FrancophonIA/ELRC3.0 huggingface dataset:
English: <{Invented name} has <no or negligible influence> <minor influence> <moderate influence> <major influence> on the ability to drive and use machines.>
Danish: <{X} påvirker <ikke eller kun i ubetydelig grad> <i mindre grad> <i moderat grad> <i væsentlig grad> evnen til at føre motorkøretøj <og> <eller> betjene maskiner.>
English: <The European Medicines Agency has deferred the obligation to submit the results of studies with <{(Invented) Name}> [or for generics: <the reference medicinal product containing {name of the active substance(s)}>] in one or more subsets of the paediatric population in {condition, as per Paediatric Investigation Plan (PIP) decision, for the granted indication} (see section 4.2 for information on paediatric use).>
Danish: <Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med <{X}> [for generiske lægemidler: <referencelægemidlet, som indeholder {navn på de(t) aktive stof(fer)}>] i en eller flere undergrupper af den pædiatriske population <ved> <med> {tilstand i den godkendte indikation i henhold til afgørelsen i det Pædiatriske Forsknings- og Udviklingsprogram (PIP)} (se pkt.
English: See section 4.>
Danish: Se <afsnit> <punkt> 4.>
English: <Pregnancy>
Danish: <Graviditet>
English: <The European Medicines Agency has waived the obligation to submit the results of studies with <{(Invented) Name}> [or for generics: <the reference medicinal product containing {name of the active substance(s)}>] in all subsets of the paediatric population in {condition as per Paediatric Investigation Plan (PIP) decision, for the granted indication} (see section 4.2 for information on paediatric use).>
Danish: <Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med <{X}> [for generiske lægemidler: <referencelægemidlet, som indeholder {navn på de(t) aktive stof(fer)}>] i alle undergrupper af den pædiatriske population <ved> <med> {tilstand i den godkendte indikation i henhold til afgørelsen i det Pædiatriske Forsknings- og Udviklingsprogram (PIP)} (se pkt.
English: <For storage conditions after <reconstitution> <dilution> <first opening> of the medicinal product, see section 6.3>
Danish: <Opbevaringsforhold efter <rekonstitution> <fortynding> <anbrud> af lægemidlet, se pkt.
English: <Distribution>
Danish: <Fordeling>
English: EQ PAGE 1
Danish: PAGE 1
English: Talk to your doctor <or> <,> <pharmacist> <or nurse> before <taking> <using> X
Danish: Kontakt lægen<,> <eller> <apotekspersonalet> <eller sundhedspersonalet>, før <De> <du> <tager> <bruger> {X}.
English: <This medicinal product must not be mixed with other medicinal products except those mentioned in section <6.6> <and> <12>.>
Danish: <<{X}> <Dette lægemiddel> må ikke blandes med andre lægemidler end dem, der er anført under pkt.
English: <If you forget to <take> <use> X>
Danish: <Hvis <De> <du> har glemt at <tage> <bruge> {X}>
English: <Justification for not including Braille accepted.>
Danish: <Fritaget fra krav om brailleskrift.>
English: Do not use this medicine after the expiry date which is stated on the <label> <carton> <bottle> <...> <after {abbreviation used for expiry date}.> <The expiry date refers to the last day of that month.>
Danish: <Tag> <Brug> ikke <{X}> <lægemidlet> efter den udløbsdato, der står på pakningen <efter Exp>.
English: You must talk to a doctor if you do not feel better or if you feel worse <after {number of} days.>>
Danish: Kontakt lægen, hvis <De> <du> får det værre, eller hvis <De> <du> ikke får det bedre <i løbet af {antal} dage>.>
English: <You must talk to a doctor if you do not feel better or if you feel worse <after {number of} days>.>
Danish: <Kontakt lægen, hvis <De> <du> får det værre, eller hvis <De> <du> ikke får det bedre <i løbet af {antal} dage>.>
English: <If you stop <taking> <using> X>
Danish: <Hvis <De> <du> holder op med at <tage> <bruge> {X}>
English: <The <safety> <and> <efficacy> of {X} in children aged {x to y} <months> <years> [or any other relevant subsets, e.g. weight, pubertal age, gender] <has> <have> not <yet> been established.>
Danish: <{Xs} <sikkerhed> <og> <virkning> hos børn i alderen {x-y} <måneder> <år> {eller andre relevante undergrupper som f.eks. vægt, pubertetsalder, køn} er <endnu> ikke klarlagt.>
English: <The score line is only there to help you break the tablet if you have difficulty swallowing it whole.>
Danish: <Delekærven er kun beregnet til, at <De> <du> kan dele tabletten, hvis <De> <du> har svært ved at sluge den hel.>
English: Do not <take> <use> X<:>
Danish: <Tag> <Brug> ikke {X}<:>
English: <{X} should not be used in children aged {x to y} <years> <months> [or any other relevant subsets, e.g. weight, pubertal age, gender] because of <safety> <efficacy> concern(s).>
Danish: <{X} bør ikke anvendes til børn i alderen {x-y} <år> <måneder> {eller andre relevante undergrupper som f.eks. vægt, pubertetsalder, køn} på grund af problemstillinger vedrørende <sikkerhed> <og> <virkning>.>
English: <There is no relevant use of {X} <in the paediatric population> <in children aged {x to y} <years>, <months> [or any other relevant subsets, e.g. weight, pubertal age, gender] <for the indication of...>.>
Danish: <Det er ikke relevant at anvende {X} <hos den pædiatriske population> <til børn i alderen {x-y} <år> <måneder> {eller andre relevante undergrupper som f.eks. vægt, pubertetsalder, køn}> <til <indikationen> {*}>.>
English: <Tell your <doctor> <or> <pharmacist> if you are <taking> <using>, have recently <taken> <used> or might <take> <use> any other medicines.>
Danish: <Fortæl <altid> <det altid til> <lægen> <eller> <apotekspersonalet>, hvis <De> <du> <tager> <bruger> anden medicin eller har gjort det for nylig.>
English: You can also report side effects directly via the national reporting system listed in HYPERLINK "http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc"Appendix V.* By reporting side effects you can help provide more information on the safety of this medicine.
Danish: <De> <Du> eller <Deres> <dine> pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i HYPERLINK "http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc" Appendiks V*.
English: Always <take> <use> this medicine exactly as described in this leaflet or as your <doctor> <,> <or> <pharmacist> <or nurse> <has> <have> told you.
Danish: <Tag> <brug> altid <{X}> <dette lægemiddel> nøjagtigt som beskrevet i denne indlægsseddel eller efter de anvisninger, <lægen> <,> <eller> <apotekspersonalet> <eller> <sundhedspersonalet>, har givet <Dem> <dig>.
English: The active substance(s) is (are)…
Danish: - Aktivt stof/aktive stoffer: {navn(e)}
English: <Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 <or {name of the residue(s)}>.>
Danish: <Overfølsomhed over for det (de) aktive stof(fer) eller over for et eller flere af hjælpestofferne anført i pkt.
English: What X contains
Danish: {X} indeholder:
English: Ask your pharmacist how to throw away medicines you no longer use.
Danish: <Spørg på apoteket, hvordan <De> <du> skal bortskaffe medicinrester.
English: <The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.>
Danish: <Tabletten har kun delekærv for at muliggøre deling af tabletten, så den er nemmere at sluge.
English: <Additional side effects in children <and adolescents>>
Danish: <Hos børn <og unge> kan endvidere ses følgende bivirkninger:>
English: If you get any side effects, talk to your <doctor> <,> <or> <pharmacist> <or nurse>.
Danish: Hvis <De> <du> oplever bivirkninger, bør <De> <du> tale med <Deres> <din> læge, sygeplejerske eller apoteket.
English: SUMMARY OF PRODUCT CHARACTERISTICS,
Danish: PRODUKTRESUME,
English: <Always <take> <use> this medicine exactly as described in this leaflet or as your <doctor> <,> <or> <pharmacist> <or nurse> <has> <have> told you.
Danish: <<Tag> <Brug> altid <{X}> <lægemidlet> nøjagtigt som beskrevet i denne indlægsseddel eller efter <lægens> <,> <eller> <apotekspersonalets> <eller sundhedspersonalets> anvisning.
English: <{X} is contraindicated in children aged {x to y} <years> <months> [or any other relevant subsets, e.g. weight, pubertal age, gender] <for the indication of...> (see section 4.3).>
Danish: <{X} er kontraindiceret til børn i alderen {x-y} <år> <måneder> {eller andre relevante undergrupper som f.eks. vægt, pubertetsalder, køn} <ved <indikationen> {*}> (se pkt.
English: <Do not throw away any medicines via wastewater <or household waste>.
Danish: Af hensyn til miljøet må <De> <du> ikke smide medicinrester i afløbet <eller> <,> toilettet <eller skraldespanden>.>
English: Ask your pharmacist if you need more information or advice.
Danish: Spørg apotekspersonalet, hvis der er mere, <De> <du> vil vide.
English: <Always <take> <use> this medicine exactly as your doctor <or pharmacist> has told you.
Danish: <<Tag> <Brug> altid <{X}> <lægemidlet> nøjagtigt efter lægens <eller apotekspersonalets> anvisning.
English: See section 4.
Danish: Se <afsnit> <punkt> 4.
English: If you have any further questions, ask your <doctor> <,> <or> <pharmacist> <or nurse>.
Danish: Er <De> <du> i tvivl, så spørg <lægen> <eller> <,> <apotekspersonalet> <eller sundhedspersonalet>.>
English: <Detailed information on this medicinal product is available on the website of {name of MS Agency (link)}>
Danish: <Yderligere oplysninger om <{X}> <dette lægemiddel> findes på Lægemiddelstyrelsens hjemmeside HYPERLINK "http://www.laegemiddelstyrelsen" www.dkma.dk.>
English: <Not relevant.>
Danish: <Der foreligger ingen data.>
English: <X contains {name the excipient(s)}>
Danish: <{X} indeholder {nævn de(t) hjælpestof(fer), hvor advarsel er påkrævet}>
English: Check with your <doctor> <or> <,> <pharmacist> <or nurse> if you are not sure.>
Danish: <Spørg <lægen> <,> <eller> <apotekspersonalet> <eller sundhedspersonalet>, hvis der er noget, <De> <du> er i tvivl om.>
English: What X looks like and contents of the pack
Danish: {Udseende og pakningsstørrelser
English: How to <take> <use> X
Danish: Sådan skal <De> <du> <tage> <bruge> {X}
English: The other <ingredient(s)> <(excipient(s))> is (are)...
Danish: - Øvrige indholdsstoffer <(hjælpestoffer)>: {navne}
English: Keep this medicine out of the sight and reach of children.
Danish: Opbevares utilgængeligt for børn.
English: The European Commission granted a marketing authorisation valid throughout the EU for ViraferonPeg on 29 May 2000.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for ViraferonPeg den 29. maj 2000.
English: They may also block the multiplication of viruses.
Danish: Desuden blokerer de muligvis formeringen af virus.
English: This document is a summary of the European Public Assessment Report (EPAR) for ViraferonPeg.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for ViraferonPeg.
English: Some studies also looked at signs of improvement of the condition of the liver.
Danish: I nogle undersøgelser undersøgte man også tegn på forbedring af leverens tilstand.
English: Depending on the severity of the side effects treatment may have to be stopped altogether (including boceprevir).
Danish: Afhængigt af bivirkningernes sværhed kan det være nødvendigt helt at standse behandlingen (herunder boceprevir).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for ViraferonPeg.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for ViraferonPeg.
English: The duration of treatment depends on the patient's condition and response to treatment, and ranges from six months to a year.
Danish: Behandlingens varighed afhænger af patientens tilstand og reaktion på behandlingen og er på mellem 6 måneder og ét år.
English: In adults, the most common side effects with ViraferonPeg (seen in more than 1 patient in 10) are viral infection, pharyngitis (sore throat), anaemia (low red blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell), loss of appetite, depression, anxiety, emotional lability (mood swings), impaired concentration, insomnia (difficulty sleeping), headache, dizziness, dyspnoea (difficulty breathing), cough, vomiting, nausea (feeling sick), abdominal pain (stomach ache), diarrhoea, dry mouth, alopecia (hair loss), pruritus (itching), dry skin, rash, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), reactions at the site of the injection, inflammation at the site of the injection, fatigue (tiredness), asthenia (weakness), irritability, chills, pyrexia (fever), influenza (flu)-like illness and weight loss.
Danish: Hos voksne er de hyppigst forekommende bivirkninger ved ViraferonPeg (set hos flere end 1 ud af 10 patienter) virusinfektion, faryngitis (ondt i halsen), anæmi (lavt antal røde blodlegemer), neutropeni (lavt antal neutrofiler, som er en type hvide blodlegemer), appetitløshed, depression, angst, emotionel labilitet (humørsvingninger), nedsat koncentrationsevne, insomni (søvnbesvær), hovedpine, svimmelhed, dyspnø (vejrtrækningsbesvær), hoste, opkastning, kvalme, mavesmerter, diarré, mundtørhed, alopeci (hårtab), kløe, tør hud, udslæt, muskelsmerter, ledsmerter, smerter i muskler og knogler, reaktioner på injektionsstedet, betændelse på injektionsstedet, træthed, asteni (svaghed), irritabilitet, kulderystelser, pyreksi (feber), influenzalignende sygdom og vægttab.
English: Because ViraferonPeg is linked to side effects such as depression, patients must be closely monitored during treatment.
Danish: Da ViraferonPeg sættes i forbindelse med bivirkninger som depression, skal patienterne overvåges nøje under behandlingen.
English: The CHMP decided that ViraferonPeg's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved ViraferonPeg er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for ViraferonPeg.
English: This decreases the rate at which the substance is removed from the body and allows the medicine to be given less often.
Danish: Dette bevirker, at stoffet udskilles langsommere af kroppen, så lægemidlet ikke skal gives så ofte.
English: The exact way that they work in viral diseases is not fully understood, but it is thought that they act as immunomodulators (substances that modify how the immune system works).
Danish: Det vides ikke nøjagtigt, hvordan de virker ved virussygdomme, men de menes at virke immunmodulerende (dvs. de ændrer den måde, kroppens immunsystem virker på).
English: The first study involved previously untreated patients while the second study involved patients who had failed previous treatment.
Danish: Den første undersøgelse omfattede tidligere ubehandlede patienter, mens den anden undersøgelse omfattede patienter, hos hvem tidligere behandling havde slået fejl.
English: Patients can inject themselves once they have been trained appropriately.
Danish: Patienterne kan selv give indsprøjtningerne, hvis de er behørigt instrueret heri.
English: These contain 50, 80, 100, 120 or 150 micrograms of peginterferon alfa-2b in 0.5 ml.
Danish: Begge leveres med et indhold på 50, 80, 100, 120 eller 150 mikrogram peginterferon alfa-2b pr. 0,5 ml.
English: It must not be used in patients who have had severe heart disease or an auto-immune disease (a disease caused by the body's own defence system attacking normal tissue), or in children or adolescents who have had severe mental disorders, particularly severe depression, thoughts about committing suicide or suicide attempts.
Danish: Det må ikke anvendes hos patienter, som har haft en alvorlig hjertesygdom eller en autoimmun sygdom (en sygdom, hvor kroppens eget immunforsvar angriber normalt væv), eller hos børn eller unge, som har haft alvorlige psykiske sygdomme, navnlig svær depression, selvmordstanker eller selvmordsforsøg.
English: In adults, it is used in combination treatments at a dose of 1.5 micrograms per kilogram body weight, or on its own at 0.5 or 1.0 micrograms/kg.
Danish: Hos voksne gives det i kombinationsbehandlinger i en dosis på 1,5 mikrogram pr. kg legemsvægt, eller det anvendes alene i en dosis på 0,5 eller 1,0 mikrogram/kg legemsvægt.
English: In children and adolescents, the dose is 60 micrograms per square metre body surface area (calculated using the patient's height and weight).
Danish: Hos børn og unge er dosis 60 mikrogram pr. m2 legemsoverfladeareal (beregnet ud fra patientens højde og vægt).
English: ViraferonPeg is also linked to weight loss and reduced growth in children and adolescents.
Danish: ViraferonPeg sættes ligeledes i forbindelse med vægttab og nedsat vækst hos børn og unge.
English: Treatment with ViraferonPeg should be started and supervised by a doctor who has experience in the management of patients with hepatitis C. ViraferonPeg is given once a week as an injection under the skin.
Danish: Behandlingen med ViraferonPeg bør indledes og overvåges af en læge med erfaring i behandling af patienter med hepatitis C. ViraferonPeg gives en gang om ugen som indsprøjtning under huden.
English: In adults (aged 18 years and older), ViraferonPeg can be used in patients who have not been treated before or whose previous treatment failed.
Danish: Hos voksne (fra 18 år) kan ViraferonPeg anvendes til ikke tidligere behandlede patienter eller hvor en tidligere behandling har slået fejl.
English: The main measure of effectiveness was the level of hepatitis C virus circulating in the blood before and after six months or a year of treatment, and at ‘follow-up', six months later.
Danish: Det primære mål for virkningen var indholdet af hepatitis Cvirus i blodet før og efter seks måneders eller et års behandling og ved opfølgningen seks måneder senere.
English: Dual therapy with ribavirin is also used in previously untreated children and adolescents (aged between three and 17 years) as long as their liver is still working normally.
Danish: Dobbeltbehandling med ribavirin anvendes desuden hos tidligere ubehandlede børn og unge (fra 3 til 17 år), så længe deres lever stadig fungerer normalt.
English: The combination of ViraferonPeg and ribavirin has also been studied in one study involving 1,354 adults whose previous treatment had failed and in one study involving 107 children and adolescents aged between three and 17 years who had not been treated before.
Danish: Kombinationen af ViraferonPeg og ribavirin blev også undersøgt i en undersøgelse, der omfattede 1 354 voksne, hvis tidligere behandling var slået fejl, og i en undersøgelse, der omfattede 107 børn og unge mellem tre og 17 år, som ikke var blevet behandlet før.
English: Around a quarter of the adults whose previous treatment had failed and around two-thirds of the children and adolescents responded to treatment with ViraferonPeg and ribavirin.
Danish: Omkring en fjerdedel af de voksne, hvis tidligere behandling var slået fejl, og omkring to tredjedele af børnene og de unge responderede på behandling med ViraferonPeg og ribavirin.
English: The Committee noted that the dual combination with ribavirin was shown to be effective against longterm hepatitis C virus infection in adults and children.
Danish: Udvalget konstaterede, at den dobbelte kombination med ribavirin var effektiv mod kronisk infektion med hepatitis C-virus hos voksne og børn.
English: The interferon alfa-2b in ViraferonPeg is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce interferon alfa-2b.
Danish: Interferon alfa-2b i ViraferonPeg fremstilles ved hjælp af en metode, der kaldes "rekombinant DNA-teknologi": Det fremstilles af en bakterie, der har fået indsat et gen (DNA), som sætter den i stand til at producere interferon alfa-2b.
English: ViraferonPeg must not be used in people who are hypersensitive (allergic) to any interferon or any of the other ingredients.
Danish: ViraferonPeg må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for nogen interferoner eller andre af indholdsstofferne.
English: ViraferonPeg must not be used in patients with a severe medical condition, severe liver problems, thyroid disease that is not controlled, epilepsy or other central nervous system problems.
Danish: ViraferonPeg må ikke anvendes hos patienter med en alvorlig sygdomstilstand, alvorlige leverproblemer, ukontrollerede skjoldbruskkirtelsygdomme, epilepsi eller andre problemer med centralnervesystemet.
English: Peginterferon alfa-2b is similar to interferon alfa-2b, which has been available in the European Union (EU) for a number of years.
Danish: Peginterferon alfa-2b ligner interferon alfa-2b, der allerede har været markedsført i Den Europæiske Union (EU) i en årrække.
English: The combination of ViraferonPeg with ribavirin was effective in patients with cirrhosis and in patients infected with HIV.
Danish: Kombinationen af ViraferonPeg og ribavirin var effektiv hos patienter med cirrose og hos hiv-smittede patienter.
English: Triple therapy led to an increase of about 30% in the number of previously early responders who were cured after six months.
Danish: Den tredobbelte behandling resulterede i en stigning på cirka 30 % i antallet af tidligere ubehandlede patienter, der reagerede hurtigt på behandlingen og var helbredt efter seks måneder.
English: The main measure of effectiveness in these studies was the number of patients who had no detectable hepatitis C virus in their blood 24 weeks after the end of the treatment and could therefore be considered to be cured.
Danish: I disse undersøgelser blev effektiviteten hovedsagelig målt på det antal patienter, der ikke havde påviselige hepatitis C-virus i blodet 24 uger efter behandlingens afslutning.
English: For the full list of all side effects reported with ViraferonPeg, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved ViraferonPeg fremgår af indlægssedlen.
English: ViraferonPeg can be given in a triple therapy combination with ribavirin and boceprevir to adults with type 1 hepatitis C whose liver is damaged but still able to work normally (compensated liver disease).
Danish: ViraferonPeg kan gives i en tredobbelt kombinationsbehandling sammen med ribavirin og boceprevir til voksne med hepatitis C type 1, hvis lever er beskadiget, men stadig virker normalt (kompenseret leversygdom).
English: In other adults with hepatitis C virus in their blood, including patients also infected with human immunodeficiency virus (HIV), ViraferonPeg is given either with ribavirin (dual therapy) or on its own if they cannot take ribavirin.
Danish: Hos andre voksne med hepatitis C-virus i blodet, herunder patienter, der desuden er smittet med humant immundefektvirus (hiv), gives ViraferonPeg enten sammen med ribavirin (dobbeltbehandling) eller alene, hvis patienterne ikke må få ribavirin.
English: ViraferonPeg, with or without ribavirin, has been compared with interferon alfa-2b in five main studies involving a total of over 6,000 adults with hepatitis C who had not been treated before, including 328 patients with cirrhosis and 507 patients also infected with HIV.
Danish: ViraferonPeg blev - henholdsvis med og uden ribavirin - sammenlignet med interferon alfa-2b i fem hovedundersøgelser, der i alt omfattede over 6 000 ikke tidligere behandlede voksne med hepatitis C, herunder 328 patienter med cirrose og 507 patienter, der også var smittet med hiv.
English: For a full list of restrictions, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger fremgår af indlægssedlen.