FrancophonIA/ELRC3.0 huggingface dataset:
English: In those situations in which the physician determines that a patient or caregiver can safely and effectively administer Retacrit subcutaneously themselves, instruction as to the proper dosage and administration should be provided.
Danish: I de situationer, hvor lægen bedømmer, at det er sikkert og effektivt at lade patienten selv eller en omsorgsperson administrere Retacrit subkutant, skal de modtage vejledning i korrekt dosering og administration.
English: Your doctor will check on this.
Danish: din læge kontrollerer dette.
English: You can press an antiseptic swab over the injection site for a few seconds after the injection.
Danish: Du kan presse en antiseptisk serviet på injektionsstedet i et par sekunder efter injektionen.
English: • You may be given iron supplements before and during Retacrit treatment to make it more effective.
Danish: • Du får måske et jerntilskud før og under behandlingen med Retacrit, for at gøre behandlingen mere effektiv.
English: • if you know, or think that it may have been accidentally frozen, or
Danish: • hvis du ved eller tror, at det ved et uheld har været nedfrosset eller
English: If you can't take medicines that prevent blood clotting, you must not have Retacrit.
Danish: Hvis du ikke kan tage lægemidler, der forebygger blodpropper, må du ikke tage Retacrit.
English: After 52 weeks, 57% of patients remained in the study, receiving a median dose of 200 IU/kg/week.
Danish: Efter 52 uger fortsatte 57 % af patienterne i studiet, hvor de fik en median dosis på 200 IE/kg/uge.
English: If signs and symptoms suggestive of these reactions appear, Retacrit should be withdrawn immediately and an alternative treatment considered.
Danish: Hvis der opstår tegn og symptomer, som tyder på sådanne reaktioner, skal Retacrit straks seponeres, og en alternativ behandling skal overvejes.
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 var hazard ratio for samlet overlevelse mellem 1,25 og 2,47 til fordel for kontrolgruppen.
English: This is more likely if you have low blood pressure or if your fistula has complications.
Danish: Det forekommer hyppigere, hvis du har lavt blodtryk, eller hvis du har komplikationer med fistlen.
English: Epoetin zeta should be used with caution in the presence of untreated, inadequately treated or poorly controllable hypertension.
Danish: Epoetin zeta skal anvendes med forsigtighed i tilfælde af ubehandlet, utilstrækkeligt behandlet eller dårlig kontrolleret hypertension.
English: • after the expiry date on the label and outer carton
Danish: • efter udløbsdatoen på etiketten og den ydre æske
English: Your doctor has carried out blood tests and decided you need Retacrit.
Danish: Din læge har taget blodprøver og besluttet, at du har behov for Retacrit.
English: If you are a patient with hepatitis C and you receive interferon and ribavirin
Danish: Hvis du har hepatitis C og får interferon og ribavirin
English: Your doctor may decide to increase your heparin dose during dialysis.
Danish: Din læge vil måske øge din heparindosis under dialysen.
English: Retacrit is indicated in adults in a predonation programme to increase the yield of autologous blood.
Danish: Retacrit er indiceret til voksne i et prædonationsprogram for at øge udbyttet af autologt blod.
English: Once the target haematocrit was achieved, the maintenance dose was individualised for each patient.
Danish: Når først den tilstræbte hæmatokritværdi var opnået, blev en individuel vedligeholdelsesdosis fastlagt for hver patient.
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: • Problem with the blood that may cause pain, dark coloured urine or increased sensitivity of the skin to sunlight (porphyria).
Danish: • Problemer med blodet, som kan give anledning til smerter, mørkfarvning af urinen eller øget hudfølsomhed over for sollys (porfyri).
English: It is unknown whether exogenous epoetin zeta is excreted in human milk.
Danish: Det vides ikke, om eksogent epoetin zeta udskilles i human mælk.
English: Iron supplements and other blood stimulants may increase the effectiveness of Retacrit.
Danish: Jerntilskud og andre blodstimulerende stoffer kan øge virkningen af Retacrit.
English: Do not double up the injections to make up for a forgotten dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Medicinal products that decrease erythropoiesis may decrease the response to epoetin zeta.
Danish: Lægemidler, der reducerer erytropoiesen, kan nedsætte responset på epoetin zeta.
English: • Do not remove the needle cover from the pre-filled syringe until you are ready to inject your medicine.
Danish: • Fjern ikke nålebeskyttelseshætten fra den fyldte sprøjte, før du er klar til at indsprøjte lægemidlet.
English: • Increased blood pressure.
Danish: • Blodtryksstigning.
English: Your doctor will monitor your blood pressure regularly while you are using Retacrit.
Danish: Lægen vil kontrollere dit blodtryk regelmæssigt, mens du får Retacrit.
English: During the maintenance phase, Retacrit can be administered either 3 times per week, and in the case of subcutaneous administration, once weekly or once every 2 weeks.
Danish: Under vedligeholdelsesfasen kan Retacrit administreres enten 3 gange ugentligt, eller i tilfælde af subkutan administration 1 gang ugentligt eller 1 gang hver 2. uge.
English: The median age of patients enrolled in the study was 11.6 years (range 0.5 to 20.1 years).
Danish: Medianalder for patienterne i studiet var 11,6 år (interval fra 0,5-20,1 år).
English: This medicinal product contains phenylalanine which may be harmful for people with phenylketonuria.
Danish: Dette lægemiddel indeholder phenylalanin, som kan være skadeligt for mennesker med fenylketonuri.
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-resultater fra humane tumorprøver tyder på, at erytropoietiner kan spille en rolle som tumorproliferatorer.
English: • if there has been a refrigerator failure.
Danish: • hvis der har været køleskabssvigt.
English: The product is for single use only.
Danish: Dette lægemiddel er kun til engangsbrug.
English: • If blood tests show your haemoglobin is too high before the operation, the treatment will be stopped.
Danish: • Hvis blodprøver viser, at dit hæmoglobintal er for højt før operationen, stoppes behandlingen.
English: Monitoring of the blood pressure should be performed, particularly at the start of therapy (see section 4.4).
Danish: Blodtrykket skal monitoreres, især i begyndelsen af behandlingen (se pkt.
English: • Retacrit is given by injection under the skin.
Danish: • Retacrit gives som en indsprøjtning under huden.
English: • When the needle is pulled out of your skin, there may be a little bleeding at the injection site.
Danish: • Når nålen trækkes ud af huden, kan det bløde lidt på injektionsstedet.
English: If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of Retacrit, treatment with Retacrit must not be restarted in this patient at any time.
Danish: Hvis patienten har udviklet en alvorlig kutan bivirkning, såsom SJS eller TEN på grund af brugen af Retacrit, må behandlingen med Retacrit ikke genoptages hos denne patient på noget tidspunkt.
English: Maintenance phase
Danish: Vedligeholdelsesfasen
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 2.833 patienter, hvoraf fire var dobbeltblindede placebokontrollerede studier og et var et åbent studie.
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 dobbeltblindede fase efterfulgt af en åben fase, hvor alle patienter fik epoetin alfa, og der blev observeret vedligeholdese af virkningen.
English: Dose (IU/kg given 3 times per week)
Danish: Dosis (IE/kg givet 3 gange ugentligt)
English: • For patients on peritoneal dialysis Retacrit may be given twice a week.
Danish: • Patienter i peritonealdialyse kan få Retacrit 2 gange om ugen.
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: Risikoen kan være højere, hvis du har andre risikofaktorer for at få blodpropper (f.eks hvis du tidligere har haft en blodprop, er overvægtig, har diabetes, har en hjertesygdom eller er sengeliggende i længere tid på grund af en operation eller sygdom).
English: There are no or limited amount of data from the use of epoetin zeta in pregnant women.
Danish: Der foreligger ingen eller begrænsede data om anvendelse af epoetin zeta til gravide kvinder.
English: Do not use this medicine if you notice that the seal is broken or if the liquid is coloured or you can see particles floating in it.
Danish: Brug ikke dette lægemiddel, hvis du kan se, at forseglingen er brudt, at væsken er farvet, eller at der flydende partikler i den.
English: ESAs are not indicated for use in this patient population,
Danish: ESA er ikke indiceret til denne patientgruppe,
English: The absolute bioavailability of subcutaneous injectable erythropoietin is approximately 20% in healthy subjects.
Danish: Den absolutte biotilgængelighed af subkutant injicerbart erythropoietin er ca. 20 % hos raske forsøgspersoner.
English: • If you are a cancer patient be aware that products that stimulate red blood cell production (like Retacrit) may act as a growth factor and therefore in theory may affect the progression of your cancer.
Danish: • Hvis du er kræftpatient, skal du være opmærksom på, at lægemidler, der stimulerer dannelsen af røde blodlegemer (som Retacrit), kan virke som en vækstfaktor og derfor teoretisk set kan påvirke, hvordan din kræft udvikler sig.
English: • For adults and children Retacrit is given as an injection either into a vein (intravenously) or a tube that goes into a vein.
Danish: • Hos voksne og børn gives Retacrit som en indsprøjtning enten i en vene (intravenøst) eller i en slange, der fører ind i en vene.
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, især pludselig, stikkende, migrænelignende hovedpine, forvirring eller krampeanfald kan være tegn på en pludselig stigning i blodtrykket.
English: The cause of your anaemia is also a factor in your doctor deciding the correct dose.
Danish: Årsagen til din blodmangel har også betydning, når din læge fastsætter den korrekte dosis.
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 livskvalitetsparametre på henholdsvis EORTC-QLQ-C30- og CLAS-skalaen.
English: Your doctor will decide if it is right for you to take them.
Danish: Din læge afgør, om du kan tage dem.
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 viste forbedringer i deres livskvalitet, der blev opretholdt i yderligere 12 måneder.
English: In all patients receiving epoetin zeta, blood pressure should be closely monitored and controlled as necessary.
Danish: Hos alle patienter i behandling med epoetin zeta, skal blodtrykket kontrolleres nøje og behandles efter behov.
English: When treatment starts, Retacrit is usually injected by medical professional or a nurse.
Danish: Når behandlingen starter, indsprøjtes Retacrit normalt af en læge eller en sygeplejerske.
English: If blood pressure cannot be controlled, epoetin zeta treatment should be discontinued.
Danish: Hvis blodtrykket ikke kan kontrolleres, skal behandling med epotin zeta seponeres.
English: The median time to target was 11 weeks and the median dose at target was 150 IU/kg/week.
Danish: Den mediane tid til målniveauet var 11 uger, og den mediane dosis ved målniveauet var 150 IE/kg/uge.
English: • Once your anaemia has been corrected, your doctor will continue to check your blood regularly.
Danish: • Når din blodmangel er korrigeret, fortsætter lægen med at kontrollere dit blod regelmæssigt.
English: Do not freeze or shake.
Danish: Må ikke fryses eller rystes.
English: If you forget to use Retacrit
Danish: Hvis du har glemt at bruge Retacrit
English: • If you are allergic to epoetin zeta or any of the other ingredients of this medicine (listed in section
Danish: • hvis du er allergisk over for epoetin zeta eller et af de øvrige indholdsstoffer i Retacrit (anført i pkt.
English: Retacrit can reduce the need for a blood transfusion.
Danish: Retacrit kan nedsætte behovet for blodtransfusion.
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: Der er ikke indberettet specifikke pædiatriske bivirkninger, der ikke er nævnt tidligere i ovenstående tabel, eller som ikke svarede til den underliggende sygdom, i denne population.
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 udlægges som sekundære til nedsat vægtstigning hos moderdyret, og relevansen for mennesker er ukendt på grund af de terapeutiske dosisniveauer.
English: • Pinch a fold of skin between your thumb and index finger.
Danish: • Klem en hudfold mellem tommel- og pegefinger.
English: Influenza-like illness may occur especially at the start of treatment.
Danish: Der kan forekomme influenzalignende symptomer, især i begyndelsen af behandlingen.
English: Treatment with Retacrit has to be initiated under the supervision of physicians experienced in the management of patients with above indications.
Danish: Behandling med Retacrit skal indledes under opsyn af en læge, som har erfaring i behandling af patienter med ovennævnte indikationer.
English: PRCA has been very rarely reported mostly in patients with kidney disease after months to years of treatment with Retacrit and other products that stimulate red blood cell production.
Danish: PRCA er blevet indberettet i meget sjældne tilfælde efter behandling i månedsvis eller årevis med Retacrit og andre produkter, som stimulerer produktionen af røde blodlegemer.
English: • You will usually continue Retacrit treatment for one month after the end of chemotherapy.
Danish: • Du fortsætter normalt behandlingen med Retacrit i 1 måned efter afslutningen af kemoterapien.
English: In controlled clinical studies, use of epoetin zeta and other ESAs have been associated with decreased locoregional tumour control or decreased overall survival:
Danish: I kontrollerede kliniske studier er anvendelsen af epoetiner zeta og andre ESA'er blevet forbundet med nedsat lokoregional tumorkontrol eller nedsat samlet overlevelse:
English: No evidence exists that indicates that treatment with epoetin zeta alters the metabolism of other medicinal products.
Danish: Det er ikke dokumenteret, at behandling med epoetin zeta ændrer andre lægemidlers metabolisme.
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 dannelse af røde bloglegemer (så lægen kan tappe mere blod fra dig ), hvis du ikke kan få transfusion med dit eget blod under eller efter en operation.
English: • Always use Retacrit exactly as instructed by your doctor or nurse.
Danish: • Brug altid Retacrit nøjagtigt efter lægens eller sygeplejerskens anvisning.
English: No unexpected adverse events were reported (see section 4.2).
Danish: Der blev ikke indberettet nogen uventede bivirkninger (se pkt.
English: Stop using Retacrit if you develop these symptoms and contact your doctor or seek medical attention immediately.
Danish: Stop med at bruge Retacrit, hvis du udvikler disse symptomer, og kontakt straks din læge eller søg lægehjælp.
English: • Blood clots (thrombosis) may form in your dialysis shunt.
Danish: • Der kan dannes blodpropper (tromboser) i din dialyse-shunt.
English: Retacrit is given alone and not mixed with other liquids for injection.
Danish: Retacrit indgives alene og må ikke blandes med andre injektionsvæsker.
English: • If you are due to have major elective orthopaedic surgery (such as hip or knee surgery), and you:
Danish: • hvis du skal have foretaget en større planlagt ortopædisk operation (f.eks. en hofte- eller knæoperation), og du:
English: Retacrit and other products that stimulate red cell production may increase the risk of developing blood clots in all patients.
Danish: Retacrit og andre produkter, der stimulerer dannelsen af røde blodlegemer, kan øge risikoen for at udvikle blodpropper hos alle patienter.
English: In addition, there was no statistical difference between the proportion of patients requiring pRBC transfusions between the Epoetin alfa group and placebo.
Danish: Desuden var der ingen statistisk forskel i andelen af patienter, der havde brug for transfusioner af pakkede erytrocytter mellem epoetin alfa-gruppen og placebogruppen.
English: All special warnings and special precautions associated with autologous predonation programmes, especially routine volume replacement, should be respected.
Danish: Alle særlige advarsler og særlige forsigtighedsregler associeret med autologe prædonationsprogrammer bør tages i betragtning, især rutinemæssig erstatning af blodtab.
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 først en sprøjte er taget ud af køleskabet og har opnået stuetemperatur (op til 25 °C), skal den enten bruges i løbet af 3 dage eller bortskaffes.
English: Retacrit may be given by injection:
Danish: Retacrit kan gives som en indsprøjtning:
English: • If you do not respond adequately to Retacrit, your doctor will check your dose and will inform you if you need to change doses of Retacrit.
Danish: • Hvis du ikke reagerer tilstrækkeligt på Retacrit, vil din læge kontrollere dosis og informere dig, hvis du har brug for at ændre dosis af Retacrit.
English: The decision to administer recombinant erythropoietin treatment 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 vurdering af fordele og risici og med inddragelse af den enkelte patient, og der skal tages højde for den specifikke kliniske sammenhæng.
English: After EPO binds to its cell surface receptor, it activates signal transduction pathways that interfere with apoptosis and stimulates erythroid cell proliferation.
Danish: Efter binding til celleoverfladens receptor aktiverer EPO overførslen af signaler, der interferer med apoptose og stimulerer erytrocytternes proliferation.
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 påvirkes af jerndepoter og tilstedeværelsen af andre medicinske problemer.
English: No evidence exists that indicates an interaction between epoetin zeta and G-CSF or GM-CSF with regard to haematological differentiation or proliferation of tumour biopsy specimens in vitro.
Danish: Der er ingen information, som tyder på interaktion mellem epoetin zeta og G-CSF eller GM-CSF med hensyn til hæmatologisk differentiering eller proliferation af tumorbiopsier in vitro.
English: • The usual starting dose of Retacrit for adults and children is 50 International Units (IU) per kilogram (/kg) of body weight given three times a week.
Danish: • Den sædvanlige startdosis af Retacrit til voksne og børn er 50 internationale enheder (IE) pr. kilogram (/kg) legemsvægt, indgivet 3 gange om ugen.
English: • If you are having dialysis treatment when you begin treatment with Retacrit, your dialysis regime may need to be adjusted.
Danish: • Hvis du får dialysebehandling, når du påbegynder behandlingen med Retacrit, er det muligt at din dialysebehandling skal justeres.
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 den næste indsprøjtning, skal du ignorere den glemte indsprøjtning, og fortsætte efter den normale plan.
English: Only take one dose of Retacrit from each syringe.
Danish: Tag kun én dosis Retacrit fra hver sprøjte.
English: • Symptoms of pure red cell aplasia (PRCA)
Danish: • Symptomer på Pure Red Cell Aplasia (PRCA)
English: Later, your doctor may suggest that you or your caregiver learn how to inject Retacrit under the skin (subcutaneously) yourself.
Danish: Senere kan lægen foreslå, at du selv eller din omsorgsperson lærer, hvordan man indsprøjter Retacrit under huden (subkutant).
English: Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Danish: Erythropoietinreceptorer kan udtrykkes på overfladen af en række forskellige tumorceller.
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 overvåges nøje for hudreaktioner.
English: Usually the injections will be given to you by a doctor, nurse or other health care professional.
Danish: Normalt får du indsprøjtningerne af en læge, en sygeplejerske eller en anden sundhedsperson.
English: Autologous predonation programme
Danish: Autologt prædonationsprogram
English: The injections should be given in the limbs or the anterior abdominal wall.
Danish: Injektionen bør gives i ekstremiteterne eller den forreste abdominalvæg.
English: • anaemia from other causes
Danish: • blodmangel af andre årsager
English: In order to improve the traceability of ESAs, the trade name and the batch number of the administered ESA should be clearly recorded (or stated) in the patient file.
Danish: For at forbedre sporbarheden af ESA'er skal handelsnavnet og batchnummeret på det adminstrerede ESA tydeligt registreres (eller.
English: Do not use Retacrit:
Danish: Brug ikke Retacrit:
English: Hypertension, Venous and arterial thrombosis
Danish: Hypertension, venøs og arteriel trombose
English: If you are taking a medicine called cyclosporin (used e.g. after kidney transplants), your doctor may order blood tests to check the level of cyclosporin while you are taking Retacrit.
Danish: Hvis du tager et lægemiddel der hedder ciclosporin (bruges f.eks. efter en nyretransplantation), kan lægen bestille blodprøver for at kontrollere niveauet af ciclosporin, mens du tager Retacrit.
English: • if the liquid is coloured or you can see particles floating in it,
Danish: • hvis væsken er farvet, eller der ses flydende partikler i den
English: Please discuss this with your doctor.
Danish: Drøft dette med din læge.
English: - The active substance is epoetin zeta (produced by recombinant DNA technology in Chinese
Danish: - Aktivt stof: epoetin zeta (fremstillet ved hjælp af rekombinant DNA-teknologi i CHO