FrancophonIA/ELRC3.0 huggingface dataset:
English: Ask your doctor for advice before taking any medicine.
Danish: Spørg Deres læge til råds, før De bruger nogen form for medicin.
English: The apparent molecular weight of erythropoietin is 32 000-40 000 Dalton.
Danish: Erythropoietins tilsyneladende molekylvægt er 32 000-40 000 Dalton.
English: Silapo is a biosimilar medicinal product.
Danish: Silapo er et biosimilært lægemiddel.
English: More severe cases have been observed with long-acting epoetins.
Danish: Der er observeret flere svære tilfælde med langtidsvirkende epoetiner.
English: If it occurs, appropriate dose adjustment should be made as provided.
Danish: Hvis dette forekommer, bør passende dosisjustering udføres som foreskrevet.
English: Three were confirmed TVE and in the remaining case (sudden death), the thromboembolic event was not confirmed.
Danish: Tre blev bekræftet som værende TVE'er og i det resterende tilfælde (pludselig død) blev den tromboemboliske hændelse ikke bekræftet.
English: This regresses during the course of continued therapy.
Danish: Denne regrederer efterhånden under fortsat terapi.
English: It is not known whether exogenous epoetin zeta is excreted in human milk.
Danish: Det vides ikke, om eksogent epoetin zeta udskilles i human mælk.
English: The following maintenance doses were observed in clinical trials after 6 months of treatment.
Danish: Er nedenstående vedligeholdelsesdoser observeret under kliniske undersøgelser efter 6 måneders behandling.
English: As with all growth factors, there is a concern that epoetins could stimulate the growth of any type of malignancy.
Danish: Ligesom med alle andre vækstfaktorer kan man frygte, at epoetiner kunne stimulere væksten af enhver type malign tumor.
English: This medicinal product is for single use only.
Danish: Dette medicinske produkt er kun til engangsbrug.
English: • can't take medicines to thin the blood
Danish: • ikke kan tage blodfortyndende medicin
English: Silapo can be used to increase the yield of autologous blood from patients in a predonation programme.
Danish: Silapo kan anvendes til at øge udbyttet af autologt blod fra patienterne i et prædonationsprogram.
English: It is recommended that initial erythroid response be assessed 8 to 12 weeks following initiation of treatment.
Danish: Det anbefales, at den indledende erythroide respons vurderes 8 til 12 uger efter start af behandling.
English: The half-life is difficult to evaluate for the subcutaneous route and is estimated to be about 24 hours.
Danish: Halveringstiden er vanskelig at vurdere ved subkutan indgivelse, men skønnes at være ca. 24 timer.
English: The treatment is divided into two stages:
Danish: Behandlingen inddeles i to faser:
English: Frequency estimate: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000), not known (frequency cannot be estimated from the available data).
Danish: Vurdering af hyppighed: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1 000 til < 1/100); sjælden (≥ 1/10 000 til < 1/1 000); meget sjælden (< 1/10 000); ikke kendt (hyppigheden kan ikke estimeres ud fra de forhåndenværende data).
English: A systematic review has also been performed involving more than 9 000 cancer patients participating in 57 clinical trials.
Danish: Der er også foretaget en systematisk gennemgang af mere end 9 000 cancerpatienter, som deltog i 57 kliniske forsøg.
English: Your doctor will decide this.
Danish: Det vil Deres læge afgøre.
English: • you have unstable angina pectoris (new or increasing chest pain)
Danish: • De har ustabil angina pectoris (nyopståede eller tiltagende brystsmerter)
English: Generally, children and adolescents under 30 kg body weight require higher maintenance doses than adults and children over 30 kg.
Danish: Generelt kræver børn og unge, som vejer under 30 kg, højere vedligeholdelsesdoser end børn, som vejer over 30 kg, og voksne.
English: There is no evidence to indicate that treatment with erythropoietin alters the metabolism of other medicinal products.
Danish: Der eksisterer ingen beviser for, at behandling med erythropoietin ændrer andre lægemidlers metabolisme.
English: Usual maintenance dose
Danish: Sædvanlig vedligeholdelsesdosis
English: • Stroke (insufficient blood supply to the brain, which may lead to inability to move one or more limbs on one side of the body, inability to understand or formulate speech, or an inability to see one side of the visual field).
Danish: • Slagtilfælde (utilstrækkelig blodtilførsel til hjernen, som kan medføre, at De ikke kan bevæge en eller flere lemmer i den ene side af kroppen, at De ikke kan forstå eller formulere tale eller ikke kan se den ene side af synsfeltet).
English: Cancer patients
Danish: Kræftpatienter
English: • you had a heart attack or stroke in the month before your treatment
Danish: • De har haft et hjerteanfald eller et slagtilfælde i måneden forud for behandlingen
English: Your healthcare professional will always record the exact product you are using.
Danish: Sundhedspersonalet vil altid registrere det nøjagtige navn på det lægemiddel, som du anvender.
English: The rashes may progress to widespread peeling of the skin and life-threatening complications.
Danish: Udslættet kan udvikle sig til udbredt afskalning af huden og livstruende komplikationer.
English: Silapo has a wide safety margin and side effects due to an overdose of using Silapo are unlikely.
Danish: Silapo har en bred sikkerhedsmargen, og bivirkninger på grund af en overdosis er usandsynlige.
English: All TVEs occurred in the epoetin alfa group and in the first 24 weeks of the study.
Danish: Alle TVE'er forekom i epoetin alfa-gruppen og i de første 24 uger af studiet.
English: Patients should not be switched to another medicinal product as anti-erythropoietin antibodies cross-react with other erythropoietins.
Danish: Patienterne bør ikke overføres til et andet produkt, da antierythropoietin-antistoffer krydsreagerer med andre erythropoietiner.
English: These serious skin rashes are often preceded by fever and/or flu-like symptoms.
Danish: Disse alvorlige hududslæt kommer ofte efter feber og/eller influenzalignende symptomer.
English: When a dose adjustment is necessary, this should be done in steps of at least four weeks.
Danish: Når en justering af dosis er nødvendig, bør det ske i trin af mindst 4 ugers varighed.
English: - increase of blood pressure.
Danish: - forhøjet blodtryk.
English: Overdose of erythropoietin may produce effects that are extensions of the pharmacological effects of the hormone.
Danish: Overdosering af erythropoietin kan fremkalde virkninger, som er udvidelser af hormonets farmakologiske virkninger.
English: A slower injection is preferable in patients who react to the treatment with “flu-like” symptoms.
Danish: En langsommere injektion er at foretrække hos patienter, som reagerer på behandlingen med "influenzalignende" symptomer.
English: Data from clinical studies with Silapo are in line with the safety profile of other authorised erythropoietins.
Danish: Data fra kliniske undersøgelser med Silapo stemmer overens med sikkerhedsprofilen for andre godkendte erythropoietiner.
English: Store in a refrigerator (2°C - 8°C).
Danish: Opbevares i køleskab (2°C - 8°C).
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: Do not use this medicine after the expiry date which is stated on the label and the carton.
Danish: Brug ikke denne medicin efter den udløbsdato, der står på pakningen („EXP“).
English: These changes are interpreted as being secondary to decreased maternal body weight gain.
Danish: Disse ændringer fortolkes som en følge af nedsat kropsvægtforøgelse hos moderen.
English: Silapo must not be used if
Danish: Silapo må ikke bruges, hvis
English: • Swelling of the ankles, feet or fingers
Danish: • Hævede ankler, fødder eller fingre
English: There are conflicting reports in the literature regarding whether erythropoietin may play a major role as tumour proliferator.
Danish: I litteraturen foreligger der rapporter, som er modstridende med hensyn til, om erythropoietin kan spille en større rolle som tumorproliferator.
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, standses behandlingen.
English: The injections can then be given by a doctor, trained nurse or other health care professional.
Danish: Indsprøjtninger med Silapo kan da gives af en læge, en uddannet sygeplejerske eller en anden sundhedsfagligt uddannet person.
English: There are no adequate and well-controlled studies in pregnant women.
Danish: Der findes ikke tilstrækkelige og velkontrollerede data fra anvendelse af erythropoietin til gravide kvinder.
English: Pharmacotherapeutic group: Other antianaemic preparations, erythropoietin ATC code: B03XA01
Danish: Farmakoterapeutisk klassifikation: Andre antianæmiske præparater, erythropoietin ATC-kode: B03XA01
English: D-61118 Bad Vilbel Tel: +49 (0) 6101 603-0
Danish: D-61118 Bad Vilbel Tlf: +49 (0) 6101 603-0
English: All of these additive factors of anaemia should also be carefully considered when deciding to increase the dose of erythropoietin in cancer patients.
Danish: Alle disse additive faktorer ved anæmi skal også overvejes omhyggeligt, når der træffes beslutning om at øge cancerpatienters erythropoietindosis.
English: Like in all patients receiving erythropoietin, blood pressure may rise during treatment with Silapo.
Danish: Som hos alle patienter, der får erythropoietin, kan blodtrykket stige under behandling med Silapo.
English: Increases in blood potassium have happened in isolated cases.
Danish: Stigninger i blodets kaliumindhold har forekommet i isolerede tilfælde.
English: The peak is always well below the peak achieved using the intravenous route (approximately 1/20th of the value).
Danish: Højdepunktet ligger altid et godt stykke under det højdepunkt, der opnås ved intravenøs indgivelse (ca. 1/20 af værdien).
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: I lyset af ovenstående er blodtransfusion i nogle kliniske situationer være den foretrukne behandling af anæmi hos patienter med cancer.
English: These reports are based on in vitro findings from human tumour samples, but are of uncertain significance in the clinical situation.
Danish: Disse rapporter er baseret på in vitro-resultater fra humane tumorprøver, men det er usikkert, om de har betydning i den kliniske situation.
English: Based on the results from clinical trials with other authorised erythropoietins approximately 8% of patients treated with erythropoietin are expected to experience adverse reactions.
Danish: På grundlag af resultaterne af kliniske afprøvninger af andre godkendte erythropoietiner forventes det, at ca. 8 % af de patienter, der behandles med erythropoietin, oplever bivirkninger.
English: In controlled clinical studies, use of epoetin alfa and other ESAs have shown:
Danish: I kontrollerede kliniske forsøg har brug af epoetin alfa og andre ESA'er vist:
English: Appropriate dose titration should be considered.
Danish: En passende dosisjustering må overvejes.
English: Mean haemoglobin levels were similar for the two treatment groups throughout the postsurgical period.
Danish: Middelværdierne for hæmoglobin var omtrent de samme i de to behandlingsgrupper under hele perioden efter operationen.
English: Silapo therapy should continue until one month after the end of chemotherapy.
Danish: Der bør fortsættes med Silapo-terapi indtil 1 måned efter kemoterapiens ophør.
English: The upper limit of the target haemoglobin concentration should not be exceeded.
Danish: Den øvre grænse for den tilsigtede hæmoglobinkoncentration må ikke overskrides.
English: If Silapo is injected under the skin the amount injected in any one place should not exceed 1 ml.
Danish: Hvis Silapo indsprøjtes under huden (subkutant), bør den mængde, der indsprøjtes på ét sted, ikke overstige 1 ml.
English: He/she will work out the correct dose of Silapo for you to use, how long the treatment should continue and by what route the medicine will be given.
Danish: Han/hun vil beregne, hvor stor en dosis Silapo, De skal have, hvor længe behandlingen bør fortsættes, og hvordan medicinen skal gives.
English: During treatment with Silapo
Danish: Under behandlingen med Silapo
English: Patients who for any reason cannot receive adequate antithrombotic prophylaxis.
Danish: Patienter, som -uanset grund -ikke kan modtage tilstrækkelig antitrombotisk profylakse.
English: You will receive Silapo during the 3 weeks before your surgery.
Danish: De vil få Silapo i 3 uger forud for Deres operation.
English: Handling instructions for Silapo:
Danish: Instruktioner vedrørende håndterng af Silapo:
English: Congenital, familial and genetic disorders
Danish: Medfødte, familiære og genetiske sygdomme
English: The dose for children and adolescents is based on body weight in kilograms.
Danish: Dosis til børn og unge er baseret på kropsvægt i kilogram.
English: The starting dose may be adjusted by your doctor until your condition is controlled.
Danish: Startdosis kan justeres af Deres læge, indtil Deres tilstand er under kontrol.
English: • have severe heart disease
Danish: • har en alvorlig hjertesygdom
English: Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced by 25 to 50% in order to maintain haemoglobin at that level.
Danish: Når først behandlingsmålet for den enkelte patient er opnået, bør dosis reduceres med 25-50% for at fastholde hæmoglobin på det niveau.
English: Name and address of the manufacturers of the biological active substance
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof
English: Information on administration
Danish: Oplysninger vedrørende administration
English: If you are a cancer patient, you should be aware that Silapo may act as a blood cell growth factor and in some circumstances may have a negative impact on your cancer.
Danish: Hvis De er kræftpatient, skal De være opmærksom på, at Silapo kan virke som en vækstfaktor for blodcellerne og i nogle tilfælde have en dårlig indflydelse på Deres kræftsygdom.
English: • have recently had a heart attack or stroke
Danish: • har haft et hjerteanfald eller et slagtilfælde for nylig
English: Adverse drug reactions reported by ≥1% of subjects treated with epoetin alfa in these trials are shown in the table below.
Danish: Bivirkninger rapporteret af ≥1 % af forsøgspersoner behandlet med epoetin alfa i disse forsøg fremgår af tabellen nedenfor.
English: Your doctor may decide to increase your heparin dose during dialysis.
Danish: Deres læge vil måske øge Deres heparindosis under dialysen.
English: Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Danish: Der kan ske ekspression af erythropoietinreceptorer på overfladen af en række forskellige tumorceller.
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 forsøg lå hazard ratio'erne for samlet overlevelse imellem 1,25 og 2,47 til kontrolgruppens fordel.
English: Your doctor can decide whether Silapo is not working properly for you and will end the treatment, if necessary.
Danish: Deres læge kan afgøre, om Silapo ikke virker efter hensigten hos Dem, og vil om nødvendigt afbryde behandlingen.
English: These increases in blood pressure can be treated with medicinal products.
Danish: Disse stigninger i blodtrykket kan behandles medicinsk.
English: In animal studies, erythropoietin has been shown to decrease foetal body weight, delay ossification and increase foetal mortality when given in weekly doses of approximately 20 times the recommended human weekly dose.
Danish: I dyrestudier er det påvist, at erythropoietin giver lavere fostervægt, forsinker ossifikationen og øger fosterdødeligheden, når det gives i ugentlige doser på ca. 20 gange den ugentlige dosis, der anbefales til mennesker.
English: Iron supplements and other blood stimulants may increase the effectiveness of Silapo.
Danish: Jerntilskud og andre blodstimulerende stoffer kan øge virkningen af Silapo.
English: After administration of erythropoietin, the number of erythrocytes, the Hb values and reticulocyte counts increase as well as the
Danish: Efter administration af erythropoietin stiger såvel erytrocyttal, Hb-værdier og reticulocyttal som
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis De ønsker yderligere oplysninger om Silapo, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Moreover, monitoring of the blood pressure is recommended particularly at the start of therapy.
Danish: Desuden anbefales det at overvåge blodtrykket, især i begyndelsen af behandlingen.
English: Silapo must not be shaken or mixed with any other liquid.
Danish: Silapo må ikke omrystes eller blandes med nogen anden væske.
English: Epoetin zeta is a copy of the human protein erythropoietin and acts in the same way.
Danish: Epoetin zeta er en kopi af det humane protein erythropoietin og virker på samme måde.
English: Pooled post-hoc analyses of clinical studies of ESAs have been performed in CRF patients (on dialysis, not on dialysis, in diabetic and non-diabetic patients).
Danish: Puljede post-hoc analyser af kliniske studier af ESA er udført hos CRF-patienter (i dialyse, ikke i dialyse, diabetiske og ikke-diabetiske patienter).
English: Tell your doctor immediately if you suddenly feel very tired or dizzy or suffer from shortness of breath.
Danish: Sig det straks til Deres læge, hvis De pludselig føler Dem meget træt eller svimmel eller lider af kortåndethed.
English: The dose you receive is based on your body weight in kilograms.
Danish: Den dosis, De får, er baseret på Deres kropsvægt i kilogram.
English: The injections are given in the limbs or the anterior abdominal wall.
Danish: Injektionerne gives i lemmerne eller i den anteriore abdominalvæg.
English: There is an increased risk for thromboembolic events in patients with cancer treated with recombinant human erythropoietin and a negative impact on overall survival cannot be excluded.
Danish: Der er en øget risiko for tromboemboliske hændelser hos patienter med cancer, som behandles med rekombinant humant erythropoietin, og en negativ virkning på samlet overlevelse kan ikke udelukkes.
English: Your doctor will check on this.
Danish: Deres læge kontrollerer dette.
English: Non response to erythropoietin therapy should prompt a search for causative factors.
Danish: Manglende respons på erythropoietin-terapi bør foranledige en søgning efter årsagsfaktorer.
English: If blood pressure cannot be well controlled, Silapo treatment should be discontinued.
Danish: Hvis blodtrykket ikke kan kontrolleres, skal Silapo-behandlingen ophøre.
English: If signs and symptoms suggestive of these reactions appear, Silapo should be withdrawn immediately and an alternative treatment considered.
Danish: Hvis der opstår tegn og symptomer, som tyder på sådanne reaktioner, skal Silapo straks seponeres, og en alternativ behandling skal overvejes.
English: This is given 3 times a week.
Danish: Denne gives 3 gange om ugen.
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 monitoreres nøje for hudreaktioner.
English: For instructions on handling of the medicinal product before administration, see section 6.6.
Danish: 6.6 vedrørende håndtering af lægemidlet før administration.
English: Haemoglobin levels should be monitored regularly.
Danish: Hæmoglobinniveauet bør overvåges regelmæssigt.
English: In most cases, the ferritin values in the serum fall simultaneously with the rise in packed cell volume.
Danish: I de fleste tilfælde falder ferritinværdierne i serum samtidig med stigningen i hæmatokrit.
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 afprøvninger kunne ikke påvise nogen signifikant forbedring af livskvalitetsparametre på hhv. EORTC-QLQ-C30-skalaen og CLAS-skalaen.
English: This is given subcutaneously once every week, with not less than 5 days between doses.
Danish: Denne dosis gives subkutant en gang ugentligt med mindst 5 dage mellem doserne.
English: The aim of treatment is to maintain your haemoglobin level between 10 and 12 g/dl as a higher haemoglobin level may increase the risk of blood clots and death.
Danish: Målet med behandling er at holde Deres hæmoglobinniveau på mellem 10 og 12 g/dl, da et højere hæmoglobinniveau kan øge risikoen for blodpropper og død.
English: Stop using Silapo if you develop these symptoms and contact your doctor or seek medical attention immediately.
Danish: Stop med at bruge Silapo, hvis du udvikler disse symptomer, og kontakt straks din læge eller søg lægehjælp.
English: The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve haemoglobin concentrations less than 13 g/dl, is unclear because few patients with these characteristics were included in the data reviewed.
Danish: Hvorvidt disse rater også gælder for administration af rekombinant humant erythropoietin til patienter med cancer, som behandles med kemoterapi, for at opnå hæmoglobinkoncentrationer på mindre end 13 g/dl, er uklart, fordi der i de gennemgåede data kun var få patienter med disse karakteristika.
English: Silapo therapy is usually started under medical supervision.
Danish: Behandling med Silapo påbegyndes sædvanligvis under lægelig overvågning.
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 opfyldte ingen af de primære formål med hensyn til at vise en reduktion i mortalitetsrisikoen, uanset årsag, i kardiovaskulær morbiditet eller slutstadiet af nyresygdom (ESRD).
English: Hyperkalaemia has been observed in isolated cases.
Danish: Hyperkalæmi er observeret i isolerede tilfælde.
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 vurdering af fordele og ulemper og med inddragelse af den enkelte patient, og der skal tages højde for den specifikke kliniske kontekst.
English: The biological efficacy of erythropoietin has been demonstrated in various animal models in vivo (normal and anaemic rats, polycythaemic mice).
Danish: Erythropoietins biologiske effektivitet er påvist hos forskellige forsøgsdyr in vivo (normale og anæmiske rotter, polycytæmiske mus).
English: For intravenous or subcutaneous use.
Danish: Intravenøs eller subkutan anvendelse.
English: The syringe is now ready for use.
Danish: Sprøjten er nu klar til brug.
English: If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of Silapo, treatment with Silapo must not be restarted in this patient at any time.
Danish: Hvis patienten har udviklet en svær kutan bivirkning såsom SJS eller TEN på grund af brugen af Silapo, må behandling med Silapo ikke genoptages hos denne patient på noget tidspunkt.