FrancophonIA/ELRC3.0 huggingface dataset:
English: Pegasys treatment was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage.
Danish: Behandling med Pegasys var ledsaget af fald i de absolutte CD4+ celletal indenfor de første uger uden reduktion i CD4+ celleprocenten.
English: (5 days after your Friday dose).
Danish: (5 dage senere).
English: Exposure to didanosine or its active metabolite (dideoxyadenosine 5'-triphosphate) is increased in vitro when didanosine is coadministered with ribavirin.
Danish: Eksponeringen af didanosin eller dets aktive metabolit (dideoxiadenosin 5'-triphosphat) øges in vitro, når didanosin administreres sammen med ribavirin.
English: There was no difference in response rate between these patients and those without advanced fibrosis or cirrhosis.
Danish: Der var ingen forskel i responsrate mellem disse patienter og patienter uden fremskreden fibrose eller cirrose.
English: ● Do not try to use the pre-filled pen again
Danish: ●Du må ikke prøve at bruge den fyldte pen igen
English: The major treatment-related change was reversible mild to moderate anaemia, the severity of which was greater than that produced by either active substance alone.
Danish: Den vigtigste behandlingsrelaterede ændring var reversibel mild til moderat anæmi, hvis sværhedsgrad var større end efter de enkelte aktive stoffer alene.
English: The interaction between theophylline and Pegasys is likely to be maximal after more than 4 weeks of Pegasys therapy.
Danish: Interaktionen mellem theophyllin og Pegasys er sandsynligvis maksimal efter mere end 4 ugers behandling med Pegasys.
English: Caution is therefore warranted in the treatment of patients with low CD4 counts.
Danish: Der bør derfor udvises forsigtighed i behandling af patienter med lavt CD4-tal.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Allow the refrigerated pre-filled pen to adjust to room temperature for about 20 minutes.
Danish: Lad den nedkølede fyldte pen tilpasse sig til stuetemperatur i omkring 20 minutter.
English: Where dose adjustment is required for moderate to severe adverse reactions (clinical and/or laboratory) initial dose reduction to 135 micrograms is generally adequate for adult patients.
Danish: Når dosisjustering er påkrævet på grund af moderate til svære bivirkninger (kliniske og/eller laboratoriemæssige) er en initial dosisreduktion til 135 mikrogram almindeligvis tilstrækkelig for voksne patienter.
English: Patients in group B had the choice to switch to treatment with Pegasys after Week 48 of the principal observation period.
Danish: Patienter i gruppe B havde valget at skifte til behandling med Pegasys efter uge 48 af den primære observationsperiode.
English: While holding pre-filled pen firmly in place, press the activation button with your thumb and immediately release the button.
Danish: Mens du holder den fyldte pen sikkert på plads, skal du trykke på aktiveringsknappen med tommelfingeren og straks slippe knappen.
English: The potency of this medicinal product should not be compared to the one of another pegylated or nonpegylated protein of the same therapeutic class.
Danish: Styrken af dette lægemiddel bør ikke sammenlignes med det fra et andet pegyleret eller non-pegyleret protein i den samme terapeutiske klasse.
English: Most laboratory abnormalities noted during the clinical trial returned to baseline levels shortly after discontinuation of treatment.
Danish: De fleste laboratorie-abnormiteter bemærket under det kliniske studie gik tilbage til baselineværdier kort tid efter seponering af behandling.
English: - Adequately controlled thyroid function (TSH and T4)
Danish: - Adækvat kontrolleret thyreoideafunktion (TSH og T4)
English: After the Week 24 follow-up visit, patients from group A, B and C entered a long-term follow-up period (lasting for 5 years after end of treatment).
Danish: Efter de opfølgende besøg i 24 uger, blev patienter fra gruppe A, B og C inkluderet i en langtids opfølgningsperiode (5 år efter afsluttet behandling).
English: The frequencies observed (4.9%) in patients receiving Pegasys/ribavirin (NV15801) are similar to those observed with other interferons.
Danish: De observerede hyppigheder (4,9 %) hos patienter, som fik Pegasys/ribavirin (NV15801), var de samme som observeret for andre interferoner.
English: Multiple regression and pooled group analyses evaluating the influence of treatment duration and use of induction dosing clearly identified treatment duration for 72 weeks as the primary driver for achieving a sustained virological response.
Danish: Flere regression- og samlede gruppeanalyser, som evaluerede påvirkningen af behandlingsvarighed og brug af induktionsdosis, identificerede klart behandlingsvarighed på 72 uger som den primære drivkraft for at opnå et vedvarende virologisk respons.
English: 55% (21 of 38) of subjects who completed the original study enrolled in the long-term follow up extending up to 6 years post-treatment.
Danish: 55 % (21 ud af 38) af de patienter, der fuldførte det orginale studie, fortsatte i langtidsopfølgningen op til 6 år efter behandling.
English: ● Clean and disinfect the skin where the injection is to be made with a cleansing swab.
Danish: • Rens og desinficer huden, hvor injektionen skal foretages, med et stykke vat.
English: ● if you are a man who is taking Pegasys in combination with ribavirin, do not have sex with a pregnant woman unless you use a condom.
Danish: ●hvis du er en mand, der tager Pegasys sammen med ribavirin, må du ikke have sex med en gravid kvinde, medmindre du anvender kondom.
English: Use of alfa interferons has been associated with exacerbation or provocation of psoriasis and sarcoidosis.
Danish: Anvendelse af interferon alfa er blevet ledsaget af eksacerbation eller provokation af psoriasis og sarcoidosis.
English: In some cases, dose modification may be necessary (see section 4.2).
Danish: I nogle tilfælde kan det være nødvendigt med modifikation af dosis (se pkt.
English: ● the medicine is any colour besides colourless to light yellow
Danish: ● medicinen er en anden farve end farveløs til lysegul
English: Once the cap is removed, the pre-filled pen should be used immediately.
Danish: Når hætten er blevet fjernet, skal den fyldte pen bruges med det samme.
English: Haematological (see also Table 3)
Danish: Hæmatologiske bivirkninger (se også tabel 3)
English: Genotype 2 and 3 (N=96)
Danish: Genotype 2 og 3 (N=96)
English: With your other hand hold the syringe as you would a pencil.
Danish: Tag sprøjten i den anden hånd, ligesom du holder på en blyant.
English: ● if you are being treated with telbivudine, a medicine for hepatitis B infection (see “Other medicines and Pegasys”).
Danish: ● hvis du bliver behandlet med telbivudin, som er et lægemiddel mod hepatitis B-infektion (se ”Brug af anden medicin sammen med Pegasys”).
English: 1) Visually check the pre-filled pen 2) Allow the pre-filled pen to adjust to room temperature 3) Clean your hands
Danish: 1) Undersøg den fyldte pen visuelt 2) Lad den fyldte pen tilpasse sig til stuetemperatur 3) Vask hænderne
English: ● if you think you are getting an infection (such as pneumonia) as when receiving Pegasys you may temporarily have a greater risk of getting an infection.
Danish: ● hvis du tror, du er ved at få en infektion (som f.eks. lungebetændelse), da du forbigående kan være mere udsat for at få en infektion, mens du får Pegasys.
English: Subcutaneous administration of Pegasys should be limited to the abdomen and thigh, as the extent of absorption based on AUC was about 20% to 30% higher upon injection in the abdomen and thigh.
Danish: Subkutan administration af Pegasys skal begrænses til abdomen og lår, idet omfanget af absorptionen baseret på AUC var omkring 20-30 % højere ved injektion i abdomen og lår.
English: 1-5% of patients treated with Pegasys developed neutralising anti-interferon antibodies.
Danish: 1-5 % af de patienter, som blev behandlet med Pegasys, udviklede neutraliserende anti-interferon antistoffer.
English: If treatment with alfa interferon is judged necessary in these patients, the presence of psychiatric co-morbidities and the potential for other substance use should be carefully assessed and adequately managed before initiating therapy.
Danish: Hvis behandling med interferon alfa vurderes at være nødvendig hos disse patienter, skal tilstedeværelsen af psykiatriske co-morbiditeter og muligheden for brug af andre stoffer nøje vurderes og være håndteret i tilstrækkelig grad før behandlingen påbegyndes.
English: Sarcoidosis, thyroiditis
Danish: Sarcoidose, thyroiditis
English: Patients with advanced fibrosis were assigned to Pegasys treatment (group C, n=10).
Danish: Patienter med fremskreden fibrose blev tildelt Pegasys behandling (gruppe C, n = 10).
English: Overall treatment for 16 weeks resulted in lower sustained viral response (65%) than treatment for 24 weeks (76%) (p < 0.0001).
Danish: Behandling i 16 uger resulterede i lavere vedvarende virologisk respons (65 %) end behandling i 24 uger (76 %) (p<0,0001).
English: ● if you have had an organ transplant (liver or kidney) or have one planned in the near future.
Danish: ● hvis du har fået en organtransplantation (lever eller nyre) eller er indstillet til at blive transplanteret i den nærmeste fremtid.
English: Moreover, the benefit of the combination of telbivudine with interferon alfa (pegylated or standard) is not currently established.
Danish: Ydermere er fordelen ved kombination af telbivudin og interferon alfa (pegyleret eller standard) ikke fastslået på nuværende tidspunkt.
English: 7) Give injection
Danish: 7) Giv injektionen
English: Response rates at the end of follow-up for the two studies are presented in Table 12.
Danish: De to studiers responsrater ved afslutningen af follow-up-perioden fremgår af tabel 12.
English: 24 weeks or 48 weeks
Danish: 24 uger eller 48 uger
English: The syringe, needle and all injection materials are intended for single use and must be discarded after the injection.
Danish: Sprøjten, kanylen og al injektionsmateriale er beregnet til engangsbrug og skal bortkastes efter injektionen.
English: 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.
Danish: 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.
English: # p-value (vs. lamivudine) < 0.01 (stratified Cochran-Mantel-Haenszel test)
Danish: # p-værdi (vs. lamivudin) <0,01 (stratificeret Cochran-Mantel-Haenszel test)
English: Patients who have detectable virus at week 12 should stop therapy.
Danish: Patienter, som har detekterbar virus ved uge 12, bør stoppe behandlingen.
English: The solution is clear and colourless to light yellow.
Danish: Opløsningen er klar og farveløs til let gullig.
English: Disposal of the injection materials
Danish: Bortskaffelse af injektionsmaterialet
English: The duration of combination treatment in children with chronic hepatitis C varies from 6 to 12 months depending on the type of virus your child is infected with and their response to therapy.
Danish: Varigheden af kombinationsbehandling hos børn med kronisk hepatitis C varierer fra 6 til 12 måneder, afhængig af den type virus dit barn er smittet med og barnets respons på behandlingen.
English: The use of Pegasys had no observable negative impact on the control of HIV viraemia during therapy or follow-up.
Danish: Anvendelsen af Pegasys havde ingen påviselig negativ indflydelse på kontrollen af hiv-viræmi under behandlingen eller under follow-up.
English: 5) Remove cap
Danish: 5) Fjern hætten
English: The mechanism behind these events is not known; thus, co-treatment with telbivudine and other interferons (pegylated or standard) may also entail an excess risk.
Danish: Mekanismen herfor er ukendt, og kombinationsbehandling med telbivudin og andre interferoner (pegyleret eller standard) kan derfor også indebære en øget risiko.
English: HBeAg negative / anti-HBe positive Study WV16241
Danish: HBeAg-negativ/anti-HBe-positiv Studie WV16241
English: ● Remove the protective cap that covers the back of the needle (1-2).
Danish: • Fjern den beskyttelseshætte, som dækker bagsiden af kanylen (1-2).
English: ● Check for air bubbles in the syringe.
Danish: • Tjek sprøjten for luftbobler.
English: ● remove the cap until you are ready to inject.
Danish: ● fjerne hætten, før du er klar til at injicere.
English: ● a short needle for the subcutaneous injection
Danish: ● en kort kanyle til subkutan injektion
English: Tell your doctor or pharmacist if you are being treated with telbivudine.
Danish: Fortæl det til din læge eller apotekspersonalet, hvis du bliver behandlet med telbivudin.
English: • Severe hepatic dysfunction or decompensated cirrhosis of the liver
Danish: • Svær hepatisk dysfunktion eller dekompenseret levercirrose
English: The first phase of decline occurs 24 to 36 hours after the first dose of Pegasys and is followed by the second phase of decline which continues over the next 4 to 16 weeks in patients who achieve a sustained response.
Danish: Faldets første fase indtræffer indenfor 24 til 36 timer efter den første Pegasys-dosis, og efterfølges af anden fase, som fortsætter de næste 4 til 16 uger hos patienter med varigt respons.
English: All patients were followed up for 24 weeks post-treatment (groups A and C), or post-principal observation period (group B).
Danish: Alle patienter blev fulgt i 24 uger efter behandlingsafslutning (gruppe A og C), eller efter den primære observationsperiode (gruppe B).
English: Store in a refrigerator (2°C - 8°C).
Danish: Opbevares i køleskab(2°C - 8°C).
English: Keep the pre-filled pen pressed on the skin for 10 seconds for injection to complete.
Danish: Hold den fyldte pen presset mod huden i 10 sekunder, så injektionen afsluttes.
English: In case of persistent or unexplained pulmonary infiltrates or pulmonary function impairment, treatment should be discontinued.
Danish: Hvis der er tegn på persisterende eller uforklarlige lungeinfiltrater eller påvirkning af lungefunktionen, skal behandlingen stoppes.
English: At the end of treatment, 43% of patients experienced a weight percentile decrease of 15 percentiles or more, and 25% (13 of 53) experienced a height percentile decrease of 15 percentiles or more on the normative growth curves.
Danish: Ved afslutning af behandling havde 43 % af patienterne oplevet et fald af vægtpercentil på 15 percentiler eller mere og 25 % (13 ud af 53) oplevede et fald af højdepercentil på 15 percentiler eller mere på de normative vækstkurver.
English: Appropriate training is recommended for non-healthcare professionals administering this medicinal product.
Danish: Det anbefales at oplære personer, som administrerer dette lægemiddel og ikke er sundhedsprofessionelle, hensigtsmæssigt.
English: Study WV16240 recruited patients who were positive for HBeAg, while study WV16241 recruited patients who were negative for HBeAg and positive for anti-HBe.
Danish: Studie WY16240 rekrutterede patienter, som var HBeAg-positive, mens studie WV16241 rekrutterede patienter, som var HBeAg-negative og anti-HBe-positive.
English: No biomarker can be identified with acceptable performance for HBeAg-negative patients with HBV genotype B or C infection.
Danish: Det er ikke muligt at identificere en biomarkør med tilstrækkelig ydeevne for HBeAg-negative patienter med HBV-genotype B eller C infektion.
English: Plasma exposure of ribavirin did not appear to be affected by concomitant administration of nucleoside reverse transcriptase inhibitors (NRTIs).
Danish: Plasmakoncentrationen of ribavirin synes ikke at påvirkes af samtidig administration af reverse nukleotid transkriptasehæmmere (NRTIs).
English: When Pegasys is used in combination with ribavirin, both male and female patients must take special precautions in their sexual activity if there is any chance for pregnancy to occur, as ribavirin can be very damaging to an unborn baby:
Danish: Når Pegasys gives sammen med ribavirin, skal både mandlige og kvindelige patienter være yderst påpasselige i deres seksuelle aktivitet, hvis der er en mulighed for, at kvinden kan blive gravid, idet ribavirin kan være yderst skadelig for det ufødte barn:
English: Ribavirin number of tablets
Danish: Antal ribavirin tabletter
English: Hold the pre-filled pen firmly with one hand and pull off the protective cap with the other hand.
Danish: Hold den fyldte pen fast i den ene hånd og træk beskyttelseshætten af med den anden hånd.
English: If necessary, an inter-disciplinary approach including a mental health care provider or addiction specialist should be considered to evaluate, treat and follow the patient.
Danish: Om nødvendigt skal en tværfaglig tilgang overvejes, herunder om en psykiatrisk behandler eller misbrugsspecialist skal bedømme, behandle og følge patienten.
English: • Autoimmune hepatitis
Danish: • Autoimmun hepatitis
English: (copies/mL) / 5.26) ** Patients switched to Pegasys treatment post-principal observation period and before Week 24 follow-up were counted as non-responders.
Danish: (kopier/ml) / 5.26) ** Patienter, som skiftede til Pegasys behandling efter den primære observationsperiode og før 24 ugers opfølgningsperiode blev regnet som ikke-responderende.
English: Histological response was similar across the three treatment groups in each study; however, patients showing a sustained response 24 weeks after the end of treatment were significantly more likely to also show histological improvement.
Danish: Det histologiske respons var det samme for de tre behandlingsgrupper i hvert studie; der var dog signifikant flere patienter med bevaret respons 24 uger efter behandlingens afslutning, som også fik histologisk bedring.
English: In addition some patients may experience vomiting.
Danish: Nogle patienter kan endvidere opleve opkastning.
English: Haematological tests should be repeated after 2 and 4 weeks and biochemical tests should be performed at 4 weeks.
Danish: Efter påbegyndelse af behandlingen skal der tages hæmatologiske prøver efter 2 og 4 uger og biokemiske prøver efter 4 uger.
English: Fever/infections
Danish: Feber/infektioner
English: Depression*, anxiety, insomnia*
Danish: Depression*, angst, søvnløshed*
English: The ultimate clinical impact of a shortened initial treatment of 16 weeks instead of 24 weeks is unknown, taking into account the need for re-treating non-responding and relapsing patients.
Danish: Den endelige kliniske betydning af en kortere initial behandling på 16 uger i stedet for 24 uger er ikke kendt med hensyn til behovet for at genbehandle patienter, som ikke reagerer på behandling, og patienter, som recidiverer.
English: Cut-off (IU/mL)
Danish: Cut-off (IE/ml)
English: Extreme care must be taken to avoid pregnancy in female patients or in partners of male patients taking Pegasys in combination with ribavirin.
Danish: Der skal iagttages yderste påpasselighed for at undgå graviditet hos kvindelige patienter og hos partnerne til mandlige patienter, som tager Pegasys i kombination med ribavirin.
English: A total of 151 patients without advanced fibrosis were 2:1 randomized to Pegasys (group A, n=101) or untreated control (group B, n=50), respectively.
Danish: I alt 151 patienter uden fremskreden fibrose blev randomiseret 2:1 henholdsvis til Pegasys (gruppe A, n = 101) eller ubehandlet kontrol (gruppe B, n = 50).
English: A puncture-proof container with lid for safe disposal of used pens
Danish: En beholder med låg (kanyleboks) til sikker bortskaffelse af brugte penne
English: Some people get depressed when taking Pegasys alone or in combination treatment with ribavirin, and in some cases people have had suicidal thoughts or aggressive behaviour (sometimes directed against others such as thoughts about threatening the life of the others).
Danish: Nogle patienter bliver deprimerede, når de tager Pegasys alene eller i kombination med ribavirin, og nogle patienter har haft selvmordstanker eller er blevet aggressive (nogle gange rettet mod andre såsom tanker om at true andre på livet).
English: No dose adjustment is required for adult patients with mild or moderate renal impairment.
Danish: Det er ikke nødvendigt at justere dosis for patienter med mild eller moderat nedsat nyrefunktion.
English: The side effect may develop at various time points during treatment, typically several months after starting treatment with Pegasys.
Danish: Bivirkningerne kan indtræde på forskellige tidspunkter under behandlingen, typisk flere måneder efter påbegyndelse af behandlingen med Pegasys.
English: If you have the impression that the effect of Pegasys is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis du mener, at virkningerne af Pegasys er for kraftige eller for svage, bør du tale med din læge eller apotekspersonalet herom.
English: Pegasys treatment may be initiated or continued if TSH levels can be maintained in the normal range by pharmaceutical means.
Danish: Behandlingen med Pegasys kan påbegyndes/fortsættes, hvis TSH-niveauet kan holdes normalt med medicin.
English: The metabolism of Pegasys is not fully characterised; however studies in rats indicate that the kidney is a major organ for excretion of radiolabelled material.
Danish: Pegasys metabolisme er ikke fuldt karakteriseret, men rottestudier tyder på, at nyrerne er et hovedorgan for udskillelse af radioaktivt mærket materiale.
English: < 10 g/dl, and ≥ 8.5 g/dl
Danish: <10 g/dl og ≥8,5 g/dl
English: Diarrhoea*, nausea*, abdominal pain*
Danish: Diarré*, kvalme*, abdominalsmerter*
English: HBV genotype A subgroup size was insufficient to be analyzed.
Danish: HBV-genotype A subgruppestørrelse var utilstrækkelig til at blive analyseret.
English: Paediatric patients 5 years of age and older
Danish: Pædiatriske patienter 5 år og ældre
English: The negative predictive value for sustained response in patients treated with Pegasys in monotherapy was 98%.
Danish: Den negativ prædiktive værdi for vedvarende respons hos patienter behandlet med Pegasys monoterapi var 98 %.
English: < 250 cells/mm3 (or febrile neutropenia): discontinue treatment.
Danish: < 250 celler/mm3 (eller febril neutropeni): seponer behandling.
English: More frequent monitoring of hepatic function was recommended in all instances.
Danish: I alle tilfælde anbefaledes hyppigere kontrol af leverfunktionen.
English: The use of peginterferon alfa-2a and ribavirin concomitantly with azathioprin should be avoided.
Danish: Brug af peginterferon alfa-2a og ribavirin sammen med azathioprin bør undgås.
English: Peginterferon alfa-2a serum concentrations are sustained throughout one full week (168 hours).
Danish: Serumkoncentrationerne af peginterferon alfa-2a vedvarer en hel uge (168 timer).
English: Pegasys pre-filled pens should not be used by children and adolescents who require doses less than 135 micrograms.
Danish: Pegasys i fyldt pen bør ikke anvendes hos børn og unge, som kræver mindre dosis end 135 mikrogram.
English: The extent of available data is not sufficient to conclude that growth inhibition due to Pegasys exposure is always reversible.
Danish: De tilgængelige data er utilstrækkelige til at konkludere, at væksthæmning efter behandling med Pegasys altid er reversibel.
English: ● the medicine is cloudy
Danish: ● medicinen er uklar
English: In both studies the treatment duration was 48 weeks, with 24 weeks of treatment-free follow-up.
Danish: I begge studier varede behandlingen 48 uger med 24 ugers behandlingsfri follow-up.
English: Paediatric patients 3 years of age and older
Danish: Pædiatriske patienter 3 år og ældre
English: ● small bandage or sterile gauze
Danish: ● et lille plaster eller steril gaze
English: Prior to initiation of Pegasys therapy, TSH and T4 levels should be evaluated.
Danish: Før Pegasysbehandlingen påbegyndes, skal niveauet af TSH og T4 undersøges.
English: Dispose of the syringe and needle safely in a closed container.
Danish: Anbring sprøjten og kanylen sikkert i en lukket beholder.