FrancophonIA/ELRC3.0 huggingface dataset:
English: COPD is a long-term disease and you should use Onbrez Breezhaler every day and not only when you have breathing problems or other symptoms of COPD.
Danish: Så længe skal du fortsætte med Onbrez Breezhaler-behandling Fortsæt med Onbrez Breezhaler-behandlingen, så længe din læge siger, at du skal gøre det. KOL er en langtidssygdom, og du skal bruge Onbrez Breezhaler hver dag og ikke blot, når du har åndedrætsbesvær eller andre symptomer på KOL.
English: Onbrez Breezhaler is a long-acting beta2-adrenergic agonist, which is only indicated for COPD and should not be used in asthma due to the absence of long-term outcome data in asthma.
Danish: Onbrez Breezhaler er en langtidsvirkende beta2-adrenerg agonist, som kun er beregnet til KOL.
English: Onbrez Breezhaler 300 microgram inhalation powder, hard capsules
Danish: Onbrez Breezhaler 300 mikrogram inhalationspulver i kapsler
English: Onbrez Breezhaler 300 microgram inhalation powder, hard capsules indacaterol
Danish: Onbrez Breezhaler 300 mikrog inhalationspulver i kapsler indacaterol
English: Onbrez Breezhaler 150 microgram inhalation powder, hard capsules
Danish: Onbrez Breezhaler 150 mikrogram inhalationspulver i kapsler
English: Onbrez Breezhaler 150 microgram inhalation powder, hard capsules indacaterol
Danish: Onbrez Breezhaler 150 mikrog inhalationspulver i kapsler indacaterol
English: How to use Onbrez Breezhaler
Danish: Sådan skal du tage Onbrez Breezhaler
English: The full EPAR for Ontruzant can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Ontruzant findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Why is Ontruzant approved?
Danish: Hvorfor blev Ontruzant godkendt?
English: What is Ontruzant and what is it used for?
Danish: Hvad er Ontruzant, og hvad anvendes det til?
English: This is a summary of the European public assessment report (EPAR) for Ontruzant.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ontruzant.
English: This means that Ontruzant is similar to another biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU).
Danish: Det betyder, at Ontruzant svarer til et biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i Den Europæiske Union (EU).
English: The study showed that 94% of women given Ontruzant and 93% of those given Herceptin survived without return or worsening of their disease when followed up for around 14 months.
Danish: Undersøgelsen viste, at 94 % af de Ontruzant-behandlede kvinder og 93 % af de Herceptin-behandlede kvinder stadig var i live uden tilbagevenden eller forværring af deres sygdom efter ca. 14 opfølgningsmåneder.
English: Ontruzant is a cancer medicine used to treat the following conditions:
Danish: Ontruzant er et lægemiddel mod kræft, der anvendes til behandling af følgende tilstande:
English: Other information about Ontruzant
Danish: Andre oplysninger om Ontruzant
English: It is not intended to provide practical advice on how to use Ontruzant.
Danish: Det er ikke en praktisk vejledning i, hvordan Ontruzant bør anvendes.
English: What measures are being taken to ensure the safe and effective use of Ontruzant?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ontruzant?
English: In addition, a study involving 875 patients with early or locally advanced breast cancer looked at the effectiveness of Ontruzant and Herceptin.
Danish: En undersøgelse af 875 patienter med tidlig eller lokalt fremskreden brystkræft vurderede også virkningen af Ontruzant og Herceptin.
English: Ontruzant is a ‘biosimilar medicine'.
Danish: Ontruzant er et "biosimilært" lægemiddel.
English: Ontruzant can only be obtained with a prescription and treatment should be started by a doctor who has experience in the use of cancer medicines.
Danish: Ontruzant udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i brug af kræftmedicin.
English: Ontruzant contains the active substance trastuzumab.
Danish: Ontruzant indeholder det aktive stof trastuzumab.
English: The reference medicine for Ontruzant is Herceptin.
Danish: Referencelægemidlet for Ontruzant er Herceptin.
English: What are the risks associated with Ontruzant?
Danish: Hvilke risici er der forbundet med Ontruzant?
English: Absence of invasive cancer cells was noted in the tissue removed at surgery in 52% of women given Ontruzant and 42% of those given Herceptin, but in the light of all the available information from the study this difference was not assessed to be relevant.
Danish: Fravær af invasive kræftceller blev observeret i det operativt fjernede væv hos 52 % af de Ontruzant-behandlede kvinder og hos 42 % af de Herceptin-behandlede kvinder, men man har vurderet, at denne forskel ikke har nogen relevans i lyset af de samlede undersøgelsesdata.
English: Ontruzant must not be used in people who are hypersensitive (allergic) to trastuzumab, mouse proteins or to any of the other ingredients.
Danish: Ontruzant må ikke anvendes hos personer, der er overfølsomme (allergiske) over for trastuzumab, museproteiner eller et af de øvrige indholdsstoffer.
English: Because Ontruzant is a biosimilar medicine, the studies on effectiveness and safety of trastuzumab carried out with Herceptin do not all need to be repeated for Ontruzant.
Danish: Da Ontruzant er et biosimilært lægemiddel, behøver de undersøgelser af trastuzumabs virkning og sikkerhed, der er udført for Herceptin, ikke at blive gentaget for Ontruzant.
English: The women received one or the other trastuzumab medicine before and after surgery, with other cancer medicines and radiotherapy according to standard practice.
Danish: Kvinderne fik enten den ene eller den anden type trastuzumabmedicin før og efter kirurgi sammen med andre kræftlægemidler og strålebehandling i henhold til gængs praksis.
English: The recommended dose depends on the patient's body weight and depends on the condition to be treated and whether Ontruzant is given weekly or three-weekly.
Danish: Den anbefalede Ontruzant-dosis afhænger af patientens kropsvægt, den tilstand, der skal behandles, og om lægemidlet gives hver uge eller hver tredje uge.
English: The most common or serious side effects with Ontruzant are heart problems, reactions related to the Ontruzant infusion, reduced levels of blood cells, especially white blood cells, infections and lung problems.
Danish: De hyppigste bivirkninger ved Ontruzant er hjerteproblemer, reaktioner i forbindelse med Ontruzantinfusionen, nedsat antal blodlegemer (navnlig hvide blodlegemer), infektioner og lungeproblemer.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Ontruzant has been shown to have a comparable quality, safety and effectiveness to Herceptin.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Ontruzant og Herceptins kvalitet, sikkerhed og virkning svarer til hinanden.
English: The active substance in Ontruzant, trastuzumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to the HER2 protein, which is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers.
Danish: Det aktive stof i Ontruzant, trastuzumab, er et monoklonalt antistof (en type protein), der er designet til at genkende og binde sig til HER2-proteinet, som er overudtrykt i ca. en fjerdedel af alle brystkræfttilfælde og en femtedel af alle mavekræfttilfælde.
English: For more information about treatment with Ontruzant, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ontruzant, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Ontruzant can only be used when the cancer has been shown to ‘overexpress HER2': this means that the cancer produces a protein called HER2 in large quantities on the surface of the tumour cells, which makes the tumour cells grow more quickly.
Danish: Ontruzant må kun anvendes, hvis kræften har såkaldt overudtryk af proteinet HER2, dvs. hvis der på overfladen af tumorcellerne produceres store mængder HER2, der får dem til at vokse hurtigere.
English: For tumours that are locally advanced (including those that are inflammatory) or more than 2 cm wide, Ontruzant is used before surgery in combination with chemotherapy and then again after surgery on its own;
Danish: Ved tumorer, som er lokalt fremskredne (herunder inflammatoriske tumorer), eller som er mere end 2 cm brede, anvendes Ontruzant før operation i kombination med kemoterapi og igen efter operation som enkeltstofbehandling
English: Laboratory studies comparing Ontruzant with Herceptin have shown that the active substance in Ontruzant is highly similar to that in Herceptin in terms of structure, purity and biological activity.
Danish: Laboratorieundersøgelser, der sammenligner Ontruzant med Herceptin, har vist, at det aktive stof i Ontruzant svarer til Herceptin, hvad angår struktur, renhed og biologisk aktivitet.
English: How is Ontruzant used?
Danish: Hvordan anvendes Ontruzant?
English: • metastatic gastric (stomach) cancer, in combination with cisplatin and either capecitabine or 5‑fluorouracil (other cancer medicines).
Danish: • metastatisk mavekræft, hvor det anvendes i kombination med cisplatin og enten capecitabin eller 5-fluorouracil (andre kræftlægemidler).
English: Ontruzant can cause cardiotoxicity (harm to the heart), including heart failure (when the heart does not work as well as it should).
Danish: Ontruzant kan forårsage hjerteskade (kardiotoksicitet), herunder hjertesvigt (nedsat hjertefunktion).
English: For the full list of all side effects and restrictions with trastuzumab, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Ontruzant fremgår af indlægssedlen.
English: On the basis of all the data provided it was concluded that Ontruzant would behave in the same way as Herceptin in its approved indications.
Danish: Ud fra de samlede data har man konkluderet, at Ontruzant har samme virkning som Herceptin i de godkendte indikationer.
English: Studies have also shown that giving Ontruzant produces similar levels of the active substance in the body to giving Herceptin.
Danish: Undersøgelser har også vist, at indgivelse af Ontruzant giver samme niveau af det aktive stof i kroppen som indgivelse af Herceptin.
English: For practical information about using Ontruzant, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Ontruzant, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What benefits of Ontruzant have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Ontruzant?
English: How does Ontruzant work?
Danish: Hvordan virker Ontruzant?
English: Therefore, the Agency's view was that, as for Herceptin, the benefit outweighs the identified risk and Ontruzant should be given marketing authorisation.
Danish: Agenturet var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for Herceptin, og anbefalede, at Ontruzant godkendes til anvendelse i EU.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ontruzant 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 Ontruzant.
English: Date of first authorisation: 25 May 2000 Date of latest renewal: 25 May 2010
Danish: Dato for første markedsføringstilladelse: 25. maj 2000 Dato for seneste fornyelse: 25. maj 2010
English: - thoughts about threatening the life of others.
Danish: • tanker om at true andre på livet.
English: - The contents should now be completely dissolved.
Danish: • Indholdet skulle nu være fuldstændigt opløst.
English: Therefore, you and your partner must take special precautions in sexual activity if there is any chance for pregnancy to occur:
Danish: Derfor skal du og din partner bruge særlige forholdsregler i jeres seksuelle aktivitet, hvis der er nogen mulighed for, at en graviditet kan opstå:
English: The study results are summarized in Table 15.
Danish: Forsøgets resultater er sammenfattet i Tabel 15.
English: PegIntron is likely to also cause this effect.
Danish: PegIntron forårsager sandsynligvis også denne effekt.
English: PegIntron showed no genotoxic potential.
Danish: PegIntron viste intet genotoksisk potentiale.
English: 327 patients completed at least 5 years of long-term follow-up and only 3 out of 366 sustained responders relapsed during the study.
Danish: 327 patienter fuldførte mindst 5 års langtidsopfølgning og kun 3 ud af 366 vedvarende responderende fik recidiv under forsøget.
English: There was no improvement in terms of fibrosis observed in this study.
Danish: Der var ingen bedring i relation til fibrose observeret i forsøget.
English: o With zidovudine or stavudine, it is not certain if ribavirin will change the way these medicines work.
Danish: • Med zidovudin eller stavudin er det ikke sikkert, om ribavirin vil ændre den måde, disse lægemidler virker på.
English: Acceptable baseline values that may be considered as a guideline prior to initiation of PegIntron therapy are:
Danish: Acceptable udgangsværdier, som kan anvendes som retningslinje før påbegyndelse af PegIntron-behandling, er:
English: Some people get depressed when taking this medicine alone or in combination treatment with ribavirin, and in some cases people have had thoughts about threatening the life of others, suicidal thoughts or aggressive behaviour (sometimes directed against others).
Danish: Nogle mennesker bliver deprimerede, når de anvender dette lægemiddel alene eller i kombinations med ribavirin, og i nogle tilfælde har personer haft tanker om at true andre på livet, selvmordstanker eller aggressiv opførsel (sommetider rettet mod andre).
English: While being treated with PegIntron, your doctor may advise to drink extra fluids to help prevent low blood pressure.
Danish: Under behandlingen med PegIntron vil lægen måske råde dig til at drikke ekstra væske for at hjælpe med at forebygge lavt blodtryk.
English: METAVIR Fibrosis score F2
Danish: METAVIR Fibrose-score F2
English: ** For patients > 120 kg, the PegIntron dose should be calculated based on the individual patient weight.
Danish: ** Ved vægt > 120 kg bør PegIntron dosis beregnes på grundlag af den enkelte patients vægt.
English: In addition, children and adolescents must not use this medicine if they have had serious nervous or mental problems, such as severe depression or thoughts of suicide.
Danish: Desuden må børn og unge ikke tage dette lægemiddel, hvis de har haft alvorlige nervøse eller mentale problemer, såsom svær depression eller selvmordstanker.
English: Use in adults - PegIntron alone
Danish: Brug hos voksne - PegIntron alene
English: No studies have been conducted in juvenile animals to examine the effects of treatment with PegIntron on growth, development, sexual maturation, and behaviour.
Danish: Der er ikke udført forsøg på unge dyr med henblik på at undersøge effekten af behandling med PegIntron på vækst, udvikling, seksuel modning og adfærd.
English: The response to treatment in both of these trials is presented in Table 13.
Danish: Respons på behandlingen i disse 2 forsøg er vist i Tabel 13.
English: This includes adults also infected with clinically stable HIV (Human Immunodeficiency Virus).
Danish: Dette omfatter også voksne som er smittet med klinisk stabilt hiv (humant immundefekt virus).
English: As adherence might be of importance for outcome of therapy, the dose of PegIntron and ribavirin should be kept as close as possible to the recommended standard dose.
Danish: Da efterlevelse kan være vigtig for udfaldet af behandlingen, skal dosis for PegIntron og ribavirin være så tæt på den anbefalede standard dosis som muligt.
English: PegIntron is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Danish: PegIntron skal kun anvendes under graviditet, hvis den mulige fordel opvejer den mulige risiko for fosteret.
English: Treatment with PegIntron in combination with ribavirin was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage.
Danish: Behandling med PegIntron i kombination med ribavirin, blev associeret med et fald i absolut CD4+celletælling inden for de 4 første uger uden en reduktion i CD4+-celleprocenten.
English: - have heart disease that has not been well controlled during the past 6 months.
Danish: • har en hjertesygdom, som ikke har været velbehandlet gennem de seneste 6 måneder.
English: In general, the adverse events seen in overdose cases involving PegIntron are consistent with the known safety profile for PegIntron; however, the severity of the events may be increased.
Danish: Generelt er bivirkninger, der er set ved tilfælde af overdosering, hvor PegIntron er involveret, i overensstemmelse med den kendte sikkerhedsprofil for PegIntron; sværhedsgraden af tilfældene kan imidlertid øges.
English: General information about taking this medicine
Danish: Generel information om brugen af dette lægemiddel:
English: - pulmonary arterial hypertension - a disease of severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels that carry blood from the heart to the lungs.
Danish: • pulmonal arteriel hypertension - en sygdom, der medfører svær forsnævring af blodkarrene i lungerne med deraf følgende højt blodtryk i de blodkar, der fører blodet fra hjertet til lungerne.
English: Histological response: Liver biopsies were obtained before and after treatment in Study 1 and were available for 210 of the 412 subjects (51 %).
Danish: Histologisk respons: Leverbiopsier blev taget før og efter behandling i Forsøg 1 og var tilgængelige for 210 af de 412 forsøgspersoner (51%).
English: No specific antidote for PegIntron is available; therefore, symptomatic treatment and close observation of the patient are recommended in cases of overdose.
Danish: Der findes ingen specifik antidot til PegIntron; i tilfælde af overdosering anbefales derfor symptomatisk behandling og tæt observation af patienten.
English: Renal clearance appears to account for 30 % of total clearance of PegIntron.
Danish: Renal udskillelse synes at være ansvarlig for 30 % af total clearance af PegIntron.
English: PegIntron should therefore not be used as long term maintenance monotherapy.
Danish: PegIntron bør derfor ikke anvendes som langtidsvedligeholdelses-monoterapi.
English: Do not inject PegIntron into an area where the skin is irritated, red, bruised, infected, or has scars, stretch marks, or lumps.
Danish: Indsprøjt ikke PegIntron på et område, hvor huden er irriteret, rød, har blå mærker, er betændt, eller har ar, strækmærker eller knuder.
English: How to self-inject PegIntron?
Danish: Hvordan du selv indsprøjter PegIntron?
English: Reduce only PegIntron dose (see note 2) if:
Danish: Reducer kun PegIntron dosis (se note 2), hvis:
English: These adverse reactions were common (≥1/100 to < 1/10) in clinical trials in patients treated with PegIntron monotherapy.
Danish: Disse bivirkninger var almindelige (≥ 1/100 til < 1/10) i kliniske forsøg hos patienter behandlet med PegIntron monoterapi.
English: If you forget to take PegIntron
Danish: Hvis du har glemt at tage PegIntron
English: It is thought that this process, at least in part, is responsible for the various cellular responses to interferon, including inhibition of virus replication in virusinfected cells, suppression of cell proliferation and such immunomodulating activities as enhancement of the phagocytic activity of macrophages and augmentation of the specific cytotoxicity of lymphocytes for target cells.
Danish: Det formodes, at denne proces, i det mindste delvist, er ansvarlig for de forskellige cellulære reaktioner på interferon, inklusive hæmning af virusreplikation i virusinficerede celler, suppression af celledeling og sådanne immunmodulerende aktiviteter som øgning af makrofagers fagocytiske aktivitet og øgning af lymfocytters specifikke cytotoksicitet for målcellerne.
English: - are taking telbivudine.
Danish: • tager telbivudin.
English: A large long-term follow-up study enrolled 567 patients after treatment in a prior study with PegIntron (with or without ribavirin).
Danish: Et stort forsøg med langtidsopfølgning inkluderede 567 patienter efter behandling i en tidligere forsøg med PegIntron (med eller uden ribavirin).
English: Two pivotal trials have been conducted, one (C/I97-010) with PegIntron monotherapy; the other (C/I98-580) with PegIntron in combination with ribavirin.
Danish: To pivotale forsøg er blevet udført, en (C/I97-010) med PegIntron monoterapi; den anden (C/I98-580) med PegIntron i kombination med ribavirin.
English: When used in combination with ribavirin, PegIntron did not cause any effects not previously seen with either active substance alone.
Danish: Ved anvendelse i kombination med ribavirin forårsagede PegIntron ikke nogen virkninger, som ikke tidligere var set med hvert aktivt stof alene.
English: The decrease in CD4+ cell counts was reversible upon dose reduction or cessation of therapy.
Danish: Faldet i CD4+celletællinger var reversible efter dosisreduktion eller behandlingsophør.
English: "Push-On Needle"
Danish: "Push-On Needle" (kanyle)
English: When the total amount of solvent is combined with the full amount of PegIntron powder, the solution will be at the correct concentration to measure your dose (i.e., the labelled amount is contained in 0.5 ml).
Danish: Når hele mængden af solvens kombineres med hele mængden af PegIntron-pulveret, vil opløsningen være i den rigtige koncentration til at afmåle din dosis (det vil sige at den anførte mængde er indeholdt i 0,5 ml).
English: The purpose of the study was to evaluate the durability of sustained virologic response (SVR) and assess the impact of continued viral negativity on clinical outcomes.
Danish: Formålet med forsøget var at vurdere varigheden af det vedvarende virologiske respons (SVR) og bestemme betydningen af den fortsatte virale negativitet på det kliniske resultat.
English: Mean (SD) PegIntron elimination half-life is approximately 40 hours (13.3 hours), with apparent clearance of 22.0 ml/hr/kg.
Danish: Gennemsnitlig (SD) PegIntron eliminationshalveringstid er cirka 40 timer (13,3 timer) med tilsyneladende clearance på 22,0 ml/time∙kg.
English: The side effect may develop at various time points during treatment, typically several months after starting treatment with PegIntron.
Danish: Bivirkningerne kan indtræde på forskellige tidspunkter under behandlingen, typisk flere måneder efter påbegyndelse af behandlingen med PegIntron.
English: Interferon monotherapy, including PegIntron, is indicated mainly in case of intolerance or contraindication to ribavirin.
Danish: Interferon-monoterapi, inklusive PegIntron, er hovedsageligt indiceret i tilfælde af intolerance eller kontraindikation over for ribavirin.
English: Women of childbearing potential/contraception in males and females PegIntron is recommended for use in fertile women only when they are using effective contraception during the treatment.
Danish: Kvinder i den fertile alder/Kontraception til mænd og kvinder PegIntron anbefales kun til brug hos fertile kvinder, når de anvender effektiv kontraception under behandlingen.
English: Patients who develop fatigue, somnolence or confusion during treatment with PegIntron are cautioned to avoid driving or operating machines.
Danish: Patienter, der udvikler træthed, søvnighed eller forvirring under behandling med PegIntron, advares mod at køre bil og betjene maskiner.
English: This may require combinations of various PegIntron dose strengths and volumes.
Danish: Dette kan kræve kombination af flere PegIntron-styrker og volumener.