FrancophonIA/ELRC3.0 huggingface dataset:
English: In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
Danish: I de fire placebokontrollerede studier lå risikoforholdet for total overlevelse mellem 1,25 og 2,47 til fordel for kontrolpersonerne.
English: You will usually receive Biopoin until 1 month after the end of chemotherapy.
Danish: Sædvanligvis får du Biopoin indtil 1 måned efter afslutning på kemoterapien.
English: Equipment that you need
Danish: Du har brug for følgende udstyr
English: Deficiencies of iron, folic acid or vitamin B12 reduce the effectiveness of epoetins and should therefore be corrected.
Danish: Mangel på jern, folinsyre eller B12-vitamin nedsætter epoetins effektivitet og bør derfor afhjælpes.
English: It acts as a mitosis-stimulating factor and differentiation hormone.
Danish: Hormonet virker som mitosestimulerende faktor og fremmer differentiering.
English: The safety of epoetin theta has been evaluated based on results from clinical studies including 972 patients.
Danish: Sikkerheden ved anvendelse af epoetin theta er evalueret på grundlag af resultater fra kliniske studier med 972 patienter.
English: Correction phase
Danish: Korrektionsfase
English: The haemoglobin levels remained within the desired target range and epoetin theta was well tolerated over a period of up to 15 months.
Danish: Hæmoglobinniveauerne holdt sig inden for målområdet, og epoetin theta var veltolereret over en periode på op til 15 måneder.
English: Push the plunger up to the number (IU) on the syringe that matches the dose of Biopoin that your doctor prescribed.
Danish: Tryk stemplet op til det antal (IE) på skalaen, der svarer til den dosis Biopoin, som din læge har ordineret.
English: It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse.
Danish: Det er vigtigt, at du ikke forsøger at give dig selv injektionen, før du har fået speciel vejledning af en læge eller sygeplejerske.
English: The target haemoglobin concentration in two studies was > 13 g/dl; in the remaining three studies it was 12-14 g/dl.
Danish: Målkoncentrationen af hæmoglobin var > 13 g/dl i to af studierne, mens den i de resterende tre studier var 12-14 g/dl.
English: Healthy people should not use Biopoin.
Danish: Raske mennesker må ikke bruge Biopoin.
English: Factors that should be considered in this assessment should include the type of tumour and its stage, the degree of anaemia, life-expectancy, the environment in which the patient is being treated, and patient preference (see section 5.1).
Danish: De faktorer, der bør medtages i vurderingen, omfatter tumortype og -stadium, graden af anæmi, forventet levetid, miljøet hvor patienten behandles og patientens præference (se pkt.
English: If you are a cancer patient you should be aware that this medicine may act as a blood cell growth factor and in some circumstances may have a negative impact on your cancer.
Danish: Hvis du har kræft, skal du være opmærksom på, at dette lægemiddel kan virke som en vækstfaktor på blodlegemer, og under visse omstændigheder kan det have en uønsket virkning på din kræftsygdom.
English: At the time of prescription, patients should be advised of the signs and symptoms and monitored closely for skin reactions.
Danish: Ved ordineringen bør patienterne gøres opmærksomme på tegn og symptomer og monitoreres nøje for hudreaktioner.
English: Check the appearance of Biopoin.
Danish: Kontroller Biopoins udseende.
English: This leaflet was last approved in .
Danish: Denne indlægsseddel blev senest godkendt.
English: Epoetin theta (recombinant human erythropoietin) is produced in Chinese Hamster Ovary Cells (CHO-K1) by recombinant DNA technology.
Danish: Epoetin theta (rekombinant humant erytropoietin) fremstilles i ovarieceller fra kinesiske hamstere (CHO-K1) ved hjælp af rekombinant dna-teknologi.
English: It is recommended that haemoglobin be monitored every two weeks until levels have stabilised and periodically thereafter.
Danish: Hæmoglobinniveauet bør monitoreres hver anden uge, indtil dette parameter er stabiliseret, og løbende derefter.
English: Therapy should be continued up to 4 weeks after the end of chemotherapy.
Danish: Behandlingen bør fortsættes indtil 4 uger efter afslutning på kemoterapien.
English: A reticulocyte count should be considered as part of the evaluation.
Danish: Det bør overvejes at lade bestemmelse af reticulocytter indgå i evalueringen.
English: Your doctor will use the lowest effective dose to control the symptoms of your anaemia.
Danish: Din læge vil anvende den laveste effektive dosis til at kontrollere symptomerne på din anæmi.
English: The pharmacokinetics of epoetin theta are independent of age or gender.
Danish: Epoetin thetas farmakokinetik er uafhængig af alder og køn.
English: As with all growth factors, there is a concern that epoetins could stimulate the growth of any type of malignancy (see section
Danish: Som ved alle vækstfaktorer er der bekymring for, om epoetiner kan stimulere væksten af maligne sygdomme uanset type (se pkt.
English: Fertility No data are available.
Danish: Fertilitet Der foreligger ingen data.
English: The therapeutic margin of epoetin theta is very wide.
Danish: Den terapeutiske margin for epoetin theta er meget bred.
English: Do not increase the dose your doctor has given you.
Danish: Du må ikke øge den dosis, som lægen har foreskrevet.
English: This may be associated with life-threatening cardiovascular complications.
Danish: Stigningen kan være forbundet med livstruende kardiovaskulære komplikationer.
English: If these reactions occur, they require the immediate attention of a physician and intensive medical care.
Danish: Sådanne reaktioner kræver omgående lægehjælp og intensiv medicinsk behandling.
English: Particular attention should be paid to sudden sharp migraine-like headaches as a possible warning signal.
Danish: Det er særlig vigtigt at være opmærksom på pludselige, jagende migrænelignende hovedpiner, som kan være et advarselssignal.
English: The safety device prevents needle stick injuries after use, so no special precautions for disposal are required.
Danish: Sikkerhedsanordningen forhindrer skader fra kanylestik efter brug, så ingen særlige forsigtighedsregler for bortskaffelse er påkrævet.
English: The maximum concentration is reached after an average of 10 to 14 hours and the average terminal half-life ranges from approximately 22 to 41 hours.
Danish: Maksimal plasmakoncentration opnåedes efter gennemsnitligt 10-14 timer, og terminal halveringstid var i gennemsnit ca. 22-41 timer.
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 blev undersøgt i fem store, kontrollerede studier, der omfattede i alt 2.833 patienter, hvoraf de fire var dobbeltblinde placebokontrollerede studier og den femte var et åbent studie.
English: If signs and symptoms suggestive of these reactions appear, epoetin theta should be withdrawn immediately and an alternative treatment considered.
Danish: Hvis der opstår tegn og symptomer, som tyder på sådanne reaktioner, skal epoetin theta straks seponeres, og en alternativ behandling skal overvejes.
English: It is unknown whether epoetin theta/metabolites are excreted in human milk, but data in neonates show no absorption or pharmacological activity of erythropoietin when given together with breast milk.
Danish: Det er ukendt, om epoetin theta/metabolitter udskilles i human mælk, men data fra nyfødte indikerer hverken absorption eller farmakologisk aktivitet af erytropoietin, når det indgives med modermælken.
English: - Allergic reactions:
Danish: - Allergiske reaktioner
English: Treatment with Biopoin is normally a long-term therapy.
Danish: Normalt gives Biopoin som langtidsbehandling.
English: This is known as a subcutaneous injection.
Danish: Dette kaldes en subkutan injektion.
English: Pharmacotherapeutic group: Other antianemic preparations, ATC code: B03XA01
Danish: Farmakoterapeutisk klassifikation: Andre midler mod anæmi, ATC-kode: B03XA01
English: The biological efficacy of epoetin theta has been demonstrated after intravenous and subcutaneous administration in various animal models in vivo (mice, rats, dogs).
Danish: Det er påvist, at epoetin theta har en biologisk effekt efter intravenøs og subkutan administration i forskellige in vivo-dyremodeller (mus, rotter, hunde).
English: The injection sites should be rotated and the injection performed slowly to avoid discomfort at the site of injection.
Danish: Der skal skiftes mellem injektionsstederne, og injektionen skal gives langsomt for at undgå ubehag ved injektionsstedet.
English: The needle will be shielded and locked automatically so that you can not prick yourself (see picture 12).
Danish: Kanylen beskyttes og låses automatisk, så du ikke kan stikke dig selv (se figur 12).
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 foretaget en dataanalyse på patientniveau af mere end 13.900 cancerpatienter (kemo-, stråle-, kemo/stråle- eller ingen terapi), som deltog i 53 kontrollerede kliniske studier, omfattende flere epoetiner.
English: Further increases of 25% of the previous dose may be made at monthly intervals until the individual target haemoglobin level is obtained.
Danish: Yderligere dosisøgning med 25 % af den foregående dosis kan foretages med en måneds interval, indtil det individuelle mål for hæmoglobinniveau nås.
English: Please speak with your doctor if you belong to one of these patient groups: - patients with liver problems, - patients with pathological changes in their red blood cells (homozygous sickle cell anaemia).
Danish: Tal med lægen, hvis du hører til en af disse patientgrupper: - patienter med leverproblemer - patienter med forandringer i de røde blodlegemer, der skyldes en sygdom (homozygot seglcelleanæmi).
English: In view of the above, in some clinical situations blood transfusion should be the preferred treatment for the management of anaemia in patients with cancer.
Danish: På dette grundlag bør blodtransfusion i visse kliniske situationer være den foretrukne behandling af anæmi hos patienter med cancer.
English: The decision to administer recombinant erythropoietins should be based on a benefit-risk assessment with the participation of the individual patient, which should take into account the specific clinical context.
Danish: Beslutningen om at give rekombinante erytropoietiner skal baseres på en benefit/risk-vurdering i samråd med den enkelte patient, hvor der tages højde for den specifikke kliniske kontekst.
English: If a dose adjustment is required to maintain the desired haemoglobin level, it is recommended that the dose be adjusted by approximately 25%.
Danish: Hvis der er behov for dosisjustering for at opretholde det ønskede hæmoglobinniveau, anbefales det at justere dosis med ca. 25 %.
English: Once you have removed your medicine from the refrigerator you must use it within this period or it must be discarded.
Danish: Når du har taget medicinen ud af køleskabet, skal du anvende den inden for denne periode - ellers skal den bortskaffes.
English: Epoetins are not approved in the management of anaemia associated with hepatitis C.
Danish: Epoetiner er ikke godkendt i behandlingen af anæmi i forbindelse med hepatitis C.
English: Biopoin is used for the treatment of anaemia accompanied by symptoms (for example fatigue, weakness and shortness of breath).
Danish: Biopoin bruges til behandling af anæmi (blodmangel) ledsaget af symptomer (for eksempel træthed, svækkelse og åndenød).
English: Depending on your individual situation a blood transfusion may be preferable.
Danish: Afhængigt af dit sygdomstilfælde kan en blodtransfusion være en bedre løsning for dig.
English: Patients were randomised to continue their current treatment or to be converted to epoetin theta (same dose as epoetin beta) in order to maintain their haemoglobin levels.
Danish: Patienterne blev randomiseret til at fortsætte den igangværende behandling eller skifte til epoetin theta (samme dosis som epoetin beta) for at fastholde deres hæmoglobinniveau.
English: If you are receiving Biopoin as an injection under the skin, your doctor may suggest that you learn how to inject yourself this medicine.
Danish: Hvis du får Biopoin som en injektion i underhuden, kan lægen foreslå, at du lærer at give dig selv indsprøjtninger.
English: Subcutaneous injections should be given into the abdomen, arm or thigh.
Danish: Subkutane injektioner bør gives i abdomen, armen eller låret.
English: Shunt thrombosis*
Danish: Shunttrombose*
English: If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of epoetin theta, treatment with epoetin theta must not be restarted in this patient at any time.
Danish: Hvis patienten har udviklet en svær kutan bivirkning såsom SJS eller TEN på grund af brugen af epoetin theta , må behandling med epoitin theta ikke genoptages hos denne patient på noget tidspunkt.
English: The solution is clear and colourless.
Danish: Opløsningen er klar og farveløs.
English: Following intravenous administration, the volume of distribution approximates to total blood volume.
Danish: Efter intravenøs administration svarer epoetin thetas fordelingsvolumen omtrent til total blodvolumen.
English: Once removed from the refrigerator, the medicinal product must be used within this period or disposed of.
Danish: Når først lægemidlet er taget ud af køleskabet, skal det anvendes i løbet af denne periode eller bortskaffes.
English: In clinical trials, patients over 75 years of age had a higher incidence of serious and severe adverse events irrespective of a causal relationship to treatment with epoetin theta.
Danish: I kliniske studier havde patienter over 75 år en højere incidens af alvorlige og svære bivirkninger uanset en eventuel årsagssammenhæng med behandling med epoetin theta.
English: Your blood pressure needs to be checked closely before and during treatment with this medicine.
Danish: Du skal have målt dit blodtryk omhyggeligt før og under behandling med dette lægemiddel.
English: Do not attempt to give this medicine to yourself without this training.
Danish: Lad være med at forsøge at give denne medicin til dig selv, før du har fået vejledning.
English: These may be signs of severely elevated blood pressure, even if your blood pressure is usually normal or low.
Danish: Det kan være tegn på stærkt forhøjet blodtryk - også selv om du plejer at have normalt eller lavt blodtryk.
English: Red blood cells are very important for distributing oxygen within your body.
Danish: De røde blodlegemer spiller en vigtig rolle, fordi de bærer ilt rundt i kroppen.
English: If you are on dialysis, medicines that prevent blood coagulation are used.
Danish: Hvis du er i dialyse, anvendes medicin, der hindrer blodet i at størkne.
English: The initial dose is 20,000 IU.
Danish: Startdosis er 20.000 IE.
English: Epoetin theta has no or negligible influence on the ability to drive and use machines.
Danish: Epoetin theta påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: It may also be necessary to reduce your dose of Biopoin or to stop the treatment with Biopoin for a short period of time.
Danish: Det kan også være nødvendigt, at du får en lavere dosis Biopoin eller holder en mindre pause i behandlingen med Biopoin.
English: Effect on tumour growth
Danish: Virkning på tumorvækst
English: Do not use it if the date has passed the last day of the month shown.
Danish: Brug ikke sprøjten, hvis den sidste dag i den nævnte måned er overskredet.
English: Box for the prescribed dose Subcutaneous or intravenous use
Danish: Æske med den ordinerede dosis Subkutan eller intravenøs anvendelse
English: In reproductive toxicity studies performed with other epoetins, effects interpreted as being secondary to decreased maternal body weight were observed at doses sufficiently in excess to the recommended human dose.
Danish: I studier af reproduktionstoksicitet med andre epoetiner er der set virkninger, der fortolkedes som sekundære til nedsat legemsvægt hos moderdyret ved doser, der oversteg den rekommanderede humane dosis i et tilstrækkeligt omfang.
English: Position the safety shield approximately 45° against a flat surface (see picture 13).
Danish: Placer sikkerhedskappen i en vinkel på ca. 45° mod en plan overflade (se figur 13).
English: Hypertension occurs in chronic renal failure patients more often during the correction phase than during the maintenance phase.
Danish: Hos patienter med kronisk nyresvigt forekommer hypertension hyppigere under korrektionsfasen end under vedligeholdelsesfasen.
English: Epoetin theta treatment should be initiated by physicians experienced in the above-mentioned indications.
Danish: Behandling med epoetin theta bør indledes af læger med erfaring inden for ovennævnte indikationer.
English: Hypertensive crisis*
Danish: Hypertensiv krise*
English: What you should do before your injection
Danish: Det skal du gøre før indsprøjtning
English: Increases in blood pressure may require treatment with antihypertensive medicinal products or a dose increase of existing antihypertensive medicinal products.
Danish: Blodtryksstigninger kan kræve behandling med antihypertensive lægemidler eller øgning af dosis i eksisterende antihypertensiv behandling.
English: Influenza-like illness*
Danish: Influenzalignende sygdom*
English: This medicine does not affect your ability to drive and use machines.
Danish: Lægemidlet påvirker ikke evnen til at føre motorkøretøj og betjene maskiner.
English: Animal studies with other epoetins do not indicate direct harmful effects with respect to reproductive toxicity (see section 5.3).
Danish: Dyreforsøg med andre epoetiner indikerer ikke direkte skadelige virkninger hvad angår reproduktionstoksicitet (se pkt.
English: If you do not respond adequately to Biopoin, your doctor will check your dose and will inform you if you need to change doses of Biopoin.
Danish: Hvis du ikke reagerer tilstrækkeligt på Biopoin, vil lægen kontrollere din dosis og fortælle dig, hvis din Biopoin-dosis skal ændres.
English: Press down the needle with a firm, quick motion until a distinct audible click is heard (see picture 14).
Danish: Stik kanylen ind med en hurtig, fast bevægelse, indtil der høres en tydeligt klik (se figur 14).
English: For instructions on how to inject the medicinal product, see package leaflet.
Danish: For instruktioner om, hvordan lægemidlet injiceres, se indlægssedlen.
English: Biopoin contains sodium
Danish: Biopoin indeholder natrium
English: Human erythropoietin is an endogenous glycoprotein hormone that is the primary regulator of erythropoiesis through specific interaction with the erythropoietin receptor on the erythroid progenitor cells in the bone marrow.
Danish: Humant erytropoietin er et endogent glykoprotein-hormon og den primære regulator af erytropoiese gennem specifik interaktion med erytropoietin-receptoren på erytroide progenitorceller i knoglemarven.
English: It is important to tell your doctor if you are pregnant, think you may be pregnant or plan to get pregnant, as the doctor may decide that you should not use this medicine.
Danish: Det er vigtigt, at du fortæller det til lægen, hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må Biopoin ikke blandes med andre lægemidler.
English: If you are a patient with chronic renal failure, your doctor will check that a particular blood parameter (haemoglobin) does not exceed a defined threshold.
Danish: Hvis du har kronisk nyresvigt, vil lægen kontrollere, at en bestemt blodværdi (hæmoglobin) ikke overstiger et vist niveau.
English: Check again to make sure the correct dose of Biopoin is in the syringe.
Danish: Kontroller det igen for at sikre dig, at sprøjten rummer den rigtige dosis Biopoin.
English: If severe polycythaemia occurs, conventional methods (phlebotomy) may be indicated to reduce the haemoglobin level.
Danish: I tilfælde af svær polycytæmi kan der være indikation for konventionel behandling (flebotomi) for at reducere hæmoglobinniveauet.
English: Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 µg/l or with transferrin saturation below 20%.
Danish: Det anbefales at give jerntilskud til alle patienter med ferritinniveau i serum <100 µg/l eller med transferrinmætning <20%.
English: In two long-term studies, the efficacy of epoetin theta was evaluated in 124 haemodialysis patients and 289 patients not yet undergoing dialysis.
Danish: I to langtidsstudier blev effekten af epoetin theta evalueret hos 124 hæmodialysepatienter og 289 patienter, der endnu ikke var i dialyse.
English: The median time to response was similar in the treatment groups with 56 days in haemodialysis patients and 49 days in patients not yet undergoing dialysis.
Danish: Der sås omtrent samme mediantid til respons i behandlingsgrupperne - 56 dage hos hæmodialysepatienter og 49 dage hos patienter, der endnu ikke var i dialyse.
English: The first study was conducted in 186 anaemic patients with non-myeloid malignancies (55% with haematological malignancies and 45% with solid tumours) receiving non-platinum chemotherapy.
Danish: Det første studie omfattede 186 anæmiske patienter med non-myeloid malign sygdom (55 % med hæmatologisk malign sygdom og 45 % med solide tumorer), der fik ikkeplatinbaseret kemoterapi.
English: The injection is given either into a vein (intravenous injection) or into the tissue just under the skin (subcutaneous injection).
Danish: Indsprøjtningen gives enten i en vene (intravenøs injektion) eller i vævet lige under huden (subkutan injektion).
English: In pre-dialysis patients with chronic renal failure following subcutaneous injection of 40 IU/kg body weight, the protracted absorption results in a concentration plateau, whereby the maximum concentration is reached after an average of approximately 14 hours.
Danish: Hos prædialysepatienter med kronisk nyresvigt efter subkutan injektion af 40 IE/kg legemsvægt medførte den langvarige absorption stabiliseret koncentration, hvor maksimal koncentration nås efter ca. 14 timer i gennemsnit.
English: Stop using Biopoin if you develop these symptoms and contact your doctor or seek medical attention immediately.
Danish: Stop med at bruge Biopoin, hvis du udvikler disse symptomer, og kontakt straks din læge eller søg lægehjælp.
English: The dose of Biopoin (expressed in International Units or IU) depends on your disease condition, your body weight and the way the injection is given (under the skin [subcutaneous injection] or into a vein [intravenous injection]).
Danish: Din dosis Biopoin (angivet i internationale enheder, IE) afhænger af din sygdomstilstand, hvor meget du vejer, og hvordan indsprøjtningen gives (under huden [subkutan injektion] eller i en vene [intravenøs injektion]).
English: Take one blister with a pre-filled syringe out of the refrigerator.
Danish: Tag en blister med en fyldt injektionssprøjte ud af køleskabet.
English: The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve haemoglobin concentrations less than 13 g/dl, is unclear because few patients with these characteristics were included in the data reviewed.
Danish: Det er ikke afklaret, i hvilket omfang disse resultater kan overføres på administration af rekombinant humant erytropoietin til patienter med kræft, der behandles med kemoterapi for at få reduceret koncentrationen af hæmoglobin til under 13 g/dl, eftersom de gennemgåede data kun omfattede få patienter med denne karakteristik.