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 interval mellem doserne af epoetin alfa (3 gange ugentligt, 1 gang ugentligt, 1 gang hver 2. uge og 1 gang hver 4. uge) opretholdt nogle af patienterne, med længere intervaller mellem doserne, ikke et tilstrækkeligt hæmoglobinniveau og opfyldte kriteriet for seponering pga. for lavt hæmoglobin i henhold til protokollen (0 % i gruppen der blev behandlet 1 gang ugentligt, 3,7 % i gruppen der blev behandlet 1 gang hver 2. uge og 3,3 % i gruppe der blev behandlet 1 gang hver 4. uge).
English: Please discuss with your doctor.
Danish: Drøft det med din læge.
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 til din operation, vil du få en daglig dosis på 300 IE/kilogram i op til 10 dage før operationen, på operationsdagen og de første 4 dage umiddelbart efter operationen.
English: Patients who develop pure red cell aplasia (PRCA) following treatment with any erythropoietin should not receive Retacrit or any other erythropoietin (see section 4.4).
Danish: Patienter, der udvikler aplasi af umodne erotrocytter (PRCA - pure red cell aplasia) efter behandling med et erythropoietin, må ikke få Retacrit eller et andet erytropoietin (se pkt.
English: Overall, based on the results of these pharmacodynamic studies in healthy subjects, the 40 000 IU once-weekly dosing regimen seems to be more efficient in producing RBCs than the biweekly regimens despite an observed similarity in reticulocyte production in the once-weekly and biweekly regimens.
Danish: Baseret på resultaterne fra disse farmakodynamiske studier hos raske forsøgspersoner ser det overordnet ud til, at regimet med 40.000 IE én gang ugentligt er mere effektivt med hensyn til at danne erytrocytter end regimet med én dosis hver anden uge, til trods for, at der blev observeret ligheder mellem retikulocytdannelsen i de to regimer.
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 haren nyresygdom, mangler du muligvisrøde blodlegemer, hvis dine nyrer ikke danner nok erytropoietin (nødvendigt forat kunne danne røde blodlegemer).
English: In case of larger volumes, more than one site should be chosen for the injection.
Danish: I tilfælde af større volumener skal injektionen fordeles på flere injektionssteder.
English: Common in dialysis Includes arterial and venous, fatal and non fatal events, such as deep venous thrombosis, pulmonary emboli, retinal thrombosis, arterial thrombosis (including myocardial infarction), cerebrovascular accidents (including cerebral infarction and cerebral haemorrhage) transient ischaemic attacks, and shunt thrombosis (including dialysis equipment) and thrombosis within arteriovenous shunt aneurisms Addressed in the subsection below and/or in section 4.4
Danish: Almindelig under dialyse Omfatter hændelser i arterier og vener, såvel dødelige som ikke-dødelige, såsom dyb venøs trombose, lungeemboli, retinal trombose, arteriel trombose (herunder myokardieinfarkt), cerebrovaskulære hændelser (herunder cerebral infarkt og hjerneblødning), transitorisk iskæmisk attack og trombose i en shunt (herunder dialyseudstyr) og trombose i aneurisme i arteriovenøs shunt Beskrevet i underafsnittet nedenfor og/eller i pkt.
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: Der er blevet udført samlede post-hoc-analyser af kliniske studier med ESA'er hos patienter med kronisk nyreinsufficiens (i dialyse, ikke i dialyse, hos patienter med og uden diabetes).
English: Dose should not be increased over the maximum of 1 050 IU/kg (total dose 80 000 IU) per week.
Danish: Dosis må ikke øges over den maksimale dosis på 1.050 IE/kg (total dosis 80.000 IE) pr. uge.
English: • If you have been diagnosed with Pure Red Cell Aplasia (the bone marrow cannot produce enough red blood cells) after previous treatment with any product that stimulates red blood cell production (including Retacrit).
Danish: • hvis du har fået diagnosen erytroblastopeni (knoglemarven kan ikke danne nok røde blodlegemer) efter tidligere behandling med et lægemiddel, der stimulerer dannelsen af røde blodlegemer (herunder Retacrit).
English: Mildly anaemic patients (haematocrit of 33 to 39%) requiring predeposit of ≥ 4 units of blood should be treated with Retacrit 600 IU/kg intravenously, 2 times per week for 3 weeks prior to surgery.
Danish: Let anæmiske patienter (hæmatokrit 33-39 %), som kræver en forudgående behandling med ≥ 4 portioner blod, skal behandles med Retacrit 600 IE/kg intravenøst 2 gange pr. uge i 3 uger forud for operationen.
English: Patients should be monitored closely to ensure that the lowest approved effective dose of Retacrit is used to provide adequate control of anaemia and of the symptoms of anaemia whilst maintaining a haemoglobin concentration below or at 12 g/dL (7.5 mmol/L).
Danish: Patienterne bør monitoreres nøje for at sikre, at den laveste godkendte, effektive dosis af Retacrit anvendes til at opnå tilstrækkelig kontrol med anæmien og symptomerne på anæmi, mens der samtidig opretholdes en hæmoglobinkoncentration under eller lig med 12 g/dl (7,5 mmol/l).
English: Your doctor will help you to decide if Retacrit is suitable for you.
Danish: I samråd med lægen kan du finde frem til, om Retacrit er velegnet til dig.
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 virkningen og sikkerheden af epoetin alfa hos voksne anæmiske patienter med lav- eller intermediær-1-risiko MDS.
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: Endvidere blev det påvist, at epoetin alfa doser på 75-150 IE/kg ugentligt opretholder hæmatokritniveauer på 36-38 % i op til seks måneder.
English: There may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with epoetin zeta.
Danish: Der kan optræde en moderat, dosisafhængig stigning i trombocyttallet inden for normalområdet under behandling med epoetin zeta.
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. hæmoglobinkoncentration i intervallet 10-13 g/dl eller 6,2-8,1 mmol/l), for hvem der ikke foreligger et autologt prædonationsprogram og med et forventet moderat blodtab (900 til 1 800 ml).
English: Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.06 in favour of controls (95% CI: 1.00, 1.12; 53 trials and 13 933 patients) and for the cancer patients receiving chemotherapy, the overall survival hazard ratio was 1.04 (95% CI: 0.97, 1.11; 38 trials and 10 441 patients).
Danish: En metaanalyse af data for samlet overlevelse gav et Hazard Ratio (HR) punktestimat på 1,06 til fordel for kontrolgruppen (95 % CI: 1.00; 1,12; 53 studier og 13.933 patienter), og for de cancerpatienter, der fik kemoterapi, var HR for samlet overlevelse 1,04 (95% CI: 0.97, 1.11; 38 studier og 10.441 patienter).
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 nedsatte signifikant risikoen for allogen transfusion hos patienter med hæmoglobin inden behandlingen på > 10 til ≤ 13 g/dl.
English: This is characterised by a sustained decrease in haemoglobin despite an increase in epoetin zeta dosage (see section 4.8).
Danish: Dette karakteriseres ved et vedvarende fald i hæmoglobin på trods af øget epoetin zeta-dosis (se pkt.
English: Shunt thrombosis 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-trombose er forekommet hos hæmodialysepatienter, især hos patienter med tendens til hypotension, eller arteriovenøse fistler med komplikationer (f.eks. stenose, aneurisme osv.).
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) 1 gang ugentligt eller 480 IE/kg (op til maksimalt 40.000 IE) 1 gang hver 2. uge.
English: Side effects from an overdose of Retacrit are unlikely.
Danish: Det er ikke sandsynligt, at du får bivirkninger på grund af overdosering med Retacrit.
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: Den tilstræbte hæmoglobinkoncentration i to studier var > 13 g/dl (8,1 mmol/l), og i de resterende tre studier var den 12-14 g/dl (7,5 til 8,7 mmol/l).
English: • Grasp the tip of the plastic needle catcher and bend it away from needle cover.
Danish: • Tag fat i spidsen af plast nålefanget og bøj den væk fra nålebeskyttelsen
English: The reported risk of these TVEs should be carefully weighed against the benefits to be derived from treatment with epoetin zeta particularly in patients with pre-existing risk factors for TVE, including obesity and prior history of TVEs (e.g., deep venous thrombosis, pulmonary embolism, and cerebral vascular accident).
Danish: Den rapporterede risiko for disse TVE'er bør afvejes nøje mod fordelene ved behandling med epoetin zeta, især hos patienter med eksisterende risikofaktorer herunder overvægt og tidligere TVE i anamnesen (f.eks. dyb venetrombose, lungeemboli og cerebrovaskulær hændelse).
English: Patients treated with epoetin alfa were also able to predeposit significantly more units of blood (epoetin alfa 300 IU/kg = 4.4 units; epoetin alfa 600 IU/kg = 4.7 units) than placebo-treated patients (2.9 units).
Danish: De patienter, der fik epoetin alfa, var også i stand til at deponere signifikant flere enheder blod (epoetin alfa 300 IE/kg = 4,4 enheder, epoetin alfa 600 IE/kg = 4,7 enheder) end patienter i placebogruppen (2,9 enheder).
English: The recommended dose is Retacrit 600 IU/kg administered subcutaneously weekly for three weeks (days -21, -14 and -7) prior to surgery and on the day of surgery.
Danish: Den anbefalede dosis Retacrit er 600 IE/kg administreret subkutant ugentligt i tre uger (dag -21, -14 og -7) før operationen samt på selve operationsdagen.
English: • Push the plunger with your thumb as far as it will go to inject the entire amount of liquid.
Danish: • Tryk stemplet så langt ind som muligt med tommelfingeren for at indsprøjte hele væskemængden.
English: Retacrit is presented as a clear and colourless solution for injection in a pre-filled syringe with a fixed injection needle.
Danish: Retacrit er en klar og farveløs injektionsvæske i fyldt injektionssprøjter med fast injektionsnål.
English: More cases have been reported with subcutaneous (SC) route of administration, compared with the IV route.
Danish: Der er rapporteret flere tilfælde efter subkutan administration sammenlignet med intravenøs administration.
English: Do not pass it on to others.
Danish: Lad derfor være med at give Retacrit til andre.
English: Epoetin alfa has been shown to stimulate red blood cell production in order to augment autologous blood collection, and to limit the decline in haemoglobin in adult patients scheduled for major elective surgery who are not expected to predeposit their complete perioperative blood needs.
Danish: Epoetin alfa har vist sig at stimulere dannelsen af erytrocytter med henblik på at øge udbyttet af autolog bloddonation og at begrænse fald i hæmoglobin hos voksne patienter, der skal gennemgå planlagt større ortopædkirurgisk indgreb, og som ikke forventes at deponere hele deres behov for perioperativt blod på forhånd.
English: Retacrit should not be used:
Danish: Retacrit må ikke bruges:
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 til at fremme autolog bloddonation hos patienter med lave hæmatokritværdier (≤ 39 % og ingen underliggende anæmi pga. jernmangel) som skulle gennemgå en planlagt større ortopæddisk operation, blev evalueret i et dobbeltblindet, placebokontrolleret studie med 204 patienter og i et enkeltblindet placebokontrolleret studie med 55 patienter.
English: Meta-analyses also indicate consistently a significantly increased relative risk of thromboembolic events in cancer patients receiving recombinant human erythropoietin (see section
Danish: Desuden viser metaanalyserne konsekvent en signifikant øget relativ risiko for tromboemboliske hændelser hos cancerpatienter, der fik rekombinant human erythropoietin (se afsnit 4.4).
English: Retacrit 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: Retacrit er indiceret til behandling af symptomatisk anæmi (hæmoglobinkoncentration på ≤ 10 g/dl) hos voksne med lav- eller intermediær-1-risiko primært myelodysplastisk syndrom (MDS), som har lavt serumerytropoietin (< 200 mE/ml).
English: The recommended total weekly dose is between 75 IU/kg and 300 IU/kg.
Danish: Den anbefalede totale ugentlige dosis er 75-300 IE/kg.
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 kronisk nyresvigt, der ikke var i dialyse, udviste en dosisafhængig og vedvarende stigning i hæmatokrit, når epoetin alfa blev administreret enten intravenøst eller subkutant.
English: The desired haemoglobin concentration range was 9.6 to 11.2 g/dL.
Danish: Den ønskede koncentration af hæmoglobin var 9,6-11,2 g/dl.
English: Take special care with other products that stimulate red blood cell production:
Danish: Vær ekstra forsigtig med at tage anden medicin, som stimulerer dannelsen af røde blodlegemer:
English: The recommended starting dose is Retacrit 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 Retacrit 450 IE/kg (maksimal total dosis er 40.000 IE) administreret subkutant en gang ugentligt med mindst 5 dage mellem doserne.
English: The greatest effects are observed in patients with low haemoglobin (≤ 13 g/dL; 8.1 mmol/L).
Danish: De største virkninger ses hos patienter med lavt hæmoglobin (≤ 13 g/dl, 8,1 mmol/l).
English: Baseline Characteristics for Subjects with sEPO <200mU/ml at Screening Randomised
Danish: Baselinekarakteristika for patienter med sEPO < 200 mE/ml ved screening Randomiseret
English: In patients scheduled for major elective orthopaedic surgery with a pretreatment haemoglobin of >10 to ≤ 13 g/dL, epoetin alfa has been shown to decrease the risk of receiving allogeneic transfusions and hasten erythroid recovery (increased haemoglobin levels, haematocrit levels, and reticulocyte counts).
Danish: Hos patienter, som skal gennemgå en større planlagt ortopædkirurgisk operation, og som før behandligen har hæmoglobin på > 10 til ≤ 13 g/dl, har epoetin alfa vist sig at nedsætte risikoen for at få allogene transfusioner og fremskynde bedring af erytrocyttallet (øget hæmoglobin, hæmatokrit og retikulocyttal).
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 studie over 20-uger med anæmiske, pædiatriske patienter, som fik myelosuppressiv kemoterapi til behandlingen af forskellige non-myeloide maligniteter.
English: Erythropoietin is a growth factor that primarily stimulates red cell production.
Danish: Erythropoietin er en vækstfaktor, der primært stimulerer dannelsen af erytrocytter.
English: Anti-erythropoeitin antibody positive
Danish: Anti-erytropoeitin-antistofpositiv
English: Following intravenous administration of erythropoietin in subjects with chronic renal failure, the volume of distribution ranged from 57-107 mL/kg after single dosing (12 IU/kg) to 42-64 mL/kg after multiple dosing (48-192 IU/kg), respectively.
Danish: Efter intravenøs administration af erythropoietin til forsøgspersoner med kronisk nyresvigt var fordelingsvolumenet henholdsvis i intervallet 57-107 ml/kg efter en enkelt dosis (12 IE/kg) og 42-64 ml/kg efter gentagne doser (48-192 IE/kg).
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl lægen eller apotekspersonalet det, hvis du tager anden medicin eller har gjort det for nylig.
English: In patients developing sudden lack of efficacy defined by a decrease in haemoglobin (1 to 2 g/dL per month) with increased need for transfusions, a reticulocyte count should be obtained and typical causes of non-response (e.g. iron, folate or Vitamin B12 deficiency, aluminium intoxication, infection or inflammation, blood loss, haemolysis and bone marrow fibrosis of any origin) should be investigated.
Danish: Hos patienter, hvor der pludseligt ses en manglende effekt defineret som et fald i hæmoglobin (1-2 g/dl eller 0,62-1,25 mmol/l pr. måned) med et øget behov for transfusioner, skal der foretages en reticulyttælling, og typiske årsager til manglende effekt (f.eks. mangel på jern, folinsyre eller B12vitamin, ved aluminiumforgiftning, infektion eller inflammation, blodtab, hæmolyse og knoglemarvsfibrose uanset årsag) bør undersøges.
English: Cancer patients being treated with epoetin zeta should have haemoglobin levels measured on a regular basis until a stable level is achieved, and periodically thereafter.
Danish: Cancerpatienter i behandling med epoetin zeta skal regelmæssigt have målt hæmoglobin, indtil der opnås et stabilt niveau, og periodisk derefter.
English: Patients should be monitored closely to ensure that the lowest approved dose of ESA is used to provide adequate control of the symptoms of anaemia.
Danish: Patienterne bør monitoreres nøje for at sikre, at den laveste godkendte dosis af ESA anvendes til at opnå tilstrækkelig kontrol med anæmisymptomerne.
English: There are no studies assessing the potential effect of epoetin zeta on male or female fertility.
Danish: Der foreligger ingen studier til vurdering af epoitin zetas potentielle virkning på fertiliteten hos mænd eller kvinder.
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: Ved klinisk data cutoff var median progressionsfri overlevelse baseret på investigators vurdering af sygdomsprogressionen 7,4 måneder i hver gruppe (HR 1,09, 95 % CI: 0,99, 1,20), hvilket indikerer, at studiets mål ikke blev opfyldt.
English: In addition, special precaution should be taken in patients with predisposition for development of DVTs.
Danish: Desuden skal der træffes særlige foranstaltninger hos patienter, som er prædisponerede for udvikling af dyb venetrombose.
English: One pack contains 1, 4 or 6 pre-filled syringes with or without a needle guard or needle-trap device.
Danish: Én pakning indeholder 1, 4 eller 6 fyldte injektionssprøjter med eller uden nålebeskyttelse eller nålefang.
English: It consists of a plastic needle “catcher” which is firmly attached to the syringe label.
Danish: Det består af et plast nålefang, som er solidt fastgjort til injektionssprøjtens etiket.
English: Epoetin zeta is not approved in the management of anaemia associated with hepatitis C.
Danish: Epoetin zeta er ikke godkendt til behandling af anæmi forbundet med hepatitis C.
English: Hypertensive crisis with encephalopathy and seizures, requiring the immediate attention of a physician and intensive medical care, have occurred also during epoetin zeta treatment in patients with previously normal or low blood pressure.
Danish: Der er forekommet hypertensive kriser med encefalopati og krampeanfald, der kræver omgående tilsyn af en læge og intensiv medicinsk behandling, også under behandling med epoetin zeta hos patienter, der hidtil havde haft normalt eller lavt blodtryk.
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: Målet med behandlingen er at holde dit hæmoglobinniveau på mellem 10 og 12 g/dl, da et højere hæmoglobinniveau kan øge risikoen for blodpropper og dødsfald.
English: An increase in heparin dose during haemodialysis is frequently required during the course of therapy with epoetin zeta as a result of the increased packed cell volume.
Danish: Det er ofte nødvendigt med en øget heparindosis under hæmodialyse ved behandling med epoietin zeta, som et resultat af øget hæmatokritværdi.
English: Once the haemoglobin level is <11 g/dL the dose can be restarted on the same dosing step or one dosing step down based on physician judgement.
Danish: Når hæmoglobinniveauet er < 11 g/dl, kan dosis alt efter lægens vurdering genstartes på samme doseringstrin eller et trin lavere.
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: Behandlingen bør kun anvendes til patienter med moderat anæmi (hæmoglobinkoncentration (Hb) i intervallet 10-13 g/dl (6,2-8,1 mmol/l, ingen jernmangel), hvis der ikke forefindes blodopbevaringsprocedurer eller de er utilstrækkelige, når det planlagte større, kirurgiske indgreb kræver en stor mængde blod (4 eller flere blodportioner til kvinder og 5 eller flere blodportioner til mænd).
English: A minimum of 4 weeks should elapse between dose increases.
Danish: Der skal gå mindst 4 uger mellem hver dosisøgning.
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 nyresvigt må vedligeholdelseskoncentrationen af hæmoglobin ikke overstige den øvre grænse i det interval, der anbefales i pkt.