FrancophonIA/ELRC3.0 huggingface dataset:
English: An increased 3H-thymidine incorporation in the erythroid nucleated spleen cells has been found in vitro (mouse spleen cell culture) after incubation with epoetin beta.
Danish: En forhøjet 3H-thymidin optagelse i miltens erythroide forstadier er blevet fundet in vitro (musemiltcellekultur) efter inkubation med epoetin beta.
English: Once the needle is inserted, release the pinch and hold the syringe tightly in place.
Danish: Så snart nålen er indsat, frigør klemmet og hold injektionssprøjten stramt på plads.
English: (2) Remove the plastic cap from the vial.
Danish: (2) Fjern plastikhætten fra hætteglasset.
English: Hypertensive crisis with encephalopathy-like symptoms (e.g. headaches and confused state, sensorimotor disorders - such as speech disturbance or impaired gait - up to tonoclonic seizures) may also occur in individual patients with otherwise normal or low blood pressure (see section 4.4).
Danish: Hypertensive kriser med encefalopatilignende symptomer (f.eks. hovedpine og forvirring, sensomotoriske sygdomme - som taleforstyrrelser, gangforstyrrelser osv. til tonisk-kloniske anfald) kan også forekomme hos patienter med normalt eller lavt blodtryk (se pkt.
English: Shunt thromboses may occur, especially in patients who have a tendency to hypotension or whose arteriovenous fistulae exhibit complications (e.g. stenoses, aneurisms), see section 4.4.
Danish: Shunttromboser kan forekomme, især hos patienter, som har tendens til hypotension eller hvis arteriovenøse fistler medfører komplikationer (f.eks. stenoser, aneurismer), se pkt.
English: In order to ensure effective erythropoiesis, iron status should be evaluated for all patients prior to and during treatment and supplementary iron therapy may be necessary and conducted in accordance with therapeutic guidelines.
Danish: For at sikre effektiv erythropoiesis, skal jernstatus evalueres hos alle patienter før og under behandlingen.
English: Almost all patients have to be treated with iron supplements during their NeoRecormon therapy.
Danish: Næsten alle patienter skal have jernsupplement når de behandles med NeoRecormon.
English: EXP The reconstituted solution is stable for 1 month if stored at 2°C - 8°C (in a refrigerator)
Danish: EXP Den rekonstituerede opløsning er holdbar i 1 måned, hvis den opbevares ved 2 °C - 8 °C (i køleskab)
English: ·Do not inject into a muscle.
Danish: ● Injicer ikke ind i en muskel.
English: · Very rarely (may affect up to 1 in 10,000 people), patients have had rising levels of potassium or phosphates in the blood.
Danish: ● Meget sjældent (forekommer hos op til 1 ud af 10.000 personer) har patienter oplevet forhøjede niveauer af kalium eller phosphat i blodet.
English: · Take the carton with the syringe(s) and needle(s) out of the refrigerator
Danish: ● Tag æsken med injektionssprøjte(r) og nål(e) ud af køleskab
English: For use of NeoRecormon in an autologous predonation programme, the official guidelines on principles of blood donation must be considered, in particular: - only patients with a PCV ³ 33 % (haemoglobin ³ 11 g/dl [6.83 mmol/l]) should donate; - special care should be taken with patients below 50 kg weight; - the single volume drawn should not exceed approx. 12 % of the patient's estimated blood volume.
Danish: Ved anvendelse af NeoRecormon i et autologt prædonationsprogram skal de officielle retningslinjer for principper ved blodtransfusion følges i særdeleshed: - kun patienter med hæmatokrit ≥ 33 % (hæmoglobin ≥ 11 g/dl [6,83 mmol/l]) bør behandles, - specielle hensyn skal tages til patienter med en legemsvægt under 50 kg, - den enkelte udtagne portion blod bør ikke overstige ca. 12 % af patientens estimerede blodvolumen.
English: Remove the larger air bubbles by gently tapping the syringe barrel with your fingers until the air bubbles rise to the top of the syringe.
Danish: Fjern de større luftbobler ved forsigtigt at knipse på injektionssprøjtens glasbeholder med dine fingre indtil luftboblerne stiger til toppen af injektionssprøjten.
English: · Do not use if the syringe has been frozen.
Danish: ● Brug ikke injektionssprøjten, hvis den har været frosset.
English: NeoRecormon therapy is started by a doctor who is an expert on your condition.
Danish: NeoRecormonbehandling påbegyndes af en læge med speciale i din lidelse.
English: For epoetin beta no clinical data on exposed pregnancies are available.
Danish: Der foreligger ikke kliniske data om eksponering for epoetin beta under graviditet.
English: In this case, proceed to step 19 and contact your healthcare provider.
Danish: 19 og kontakt sundhedspersonalet.
English: Epoetin beta treatment-related headache and hypertension which can be treated with drugs are common (see section 4.4).
Danish: Hovedpine og hypertension, som er relateret til behandlingen med epoetin beta, og som kan behandles med lægemidler, er almindelig (se pkt.
English: 15 Pinch the selected injection site and fully insert the needle at a 45° to 90° angle with a quick, firm action.
Danish: Klem det valgte injektionssted og sæt nålen helt ind med en 45° til 90° vinkel med en hurtig og fast bevægelse.
English: · Preventing anaemia in premature infants (weighing 750 to 1500 g and born at less than 34 weeks).
Danish: • forebyggelse af blodmangel hos for tidligt fødte (præmature) spædbørn (som vejer mellem 750 og 1500 g og født før 34. uge).
English: The indication for treatment with NeoRecormon of nephrosclerotic patients not yet undergoing dialysis should be defined individually, as a possible acceleration of progression of renal failure cannot be ruled out with certainty.
Danish: Indikation for behandling med NeoRecormon af nefrosklerotiske patienter, som endnu ikke får dialyse, skal fastlægges individuelt, da en mulig acceleration af progredierende nyresvigt ikke kan udelukkes.
English: NeoRecormon is indicated for: - Treatment of symptomatic anaemia associated with chronic renal failure in adult and paediatric patients.
Danish: NeoRecormon er indiceret til: - behandling af symptomatisk anæmi i forbindelse med kronisk nyresvigt (CRF) hos voksne og pædiatriske patienter.
English: Traceability of NeoRecormon
Danish: Sporbarhed af NeoRecormon
English: (3) Disinfect the rubber seal with alcohol.
Danish: (3) Desinficer gummiproppen med sprit.
English: ·Do not touch the injection site again before giving the injection.
Danish: ● Rør ikke ved injektionsstedet igen inden indgivelse af injektionen.
English: If you have missed an injection, or injected too little, talk to your doctor.
Danish: Hvis du har glemt en injektion eller injiceret for lidt, så tal med lægen.
English: · Treating symptomatic anaemia caused by chronic kidney disease (renal anaemia) in patients on dialysis, or not yet on dialysis.
Danish: • behandling af symptomgivende blodmangel forårsaget af kronisk nyresygdom (renal anæmi) hos patienter i dialyse eller som endnu ikke er i dialyse.
English: To avoid the risk of cross-infection always follow aseptic techniques and use disposable sterile syringes and needles for each administration.
Danish: For at undgå risiko for krydsinfektion skal der altid anvendes aseptisk procedure og engangssprøjter og engangsnåle ved hver administration.
English: If you develop a serious rash or another of these skin symptoms, stop taking NeoRecormon 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 NeoRecormon og straks kontakte din læge eller søge lægehjælp.
English: Caution should be exercised with escalation of NeoRecormon 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 NeoRecormon-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: Store at +2°C to +8°C
Danish: Opbevares ved +2 °C - +8 °C
English: Withdraw all the solvent into the syringe.
Danish: Træk al solvens op i sprøjten.
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 intra-patientvariabilitet kan der hos en patient til tider observeres individuelle hæmoglobinværdier over og under det ønskede hæmoglobinniveau.
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 forsøg med epoetin alfa eller darbepoetin alfa viste, at hyppigheden for apopleksi er almindelig.
English: · Check the expiration date on the syringe and the needle.
Danish: ● Undersøg udløbsdatoen på injektionssprøjten og nålen.
English: 5000 IU/ ml 500 IU 1000 IU 1500 IU 2000 IU 2500 IU 3000 IU 3500 IU 4000 IU 4500 IU 5000 IU 0.1 ml 0.2 ml 0.3 ml 0.4 ml 0.5 ml 0.6 ml 0.7 ml 0.8 ml 0.9 ml
Danish: 500 IE 1.000 IE 1.500 IE 2.000 IE 2.500 IE 3.000 IE 3.500 IE 4.000 IE 4.500 IE 5.000 IE 0,1 ml
English: In premature infants there may be a slight rise in platelet counts, particularly up to day 12 - 14 of life, therefore platelets should be monitored regularly.
Danish: Hos præmature børn kan der forekomme en lille stigning i trombocyttallet, specielt op til 12-14 dages alderen.
English: L-Threonine,
Danish: L-Threonin,
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om NeoRecormon, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: In patients in an autologous blood predonation programme there may be an increase in platelet count, mostly within the normal range.
Danish: Hos patienter i et autologt blod-prædoneringsprogram kan der forekomme en stigning i trombocyttallet, for det meste indenfor referenceområdet.
English: Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician's evaluation of the individual patient's clinical course and condition is necessary.
Danish: Anæmiske symptomer og følgesygdomme kan variere med alder, køn og samlet sygdomsbelastning: en læges evaluering af den enkelte patients kliniske forløb og tilstand er nødvendig.
English: It is therefore recommended to monitor blood pressure, in particular in the initial treatment phase in cancer patients.
Danish: Det anbefales derfor at kontrollere blodtrykket, specielt i begyndelsen af behandlingen hos cancerpatienter.
English: * produced in Chinese Hamster Ovary cells (CHO) by recombinant DNA technology
Danish: *Produceret i ovarieceller fra kinesisk hamster (KHO) ved rekombinant DNA-teknologi.
English: The weekly dose can also be divided into daily doses.
Danish: Den ugentlige dosis kan også blive fordelt på daglige doser.
English: · Rarely (may affect up to 1 in 1,000 people), allergies or skin reactions, such as rash or hives, itching or reactions around the injection site have occurred.
Danish: ● Sjældne tilfælde (forekommer hos op til 1 ud 1000 personer) af allergi eller hudreaktioner såsom udslæt eller nældefeber, kløe eller reaktioner ved injektionsstedet er set.
English: Your injections are given under the skin or into a vein.
Danish: Injektionerne gives under huden eller i en vene.
English: However, a causal relationship with treatment with NeoRecormon could not be established.
Danish: Der kan dog ikke påvises en sammenhæng med behandling af NeoRecormon.
English: Erythropoietin is a glycoprotein that stimulates the formation of erythrocytes from its committed progenitors.
Danish: Erythropoietin er et glykoprotein, der stimulerer dannelsen af erytrocytter fra særlige stamceller.
English: The number of platelets can rise slightly to moderately during epoetin treatment, and this can cause changes in blood clotting.
Danish: Antallet af blodplader kan øges lidt eller moderat under epoetinbehandling, og det kan betyde ændringer i blodstørkningsprocessen.
English: In most cases, a fall in serum ferritin values simultaneous with a rise in packed cell volume is observed (see section 4.4).
Danish: I de fleste tilfælde ses et fald i serumferritinværdierne samtidig med en stigning i det samlede cellevolumen (se pkt.
English: L-Glutamic acid,
Danish: L-Glutaminsyre,
English: · Symptomatic anaemia caused by chronic kidney disease
Danish: ● Symptomgivende blodmangel forårsaget af kronisk nyresygdom
English: Misuse of NeoRecormon by healthy people may lead to an increase in blood cells and consequently thicken the blood.
Danish: Misbrug af NeoRecormon af raske personer kan medføre et øget antal blodplader og dermed gøre blodet mere tyktflydende.
English: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000
Danish: Frekvenskategorierne er defineret på følgende måde: meget almindelig (≥1/10); almindelig (≥1/100, <1/10); ikke almindelig (≥1/1.000, <1/100); sjælden (≥1/10.000, <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Remove one syringe from the pack and check that the solution is clear, colourless and practically free from visible particles.
Danish: Fjern en sprøjte fra pakningen og check at opløsningen er klar, farveløs og fri for synlige partikler.
English: These increases in blood pressure can be treated with medicinal products.
Danish: Denne stigning i blodtrykket kan behandles medicinsk.
English: If you think you have injected more NeoRecormon than you should, contact your doctor.
Danish: Hvis du tror, at du har injiceret mere NeoRecormon end du skulle, så kontakt lægen.
English: You can press a dry sterile pad over the injection site.
Danish: Du kan presse en tør steril serviet på injektionsstedet.
English: It contains a hormone called epoetin beta, which stimulates the production of red blood cells.
Danish: NeoRecormon indeholder et hormon, som kaldes epoetin beta, som stimulerer produktionen af røde blodlegemer.
English: Early shunt revision and thrombosis prophylaxis by administration of acetylsalicylic acid, for example, should be considered in chronic renal failure patients at risk of shunt thrombosis.
Danish: Tidlig fistelomlægning og tromboseprofylakse ved administration af f.eks. acetylsalicylsyre bør overvejes hos patienter med kronisk nyresvigt, hvor der er risiko for fisteltrombose.
English: Prevention of anaemia of prematurity
Danish: Forebyggelse af anæmi hos præmature:
English: When you donate blood, NeoRecormon will be given to you at the end of a donation session.
Danish: Når du donerer blod vil NeoRecormon blive indgivet efter hver bloddonation.
English: In clinical trials, an increased risk of death and serious cardiovascular events or cerebrovascular events including stroke was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/dl (7.5 mmol/l).
Danish: I kliniske studier blev der observeret en øget risiko for dødsfald og alvorlige kardiovaskulære hændelser eller cerebrovaskulære hændelser, inklusive apopleksi, når erythropoiese-stimulerende stoffer (ESAs) blev administreret for at opnå en hæmoglobinkoncentration over 12 g/dl (7,5 mmol/l).
English: Storage Instructions
Danish: Opbevaringsvejledning
English: In very rare cases, particularly when starting treatment, epoetin beta treatment-related flu-like symptoms such as fever, chills, headaches, pain in the limbs, malaise and/or bone pain have been reported.
Danish: I meget sjældne tilfælde, især i starten af behandlingen, er influenza-lignende symptomer såsom feber, kulderystninger, hovedpine, smerter i ekstremiteterne, utilpashed og/eller knoglesmerter blevet rapporteret i forbindelse med epoetin betabehandling.
English: Platelet counts and haemoglobin level should also be monitored at regular intervals in cancer patients.
Danish: Blodpladeantal og hæmoglobinniveau bør monitoreres regelmæssigt hos cancerpatienter.
English: The following instructions explain how to give an injection of NeoRecormon.
Danish: Den følgende brugsanvisning forklarer hvordan en injektion af NeoRecormon skal gives.
English: This can in turn lead to life-threatening complications of the heart or blood vessels.
Danish: Det kan medføre livstruende komplikationer i hjertet eller i blodkarrene.
English: · Keep your unused syringe(s) in the original carton and store in a refrigerator at 2˚C to 8˚C.
Danish: ● Opbevar din(e) ubrugte injektionssprøjte(r) i den originale æske, og opbevar i køleskab ved 2˚C - 8˚C.
English: · Very rarely (may affect up to 1 in 10,000 people) a severe form of allergic reaction has occurred, especially just after an injection.
Danish: ● Meget sjældne tilfælde (forekommer hos op til 1 ud af 10.000 personer) af en alvorlig form for allergisk reaktion er set, specielt lige efter en injektion.
English: In controlled clinical studies, use of NeoRecormon and other erythropoiesis-stimulating agents (ESAs) have shown:
Danish: Anvendelse af NeoRecormon og andre erytropoiesisstimulerende stoffer (ESAs) i kontrollerede kliniske studier har vist:
English: a) Correcting the anaemia
Danish: a) Korrektion af blodmanglen
English: blood volume [ml] = 44 [ml/kg] x body weight [kg] + 1600 [ml] (body weight ³ 45 kg)
Danish: blodvolumen (ml) = 44 (ml/kg) x legemsvægt (kg) + 1600 (ml) (Legemsvægt > 45 kg)
English: If there is an increase in platelets of more than 150 x 109/l or if platelets rise above the normal range, treatment with NeoRecormon should be discontinued.
Danish: Hvis trombocyttallet stiger med mere end 150 x 109/l, eller hvis trombocyttallet stiger til over øvre referencegrænse, skal behandlingen med NeoRecormon afbrydes.
English: Patients in an autologous blood predonation programme Patients in an autologous blood predonation programme have been reported to show a slightly higher frequency of thromboembolic events.
Danish: Patienter i autologt blodprædonationsprogram, udviser en lille forøget frekvens i forekomsten af tromboemboliske hændelser.
English: In addition, transient increases in serum potassium and phosphate levels have been observed in isolated cases (see section 4.4).
Danish: Yderligere er forbigående øgning af serumkalium og serumphosphat observeret i enkelte tilfælde (se pkt.
English: People who are not on haemodialysis will usually have injections under the skin.
Danish: Patienter, der ikke er i hæmodialyse vil sædvanligvis få injektionerne under huden.
English: This NeoRecormon presentation contains white lyophilisate and solvent.
Danish: Dette NeoRecormon indeholder et hvidt lyofilisat og solvens.
English: In patients with baseline haemoglobin ≤ 10 g/dl (n=899), the hazard ratio point estimate for survival was 0.98 (95 % CI 0.68 to 1.40).
Danish: Hos patienter med en baseline hæmoglobinkoncentration på ≤ 10 g/dl (n=899) var hazard ratioen for overlevelse 0,98 (95 % konfidensinterval: 0,68 til 1,40).
English: · Do not use if the syringe has been dropped or damaged.
Danish: ● Brug ikke injektionssprøjten, hvis den er blevet tabt eller beskadiget.
English: Treatment should only be given to patients with moderate anaemia (Hb 10 - 13 g/dl [6.21 - 8.07 mmol/l], no iron deficiency) if blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).
Danish: Behandlingen bør kun gives til patienter med moderat anæmi (hæmoglobinværdien 10 - 13 g/dl [6,21 - 8,07 mmol/l] og ingen jernmangel), hvis blodopbevaringsprocedure ikke er tilgængelig eller er utilstrækkelig, når det planlagte store kirurgiske indgreb kræver en stor mængde blod (4 eller flere blodportioner for kvinder eller 5 eller flere portioner for mænd).
English: If you do not respond adequately to NeoRecormon, your doctor will check your dose and will inform you if you need to change doses of NeoRecormon.
Danish: Hvis du ikke respondere tilstrækkeligt på NeoRecormon, vil din læge tjekke din dosis og informere dig om, hvis du skal ændre dosis af NeoRecormon.
English: · Check the liquid in the syringe.
Danish: ● Undersøg væsken i injektionssprøjten.
English: An individual patient data based meta-analysis, which included data from all 12 controlled clinical studies in anaemic cancer patients conducted with NeoRecormon (n=2301), showed an overall hazard ratio point estimate for survival of 1.13 in favour of controls (95 % CI 0.87, 1.46).
Danish: En individuel patientdata-baseret meta-analyse, som inkluderede data fra alle 12 kontrollerede kliniske studier af anæmiske cancerpatienter, som blev behandlet med NeoRecormon (n=2301), viste en samlet hazard ratio for overlevelse på 1,13 i kontrolgruppens favør (95 % konfidensinterval: 0,87, 1,46).
English: Your doctor may treat the high blood pressure with drugs or temporarily interrupt your NeoRecormon therapy.
Danish: Lægen kan behandle det forhøjede blodtryk med lægemidler eller afbryde NeoRecormonbehandlingen for en tid.
English: For both routes of administration, the maximum dose should not exceed 720 IU/kg per week.
Danish: For begge administrationsveje må den maksimale dosis ikke overskride 720 IE/kg pr. uge.
English: If you think you have been injected more NeoRecormon than you should, contact your doctor.
Danish: Hvis du tror at du har fået injiceret mere NeoRecormon end du skulle, så kontakt lægen.
English: Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician's evaluation of the individual patient's clinical course and condition is necessary.
Danish: Behandling af symptomatisk anæmi hos voksne og pædiatriske patienter med kronisk nyresvigt: Anæmiske symptomer og følgesygdomme kan variere med alder, køn og samlet sygdomsbelastning: en læges evaluering af den enkelte patients kliniske forløb og tilstand er nødvendig.
English: INSTRUCTIONS ON USE (on the cover inside) Handling steps
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN (Mærkning af inderside)
English: In patients with a poor haemoglobin response to epoetins, alternative explanations for the poor response should be considered (see sections 4.2 and
Danish: Hos patienter med ringe hæmoglobinrespons på epoetiner, bør alternative forklaringer på det ringe respons overvejes (se pkt.
English: 9 Choose an injection site: · The recommended injection sites are the top of your thigh or the lower part of your abdomen below the belly button.
Danish: ● De anbefalede injektionssteder er øverst på låret eller den nedre del af din mave under navlen.
English: Preparation of NeoRecormon Multidose solution (1) Take the vial with the freeze-dried substance out of the package.
Danish: Tilberedning af NeoRecormon Flerdosis injektionsvæske (1) Tag hætteglasset med den frysetørrede substans ud af pakningen.
English: Endogenous red cell reserve [ml]
Danish: Endogen reserve af røde blodlegemer [ml] Endogen reserve af røde blodlegemer [ml]
English: Patients should be monitored closely to ensure that the lowest approved effective dose of NeoRecormon is used to provide adequate control of the symptoms of anaemia whilst maintaining a haemoglobin concentration below to 12g/dl (7.45mmol/l).
Danish: Patienterne bør monitoreres nøje for at sikre, at den laveste godkendte effektive dosis af NeoRecormon der kan kontrollere de anæmiske symptomer i tilstrækkelig grad, anvendes, mens en hæmoglobin-koncentration under eller på 12 g/dl (7,45 mmol) opretholdes.
English: It acts as a mitosis stimulating factor and differentiation hormone Epoetin beta, the active substance of NeoRecormon, is identical in its amino acid and carbohydrate composition to erythropoietin that has been isolated from the urine of anaemic patients.
Danish: Epoetin beta, den aktive substans i NeoRecormon, er identisk i dets aminosyre- og kulhydratsammensætning med erythropoietin, som er isoleret fra urinen hos patienter med blodmangel.
English: Remove one needle from the pack, fix it on the syringe and remove the protective cap from the needle.
Danish: Fjern en nål fra pakningen, sæt den på sprøjten og fjern den beskyttende hætte fra nålen.