FrancophonIA/ELRC3.0 huggingface dataset:
English: Meta-analyses also indicate consistently a significantly increased relative risk of thromboembolic events in cancer patients receiving recombinant human erythropoietin (see section 4.4).
Danish: Meta-analyser indikerer også overensstemmende en signifikant øget relativ risiko for tromboemboliske hændelser hos cancerpatienter, som får rekombinant humant erytropoietin (se pkt.
English: MIRCERA has not been studied in pregnant or breast-feeding women.
Danish: MIRCERA er ikke undersøgt hos gravide eller ammende kvinder.
English: The safety and efficacy of MIRCERA therapy has not been established in patients with haemoglobinopathies, seizures, bleeding or a recent history of bleeding requiring transfusions or with platelet levels greater than 500 x 109/l.
Danish: Sikkerhed og virkning af behandling med MIRCERA er ikke dokumenteret hos patienter med hæmoglobinopatier, kramper, blødning eller nylig blødning, som kræver tranfusion, eller hos patienter med trombocyttal over 500 x 109/l.
English: Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard or not intact.
Danish: Injicer ikke i modermærker, ar, blå mærker eller områder, hvor huden er øm, rød, hård eller beskadiget.
English: Alternatively, a starting dose of 0.6 microgram/kg bodyweight may be administered once every two weeks as a single intravenous or subcutaneous injection in patients on dialysis or not on dialysis.
Danish: Alternativt kan en initialdosis på 0,6 mikrogram/kg legemsvægt administreres én gang hver 2. uge som en enkelt intravenøs eller subkutan injektion til patienter, som er eller ikke er i dialyse.
English: The first injection should start at the next scheduled dose of the previously administered darbepoetin alfa or epoetin.
Danish: Den første injektion skal gives på tidspunktet for den næste planlagte dosis af det tidligere administrerede darbepoetin alfa eller epoetin.
English: Place a sterile cotton ball or gauze over the injection site and press for several seconds.
Danish: • Pres et stykke sterilt vat eller gaze over injektionsstedet i et par sekunder.
English: Do not release the plunger before the end of injection or before the plunger is completely depressed.
Danish: Slip ikke stemplet, før injektionen er slut, eller før stemplet er trykket helt i bund.
English: MIRCERA pre-filled syringe Instructions For Use
Danish: MIRCERA fyldt injektionssprøjte Instruktioner vedrørende anvendelse
English: Your doctor will decide to treat you with MIRCERA administered as a single injection once a month.
Danish: Lægen afgør, om du skal behandles med MIRCERA som en injektion én gang om måneden.
English: Name and address of the manufacturer responsible for batch release for the pre-filled syringes
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse af fyldte injektionssprøjter
English: • If you are a patient with chronic kidney disease and anemia treated with an ESA and are also a cancer patient you should be aware that ESAs, might have a negative impact on your condition.
Danish: • Hvis du har en kronisk nyresygdom og blodmangel, som behandles med et erytropoiesestimulerende stof (ESA), og du også har kræft, skal du være opmærksom på at ESAs kan have en negativ indflydelse på din tilstand.
English: · Do not use the pre-filled syringe if syringe, or the plastic tray containing the syringe appears to be damaged.
Danish: • Brug ikke den fyldte injektionssprøjte, hvis injektionssprøjten, den ydre pakning, eller plastikbakken, der indeholder injektionssprøjten, ser ud til at være beskadiget.
English: MIRCERA has not shown evidence of impaired fertility in animals.
Danish: For MIRCERA er der ikke bevis for nedsat frugtbarhed hos dyr.
English: If high blood pressure is difficult to control by medical treatment or dietary measures, the dose must be reduced or administration discontinued (see section 4.2).
Danish: Hvis for højt blodtryk er vanskeligt at kontrollere med medicinsk behandling eller med kostforanstaltninger, skal dosis nedsættes, eller behandlingen seponeres (se pkt.
English: • Your doctor may initiate treatment with MIRCERA if your haemoglobin level is 10 g/dl (6.21 mmol/l) or less.
Danish: • Din læge kan påbegynde behandling med MIRCERA, hvis dit hæmoglobinniveau er 10 g/dl (6,21 mmol/l) eller lavere.
English: If you have developed PRCA, your MIRCERA treatment will be discontinued.
Danish: Hvis du har fået PRCA, vil behandlingen med MIRCERA blive stoppet.
English: The potency of methoxy polyethene glycol-epoetin beta should not be compared to the potency of another pegylated or non-pegylated protein of the same therapeutic class.
Danish: Virkningsgraden af methoxypolyethylenglycol-epoetin beta bør ikke sammenlignes med andre pegylerede eller ikke-pegylerede proteiner i den samme terapeutiske klasse.
English: Data from a controlled clinical trial with epoetin alfa or darbepoetin alfa reported an incidence of stroke as common.
Danish: Data fra et kontrolleret klinisk studie med epoetin alfa eller darbepoetin alfa viste, at hyppigheden af apopleksi er almindelig.
English: It can be injected subcutaneously in the abdomen, arm or thigh.
Danish: Det kan injiceres subkutant i abdomen, arm eller lår.
English: METHOD OF ADMINISTRATION Read the package leaflet before use
Danish: ADMINISTRATIONSMETODE Læs indlæssedlen før brug
English: In case PRCA is diagnosed, therapy with MIRCERA must be discontinued and patients should not be switched to another ESA.
Danish: Hvis diagnosen PRCA stilles, skal behandlingen med MIRCERA afbrydes, og patienten skal ikke skiftes over til et andet ESA.
English: Using it can lead to too high haemoglobin levels and cause problems with the heart or blood vessels that may be life-threatening.
Danish: Det kan medføre for høj hæmoglobinkoncentration og give problemer med hjerte og blodkar, som kan være livstruende.
English: If you are on dialysis, the recommended starting dose is 0.6 micrograms for every kilogram of your body weight.
Danish: Hvis du er i dialyse, er den anbefalede startdosis 0,6 mikrogram pr. kg legemsvægt.
English: Treatment with MIRCERA is not recommended in children and adolescents, because it has not been studied in these patients.
Danish: Børn og unge bør ikke behandles med MIRCERA, fordi det ikke er undersøgt hos disse patientgrupper.
English: A common side effect (may affect up to 1 in 10 people) is hypertension (high blood pressure).
Danish: En almindelig bivirkning (forekommer hos mellem 1 og 10 patienter/behandlede ud af 100) er hypertension (forhøjet blodtryk).
English: If you develop a serious rash or another of these skin symptoms stop taking Mircera and contact your doctor or seek medical attention immediately.
Danish: Hvis du udvikler et alvorligt udslæt eller får andre af disse hudsymptomer, skal du stoppe med at tage Mircera og straks kontakte din læge eller søge lægehjælp.
English: Physical, cognitive, or sexual developments in the offspring of mothers receiving methoxy polyethylene glycol-epoetin beta during gestation and lactation were not affected.
Danish: Den fysiske, kognitive eller seksuelle udvikling hos afkom af moderdyr, der fik methoxypolyethylenglycol-epoetin beta under drægtighed og diegivning, blev ikke påvirket.
English: Caution should be exercised with escalation of MIRCERA doses in patients with chronic renal failure since high cumulative epoetin doses may be associated with an increased risk of mortality, serious cardiovascular and cerebrovascular events.
Danish: Der skal udvises forsigtighed ved øgning af Mircera-dosis hos patienter med kronisk nyreinsufficiens, da høje kumulative doser af epoetin kan være associeret med en øget risiko for død og alvorlige kardiovaskulære og cerebrovaskulære hændelser.
English: During treatment with MIRCERA
Danish: Under behandlingen med MIRCERA
English: Failure to respond to MIRCERA therapy should prompt for a search for causative factors.
Danish: Manglende respons på behandling med MIRCERA bør give anledning til en søgen efter kausale årsager.
English: Pooled post-hoc analyses of clinical studies of ESAs have been performed in chronic renal failure patients (on dialysis, not on dialysis, in diabetic and non-diabetic patients).
Danish: Samlede post-hoc analyser af kliniske studier med ESAs har været udført hos patienter med kronisk nyreinsufficiens (i dialyse, ikke i dialyse, med diabetes og uden diabetes).
English: • It is not known if MIRCERA has a different effect in patients with haemoglobinopathies (disorders associated with abnormal haemoglobin), past or present bleeding, seizures or with a high blood platelet count.
Danish: • Det vides ikke om MIRCERA har en anden virkning på patienter med hæmoglobinopatier (sygdomme, som ledsages af unormalt hæmoglobin), tidligere eller nuværende blødning, kramper eller højt trombocyttal.
English: PRCA in patients with Hepatitis C: A paradoxical decrease in haemoglobin and development of severe anaemia associated with low reticulocyte counts should prompt to discontinue treatment with epoetin and perform anti-erythropoietin antibody testing.
Danish: PRCA hos patienter med hepatitis C: Ved en paradoks reduktion i hæmoglobin og udvikling af svær anæmi associeret med lave reticulocyttal skal behandling med epoetin straks ophøre og antierytropoietin-antistofmåling udføres.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Danish: Yderligere oplysninger om MIRCERA findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: In a post-authorisation safety study with long treatment exposure of up to 8.4 years, baseline platelet counts below 100 x 109/l was present in 2.1% of patients in the MIRCERA group and 2.4% of patients in other ESAs group.
Danish: I et sikkerhedsstudie udført efter udstedelse af markedsføringstilladelse med lang behandlingstid op til 8,4 år, blev der set baseline trombocyttal under 100 x 109/l hos 2,1 % af patienterne i MIRCERA gruppen og 2,4 % af patienterne i andre ESAs grupper.
English: The safety and efficacy of MIRCERA therapy in other indications, including anaemia in patients with cancer, has not been established.
Danish: Sikkerhed og virkning af behandling med MIRCERA til andre indikationer, inklusive anæmi hos patienter med kræft er ikke dokumenteret.
English: Patients should be monitored closely to ensure that the lowest approved effective dose of MIRCERA is used to provide adequate control of the symptoms of anaemia whilst maintaining a haemoglobin concentration below or at 12 g/dl (7.45 mmol/l).
Danish: Patienter bør nøje monitoreres for at sikre, at den lavest godkendte effektive dosis MIRCERA anvendes til at sikre tilstrækkelig kontrol af de anæmiske symptomer, mens hæmoglobinkoncentration holdes under eller på 12 g/dl (7,45 mmol/l).
English: Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.06 in favour of controls (95% CI: 1.00, 1.12; 53 trials and 13,933 patients) and for the cancer patients receiving chemotherapy, the overall survival hazard ratio was 1.04 (95% CI: 0.97, 1.11; 38 trials and 10,441 patients).
Danish: En meta-analyse af data for total overlevelse gav et hazard ratio punktestimat på 1,06 til fordel for kontrolgruppen (95% konfidensinterval: 1,00-1,12; 53 forsøg og 13.933 patienter); for de cancerpatienter, som fik kemoterapi, var hazard ratio for total overlevelse 1,04 (95% konfidensinterval: 0,97-1,11; 38 forsøg og 10.441 patienter).
English: If your blood pressure is high and cannot be controlled, either by appropriate medicines or a special diet, your doctor will interrupt your MIRCERA treatment or reduce the dose.
Danish: Hvis blodtrykket er for højt og ikke kan kontrolleres med passende medicin eller diæt, vil lægen stoppe behandlingen med MIRCERA eller sætte dosis ned.
English: If you miss a dose of MIRCERA administer the missed dose as soon as you remember and talk to your doctor about when to use the next doses.
Danish: Hvis du glemmer en dosis MIRCERA, skal du tage den glemte dosis så snart, du kommer i tanke om det og spørge din læge om, hvornår du skal tage de næste doser.
English: Only one dose should be administered per syringe.
Danish: Der må kun gives en dosis pr. sprøjte.
English: Step 4.
Danish: Se punkt 4.
English: Further injections can be given by a healthcare professional or, after you have been trained, you can inject MIRCERA yourself (see instructions at the end of this leaflet.)
Danish: Du kan også selv injicere MIRCERA, efter du er blevet trænet (se vejledningen i slutningen af indlægssedlen).
English: Four randomized controlled studies were performed in dialysis patients currently treated with darbepoetin alfa or epoetin at the time of enrollment.
Danish: Der er udført fire randomiserede, kontrollerede studier med dialysepatienter, som ved studiestart blev behandlet med enten darbepoetin alfa eller epoetin.
English: Once you have removed your medicine from the refrigerator you must use it within this period of one month.
Danish: Når først lægemidlet er taget ud af køleskabet, skal det anvendes indenfor denne periode på en måned.
English: Monthly MIRCERA intravenous or subcutaneous dose (microgram/once monthly)
Danish: Månedlig dosis af MIRCERA, intravenøst eller subkutant (mikrogram/én gang månedligt)
English: A rise in haemoglobin of greater than 2 g/dl (1.24 mmol/l) over a four-week period should be avoided.
Danish: En stigning i hæmoglobin på mere en 2 g/dl (1,24 mmol/l) over en 4 ugers periode bør undgås.
English: If your healthcare professional has recommended injection of MIRCERA into a vein, you should follow the procedure described below.
Danish: Hvis sundhedspersonalet har informeret dig om at injicere MIRCERA i en vene, skal du følge anvisningen beskrevet herunder.
English: Remove the plastic tray of the MIRCERA pre-filled syringe from the box without peeling back the protective film.
Danish: Tag plastikbakken med MIRCERA fyldt injektionssprøjte ud af æsken uden at fjerne beskyttelsesfilmen.
English: Haemoglobin concentration: In patients with chronic kidney disease, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2.
Danish: Hæmoglobinkoncentration: Hos patienter med kronisk nyreinsufficiens bør opretholdelse af hæmoglobinkoncentrationen ikke overskride den øvre grænse for den ønskede hæmoglobinkoncentration, som anbefalet under pkt.
English: The following instructions explain how to use the MIRCERA pre-filled syringe to give yourself an injection.
Danish: Følgende instruktioner forklarer, hvordan du skal bruge MIRCERA fyldte injektionssprøjter, når du selv skal foretage injektionen.
English: · Do not remove the needle shield until you are ready to perform an injection.
Danish: • Fjern ikke kanylens beskyttelseshætte, før du er klar til at injicere.
English: Studies in animals have shown no evidence of impaired fertility (see section 5.3).
Danish: Dyreforsøg har vist, at der ikke er nogen evidens for nedsat fertilitet (se pkt.
English: • If you are not currently treated with an ESA If you are not on dialysis, the recommended starting dose of MIRCERA is 1.2 micrograms for every kilogram of your body weight to be administered under the skin once every month as a single injection.
Danish: • Hvis du ikke er i behandling med et ESA Hvis du ikke er i dialyse, er den anbefalede startdosis af MIRCERA 1,2 mikrogram pr.kg legemsvægt, som skal gives som en enkelt injektion under huden en gang om måneden.
English: The carcinogenic potential of methoxy polyethylene glycol-epoetin beta has not been evaluated in long-term animal studies.
Danish: Methoxypolyethylenglycol-epoetin betas carcinogene potentiale er ikke undersøgt i langtidsdyreforsøg.
English: · Never re-use a syringe.
Danish: • Genbrug aldrig en injektionssprøjte.
English: The dose is to be administered once every two weeks as a single injection under the skin or into a vein.
Danish: Dosis skal gives én gang hver 2. uge som en enkelt injektion under huden eller i en vene.
English: When MIRCERA was administered subcutaneously to male and female rats prior to and during mating, reproductive performance, fertility, and sperm assessment parameters were not affected.
Danish: Når MIRCERA blev administreret subkutant til han- og hunrotter før og under parring, blev parametre til vurdering af forplantningsevne, fertilitet og sæd ikke påvirket.
English: Remove the box containing the MIRCERA pre-filled syringe from the refrigerator.
Danish: Tag æsken indeholdende MIRCERA fyldt injektionssprøjte ud af køleskabet.
English: • Your doctor will check that your haemoglobin does not exceed a certain level, as high haemoglobin could put you at risk of having a problem of the heart or the blood vessels and could increase risk of thrombosis, including pulmonary embolism, myocardial infarction, stroke and death.
Danish: • Din læge vil kontrollere, at dit hæmoglobin ikke overskrider et bestemt niveau, da højt hæmoglobin kan medføre risiko for problemer med hjerte og blodkar og øge risikoen for blodprop, inklusive blodprop i lungen, hjerteanfald, slagtilfælde og død.
English: • vascular access thrombosis (blood clots in your dialysis access).
Danish: • blodpropper i adgangen til blodkarrene ved dialyse (fisteltromboser)
English: You may remove your MIRCERA pre-filled syringe from the refrigerator and store it at a room temperature not above 30 °C for a single period of one month.
Danish: Du må gerne tage din MIRCERA fyldte sprøjte ud af køleskabet og opbevare den ved stuetemperatur i en enkelt periode på én måned, dog ikke ved temperaturer over 30 ºC.
English: Table 1: MIRCERA starting doses Previous weekly darbepoetin alfa intravenous or subcutaneous dose (microgram/week)
Danish: Tabel 1: MIRCERA initialdosis Tidligere ugentlig dosis af darbepoetin alfa, intravenøst eller subkutant (mikrogram/uge)
English: METHOD AND ROUTE(S) OF ADMINISTRATION For subcutaneous or intravenous use Read the package leaflet before use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til subkutan eller intravenøs anvendelse Læs indlægssedlen inden brug
English: These antibodies have been shown to cross-react with all ESAs, and patients suspected or confirmed to have antibodies to erythropoietin should not be switched to MIRCERA (see section 4.8).
Danish: Det er vist, at disse antistoffer krydsreagerer med alle ESAs, og patienter, som mistænkes for eller vides at have antistoffer over for erytropoietin, bør derfor ikke skiftes over til MIRCERA (se pkt.
English: 4.2 Posology and method of administration.
Danish: 4.2 Dosering og administration
English: Patients not currently treated with an erythropoiesis stimulating agent (ESA): In order to increase haemoglobin levels to greater than 10 g/dl (6.21 mmol/l), the recommended starting dose in patients not on dialysis is 1.2 microgram/kg body weight, administered once every month as a single subcutaneous injection.
Danish: Patienter, som ikke i øjeblikket er i behandling med et erytropoiese-stimulerende agens (ESA): For at øge hæmoglobinniveauerne til over 10 g/dl (6,21 mmol/l) er den anbefalede initialdosis til patienter, som ikke er i dialyse, 1,2 mikrogram/kg legemsvægt, administreret én gang om måneden som én enkelt subkutan injektion.
English: If you are advised to inject MIRCERA under your skin, please administer your dose as described below.
Danish: Hvis du er blevet informeret om at injicere MIRCERA under huden, skal du indgive dosis som beskrevet herunder.
English: In case PRCA is diagnosed, therapy with MIRCERA must be discontinued, and patients should not be switched to another recombinant erythropoietic protein (see section 4.4).
Danish: Hvis PRCA diagnosticeres, skal behandlingen med MIRCERA seponeres, og patienterne bør ikke skiftes til et andet rekombinant erytropoietisk protein (se pkt.
English: • hypertensive encephalopathy (very high blood pressure that can result in headache, especially sudden, stabbing, migraine-like headache, confusion, speech disturbances, fits or convulsions).
Danish: • meget højt blodtryk, som kan give hovedpine, specielt pludselig, bankende migrænelignende hovedpine, forvirring, taleforstyrrelser, kramper (hypertensiv encefalopati).
English: Previous weekly epoetin intravenous or subcutaneous dose (IU/week)
Danish: Tidligere ugentlig dosis af epoetin, intravenøst eller subkutant (IE/uge)
English: · Never attempt to take the syringe apart.
Danish: • Forsøg aldrig at skille injektionssprøjten ad.
English: Like the natural hormone erythropoietin, MIRCERA increases the number of red blood cells and haemoglobin level in your blood.
Danish: Ligesom det naturlige hormon erytropoietin øger det antallet af røde blodlegemer og blodprocenten i dit blod.
English: Before treatment with MIRCERA
Danish: Før behandling med MIRCERA
English: The dose may be increased by approximately 25% of the previous dose if the rate of rise in haemoglobin is less than 1.0 g/dl (0.621 mmol/l) over a month.
Danish: Dosis kan øges med ca. 25 % af den tidligere dosis, hvis hæmoglobinkoncentrationen øges med mindre end 1,0 g/dl (0,621 mmol/l) på en måned.
English: Slowly push the plunger with the thumb while holding the syringe with the forefinger and the middle finger against the finger grips until all the medicine is injected.
Danish: Tryk stemplet langsomt ind med tommelfingeren, mens injektionssprøjten holdes med pegefingeren og langfingeren mod fingergrebene, indtil al medicinen er injiceret.
English: Thrombosis*
Danish: Trombose*
English: MIRCERA is indicated to treat only the symptomatic anaemia caused by chronic kidney disease.
Danish: MIRCERA bruges kun til behandling af symptomatisk blodmangel, som skyldes kronisk nyresygdom.
English: The strength indicates the quantity of the protein moiety of the methoxy polyethylene glycol-epoetin beta molecule without consideration of the glycosylation.
Danish: Styrken angiver mængden af proteinindholdet i methoxypolyethylenglycol-epoetin betamolekylet uden hensyn til glycosyleringen.
English: Treatment with MIRCERA has to be initiated under the supervision of a physician experienced in the management of patients with renal impairment.
Danish: Behandling med MIRCERA skal påbegyndes under supervision af en læge med erfaring med behandling af patienter med kronisk nyreinsufficiens.
English: Push the plunger with the thumb while holding the syringe with the forefinger and the middle finger against the finger grips until all the medicine is injected.
Danish: Tryk stemplet ind med tommelfingeren, mens injektionssprøjten holdes med pegefingeren og langfingeren mod fingergrebene, indtil al medicinen er injiceret.
English: • Your doctor will check the amount of iron in your blood before and during MIRCERA treatment.
Danish: • Din læge vil kontrollere jernindholdet i blodet før og under behandlingen med MIRCERA.
English: A comparison of serum concentrations of methoxy polyethylene glycol-epoetin beta measured before and after haemodialysis in 41 CKD patients showed that haemodialysis has no effect on the pharmacokinetics of this medicinal product.
Danish: En sammenligning af serumkoncentrationerne af methoxypolyethylenglycol-epoetin beta hos 41 kronisk nyreinsufficiente patienter, bestemt før og efter hæmodialyse, viste at hæmodialyse ingen effekt har på farmakokinetikken af dette lægemiddel.
English: The elimination half-life after intravenous administration of methoxy polyethylene glycol-epoetin beta is 134 hours.
Danish: Eliminationshalveringstiden efter intravenøs administration af methoxypolyethylenglycol-epoetin beta er 134 timer.
English: In clinical trials, an increased risk of death, serious cardiovascular events including thrombosis or cerebrovascular events including stroke was observed when ESAs were administered to target a haemoglobin of greater than 12 g/dl (7.5 mmol/l) (see section 4.8).
Danish: I kliniske studier blev der observeret en øget risiko for død og alvorlige kardiovaskulære hændelser, inklusive trombose eller cerebrovaskulære hændelser, inklusive apopleksi, når ESAs blev administreret for at opnå en hæmoglobinkoncentration over 12 g/dl (7,5 mmol/l) (se pkt.
English: MIRCERA can be injected under the skin in the abdomen, arm or thigh; or into a vein.
Danish: MIRCERA kan injiceres under huden på maven, armen eller låret eller i en vene.