FrancophonIA/ELRC3.0 huggingface dataset:
English: • Your doctor may initiate treatment with Retacrit if your haemoglobin is 10 g/dL or less.
Danish: • Din læge kan indlede behandling med Retacrit, hvis dit hæmoglobin er 10 g/dl eller lavere.
English: Tell the doctor or nurse immediately if you think too much Retacrit has been injected.
Danish: Du skal straks underrette lægen eller sygeplejersken, hvis du mener, at der er indsprøjtet for meget Retacrit.
English: Your doctor will decide how Retacrit will be injected.
Danish: Din læge afgør, hvordan Retacrit skal indsprøjtes.
English: In cell cultures of human bone marrow cells, epoetin alfa stimulates erythropoiesis specifically and does not affect leucopoiesis.
Danish: I cellekulturer fra humane knoglemarvsceller stimulerer epoetin alfa specifikt erytropoiese uden påvirkninger af leukopoiese.
English: Prolonged vigorous shaking may damage the product.
Danish: Langvarig, voldsom rysten kan beskadige præparatet.
English: Of the patients who achieved the target, 90% did so on a 3 times-per-week dosing regimen.
Danish: Blandt dem, der nåede målniveauet, gjorde 90 % af patienterne det ved hjælp af 3 ugentlige doser.
English: Haemoglobin (g/L)
Danish: Hæmoglobin (g/l)
English: This includes patients on dialysis and patients not yet on dialysis.
Danish: Dette gælder også for patienter i dialyse og patienter, der endnu ikke er i dialyse.
English: You may still be able to use Retacrit, but discuss it with your doctor first.
Danish: Du vil fortsat måske kunne tage Retacrit, men drøft det med din læge først.
English: Diarrhoea, Nausea, Vomiting Very common
Danish: Diaré, kvalme, opkastning Meget almindelig
English: • Retacrit is given by injection into a vein immediately after you have donated blood for 3 weeks before your surgery.
Danish: • Retacrit gives som en indsprøjtning i en vene umiddelbart efter, du har doneret blod, 3 uger forud for din operation.
English: Use an antiseptic swab on the injection site, to disinfect it.
Danish: Brug en antiseptisk serviet på injektionsstedet for at desinficere det.
English: 6.6 Special precautions for disposal and other handling
Danish: 6.6 Regler for bortskaffelsen og anden håndtering
English: A randomised, open-label, multicentre study was conducted in 2 098 anaemic women with metastatic breast cancer, who received first line or second line chemotherapy.
Danish: Der blev udført et randomiseret, åbent multicenterstudie med 2.098 anæmiske kvinder med metastatisk brystcancer, som fik førstelinje eller andenlinje kemoterapi.
English: Talk to your doctor, pharmacist or nurse before using Retacrit.
Danish: Kontakt lægen, apotekspersonalet eller sygeplejersken, før du tager Retacrit.
English: Retacritcanreduce the need for a blood transfusionin these patients.
Danish: Retacrit kan nedsætte behovet for en blodtransfusionhos disse patienter.
English: EPO is involved in all phases of erythroid development, and has its principal effect at the level of erythroid precursors.
Danish: EPO er involveret i alle faser af erytrocytudviklingen og virker primært på erytrocytternes forstadier.
English: Your Retacrit dose and frequency of administration may be further adjusted to maintain your response to treatment.
Danish: Din dosis af Retacrit og hvor ofte det skal gives, kan justeres yderligere for at fastholde virkningen af behandlingen.
English: • If you are a cancer patient, be aware that use of Retacrit may be associated with shorter survival and a higher death rate in head and neck, and metastatic breast cancer patients who are receiving chemotherapy.
Danish: • Hvis du er kræftpatient, skal du være opmærksom på, at brugen af Retacrit kan være forbundet med kortere overlevelse og større dødelighed hos patienter med hoved- og halskræft samt patienter med metastatisk brystkræft, som får kemoterapi.
English: Correction phase
Danish: Korrigeringsfasen
English: This medicine contains phenylalanine and may be harmful for people with phenylketonuria (genetic enzyme deficiency that increases excretion of a chemical (phenylketone) in urine and may cause nervous system disorders).
Danish: Denne medicin indeholder phenylalanin og kan være skadeligt, for mennesker med Føllings sygdom (fenylketonuri)(genetisk betinget enzymmangel, som øger udskillelsen af et kemisk stof (fenylketon) i urinen og kan forårsage sygdomme i nervesystemet) .
English: These patients responded to epoetin alfa therapy in a manner similar to that observed in patients on dialysis.
Danish: Disse patienter responderede på behandling med epoetin alfa på tilsvarende måde, som blev observeret hos dialysepatienter.
English: Talk to your doctor if any of the following apply to you.
Danish: Tal med lægen, hvis noget af følgende gælder for dig.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I : Produktresumé; pkt 4.2).
English: A patient-level data analysis has also been performed on more than 13 900 cancer patients (chemo-, radio-, chemoradio-, or no therapy) participating in 53 controlled clinical trials involving several epoetins.
Danish: Der er også udført en analyse af patientdata fra mere end 13.900 cancerpatienter (kemoterapi, strålebehandling, kemoterapi+strålebehandling eller ingen behandling), i 53 kontrollerede, kliniske studier med flere epoetiner.
English: As with any other injectable product, check that there are no particles in the solution or change in colour.
Danish: Ligesom for andre injektionspræparater skal det kontrolleres, at opløsningen er fri for partikler og uden farveændringer.
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 nyresvigt hos mennesker og kan muligvis relateres til sekundær hyperparatyroidisme eller ukendte faktorer.
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 de der fik epoetin alfa 300 IE/kg, 23 % af de der fik epoetin alfa 100 IE/kg og 45 % af placebobehandlede patienter fik brug for transfusion.
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 hos hepatitis C patienter i behandling med interferon og ribavirin, der samtidigt er blevet behandlet med ESA'er.
English: You may have chest pain, breathlessness, and painful swelling and redness, usually in the leg as symptoms.
Danish: Du kan få brystsmerter, åndenød, smertefuld hævelse og rødme, sædvanligvis i benene som symptom.
English: In animal studies, epoetin alfa has been shown to decrease foetal body weight, delay ossification and increase foetal mortality when given in weekly doses of approximately 20 times the recommended human weekly dose.
Danish: Dyrestudier har påvist, at epoetin alfa nedsætter føtal legemsvægt, forsinker ossifikationen og øger fosterdødeligheden, når det gives i ugentlige doser på ca. 20 gange den anbefaledeugentlige, humane dosis.
English: Surgery patients who for any reason cannot receive adequate antithrombotic prophylaxis.
Danish: Kirurgiske patienter, der af forskellige årsager ikke kan gives tilstrækkelig tromboseprofylakse.
English: Tell your doctor or nurse immediately if you are aware of any of these effects, or if you notice any other effects while you are receiving treatment with Retacrit.
Danish: Fortæl det straks til lægen eller sygeplejersken, hvis du bliver opmærksom på nogen af disse bivirkninger, eller hvis du bemærker andre bivirkninger, mens du får behandling med Retacrit.
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 zeta administration until the serum potassium level has been corrected.
Danish: Hvis der ses et forhøjet eller stigende serumkalium skal det, ud over passende behandling af hyperkalæmien, overvejes at ophøre med administrationen af epoetin zeta, indtil serumkalium er blevet korrigeret.
English: • Skin rashes, which may result from an allergic reaction.
Danish: • Hududslæt, som kan stamme fra en overfølsomhedsreaktion.
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, mikrokernelegemer hos mus eller genmutation ved HGPRT-locus.
English: Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Danish: Kontrollerede kliniske studier har ikke vist signifikante fordele, som kunne tilskrives behandling med epoetiner, når hæmoglobinkoncentrationen øges udover det niveau, der er nødvendigt for at kontrollere symptomerne på anæmi og for at undgå blodtransfusion.
English: Epoetin alfa therapy reduced the risk of exposure to allogeneic blood by 50% compared to patients not receiving epoetin alfa.
Danish: Behandling med epoetin alfa nedsatte risikoen for eksponering for allogent blod med 50 % sammenlignet med patienter, der ikke fik epoetin alfa.
English: The erythropoietic response observed in both treatment groups resulted in similar transfusion rates (16% in the 600 IU/kg weekly group and 20% in the 300 IU/kg daily group).
Danish: Det erytropoietiske respons, der blev observeret i begge behandlingsgrupper, resulterede i sammenlignelige transfusionsrater (16 % i gruppen der fik 600 IE/kg ugentligt og 20 % i gruppen, der fik 300 IE/kg dagligt).
English: When this access (via a vein or tube) is not readily available, your doctor may decide that Retacrit should be injected under the skin (subcutaneously).
Danish: Hvis denne adgangsvej (via en vene eller slange) ikke er umiddelbart tilgængeligt, kan lægen beslutte, at Retacrit skal indsprøjtes under huden (subkutant).
English: Retacrit therapy should continue until one month after the end of chemotherapy.
Danish: Behandling med Retacrit skal fortsætte indtil en måned efter endt kemoterapi.
English: • Retacrit is given by injection under the skin each week for three weeks before surgery and on the day of surgery.
Danish: • Retacrit gives som indsprøjtning under huden hver uge i 3 uger før operationen og på operationsdagen.
English: Retacrit contains the active substance epoetin zeta - a protein that stimulates the bone marrow to produce more red blood cells which carry haemoglobin (a substance that transports oxygen).
Danish: Retacrit indeholder det aktive stof epoetin zeta - et protein, som stimulerer knoglemarven til at danne flere røde blodlegemer, der indeholder hæmoglobin (et stof, som transporterer ilt).
English: The most frequent adverse drug reaction during treatment with epoetin alfa is a dose-dependent increase in blood pressure or aggravation of existing hypertension.
Danish: Den hyppigste bivirkning ved behandling med epoetin alfa er en dosisafhængig blodtryksstigning eller forværring af eksisterende hypertension.
English: If you are given a product in this group other than Retacrit during your treatment, speak to your doctor or pharmacist before using it.
Danish: Hvis du får et andet produkt fra denne gruppe end Retacrit, skal du tale med din læge eller apotekspersonalet, før du bruger det.
English: Of a total 3 417 subjects in 25 randomised, double-blinded, placebo or standard of care controlled studies, the overall safety profile of epoetin alfa was evaluated in 2 094 anaemic subjects.
Danish: Ud af i alt 3.417 forsøgspersoner i 25 randomiserede, dobbeltblindede studier kontrolleret med placebo eller standardbehandling, blev den samlede sikkerhedsprofil for epoetin alfa evalueret hos 2.094 anæmiske forsøgspersoner.
English: • When the plunger is pushed as far as it will go, take out the needle and let go of the skin.
Danish: • Når stemplet er trykket så langt ind, som det kan komme, tages nålen ud, og hudfolden slippes.
English: • Your doctor will order regular blood tests to see how your anaemia is responding and may adjust the dose, usually no more frequently than every four weeks.
Danish: • Din læge vil bestille blodprøver regelmæssigt for at se, hvordan din blodmangel påvirkes, og lægen vil muligvis justere dosis, i reglen ikke oftere end hver 4. uge.
English: This regresses during the course of continued therapy.
Danish: Dette normaliseres under den fortsatte behandling.
English: A randomized prospective trial (CHOIR) evaluated 1,432 anaemic chronic renal failure patients who were not undergoing dialysis.
Danish: Et randomiseret, prospektivt studie (CHOIR) evaluerede 1.432 anæmiske patienter med kronisk nyresvigt, der ikke var i dialyse.
English: In the three largest clinical trials conducted in adult patients on dialysis, the median maintenance dose necessary to maintain the haematocrit between 30 to 36% was approximately 75 IU/kg given 3 times per week.
Danish: I de tre største kliniske studier, der blev udført hos voksne patienter i dialyse, var den nødvendige mediane vedligeholdelsesdosis for at opretholde en hæmatokrit på 30-36 %, ca. 75 IE/kg 3 gange ugentligt.
English: Do not use this medicine after the expiry date which is stated on the box and on the label after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen og etiketten efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Based on information available to date, correction of anaemia with epoetin zeta in adult patients with renal insufficiency not yet undergoing dialysis does not accelerate the rate of progression of renal insufficiency.
Danish: Baseret på den til dato tilgængelige information medfører korrektion af anæmi med epoetin zeta hos voksne patienter med nyreinsufficiens, som endnu ikke er i dialyse, ikke acceleret progressionshastighed af nyreinsufficiensen.
English: Additionally, cerebrovascular accidents (including cerebral infarction, cerebral haemorrhage and transient ischaemic attacks) have been reported.
Danish: Desuden er der indberettet cerebrovaskulære hændelser (herunder cerebralt infarkt, hjerneblødning og transitoriske iskæmiske anfald).
English: • epileptic seizures or fits
Danish: • epileptiske anfald eller kramper
English: Very rarely, development of or exacerbation of porphyria has been observed in epoetin zeta-treated patients.
Danish: Der er i meget sjældne tilfælde observeret udvikling eller forværring af porfyri hos patienter i behandling med epoetin zeta.
English: Since cyclosporin is bound by RBCs there is potential for a drug interaction.
Danish: Da ciclosporin er bundet til erytrocytter, er der mulighed for lægemiddelinteraktion.
English: The first evidence of a response to epoetin alfa is an increase in the reticulocyte count within 10 days, followed by increases in the red cell count, haemoglobin and haematocrit, usually within 2 to 6 weeks.
Danish: Det første tegn på respons på epoetin alfa er stigning i retikulocyttallet indenfor 10 dage, efterfulgt af stigning i antal erytrocytter, hæmoglobin og hæmatokrit, sædvanligvis i løbet af 2-6 uger.
English: • can't take medicines to thin the blood
Danish: • ikke kan tage blodfortyndende medicin.
English: • Place the plastic catcher of the needle-trap against a hard, stable surface and with one hand pivot the syringe barrel upward against the needle forcing the needle into the catcher where it locks in place (an audible 'click” is heard when the needle is locked in the catcher).
Danish: Placer plast nålefanget mod en hård, stabil overflade og med den ene hånd på injektionssprøjtens cylinder, opad mod nålen, tvinges nålen ind i nålefangeren, hvor den låses på plads (der høres et 'klik', når nålen er låst i fangeren).
English: Chronic renal failure patients treated with epoetin zeta by the subcutaneous route should be monitored regularly for loss of efficacy, defined as absent or decreased response to epoetin zeta treatment in patients who previously responded to such therapy.
Danish: Patienter med kronisk nyresvigt, der behandles subkutant med epoetin zeta, bør kontrolleres regelmæssigt for tab af effekt, defineret som manglende eller nedsat respons på behandlingen med epoetin zeta hos patienter, som tidligere har responderet på denne behandling.
English: Cytotoxic actions of epoetin alfa on bone marrow cells could not be detected.
Danish: Cytotoksiske virkninger af epoetin alfa på knoglemarvsceller kunne ikke påvises.
English: • Either into a vein or a tube that goes into a vein (intravenously)
Danish: • enten i en vene eller i en slange, der går ind i en vene (intravenøst),
English: You may still be able to use Retacrit, but discuss it with your doctor first:
Danish: Det er muligt, at du alligevel kan bruge Retacrit, men drøft det med din læge først:
English: Your syringe has a needle-trap attached to it which is designed to specifically help prevent accidental needle stick injuries following the proper administration of injectable medicines.
Danish: Injektionssprøjten kan have vedhæftet et nålefang, som er designet specifikt for at hjælpe med at forhindre skader fra utilsigtede nålestik, efter korrekt administration af medicin til indsprøjtning.
English: Porphyria acute
Danish: Porfyri, akut
English: The percentage of subjects who were transfused in the epoetin alfa group decreased from 51.8% in the 8 weeks prior to baseline to 24.7% between weeks 16 and 24, compared to the placebo group which had an increase in transfusion rate from 48.9% to 54.1% over the same time periods.
Danish: Procentdelen af patienter, som som fik transfusion i epoetin alfa-gruppen, faldt fra 51,8 % i de 8 uger før baseline til 24,7 % mellem uge 16 og 24 sammenlignet med placebogruppen, som havde en stigning i transfusionsraten fra 48,9 % til 54,1 % over de samme tidsperioder.
English: In addition, thrombocythaemia above the normal range has been reported.
Danish: Der er desuden rapporteret tilfælde af trombocytose over det normale område.
English: Epoetin alfa was administered subcutaneously for 10 days prior to surgery, on the day of surgery, and for four days after surgery.
Danish: Epoetin alfa blev administreret subkutant i 10 dage før operationen, på operationsdagen og i fire dage efter operationen.
English: If possible, iron supplementation should be initiated prior to starting epoetin zeta therapy to achieve adequate iron stores.
Danish: Om muligtpåbegyndes jerntilskuddet, før behandling med epoetin zeta startes, så der opnås tilstrækkelige jerndepoter.
English: The use of Retacrit 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 Retacrit til patienter, som skal gennemgå en planlagt større elektiv ortopædkirurgisk operation, og som ikke skal deltage i et autologt prædonationprogram, er kontraindiceret hos patienter med svære koronare, perifere arterielle, carotide eller cerebrale vaskulære sygdomme, inklusive patienter med nyligt myokardieinfarkt eller cerebral vaskulær hændelse.
English: Epoetin zeta is a copy of the human protein erythropoietin (ee-rith-roe-po-eh-tin) and acts in the same way.
Danish: Epoetin zeta er en kopi af det naturligt forekommende protein erythropoietin (e-ry-tro-po-e-tin) og virker på samme måde.
English: INTERMEDIATE CARTON (WITHOUT BLUE BOX) COMPONENT OF MULTIPACK
Danish: KARTON (UDEN BLÅ BOKS) DEL AF MULTIPAKNING
English: o 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 af renal oprindelse ledsaget af kliniske symptomer hos patienterne (se pkt.
English: The mean volume of distribution was 49.3 mL/kg after intravenous doses of 50 and 100 IU/kg in healthy subjects.
Danish: Det gennemsnitlige fordelingsvolumen var 49,3 ml/kg efter intravenøse doser på 50 og 100 IE/kg hos raske forsøgspersoner.
English: If you visit a hospital, clinic or family doctor, tell them you are having Retacrit treatment.
Danish: Hvis du er på hospitalet, lægeklinik eller hos egen læge, skal du fortælle, at du er i behandling med Retacrit.
English: Retacrit contains phenylalanine
Danish: Retacrit indeholder phenylalanin
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 studiet over 16 uger (n = 222) var der hos patienter, som blev behandlet med epoetin alfa, ingen statistisk signifikant virkning på patientindberettede eller forældreindberettede resultater af Paediatric Quality of Life Inventory eller Cancer Module i forhold til placebo (primært effektendepunkt).
English: Your doctor will decide this.
Danish: Det afgør din læge.
English: It is important to tell your doctor if any of the following apply to you.
Danish: Det er vigtigt at fortælle din læge, hvis noget af nedenstående gælder for dig.
English: Following subcutaneous injection, serum levels of erythropoietin reach a peak between 12 and 18 hours post-dose.
Danish: Efter subkutan injektion af erythropoietin nås maksimal serumkoncentration 12-18 timer efter indgift.
English: 17.UNIQUE IDENTIFIER - 2D BARCODE
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
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 designet til at udelukke en 15 % stigning i risikoen for tumorprogression eller død med epoetin alfa plus standardbehandling sammenlignet med standardbehandling alene.
English: In clinical trials at starting doses of 50 to 150 IU/kg, three times per week, approximately 95% of all patients responded with a clinically significant increase in haematocrit.
Danish: I kliniske studier med startdoser på 50-150 IE/kg tre gange ugentligt responderede ca. 95 % af alle patienter med en klinisk signifikant stigning i hæmatokrit.
English: A half-life of approximately 6.2 to 8.7 hours has been reported in paediatric subjects with chronic renal failure following multiple dose intravenous administration of erythropoietin.
Danish: Der er rapporteret en halveringstid på ca. 6,2-8,7 timer hos pædiatriske forsøgspersoner med kronisk nyresvigt efter intravenøs administration af gentagne doser erythropoietiner.
English: The exposure of paediatric patients with chronic renal failure on haemodialysis in clinical trials and post-marketing experience is limited.
Danish: Eksponering af pædiatriske patienter med kronisk nyresvigt i hæmodialyse i kliniske studier og postmarketing er begrænset.
English: Recombinant human EPO (epoetin zeta), expressed in Chinese hamster ovary cells, has a 165 amino acid sequence identical to that of human urinary EPO; the 2 are indistinguishable on the basis of functional assays.
Danish: Rekombinant humant EPO (epoetin zeta), udtrykt i ovarieceller fra kinesiske hamstere, har en sekvens på 165 aminosyrer, der er identisk med sekvensen for EPO i human urin.
English: These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia associated with various common cancers who received recombinant human erythropoietin compared to controls.
Danish: Disse studier viste en konsekvent uforklarlig statistisk signifikant overdødelighed hos patienter, der havde anæmi i forbindelse med forskellige almindelige cancerformer, og som fik rekombinant humant erythropoietin sammenlignet med kontrolgruppen.