FrancophonIA/ELRC3.0 huggingface dataset:
English: Early virological response by week 12, defined as a 2 log viral load decrease or undetectable levels of HCV RNA has been shown to be predictive for sustained response (see Tables 2 and 13).
Danish: Tidligt virologisk respons ved uge 12, defineret som et 2 log viralt fald eller ikke-detekterbare koncentrationer af HCV-RNA har vist sig at være prædiktivt for vedvarende respons (se tabel 2 og
English: ● if you are infected with both the hepatitis C virus and the human immunodeficiency virus, and your liver does not work properly (e.g. your skin has become yellow).
Danish: ● hvis du har infektioner med både hepatitis C og hiv og din lever ikke fungerer, som den skal (f.eks. hvis din hud bliver gul).
English: Excipient with known effect: Benzyl alcohol (10 mg/ 1 ml)
Danish: Hjælpestof, som behandleren skal være opmærksom på: Benzylalkohol (10 mg/1 ml)
English: ● Pull the needle straight out of the skin.
Danish: • Træk kanylen ud af huden.
English: Limited safety data are available in co-infected patients with CD4+ cell counts <200/µl.
Danish: Der foreligger begrænsede sikkerhedsdata hos co-inficerede patienter med CD4+ celletal < 200/μl.
English: If you realise you missed your injection 6 days after it was scheduled, you should wait and take your dose on the next day, your regularly scheduled day.
Danish: Hvis du opdager, at du har glemt injektionen 6 dage efter, den var planlagt, skal du vente med at tage den indtil næste dag, som er din normalt planlagte dag.
English: Never re-attach protective cap after removal.
Danish: Sæt aldrig hætten på igen efter, at den er blevet fjernet.
English: The absorption of Pegasys is sustained with peak serum concentrations reached 72 to 96 hours after dosing.
Danish: Absorptionen af Pegasys vedvarer, og serum-peakkoncentrationen nås efter 72 til 96 timers behandling.
English: Growth inhibition was observed in paediatric patients (see section 4.4).
Danish: Væksthæmning blev observeret hos pædiatriske patienter (se pkt.
English: Therefore, the combination of Pegasys with telbivudine is contraindicated.
Danish: Kombinationen af Pegasys og telbivudin er derfor kontraindiceret.
English: Exposure to Pegasys was decreased in studies following administration of Pegasys in the arm compared to administration in the abdomen and thigh.
Danish: Eksponeringen for Pegasys var nedsat i studier, som anvendte administration af Pegasys i armen, sammenlignet med administration i abdomen eller lår.
English: Dose-response in monotherapy
Danish: Dosis-respons under monoterapi
English: Table 20: Sustained virological response in HALT-C by previous treatment regimen in nonresponder population
Danish: Tabel 20:Vedvarende virologisk respons i HALT-C ved tidligere behandling hos ikkeresponderende population
English: Adult and paediatric patients with preexisting ophthalmologic disorders (e.g., diabetic or hypertensive retinopathy) should receive periodic ophthalmologic exams during Pegasys therapy.
Danish: Voksne og pædiatriske patienter, som allerede har øjensygdomme (f.eks. diabetisk eller hypertensiv retinopati), skal have foretaget periodiske øjenundersøgelser under behandlingen med Pegasys.
English: ● a long needle to withdraw Pegasys from the vial
Danish: ● en lang kanyle til at trække Pegasys op af hætteglasset
English: Wheezing Interstitial pneumonitis including fatal outcome, pulmonary embolism
Danish: Interstitiel pneumonitis inklusiv dødelig udgang, lungeemboli
English: Pulmonary arterial hypertension§
Danish: Pulmonal arteriel hypertension§
English: The pharmacokinetics of Pegasys were similar between healthy subjects and patients with hepatitis B or C. Comparable exposure and pharmacokinetic profiles were seen in cirrhotic (Child-Pugh Grade A) and non-cirrhotic patients.
Danish: Pegasys's farmakokinetik var ens hos raske forsøgspersoner og hos patienter med hepatitis B eller C. Der blev set sammenlignelige eksponeringer og farmakokinetiske profiler hos patienter med cirrose (Child-Pugh grad A) og patienter uden cirrose.
English: In patients with cardiovascular disease, anaemia may necessitate dose reduction or discontinuation of ribavirin (see section 4.2).
Danish: Hos patienter med kardiovaskulær sygdom, kan anæmi nødvendiggøre dosisreduktion eller afbrydelse af behandling med ribavirin (se pkt.
English: Paediatric patients treated with Pegasys plus ribavirin combination therapy showed a delay in weight and height increases after 48 weeks of therapy compared with baseline.
Danish: Pædiatriske patienter behandlet med Pegasys plus ribavirin kombinationsbehandling udviste en forsinket vægt- og højdestigning efter 48 ugers behandling sammenlignet med baseline.
English: Table 24: HBeAg seroconversion rates (%) by HBV-DNA decline from baseline to week 12 of Pegasys treatment in paediatric patients
Danish: Tabel 24: HBeAg sero-konversionshastighed (%) for HBV-DNA fald fra baseline til uge 12 af Pegasys behandlingen hos pædiatriske patienter
English: Study NV15495 specifically recruited patients with a histological diagnosis of cirrhosis (about 80%) or transition to cirrhosis (about 20%).
Danish: I det kliniske studie NV15495 blev der specielt rekrutteret patienter med histologisk diagnosticeret cirrose (omkring 80 %) eller begyndende cirrose (omkring 20 %).
English: Baseline variables in co-infected cirrhotic patients that may be associated with hepatic decompensation include: increased serum bilirubin, decreased haemoglobin, increased alkaline phosphatase or decreased platelet count, and treatment with didanosine (ddI).
Danish: Baseline-variabler hos co-inficerede cirrotiske patienter, som kan være relateret til hepatisk dekompensation, omfatter: Forhøjet serum-bilirubin, nedsat hæmoglobin, forhøjet basisk phosphatase eller nedsat trombocyttal samt behandling med didanosin (ddI).
English: Interferon alfa-2a is conjugated with bis-[monomethoxy polyethylene glycol] at a degree of substitution of one mole of polymer/mole of protein.
Danish: Interferon alfa-2a er konjugeret med bis-[monomethoxy polyethylenglycol] med en substitutionsgrad på ét mol af polymer/mol protein.
English: In another clinical trial, non-responder patients with advanced fibrosis or cirrhosis (Ishak score of 3 to 6) and baseline platelet counts as low as 50,000 cells/mm3 were treated for 48 weeks.
Danish: I et andet klinisk studie blev ikke-responderende patienter med fremskreden fibrose eller cirrose (Ishak score mellem 3 og 6) og baseline blodpladetal så lavt som 50.000 celler/mm3 behandlet i 48 uger.
English: ● Clean the rubber top of the vial with a cleansing swab.
Danish: • Rens gummiet på toppen af hætteglasset med et stykke rensevat.
English: In patients receiving Pegasys monotherapy in study WV16241, the rate of HBV DNA response and ALT normalisation 12 months after end of treatment were 42% (41/97) and 59% (58/99), respectively.
Danish: Hos patienter, der fik Pegasys-monoterapi i studie WV16241, var raten af HBV-DNA respons og ALAT-normalisering 12 måneder efter afslutning af behandling henholdsvis 42 % (41/97) og 59 % (58/99).
English: • Hypersensitivity to the active substance, to alfa interferons, or to any of the excipients listed in section 6.1
Danish: • Overfølsomhed overfor det aktive stof, overfor interferon alfa eller overfor et eller flere af hjælpestofferne anført i punkt 6.1
English: Patients with existence of, or history of severe psychiatric conditions: If treatment with Pegasys is judged necessary in patients with existence or history of severe psychiatric conditions, this should only be initiated after having ensured appropriate individualised diagnostic and therapeutic management of the psychiatric condition.
Danish: Patienter med eksisterende eller svære psykiatriske sygdomme i anamnesen: Hvis behandling med Pegasys er vurderet at være nødvendig hos patienter, som har eller tidligere har haft svære psykiatriske lidelser, bør behandlingen kun påbegyndes, når den psykiatriske lidelse er individuelt diagnosticeret og behandlet på passende måde.
English: Patients co-infected with HIV and receiving Highly Active Anti-Retroviral Therapy (HAART) may be at increased risk of developing lactic acidosis.
Danish: Patienter, som også er smittet med hiv, og som får højaktiv, antiretroviral behandling (HAART), kan have en øget risiko for at udvikle lactacidosis.
English: HBsAg Seroconversion
Danish: HBsAg-serokonversion
English: Absolute Neutrophil Count
Danish: Absolut neutrofilocyttal
English: After intravenous administration, the terminal half-life of peginterferon alfa2a in healthy subjects is approximately 60 to 80 hours compared to values of 3-4 hours for standard interferon.
Danish: Efter intravenøs administration er den terminale halveringstid for peginterferon alfa-2a hos raske forsøgspersoner ca. 60 til 80 timer, sammenlignet med 3-4 timer for standard-interferon.
English: In a direct comparison with 90 micrograms, the 180 micrograms-dose was associated with superior sustained virological response in patients with cirrhosis, but in a study in non-cirrhotic patients very similar results were obtained with doses of 135 micrograms and 180 micrograms.
Danish: I en direkte sammenligning med 90 mikrogram var en dosis på 180 mikrogram forbundet med et større vedvarende virologisk respons hos patienter med cirrose, men hos non-cirrotiske patienter var resultaterne meget ens efter hhv. 135 mikrogram og 180 mikrogram.
English: You should inject your regularly scheduled dose immediately on Friday and take your next injection on Wednesday
Danish: Du skal nu tage injektionen om fredagen så hurtigt som muligt og tage den næste injektion om onsdagen
English: Lamivudine 100 mg
Danish: Lamivudin 100 mg
English: Pegasys must not be given to children below the age of 3 years because it contains benzyl alcohol and may cause toxic reactions and allergic reactions in these children.
Danish: 3 år, fordi det indeholder benzylalkohol og kan forårsage giftige reaktioner og allergiske reaktioner hos disse børn.
English: In clinical trials with Pegasys in HBV, marked transaminase flares have been accompanied by mild changes in other measures of hepatic function and without evidence of hepatic decompensation.
Danish: I de kliniske studier med Pegasys ved HBV har markante aminotransferasestigninger været ledsaget af lette ændringer i andre mål for leverfunktionen og uden evidens for hepatisk dekompensation.
English: Patients who achieved undetectable levels of HCV RNA after 20 weeks of treatment remained on Pegasys plus ribavirin combination therapy for a total of 48 weeks and were then followed for 24 weeks after the end of treatment.
Danish: Patienter, som opnåede ikke-detekterbare niveauer af HCV-RNA efter 20 ugers behandling, fortsatte i Pegasys plus ribavirin kombinationsbehandling i sammenlagt 48 uger og blev siden fulgt i 24 uger efter afsluttet behandling.
English: Driving and using machines Do not drive or use machines if you feel drowsy, tired, or confused while taking Pegasys.
Danish: Du må ikke køre bil eller motorcykel og lad være med at cykle eller arbejde med værktøj eller maskiner, hvis du føler dig omtåget, træt eller konfus, mens du tager Pegasys.
English: The data indicated that shortening treatment to 16 weeks is associated with a higher risk of relapse (see Table 18).
Danish: Data indikerer, at afkortning af behandlingsvarighed til 16 uger er forbundet med højere risiko for relaps (se tabel 18).
English: HCV monoinfected patients and HBV monoinfected patients
Danish: HCV-monoinficerede patienter og HBV-monoinficerede patienter
English: All treatment arms had 24 week treatment-free follow-up.
Danish: Alle behandlingsarme havde en 24 ugers behandlingsfri opfølgningsperiode.
English: Patients who still have detectable levels of HCV-RNA despite an initial 24 weeks of therapy, should discontinue therapy, as it is unlikely they will be able to achieve a sustained virological response with continued therapy.
Danish: Behandlingen skal seponeres hos patienter, som stadig har detekterbare niveauer af HCV-RNA på trods af en initial 24 ugers behandling, idet det ikke er sandsynligt, at disse patienter vil opnå et vedvarende virologisk respons med fortsat behandling.
English: Alopecia, dermatitis, pruritis, dry skin
Danish: Alopeci, dermatitis, kløe, tør hud
English: Among patients from study WV16240, who received Pegasys monotherapy and entered the long-term follow-up study, the rate of sustained HBeAg seroconversion 12 months after the end of therapy was 48% (73/153).
Danish: Blandt patienter fra studie WV16240, som fik Pegasys-monoterapi og indgik i langtidsfollow-up-studiet, var raten af vedvarende HbeAg-serokonversion 12 måneder efter afslutningen af behandlingen 48 % (73/153).
English: • When receiving Pegasys, your child may have slower growth and development (see section 4).
Danish: ● Dit barn kan have langsommere vækst og udvikling, mens barnet får Pegasys (se punkt 4).
English: While fever may be associated with the flu-like syndrome reported commonly during interferon therapy, other causes of persistent fever, particularly serious infections (bacterial, viral, fungal) must be ruled out, especially in patients with neutropenia.
Danish: Medens feber kan være del af det influenzalignede syndrom, som ofte rapporteres under behandling med interferon, skal andre årsager til vedvarende feber udelukkes, specielt alvorlige infektioner (bakterielle, virale og fungale), især hos patienter med neutropeni.
English: ● Select the injection site in the abdomen or thigh (except your navel or waistline).
Danish: • Vælg et injektionssted på maven eller låret (bortset fra navlen eller taljen).
English: Pegasys is used to treat chronic hepatitis B or chronic hepatitis C in adults.
Danish: Pegasys anvendes til behandling af kronisk hepatitis B eller kronisk hepatitis C hos voksne.
English: Patients with substance use/abuse: HCV infected patients having a co-occurring substance use disorder (alcohol, cannabis, etc) are at an increased risk of developing psychiatric disorders or exacerbation of already existing psychiatric disorders when treated with alfa interferon.
Danish: HCV-inficerede patienter, der samtidigt har et stofmisbrug (alkohol, cannabis, osv.), har en øget risiko for at udvikle psykiatriske sygdomme eller forværring af allerede eksisterende psykiatriske sygdomme under behandling med interferon alfa.
English: TSH levels should be determined during the course of therapy if a patient develops clinical symptoms consistent with possible thyroid dysfunction (see section 4.8).
Danish: TSH-niveauet skal kontrolleres under behandlingen, hvis en patient får kliniske symptomer på en mulig dysfunktion af thyroidea (se pkt.
English: Caution should be exercised when administering Pegasys in combination with other potentially myelosuppressive agents.
Danish: Der skal udvises forsigtighed, hvis Pegasys kombineres med andre potentielt myelosuppresive stoffer.
English: ● Remove the needle guard without touching the needle and keep the syringe with the needle in your hand.
Danish: • Fjern beskyttelseshætten fra kanylen uden at røre ved kanylen og behold sprøjten med kanylen i hånden.
English: Reports of fatal hepatic failure as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactataemia/lactic acidosis have been reported with use of ribavirin.
Danish: Der er rapporteret om fatal leversvigt samt perifer neuropati, pancreatitis og symptomatisk hyperlaktæmi/mælkesyreacidose under anvendelse af ribavirin.
English: ● Hold the vial and syringe in one hand and turn the vial and the syringe upside down (4).
Danish: • Hold hætteglas og sprøjte i den ene hånd og vend hætteglasset opad og sprøjten nedad (4).
English: Anaphylaxis, systemic lupus erythematosu s rheumatoid arthritis
Danish: Anafylaksi, systemisk lupus erytematosus, rheumatoid arthritis
English: In humans, the systemic clearance of peginterferon alfa-2a is about 100-fold lower than that of the native interferon alfa-2a.
Danish: Hos mennesker er den systemiske clearance af peginterferon alfa-2a ca. 100 gange lavere end clearance for nativ interferon alfa-2a.
English: There are no or limited amount of data from the use of peginterferon alfa-2a in pregnant women.
Danish: Der er ingen eller utilstrækkelige data om brugen af peginterferon alfa-2a til gravide kvinder.
English: Table 10: Adverse reactions reported among paediatric patients infected with HCV and assigned to Pegasys plus ribavirin in study NV17424
Danish: Tabel 10: Bivirkninger rapporteret blandt pædiatriske patienter inficeret med HCV, som fik Pegasys plus ribavirin i studie NV17424
English: Hypoglycaemia, hyperglycaemia and diabetes mellitus have been observed with Pegasys (see section 4.8).
Danish: Hypoglykæmi, hyperglykæmi og diabetes mellitus er observeret med Pegasys (se pkt.
English: Patients missing HCV RNA results at week 12 have been excluded from the analysis.
Danish: Patienter, som ikke havde HCV-RNA-resultater ved uge 12, blev eksluderet fra analysen.
English: Please refer to the respective Summary of Product Characteristics of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with Pegasys with or without ribavirin.
Danish: Der henvises til produktresuméerne for de retrovirale lægemidler, som skal gives samtidig med HCVbehandling vedrørende opmærksomhed på og håndtering af toksicitet specifikt for hvert produkt samt for potentielt overlap af toksicitet med Pegasys med eller uden ribavirin.
English: Patients with signs or symptoms compatible with autoimmune disorders should be evaluated carefully, and the benefit-risk of continued interferon therapy should be re-assessed (see also Endocrine system in sections 4.4 and 4.8).
Danish: Patienter med tegn og symptomer som svarer til autoimmune lidelser skal undersøges omhyggeligt, og fordele og ulemper ved fortsat behandling skal genvurderes (se også Det endokrine system i pkt.
English: Influenza-like illness, injection site reaction, irritability, fatigue
Danish: Influenza-lignende sygdom, reaktion på injektionsstedet, irritabilitet, træthed
English: Bronchitis, upper respiratory infection, oral candidiasis, herpes simplex, fungal, viral and bacterial infections
Danish: Bronkitis, øvre luftvejsinfektioner, oral candidiasis, herpes simplex, svampeinfektioner, virale og bakterielle infektioner
English: What Pegasys contains
Danish: Pegasys indeholder
English: If you use more Pegasys than you should Contact your doctor or pharmacist as soon as possible.
Danish: Hvis du har taget for meget Pegasys Kontakt din læge eller apotekspersonalet så hurtigt som muligt.
English: Because of the potential for adverse reactions in breastfed infants, breastfeeding should be discontinued prior to initiation of treatment.
Danish: På grund af risikoen for bivirkninger hos børn, som ammes, skal amning afbrydes før behandlingen påbegyndes.
English: Pegasys pharmacokinetics have been characterized in paediatric patients with CHB (YV25718), as well as in paediatric patients with CHC (NR16141), using population pharmacokinetics.
Danish: Pegasys' farmakokinetik er karakteriseret hos pædiatriske patienter med kronisk hepatitis B (YV25718), så vel hos pædiatriske patienter med kronisk hepatitis C (NR16141), ud fra populations farmakokinetik.
English: The expected benefit of treatment should be carefully weighed against the safety findings observed for children and adolescents in the clinical trials on a case by case basis (see sections 4.8 and 5.1).
Danish: Den forventede behandlingsfordel bør i hvert enkelt tilfælde opvejes nøje imod de sikkerhedsmæssige fund, der er observeret hos børn og unge i de kliniske studier (se pkt.
English: The recommended dosage and duration of Pegasys for both HBeAg-positive and HBeAg-negative CHB is 180 micrograms once weekly for 48 weeks.
Danish: Den anbefalede dosis og behandlingsvarighed af Pegasys til såvel HBeAg-positiv og HBeAg-negativ kronisk hepatitis B er 180 mikrogram én gang ugentlig i 48 uger.
English: This myelotoxicity was reversible within 4 to 6 weeks upon withdrawal of HCV antiviral therapy and concomitant azathioprine and did not recur upon re-introduction of either treatment alone (see section
Danish: Denne myelotoksicitet var reversibel inden for 4 til 6 uger efter ophør af HCV-antiviral-behandling sammen med azathioprin og opstod ikke igen ved genoptagelse af behandlingerne hver for sig (se pkt.
English: 2) Allow the pre-filled pen to adjust to room temperature
Danish: 2) Lad den fyldte pen tilpasse sig til stuetemperatur
English: The ribavirin dose should be administered with food.
Danish: Ribavirin skal gives sammen med mad.
English: The most frequently reported adverse reactions with Pegasys 180 micrograms were mostly mild to moderate in severity and were manageable without the need for modification of doses or discontinuation of therapy.
Danish: Sværhedsgraden af de hyppigst rapporterede bivirkninger efter 180 mikrogram Pegasys var for det meste mild til moderat, og bivirkningerne kunne behandles uden behov for justering af dosis eller seponering af behandlingen.
English: Interferon alfa-2b 3 MIU Ribavirin mg (N=444) 48 weeks
Danish: Interferon alfa-2b 3 MIE Ribavirin mg (N=444) 48 uger
English: Pegasys 360/180 or 180 mcg
Danish: Pegasys 360/180 eller 180 mikrogram
English: HIV-HCV co-infection
Danish: Hiv-HCV-co-infektion
English: Decreases in haemoglobin, neutrophils, platelets or increased ALT may require dose reduction or permanent discontinuation from treatment (see section 4.2).
Danish: Fald i hæmoglobin, neutrofilocytter, blodplader eller øget ALAT-niveauer kan kræve dosisreduktion eller permanent seponering af behandling (se pkt.
English: For persistent ALT values ≥10 x ULN discontinue treatment.
Danish: For vedvarende ALAT-værdier ≥10 x øvre referencegrænse: seponer behandling.
English: There is limited experience with Pegasys in treating paediatric patients with CHC aged 3 to 5 years, or who have failed to be adequately treated previously.
Danish: Der er begrænset erfaring med Pegasys til behandling af pædiatriske patienter med kronisk hepatitis C i alderen 3 til 5 år, eller som har en tidligere fejlslagen behandling.
English: Pegasys treatment was associated with clinically significant abnormalities in thyroid laboratory values requiring clinical intervention (see section 4.4).
Danish: Behandling med Pegasys blev ledsaget af klinisk signifikante abnormiteter i thyreoidealaboratorieværdier, som krævede klinisk intervention (se pkt.
English: From mass balance, tissue distribution and whole body autoradioluminography studies performed in rats, peginterferon alfa-2a is distributed to the liver, kidney and bone marrow in addition to being highly concentrated in the blood.
Danish: I henhold til studier på rotter om massebalance, vævsdistribution og helkropsautoradioluminografi fordeles peginterferon alfa-2a, udover at opkoncentreres i blodet, til lever, nyrer og knoglemarv.
English: The use of Pegasys in children and adolescents with existence of or history of severe psychiatric conditions is contraindicated (see section 4.3).
Danish: Brug af Pegasys hos børn og unge, som har eller tidligere har haft en svær psykiatrisk tilstand er kontraindiceret (se pkt.
English: Available in packs of 1, 4 or a multipack of 12 (2 packs of 6) pre-filled syringes.
Danish: Findes i en pakning med 1, 4 eller en multipakning med 12 (2 pakker med 6) fyldte injektionssprøjter.
English: Blood disorders: Aplastic anaemia (failure of the bone marrow to produce red blood cells, white blood cells and platelets)
Danish: Blod: Aplastisk anæmi (svigt i knoglemarvens produktion af røde blodceller, hvide blodceller og blodplader).
English: It is recommended that Pegasys pre-filled syringes be used for paediatric patients.
Danish: Det anbefales, at Pegasys forfyldte injektionssprøjter anvendes til pædiatriske patienter.
English: Preparing the syringe and needle for injection
Danish: Forbered sprøjten og kanylen til injektion
English: Patient ‘weight for age' and ‘height for age' percentiles of the normative population decreased during treatment.
Danish: Patienternes vægt sammenlignet med alder og højde sammenlignet med alder-percentiler i forhold til den normative population faldt under behandlingen.