FrancophonIA/ELRC3.0 huggingface dataset:
English: Not known: frequency cannot be estimated from available data
Danish: Ikke kendt: kan ikke vurderes ud fra forhåndenværende data
English: Caution should be exercised when prescribing Aranesp to pregnant women.
Danish: Der bør udvises forsigtighed ved ordinering af Aranesp til gravide kvinder.
English: These included myelofibrosis and splenic hypertrophy as well as broadening of the ECG-QRS complex in dogs but no dysrhythmia and no effect on the QT interval were observed.
Danish: Der var bl.a. tale om myelofibrose og milt hypertrofi, såvel som en øgning af bredden af EKG-QRS komplekset hos hunde, men der observeredes ingen dysrythmia og ingen effekt på QT intervallet.
English: Epoetins are not approved in the management of anaemia associated with hepatitis C.
Danish: Epoetiner er ikke godkendt til behandling af anæmi i forbindelse med hepatitis C.
English: Adverse events at very high doses were all considered to be related to an exaggerated pharmacological effect (decreased tissue perfusion due to increased blood viscosity).
Danish: Bivirkninger ved meget høje doser, blev alle vurderet at være relateret til en forhøjet farmakologisk effekt (nedsat vævsperfusion pga. øget blodviskositet).
English: Special warnings: - If you have symptoms which include unusual tiredness and a lack of energy this could mean you have pure red cell aplasia (PRCA), which has been reported in patients.
Danish: Forsigtighedsregler: - Hvis De har symptomer, der omfatter unormal træthed og mangel på energi, kan det betyde, at De har pure red cell aplasi (PRCA), der er blevet rapporteret hos patienter.
English: Check the appearance of Aranesp.
Danish: Kontroller udseendet af Aranesp.
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 desuden udført en data-analyse på patientniveau med mere end 13.900 cancerpatienter (kemoterapi, stråleterapi, kemo-/stråleterapi eller ingen behandling), der deltog i 53 kontrollerede kliniske forsøg med adskillige epoetiner.
English: Deficiencies of iron, folic acid or vitamin B12 reduce the effectiveness of ESAs and should therefore be corrected.
Danish: Mangel på jern, folinsyre eller cyanocobalamin reducerer effektiviteten af ESA'er og bør derfor afhjælpes.
English: Yellow safety guard
Danish: Gul sikkerhedsanordning
English: Only solutions which are colourless, clear or slightly opalescent, should be injected.
Danish: Kun opløsninger som er farveløse, klare eller let opaliserede bør injiceres.
English: Despite these molecular changes, darbepoetin alfa retains a very narrow specificity for the erythropoietin receptor.
Danish: På trods af disse molekylære ændringer bibeholder darbepoetin alfa en meget præcis specificitet for erytropoietinreceptoren.
English: Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 mcg/L or whose transferrin saturation is below 20%.
Danish: Supplerende jerntilskud anbefales til alle patienter med serum-ferritin under 100 mikrog/l eller med transferrinmætning under 20 %.
English: • Keep the pre-filled pen and all medicines out of the reach of children.
Danish: • Opbevar den fyldte pen og alle lægemidler utilgængeligt for børn.
English: Your doctor will use the lowest effective dose to control the symptoms of your anaemia.
Danish: Lægen vil bruge den laveste effektive dosis til kontrol af symptomerne på anæmi.
English: Date of latest renewal: 19 May 2006
Danish: Dato for første markedsføringstilladelse: 08. juni 2001 Dato for seneste fornyelse: 19. maj 2006
English: Your doctor, nurse or pharmacist will tell you how much Aranesp you need and how frequently it should be injected.
Danish: Deres læge eller sygeplejerske vil fortælle Dem, hvor meget Aranesp De har behov for, og hvor ofte det skal injiceres.
English: Your blood pressure will also be checked regularly, particularly at the beginning of your treatment.
Danish: Deres læge vil jævnligt kontrollere Deres blodtryk, hyppigst i begyndelsen af behandlingen.
English: Injecting the solution with the air bubble is harmless.
Danish: Injektion af væsken med boble er ikke skadeligt.
English: Do not touch the injection site before injecting Choose a different site each time you give yourself an injection.
Danish: Rør ikke ved injektionsstedet inden injektionen Vælg et nyt sted, hver gang De giver Dem selv en injektion.
English: Darbepoetin alfa has five N-linked carbohydrate chains whereas the endogenous hormone and recombinant human erythropoietins (r-HuEPO) have three.
Danish: Darbepoetin alfa har fem N-koblede kulhydratkæder, hvor det endogene hormon og recombinante humane erytropoietiner (r-HuEPO) har tre.
English: If an elevated or rising potassium level is observed then consideration should be given to ceasing Aranesp administration until the level has been corrected.
Danish: Hvis et forhøjet eller stigende kaliumniveau observeres, bør det overvejes at seponere Aranesp, indtil niveauet er blevet korrigeret.
English: If blood pressure is difficult to control by initiation of appropriate measures, the haemoglobin may be reduced by decreasing or withholding the dose of Aranesp (see section 4.2).
Danish: Hvis blodtrykket er vanskeligt at kontrollere selv efter iværksættelse af passende foranstaltninger, kan hæmoglobin reduceres ved at sænke eller seponere doseringen af Aranesp (se pkt.
English: Non-response to therapy with Aranesp should prompt a search for causative factors.
Danish: Manglende effekt af behandling med Aranesp bør foranledige en søgning efter forårsagende faktorer.
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, der fungerer som den primære regulator af erytropoiesen gennem specifik interaktion med erytropoietin-receptoren på den erythroide stamcelle i knoglemarven.
English: Hypersensitivity reactions were also very common in the placebo groups.
Danish: Overfølsomhedsreaktioner var også meget almindelige i placebogrupperne.
English: In order to correct your anaemia, your initial dose will be
Danish: For at rette op på Deres blodmangel, vil initialdosis være
English: If you need to use the same injection site, just make sure it is not the same spot on that site you used last time.
Danish: Hvis De er nødt til at bruge det samme injektionssted, så sørg blot for, at det ikke er præcis samme sted som sidste gang.
English: In order to improve the traceability of erythropoiesis-stimulating agents (ESAs), the trade name of the administered ESA should be clearly recorded (or stated) in the patient file.
Danish: For bedre at kunne spore erytropoiesestimulerende stoffer (ESA'er) skal navnet på det administrerede ESA tydeligt angives i patientjournalen.
English: The route of injection is the same as with r-HuEPO but your doctor will tell you how much you should take, and when, and may adjust your dose if necessary.
Danish: Det injiceres på samme måde som r-HuEPO, men Deres læge vil fortælle hvilken dosis De skal tage og hvornår De skal tage den og vil om nødvendigt justere Deres dosis.
English: Important: You must push all the way down but do not touch the red start button until you are ready to inject.
Danish: Vigtigt: De skal trykke helt ned, men undgå at berøre den røde startknap, før De er klar til at injicere.
English: Aranesp treatment should be initiated by physicians experienced in the above mentioned indications.
Danish: Behandling med Aranesp må kun påbegyndes af en læge med erfaring inden for de ovennævnte indikationer.
English: If this changes you will start on the same dose as you have been receiving and your doctor will take blood samples to make sure that your anaemia is still being managed correctly.
Danish: Hvis denne ændring sker, vil De starte med den samme dosis som De fik tidligere, og Deres læge vil tage blodprøver for at sikre sig at Deres blodmangel stadig behandles korrekt.
English: Darbepoetin alfa stimulates erythropoiesis by the same mechanism as the endogenous hormone.
Danish: Darbepoetin alfa stimulerer erytropoiesen ved samme mekanisme som det endogene hormon.
English: Dose increases must not be made more frequently than once every four weeks.
Danish: Dosis må ikke øges mere end én gang hver 4. uge.
English: • Shortness of breath (allergic bronchospasm)
Danish: • Stakåndethed (allergisk bronkospasme)
English: How do I prepare my Aranesp injection?
Danish: Hvordan forbereder jeg min Aranesp injektion?
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af PSUR'er for dette lægemiddel fremgår af listen over EUreferencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Your doctor may decide to change the way that your injection is given (either under the skin or into a vein).
Danish: Deres læge kan beslutte at ændre administreringsform (enten under huden eller i en vene).
English: Incidence of adverse reactions from controlled clinical studies and post-marketing experience are: MedDRA system organ class
Danish: Forekomsten af bivirkninger i kontrollerede kliniske studier og efter markedsføring af produktet er: MedDRA systemorganklasse
English: Depending on your individual situation a blood transfusion may be preferable.
Danish: En blodtransfusion kan være at foretrække afhængigt af din individuelle situation.
English: Pharmacokinetic parameters did not change on multiple dosing over 12 weeks (dosing every week or every two weeks).
Danish: Der var ingen ændring i de farmakokinetiske parametre ved gentagen indgift over 12 uger (dosering hver uge eller hver anden uge).
English: Since the liver is thought to be the principal route of elimination of darbepoetin alfa and r-HuEPO, Aranesp should be used with caution in patients with liver disease.
Danish: Da leveren antages at være den primære eliminationsvej for darbepoetin alfa og r-HuEPO, bør Aranesp altid anvendes med forsigtighed af patienter med leversygdom.
English: A reticulocyte count should be considered as part of the evaluation.
Danish: Som en del af vurderingen bør en tælling af retikulocytterne overvejes.
English: Part of the pre-filled pen may be broken even if you cannot see the break.
Danish: Dele af den fyldte pen kan være blevet ødelagt, hvilket De muligvis ikke vil kunne se.
English: Use a new pre-filled pen.
Danish: Brug en ny fyldt pen.
English: What should I do before I give myself a subcutaneous injection of Aranesp?
Danish: Hvad skal jeg gøre før jeg selv foretager subkutan indsprøjtning med Aranesp?
English: The safety and effectiveness of once every three weeks dosing of Aranesp therapy in reducing the requirement for red blood cell transfusions in patients undergoing chemotherapy was assessed in a randomised, double-blind, multinational study.
Danish: Sikkerheden og effektiviteten af behandling med Aranesp indgivet én gang hver tredje uge med det formål at reducere behovet for transfusion af røde blodlegemer hos patienter, som får kemoterapi, blev undersøgt i en randomiseret, dobbeltblind multinational studie.
English: • Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)
Danish: • Opsvulmen af ansigt, læber, mund, tunge eller hals, hvilket kan føre til besvær med at synke eller trække vejret (angioødem)
English: • Alcohol wipes
Danish: • Spritservietter
English: • Store the pre-filled pen in the refrigerator (2ºC - 8ºC).
Danish: • Opbevar den fyldte pen i køleskabet (2 °C - 8 °C).
English: Only use each syringe for one injection.
Danish: Anvend kun hver fyldt injektionssprøjte til én indsprøjtning.
English: This box containing 1 pre-filled pen, is part of a 4-multipack SureClick x4
Danish: Denne æske, der indeholder 1 fyldt pen til engangsbrug, er del af en pakning med 4 stk SureClick x 4
English: Do not leave the pre-filled pen in direct sunlight.
Danish: Efterlad ikke den fyldte pen i direkte sollys.
English: Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Danish: Dyreforsøg viser ikke direkte skadelige virkninger for graviditet, embryoets/fostrets udvikling, fødslen eller den postnatale udvikling.
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis De bruger anden medicin, for nylig har brugt anden medicin eller planlægger at bruge anden medicin.
English: Do not put the pre-filled pen back in the refrigerator once it has reached room temperature.
Danish: Læg ikke den fyldte pen tilbage i køleskabet, når den først har nået stuetemperatur.
English: You may notice a small air bubble in the pre-filled syringe.
Danish: Det kan være, at De kan se en lille luftboble i den fyldte injektionssprøjten.
English: Your treatment will continue until approximately four weeks after the end of your chemotherapy.
Danish: Behandlingen skal fortsætte til cirka 4 uger efter endt kemoterapi.
English: SJS/TEN, erythema multiforme, blistering, skin exfoliation
Danish: SJS/TEN, erythema multiforme, blæredannelse, hudafskalning
English: In kidney failure, the kidney does not produce enough of the natural hormone erythropoietin which can often cause anaemia.
Danish: Ved nyresvigt producerer nyrerne ikke nok af det naturlige hormon erythropoietin, hvilket ofte kan forårsage blodmangel.
English: To give yourself an injection you will need:
Danish: For at foretage injektion skal De bruge:
English: Push the plunger with a slow constant pressure, always keeping your skin pinched, until the syringe is empty.
Danish: Tryk på stemplet med et langsomt, konstant pres, idet der hele tiden holdes fast i huden, indtil sprøjten er tom.
English: Pharmacotherapeutic group: Anti-anaemic preparations, other anti-anaemic preparations, ATC Code: B03XA02.
Danish: Farmakoterapeutisk klassifikation: midler mod anæmi, andre midler mod anæmi, ATC-kode: B03XA02.
English: If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
Danish: Hvis en dosisjustering er påkrævet for at fastholde hæmoglobinkoncentrationen på det ønskede niveau, anbefales det, at dosis justeres med ca. 25 %.
English: Do not touch this area again before injecting.
Danish: Rør ikke ved dette område igen inden injektionen.
English: This has been predominantly reported in patients with CRF treated subcutaneously.
Danish: Dette er hovedsageligt blevet rapporteret hos patienter med CRF, som behandles subkutant.
English: • 0.45 micrograms once weekly.
Danish: • 0,45 mikrogram én gang ugentligt.
English: Your normal dialysis routine will not affect the ability of Aranesp to treat your anaemia.
Danish: Deres normale dialyserutine vil ikke påvirke Aranesps evne til at behandle Deres blodmangel.
English: • Outer area of upper arm (only if someone else is giving you the injection) Clean the injection site with an alcohol wipe.
Danish: • det udvendige område af overarmen (kun hvis en anden person giver injektionen) Rengør injektionsstedet med en spritserviet.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF ΟG FREMSTILLERΕ ANSVARLIGE FOR BATCHFRIGIVELSE
English: • Bruising and bleeding at the site of injection
Danish: • Blodudtrædning og blødning ved injektionsstedet
English: C Gather all the materials needed for your injection.
Danish: C Læg alt nødvendigt udstyr til injektionen frem.
English: The production of erythropoietin primarily occurs in and is regulated by the kidney in response to changes in tissue oxygenation.
Danish: Produktionen af erytropoietin foregår primært i og reguleres af nyrerne som resultat af ændringer i iltningen af vævet.
English: At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions.
Danish: Patienterne skal ved ordinationen informeres om tegnene og symptomerne og monitoreres nøje for hudreaktioner.
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, som bør overvejes i forbindelse med denne vurdering, er tumortype og tumorstadie, anæmiens udstrækning, forventet levetid, patientens behandlingsmiljø og patientens ønsker (se pkt.
English: In the once every three weeks group, 72% of patients required dose reductions.
Danish: I gruppen, som modtog dosis én gang hver tredje uge, krævede 72 % af patienterne dosisreduktioner.
English: Very common: may affect more than 1 in 10 people • Allergic reactions
Danish: Meget almindelig: kan ramme mere end 1 ud af 10 personer • Allergiske reaktioner
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, der kunne tilskrives indgift af epoetiner, når hæmoglobinkoncentrationen forhøjes til over det niveau, der er nødvendigt for at kontrollere symptomer på anæmi og undgå blodtransfusion.
English: The Aranesp (SureClick) pre-filled pen delivers the complete dose of each presentation.
Danish: Aranesp (SureClick) fyldt pen giver en fuld dosis af hver styrke.
English: Step 2: Get ready E Pull the grey cap straight off, only when you are ready to inject.
Danish: Trin 2: Klargøring E Træk kun den grå hætte af, når De er klar til at injicere.
English: Aranesp may be administered subcutaneously by the patient or a carer after being trained by a doctor, nurse or pharmacist.
Danish: Aranesp indgives subkutant af patienten eller en plejeperson efter at have modtaget undervisning af en læge, sygeplejerske eller farmaceut.
English: How do you or the person injecting you, use the Aranesp pre-filled syringe?
Danish: Hvordan skal De eller den person, der foretager indsprøjtningen, bruge den fyldte injektionssprøjte med Aranesp?
English: • 0.75 micrograms once every two weeks, or
Danish: • 0,75 mikrogram én gang hver anden uge eller
English: EPO-ANE-3010, a randomised, open-label, multicentre study was conducted in 2,098 anaemic women with metastatic breast cancer, who received first line or second line chemotherapy.
Danish: EPO-ANE-3010, et randomiseret, åbent multicenterstudie, blev udført med 2.098 anæmiske kvinder med metastatisk brystcancer, som fik førstelinje- eller andenlinje-kemoterapi.
English: Dose changes in the maintenance phase of treatment should not be made more frequently than every two weeks.
Danish: Ændringer i dosis må i vedligeholdelsesfasen ikke foretages oftere end hver anden uge.
English: Not known2
Danish: Ikke kendt2
English: Never inject Aranesp into a vein yourself.
Danish: De må aldrig selv injicere Aranesp i en vene.
English: Your doctor has decided that the Aranesp pre-filled pen is the best way for you, a nurse or a carer to inject Aranesp.
Danish: Deres læge har besluttet, at den fyldte pen med Aranesp er den bedste måde for Dem, en sygeplejerske eller andet plejepersonale at injicere Aranesp på.
English: - The active substance is darbepoetin alfa, r-HuEPO (erythropoietin produced by genetechnology).
Danish: - Aktivt stof: darbepoetin alfa, r-HuEPO (erythropoietin, produceret ved hjælp af genteknologi).
English: Aranesp therapy should be discontinued approximately four weeks after the end of chemotherapy.
Danish: Aranesp bør seponeres ca. 4 uger efter endt kemoterapibehandling.
English: Clinical studies have demonstrated that darbepoetin alfa had similar effectiveness when administered as a single injection either once every three weeks, once every two weeks, or weekly without any increase in total dose requirements.
Danish: Kliniske studier har vist, at darbepoetin alfa havde lignende effekt, når denne blev givet som enkelt injektion enten én gang hver tredje uge, én gang hver anden uge eller ugentligt uden øgning i totalt dosisbehov.
English: • Stomach area (abdomen), except for a 5 cm (2-inch) area right around your navel
Danish: • Maveområdet (abdomen) undtagen et område på 5 cm omkring navlen
English: • Do not put the cap back on used needles, as you may accidentally prick yourself.
Danish: • Sæt ikke beskyttelseshætten tilbage på brugte kanyler, da De kan komme til at stikke Dem ved et uheld.
English: Any medicinal product remaining should be disposed of.
Danish: Enhver medicinrest, der måtte være tilbage, bør kasseres.
English: • The expiry date printed on the label has passed the last day of the month shown.
Danish: • Udløbsdatoen, der er trykt på etiketten, er overskredet (sidste dag i den viste måned er passeret).
English: Where the same sampling duration was used, observed pharmacokinetic data and population pharmacokinetic modelling demonstrated that the pharmacokinetics of darbepoetin alfa was similar for paediatric and adult patients with CRF.
Danish: Hvor der blev brugt samme prøvetagningsperiode, viste farmakokinetiske data og populationsfarmakokinetisk modellering, at darbepoetin alfas farmakokinetiske egenskaber var de samme hos børn og voksne med kronisk nyresvigt.
English: If you do not respond adequately to Aranesp, your doctor will check your dose and will inform you if you need to change doses of Aranesp.
Danish: Hvis De ikke reagerer tilstrækkeligt på Aranesp, vil lægen kontrollere Deres dosis og informere Dem, hvis De skal ændre Deres dosis af Aranesp.
English: In all studies in rats and dogs darbepoetin alfa produced marked increases in haemoglobin, haematocrits, red blood cell counts and reticulocytes, which correspond to the expected pharmacological effects.
Danish: I alle studier af darbepoetin alfa udført på rotter og hunde, sås en markant stigning i hæmoglobin, hæmatokrit, antallet af røde blodlegemer og retikulocytter, som svarer til den forventede farmakologiske effekt.
English: It is not known whether darbepoetin alfa is excreted in human milk.
Danish: Det vides ikke, om darbepoetin alfa udskilles i mælken hos mennesker.
English: Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced by 25 to 50% in order to ensure that the lowest approved dose of Aranesp is used to maintain haemoglobin at a level that controls the symptoms of anaemia.
Danish: Når det kliniske resultat for den enkelte patient er opnået, skal dosis reduceres med 25 til 50 % for at sikre, at der anvendes den lavest godkendte Aranesp-dosis til at fastholde hæmoglobinkoncentrationen på et niveau, hvor symptomerne på anæmi kan kontrolleres.
English: These antibodies have been shown to cross-react with all erythropoietic proteins, and patients suspected or confirmed to have neutralising antibodies to erythropoietin should not be switched to Aranesp (see section 4.8).
Danish: Disse antistoffer har vist sig at krydsreagere med alle erytropoietinproteiner, og patienter der er under mistanke for at have eller som har fået bekræftet tilstedeværelsen af neutraliserende antistoffer mod erytropoietin, bør ikke overgå til behandling med Aranesp (se pkt.
English: • Aranesp is given as an injection into the tissue just under the skin (subcutaneous injection).
Danish: • Aranesp gives som en injektion i vævet lige under huden (subkutan injektion).
English: The additional sugar residues are molecularly indistinct from those on the endogenous hormone.
Danish: De ekstra sukkerdele kan molekylært ikke skelnes fra dem på det endogene hormon.