FrancophonIA/ELRC3.0 huggingface dataset:
English: In 2 studies with extended interval dosing of epoetin alfa (3 times per week, once weekly, once every 2 weeks, and once every 4 weeks) some patients with longer dosing intervals did not maintain adequate haemoglobin levels and reached protocol-defined haemoglobin withdrawal criteria (0% in once weekly, 3.7% in once-every-2-weeks, and 3.3% in the once-every-4-weeks groups).
Danish: I 2 studier med forlænget intervaldosering af epoetin alfa (3 gange ugentligt, én gang ugentligt, én gang hver anden uge og én gang hver 4. uge) opretholdt nogle patienter ikke tilstrækkelige hæmoglobinniveauer ved længere doseringsintervaller og nåede protokoldefinerede tilbagetrækningskriterier for hæmoglobin (0% i gruppen med dosering én gang ugentligt, 3,7% i gruppen med dosering én gang hver anden uge og 3,3% i gruppe med dosering én gang hver 4. uge).
English: You may have chest pain, breathlessness, and painful swelling and redness, usually in the leg as symptoms.
Danish: Du kan have brystsmerter, åndenød samt smertefuld hævelse og rødme, normalt af ben, som symptomer.
English: • Blood clots may also form in your haemodialysis system.
Danish: • Der kan også dannes blodpropper i dit hæmodialyse-system.
English: This regresses during the course of continued therapy.
Danish: Dette forhold normaliserer sig over det fortsatte behandlingsforløb.
English: Insert the needle into the skin fold with a quick, firm action.
Danish: Indsæt kanylen i hudfolden med en hurtig, fast bevægelse.
English: Overdosage of epoetin alfa may produce effects that are extensions of the pharmacological effects of the hormone.
Danish: Overdosering med epoetin alfa kan give symptomer i form af en forstærket effekt af hormonets farmakologiske virkninger.
English: Sixteen percent of epoetin alfa 300 IU/kg, 23% of epoetin alfa 100 IU/kg and 45% of placebo-treated patients required transfusion.
Danish: 16% af patienterne på epoetin alfa 300 IE/kg, 23% af patienterne på epoetin alfa 100 IE/kg og 45% af patienterne på placebo havde behov for transfusion.
English: It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse.
Danish: Det er vigtigt, at du ikke prøver at give dig selv indsprøjtningen, medmindre du er blevet instrueret af lægen eller sundhedspersonalet.
English: Bone marrow fibrosis is a known complication of chronic renal failure in humans and may be related to secondary hyperparathyroidism or unknown factors.
Danish: Knoglemarvsfibrose er en kendt komplikation ved kronisk nyreinsufficiens hos mennesker, der kan relateres til sekundær hyperparathyroidisme eller ukendte faktorer.
English: Included were 228 epoetin alfa-treated CRF subjects in 4 chronic renal failure studies (2 studies in pre-dialysis [N = 131 exposed CRF subjects] and 2 in dialysis [N = 97 exposed CRF subjects]; 1,404 exposed cancer subjects in 16 studies of anaemia due to chemotherapy; 147 exposed subjects in 2 studies for autologous blood donation; 213 exposed subjects in 1 study in the perisurgical period, and 102 exposed subjects in 2 MDS studies.
Danish: De omfattede 228 epoetin alfa-behandlede personer med CRF i 4 studier af kronisk nyresvigt (2 studier af prædialyse [N = 131 eksponerede personer med CRF] og 2 af dialyse [N = 97 eksponerede personer med CRF], 1.404 eksponerede personer med cancer i 16 studier af anæmi forårsaget af kemoterapi, 147 eksponerede personer i 2 studier af autolog bloddonation; 213 eksponerede personer i 1 studie i den perikirurgiske periode, og 102 eksponerede personer i 2 MDS-studier.
English: In the 16-week study (n = 222), in the epoetin alfa-treated patients there was no statistically significant effect on patient-reported or parent-reported Paediatric Quality of Life Inventory or Cancer Module scores compared with placebo (primary efficacy endpoint).
Danish: I 16-ugers studiet (n = 222) var der i epoetin alfa-behandlede patienter ingen statistisk signifikant virkning på patientindberettede eller forældreindberettede scorer i Paediatric Quality of Life Inventory eller Cancer Module sammlignet med placebo (primært virkningsendepunkt).
English: No evidence exists that indicates an interaction between epoetin alfa and granulocyte colony-stimulating factor (G-CSF) or granulocyte macrophage colony-stimulating factor (GM-CSF) with regard to haematological differentiation or proliferation of tumour biopsy specimens in vitro.
Danish: Der foreligger ingen data, der indikerer interaktion mellem epoetin alfa og granulocyt-kolonistimulerende faktor (G-CSF) eller granulocyt-makrofag-stimulerende faktor (GM-CSF) med hensyn til hæmatologisk differentiering eller proliferation fra tumorbiopsier in vitro.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL/SYRINGE
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET/INJEKTIONSSPRØJTE
English: If you have kidney disease, you may be short of red blood cells if your kidney does not produce enough erythropoietin (necessary for red cell production).
Danish: Hvis du har en nyresygdom kan du mangle røde blodlegemer, hvis dine nyrer ikke danner nok erytropoietin (som er nødvendigt for dannelsen af røde blodlegemer).
English: Screening sEPO < 200 mU/mL (N) Haemoglobin (g/L) N
Danish: Screening for sEPO < 200 mE/ml (N) Hæmoglobin (g/l)
English: This was a non inferiority study designed to rule out a 15% risk increase in tumour progression or death of epoetin alfa plus standard of care (SOC) as compared with SOC alone.
Danish: Dette var et non-inferioritetsstudie, der var designet til at udelukke en 15% risikostigning i tumorprogression eller død med epoetin alfa plus standardbehandling sammenlignet med standardbehandling alene.
English: Meta-analyses also indicate consistently a significantly increased relative risk of thromboembolic events in cancer patients receiving recombinant human erythropoietin (see section 4.4).
Danish: Metaanalyser indikerer også konsekvent en signifikant forøget relativ risiko for tromboemboliske hændelser hos cancerpatienter, der får rekombinant humant erytropoietin (se pkt.
English: - Patients who develop pure red cell aplasia (PRCA) following treatment with any erythropoietin should not receive Epoetin alfa HEXAL or any other erythropoietin (see section 4.4).
Danish: - Patienter, der udvikler pure red cell aplasia (PRCA) efter behandling med erytropoietin, bør ikke få Epoetin alfa HEXAL eller noget andet erytropoietin-præparat (se pkt.
English: Epoetin alfa HEXAL may not be suitable for you.
Danish: Det kan være, at Epoetin alfa HEXAL ikke passer til dig.
English: Your doctor will help you to decide if Epoetin alfa HEXAL is suitable for you.
Danish: Din læge vil hjælpe dig med at beslutte, om Epoetin alfa HEXAL er egnet til dig.
English: • If there is a medical need to reduce the time before your operation, you will be given a daily dose of 300 IU/kg for up to ten days before surgery, on the day of surgery and for four days immediately afterwards.
Danish: • Hvis der er et medicinsk behov for at afkorte tiden før din operation, vil du få en daglig dosis på 300 IE/kg i op til 10 dage før operationen, på operationsdagen og i de 4 dage umiddelbart efter operationen.
English: Cases have also been reported in patients with hepatitis C treated with interferon and ribavirin, when ESAs are used concomitantly.
Danish: Der er også blevet rapporteret tilfælde, hvor patienter i behandling med interferon og ribavirin for hepatitis C samtidigt er blevet behandlet med ESA'er.
English: This is characterised by a sustained decrease in haemoglobin despite an increase in epoetin alfa dosage (see section 4.8).
Danish: Dette er karakteriseret ved en vedvarende reduktion i hæmoglobin på trods af en øget dosering af epoetin alfa (se pkt.
English: A randomised prospective trial evaluated 1,432 anaemic chronic renal failure patients who were not undergoing dialysis.
Danish: Et randomiseret, prospektivt studie evaluerede 1.432 anæmiske patienter med kronisk nyresvigt, der ikke var i dialyse.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy with epoetin alfa taking into account the benefit of breast-feeding for the child and the benefit of epoetin alfa therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med epoetin alfa skal seponeres/undlades, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele af epoetin alfa for moderen.
English: If you are given a product in this group other than Epoetin alfa HEXAL during your treatment, speak to your doctor or pharmacist before using it.
Danish: Hvis du får et andet lægemiddel end Epoetin alfa HEXAL fra denne gruppe i løbet af din behandling, skal du tale med lægen eller apoteket, før du bruger det.
English: • For adults and children Epoetin alfa HEXAL is given as an injection either into a vein (intravenously) or a tube that goes into a vein.
Danish: • Epoetin alfa HEXAL gives til voksne og børn som en indsprøjtning enten i en vene (intravenøst) eller i en slange, der er indsat i en vene.
English: These include venous and arterial thromboses and embolism (including some with fatal outcomes), such as deep venous thrombosis, pulmonary emboli, retinal thrombosis, and myocardial infarction.
Danish: Disse omfatter venøse og arterielle tromboser og embolier (herunder nogle med dødeligt udfald), såsom dyb venetrombose, lungeemboli, retinal trombose og myokardieinfarkt.
English: Later, your doctor may suggest that you or your caregiver learn how to inject Epoetin alfa HEXAL under the skin (subcutaneously) yourself.
Danish: Senere kan din læge foreslå, at du selv eller din omsorgsperson lærer at injicere Epoetin alfa HEXAL under huden (subkutant).
English: Patients with CRF not on dialysis demonstrated a dose-dependent and sustained increase in haematocrit when epoetin alfa was administered by either an intravenous or subcutaneous route.
Danish: Patienter med CRF, der ikke var i dialyse, udviste en dosisafhængig og vedvarende stigning i hæmatokrit, når epoetin alfa blev administreret enten intravenøst eller subkutant.
English: Erythroid response during the first 24 weeks of the study was demonstrated by 27/85 (31.8%) of the subjects in the epoetin alfa group compared to 2/45 (4.4%) of the subjects in the placebo group (p < 0.001).
Danish: Erythroid-respons i de første 24 uger af studiet blev påvist hos 27/85 (31,8%) af forsøgspersonerne i epoetin alfa-gruppen sammenlignet med 2/45 (4,4%) af patienterne i placebogruppen (p < 0,001).
English: In studies to explore extending the dosing interval (40,000 IU once weekly and 80,000, 100,000, and 120,000 IU biweekly), a linear but non-dose-proportional relationship was observed between mean Cmax and dose, and between mean AUC and dose at steady state.
Danish: I studier, der undersøgte en forlængelse af doseringsintervallet (40.000 IE én gang ugentligt og 80.000, 100.000 og 120.000 IE hver anden uge), blev der observeret et lineært, men ikke dosisproportionalt forhold mellem gennemsnitlig Cmax og dosis og mellem gennemsnitlig AUC og dosis ved steady state.
English: The exposure of paediatric patients with chronic renal failure on haemodialysis in clinical trials and post-marketing experience is limited.
Danish: Erfaringen med eksponering hos pædiatriske patienter med kronisk nyresvigt i hæmodialyse i kliniske studier og efter markedsføring er begrænset.
English: All other causes of anaemia (iron, folate or vitamin B12 deficiency, aluminium intoxication, infection or inflammation, blood loss, haemolysis and bone marrow fibrosis of any origin) should be evaluated and treated prior to initiating therapy with epoetin alfa, and when deciding to increase the dose.
Danish: Alle andre årsager til anæmi (mangel på jern, folat eller B12-vitamin, aluminiumsforgiftning, infektion eller inflammation, blodtab, hæmolyse og knoglemarvsfibrose af alle årsager) skal evalueres og behandles, inden behandlingen med epoetin alfa påbegyndes, og når det besluttes at øge dosis.
English: In repeated dose toxicological studies in dogs and rats, but not in monkeys, epoetin alfa therapy was associated with subclinical bone marrow fibrosis.
Danish: I toksikologiske studier med gentagne doser med hunde og rotter, men ikke med aber, var behandlingen med epoetin alfa forbundet med subklinisk knoglemarvsfibrose.
English: Treatment with Epoetin alfa HEXAL has to be initiated under the supervision of physicians experienced in the management of patients with the above indications.
Danish: Behandling med Epoetin alfa HEXAL må kun påbegyndes under supervision af en læge med erfaring i behandlingen af patienter, hvor ovenstående indikationer er relevante.
English: In the 20-week study (n = 225), no significant difference was observed in the primary efficacy endpoint, i.e. the proportion of patients who required a RBC transfusion after Day 28 (62% of epoetin alfa patients versus 69% of standard therapy patients).
Danish: I 20-ugers studiet (n = 225) blev der ikke observeret nogen signifikant forskel i det primære virkningsendepunkt, dvs. proportionen af patienter, der havde brug for blodtransfusion med røde blodlegemer efter dag 28 (62% af epoetin alfa-patienter sammenlignet med 69% af patienterne i standardbehandling).
English: Patients were stratified according to their baseline haemoglobin (≤ 10 g/dL, > 10 to ≤ 13 g/dL and > 13 g/dL).
Danish: Patienterne blev stratificeret i henhold til deres hæmoglobin ved baseline (≤ 10 g/dl, > 10 til ≤ 13 g/dl og > 13 g/dl).
English: There may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with epoetin alfa.
Danish: Der kan forekomme en moderat dosisafhængig stigning i trombocyttallet inden for normalområdet under behandlingen med epoetin alfa.
English: Instructions on how to inject yourself (for patients with symptomatic anaemia caused by kidney disease, for adult patients receiving chemotherapy, adult patients scheduled for orthopaedic surgery, or adult patients with myelodysplastic syndromes only)
Danish: Instruktion i, hvordan du giver dig selv en indsprøjtning (kun til patienter med symptomatisk anæmi forårsaget af nyresygdom til voksne patienter, der får kemoterapi, voksne patienter, som skal gennemgå ortopædkirurgi og voksne patienter med myelodysplastiske syndromer)
English: Epoetin alfa does not induce bacterial gene mutation (Ames Test), chromosomal aberrations in mammalian cells, micronuclei in mice, or gene mutation at the HGPRT locus.
Danish: Epoetin alfa inducerer ikke bakteriel genmutation (Ames-test), kromosomafvigelser i pattedyrsceller, mikronuklei hos mus eller genmutation ved HGPRT-locus.
English: The needle safety guard will rapidly move to cover the needle.
Danish: Kanylebeskyttelsen flytter sig hurtigt for at dække kanylen.
English: Because Epoetin alfa HEXAL stimulates the production of red blood cells, doctors can take more blood from these people.
Danish: Da Epoetin alfa HEXAL stimulerer produktionen af røde blodlegemer, kan lægerne udtage mere blod fra disse personer.
English: A slower administration is preferable in patients who react to the treatment with “flu-like” symptoms (see section 4.8).
Danish: En langsommere administration kan være at foretrække hos patienter, der reagerer med influenzalignende symptomer på behandlingen (se pkt.
English: The aim of treatment is to maintain your haemoglobin level between 10 and 12 g/dL as a higher haemoglobin level may increase the risk of blood clots and death.
Danish: Formålet med behandlingen er at opretholde dit hæmoglobinniveau mellem 10 og 12 g/dl, da et højere hæmoglobinniveau kan øge risikoen for blodpropper og død.
English: If the patient loses response or haemoglobin concentration drops by ≥ 1 g/dL upon dose reduction the dose should be increased by one dosing step.
Danish: Hvis patienten mister respons, eller hæmoglobinkoncentrationen falder med ≥ 1 g/dl efter dosisreduktion, skal dosen øges med ét doseringstrin.
English: In 5 small, open label, uncontrolled studies (number of patients ranged from 9-22, total N = 72), Epoetin alfa has been administered subcutaneously in children at starting doses of 100 IU/kg/week to 150 IU/kg/week with the possibility to increase up to 300 IU/kg/week.
Danish: I 5 små, åbne ukontrollerede studier (antal af patienter lå fra 9-22, total N = 72) blev Epoetin alfa administreret subkutant hos børn med startdoser på 100 IE/kg/uge til 150 IE/kg/uge med mulighed for at øge dosis til 300 IE/kg/uge.
English: Further pharmacodynamic studies explored 40,000 IU once weekly versus 150 IU/kg 3 times per week.
Danish: Yderligere farmakodynamiske studier undersøgte 40.000 IE én gang ugentligt versus 150 IE/kg 3 gange ugentligt.
English: In all patients, haemoglobin levels should be closely monitored due to a potential increased risk of thromboembolic events and fatal outcomes when patients are treated at haemoglobin levels above the concentration range for the indication of use.
Danish: Hos alle patienter bør hæmoglobinniveauerne monitoreres nøje pga. en mulig forhøjet risiko for tromboemboliske hændelser og dødeligt udfald, når patienter med hæmoglobinniveauer over koncentrationsintervallet for indikationen behandles.
English: 40,000 IU/mL:
Danish: 40.000 IE/ml:
English: Chronic renal failure patients treated with epoetin alfa by the subcutaneous route should be monitored regularly for loss of efficacy, defined as absent or decreased response to epoetin alfa treatment in patients who previously responded to such therapy.
Danish: Patienter med kronisk nyresvigt, der behandles med epoetin alfa, bør monitoreres regelmæssigt for tab af effekt, defineret som manglende eller reduceret respons på epoetin alfa hos patienter, som tidligere har responderet.
English: In the randomised, double-blind, placebo-controlled, multicentre study 4 (4.7%) subjects experienced TVEs (sudden death, ischaemic stroke, embolism, and phlebitis).
Danish: I det randomiserede, dobbeltblindede, placebokontrollerede multicenterstudie oplevede 4 (4,7%) af forsøgspersonerne TVE'er (pludselig død, iskæmisk slagtilfælde, emboli og flebitis).
English: Epoetin alfa HEXAL is given alone and not mixed with other liquids for injection.
Danish: Epoetin alfa HEXAL gives alene og må ikke blandes med andre væsker til indsprøjtning.
English: • Nose or airway congestion.
Danish: • Tilstopning af næse eller luftveje.
English: Epoetin alfa HEXAL is used in moderately anaemic adults who donate some of their blood before surgery, so that it can be given back to them during or after the operation.
Danish: Epoetin alfa HEXAL anvendes til voksne med moderat anæmi, som før en operation donerer noget af deres blod, så det kan gives til dem igen under eller efter operationen.
English: All of the responding subjects were in the stratum with sEPO < 200 mU/mL during screening.
Danish: Alle de responderende forsøgspersoner var i stratummet med sEPO < 200 mE/ml under screening.
English: The maximum dosage should not exceed 150 IU/kg, 3 times per week, 240 IU/kg (up to a maximum of 20,000 IU) once weekly, or 480 IU/kg (up to a maximum of 40,000 IU) once every 2 weeks.
Danish: Den maksimale dosis bør ikke overstige 150 IE/kg 3 gange ugentligt, 240 IE/kg (op til maksimalt 20.000 IE) én gang ugentligt eller 480 IE/kg (op til maksimalt 40.000 IE) én gang hver anden uge.
English: When this access (via a vein or tube) is not readily available, your doctor may decide that Epoetin alfa HEXAL should be injected under the skin (subcutaneously).
Danish: Hvis denne adgang (i en vene eller slange) ikke er let tilgængelig, kan din læge beslutte, at Epoetin alfa HEXAL skal indsprøjtes under huden (subkutant).
English: The recommended total weekly dose is between 75 IU/kg and 300 IU/kg.
Danish: Den anbefalede totale ugentlige dosis er mellem 75 og 300 IE/kg.
English: Pooled post-hoc analyses of clinical studies of ESAs have been performed in chronic renal failure patients (on dialysis, not on dialysis, in diabetic and non-diabetic patients).
Danish: Puljede post-hoc-analyser af kliniske studier med ESA'er er blevet udført hos patienter med kronisk nyreinsufficiens (i dialyse, ikke i dialyse, hos patienter med og uden diabetes).
English: Despite differences in concentration-time profiles the pharmacodynamic response (as measured by changes in percent reticulocytes, haemoglobin, and total RBCs) was similar between these regimens.
Danish: Trods forskelle i koncentration versus tid-profilen var det farmakodynamiske respons (målt ved ændringer i procent retikulocytter, hæmoglobin og totalt antal røde blodlegemer) sammenligneligt mellem disse behandlingsprogrammer.
English: The decision to administer recombinant erythropoietin treatment should be based on a benefit-risk assessment with the participation of the individual patient, which should take into account the specific clinical context.
Danish: Beslutningen om at give behandling med rekombinante erytropoietiner skal baseres på en benefit-risk-bedømmelse af den enkelte patient.
English: Medicinal product ineffective3
Danish: Perifert ødem Ineffektivt lægemiddel3
English: - increased risk of death when administered to achieve a haemoglobin concentration level of 12 g/dL (7.5 mmol/L) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
Danish: - øget risiko for død, når stofferne gives for at opnå en hæmoglobinkoncentration på 12 g/dl (7,5 mmol/l) hos patienter med aktiv malign sygdom, som hverken får kemoterapi eller strålebehandling.
English: • Your doctor will maintain your haemoglobin level between 10 and 12 g/dL as a high haemoglobin level may increase the risk of blood clots and death.
Danish: • Din læge vil vedligeholde dit hæmoglobinniveau mellem 10 og 12 g/dl, da et højt hæmoglobinniveau kan øge risikoen for blodpropper og død.
English: • If you are on a more extended dosing interval (greater than once weekly) of Epoetin alfa HEXAL, you may not maintain adequate haemoglobin levels and you may require an increase in Epoetin alfa HEXAL dose or frequency of administration.
Danish: • Hvis du har et mere udvidet doseringsinterval (længere end én uge) af Epoetin alfa HEXAL, vil du måske ikke opretholde tilstrækkelige hæmoglobinniveauer, og du kan have behov for en større dosis Epoetin alfa HEXAL eller hyppigere indgivelse.
English: Epoetin alfa therapy should continue until one month after the end of chemotherapy.
Danish: Behandling med epoetin alfa bør fortsætte indtil en måned efter endt kemoterapi.
English: In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the haemoglobin concentration range as recommended in section 4.2.
Danish: Hos patienter med kronisk nyerinsufficiens må vedligeholdelseskoncentrationen af hæmoglobin ikke overstige den øvre grænse for koncentrationsintervallet for hæmoglobin, som anbefales i pkt.
English: Available evidence suggests patients with haematological malignancies and solid tumours respond equivalently to epoetin alfa therapy, and that patients with or without tumour infiltration of the bone marrow respond equivalently to epoetin alfa therapy.
Danish: Tilgængelige data tyder på, at patienter med hæmatologiske maligniteter og solide tumorer responderer ækvivalent på behandling med epoetin alfa, og at patienter med eller uden tumorinfiltration af knoglemarven responderer ækvivalent på behandling med epoetin alfa.
English: • Always use Epoetin alfa HEXAL exactly as instructed by your doctor or nurse.
Danish: • Brug altid Epoetin alfa HEXAL nøjagtigt efter lægens eller sundhedspersonalet anvisning.