FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be monitored closely to ensure that the lowest approved dose of Silapo is used to provide adequate control of the symptoms of anaemia.
Danish: Patienterne bør monitoreres nøje for at sikre, at den lavest godkendte dosis af Silapo anvendes til at sørge for tilstrækkelig kontrol af de anæmiske symptomer.
English: You should inform the doctor or nurse immediately if you think too much Silapo has been injected.
Danish: De bør straks underrette lægen eller sygeplejersken, hvis De mener, at De har taget for meget Silapo.
English: In order to improve the traceability of erythropoiesis-stimulating agents (ESAs), the name of the prescribed ESA should be clearly recorded (or: stated) in the patient file.
Danish: For at forbedre sporbarheden af erythropoietin stimulerende stoffer (ESA'er) bør navnet på det ordinerede ESA angives i patientens journal.
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: En dataanalyse på patient-niveau er også blevet udført på mere end 13 900 cancerpatienter (kemo-, stråle-, kemo-stråle- eller ingen behandling), som medvirkede i 53 kontrollerede, kliniske undersøgelser, som omfattende flere epoetiner.
English: There may be a rise in the level of platelets (cells that help blood clotting) during treatment with this medicine.
Danish: Der kan forekomme en stigning i antallet af blodplader (celler, der er med til at få blodet til at størkne) under behandlingen med denne medicin.
English: Two subjects had significant risk factors (atrial fibrillation, heart failure and thrombophlebitis).
Danish: To forsøgspersoner havde væsentlige risikofaktorer (atrieflimren, hjerteinsufficiens og tromboflebitis).
English: Target Hb (10 - 12 g/dl)
Danish: Målkoncentration af Hb (10-12 g/dl)
English: However, since ciclosporin is bound by red blood cells there is potential for interactions with other medicinal products.
Danish: Da ciclosporin er bundet til RBC'er, er der imidlertid en mulighed for interaktion med andre lægemidler.
English: Changing from injecting into a vein to injecting under the skin (from intravenous into subcutaneous injection)
Danish: Skift fra indsprøjtning i en blodåre til indsprøjtning under huden (fra intravenøs til subkutan indsprøjtning)
English: Median time from baseline to first transfusion was statistically significantly longer in the epoetin alfa group compared to placebo (49 vs. 37 days; p=0.046).
Danish: Mediantiden fra baseline til den første transfusion var statistisk signifikant længere i epoetin alfagruppen sammenlignet med placebo (49 vs. 37 dage; p = 0,046).
English: • Silapo is given by injection under the skin each week for three weeks before surgery and on the day of surgery.
Danish: • Silapo gives som injektion under huden hver uge i 3 uger før operationen og på dagen for operationen.
English: Epoetins are not approved in the management of anaemia associated with hepatitis C.
Danish: Epoetiner er ikke godkendt til behandling af anæmi associeret med hepatitis C.
English: Survival and tumour progression have been examined in five large controlled studies involving a total of 2 833 patients, of which four were double-blind placebo-controlled studies and one was an openlabel study.
Danish: Overlevelse og tumorprogression er undersøgt i fem store kontrollerede forsøg med i alt 2 833 patienter, hvoraf fire var dobbeltblinde placebokontrollerede forsøg og et var et åbent forsøg.
English: If you do not respond adequately to Silapo, your doctor will check your dose and will inform you if you need to change doses of Silapo.
Danish: Hvis De ikke reagerer tilstrækkeligt på Silapo, vil Deres læge kontrollere dosis og informere Dem, hvis De har brug for at ændre dosis af Silapo.
English: Consequently, haemoglobin and blood pressure should be closely monitored.
Danish: Hæmoglobin og blodtryk bør derfor monitoreres nøje.
English: Pure red cell aplasia Thrombocythemia
Danish: Pure red cell aplasia (PRCA) trombocytæmi
English: Antibody-mediated erythroblastopenia (PRCA) has been reported after months to years of treatment with epoetin alfa.
Danish: Antistofforårsaget erytroblastopeni (PRCA) er blevet rapporteret efter måneder til års behandling med epoetin alfa.
English: Maintenance phase: During the maintenance phase, Silapo can be administered either 3 times per week, and in the case of subcutaneous administration, once weekly or once every 2 weeks.
Danish: I vedligeholdelsesfasen kan Silapo administreres enten 3 gange ugentligt, eller i tilfælde af subkutan administration en gang om ugen eller en gang hver 2. uge.
English: This is given 3 times a week by injection under the skin.
Danish: Denne gives 3 gange om ugen som indsprøjtning under huden.
English: PRCA may be caused by the production of antibodies against the erythropoietin product and, in the following, to your own erythropoietin.
Danish: PRCA kan skyldes, at der dannes antistoffer mod erythropoietin-produktet og efterfølgende mod kroppens eget erythropoietin.
English: The bioavailability of subcutaneous injectable erythropoietin is much lower than that of the intravenous medicinal product and is approximately 20%.
Danish: Biotilgængeligheden af injicerbart erythropoietin er meget lavere end af produktet til intravenøs indgivelse: ca. 20 %.
English: In haemodialysed patients, a bolus injection may be given during the dialysis session through a suitable venous port in the dialysis line.
Danish: Til hæmodialysepatienter kan der gives en bolusinjektion under dialysesessionen gennem en passende veneport i dialyselinien.
English: Hypertensive crisis
Danish: Hypertensiv krise
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge eller apotekspersonalet til råds, De tager dette lægemiddel.
English: • High levels of blood potassium which can cause abnormal heart rhythm (this is a very common side effect in patients on dialysis).
Danish: • Unormalt højt indhold af kalium i blodet, som kan give unormal hjerterytme (dette er en meget almindelig bivirkning hos dialysepatienter).
English: 61118 Bad Vilbel Germany
Danish: 61118 Bad Vilbel Tyskland
English: After your condition has been brought under control, you will receive regular doses of Silapo (3 times a week, or, if you have your injections under the skin, it may also be given once weekly or once every 2 weeks).
Danish: Når Deres tilstand er bragt under kontrol, vil De få regelmæssige Silapodoser (3 gange om ugen, eller hvis De får injektionerne under huden, kan det også gives en gang ugentligt eller en gang hver 2. uge).
English: Although this complication is very rare, you should be aware that if you develop it, you would need to have regular blood transfusions, possibly lifelong, to treat your anaemia and the Silapo therapy would have to be discontinued.
Danish: Selv om denne komplikation er sjælden, bør De være opmærksom på, at De, hvis De får den, jævnligt skal have blodtransfusioner, muligvis resten af livet, til behandling af Deres blodmangel, og at Silapo-terapien må afbrydes.
English: Epoetins are growth factors that primarily stimulate red blood cell production.
Danish: Epoetiner er vækstfaktorer, som primært stimulerer produktionen af røde blodceller.
English: Treatment should only be given to patients with moderate anaemia (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 (ingen jernmangel), hvis blodopbevaringsprocedure ikke er tilgængelig eller er utilstrækkelige, når det planlagte større, kirurgiske operation kræver en stort mængde blod (4 eller flere blodportioner for kvinder og 5 eller flere enheder for mænd).
English: • It may have been accidentally frozen.
Danish: • det ved et uheld er blevet frosset
English: The target haemoglobin concentration in two studies was > 13 g/dl; in the remaining three studies it was 12-14 g/dl.
Danish: Den tilstræbte hæmoglobinkoncentration i to forsøg var > 13 g/dl, og i de øvrige tre forsøg var den 12-14 g/dl.
English: All other causes of anaemia (iron deficiency, haemolysis, blood loss, vitamin B12- or folate deficiencies) should be considered and treated prior to initiating and during therapy with Silapo.
Danish: Alle andre årsager til anæmi (jernmangel, hæmolyse, blodtab, B12-vitamin- eller folatmangel) skal overvejes og behandles forud for påbegyndelse af og under terapi med Silapo.
English: However, your doctor may decide that it is right for you to learn how to inject Silapo under the skin (subcutaneously) yourself.
Danish: Deres læge kan dog beslutte, at det er en god ide, at De lærer selv at indsprøjte Silapo under huden (subkutant).
English: • Blood clots (thrombosis) may form in your dialysis shunt.
Danish: • Der kan dannes blodpropper (tromboser) i Deres dialyse-shunt.
English: *Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell line.
Danish: *Produceret med anvendelse af rekombinant DNA-teknologi i en kinesisk hamsterovarie (CHO)cellelinie.
English: • you are at risk of blood clots in the veins (deep venous thrombosis) - for example, if you have had clots before.
Danish: • De har risiko for blodpropdannelse i venerne (dyb venetrombose) - for eksempel, hvis De tidligere har haft blodpropper.
English: Cases have been reported in patients with hepatitis C treated with interferon and ribavirin, when epoetins are used concomitantly.
Danish: Sådanne tilfælde er rapporteret hos patienter med hepatitis C, behandlet med interferon og ribavirin, som samtidigt er behandlet med epoetiner.
English: Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur.
Danish: Der kan også opstå sår i mund, hals, næse, kønsorganer og øjne (røde og hævede øjne).
English: Good blood management practices should always be used in the perisurgical setting.
Danish: God blodbehandlingspraksis bør altid anvendes i forbindelse med kirurgi.
English: Hypertensive crisis with encephalopathylike symptoms can occur.
Danish: Der kan også opstå hypertensive kriser med encefalopatilignende symptomer.
English: In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression in patients with anaemia associated with cancer.
Danish: I adskillige kontrollerede studier er det ikke påvist at Epoetin kan forbedre den overordnede overlevelse eller mindske risikoen for tumorprogression hos patienter med cancerrelateret anæmi.
English: Phlebotomy may be performed if excessively high haemoglobin levels occur.
Danish: Flebotomi kan udføres, hvis der forekommer alt for høje hæmoglobinniveauer.
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 % der fik epoetin alfa 300 IE/kg, 23 % der fik epoetin alfa 100 IE/kg og 45 % af placebobehandlede patienter fik brug for transfusion.
English: Silapo must not be administered by intravenous infusion.
Danish: Silapo må ikke administreres ved intravenøs infusion.
English: The recommended total weekly dose is between 75 and 300 IU/kg.
Danish: Den anbefalede totale ugentlige dosis er mellem 75 og 300 IE/kg.
English: Erythropoietin is a glycoprotein that stimulates, as a mitosis-stimulating factor and differentiating hormone, the formation of erythrocytes from precursors of the stem cell compartment.
Danish: Erythropoietin er et glykoprotein, der som mitosestimulerende faktor og differentierende hormon stimulerer dannelsen af erytrocytter ved at stimulere forstadier i knoglemarven.
English: The most frequent adverse 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: For the purpose of ambulatory use, the patient may remove the product from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 3 days.
Danish: Med henblik på ambulant anvendelse kan patienten tage præparatet ud af køleskabet og opbevare det ved stuetemperatur (op til 25°C) i en enkelt periode på op til 3 dage.
English: Dose increases and decreases should be done one dosing step at a time (see diagram below).
Danish: Dosisøgninger og -sænkninger skal foretages med et doseringstrin ad gangen (se diagrammet herunder).
English: After 4 weeks of treatment the time to first transfusion was further increased in the epoetin alfa group (142 vs. 50 days, p=0.007).
Danish: Efter 4 ugers behandling øgedes tiden til første transfusion yderligere i epoetin alfa-gruppen (142 vs. 50 dage, p = 0,007).
English: 4.7 Effects on ability to drive and use machines
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner.
English: Erythroid response was defined according to International Working Group (IWG) 2006 criteria as a haemoglobin increase ≥1.5 g/dl from baseline or a 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, and a response duration of at least 8 weeks.
Danish: Erythroidrespons blev defineret ud fra kriterierne fastlagt af International Working Group (IWG) i 2006 som en hæmoglobinstigning på ≥ 1,5 g/dl fra baseline eller en reduktion af transfunderede RBC enheder med et absolut antal på mindst 4 enheder hver 8. uge, sammenlignet med de 8 uger før baseline, og en responsvarighed på mindst 8 uger.
English: Hypertension, Venous and arterial thromboses
Danish: Hypertension, venøs og arteriel trombose
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 erytopoietiske respons 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: This is characterised by a sustained decrease in haemoglobin despite an increase in Silapo dosage.
Danish: Dette er karakteriseret ved et vedvarende hæmoglobinfald trods øgning af Silapodosis.
English: It could be shown with the aid of cell cultures of human bone marrow cells that erythropoietin stimulates erythropoiesis specifically and does not affect leukopoiesis.
Danish: Ved hjælp af cellekulturer fra human knoglemarv kunne det vises, at erythropoietin specifikt stimulerer erytropoiesen og ikke indvirker på leukopoiesen.
English: • have severe disorders of the veins and arteries
Danish: • har alvorlige vene- og arterielidelser
English: Anti-erythropoeitin antibody positive
Danish: Anti-erytropoeitin-antistof-positiv
English: Silapo must not be mixed with other medicinal products (see section 6.2).
Danish: Silapo må ikke blandes med andre medicinske produkter (se pkt.
English: In case Silapo is injected under the skin (subcutaneously) you can also inject the solution yourself once you have been shown how.
Danish: Hvis Silapo indsprøjtes under huden (subkutant), kan De også selv foretage indsprøjtningen når De har fået vist, hvordan det skal gøres.
English: • Redness, burning and pain at the site of injection
Danish: • Rødme, svie og smerte på injektionsstedet
English: Following subcutaneous injection, serum levels of erythropoietin are much lower than the levels achieved following intravenous injection, the levels increase slowly and reach a peak between 12 and 18 hours postdose.
Danish: Efter subkutan injektion er serumniveauerne af erythropoietin meget lavere end de niveauer, der er opnået efter intravenøs injektion; niveauerne stiger langsomt og når et højdepunkt mellem 12 og
English: Clear, colourless solution.
Danish: Klar, farveløs opløsning.
English: PRCA means the inability to produce enough red blood cells in the bone marrow.
Danish: PRCA betyder manglende evne til at danne tilstrækkeligt mange røde blodlegemer i knoglemarven.
English: ≤2 RBC Units ˃2 and ≤4 RBC Units ˃4 RBC Units No one subject did not have sEPO data in the ≥200 mU/ml stratum there were 13 subjects in the epoetin alfa group and 6 subjects in the placebo group
Danish: Ja ≤ 2 RBC enheder ˃ 2 og ≤ 4 RBC enheder ˃ 4 RBC enheder Ingen en patient havde ikke sEPO data i stratummet ≥ 200 mE/ml var der 13 patienter i epoetin alfa-gruppen og 6 patienter i placebogruppen
English: Consequently, erythropoietin should generally be used during pregnancy and lactation only if the potential benefit outweighs the potential risk to the foetus.
Danish: Erythropoietin bør derfor kun anvendes under graviditet og amning, hvis de potentielle fordele opvejer den potentielle risiko for barnet.
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 blev transfunderet 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: 3H-thymidine incorporation in the erythroid nucleated spleen cells has been found in vitro (mouse spleen cell culture) after incubation with erythropoietin.
Danish: 3H-thymidin i de erytroide kerneholdige miltceller er fundet in vitro (kultur af miltceller fra mus) efter inkubering med erythropoietin.
English: If erythropoietin is given concomitantly with ciclosporin, blood levels of ciclosporin should be monitored and the dose of ciclosporin adjusted as the haematocrit rises.
Danish: Hvis erythropoietin gives sideløbende med ciclosporin, bør ciclosporinniveauet i blodet monitoreres, og ciclosporindosis skal justeres, efterhånden som hæmatokritten stiger.
English: You will receive appropriate training to enable you to do this.
Danish: De vil i så fald modtage passende undervisning.
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 forsøg har ikke vist signifikante fordele, som kunne tilskrives indgift af epoetiner, når hæmoglobinkoncentrationen øges til over det niveau, som er nødvendigt for at kontrollere symptomer på anæmi og undgå blodtransfusion.
English: • Blood clot in an artificial kidney.
Danish: • Blodprop i en kunstig nyre.
English: The syringe can be removed from the refrigerator and left at room temperature for a single period of maximum 3 days (but not above 25°C).
Danish: Sprøjterne kan tages ud af køleskabet og opbevares udenfor køleskab i op til maksimalt 3 dage (men ikke over 25°C).
English: Measurement of erythropoietin following multiple dose intravenous administration revealed a half-life of approximately 4 hours in healthy volunteers and a somewhat more prolonged half-life of approximately 5 hours in renal failure patients.
Danish: Måling af erythropoietin efter intravenøs indgivelse af multiple doser viste en halveringstid på 4 timer hos normale frivillige forsøgspersoner og en noget forlænget halveringstid hos nyresvigtpatienter, ca. 5 timer.
English: The four carbohydrate chains are attached via three N-glycosidic bonds and one O-glycosidic bond to the protein.
Danish: De fire kulhydratkæder er bundet til proteinet via tre N-glykosidbindinger og en O-glykosidbinding.
English: Silapo is given by injection under the skin.
Danish: Silapo gives som en indsprøjtning under huden.
English: Factors that should be considered in this assessment should include the type of tumour and its stage; the degree of anaemia; lifeexpectancy; the environment in which the patient is being treated; and patient preference (see section
Danish: Denne vurdering bør omfatte faktorer som tumortype og stadie, grad af anæmi, forventet levetid, det behandlende miljø og patientpreference (se pkt.
English: Overall survival outcome in the trials could not be satisfactorily explained by differences in the incidence of thrombosis and related complications between those given recombinant human erythropoietin and those in the control group.
Danish: Den samlede overlevelsesrate i undersøgelserne kunne ikke forklares tilfredsstillende med forskellen i incidens af trombose og relaterede komplikationer imellem dem, som fik rekombinant humant erythropoietin og dem i kontrolgruppen.
English: Chronic renal failure patients treated with Silapo by the subcutaneous route should be monitored regularly for loss of efficacy, defined as absent or decreased response to Silapo treatment in patients who previously responded to such therapy.
Danish: Patienter med kronisk nyresvigt, som behandles med Silapo subkutant, bør kontrolleres regelmæssigt for tab af effekt, som er defineret ved manglende eller nedsat respons på behandlingen med Silapo hos patienter, som tidligere har responderet på denne behandling.
English: An increased relative risk of thromboembolic events (RR 1.67, 95% CI: 1.35, 2.06, 35 trials and 6 769 patients) was observed in patients treated with recombinant human erythropoietin.
Danish: En øget relativ risiko for thromboemboliske hændelser (RR 1,67, 95% konfidensinterval: 1,35, 2,06, 35 undersøgelser og 6 769 patienter) sås hos patienter behandlet med rekombinant humant erythropoietin.
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 Silapo.
Danish: Fortæl det straks til lægen eller sygeplejersken, hvis De bliver opmærksom på nogen af disse bivirkninger, eller hvis De bemærker andre bivirkninger, mens De får behandling med Silapo.
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, dobbeltblinde studier kontrolleret med placebo eller standardbehandling, blev den samlede sikkerhedsprofil for epoetin alfa evalueret hos 2 094 anæmiske forsøgspersoner.
English: Calcium chloride dihydrate Polysorbate 20
Danish: Calciumchloriddihydrat Polysorbat 20
English: The incidence of bone marrow fibrosis was not increased in a study of haemodialysis patients who were treated with erythropoietin for 3 years compared to a matched control group of dialysis patients who had not been treated with erythropoietin).
Danish: Forekomsten af knoglemarvsfibrose blev ikke forøget i en undersøgelse af hæmodialysepatienter, som blev behandlet med erythropoietin i 3 år, sammelignet med en tilsvarende kontrolgruppe af dialysepatienter, som ikke var blevet behandlet med erythropoietin).
English: Subjects were stratified by serum erythropoetin (sEPO) level and prior transfusion status at screening.
Danish: Patienterne stratificeredes efter serumniveau af erythropoetin (sEPO) og tidligere transfusionsstatus ved screening.
English: Based on information available to date, correction of anaemia with erythropoietin 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 erythropoietin hos voksne patienter med renal insufficiens, som endnu ikke er i dialyse, ikke en stigning af progressionsraten for den renale insufficiens.
English: You may have chest pain, breathlessness, and painful swelling and redness, usually in the leg as symptoms.
Danish: De kan få brystsmerter, åndenød, smertefuld hævelse og rødme, sædvanligvis i benene som symptom.