FrancophonIA/ELRC3.0 huggingface dataset:
English: Response rates in these trials were increased with compliance.
Danish: Responsrater i disse undersøgelser steg med compliance.
English: These are all very serious side effects.
Danish: Disse er alle meget alvorlige bivirkninger.
English: Please discard these appropriately and safely.
Danish: Smid venligst disse ud på en passende og sikker måde.
English: You may need urgent medical attention or hospitalisation.
Danish: De kan have behov for hurtig lægehjælp eller hospitalsindlæggelse.
English: These very serious side effects are very rare.
Danish: Disse meget alvorlige bivirkninger er meget sjældne.
English: Pure red cell aplasia, a condition where the body stopped or reduced the production of red blood cells, has been reported.
Danish: Pure red cell aplasi, en tilstand, hvor kroppen er ophørt med eller har nedsat produktionen af røde blodlegemer, er blevet rapporteret.
English: Fluid replacement may be necessary.
Danish: Væsketilskud kan blive nødvendig.
English: Treatment must be initiated by a physician experienced in the management of the disease.
Danish: Behandling skal initieres af en læge med erfaring i behandling af sygdommen.
English: Change your injection site each time.
Danish: Varier Deres injektionssted hver gang.
English: if you have severe heart disease.
Danish: hvis De har alvorlig hjertesygdom.
English: For all patients:
Danish: For alle patienter:
English: The pen is now ready to use.
Danish: Pennen er nu klar til brug.
English: Genotype 1: The recommended duration of treatment is one year.
Danish: Genotype 1: Den anbefalede behandlingsvarighed er et år.
English: The effect on human pregnancy is not known.
Danish: Virkningen på graviditet hos mennesker er ukendt.
English: At that point check that you have the correct dose.
Danish: Kontroller nu at De får den korrekte dosis.
English: This causes severe anaemia, symptoms of which would include unusual tiredness and a lack of energy.
Danish: Dette forårsager svær anæmi, og symptomer herpå ville omfatte usædvanlig træthed og mangel på energi.
English: Please make sure to select an appropriate dosage form and strength.
Danish: Vær sikker på at vælge en hensigtsmæssig formulering og styrke.
English: Interferons may affect the oxidative metabolic process.
Danish: Interferoner kan påvirke den oksidative metaboliske proces.
English: The optimal duration of therapy with Viraferon alone is not yet fully established, but a therapy of between 12 and 18 months is advised.
Danish: Den optimale behandlingsvarighed med Viraferon alene er endnu ikke fuldstændig fastsat, men en behandling på mellem 12 og 18 måneder anbefales.
English: Do not attempt to inject yourself unless you are sure you understand the procedure and requirement of selfinjection.
Danish: Forsøg ikke selv at injicere med mindre De er sikker på, at De forstår proceduren og forudsætningen for selv-injektion.
English: Viraferon must be used with caution in fertile men.
Danish: Viraferon skal anvendes med forsigtighed hos fertile mænd.
English: In studies in pregnant animals, interferons have sometimes caused miscarriage.
Danish: I undersøgelser på drægtige dyr, har interferoner undertiden forårsaget abort.
English: Take special care with Viraferon if you are pregnant or planning to become pregnant (see Pregnancy).
Danish: Vær ekstra forsigtig med at bruge Viraferon hvis De er gravid eller planlægger at blive gravid (se Graviditet).
English: Three major classes of interferons have been identified: alpha, beta and gamma.
Danish: Tre væsentlige klasser af interferon er blevet identificeret: Alfa, beta og gamma.
English: Multidose presentations must be for individual patient use only.
Danish: Flerdosispakninger er kun beregnet til individuel patientanvendelse.
English: Volume (ml)
Danish: Mængde (ml)
English: Laboratory Tests:
Danish: Laboratorieundersøgelser:
English: Do not take a double dose to make up for a forgotten dose.
Danish: De må ikke tage en dobbeltdosis som erstatning for en glemt dosis.
English: Viraferon is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Danish: Viraferon må kun anvendes under graviditet, hvis den mulige gavn berettiger den potentielle risiko for fosteret.
English: One dose of Viraferon is given on each scheduled day.
Danish: En dosis af Viraferon gives på hver fastlagte dag.
English: The detectable titres are low in almost all cases and have not been regularly associated with loss of response or any other autoimmune phenomenon.
Danish: De fundne titre var lave i næsten alle tilfælde og har normalt ikke medført tab af respons eller andre autoimmune fænomener.
English: The solution should be used immediately after reconstitution.
Danish: Opløsningen bør bruges straks efter rekonstituering.
English: when receiving Viraferon, you may temporarily have a greater risk of getting an infection.
Danish: Når De får Viraferon, kan De midlertidigt have en større risiko for at få en infektion.
English: The aetiology has not been defined.
Danish: Ætiologien er ikke fastlagt.
English: However, during the 6 months after treatment, this trend was generally reversed, although a few children did not return to their previous rate of growth within the first year after completing treatment.
Danish: Under de 6 måneder efter behandling var dette imidlertid generelt vendt igen, dog var der få børn som ikke vendte tilbage til deres tidligere væksthastighed indenfor det første år efter fuldført behandling.
English: Dosages that are to be administered 3 times a week are best given every other day.
Danish: Doser, der skal indgives 3 gange om ugen, gives bedst hver anden dag.
English: While these effects are generally reversible, in a few patients full resolution took up to three weeks.
Danish: Selv om disse effekter sædvanligvis er reversible, tog fuld restitution op til 3 uger hos nogle få patienter.
English: Use Viraferon exactly as prescribed by your doctor.
Danish: Anvend Viraferon nøjagtigt som foreskrevet af deres læge.
English: If this reaction occurs, they should be advised to rinse out their mouth thoroughly afterwards.
Danish: Hvis denne reaktion forekommer, bør de anbefales at skylle deres mund omhyggeligt bagefter.
English: Genotype 2/3: The recommended duration of treatment is 24 weeks.
Danish: Genotype 2/3: Den anbefalede behandlingsvarighed er 24 uger.
English: The usual starting dose for each condition follows; however, individual doses may vary, and the doctor may change your dose based on your specific needs:
Danish: Den almindelige begyndelsesdosis for hver sygdom angives nedenfor, men individuelle doser kan variere, og lægen kan ændre Deres dosis på grund af Deres specielle behov:
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http://www.emea.europa.eu/
English: Severity was generally mild to moderate.
Danish: Sværhedsgraden var generelt let til moderat.
English: Cleanse and disinfect the skin where the injection is to be made.
Danish: Rens og desinficer huden, hvor injektionen skal foretages.
English: Virological response is defined as absence of detectable HCV-RNA at Week 12.
Danish: Virologisk respons er defineret som fravær af påviselig HCV-RNA i uge 12.
English: If no drop appears, use a different pen, and return the faulty pen to your provider.
Danish: Hvis der ikke fremkommer en dråbe, så brug en anden pen, og returner den svigtende pen til Deres leverandør.
English: The Kaplan-Meier estimate for continued sustained response over 5 years for all patients is 97 % with a 95 % Confidence Interval of [95 %, 99 %].
Danish: Kaplan-Meier estimatet for fortsat vedvarende respons over 5 år for alle patienter er 97 % med et 95 % konfidensinterval på [95 %, 99 %].
English: 3 times a week (n = 54)
Danish: 3 gange om ugen (n = 54)
English: However, this does not preclude the occurrence of hepatic events in patients with cirrhosis (including hepatocarcinoma).
Danish: Dette udelukker imidlertid ikke forekomsten af hepatiske tilfælde i patienter med cirrhosis (inklusive hepatocarcinoma).
English: - if you are a man who is taking ribavirin, do not have sex with a pregnant woman unless you use a condom.
Danish: - hvis De er en mand, der tager ribavirin, så hav ikke samleje med en gravid kvinde med mindre De bruger et kondom.
English: Since a small amount of air may collect in the injection needle and reservoir during storage, the next step is to remove any air bubbles.
Danish: Da en lille mængde luft kan samles i kanylen og beholderen under opbevaring, er det næste trin at fjerne eventuelle luftbobler.
English: You may want to consider asking a family member or close friend to help you stay alert to signs of depression or changes in your behaviour.
Danish: De vil måske overveje at bede et familiemedlem eller en tæt ven hjælpe Dem med at være opmærksom på tegn på depression eller ændringer i Deres opførsel.
English: Do not use Viraferon after the expiry date which is stated on the package.
Danish: Brug ikke Viraferon efter den udløbsdato, der står på pakningen.
English: Note: some air may remain in the pen, but this is not important as you have removed the air from the injection needle and the dose will be accurate.
Danish: Bemærk: Der kan være lidt luft tilbage i pennen, men dette er ikke vigtigt, da De har fjernet luften fra kanylen, og dosis vil være nøjagtig.
English: IU/kg/day for 3 months caused no remarkable toxicity.
Danish: /kg/dag i 3 måneder forårsagede ingen mærkbar toksicitet.
English: All patients in these trials received 3 MIU of Viraferon three times a week.
Danish: Alle patienter i disse undersøgelser fik 3 MIE Viraferon tre gange om ugen.
English: Human interferon receptors, as isolated from human lymphoblastoid (Daudi) cells, appear to be highly asymmetric proteins.
Danish: Humane interferonreceptorer isolerede fra humane lymfoblast (Daudi) celler synes at være stærkt asymmetriske proteiner.
English: Viraferon can be put back in the refrigerator at any time during this seven-day period.
Danish: Viraferon kan sættes tilbage i køleskab på et hvilket som helst tidspunkt i denne syv dages periode.
English: Interferons exert their cellular activities by binding to specific membrane receptors on the cell surface.
Danish: Interferoner udøver deres cellulære aktiviteter ved at binde sig til specifikke membranreceptorer på celleoverfladen.
English: Contact your doctor or pharmacist if needed.
Danish: Kontakt Deres læge eller apotek efter behov.
English: With one hand, pinch a fold of loose skin.
Danish: Med den ene hånd klemmes en fold af løs hud.
English: Diagrams A and B show you all the different parts of the pen and the injection needle.
Danish: Diagrammerne A og B viser Dem alle de forskellige dele af pennen og kanylen.
English: A total of 118 patients were enrolled: 57 % male, 80 % Caucasian, and 78 % genotype 1,64 % ≤ 12 years of age.
Danish: I alt 118 patienter blev inkluderet: 57 % mænd, 80 % kaukasiske og 78 % genotype 1, 64 % i alderen ≤ 12 år.
English: It is recommended that patients be treated with Viraferon alone for at least 3 to 4 months, at which point HCV-RNA status should be determined.
Danish: Det anbefales, at patienter behandles med Viraferon alene i mindst 3 til 4 måneder, hvorefter HCVRNA status bør bestemmes.
English: Viral infection, pharyngitis
Danish: Virusinfektion, pharyngitis
English: If the solution is cold, warm the syringe between your palms.
Danish: Hvis opløsningen er kold, så varm sprøjten mellem Deres håndflader.
English: If you have them, you may have had a serious allergic reaction to Viraferon.
Danish: Hvis De har dem, kan De have fået en alvorlig allergisk reaktion over for Viraferon.
English: Check with your doctor immediately if you have any of these symptoms.
Danish: Kontakt straks Deres læge, hvis De har et af disse symptomer.
English: Cmax occurred three to 12 hours after the lower dose and six to eight hours after the higher dose.
Danish: Cmax sås tre til 12 timer efter den laveste dosis og seks til otte timer efter den højeste dosis.
English: Viraferon should be given alone mainly in case of intolerance or contraindication to ribavirin.
Danish: Viraferon bør hovedsageligt gives alene i tilfælde af intolerance eller kontraindikation for ribavirin.
English: if you have advanced decompensated (uncontrolled) liver disease.
Danish: hvis De har fremskreden ubehandlet (ukontrolleret) leversygdom.
English: Treatment should be continued in patients who exhibit negative HCV-RNA.
Danish: Behandling bør fortsættes hos patienter, der udviser negativ HCV-RNA.
English: If it does not have a clear uniform appearance or if it contains any particles, do not use.
Danish: Hvis den ikke har et klart, ensartet udseende, så anvend den ikke.
English: In adult patients receiving interferon in combination with ribavirin, the achieved sustained response rate is 47 %.
Danish: Hos voksne patienter, som modtager interferon i kombination med ribavirin, er den opnåede vedvarende respons rate 47 %.
English: During the one year of treatment, many children did not grow or gain weight as much as expected.
Danish: Under et års behandling havde mange børn ikke den forventede øgning i højde eller vægt.
English: No case of overdose has been reported that has led to acute clinical manifestations.
Danish: Der er ingen meddelelser om tilfælde af overdosering, der har medført akutte kliniske symptomer.
English: Epilepsy and/or compromised central nervous system (CNS) function (see section 4.4).
Danish: Epilepsi og/eller kompromitteret centralnervesystem (CNS) funktion (se pkt.
English: *4 full turns correspond to the maximum dose to be administered in one injection.
Danish: *4 hele drejninger svarer til den maksimale dosis som kan administreres ved én injektion.
English: Long-Term efficacy data
Danish: Langtidsdata
English: The dosage will vary according to the disease being treated.
Danish: Doseringen vil afhænge af sygdommen, der behandles.
English: The response to treatment in both of these trials is presented in Table 4.
Danish: Respons på behandlingen i begge disse undersøgelser er vist i Tabel 4.
English: Check with your doctor if you think you are getting an infection.
Danish: Spørg Deres læge til råds, hvis De tror, at De er ved at få en infektion.
English: Some children have had a decrease in their rate of growth (height and weight).
Danish: Nogle børn har haft et fald i deres væksthastighed (højde og vægt).
English: 462 patients completed at least 5 years of long-term follow-up and only 12 sustained responders' out of 492 relapsed during this study.
Danish: 446 patienter fuldendte mindst 5 års langtidsopfølgning og kun 12 vedvarende responders ud af 492 fik tilbagefald under denne undersøgelse.
English: Patients should be closely monitored for any signs or symptoms of psychiatric disorders.
Danish: Patienter bør følges nøje for eventuelle tegn eller symptomer på psykiatriske lidelser.
English: Driving and using machines Do not drive or use machinery if you become drowsy, tired, or confused from this medicine.
Danish: Kør ikke bil og betjen ikke værktøj eller maskiner, hvis De bliver døsig, træt eller forvirret af denne medicin.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE OF THE MEDICINAL PRODUCT
Danish: • BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG
English: Other side effects not listed above may also occur in some patients.
Danish: Andre bivirkninger end de ovenfor anførte kan hos nogle patienter også forekomme.
English: Ask your pharmacist how to dispose of medicines no longer required.
Danish: Spørg Deres apotek hvad De skal gøre ved medicin, der ikke længere er nødvendig.
English: Once the correct dose is set you are ready to give the injection.
Danish: Når den korrekte dosis er indstillet, er De klar til at give indsprøjtningen.
English: Date of last renewal : 23 May 2005
Danish: Dato for første tilladelse : 9. marts 2000 Dato for seneste fornyelse : 23. maj 2005
English: This will allow the push button to move freely, ensuring that the correct dose is set.
Danish: Dette vil gøre det muligt, at trykknappen kan bevæges frit, således at den korrekte dosis kan indstilles.
English: The mechanism by which Viraferon may alter thyroid status is unknown.
Danish: Mekanismen med hvilken Viraferon kan ændre thyreoideafunktionen er ukendt.
English: Be sure the solution is at room temperature up to 25°C.
Danish: Vær sikker på, at opløsningen har stuetemperatur op til 25°C.
English: If your female partner is not pregnant now but is of childbearing age, she must be tested for pregnancy each month during treatment and for the 7 months after treatment has stopped.
Danish: Hvis Deres kvindelige partner ikke er gravid nu, men er i den fødedygtige alder, skal hun testes for graviditet hver måned under behandling, og i 7 måneder efter behandlingen er stoppet.
English: However, based on interim data from a long-term follow-up study, 12 (14 %) of 84 children had a > 15 percentile decrease in rate of linear growth, of whom 5 (6 %) children had a > 30 percentile decrease despite being off treatment for more than 1 year.
Danish: Baseret på foreløbige data fra en langsigtet opfølgningsundersøgelse, havde 12 (14 %) af 84 børn dog en > 15 procent nedgang i hastigheden af linear vækst, af hvilke 5 (6 %) børn havde en > 30 procent nedgang på trods af, at behandlingen havde været afbrudt i mere end et år.
English: Dose modifications were required in 30 % of patients, most commonly for anaemia and neutropaenia.
Danish: Dosisjusteringer var nødvendige hos 30 % af patienterne, mest almindeligt for anæmi og neutropeni.
English: The reconstituted solutions are isotonic for parenteral administration.
Danish: De færdigtilberedte opløsninger er isotoniske til parenteral indgift.
English: Although interferon is generally recognised as being species specific, toxicity studies in animals were conducted.
Danish: Skønt interferon almindeligvis anerkendes som værende artsspecifik, blev toksikologiske undersøgelser i dyr udført.
English: Loss of consciousness has occurred very rarely, mostly in elderly patients treated at high doses.
Danish: Tab af bevidstheden er forekommet meget sjældent, for det meste hos ældre patienter, behandlet med høje doser.
English: If you are scheduled to inject this product every day, and you accidentally missed a full day's dose, continue treatment at the usual dose the following day.
Danish: Hvis De skal injicere dette lægemiddel hver dag, og De ved et uheld kom til at springe en hel dagsdosis over, så fortsæt behandling med den sædvanlige dosis næste dag.
English: Caution must be exercised when administering Viraferon in combination with other potentially myelosuppressive agents.
Danish: Der bør udøves forsigtighed, når Viraferon indgives i kombination med andre potentielt myelosuppressive midler.
English: Cases of stroke (cerebrovascular events) have been reported.
Danish: Slagtilfælde (cerebrovaskulære tilfælde) er blevet rapporteret.
English: Sodium chloride,
Danish: Natriumchlorid,
English: Both subcutaneous and intramuscular administration resulted in bioavailabilities greater than 100 %.
Danish: Både subkutan og intramuskulær indgift gav en biotilgængelighed på mere end 100 %.
English: This medicine contains human albumin solution as an excipient.
Danish: Dette lægemiddel indeholder human albumin som hjælpestof.
English: This also applies to any unknown or emerging viruses or other types of infections.
Danish: Dette gælder også for alle ukendte eller nye opstående vira eller andre typer af infektioner.
English: Patients who fail to achieve virological response at 12 weeks are highly unlikely to become sustained virological responders (negative predictive value 96 %).
Danish: Patienter, der ikke opnår virologisk respons efter 12 uger, har meget lille sandsynlighed for at blive vedvarende virologiske responders (negativ prædiktiv værdi 96 %).
English: Press the injection site with a small bandage or sterile gauze if necessary for several seconds.
Danish: Pres på injektionsstedet med en lille forbinding eller steril gaze om nødvendigt i adskillige sekunder.
English: HCV genotype and baseline virus load are prognostic factors which are known to affect response rates.
Danish: HCV genotype og baseline virusmængde er prognostiske faktorer, som er kendt for at kunne påvirke responsrater.
English: If you are injecting this medicine yourself, you will be instructed how to prepare and give the injection.
Danish: Hvis De selv injicerer denne medicin, vil de blive instrueret i at tilberede og indgive injektionen.
English: These may signal serious side effects that may need urgent medical attention.
Danish: Ovennævnte kan være tegn på alvorlige bivirkninger, som kan kræve hurtig lægehjælp.
English: Viraferon is usually intended for subcutaneous use.
Danish: Viraferon er sædvanligvis beregnet til subkutan anvendelse.
English: Naïve patients:
Danish: Naive patienter:
English: Your doctor will test your blood to ensure that your white blood cell (cells that fight infection) and red blood cell (cells that carry iron and oxygen) counts, platelets (blood clotting cells) and other laboratory values are at acceptable levels.
Danish: Deres læge vil undersøge Deres blod for at sikre, at antallet af Deres hvide blodlegemer (celler, som bekæmper infektion) og røde blodlegemer (celler, som bærer jern og ilt), blodplader (blodstørkningsceller) og andre laboratorieværdier er på acceptable niveauer.
English: Like all medicines, Viraferon can cause side effects, although not everybody gets them.
Danish: Viraferon kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: if you have had a severe nervous or mental disorder.
Danish: hvis De har haft en alvorlig nervøs eller mental lidelse.
English: Read all of this leaflet carefully before you start using this medicine.
Danish: Læs denne indlægsseddel grundigt, inden De begynder at tage medicinen.
English: Do not use Viraferon if you are allergic (hypersensitive) to interferon or any of the other ingredients of Viraferon.
Danish: Brug ikke Viraferon hvis De er overfølsom (allergisk) over for interferon eller et af de øvrige indholdsstoffer.
English: If any of the following side effects happen, stop taking Viraferon and tell your doctor immediately or go to the casualty department at your nearest hospital:
Danish: Hvis en af følgende bivirkninger forekommer, så ophør med at anvende Viraferon og kontakt omgående Deres læge eller tag på skadestuen på Deres nærmeste hospital:
English: They exhibit selectivity for human but not murine interferons, suggesting species specificity.
Danish: De udviser selektivitet over for humane, men ikke murine interferoner, og viser således artsspecificitet.
English: In adult patients with loss of HBeAg and HBV-DNA, a significant reduction in morbidity and mortality has been observed.
Danish: Hos voksne patienter med nedsættelse af HbeAg og HBV-DNA er set en signifikant reduktion i morbiditet og mortalitet.
English: Virological responses after 1 year of treatment and 6 months of follow-up were 36 % for genotype 1 and 81 % for genotype 2/3/4.
Danish: Virologisk respons efter 1 års behandling og 6 måneders opfølgning var 36 % for genotype 1 og 81 % for genotype 2/3/4.
English: Overall Response
Danish: Samlet respons
English: For paediatric patients who weigh < 47 kg or cannot swallow capsules, see ribavirin oral solution SPC).
Danish: For pædiatriske patienter, der vejer < 47 kg eller ikke kan synke kapsler, se produktresume for ribavirin oral opløsning).
English: However, as for any pharmacologically active compound, symptomatic treatment with frequent monitoring of vital signs and close observation of the patient is indicated.
Danish: Som for ethvert farmakologisk aktivt stof er symptomatisk behandling med hyppig monitorering af vitale tegn og tæt observation af patienten dog indiceret.
English: Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Danish: Fremstillere af disse produkter medtager også trin i behandlingen af blod eller plasma, som kan inaktivere eller fjerne vira.