FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients in groups A and C (n=111) were treated with Pegasys once weekly for 48 weeks according to BSA categories, whereas patients in group B were observed for a period of 48 weeks (principal observation period).
Danish: Patienter i gruppe A og C (n = 111) blev behandlet med Pegasys en gang ugentligt i 48 uger efter legemsoverfladeareal (BSA) kategorier, hvorimod patienter i gruppe B blev observeret i en periode på 48 uger (primær observationsperiode).
English: When deciding to initiate treatment in childhood, it is important to consider growth inhibition induced by combination therapy.
Danish: Når det besluttes at initiere behandlingen i barndommen, er det vigtigt at overveje væksthæmning forårsaget af kombinationsbehandling.
English: Patients predisposed to the development of autoimmune disorders may be at increased risk.
Danish: Patienter, som er prædisponeret til udvikling af autoimmune forstyrrelser kan have forøget risiko.
English: Sustained response
Danish: Vedvarende respons
English: Table 3: Dose adjustment for adverse reactions in adult patients (for further guidance see also text above)
Danish: Tabel 3: Dosisjustering for bivirkninger hos voksne patienter (se endvidere teksten ovenfor for yderligere vejledning)
English: Positive predictive values of 45% (50/110) and 70% (59/84) were observed for genotype 1 and genotype 2/3 HIV-HCV co-infected patients receiving combination therapy.
Danish: Der blev set positive prædiktive værdier på 45 % (50/110) og 70 % (59/84) hos hhv. genotype 1 og genotype 2/3 hiv-HCV-co-inficerede patienter i kombinationsbehandling.
English: Treatment difference [95%CI]
Danish: Behandlingsforskel [95 % konfidensinterval]
English: 180 micrograms <75 kg = 1000 mg ≥75 kg = 1200 mg
Danish: 180 mikrogram <75 kg = 1.000 mg ≥75 kg = 1.200 mg
English: Patients should be closely monitored during therapy and even after treatment discontinuation.
Danish: Patienterne bør følges tæt under behandlingen og selv efter behandlingsophør.
English: A return to original dosing is not recommended.
Danish: Det anbefales dog ikke at vende tilbage til den oprindelige dosis.
English: At 2 years posttreatment, 16% (6 of 38) of patients remained 15 percentiles or more below their baseline weight curve and 11% (4 of 38) remained 15 percentiles or more below their baseline height curve.
Danish: 2 år efter behandlingen forblev 16 % (6 ud af 38) af patienterne 15 percentiler eller mere under deres baseline vægtkurve og 11 % (4 ud af 38) forblev 15 percentiler eller mere under deres baseline højdekurve.
English: The peak to trough ratio after 48 weeks of treatment is about 1.5 to 2.
Danish: Peak/trough forholdet efter 48 uger er ca. 1,5 til 2.
English: For paediatric patients, based on toxicities, up to three levels of dose modification can be made before dose interruption or discontinuation is considered (see Table 5).
Danish: Baseret på toksiciteter, kan der for pædiatiske patienter foretages op til 3 niveau dosisændringer før dosisafbrydelse eller seponering overvejes (se tabel 5)
English: Pancytopenia and bone marrow suppression have been reported in the literature to occur within 3 to 7 weeks after the administration of a peginterferon and ribavirin concomitantly with azathioprine.
Danish: Pancytopeni og knoglemarvssuppression er blevet rapporteret i litteraturen til at indtræde inden for 3 til 7 uger efter administrationen af peginterferon og ribavirin samtidig med azathioprin.
English: ● Slowly pull back the plunger to withdraw a bit more than the dose prescribed by your doctor into the syringe.
Danish: • Træk langsomt stemplet tilbage for at trække lidt mere end den ordinerede dosis op i sprøjten.
English: Both studies compared Pegasys plus placebo vs Pegasys plus lamivudine vs lamivudine alone.
Danish: Begge studier sammenlignede Pegasys plus placebo med Pegasys plus lamivudin og lamivudin alene.
English: At the end of 2 years follow-up after treatment, most patients had returned to baseline normative growth curve percentiles for weight and height (mean weight percentile was 64% at baseline and 60% at 2 years post-treatment; mean height percentile was 54% at baseline and 56% at 2 years post-treatment).
Danish: Ved afslutning af 2-års opfølgningen efter behandling, var de fleste patienter vendt tilbage til baseline normative vækstkurvepercentiler for vægt og højde (gennemsnitsvægtpercentil var 64 % ved baseline og 60 % 2 år efter behandling; gennemsnitshøjdepercentil var 54 % ved baseline og 56 % 2 år efter behandling).
English: 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.
Danish: Forværring af anæmi pga. ribavirin er rapporteret, når zidovudin anvendes som del af hiv-behandling, dog er den eksakte mekanisme stadig ikke belyst.
English: Treatment with interferon alfa-2a resulted in a statistically significant increase in abortifacient activity in rhesus monkeys.
Danish: Behandling med interferon alfa-2a medførte en statistisk signifikant stigning i abortfremkaldende aktivitet hos rhesusaber.
English: Lactic acidosis and worsening liver function are side effects associated with Highly Active Anti-Retroviral Therapy (HAART), an HIV treatment.
Danish: Mælkesyreacidose og forværret leverfunktion er bivirkninger, som forbindes med ”Highly Active Anti-Retroviral Therapy”, HAART, som er en hiv-behandling.
English: These patients had stable HIV disease and mean CD4 T-cell count was about 500 cells/µl.
Danish: Disse patienter havde stabil hiv-sygdom og gennemsnittet af CD4 Tcelletal var omkring 500 celler/µl.
English: In both studies, Pegasys apparent clearance and apparent volume of distribution were related linearly to body size ie. either BSA (NR16141) or body weight (YV25718).
Danish: I begge studier var Pegasys' tydelige clearance og tydelige fordelingsvolume relateret lineært til kropsstørrelse dvs. enten legemsoverfladeareal (NR16141) eller kropsvægt (YV25718).
English: Treatment with Pegasys should be discontinued immediately in patients with hepatic decompensation.
Danish: Behandling med Pegasys bør afbrydes øjeblikkeligt hos patienter med hepatisk dekompensation.
English: Ischaemic colitis, tongue pigmentation
Danish: Iskæmisk colitis, pigmentering af tunge
English: b Patients who achieved viral suppression at week 12 but were missing HCV RNA results at the end of follow-up were considered to be non-responders.
Danish: b Patienter, som opnåede viral suppression ved uge 12, men manglede HCV-RNA-resultater ved slutningen af opfølgningsperioden, blev anset for at være ikke-responderende.
English: ● Allow the solution to reach room temperature before injection or warm the syringe between your palms.
Danish: • Sørg for, at opløsningen har stuetemperatur, før injektionen eller varm sprøjten mellem håndfladerne.
English: Study NV15496 + NV15497 + NV15801
Danish: Studie NV15496 + NV15497 + NV15801
English: Reproductive toxicity studies have not been performed with Pegasys.
Danish: Der er ikke udført reproduktionsstudier med Pegasys.
English: Must not be given to premature babies, neonates or children up to 3 years old.
Danish: Må ikke indgives til præmature (for tidligt fødte) babyer, nyfødte eller børn op til 3 år.
English: Injury or poisoning: Substance overdose
Danish: Traumer og forgiftninger: Overdosering
English: ● if you have thyroid disease that is not well controlled with medicines.
Danish: ● hvis du har en sygdom i skjoldbruskkirtlen, som ikke kan kontrolleres med medicin.
English: 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.
Danish: Uønskede hændelser eller laboratorie-abnormiteter medførte, at 5 % af patienterne skulle have seponeret Pegasys-behandlingen, mens mindre end 1 % af patienterne skulle have seponeret lamivudin-behandlingen grundet disse årsager.
English: During treatment your doctor will take blood samples regularly to check for changes in your white blood cells (cells that fight infection), red blood cells (cells that carry oxygen), platelets (blood clotting cells), liver function, glucose (blood sugar levels) or changes in other laboratory values.
Danish: Under behandlingen vil din læge regelmæssigt tage blodprøver for at undersøge evt. ændringer i dine hvide blodceller (celler der bekæmper infektion), røde blodceller (celler der bærer ilt), blodplader (celler der får blodet til at størkne), leverfunktionen, glukose (blodsukkeret) eller ændringer i andre laboratorieværdier.
English: Pegasys is used alone only if you cannot take ribavirin for any reason.
Danish: Pegasys gives kun alene, hvis du af en eller anden årsag ikke kan tage ribavirin.
English: After the injection: Wipe the injection site with the alcohol pad, if necessary.
Danish: Efter injektionen: Tør injektionsstedet med spritservietten, hvis det er nødvendigt.
English: For HBV genotype A and D, subgroup size was insufficient to be analyzed.
Danish: HBVgenotype A og D subgruppe-størrelse var utilstrækkelig til at blive analyseret.
English: Hormone system disorders: Diabetes (high blood sugar) Metabolic disorders: Dehydration
Danish: Hormonsystemet: Diabetes (højt indhold af sukker i blodet) Metaboliske forstyrrelser: Dehydrering
English: Both chronic hepatitis B and C are viral infections of the liver.
Danish: Både kronisk hepatitis B og C er virusinfektioner i leveren.
English: *Results indicate undetectable HCV-RNA defined as HCV RNA less than 50 IU/ml at 24 weeks post-treatment using the AMPLICOR HCV test v2.
Danish: *Resultater indikerer ikke-detekterbar HCV-RNA defineret som HCV-RNA mindre end 50 IE/ml ved 24 uger efter behandlingsafslutning ved brug af AMPLICOR HCV-test v2.
English: Peginterferon alfa-2a is found predominantly in the bloodstream and extracellular fluid as seen by the volume of distribution at steady-state (Vd) of 6 to 14 litres in humans after intravenous administration.
Danish: Peginterferon alfa-2a findes fortrinsvis i blodet og ekstracellulærvæsken, som det fremgår af distributionsvolumenet i steady-state (Vd) på 6 til 14 liter hos mennesker efter intravenøs administration.
English: Your doctor has determined the exact dose of Pegasys for your child and will tell you how often to use it.
Danish: Din læge har fastsat den nøjagtige dosis Pegasys for dit barn, og lægen vil fortælle dig, hvor ofte dit barn skal anvende det.
English: Some children and adolescents treated with Pegasys for chronic hepatitis B for 48 weeks did not grow or gain weight as much as expected for their age.
Danish: Nogle børn og unge behandlet med Pegasys for kronisk hepatitis B i 48 uger voksede ikke eller tog ikke på i vægt som forventet for deres alder.
English: 4) Choose and prepare an injection site 5) Remove cap
Danish: 4) Vælg og forbered et injektionssted 5) Fjern hætten
English: Pegasys contains benzyl alcohol.
Danish: Pegasys indeholder benzylalkohol.
English: Reduce ribavirin to 600 mg
Danish: Reducer ribavirin til 600 mg
English: ● if you are an adult who has or had a history of substance abuse (e.g. alcohol or drugs)
Danish: ● hvis du er voksen og har eller tidligere har haft et stofmisbrug (f.eks. alkohol eller narkotika/medicin).
English: Discontinue combination
Danish: Stop kombinationsbehandlingen
English: The safety profiles in both ribavirin groups were consistent with the known safety profile of Pegasys plus ribavirin combination treatment and not indicative of any relevant differences, with the exception of a slight increase in anaemia in the high dose ribavirin arm.
Danish: Sikkerhedsprofilen i begge ribaviringrupper var konsistent med den kendte sikkerhedsprofil for Pegasys plus ribavirin kombinationsbehandling og indikerede ikke nogle relevante forskelle med undtagelse af en lettere stigning af anæmi i gruppen med den høje dosis ribavirin.
English: Ask your doctor, hospital or pharmacist for an appropriate container.
Danish: Spørg lægen, sygehuset eller apotekspersonalet om en egnet beholder.
English: Psychiatric and Central Nervous System (CNS): Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during Pegasys therapy, and even after treatment discontinuation mainly during the 6-month follow-up period.
Danish: Psykiatri og centralnervesystemet (CNS): Der er set svære symptomer fra centralnervesystemet, specielt depression, suicidale tanker og suicidalforsøg, hos nogle patienter, som er i behandling med Pegasys, og selv efter behandlingen er stoppet, hovedsageligt under den 6-måneders follow-up periode.
English: Pegasys must be used with caution in patients with psoriasis, and in cases of onset or worsening of psoriatic lesions, discontinuation of therapy should be considered.
Danish: Pegasys skal anvendes med forsigtighed hos patienter med psoriasis, og hvis der forekommer udbrud eller forværring af psoriasislæsioner, skal det overvejes at stoppe behandlingen.
English: The Pegasys pre-filled pen is intended to be used in a home-setting by patients who have been properly instructed.
Danish: Den fyldte pen med Pegasys er påtænkt til brug i hjemmet af patienter, som er blevet korrekt instrueret.
English: A total of 283/1351 (21%) of patients had advanced fibrosis or cirrhosis, 85/1351 (6%) had cirrhosis.
Danish: I alt havde 283/1.351 (21 %) af patienterne fremskreden fibrose eller cirrose, 85/1.351 (6 %) havde cirrose.
English: Visually examine the pre-filled pen, as well as the medicine through the viewing window.
Danish: Undersøg den fyldte pen visuelt og medicinen igennem vinduet.
English: Table 23: HBeAg seroconversion rates (%) by HBV genotype and baseline ALT levels Group A (Pegasys treatment) (N=101)
Danish: Tabel 23: HBeAg sero-konversion rate (%) for HBV genotype og ALAT-niveauer ved baseline Gruppe A (Pegasys behandling) (N=101)
English: The posology of Pegasys in paediatric patients is based on the Body Surface Area (BSA).
Danish: Doseringen af Pegasys i pædiatriske patienter er baseret på legemsoverfladeareal (BSA).
English: Collect the necessary items before beginning: Included in the pack:
Danish: Tag de nødvendige ting frem, før du påbegynder injektionen: Indlagt i pakningen:
English: If you forget to take Pegasys
Danish: Hvis du har glemt at tage Pegasys
English: Pegasys is designed for administration by the patient or carer.
Danish: Pegasys er designet til at administreres af patienten eller af plejepersonalet.
English: All patients were followed for 24 weeks post-treatment.
Danish: Alle patienter blev fulgt i 24 uger efter behandlingsafslutning.
English: Haemoglobin - stable cardiac disease decrease ≥ 2 g/dl during any 4 weeks
Danish: Hæmoglobin - stabil hjertesygdom fald på ≥2 g/dl i løbet af 4 uger
English: Place pre-filled pen straight up on the skin fold at a right angle (90°) on the injection site.
Danish: Placer den fyldte pen direkte på hudfolden i en ret vinkel (90°) på injektionsstedet.
English: Cases of pulmonary arterial hypertension (PAH) have been reported with interferon alfa products, notably in patients with risk factors for PAH (such as portal hypertension, HIV infection, cirrhosis).
Danish: Der er indberettet tilfælde af pulmonal arteriel hypertension (PAH) i forbindelse med lægemidler indeholdende interferon alfa, navnlig hos patienter med risikofaktorer for PAH (såsom portalhypertension, hivinfektion og cirrose).
English: No response by week
Danish: Intet respons ved uge 12
English: The development of auto-antibodies and autoimmune disorders has been reported during treatment with alfa interferons.
Danish: Der er rapporteret om udvikling af autoantistoffer og autoimmunsygdomme under behandling med interferon alfa.
English: The SVRs reported in the treatment arms of this study were similar to the corresponding treatment arms from study NV15942.
Danish: Det vedvarende virologiske respons rapporteret i behandlingsarmen i dette studie lignede den korresponderende behandlingsarm for studie NV15942.
English: Modified Assessment Assessment
Danish: Modificeret vurdering Vurdering
English: If your female partner is not pregnant now, but is of childbearing potential, she must be tested for pregnancy each month during treatment and for the 7 months after treatment has stopped.
Danish: Hvis din kvindelige partner ikke er gravid på nuværende tidspunkt, men er i den fertile alder, skal hun have foretaget graviditetstest hver måned under behandlingen og i hver af de 7 måneder efter behandlingen er stoppet.
English: If there is any deterioration of cardiovascular status, therapy should be suspended or discontinued.
Danish: Hvis der indtræffer forværringer af den kardiovaskulære status, skal behandlingen afbrydes midlertidigt eller helt stoppes.
English: HCV RNA levels decline in a biphasic manner in responding patients with hepatitis C who have received treatment with 180 micrograms Pegasys.
Danish: HCV-RNA-niveauet falder bifasisk hos responderende patienter med hepatitis C, som har fået behandling med 180 mikrogram Pegasys.
English: There are no data in paediatric patients coinfected with HCV/HIV or with renal impairment.
Danish: Der er ingen data tilgængelig hos pædiatriske patienter co-inficeret med HCV/hiv eller med nedsat nyrefunktion.
English: Press the pre-filled pen firmly against the skin until the needle-shield is completely pushed into the pen.
Danish: Pres den fyldte pen fast mod huden, indtil kanylebeskyttelsen er skubbet fuldstændig ind i pennen.
English: It is recommended that Pegasys pre-filled syringes be used for children and adolescents, as they allow for dose adjustments.
Danish: Det anbefales at bruge Pegasys fyldte injektionssprøjter til børn og unge, idet de tillader dosisjusteringer.
English: The frequency and severity of the most commonly reported adverse reactions with Pegasys are similar to those reported with interferon alfa-2a (see Table 9).
Danish: Hyppigheden og sværhedsgraden af de almindeligst rapporterede bivirkninger med Pegasys er tilsvarende dem, som er rapporteret med interferon alfa-2a (se tabel 9).
English: Contact your doctor or pharmacist if you need any help determining how to manage a missed dose of Pegasys.
Danish: Kontakt lægen eller apotekspersonalet, hvis du har brug for hjælp med hensyn til, hvad du skal gøre, hvis du glemmer at tage en Pegasys-dosis.
English: If VKH syndrome is suspected, antiviral treatment should be withdrawn and corticosteroid therapy discussed (see section 4.8).
Danish: Hvis der er mistanke om VKH-syndrom, skal antiviral behandling seponeres, og kortikosteroidbehandling diskuteres (se pkt.
English: For a few subjects who were more than 15 percentiles below their baseline height curve at 2 years post-treatment, they either returned to baseline comparable height percentiles at 6 years post-treatment or a non-treatment related causative factor has been identified.
Danish: Enkelte patienter, der lå mere end 15 percentiler under deres baseline-højdekurve 2 år efter behandling, vendte enten tilbage til højdepercentiler, der var sammenlignelige med baseline, 6 år efter behandling, eller der blev identificeret en ikke-behandlingsrelateret årsagssammenhæng.
English: 6) Place the pre-filled pen on the injection site
Danish: 6) Placér den fyldte pen på injektionsstedet
English: Available data for patients infected with genotype 5 or 6 are limited; therefore combination treatment with 1,000/1,200 mg of ribavirin for 48 weeks is recommended.
Danish: Data for patienter inficeret med genotype 5 og 6 er begrænset; derfor anbefales kombinationsbehandling med 1.000/1.200 mg ribavirin i 48 uger.
English: If symptoms of psychiatric disorders appear, the potential seriousness of these undesirable effects must be borne in mind by the prescribing physician and the need for adequate therapeutic management should be considered.
Danish: Hvis symptomer på psykiatriske sygdomme forekommer, skal den potentielle alvorlighed af disse bivirkninger vurderes af lægen og behovet for tilstrækkelig medicinsk behandling skal overvejes.
English: However, several independent studies have demonstrated the 135mcg dose to be safe, efficacious and well tolerated, in patients with ESRD (see section 4.2).
Danish: Det er dog i flere uafhængige studier vist at en dosis på 135 mikrogram er sikker, effektiv og veltolereret blandt patienter med terminal nyresygdom (se pkt.
English: May cause toxic reactions and allergic reactions in infants and children up to 3 years old.
Danish: Det kan medføre toksiske reaktioner og allergiske reaktioner hos nyfødte og børn op til 3 år.
English: ● if you have advanced liver disease and your liver does not work properly (e.g. your skin has become yellow).
Danish: ● hvis du har fremskreden leversygdom og din lever ikke fungerer, som den skal (f.eks. hvis din hud bliver gul).
English: If you have this reaction, be sure to rinse your mouth thoroughly afterwards.
Danish: Hvis du oplever dette, så skyl munden grundigt efterfølgende.
English: The response rate was lower in patients with no to minimal increase in ALT level at baseline (see Section 5.1).
Danish: Responsraten var lavere hos patienter uden eller med minimal stigning i ALAT-niveau ved baseline (se pkt.
English: Based on drug exposure, pharmacodynamic response and tolerability, a lower dose of Pegasys is not needed in the geriatric patient (see section 4.2).
Danish: Baseret på lægemiddelbelastning, farmakodynamisk respons og tolerabilitet er det ikke nødvendigt med en lavere Pegasys-dosis til ældre patienter (se pkt.
English: ● if you are a woman of childbearing potential who is taking Pegasys in combination with ribavirin, you must have a negative pregnancy test before treatment, each month during therapy and for the 4 months after treatment is stopped.
Danish: ●hvis du er en kvinde i den fertile alder og tager Pegasys sammen med ribavirin, skal du have foretaget en graviditetstest, der er negativ, før behandlingen påbegyndes, hver måned under behandlingen og i hver af de 4 måneder efter behandlingen er stoppet.
English: Therapy should initially be re-instituted at 90 micrograms Pegasys and the neutrophil count monitored.
Danish: Behandlingen bør da genoptages med 90 mikrogram Pegasys, og neutrofilocyttallet skal kontrolleres.
English: It is unknown whether peginterferon alfa-2a/metabolites are excreted in human milk.
Danish: Det vides ikke, om peginterferon alfa-2a/metabolitter udskilles i human mælk.
English: ● With one hand, pinch a fold of loose skin.
Danish: • Klem med den ene hånd en løs hudfold sammen.
English: Modified Assessment
Danish: Modificeret vurdering
English: Hepatic neoplasm
Danish: Hepatisk neoplasma
English: copies/ml.
Danish: kopier/ml.
English: Regardless of the starting dose or degree of renal impairment, patients should be monitored and appropriate dose reductions of Pegasys during the course of therapy should be made in the event of adverse reactions.
Danish: Uanset initialdosis eller den nedsatte nyrefunktions sværhedsgrad skal patienterne monitoreres, og der skal foretages passende reduktion af Pegasys-dosis under behandlingen, hvis der kommer bivirkninger.
English: 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.
Danish: Co-inficerede patienter med fremskreden cirrose, som får HAART kan have en øget risiko for at udvikle hepatisk dekompensation og mulig død, hvis de behandles med ribavirin i kombination med interferoner, inklusiv Pegasys.
English: The Child-Pugh scoring may be affected by factors related to treatment (i.e. indirect hyperbilirubinemia, decreased albumin) and not necessarily attributable to hepatic decompensation.
Danish: Child-Pugh-score kan blive påvirket af faktorer relateret til behandling (dvs. indirekte hyperbilirubinæmi, formindsket albumin) og kan ikke nødvendigvis tilskrives den hepatiske dekompensation.