FrancophonIA/ELRC3.0 huggingface dataset:
English: • An increase in levels of small blood cells (called platelets), which are normally involved in the formation of a blood clot may occur, particularly when starting treatment.
Danish: • Der kan forekomme en stigning i niveauet af små blodlegemer (kaldet blodplader), som normalt medvirker til dannelsen af en blodprop, især ved behandlingsstart.
English: Treatment with Silapo has to be initiated under the supervision of physicians experienced in the management of patients with above indications.
Danish: Behandling med Silapo skal indledes under opsyn af en læge, som har erfaring i behandling af patienter med ovennævnte indikationer.
English: In some pre-clinical toxicological studies in dogs and rats, but not in monkeys, erythropoietin therapy was associated with subclinical bone marrow fibrosis (bone marrow fibrosis is a known complication of chronic renal failure in humans and may be related to secondary hyperparathyroidism or unknown factors.
Danish: I nogle prækliniske toksikologiske undersøgelser med hunde og rotter, men ikke aber, blev erythropoietin-terapien associeret med subklinisk knoglemarvsfibrose (knoglemarvsfibrose er en kendt komplikation ved kronisk nyresvigt hos mennesker og kan relateres til sekundær hyperparatyroidisme eller ukendte faktorer.
English: Silapo is indicated for non-iron deficient adults prior to major elective orthopaedic surgery having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions.
Danish: Silapo er indiceret til voksne uden jernmangel før en større elektiv ortopædisk operation, hvor der er formodning om en høj risiko for transfusionskomplikationer, for at reducere eksponeringen for allogene blodtransfusioner.
English: Studies in animals have shown reproduction toxicity (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet (se pkt.
English: Dose (IU/kg given 3 times per week)
Danish: Dosis (IE/kg 3 gange ugentligt)
English: PRCA causes sudden and severe anaemia.
Danish: PRCA kan føre til pludselig og alvorlig blodmangel.
English: Patients who develop Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin must not receive Silapo or any other erythropoietin (see section 4.4).
Danish: Patienter, som udvikler Pure Red Cell Aplasia (PRCA) efter behandling med et erythropoietin må ikke få Silapo eller noget andet erythropoietin (se pkt.
English: Hypertension may occur in epoetin alfa treated patients.
Danish: Hypertension kan forekomme hos patienter i behandling med epoetin alfa.
English: In particular, if you are taking a medicine containing the active substance ciclosporin to suppress your immune system after a kidney transplant, your doctor may order special blood tests to measure ciclosporin levels while you are taking Silapo.
Danish: Hvis De tager et lægemiddel, der indeholder det aktive stof ciclosporin, for at hæmme Deres immunforsvar efter en nyretransplantation, vil Deres læge måske foreskrive særlige blodprøver for at måle ciclosporinniveaut, mens De tager Silapo.
English: Leucine
Danish: Leucin
English: At the time of donating blood, Silapo should be administered after the completion of the blood donation procedure.
Danish: På bloddonationstidspunktet skal der gives Silapo, efter at donationsproceduren er afsluttet.
English: Several controlled clinical studies in which epoetins were administered to patients with a variety of common tumours including squamous head and neck cancer, lung cancer, and breast cancer, have shown an unexplained excess mortality.
Danish: Flere kontrollerede kliniske forsøg, hvor epoetiner blev givet til patienter med en række forskellige almindelige tumorer, herunder planocellulær cancer i hoved og hals, lungecancer og brystcancer, har vist en uforklarlig overdødelighed.
English: Once your condition is controlled you will receive regular doses of Silapo.
Danish: Når Deres tilstand er under kontrol, vil De regelmæssigt få doser af Silapo.
English: Take one sealed syringe blister and leave it to stand for a few minutes until it reaches room temperature prior to using it.
Danish: Tag en enkelt sprøjte i forseglet blisterpakning, og lad den stå, indtil den har stuetemperatur, før De anvender den.
English: If you are pregnant or breast-feeding, Silapo should be used only if the potential benefit outweighs the potential risk to the foetus.
Danish: Hvis De er gravid eller ammer, bør Silapo kun anvendes, hvis den mulige fordel opvejer den mulige risiko for barnet.
English: Porphyria acute
Danish: Akut porfyri
English: Treatment of adult patients with low- or intermediate-1-risk MDS
Danish: Behandling af voksne patienter med lav- eller intermediær-1-risiko MDS
English: Phenylalanine
Danish: Phenylalanin
English: Your doctor may decide that it is better for you to receive Silapo by injection under the skin (subcutaneous) rather than into a vein (intravenous).
Danish: Deres læge vil måske beslutte, at det er bedre for Dem at få Silapo som indsprøjtning under huden (subkutant) frem for gennem en blodåre (intravenøst).
English: The starting dose may be adjusted by your doctor depending on how your anaemia responds to treatment; you will usually receive Silapo until 1 month after the end of chemotherapy.
Danish: Deres læge kan regulere startdosis afhængig af, hvordan Deres blodmangel påvirkes af behandlingen; De vil som regel få Silapo indtil 1 måned efter kemoterapiens afslutning.
English: Do not use Silapo if:
Danish: Brug ikke Silapo, hvis:
English: If the solution is given into a vein, it should be injected over 1-5 minutes.
Danish: Hvis opløsningen gives i en blodåre (vene), skal den indsprøjtes i løbet af 1-5 minutter.
English: If PRCA is diagnosed, therapy with Silapo must be immediately discontinued and testing for erythropoietin antibodies should be considered.
Danish: Hvis der diagnosticeres PRCA, skal Silapo-terapien straks ophøre, og det skal overvejes at teste for antistoffer mod erythropoietin.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosisenhed, dvs. det er i det væsentlige natrium-frit.
English: Isoleucine
Danish: Isoleucin
English: Occlusion of the dialysis system is possible if heparinisation is not optimum.
Danish: Okklusion af dialysesystemet kan forekomme, hvis hepariniseringen ikke er optimal.
English: Erythropoietin did not show any changes in bacterial and mammalian cell culture mutagenicity tests and an in vivo micronucleus test in mice.
Danish: Erythropoietin viste ingen ændringer ved mutagenicitetstest af bakterie- og mammalcellekulturer eller ved in vivo-mikronukleustest af mus.
English: • Skin rashes and swelling around the eyes (oedema), which may result from an allergic reaction.
Danish: • Hududslæt og hævelse omkring øjnene (ødemer), som kan stamme fra en overfølsomhedsreaktion.
English: in moderately anaemic patients who are going to have surgery and prior to it, donate blood so that their own blood can be given to them during or after surgery (autologous pre-donation).
Danish: til patienter med moderat blodmangel, som skal opereres og forud for operationen afgive blod for at kunne få deres eget blod under eller efter operationen (autolog prædonation).
English: If this occurs it can result in severe anaemia, the symptoms of which are unusual tiredness, feeling dizzy or breathlessness.
Danish: Hvis det forekommer, kan det medføre alvorlig blodmangel, hvor symptomerne er usædvanlig træthed, svimmelhedsfølelse eller kortåndethed.
English: When your condition has been brought under control, you will receive regular doses of Silapo, 2 or 3 times a week.
Danish: Når Deres tilstand er bragt under kontrol, vil De regelmæssigt få doser af Silapo 2 eller 3 gange om ugen.
English: Your doctor will conduct investigations, for example blood tests, to help decide if it is necessary for you to have Silapo.
Danish: Deres læge vil foretage undersøgelser, for eksempel tage blodprøver, for at kunne afgøre, om det er nødvendigt, at De får Silapo.
English: if you are due to have major elective orthopaedic surgery (such as hip or knee surgery), and you:
Danish: • hvis du står over for en større planlagt ortopædisk operation (f.eks. en hofte- eller knæoperation), og du:
English: Intravenous injection
Danish: Intravenøs injektion
English: Vary the site from day to day.
Danish: Vælg et nyt sted fra til dag
English: Use should be restricted to patients with moderate anaemia (e.g. haemoglobin concentration range between 10 to 13 g/dl) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1 800 ml).
Danish: Anvendelsen bør begrænses til patienter med moderat anæmi (f.eks. koncentration af hæmoglobin i intervallet 10-13 g/dl), hvor der ikke forefindes et autologt prædonationsprogram, og med et forventet moderat blodtab (900-1800 ml).
English: Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
Danish: På grund af variabilitet hos den enkelte patient kan der af og til observeres individuelle hæmoglobinværdier for en patient, som ligger over og under det ønskede hæmoglobinniveau.
English: These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia associated with various common cancers who received recombinant human erythropoietin compared to controls.
Danish: Disse forsøg har vist en vedvarende uforklarlig statistisk signifikant overdødelighed hos patienter, som har anæmi i forbindelse med forskellige almindelige cancertyper, og som fik rekombinant humant erythropoietin sammenlignet med kontrolgrupper.
English: Check with your doctor if you are not sure.
Danish: Tal med Deres læge, hvis De er i tvivl.
English: Dialysis prescriptions may have to be adjusted periodically to maintain urea, creatinine and potassium in the desired range.
Danish: Ordineringen af dialyse skal måske justeres periodisk for at holde urinstof-, kreatinin- og kalium-niveauerne indenfor det ønskede område.
English: Other causes of PRCA should be excluded, and appropriate therapy initiated.
Danish: Andre årsager til pure red cell aplasia bør udelukkes og passende terapi igangsættes.
English: D-61118 Bad Vilbel Germany
Danish: D-61118 Bad Vilbel Tyskland
English: Patients were stratified according to their baseline haemoglobin (≤ 10 g/dl, > 10 to ≤ 13 g/dl and > 13 g/dl).
Danish: Patienterne blev inddelt efter deres hæmoglobinværdi ved baseline (≤10 g/dl, >10 til ≤13 g/dl og >13 g/dl).
English: Remember to tell your doctor that you are receiving Silapo if you have to visit the hospital or family doctor for any treatment including a blood test, as Silapo may affect the results.
Danish: Husk at oplyse, at De får Silapo, hvis De behandles på et hospital eller af Deres egen læge, eller hvis De skal have taget blodprøver, da Silapo kan påvirke resultaterne.
English: Blockage of the dialysis system is possible if heparinisation is not optimum.
Danish: Dialysesystemet kan blive blokeret, hvis hepariniseringen ikke er optimal.
English: Therefore, routine volume replacement should be performed in such patients.
Danish: Derfor skal disse patienter rutinemæssigt have volumenerstatningsbehandling.
English: • Blood clots may also form in your haemodialysis system.
Danish: • Der kan også dannes blodpropper i Deres hæmodialysesystem.
English: If the patient loses response or haemoglobin concentration drops by ≥1 g/dl upon dose reduction the dose should be increased by one dosing step.
Danish: Hvis patienten mister respons, eller hæmoglobinkoncentrationen falder med ≥ 1 g/dl ved dosisreduktion, skal dosis øges med et doseringstrin.
English: Epoetin alfa was administered subcutaneously for 10 days prior to surgery, on the day of surgery, and for four days after surgery.
Danish: Epoetin alfa blev administreret subkutant i 10 dage før operationen, på operationsdagen og i 4 dage efter operationen.
English: Erythropoietin is a growth factor that primarily stimulates red cell production.
Danish: Erythropoietin er en vækstfaktor, som primært stimulerer produktionen af røde blodceller.
English: SJS/TEN can appear initially as reddish target-like spots or circular patches often with central blisters on the trunk.
Danish: SJS/TEN kan i begyndelsen vise sig som rødlige, målskivelignende pletter eller runde områder, ofte med blærer centralt på kroppen.
English: The studies either recruited patients who were being treated with chemotherapy (two studies) or used patient populations in which erythropoiesis stimulating agents are not indicated: anaemia in patients with cancer not receiving chemotherapy, and head and neck cancer patients receiving radiotherapy.
Danish: Forsøgene rekrutterede enten patienter, som var i behandling med kemoterapi (to forsøg) eller benyttede patientpopulationer, hvor erytropoiese-stimulerende stoffer ikke er indiceret: anæmi hos patienter med cancer, som ikke fik kemoterapi, og hoved- og halscancer hos patienter, som fik strålebehandling.
English: A paradoxical decrease in haemoglobin and development of severe anaemia associated with low reticulocyte counts should prompt to discontinue treatment with epoetin and perform antierythropoietin antibody testing.
Danish: Et paradoksalt fald i hæmoglobiniveau og udvikling af svær anæmi, associeret med lavt retikulocyttal, bør føre til øjeblikkelig afbrydelse af behandlingen med epoetin, og der bør udføres en antierythropoietin-antistoftest.
English: Take special care with other products that stimulate red blood cell production: Silapo is one of a group of products that stimulate the production of red blood cells like the human protein erythropoietin does.
Danish: Vær ekstra forsigtig med at tage anden medicin, som stimulerer dannelsen af røde blodlegemer: Silapo tilhører en gruppe medicin, som stimulerer dannelsen af røde blodlegemer på samme måde som det humane protein erythropoietin.
English: In the randomised, double-blind, placebo-controlled, multicentre study 4 (4.7%) subjects experienced TVEs (sudden death, ischaemic stroke, embolism, and phlebitis).
Danish: I det randomiserede, dobbeltblinde, placebokontrollerede multicenterstudie oplevede 4 (4,7 %) patienter TVE'er (pludselig død, iskæmisk slagtilfælde, embolisme og flebitis).
English: The pre-filled syringe is ready for use.
Danish: Den fyldte sprøjte er klar til brug.
English: Diarrhoea, Nausea, Vomiting
Danish: Diaré, kvalme, opkastning
English: Epoetin zeta is identical in its amino acid sequence and similar in carbohydrate composition to endogenous human erythropoietin that has been isolated from the urine of anaemic patients.
Danish: Epoetin zeta er med hensyn til aminosyresekvens og kulhydratsammensætning identisk med endogent humant erythropoietin, som er isoleret fra urin fra anæmipatienter.
English: If possible, iron supplementation should be initiated prior to starting epoetin zeta therapy to achieve adequate iron stores.
Danish: Om muligt påbegyndes jerntilskuddet før indledning af epoetin zeta-behandling, så der opnås tilstrækkelige jerndepoter.
English: Your doctor will order regular blood tests to ensure that your medicine is continuing to work properly.
Danish: Deres læge vil foreskrive regelmæssige blodprøver for at sikre, at Deres medicin fortsætter med at virke, som den skal.
English: When a dose adjustment is necessary, this should be done in steps of 25 IU/kg, 3 times per week at intervals of at least 4 weeks until the desired goal is achieved.
Danish: Når en regulering af dosis er nødvendig, bør den ske i trin på 25 IE/kg 3 gange om ugen med intervaller på mindst 4 uger, indtil det ønskede mål er nået.
English: Correction phase: Starting dose of 50 IU/kg 3 times per week, followed if necessary by a dose increase with 25 IU/kg increments (3 times per week) until the desired goal is achieved (this should be done in steps of at least four weeks).
Danish: Korrektionsfasen: Startdosis på 50 IE/kg 3 gange om ugen, om nødvendigt efterfulgt af en øgning af doseringen med 25 IE/kg ad gangen (3 gange om ugen), indtil det ønskede mål er nået (dette bør ske i trin på minimum 4 uger).
English: Caution should be exercised with escalation of Silapo 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 optrapning af Silapo-dosis hos patienter med kronisk nyreinsufficiens, da høje kumulative epoetindoser kan være forbundet med en øget risiko for død og alvorlige kardiovaskulære og cerebrovaskulære hændelser.
English: A randomised, double-blind, placebo-controlled, multicentre study evaluated the efficacy and safety of epoetin alfa in adult anaemic subjects with low- or intermediate-1-risk MDS.
Danish: I et randomiseret, dobbeltblindt, placebokontrolleret, multicenterstudie evalueredes virkningen og sikkerheden af epoetin alfa hos voksne anæmiske patienter med lav- eller intermediær-1-risiko MDS.
English: Mildly anaemic patients (haematocrit of 33-39%) requiring predeposit of ≥ 4 units of blood should be treated with Silapo at a dose of 600 IU/kg body weight 2 times weekly for 3 weeks prior to surgery.
Danish: Let anæmiske patienter (hæmatokrit 33-39 %), som kræver en forudgående behandling med ≥ 4 enheder blod, skal behandles med Silapo med en dosis på 600 IE/kg legemsvægt 2 gange ugentligt i 3 uger forud for operationen.
English: There may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with erythropoietin.
Danish: Der kan optræde en moderat, dosisafhængig stigning i trombocyttallet inden for normalområdet under behandling med erythropoietin.
English: In patients developing sudden lack of efficacy, defined by a decrease in haemoglobin (1-2 g/dl per month) with increased need for transfusions, a reticulocyte count should be obtained and typical causes of non-response (e.g. iron, folate, or Vitamin B12-deficiency, aluminium intoxication, infection or inflammation, blood loss, and haemolysis) should be investigated.
Danish: Hos patienter, hvor der udvikles pludselig mangel på virkning, defineret som et fald i hæmoglobin (1-2 g/dl pr. måned) med øget transfusionsbehov, bør der foretages en reticulocyttælling, og de typiske årsager (fx jern-, folat- eller B12-vitaminmangel, aluminiumsforgiftning, infektion eller inflammation, blodtab og hæmolyse) bør undersøges.
English: If you stop using Silapo
Danish: Hvis De holder op med at bruge Silapo
English: Talk to your doctor before using Silapo if you know you are suffering, or have suffered, from any of the following: epileptic seizures liver disease cancer anaemia from other causes heart disease (such as angina) disorders of blood circulation resulting in pins and needles or cold hands or feet or muscle cramps in the legs blood clots/blood clotting disorders kidney disease.
Danish: Sig det til Deres læge, før De anvender Silapo,, hvis De ved, at De lider af eller har lidt af følgende: epileptiske anfald leversygdomme kræft blodmangel af andre årsager hjertesygdomme (for eksempel angina pectoris) kredsløbssygdomme med sovende eller kolde hænder eller fødder eller muskelkramper i benene blodpropper/sygdomme, som giver blodpropper nyresygdomme.
English: Adult patients with low- or intermediate-1-risk MDS
Danish: Voksne patienter med lav- eller intermediær-1-risiko MDS
English: Shunt thromboses may occur, especially in patients who have a tendency to hypotension or whose arteriovenous fistulae exhibit complications (e.g. stenoses, aneurysms, etc.).
Danish: Shunt-trombose kan opstå, især hos patienter med tendens til hypotension, eller hvis arteriovenøse fistler giver komplikationer (f.eks. stenose, aneurisme).
English: • increased risk of death when administered to target a haemoglobin of 12 g/dl (7.5 mmol/l) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
Danish: • øget risiko for død, når stofferne gives for at tilstræbe et hæmoglobinniveau på 12 g/dl (7,5 mmol/l) hos patienter med aktiv malign sygdom, som hverken får kemoterapi eller strålebehandling.
English: Afterwards, your doctor may order blood tests to see if any adjustment in dose is required.
Danish: Bagefter vil Deres læge måske forskrive blodprøver for at se, om der er behov for en justering af dosis.
English: You should check with your doctor or pharmacist if you are not sure.
Danish: De bør spørge Deres læge eller på apoteket, hvis De er i tvivl.
English: As with other haematopoietic growth factors, erythropoietin has shown in vitro stimulating properties on human endothelial cells.
Danish: Ligesom andre hæmatopoietiske vækstfaktorer har erythropoietin vist sig at stimulere humane endotelceller in vitro.
English: This is more likely if you have low blood pressure or if your fistula has complications.
Danish: De har lavt blodtryk, eller hvis De har komplikationer med fistlen.
English: Glutamic acid
Danish: Glutaminsyre
English: Your doctor will order blood tests, and may adjust the dose, depending on how your anaemia responds to Silapo treatment.
Danish: Deres læge vil foreskrive blodprøver og vil måske justere dosis, afhængigt af hvordan Deres blodmangel reagerer på behandling med Silapo.
English: In the indication "increasing the yield of autologous blood": myocardial infarction or stroke in the month preceding treatment, unstable angina pectoris, increased risk of deep venous thrombosis such as history of venous thromboembolic disease.
Danish: Ved indikationen ”øgning af udbyttet af autologt blod”: myokardial infarkt eller slagtilfælde i måneden forud for behandlingen, ustabil angina pectoris, øget risiko for dyb venetrombose, eksempelvis på grund af tromboembolisk venesygdom.
English: Therefore, you should discuss the benefits of Silapo with your doctor, particularly if you are obese or have a history of blood clots/blood clotting disorders.
Danish: Derfor bør De diskutere fordelene ved Silapo med Deres læge, især hvis De er overvægtig eller tidligere har haft blodpropper eller blodpropdannende lidelser.
English: Silapo can be used to increase haemoglobin concentration in symptomatic anaemia (haemoglobin concentration of ≤10 g/dl) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (<200 mU/ml).
Danish: Silapo kan anvendes til at øge hæmoglobinkoncentrationen ved symptomatisk anæmi (hæmoglobinkoncentration på ≤ 10 g/dl) hos voksne med primære lav- eller intermediær-1risiko myelodysplastiske syndromer (MDS), som har lavt erythropoietin i serum (< 200 mE/ml).
English: The effect of epoetin alfa (300 IU/kg or 100 IU/kg) on the exposure to allogeneic blood transfusion has been evaluated in a placebo-controlled, double-blind clinical trial in non-iron deficient adult patients scheduled for major elective orthopaedic hip or knee surgery.
Danish: Virkningen af epoetin alfa (300 IE/kg eller 100 IE/kg) på eksponeringen for allogen blodtransfusion blev evalueret i et placebokontrolleret, dobbeltblindt klinisk studie af voksne patienter uden jernmangel med planlagt større elektiv ortopædisk hofte- eller knæoperation.
English: The use of Silapo in patients scheduled for major elective orthopaedic surgery and not participating in an autologous blood predonation programme is contraindicated in patients with severe coronary, peripheral arterial, carotid or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident.
Danish: Brugen af Silapotil patienter, som skal gennemgå en planlagt større elektiv ortopædisk operation, og som ikke skal deltage i et autologt blodtransfusionsprogram, er kontraindiceret hos patienter med alvorlige koronare, perifere arterielle, carotis eller cerebrale vaskulære sygdomme samt patienter med nyligt opdaget myokardieinfarkt eller cerebrovaskulær katastrofe.