FrancophonIA/ELRC3.0 huggingface dataset:
English: The administered dose should be reduced by 50 % in case of occurrence of haematological disorders (white blood cells < 1,500/mm 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 blodlegemer < 1.500/mm 3, granulocytter < 1.000/mm 3, thrombocytter < 100.000/mm 3).
English: IntronA 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 IntronA used alone or in combination with ribavirin.
Danish: IntronA 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 virkningen af IntronA anvendt alene eller i kombination med ribavirin.
English: If you take telbivudine with a pegylated interferon alfa-2a or any type of injectable interferon product, your risk of developing peripheral neuropathy (numbness, tingling and/or burning sensations in the arms and/or legs) is higher.
Danish: Hvis du tager telbivudin sammen med pegyleret interferon alfa-2a eller en anden form for interferonmedicin til injektion, har du større risiko for at udvikle perifer neuropati (følelsesløshed, snurrende og/eller brændende fornemmelse i arme og/eller ben).
English: Treatment of adult patients with Philadelphia chromosome or bcr/abl translocation positive chronic myelogenous leukaemia.
Danish: Behandling af voksne patienter med Philadelphia kromosom eller bcr/abl translokationspositiv kronisk myeloid leukæmi.
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 nedtrapning af korttids-kortikosteroid.
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 non-hepatitis personer samt hos nogle patienter med kronisk hepatitis B samtidig med udskillelse af viral DNAp.
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: The activity of IntronA is expressed in terms of IU, with 1 mg of recombinant interferon alfa-2b protein corresponding to 2.6 x l0
Danish: Aktiviteten af IntronA udtrykkes i IE, med 1 mg af rekombinant interferon alfa-2b protein svarende til 2,6 x 10
English: The adverse reactions listed in Table 2 are based on experience from the two multicentre children and adolescent clinical trials.
Danish: De bivirkninger, der er listet i Tabel 2, er baseret på erfaringer fra to multicentre kliniske undersøgelser med børn og unge.
English: Patients with substance use/abuse:
Danish: Patienter med misbrug:
English: Treatment should be discontinued in case of severe leukopaenia (< 1,200/mm 3), severe neutropaenia (< 750/mm or severe thrombocytopaenia (< 70,000/mm
Danish: Behandlingen skal seponeres i tilfælde af svær leukopeni (< 1.200/mm 3), svær neutropeni (< 750/mm 3) eller svær trombocytopeni (< 70.000/mm
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: c: Patients with genotype 3 low viral load (< 600,000 IU/mL) were to receive 24 weeks of treatment while those with genotype 3 and high viral load (≥ 600,000 IU/mL) were to receive 48 weeks of treatment.
Danish: c: Patienter med genotype 3 og lav virusbelastning (< 600.000 IE/ml) skulle have behandling i 24 uger, mens patienter med genotype 3 og høj virusbelastning (≥ 600.000 IE/ml) skulle have behandling i 48 uger.
English: Hypertriglyceridemia
Danish: Hypertriglyceridæmi
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, or have a history of substance abuse (e.g., alcohol or drugs).
Danish: Fortæl din læge, hvis du nogensinde er blevet behandlet for depression eller andre psykiske lidelser, forvirring, bevidstløshed, selvmordstanker eller selvmordsforsøg, eller tidligere har haft et misbrug (f.eks. af alkohol eller stoffer).
English: Included are hairy cell leukaemia, chronic myelogenous leukaemia, multiple myeloma, follicular lymphoma, carcinoid tumour, and malignant melanoma.
Danish: Omfattet er hårcelleleukæmi, kronisk myeloid leukæmi, myelomatose, follikulært lymfom, karcinoid tumor og malignt melanom.
English: Discontinue treatment with IntronA in patients with chronic hepatitis who develop prolongation of coagulation markers which might indicate liver decomposition.
Danish: Behandling med IntronA bør afbrydes hos patienter med kronisk hepatitis, som udvikler forlængelse af koagulationsmarkører, der kan være tegn på leverinsufficiens.
English: HCV infected patients having a co-occurring substance use disorder (alcohol, cannabis, etc) are at an increased risk of developing psychiatric disorders or exacerbation of already existing psychiatric disorders when treated with alpha interferon.
Danish: HCV-inficerede patienter, der samtidig er misbrugere (af alkohol, cannabis osv.) har en øget risiko for udvikling af psykiske lidelser eller forværring af allerede eksisterende psykiske lidelser under behandling med interferon alfa.
English: Multiple-dose pharmacokinetic properties for IntronA injection and ribavirin capsules in children and adolescents with chronic hepatitis C, between 5 and 16 years of age, are summarized in Table 7.
Danish: Flerdosis farmakokinetiske egenskaber for IntronA injektionsvæske og ribavirin kapsler hos børn og unge med kronisk hepatitis C i alderen 5 til 16 år er opsummeret i Tabel 7.
English: IntronA is a sterile, stable, formulation of highly purified interferon alfa-2b produced by recombinant DNA techniques.
Danish: IntronA er en steril, stabil, formulering af højt oprenset interferon alfa-2b produceret ved rekombinant DNA-teknik.
English: Any patient developing liver function abnormalities during treatment with IntronA must be monitored closely and treatment discontinued if signs and symptoms progress.
Danish: Enhver patient, der viser unormal leverfunktion under IntronA-behandlingen, skal følges tæt og behandlingen skal afbrydes, hvis der er tegn og symptomer på forværring.
English: IntronA may be administered using either glass or plastic disposable injection syringes.
Danish: IntronA kan indgives ved brug af enten glas- eller plastik-éngangsinjektionssprøjter.
English: If you are receiving HAART, the addition of IntronA and ribavirin may increase your risk of lactic acidosis and of liver failure.
Danish: Hvis du modtager HAART, kan tilføjelse af IntronA og ribavirin øge din risiko for mælkesyreacidose og leversvigt.
English: If unable to activate, discard immediately into an approved sharps collector.
Danish: Hvis det ikke er muligt at aktivere sikkerhedsmekanismen, så smid straks sprøjten i en godkendt beholder til skarpe genstande.
English: Patients with existence of, or history of severe psychiatric conditions:
Danish: Patienter med aktuelle eller tidligere alvorlige psykiatriske lidelser:
English: In clinical trials conducted in the hepatitis C population, patients were treated with IntronA alone or in combination with ribavirin for one year.
Danish: I kliniske undersøgelser udført hos patienter med hepatitis C, blev forsøgspersonerne behandlet med IntronA alene eller i kombination med ribavirin i et år.
English: Pharyngitis*, infection viral* Bronchitis, sinusitis, herpes simplex (resistance), rhinitis Bacterial infection
Danish: Pharyngitis*, viral infektion* Bronkitis, sinuitis, herpes simplex (resistent), rhinitis Bakterieinfektion
English: While being treated with IntronA, your doctor may want you to drink extra fluids to help prevent low blood pressure.
Danish: Brug af IntronA sammen med mad, drikke og alkohol Din læge kan anbefale dig at drikke ekstra væske for at hjælpe med at forebygge lavt blodtryk.
English: In patients who are in the plateau phase (more than 50 % reduction of myeloma protein) following initial induction chemotherapy, interferon alfa-2b may be administered as monotherapy, subcutaneously, at a dose of 3 million IU/m2 three times a week (every other day).
Danish: Hos patienter, som er i plateaufase (mere end 50 % reduktion af myelom-protein) efter initial induktionskemoterapi, kan interferon alfa-2b gives som monoterapi, subkutant i en dosering på 3 millioner IE/m2 tre gange om ugen (hver anden dag).
English: For user convenience, the needle protection device can be rotated for ease of injection (Diagram B).
Danish: For nemheds skyld kan kanylehætten drejes, så det er lettere at injicere (Diagram B).
English: Interferon neutralising factor assays were performed on serum samples of patients who received IntronA in Schering-Plough monitored clinical trials.
Danish: Undersøgelser af interferonneutraliserende faktor har været udført på serumprøver fra patienter, som fik IntronA i kliniske undersøgelser udført af Schering-Plough.
English: Table 1 Adverse reactions reported during clinical trials or following the marketing use of IntronA alone or in combination with ribavirin
Danish: Tabel 1 Bivirkninger rapporteret ved kliniske undersøgelser eller efter markedsføring af IntronA alene eller i kombination med ribavirin
English: §, retinopathies (including macular oedema), retinal artery or vein obstruction
Danish: §, retinopatier (inklusive makulært ødem), retinal arterie- eller veneobstruktion
English: Additionally, patients treated with IntronA and ribavirin combination therapy and zidovudine could be at increased risk of developing anaemia (low number of red blood cells).
Danish: Patienter behandlet med IntronA og ribavirin kombinationsbehandling og zidovudin kan herudover have en øget risiko for at udvikle anæmi (lavt antal røde blodceller).
English: Table 4 Sustained virological response based on genotype after IntronA in combination with ribavirin versus pegylated interferon alfa-2b in combination with ribavirin in HCV/HIV co-infected patients Study 1
Danish: Tabel 4 Vedvarende virologisk respons baseret på genotype efter IntronA i kombination med ribavirin versus pegyleret interferon alfa-2b i kombination med ribavirin hos patienter med samtidig infektion af HCV/hiv Undersøgelse 1
English: Thyroid dysfunction during treatment with interferon alfa-2b and ribavirin has been observed.
Danish: Thyroideadysfunktion har været observeret under behandling med interferon alfa-2b og ribavirin.
English: p value pegylated interferon alfa-2b (100 or c µg/week) + ribavirin
Danish: p værdi pegyleret interferon alfa-2b (100 eller c µg/uge) + ribavirin
English: All but one of the paediatric subjects remained sustained virologic responders during long-term follow-up after completion of treatment with interferon alfa-2b plus ribavirin.
Danish: Alle på nær en af de pædiatriske patienter forblev vedvarende virologisk respondenter under den langvarige opfølgning efter afslutning af behandling med interferon alfa-2b plus ribavirin.
English: At the beginning of treatment with IntronA, you may experience a flu-like reaction, with fever, fatigue, headache, muscle ache, joint pain and chills/rigors.
Danish: I begyndelsen af behandlingen med IntronA kan du få en influenzalignende reaktion med feber, træthed, hovedpine, muskelømhed, ledsmerte og kulderystelser.
English: Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during IntronA therapy, and even after treatment discontinuation mainly during the 6-month follow-up period.
Danish: Psykiatriske sygdomme og sygdomme i centralnervesystemet (CNS) Alvorlige CNS-påvirkninger, særlig depression, selvmordstanker og selvmordsforsøg er set hos nogle patienter under IntronA-behandling, og selv efter behandlingsophør især under 6-måneders opfølgningsperioden.
English: Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis B viral replication (presence of DNA of hepatitis B virus (HBV-DNA) and hepatitis B antigen (HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and/or fibrosis.
Danish: Behandling af voksne patienter med kronisk hepatitis B forbundet med tegn på hepatitis B virusreplikation (tilstedeværelse af DNA fra hepatitis B-virus (HBV-DNA) og hepatitis B-antigen (HBeAg), forhøjet alaninaminotransferase (ALAT) og histologisk påvist aktiv leverinflammation og/eller fibrose.
English: (affects less than 1 user in 10,000)
Danish: (påvirker flere end 1 af 10 brugere)
English: Among children and adolescents treated with IntronA 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 IntronA 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: Thyroid supplemental monitoring specific for children and adolescents Approximately 12 % of children treated with interferon alfa-2b and ribavirin combination therapy developed increase in thyroid stimulating hormone (TSH).
Danish: Supplerende thyroideamonitorering specifikt for børn og unge Omtrent 12 % af børn behandlet i kombinationterapi med interferon alfa-2b og ribavirin fik øget thyroideastimulerende hormon (TSH).
English: Naïve patients (adults)
Danish: Naive patienter (voksne)
English: Suicide, suicide attempts, aggressive behaviour (sometimes directed against others), psychosis including hallucinations
Danish: Selvmord, selvmordsforsøg, aggressiv adfærd (nogle gange rettet mod andre), psykose inklusive hallucinationer Morderiske tanker, ændring af mental tilstand
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: 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 afstødning efter nyretransplantation.
English: IntronA (3 MIU TIW) + ribavirin
Danish: IntronA (3 MIE TIW) + ribavirin
English: Adequate hydration must be maintained in patients undergoing IntronA therapy since hypotension related to fluid depletion has been seen in some patients.
Danish: Tilstrækkelig hydreringstilstand skal opretholdes hos patienter, der gennemgår IntronA-behandling, idet hypotension på grund af væskemangel er set hos nogle patienter.
English: Chronic Hepatitis C - Combination therapy with ribavirin In clinical trials of 118 children and adolescents (3 to 16 years of age), 6 % discontinued therapy due to adverse reactions.
Danish: Kronisk hepatitis C - Kombinationsbehandling med ribavirin I kliniske undersøgelser med 118 børn og unge 3 til 16 år afbrød 6 % behandling på grund af bivirkninger.
English: Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of IntronA therapy.
Danish: Hjertearytmier (især supraventrikulære) responderer normalt på sædvanlig behandling, men seponering af IntronA-behandling kan være nødvendig.
English: IntronA is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for hepatitis C virus RNA (HCV-RNA) (see section 4.4).
Danish: IntronA er beregnet til behandling af voksne patienter med kronisk hepatitis C, som har forhøjede transaminaser uden leverdekompensation, og som er positive for hepatitis C virus-RNA (HCV-RNA) (se pkt.
English: High tumour burden is defined as having at least one of the following: bulky tumour mass (> 7 cm), involvement of three or more nodal sites (each > 3 cm), systemic symptoms (weight loss > 10 %, pyrexia > 38°C for more than 8 days, or nocturnal sweats), splenomegaly beyond the umbilicus, major organ obstruction or compression syndrome, orbital or epidural involvement, serous effusion, or leukaemia.
Danish: Stor tumorbyrde er defineret som at have mindst et af følgende kriterier: Stor tumorbyrde (> 7 cm), involvering af mindst tre nodale områder (hver > 3 cm), systemiske symptomer (vægttab > 10 %, feber > 38C i mere end 8 dage, eller natlige svedeture), splenomegali til under navlen, obstruktion af større organ eller kompressionssyndrom, orbital eller epidural involvering, serøs ekssudation eller leukæmi.
English: Pull back on the plunger slowly to draw the correct dose as prescribed by your doctor into the syringe.
Danish: Træk stemplet langsomt tilbage for at udtage den rigtige dosis, som foreskrevet af din læge, i sprøjten.
English: Prior to initiation of IntronA therapy, TSH levels must be evaluated and any thyroid abnormality detected at that time must be treated with conventional therapy.
Danish: Inden initiering af IntronA-behandling skal TSH-niveauet evalueres, og mulige thyroideaabnormaliteter detekteret på dette tidspunkt skal behandles med konventionel behandling.
English: Children and adolescents 3 to 16 years of age with compensated chronic hepatitis C and detectable HCV-RNA (assessed by a central laboratory using a research-based RT-PCR assay) were enrolled in two multicentre trials and received IntronA 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 centrallaboratorium ved brug af en forskningsbaseret RT-PCR-analyse) blev inkluderet i to multicenter undersøgelser og fik IntronA 3 MIE/m2 tre gange om ugen plus ribavirin 15 mg/kg per dag i 1 år efterfulgt af 6 måneders opfølgning efter behandling.
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 trombotisk trombocytopenisk purpura, vasculitis, neuropatier inklusive mononeuropatier (se også pkt.
English: Therapy may continue for as long as the patient responds to interferon alfa-2b treatment.
Danish: Behandlingen bør fortsætte, så længe patienten responderer på interferon alfa-2b behandling.
English: Any patient developing pyrexia, 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: Insert the needle into the vial containing the IntronA solution and inject air into the vial.
Danish: Indfør kanylen i hætteglasset indeholdende IntronA opløsningen og injicer luft i hætteglasset.
English: Be sure the tip of needle is in the IntronA solution.
Danish: Se efter, at spidsen af kanylen er i IntronA opløsningen.
English: As with all parenteral medicinal products, prior to administration inspect IntronA, solution for injection or infusion, visually for particulate matter and discolouration.
Danish: I lighed med alle parenterale lægemidler undersøges IntronA, injektionsvæske-/infusionsvæske, opløsning visuelt for partikler og misfarvning før brugen.
English: Effect on fertility Interferon may impair fertility (see section 4.6 and section 5.3).
Danish: Virkning på fertilitet Interferon kan forringe fertiliteten (se pkt.
English: IntronA solution for injection or infusion may be injected directly after withdrawal of the appropriate doses from the vial with a sterile injection syringe.
Danish: IntronA injektionsvæske-/infusionsvæske, opløsning kan injiceres direkte efter at den foreskrevne dosis er trukket op fra hætteglasset med en steril injektionssprøjte.
English: When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that resulted in reduced final adult height in some patients.
Danish: Ved beslutning om ikke at udsætte behandlingen til barnet er voksent, er det vigtigt at betænke, at kombinationsbehandlingen forårsagede væksthæmning, som medførte reduceret sluthøjde hos nogle patienter.
English: What you need to know before you use IntronA
Danish: Det skal du vide, før du begynder at tage IntronA
English: If ALT flares during IntronA therapy to greater than or equal to 2 times baseline, IntronA therapy may be continued unless signs and symptoms of liver failure are observed.
Danish: Hvis ALAT blusser op under IntronA-behandling til større end eller lig med 2 gange basisniveau, kan man fortsætte IntronAbehandling med mindre der er tegn og symptomer på leversvigt.
English: Detailed instructions for subcutaneous administration are provided with this leaflet (see section “HOW TO SELF INJECT INTRONA” at the end of the leaflet).
Danish: Detaljerede vejledninger i subkutan indgift gives med denne indlægsseddel (se punktet ”Sådan injicerer du selv IntronA” sidst i indlægssedlen).
English: Treatment of high tumour burden follicular lymphoma as adjunct to appropriate combination induction chemotherapy such as a CHOP-like regimen.
Danish: Behandling af follikulær lymfom med stor tumorbyrde i kombination med passende induktionskemoterapi, såsom CHOP-lignende regimer.
English: Combination of IntronA with telbivudine.
Danish: - IntronA i kombination med telbivudin.
English: Chronic hepatitis C
Danish: Kronisk hepatitis C
English: IntronA has been classified as recombinant interferon alfa-2b.
Danish: IntronA er blevet klassificeret som rekombinant interferon alfa-2b.
English: Chronic myelogenous leukaemia
Danish: Kronisk myeloid leukæmi
English: As maintenance treatment, the recommended dose is 10 million IU/m2 administered subcutaneously three days a week (every other day) for 48 weeks.
Danish: Som vedligeholdelsesbehandling er den anbefalede dosis 10 millioner IE/m2 indgivet subkutant tre gange om ugen (hver anden dag) i 48 uger.
English: Detailed instructions for the subcutaneous use of the product are provided with the package leaflet (refer to “How to self inject IntronA”).
Danish: Detaljerede instruktioner til den subkutane anvendelse af præparatet følger med indlægssedlen (se ”Sådan injicerer du selv IntronA”).
English: If treatment with alpha interferon is judged necessary in these patients, the presence of psychiatric co-morbidities and the potential for other substance use should be carefully assessed and adequately managed before initiating therapy.
Danish: Hvis behandling med interferon alfa vurderes nødvendig hos disse patienter, skal tilstedeværelsen af samtidig psykisk sygdom og potentialet for andet misbrug vurderes omhyggeligt og håndteres i tilstrækkelig grad, før behandling startes.