FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean serum interferon concentrations following subcutaneous and intramuscular injections were comparable.
Danish: De gennemsnitlige serumkoncentrationer af interferon efter subkutane og intramuskulære injektioner var sammenlignelige.
English: The population enrolled mainly consisted in children with mild to moderate hepatitis C. Sustained virological response rates in children and adolescents were similar to those in adults.
Danish: Den inkluderede population bestod hovedsageligt af børn med mild til moderat hepatitis C. Vedvarende virologiske responsrater hos børn og unge svarede til dem, der sås hos voksne.
English: Check with your doctor immediately if any of the following side effects occur:
Danish: Kontakt Deres læge så hurtigt som muligt, hvis en af følgende bivirkninger forekommer:
English: Children and adolescents: if you have had serious nervous or mental problems, such as severe depression or thoughts of suicide.
Danish: Børn og unge: hvis De har haft alvorlig nervøs eller mental sygdom, såsom alvorlig depression eller selvmordstanker.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER SP Europe, 73, rue de Stalle, B-1180 Bruxelles, Belgium
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN SP Europe, 73, rue de Stalle, B-1180 Bruxelles, Belgien
English: if you have hepatitis and have been treated recently with medications that suppress the immune system (other than short-term treatment with cortisone-type medicine).
Danish: hvis De har leverbetændelse og er blevet behandlet for nylig med medicin, der undertrykker immunsystemet (andet end korttidsbehandling med cortisonlignende medicin).
English: In studies of interferon use in non-human primates, abnormalities of the menstrual cycle have been observed (see section 4.4).
Danish: I undersøgelser af interferon anvendelse i ikke-humane primater har forstyrrelser i menstruationscyklus været set (se pkt.
English: Select the injection site.
Danish: Vælg injektionsstedet.
English: Injections of human recombinant interferon alfa-2b for up to three months have shown no evidence of toxicity in mice, rats, and rabbits.
Danish: Injektioner med human rekombinant interferon alfa-2b i op til tre måneder har ikke vist tegn på toksicitet hos mus, rotter og kaniner.
English: Paediatric Use: Children are particularly prone to develop depression when being treated with Viraferon and ribavirin.
Danish: Pædiatrisk anvendelse: Børn er særligt udsatte for at udvikle depression, når de behandles med Viraferon og ribavirin.
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Danish: Standardmetoder til forebyggelse af infektioner, der stammer fra anvendelse af lægemidler fremstillet fra humant blod eller plasma, omfatter udvælgelse af donorer, screening af individuelle donationer og plasmapools for specifikke markører for infektion og inklusion af effektive fremstillingstrin for inaktivering/fjernelse af vira.
English: If you use more Viraferon than you should Contact your doctor or healthcare professional as soon as possible.
Danish: Hvis De har brugt for meget Viraferon Kontakt snarest muligt Deres læge eller sundhedsplejepersonale.
English: In these patients, the addition of ribavirin to Viraferon increased by as much as 10-fold the efficacy of Viraferon used alone in the treatment of chronic hepatitis C (48.6 % vs. 4.7 %).
Danish: Hos disse patienter øgede supplement af ribavirin til Viraferon helt op til 10 gange effekten af Viraferon anvendt alene i behandlingen af kronisk hepatitis C (48,6 % mod 4,7 %).
English: This means that Viraferon is injected with a short needle into the fatty tissue just under the skin.
Danish: Dette betyder, at Viraferon injiceres med en kort kanyle i fedtvævet lige under huden.
English: After withdrawal of the dose, any remaining solution must be discarded.
Danish: Efter optrækning af dosis, skal eventuel restopløsning bortkastes.
English: If thyroid abnormalities are detected, the patient's thyroid status should be evaluated and treated as clinically appropriate.
Danish: Hvis thyreoideaabnormaliteter detekteres, bør patientens thyreoideastatus evalueres og behandles klinisk passende.
English: This must be considered during concomitant therapy with medicinal products metabolised by this route, such as the xanthine derivatives theophylline or aminophylline.
Danish: Dette skal tages i betragtning ved samtidig behandling med præparater, der metaboliseres på denne måde, såsom xanthin-derivaterne theophyllin eller aminophyllin.
English: If you are prescribed Viraferon in combination with another medicine, please refer also to the Package Leaflet of the medicine to be used in combination.
Danish: Hvis De har fået ordineret Viraferon i kombination med et andet lægemiddel, så læs venligst også indlægssedlen for det lægemiddel, der skal anvendes i kombinationen.
English: if you develop symptoms of a severe allergic reaction (such as difficulty in breathing, wheezing, or hives) while on this medication seek medical help immediately.
Danish: hvis De udvikler symptomer på en alvorlig allergisk reaktion (såsom vejrtrækningsbesvær, hiven efter vejret eller udslæt) under behandling med denne medicin, så søg straks lægehjælp.
English: 1 full turn (5 clicks) 6 clicks 7 clicks 8 clicks 9 clicks 2 full turns (10 clicks) 11 clicks 12 clicks 13 clicks 14 clicks 3 full turns (15 clicks) 16 clicks 17 clicks 18 clicks 19 clicks 4 full turns (20 clicks)*
Danish: 1 hel drejning (5 klik) 6 klik 7 klik 8 klik 9 klik 2 hele drejninger (10 klik) 11 klik 12 klik 13 klik 14 klik 3 hele drejninger (15 klik) 16 klik 17 klik 18 klik 19 klik 4 hele drejninger (20 klik)*
English: Recombinant interferon alfa-2b has exhibited antiproliferative effects in studies employing both animal and human cell culture systems as well as human tumour xenografts in animals.
Danish: Rekombinant interferon alfa-2b har vist antiproliferative effekter i undersøgelser under anvendelse af både animale og humane cellekultursystemer, såvel som humane tumor xentotransplantater på dyr.
English: Do not aim the stream at the white powder at the bottom of the vial.
Danish: Ret ikke strømmen mod det hvide pulver i bunden af hætteglasset.
English: The development of auto-antibodies and autoimmune disorders has been reported during treatment with alpha interferons.
Danish: Udvikling af auto-antistoffer og autoimmune lidelser er blevet rapporteret under behandling med alfa interferoner.
English: Be sure the solution is at room temperature at the time of injection.
Danish: Vær sikker på, at opløsningen har stuetemperatur på injektionstidspunktet.
English: Superior efficacy has been demonstrated with the combination of pegylated interferon with ribavirin (sustained response rate of 61 % achieved in a study performed in naïve patients with a ribavirin dose > 10.6 mg/kg, p < 0.01).
Danish: Bedre effekt er blevet demonstreret med kombinationen af pegyleret interferon med ribavirin (vedvarende respons rate 61 % opnået i en undersøgelse udført hos naive patienter med en ribavirin dosis > 10,6 mg/kg, p < 0,01).
English: Some people get depressed when taking Viraferon alone or in combination treatment with ribavirin, and in some cases people had suicidal thoughts or aggressive behaviour (sometimes directed against others).
Danish: Nogle mennesker bliver deprimerede, når de anvender Rebetol i kombinationsbehandling med et interferon, og i nogle tilfælde fik mennesker selvmordstanker eller aggressiv opførsel (sommetider rettet mod andre).
English: Any patient complaining of changes in visual acuity or visual fields, or reporting other ophthalmologic symptoms during treatment with Viraferon, must have a prompt and complete eye examination.
Danish: Enhver patient, som klager over forandringer i den visuelle skarphed eller synsfeltet, eller rapporterer om andre oftalmologiske symptomer under behandling med Viraferon, skal straks have foretaget en fuldstændig øjenundersøgelse.
English: After intravenous administration, serum interferon levels peaked (135 to 273 IU/ml) by the end of the infusion, then declined at a slightly more rapid rate than after subcutaneous or intramuscular administration of medicinal product, becoming undetectable four hours after the infusion.
Danish: Efter intravenøs indgift sås det maksimale interferonniveau (135-273 IE/ml) ved slutningen af infusionen, og herefter faldt det med en lidt hurtigere hastighed end efter subkutan eller intramuskulær indgift, idet det ikke kunne påvises fire timer efter infusion.
English: Results of animal reproduction studies indicate that recombinant interferon alfa-2b was not teratogenic in rats or rabbits, nor did it adversely affect pregnancy, foetal development or reproductive capacity in offspring of treated rats.
Danish: Resultater fra dyrereproduktionsundersøgelser indicerer, at rekombinant interferon alfa-2b ikke var teratogent hos rotter eller kaniner, ej heller påvirkede det i skadelig grad graviditet, fosterudvikling eller reproduktionsevne i efterkommere af behandlede rotter.
English: Rarely reported side effects (at least 1 in every 10,000 patients, but less than 1 in every 1,000 patients): pneumonia
Danish: Sjældent rapporterede bivirkninger (mindst 1 ud af 10.000 patienter, men mindre end 1 ud af 1.000 patienter):
English: Adding treatment with alfa interferons alone or in combination with ribavirin may increase the risk in this patient subset.
Danish: Supplerende behandling med alfa interferoner alene eller i kombination med ribavirin kan medføre øget risiko for denne undergruppe af patienter.
English: There are no data in children or adolescents with a history of cardiac disease.
Danish: Der er ingen resultater hos børn eller unge med tidligere hjertesygdom.
English: Pull back on the plunger slowly to draw the correct dose as prescribed by your doctor into the syringe.
Danish: Træk stemplet langsomt tilbage for at udtage den rigtige dosis, som foreskrevet af Deres læge, i sprøjten.
English: 3 times a week for 6 months) has been given to children with chronic active hepatitis B. Because of a methodological flaw, efficacy could not be demonstrated.
Danish: 3 gange om ugen i 6 måneder) er blevet givet til børn med kronisk aktiv hepatitis B. På grund af en metodesvaghed, kunne effekt ikke påvises.
English: Current clinical experience in patients who remain on interferon alfa-2b for 4 to 6 months indicates that therapy can produce clearance of serum HBV-DNA.
Danish: Nuværende kliniske erfaringer med patienter, som forbliver i interferon alfa-2b behandling i 4 til 6 måneder, viser, at behandlingen kan give elimination af serum HBV-DNA.
English: Each pen is intended for a maximum four-week use period and must then be discarded.
Danish: Hver pen er beregnet til at kunne anvendes i højst fire uger og skal så bortskaffes.
English: a: p value based on Cochran-Mantel Haenszel Chi square test. b: p value based on chi-square test. c: subjects < 75 kg received 100 µg/week pegylated interferon alfa-2b and subjects ≥ 75 kg received 150 µg/week pegylated interferon alfa-2b.
Danish: a: p værdi baseret på Cochran-Mantel Haenszel Chi kvadrat-test. b: p værdi baseret på chi-kvadrat-test. c: forsøgspersoner < 75 kg fik 100 µg/uge pegyleret interferon alfa-2b og forsøgspersoner ≥ 75 kg fik 150 µg/uge pegyleret interferon alfa-2b.
English: While this has been reported more often in patients with chronic hepatitis C treated with interferon alpha, it has also been reported in patients with oncologic diseases treated with interferon alpha.
Danish: Mens dette er rapporteret oftere hos patienter med kronisk hepatitis C behandlet med interferon-alfa, er det også rapporteret hos patienter med onkologiske sygdomme behandlet med interferon-alfa.
English: Moderate to severe adverse experiences may require modification of the patient's dosage regimen, or in some cases, termination of Viraferon therapy.
Danish: Moderate til alvorlige bivirkninger kan nødvendiggøre justering af patientens dosering eller i nogle tilfælde afbrydelse af Viraferon-behandling.
English: During concomitant therapy with xanthine agents, serum theophylline levels must be monitored and dosage adjusted if necessary.
Danish: Ved samtidig behandling med xanthin-præparater bør serum-theophyllin-niveau monitoreres og dosis om nødvendigt justeres.
English: Discontinuation of Viraferon should be considered in patients who develop new or worsening ophthalmological disorders.
Danish: Seponering af Viraferon bør overvejes hos patienter, som udvikler nye eller forværrede oftalmologiske lidelser.
English: Insert the needle into the pinched skin at an angle of 45° to 90°.
Danish: Stik kanylen ind i den sammenklemte hud i en vinkel på 45° til 90°.
English: Cases of Vogt-Koyanagi-Harada (VKH) syndrome have been reported in patients with chronic hepatitis C treated with interferon.
Danish: Tilfælde af Vogt-Koyanagi-Harada (VKH) syndrom har været rapporteret hos patienter med kronisk hepatitis C, der blev behandlet med interferon.
English: Pure red cell aplasia, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura
Danish: Pure red cell aplasi, idiopatisk thrombocytopenisk purpura, thrombotisk thrombocytopenisk purpura
English: Solvent: water for injections 1 ml/ampoule
Danish: Solvens: Vand til injektionsvæsker 1 ml/ampul
English: These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections.
Danish: Metoderne omfatter omhyggelig udvælgelse af blod- og plasmadonorer for at sikre, at donorer med risiko for at bære infektioner udelukkes, og undersøgelse af hver mængde afgivet blod og samlede plasmamængder for tegn på virus/infektioner.
English: Chronic hepatitis with decompensated cirrhosis of the liver.
Danish: Kronisk hepatitis med dekompenseret levercirrose.
English: Growth and Development: During a 1-year course of therapy there was a decrease in the rate of linear growth (mean percentile decrease of 9 %) and a decrease in the rate of weight gain (mean percentile decrease of 13 %).
Danish: Vækst og udvikling: Under et 1-årigt behandlingsforløb var der et fald i hastigheden for lineær vækst (gennemsnitlig procentvist fald på 9 %) og et fald i hastigheden for vægtøgning (gennemsnitlig procentvist fald på 13 %).
English: Volume to be withdrawn according to the dose:
Danish: Mængde som skal udtrækkes svarende til dosen:
English: Children 3 years of age and older and adolescents3 million IU/m
Danish: Børn og unge i alderen 3 år eller ældre3 millioner IE/m
English: 3 times a week ribavirin 15 mg/kg/day
Danish: 3 gange om ugen ribavirin 15 mg/kg/dag
English: The duration of therapy was 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load < 800,000 IU/ml (Amplicor) who were treated for 24 weeks with a 6-month follow-up period.
Danish: Behandlingsvarigheden var 48 uger med en opfølgningsperiode på 6 måneder med undtagelse af de patienter, der var inficeret med genotype 2 og 3 og viral load < 800.000 IE/ml (Amplicor), som blev behandlet i 24 uger med en opfølgningsperiode på 6 måneder.
English: Clinical trials in paediatric patients with chronic hepatitis C:
Danish: Kliniske undersøgelser hos pædiatriske patienter med kronisk hepatitis C:
English: Your doctor will monitor you for signs and symptoms of these conditions (Please be sure to read the ribavirin Patient Leaflet also).
Danish: Deres læge vil kontrollere Dem for sygdomstegn og symptomer på disse tilstande (Læs endelig også ribavirin indlægssedlen).
English: Sufficient needles and swabs are provided to use the Viraferon pen for administering the smallest measurable doses.
Danish: Et tilstrækkeligt antal kanyler og renseservietter er vedlagt til anvendelse af Viraferon pennen ved indgift af de mindste målelige doser.
English: There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes.
Danish: Der er ingen rapporter om virusoverførsler med albumin fremstillet efter European Pharmacopoeia specifikationer med fastlagte procedurer.
English: Adult patients with a history of congestive heart failure, myocardial infarction and/or previous or current arrhythmic disorders, who require Viraferon therapy, must be closely monitored.
Danish: Voksne patienter med tidligere hjerteinsufficiens, myokardieinfarkt og/eller tidligere eller eksisterende arytmisygdomme, som kræver Viraferon-behandling, skal følges tæt.
English: Other negative prognostic factors (age > 40 years, male gender, bridging fibrosis) should be taken into account in order to extend therapy to 12 months.
Danish: Andre negative prognostiske faktorer (alder > 40 år, hankøn, bridging fibrose) bør tages i betragtning ved fortsat behandling til 12 måneder.
English: If air bubbles do form, wait until the solution has settled and all bubbles have risen to the top of the solution and disappeared before withdrawing your dose from the vial.
Danish: Hvis der dannes luftbobler, vent indtil opløsningen har sat sig, og alle bobler er steget op til overfladen af opløsningen og er forsvundet, før De udtager Deres dosis fra hætteglasset.
English: Remove the pen from the refrigerator approximately 30 minutes before administration to allow the injectable solution to reach room temperature (not more than 25°C).
Danish: Pennen fjernes fra køleskabet cirka 30 minutter før indgift, for at tillade injektionsvæsken at få stuetemperatur (ikke mere end 25°C).
English: During clinical trials, patients who failed to show a virologic response after 6 months of treatment (HCVRNA below lower limit of detection) did not become sustained virologic responders (HCV-RNA below lower limit of detection six months after withdrawal of treatment).
Danish: I kliniske undersøgelser blev patienter, som ikke udviste virologisk respons efter 6 måneders behandling (HCV-RNA under nedre detektionsgrænse), ikke vedvarende virologiske respondere (HCV-RNA under nedre detektionsgrænse 6 måneder efter ophørt behandling).
English: Although the exact antiviral mode of action of recombinant interferon alfa-2b is unknown, it appears to alter the host cell metabolism.
Danish: Skønt den nøjagtige antivirale virkningsmekanisme af rekombinant alfa-2b er ukendt, synes det at ændre værtscellemetabolismen.
English: Table 3 Sustained virologic response rates with Viraferon + ribavirin (one year of treatment) by genotype and viral load
Danish: Tabel 3 Vedvarende virologiske responsrater med Viraferon + ribavirin (et års behandling) efter genotype og virusmængde
English: You are now ready to inject the dose.
Danish: De er nu klar til at injicere dosis.
English: Do not exceed the recommended dosage, and take Viraferon for as long as prescribed.
Danish: Overskrid ikke den anbefalede dosering, og anvend Viraferon så længe som ordineret.
English: Caution must be observed also in patients with coagulation disorders (e.g., thrombophlebitis, pulmonary embolism) or severe myelosuppression.
Danish: Varsomhed skal ligeledes iagttages hos patienter med koagulationsforstyrrelser (såsom thrombophlebitis, lungeemboli) eller alvorlig myelosuppression.
English: Treatment should be continued for another 6-month period (i.e., a total of 12 months) in patients who exhibit negative HCV-RNA at month 6, and with viral genotype 1 (as determined in a pre-treatment sample) and high pre-treatment viral load.
Danish: Behandling bør fortsættes i yderligere en 6-måneders periode (det vil sige i alt 12 måneder) hos patienter, der udviser negativ HCV-RNA ved 6 måneder, og ved viral genotype 1 (bestemt ved en prøve før behandling) og høj virusmængde før behandling.
English: This enhancement in efficacy included loss of serum HCV (< 100 copies/ml by PCR), improvement in hepatic inflammation, and normalisation of ALT, and was sustained when measured 6 months after the end of treatment.
Danish: Denne forøgelse af effekten omfattede tab af serum HCV (< 100 kopier/ml ved PCR), forbedring i leverinflammation og normalisering af ALAT, og var opretholdt ved måling 6 måneder efter afsluttet behandling.
English: There are no reports of virus infections with albumin manufactured to European Pharmacopoeia specifications by established processes.
Danish: Der er ingen rapporter om virusinfektioner med albumin fremstillet efter European Pharmacopoeia specifikationer med fastlagte procedurer.
English: After each complete turn make sure that the triangle is opposite the dosage indicator (see Diagram O).
Danish: Efter hver hel drejning efterses at trekanten står overfor doseringsviseren (se Diagram O).
English: Remove the needle guard without touching the needle, and fill the syringe with air by pulling the plunger to the level that represents your dose as prescribed by your doctor.
Danish: Fjern kanylehætten uden at røre ved kanylen, og fyld sprøjten med luft ved at trække stemplet til det niveau, der svarer til Deres dosis som foreskrevet af Deres læge.
English: Tap the top of the ampoule of solvent gently to make sure that all the liquid is at the bottom of the ampoule.
Danish: Bank let på toppen af ampullen med solvens for at sikre, at al væsken er i bunden af ampullen.
English: Sustained virologic response rates for treatment groups treated for one year with Viraferon alone or in combination with ribavirin (from two studies) are shown in Table 3.
Danish: Vedvarende virologiske responsrater for behandlingsgrupper behandlet i et år med Viraferon alene eller i kombination med ribavirin (fra to undersøgelser) er vist i Tabel 3.
English: If you are exceptionally thin, use only the thigh or outer surface of the arm for injection.
Danish: Hvis De er usædvanligt tynd, brug kun låret eller ydersiden af overarmen til injektion.
English: An improvement in liver histology has been observed.
Danish: Forbedring i leverhistologien er set.
English: Hepatomegaly Hepatotoxicity, (including fatality)
Danish: Hepatomegali Hepatotoksicitet, (inklusive dødsfald)
English: More significant obtundation and coma, including cases of encephalopathy, have been observed in some patients, usually elderly, treated at higher doses.
Danish: Mere signifikant omtågethed samt coma, inklusive tilfælde af encefalopati, er set hos nogle patienter, sædvanligvis hos ældre patienter behandlet med højere doser.
English: If you see any bubbles, pull the plunger slightly back; tap the syringe gently, with the needle pointing up, until the bubbles disappear.
Danish: Hvis De ser nogle bobler, træk stemplet lidt tilbage; bank let på sprøjten, med kanylen pegende opad, indtil boblerne forsvinder.
English: (See ribavirin capsule SPC for dose of ribavirin capsules and dosage modification guidelines for combination therapy.
Danish: (Se produktresume for ribavirin kapsler med henblik på dosis af ribavirin kapsler og retningslinierne for dosisindstilling ved kombinationsbehandling.
English: What Viraferon contains
Danish: Viraferon indeholder
English: Pharmacotherapeutic group: Immunostimulants, cytokines and immunomodulators, interferons, interferon alfa-2b, ATC code: L03A B05
Danish: Farmakoterapeutisk klassifikation: Immunstimulerende midler, cytokiner og immunmodulatorer, interferoner, interferon alfa-2b, ATC-kode: L03A B05
English: It is strongly recommended that every time you receive a dose of Viraferon the name and batch number of the product are recorded in order to maintain a record of the batches used.
Danish: Det anbefales kraftigt hver gang De får en dosis Viraferon at registrere navn og batchnummer på præparatet for at bevare en optegnelse over de anvendte batcher.
English: • swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing; hives; fainting.
Danish: • hævelse af hænder, fødder, ankler, ansigt, læber, mund eller hals, hvilket kan give besvær med at synke eller trække vejret; kløende udslæt; besvimelse.