FrancophonIA/ELRC3.0 huggingface dataset:
English: Every one or two weeks, the doctor may adjust your dose to find your individual maintenance dose.
Danish: Hver uge eller hver anden uge vil lægen måske justere dosis for at finde den individuelle vedligeholdelsesdosis.
English: Preparing for injection
Danish: Forberedelse af injektion
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 den enkelte patient har nået det terapeutiske mål, bør dosis reduceres med 25-50 % for at fastholde hæmoglobinniveauet.
English: The biological efficacy of epoetin beta has been demonstrated after intravenous and subcutaneous administration in various animal models in vivo (normal and uraemic rats, polycythaemic mice, dogs).
Danish: Den biologiske effekt af epoetin beta er blevet påvist efter intravenøs og subkutan administration hos forskellige dyrearter in vivo (normale og uræmiske rotter, polycytæmiske mus, hunde).
English: If you have phenylketonuria, talk to your doctor about your treatment with NeoRecormon.
Danish: Hvis du har phenylketonuri, så tal med lægen om din NeoRecormonbehandling.
English: Patients should be monitored closely to ensure that the lowest approved dose of NeoRecormon is used to provide adequate control of the symptoms of anaemia.
Danish: Patienterne bør monitoreres nøje for at sikre, at den lavest godkendte dosis af NeoRecormon anvendes til at sørge for tilstrækkelig kontrol af de anæmiske symptomer.
English: · in infants or young children up to 3 years, since NeoRecormon Multidose solvent contains benzyl alcohol as a preservative
Danish: • til spædbørn eller små børn under 3 år, idet NeoRecormon Flerdosis indeholder benzylalkohol som konservering i solvenset
English: Patients who are stable on a once weekly dosing regimen may be switched to once every two weeks administration.
Danish: Patienter, der er stabile på én gang ugentlig dosering, kan skifte til at få administration hver anden uge.
English: Your doctor may initiate treatment with NeoRecormon if your haemoglobin level is 10 g/dL or less.
Danish: Din læge vil måske påbegynde behandling med NeoRecormon, hvis dit hæmoglobinniveau er 10 g/dl eller mindre.
English: ·Do not inject into a red or swollen area.
Danish: ● Injicer ikke ind i et rødt eller hævet område.
English: Take special care with other products that stimulate red blood cell production:
Danish: Vær ekstra forsigtig med at anvende andre lægemidler, som stimulerer produktionen af røde blodceller:
English: - Prevention of anaemia of prematurity in infants with a birth weight of 750 to 1500 g and a gestational age of less than 34 weeks.
Danish: - forebyggelse af anæmi hos præmature børn med en fødselsvægt på 750-1500 g og en svangerskabsalder på mindre end 34 uger.
English: L-Phenylalanine,
Danish: L-Phenylalanin,
English: Do not increase the dose your doctor has given you.
Danish: Øg ikke den dosis, som lægen har foreskrevet.
English: The target haemoglobin concentration in two studies was >13 g/dl; in the remaining three studies it was 12-14 g/dl.
Danish: Den tilstræbte hæmoglobinkoncentration i to studier var > 13 g/dl; i de øvrige studier var den 1214 g/dl.
English: Additional side effects in people donating their own blood before surgery · A slight increase in the occurrence of blood clots has been observed.
Danish: Yderligere bivirkninger hos patienter, som donerer deres eget blod før operation ● En lille forøgelse af forekomsten af blodpropper er observeret.
English: (8) Penetrate the seal with the needle to a depth of about 1 cm and slowly inject the solvent into the vial.
Danish: (8) Stiknålen ned igennem forseglingen til en dybde af ca. 1 cm og injicer langsomt solvensen ned i hætteglasset.
English: An increased relative risk for thromboembolic events was observed in the overall population (RR 1.62, 95 % CI: 1.13, 2.31).
Danish: En øget relativ risiko for tromboemboliske hændelser blev observeret i den samlede population (RR: 1,62, 95 % konfidensinterval; 1,13, 2,31).
English: Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Danish: Kontrollerede kliniske studier har ikke vist signifikante fordele, der kan tilskrives administration af epoetiner, når hæmoglobinkoncentrationen øges over niveauet, som er nødvendigt for at kontrollere anæmisymptomerne og for at undgå blodtransfusion.
English: PRCA means that the body stopped or reduced the production of red blood cells.
Danish: Pure red cell aplasia betyder, at kroppen har stoppet eller nedsat produktionen af røde blodlegemer.
English: Treatment should be reserved for patients in whom it is considered of particular importance to avoid homologous blood transfusion taking into consideration the risk/benefit assessment for homologous transfusions.
Danish: Behandlingen bør reserveres patienter for hvem, det betragtes som særdeles vigtigt at undgå homolog blodtransfusion, idet man vurderer fordele/ulemper ved homolog blodtransfusion.
English: Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid puncture of peripheral veins.
Danish: Subkutan anvendelse foretrækkes til patienter, som ikke er i hæmodialyse, for at undgå perforering af de perifere vener.
English: What NeoRecormon contains
Danish: Hvad NeoRecormon indeholder
English: · Pull the rubber cap off the end of the syringe (A).
Danish: ● Træk gummiproppen af enden af injektionssprøjten (A).
English: Investigations in cell cultures of human bone marrow cells showed that epoetin beta stimulates erythropoiesis specifically and does not affect leucopoiesis.
Danish: Det kan vises ved hjælp af cellekulturer fra humane knoglemarvsceller, at epoetin beta stimulerer specielt erythropoiese og ikke påvirker leukopoiese.
English: 7 Place the syringe on a clean, flat surface until ready for use.
Danish: Placer injektionssprøjten på en ren, flad overflade indtil den er klar til brug.
English: Meta-analyses also indicate consistently a significantly increased relative risk of thromboembolic events in cancer patients receiving recombinant human erythropoietin (see section
Danish: Meta-analyser indikerer også konsekvent en signifikant øget relativ risiko for tromboemboliske hændelser hos cancerpatienter, som får rekombinant humant erythropoietin (se pkt.
English: The initial weekly dose is 30,000 IU.
Danish: Den ugentlige begyndelsesdosis er 30.000 IE.
English: Do not use the syringe or the needle if the expiration date has passed.
Danish: Brug ikke injektionssprøjten eller nålen, hvis udløbsdatoen er overskredet.
English: The terminal half-life is higher than after intravenous administration, with an average of 13 - 28 hours.
Danish: Halveringstiden for beta-fasen (eliminationsfasen) er højere end efter intravenøs administration med et gennemsnit på 13-28 timer.
English: These include fever, chills, headaches, pain in the limbs, bone pain and/or feeling generally unwell.
Danish: Det omfatter feber, kulderystelser, hovedpine, smerter i ben og arme, smerter i knoglerne og/eller generel følelse af utilpashed.
English: NeoRecormon is one of a group of products that stimulate the production of red blood cells like the human protein erythropoietin does.
Danish: NeoRecormon tilhører en gruppe lægemidler, som stimulerer produktionen af røde blodceller, ligesom det humane protein, erythropoietin gør.
English: The therapy should be continued for up to 4 weeks after the end of chemotherapy.
Danish: Behandlingen bør fortsættes i op til fire uger efter endt kemoterapi.
English: If you are a cancer patient you should be aware that NeoRecormon may act as a blood cell growth factor and in some circumstances may have a negative impact on your cancer.
Danish: Hvis du er cancerpatient, skal du være opmærksom på, at NeoRecormon kan virke som en blodcellevækstfaktor, og at den i nogle tilfælde kan have en negativ virkning på din cancer.
English: Important: Always keep the sharps disposal container out of reach of children.
Danish: Vigtigt: Opbevar altid beholderen til skarpe genstande utilgængeligt for børn.
English: An increase in blood pressure or aggravation of existing hypertension, especially in cases of rapid PCV increase can occur.
Danish: Stigning i blodtrykket eller forværring af eksisterende forhøjet blodtryk, især i tilfælde af hurtig stigning i hæmatokrit, kan forekomme.
English: Premature infants A fall in serum ferritin values is very common (see section 4.4).
Danish: Præmature børn Et fald i serumferritinværdierne er meget almindeligt (se pkt.
English: Therapy with NeoRecormon should be initiated by physicians experienced in the above mentioned indications.
Danish: Behandling med NeoRecormon bør initieres af speciallæge med erfaring i ovennævnte indikationer.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5000 IU/1 ml
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 5.000 IE/1 ml
English: Before you begin · Do not take the needle cap off until you are ready to inject NeoRecormon.
Danish: ● Tag ikke nålehætten af indtil du er klar til at injicere NeoRecormon.
English: If blood pressure rises cannot be controlled by drug therapy, a transient interruption of NeoRecormon therapy is recommended.
Danish: Hvis stigningen i blodtrykket ikke kan kontrolleres medicinsk, kan en forbigående afbrydelse af NeoRecormonbehandlingen anbefales.
English: Pharmacotherapeutic group: antianemic, ATC code: B03XA01
Danish: Farmakoterapeutisk klassifikation: Midler mod anæmi, ATC-kode: B03XA01
English: Use the syringe within 5 minutes of removing the cap; otherwise, the needle may clog.
Danish: Brug injektionssprøjten inden for 5 minutter efter fjernelse af hætten, ellers kan nålen tilstoppe.
English: Only solutions which are clear or slightly opalescent, colourless and practically free of visible particles may be injected.
Danish: Kun klare eller svagt opaliserende, farveløse opløsninger, der er fri for synlige partikler, må injiceres.
English: NeoRecormon in reconstituted multidose solution contains benzyl alcohol which may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Danish: NeoRecormon i rekonstitueret Flerdosisopløsning indeholder benzylalkohol, som kan forårsage toksiske reaktioner og anafylaktiske reaktioner hos spædbørn og børn op til 3 år.
English: Severe aluminium overload due to treatment of renal failure may compromise the effectiveness of NeoRecormon.
Danish: Alvorlig aluminium intoksikation som følge af behandling for nyresvigt kan kompromittere virkningen af NeoRecormon.
English: Your doctor will use the lowest effective dose to control the symptoms of your anaemia.
Danish: Din læge vil bruge den laveste effektive dosis til at kontrollere symptomerne på din anæmi.
English: After subcutaneous administration of epoetin beta to uraemic patients, the protracted absorption results in a serum concentration plateau, whereby the maximum concentration is reached after an average of 12 - 28 hours.
Danish: Efter subkutan administration med epoetin beta hos uræmiske patienter resulterer den protraherede absorption i et serumkoncentrationsniveau, hvorved maksimumkoncentrationen nås efter et gennemsnit på 12-28 timer.
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 hæmoglobin og udvikling af svær anæmi associeret med lave reticulocyttal skal medføre, at behandling med epoetin straks ophører og anti-erythropoietin-antistofmåling udføres.
English: If your body produces neutralising antibodies, your doctor will discontinue therapy with NeoRecormon, and determine the best course of action to treat your anaemia.
Danish: Hvis din krop producerer neutraliserende antistoffer, vil din læge afbryde behandlingen med NeoRecormon og afgøre den bedste metode til at behandle din blodmangel.
English: Then, slowly push the plunger up to push the air bubbles out of the syringe.
Danish: Skub derefter langsomt stemplet op for at skubbe luftboblerne ud af injektionssprøjten.
English: For storage conditions of the reconstituted medicinal product see section 6.3.
Danish: Opbevaringsbetingelser for det rekonstituerede lægemiddel, se pkt.
English: (10) Before and after reconstitution NeoRecormon Multidose must be stored at +2° to +8°C (refrigerator).
Danish: (10) Før og efter rekonstitueringen skal NeoRecormon Flerdosis opbevares i køleskab ved 2 ºC - 8 ºC
English: 10 Wipe the injection site with an alcohol swab and let it air dry for 10 seconds.
Danish: Tør injektionsstedet med en alkoholserviet og lad det lufttørre i 10 sekunder.
English: Clinical studies have shown a higher frequency of thromboembolic events in cancer patients treated with NeoRecormon compared to untreated controls or placebo.
Danish: Kliniske studier har vist en højere frekvens af tromboemboliske hændelser hos cancerpatienter, som behandles med NeoRecormon, sammenlignet med ubehandlede kontrolgrupper eller placebo.
English: Cytotoxic actions of epoetin beta on bone marrow or on human skin cells were not detected.
Danish: Cytotoksisk virkning af epoetin beta på knoglemarv eller på humane hudceller er ikke set.
English: The doctor may continue to increase your dose at monthly intervals if necessary.
Danish: Lægen vil måske fortsætte med at øge dosis med månedlige intervaller, hvis det viser sig nødvendigt.
English: On those occasions where the patient's PCV allows blood donation, i.e. PCV ³ 33 %, NeoRecormon is administered at the end of blood donation.
Danish: I de situationer, hvor patientens hæmatokrit tillader blodtapning, dvs. hæmatokrit over 33 % administreres NeoRecormon umiddelbart efter blodtapning.
English: 1 Find a well-lighted, clean, flat, working surface.
Danish: Find en veloplyst, ren, flad overflade til at arbejde på.
English: Stop using NeoRecormon if you develop these symptoms and contact your doctor or seek medical attention immediately.
Danish: Stop med at bruge NeoRecormon, hvis du udvikler disse symptomer, og kontakt straks din læge eller søg lægehjælp.
English: Driving and using machines No effects on ability to drive or use machines have been observed.
Danish: Trafik- og arbejdssikkerhed Ingen effekt på evnen til at køre bil eller anvende maskiner er observeret.
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 studier har vist en konsistent uforklarlig statistisk signifikant overdødelighed hos patienter, som har anæmi i følgeskab med diverse almindelige cancerformer, og som har fået rekombinant human erythropoietin, sammenlignet med kontrolgruppen.
English: This is because one cannot rule out a possible acceleration of progression of kidney disease with absolute certainty.
Danish: Det skyldes, at det ikke helt kan udelukkes, at en forværring af nyresygdommen fremskyndes.
English: If you get unusual wheezing or difficulty breathing; swollen tongue, face or throat, or swelling around the injection site; if you feel lightheaded or faint or if you collapse, call your doctor at once.
Danish: Hvis du oplever udsædvanlig hvæsen eller hiven efter vejret, opsvulmet tunge, ansigt eller hals, eller opsvulmet injektionssted; hvis du føler dig svimmel, besvimer eller kollapser, skal du fortælle det til lægen med det samme.
English: Check that the solution is clear, colourless and practically free from particles.
Danish: Kontroller, at opløsningen er klar, farveløs og praktisk taget fri for partikler.
English: Factors that should be considered in this assessment should include the type of tumour and its stage; the degree of anaemia; lifeexpectancy; the environment in which the patient is being treated; and patient preference (see section
Danish: De faktorer, som bør overvejes i denne analyse, bør inkludere typen af tumor og dens stadie, graden af anæmi, forventet levealder, patientens behandlingsomgivelser og patientens præference (se pkt.
English: To avoid the risk of contamination of the contents always observe aseptic techniques (i.e. use disposable sterile syringes and needles to administer each dose) and strictly follow the handling instructions below.
Danish: For at undgå risiko for kontaminering af indholdet skal der altid anvendes aseptisk teknik (f.eks. sterile engangssprøjter og engangsnåle til administration af hver dosis) og brugervejledningen nedenfor følges nøje.
English: The maximum dose should not exceed 60,000 IU per week.
Danish: Maksimumdosis bør ikke overskride 60.000 IE pr. uge.
English: Treatment with NeoRecormon is normally a long-term therapy.
Danish: Behandling med NeoRecormon er normalt en langtidsbehandling.
English: Under no circumstances should more than one dose be administered per syringe; the medicinal product is for single use only.
Danish: Der må under ingen omstændigheder administreres mere end én dosis per sprøjte.
English: · The active substance is epoetin beta.
Danish: • Det aktive stof er epoetin beta.
English: In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2.
Danish: Hos patienter med kronisk nyresvigt bør vedligeholdelses-hæmoglobinkoncentrationen ikke overstige den øvre grænse for den tilstræbte hæmoglobinkoncentration, som anbefales i pkt.
English: · Do not try to remove the used injection needle from the used syringe.
Danish: ● Forsøg ikke at fjerne den brugte injektionsnål fra den brugte injektionssprøjte.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf bør bortskaffes i henhold til lokale retningslinjer.
English: Effect on tumour growth
Danish: Virkninger på tumorvækst
English: The ability to donate blood depends predominantly on the patient's blood volume and baseline PCV.
Danish: Muligheden for at afgive blod afhænger hovedsagelig af patientens blodvolumen og hæmatokrit.
English: · Do not use if the expiration date has passed, if the syringe is dropped or damaged, or if the carton appears to be tampered with.
Danish: ● Brug den ikke, hvis udløbsdato er overskredet, injektionssprøjten er blevet tabt eller beskadiget eller hvis æsken synes at være åbnet.
English: L-Leucine,
Danish: L-Leucin,
English: The lyophilisate is white and the solvent is clear and colourless.
Danish: Lyofilisatet er hvidt, og solvens er klar og farveløs.
English: NeoRecormon Multidose contains benzyl alcohol as a preservative and must therefore not be given to infants or young children up to three years old.
Danish: NeoRecormon Flerdosis indeholder benzylalkohol som konserveringsmiddel og må derfor ikke gives til spædbørn og små børn yngre end 3 år.
English: L-Glutamic acid, L-Phenylalanine.
Danish: L-Glutaminsyre, L-Phenylalanin
English: Your doctor will regularly check your blood pressure, particularly at the beginning of therapy.
Danish: Din læge vil regelmæssigt kontrollere dit blodtryk, især i begyndelsen af behandlingen.
English: The recommended initial dose is 30,000 IU per week (corresponding to approximately 450 IU/kg body weight per week, based on an average weighted patient).
Danish: Den anbefalede initialdosis er 30.000 IE om ugen (dette svarer omtrent til 450 IE/kg/uge beregnet med gennemsnitsvægten for en patient).
English: Pooled post-hoc analyses of clinical studies with ESAs have been performed in CRF patients (on dialysis, not on dialysis, with or without diabetes).
Danish: Puljede post-hoc analyser af kliniske studier med ESAs har været udført hos patienter med kronisk nyreinsufficiens (i dialyse, ikke i dialyse, diabetiske- og ikke-diabetiske patienter).
English: Chemical and physical in-use stability of the reconstituted solution has been demonstrated for one month at 2°C - 8°C.
Danish: Kemisk og fysisk stabilitet af den rekonstituerede opløsning er vist for én måned ved 2 °C - 8 °C.
English: The dose of NeoRecormon depends on your disease condition, the way the injection is given (under the skin or into a vein) and your body weight.
Danish: Mængden af NeoRecormondosis afhænger af din sygdom og hvordan injektionen er givet (under huden eller i en vene) og også af din legemsvægt.
English: EU/1/97/031/ 025-026 EU/1/97/031/029-030 EU/1/97/031/031-032 EU/1/97/031/033-034 EU/1/97/031/035-036 EU/1/97/031/037-038 EU/1/97/031/041-042 EU/1/97/031/043-044 EU/1/97/031/045-046
Danish: EU/1/97/031/031 - 032EU/1/97/031/033 - 034 EU/1/97/031/035 - 036
English: These antibodies have been shown to cross-react with all erythropoietic proteins, and patients suspected or confirmed to have neutralising antibodies to erythropoietin should not be switched to NeoRecormon (see section 4.8).
Danish: Disse antistoffer har vist sig at kunne krydsreagere med alle erythropoietinproteiner, og patienter, for hvem der er mistanke om eller påvist neutraliserende antistoffer overfor erythropoietin, skal ikke skifte til NeoRecormon (se pkt.
English: Subcutaneous and intravenous use after reconstitution as directed.
Danish: Subkutan og intravenøs anvendelse efter rekonstituering som foreskrevet.
English: Its use in this indication must be balanced against the reported increased risk of thromboembolic events.
Danish: NeoRecormons anvendelse til denne indikation må afvejes overfor en rapporteret forøget risiko for tromboemboliske tilfælde.
English: Use disposable sterile syringes and needles for each dose
Danish: Brug engangsnåle og engangssprøjter ved hver dosis
English: Both variables determine the endogenous red cell reserve, which can be calculated according to the following formula.
Danish: Begge faktorer bestemmer den til rådighed værende mængde af røde blodlegemer, som kan beregnes i henhold til følgende formel:
English: Treatment with NeoRecormon should be temporarily discontinued if haemoglobin levels exceed 13 g/dl (8.1 mmol/l).
Danish: Behandling med NeoRecormon bør midlertidigt afbrydes, hvis hæmoglobinniveauet overstiger 13 g/dl (8,1 mmol/l).
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Spørg lægen eller på apotekspersonalet, inden du tager nogen form for medicin.
English: Do not use the syringe if the liquid is cloudy, discoloured, or has particles.
Danish: Brug ikke injektionssprøjten, hvis væsken er uklar, misfarvet eller indeholder partikler.
English: After administration of epoetin beta, the number of erythrocytes, the Hb values and reticulocyte counts increase as well as the 59Fe-incorporation rate.
Danish: Efter indgift af epoetin beta øges antallet af erytrocytter, Hb-værdien og retikulocytantallet såvel som 59Fe optagelseshastigheden.
English: Clean the injection port as instructed by the provider.
Danish: Rengør venflon som instrueret af fabrikanten.
English: If you are a nephrosclerotic patient and you are not on dialysis, your doctor will decide whether treatment is right for you.
Danish: Hvis du har skrumpenyre (nefrosklerose), og endnu ikke er i dialysebehandling, vil lægen afgøre, om behandlingen er rigtig for dig.
English: Labelling of the stand
Danish: Mærkning af standsen
English: If your red blood cell level is stable on a once weekly dosing regimen, your dose may be switched to once every two weeks administration.
Danish: Hvis niveauet af røde blodlegemer er stabilt ved en ugentlig dosering, kan din dosis blive givet hver anden uge.
English: · Call a doctor at once if you get headaches, especially sudden, stabbing, migraine-like headaches, confusion, speech disturbance, unsteady walking, fits or convulsions.
Danish: ● Tilkald lægen med det samme hvis du oplever hovedpine, især pludselig, stikkende, migrænelignende hovedpine, forvirring, taleforstyrrelser, besværet gang, anfald og kramper.