FrancophonIA/ELRC3.0 huggingface dataset:
English: No paediatric-specific adverse reactions not mentioned previously in the table above, or any that were not consistent with the underlying disease were reported in this population.
Danish: Ingen pædiatrispecifikke bivirkninger, der ikke er nævnt i tabellen ovenfor, eller som ikke var i overensstemmelse med den underliggende sygdom, blev rapporteret hos denne population.
English: As with all growth factors, there is a concern that epoetins could stimulate the growth of tumours.
Danish: Som ved alle vækstfaktorer er der en risiko for, at epoietiner kan stimulere væksten af tumorer.
English: 300 IU/kg
Danish: 300 IE/kg
English: It is unknown whether exogenous epoetin alfa is excreted in human milk.
Danish: Det er ukendt, om eksogent epoetin alfa udskilles i human mælk.
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 tage blodprøver regelmæssigt for at se, hvordan din anæmi responderer, og kan justere dosis, normalt ikke hyppigere end hver fjerde uge.
English: In general, all pharmacodynamic markers increased in a linear manner with dose reaching a maximum response at the highest dose levels.
Danish: Generelt steg alle farmakodynamiske markører lineært med dosis, og et maksimalt respons blev nået ved de højeste dosisniveauer.
English: Eighty-one percent of patients achieved the haemoglobin concentration level.
Danish: 81% af patienter opnåede hæmoglobinkoncentrationen.
English: Do not release the pressure on the plunger!
Danish: Du må ikke slippe trykket på stemplet!
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: I relation til ovenstående bør blodtransfusion i visse kliniske situationer være den foretrukne behandling af anæmi hos patienter med cancer.
English: As with any other injectable product, check that there are no particles in the solution or change in colour.
Danish: Som for andre injicerbare præparater skal det kontrolleres, at opløsningen ikke indeholder partikler eller ændrer farve.
English: • to stimulate the production of your red blood cells (so that doctors can take more blood from you) if you cannot have transfusions with your own blood during or after surgery.
Danish: • for at stimulere dannelsen af røde blodlegemer (så lægerne kan tappe mere blod fra dig), hvis du ikke kan få transfusioner med dit eget blod under og efter operationen.
English: • Symptoms of pure red cell aplasia (PRCA)
Danish: • Symptomer på pure red cell aplasia (PRCA)
English: In case of larger volumes, more than one site should be chosen for the injection.
Danish: Ved større mængder bør der derfor vælges mere end ét injektionssted.
English: • have severe disorders of the veins and arteries
Danish: • har alvorlige sygdomme i venerne og arterierne
English: • Only use Epoetin alfa HEXAL if it has been stored correctly - see section 5, How to store
Danish: • Brug kun Epoetin alfa HEXAL, hvis det er opbevaret korrekt - se punkt 5, Opbevaring.
English: The pharmacokinetic profile of epoetin alfa in children and adolescents appears to be similar to that of adults.
Danish: Den farmakokinetiske profil for epoetin alfa hos børn og unge synes at være sammenlignelig med profilen hos voksne.
English: These changes are interpreted as being secondary to decreased maternal body weight gain, and the significance to humans is unknown given therapeutic dose levels.
Danish: Disse ændringer fortolkes som sekundære til moderens nedsatte vægtøgning, og betydningen for mennesker er ukendt ved terapeutiske dosisniveauer.
English: Usually the injections will be given to you by a doctor, nurse or other health care professional.
Danish: Normalt vil du få injektionerne af en læge, sygeplejerske eller andet sundhedspersonale.
English: PRCA causes sudden and severe anaemia.
Danish: PRCA kan føre til pludselig og svær anæmi.
English: No evidence exists that indicates that treatment with epoetin alfa alters the metabolism of other medicinal products.
Danish: Der foreligger ingen data, som indikerer, at behandling med epoetin alfa ændrer metaboliseringen af andre lægemidler.
English: • Increased blood pressure.
Danish: • Forhøjet blodtryk.
English: • a swollen face, lips, mouth, tongue or throat,
Danish: • hævelse af ansigt, læber, mund, tunge eller hals,
English: • Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter ”EXP”.
English: Tell your doctor or nurse immediately if you notice any of the effects in this list.
Danish: Fortæl det straks til din læge eller sundhedspersonalet, hvis du bemærker nogle af bivirkningerne i denne liste.
English: After 52 weeks, 57% of patients remained in the study, receiving a median dose of 200 IU/kg/week.
Danish: Efter 52 uger var 57% af patienterne stadig i studiet, og de fik en mediandosis på 200 IE/kg/uge.
English: Adverse Reaction (Preferred Term Level)
Danish: Bivirkning (foretrukken terminologi)
English: Influenza-like illness may occur especially at the start of treatment.
Danish: Influenzalignende symptomer kan især optræde i begyndelsen af behandlingen.
English: If you are within a day of your next injection, forget the missed one and carry on with your normal schedule.
Danish: Hvis der er mindre end en dag til din næste indsprøjtning, skal du springe over din glemte indsprøjtning og fortsætte med dit normale program.
English: Target Hb
Danish: Målkoncentration af Hb
English: A defined concentration-time profile with peak and return to baseline was observed for changes in percent reticulocytes.
Danish: En veldefineret koncentration versus tid-profil med maksimum og tilbagevenden til baseline blev observeret for ændringer i procent retikulocytter.
English: • if there has been a refrigerator failure,
Danish: • hvis køleskabet har svigtet,
English: Epoetin alfa HEXAL should not be used and discarded - if the liquid is coloured or you can see particles floating in it, - if the seal is broken, - if you know, or think that it may have been accidentally frozen, or - if there has been a refrigerator failure.
Danish: Epoetin alfa HEXAL må ikke bruges og skal bortskaffes, - hvis væsken er farvet eller du kan se, at der flyder partikler rundt i den, - hvis forseglingen er brudt, - hvis du ved eller tror den utilsigtet har været nedfrosset eller - hvis køleskabet har svigtet.
English: • after the expiry date on the label and outer carton
Danish: • efter den udløbsdato, der står på etiketten og den ydre karton
English: Mean Median Range 95% CI for mean Prior Transfusions N Yes
Danish: Middel Median Interval 95% CI for middel Tidligere transfusioner N Ja
English: The median age of patients enrolled in the study was 11.6 years (range 0.5 to 20.1 years).
Danish: Medianalderen for patienterne i studiet var 11,6 år (interval fra 0,5-20,1 år).
English: There are no or limited amount of data from the use of epoetin alfa in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af epoetin alfa til gravide kvinder.
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: Faktorer, som bør overvejes i denne bedømmelse, skal inkludere tumorens type og stadium, graden af anæmi, forventet levetid, det miljø, patienten behandles i, og patientens præference (se pkt.
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 hazard ratio'erne for samlet overlevelse imellem 1,25 og 2,47 til kontrolgruppens fordel.
English: Some people, depending on why they need Epoetin alfa HEXAL treatment, may later learn how to inject themselves under the skin: see
Danish: Nogle personer, afhængig af hvorfor de behøver behandling med Epoetin alfa HEXAL, kan senere lære at indsprøjte sig selv under huden: se
English: PRCA means the bone marrow does not make enough red blood cells.
Danish: PRCA resulterer i, at knoglemarven ikke danner tilstrækkeligt mange røde blodlegemer.
English: Monitoring of the blood pressure should be performed, particularly at the start of therapy (see section 4.4).
Danish: Det anbefales at monitorere blodtrykket, især i begyndelsen af behandlingen (se pkt.
English: In those situations in which the physician determines that a patient or caregiver can safely and effectively administer Epoetin alfa HEXAL subcutaneously themselves, instruction as to the proper dosage and administration should be provided.
Danish: I de situationer, hvor lægen bedømmer, at patienten selv eller en omsorgsperson kan administrere Epoetin alfa HEXAL sikkert og effektivt subkutant, skal der gives instruktioner om korrekt dosering og administration.
English: - The active substance is: epoetin alfa (for quantity see the table below).
Danish: - Aktivt stof: epoetin alfa (se tabellen nedenfor for kvantiteter).
English: Your doctor may decide to increase your heparin dose during dialysis.
Danish: Din læge kan beslutte at forhøje din heparindosis under dialysen.
English: This risk may be higher if you have other risk factors for developing blood clots (for example, if you have had a blood clot in the past or are overweight, have diabetes, have heart disease or you are off your feet for a long time because of surgery or illness).
Danish: Denne risiko kan være højere, hvis du har andre risikofaktorer for at udvikle blodpropper (for eksempel hvis du tidligere har haft en blodprop, eller hvis du er overvægtig, har sukkersyge eller hjertesygdom, eller hvis du er sengeliggende i lang tid på grund af en operation eller sygdom).
English: If it occurs, appropriate dose adjustment should be made as provided.
Danish: Hvis det forekommer, skal dosis justeres på passende vis som foreskrevet.
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 open-label study.
Danish: Overlevelse og tumorprogression er undersøgt i fem store kontrollerede studier med i alt 2833 patienter, hvoraf fire var dobbeltblinde placebokontrollerede studier og et var et åbent studie.
English: Medicinal products that decrease erythropoiesis may decrease the response to epoetin alfa.
Danish: Lægemidler, der reducerer erytropoiesen, kan reducere responset på epoetin alfa.
English: In some studies, the double-blind phase was followed by an open-label phase during which all patients received epoetin alfa and a maintenance of effect was observed.
Danish: I nogle studier blev den dobbeltblinde fase efterfulgt af en åben fase, hvor alle patienter fik epoetin alfa, og det blev observeret, at virkningen blev opreteholdt.
English: Dose increases and decreases should be done one dosing step at a time (see diagram below).
Danish: Dosisforøgelser og -reduktioner skal ske med ét doseringstrin ad gangen (se diagram nedenfor).
English: This is more likely if you have low blood pressure or if your fistula has complications.
Danish: Der er størst risiko for dette, hvis du har lavt blodtryk, eller hvis der er komplikationer med din fistel.
English: The median time to target was 11 weeks and the median dose at target was 150 IU/kg/week.
Danish: Mediantiden til målet var 11 uger, og den mediane dosis ved målet var 150 IE/kg/uge.
English: Consequently, epoetin alfa should be used in pregnancy only if the potential benefit outweighs the potential risk to the foetus.
Danish: Som et resultat heraf bør epoetin alfa kun anvendes under graviditet, hvis de mulige fordele opvejer den mulige risiko for fostret.
English: Very rarely, development of or exacerbation of porphyria has been observed in epoetin alfa-treated patients.
Danish: Der er meget sjældent blevet observeret udvikling af eller forværring af porfyri hos epoetin alfabehandlede patienter.
English: Patients from the group treated with epoetin alfa were also enrolled in an open-label extension study which demonstrated improvements in their quality of life that were maintained for an additional 12 months.
Danish: Patienter fra epoetin alfa-gruppen indgik også i et åbent forlængelsesstudie, som påviste forbedringer i deres livskvalitet, der blev opretholdt i yderligere 12 måneder.
English: Conflicting reports in the literature, based on in vitro findings from human tumour samples, suggest erythropoietins may play a role as tumour proliferators.
Danish: Modstridende rapporter i litteraturen, baseret på in vitro-fund fra humane tumorprøver, tyder på, at erytropoietiner kan spille en rolle som tumorproliferatorer.
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-, radio-, kemoradio- eller ingen terapi), som deltog i 53 kontrollerede kliniske studier, omfattende flere epoetiner.
English: It is recommended that the platelet count is regularly monitored during the first 8 weeks of therapy.
Danish: Det anbefales at kontrollere trombocyttallet regelmæssigt i de første 8 uger af behandlingen.
English: A minimum of 4 weeks should elapse between dose increases.
Danish: Der skal gå mindst 4 uger mellem dosisforøgelser.
English: • if you are allergic to epoetin alfa or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for epoetin alfa eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: In order to improve the traceability of erythropoiesis-stimulating agents (ESAs), the trade name and the batch number of the administered ESA should be clearly recorded (or stated) in the patient file.
Danish: For bedre at kunne spore erytropoiese-stimulerende stoffer (ESA'er) skal navnet og batchnummeret på den indgivne ESA tydeligt noteres i patientens journal.
English: • High levels of blood potassium which can cause abnormal heart rhythm (this is a very common side effect in patients on dialysis).
Danish: • Højt niveau af kalium i blodet, hvilket kan føre til en unormal hjerterytme (puls) (dette er en meget almindelig bivirkning hos patienter i dialyse).
English: Once a syringe has been removed from the refrigerator and has reached room temperature (up to 25°C) it must either be used within 3 days or disposed of.
Danish: Når du først har taget en sprøjte ud af køleskabet og den har nået rumtemperatur (op til 25 °C), skal du enten bruge den i løbet af 3 dage eller smide den ud.
English: During the maintenance phase, Epoetin alfa HEXAL 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 Epoetin alfa HEXAL administreres enten 3 gange ugentligt eller, i tilfælde af subkutan administration, én gang ugentligt eller én gang hver anden uge.
English: In controlled clinical studies, use of epoetin alfa and other ESAs have been associated with decreased locoregional tumour control or decreased overall survival:
Danish: I kontrollerede kliniske studier er anvendelsen af epoetin alfa og andre ESA'er forbundet med reduceret lokoregional tumorkontrol eller reduceret samlet overlevelse:
English: • Do not attempt to inject yourself unless you have been trained to do so by your doctor or nurse.
Danish: • Forsøg ikke at give dig selv en indsprøjtning, medmindre du er blevet trænet i det af din læge eller sundhedspersonalet.
English: • Your doctor may initiate treatment with Epoetin alfa HEXAL if your haemoglobin is 10 g/dL or less.
Danish: • Din læge kan påbegynde behandling med Epoetin alfa HEXAL, hvis dit hæmoglobinniveau er 10 g/dl eller mindre.
English: • unusual tiredness,
Danish: • usædvanlig træthed,
English: If Epoetin alfa HEXAL is injected under the skin (subcutaneously), the amount injected is not normally more than one millilitre (1 mL) in a single injection.
Danish: Hvis Epoetin alfa HEXAL indsprøjtes under huden (subkutant), er mængden, der indsprøjtes normalt ikke over en milliliter (1 ml) i en enkelt indsprøjtning.
English: Please tell your doctor about any of these things.
Danish: Fortæl lægen om disse ting.
English: Two other smaller, randomised, placebo-controlled trials failed to show a significant improvement in quality of life parameters on the EORTC-QLQ-C30 scale or CLAS, respectively.
Danish: To andre, mindre, randomiserede placebokontrollerede studier viste ingen signifikant forbedring i livskvalitetsparametrene på skalaerne EORTC-QLQ-C30 og CLAS.
English: If signs and symptoms suggestive of these reactions appear, Epoetin alfa HEXAL should be withdrawn immediately and an alternative treatment considered.
Danish: Hvis der opstår tegn og symptomer, som tyder på sådanne reaktioner, skal Epoetin alfa HEXAL straks seponeres, og en alternativ behandling skal overvejes.
English: 25, D-83607 Holzkirchen, Germany
Danish: 25, D-83607 Holzkirchen, Tyskland
English: In most cases, the ferritin values in the serum fall simultaneously with the rise in packed cell volume.
Danish: I de fleste tilfælde falder jernværdierne i serum samtidigt med stigningen i hæmatokrit.
English: Headaches, particularly sudden, stabbing migraine-like headaches, feeling confused or having fits may be signs of a sudden increase in blood pressure.
Danish: Hovedpine, specielt pludselig opståen af dunkende migrænelignende hovedpine, følelse af at være forvirret eller krampeanfald kan være tegn på en pludselig forhøjelse af blodtrykket.
English: Mean haemoglobin levels were similar for the two treatment groups throughout the postsurgical period.
Danish: De gennemsnitlige hæmoglobinniveauer var sammenlignelige i de to behandlingsgrupper i hele perioden efter kirurgi.
English: The absolute bioavailability of subcutaneous injectable epoetin alfa is approximately 20% in healthy subjects.
Danish: Den absolutte biotilgængelighed af subkutant injiceret epoetin alfa er ca. 20% hos raske personer.
English: • Swelling of the ankles, feet or fingers.
Danish: • Hævede ankler, fødder og fingre.
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 i løbet af 10 dage, efterfulgt af stigning i antal røde blodlegemer, hæmoglobin og hæmatokrit, normalt i løbet af 2 til 6 uger.
English: - All contraindications associated with autologous blood predonation programmes should be respected in patients being supplemented with Epoetin alfa HEXAL.
Danish: - Alle kontraindikationer forbundet med autologe prædonationsprogrammer skal respekteres hos patienter, der får supplerende Epoetin alfa HEXAL.
English: - Surgery patients who for any reason cannot receive adequate antithrombotic prophylaxis.
Danish: - Operationspatienter, der af forskellige årsager ikke kan gives tilstrækkelig antitrombotisk profylakse.
English: • if there has been a refrigerator failure.
Danish: • hvis køleskabet har svigtet.
English: Diarrhoea, Nausea, Vomiting Very common
Danish: Diarré, Kvalme, Opkastning Meget almindelig
English: • Either into a vein or a tube that goes into a vein (intravenously)
Danish: • Enten i en vene eller i en slange, der er indsat i en vene (intravenøst)
English: Prolonged vigorous shaking may damage the product.
Danish: Langvarig kraftig omrystning kan beskadige præparatet.
English: • Blood clots (thrombosis) may form in your dialysis shunt.
Danish: • Der kan dannes blodpropper (trombose) i din dialyse-shunt.
English: Hypertension, Venous and arterial thromboses2
Danish: Hypertension, Venøs og arteriel trombose2
English: This is of uncertain significance in the clinical situation.
Danish: Det vides ikke med sikkerhed, om dette har klinisk betydning.
English: Only use each syringe for one injection.
Danish: Brug kun sprøjten til én indsprøjtning.
English: For patients on peritoneal dialysis Epoetin alfa HEXAL may be given twice a week.
Danish: For patienter i peritonealdialyse kan Epoetin alfa HEXAL gives 2 gange ugentligt.
English: Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Danish: Erytropoietinreceptorer kan udtrykkes på overfladen af flere forskellige tumorceller.
English: The dose of Epoetin alfa HEXAL you receive is based on your body weight in kilograms.
Danish: Den Epoetin alfa HEXAL-dosis, du får, er baseret på din kropsvægt i kilo.
English: If blood pressure cannot be controlled, epoetin alfa treatment should be discontinued.
Danish: Hvis blodtrykket ikke kan kontrolleres, skal behandlingen med epoetin alfa stoppes.
English: In cell cultures of human bone marrow cells, epoetin alfa stimulates erythropoiesis specifically and does not affect leucopoiesis.
Danish: I cellekulturer af humane knoglemarvsceller stimulerer epoetin alfa specifikt erytropoiese, og det påvirker ikke leukopoiese.
English: The haemoglobin response varies between patients and may be impacted by iron stores and the presence of concurrent medical problems.
Danish: Hæmoglobinresponset varierer fra patient til patient og kan være påvirket af jerndepoter og af tilstedeværelsen af andre medicinske problemer.
English: In addition, thrombocythaemia above the normal range has been reported.
Danish: Desuden er der rapporteret trombocytæmi over normalområdet.
English: D-83607 Holzkirchen Germany
Danish: D-83607 Holzkirchen Tyskland
English: Pure red cell aplasia3, Thrombocythaemia
Danish: Pure red cell aplasia3, Trombocytæmi
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: I dyrestudier er det påvist, at epoetin alfa nedsætter fostervægten, forsinker knogledannelsen og øger fostermortaliteten, når det gives i ugentlige doser på ca. 20 gange den anbefalede ugentlige dosis til mennesker.
English: Form a skin fold by pinching the skin between thumb and forefinger.
Danish: Lav en hudfold ved at klemme huden mellem tommelfingeren og pegefingeren.
English: Treatment with Epoetin alfa HEXAL is divided into two stages - correction and maintenance phase.
Danish: Behandlingen med Epoetin alfa HEXAL er opdelt i 2 faser - en korrigeringsfase og vedligeholdelsesfase.
English: However the product is for single use only.
Danish: Dette præparat er imidlertid kun til engangsbrug.
English: Each graduation ring corresponds to a volume of 0.1 mL.
Danish: Hver delestreg svarer til et volumen på 0,1 ml.
English: • You will usually continue Epoetin alfa HEXAL treatment for one month after the end of chemotherapy.
Danish: • Du vil normalt fortsætte behandlingen med Epoetin alfa HEXAL i én måned efter afslutningen af kemoterapien.
English: If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of Epoetin alfa HEXAL, treatment with Epoetin alfa HEXAL 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 alfa HEXAL, må behandling med Epoetin alfa HEXAL ikke genoptages hos denne patient på noget tidspunkt.
English: • The usual starting dose of Epoetin alfa HEXAL for adults and children is 50 International Units (IU) per kilogram (/kg) of body weight given three times a week.
Danish: • Den normale startdosis af Epoetin alfa HEXAL til voksne og børn er 50 internationale enheder (IE) pr. kilogram (/kg) kropsvægt, som gives 3 gange om ugen.
English: Adverse drug reactions reported by ≥ 1% of subjects treated with epoetin alfa in these trials are shown in the table below.
Danish: Bivirkninger rapporteret af ≥ 1% af personerne i behandling med epoetin alfa i disse studier er vist i tabellen nedenfor.