FrancophonIA/ELRC3.0 huggingface dataset:
English: In these two studies, 180 haemodialysis patients and 193 patients not undergoing dialysis were switched from maintenance phase treatment with epoetin beta to treatment with epoetin theta for a period of six months showing stable haemoglobin values and a similar safety profile as epoetin beta.
Danish: I de to studier blev 180 hæmodialysepatienter og 193 patienter, der endnu ikke var i dialyse, skiftet fra vedligeholdelsesbehandling med epoetin beta til behandling med epoetin theta i en seksmåneders periode, hvor de udviste stabile hæmoglobinværdier og en sikkerhedsprofil som for epoetin beta.
English: After administration of epoetin theta, the number of erythrocytes, the haematocrit values and reticulocyte counts increase.
Danish: Efter administration af epoetin theta øges antallet af erytrocytter og reticulocytter samt hæmatokritværdien.
English: - The active substance is epoetin theta.
Danish: - Aktivt stof: epoetin theta.
English: A systematic review has also been performed involving more than 9,000 cancer patients participating in 57 clinical trials.
Danish: Desuden blev der gennemført en systematisk gennemgang af 57 kliniske studier, der omfattede over 9.000 cancerpatienter.
English: - if you are allergic to epoetin theta, another epoetin or any of the other ingredients of this medicine (listed in section 6);
Danish: - hvis du er allergisk over for epoetin theta, andre epoetiner eller et af de øvrige indholdsstoffer i Biopoin (angivet i punkt 6).
English: During the evaluation period (weeks 15 to 26), the mean and median level of haemoglobin in patients treated with epoetin theta was virtually identical to their baseline haemoglobin level.
Danish: Under evalueringsperioden (uge 15-26) var det gennemsnitlige og mediane hæmoglobinniveau hos patienter, der fik epoetin theta, næsten det samme som ved baseline.
English: Subcutaneous use is preferable in patients who are not undergoing haemodialysis, in order to avoid puncturing peripheral veins.
Danish: Subkutan anvendelse bør foretrækkes til patienter, som ikke er i hæmodialyse, for at undgå at punktere perifere vener.
English: The dose may be increased after 4 weeks to 80 IU/kg, 3 times per week, and by further increases of 25% of the previous dose at monthly intervals, if needed.
Danish: Denne dosis kan øges efter 4 uger til 80 IE/kg 3 gange ugentligt og yderligere med 25 % af den foregående dosis med en måneds interval efter behov.
English: Even at very high blood levels, no symptoms of poisoning have been observed.
Danish: Der er ikke set symptomer på forgiftning selv ved meget høje niveauer i blodet.
English: If epoetin theta is substituted for another epoetin, the same route of administration should be used.
Danish: Hvis epoetin theta anvendes som erstatning for et andet epoetin, bør der anvendes samme administrationsvej.
English: Two of the studies recruited patients who were being treated with chemotherapy.
Danish: Til to af studierne rekrutteredes patienter i behandling med kemoterapi.
English: Pooled post-hoc analyses of clinical studies of epoetins have been performed in chronic renal failure patients (on dialysis, not on dialysis, in diabetic and non-diabetic patients).
Danish: Puljede post-hoc-analyser af kliniske studier med epoetiner er blevet udført hos patienter med kronisk nyresvigt (i dialyse, ikke i dialyse, hos patienter med og uden diabetes).
English: If your iron level is too low, your doctor may also prescribe you an iron preparation.
Danish: Hvis du har jernmangel, kan lægen også ordinere et jernpræparat.
English: You may experience the following additional side effects:
Danish: Desuden kan følgende bivirkninger forekomme:
English: This is because one cannot rule out a possible acceleration of progression of kidney disease with absolute certainty.
Danish: Det skyldes, at det ikke helt kan udelukkes, at nyresygdommen accelererer.
English: If the haemoglobin level continues to increase, therapy should be interrupted until the haemoglobin level begins to decrease, at which point therapy should be restarted at a dose approximately 25% below the previously administered dose.
Danish: Hvis hæmoglobinniveauet fortsat stiger, bør behandlingen afbrydes, indtil niveauet begynder at falde, og på dette tidspunkt bør behandlingen genoptages med en dosis, der ligger ca. 25 % under den sidst administrerede dosis.
English: If you have hardening of the blood vessels in your kidneys (nephrosclerosis) but do not need to undergo dialysis, your doctor will consider whether treatment is suitable for you.
Danish: Hvis blodårerne i dine nyrer er blevet hårde (nefrosklerose eller skrumpenyre), men du ikke har behov for dialyse, vil lægen undersøge, om du skal behandles for dette.
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 flere kontrollerede studier medførte brug af epoetiner ikke forbedring af total overlevelse eller nedsættelse af risikoen for tumorprogression hos patienter med cancerrelateret anæmi.
English: In addition, a reduction of the administered dose of epoetin theta needs to be considered.
Danish: Desuden skal det overvejes, om det er nødvendigt at reducere doseringen af epoetin theta.
English: If, after an additional 4 weeks of therapy, the haemoglobin increase is still insufficient an increase of the weekly dose to 60,000 IU should be considered.
Danish: Hvis stigningen i hæmoglobin stadig er utilstrækkelig efter yderligere 4 ugers behandling, bør det overvejes at øge den ugentlige dosis til 60.000 IE.
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: Der observeredes en øget relativ risiko for tromboemboliske hændelser (RR 1,67, 95 % KI: 1,35 - 2,06; 35 studier og 6.769 patienter) hos patienter, der fik rekombinant humant erytropoietin.
English: The second study was conducted in 223 patients with various solid tumours receiving platinum-containing chemotherapy.
Danish: Det andet studie omfattede 223 patienter med forskellige solide tumorer, der fik platinbaseret kemoterapi.
English: Biopoin contains the active substance epoetin theta, which is almost identical to erythropoietin, a natural hormone produced by your body.
Danish: Biopoin indeholder det aktive stof epoetin theta, som er næsten identisk med det naturlige hormon erytropoietin, der dannes i kroppen.
English: Pull straight as shown in picture 5.
Danish: Træk det direkte af som vist i figur 5.
English: Hydrochloric acid (6 M) (for pH adjustment) Water for injections
Danish: Saltsyre (6 M) (til justering af pH) Vand til injektionsvæsker
English: This section contains information on how to give yourself an injection of Biopoin under the skin.
Danish: I dette punkt kan du finde oplysninger om, hvordan du kan give dig selv en injektion Biopoin i underhuden.
English: The most frequent adverse reactions are hypertension, influenza-like illness and headache.
Danish: De hyppigste bivirkninger er hypertension, influenzalignende sygdom og hovedpine.
English: The production of erythropoietin primarily occurs in and is regulated by the kidney in response to changes in tissue oxygenation.
Danish: Erytropoietin dannes primært i og reguleres af nyrerne som respons på forandringer i vævsiltning.
English: In the presence of hypertension or existing cardiovascular, cerebrovascular or peripheral vascular diseases, the increase in haemoglobin and the target haemoglobin value should be determined individually taking into account the clinical picture.
Danish: I tilfælde af hypertension eller eksisterende kardiovaskulære lidelser, cerebrovaskulære lidelser eller perifer arterielidelse bør stigningen i hæmoglobin og målværdien for hæmoglobin bestemmes individuelt under hensyntagen til det kliniske billede.
English: Sodium dihydrogen phosphate dihydrate Sodium chloride
Danish: Natriumdihydrogenphosphatdihydrat Natriumchlorid
English: Epoetins are growth factors that primarily stimulate red blood cell production.
Danish: Epoetiner er vækstfaktorer, der primært stimulerer dannelsen af røde blodlegemer.
English: There are flaps at the end of the needle bag.
Danish: Der er flige for enden af kanyleposen.
English: Pull straight as shown in picture 4.
Danish: Træk det direkte af som vist i figur 4.
English: Due to limited experience, the efficacy and safety of epoetin theta could not be assessed in patients with impaired liver function or homozygous sickle cell anaemia.
Danish: På grund af begrænset erfaring har det ikke været muligt at bedømme epoetin thetas virkning og sikkerhed hos patienter med nedsat leverfunktion eller homozygot seglcelleanæmi.
English: Only use each syringe for one injection.
Danish: Hver injektionssprøjte må kun bruges til én injektion.
English: Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, aluminium intoxication, underlying haematological diseases or bone marrow fibrosis may also compromise the erythropoietic response.
Danish: Interkurrente infektioner, inflammatoriske eller traumatiske hændelser, okkult blodtab, hæmolyse, aluminiumsforgiftning, underliggende hæmatologiske sygdomme eller knoglemarvsfibrose kan også nedsætte det erytropoietiske respons.
English: Do not use any Biopoin that is left in the syringe.
Danish: Brug ikke en eventuel rest af Biopoin i sprøjten.
English: If your blood pressure rises, your doctor may give you medicines to reduce your blood pressure.
Danish: Hvis dit blodtryk stiger, kan lægen give dig medicin til at sænke det.
English: Caution should be exercised with escalation of epoetin theta doses in patients with chronic renal failure since high cumulative epoetin doses may be associated with an increased risk of mortality, serious cardiovascular and cerebrovascular events.
Danish: Der skal udvises forsigtighed, når dosis af epoetin theta optrappes hos patienter med kronisk nyresvigt, da høje kumulative epoetin-doser kan være forbundet med en øget risiko for mortalitet og alvorlige kardiovaskulære og cerebrovaskulære hændelser.
English: Contents of the pack and other information What Biopoin contains
Danish: Pakningsstørrelser og yderligere oplysninger Biopoin indeholder:
English: Pure red cell aplasia (PRCA)
Danish: Aplasi med umodne røde blodlegemer (PRCA)
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere oplysninger om Biopoin findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: In the clinical studies, patients not yet undergoing dialysis (subcutaneous administration) discontinued the study more frequently than haemodialysis patients (intravenous administration) as they had to terminate the study when starting dialysis.
Danish: I de kliniske studier udgik patienter, der endnu ikke var i dialyse (subkutan anvendelse) hyppigere end hæmodialysepatienter (intravenøs anvendelse), da de var nødt til at afbryde studiet, når de kom i dialyse.
English: Symptomatic anaemia associated with chronic renal failure The use of epoetin theta in nephrosclerotic patients not yet undergoing dialysis should be defined individually, as a possible accelerated progression of renal failure cannot be ruled out with certainty.
Danish: Symptomatisk anæmi i forbindelse med kronisk nyresvigt Anvendelse af epoetin theta til nefrosklerotiske patienter, der endnu ikke er i dialyse, bør vurderes individuelt, da en mulig acceleration af progredierende nyresvigt ikke kan udelukkes med sikkerhed.
English: Two randomised controlled studies were conducted in 270 haemodialysis patients and 288 patients not yet undergoing dialysis, who were on stable treatment with epoetin beta.
Danish: Der blev gennemført to randomiserede, kontrollerede studier med 270 hæmodialysepatienter og 288, der endnu ikke var i dialyse, som alle var i stabil behandling med epoetin beta.
English: Your doctor will carry out blood tests regularly and adjust the dosage or suspend the treatment if necessary.
Danish: Lægen sørger for løbende blodprøvekontrol og vil ændre dosis eller indføre en pause i behandlingen efter behov.
English: If epoetin theta is substituted for another epoetin, haemoglobin level should be monitored closely and the same route of administration should be used.
Danish: Hvis epoetin theta anvendes som erstatning for et andet epoetin, bør hæmoglobinniveauet monitoreres nøje, og den samme administrationsvej bør anvendes.
English: Meta-analyses also indicate consistently a significantly increased relative risk of thromboembolic events in cancer patients receiving recombinant human erythropoietin (see section
Danish: Metaanalyser indikerer også overensstemmende en signifikant forøget relativ risiko for tromboemboliske hændelser hos cancerpatienter, der får rekombinant humant erytropoietin (se pkt.
English: Erythropoietin is produced in your kidneys and stimulates your bone marrow to produce red blood cells.
Danish: Erytropoietin dannes i nyrerne og stimulerer knoglemarven til at danne røde blodlegemer.
English: Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: You may notice small air bubbles in the pre-filled syringe.
Danish: Måske kan der ses små luftbobler inde i den fyldte injektionssprøjte.
English: Can be stored at room temperature (not above 25 °C) for up to 7 days within the shelf life.
Danish: Kan opbevares ved stuetemperatur (ikke over 25 °C) i op til 7 dage inden for opbevaringstiden.
English: If you develop a serious rash or another of these skin symptoms, stop using Biopoin 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 bruge Biopoin og straks kontakte din læge eller søge lægehjælp.
English: The terminal half-life is higher than after intravenous administration, with an average of 25 hours after single dosing and 34 hours in steady state after repeated dosing three times weekly, without leading to an accumulation of epoetin theta.
Danish: Den terminale halveringstid er længere end efter intravenøs administration, i gennemsnit 25 timer efter en enkelt indgift og 34 timer ved steady state efter gentagne doser tre gange ugentligt, uden at dette fører til akkumulering af epoetin theta.
English: In addition, the iron level in your blood will be checked before and during treatment with this medicine.
Danish: Desuden skal du have målt blodets indhold af jern før og under behandling med dette lægemiddel.
English: Treatment with epoetin theta is divided into two stages.
Danish: Behandling med epoetin theta inddeles i to faser.
English: One of the most frequent adverse reactions during treatment with epoetin theta is an increase in blood pressure or aggravation of existing hypertension particularly during the initial treatment phase.
Danish: En af de hyppigste bivirkninger under behandling med epoetin theta er forhøjet blodtryk eller forværring af eksisterende hypertension, navnlig i den indledende fase af behandlingen.
English: If the frequency of administration is changed, haemoglobin level should be monitored closely and dose adjustments may be necessary.
Danish: Ved ændring i administrationshyppighed bør hæmoglobinniveauet monitoreres nøje, og der kan opstå behov for dosisjustering.
English: Cases have been reported in patients with hepatitis C treated with interferon and ribavirin, when epoetins are used concomitantly.
Danish: Der er rapporteret tilfælde, hvor patienter i behandling med interferon og ribavirin for hepatitis C samtidigt er blevet behandlet med epoetiner.
English: In controlled clinical studies, use of epoetins has shown: - shortened time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a haemoglobin level in excess of 14 g/dl (8.69 mmol/l), - shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin value of 12-14 g/dl (7.45-8.69 mmol/l), - increased risk of death when administered to target a haemoglobin value of 12 g/dl (7.45 mmol/l) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
Danish: I kontrollerede kliniske studier medførte brug af epoetiner: - kortere tid til tumorprogression hos patienter med fremskreden hoved-hals-cancer, der fik strålebehandling, når det blev målrettet til at nå en hæmoglobinværdi over 14 g/dl (8,69 mmol/l), - nedsat total overlevelse og stigning i dødsfald, der blev tilskrevet sygdomsprogression efter 4 måneder, hos patienter med metastaserende brystcancer, der fik kemoterapi, når det blev målrettet til at nå et hæmoglobinniveau på 12-14 g/dl (7,45-8,69 mmol/l), - en øget risiko for død, når det blev målrettet til at nå en hæmoglobinværdi på 12 g/dl (7,45 mmol/l) hos patienter med aktiv malign sygdom, der hverken fik kemoterapi eller strålebehandling.
English: If PRCA is diagnosed, therapy with epoetin theta must be discontinued and patients should not be switched to another recombinant epoetin (see section 4.4).
Danish: Hvis der diagnosticeres PRCA, skal behandlingen med epoetin theta seponeres, og patienterne må ikke skiftes til et andet rekombinant epoetin (se pkt.
English: Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when the haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Danish: I kontrollerede kliniske studier sås ikke signifikante fordele ved administration af epoetin i doser, der øger hæmoglobinkoncentrationen til et højere niveau end nødvendigt for at kontrollere symptomerne på anæmi og undgå blodtransfusion.
English: Put the shielded needle without hesitation and in one continuous motion fully into the skin as shown by your doctor or nurse.
Danish: Stik kanylen med beskytteren uden tøven og i en kontinuerlig bevægelse helt ind i huden, sådan som lægen eller sygeplejersken har vist dig.
English: If blood pressure values remain high, temporary interruption of epoetin theta therapy may be required.
Danish: Hvis blodtrykket fortsat er højt, kan det være nødvendigt med en midlertidig pause i behandlingen med epoetin theta.
English: With the syringe pointing upwards, expel all air from the syringe by pushing the plunger slowly upwards.
Danish: Vend sprøjten med spidsen opad og pres al luften ud af sprøjten ved at trykke stemplet langsomt opad.
English: Patients should be monitored closely to ensure that the lowest approved dose of epoetin theta is used to provide adequate control of the symptoms of anaemia.
Danish: Patienterne bør monitoreres nøje for at sikre brug af den laveste godkendte dosis epoetin theta, der kan kontrollere symptomerne på anæmi i tilstrækkelig grad.
English: Common in cancer patients (may affect up to 1 in 10 people) - Joint pain.
Danish: Almindelige hos kræftpatienter (kan forekomme hos op til 1 ud af 10 personer) - Ledsmerter.
English: Otherwise the increased number of red blood cells may cause blocking of the arterio-venous fistula (an artificial connection between an artery and a vein which is surgically prepared in dialysis patients).
Danish: Ellers kan det øgede antal røde blodlegemer tilstoppe den arteriovenøse fistel - en kunstig forbindelse mellem to blodårer, en arterie og en vene, som oprettes hos dialysepatienter ved en operation.
English: Subcutaneous administration
Danish: Subkutan administration
English: The dose may be increased after 4 weeks to 40 IU/kg, 3 times per week, if the increase in haemoglobin is not adequate (< 1 g/dl [0.62 mmol/l] within 4 weeks).
Danish: Denne dosis kan øges efter 4 uger til 40 IE/kg 3 gange ugentligt, hvis hæmoglobinniveauet ikke stiger tilstrækkeligt (<1 g/dl [0,62 mmol/l] i løbet af 4 uger).
English: Common (may affect up to 1 in 10 people) - Headache; - High blood pressure; - Flu-like symptoms, such as fever, chills, feeling of weakness, tiredness; - Skin reactions, such as rash, itching or reactions around the injection site.
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 personer) - Hovedpine - Højt blodtryk - Influenzalignende symptomer såsom feber, kuldegysninger, svækkelse, træthed - Hudreaktioner så som udslæt, kløe eller reaktioner ved injektionsstedet.
English: Common in patients with chronic renal failure (may affect up to 1 in 10 people) - Blood clot in the arterio-venous fistula in patients on dialysis.
Danish: Almindelige hos patienter med kronisk nyresvigt (kan forekomme hos op til 1 ud af 10 personer) - Blodprop i den arteriovenøse fistel hos patienter i dialyse.
English: Once an adequate number of red blood cells has been reached, the maintenance dose required to keep the number constant will be determined by your doctor.
Danish: b) Opretholdelse af et tilstrækkeligt antal røde blodlegemer Når du først har opnået et tilstrækkeligt antal røde blodlegemer, fastsætter lægen en vedligeholdelsesdosis, der skal holde dette antal på et konstant niveau.
English: No accumulation of epoetin theta was observed.
Danish: Der sås ikke akkumulering af epoetin theta.
English: Intravenous administration: Patients who are stable on a three times weekly dosing regimen may be switched to twice-weekly administration.
Danish: Intravenøs anvendelse: Patienter, som er stabile på et behandlingsregime med tre ugentlige injektioner, kan skifte til to ugentlige injektioner.
English: Production of endogenous erythropoietin is impaired in patients with chronic renal failure and the primary cause of their anaemia is erythropoietin deficiency.
Danish: Dannelse af endogent erytropoietin er nedsat hos patienter med kronisk nyresvigt, og den primære årsag til anæmi hos disse er erytropoietin-mangel.
English: As a precautionary measure, it is preferable to avoid the use of Biopoin during pregnancy.
Danish: For en sikkerheds skyld bør Biopoin undgås under graviditeten.
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: Total overlevelse kunne ikke forklares tilfredsstillende med henvisning til forskellig tromboseincidens og beslægtede komplikationer hos personer, der fik rekombinant humant erytropoietin, og personer i kontrolgruppen.
English: In these patients, erythropoietin deficiency and a reduced response of erythroid progenitor cells to endogenous erythropoietin both contribute significantly towards their anaemia.
Danish: Hos disse patienter medvirker både erytropoietinmangel og progenitorcellernes nedsatte respons på endogent erytropoietin signifikant til, at de får anæmi.
English: If you stop using Biopoin
Danish: Hvis du holder op med at bruge Biopoin
English: You may remove Biopoin from the refrigerator and store it not above 25 °C for a single period of up to 7 days without exceeding the expiry date.
Danish: Du kan tage Biopoin ud af køleskabet og opbevare den ved højst 25 °C i en enkelt periode på op til 7 dage uden at overskride udløbsdatoen.
English: Check the expiry date on the pre-filled syringe label (EXP).
Danish: Kontroller udløbsdatoen (Exp) på den fyldte injektionssprøjtes etiket.
English: In both studies, treatment with epoetin theta resulted in a significant haemoglobin response (p < 0.001), defined as an increase in haemoglobin of ≥ 2 g/dl without transfusion, and a significant reduction in transfusion requirements (p < 0.05) in comparison to placebo.
Danish: I begge studier medførte behandling med epoetin theta et signifikant hæmoglobinrespons (p <0,001), defineret som en stigning i hæmoglobin på ≥ 2 g/dl uden transfusion,