FrancophonIA/ELRC3.0 huggingface dataset:
English: Urine levels of interferon were below the detection limit following each of the three routes of administration.
Danish: Urinkoncentrationen af interferon var under detektionsgrænsen efter indgift ved alle tre indgiftsmåder.
English: Pull off the cap of the pen and disinfect the rubber membrane (see Diagram C) with one cleansing swab.
Danish: Tag hætten af pennen og desinficer gummimembranen (se Diagram C) med en renseserviet.
English: For multidose vials, be sure to return the vial to the refrigerator.
Danish: Ved flerdosis hætteglas, husk at sætte hætteglasset tilbage i køleskabet.
English: High doses of other forms of interferons alpha and beta are known to produce dose-related anovulatory and abortifacient effects in rhesus monkeys.
Danish: Høje doser af andre former af interferon alfa og beta er kendt for at producere dosisrelateret anovulatorisk og abortfremkaldende virkning hos rhesus aber.
English: If you are self-administering treatment, or if you are the caregiver of a child taking Viraferon in combination with ribavirin, inject the recommended dose as soon as you remember and continue treatment as usual.
Danish: Hvis De selv injicerer behandlingen, eller hvis De tager Dem af et barn, der anvender Viraferon i kombination med ribavirin, så injicer den anbefalede dosis, så snart De husker det og fortsæt behandlingen som sædvanligt.
English: Note that the rear portion of the injection needle is revealed once the protective tab is removed (see Diagram D).
Danish: Bemærk at den bageste del af kanylen bliver synlig, når beskyttelsesklappen er fjernet (se Diagram D).
English: Adult patients: Viraferon alone or in combination with ribavirin has been studied in 4 randomised Phase III clinical trials in 2,552 interferon-naïve patients with chronic hepatitis C. The trials compared the efficacy of Viraferon used alone or in combination with ribavirin.
Danish: Voksne patienter: Viraferon alene eller i kombination med ribavirin er blevet undersøgt i 4 randomiserede fase III kliniske undersøgelser hos 2.552 interferon-naive patienter med kronisk hepatitis C. Undersøgelserne sammenlignede effekten af Viraferon anvendt alene eller i kombination med ribavirin.
English: Thyroid dysfunction during treatment with interferon alfa-2b and ribavirin has been observed.
Danish: Thyreoideadysfunktion under behandling med interferon alfa-2b og ribavirin har været observeret.
English: With your other hand, pick up the pen and hold it as you would a pencil.
Danish: Med Deres anden hånd tages sprøjten op og holdes, som De ville holde en blyant.
English: Studies with other interferons have demonstrated species specificity.
Danish: Undersøgelser med andre interferoner har vist artsspecificitet.
English: In clinical trials conducted in the hepatitis C population, patients were treated with Viraferon alone or in combination with ribavirin for one year.
Danish: I kliniske undersøgelser udført hos patienter med hepatitis C, blev forsøgspersonerne behandlet med Viraferon alene eller i kombination med ribavirin i et år.
English: Tap the reservoir with your finger so that any air bubbles rise to the top of the reservoir, just below the injection needle (Diagram I).
Danish: Bank let på beholderen med Deres finger, så eventuelle luftbobler stiger mod toppen af beholderen, lige under kanylen (Diagram I).
English: Discontinue treatment with Viraferon in patients with chronic hepatitis who develop prolongation of coagulation markers which might indicate liver decompensation.
Danish: Behandling med Viraferon bør afbrydes hos patienter med kronisk hepatitis, som udvikler forlængelse af koagulationsmarkører, der kan være tegn på leverinsufficiens.
English: Hypocalcaemia, dehydration, hyperuricemia, thirst
Danish: Hypokalcæmi, dehydrering, hyperuricæmi, tørst
English: Hepatic function abnormal
Danish: Unormal hepatisk funktion
English: It is obtained from a clone of E. coli, which harbours a genetically engineered plasmid hybrid encompassing an interferon alfa-2b gene from human leukocytes.
Danish: Det fås fra en klon af E.coli, som huser et genetisk fremstillet plasmid, hybridiseret med et interferon alfa-2b gen fra humane leukocytter.
English: The following instructions explain how to inject Viraferon yourself.
Danish: Følgende vejledninger forklarer, hvordan De selv injicerer Viraferon.
English: SVR after treatment of chronic HCV with non pegylated interferon alfa-2b (with or without ribavirin) results in long-term clearance of the virus providing resolution of the hepatic infection and clinical 'cure' from chronic HCV.
Danish: SVR efter behandling af kronisk HCV med ikke pegyleret interferon alfa-2b (med eller uden ribavirin) resulterer i langtidsclearance af virus hvilket medfører resolution af den hepatiske infektion og klinisk 'helbredelse' af kronisk HCV.
English: With your other hand hold the syringe as you would a pencil.
Danish: Hold sprøjten med Deres anden hånd, som De ville holde en blyant.
English: Relapse patients: A total of 345 interferon alpha relapse patients were treated in two clinical trials with Viraferon monotherapy or in combination with ribavirin.
Danish: Relaps patienter: I alt 345interferon alfa relaps patienter blev behandlet i to kliniske undersøgelser med Viraferon monoterapi eller i kombination med ribavirin.
English: Slowly inject the diluent, aiming the stream of liquid at the glass wall of the vial in order to avoid production of air bubbles.
Danish: Injicer langsomt opløsningsvæsken, ved at rette væskestrømmen mod glasvæggen i hætteglasset for at undgå dannelse af luftbobler.
English: Additionally, patients treated with Viraferon and ribavirin combination therapy and zidovudine could be at increased risk of developing anaemia (low number of red blood cells).
Danish: Patienter behandlet med Viraferon og ribavirin kombinationsbehandling og zidovudin kan herudover have en øget risiko for at udvikle anæmi (lavt antal røde blodceller).
English: If you are receiving HAART, the addition of Viraferon and ribavirin may increase your risk of lactic acidosis and of liver failure.
Danish: Hvis De modtager HAART, kan tilføjelse af Viraferon og ribavirin øge Deres risiko for mælkesyreacidose og leversvigt.
English: Children and adolescents: The efficacy and safety of Viraferon in combination with ribavirin has been studied in children and adolescents who have not been previously treated for chronic hepatitis C.
Danish: Børn og unge: Effekt og sikkerhed ved Viraferon i kombination med ribavirin er blevet undersøgt hos børn og unge, der ikke tidligere har været behandlet for kronisk hepatitis C.
English: Eligible patients for these trials had chronic hepatitis C confirmed by a positive HCV-RNA polymerase chain reaction assay (PCR) (> 100 copies/ml), a liver biopsy consistent with a histologic diagnosis of chronic hepatitis with no other cause for the chronic hepatitis, and abnormal serum ALT.
Danish: Patienter, der kunne indgå i disse undersøgelser, havde kronisk hepatitis C bekræftet ved en positiv HCV-RNA polymerasekædereaktions assay (PCR) (> 100 kopier/ml), en leverbiopsi i overensstemmelse med en histologisk diagnose med kronisk hepatitis uden anden årsag til den kroniske hepatitis, og abnorm serum ALAT.
English: In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with the combination of Viraferon and ribavirin.
Danish: Herudover kan mundtørhed have en skadelig virkning på tænder og mundslimhinder under langtidsbehandling med kombinationen af Viraferon og ribavirin.
English: Viraferon (3 MIU TIW) + ribavirin
Danish: Viraferon (3 MIE TIW) + ribavirin
English: Due to the lack of data in children with severe progression of the disease, and the potential for undesirable effects, the benefit/risk of the combination of ribavirin and interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Danish: Grundet manglende resultater fra børn med alvorlig sygdomsprogression, samt muligheden for bivirkninger, bør forholdet mellem fordele og ulemper af kombinationen ribavirin og interferon alfa-2b overvejes nøje i denne population (se pkt.
English: If ALT flares during Viraferon therapy to greater than or equal to 2 times baseline, Viraferon therapy may be continued unless signs and symptoms of liver failure are observed.
Danish: Hvis ALAT blusser op under Viraferon-behandling til større end eller lig med 2 gange basisniveau, kan man fortsætte Viraferonbehandling med mindre der er tegn og symptomer på leversvigt.
English: Chronic Hepatitis B: Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis B viral replication (presence of HBV-DNA and HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and/or fibrosis.
Danish: Kronisk hepatitis B: Behandling af voksne patienter med kronisk hepatitis B forbundet med tegn på hepatitis B virusreplikation (tilstedeværelse af HBV-DNA og HBeAg), forhøjet alaninaminotransferase (ALAT) og histologisk påvist aktiv leverinflammation og/eller fibrose.
English: Among children and adolescents treated with Viraferon in combination with ribavirin, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4 % vs 1 %) during treatment and during the 6-month follow-up after treatment.
Danish: Blandt børn og unge behandlet med Viraferon i kombination med ribavirin blev selvmordstanker eller -forsøg rapporteret oftere end hos voksne patienter (2,4 % mod 1 %) under behandling og under den 6-måneders opfølgning efter behandling.
English: This syndrome is a granulomatous inflammatory disorder affecting the eyes, auditory system, meninges, and skin.
Danish: Dette syndrom er en granulomatøs inflammatorisk lidelse, der kan påvirke synet, hørelsen, hjernehinden og huden.
English: Immediately contact the doctor or seek emergency care if they display any unusual behavioural symptoms, feel depressed, or feel they want to harm themselves or others.
Danish: Kontakt straks Deres læge eller søg akut hjælp, hvis De bemærker nogen som helst tegn på usædvanlig opførsel, føler at De bliver deprimeret eller ønsker at skade Dem selv eller andre.
English: Clear and colourless solvent.
Danish: Klart og farveløst opløsningsmiddel.
English: Any patient developing liver function abnormalities during treatment with Viraferon must be monitored closely and treatment discontinued if signs and symptoms progress.
Danish: Enhver patient, der viser unormal leverfunktion under Viraferonbehandlingen, skal følges tæt og behandlingen skal afbrydes, hvis der er tegn og symptomer på forværring.
English: If psychiatric symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with Viraferon be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Danish: Hvis psykiatriske symptomer vedvarer eller forværres, eller selvmordstanker identificeres, anbefales det, at behandling med Viraferon afbrydes, og patienten følges med passende psykiatrisk intervention.
English: During ALT flare, liver function tests: ALT, prothrombin time, alkaline phosphatase, albumin and bilirubin must be monitored at two-week intervals.
Danish: Under ALAT opblussen skal man foretage leverfunktionsundersøgelser: ALAT, protrombintid, basisk fosfatase, albumin og bilirubin med to ugers interval.
English: At the beginning of treatment with Viraferon, you may experience a flu-like reaction, with fever, fatigue, headache, muscle ache, joint pain and chills/rigors.
Danish: I begyndelsen af behandlingen med Viraferon kan De få en influenzalignende reaktion med feber, træthed, hovedpine, muskelømhed, ledsmerte og kulderystelser.
English: The appropriate dose can then be withdrawn with a sterile injection syringe and injected.
Danish: Herefter trækkes den passende dosis op med en steril injektionssprøjte og injiceres.
English: Preliminary data indicates that interferon alpha therapy may be associated with an increased rate of kidney graft rejection.
Danish: Tidlige resultater indikerer, at interferon alfa behandling kan forbindes med en øget incidens af frastødning efter nyretransplantation.
English: HOW TO SELF INJECT VIRAFERON
Danish: HVORDAN INJICERER DE SELV VIRAFERON
English: Vertigo, tinnitus Hearing loss, hearing disorder
Danish: Vertigo, tinnitus Tab af hørelse, høreforstyrrelser
English: Palpitation, tachycardia Cardiomyopathy
Danish: Palpitation, tachycardi Cardiomyopati
English: Cardiovascular (CVS) adverse events, particularly arrhythmia, appeared to be correlated mostly with preexisting CVS disease and prior therapy with cardiotoxic agents (see section 4.4).
Danish: Kardiovaskulære (CV) bivirkninger, specielt arytmi, syntes for det meste at være indbyrdes forbundet med tidligere CV sygdom og tidligere behandling med kardiotoksiske stoffer (se pkt.
English: Insert the needle in the ampoule of solvent and withdraw the total amount of solvent.
Danish: Indfør kanylen i ampullen med solvens og træk hele mængden af solvens op.
English: Mutagenicity studies with interferon alfa-2b revealed no adverse events.
Danish: Mutagenicitetsundersøgelser med interferon alfa-2b afslørede ingen bivirkninger.
English: Adequate hydration must be maintained in patients undergoing Viraferon therapy since hypotension related to fluid depletion has been seen in some patients.
Danish: Tilstrækkelig hydreringstilstand skal opretholdes hos patienter, der gennemgår Viraferon-behandling, idet hypotension på grund af væskemangel er set hos nogle patienter.
English: Replace the pen cap with the triangle once again opposite the dosage indicator as shown in Diagram T. Then return the pen to the refrigerator.
Danish: Sæt igen penhætten på med trekanten over for doseringsviseren som vist i Diagram T. Læg pennen tilbage i køleskabet.
English: Male patients and their female partners must each use an effective contraceptive during treatment and for 7 months after treatment has been concluded (see ribavirin SPC).
Danish: Mandlige patienter og deres kvindelige partnere skal begge anvende en effektiv antikonception under behandling og i 7 måneder efter behandlingen er afsluttet (Se Ribavirin SPC).
English: Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of Viraferon therapy.
Danish: Hjertearytmier (især supraventrikulære) responderer normalt på sædvanlig behandling, men seponering af Viraferon-behandling kan være nødvendig.
English: Viraferon was administered at a dose of 3 MIU 3 times a week as monotherapy or in combination with ribavirin.
Danish: Viraferon blev indgivet i en dosis på 3 MIE 3 gange om ugen som monoterapi eller i kombination med ribavirin.
English: If such a reaction develops, discontinue the medication and institute appropriate medical therapy.
Danish: Hvis en sådan reaktion opstår, skal behandlingen afbrydes og nødvendig medicinsk behandling påbegyndes.
English: In general, the adverse event profile in the limited paediatric population studied was similar to that observed in adults, although there is a paediatric specific concern regarding growth inhibition as decrease in height (mean percentile decrease of growth velocity of 9 %) and weight (mean percentile decrease of 13 %) percentile were observed during treatment (see section 4.4).
Danish: Generelt svarede bivirkningsprofilen i den begrænsede undersøgte pædiatriske population til den profil, der er observeret hos voksne, selvom der er en specifik pædiatrisk bekymring vedrørende væksthæmning, da en procentvis formindsket højde (gennemsnitlig procentvis nedgang i væksthastighed på 9 %) og vægt (gennemsnitlig procentvis nedgang på 13 %) blev observeret under behandling (se pkt.
English: Viraferon is a sterile, stable, formulation of highly purified interferon alfa-2b produced by recombinant DNA techniques.
Danish: Viraferon er en steril, stabil, formulering af højt oprenset interferon alfa-2b produceret ved rekombinant DNA-teknik.
English: Chronic hepatitis in patients who are being or have been treated recently with immunosuppressive agents excluding short term corticosteroid withdrawal.
Danish: Kronisk hepatitis hos patienter, som bliver eller for nylig er blevet behandlet med immunsuppressive stoffer, bortset fra korttids korticosteroid afbrydelse.
English: §, virilism Hyperthyroidism
Danish: §, virilisering Hyperthyroidisme
English: Do not touch the tip of the syringe.
Danish: Rør ikke ved spidsen af sprøjten.
English: Keeping the push button down, leave the injection needle in place for a few seconds to allow the Viraferon, solution for injection, to distribute under the skin, then remove.
Danish: Lad kanylen sidde i nogle få sekunder med trykknappen presset i bund for at Viraferon, injektionsvæske, opløsning kan fordeles under huden, hvorefter den fjernes.
English: Hold the pen by the barrel and turn the reservoir in the direction as indicated by the arrow in Diagram J (clockwise) until you feel it click.
Danish: Hold pennen på cylinderen og drej beholderen i pilens retning som vist i Diagram J (med uret), indtil De kan mærke den klikke.
English: Clinically significant laboratory abnormalities, most frequently occurring at doses greater than 10 million IU daily, include reduction in granulocyte and white blood cell counts; decreases in haemoglobin level and platelet count; increases in alkaline phosphatase, LDH, serum creatinine and serum urea nitrogen levels.
Danish: Klinisk signifikante laboratorieafvigelser er hyppigst set med doser større end 10 millioner IE dagligt og omfatter reduktion i antal af granulocytter og hvide blodlegemer, nedsat hæmoglobinniveau og trombocyttal, øgning i basisk fosfatase, LDH, serum-kreatinin og serum-urinstof.
English: Other CNS effects including aggressive behaviour (sometimes directed against others), confusion and alterations of mental status have been observed with alpha interferons.
Danish: Andre CNS virkninger inklusive aggressiv opførsel (sommetider rettet mod andre), forvirring og ændret mental tilstand, er blevet set med alfa interferoner.
English: Turn the vial and the syringe upside down in one hand.
Danish: Vend hætteglasset og sprøjten med bunden i vejret i den ene hånd.
English: Chronic hepatitis B:
Danish: Kronisk hepatitis B:
English: It is not known whether the components of this medicinal product are excreted in human milk.
Danish: Det er uvist om dette lægemiddel udskilles i modermælk.
English: Effect on fertility: Interferon may impair fertility (see section 4.6 and section 5.3).
Danish: Effekt på fertilitet: Interferon kan forringe fertiliteten (se pkt.
English: Prior to initiation of Viraferon therapy, TSH levels must be evaluated and any thyroid abnormality detected at that time must be treated with conventional therapy.
Danish: Inden initiering af Viraferon behandling, skal TSH niveauet evalueres og mulige thyreoideaabnormaliteter detekteret på dette tidspunkt, skal behandles med konventionel behandling.
English: Gently push the injection needle onto the pen as shown in Diagram E. (Notice that the rear portion of the injection needle will pierce through the rubber membrane that you disinfected previously).
Danish: Skub forsigtigt kanylen ind på pennen som vist i Diagram E. (Bemærk at den bageste del af kanylen vil gennemtrænge den gummimembran, som De tidligere desinficerede.)
English: Existence of, or history of severe psychiatric condition, particularly severe depression, suicidal ideation or suicide attempt.
Danish: Nuværende eller tidligere alvorlig psykiatrisk lidelse, især alvorlig depression, selvmordstanker eller selvmordsforsøg.
English: As in adult patients, children and adolescents experienced other psychiatric adverse events (e.g., depression, emotional lability, and somnolence).
Danish: Som hos voksne patienter oplevede børn og unge andre psykiatriske bivirkninger (såsom depression, emotionel labilitet og døsighed).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton
English: Children and adolescents 3 to 16 years of age with compensated chronic hepatitis C and detectable HCVRNA (assessed by a central laboratory using a research-based RT-PCR assay) were enrolled in two multicentre trials and received Viraferon 3 MIU/m2 3 times a week plus ribavirin 15 mg/kg per day for 1 year followed by 6 months follow-up after-treatment.
Danish: Børn og unge i alderen 3 til 16 år med kompenseret kronisk hepatitis C og påviselig HCV RNA (målt hos et centralt laboratorium ved brug af en forskningsbaseret RT-PCR analyse) blev inkluderet i to multicenter undersøgelser og fik Viraferon 3 MIE/m tre gange om ugen plus ribavirin 15 mg/kg per dag i 1 år efterfulgt af 6 måneders opfølgning efter behandling.
English: For safety with respect to transmissible agents, see section 4.4.
Danish: For sikkerhed med hensyn til overførbare infektioner, se pkt.
English: 3), severe neutropaenia (< 750/mm 3) or severe discontinued in case of severe leukopaenia (< 1,200/mm thrombocytopaenia (< 70,000/mm3).
Danish: 3), svær neutropeni (< 750/mm 3) eller svær skal seponeres i tilfælde af svær leukopeni (< 1.200/mm thrombocytopeni (< 70.000/mm
English: If a treatment with interferon alfa-2b is judged necessary in adult patients with existence or history of severe psychiatric conditions, this should only be initiated after having ensured appropriate individualised diagnostic and therapeutic management of the psychiatric condition.
Danish: Patienter med eksisterende eller tidligere alvorlig psykiatriske lidelser: Hvis behandling med interferon alfa-2b vurderes nødvendig hos voksne patienter med eksisterende eller tidligere alvorlige psykiatriske lidelser, bør denne kun initieres efter en passende individualiseret diagnosticering og terapeutisk håndtering af den psykiatriske lidelse er blevet sikret.
English: Water for injections q.s.
Danish: Sterilt vand q.s.
English: These symptoms have been reported more frequently when shosaikoto, a Chinese herbal medicine, is administered concomitantly with interferon alpha (see section 4.4).
Danish: Disse symptomer er blevet rapporteret oftere, når shosaikoto, en kinesisk urtemedicin, gives samtidig med interferon-alfa (se pkt.
English: HCV/HIV Co-infected patients
Danish: Samtidig infektion med HCV/HIV
English: Supplemental monitoring specific for children and adolescents Thyroid Monitoring: Approximately 12 % of children treated with interferon alfa-2b and ribavirin developed increase in TSH.
Danish: Thyreoidea monitorering: Omtrent 12 % af børn behandlet med interferon alfa-2b og ribavirin udviklede en forøgning af TSH.
English: 12 multiple dose vials
Danish: 12 flerdosis hætteglas
English: The adverse reactions listed in Table 2 are based on experience from paediatric clinical trials.
Danish: De bivirkninger, der er listet i Tabel 2, er baseret på erfaringer fra kliniske undersøgelser med børn.
English: A wide variety of autoimmune and immune-mediated disorders have been reported with alpha interferons including thyroid disorders, systemic lupus erythematosus, rheumatoid arthritis (new or aggravated), idiopathic and thrombotic thrombocytopenic purpura, vasculitis, neuropathies including mononeuropathies (see also section 4.4).
Danish: Mange forskellige autoimmune og immunmedierede sygdomme er blevet rapporteret med alfainterferoner inklusive thyroidealidelser, systemisk lupus erythematosus, reumatoid athritis (ny eller forværret), idiopatisk og thrombotisk thrombocytopenisk purpura, vasculitis, neuropatier inklusive mononeuropatier (se også pkt.
English: Virological response in previously untreated paediatric patients Viraferon 3 MIU/m2 3 times a week ribavirin 15 mg/kg/day
Danish: Tabel 5 Virologisk respons hos tidligere ubehandlede pædiatriske patienter Viraferon 3 MIE/m2 3 gange om ugen ribavirin 15 mg/kg/dag
English: Prior to initiation of Viraferon therapy for the treatment of chronic hepatitis C, evaluate serum thyroid-stimulating hormone (TSH) levels.
Danish: Før påbegyndelse med Viraferon-behandling af kronisk hepatitis C, bør thyroidstimulerende hormon (TSH) koncentrationen måles.