FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of Viraferon with ribavirin increased the efficacy of Viraferon by at least two fold for the treatment of chronic heptatitis C in naïve patients.
Danish: Samtidig indgift af Viraferon med ribavirin øgede effekten af Viraferon til mindst det dobbelte ved behandling af kronisk heptatitis C hos naive patienter.
English: Adults: The efficacy of Viraferon is enhanced when given in combination with ribavirin.
Danish: Voksne: Effekten af Viraferon er øget ved indgift i kombination med ribavirin.
English: Therefore, do not breast-feed an infant if you are taking Viraferon.
Danish: Am derfor ikke et spædbarn hvis De tager Viraferon.
English: The use of interferon alfa-2b in children and adolescents with existence of or history of severe psychiatric conditions is contraindicated (see section 4.3).
Danish: Brugen af interferon alfa-2b hos børn og unge med eksisterende eller tidligere alvorlige psykiatriske lidelser er kontraindiceret (se pkt.
English: Depression, insomnia, anxiety, emotional lability*, agitation, nervousness
Danish: Depression, søvnløshed, angst, følelsesmæssig ustabilitet*, agitation, nervøsitet
English: 3 times a week (every other day) injected subcutaneously (under the skin) in combination with ribavirin (Please also see ribavirin package leaflet).
Danish: 3 gange om ugen (hver anden dag) injiceret subkutant (under huden) i kombination med ribavirin (se venligst også ribavirin indlægssedlen).
English: Keeping the pen pointing upwards, press the push button up fully and see if a drop of Viraferon, solution for injection, appears at the injection needle tip (Notice the drop at the tip of injection needle in Diagram K below).
Danish: Hold stadig pennen opad, og pres trykknappen helt op og se om en dråbe Viraferon, injektionsvæske, opløsning, fremkommer ved kanylespidsen (Bemærk dråben ved kanylespidsen i Diagram K nedenfor).
English: Very rarely sarcoidosis, (a disease characterised by persistent fever, weight loss, joint pain and swelling, skin lesions and swollen glands) has been reported.
Danish: I meget sjældne tilfælde er der rapporteret sarcoidosis (en sygdom karakteriseret ved længerevarende feber, vægttab, ledsmerte og -opsvulmen, hudskader og opsvulmede kirtler).
English: Based on the results of clinical trials, in which data are available for 12 months of treatment, it is recommended that patients be treated with Viraferon in combination with ribavirin for at least 6 months.
Danish: På baggrund af resultater fra kliniske undersøgelser, i hvilke data er til rådighed for 12 måneders behandling, anbefales det, at patienter behandles med Viraferon i kombination med ribavirin i mindst 6 måneder.
English: If the product is not used during this four-week period, it should be discarded.
Danish: Hvis præparatet ikke anvendes under denne fire ugers periode, skal det bortkastes.
English: Viraferon (interferon alfa-2b) modifies the response of the body's immune system to help fight infections and severe diseases.
Danish: VIRAFERONS VIRKNING OG HVAD DE SKAL BRUGE DET TIL Viraferon (interferon alfa-2b) supplerer reaktionen fra kroppens immunsystem med henblik på at bekæmpe infektioner og alvorlige sygdomme.
English: Do not massage the injection site.
Danish: Masser ikke injektionsstedet.
English: Viraferon must be used cautiously in patients with debilitating medical conditions, such as those with a history of pulmonary disease (e.g., chronic obstructive pulmonary disease) or diabetes mellitus prone to ketoacidosis.
Danish: Viraferon skal anvendes med forsigtighed hos patienter med invaliderende sygdom, som for eksempel patienter med tidligere lungesygdom (såsom kronisk obstruktiv lungesygdom) eller diabetes mellitus med tendens til ketoacidosis.
English: The push button scale tells you what dose has been set.
Danish: Trykknapskalaen fortæller Dem den indstillede dosis.
English: Do not shake.
Danish: Omrystes ikke.
English: Based on the results of clinical trials, in which data are available for 6 months of treatment, it is recommended that patients be treated with Viraferon in combination with ribavirin for 6 months.
Danish: På baggrund af resultater fra kliniske undersøgelser, i hvilke data er til rådighed for 6 måneders behandling, anbefales det, at patienter behandles med Viraferon i kombination med ribavirin i 6 måneder.
English: If adverse events develop during the course of treatment with Viraferon for any indication, modify the dosage or discontinue therapy temporarily until the adverse events abate.
Danish: Hvis der opstår bivirkninger under behandling med Viraferon uanset indikation skal dosis justeres eller behandlingen afbrydes midlertidigt, indtil bivirkningerne aftager.
English: Dispose of the syringe and needles safely in a closed container.
Danish: Smid sprøjten og kanylerne sikkert ud i en lukket beholder.
English: Patients treated with Viraferon and ribavirin combination therapy and zidovudine could be at increased risk of developing anaemia.
Danish: Patienter behandlet med Viraferon og ribavirin kombinationsbehandling og zidovudin kan have øget risiko for at udvikle anæmi.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Viraferon
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Solvens til Viraferon
English: Suicide, suicide attempts, aggressive behaviour (sometimes directed against others), psychosis including hallucinations Mental status change§
Danish: Selvmord, selvmordsforsøg, aggressiv adfærd (nogle gange rettet mod andre), psykose inklusive hallucinationer Ændring af mental tilstand§
English: If you are a male patient, you and your partner must each use an effective contraceptive during the time you are taking ribavirin and for 7 months after stopping treatment.
Danish: Hvis De er en mandlig patient, skal De og Deres partner hver bruge en effektiv antikonception i den periode, De tager ribavirin og 7 måneder efter behandlingen er stoppet.
English: After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).
Danish: Anvend den færdige opløsning straks efter færdigtilberedning eller inden for 24 timer ved opbevaring i køleskab (2°C - 8°C).
English: Virological response in previously untreated paediatric patients Viraferon 3 MIU/m
Danish: Tabel 5 Virologisk respons hos tidligere ubehandlede pædiatriske patienter Viraferon 3 MIE/m
English: Viraferon is used in combination with ribavirin in children and adolescents 3 years of age and older who have previously untreated chronic hepatitis C.
Danish: Viraferon anvendes i kombination med ribavirin hos børn og unge i alderen 3 år eller ældre, som har tidligere ubehandlet kronisk hepatitis C.
English: The abnormalities were controlled by conventional therapy for thyroid dysfunction.
Danish: Forandringerne kunne kontrolleres med konventionel behandling for thyreoideadysfunktion.
English: Patients were randomized to receive either pegylated interferon alfa-2b (100 or 150 µg /week based on weight) plus ribavirin (800-1,200 mg/day based on weight) or Viraferon (3 MIU TIW) plus ribavirin (800-1,200 mg/day based on weight).
Danish: Patienterne blev randomiseret til at få enten pegyleret interferon alfa-2b (100 eller 150 µg /uge baseret på vægt) plus ribavirin (8001.200 mg/dag baseret på vægt) eller Viraferon (3 MIE TIW) plus ribavirin (800-1.200 mg/dag baseret på vægt).
English: Insert the needle into the vial containing the Viraferon solution and inject air into the vial.
Danish: Indfør kanylen i hætteglasset indeholdende Viraferon opløsningen og injicer luft i hætteglasset.
English: Viraferon solution for injection, may be injected directly after withdrawal of the appropriate doses from the vial with a sterile injection syringe.
Danish: Viraferon injektionsvæske, opløsning kan injiceres direkte efter at den foreskrevne dosis er trukket op fra hætteglasset med en steril injektionssprøjte.
English: Mean (% CV) multiple-dose pharmacokinetic parameters for Viraferon and ribavirin capsules when administered to children or adolescents with chronic hepatitis C Parameter
Danish: Gennemsnitlig (% CV) flerdosis farmakokinetiske parametre for Viraferon og ribavirin kapsler ved indgift til børn eller unge med kronisk hepatitis C PARAMETER
English: Do not use if discolouration or particulate matter is present.
Danish: Anvend den ikke i tilfælde af misfarvning eller tilstedeværelse af bundfald.
English: N=503 C95-132/I95-143
Danish: I N=503 C95-132/I95-143
English: Chronic hepatitis B: 5 to 10 million IU 3 times a week (every other day) injected subcutaneously (under the skin).
Danish: Kronisk hepatitis B: 5 til 10 millioner IE 3 gange om ugen (hver anden dag) injiceret subkutant (under huden).
English: The administered dose should be reduced by 50 % in case of occurrence of haematological disorders (white 3, granulocytes < 1,000/mm 3, thrombocytes < 100,000/mm 3).
Danish: Den givne dosis skal reduceres med 50 % i tilfælde af forekomst af hæmatologiske lidelser (hvide 3, granulocytter < 1.000/mm 3, thrombocytter < 100.000/mm 3).
English: Preparation Collect necessary items before you begin: the Viraferon multidose pen; a needle for subcutaneous injection (provided in the packaging); a cleansing swab.
Danish: Forberedelse Saml det nødvendige udstyr, før De begynder: Viraferon flerdosispennen, en kanyle til subkutan injektion (vedlagt i pakningen), en renseserviet.
English: The activity of Viraferon is expressed in terms of IU, with 1 mg of recombinant interferon alfa-2b protein corresponding to 2.6 x l0
Danish: Aktiviteten af Viraferon udtrykkes i IE, med 1 mg af rekombinant interferon alfa-2b protein svarende til 2,6 x 10
English: Chronic Hepatitis B: The recommended dosage is in the range 5 to 10 million IU administered subcutaneously three times a week (every other day) for a period of 4 to 6 months.
Danish: Kronisk hepatitis B: Den anbefalede dosering er fra 5 til 10 millioner IE, givet subkutant tre gange om ugen (hver anden dag) i en periode på 4-6 måneder.
English: Very common: *These events were only common with Viraferon alone See section 4.4
Danish: Vægttab *Disse hændelser var kun almindelige med Viraferon alene Se pkt.
English: Blood and lymphatic system disorders Very common:
Danish: Blod og lymfesystem Meget almindelig: Almindelig:
English: PHARMACEUTICAL FORM Solution for injection Solution is clear and colourless.
Danish: LÆGEMIDDELFORM Injektionsvæske, opløsning Opløsningen er klar og farveløs.
English: Measuring the dose of Viraferon from the reconstituted powder for injection Turn the vial and the syringe upside down in one hand.
Danish: Afmåling af Viraferon dosis fra det færdigtilberedte pulver til injektionsvæske Vend hætteglasset og sprøjten med bunden i vejret i den ene hånd.
English: Viraferon (3 MIU TIW) + ribavirin (800 mg)
Danish: Viraferon (3 MIE TIW) + ribavirin (800 mg)
English: Then, pull off the inner injection needle cap carefully, bearing in mind that the injection needle will now be exposed (Diagram H).
Danish: Træk herefter den indre kanylehætte forsigtigt af med tanke på, at kanylen nu bliver fri (Diagram H).
English: To prepare the Viraferon solution insert the needle through the rubber top of the Viraferon vial and gently place the needle tip against the glass wall of the vial without touching the cleaned top of the vial with your hands.
Danish: For at forberede Viraferon opløsningen, stik kanylen gennem gummimembranen på Viraferon hætteglasset og placer blidt kanylespidsen mod glasvæggen i hætteglasset uden at røre den rensede membran på hætteglasset med Deres hænder.
English: Viraferon is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV (see section 4.4).
Danish: Viraferon er beregnet til behandling af voksne patienter med kronisk hepatitis C, som har forhøjede transaminaser uden leverdekompensation, og som er positive med hensyn til HCV-RNA eller anti-HCV (se pkt.
English: Dental and periodontal disorders: Dental and periodontal disorders, which may lead to loss of teeth, have been reported in patients receiving Viraferon and ribavirin combination therapy.
Danish: Dentale og parodontale lidelser: Dentale og parodontale lidelser, som kan føre til tab af tænder, er blevet rapporteret hos patienter, der fik Viraferon og ribavirin kombinationsbehandling.
English: Remove the needle guard without touching the needle and keep the syringe with the needle in your hand.
Danish: Fjern kanylehætten uden at røre kanylen og hold sprøjten med kanylen i Deres hånd.
English: Hold the syringe with the needle in the vial pointing up, remove the syringe from the long needle leaving the needle in the vial and without touching the tip of the syringe.
Danish: Hold sprøjten med kanylen i hætteglasset opad, fjern sprøjten fra den lange kanyle, efterladende kanylen i hætteglasset og uden at røre spidsen af sprøjten.
English: Now screw the injection needle onto the pen securely by turning it in a clockwise direction (see Diagram F).
Danish: Nu skrues kanylen fast på pennen ved at dreje den i retning med uret (se Diagram F).
English: Depression, emotional lability, insomnia Suicidal ideation, aggressive reaction, confusion, behaviour disorder, agitation, somnambulism, anxiety, nervousness, sleep disorder, abnormal dreaming, apathy
Danish: Depression, emotionel ustabilitet, søvnløshed Selvmordstanker, aggressiv reaktion, forvirring, adfærdsforstyrrelser, agitation, søvngængeri, angst, nervøsitet, søvnforstyrrelser, unormale drømme, apati
English: Patients were randomized to receive either pegylated interferon alfa-2b (1.5 µg/kg/week) plus ribavirin (800 mg/day) or Viraferon (3 MIU TIW) plus ribavirin (800 mg/day) for 48 weeks with a follow-up period of 6 months.
Danish: Patienterne blev randomiseret til enten at få pegyleret interferon alfa 2b (1,5 µg/kg/uge) plus ribavirin (800 mg/dag) eller Viraferon (3 MIE TIW) plus ribavirin (800 mg/dag) i 48 uger med en opfølgningsperiode på 6 måneder.
English: Rarely:
Danish: Sjælden:
English: Viraferon is intended for use, in a combination regimen with ribavirin, for the treatment of children and adolescents 3 years of age and older, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for serum HCV-RNA.
Danish: Viraferon er beregnet til anvendelse, i kombination med ribavirin, til behandling af børn og unge i alderen 3 år eller ældre, som lider af tidligere ubehandlet kronisk hepatitis C uden leverdekompensation, og som er positive med hensyn til serum HCV-RNA.
English: The expected benefit of treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials (see sections 4.4, 4.8 and 5.1).
Danish: Den forventede gavn af behandling bør afvejes mod de sikkerhedsfund, der er observeret hos pædiatriske patienter i kliniske undersøgelser (se pkt.
English: The vial, ampoule and injection materials intended for single use must be discarded.
Danish: Hætteglasset, ampullen og injektionsmaterialerne beregnet til engangsbrug skal bortkastes.
English: If the product is not used during the seven-day period, it should be discarded.
Danish: Hvis præparatet ikke anvendes under denne syv dages periode, skal det bortkastes.
English: Monotherapy: Infrequently, adult patients treated for chronic hepatitis C with Viraferon developed thyroid abnormalities, either hypothyroidism or hyperthyroidism.
Danish: Monoterapi: Voksne patienter, som var i behandling med Viraferon for kronisk hepatitis C, viste med mindre hyppighed unormal thyreoideafunktion, enten hypothyreoidisme eller hyperthyreoidisme.
English: Micturition frequency Renal failure, renal insufficiency, nephrotic syndrome
Danish: Hyppig vandladning Nyresvigt, nyreinsufficiens, nefrotisk syndrom
English: Immune system disorders Very rarely:
Danish: Immunsystemet Meget sjælden: Ikke kendt:
English: Chronic hepatitis C: Adults - 3 million IU 3 times a week (every other day) injected subcutaneously (under the skin) in combination with ribavirin or alone.
Danish: Kronisk hepatitis C: Voksne - 3 millioner IE 3 gange om ugen (hver anden dag) injiceret subkutant (under huden) i kombination med ribavirin eller alene.
English: Measuring the dose of Viraferon
Danish: Afmåling af Viraferon dosis
English: First, pull off the outer injection needle cap (Diagram G).
Danish: Træk først den ydre kanylehætte af (Diagram G).
English: As with all parenteral medicinal products, prior to administration inspect Viraferon, solution for injection, visually for particulate matter and discolouration.
Danish: I lighed med alle parenterale lægemidler undersøges Viraferon, injektionsvæske, opløsning visuelt for partikler og misfarvning før brugen.
English: Chronic Hepatitis C:
Danish: Kronisk hepatitis C:
English: Using a sterilised injection syringe and injection needle, inject 1 ml water for injections into the vial of Viraferon.
Danish: Med en steril injektionssprøjte og kanyle indsprøjtes 1 ml vand til injektionsvæsker i hætteglasset med Viraferon.
English: The pen is designed to deliver its contents of 60 million IU in doses ranging from 5 to 20 million IU.
Danish: Pennen er designet til at afgive sit indhold af 60 millioner IE i doser fra 5 til 20 millioner IE.
English: Hyperkinesia, tremor, dysphonia, paresthaesia, hypoaesthesia, hyperaesthesia, concentration impaired, somnolence
Danish: Hyperkinesi, tremor, dysfoni, parestesi, hypoestesi, hyperestesi, koncentrationsbesvær, søvnighed
English: Very rarely reported side effects (less than 1 in every 10,000 patients): low blood pressure, puffy face, diabetes, leg cramps, back pain, kidney problems, nerve damage, bleeding gums, aplastic anaemia.
Danish: Meget sjældent rapporterede bivirkninger (mindre end 1 ud af 10.000 patienter: lavt blodtryk, opsvulmet ansigt, diabetes, benkramper, rygsmerter, nyrelidelser, nerveskade, blødende tandkød, aplastisk anæmi.
English: Male: testicular pain
Danish: Mænd: testikelsmerter
English: Use the injection needles provided in the packaging only for Viraferon.
Danish: Brug kun kanylerne, der er vedlagt i pakningen, til Viraferon.
English: if you develop symptoms associated with a cold or other respiratory infection, such as fever, cough, or any difficulty in breathing, tell your doctor.
Danish: hvis De udvikler symptomer i forbindelse med en forkølelse eller anden luftvejsinfektion, såsom feber, hoste eller besvær med vejrtrækningen, så fortæl Deres læge det. hvis De bemærker usædvanlig blødning eller blå mærker, så spørg straks Deres læge til råds.
English: Liver graft rejection has also been reported.
Danish: Frastødning efter levertransplantation er også rapporteret.
English: Dental and gum disorders, which may lead to loss of teeth, have been reported in patients receiving Viraferon and ribavirin combination therapy.
Danish: Tand- og tandkødslidelser, som kan lede til tab af tænder, er blevet rapporteret hos patienter, der fik Viraferon og ribavirin kombinationsbehandling.
English: Hypersensitivity to the active substance or to any of the excipients.
Danish: Overfølsomhed over for det (de) aktive stof(fer) eller over for et eller flere af hjælpestofferne.
English: Pack sizes of 1, 2 or 8
Danish: Pakningsstørrelse á 1, 2 eller 8.
English: Completely unscrew the injection needle assembly using an anti-clockwise turning motion as shown in Diagram R. Then carefully lift it off the pen and discard the capped injection needle (see Diagram S).
Danish: Skru kanyledelen fuldstændig af ved at dreje mod uret som vist i Diagram R. Løft den herefter forsigtigt af pennen og smid kanylen med hætten på væk (se Diagram S).
English: Carefully replace the outer injection needle cap (See Diagram Q).
Danish: Sæt forsigtigt den ydre kanylehætte på (se Diagram Q).
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, 4.2).
Danish: MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I: Produktresumé; pkt.
English: Replace the Viraferon, solution for injection, multidose pen cap with the ‘triangle' opposite the dosage indicator as seen in Diagram L.
Danish: Sæt penhætten tilbage på Viraferon, injektionsvæske, opløsning, flerdosispennen med ‘trekanten' overfor doseringsviseren som vist i Diagram L.
English: The pen is designed to deliver its contents of 18 million IU in doses ranging from 1.5 to 6 million IU.
Danish: Pennen er designet til at afgive sit indhold af 18 millioner IE i doser fra 1,5 til 6 millioner IE.
English: Sarcoidosis, exacerbation of sarcoidosis Systemic lupus erythematosus, vasculitis, rheumatoid arthritis (new or aggravated), Vogt-Koyanagi-Harada syndrome, acute hypersensitivity reactions including urticaria, angioedema, bronchoconstriction, anaphylaxis§
Danish: Sarcoidose, forværring af sarcoidose Systemisk lupus erythematose, vaskulitis, reumatoid arthritis (ny eller forværret), Vogt-Koyanagi-Harada syndrom, akutte overfølsomhedsreaktioner inklusive nældefeber, angioødem, bronkokonstriktion, anafylakse§
English: In Table 1 the frequency of patients reporting (treatment related) undesirable effects is presented from clinical trials in naïve patients treated for one year.
Danish: I Tabel 1 er hyppigheden af patienter, der rapporterede (behandlingsrelaterede) bivirkninger, vist.
English: Sustained virological response based on genotype after Viraferon in combination with ribavirin versus pegylated interferon alfa-2b in combination with ribavirin in HCV/HIV co-infected patients
Danish: Tabel 4 Vedvarende virologisk respons baseret på genotype efter Viraferon i kombination med ribavirin versus pegyleret interferon alfa-2b i kombination med ribavirin hos patienter med samtidig infektion af HCV/HIV
English: You and your partner must each use an effective contraceptive during the time you are taking ribavirin and for 4 months after stopping treatment.
Danish: De og Deres partner skal begge anvende en effektiv antikonception i den periode, De tager ribavirin og i 4 måneder efter behandlingen er afsluttet.
English: Rhabdomyolysis, myositis, leg cramps, back pain
Danish: Rhabdomyolyse, myositis, benkramper, rygsmerte
English: Replace the needle guard and place the syringe with the needle on a flat surface.
Danish: Sæt kanylehætten på igen og læg sprøjten med kanylen på en jævn overflade.
English: After first opening the container: Chemical and physical in-use stability has been demonstrated for 28 days at 2ºC - 8ºC.
Danish: Efter første anvendelse: Fysisk-kemisk stabilitet under brug er vist i 28 dage ved 2°C - 8°C.
English: Periodontal disorder NOS, dental disorder NOS
Danish: Periodontallidelse NOS, tandlidelse NOS
English: If the product is not reconstituted during the four-week period, it cannot be put back in the refrigerator for a new storage period and must be discarded.
Danish: Hvis det ikke færdigtilberedes inden fire ugers perioden, kan det ikke sættes tilbage i køleskabet, men skal destrueres.
English: Solvent: water for injections
Danish: Solvens: Vand til injektionsvæsker.
English: Children 3 years of age or older and adolescents: Interferon alfa-2b 3 MIU/m2 is administered subcutaneously 3 times a week (every other day) in combination with ribavirin capsules or oral solution administered orally in two divided doses daily with food (morning and evening).
Danish: Børn i alderen 3 år eller derover og unge: Interferon alfa-2b 3 millioner IE/m2 indgives subkutant 3 gange om ugen (hver anden dag) i kombination med ribavirin kapsler eller oral opløsning indgivet oralt fordelt på to daglige doser til et måltid (morgen og aften).
English: From a microbiological point of view, once opened, the product may be stored for a maximum of 27 days at 2ºC - 8ºC.
Danish: Fra et mikrobiologisk synspunkt kan produktet når det er åbnet opbevares i maksimalt 27 dage ved 2°C - 8°C.
English: N=505 C95-132/I95-143
Danish: I/R N=505 C95-132/I95-143
English: The vial and injection materials intended for single use must be discarded.
Danish: Hætteglasset og injektionsmaterialerne beregnet til engangsbrug skal bortkastes.
English: Chemical and physical in-use stability has been demonstrated for 27 days at 2ºC - 8ºC.
Danish: Fysisk-kemisk stabilitet under brug er vist i 27 dage ved 2°C - 8°C.