natgillin/translations-raw huggingface dataset:
I modsætning til ved 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.
In chronic hepatitis B, unlike chronic hepatitis C, disease exacerbations during therapy are not uncommon and are characterised by transient and potentially significant increases in serum ALT.
I de kliniske studier med Pegasys ved HBV har markante transaminasestigninger været ledsaget af lette ændringer i andre mål for leverfunktionen og uden evidens for hepatisk dekompensation.
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.
I ca. halvdelen af de tilfælde, hvor stigningen oversteg 10 gange øvre referencegrænse, blev Pegasys- dosis reduceret eller seponeret, indtil transaminasestigningerne var forsvundet, hvorimod behandlingen fortsatte uændret i de resterende tilfælde.
In approximately half the case of flares exceeding 10 times the upper limit of normal, Pegasys dosing was reduced or withheld until the transaminase elevations subsided, while in the rest therapy was continued unchanged.
Overfølsomhed Der er kun sjældent observeret alvorlige, akutte overfølsomhedsreaktioner (f. eks. urticaria, angioødem, bronkokonstriktion og anafylaksi) under behandling med alfa- interferon.
Hypersensitivity Serious, acute hypersensitivity reaction (eg, urticaria, angioedema, bronchoconstriction, anaphylaxis) have been rarely observed during alpha interferon therapy.
9 Autoimmune sygdomme Der er rapporteret om udvikling af autoantistoffer og autoimmunsygdomme under behandling med alfa- interferoner.
Autoimmune disease The development of auto-antibodies and autoimmune disorders has been reported during treatment with alpha interferons.
4. 4 og 4. 8).
Patients with signs or symptoms compatible with autoimmune disorders should be evaluated carefully, and the benefit-risk of continued interferon therapy should be reassessed (see also Endocrine System in sections 4.4 and 4.8).
Feber/ infektioner 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.
Fever/ infections 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.
Der er blevet rapporteret alvorlige infektioner (bakterielle, virale og fungale) under behandlingen med alfa interferoner herunder Pegasys.
Serious infections (bacterial, viral, fungal) have been reported during treatment with alpha interferons including Pegasys.
En passende anti- infektiøs behandling bør påbegyndes øjeblikkeligt, og det bør overvejes at afbryde behandlingen.
Appropriate anti-infective therapy should be started immediately and discontinuation of therapy should be considered.
Øjenforandringer Som tilfældet er for andre interferoner, er der efter behandling med Pegasys i sjældne tilfælde rapporteret om retinopati, inklusive retinal hæmoragi, ekssudater, papilødem, optisk neuropati og obstruktion af arterier og vener i retina, som kan medføre synstab.
9 Ocular changes As with other interferons retinopathy including retinal haemorrhages, cotton wool spots, papilloedema, optic neuropathy and retinal artery or vein obstruction which may result in loss of vision have been reported in rare instances with Pegasys.
Patienter, som allerede har øjensygdomme (f. eks. diabetisk eller hypertensiv retinopati), skal have foretaget periodiske øjenundersøgelser under behandlingen med Pegasys.
Patients with preexisting ophthalmologic disorders (eg, diabetic or hypertensive retinopathy) should receive periodic ophthalmologic exams during Pegasys therapy.
Lungeforandringer Som det er tilfældet for andre alfa- interferoner, er der under behandling med Pegasys rapporteret om lungesymptomer, inklusive dyspnø, lungeinfiltrater, pneumoni og pneumonitis.
Pulmonary changes As with other alpha interferons, pulmonary symptoms, including dyspnoea, pulmonary infiltrates, pneumonia, and pneumonitis have been reported during therapy with Pegasys.
Sygdomme i huden Anvendelse af alfa- interferoner er blevet ledsaget af eksacerbation eller provokation af psoriasis og sarcoidosis.
Skin disorder Use of alpha interferons has been associated with exacerbation or provocation of psoriasis and sarcoidosis.
Transplantation Sikkerhed og effekt af behandling med Pegasys er ikke dokumenteret hos patienter, som har fået foretaget levertransplantation.
Transplantation The safety and efficacy of Pegasys treatment have not been established in patients with liver transplantation.
Hiv- HCV- co- infektion Der henvises til produktresuméerne for de retrovirale lægemidler, som skal gives samtidig med HCV - behandling vedrørende opmærksomhed på og håndtering af toksicitet specifikt for hvert produkt samt for potentielt overlap af toksicitet med Pegasys med eller uden ribavirin.
HIV-HCV coinfection 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.
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.
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).
Patienter, som også er smittet med hiv, og som får højaktiv, antiretroviral behandling (HAART), har måske en øget risiko for at udvikle lactacidosis.
Patients co-infected with HIV and receiving Highly Active Anti-Retroviral Therapy (HAART) may be at increased risk of developing lactic acidosis.
Der skal derfor iagttages forsigtighed, når Pegasys og ribavirin gives som adjuvans til HAART- behandling (se produktresuméet for ribavirin).
Caution should therefore be exercised when adding Pegasys and ribavirin to HAART therapy (see ribavirin SPC).
Co- inficerede patienter med fremskreden cirrose, som får HAART har måske en øget risiko for at udvikle hepatisk dekompensation og mulig død, hvis de behandles med ribavirin i kombination med interferoner, inklusiv Pegasys.
Co-infected patients with advanced cirrhosis receiving HAART may also be at increased risk of hepatic decompensation and possibly death if treated with ribavirin in combination with interferons, including Pegasys.
Forhøjet serum- bilirubin, nedsat hæmoglobin, forhøjet basisk phosphatase eller nedsat trombocyttal samt behandling med didanosin (ddI).
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).
4. 5).
The concomitant use of ribavirin with zidovudine is not recommended due to an increased risk of anaemia (see section 4.5).
Co- inficerede patienter skal monitoreres tæt, Child- Pugh- score skal vurderes under behandlingen, og behandlingen skal straks afbrydes, hvis Child- Pugh- score progredierer til 7 eller derover.
Co-infected patients should be closely monitored, assessing their Child-Pugh score during treatment, and should be immediately discontinued if they progress to a Child-Pugh score of 7 or greater.
Hos patienter, der er co- inficeret med hiv- HCV, er begrænsede effekt - og sikkerhedsdata (N = 51) tilgængelige hos personer med CD4- tal mindre end 200 celler/ µl.
In patients co-infected with HIV-HCV, limited efficacy and safety data (N = 51) are available in subjects with CD4 counts less than 200 cells/ uL.
Der bør derfor udvises forsigtighed i behandling af patienter med lavt CD4- tal.
Caution is therefore warranted in the treatment of patients with low CD4 counts.
Dentale og parodontale lidelser Der er blevet rapporteret dentale og parodontale lidelser, som kan føre til tab af tænder, hos patienter, der får kombinationsbehandling med Pegasys og ribavirin.
Dental and periodontal disorders Dental and periodontal disorders, which may lead to loss of teeth, have been reported in patients receiving Pegasys and ribavirin combination therapy.
Patienter bør børste deres tænder grundigt 2 gange om dagen og gennemgå regelmæssige tandeftersyn.
Patients should brush their teeth thoroughly twice daily and have regular
Studiet viste ingen signifikant reduktion i hastigheden af fibroseprogressionen eller relaterede kliniske hændelser.
Use of peginterferon as long term maintenance monotherapy (unapproved use) In a randomised, controlled US study (HALT-C) of HCV non-responder patients with varied degrees of fibrosis where 3.5 years of treatment with 90 micrograms/ week of Pegasys monotherapy was studied, no significant reductions were observed in the rate of fibrosis progression or related clinical events.
Det tyder på, at Pegasys ingen effekt har på in vivo metabolisk aktivitet af cytokrom P450 3A4, 2C9, 2C19 og 2D6 isoenzymer.
Administration of Pegasys 180 micrograms once weekly for 4 weeks in healthy male subjects did not show any effect on mephenytoin, dapsone, debrisoquine and tolbutamide pharmacokinetics profiles, suggesting that Pegasys has no effect on in vivo metabolic activity of cytochrome P450 3A4, 2C9, 2C19 and 2D6 isozymes.
I det samme studie blev der set en 25% stigning i AUC for theophyllin (markør for cytokrom P450 1A2 aktivitet), hvilket viser, at Pegasys er en hæmmer af cytokrom P450 1A2 aktivitet.
In the same study, a 25% increase in the AUC of theophylline (marker of cytochrome P450 1A2 activity) was observed, demonstrating that Pegasys is an inhibitor of cytochrome P450 1A2 activity.
Resultater fra farmakokinetiske substudier fra pivotale fase III- studier viste ingen farmakokinetisk interaktion af lamivudin på Pegasys hos HBV- patienter eller mellem Pegasys og ribavirin hos HCV - patienter.
Results from pharmacokinetic substudies of pivotal phase III trials demonstrated no pharmacokinetic interaction of lamivudine on Pegasys in HBV patients or between Pegasys and ribavirin in HCV patients.
Dette var forbundet med gennemsnitlige methadonkoncentrationer, der lå 10% til 15% højere end ved baseline.
In a pharmacokinetic study of 24 HCV patients concomitantly receiving methadone maintenance therapy (median dose 95 mg; range 30 mg to 150 mg), treatment with Pegasys 180 micrograms sc once weekly for 4 weeks was associated with mean methadone levels that were 10% to 15% higher than at baseline.
Specielt hos patienter, der får en høj methadondosis, bør risikoen for forlængelse af QTc- intervallet tages i betragtning.
Especially in patients on a high dose of methadone, the risk for QTc prolongation should be considered.
Hiv- HCV- co- inficerede patienter Der kunne ikke påvises nogen lægemiddelinteraktion hos 47 hiv- HCV- co- inficerede patienter, som fuldførte et 12 ugers farmakokinetisk delstudie med henblik på at undersøge ribavirins effekt på den intracellulære phosphorylering af visse reverse nukleotid transkriptasehæmmere (lamivudin og zidovudin eller stavudin).
HIV-HCV co-infected patients No apparent evidence of drug interaction was observed in 47 HIV-HCV co-infected patients who completed a 12 week pharmacokinetic substudy to examine the effect of ribavirin on the intracellular phosphorylation of some nucleoside reverse transcriptase inhibitors (lamivudine and zidovudine or stavudine).
Plasmakoncentrationen of ribavirin synes ikke at påvirkes af samtidig administration af reverse nukleotid transkriptasehæmmere (NRTIs).
However, due to high variability, the confidence intervals were quite wide. Plasma exposure of ribavirin did not appear to be affected by concomitant administration of nucleoside reverse transcriptase inhibitors (NRTIs).
11 Samtidig administration af ribavirin og didanosin anbefales ikke.
Co-administration of ribavirin and didanosine is not recommended.
Ekspositionen for didanosin eller dets aktive metabolit (dideoxiadenosin 5 ’ - triphosphat) øges in vitro, når didanosin administreres sammen med ribavirin.
Exposure to didanosine or its active metabolite (dideoxyadenosine 5’ -triphosphate) is increased in vitro when didanosine is co- administered with ribavirin.
Der er rapporteret om fatal leversvigt samt perifer neuropati, pancreatitis og symptomatisk hyperlaktæmi/ mælkesyreacidose under anvendelse af ribavirin.
Reports of fatal hepatic failure as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactataemia/ lactic acidosis have been reported with use of ribavirin.
Forværring af anæmi pga. ribavirin er rapporteret, når zidovudin anvendes som del af hiv- behandling, dog er den eksakte mekanisme stadig ikke belyst.
Exacerbation of anaemia due to ribavirin has been reported when zidovudine is part of the regimen used to treat HIV although the exact mechanism remains to be elucidated.
Kombinationsterapi med ribavirin og zidovudine anbefales ikke, idet der er en forhøjet risiko for udvikling af anæmi (se pkt.
The concomitant use of ribavirin with zidovudine is not recommended due to an increased risk of anaemia (see section 4.4).
Hvis anæmi allerede er fastslået, bør det overvejes, om zidovudin i et ART behandlingsregime bør erstattes.
Consideration should be given to replacing zidovudine in a combination ART regimen if this is already established.
4. 6 Graviditet og amning
11 4.6 Pregnancy and lactation
Der forelægger ikke tilstrækkelig data om brugen af peginterferon alfa- 2a til gravide kvinder.
There are no adequate data on the use of peginterferon alfa-2a in pregnant women.
5. 3), og den potentielle risiko for mennesker er ukendt.
Studies in animals with interferon alfa-2a have shown reproductive toxicity (see section 5.3) and the potential risk for humans is unknown.
Det vides ikke, om indholdsstofferne i dette lægemiddel udskilles i modermælk.
It is not known whether the components of this medicinal product are excreted in human milk.
På grund af risikoen for bivirkninger hos børn, som ammes, skal denne afbrydes før behandlingen påbegyndes.
Because of the potential for adverse reactions in nursing infants, nursing should be discontinued prior to initiation of treatment.
Anvendelse med ribavirin Der er set signifikant teratogen og/ eller embryocid effekt hos alle forsøgsdyr, som har været eksponeret for ribavirin.
Use with ribavirin Significant teratogenic and/ or embryocidal effects have been demonstrated in all animal species exposed to ribavirin.
Kvindelige patienter i den fødedygtige alder og deres partnere skal hver anvende en effektiv præventionsform under behandlingen og i 4 måneder efter behandlingen er ophørt.
Female patients of childbearing potential and their partners must each use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
Mandlige patienter og deres kvindelige partnere skal hver anvende en sikker præventionsform under behandlingen og i 7 måneder efter behandlingen er ophørt.
Male patients and their female partners must each use an effective contraceptive during treatment and for 7 months after treatment has been concluded.
Der henvises til produktresuméet for ribavirin.
Please refer to the ribavirin SPC.
Pegasys påvirker i mindre eller moderat grad evnen til at føre motorkøretøj eller betjene maskiner.
Pegasys has a minor or moderate influence on the ability to drive and use machines.
Patienter, som udvikler svimmelhed, konfusion, søvnighed eller træthed, skal advares om ikke at føre bil eller betjene maskiner.
Patients who develop dizziness, confusion, somnolence or fatigue should be cautioned to avoid driving or operating machinery.
Erfaringer fra kliniske studier
Experience from clinical trials
Hyppigheden og sværhedsgraden af de almindeligst rapporterede bivirkninger efter Pegasys er som rapporteret hos patienter, som behandledes med interferon alfa- 2a (se tabel 4).
The frequency and severity of the most commonly reported adverse reactions with Pegasys are similar to those reported with interferon alfa-2a (see Table 4).
Sværhedsgraden af de hyppigst rapporterede bivirkninger efter 180 mikrogram Pegasys var for det meste let til moderat, og bivirkningerne kunne behandles uden behov for justering af dosis eller afbrydelse af behandlingen.
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.
Kronisk hepatitis B:
Chronic hepatitis B
I kliniske studier med 48 ugers behandling og 24 ugers follow- up svarede sikkerhedsprofilen for Pegasys ved kronisk hepatitis B til sikkerhedsprofilen for kronisk hepatitis C.
In clinical trials of 48 week treatment and 24 weeks follow-up, the safety profile for Pegasys in chronic hepatitis B was similar to that seen in chronic hepatitis C.
6% af de patienter, der blev behandlet med Pegasys, oplevede alvorlige uønskede hændelser under forsøget sammenlignet med 4% af patienterne, der blev behandlet med lamivudin.
With the exception of pyrexia the frequency of the majority of the reported adverse reactions was notably less in CHB patients treated with Pegasys monotherapy compared with HCV patients treated with Pegasys monotherapy (see Table 4) Adverse events were experienced by 88% of Pegasys-treated patients as compared with 53% of patients in the lamivudine comparator group, while 6% of the Pegasys-treated and 4% of the lamivudine-treated patients experienced serious adverse events during the studies.
Uønskede hændelser eller laboratorie- abnormaliteter medførte, at 5% af patienterne skulle have seponeret Pegasys- behandlingen, mens mindre end 1% af patienterne skulle have seponeret lamivudin- behandlingen grundet disse årsager.
Adverse events or laboratory abnormalities led to 5% of patients withdrawing from Pegasys treatment, while less than 1% of patients withdrew from lamivudine treatment for these reasons.
Kronisk hepatitis C hos tidligere ikke- responderende patienter
Chronic hepatitis C in prior non-responder patients
Overordnet svarede sikkerhedsprofilen for Pegasys i kombination med ribavirin hos tidligere ikke - responderende patienter til den hos naive patienter.
Overall, the safety profile for Pegasys in combination with ribavirin in prior non-responder patients was similar to that in naïve patients.
I et klinisk forsøg med patienter, som ikke havde responderet tidligere på pegyleret interferon alfa- 2b/ ribavirin, blev patienterne enten behandlet i 48 eller 72 uger.
In a clinical trial of non-responder patients to prior pegylated interferon alfa-2b/ ribavirin, which exposed patients to either 48 or 72 weeks of treatment, the frequency of withdrawal for adverse events or laboratory abnormalities from Pegasys treatment and
Hyppigheden for seponering på grund af uønskede hændelser eller laboratorieabnormiteter fra Pegasys- behandling og ribavirin- behandling var henholdsvis 6% og 7% i 48 ugers armene og henholdsvis 12% og 13% i 72 ugers armene.
12 ribavirin treatment was 6% and 7%, respectively, in the 48 week arms and 12% and 13%, respectively, in the 72 week arms.
Tilsvarende var hyppigheden for seponering af Pegasys- behandling og ribavirin- behandling 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%).
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%).
Patienter, som blev seponeret fra tidligere behandling med pegyleret interferon alfa- 2b/ ribavirin på grund af hæmatologisk toksicitet, blev udelukket fra deltagelse i dette forsøg.
Patients who withdrew from previous therapy with pegylated interferon alfa-2b/ ribavirin because of hematological toxicity were excluded from enrolling in this trial.
I et andet klinisk forsøg blev ikke- responderende patienter med fremskreden fibrose eller cirrose (Ishak score mellem 3 og 6) og baseline blodpladetal så lavt som 50. 000/ mm3 behandlet i 48 uger.
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/ mm3 were treated for 48 weeks.
4. 4).
Haematologic laboratory abnormalities observed during the first 20 weeks of the trial included anemia (26% of patients experienced a hemoglobin level of < 10 g/ dL), neutropenia (30% experienced an ANC < 750/ mm3), and thrombocytopenia (13% experienced a platelet count < 50,000/ mm3) (see section 4.4).
Kronisk hepatitis C og hiv- co- infektion:
Chronic hepatitis C and HIV co-infection
Hos hiv- HCV- patienter, som får kombinationsbehandling med Pegasys og ribavirin, er der rapporteret om andre bivirkninger hos mellem 1% og 2% af patienterne: hyperlaktacidæmi/ mælkesyreacidose, influenza, pneumoni, affektlabilitet, apati, tinnitus, pharyngolaryngeale smerter, cheilitis, erhvervet lipodystrofi og chromaturi.
In HIV-HCV co-infected patients, the clinical adverse event profiles reported for Pegasys, alone or in combination with ribavirin, were similar to those observed in HCV mono-infected patients For HIV- HCV patients receiving Pegasys and ribavirin combination therapy other undesirable effects have been reported in ≥ 1% to ≤ 2% of patients: hyperlactacidaemia/ lactic acidosis, influenza, pneumonia, affect lability, apathy, tinnitus, pharyngolaryngeal pain, cheilitis, acquired lipodystrophy and chromaturia.
Anvendelsen af Pegasys havde ingen påviselig negativ indflydelse på kontrollen af hiv- viræmi under behandlingen eller under follow- up.
The use of Pegasys had no observable negative impact on the control of HIV viraemia during therapy or follow-up.
Der foreligger begrænsede sikkerhedsdata (n=51) hos co- inficerede patienter med CD4+ celletal < 200/ μl.
Limited safety data (N= 51) are available in co- infected patients with CD4+ cell counts < 200/ µl.
Tabel 4 sammenfatter bivirkningerne, der blev rapporteret med Pegasys- monoterapi hos patienter med kronisk hepatitis B eller kronisk hepatitis C samt hos kronisk hepatitis C- patienter, der fik Pegasys i kombination med ribavirin.
Table 4 summarises the undesirable effects reported with Pegasys monotherapy in CHB or CHC patients and with Pegasys in combination with ribavirin in CHC patients.
13 Tabel 4:
Table 4:
Bivirkninger rapporteret med Pegasys- monoterapi hos patienter med HBV eller HCV eller hos HCV- patienter i kombinationsbehandling med ribavirin System - organklasse
Undesirable Effects Reported with Pegasys Monotherapy for HBV or HCV or In Combination with Ribavirin for HCV Patients Body system
Meget almindelig ≥1/ 10
Very Common ≥ 1/ 10
Ikke almindelig ≥1/ 1. 000 til < 1/ 100
Uncommon ≥ 1/ 1000 to < 1/ 100
Sjælden ≥1/ 10. 000 til < 1/ 1. 000
Rare ≥ 1/ 10,000 to < 1/ 1000
Meget sjælden < 1/ 10. 000
Very rare < 1/ 10,000
Øvre luftvejsinfektioner, bronkitis, oral candidiasis, herpes simplex, svampeinfek - tioner, virale og bakterielle infektioner
Upper respiratory infection, bronchitis, oral candidiasis, herpes simplex, fungal, viral and bacterial infections
Endocarditis, otitis externa
Endocarditis, otitis externa
Trombocytopeni, anæmi, lymfadenopati
Thrombocytopenia, anaemia, lymphadenopathy
Aplastisk anæmi
Aplastic anemia
Anafylaksi, systemisk lupus erytematosus, rheumatoid arthritis
Anaphylaxis, systemic lupus erythematosus, rheumatoid arthritis
Idiopatisk eller trombotisk trombocyto - penisk purpura
Idiopathic or thrombotic thrombocytopenic purpura
Anoreksi
Diabetes
Hypothyroidisme, hyperthyroidisme
Very Common ≥ 1/ 10 Anorexia
Diabetes Dehydrering
Common ≥ 1/ 100 to < 1/ 10
Diabetisk ketoacidose
Very rare < 1/ 10,000
Depression *, angst, søvnløshed *
Depression*, anxiety, insomnia*