FrancophonIA/ELRC3.0 huggingface dataset:
English: Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid puncture of peripheral veins.
Danish: Subkutan anvendelse er at foretrække hos patienter, der ikke modtager dialyse, for at undgå at skulle stikke i ydre vener.
English: - The active substance is epoetin delta, 0.5 ml of the solution containing 1,000 IU (International Units) (2,000 IU/ml), 0.5 ml of the solution containing 2,000 IU (4,000 IU/ml), 0.3 ml of the solution containing 3,000 IU (10,000 IU/ml), 0.4ml of the solution containing 4,000 IU (10,000 IU/ml), 0.5 ml of the solution containing 5,000 IU (10,000 IU/ml), 0.3 ml of the solution containing 6,000 IU (20,000 IU/ml), 0.4 ml of the solution containing 8,000 IU (20,000 IU/ml), or 0.5 ml of the solution containing 10,000 IU/ml (20,000 IU/ml) of epoetin
Danish: - Aktive stoffer: Epoetin delta, 0,5 ml opløsning indeholder 1.000 IE (internationale enheder) (2.000 IE/ml), 0,5 ml opløsning indeholder 2.000 IE (4.000 IE/ml), 0,3 ml opløsning indeholder 3.000 IE (10.000 IE/ml), 0,4 ml opløsning indeholder 4.000 IE (10.000 IE/ml), 0,5 ml opløsning indeholder 5.000 IE (10.000 IE/ml), 0,3 ml opløsning indeholder 6.000 IE (20.000 IE/ml), 0,4 ml opløsning indeholder 8.000 IE (20.000 IE/ml), eller 0,5 ml opløsning indeholder 10.000 IE (20.000 IE/ml) epoetin delta.
English: Dynepo should be administered either subcutaneously or intravenously in order to increase haemoglobin to not greater than 12 g/dL (7.5 mmol/L).
Danish: Dynepo skal indgives enten subkutant eller intravenøst for at forhøje hæmoglobin til ikke mere end 12 g/dl (7,5 mmol/l).
English: Overall survival outcome in the trials could not be satisfactorily explained by differences in the incidence of thrombosis and related complications between those given recombinant human erythropoietin and those in the control group.
Danish: Overordnede resultater for overlevelse i forsøgene kunne ikke forklares tilfredsstillende med forskelle i forekomsten af trombose og relaterede komplikationer blandt de patienter, der modtog rekombinant, human erythropoietin, og patienterne i kontrolgruppen.
English: The solution is clear, colourless and waterlike with no visible particles.
Danish: Opløsningen er klar, farveløs og vandig uden synlige partikler.
English: Driving and using machines No effects on ability to drive and use machines have been observed.
Danish: Der er ikke set påvirkninger af evnen til at køre bil eller anvende maskiner.
English: Your doctor should maintain your haemoglobin level within the target range of 10 to 12 g/dl.
Danish: Din læge skal holde dit hæmoglobinniveau inden for målområdet på 10 til 12 g/dl.
English: Most of patients with chronic renal failure have a history of hypertension.
Danish: De fleste patienter med kronisk nyresvigt har en fortid med for højt blodtryk.
English: Unopened pre-filled syringes may be kept un-refrigerated but below 25oC for a single maximum period of 5 days.
Danish: Uåbnede, fyldte sprøjter kan opbevares uden for køleskab, men ved under 25°C, i en enkelt periode på højst 5 dage.
English: Depress the plunger slowly and evenly while holding the syringe barrel, always keeping your skin pinched.
Danish: Skub stemplet ned langsomt og jævnt, mens du holder fast omkring sprøjtens cylinder, og idet
English: The extent to which the outcomes observed in the clinical studies discussed above may apply to this patient population is unclear, specifically considering that the dosages administered in the renal indication are lower than in the cancer indication.
Danish: Det er uklart i hvilken grad de observerede resultater i de kliniske forsøg, omtalt ovenfor kan omfatte denne patientpopulation, især taget i betragtning af, at doseringer, der administreres ved nyreindikation, er lavere end for cancerindikation.
English: Although it has not been observed with Dynepo, since anaphylactoid reactions may occur with erythropoietin, it is recommended that the first dose be administered under medical supervision.
Danish: Selv om det ikke er blevet observeret med Dynepo, anbefales det at administrere den første dosis under lægelig opsyn, da anafylaktiske reaktioner kan opstå ved erythropoietinbehandling.
English: Increases in blood pressure may require treatment with anti-hypertensive medicines or dosing increase of existing anti-hypertensive medications.
Danish: Forhøjelse blodtrykket kan kræve behandling med anti-hypertensiva eller dosisforhøjelse af allerede ordineret anti-hypertinsiva.
English: The maximum dose of epoetin delta that can be safely administered in single or multiple doses has not been determined.
Danish: Den maksimale, uskadelige dosis epoetin delta som kan gives, enten som enkel dosis eller multi dosis, er
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
Danish: MINDSTEKRAV TIL MÆRKNINGPÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTERKORT
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2oC - 8oC)
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab (2ºC - 8ºC)
English: During haemodialysis, patients treated with Dynepo may require increased anticoagulation treatment to prevent clotting of the arterio-venous shunt.
Danish: Under hæmodialyse kan patienter som behandles med Dynepo, få brug for øget antikoalgulationsbehandling, for at forhindre koagulation af den arteriovenøse anastomose.
English: Prefilled Type I glass syringe with bromobutyl rubber stopper, 27 gauge stainless steel needle with rigid natural rubber and polystyrene needle shield, polystyrene plunger rod and a needle safety guard.
Danish: Forfyldt type I-glassprøjte med brombutyl-gummiprop, 27 gauge rustfri stålkanyle med kanylehætte af stift naturgummi og polystyren, polystyren stempelstang og en sikkerhedsanordning til kanylen.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder må dette lægemiddel ikke
English: In consequence, dose adjustment should not be made more frequently than once a month, unless clinically indicated.
Danish: Derfor bør dosisjustering ikke foretages oftere end 1 gang om
English: Occasionally, your individual haemoglobin values may be above and below this recommended target level.
Danish: Deres individuelle hæmoglobinværdier kan til tider ligge over og under dette anbefalede niveau.
English: Pharmacotherapeutic group: Antianaemic - ATC code: B03XA.
Danish: Farmakoterapeutisk klassifikation: Middel mod anæmi, ATC-kode: B03XA.
English: Do not shake the syringe before use.
Danish: Ryst ikke kanylen før anvendelse..
English: During the clinical trials, there were no indications of development of neutralising antibodies to epoetin delta in humans based on the clinical response.
Danish: Under de kliniske afprøvninger var der, baseret på den kliniske respons, ingen indikation for udvikling af neutraliserende antistoffer for epoetin-delta hos mennesker.
English: Available in packs of 6 pre-filled syringes.
Danish: Findes i pakker med 6 stk. fyldte injektionssprøjter.
English: Dynepo is not indicated for the management of anaemia associated with cancer.
Danish: Dynepo er ikke indiceret til behandling af anæmi i forbindelse med cancer.
English: Severe reactions, possibly fatal, involving the heart and blood vessels may occur.
Danish: Der kan opstå alvorlige, muligvis dødelige, bivirkninger,
English: Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Danish: Hvis du tager eller for nylig har taget andre lægemidler, bør du oplyse din læge eller apotek herom, også hvis der er tale om ikke-receptpligtige lægemidler.
English: In the open-label study there was no difference in overall survival between patients treated with recombinant human erythropoietin and controls.
Danish: I den ublindede undersøgelse var der ingen forskel på generel overlevelse blandt patienter, der blev behandlet med rekombinant, human erythropoietin og kontrolgrupper.
English: Take your Dynepo pre-filled syringe out of the refrigerator.
Danish: Hvad du skal gøre, før du foretager en selvinjektion med Dynepo Tag din forfyldte Dynepo-sprøjte ud af køleskabet.
English: Starting dose is 50 IU/kg three times a week if administered intravenously.
Danish: Startdosis er 50 IE/kg tre gange ugentligt, hvis administreret intravenøst.
English: Occasionally, your individual haemoglobin values may be below and above this recommended target level.
Danish: Til tider kan dine individuelle hæmoglobinniveauer ligge under og over det anbefalede niveau.
English: Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/dL (6.2 mmol/l) to 12g/dL (7.5mmol/l).
Danish: Hæmoglobinvariabilitet bør håndteres via dosisjustering, med hensyntagen til hæmoglobinmålintervallet på 10 g/dl (6,2 mmol/l) til 12 g/dl (8,5 mmol/l).
English: Subcutaneous administration results in a similar pattern of erythropoietic stimulation as after intravenous administration.
Danish: Subkutan tilførsel resulterer i et mønster for erythropoietinstimulering svarende til det, som ses efter intravenøs tilførsel.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SYRINGE LABEL
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: The marketing authorisation holder for Dynepo is Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire, RG24 8EP, United Kingdom
Danish: Indehaveren af markedsføringstilladelsen og fremstiller Indehaveren af markedsføringstilladelsen for Dynepo er Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire, RG24 8EP, United
English: The frequency of adverse events that were experienced during Dynepo therapy is tabulated below.
Danish: Hyppigheden, hvormed bivirkningerne optrådte under behandling med Dynepo, er vist i nedenstående tabel.
English: The manufacturer is Shire Human Genetic Therapies AB, Åldermansgatan 2, P.O.
Danish: Fremstiller er Shire Human Genetic Therapies AB, Åldermansgatan 2, P.O. Box 1117, SE-221 04
English: Do not use any remaining liquid.
Danish: Resterende opløsning må ikke bruges.
English: Your doctor will closely monitor your haemoglobin concentration level to keep it within the target range of 10 to 12 g/dl and may therefore need to change your dosage of Dynepo accordingly.
Danish: Vær ekstra forsigtig med at bruge Dynepo din læge vil nøje overvåge Deres niveau af hæmoglobinkoncentration, for at holde det inden for et område på 10 til 12 g/dl, og vil muligvis ændre Deres dosis af Dynepo herefter.
English: Clinical experience with epoetins suggest hypertension and thrombosis risk may be reduced by titrating the dose to maintain haemoglobin levels between 10 to 12 g/dl.
Danish: Klinisk erfaring med epoetiner peger på, at risikoen for hypertension og trombose kan nedbringes ved at titrere dosis for at opretholde et
English: There is therefore consistent evidence to suggest that there may be significant harm to patients with cancer who are treated with recombinant human erythropoietin.
Danish: Der er derfor pålideligt bevis for, at kræftpatienter, der behandles med rekombinant, human erythropoietin, udsættes for markant skade.
English: Let go of the plunger allowing the syringe to move up inside the device until the entire needle is
Danish: Slip stemplet, og lad sprøjten bevæge sig ind i anordningen, indtil hele kanylen er dækket.
English: Treatment with Dynepo should be initiated by physicians experienced in the treatment of anaemia associated with CRF..
Danish: Behandling med Dynepo bør kun påbegyndes af læger med erfaring inden for behandling af anæmi i
English: Once hypertension is controlled with more intensified therapy, Dynepo therapy should be re-started at a reduced dose.
Danish: Når hypertensionen er bragt under kontrol med en mere intensiv behandling, bør Dynepo
English: Particular attention should be paid to sudden sharp migraine-like headaches as a possible warning signal.
Danish: Særskilt opmærksomhed skal rettes mod pludselige skarpe, migræneagtige
English: Excipients: sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, sodium chloride, polysorbate 20 and water for injections.
Danish: Hjælpestoffer: Natriumfosfat monobasisk monohydrat, natriumfosfat dibasisk heptahydrat, natriumklorid, polysorbat 20 og vand til injektionsvæsker.
English: Injecting the solution with the air bubble is harmless.
Danish: Der sker ikke noget ved at injicere opløsningen med luftboblen.
English: Pain Injection site reaction (e.g. pain, haemorrhage) Flu-syndrome
Danish: Smertereaktioner på injektionsstedet (f.eks. smerter, blødning) Influenzalignende symptomer
English: Store in a refrigerator (2 C - 8 C).
Danish: Opbevares i køleskab (2°C - 8°C).
English: - The other ingredients of Dynepo are sodium phosphate monobasic (monohydrate), sodium phosphate dibasic (heptahydrate), polysorbate 20, sodium chloride and water for injections
Danish: - Øvrige indholdsstoffer: Monobasisk natriumfosfat (monohydrat), dibasisk natriumfosfat (heptahydrat), polysorbat 20, natriumklorid og vand til injektionsvæske.
English: Water for injections
Danish: ETIKET PÅ SPRØJTE
English: Information on how to give yourself an injection of Dynepo This section contains information on how to give yourself an injection of Dynepo.
Danish: Dette afsnit indeholder oplysninger om, hvordan du kan give dig selv en injektion med Dynepo.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) AF DET (DE) BIOLOGISK AKTIVE STOF (FER) OG INDEHAVER (E) AF VIRKSOMHEDSGODKENDELSE (R) ANSVARLIG (E) FOR BATCHFRIGIVELSE
English: Do not touch the needle or push the
Danish: Berør ikke kanylen og skub ikke til stemplet.
English: However, so far, no interactions with other medicines have been reported during treatment with Dynepo.
Danish: Til dato er der ikke rapporteret om interaktioner med anden medicin i forbindelse med behandling med
English: Dynepo is provided with a needle guard for your protection and you will be shown how to use this by your doctor or nurse.
Danish: Dynepo leveres med kanyleafskærmning for at beskytte dig, og din læge eller sygeplejerske vil vise dig, hvordan du anvender den. Du bedes kontakte din læge eller sygeplejerske, hvis du er usikker mht. til at foretage injektionen, eller hvis du har spørgsmål.
English: Dynepo is used for treating the symptoms of anaemia (which include tiredness, weakness and shortness of breath) associated with chronic renal failure in adult patients, Anaemia is a blood disorder characterised by a decrease in red blood cells.
Danish: Dynepo anvendes til behandling af symptomer af anæmi (som inkluderer træthed, svaghed og åndenød) i forbindelse med kronisk nyresvigt hos voksne patienter.
English: Injecting Dynepo yourself
Danish: Information om, hvordan du selv injicerer Dynepo
English: • Vitamin deficiencies, i.e., folic acid or vitamin B12 deficiencies
Danish: • Hæmoglobinopathier så som thalassemi eller seglcelleanæmi • Vitaminmangel, fx. Folinsyre-eller vitamin B12-mangel
English: Find a comfortable, well-lit place and put the Dynepo pre-filled syringe where you can reach it. How do I prepare my Dynepo injection?
Danish: Find et behageligt, godt oplyst sted, og anbring den forfyldte injektionssprøjte med Dynepo inden for rækkevidde.
English: Epoetin delta is a human erythropoietin made by a technology process called gene-activation, which uses a human cell line.
Danish: Epoetin delta er et humant erythropoietin, udviklet med en teknologisk proces kaldet gen-aktivering, Epoetin delta er et hormon, som stimulerer produktionen af røde blodlegemer i knoglemarven.
English: Dynepo can be given in a very large range of doses.
Danish: De doser, som Dynepo kan gives i, svinger meget.
English: Therefore, prior to and during Dynepo therapy, the patient's iron stores, including transferrin saturation and serum ferritin, should be evaluated.
Danish: Derfor skal patientens jerndepoter, heriblandt transferrinmætning og serumferritin, bestemmes før og i løbet af en Dynepo-behandling.
English: No interactions have been reported during treatment with Dynepo in the course of clinical trials.
Danish: Der er ikke indberettet tilfælde af interaktion i forbindelse med Dynepo-behandling i kliniske studier.
English: The syringe is pre-assembled with a needle safety guard to prevent needle stick injury.
Danish: Injektionssprøjten er udstyret med en sikkerhedssanordning til forebyggelse af kanylestikskader.
English: The maintenance dose will be then decided by your doctor to maintain the level of your haemoglobin within the target range.
Danish: Din læge vil beslutte, hvilken vedligeholdelsesdosis du skal have for at holde dit hæmoglobinniveau
English: Vereinigtes Königreich/Royaume-Uni, Verenigd Kononkrijk
Danish: Británie/Storbritannien/Ühendkuningriik/ Hνωµέυο Βασίλειο/United Kingdom/Bretland/ Lielbritānija/Jungtinė
English: To give yourself a subcutaneous injection you will need a new pre-filled syringe of Dynepo with needle guard.
Danish: For at kunne udføre injektionen, skal du bruge: • En ny, forfyldt injektionssprøjte med kanyleafskærmning med Dynepo.
English: Patients with homozygous sickle cell disease and renal failure should where possible be maintained at a total haemoglobin concentration between 7 and 9 g/dl.
Danish: Patienter med homozygot seglcelleanæmi og nyresvigt bør, hvis muligt, fastholdes på en total
English: The required weekly dose of Dynepo is lower when Dynepo is administered subcutaneously compared to intravenously.
Danish: Når Dynepo administreres subkutant er den nødvendige ugentlige dosis lavere, end når Dynepo
English: Dynepo is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult patients.
Danish: Dynepo er indiceret til behandling af symptomatisk anæmi hos voksne patienter med kronisk nyresvigt.
English: Pruritus
Danish: Kramper
English: Dynepo therapy is usually a long-term treatment.
Danish: Som regel skal du behandles med Dynepo i lang tid.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Use only clear and colourless solutions.
Danish: Brug kun opløsninger, som er klare og farveløse.
English: Your haemoglobin level should then be controlled at regular intervals.
Danish: Derefter bør dit hæmoglobinniveau kontrolleres
English: Keep syringes in the outer carton to protect from light.
Danish: Opbevar injektionssprøjterne i den ydre karton, for at beskytte mod lys.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Danish: Detaljeret information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs
English: България / Česká Republika/ Danmark/ Eesti/ Ελλάδα/ Ireland/ Ísland/ Κύπρος/ Latvija/ Lietuva/ Magyarország/ Malta/ Nederland/ Norge/ Österreich/Polska/ România/ Slovenija/ Slovenská Republika/ Suomi/ Sverige/United Kingdom
Danish: Karalystė/Nagy-Britannia/Verenigd Koninkrijk/ Storbritannia/Wielka Brytania/Marea Britanie/Velika Britanija/Vel'ká Británia/Iso-Britannia/Storbritannien
English: Epoetin delta
Danish: Mavetarmkanalen
English: In patients not on haemodialysis, where intravenous access is not readily available, Dynepo is usually given subcutaneously.
Danish: Dynepo gives normalt subkutant til patienter, som ikke er i dialyse, hvor intravenøs adgang ikke er mulig.
English: Measurable concentrations of erythropoietin are maintained in the serum for at least 24 hours following doses ranging from 50 IU/kg to 300 IU/kg.
Danish: Efter administration af doser fra 50 IE/kg til 300 IE/kg forefindes der målelige koncentrationer af erythropoietin i mindst 24 timer.
English: The dosage of Dynepo must be adjusted individually to maintain the level of haemoglobin within the target range of 10 to 12g/dl.
Danish: Doseringen af Dynepo skal justeres individuelt for at opretholde hæmoglobinniveauet inden for
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Danish: Indehaveren af markedsføringstilladelsen forpligter sig til at gennemføre farmakovigilansaktiviteter,
English: Subcutaneous self administration may be used after training by a medical professional.
Danish: Subkutan selvinjektion kan anvendes efter
English: Solution for injection, 0.5ml of epoetin delta in a pre-filled syringe: pack size of 6
Danish: 0,5 ml epoetin delta i fyldt injektionssprøjte: pakning med 6.
English: Dose should be increased by 25 % - 50 % if: - Haemoglobin falls below < 10 g/dl and - The rate of increase of haemoglobin is below 0.7 g/dl in any 4 week period.
Danish: - Stigningsraten for hæmoglobin ligger under 0,7 g/dl over en 4 ugers periode.
English: Dose Management
Danish: Dosisjustering
English: Solution for injection, 0.4ml of epoetin delta in a pre-filled syringe: pack size of 6
Danish: 0,4 ml epoetin delta i fyldt injektionssprøjte: pakning med 6.
English: - This medicine has been prescribed for you.
Danish: Lægen har ordineret Dypeno til Dem personligt.
English: Uncontrolled hypertension.
Danish: Injektionsvæske, opløsning.
English: Solution for injection, 0.3ml of epoetin delta in a pre-filled syringe: pack size of 6
Danish: 0,3 ml epoetin delta i fyldt injektionssprøjte: pakning med 6.
English: (10,000 IU/ml°)
Danish: Sjælden (≥1/10.000 til, <1/1.000)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/211/010
Danish: Almindelig (≥1/100 til, <1/10)
English: Pre-filled syringe containing 8,000 IU per 0.4 ml dose (20,000 IU/ml) of the active substance epoetin delta.
Danish: Fyldte injektionssprøjter indeholdende 8.000 IE pr. 0,4 ml (20.000 IE/ml) af den aktive substans epoetin delta.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Danish: FREMSTILLER(E) AF DET (DE) BIOLOGISK AKTIVE STOF (FER) OG INDEHAVER (E) AF VIRKSOMHEDSGODKENDELSE (R) ANSVARLIG (E) FOR
English: NAME OF THE MEDICINAL PRODUCT Dynepo 8,000 IU/0.4ml Injection
Danish: LÆGEMIDLETS NAVN Dynepo, 8.000 IE/0,4 ml Injektionsvæske
English: NAME OF THE MEDICINAL PRODUCT Dynepo 6,000 IU/0.3ml Injection
Danish: LÆGEMIDLETS NAVN Dynepo, 6.000 IE/0,3 ml Injektionsvæske
English: Pre-filled syringe containing 6,000 IU per 0.3 ml dose (20,000 IU/ml) of the active substance epoetin delta.
Danish: Fyldte injektionssprøjter indeholdende 6.000 IE pr. 0,3 ml (20.000 IE/ml) af den aktive substans epoetin delta.
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: - Spørg lægen eller på apoteket, hvis der er mere, du vil vide mere.
English: Pre-filled syringe containing 4,000 IU per 0.4 ml dose (10,000 IU/ml) of the active substance epoetin delta.
Danish: Fyldte injektionssprøjter indeholdende 4.000 IE pr. 0,4 ml (10.000 IE/ml) af den aktive substans epoetin delta.
English: Pre-filled syringe containing 1,000 IU per 0.5 ml dose (2,000 IU/ml) of the active substance epoetin delta.
Danish: Fyldte injektionssprøjter indeholdende 1.000 IE pr. 0,5 ml (2.000 IE/ml) af den aktive substans epoetin delta.
English: Pre-filled syringe containing 3,000 IU per 0.3 ml dose (10,000 IU/ml) of the active substance epoetin delta.
Danish: Fyldte injektionssprøjter indeholdende 3.000 IE pr. 0,3 ml (10.000 IE/ml) af den aktive substans epoetin delta.
English: Pre-filled syringe containing 2,000 IU per 0.5 ml dose (4,000 IU/ml) of the active substance epoetin delta.
Danish: Fyldte injektionssprøjter indeholdende 2.000 IE pr. 0,5 ml (4.000 IE/ml) af den aktive substans epoetin delta.
English: Pre-filled syringe containing 10,000 IU per 0.5 ml dose (20,000 IU/ml) of the active substance epoetin delta.
Danish: Fyldte injektionssprøjter indeholdende 10.000 IE pr. 0,5 ml (20.000 IE/ml) af den aktive substans epoetin delta.
English: Solution for injection in a pre-filled syringe.
Danish: Opbevar injektionssprøjterne i den ydre
English: NAME OF THE MEDICINAL PRODUCT Dynepo 4,000 IU/0.4ml Injection
Danish: LÆGEMIDLETS NAVN Dynepo, 4.000 IE/0,4 ml Injektionsvæske
English: NAME OF THE MEDICINAL PRODUCT Dynepo 3,000 IU/0.3ml Injection
Danish: LÆGEMIDLETS NAVN Dynepo, 3.000 IE/0,3 ml Injektionsvæske
English: • Malnutrition
Danish: Vaskulære sygdomme