FrancophonIA/ELRC3.0 huggingface dataset:
English: Multipack: 12 (2 packs of 6) pre-filled syringes + 12 injection needles 180 micrograms/0.5 ml
Danish: Multipakning: 12 (2 pakker á 6) fyldte injektionssprøjter + 12 kanyler 180 mikrogram/0,5 ml
English: *The active substance, peginterferon alfa-2a, is a covalent conjugate of the protein interferon alfa-2a produced by recombinant DNA technology in Escherichia coli with bis-[monomethoxy polyethylene glycol].
Danish: *Det aktive indholdsstof, peginterferon alfa-2a, er et kovalent konjugat af proteinet interferon alfa-2a produceret ved rekombinant DNA-teknologi ud fra Escherichia coli med bis-[monomethoxy polyethylenglycol].
English: In clinical trials, Pegasys treatment was associated with decreases in both total white blood cell (WBC) count and ANC, usually starting within the first 2 weeks of treatment (see section 4.8).
Danish: I de kliniske studier blev behandlingen med Pegasys ledsaget af et fald i både leukocyttallet (WBC) og i det absolutte neutrofilocyttal (ANC), begyndende sædvanligvis indenfor de første to uger af behandlingen (se pkt.
English: All HCV genotypes** HCV genotype 1
Danish: Alle HCV-genotyper**
English: The following instructions explain how to use Pegasys single dose vials to inject yourself or your child.
Danish: Nedenstående anvisninger forklarer, hvordan Pegasys enkeltdosishætteglas anvendes, når du skal give dig selv eller dit barninjektionen.
English: The “Instructions for the User”, provided in the carton, must be followed carefully by the patient.
Danish: Vejledningen ”Hvordan foretages injektion af Pegasys”, som findes i pakningen, skal nøje følges af patienten.
English: If the Pegasys dose is reduced or withheld, therapy can be restored once the flare is subsiding (see section 4.4).
Danish: Hvis dosis af Pegasys reduceres eller seponeres, kan behandlingen genoptages, når stigningen er forsvundet (se pkt.
English: Therefore, do not breast-feed an infant if you are taking Pegasys.
Danish: Du må derfor ikke amme, hvis du tager Pegasys.
English: Liver and renal graft rejections have been reported with Pegasys, alone or in combination with ribavirin.
Danish: Afstødning af lever- og nyretransplantater er blevet rapporteret ved behandling med Pegasys alene eller i kombination med ribavirin.
English: In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with the combination of Pegasys and ribavirin.
Danish: Mundtørhed kan endvidere have en skadelig virkning på tænder og belægninger i munden under langtidsbehandling med kombinationen af Pegasys og ribavirin.
English: 12 pre-filled pens
Danish: 12 fyldte penne
English: Lamivudine 100 mg (N=179)
Danish: Lamivudin 100 mg (N=179)
English: Tell your doctor immediately if you notice any of the following side effects: severe chest pain; persistent cough; irregular heartbeat; trouble breathing; confusion; depression; severe stomach pain; blood in stool (or black, tarry stools); severe nosebleed; fever or chills; problems with your eyesight.
Danish: Fortæl straks lægen, hvis du bemærker nogle af følgende bivirkninger: Svære brystsmerter, vedvarende hoste, uregelmæssige hjerteslag, åndedrætsbesvær, konfusion, depression, svære mavesmerter, blod i afføringen (eller sort, tjærefarvet afføring), svær næseblod, feber eller kulderystelser eller problemer med synet.
English: Dizziness, disturbance in attention, migraine
Danish: Svimmelhed, opmærksomhedsforstyrrelse, migræne
English: In CHB or CHC patients, peginterferon alfa-2a serum concentrations accumulate 2 to 3 fold after 6 to 8 weeks of once weekly dosing compared to single dose values.
Danish: Hos patienter med kronisk hepatitis B eller C akkumulerer serumkoncentrationen af peginterferon alfa-2a 2 til 3 gange efter 6 til 8 ugers behandling én gang ugentlig, sammenlignet med enkeltdoser.
English: Pegasys treatment should be discontinued in patients who develop new or worsening ophthalmologic disorders.
Danish: Behandlingen med Pegasys skal afbrydes hos patienter, som udvikler øjensygdomme eller forværring af øjensygdomme.
English: Anaemia (haemoglobin < 10 g/dl) was reported in 7% and 14% of patients treated with Pegasys monotherapy or in combination therapy, respectively.
Danish: Der blev rapporteret anæmi (hæmoglobin <10 g/dl) hos henholdsvis 7 % og 14 % af patienterne, som fik Pegasys-monoterapi eller kombinationsbehandling.
English: Platelet <25,000 cells/mm3: discontinue treatment.
Danish: Blodplader <25.000 celler/mm3: seponer behandling.
English: Idiopathic or thrombotic thrombocytop enic purpura
Danish: Idiopatisk eller trombotisk trombocytopenisk purpura
English: Exposure to Pegasys was decreased in studies following administration of Pegasys in the arm (see section 5.2).
Danish: Eksponering af Pegasys var nedsat i studier, som anvendte administration af Pegasys i armen (se pkt.
English: Infectious mononucleosis, pharyngitis streptococcal, influenza, gastroenteritis viral, candidiasis, gastroenteritis, tooth abscess, hordeolum, urinary tract infection, nasopharyngitis
Danish: Infektiøs mononukleose, pharyngitis streptokokinfektion, influenza, viral gastroenteritis, candidiasis, gastroenteritis, tandbyld, hordeolum, urinvejsinfektion, nasopharyngitis
English: The following instructions explain how to use Pegasys pre-filled syringes to inject yourself or your child.
Danish: Nedenstående anvisninger forklarer, hvordan Pegasys fyldt injektionssprøjte anvendes, når du skal give dig selv eller dit barninjektionen.
English: The possibility to consider shortening treatment duration to 24 weeks in genotype 1 and 4 patients was examined based on a sustained rapid virological response observed in patients with rapid virological response at week 4 in studies NV15942 and ML17131 (see Table 15).
Danish: Det er blevet undersøgt, om behandlingsvarigheden muligvis kan forkortes til 24 uger hos patienter med genotype 1 og 4, baseret på den vedvarende virologiske responsrate, der er observeret hos patienter med hurtig virologisk respons ved uge 4 i studierne NV15942 og ML17131 (se tabel 15).
English: • In paediatric patients, the presence of, or history of severe psychiatric condition, particularly severe depression, suicidal ideation or suicidal attempt.
Danish: • Pædiatriske patienter, som har eller tidligere har haft en svær psykiatrisk tilstand især svær depression, suicidale tanker eller selvmordsforsøg.
English: Also contains sodium chloride, polysorbate 80, benzyl alcohol (see leaflet for further information), sodium acetate, acetic acid and water for injections.
Danish: Indeholder også natriumchlorid, polysorbat 80, benzylalkohol (se indlægssedlen for yderligere information), natriumacetat, eddikesyre, og vand til injektionsvæsker.
English: The possibility of shortening treatment duration to 16 weeks in genotype 2 or 3 patients was examined based on a sustained virological response observed in patients with rapid virological response by week 4 in study NV17317 (see Table 17).
Danish: Muligheden for afkortelse af behandlingsvarigheden til 16 uger hos patienter med genotype 2 eller 3 blev undersøgt, baseret på et vedvarende virologisk respons hos patienter, som havde et hurtigt virologisk respons ved uge 4 i studie NV17317 (se tabel 17).
English: How to inject Pegasys
Danish: Hvordan foretages injektion af Pegasys
English: The conjugation of PEG reagent (bis-monomethoxypolyethylene glycol) to interferon alfa-2a forms a pegylated interferon alfa-2a (Pegasys).
Danish: Ved konjugering af PEG-reagens (bis-monomethoxypolyethylenglycol) til interferon alfa-2a dannes et pegyleret interferon alfa-2a (Pegasys).
English: In a clinical trial (YV25718) with 111 paediatric patients (3 to 17 years of age) treated with Pegasys for 48 weeks, the safety profile was consistent with that seen in adults with CHB and in paediatric patients with CHC.
Danish: I et klinisk studie (YV25718) med 111 pædiatriske patienter (3 til 17 år) behandlet med Pegasys i 48 uger, var sikkerhedsprofilen tilsvarende den, som blev observeret hos voksne med kronisk hepatitis B og hos pædiatriske patienter med kronisk hepatitis C.
English: Use with ribavirin
Danish: Anvendelse med ribavirin
English: While most children returned to their projected height within two years after completing treatment, and the majority of the remaining children within six years after completing treatment, it remains possible that Pegasys may affect the final adult height.
Danish: Efter afslutning af behandlingen opnåede de fleste børn deres forventede højde inden for to år, og hovedparten af de resterende børn inden for seks år efter afsluttet behandling.
English: Psychiatric and nervous system disorders: Feeling depressed (feeling low, feeling bad about yourself or feeling hopeless), anxiety, inability to sleep, headache, difficulty concentrating and dizziness Breathing disorders: Cough, shortness of breath
Danish: Psykiske forstyrrelser og nervesystemet: Du føler dig deprimeret (føler dig ringe, tænker dårligt om dig selv eller føler dig håbløs), angst, søvnløshed, hovedpine, koncentrationsbesvær og svimmelhed Luftveje: Hoste, kortåndethed
English: If you realise you missed your injection 1 or 2 days after it was scheduled, you should inject your recommended dose as soon as possible.
Danish: Hvis du opdager, at du har glemt injektionen 1-2 dage efter, den var planlagt, skal du injicere den anbefalede dosis så hurtigt som muligt.
English: In study NR16071, HCV patients with normal ALT values were randomised to receive Pegasys 180 micrograms/week and ribavirin 800 milligrams/day for either 24 or 48 weeks followed by a 24 week treatment free follow-up period or no treatment for 72 weeks.
Danish: I studie NR16071 blev HCV-patienter med normale ALAT-værdier randomiseret til at få Pegasys 180 mikrogram/uge og ribavirin 800 milligram/dag i enten 24 eller 48 uger efterfulgt af 24-ugers behandlingsfri follow-up periode eller ingen behandling i 72 uger.
English: The non-clinical toxicity studies conducted with Pegasys were limited due to species specificity of interferons.
Danish: Prækliniske toksicitetsstudier med Pegasys var begrænsede af artsspecificitet for interferoner.
English: ● if you have ever had depression or symptoms associated with depression (e.g. feelings of sadness, dejection, etc.).
Danish: ● hvis du nogensinde har haft en depression eller symptomer på depression (f.eks. føler dig nedtrykt, modløs osv.).
English: ● Remove the protective cap from the Pegasys vial (1).
Danish: • Fjern beskyttelseshætten fra Pegasys hætteglasset (1).
English: Moderate (ANC: 0.749 - 0.5 x 109/l) and severe (ANC: < 0.5 x 109/l) neutropenia was observed respectively in 24% (216/887) and 5% (41/887) of patients receiving Pegasys 180 micrograms and ribavirin 1000/1200 milligrams for 48 weeks.
Danish: Moderat (absolut neutrofilocyttal: 0,749-0,5 x 109/l) og svær (absolut neutrofilocyttal: <0,5 x 109/l) neutropeni blev set hos henholdsvis 24 % (216/887) og 5 % (41/887) af de patienter, som fik 180 mikrogram Pegasys og 1.000/1.200 milligram ribavirin i 48 uger.
English: 180 micrograms/1 ml
Danish: 180 mikrogram/1 ml
English: Treatment discontinuation is recommended when platelet count decreases to levels < 25,000 cells/mm3.
Danish: Det anbefales at afbryde behandlingen, hvis trombocyttallet falder til <25.000 celler/mm3.
English: Lamivudine 100 mg (N=271)
Danish: Lamivudin 100 mg (N=271)
English: Pegasys possesses the in vitro antiviral and antiproliferative activities that are characteristic of interferon alfa-2a.
Danish: In vitro har Pegasys de samme antivirale og antiproliferative virkninger, som er karakteristisk for interferon alfa-2a.
English: Study NV15942
Danish: Studie NV15942
English: ● The active substance is peginterferon alfa-2a.
Danish: ● Aktivt stof: peginterferon alfa-2a.
English: Specific recommendations for management of treatment-emergent anaemia in adults are as follows: ribavirin should be reduced to 600 milligrams/day (200 milligrams in the morning and 400 milligrams in the evening) if either of the following apply: (1) a patient without significant cardiovascular disease experiences a fall in haemoglobin to < 10 g/dl and ≥ 8.5 g/dl, or (2) a patient with stable cardiovascular disease experiences a fall in haemoglobin by ≥ 2 g/dl during any 4 weeks of treatment.
Danish: Til behandling af anæmi, som viser sig under behandlingen hos voksne, gælder følgende specifikke rekommendationer: Hvis et af følgende indtræffer skal ribavirindosis reduceres til 600 mg/dag (200 mg om morgenen og 400 mg om aftenen): (1) hæmoglobin falder til <10 g/dl og ≥8,5 g/dl hos en patient uden signifikant kardiovaskulær sygdom eller (2) hæmoglobin falder med ≥2 g/dl under en 4
English: 800 mg(a)
Danish: 180 mikrogram 800 mg(a)
English: Psychiatric and nervous system disorders: Thoughts of suicide, hallucinations (severe problems with personality and deterioration in normal social functioning),peripheral neuropathy (disorder of the nerves affecting the extremities)
Danish: Psykiske forstyrrelser og nervesystemet: Selvmordstanker og hallucinationer (svære problemer med personligheden og forringelse af normal social funktion), perifer neuropati (forstyrrelser i nerverne der påvirker ben og arme)
English: Prior to beginning Pegasys therapy, standard haematological and biochemical laboratory tests are recommended for all patients.
Danish: Laboratorieundersøgelser før og under behandlingen Før behandlingen med Pegasys påbegyndes, anbefales det at foretage hæmatologiske og biokemiske laboratorieundersøgelser på alle patienter.
English: Talk to your doctor, pharmacist or nurse before using Pegasys
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Pegasys
English: Increases in ALT levels above baseline have been observed in patients treated with Pegasys, including patients with a viral response.
Danish: Der er set stigninger af ALAT, i forhold til baseline, hos patienter, som behandles med Pegasys, inklusive patienter med viralt respons.
English: Combination therapy with ribavirin in chronic hepatitis C In the case of combination therapy with Pegasys and ribavirin, please follow the dosing regimen recommended by your doctor.
Danish: Kombinationsbehandling med ribavirin ved kronisk hepatitis C Hvis Pegasys gives i kombination med ribavirin, skal du følge den dosering, som din læge har anbefalet.
English: May cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Danish: Kan forårsage toksiske og anafylaktoide reaktioner hos spædbørn og børn op til 3 år.
English: Although limited, data indicated that shortening treatment to 24 weeks might be associated with a higher risk of relapse (see Table 16).
Danish: En begrænset mængde data viser, at en forkortelse af behandlingen til 24 uger kan være forbundet med højere risiko for recidiv (se tabel 16).
English: Patients with these conditions who cannot be effectively controlled by medication should not begin Pegasys monotherapy or Pegasys/ribavirin combination therapy.
Danish: Patienter med disse tilstande, som ikke effektivt kan kontrolleres med medicinering, bør ikke påbegynde Pegasys-monoterapi eller Pegasys/ribavirin kombinationsbehandling.
English: ● if you are allergic to peginterferon-alfa-2a, to any interferon or any of the other ingredients of this medicine (listed in section 6).
Danish: ● hvis du er allergisk over for peginterferon alfa-2a, andre interferoner eller et af de øvrige indholdsstoffer i Pegasys (angivet i punkt 6).
English: Treatment with Pegasys was associated with decreases in haematological values (leucopenia, neutropenia, lymphopenia, thrombocytopenia and haemoglobin), which generally improved with dose modification, and returned to pre-treatment levels within 4-8 weeks upon cessation of therapy (see sections 4.2 and 4.4).
Danish: Behandling med Pegasys blev ledsaget af fald i hæmatologiske værdier (leukopeni, neutropeni, lymfocytopeni, trombocytopeni og hæmoglobin), som generelt blev forbedret ved justering af dosis, og som indenfor 4-8 uger efter ophør af behandlingen vendte tilbage til niveauet før behandling (se pkt.
English: The solution for injection is for single use only.
Danish: Opløsningen til injektion er til engangsbrug.
English: In case of intolerance to ribavirin, Pegasys monotherapy should be continued.
Danish: Hvis der indtræffer intolerans overfor ribavirin, fortsættes behandlingen med Pegasys monoterapi.
English: When increases in ALT levels are progressive despite dose reduction, or are accompanied by increased bilirubin or evidence of hepatic decompensation, therapy should be discontinued (see section 4.4).
Danish: Hvis ALAT-værdierne progredierer, trods dosisreduktion, eller ledsages af forhøjet bilirubin eller tegn på leverdekompensation, skal behandlingen afbrydes (se pkt.
English: Eye disorders: Bleeding in the retina (back of the eye) Ear disorders: Hearing loss
Danish: Øjne: Blødning i nethinden (bagsiden af øjet)
English: 0.5 ml of solution for injection in pre-filled syringe (siliconised Type I glass) with a plunger stopper and tip cap (butyl rubber laminated on the product facing side with fluororesin) with a needle.
Danish: 0,5 ml af opløsning til injektion i en fyldt injektionssprøjte (type I silikoniseret glas) med en stempelprop og en tophætte (butylgummi lamineret med fluororesin på den side, der vender mod indholdet) med en kanyle.
English: Pyrexia, rigors*, pain*, asthenia, fatigue, injection site reaction*, irritability*
Danish: Pyreksi, kulderystelser*, smerter*, asteni, træthed, reaktioner på injektionsstedet*, irritabilitet*
English: There are no data on the effects of peginterferon alfa-2a on fertility in women.
Danish: Der er ingen data om peginterferon alfa-2as virkning på kvinders fertilitet.
English: If you realise you missed your injection 3 to 5 days after it was scheduled, you should take your injection at the recommended dose as soon as possible.
Danish: Hvis du opdager, at du har glemt injektionen 3-5 dage efter, den var planlagt, skal du injicere den anbefalede dosis så hurtigt som muligt.
English: The strength indicates the quantity of the interferon alfa-2a moiety of peginterferon alfa-2a without consideration of the pegylation.
Danish: Styrken indikerer størrelsen af interferon alfa-2a delen af peginterferon alfa-2a uden hensyntagen til pegyleringen.
English: Haemoglobin - no cardiac disease
Danish: Hæmoglobin - ingen hjertesygdom
English: 1 ml of solution for injection in vial (Type I glass) with stopper (rubber butyl).
Danish: 1 ml af opløsning til injektion i hætteglas (type I glas) med hætte (butylgummi).
English: Therefore, the combination of Pegasys with telbivudine is contraindicated (see section 4.3).
Danish: Kombinationen af Pegasys og telbivudin er derfor kontraindiceret (se pkt.
English: Patients infected with HCV genotypes other than genotype 1 should receive 800 mg daily of ribavirin.
Danish: Patienter, som er inficeret med andre HCV-genotyper end HCV-genotype 1, bør få 800 mg ribavirin daglig.
English: In the HALT-C study, patients with CHC and advanced fibrosis or cirrhosis who were non-responders to previous treatment with interferon alfa or pegylated interferon alfa monotherapy or in combination therapy with ribavirin were treated with Pegasys 180 mcg/week and ribavirin 1000/1200 mg daily.
Danish: Patienter med kronisk hepatitis C og fremskreden fibrose eller cirrose, som ikke havde responderet på tidligere behandling med interferon alfa eller pegyleret interferon alfa-monobehandling eller kombinationsbehandling med ribavirin, blev i HALT-C studiet behandlet med Pegasys 180 mikrogram/uge og ribavirin 1.000/1.200 mg daglig.
English: Cerebral ischaemia
Danish: Cerebral iskæmi
English: You or your partner must use an effective contraceptive during the time you are taking the treatment and for 7 months after stopping treatment.
Danish: Du eller din partner skal anvende en effektiv præventionsform i hele den periode, du er i behandling, og i 7 måneder efter behandlingen er stoppet.
English: All patients should have a baseline eye examination.
Danish: Alle patienter skal have foretaget en øjenundersøgelse inden start af behandling.
English: In chronic hepatitis B the duration of Pegasys treatment is 48 weeks.
Danish: Varigheden af Pegasys behandlingen for kronisk hepatitis B er 48 uger.
English: Low viral load High viral load
Danish: Lav viral belastning Høj viral belastning
English: Study NV15495
Danish: Studie NV15495
English: Similarly for patients with cirrhosis or transition to cirrhosis, the frequencies of withdrawal from Pegasys treatment and ribavirin treatment were higher in the 72-week treatment arms (13% and 15%) than in the 48-week arms (6% and 6%).
Danish: Tilsvarende var hyppigheden for seponering af Pegasysbehandling og ribavirinbehandling for patienter med cirrose eller i overgang til cirrose højere i 72 ugers-behandlingsarmene (13 % og 15 %) end i 48 ugers-armene (6 % og 6 %).
English: copies/mL.
Danish: kopier/ml
English: Duration of therapy when Pegasys is used in combination with other medicinal products Refer also to the Summary of Product Characteristics of the medicinal products that are used in combination with Pegasys.
Danish: Behandlingsvarighed, når Pegasys gives i kombination med andre lægemidler Der henvises til produktresuméerne for de lægemidler, der gives sammen med Pegasys.
English: Pegasys given alone or in combination with ribavirin is usually given at a dose of 180 micrograms once a week.
Danish: Når Pegasys gives alene eller i kombination med ribavirin, gives det normalt i en dosis på 180 mikrogram én gang om ugen.
English: Genotype 4 with RVR*
Danish: Genotype 4 med RVR*
English: In study NR15961, patients concurrently treated with stavudine and interferon therapy with or without ribavirin, the incidence of pancreatitis and/or lactic acidosis was 3% (12/398).
Danish: I studie NR15961 var incidencen af pankreatitis og/eller lactacidosis 3 % (12/398) hos patienter, der samtidig blev behandlet med stavudin og interferon med eller uden ribavirin.
English: Replace the needle guard and place the syringe in a horizontal position until ready for use.
Danish: Sæt beskyttelseshætten tilbage på kanylen og anbring sprøjten i vandret stilling, indtil den skal bruges.
English: Pegasys is administered subcutaneously in the abdomen or thigh.
Danish: Pegasys administreres subkutant i abdomen eller i et lår.
English: 25,000 to cells/mm3
Danish: 25.000 til celler/mm3
English: You may see a small drop(s) or loss of some liquid coming out of the pen.
Danish: Du kan evt. se lille dråbe/små dråber eller væske, som kommer ud af pennen, som er helt normalt.
English: Infections: Lung infection, skin infections
Danish: Infektioner: Lungeinfektion, hudinfektion
English: Place used pre-filled pen and cap in a puncture-proof disposable container that is available through your pharmacy or healthcare provider.
Danish: Anbring den brugte fyldte pen og hætte i en beholder til sikker bortskaffelse af brugte penne (kanyleboks), som kan rekvireres på apoteket eller hos sundhedspersonalet.
English: All clinical trials recruited patients with CHB who had active viral replication measured by HBV DNA, elevated levels of ALT and a liver biopsy consistent with chronic hepatitis.
Danish: Alle kliniske studier rekrutterede patienter med kronisk hepatitis B med aktiv viral replikation bedømt ved HBV-DNA, forhøjede ALAT-niveauer og en leverbiopsi, som var konsistent med kronisk hepatitis.
English: Pegasys treatment has been associated with decreases in platelet count, which returned to pretreatment levels during the post-treatment observation period (see section 4.8).
Danish: Behandling med Pegasys var ledsaget af et fald i trombocyttallet, som vendte tilbage til niveauet før behandlingen i observationsperioden efter behandlingen (se pkt.
English: As with other alfa interferons, prolongation of the menstrual cycle was observed following administration of peginterferon alfa-2a to female monkeys.
Danish: Som for andre interferon alfa blev der hos hunaber observeret en forlængelse af menstruationscyklus efter administration af peginterferon alfa2a.
English: Myocardial infarction, congestive heart failure, cardiomyopat hy, angina, arrhythmia, atrial fibrillation, pericarditis, supraventricu lar tachycardia
Danish: Myokardieinfarkt, kongestiv hjertesygdom, kardiomyopati, angina, arytmier, atrieflimren, pericarditis, supraventrikulær takykardi