FrancophonIA/ELRC3.0 huggingface dataset:
English: In that stratum, 20/40 (50%) subjects without prior transfusions demonstrated erythroid response during the first 24 weeks, compared with 7/31 (22.6%) subjects with prior transfusions (two subjects with prior transfusion reached primary endpoint based on reduction of RBC units transfused by an absolute number of at least 4 units every 8 weeks compared to the 8 weeks prior to baseline).
Danish: I dette stratum viste 20/40 (50%) forsøgspersoner uden forudgående transfusioner erythroid-respons i de første 24 uger sammenlignet med 7/31 (22,6%) forsøgspersoner med forudgående transfusioner (to forsøgspersoner med forudgående transfusion nåede primært endepunkt baseret på reduktion i transfunderede enheder af røde blodlegemer med et absolut antal på mindst 4 enheder hver 8. uge sammenlignet med de 8 uger før baseline).
English: Porphyria acute3
Danish: Akut porfyri3
English: Cytotoxic actions of epoetin alfa on bone marrow cells could not be detected.
Danish: Cytotoksiske virkninger af epoetin alfa på knoglemarvsceller kunne ikke detekteres.
English: A paradoxical decrease in haemoglobin and development of severe anaemia associated with low reticulocyte counts should prompt to discontinue treatment with epoetin alfa and perform anti-erythropoietin antibody testing.
Danish: En paradoks reduktion i hæmoglobin og udvikling af svær anæmi forbundet med lavt reticulocyttal bør medføre seponering af epoetin alfa og bestemmelse af anti-erytropoietin-antistoffer.
English: If you are not sure about giving the injection or you have any questions, please ask your doctor or nurse for help.
Danish: Hvis du føler dig usikker,eller hvis du har spørgsmål, skal du bede lægen eller sundhedspersonalet om hjælp.
English: A randomised, double-blind, placebo-controlled, multicentre study evaluated the efficacy and safety of epoetin alfa in adult anaemic subjects with low- or intermediate-1-risk MDS.
Danish: I et randomiseret, dobbeltblindet, placebokontrolleret multicenterstudie evalueredes effektiviteten og sikkerheden af epoetin alfa hos voksne forsøgspersoner med MDS med lav eller intermediær risiko 1.
English: • Your doctor will order blood tests, and may adjust the dose, depending on how your anaemia responds to Epoetin alfa HEXAL treatment.
Danish: • Din læge vil rekvirere blodprøver og kan justere dosis, afhængig af, hvordan din anæmi påvirkes af behandlingen med Epoetin alfa HEXAL.
English: 2,000 IU/mL:
Danish: 2.000 IE/ml:
English: Depress the plunger slowly and evenly until the entire dose has been given and the plunger cannot be depressed any further.
Danish: Tryk stemplet langsomt og jævnt i bund til hele dosis er givet, og stemplet ikke kan trykkes længere ned.
English: Good blood management practices should always be used in the perisurgical setting.
Danish: God praksis for håndtering af blod skal altid iagttages i forbindelse med en operation.
English: Treatment of adult patients with low- or intermediate-1-risk MDS
Danish: Behandling af voksne patienter med MDS med lav eller intermediær risiko 1
English: In a prospective, randomised, double-blind, placebo-controlled trial conducted in 375 anaemic patients with various non-myeloid malignancies receiving non-platinum chemotherapy, there was a significant reduction of anaemia-related sequelae (e.g. fatigue, decreased energy, and activity reduction), as measured by the following instruments and scales: Functional Assessment of Cancer Therapy-Anaemia (FACT-An) general scale, FACT-An fatigue scale, and Cancer Linear Analogue Scale (CLAS).
Danish: I et prospektivt, randomiseret, dobbeltblindt, placebokontrolleret studie med 375 anæmiske patienter med forskellige non-myeloide maligniteter, der var i behandling med ikke-platinholdig kemoterapi, sås en signifikant reduktion af anæmirelaterede følger (f.eks. træthed, nedsat energi og nedsat aktivitet) målt efter følgende klassificering: Functional Assessment of Cancer Therapy-Anemia (FACT-An) general scale, FACT-An fatique scale, og Cancer Linear Analogue Scale (CLAS).
English: Comparable intensity of chemotherapy in the epoetin alfa and placebo groups in the chemotherapy trials was demonstrated by a similar area under the neutrophil time curve in patients treated with epoetin alfa and placebo-treated patients, as well as by a similar proportion of patients in groups treated with epoetin alfa and placebo-treated groups whose absolute neutrophil counts fell below 1,000 and 500 cells/µL.
Danish: En sammenlignelig intensitet af kemoterapibehandlingen i grupperne med epoetin alfa og placebo i kemoterapistudier blev vist ved et sammenligneligt areal under neutrofil-tid-kurven hos patienter i behandling med epoetin alfa og patienter i placebogruppen, samt ved en sammenlignelig andel af patienter i epoetin alfa-gruppen og placebogruppen, hvor det absolutte neutrofiltal faldt til under 1.000 og 500 celler/µl.
English: • Epoetin alfa HEXAL is given by injection under the skin each week for three weeks before surgery and on the day of surgery.
Danish: • Epoetin alfa HEXAL gives via indsprøjtning under huden hver uge i tre uger inden operationen og på operationsdagen.
English: Epoetin alfa HEXAL is provided with or without a needle safety guard and you will be shown how to use this by your doctor or nurse.
Danish: Epoetin alfa HEXAL leveres med eller uden kanylebeskyttelse, og lægen eller sundhedspersonalet viser dig, hvordan du anvender den.
English: • if you have high blood pressure not properly controlled with medicines.
Danish: • hvis du lider af forhøjet blodtryk, der er svært at regulere med medicin.
English: The effect of epoetin alfa in facilitating autologous blood donation in patients with low haematocrits (≤ 39% and no underlying anaemia due to iron deficiency) scheduled for major orthopaedic surgery was evaluated in a double-blind, placebo-controlled study conducted in 204 patients, and a single-blind placebo controlled study in 55 patients.
Danish: Virkningen af epoetin alfa på at facilitere autolog bloddonation hos patienter med lav hæmatokrit (≤ 39% og ingen underliggende anæmi på grund af jernmangel) med planlagt større ortopædkirurgi blev evalueret i et dobbeltblindet, placebokontrolleret studie med 204 patienter og i et enkeltblindet placebokontrolleret studie med 55 patienter.
English: These may affect more than 1 in 10 people.
Danish: Disse kan forekomme hos flere end 1 ud af 10 personer.
English: Epoetin alfa HEXAL can reduce the need for a blood transfusion in these patients.
Danish: Epoetin alfa HEXAL kan nedsætte behovet for en blodtransfusion hos disse patienter.
English: Talk to your doctor, pharmacist or nurse before using Epoetin alfa HEXAL.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Epoetin alfa HEXAL.
English: There are no studies assessing the potential effect of epoetin alfa on male or female fertility.
Danish: Der foreligger ingen studier, som har vurderet epoetin alfas mulige virkning på fertilitet hos hanner og hunner.
English: Patients were assigned to epoetin alfa treatment targeting a maintenance haemoglobin level of 13.5 g/dL (higher than the recommended haemoglobin concentration level) or 11.3 g/dL.
Danish: Patienter fik tildelt behandling med epoetin alfa med et mål for hæmoglobinniveau på 13,5 g/dl (højere end den anbefalede hæmoglobinkoncentration) eller 11,3 g/dl.
English: Moreover, epoetin alfa doses of 75 to 150 IU/kg per week have been shown to maintain haematocrits of 36 to 38% for up to six months.
Danish: Desuden er det vist, at epoetin alfa i doser på 75 til 150 IE/kg ugentligt opretholder hæmatokritniveauer på 36 til 38% i op til seks måneder.
English: - in adults with renal insufficiency not yet undergoing dialysis for the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients (see section 4.4).
Danish: - hos voksne med nyreinsufficiens, der endnu ikke er i dialyse, til behandling af svær anæmi, der er nyrerelateret og forbundet med kliniske symptomer hos patienten (se pkt.
English: If you develop a serious rash or another of these skin symptoms, stop taking Epoetin alfa HEXAL and contact your doctor or seek medical attention immediately.
Danish: Hvis du udvikler et alvorligt udslæt eller får andre af disse hudsymptomer, skal du stoppe med at tage Epoetin alfa HEXAL og straks kontakte din læge eller søge lægehjælp
English: If an elevated or rising serum potassium level is detected, then in addition to appropriate treatment of the hyperkalaemia, consideration should be given to ceasing epoetin alfa administration until the serum potassium level has been corrected.
Danish: Såfremt der ses en forhøjet eller stigende serumkaliumkoncentration i tillæg til en hensigtsmæssig behandling for hyperkaliæmi, bør det overvejes at stoppe indgiften af epoetin alfa, indtil serumkalium-niveauet er blevet korrigeret.
English: The use of Epoetin alfa HEXAL in patients scheduled for major elective orthopaedic surgery and not participating in an autologous blood predonation programme is contraindicated in patients with severe coronary, peripheral arterial, carotid or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident.
Danish: Brug af Epoetin alfa HEXAL hos patienter, der er planlagt til større elektiv ortopædkirurgi, og som ikke deltager i en autolog prædonation af blod, er kontraindiceret, hvis patienten lider af en alvorlig koronar, perifer arteriel, karotid eller cerebrovaskulær lidelse, herunder for nyligt har fået konstateret myokardieinfarkt eller hjerneblødning.
English: In chronic renal failure patients, the half-life of intravenously administered epoetin alfa is slightly prolonged, approximately 5 hours, compared to healthy subjects.
Danish: Hos patienter med kronisk nyresvigt er halveringstiden for intravenøst administreret epoetin alfa en smule forlænget, ca. 5 timer, sammenlignet med raske personer.
English: 1,000 IU/0.5 mL 2,000 IU/1 mL
Danish: 1.000 IE/0,5 ml 2.000 IE/1 ml
English: In a double-blind, placebo-controlled, multicentre, quality of life study in CRF patients on haemodialysis, clinically and statistically significant improvement was shown in the patients treated with epoetin alfa compared to the placebo group when measuring fatigue, physical symptoms, relationships and depression (Kidney Disease Questionnaire) after six months of therapy.
Danish: I et dobbeltblindet, placebokontrolleret multicenterstudie af livskvalitet hos CRF-patienter i hæmodialyse blev der vist klinisk og statistisk signifikant forbedring hos patienter i behandling med epoetin alfa, sammenlignet med placebogruppen, ved måling af træthed, fysiske symptomer, sociale relationer og depression (spørgeskema for nyresygdom) efter seks måneders behandling.
English: The desired haemoglobin concentration level in two studies was > 13 g/dL (8.1 mmol/L); in the remaining three studies it was 12 to 14 g/dL (7.5 to 8.7 mmol/L).
Danish: Det ønskede hæmoglobinkoncentration i to studier var > 13 g/dl (8,1 mmol/l), og i de øvrige tre studier var den 12 til 14 g/dl (7,5 til 8,7 mmol/l).
English: Patients scheduled for major elective orthopaedic surgery should receive adequate antithrombotic prophylaxis, as thrombotic and vascular events may occur in surgical patients, especially in those with underlying cardiovascular disease.
Danish: Patienter, der er planlagt til større ortopædkirurgisk operation, bør gives tilstrækkelig antitrombotisk profylakse, da der kan opstå trombotiske eller vaskulære problemer hos operationspatienterne, især hos patienter med hjertekarsygdomme.
English: - For patients in an autologous predonation programme, iron supplementation (elemental iron 200 mg/day orally) should be administered several weeks prior to initiating the autologous predeposit in order to achieve high iron stores prior to starting epoetin alfa therapy, and throughout the course of epoetin alfa therapy.
Danish: - For patienter i et autologt prædonationsprogram bør jerntilskud (elementært jern 200 mg/dag oralt) administreres flere uger før den autologe prædeponering for at opnå store jerndepoter, før behandlingen med epoetin alfa startes, samt i hele behandlingsforløbet med epoetin alfa.
English: No a one subject did not have sEPO data b in the ≥ 200 mU/mL stratum there were 13 subjects in the epoetin alfa group and 6 subjects in the placebo group
Danish: Nej a én forsøgsperson havde ingen sEPO-data b i stratummet med ≥ 200 mE/ml var der 13 forsøgspersoner i epoetin alfa-gruppen og
English: Epoetin alfa HEXAL should be administered after the completion of the blood donation procedure.
Danish: Epoetin alfa HEXAL skal administreres, efter at bloddonationen er afsluttet.
English: Remove one syringe from the pack and remove the protective cap from the injection needle.
Danish: Tag en sprøjte ud af pakken og tag den beskyttende hætte af kanylen.
English: Epoetin alfa HEXAL is indicated for the treatment of symptomatic anaemia (haemoglobin concentration of ≤ 10 g/dL) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (< 200 mU/mL).
Danish: Epoetin alfa HEXAL er indiceret til behandling af symptomatisk anæmi (hæmoglobinkoncentration på ≤ 10 g/dl) hos voksne med primære myelodysplastiske syndromer (MDS) med lav eller intermediær risiko 1, som har lavt serum-erythropoietin (< 200 mE/ml).
English: • Epoetin alfa HEXAL is given by injection into a vein immediately after you have donated blood for 3 weeks before your surgery.
Danish: • Epoetin alfa HEXAL gives via indsprøjtning i en vene, lige efter du har fået tappet blod i 3 uger før operationen.
English: The recommended starting dose is Epoetin alfa HEXAL 450 IU/kg (maximum total dose is 40,000 IU) administered subcutaneously once every week, with not less than 5 days between doses.
Danish: Den anbefalede startdosis er Epoetin alfa HEXAL 450 IE/kg (maksimal samlet dosis er 40.000 IE) administreret subkutant én gang om ugen og med mindst 5 dage mellem hver dosis.
English: Shunt thromboses have occurred in haemodialysis patients, especially in those who have a tendency to hypotension or whose arteriovenous fistulae exhibit complications (e.g. stenoses, aneurysms, etc.).
Danish: Shunt-tromboser er forekommet hos patienter i hæmodialyse, specielt hos patienter, som har en tendens til hypotension, eller hvis arteriovenøse fistler giver komplikationer (f.eks. stenoser, aneurismer mm.).
English: In female adult patients with metastatic breast cancer, subcutaneous co-administration of 40,000 IU/mL epoetin alfa with trastuzumab 6 mg/kg had no effect on the pharmacokinetics of trastuzumab.
Danish: Hos voksne kvindelige patienter med metastatisk brystcancer havde samtidig subkutan administration af 40.000 IE/ml epoetin alfa og trastuzumab 6 mg/kg ingen virkning på trastuzumabs farmakokinetik.
English: Epoetin alfa 600 IU/kg (administered intravenously or subcutaneously once weekly) has been evaluated in a randomised, double-blind, placebo-controlled, 16-week study and in a randomised, controlled, open-label, 20-week study in anaemic paediatric patients receiving myelosuppressive chemotherapy for the treatment of various childhood non-myeloid malignancies.
Danish: Epoetin alfa 600 IE/kg (administreret intravenøst eller subkutant en gang ugentligt) er blevet evalueret i et randomiseret, dobbeltblindet, placebokontrolleret 16-ugers studie og i et randomiseret, kontrolleret, åbent 20-ugers studie med anæmiske, pædiatriske patienter, der fik myelosuppressiv kemoterapi til behandlingen af forskellige non-myeloide maligniteter.
English: In healthy subjects, a dose-proportional increase in serum epoetin alfa concentrations was observed after intravenous administration of 150 and 300 IU/kg, 3 times per week.
Danish: Hos raske personer blev der observeret en dosisproportional stigning i serumkoncentrationen af epoetin alfa efter intravenøs administration af 150 og 300 IE/kg 3 gange ugentligt.
English: Epoetin alfa HEXAL contains the active substance epoetin alfa, a protein that stimulates the bone marrow to produce more red blood cells which carry haemoglobin (a substance that transports oxygen).
Danish: Epoetin alfa HEXAL indeholder det aktive stof epoetin alfa, et protein som stimulerer knoglemarven til at danne flere røde blodlegemer, der bærer hæmoglobin (et stof, der transporterer oxygen).
English: • difficulty swallowing or breathing,
Danish: • synke- eller åndedrætsbesvær,
English: At the time of clinical data cutoff, the median progression free survival (PFS) per investigator assessment of disease progression was 7.4 months in each arm (HR 1.09, 95% CI: 0.99, 1.20), indicating the study objective was not met.
Danish: På skæringstidspunktet for de kliniske data var den mediane progressionsfri overlevelse (PFS) pr. investigatorvurdering af sygdomsprogressionen 7,4 måneder i hver gruppe (HR 1,09, 95% KI: 0,99, 1,20), hvilket angiver, at studiets mål ikke blev opfyldt.
English: Treatment should only be given to patients with moderate anaemia (haemoglobin [Hb] concentration range between 10 to 13 g/dL [6.2 to 8.1 mmol/L], no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).
Danish: Behandling bør kun gives til patienter med moderat anæmi (hæmoglobin [Hb] koncentrationsinterval fra 10-13 g/dl [6,2-8,1 mmol/l], uden jernmangel), hvis der ikke findes procedurer til at gemme blod, eller hvis de er utilstrækkelige, når den planlagte, større, elektive operation kræver en stor mængde blod (4 enheder blod eller derover til kvinder eller 5 enheder eller derover til mænd).
English: Mildly anaemic patients (haematocrit of 33 to 39%) requiring predeposit of ≥ 4 units of blood should be treated with Epoetin alfa HEXAL 600 IU/kg intravenously, 2 times per week for 3 weeks prior to surgery.
Danish: Patienter med let anæmi (hæmatokrit på 33 til 39%), som forud skal deponere ≥ 4 enheder blod, skal behandles med Epoetin alfa HEXAL 600 IE/kg intravenøst 2 gange ugentligt i 3 uger før operationen.
English: • Bone or muscle pain.
Danish: • Knogle- eller muskelsmerter.
English: Epoetin alfa was administered at 75 IU/kg/week intravenously in 2 or 3 divided doses post-dialysis, titrated by 75 IU/kg/week at intervals of 4 weeks (up to a maximum of 300 IU/kg/week), to achieve a 1 g/dL/month increase in haemoglobin.
Danish: Epoetin alfa blev administreret som 75 IE/kg/uge intravenøst i 2 eller 3 delte doser efter dialyse, titreret med 75 IE/kg/uge med intervaller på 4 uger (op til maksimalt 300 IE/kg/uge), for at opnå en hæmoglobinstigning på 1 g/dl/måned.
English: If you have these symptoms during injection into the vein, a slower delivery of the injection may help to avoid them in the future.
Danish: Hvis du får disse symptomer, når Epoetin alfa HEXAL injiceres i venen, kan det hjælpe med til at undgå dem, hvis injektionen i fremtiden gives langsommere.
English: Pre-filled syringes (glass type I), with or without a needle safety guard, with plunger stopper (Teflon-faced rubber) sealed in a blister.
Danish: Fyldt injektionssprøjte (type I-glas), med eller uden kanylebeskytter, med stempelprop (teflonbelagt gummi), forseglet i en blisterpakning.
English: Use should be restricted to patients with moderate anaemia (e.g. haemoglobin concentration range between 10 to 13 g/dL or 6.2 to 8.1 mmol/L) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1,800 mL).
Danish: Anvendelsen bør begrænses til patienter med moderat anæmi (f.eks. hæmoglobin-koncentrationsinterval fra 10-13 g/dl eller fra 6,2-8,1 mmol/l), for hvem der ikke forefindes autolog prædonation af blod, og med forventet moderat blodtab (900-1800 ml).
English: Epoetin alfa 300 IU/kg significantly reduced the risk of allogeneic transfusion in patients with a pretreatment haemoglobin of > 10 to ≤ 13 g/dL.
Danish: Epoetin alfa 300 IE/kg reducerede risikoen for allogen transfusion hos patienter med hæmoglobin før behandling på > 10 til ≤ 13 g/dl.
English: - an observed 9% increase in risk for progress of disease (PD) or death in the epoetin alfa plus SOC group from a primary analysis and a 15% increased risk that cannot be statistically ruled out in patients with metastatic breast cancer receiving chemotherapy when administered to achieve a haemoglobin concentration range of 10 to 12 g/dL (6.2 to 7.5 mmol/L).
Danish: - en observeret 9% stigning i risikoen for sygdomsprogression eller død hos epoetin alfa plus standardbehandlingsgruppen i en primær analyse og en 15% øget risiko, der ikke statistisk kan udelukkes hos patienter med metastatisk brystcancer, som får kemoterapi, når stofferne gives for at opnå en hæmoglobinkoncentration på 10 til 12 g/dl (6,2 til 7,5 mmol/l).
English: Alternatively, the injection can be given at the end of the dialysis session via the fistula needle tubing, followed by 10 mL of isotonic saline to rinse the tubing and ensure satisfactory injection of the product into the circulation (see Posology, “Adult haemodialysis patients”).
Danish: Alternativt kan injektionen gives via slangen med fistelnålen efter dialysen, efterfulgt af 10 ml isotonisk saltvand for at rense slangen og sikre tilfredsstillende injektion af præparatet i blodbanen (se Dosering, ”Voksne hæmodialysepatienter”).
English: Epoetin alfa has been studied in clinical trials in adult anaemic cancer patients with lymphoid and solid tumors, and patients on various chemotherapy regimens, including platinum and non-platinum-containing regimens.
Danish: Epoetin alfa er blevet undersøgt i kliniske studier hos voksne anæmiske cancerpatienter med lymfoide og solide tumorer og hos patienter i behandling med forskellige kemoterapiregimer, herunder platinog ikke-platinholdige behandlingsprogrammer.
English: Patients should be monitored closely to ensure that the lowest approved dose of erythropoiesis-stimulating agent (ESA) is used to provide adequate control of the symptoms of anaemia.
Danish: Patienterne skal monitoreres nøje for at sikre, at der anvendes den laveste godkendte dosis erytropoiese-stimulerende stof (ESA) til at opnå tilstrækkelig kontrol med symptomerne på anæmi.
English: The half-life for the subcutaneous route is estimated to be approximately 24 hours in healthy subjects.
Danish: Halveringstiden efter subkutan indgift er beregnet til at være ca. 24 timer hos raske personer.
English: After single doses (20,000 to 160,000 IU subcutaneously) of epoetin alfa, a dose-dependent response was observed for the pharmacodynamic markers investigated including: reticulocytes, RBCs, and haemoglobin.
Danish: Efter enkeltdoser (20.000-160.000 IE subkutant) af epoetin alfa blev der observeret et dosisafhængigt respons for de undersøgte farmakodynamiske markører, herunder retikulocytter, røde blodlegemer og hæmoglobin.
English: • The starting dose is either 150 IU per kilogram body weight three times a week or 450 IU per kilogram body weight once a week.
Danish: • Startdosis er enten 150 IE per kilogram kropsvægt 3 gange om ugen eller 450 IE pr. kilo kropsvægt én gang om ugen.
English: Administer the amount required.
Danish: Indgiv den påkrævede dosis.
English: An open-label, parallel-group trial in non-iron deficient adult subjects with a pretreatment haemoglobin of ≥ 10 to ≤ 13 g/dL who were scheduled for major orthopaedic hip or knee surgery compared epoetin alfa 300 IU/kg subcutaneously daily for 10 days prior to surgery, on the day of surgery and for four days after surgery to epoetin alfa 600 IU/kg subcutaneously once weekly for 3 weeks prior to surgery and on the day of surgery.
Danish: Et åbent studie med parallelle grupper af voksne personer uden jernmangel med hæmoglobin før behandling på ≥ 10 til ≤ 13 g/dl med planlagt større ortopædkirurgisk operation af hofte eller knæ sammenlignede epoetin alfa 300 IE/kg subkutant dagligt i 10 dage før operationen, på operationsdagen og i fire dage efter operationen med epoetin alfa 600 IE/kg subkutant én gang ugentligt i 3 uger før operationen og på operationsdagen.