FrancophonIA/ELRC3.0 huggingface dataset:
English: What you need to know before you use Pegasys
Danish: Det skal du vide, før du begynder at tage Pegasys
English: In subjects older than 62 years, the absorption of Pegasys after a single subcutaneous injection of 180 micrograms was delayed but still sustained compared to young healthy subjects (tmax of 115 hours vs. 82 hours, older than 62 years vs. younger, respectively).
Danish: Efter en enkelt subkutan injektion af 180 mikrogram hos forsøgspersoner over 62 år var absorptionen af Pegasys forsinket, men stadig forlænget, sammenlignet med unge raske forsøgspersoner (Tmax på 115 timer versus 82 timer hos ældre over 62 år versus yngre).
English: Patients who develop these conditions during treatment and cannot be controlled with medication should discontinue Pegasys or Pegasys/ribavirin therapy.
Danish: Patienter, der udvikler disse tilstande under behandlingen, og som ikke kan kontrolleres med medicinering, bør afbryde behandlingen med Pegasys eller Pegasys/ribavirin.
English: The absolute bioavailability of Pegasys is 84% and is similar to that seen with interferon alfa-2a.
Danish: Den absolutte biotilgængelighed af Pegasys er 84 %, og den svarer til biotilgængeligheden hos interferon alfa-2a.
English: Adult chronic hepatitis C prior treatment non-responder patients In study MV17150, patients who were non-responders to previous therapy with pegylated interferon alfa-2b plus ribavirin were randomised to four different treatments:
Danish: Voksne patienter med kronisk hepatitis C, som ikke har responderet på tidligere behandling I studie MV17150 blev patienter, som ikke havde responderet på tidligere behandling med pegyleret interferon alfa-2b plus ribavirin, randomiseret til 4 forskellige behandlinger:
English: Overall, the safety profile for Pegasys in combination with ribavirin in prior non-responder patients was similar to that in naïve patients.
Danish: Overordnet svarede sikkerhedsprofilen for Pegasys i kombination med ribavirin hos tidligere ikkeresponderende patienter til den hos naive patienter.
English: A total of 55 patients received initial combination treatment of Pegasys plus ribavirin, of whom 51% were female, 82% were Caucasian, and 82% were infected with HCV genotype 1.
Danish: Deraf var 51 % piger, 82 % var kaukasiske og 82 % var inficeret med HCV-genotype 1.
English: Wash your hands carefully before handling any of the items.
Danish: Vask hænderne grundigt, før du foretager dig yderligere.
English: Ask your healthcare provider any questions you may have.
Danish: Tal med sundhedspersonalet, hvis du har spørgsmål.
English: When Pegasys is used alone in hepatitis B or C patients, some of these effects are less likely to occur.
Danish: Hvis Pegasys anvendes som eneste præparat hos patienter med hepatitis B eller C forekommer nogle af disse bivirkninger sjældnere.
English: 1 Cochran-Mantel-Haenszel test, stratified by genotype (A vs. non-A) and baseline ALT (< 5 × ULN and >= 5 × ULN) 2 Fisher's Exact Test
Danish: Cochran-Mantel-Haenszel test, stratificeret af genotype (A versus ikke-A) og baseline ALAT (<5x øvre referencegrænse og ≥5x øvre referencegrænse)
English: Pegasys has not been evaluated in patients with decompensated cirrhosis (e.g., Child-Pugh B or C or bleeding oesophageal varices) (see section 4.3).
Danish: Pegasys er ikke undersøgt hos patienter med dekompenseret cirrose (f.eks. Child Pugh B/C eller blødende øsofagusvaricer (se pkt.
English: Activation button
Danish: Aktiveringsknap
English: Pegasys treatment was associated with abnormal laboratory values: ALT increase, bilirubin increase, electrolyte disturbance (hypokalaemia, hypocalcaemia, hypophosphataemia), hyperglycaemia, hypoglycaemia and elevated triglycerides (see section 4.4.).
Danish: Behandling med Pegasys blev ledsaget af abnorme laboratorieværdier: ALAT-stigninger, stigning i bilirubin, elektrolytforstyrrelser (hypokaliæmi, hypocalcæmi, hypofosfatæmi), hyperglykæmi, hypoglykæmi og forhøjede triglycerider (se pkt.
English: Dose adjustment for adverse reactions in adult patients
Danish: Justering af dosis på grund af bivirkninger hos voksne patienter
English: Other CNS effects including aggressive behaviour (sometimes directed against others such as homicidal ideation), bipolar disorders, mania, confusion and alterations of mental status have been observed with alfa interferons.
Danish: Andre symptomer fra centralnervesystemet omfattende aggressiv adfærd (nogle gange rettet mod andre såsom drabstanker), bipolære affektive sindslidelser, mani, konfusion og psykiske ændringer er observeret ved interferon alfa.
English: Dose reduction to 90 micrograms is recommended if the platelet count is 25,000 to < 50,000 cells/mm3.
Danish: Det anbefales at nedsætte dosis til 90 mikrogram, hvis trombocyttallet er 25.000 til <50.000 celler/mm3.
English: Do not use Pegasys
Danish: Tag ikke Pegasys
English: ● if you develop symptoms of Vogt-Koyanagi-Harada syndrome; combination of complaints of neck stiffness, headache, loss of colour in skin or hair, eye disorders (such as blurred vision), and/or hearing abnormality (such as ringing in the ears).
Danish: ● hvis du udvikler symptomer på Vogt-Koyanagi-Haradas syndrom: kombination af symptomer i form af stivhed i nakken, hovedpine, tab af farve i hud eller hår, øjenforstyrrelse (såsom uklart syn) og/eller problemer med hørelsen (såsom ringen for ørerne).
English: One step dose modification (Approx. 7.5 mg/kg/day)
Danish: Et trins dosisjustering (Ca. 7,5 mg/kg/dag)
English: It is presently not clear whether a higher dose of ribavirin (e.g.1000/1200 mg/day based on body weight) results in higher SVR rates than does the 800 mg/day, when treatment is shortened to 16 weeks.
Danish: På nuværende tidspunkt vides det ikke, om en højere dosis af ribavirin (f.eks. 1.000/1.200 mg/dag baseret på kropsvægt) resulterer i højere vedvarende virologiske responsrater (SVR) end 800 mg/dag, når behandlingen er afkortet til 16 uger.
English: In HIV-HCV co-infected patients, the clinical adverse reaction profiles reported for Pegasys, alone or in combination with ribavirin, were similar to those observed in HCV mono-infected patients.
Danish: Hos hiv-HCV-co-inficerede patienter var profilen af indberettede kliniske bivirkninger for Pegasys, alene eller i kombination med ribavirin, tilsvarende profilen hos HCV-monoinficerede patienter.
English: Study NV15801
Danish: Studie NV15801
English: Once you have started Pegasys treatment, talk to your doctor, nurse or pharmacist:
Danish: Når din behandling med Pegasys er påbegyndt, skal du kontakte lægen, sundhedspersonalet eller apotekspersonalet:
English: Laboratory values for HIV-HCV co-infected patients Although haematological toxicities of neutropenia, thrombocytopenia and anaemia occurred more frequently in HIV-HCV patients, the majority could be managed by dose modification and the use of growth factors and infrequently required premature discontinuation of treatment.
Danish: Laboratorieværdier hos hiv-HCV-co-inficerede patienter Selvom hæmatologisk toksicitet som neutropeni, trombocytopeni og anæmi indtraf hyppigere hos hivHCV-patienter, kunne størstedelen af tilfældene af hæmatologisk toksicitet håndteres ved hjælp af dosismodifikation og anvendelse af vækstfaktorer.
English: Pegasys pre-filled pen
Danish: Pegasys fyldt pen
English: Pegasys in combination with ribavirin is indicated for the treatment of CHC in treatment-naïve children and adolescents 5 years of age and older who are positive for serum HCV-RNA.
Danish: Pegasys er i kombination med ribavirin indiceret til behandling af kronisk hepatitis C hos behandlingsnaive børn og unge 5 år og ældre, som er positive for serum-HCV-RNA.
English: The recommended duration of therapy is 48 weeks in patients with CHB. Before initiating therapy for CHB, persistently elevated serum ALT levels should have been documented.
Danish: Den anbefalede behandlingsvarighed er 48 uger for patienter med kronisk hepatitis B. Inden behandling af kronisk hepatitis B påbegyndes, skal vedvarende forhøjede serum ALATniveauer være dokumenteret.
English: Table 12: Serological, virological and biochemical responses in chronic hepatitis B HBeAg positive Study WV16240
Danish: Tabel 12: Serologisk, virologisk og biokemisk respons ved kronisk hepatitis B HBeAg-positiv Studie WV16240
English: Severe adverse reactions were reported in 2 patients in the Pegasys plus ribavirin combination therapy group (hyperglycaemia and cholecystectomy).
Danish: Svære bivirkninger blev rapporteret hos 2 patienter i gruppen, som fik Pegasys plus ribavirin kombinationsbehandling (hyperglykæmi og kolecystektomi).
English: Flushing Hypertension Cerebral haemorrhage, vasculitis
Danish: Hypertension Hjerneblødning, vasculitis
English: The risk of growth inhibition should be weighed against the disease characteristics of the child, such as evidence of disease progression (notably fibrosis), co-morbidities that may negatively influence the disease progression (such as HIV co-infection), as well as prognostic factors of response (for HBVinfection mainly HBV genotype and ALT levels; for HCV-infection mainly HCV genotype and HCV-RNA levels) (see section 5.1).
Danish: Risikoen for væksthæmning skal vejes op imod barnets sygdomskarakteristika, såsom evidens for sygdomsprogression (især fibrose), co-morbiditeter, som kan påvirke sygdomsprogression negativt (såsom hiv-co-infektion), såvel som prognostiske faktorer på responset(for HBVinfektion primært HBV genotype og ALAT-niveauer; for HCV-infektion primært HCV genotype og HCV-RNA-niveauer ) (se pkt.
English: Genotype 2 or 3 RVR
Danish: Genotype 2 eller 3 RVR
English: Following a single subcutaneous injection of Pegasys 180 micrograms in healthy subjects, serum concentrations of peginterferon alfa-2a are measurable within 3 to 6 hours.
Danish: Efter en enkelt subkutan injektion med Pegasys 180 mikrogram til raske forsøgspersoner opnås der målelige serumkoncentrationer af peginterferon alfa-2a i løbet af 3 til 6 timer.
English: Patients receiving azathioprin in combination with ribavirin and peginterferon are at increased risk of developing severe blood disorders.
Danish: Patienter, som får azathioprin i kombination med ribavirin og peginterferon, har øget risiko for at udvikle alvorlige blodsygdomme.
English: The following may be considered as baseline values for initiation of treatment: - Platelet count ≥ 90,000 cells/mm3 - ANC ≥ 1500 cells/mm3
Danish: Følgende værdier kan anses som baselineværdier ved påbegyndelsen af behandlingen: - Trombocyttal ≥90.000 celler/mm3 - Absolut neutrofilocyttal (ANC) ≥1.500 celler/mm3
English: Dose adjustement in paediatric patients - dual therapy with Pegasys and ribavirin
Danish: Dosisjustering hos pædiatriske patienter - kombinationsbehandling med Pegasys og ribavirin
English: Ribavirin should be discontinued if either of the following applies: (1) a patient without significant cardiovascular disease experiences a fall in haemoglobin confirmed to < 8.5 g/dl; (2) a patient with stable cardiovascular disease maintains a haemoglobin value < 12 g/dl despite 4 weeks on a reduced dose.
Danish: Ribavirin skal seponeres, hvis et af følgende indtræffer: (1)hæmoglobin falder til <8,5 g/dl hos en patient uden signifikant kardiovaskulær sygdom eller (2) hæmoglobin holder sig på <12 g/dl hos en patient med stabil kardiovaskulær sygdom til trods for, at dosis har været reduceret i 4 uger.
English: Store the container out of reach of children at all times.
Danish: Opbevar altid beholderen utilgængeligt for børn.
English: Aggression, mood alteration, emotional disorders, nervousness, libido decreased
Danish: Aggression, ændringer i stemningslejet, emotionelle sygdomme, nervøsitet, nedsat libido
English: 500 to < 750 cells/mm3
Danish: 500 til <750 celler/mm3
English: It is important to consider the treatment with Pegasys +/- ribavirin induced a growth inhibition during treatment, the reversibility of which is uncertain.
Danish: Det er vigtigt at tage hensyn til, at behandling med Pegasys +/- ribavirin inducerede en væksthæmning under behandling, hvoraf reversibiliteten er usikker.
English: For children and adolescents aged 5 to 17 years with CHC, the recommended dose of ribavirin is based on the patient's body weight, with a target dose of 15 mg/kg/day, divided in two daily doses.
Danish: Den anbefalede dosis af ribavirin til børn og unge fra 5 til 17 år med kronisk hepatitis C baseres på patientens kropsvægt med en måldosis på 15 mg/kg/dag fordelt på to daglige doser.
English: Adjustments in the recommended dosage of 180 micrograms once weekly are not necessary when instituting Pegasys therapy in elderly patients (see section 5.2).
Danish: Det er ikke nødvendigt at justere den anbefalede dosis på 180 mikrogram, når der påbegyndes Pegasysbehandling af ældre patienter (se pkt.
English: Site of administration
Danish: Administrationssted
English: The use of Pegasys and ribavirin combination therapy in CHC patients who failed prior treatment has not been adequately studied in patients who discontinued prior therapy for haematological adverse reactions.
Danish: Brugen af Pegasys og ribavirin i kombinationsbehandling hos kroniske hepatitis C-patienter, hvor tidligere behandling har svigtet, er ikke blevet undersøgt tilstrækkeligt hos patienter, som har afbrudt tidligere behandling på grund af hæmatologiske bivirkninger.
English: Weekly dose (mcg)
Danish: Ugentlig dosis (mikrogram)
English: Overall 16 weeks of treatment may be associated with a lower chance of response and is associated with a higher risk of relapse than a 24-week treatment duration (see section 5.1).
Danish: Generelt kan 16 ugers behandling være associeret med mindre chance for respons og en større risiko for relaps end for en 24 ugers behandlingsvarighed (se pkt.
English: Back pain, pain in extremity
Danish: Rygsmerter, smerte i ekstremiteter
English: Thyroid function abnormalities or worsening of pre-existing thyroid disorders have been reported with the use of alfa interferons, including Pegasys.
Danish: Abnorm thyreoideafunktion eller forværring af thyreoideasygdomme er rapporteret efter anvendelse af interferon alfa, inklusive Pegasys.
English: ● Insert the needle through the rubber top of the Pegasys vial (3).
Danish: • Stik kanylen gennem gummihætten på toppen af hætteglasset med Pegasys (3).
English: Serious, acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) have been rarely observed during alfa interferon therapy.
Danish: Der er kun sjældent observeret alvorlige, akutte overfølsomhedsreaktioner (f.eks. urticaria, angioødem, bronkokonstriktion og anafylaksi) under behandling med interferon alfa.
English: Haematologic laboratory abnormalities observed during the first 20 weeks of the trial included anaemia (26% of patients experienced a haemoglobin level of <10 g/dl), neutropenia (30% experienced an ANC <750 cells/mm3), and thrombocytopenia (13% experienced a platelet count <50,000 cells/mm3) (see section 4.4).
Danish: Hæmatologiske laboratorieabnormiteter observeret i løbet af de første 20 uger af studiet inkluderede anæmi (26 % af patienterne oplevede hæmaglobinniveau <10 g/dl), neutropeni (30 % oplevede en ANC <750 celler/mm3) og trombocytopeni (13 % oplevede blodpladetal <50.000 celler/mm3) (se pkt.
English: Muscle and bone disorders: Serious muscle damage and pain 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: Luftveje: 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: A clinical trial evaluated 50 CHC patients with either moderate (creatinine clearance 30 to 50 mL/min) or severe (creatinine clearance less than 30 mL/min) renal impairment, or with end stage renal disease (ESRD) requiring chronic hemodialysis (HD).
Danish: Et klinisk studie undersøgte 50 patienter med kronisk hepatitis C der havde enten moderat nedsat nyrefunktion (kreatinin clearance på 30 til 50 ml/min), svært nedsat nyrefunktion (kreatinin clearance mindre end 30 ml/min) eller terminal nyresygdom, der kræver kronisk hæmodialyse.
English: - genotype 4 who become HCV RNA negative at week 4 and remain HCV RNA negative at week 24.
Danish: som bliver HCV-RNA-negative ved uge 4 og forbliver negative ved uge 24.
English: The percentage of patients with cirrhosis who withdrew from treatment was similar to that of the overall population in each treatment group.
Danish: Seponeringsraterne for patienter med cirrose svarede til raterne i hele populationen i hver behandlingsgruppe.
English: Confirmatory clinical trials in adult treatment-naïve patients All clinical trials recruited interferon-naïve patients with CHC confirmed by detectable levels of serum HCV RNA, elevated levels of ALT (with the exception of study NR16071) and a liver biopsy consistent with chronic hepatitis.
Danish: Bekræftende kliniske studier hos voksne behandlingsnaive patienter I alle klinske studier indgik interferon-naive patienter med kronisk hepatitis C, hvor diagnosen blev verificeret ved detekterbare niveauer af serum-HCV-RNA, forhøjede niveauer af ALAT (med undtagelse af studie NR16071) og en leverbiopsi, der korrelerer med kronisk hepatitis.
English: Pegasys contains the active substance peginterferon alfa-2a, which is a long-acting interferon.
Danish: Pegasys indeholder det aktive indholdsstof peginterferon alfa-2a, som er et langtidsvirkende interferon.
English: However, an overall 24 weeks treatment duration may be associated with a higher risk of relapse than a 48 weeks treatment duration (see section 5.1).
Danish: En samlet behandlingsperiode på 24 uger kan dog være forbundet med større risiko for recidiv end en behandlingsperiode på 48 uger (se pkt.
English: With the syringe pointing up, make certain that the tip of the needle is in the Pegasys solution.
Danish: Med sprøjten pegende opad forvisser du dig om, at kanylens spids befinder sig i Pegasysopløsningen.
English: Pegasys combination therapy non-cirrhotic and cirrhotic cirrhotic non-cirrhotic and cirrhotic
Danish: Pegasys kombinationsterapi med og uden cirrose med cirrose med og uden cirrose
English: The sustained viral response achieved with 16 weeks of treatment and with 24 weeks of treatment was also examined in a retrospective subgroup analysis of patients who were HCV RNA negative by week 4 and had a LVL at baseline (see Table 17).
Danish: Det vedvarende virologiske respons opnået efter 16 uger og 24 ugers behandling blev også undersøgt i en retrospektiv undergruppe-undersøgelse af patienter, som var HCV-RNA-negative ved uge 4, og som havde en lav virologisk belastning ved baseline (se tabel 17).
English: The safety and efficacy of Pegasys and ribavirin treatment have not been established in patients with liver and other transplantations.
Danish: Sikkerhed og virkning af behandling med Pegasys og ribavirin er ikke dokumenteret hos patienter, som har fået foretaget levertransplantation og andre transplantationer.
English: For children and adolescents aged 3 to 17 years with CHB and having a BSA greater than 0.54 m2 and for children and adolescents aged 5 to 17 years with CHC and having a BSA greater than 0.71 m2, the recommended doses for Pegasys are provided in Table 4.
Danish: For børn og unge i alderen 3 til 17 år med kronisk hepatitis B, og med et legemsoverfladeareal (BSA) større end 0,54 m2 og for børn og unge i alderen 5 til 17 år med kronisk hepatitis C og med et legemsoverfladeareal større end 0,71 m2, er de anbefalede doser for Pegasys angivet i tabel 5.
English: Pegasys use is restricted to children and adolescents with chronic hepatitis C aged 5 years and above or children and adolescents with chronic hepatitis B aged 3 years and above.
Danish: Anvendelse af Pegasys er begrænset til børn og unge med kronisk hepatitis C som er 5 år og ældre, eller børn og unge med kronisk hepatitis B, som er 3 år og ældre.
English: Male patients or their female partners must use an effective contraceptive during treatment and for 7 months after treatment has been concluded.
Danish: Mandlige patienter eller deres kvindelige partnere skal anvende sikker prævention under behandlingen og i 7 måneder efter, behandlingen er ophørt.
English: The probabilities of not achieving a sustained virological response with 48 or 72 weeks of treatment if viral suppression was not achieved at week 12 were 96% (363 of 380) and 96% (324 of 339), respectively.
Danish: Sandsynligheden for ikke at opnå et vedvarende virologisk respons med 48 eller 72 ugers behandling, hvis viral suppression ikke var opnået ved uge 12, var henholdsvis 96 % (363/380) og 96 % (324/339).
English: In CHB, unlike CHC, disease exacerbations during therapy are not uncommon and are characterised by transient and potentially significant increases in serum ALT.
Danish: I modsætning til patienter med kronisk hepatitis C er eksacerbationer under behandlingen ikke ualmindelige hos patienter med kronisk hepatitis B, og de er karakteriserede ved forbigående og potentielt signifikante stigninger i serum-ALAT.
English: For patients with ANC < 500 cells/mm3 treatment should be suspended until ANC values return to > 1000 cells/mm3.
Danish: Hos patienter med et ANC <500 celler/mm3 skal behandlingen afbrydes, indtil det absolutte neutrofilocyttal er >1.000 celler/mm3.
English: Chronic hepatitis C in prior non-responder patients
Danish: Kronisk hepatitis C hos tidligere ikke-responderende patienter
English: Skin disorders: Toxic epidermal necrolysis/Stevens Johnson Syndrome/erythema multiforme (a spectrum of rashes with varying degrees of severity including death which may be associated with blisters in the mouth, nose, eyes and other mucosal membranes and sloughing of the affected area of the skin), angioedema (swelling in the skin and mucosa)
Danish: Hud: Toksisk epidermal nekrolyse/Stevens-Johnsons syndrom/erytem multiforme (en række udslæt med forskellige sværhedsgrader, herunder dødsfald, som kan være forbundet med blister i munden, næsen, øjnene og andre slimhinder samt afstødning af væv fra de angrebne hudområder) og angioødem (hævelse af hud og slimhinder).
English: From the YV25718 study, 31 paediatric patients 3 to 17 years of age with CHB participated in the PK sub-study and received Pegasys according to a BSA category dosing regimen.
Danish: Ud fra YV25718 studiet, deltog i alt 31 pædiatriske patienter i alderen 3 til 17 år med kronisk hepatitis B i PK sub-studiet og fik Pegasys ifølge dosisregimet for legemsoverfladeareal kategorien.
English: In the paediatric study, the most prevalent adverse reactions in patients treated with combination therapy for up to 48 weeks with Pegasys and ribavirin were influenza-like illness (91%), headache (64%), gastrointestinal disorder (56%), and injection-site reaction (45%).
Danish: I det pædiatriske studie hos patienter behandlet med Pegasys og ribavirin kombinationsbehandling i op til 48 uger var de mest udbredte bivirkninger influenzalignende sygdom (91 %), hovedpine (64 %), gastrointestinale lidelser (56 %), og reaktion på injektionsstedet (45 %).
English: The recommended duration of Pegasys monotherapy is 48 weeks.
Danish: Den anbefalede varighed for monoterapi med Pegasys er 48 uger.
English: 180 micrograms
Danish: 180 mikrogram
English: Chronic Hepatitis C: Pegasys is used in combination with other medicines, for the treatment of chronic hepatitis C (CHC).
Danish: Kronisk hepatitis C: Pegasys anvendes i kombination med andre lægemidler til behandling af kronisk hepatitis C.
English: Table 18: Relapse of virological response after the end of treatment in genotype 2 or 3 patients with a rapid viral response
Danish: Tabel 18: Relaps af virologisk respons efter endt behandling hos patienter med genotype 2 eller 3 med hurtigt virologisk respons
English: Pegasys is contraindicated in neonates and young children up to 3 years old due to the excipient benzyl alcohol (see sections 4.3 and 4.4).
Danish: Pegasys er kontraindiceret hos nyfødte og små børn op til 3 år på grund af hjælpestoffet benzylalkohol (se pkt.
English: There is no further accumulation after 8 weeks of once weekly dosing.
Danish: Efter 8 ugers behandling med ugentlige doser er der ingen yderligere akkumulation.