FrancophonIA/ELRC3.0 huggingface dataset:
English: In adults, the most common side effects with PegIntron (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 PegIntron (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 PegIntron is linked to side effects such as depression, patients must be closely monitored during treatment.
Danish: Da PegIntron sættes i forbindelse med bivirkninger som depression, skal patienterne overvåges nøje under behandlingen.
English: PegIntron is also linked to weight loss and reduced growth in children and adolescents.
Danish: PegIntron sættes ligeledes i forbindelse med vægttab og nedsat vækst hos børn og unge.
English: The CHMP decided that PegIntron's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved PegIntron er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for PegIntron.
English: For more information about treatment with PegIntron, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med PegIntron, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Other information about PegIntron:
Danish: Andre oplysninger om PegIntron
English: Treatment with PegIntron should be started and supervised by a doctor who has experience in the management of patients with hepatitis C. PegIntron is given once a week as an injection under the skin.
Danish: Behandlingen med PegIntron bør indledes og overvåges af en læge med erfaring i behandling af patienter med hepatitis C. PegIntron gives en gang om ugen som indsprøjtning under huden.
English: In adults (aged 18 years and older), PegIntron can be used in patients who have not been treated before or whose previous treatment failed.
Danish: Hos voksne (fra 18. år) kan PegIntron anvendes til ikke tidligere behandlede patienter eller hvor en tidligere behandling har slået fejl.
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 kombinationsbehandling sammen med ribavirin 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: The combination of PegIntron 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 PegIntron 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: What is the risk associated with PegIntron?
Danish: Hvilken risiko er der forbundet med PegIntron?
English: PegIntron must not be used in people who are hypersensitive (allergic) to any interferon or any of the other ingredients.
Danish: PegIntron må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for nogen interferoner eller andre af indholdsstofferne.
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 PegIntron 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 PegIntron og ribavirin.
English: Triple therapy led to an increase of about 30% in the number of previously untreated early responders who were cured.
Danish: Den tredobbelte behandling resulterede i en stigning på cirka 30 % i antallet af tidligere ubehandlede patienter, der reagerede hurtigt på behandlingen og blev helbredt.
English: PegIntron 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: PegIntron må ikke anvendes hos patienter med en alvorlig sygdomstilstand, alvorlige leverproblemer, ukontrollerede skjoldbruskkirtelsygdomme, epilepsi eller andre problemer med centralnervesystemet.
English: The interferon alfa-2b in PegIntron 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 PegIntron 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: The combination of PegIntron with ribavirin was effective in patients with cirrhosis and in patients infected with HIV.
Danish: Kombinationen af PegIntron og ribavirin var effektiv hos patienter med cirrose og hos hiv-smittede patienter.
English: Why has PegIntron been approved?
Danish: Hvorfor blev PegIntron godkendt?
English: In other adults with hepatitis C virus in their blood, including patients also infected with human immunodeficiency virus (HIV), PegIntron 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 PegIntron enten sammen med ribavirin (dobbeltbehandling) eller alene, hvis patienterne ikke må få ribavirin.
English: PegIntron 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: PegIntron 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: For the full list of all side effects reported with PegIntron, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved PegIntron fremgår af indlægssedlen.
English: PegIntron, 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: PegIntron 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: PegIntron is a medicine that contains the active substance peginterferon alfa-2b.
Danish: PegIntron er et lægemiddel, der indeholder det aktive stof peginterferon alfa-2b.
English: In adults, PegIntron was more effective than interferon alfa-2b in patients who had not been treated before, with around a quarter of the patients responding to PegIntron alone and around a half responding to the combination of PegIntron and ribavirin.
Danish: Hos voksne var PegIntron mere effektivt end interferon alfa-2b til ikke tidligere behandlede patienter, idet ca. en fjerdedel af patienterne responderede på PegIntron alene, og ca. halvdelen responderede på kombinationen af PegIntron og ribavirin.
English: The active substance in PegIntron, peginterferon alfa-2b, belongs to the group ‘interferons'.
Danish: Det aktive stof i PegIntron, peginterferon alfa-2b, tilhører gruppen af "interferoner".
English: What is PegIntron?
Danish: Hvad er PegIntron?
English: In PegIntron, the interferon alfa-2b has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Danish: I PegIntron er interferon alfa-2b blevet "pegyleret" (dvs. bundet til det kemiske stof polyethylenglycol).
English: There is also a marked increase in cure rates in patients with long-term type 1 hepatitis C when given the triple therapy of PegIntron in combination with ribavirin and boceprevir.
Danish: Der var desuden en markant stigning i helbredelsesprocenten hos patienter med kronisk hepatitis C type 1, når de fik den tredobbelte behandling bestående af PegIntron i kombination med ribavirin og boceprevir.
English: In the studies on triple therapy in patients with type 1 hepatitis C and compensated liver disease, PegIntron in combination with ribavirin and boceprevir was shown to be more effective than the dual combination of PegIntron with ribavirin alone.
Danish: I undersøgelserne med tredobbelt kombinationsbehandling ved hepatitis C type 1 og kompenseret leversygdom var PegIntron i kombination med ribavirin og boceprevir mere effektivt end den dobbelte kombination af PegIntron og ribavirin alene.
English: Depending on the severity of the side effects treatment may have to be stopped altogether (including boceprevir).Patients can inject themselves once they have been trained appropriately.
Danish: Afhængigt af graden af bivirkningerne kan det være nødvendigt helt at standse behandlingen (herunder boceprevir).
English: What is PegIntron used for?
Danish: Hvad anvendes PegIntron til?
English: PegIntron is used to treat long-term hepatitis C (a disease of the liver due to infection with the hepatitis C virus) in patients aged three years and older.
Danish: PegIntron anvendes til behandling af patienter i alderen 3 år og opad med langvarig hepatitis C (leverbetændelse forårsaget af hepatitis C-virus).
English: How has PegIntron been studied?
Danish: Hvordan blev PegIntron undersøgt?
English: In children and adolescents receiving PegIntron in combination with ribavirin, side effects were similar to adults, although reduced growth was also seen in more than 1 patient in 10.
Danish: Hos børn og unge, der fik PegIntron i kombination med ribavirin, var bivirkningerne de samme som hos voksne.
English: What benefit has PegIntron shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved PegIntron?
English: The doses of ribavirin and PegIntron may need to be adjusted for patients who experience side effects.
Danish: I tilfælde af bivirkninger kan det være nødvendigt at justere dosis af ribavirin og PegIntron.
English: How is PegIntron used?
Danish: Hvordan anvendes PegIntron?
English: How does PegIntron work?
Danish: Hvordan virker PegIntron?
English: Two main studies involving 1,503 adult patients with type 1 hepatitis C and compensated liver disease investigated the effect of PegIntron in a triple therapy combination with ribavirin and boceprevir compared with PegIntron and ribavirin alone.
Danish: Undersøgelserne vedrørte virkningen af PegIntron i en tredobbelt kombinationsbehandling med ribavirin og boceprevir, som blev sammenlignet med PegIntron og ribavirin alene.
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented.
Danish: Medlemsstaterne skal sikre, at alle betingelserne eller begrænsingerne vedrørende sikker og effektiv anvendelse af lægemidlet, som beskrives nedenfor, implementeres.
English: The Member States shall ensure that the MAH provides all physicians who are expected to prescribe or use Tamiflu a Direct Healthcare Professional Communication (DHPC) letter, the text of which is appended to the CHMP assessment report.
Danish: Medlemsstaterne skal sikre at indehaveren af markedsføringstilladelsen leverer et Direct Healthcare Professional Communication (DHPC)-brev til alle læger, som forventes at ordinere eller anvende Tamiflu.
English: The Member States shall agree with the MAH the communication plan for the DHPC letter.
Danish: Medlemsstaterne skal aftale en kommunikationsplan for DHPC-brevet med indehaveren af markedsføringstilladelsen.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET, SOM SKAL IMPLEMENTERES I MEDLEMSSTATERNE
English: ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BILAG BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET, SOM SKAL IMPLEMENTERES I MEDLEMSSTATERNE
English: Overall, the safety profile was considered acceptable.
Danish: Sikkerhedsprofilen vurderes overordnet set til at være acceptabel.
English: The doctor may decide that patients or their caregivers can inject the medicine themselves after they have been properly trained.
Danish: Lægen kan træffe beslutning om, at patienter eller deres plejere selv må indsprøjte lægemidlet efter at have fået tilstrækkelig oplæring.
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3151551
Danish: Yderligere information om lægemidler til sjældne sygdomme kan findes her: ema.europa.eu/medicines/human/orphan-designations/eu3151551
English: As for all medicines, data on the use of Takhzyro are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Takhzyro løbende overvåget.
English: Other information about Takhzyro
Danish: Andre oplysninger om Takhzyro
English: Further information on Takhzyro can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Takhzyro.
Danish: Yderligere information om Takhzyro findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Takhzyro.
English: The recommended starting dose of Takhzyro is 300 mg every 2 weeks.
Danish: Den anbefalede startdosis er 300 mg hver 2. uge.
English: If the patient remains free of attacks with the two-weekly dose, the doctor can reduce the frequency to once every 4 weeks.
Danish: Hvis patienten forbliver anfaldsfri under behandlingen med dosis hver 2. uge, kan lægen ændre hyppigheden til en gang hver 4. uge.
English: For more information about using Takhzyro, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Takhzyro, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: The European Medicines Agency therefore decided that Takhzyro's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Takhzyro opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Side effects reported with Takhzyro are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Takhzyro vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Hereditary angioedema is rare, and Takhzyro was designated an ‘orphan medicine' (a medicine used in rare diseases) on 9 October 2015.
Danish: Hereditært angioødem er sjældent, og Takhzyro blev udpeget som "lægemiddel til sjældne sygdomme" den 9. oktober 2015.
English: Takhzyro contains the active substance lanadelumab.
Danish: Takhzyro indeholder det aktive stof lanadelumab.
English: Patients experienced on average 0.3 attacks per month when given Takhzyro injections every 2 weeks and 0.5 attacks when given injections every 4 weeks.
Danish: Patienterne oplevede i gennemsnit 0,3 anfald i måneden ved indsprøjtninger med Takhzyro hver 2. uge og 0,5 anfald ved indsprøjtninger hver 4. uge.
English: What measures are being taken to ensure the safe and effective use of Takhzyro?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Takhzyro?
English: Attacks of hereditary angioedema can be life threatening when the swelling around the throat presses against the airway.
Danish: Anfald af hereditært angioødem kan være livstruende, når hævelsen omkring halsen trykker imod luftvejen.
English: An overview of Takhzyro and why it is authorised in the EU
Danish: En oversigt over Takhzyro, og hvorfor det er godkendt i EU
English: Takhzyro was found to be effective in reducing the number of angioedema attacks in a main study in 126 adults and children above 12 years of age with hereditary angioedema.
Danish: Takhzyro var effektivt til at reducere antallet af angioødemanfald i et hovedstudie, der omfattede 126 voksne og børn på over 12 år med hereditært angioødem.
English: Takhzyro can only be obtained with a prescription and should be started under supervision of a doctor experienced in managing hereditary angioedema.
Danish: Takhzyro udleveres kun efter recept og bør iværksættes under opsyn af en læge med erfaring i håndtering af hereditært angioødem.
English: Patients with angioedema have rapid swelling under the skin in areas such as the face, throat, arms and legs.
Danish: Patienter med angioødem får hurtig hævelse under huden i bl.a. ansigtet, halsen, armene og benene.
English: Why is Takhzyro authorised in the EU?
Danish: Hvorfor blev Takhzyro godkendt i EU?
English: Takhzyro is effective in preventing angioedema attacks and the fact that it only needs to be given every 2 or 4 weeks was considered an advantage over existing treatments.
Danish: Takhzyro er effektivt til at forebygge angioødemanfald, og det blev betragtet som en fordel i forhold til eksisterende behandlinger, at det kun skal gives hver 2. eller hver 4. uge.
English: The active substance in Takhzyro, lanadelumab, works by attaching to and blocking an enzyme in the blood called 'kallikrein', which has several functions, including increasing levels of bradykinin.
Danish: Det aktive stof i Takhzyro, lanadelumab, virker ved at binde sig til og blokere et enzym i blodet kaldet "kallikrein", som har flere funktioner og bl.a. øger niveauet af bradykinin.
English: Patients with hereditary angioedema have high levels of a substance called ‘bradykinin', which causes blood vessels to widen and leak fluid into the surrounding tissue leading to the swelling attacks seen in angioedema.
Danish: Patienter med hereditært angioødem har høje niveauer af et stof kaldet "bradykinin", som får blodkarrene til at udvide sig og afgive væske i det omkringliggende væv, hvilket medfører de anfald af hævelse, der ses ved angioødem.
English: What is Takhzyro and what is it used for?
Danish: Hvad er Takhzyro, og hvad anvendes det til?
English: Takhzyro is a medicine used to prevent attacks of hereditary angioedema in patients aged 12 years and over.
Danish: Takhzyro er et lægemiddel, der anvendes til at forebygge anfald af hereditært (arveligt) angioødem hos patienter på 12 år og derover.
English: By blocking the actions of kallikrein, lanadelumab helps to prevent the swelling and related symptoms of angioedema.
Danish: Ved at blokere for kallikreinaktiviteten hjælper lanadelumab med at forebygge hævelsen og relaterede symptomer i forbindelse med angioødem.
English: For the full list of side effects and restrictions with Takhzyro, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Takhzyro fremgår af indlægssedlen.
English: The most common side effects with Takhzyro (which may affect more than 1 patient in 10) are reactions at the site of injection including erythema (redness), bruising and pain.
Danish: De hyppigste bivirkninger ved Takhzyro (som optræder hos mere end 1 ud af 10 patienter) er reaktioner på injektionsstedet, herunder rødmen, blå mærker og smerter.
English: What are the risks associated with Takhzyro?
Danish: Hvilke risici er der forbundet med Takhzyro?
English: Takhzyro is given as an injection under the skin, preferably in the abdomen (belly), thighs or upper arms.
Danish: Takhzyro gives som en injektion under huden, fortrinsvis i maven, lårene eller overarmene.
English: This compared with 2 attacks per month for patients on placebo (a dummy treatment).
Danish: Til sammenligning oplevede de patienter, der fik placebo (en uvirksom behandling), to anfald i måneden.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Takhzyro 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 Takhzyro.
English: EMA/734573/2018
Danish: Takhzyro (lanadelumab) EMA/734573/2018
English: How is Takhzyro used?
Danish: Hvordan anvendes Takhzyro?
English: What benefits of Takhzyro have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Takhzyro?
English: How does Takhzyro work?
Danish: Hvordan virker Takhzyro?
English: Date of first authorisation: 13 July 2017
Danish: Dato for første markedsføringstilladelse: 13. juli, 2017
English: • if you think you may need any vaccinations in the near future, including vaccinations for travel to other countries.
Danish: • hvis du tror, du måske har brug for at blive vaccineret i nær fremtid, inklusive vaccinationer for at rejse til andre lande.
English: Key results from all four studies are summarised in table 4.
Danish: Nøgleresultater fra alle fire studier er opsummeret i tabel 4.
English: Of 356 patients evaluated for HACA, 1.1 % (4 patients) were positive.
Danish: Af 356 patienter, der blev vurderet for HACA, var 1,1 % (4 patienter) positive.
English: p-value (Wald test, not
Danish: p-værdi (Wald test, ikke justeret)
English: OS rates - survival rates at the time of the analyses
Danish: OS rates - Overlevelsesrater ved analysetiden
English: Your doctor will decide if you should receive other treatment at the same time.
Danish: Din læge vil tage stilling til, om du bør få anden medicin samtidigt.
English: Rituzena will be given to you once a week for 4 weeks.
Danish: Rituzena gives en gang ugentligt i 4 uger.
English: Read this leaflet carefully before you start taking this medicine because it contains important
Danish: Læs denne indlægsseddel grundigt, inden du begynder at få dette lægemiddel, da den indeholder
English: The two treatment groups were well balanced in baseline disease characteristics and disease status.
Danish: De to behandlingsgrupper var godt afbalanceret i forhold til baseline karakteristik og sygdomsstatus.
English: Do not have Rituzena if you have an active infection or a serious problem with your
Danish: Du må ikke få Rituzena, hvis du har en aktiv infektion eller alvorlige problemer med dit
English: • recurrence of a previous Hepatitis B infection
Danish: • genopblussen af tidligere hepatitis B-infektion
English: Stamullen, Co. Meath K32 YD60, Ireland
Danish: Stamullen, Co. Meath K32 YD60, Irland