkter.
English: Enzepi should be taken during meals or snacks with a drink of water or juice.
Danish: Enzepi skal tages sammen med et måltid eller et mellemmåltid og et glas vand eller juice.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Enzepi's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Enzepi opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Enzepi?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Enzepi?
English: Enzepi can only be obtained with a prescription.
Danish: Enzepi udleveres kun efter recept.
English: Enzepi will therefore help the body absorb nutrients better, especially fats.
Danish: Enzepi hjælper dermed kroppen med bedre at optage næringsstoffer, især fedtstoffer.
English: It is not intended to provide practical advice on how to use Enzepi.
Danish: Det er ikke en praktisk vejledning i, hvordan Enzepi bør anvendes.
English: In clinical trials most side effects were mild to moderate in severity.
Danish: I de kliniske undersøgelser var de fleste bivirkninger milde til moderate.
English: The appropriate dose depends on the symptoms of the disease, amount of fat in the stool, fat content of the diet and the patient's weight.
Danish: Den rette dosis afhænger af symptomerne på sygdommen, fedtindholdet i afføringen, fedtindholdet i kosten og patientens legemsvægt.
English: What is Enzepi and what is it used for?
Danish: Hvad er Enzepi, og hvad anvendes det til?
English: Why is Enzepi approved?
Danish: Hvorfor blev Enzepi godkendt?
English: Enzepi is a medicine used to treat adults and children whose pancreas does not produce enough enzymes (a condition known as pancreatic insufficiency) due to cystic fibrosis or other conditions such as pancreatic cancer.
Danish: Enzepi er et lægemiddel, der bruges til at behandle voksne og børn, hvis bugspytkirtel ikke producerer nok enzymer (en lidelse, der kaldes pancreatisk insufficiens) på grund af cystisk fibrose eller andre lidelser, f.eks. kræft i bugspytkirtlen.
English: Enzepi pancreas powder
Danish: Pancreaspulver
English: The most common side effects with Enzepi (which may affect more than 1 in 100 people) are effects on the gut (abdominal pain, bloating, diarrhoea, vomiting, constipation and nausea) and headache.
Danish: De mest almindelige bivirkninger ved Enzepi (som kan forekomme hos mere end 1 ud af 100 patienter) er påvirkning af tarmsystemet (mavesmerter, oppustethed, diarré, opkastning, forstoppelse og kvalme) og hovedpine.
English: What are the risks associated with Enzepi?
Danish: Hvilke risici er der forbundet med Enzepi?
English: The CHMP considered that the use of pancreas powder to treat pancreatic insufficiency has been well established in medical practice for more than 20 years.
Danish: CHMP har taget hensyn til, at brugen af pancreaspulver til behandling af pancreatisk insufficiens har været almindeligt anerkendt i klinisk praksis i mere end 20 år.
English: Pancreas powder is a well-known substance that has been authorised in the treatment of pancreatic insufficiency for many years.
Danish: Pancreaspulver er et kendt stof, der har været godkendt til behandling af pancreatisk insufficiens i mange år.
English: A lack of these enzymes leads to poor growth, weight loss, abdominal pain and diarrhoea.
Danish: En mangel på disse enzymer medfører ringe vækst, vægttab, mavesmerter og diarré.
English: For more information about treatment with Enzepi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Enzepi, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Enzepi was shown to be as effective as the already well-known marketed medicine.
Danish: Det er påvist, at Enzepi er lige så virkningsfuldt som det allerede godkendte lægemiddel.
English: The most important serious side effects observed with all pancreatic enzyme medicines are anaphylactic (allergic) reactions and fibrosing colonopathy (scarring and thickening of the bowel wall).
Danish: De alvorligste bivirkninger, der er set ved lægemidler med pancreasenzymer, er anafylaktiske (allergiske) reaktioner og fibroserende colonopati (ardannelse og fortykkelse af tarmvæggen).
English: The active substance of Enzepi, pancreas powder, is intended to replace missing enzymes in patients whose pancreas does not produce sufficient amounts of them.
Danish: Det aktive stof i Enzepi, pancreaspulver, er beregnet til at erstatte de manglende enzymer hos patienter, hvis bugspytkirtel ikke producerer nok af disse.
English: Enzepi has been shown to be as effective as an already authorised medicine containing pancreas powder and used in pancreatic insufficiency.
Danish: Det er påvist, at Enzepi er lige så virkningsfuldt som et allerede godkendt lægemiddel, der indeholder pancreaspulver, og som anvendes til pancreatisk insufficiens.
English: It contains enzymes that help with the digestion of fats, carbohydrates and proteins.
Danish: Det indeholder enzymer, som hjælper med at nedbryde fedtstoffer, kulhydrater og proteiner.
English: For the full list of restrictions and all side effects reported with Enzepi, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger og indberettede bivirkninger ved Enzepi fremgår af indlægssedlen.
English: The active substance in Enzepi is pancreas powder which is obtained from pig pancreas.
Danish: Det aktive stof i Enzepi er pancreaspulver, som er udvundet af bugspytkirtler fra svin.
English: For practical information about using Enzepi, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Enzepi, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Pancreas enzymes are needed to digest fats, carbohydrates and proteins.
Danish: Pancreasenzymer er nødvendige for at kunne nedbryde fedtstoffer, kulhydrater og proteiner.
English: How does Enzepi work?
Danish: Hvordan virker Enzepi?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Enzepi have been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Enzepi.
English: What benefits of Enzepi have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Enzepi?
English: How is Enzepi used?
Danish: Hvordan anvendes Enzepi?
English: For patients who cannot swallow capsules, the capsules may be opened and the content mixed with a small amount of acidic food such as fruit puree which should be swallowed immediately without chewing.
Danish: blande indholdet med en lille mængde syrlig mad, f.eks. frugtpuré, som så skal synkes med det samme uden at tygge.
English: Such patients should be closely monitored.
Danish: Sådanne patienter skal nøje overvåges.
English: a) Grade 1:
Danish: a) Grad 1:
English: They can occur despite the use of premedication.
Danish: De kan opstå trods anvendelse af præmedicinering.
English: Blepharitis; keratitis.
Danish: Blefaritis; keratitis.
English: A close monitoring of patients, particularly during the first administration, is required.
Danish: Der kræves nøje overvågning af patienterne, især i løbet af første administration.
English: In this study EGFR expression was not an inclusion criterion.
Danish: I dette studie var EGFR-ekspression ikke et inklusionskriterium.
English: Sufficient data from pregnant or lactating women are not available.
Danish: Der foreligger ikke tilstrækkelige data fra gravide eller ammende kvinder.
English: From a microbiological point of view, the product shall be used immediately after opening.
Danish: Fra et mikrobiologisk synspunkt skal produktet anvendes omgående efter åbningen.
English: The recommended infusion period is 120 minutes.
Danish: Den anbefalede infusionstid er 120 minutter.
English: Current data on the development of HACAs is limited.
Danish: Aktuelle data for udviklingen af HACA er begrænsede.
English: Such reactions may be allergic in nature.
Danish: Sådanne reaktioner kan være af allergisk natur.
English: Overall, no clinically relevant difference between genders was observed.
Danish: Generelt blev der ikke observeret nogen klinisk relevant forskel mellem de to køn.
English: Date of latest renewal: 29/06/2009
Danish: Dato for seneste fornyelse: 29/06/2009
English: • severe breathing difficulties which develop rapidly
Danish: • svære vejrtrækningsproblemer, som udvikler sig hurtigt
English: Variable/ statistic
Danish: Variable/ statistisk
English: CRS is normally most severe in relation to the first infusion.
Danish: CRS er normalt sværest i relation til den første infusion.
English: • excessive growth of hair
Danish: • øget vækst af hår
English: RAS is one of the most frequently activated family of oncogenes in human cancers.
Danish: RAS er en af de hyppigst aktiverede onkogen-familier ved human cancer.
English: The pharmacokinetic results were comparable to those in adults.
Danish: De farmakokinetiske resultater var sammenlignelige med resultaterne hos voksne.
English: continue slow infusion under close supervision b) Grade 2:
Danish: fortsæt langsom infusion under nøje overvågning b) Grad 2:
English: Before the first dose, you will receive an antiallergic medicine in order to reduce the risk of an allergic reaction.
Danish: Før første dosis får du et lægemiddel mod allergi for at nedsætte risikoen for en allergisk reaktion.
English: Contact lens use is also a risk factor for keratitis and ulceration.
Danish: Brug af kontaktlinser er også en risikofaktor for keratitis og ulceration.
English: Availability of resuscitation equipment must be ensured.
Danish: Nødudstyr til genoplivning skal være tilgængeligt.
English: Data for the XELOX regimen and the third experimental arm are not presented.
Danish: Data for XELOX-regimet og den tredje eksperimentelle arm præsenteres ikke.
English: On the basis of this data and since no independent review of imaging data was conducted, results in relation to mutation status are considered non-interpretable.
Danish: På grundlag af disse data, og da der ikke er blevet foretaget en uafhængig kontrol af billeddata, skal resultaterne i forhold til mutationsstatus anses for ikke-fortolkelige.
English: In some studies association with age ≥ 65 years or performance status has been observed.
Danish: I nogle undersøgelser blev en sammenhæng med alder ≥ 65 år eller performance-status observeret.
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 to 8ºC, unless opening has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes omgående, er opbevaringstid og -betingelser før brug brugerens ansvar og overstiger normalt ikke 24 timer ved 2 til 8°C, medmindre pakningen er åbnet under kontrollerede og validerede aseptiske forhold.
English: Increase in liver enzyme levels (ASAT, ALAT, AP).
Danish: Stigning i leverenzymniveauer (ASAT, ALAT, AP).
English: Analyses on the RAS wild-type population are required to appropriately evaluate these data
Danish: Det er nødvendigt at analysere RAS-vildtype-populationen for at evaluere disse data på passende vis.
English: For the subsequent weekly doses, the recommended infusion period is 60 minutes.
Danish: For de følgende ugentlige doser er den anbefalede infusionstid 60 minutter.
English: The duration of treatment may vary depending on your disease as well as from person to person and your doctor will therefore discuss with you how long you will receive Erbitux.
Danish: Behandlingens varighed kan svinge afhængig af din sygdom samt fra person til person, og lægen vil derfor drøfte med dig, hvor længe du skal have Erbitux.
English: The following definitions apply to the frequency terminology used hereafter: Very common ( 1/10)
Danish: Følgende definitioner gælder for den hyppighedsterminologi, som anvendes herefter: Meget almindelig (≥ 1/10)
English: As a result of this binding, the cancer cell can no longer receive the messages it needs for growth, progression and metastasis.
Danish: På grund af denne binding kan kræftcellen ikke længere modtage de signaler, den har brug for, til vækst og udvikling og til at danne metastaser.
English: Therefore, please make sure that you also read the package leaflet for the other medicines.
Danish: Du bedes derfor sørge for også at læse indlægssedlen til den anden medicin.
English: Tell your doctor if you are pregnant or if you are not using reliable contraception (speak to your doctor if you are not sure).
Danish: Tal med lægen, hvis du er gravid, eller du ikke anvender sikker prævention (tal med lægen, hvis du ikke er sikker).
English: Several pathways have been described that may contribute to the metabolism of antibodies.
Danish: Der er beskrevet flere veje, som kan være medvirkende til metaboliseringen af antistoffer.
English: • chest pain (a symptom of side effects on your heart) If such symptoms occur, speak to a doctor immediately.
Danish: • brystsmerter (et symptom på bivirkninger i hjertet) Hvis disse symptomer opstår, skal du omgående tale med lægen.
English: However, since it does not contain any antimicrobial preservative or bacteriostatic agent, it is intended for immediate use.
Danish: Da det imidlertid ikke indeholder noget antimikrobielt konserveringsmiddel eller bakteriehæmmende stof, er det beregnet til omgående brug.
English: Neutropenia and related infectious complications
Danish: Neutropeni og dermed forbundne infektiøse komplikationer
English: Only in study EMR 62 202-007, a post-hoc analysis was not possible.
Danish: Kun i studie EMR 62 202-007 var det ikke muligt at foretage en post-hoc-analyse.
English: Monoclonal antibodies are proteins that specifically recognise and bind to other unique proteins called antigens.
Danish: Monoklonale antistoffer er proteiner, som specifikt genkender og binder sig til andre særlige proteiner kaldet antigener.
English: Merck Healthcare KGaA Frankfurter Straße 250 64293 Darmstadt Germany
Danish: Merck Healthcare KGaA Frankfurter Straße 250 64293 Darmstadt Tyskland
English: This premedication is recommended prior to all subsequent infusions.
Danish: Denne præmedicinering anbefales før alle efterfølgende infusioner.
English: No new safety signals were identified in paediatric patients as reported from a phase-I study.
Danish: Ingen nye sikkerhedssignaler blev identificeret hos pædiatriske patienter efter rapporter fra et fase I-studie.
English: EGFR is involved in foetal development.
Danish: EGFR er involveret i udviklingen af fosteret.
English: Erbitux is used to treat two different types of cancer:
Danish: Erbitux bruges i behandlingen af to forskellige former for kræft:
English: 1082 MA Amsterdam The Netherlands
Danish: 1082 MA Amsterdam Holland
English: • haemoglobin < 9 g/dL
Danish: • hæmoglobin < 9 g/dl
English: Your doctor will then discuss with you the risks and benefits of using Erbitux in these situations.
Danish: Lægen vil drøfte risici og fordele ved at anvende Erbitux i disse tilfælde.
English: If keratitis is diagnosed, the benefits and risks of continuing treatment should be carefully considered.
Danish: Hvis keratitis diagnosticeres, skal fordele og risici ved fortsat behandling nøje overvejes.
English: Treatment with Erbitux must then be stopped.
Danish: Behandling med Erbitux skal i så fald stoppes.
English: Your doctor will discuss with you whether you need to consult a specialist.
Danish: Din læge vil drøfte med dig, om du skal kontakte en specialist.
English: The protein product of the proto-oncogene RAS (rat sarcoma) is a central down-stream signaltransducer of EGFR.
Danish: Proteinproduktet af proto-onkogenet RAS (rat sarcoma) er en central, downstream signaltransducer for EGFR.
English: It is recommended to warn patients of the possibility of such a late onset and instruct them to contact their physician if symptoms or signs of an infusion-related reaction occur.
Danish: Det anbefales at advare patienterne om muligheden for en sådan forsinket indtræden og at informere dem om at kontakte deres læge, hvis de får symptomer eller tegn på en infusionsrelateret reaktion.
English: It is strongly recommended that Erbitux be given during pregnancy or to any woman not employing adequate contraception only if the potential benefit for the mother justifies a potential risk to the foetus.
Danish: Det anbefales kraftigt, at Erbitux kun gives under graviditet eller til kvinder, som benytter adækvat prævention, hvis den potentielle fordel for moderen retfærdiggør en potentiel risiko for fostret.
English: Thus, a benefit-risk ratio for this combination has not yet been established.
Danish: Der er derfor endnu ikke opstillet noget benfit-risk-forhold for denne kombination.
English: Evidence of wild-type RAS (KRAS and NRAS) status is required before initiating treatment with Erbitux.
Danish: Dokumentation for vildtype-RAS-status (KRAS og NRAS) er påkrævet, inden behandling med Erbitux iværksættes.
English: Frequency not known (cannot be estimated from the available data) An asterisk (*) indicates that additional information on the respective undesirable effect is provided below the table.
Danish: Hyppighed ikke kendt (kan ikke estimeres ud fra forhåndenværende data) En stjerne (*) betyder, at yderligere information om den respektive bivirkning gives under tabellen.
English: In addition, hypokalaemia may develop as a consequence of diarrhoea.
Danish: Der kan desuden udvikles hypokalæmi som følge af diaré.
English: Your doctor will decide whether treatment has to be stopped.
Danish: Lægen vil afgøre, om behandlingen skal stoppes.
English: Mucositis may lead to epistaxis.
Danish: Mucositis kan medføre epistaxis.
English: Dosage and administration
Danish: Dosering og administration
English: Once opened, Erbitux is intended for immediate use.
Danish: Efter åbning er Erbitux beregnet til omgående brug.
English: Non-clinical data on genotoxicity and local tolerance including accidental administration by routes other than the intended infusion revealed no special hazard for humans.
Danish: Prækliniske data for genotoksicitet og lokal tolerance, herunder utilsigtet indgift ad andre veje end den tilsigtede infusion, viser ingen speciel risiko for mennesker.
English: According to clinical practice guidelines prophylactic use of oral tetracyclines (6 - 8 weeks) and topical application of 1% hydrocortisone cream with moisturiser should be considered.
Danish: I henhold til retningslinjer for klinisk praksis kan profylaktisk anvendelse af orale tetracykliner (6-8 uger) og topikal applikation af fugtighedsbevarende 1% hydrocortisoncreme overvejes.
English: All of these pathways involve the biodegradation of the antibody to smaller molecules, i.e. small peptides or amino acids.
Danish: Alle disse veje omfatter biologisk nedbrydning af antistoffet til mindre molekyler, dvs. små peptider eller aminosyrer.
English: Do not drive or use any tools or machines if you experience treatment-related symptoms that affect your ability to concentrate and react.
Danish: Du må ikke føre motorkøretøj eller bruge maskiner, hvis du oplever behandlingsrelaterede symptomer, som påvirker din koncentrations- og reaktionsevne.
English: OTHER Store in a refrigerator.
Danish: Opbevares i køleskab.
English: Overall, measurable HACA titres were noted in 3.4% of the patients studied, with incidences ranging from 0% to 9.6% in the target indication studies.
Danish: Generelt blev der set målbare HACA-titrer hos 3,4% af de undersøgte patienter med incidenser i intervallet fra 0% til 9,6% i studiergene med målindikationer.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Intravenøs anvendelse.
English: KRAS mutational status was available for 2072 patients.
Danish: KRAS-mutationsstatus var tilgængelig for 2.072 patienter.
English: Talk to your doctor before using Erbitux, if any of the following information is not clear.
Danish: Kontakt lægen, før du bruger Erbitux, hvis nogle af følgende informationer ikke er klare.
English: Your doctor will discuss appropriate measures with you.
Danish: Din læge vil tale med dig om passende foranstaltninger.
English: It further induces the internalisation of EGFR, which can lead to downregulation of EGFR.
Danish: Det forårsager yderligere optagelse af EGFR i cellerne, hvilket kan medføre ned-regulering af EGFR.
English: In these patients cetuximab should be administered only after a careful assessment of benefit/risk, including alternative treatments, and only under close supervision of well trained personnel with resuscitation equipment ready.
Danish: Cetuximab bør kun administreres til disse patienter efter nøje vurdering af benefit/risk-forholdet, inklusive alternative behandlinger, og kun under nøje overvågning fra veluddannet personale, der står klar med genoplivningsudstyr.
English: Stevens-Johnson syndrome/toxic epidermal necrolysis.
Danish: Stevens-Johnsons syndrom/toksisk epidermal nekrolyse.
English: Diarrhoea; nausea; vomiting.
Danish: Diaré; kvalme; opkastning.
English: If an infusion-related reaction develops later during the infusion or at a subsequent infusion further management will depend on its severity:
Danish: Hvis en infusionsrelateret reaktion udvikles senere under infusionen eller ved en efterfølgende infusion, vil den videre håndtering være afhængig af reaktionens sværhedsgrad:
English: • drying out which may be due to diarrhoea or reduced fluid intake
Danish: • udtørring, som kan skyldes diaré eller formindsket væskeoptagelse
English: The majority of patients included had an ECOG performance status of ≤ 1.
Danish: Størstedelen af de inkluderede patienter havde en ECOGperformancestatus på ≤ 1.
English: There is no relevant use of Erbitux in children and adolescents.
Danish: Der er ingen relevante indikationer for brug af Erbitux til børn og unge.
English: A careful benefit/risk assessment should be undertaken including consideration whether the patient may have preformed IgE antibodies before a subsequent infusion is given.
Danish: Der skal foretages en omhyggelig vurdering af benefit/risk-forholdet, inklusive overvejelse om patienten muligvis allerede har dannet IgE-antistoffer, inden en efterfølgende infusion gives.
English: They usually disappear over time after the end of Erbitux therapy.
Danish: De forsvinder som regel med tiden efter afsluttet Erbitux-behandling.
English: Cases of interstitial lung disease (ILD), including fatal cases, have been reported, with the majority of patients from the Japanese population.
Danish: Der er rapporteret om tilfælde af interstitiel lungesygdom (interstitial lung disease, ILD), herunder dødelige tilfælde, hvor størstedelen af patienterne er fra den japanske population.
English: Do not breast-feed your baby during the period over which you are being treated with Erbitux and for two months after the last dose.
Danish: Du må ikke amme dit barn i den periode, hvor du bliver behandlet med Erbitux og to måneder efter sidste dosis.