FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are injecting this medicine yourself, you will be instructed how to give the injection.
Danish: Hvis du selv injicerer lægemidlet, vil du blive instrueret i, hvordan injektionen skal gives.
English: Tell your doctor if you are taking medicines for asthma, because the dose for your asthma medicine may need to be changed.
Danish: Du skal fortælle det til lægen, hvis du tager astmamedicin, fordi det kan være nødvendigt at ændre dosis af din astmamedicin.
English: Any patient complaining of decrease or loss of vision must have a prompt and complete eye examination.
Danish: Alle patienter, som klager over nedsat syn eller tab af syn, skal straks have foretaget en fuldstændig øjenundersøgelse.
English: All patients who completed the phase III studies were eligible for entry into a long-term follow-up study (WV16866).
Danish: Alle patienter, som fuldendte fase III-studierne, var egnede til at indgå i et langtids-follow-up-studie (WV16866).
English: For spontaneous reports of undesirable effects from post-marketing experience, the frequency is not known (cannot be estimated from the available data).
Danish: For spontane bivirkningsindberetninger modtaget efter markedsføring er hyppigheden ukendt (kan ikke estimeres ud fra tilgængelige data).
English: Detailed instructions are provided at the end of this leaflet (see “How to inject Pegasys”).
Danish: Der findes en detaljeret brugsanvisning i slutningen af denne indlægsseddel (se ”Hvordan foretages injektion af Pegasys”).
English: You will find the expiration date on the box as well as on the label of the pre-filled pen itself.
Danish: Du finder udløbsdatoen på pakningen og på etiketten på selve den fyldte pen.
English: No single biomarker with a cut-off can be identified to optimize all the operating characteristics (negative predictive value [NPV], sensitivity, specificity) and practical characteristics (simplicity, convenience).
Danish: Det er ikke muligt at identificere en enkelt biomarkør med cut-off til at optimere alle operationelle egenskaber (negativ prædiktiv værdi (NPV), sensitivitet, specificitet) og praktiske egenskaber (enkelhed, bekvemmelighed).
English: Body weight kg (lbs)
Danish: Kropsvægt kg (lbs)
English: Date of latest renewal: 20 June 2007
Danish: Dato for første markedsføringstilladelse: 20. juni 2002 Dato for seneste fornyelse: 20. juni 2007
English: Please check with your doctor and follow the recommended duration of treatment.
Danish: Tjek det hos din læge og følg den anbefalede behandlingsvarighed.
English: It should be inspected visually for particulate matter and discoloration before administration.
Danish: Den skal undersøges visuelt for partikler og misfarvning før administrationen.
English: If this reaction occurs, they should be advised to rinse out their mouth thoroughly afterwards.
Danish: Hvis dette sker, bør de rådes til at skylle munden grundigt efterfølgende.
English: Consideration for early treatment discontinuation should be evaluated in the context of a particular clinical situation.
Danish: Overvejelser om tidlig seponering af behandling skal evalueres i forhold til en specifik klinisk situation.
English: Whenever possible the child should be treated after the pubertal growth spurt, in order to reduce the risk of growth inhibition.
Danish: Når som helst det er muligt, bør barnet behandles efter vækstspurten i puberteten, for at nedsætte risikoen for væksthæmning.
English: Placebo 48 weeks
Danish: Placebo 48 uger
English: Co-administration of ribavirin and didanosine is not recommended.
Danish: Samtidig administration af ribavirin og didanosin anbefales ikke.
English: Group B** Untreated (N=50)
Danish: Gruppe B** Ubehandlet (N=50)
English: • If your child has or has ever had a psychiatric disorder, talk to your doctor, who will monitor your child for signs or symptoms of depression (see section 4).
Danish: ● Hvis dit barn har eller har haft en psykiatrisk sygdom, skal du tale med din læge, som vil monitorere dit barn for symptomer på depression (se punkt 4).
English: ≥2 log10 decline
Danish: ≥2 log10 fald
English: Physicians considering treatment in these patients should carefully weigh the risks versus the benefits of re-treatment.
Danish: Læger, som overvejer behandling af disse patienter, bør omhyggeligt overveje risici versus fordele ved genbehandling.
English: Your other hand will be free to move the plunger of the syringe.
Danish: Den anden hånd har du fri til at bevæge sprøjtens stempel.
English: NPV Sensitivity Specificity HBeAg-positive(a)
Danish: NPV Sensitivitet Specificitet HBeAg-positiv(a)
English: ● any part of the pre-filled pen appears to be damaged
Danish: ● hvilken som helst del af den fyldte pen ser ud til at være beskadiget
English: ● if you have, so called autoimmune hepatitis.
Danish: ● hvis du har såkaldt autoimmun hepatitis.
English: HBV DNA response *
Danish: HBV-DNA respons *
English: This would be particularly important in patients with a known history of zidovudine induced anaemia.
Danish: Dette vil specielt være vigtigt for patienter med en kendt historie for zidovudin induceret anæmi.
English: ● Press the injection site with a small bandage or sterile gauze if necessary for several seconds.
Danish: • Tryk på injektionsstedet med en lille bandage eller med et sterilt gazebind, om nødvendigt i et par sekunder.
English: ● if you have psoriasis, it may get worse during treatment with Pegasys.
Danish: ● hvis du har psoriasis, kan den forværres under behandlingen med Pegasys.
English: The decision to treat should be made on a case by case basis (see section 4.4).
Danish: Beslutningen om behandling bør tages sag for sag (se pkt.
English: The duration of combination treatment varies from 4 to 18 months depending on the type of virus you are infected with, on treatment response and whether you have been treated before.
Danish: Varigheden af kombinationsbehandlingen varierer fra 4 til 18 måneder, afhængig af den type virus du er smittet med, din respons på behandlingen og om du er blevet behandlet før.
English: Pegasys is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Danish: Pegasys må kun anvendes under graviditet, hvis den potentielle gavnlige effekt berettiger den potentielle risiko for fosteret.
English: Operating characteristics of these biomarkers are presented in Table 11.
Danish: Operationelle egenskaber af disse biomarkører er vist i tabel 11.
English: Hyperglycaemia, type 1 diabetes mellitus
Danish: Hyperglykæmi, type 1 diabetes mellitus
English: There are no data on long-term effects on sexual maturation.
Danish: Der foreligger ingen data om langtidsvirkning på seksuel modning.
English: Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin.
Danish: Der er vist signifikant teratogen og/eller embryocid effekt hos alle dyrearter, som har været eksponeret for ribavirin.
English: All patients should be closely monitored for any signs or symptoms of psychiatric disorders.
Danish: Alle patienter skal monitoreres nøje for tegn eller symptomer på psykiatriske sygdomme.
English: Increased alanine aminotransferase (ALT)
Danish: Forhøjet alaninaminotransferase (ALAT)
English: Additional testing should be performed periodically during therapy (including glucose monitoring).
Danish: Yderligere prøver skal tages periodisk under behandlingen (inklusiv glukosemonitorering).
English: The terminal half-life may not only reflect the elimination phase of the compound, but may also reflect the sustained absorption of Pegasys.
Danish: Den terminale halveringstid afspejler måske ikke kun præparatets eliminationsfase, men også den forlængede absorption af Pegasys.
English: ● if you are coinfected with HIV and treated with anti HIV medicinal products.
Danish: ● hvis du også er smittet med hiv og behandles med anti-hiv-medicin.
English: NOTE: The cap contains a loose-fitting metal tube.
Danish: BEMÆRK:Hætten indeholder et løstsiddende metalrør.
English: Patients who develop dizziness, confusion, somnolence or fatigue should be cautioned to avoid driving or operating machinery.
Danish: Patienter, som udvikler svimmelhed, konfusion, søvnighed eller træthed, skal advares om ikke at føre motorkøretøjer og betjene maskiner.
English: Although no teratogenic effects were seen in the offspring delivered at term, adverse effects in humans cannot be excluded.
Danish: Selvom der ikke er set teratogene effekter hos afkommet ved fødslen, kan skadelige virkninger hos mennesker ikke udelukkes.
English: ● a container for the waste material
Danish: ● en beholder til affald
English: Treatment should be initiated only by a physician experienced in the treatment of patients with hepatitis B or C.
Danish: Behandlingen må kun påbegyndes af en læge med erfaring i behandling af patienter med hepatitis B eller C.
English: Only HIV-HCV co-infected patients were included in the study NR15961 (see Table 21).
Danish: Kun hiv-HCV-co-inficerede patienter blev inkluderet i studie NR15961 (se tabel 21).
English: Study ML17131
Danish: Studie ML17131
English: Choose a place on your stomach or thigh (see the picture).
Danish: Vælg et sted på maven eller låret (se billede).
English: ● Insert the needle all the way into the pinched skin at an angle of 45° to 90° (6).
Danish: • Stik kanylen helt ind i den sammenklemte hud i en vinkel på 45° til 90° (6).
English: Overdoses involving between two injections on consecutive days (instead of weekly interval) up to daily injections for 1 week (i.e., 1260 micrograms/week) have been reported.
Danish: Der er rapporteret om overdosering omfattende intervallet mellem 2 injektioner på to konsekutive dage (i stedet for ugentlige intervaller) op til daglige injektioner i 1 uge (dvs. 1260 mikrogram/uge).
English: ● if you have ever had anaemia.
Danish: ● hvis du nogensinde har haft blodmangel.
English: The dose reduction levels are provided in Table 8.
Danish: Dosisreduktion er opgivet i tabel 8.
English: ● expose to excessive forces or shock.
Danish: ● udsætte pennen for stor kraftpåvirkning eller shock.
English: Predictability of response
Danish: Responsets forudsigelighed
English: Be sure not to touch the cleaned area prior to injection.
Danish: Pas på ikke at berøre det rensede område før injektionen.
English: All patients received ribavirin (1000 or 1200 mg/day) in combination with Pegasys.
Danish: Alle patienterne fik ribavirin (1.000 eller 1.200 mg/dag) i kombination med Pegasys.
English: Side effects with unknown frequency:
Danish: Bivirkninger, hvor frekvensen ikke kendes:
English: ● if you have a problem with your liver other than hepatitis B or C.
Danish: ● hvis du har andre problemer med leveren end hepatitis B eller C.
English:  The pre-filled pen is now unlocked and ready for injection.
Danish:  Den fyldte pen er nu låst op og klar til injektion.
English: Pegasys has minor or moderate influence on the ability to drive and use machines.
Danish: Pegasys påvirker i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: The difference between treatment regimens was in general not influenced by presence/absence of cirrhosis; therefore treatment recommendations for genotype 1, 2 or 3 are independent of this baseline characteristic.
Danish: Forskellen mellem behandlingsregimerne var generelt ikke påvirket af forekomst/fravær af cirrose; derfor er behandlingsanbefalingerne for genotype 1, 2 og 3 uafhængige af denne baselinekarakteristika.
English: Patients with cirrhosis were not enrolled in this study.
Danish: Patienter med cirrose blev ikke inkluderet i dette studie.
English: Educational problem
Danish: Uddannelsesmæssige problemer
English: If this occurs, therapy must be discontinued and appropriate medical therapy instituted immediately.
Danish: Hvis det sker, skal behandlingen afbrydes, og der skal straks påbegyndes passende medicinsk behandling.
English: Monotherapy for hepatitis C should only be considered in case of contraindication to other medicinal products.
Danish: Monoterapi til behandling af hepatitis C bør kun overvejes i tilfælde af kontraindikation mod andre lægemidler.
English: Your next injection will be on the Monday, 5 days later after the Wednesday injection.
Danish: Næste injektion tages om mandagen, 5 dage efter injektionen om onsdagen.
English: ● the needle-shield may not have locked.
Danish: ●kan det være, at kanylebeskyttelsen ikke er låst.
English: Be sure to seek emergency care if you notice that you are becoming depressed or have suicidal thoughts or change in your behaviour.
Danish: Søg omgående behandling, hvis du bemærker, at du bliver deprimeret eller får selvmordstanker eller hvis din adfærd ændrer sig.
English: Suicidal ideation, hallucinations
Danish: Selvmordstanker, hallucinationer
English: The usual dose of Pegasys is based on your child's height and weight.
Danish: Den sædvanlige dosis af Pegasys er baseret på dit barns højde og vægt.
English: The study demonstrated that the post-treatment recovery in growth at 2 years post-treatment was maintained to 6 years post-treatment.
Danish: Studiet viste, at vækstforbedringen 2 år efter behandling var fastholdt 6 år efter behandling.
English: Make sure you have taken your thumb off the activation button.
Danish: Vær sikker på, at du har flyttet tommelfingeren fra aktiveringsknappen.
English: The probability for sustained virological response varied depending upon the previous treatment regimen; see Table 20.
Danish: Sandsynligheden for et vedvarende virologisk respons varierede som følge af den tidligere behandling; se tabel 20.
English: Pegylated interferon Interferon plus ribavirin Pegylated interferon plus ribavirin
Danish: Pegyleret interferon Interferon plus ribavirin Pegyleret interferon plus ribavirin
English: Do not use Pegasys if you are taking telbivudine (see “Do not use Pegasys”) because the combination of these medicines increases the risk of developing peripheral neuropathy (numbness, tingling, and/or burning sensations in the arms and/or legs).
Danish: Tag ikke Pegasys, hvis du tager telbivudin (se ”Tag ikke Pegasys”), da kombinationen af disse lægemidler øger risikoen for at udvikle perifer neuropati (følelsesløshed, prikken og/eller brændende fornemmelse i arme og/eller ben).
English: Take your next doses at 5 day intervals until you return to your regularly scheduled day of the week.
Danish: Tag de næste doser med 5 dages mellemrum, indtil du igen når den planlagte ugedag.
English: Genotype-A (N=9) Responder Genotype-B (N=21) Responder Genotype-C (N=34) Responder Genotype-D (N=31) Responder
Danish: Genotype-A (N=9) Respondenter Genotype-B (N=21) Respondenter Genotype-C (N=34) Respondenter Genotype-D (N=31) Respondenter
English: ● attempt to open or dismantle the pre-filled pen.
Danish: ● forsøge at åbne eller skille den fyldte pen ad.
English: In general, the safety profile observed in paediatric patients was similar to that seen in adults.
Danish: Generelt var sikkerhedsprofilen, som blev observeret hos pædiatriske patienter, tilsvarende den, som blev set hos voksne.
English: Especially in patients on a high dose of methadone, the risk for QTc prolongation should be considered.
Danish: Specielt hos patienter, der får en høj methadondosis, bør risikoen for forlængelse af QTc-intervallet tages i betragtning.
English: Appropriate antiinfective therapy should be started immediately and discontinuation of therapy should be considered.
Danish: En passende anti-infektiøs behandling bør påbegyndes øjeblikkeligt, og det bør overvejes at afbryde behandlingen.
English: The risk of developing anaemia is higher in the female population.
Danish: Risikoen for at udvikle anæmi er højere hos de kvindelige patienter.
English: Must not be given to premature babies or neonates.
Danish: Må ikke gives til præmature og nyfødte børn.
English: Do not massage the injection site.
Danish: Lad være med at massere injektionsstedet.
English: As an example: Your regular weekly Pegasys injection is on Monday.
Danish: Eksempelvis: Normalt tager du den ugentlige Pegasys-injektion om mandagen.
English: A full listing of adverse reactions reported in this treatment group (n=55) is provided in Table 10.
Danish: En detaljeret liste over bivirkninger rapporteret i denne behandlingsgruppe (n=55) er sammenfattet i tabel 10.
English: No sustained response
Danish: Intet vedvarende respons
English: For hepatitis C virus (HCV) genotype specific activity, see sections 4.2 and 5.1.
Danish: For hepatitis C virus (HCV) genotypespecifik aktivitet, se punkt 4.2 og 5.1.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler
English: Pharmacotherapeutic group: Immunostimulants, interferons, ATC code: L03AB11
Danish: Farmakoterapeutisk klassifikation: Immunstimulanter, interferoner, ATC-kode: L03AB11
English: • A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months (see section 4.4)
Danish: • Anamnese med præ-eksisterende svær hjertesygdom, inklusive ustabil eller ukontrolleret hjertesygdom i de forudgående seks måneder (se pkt.
English: 4) Choose and prepare an injection site
Danish: 4) Vælg og forbered et injektionssted
English: You should brush your teeth thoroughly twice daily and have regular dental examinations.
Danish: Du bør børste dine tænder grundigt 2 gange om dagen og få foretaget regelmæssige tandeftersyn.
English: None of these patients experienced unusual, serious or treatment-limiting events.
Danish: Ingen af patienterne fik usædvanlige, alvorlige eller behandlingslimiterende bivirkninger.
English: All genotypes (N=101) Responder
Danish: Alle genotyper (N=101) Respondenter
English: The Child-Pugh classification divides patients into groups A, B, and C, or "Mild", "Moderate" and "Severe" corresponding to scores of 5-6, 7-9 and 10-15, respectively.
Danish: Child-Pugh-klassifikationen inddeler patienterne i gruppe A, B og C eller ”mild”, ”moderat” og ”svær” svarende til henholdsvis score 5-6, 7-9 og 10-15.
English: Push the plunger up slowly to the correct dose.
Danish: Skub langsomt stemplet op til den korrekte dosis.
English: ● a 1 ml syringe
Danish: ● en 1 ml sprøjte
English: Patients should brush their teeth thoroughly twice daily and have regular dental examinations.
Danish: Patienter bør børste deres tænder grundigt 2 gange om dagen og gennemgå regelmæssige tandeftersyn.
English: ● if you have diabetes or high blood pressure, your doctor may ask you to have an eye examination.
Danish: ● hvis du har sukkersyge eller forhøjet blodtryk, vil lægen måske bede dig om at blive undersøgt af en øjenlæge.
English: You can save the swab to clean the skin area where you will inject Pegasys.
Danish: Du kan gemme vattet til at rense huden, hvor du vil injicere Pegasys.
English: You remember on Friday that you forgot to take your injection on Monday (4 days late).
Danish: Om fredagen kommer du i tanker om, at du glemte at tage injektionen om mandagen (4 dage senere).
English: • HIV-HCV patients with cirrhosis and a Child-Pugh score ≥ 6, except if only due to indirect hyperbilirubinemia caused by medicinal products such as atazanavir and indinavir
Danish: • Hiv-HCV-patienter med cirrose og en Child-Pugh-score ≥6, undtagen hvis det udelukkende skyldes indirekte hyperbilirubinæmi forårsaget af lægemidler, såsom atazanavir og indinavir
English: Other published on-treatment biomarkers that are predictive of the final outcome of Pegasys treatment may be considered.
Danish: Andre publiserede biomarkører under behandling, som er prædiktive for resultatet af Pegasysbehandlingen, kan overvejes.
English: For persistent or increasing elevations ≥5 but <10 x ULN, reduce dose with a 1 level adjustment and monitor weekly ALT level to ensure it is stable or decreasing.
Danish: For vedvarende eller øgede stigninger ≥5 men <10 x øvre referencegrænse: reducer dosis med 1. niveau justering og monitorer ALAT-værdier ugentligt for at sikre at de er stabile eller faldende.
English: This syndrome is a granulomatous inflammatory disorder affecting the eyes, auditory system, meninges, and skin.
Danish: Dette syndrom er en granulomatøs inflammatorisk sygdom, som påvirker øjnene, det auditive system, meninges og huden.
English: Pegasys is intended for subcutaneous use (under the skin).
Danish: Pegasys er beregnet til subkutan anvendelse (under huden).
English: Ribavirin therapy is contraindicated in women who are pregnant.
Danish: Behandling med ribavirin er kontraindiceret til gravide kvinder.
English: Anti-interferon antibodies
Danish: Anti-interferon antistoffer
English: Odds Ratio (95% CI)
Danish: Odds Ratio (95% konfidensinterval)
English: Psychiatric evaluation abnormal
Danish: Anormal psykisk vurdering
English: Dispose of the full container as instructed by your healthcare provider or pharmacist.
Danish: Bortskaf den fyldte beholder, som instrueret af sundhedspersonalet eller apotekspersonalet.
English: In some cases, dose reduction to 90 micrograms or 45 micrograms is necessary.
Danish: I nogle tilfælde er det nødvendigt at nedsætte dosis til 90 eller 45 mikrogram.
English: Group A (Pegasys treatment) (N=101)
Danish: Gruppe A (Pegasys behandling) (N=101)
English: ● if you have been withdrawn from previous therapy for Hepatitis C because of anaemia or low blood count.
Danish: ● hvis du har afbrudt tidligere behandling af hepatitis C på grund af blodmangel eller lav blodprocent.
English: The study was not powered for efficacy considerations.
Danish: Studiet havde ikke tilstrækkelig styrke til overvejelser om virkning.
English: Patients who initiate treatment prior to their 18th birthday should maintain paediatric dosing through the completion of therapy.
Danish: Patienter, som starter behandling før deres 18 års fødselsdag, bør fortsætte med pædiatrisk dosering indtil behandlingen afsluttes.
English: The terminal half-life after subcutaneous administration in patients is longer with a mean value of 160 hours (84 to 353 hours).
Danish: Den terminale halveringstid efter subkutan administration hos patienter er længere med et middeltal på 160 timer (84 til 353 timer).
English: Within each frequency grouping, adverse reactions are presented in decreasing order of seriousness.
Danish: Inden for hver frekvensgruppe er bivirkningerne opstillet efter faldende alvorlighed.
English: If ALT increase is progressive or persistent, the dose should be reduced initially to 135 micrograms.
Danish: Hvis ALAT-forhøjelserne progredierer eller persisterer, skal dosis initialt nedsættes til 135 mikrogram.
English: The recommended total duration of therapy is 48 weeks.
Danish: Den anbefalede totale behandlingsvarighed er 48 uger.
English: Keep the protective cap on the pre-filled pen until Step 5.
Danish: Behold beskyttelseshætten på den fyldte pen indtil trin 5.
English: Take your next injection on the regularly scheduled day.
Danish: Giv den næste injektion på den planlagte dag.
English: Lift the pre-filled pen straight up (90° angle).
Danish: Løft den fyldte pen lige op (90° vinkel).
English: Chronic Hepatitis B: Pegasys is usually used alone.
Danish: Kronisk hepatitis B: Pegasys anvendes normalt alene.
English: However, due to high variability, the confidence intervals were quite wide.
Danish: Sikkerhedsgrænserne var imidlertid relativt bredde på grund af den store variation.
English: ● Visually inspect the solution prior to administration: do not use if it is discoloured or if particles are present.
Danish: • Undersøg opløsningen visuelt før administrationen: Anvend den ikke, hvis den er misfarvet, eller hvis den indeholder partikler.
English: cells/mm3
Danish: celler/mm3
English: ● Wait for the area to dry.
Danish: • Vent til huden er tør.