FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor will work out the right dose for you.
Danish: Lægen vil udregne den rigtige dosis for dig.
English: · An increase in the occurrence of blood clots has been observed.
Danish: ● En forøgelse af forekomsten af blodpropper er observeret.
English: Do not use glass materials for injection, use only plastic materials.
Danish: Anvend ikke glasmateriale til injektion, anvend kun plastmaterialer.
English: · Contact your healthcare professional if you have any questions.
Danish: ● Kontakt sundhedspersonalet, hvis du har spørgsmål.
English: Occlusion of the dialysis system is possible if heparinisation is not optimum.
Danish: Okklusion af dialysesystemet er mulig, hvis hepariniseringen ikke er optimal.
English: This amount should be that quantity which is expected to be sufficient to avoid homologous blood transfusions.
Danish: Denne mængde bør svare til, hvad der forventes at være sufficient for at undgå homolog blodtransfusion.
English: Caution should be exercised when prescribing to pregnant women.
Danish: Der skal udvises forsigtighed ved ordination til gravide kvinder.
English: The requirements for submission of periodic safety update reports 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 updatespublished on the European medicines web-portal
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: This is a multidose preparation from which different single doses can be withdrawn over a period of 1 month after dissolution.
Danish: Dette er et Flerdosis præparat, hvor forskellige enkeltdoser kan udtages fra, i en periode på 1 måned efter rekonstitution.
English: These may be signs of severely elevated blood pressure (hypertensive crisis), even if your blood pressure is usually normal or low.
Danish: Dette kan være tegn på alvorligt, forhøjet blodtryk (hypertensiv krise), selvom dit blodtryk som regel er lavt eller normalt.
English: Put the protective cap on the top of the device.
Danish: Sæt beskyttelseshætten på toppen af device.
English: The clinical results obtained so far do not indicate any interaction of NeoRecormon with other medicinal products.
Danish: De kliniske resultater, der er opnået indtil nu, viser ingen interaktion mellem NeoRecormon og andre lægemidler.
English: The first dose is usually given to you under medical supervision, because of the possibility of an allergic reaction.
Danish: Den første dosis gives normalt under lægeligt opsyn på grund af risikoen for allergiske reaktioner.
English: The required amount of pre-donated blood is expressed in units whereby one unit in the nomogram is equivalent to 180 ml red cells.
Danish: Den krævede mængde prædoneret blod udtrykkes i enheder, hvor en enhed i nomogrammet er ækvivalent med 180 ml røde blodlegemer.
English: Particular attention should be paid to sudden stabbing migraine like headaches as a possible warning sign.
Danish: Opmærksomheden skal i særdeleshed henledes på pludseligt opståede migrænelignende hovedpiner, som et muligt advarselssignal.
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 at forbedre sporbarheden af erytropoiese-stimulerende stoffer (ESAs) skal navnet på det ordinerede ESA tydeligt registreres (eller angives) i patientjournalen.
English: Adverse reactions are listed according to MedDRA system organ class and frequency category.
Danish: Bivirkninger er angivet efter MedDRA-systemorganklasse og frekvenskategori.
English: · Gently twist until it is fully attached (C)
Danish: ● Vrid forsigtigt indtil den er fuldt fastgjort (C).
English: 17 There may be a little bleeding at the injection site.
Danish: Der kan være lidt blødning på injektionsstedet.
English: · Do not speed up the warming process in any way, and do not put the syringe in a microwave or in warm water.
Danish: ● Fremskynd ikke opvarmningen på nogen måde og kom ikke injektionssprøjten i en mikrobølgeovn eller i varmt vand.
English: Therefore, it is recommended that the platelet count be determined at least once a week in these patients.
Danish: Derfor anbefales det, at trombocyttallet hos disse patienter kontrolleres mindst én gang om ugen.
English: In the absence of compatibility studies, this medicinal product should not be mixed with other medicinal products.
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, bør dette lægemiddel ikke blandes med andre lægemidler.
English: However, in controlled clinical studies no increased incidence of hypersensitivity reactions was found.
Danish: I kontrollerede kliniske studier blev der imidlertid ikke fundet nogen øgning i forekomsten af overfølsomhedsreaktioner.
English: Your doctor will take regular blood samples.
Danish: Din læge vil tage regelmæssige blodprøver.
English: Bioavailability of epoetin beta after subcutaneous administration is between 23 and 42 % as compared with intravenous administration.
Danish: Epoetin beta's biotilgængelighed efter subkutan administration er mellem 23 og 42 % sammenlignet med intravenøs administration.
English: Subsequently, the dose is adjusted at intervals of one or two weeks individually for the patient (maintenance dose).
Danish: Som følge heraf skal doseringen tilpasses med intervaller på 1 eller 2 uger individuelt for hver patient (vedligeholdelsesdosis).
English: (7) Hold the OPC (One-Point-Cut) ampoule with the blue point upwards.
Danish: (7) Hold OPC (One-Point-Cut) ampullen med det blå mærke opad.
English: · Remove the needle from its blister.
Danish: ● Fjern nålen fra dens blister.
English: Make sure you always hold the syringe as shown in the picture below.
Danish: Sørg altid for at holde injektionssprøjten, som vist på billedet nedenfor.
English: Do not take a double dose to make up for any forgotten doses.
Danish: Tag ikke dobbeltdoser i stedet for glemte doser.
English: Your healthcare provider will show you how to prepare and inject NeoRecormon properly before you use it for the first time.
Danish: Sundhedspersonalet vil vise dig, hvordan du forbereder og injicerer NeoRecormon korrekt, inden du tager det for første gang.
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 hos patienter med hepatitis C, som har været behandlet med interferon og ribavirin, når epoetiner er anvendt samtidigt.
English: You must talk to your doctor if you do not feel better or if you feel worse.
Danish: Kontakt lægen, hvis du får det værre, eller hvis du ikke får det bedre.
English: Data on the once weekly dosing schedule are based on clinical studies with a treatment duration of 24 weeks.
Danish: Data for den én gang ugentlige dosering er baseret på kliniske studier med en behandlingsvarighed på 24 uger.
English: Remark: If the syringe does not reach room temperature, this could cause the injection to feel uncomfortable and make it hard to push the plunger.
Danish: Bemærkning: Hvis ikke injektionssprøjten opnår stuetemperatur, kan injektionen føles ubehagelig og gøre det svært at presse stemplet.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Danish: Dyrestudier viser ikke direkte eller indirekte skadelige virkninger på graviditet, embryoets/fostrets udvikling, fødslen eller den postnatale udvikling (se pkt.
English: Your doctor might prescribe acetylsalicylic acid or modify the shunt.
Danish: Lægen vil måske ordinere acetylsalicylsyre eller ændre på fistlen.
English: Leave the needle cap on while it warms up.
Danish: Lad nålehætten sidde på mens den varmer op.
English: Your doctor will always record the exact product you are using.
Danish: Din læge vil altid notere præcist det lægemiddel, du bruger, i din journal.
English: Two of the studies recruited patients who were being treated with chemotherapy.
Danish: I to af studierne rekrutteredes patienter, som var i kemoterapibehandling.
English: The injections of epoetin beta will increase the amount of blood that can be taken from your body before surgery and given back during or after the operation (this is an autologous transfusion).
Danish: Injektioner af epoetin beta øger mængden af blod, som kan tappes fra kroppen før operation, og som kan gives tilbage under eller efter en operation (dette kaldes en autolog transfusion).
English: A carcinogenicity study with homologous erythropoietin in mice did not reveal any signs of proliferative or tumourigenic potential.
Danish: En karcinogenicitetsundersøgelse med homologt erythropoietin i mus viste ingen tegn på proliferativt eller carcinogent potentiale.
English: · Keep your fingers behind the safety shield and away from the needle at all times.
Danish: ● Hold dine fingre bagved beskyttelseshylstret og væk fra nålen hele tiden.
English: NeoRecormon is administered twice weekly over 4 weeks.
Danish: NeoRecormon indgives 2 gange ugentlig i 4 uger.
English: A patient-level data analysis has also been performed on more than 13,900 cancer patients (chemo-, radio-, chemoradio- or no therapy) participating in 53 controlled clinical trials involving several epoetins.
Danish: En dataanalyse på patientniveau er også blevet udført for mere end 13.900 cancerpatienter (kemo-, radio-, kemoradio- eller ingen behandling), som deltog i 53 kontrollerede kliniske studier, som involverede flere epoetiner.
English: Hypertensive crisis with encephalopathy-like symptoms may occur and require the immediate attention of a physician and intensive medical care.
Danish: Hypertensive kriser med encephalopati-lignende symptomer kan forekomme, hvilket kræver umiddelbar opmærksomhed af en læge og intensiv medicinsk behandling.
English: It is recommended that the platelet count be monitored regularly during the first 8 weeks of therapy.
Danish: Det anbefales, at trombocyttallet kontrolleres regelmæssigt under de første 8 ugers behandling.
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 placebo-kontrollerede studier var hazard ratio for total overlevelse mellem 1,25 og 2,47 i kontrolgruppens favør.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: ● når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl er nået.
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: Set i lyset af ovenstående bør blodtransfusion i visse kliniske situationer være den fortrukne behandling for at styre anæmien i patienter med cancer.
English: Injections are given under the skin.
Danish: Injektionerne gives under huden
English: The study did not meet either primary objective of demonstrating a reduction in risk for all-cause mortality, cardiovascular morbidity, or end stage renal disease (ESRD).
Danish: Studiet nåede ingen af de primære mål − at demonstrere en reduktion af risikoen for død (af alle årsager), kardiovaskulær morbiditet eller nyresygdom i slutstadiet (ESRD).
English: These reactions were mild or moderate in nature and subsided after a couple of hours or days.
Danish: Disse reaktioner var milde eller moderate og forsvandt efter få timer eller dage.
English: b) Maintaining sufficient red blood cell levels The maintenance dose: Once your red blood cells reach an acceptable level, the dose is reduced to half of the dose used to correct the anaemia.
Danish: b) Vedligeholdelse af niveauet af røde blodlegemer Vedligeholdelsesdosis: Når niveauet af røde blodlegemer har nået et acceptabelt niveau, bliver dosis reduceret til halvdelen af, hvad der skal til for at korrigere blodmanglen.
English: Be sure that you read, understand and follow the Instructions for Use as well as the package leaflet before injecting NeoRecormon.
Danish: Vær sikker på, at du læser, forstår og følger brugsanvisningen samt indlægssedlen inden du injicerer NeoRecormon.
English: Folic acid and vitamin B12 deficiencies should be ruled out as they reduce the effectiveness of NeoRecormon.
Danish: Folinsyre og vitamin B12 mangel bør udelukkes, da de nedsætter NeoRecormon's virkning.
English: · Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard or not intact.
Danish: ● Injicer ikke ind i modermærker, ar, blå mærker eller områder hvor huden er øm, rød, hård eller ikke intakt.
English: NeoRecormon has no influence on the ability to drive and use machines.
Danish: NeoRecormon påvirker ikke evnen til at føre motorkøretøj og betjene maskiner.
English: - Increasing the yield of autologous blood from patients in a pre-donation programme.
Danish: - at øge udbyttet af autologt blod for patienter i et prædonationsprogram.
English: Based on results from clinical trials including 1725 patients approximately 8 % of patients treated with NeoRecormon are expected to experience adverse reactions.
Danish: Baseret på kliniske studier, der inkluderede 1.725 patienter, forventes omkring 8 % af de patienter, der bliver behandlet med NeoRecormon at opleve bivirkninger.
English: Remark: If you have a multipack, put the carton with the remaining syringe(s) and needle(s) back into the refrigerator
Danish: Bemærkning: Hvis du har en multipakning, så sæt æsken med den(de) resterende injektionssprøjte(r) tilbage i køleskab
English: In this case dose increases may be necessary.
Danish: I dette tilfælde er en dosisforøgelse nødvendig.
English: NeoRecormon is provided in the following pack-sizes:
Danish: NeoRecormon leveres i følgende pakningsstørrelser:
English: In this case you should not be switched to NeoRecormon.
Danish: I en sådan situation bør du ikke skifte til NeoRecormon.
English: Consult your healthcare provider if you require further information.
Danish: Kontakt sundhedspersonalet, hvis du har brug for yderligere information.
English: Epoetin beta is produced by a specialised genetic technology and works in exactly the same way as the natural hormone erythropoietin.
Danish: Epoetin beta er produceret ved hjælp af speciel genteknologi og virker på samme måde som det naturligt forekommende hormon, erythropoietin.
English: These serious skin rashes are often preceded by fever and/or flu-likes symptoms.
Danish: Disse alvorlige hududslæt kommer ofte efter feber og/eller influenzalignende symptomer.
English: Particularly at beginning of therapy, regular monitoring of the blood pressure is recommended, including between dialyses.
Danish: Især i begyndelsen af behandlingen anbefales det at kontrollere blodtrykket regelmæssigt, også mellem dialyser.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and toxicity to reproduction.
Danish: De præ-kliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og reproduktionstoksicitet.
English: Hypertension Hypertensive crisis
Danish: Hypertensiv krise
English: Holding the syringe with one hand, press the safety shield down against a flat surface with a firm, quick motion until you hear a “click” (B).
Danish: Hold injektionssprøjten med én hånd, pres beskyttelseshylstret ned mod en flad overflade med en fast, hurtig bevægelse indtil du hører et ”klik” (B).
English: This causes severe anaemia, symptoms of which would include unusual tiredness and a lack of energy.
Danish: Det kan give alvorlig blodmangel, og symptomerne omfatter usædvanlig træthed og mangel på energi.
English: Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Danish: Erythropoietinreceptorer kan være udtrykt på overfladen af forskellige tumorceller.
English: 2 Check the carton has not been damaged and check the expiration date on the carton has not passed.
Danish: Undersøg, at æsken ikke er beskadiget og at udløbsdato ikke er overskredet.
English: Change vein with each injection to prevent soreness in one spot.
Danish: Skift blodåre ved hver injektion for at undgå ømhed på ét sted.
English: This regresses during the course of continued therapy.
Danish: Den forsvinder under fortsat behandling.
English: Solvent: 10 ml ampoule (type I glass).
Danish: Solvens: 10 ml ampul (type Iglas).
English: Further injections are given by your doctor or, after you have been trained, you can inject NeoRecormon yourself (see instructions at the end of this leaflet.)
Danish: Yderligere injektioner gives af din læge eller du kan selv injicere NeoRecormon efter du er blev trænet (se brugsanvisning til sidst i denne indlægsseddel).
English: In trials, children usually needed higher doses of NeoRecormon (the younger the child, the higher the dose).
Danish: I studier har børn som regel haft behov for større doser af NeoRecormon (jo yngre barn, des højere dosis).
English: (4) Take the reconstitution and withdrawal device (which allows sterile air exchange) out of the blister and remove the protective cover from the spike.
Danish: (4) Tag devicet til rekonstituering og optrækning (som tillader udveksling af steril luft) ud af æsken og fjern beskyttelseshætten fra spidsen.
English: Do not inject within 5 cm (2 inches) area directly around your belly button.
Danish: Injicer ikke inden for et 5 cm område rundt om din navle.
English: (9) Swirl the vial gently until the lyophilisate has dissolved.
Danish: (9) Hætteglasset vendes forsigtigt, indtil lyofilisatet er opløst.
English: NeoRecormon has not shown evidence of impaired fertility in animals.
Danish: NeoRecormon har ikke vist tegn på at nedsætte frugtbarheden hos dyr.
English: · Do not use NeoRecormon after the expiry date which is stated on the carton and label.
Danish: ● Brug ikke NeoRecormon efter den udløbsdato, der står på etiketten og æskeen.
English: To maintain an Hb of between 10 and 12 g/dl, the dosage is initially reduced to half of the previously administered amount.
Danish: For at vedligeholde et hæmoglobinniveau på mellem 10 - 12 g/dl skal dosis initialt reduceres til halvdelen af den tidligere administrerede mængde.
English: · Periodic Safety Update Reports
Danish: ● Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression in patients with anaemia associated with cancer.
Danish: I adskillige kontrollerede studier har epoetiner ikke vist at kunne forbedre total overlevelse eller mindske risikoen for tumorprogression hos patienter, der har anæmi i forbindelse med cancer.
English: · Injection needle(s) (27G or 30G (depending on the prescribed strengths of the medicine) with safety shield (used for priming, setting the dose and injecting the medicine).
Danish: ● Injektionsnål(e) 27G eller 30G (afhængig af den ordinerede styrke af medicinen) med beskyttelseshylster (bruges til fjernelse af luften, indstilling af dosis og til injektion af medicinen).
English: The therapeutic margin of NeoRecormon is very wide.
Danish: NeoRecormons terapeutiske margen er meget bred.
English: Be careful when taking out the syringe.
Danish: Vær forsigtig, når injektionssprøjten tages ud.
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 administrere rekombinante erythropoietiner bør bygge på en fordel-risiko-analyse med deltagelse af den enkelte patient.
English: These reactions were usually mild to moderate and went away within a few hours or days.
Danish: Disse symptomer er som oftest milde til moderate og forsvinder i løbet af få timer eller dage.
English: This may be associated with life-threatening complications of the cardiovascular system.
Danish: Dette kan føre til livstruende kardiovaskulære komplikationer.
English: Animal experiments revealed that epoetin beta does not increase the myelotoxicity of cytostatic medicinal products like etoposide, cisplatin, cyclophosphamide, and fluorouracil.
Danish: Dyreeksperimentelle studier viste, at epoetin beta ikke potenserer myelotoksiciteten af cytostatika, såsom etoposid, cisplatin, cyclofosfamid og fluorouracil.
English: Even at very high blood levels, no symptoms of poisoning have been observed.
Danish: Selv ved meget høje doser i blodet, er der ikke set symptomer på forgiftning.
English: · Set aside the syringe for 30 minutes so it can warm up on its own to room temperature.
Danish: ● Læg injektionssprøjten til side i 30 minutter, så den kan varme op til stuetemperatur.
English: Therefore this should be taken into consideration in patients affected with severe forms of phenylketonuria.
Danish: Dette bør tages i betragtning for patienter som lider af alvorlige former for phenylketonuri.
English: The maximum dose should not exceed 1600 IU/kg body weight per week for intravenous or 1200 IU/kg per week for subcutaneous administration.
Danish: Maksimal dosis må ikke overstige 1600 IE/kg legemsvægt pr. uge ved intravenøs eller 1200 IE/kg pr. uge ved subkutan administration.
English: Pharmacokinetic investigations in healthy volunteers and uraemic patients show that the half-life of intravenously administered epoetin beta is between 4 and 12 hours and that the distribution volume corresponds to one to two times the plasma volume.
Danish: Farmakokinetiske studier hos raske, frivillige personer og hos uræmiske patienter viser, at halveringstiden af intravenøst administreret epoetin beta er mellem 4 og 12 timer, og at fordelingsvolumenet svarer til 1-2 gange plasmavolumenet.
English: It is unknown whether epoetin beta is excreted in human milk.
Danish: Det vides ikke, om epoetin beta udskilles i human mælk.
English: After initiation of therapy, your doctor will maintain your haemoglobin level between 10 and 12 g/dL.
Danish: Efter påbegyndt behandling vil din læge opretholde dit hæmoglobinniveau på mellem 10 og 12 g/dl.
English: 18 Move the safety shield forward 90°, away from the syringe barrel (A).
Danish: Bevæg beskyttelseshylstret fremad 90°, væk fra injektionssprøjtens glasbeholder (A).
English: Your doctor will carry out regular blood tests to monitor how your anaemia is responding to treatment by measuring your haemoglobin level.
Danish: Din læge vil tage regelmæssige blodprøver for at overvåge, hvordan din anæmi responderer til behandlingen ved at måle dit hæmoglobinniveau.
English: The haemoglobin values should not exceed a value of 12 g/dL.
Danish: Hæmoglobinniveauet må ikke overstige en værdi på 12 g/dl.
English: Even at very high serum levels no symptoms of poisoning have been observed.
Danish: Selv ved høje serumniveauer er der ikke observeret symptomer på forgiftning.
English: After single dose administration of epoetin beta no effects on behaviour or locomotor activity of mice and circulatory or respiratory function of dogs were observed.
Danish: Efter en enkelt administration af epoetin beta kunne der ikke konstateres nogen virkninger på adfærd eller lokomotorisk aktivitet hos mus og kredsløbs- eller respirationsfunktion hos hunde.
English: Preparation of a single injection (1) Before withdrawing each dose disinfect the rubber seal of the device with alcohol.
Danish: Tilberedning af en enkelt injektion (1) Før udtagning af hver dosis desinficeres gummiproppen på devicet med sprit .