FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of IntronA were studied in healthy volunteers following single 5 million IU/m and 10 million IU doses administered subcutaneously, at 5 million IU/m2 administered intramuscularly and as a 30-minute intravenous infusion.
Danish: Farmakokinetikken af IntronA blev undersøgt hos raske forsøgspersoner efter enkeltdoser på 5 millioner IE/m2 og 10 millioner IE indgivet subkutant, ved doser på 5 millioner IE/m2 indgivet intramuskulært og som en 30 minutters intravenøs infusion.
English: Adjunctively with chemotherapy, interferon alfa-2b may be administered subcutaneously, at a dose of 5 million IU three times a week (every other day) for a duration of 18 months.
Danish: Supplerende til kemoterapi kan interferon alfa-2b gives subkutant i en dosis på 5 millioner IE tre gange ugentlig (hver anden dag) i en periode på 18 måneder.
English: Hepatomegaly Hepatotoxicity, (including fatality)
Danish: Hepatomegali Hepatotoksicitet, (inklusive letale tilfælde)
English: Case by case benefit/risk assessment in children The expected benefit of treatment should be carefully weighed against the safety findings observed for children and adolescents in the clinical trials (see sections 4.8 and 5.1).
Danish: Den forventede fordel ved behandling skal nøje vægtes mod de sikkerhedsresultater observeret hos børn og unge i de kliniske forsøg (se pkt.
English: Administration of IntronA in combination with other chemotherapeutic agents (e.g., Ara-C, cyclophosphamide, doxorubicin, teniposide) may lead to increased risk of toxicity (severity and duration), which may be life-threatening or fatal as a result of the concomitantly administered medicinal product.
Danish: Indgift af IntronA i kombination med andre kemoterapeutika (såsom Ara-C, cyclophosphamid, doxorubicin, teniposid) kan føre til forøget risiko for toksicitet (sværhedsgrad og varighed), som kan være livstruende eller fatal som et resultat af det samtidigt indgivne lægemiddel.
English: If such a reaction develops, discontinue the medicine and institute appropriate medical therapy.
Danish: Hvis en sådan reaktion opstår, skal behandlingen afbrydes og nødvendig medicinsk behandling påbegyndes.
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: Sarkoidose, forværring af sarkoidose Systemisk lupus erythematosus, vaskulitis, reumatoid artritis (ny eller forværret), Vogt-Koyanagi-Harada syndrom, akutte overfølsomhedsreaktioner inklusive urticaria, angioødem, bronkokonstriktion, anafylakse
English: IntronA 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: IntronA 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 abnormalities were controlled by conventional therapy for thyroid dysfunction.
Danish: Forandringerne kunne kontrolleres med konventionel behandling for thyroideadysfunktion.
English: Male patients or their female partners must use an effective contraceptive during treatment and for 7 months after treatment has been concluded (see ribavirin SPC).
Danish: Mandlige patienter eller deres kvindelige partnere skal anvende effektiv antikonception under behandling og i 7 måneder efter, behandlingen er afsluttet (Se produktresumeet for ribavirin).
English: Once opened, the medicine may be stored for a maximum of 28 days at 2ºC - 8ºC.
Danish: Produktet kan, når det er åbnet, opbevares i maksimalt 28 dage ved 2C - 8C.
English: Pure red cell aplasia, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura
Danish: Pure red cell aplasia, idiopatisk trombocytopenisk purpura, trombotisk trombocytopenisk purpura
English: Other CNS effects including aggressive behaviour (sometimes directed against others such as homicidal ideation), bipolar disorders, mania, confusion and alterations of mental status have been observed with alpha interferons.
Danish: Andre CNS-påvirkninger inklusive aggressiv opførsel (sommetider rettet mod andre såsom drabstanker), bipolare lidelser, mani, forvirring og ændret mental tilstand, er blevet set med alfa interferoner.
English: Carcinoid tumour
Danish: Carcinoid tumor
English: See section 4.4 Class label for interferon products, see below Pulmonary arterial hypertension.
Danish: 4.4 Vedrørende klassebetegnelse for interferonlægemidler: se pulmonal arteriel hypertension nedenfor
English: Patients who received IntronA plus ribavirin were less likely to respond than patients who received pegylated interferon alfa-2b and ribavirin.
Danish: Det var mindre sandsynligt, at patienter, der fik IntronA plus ribavirin, responderede, end patienter, der fik pegyleret interferon alfa-2b og ribavirin.
English: Dispose of the syringe and needle safely in a closed container.
Danish: Smid sprøjten og kanylerne sikkert ud i en lukket beholder.
English: IntronA (3 MIU TIW) + ribavirin (800 mg)
Danish: IntronA (3 MIE TIW) + ribavirin (800 mg)
English: Ensure that needle with needle guard is firmly attached to the syringe by pushing while turning the needle guard.
Danish: Du skal sikre dig, at kanylen med kanylehætten sidder fast på sprøjten ved at skubbe, mens du drejer kanylehætten.
English: Therefore, the combination of IntronA with telbivudine is contraindicated.
Danish: Kombinationen af IntronA og telbivudin er derfor kontraindiceret.
English: Prior to initiation of IntronA therapy for the treatment of chronic hepatitis C, evaluate serum thyroid-stimulating hormone (TSH) levels.
Danish: Før påbegyndelse med IntronA-behandling af kronisk hepatitis C, bør thyroidstimulerende hormon (TSH) koncentrationen måles.
English: You must use an effective contraceptive during the time you are taking ribavirin and for 4 months after stopping treatment.
Danish: Du skal anvende effektiv antikonception i den periode, hvor du tager ribavirin, og i 4 måneder efter behandlingen er afsluttet.
English: (%)) in previously untreated children and adolescents by genotype and treatment duration - All subjects n = 107 24 weeks
Danish: Tabel 6 Vedvarende virologisk responsrate (na,b (%)) hos tidligere ubehandlede børn og unge efter genotype og behandlingsvarighed - Alle forsøgspersoner n = 107 24 uger
English: Hypocalcaemia, dehydration, hyperuricemia, thirst Hyperglycaemia, hypertriglyceridaemia
Danish: Hypokalcæmi, dehydrering, hyperurikæmi, tørst Hyperglykæmi, hypertriglyceridæmi
English: When the white blood cell count is controlled, administer the maximum tolerated dose of IntronA (4 to 5 million IU/m daily) to maintain haematological remission.
Danish: Når leucocyttallet er under kontrol, bør den maksimalt tolererede dosis IntronA (4 til 5 millioner IE/m2 daglig) indgives for at vedligeholde den hæmatologiske remission.
English: Children and adolescent population
Danish: Børn og unge
English: IntronA was administered at a dose of 3 MIU 3 times a week as monotherapy or in combination with ribavirin.
Danish: IntronA blev indgivet i en dosis på 3 MIE 3 gange om ugen som monoterapi eller i kombination med ribavirin.
English: Results from the clinical trial conducted with pegylated interferon alfa-2b and ribavirin In a multicentre trial children and adolescents 3 to 17 years of age with compensated chronic hepatitis C and detectable HCV-RNA were treated with peginterferon alfa-2b 60 g/m2 plus ribavirin
Danish: Resultater fra den kliniske undersøgelse med pegyleret interferon alfa-2b og ribavirin I et multicenterforsøg blev børn og unge i alderen 3 til 17 år med kompenseret kronisk hepatitis C og påviselig HCV-RNA behandlet med peginterferon alfa-2b 60 μg/m2 én gang ugentligt plus ribavirin
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 IntronA and ribavirin.
Danish: Herudover kan mundtørhed have en skadelig virkning på tænder og mundslimhinder under langtidsbehandling med kombinationen af IntronA og ribavirin.
English: Obtundation, coma and encephalopathy
Danish: Sløvhed, koma og encefalopati
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 IntronA 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 IntronA i kombination med ribavirin i mindst 6 måneder.
English: Administration of IntronA in combination with other chemotherapeutic agents (e.g., Ara-C, cyclophosphamide, doxorubicin, teniposide) may lead to increased risk of toxicity (severity and duration) (see section 4.4).
Danish: Indgift af IntronA i kombination med andre kemoterapeutika (såsom Ara-C, cyclophosphamid, doxorubicin, teniposid) kan føre til forøget risiko for toksicitet (sværhedsgrad og varighed) (se pkt.
English: Children and adolescent population: Growth and development (chronic hepatitis C) During the course of interferon (standard and pegylated)/ribavirin combination therapy lasting up to 48 weeks in patients ages 3 through 17 years, weight loss and growth inhibition were common (see sections 4.8 and 5.1).
Danish: Børn og unge: Vækst og udvikling (kronisk hepatitis C) Under behandlingsforløbet med interferon (standard og pegyleret)/ribavirin i kombinationsbehandling, der varede op til 48 uger hos patienter i alderen 3 til 17 år, var vægttab og væksthæmning almindeligt (se pkt.
English: Females of childbearing potential must use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
Danish: Fertile kvinder skal anvende effektiv antikonception under behandling og i 4 måneder efter behandlingen er afsluttet.
English: Hypothyroidism Hyperthyroidism
Danish: Hypotyroidisme Hypertyroidisme
English: §, sepsis Hepatitis B reactivation in HCV/HBV co-infected patients
Danish: Reaktivering af hepatitis B hos HCV/HBV co-inficerede patienter
English: Hairy cell leukaemia The recommended dose is 2 million IU/m2 administered subcutaneously three times a week (every other day) for both splenectomised and non-splenectomised patients.
Danish: Hårcelleleukæmi Den anbefalede dosering er 2 millioner IE/m2 givet subkutant tre gange om ugen (hver anden dag) for både splenektomerede og ikke splenektomerede patienter.
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 IntronA (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 (800-1.200 mg/dag baseret på vægt) eller IntronA (3 MIE TIW) plus ribavirin (800-1.200 mg/dag baseret på vægt).
English: - The active substance is recombinant interferon alfa-2b.
Danish: - Aktivt stof: Rekombinant interferon alfa-2b.
English: If adverse events develop during the course of treatment with IntronA for any indication, modify the dose or discontinue therapy temporarily until the adverse events abate.
Danish: Hvis der opstår bivirkninger under behandling med IntronA uanset indikation skal dosis justeres eller behandlingen afbrydes midlertidigt, indtil bivirkningerne aftager.
English: Clean the rubber stopper on the top of the vial containing the IntronA solution with a cleansing swab.
Danish: Rens gummimembranen øverst på hætteglasset, der indeholder den færdigtilberedte opløsning IntronA, med en renseserviet.
English: If you are a male patient, you or your partner must use an effective contraceptive during the time you are taking ribavirin and for 7 months after stopping treatment.
Danish: Hvis du er en mandlig patient, skal du eller din partner bruge effektiv antikonception i den periode, du tager ribavirin og i 7 måneder efter behandlingen er stoppet.
English: A total of 345 interferon alpha relapse patients were treated in two clinical trials with IntronA monotherapy or in combination with ribavirin.
Danish: I alt 345 interferon alfa relaps-patienter blev behandlet i to kliniske undersøgelser med IntronA monoterapi eller i kombination med ribavirin.
English: - if you are being treated with telbivudine (see section "Other medicines and IntronA").
Danish: - hvis du er i behandling med telbivudin (se punktet "Brug af anden medicin sammen med IntronA").
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 IntronA 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 IntronA i kombination med ribavirin i 6 måneder.
English: Fungal infection, bacterial infection, pulmonary infection, otitis media, tooth abscess, herpes simplex, urinary tract infection, vaginitis, gastroenteritis
Danish: Svampeinfektion, bakteriel infektion, lungeinfektion, otitis media, tand absces, herpes simplex, urinvejsinfektion, vaginitis, gastroenteritis
English: Children and adolescents - Existence of, or history of severe psychiatric condition, particularly severe depression, suicidal ideation or suicide attempt.
Danish: Børn og unge - Nuværende eller tidligere alvorlig psykiatrisk lidelse, især alvorlig depression, selvmordstanker eller selvmordsforsøg.
English: Other medicines and IntronA
Danish: Brug af anden medicin sammen med IntronA
English: Chronic hepatitis C in children and adolescent population Three clinical trials have been conducted in children and adolescents; two with standard interferon and ribavirin and one with pegylated interferon and ribavirin.
Danish: Der er udført tre kliniske undersøgelser med børn og unge; to med standard-interferon og ribavirin og en med pegyleret interferon og ribavirin.
English: Patients treated with IntronA and ribavirin combination therapy and zidovudine could be at increased risk of developing anaemia.
Danish: Patienter behandlet med IntronA og ribavirin kombinationsbehandling og zidovudin kan have øget risiko for at udvikle anæmi.
English: Table 7 Mean (% CV) multiple-dose pharmacokinetic parameters for IntronA and ribavirin capsules when administered to children or adolescents with chronic hepatitis C
Danish: Tabel 7 Gennemsnitlig (% CV) flerdosis farmakokinetiske parametre for IntronA og ribavirin kapsler ved indgift til børn eller unge med kronisk hepatitis C PARAMETER
English: The population enrolled mainly consisted of children with mild to moderate hepatitis C. 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 peginterferon alfa-2b with ribavirin needs to be carefully considered in this population (see peginterferon alfa-2b and ribavirin SPCs section 4.4).
Danish: Populationen, der var tilmeldt, bestod hovedsageligt af børn med mild til moderat hepatitis C. På grund af mangel på data hos børn med svær sygdomsprogression og risikoen for bivirkninger skal forholdet mellem fordele og risici for kombinationen peginterferon alfa-2b og ribavirin overvejes nøje hos denne population (se pkt.
English: 3 or ALT/AST rises to > 10 x upper limit of normal, discontinue interferon alfa-2b therapy.
Danish: 3 eller ALAT/ASAT stiger til > 10 gange den øvre normalgrænse, skal interferon alfa-2b behandling afbrydes.
English: 18 million IU/3 mL
Danish: 18 millioner IE/3 ml
English: As induction therapy, interferon alfa-2b is administered intravenously at a dose of 20 million IU/m daily for five days a week for a four-week period; the calculated interferon alfa-2b dose is added to sodium chloride 9 mg/mL (0.9 %) solution for injection and administered as a 20-minute infusion (see section 6.6).
Danish: Som induktionsterapi gives interferon alfa-2b intravenøst i en dosis på 20 millioner IE/m2 dagligt i fem dage om ugen i en fire ugers periode; den beregnede interferon alfa-2b dosis sættes til natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning og gives som en 20 minutters infusion (se pkt.
English: It is important to consider that the combination therapy induced a growth inhibition that resulted in reduced final adult height in some patients.
Danish: - Det er vigtigt at overveje, at kombinationsbehandlingen inducerede væksthæmning, som medførte reduceret final sluthøjde hos nogle patienter.
English: Co-administration of IntronA with ribavirin increased the efficacy of IntronA by at least two fold for the treatment of chronic hepatitis C in naïve patients.
Danish: Samtidig indgift af IntronA med ribavirin øgede virkningen af IntronA til mindst det dobbelte ved behandling af kronisk hepatitis C hos naive patienter.
English: The use of interferon alfa-2b in children and adolescents with existence of or history of severe psychiatric conditions is contraindicated (see section “Do not use IntronA”).
Danish: Anvendelse af interferon alfa-2b hos børn og unge med nuværende eller tidligere alvorlige psykiske forstyrrelser er kontraindiceret (se punktet ”Tag ikke IntronA”).
English: Patients were randomized to receive either pegylated interferon alfa-2b (1.5 µg/kg/week) plus ribavirin (800 mg/day) or IntronA (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 IntronA (3 MIE TIW) plus ribavirin (800 mg/dag) i 48 uger med en opfølgningsperiode på 6 måneder.
English: pegylated interferon alfa2b (1.5 µg/kg/ week) + ribavirin (800 mg)
Danish: pegyleret interferon alfa2b (1,5 µg/kg/ uge) + ribavirin (800 mg)
English: Therefore, the combination of IntronA with telbivudine is contraindicated (see section 4.3).
Danish: Kombination af IntronA og telbivudin er derfor kontraindiceret (se pkt.
English: Infrequently, adult patients treated for chronic hepatitis C with IntronA developed thyroid abnormalities, either hypothyroidism or hyperthyroidism.
Danish: Voksne patienter, som var i behandling med IntronA for kronisk hepatitis C, viste med mindre hyppighed unormal thyroideafunktion, enten hypothyreoidisme eller hyperthyreoidisme.
English: 10 million IU/mL
Danish: 10 millioner IE/ml
English: Very rarely reported side effects: low blood pressure, puffy face, diabetes, leg cramps, back pain, kidney problems, nerve damage, bleeding gums, aplastic anaemia.
Danish: Meget sjældne bivirkninger: lavt blodtryk, opsvulmet ansigt, diabetes, benkramper, rygsmerter, nyreproblemer, nerveødelæggelse, blødende tandkød, aplastisk anæmi.
English: If thyroid abnormalities are detected, the patient's thyroid status should be evaluated and treated as clinically appropriate.
Danish: Hvis thyroideaabnormaliteter detekteres, bør patientens thyroideastatus evalueres, og passende behandling initieres efter klinisk overvejelse.
English: Due to the lack of data in these two multicentre trials for 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 de to multicenterforsøg for 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: Cerebrovascular haemorrhage, cerebrovascular ischaemia, seizure, impaired consciousness, encephalopathy Mononeuropathies, coma
Danish: Cerebrovaskulær blødning, cerebrovaskulær iskæmi, kramper, bevidsthedsforstyrrelse, encefalopati Mononeuropatier, koma
English: IntronA 18 MIU
Danish: IntronA 18 MIE
English: Children 3 years of age or older and adolescents IntronA 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 IntronA 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: - IntronA in combination with ribavirin
Danish: - IntronA i kombination med ribavirin
English: Vial label
Danish: Hætteglas etiket
English: Pack of 12 vials
Danish: Pakning a 12 hætteglas
English: Additionally, Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin and the membranes of the ears, brain and spinal cord), thoughts about threatening the life of others, mania (excessive or unreasonable enthusiasm), bipolar disorders (mood disorders characterized by alternating episodes of sadness and excitement), congestive heart failure, pericardial effusion (a fluid collection that develops between the pericardium (the lining of the heart) and the heart itself), pulmonary fibrosis (scarring of the lungs), and hepatitis B reactivation in HCV/HBV co-infected patients (recurrence of hepatitis B disease) have been reported with IntronA use.
Danish: Desuden er følgende set ved behandling med IntronA: Vogt-Koyanagi-Harada syndrom (en autoimmun inflammatorisk lidelse, der påvirker øjnene, huden og membraner i ører, hjerne og rygmarv), tanker om at true andre mennesker på livet, mani (unormalt stor eller unødvendig entusiasme), bipolare lidelser (humørsvingninger karakteriseret ved vekslende episoder af tungsind og begejstring), hjertesvigt, perikardie-effusion (væskeansamling mellem perikardiet (hjertesækken) og selve hjertet), lungefibrose (dannelse af arvæv i lungerne) og reaktivering af hepatitis B hos patienter med samtidig infektion med HCV og HBV (tilbagevenden af hepatitis B-sygdom).
English: Belgique/België/Belgien MSD Belgium BVBA/SPRL Tél/Tel: 0800 38 693 (+32(0)27766211) dpoc_belux@merck.com
Danish: België/Belgique/Belgien MSD Belgium BVBA/SPRL Tél/Tel: 0800 38 693 (+32(0)27766211) dpoc_belux@merck.com
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 du udvikler symptomer i forbindelse med en forkølelse eller anden luftvejsinfektion, såsom feber, hoste eller besvær med vejrtrækningen, så fortæl din læge det. - hvis du bemærker usædvanlig blødning eller blå mærker, så spørg straks din læge til råds.
English: Children 3 years of age and older and adolescents - 3 million IU/m2 3 times a week (every other day) injected subcutaneously (under the skin) in combination with ribavirin (Please also see ribavirin package leaflet).
Danish: Børn og unge i alderen 3 år eller ældre3 millioner IE/m2 3 gange om ugen (hver anden dag) injiceret subkutant (under huden) i kombination med ribavirin (se venligst også ribavirin indlægssedlen).
English: The recommended dose 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: 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: 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).
Danish: Følgende kategorier er anvendt: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10).
English: IntronA is given in combination with ribavirin.
Danish: IntronA anvendes i kombination med ribavirin.