FrancophonIA/ELRC3.0 huggingface dataset:
English: International Units are determined by comparison of the activity of the recombinant interferon alfa-2b with the activity of the international reference preparation of human leukocyte interferon established by the World Health Organisation.
Danish: IE. Internationale enheder fastsættes ved at sammenligne aktiviteten af rekombinant interferon alfa-2b med aktiviteten af den internationale referencestandard af human leukocyt interferon fastsat af verdenssundhedsorganisationen WHO.
English: Be sure to discuss this with your doctor.
Danish: Dette skal diskuteres med Deres læge.
English: Your doctor will determine the exact dosage schedule and regimen according to your needs.
Danish: Deres læge vil bestemme den nøjagtige dosering og kur afhængig af Deres behov.
English: It is strongly recommended that every time that Viraferon is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Danish: Det anbefales kraftigt hver gang Viraferon anvendes til en patient, at navn og batchnummer for præparatet registreres for at bevare en forbindelse mellem patienten og batchen af præparatet.
English: While fever may be associated with the flu-like syndrome reported commonly during interferon therapy, other causes of persistent fever must be ruled out.
Danish: Da feber kan ses sammen med de influenzalignende reaktioner, der sædvanligvis rapporteres under interferonbehandling, bør andre årsager til vedvarende feber udelukkes.
English: Because of the potential for adverse reactions in nursing infants, nursing should be discontinued prior to initiation of treatment.
Danish: Af hensyn til muligheden for bivirkninger hos de ammede børn, bør amning afbrydes før påbegyndelse af behandling.
English: However, certain monkey species, eg, rhesus monkeys, are susceptible to pharmacodynamic stimulation upon exposure to human type 1 interferons.
Danish: Imidlertid er visse abearter, såsom rhesus aber, modtagelige for farmakodynamisk stimulation ved udsættelse for human type 1 interferoner.
English: Hypertension Peripheral ischaemia, hypotension
Danish: Hypertension Perifer iskæmi, hypotension
English: In a large study, 1,071 patients were enrolled after treatment in a prior non pegylated interferon alfa-2b or non pegylated interferon alfa-2b/ribavirin study to evaluate the durability of sustained virologic response and assess the impact of continued viral negativity on clinical outcomes.
Danish: I en stor undersøgelse, blev 1.071 patienter inkluderet efter behandling i en tidligere ikke pegyleret interferon alfa-2b eller ikke pegyleret interferon alfa-2b/ribavirin undersøgelse for at evaluere varigheden af vedvarende virologisk respons og bestemme virkningen af fortsat viral negativitet på kliniske resultater.
English: Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with Viraferon.
Danish: Lungeinfiltrat, pneumonitis og pneumonia, undertiden resulterende i dødsfald, er sjældent blevet observeret hos interferon-alfa behandlede patienter, inklusive de, som er behandlet med Viraferon.
English: Alopecia, pruritus*, skin dry*, rash*, sweating increased Psoriasis (new or aggravated)
Danish: Alopeci, pruritus*, tør hud*, udslæt*, øget svedtendens Psoriasis (ny eller forværret)
English: Tell your doctor if you have ever had a heart attack or a heart problem; if you have a history of breathing irregularities or pneumonia, problems with blood clotting, liver condition, thyroid problems, diabetes, or high or low blood pressure.
Danish: Fortæl Deres læge, hvis De nogensinde har haft et hjerteanfald eller en hjertelidelse; hvis De tidligere har haft vejrtrækningsbesvær eller lungebetændelse, problemer med blodstørkningen, leverfunktionen, thyreoidealidelser, diabetes, eller højt eller lavt blodtryk.
English: If such symptoms appear, the potential seriousness of these undesirable effects must be borne in mind by the prescribing physician and the need for adequate therapeutic management should be considered.
Danish: Hvis sådanne symptomer forekommer, skal den foreskrivende læge være opmærksom på den potentielle alvor af disse bivirkninger, og behovet for passende terapeutisk håndtering bør overvejes.
English: The relative benefit of combination therapy with Viraferon + ribavirin is particularly significant in the most difficult to treat subgroup of patients (genotype 1 and high virus load) (Table 3).
Danish: Den relative gavn af kombinationsbehandling med Viraferon + ribavirin er særlig signifikant i de undergrupper af patienter, der er vanskeligst at behandle (genotype 1 og høj virusmængde) (Tabel 3).
English: To set the correct dose, turn the cap as many times as indicated as follows:
Danish: For at indstille den korrekte dosis, drejes penhætten så mange gange, som anført nedenfor:
English: Ribavirin 15 mg/kg/day as 2 divided doses (n = 17)
Danish: Ribavirin 15 mg/kg/dag fordelt på 2 doser (n = 17)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation : 9 March 2000
Danish: Dato for første tilladelse : 9. marts 2000
English: Combination therapy with ribavirin: Ribavirin causes serious birth defects when administered during pregnancy.
Danish: Kombinationsbehandling med ribavirin: Ribavirin forårsager alvorlige fosterskader ved anvendelse under graviditet.
English: For doses corresponding to clicks intermediate between full turns, the scale should line up between the two appropriate full-turn dose markings.
Danish: For doser som svarer til klik imellem hele omdrejninger skal skalaen tilsvarende være mellem stregerne for de to hele omdrejningsdoser.
English: Study 2 (P02080) was a randomized, single centre study that enrolled 95 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
Danish: Undersøgelse 2 (P02080) var en randomiseret enkeltcenterundersøgelse, der inkluderede 95 tidligere ubehandlede voksne patienter med kronisk hepatitis C, der samtidig var inficeret med HIV.
English: If you forget to take Viraferon
Danish: Hvis De har glemt at bruge Viraferon
English: Additionally, Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin and the membranes of the ears, brain and spinal cord) has been reported with Viraferon use.
Danish: Vogt-Koyanagi-Harada syndrom (en autoimmun inflammatorisk lidelse, der påvirker øjnene, huden og membraner i ører, hjerne og rygmarv) har endvidere været set ved anvendelsen af Viraferon.
English: Patients who also have HIV infection: Lactic acidosis and worsening liver function are side effects associated with Highly Active Anti-Retroviral Therapy (HAART), an HIV treatment.
Danish: Patienter, som også har HIV infektion: Mælkesyreacidose og nedsat leverfunktion er bivirkninger, som er forbundet med højaktiv anti-retroviral terapi (HAART), en HIV behandling.
English: Take the pen out of the refrigerator about one-half hour before administering the dose so that the solution in the pen is at room temperature when it is injected.
Danish: Tag pennen ud af køleskabet cirka en halv time før indgift af dosis, således at opløsningen i pennen har stuetemperatur, når den indsprøjtes.
English: Any patient developing fever, cough, dyspnea or other respiratory symptoms must have a chest X-ray taken.
Danish: Enhver patient, som udvikler feber, hoste, kortåndethed eller andre åndedrætssymptomer, bør have taget røntgen af thorax.
English: A maximum of 48 hours (two days) of exposure to 25°C is permitted over the four-week period to cover accidental delays in returning the pen to the refrigerator.
Danish: Maksimalt 48 timers (to dages) udsættelse for 25°C er tilladt i den fire ugers periode for at tage højde for tilfældige forsinkelser med at lægge pennen tilbage i køleskabet.
English: Viraferon 3 MIU/m2 3 times a week (n = 54)
Danish: Viraferon 3 MIE/m2 3 gange om ugen (n = 54)
English: Ear and labyrinth Common:
Danish: Øre og labyrint Almindelig:
English: If VKH syndrome is suspected, antiviral treatment should be withdrawn and corticosteroid therapy discussed (see section 4.8).
Danish: Hvis der er mistanke om VKH syndrom, bør antiviral behandling stoppes og kortikosteroid behandling diskuteres (se pkt.
English: Periodic visual examinations during Viraferon therapy are recommended particularly in patients with disorders that may be associated with retinopathy, such as diabetes mellitus or hypertension.
Danish: Regelmæssige synsundersøgelser under Viraferon behandling anbefales især hos patienter med sygdomme, der kan være forbundet med retinopati, såsom diabetes mellitus eller hypertension.
English: Recombinant interferon alfa-2b is a water-soluble protein with a molecular weight of approximately 19,300 daltons.
Danish: Rekombinant interferon alfa-2b er et vandopløseligt protein med en molekylvægt på cirka 19.300 daltons.
English: In addition, preclicinal juvenile toxicity results have demonstrated a minor, dose-related decrease in overall growth in neonatal rats dosed with ribavirin (see section 5.3).
Danish: Prækliniske toksicitetsresultater hos unge har endvidere vist et mindre dosisrelateret fald i samlet vækst hos neonatale rotter, der fik ribavirin (se pkt.
English: The push button scale will show you the dose set (see Diagram N below).
Danish: Trykknapskalaen vil vise Dem den indstillede dosis (se diagram N nedenfor).
English: Viraferon may be administered using either glass or plastic disposable injection syringes.
Danish: Viraferon kan indgives ved brug af enten glas- eller plastik-éngangsinjektionssprøjter.
English: Co-infected patients with advanced cirrhosis receiving HAART may be at increased risk of hepatic decompensation and death.
Danish: Co-inficerede patienter med fremskreden cirrhose, der får HAART, kan have øget risiko for nedsat leverfunktion og død.
English: Be sure to seek emergency care if you notice that you are becoming depressed or have suicidal thoughts or change in your behaviour.
Danish: Søg endelig akut hjælp, hvis De bemærker, at De bliver deprimeret eller har selvmordstanker eller ændrer Deres opførsel.
English: Caution should be used when adding Viraferon and ribavirin to HAART therapy (see ribavirin SPC).
Danish: Forsigtighed bør udvises, når Viraferon og ribavirin adderes til HAART terapi (se ribavirin produktresume).
English: The use of interferon alfa-2b in children and adolescents with existence of or history of severe psychiatric conditions is contraindicated (see “Do not use Viraferon”) if you have ever had depression or develop symptoms associated with depression (e.g. feelings of sadness, dejection, etc.) while on treatment with Viraferon (see section 4).
Danish: Anvendelse af interferon alfa-2b hos børn og unge med nuværende eller tidligere alvorlige psykiske lidelser er kontraindiceret (se ”Brug ikke Viraferon”) hvis De nogensinde har haft en depression eller får symptomer, som er forbundet med depression (såsom følelse af tristhed, modløshed eller andet), under behandling med Viraferon (se pkt.
English: Tell your doctor if you have ever been treated for depression or any other psychiatric disorder; confusion; unconsciousness; thoughts of suicide or attempted suicide.
Danish: Fortæl Deres læge, hvis De nogensinde er blevet behandlet for depression eller andre psykiatriske lidelser, forvirring, bevidstløshed, selvmordstanker eller selvmordsforsøg.
English: Keep the outer injection needle cap for later use.
Danish: Behold den ydre kanylehætte til senere brug.
English: d p value b
Danish: d p værdi b
English: Interferon alfa-2b (6 MIU/m2 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: Interferon alfa-2b (6 MIE/m2 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: Hold the Viraferon vial upright without touching the cleaned top of the vial with your hands.
Danish: Hold Viraferon hætteglasset lodret uden at røre den rensede top af hætteglasset med Deres hænder.
English: The reconstituted solution should be clear and colourless.
Danish: Den rekonstituerede opløsning skal være klar og farveløs.
English: The best sites for injection are tissues with a layer of fat between skin and muscle: thigh, outer surface of the upper arm (you may need the assistance of another person to use this site), abdomen (except the navel or waistline).
Danish: De bedste steder til injektion er væv med et fedtlag mellem hud og muskel: Lår, ydersiden af overarmen (De skal eventuelt have hjælp af en anden person for at bruge dette sted), underlivet (undtagen navlen og taljen).
English: Discontinuation of Viraferon therapy has not reversed thyroid dysfunction occurring during treatment (also see Children and adolescents, Thyroid monitoring).
Danish: Seponering af Viraferon-behandling har ikke ændret thyreoideadysfunktion opstået under behandlingen (se også børn og unge, thyreoidea monitorering).
English: Insert the needle into the pinched skin at an angle of approximately 45°.
Danish: Stik kanylen ind i den sammenklemte hud med en vinkel på cirka 45°.
English: However, the chemical and physical in-use stability has been demonstrated for 24 hours at 25ºC.
Danish: Fysisk-kemisk stabilitet under brug er imidlertid vist i 24 timer ved 25°C.
English: Viraferon is used in adult patients for the treatment of chronic hepatitis B or C, which are viral infections of the liver.
Danish: Viraferon anvendes hos voksne patienter til behandling af kronisk hepatitis B og C, der er virusinfektioner i leveren.
English: Relapse patients (adults): Viraferon is given in combination with ribavirin.
Danish: Relaps patienter (voksne): Viraferon anvendes i kombination med ribavirin.
English: Interferon neutralising factor assays were performed on serum samples of patients who received Viraferon in Schering-Plough monitored clinical trials.
Danish: Undersøgelser af interferonneutraliserende faktor har været udført på serumprøver fra patienter, som fik Viraferon i Schering-Plough monitorerede kliniske undersøgelser.
English: While being treated with Viraferon, your doctor may want you to drink extra fluids to help prevent low blood pressure.
Danish: Brug af Viraferon sammen med mad og drikke Deres læge kan anbefale Dem at drikke ekstra væske for at hjælpe med at forebygge lavt blodtryk.
English: Prompt discontinuation of interferon alpha administration and treatment with corticosteroids appear to be associated with resolution of pulmonary adverse events.
Danish: Hurtig afbrydelse af interferon-alfa indgift og behandling med kortikosteroider synes at være forbundet med ophør af pulmonale bivirkninger.
English: Acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) to interferon alfa-2b have been observed rarely during Viraferon therapy.
Danish: Akutte overfølsomhedsreaktioner (såsom urticaria, angioødem, bronkokonstriktion, anafylaksi) over for interferon alfa-2b har sjældent været observeret under Viraferon behandling.
English: Physicians are advised to monitor the growth of children taking ribavirin in combination with interferon alfa-2b.
Danish: Det anbefales at læger monitorerer væksten af børn, der tager ribavirin i kombination med interferon alfa2b.
English: Adverse reactions reported during clinical trials or following the marketing use of Viraferon alone or in combination with ribavirin
Danish: Bivirkninger rapporteret ved kliniske undersøgelser eller efter markedsføring af Viraferon alene eller i kombination med ribavirin
English: Pre-existing thyroid disease unless it can be controlled with conventional treatment.
Danish: Tidligere thyreoideasygdom, medmindre den er velkontrolleret med konventionel behandling.
English: §, hyperthyroidism Hypothyroidism Diabetes, aggravated diabetes
Danish: §, hyperthyroidisme Hypothyroidisme Diabetes, forværret diabetes
English: If you have this reaction, be sure to rinse your mouth thoroughly afterwards.
Danish: Hvis De gør det, så husk at skylle Deres mund omhyggeligt bagefter.
English: Cardiomyopathy, that may be reversible upon discontinuation of interferon alpha, has been reported rarely in patients without prior evidence of cardiac disease (see section 4.4).
Danish: Kardiomyopati, som kan være reversibel efter seponering af interferon alfa, er blevet rapporteret sjældent hos patienter uden tidligere observeret hjertesygdom (se pkt.
English: Confusion, sleep disorder, libido decreased Suicide ideation
Danish: Forvirring, søvnforstyrrelser, nedsat libido Selvmordstanker
English: Use a new injection needle for each dose.
Danish: Brug en ny kanyle til hver dosis.
English: The clear and colourless solution is contained in a glass cartridge.
Danish: Den klare og farveløse opløsning er emballeret i en glas patron.
English: Standard haematological tests and blood chemistries (complete blood count and differential, platelet count, electrolytes, liver enzymes, serum protein, serum bilirubin and serum creatinine) are to be conducted in all patients prior to and periodically during systemic treatment with Viraferon.
Danish: Standard hæmatologiske prøver og klinisk-kemiske blodundersøgelser (komplet blodtælling og differentialtælling, trombocyttal, elektrolytter, leverenzymer, serum-protein, serum-bilirubin og serumkreatinin) bør udføres hos alle patienter før og med faste intervaller under systemisk Viraferon-behandling.
English: A history of severe pre-existing cardiac disease, e.g., uncontrolled congestive heart failure, recent myocardial infarction, severe arrhythmic disorders.
Danish: Anamnese med alvorlig tidligere hjertesygdom, såsom ukontrolleret hjerteinsufficiens, nylig myokardieinfarkt, svære arytmilidelser.
English: Study 1 (RIBAVIC; P01017) was a randomized, multicentre study which enrolled 412 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
Danish: Undersøgelse 1 (RIBAVIC; P01017) var en randomiseret multicenterundersøgelse, der inkluderede 412 tidligere ubehandlede voksne patienter med kronisk hepatitis C, der samtidig var inficeret med HIV.
English: Children and adolescents: Multiple-dose pharmacokinetic properties for Viraferon injection and ribavirin capsules in children and adolescents with chronic hepatitis C, between 5 and 16 years of age, are summarized in Table 6.
Danish: Børn og unge: Flerdosis farmakokinetiske egenskaber for Viraferon injektionsvæske og ribavirin kapsler hos børn og unge med kronisk hepatitis C i alderen 5 til 16 år er opsummeret i Tabel 6.
English: To dissolve the white contents, swirl the Viraferon vial with a gentle rotary motion leaving the syringe needle in the vial, until the contents are completely dissolved.
Danish: For at opløse det hvide indhold, sving Viraferon hætteglasset med en blid roterende bevægelse, mens sprøjtekanylen stadig sidder i hætteglasset, indtil indholdet er fuldstændig opløst.
English: Viraferon (3 MIU 3 times a week) I/R Viraferon (3 MIU 3 times a week) + ribavirin (1,000/1,200 mg/day)
Danish: Viraferon (3 MIE 3 gange om ugen) I/R Viraferon (3 MIE 3 gange om ugen) + ribavirin (1.000/1.200 mg/dag)
English: The decision to treat should be made on a case by case basis, taking into account any evidence of disease progression such as hepatic inflammation and fibrosis, as well as prognostic factors for response, HCV genotype and viral load.
Danish: Beslutningen om at behandle bør tages individuelt fra patient til patient, under hensyntagen til tegn på sygdomsprogression såsom leverinflammation og fibrose, såvel som prognostiske faktorer for respons, HCV genotype og virusmængde.
English: Psychiatric and central nervous system (CNS): Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during Viraferon therapy, and even after treatment discontinuation mainly during the 6-month follow-up periodand in the follow-up period.
Danish: Psykiatri og centralnervesystem (CNS): Alvorlig CNS-påvirkning, særlig depression, selvmordstanker og selvmordsforsøg er set hos nogle patienter under Viraferon-behandling, og selv efter behandlingsophør især under 6-måneders opfølgningsperioden.
English: Interferon alfa-2b (6 MIU/m
Danish: Interferon alfa-2b (6 MIE/m
English: After reconstitution: An immediate use is recommended.
Danish: Færdigtilberedt produkt: Det anbefales, at produktet anvendes med det samme.
English: Viraferon has been classified as recombinant interferon alfa-2b.
Danish: Viraferon er blevet klassificeret som rekombinant interferon alfa-2b.
English: If the chest X-ray shows pulmonary infiltrates or there is evidence of pulmonary function impairment, the patient is to be monitored closely, and, if appropriate, discontinue interferon alpha.
Danish: Hvis røntgen af thorax viser lungeinfiltrat eller der er tegn på lungefunktionsnedsættelse, skal patienten følges nøje, og hvis det skønnes nødvendigt, skal interferon-alfa behandlingen afbrydes.
English: Recombinant interferon alfa-2b also inhibits viral replication in vitro and in vivo.
Danish: Rekombinant interferon alfa-2b hæmmer også viral replikation in vitro og in vivo.
English: It is recommended that those patients who have pre-existing cardiac abnormalities and/or are in advanced stages of cancer have electrocardiograms taken prior to and during the course of treatment.
Danish: De patienter, som har haft hjerteanomalier og/eller er i fremskreden cancerstadie, skal have taget elektrokardiogram før og under behandling.
English: If persistent or recurrent intolerance develops following adequate dosage adjustment, or disease progresses, discontinue treatment with Viraferon.
Danish: Hvis der opstår vedvarende eller tilbagevendende intolerance til trods for tilstrækkelig dosisjustering, eller hvis sygdommen progredierer, skal behandling med Viraferon afbrydes.
English: Increase in serum ALT/AST (SGPT/SGOT) levels have been noted as an abnormality in some non-hepatitis subjects and also in some patients with chronic hepatitis B coincident with clearance of viral DNAp.
Danish: Forøgelse i serum ALAT/ASAT (SGPT/SGOT)-koncentrationer er blevet observeret som en abnormitet hos nogle nonhepatitis personer samt hos nogle patienter med kronisk hepatitis B samtidig med udskillelse af viral DNAp.
English: In clinical trials using Viraferon therapy, 2.8 % patients overall developed thyroid abnormalities.
Danish: I kliniske undersøgelser med Viraferon-behandling udviklede 2,8 % af patienterne unormal thyreoideafunktion.
English: A new injection needle must be used for each dose.
Danish: En ny kanyle skal anvendes til hver dosering.
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100, <1/10); rarely (≥1/10,000, <1/1,000); very rarely (<1/10,000); not known.
Danish: Indenfor systemorganklasserne, er bivirkningerne listet under overskrifter efter hyppighed under anvendelse af følgende kategorier: meget almindelig (≥1/10); almindelig (≥1/100, <1/10); sjælden (≥1/10.000, <1/1.000); meget sjælden (<1/10.000); ikke kendt.
English: Then press the push button down fully (see Diagram P).
Danish: Trykknappen presses herefter fuldstændigt i bund (se Diagram P).
English: Severe renal or hepatic dysfunction; including that caused by metastases.
Danish: Alvorlig nyre- eller leverlidelse, inklusive lidelser forårsaget af metastaser.
English: The pen is now ready to set the dose.
Danish: Pennen er nu klar til at indstille dosis.
English: You can save the swab to clean the skin area where you will inject the dose.
Danish: De kan gemme servietten til at rense hudområdet, hvor De vil injicere dosis.
English: The pen can only be fully capped when the triangle on the cap scale is aligned with the dosage indicator on the barrel.
Danish: Pennen kan kun lukkes fuldstændigt, når trekanten på hætteskalaen er ud for doseringsviseren på cylinderen.
English: One ampoule of solvent contains 1 ml of water for injections.
Danish: En ampul med solvens indeholder 1 ml vand til injektionsvæsker.
English: Rubber membrane
Danish: Gummimembran