FrancophonIA/ELRC3.0 huggingface dataset:
English: ADYNOVI has an extended half-life of 1.4 to 1.5-fold compared to recombinant human coagulation factor VIII (octocog alfa) in the adolescent and adult population, as determined based on one stage clotting and chromogenic assays, respectively.
Danish: ADYNOVI har 1,4-1,5 gange forlænget halveringstid sammenlignet med human rekombinant koagulationsfaktor VIII (octocog alfa) hos den unge og voksne population, bestemt ved henholdsvis en et-trins koagulationsanalyse og kromogen analyse.
English: The solution should be administered slowly, at a rate as determined by the patient's comfort level, not to exceed 10 ml per minute.
Danish: Opløsningen skal administreres langsomt med en hastighed, der er behagelig for patienten, maksimalt 10 ml i minuttet.
English: Administration Steps:
Danish: Administrationstrin:
English: ADYNOVI in BAXJECT III system: Keep the sealed blister in the outer carton in order to protect from light.
Danish: ADYNOVI i BAXJECT III-system: Opbevar den forseglede blister i den ydre karton for at beskytte mod lys.
English: For major surgeries, the preoperative loading dose ranged from 36 IU/kg to 109 IU/kg (median: 63 IU/kg); and postoperative total dose ranged from 186 IU/kg to 1320 IU/kg (median: 490 IU/kg).
Danish: Ved større kirurgiske indgreb lå den præoperative loadingdosis i området fra 36 IE/kg til 109 IE/kg (median: 63 IE/kg), og den postoperative totale dosis lå i området fra 186 IE/kg til 1320 IE/kg (median: 490 IE/kg).
English: During the shelf life the powder vial may be kept at room temperature (up to 30 °C) for a single period not exceeding 3 months.
Danish: I holdbarhedsperioden kan hætteglasset med pulver opbevares ved stuetemperatur (op til 30 °C) i én enkelt periode på maksimalt 3 måneder.
English: If this happens, you should contact your doctor immediately.
Danish: Kontakt straks din læge, hvis dette sker.
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Danish: Patienterne bør informeres om de tidlige tegn på overfølsomhedsreaktioner inklusive nældefeber, generaliseret urticaria, thoraxkonstriktion, hvæsende åndedræt, hypotension og anafylaksi.
English: Marketing Authorisation Holder Baxalta Innovations GmbH Industriestrasse 67
Danish: Indehaver af markedsføringstilladelsen Baxalta Innovations GmbH Industriestrasse 67
English: Paediatric Pharmacokinetics
Danish: Pædiatrisk farmakokinetik
English: Press straight down to fully insert the clear plastic spike through the solvent vial stopper (Figure B).
Danish: Tryk lige ned for at stikke den gennemsigtige plastikspids helt gennem proppen på hætteglasset med solvens (figur B).
English: ADYNOVI with BAXJECT II Hi-Flow device: Keep the vial in the outer carton in order to protect from light.
Danish: ADYNOVI med BAXJECT II Hi-Flow-udstyr: Opbevar hætteglasset i den ydre karton for at beskytte mod lys.
English: Skin and subcutaneous tissue disorders Rash
Danish: Hud og subkutane væv
English: Each powder vial contains nominally 250, 500, 1000, or 2000 IU rurioctocog alfa pegol.
Danish: Hvert hætteglas med pulver indeholder nominelt 250, 500, 1000 eller 2000 IE rurioctocog alfa pegol.
English: Hypersensitivity to the active substance, to the parent molecule octocog alfa or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof, over for modermolekylet octocog alfa eller over for et eller flere af hjælpestofferne anført i pkt.
English: The half-life extension in the paediatric population was 1.3 to 1.5 fold using both the one stage clotting and chromogenic assays.
Danish: Forlængelsen i halveringstid i den pædiatriske population var 1,3-1,5 gange med både et-trins koagulationsanalyse og kromogen analyse.
English: Rurioctocog alfa pegol is a covalent conjugate of octocog alfa consisting of 2,332 amino acids with polyethylene glycol (PEG) reagent (MW 20 kDa).
Danish: Rurioctocog alfa pegol er et kovalent konjugat af octocog alfa bestående af 2.332 aminosyrer med polyethylenglycol (PEG)-reagens (MW 20 kDa).
English: For long term prophylaxis, the recommended dose is 40 to 50 IU of ADYNOVI per kg bodyweight twice weekly in 3 to 4 day intervals.
Danish: Til langtidsprofylakse er den anbefalede dosis 40 til 50 IE ADYNOVI pr. kg legemsvægt to gange ugentligt i intervaller på 3 til 4 dage.
English: Rurioctocog alfa pegol, is a pegylated recombinant human factor VIII with an extended half-life.
Danish: Rurioctocog alfa pegol er en pegyleret rekombinant human faktor VIII med forlænget halveringstid.
English: It is strongly recommended that every time ADYNOVI is administered, the name and batch number of the product are recorded.
Danish: Det anbefales stærkt, at navn og batchnummer på produktet registreres, hver gang du bruger ADYNOVI.
English: Forty out of 101 subjects (40%) experienced no bleeding episodes, 58 out of 101 subjects (57%) experienced no joint bleeding episodes, and 58 out of 101 subjects (57%) experienced no spontaneous bleeding episodes in the prophylaxis arm. All subjects in the on-demand arm experienced a bleeding episode, including a joint or spontaneous bleeding episode.
Danish: 40 af 101 forsøgspersoner (40 %) oplevede ingen blødningsepisoder, 58 af 101 forsøgspersoner (57 %) oplevede ingen blødningsepisoder i led, og 58 af 101 forsøgspersoner (57 %) oplevede ingen spontane blødningsepisoder i profylaksearmen.
English: Prevention of bleeding The usual dose of ADYNOVI is 40 to 50 IU per kg body weight, administered 2 times per week.
Danish: Forebyggelse af blødning Den sædvanlige dosis af ADYNOVI er 40 til 50 IE pr. kg legemsvægt 2 gange ugentligt.
English: Incremental recovery [(IU/dL)/(IU/kg)]
Danish: Trinvis bedring [(IE/dl/(IE/kg)]
English: If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.
Danish: Kateterrelaterede komplikationer under behandling Når det er nødvendigt at anvende et centralt venekateter (CVK), bør risikoen for CVK-relaterede komplikationer, herunder lokale infektioner, bakteriæmi og trombose på kateterstedet, tages i betragtning.
English: Quickly insert the purple plastic spike fully into the powder vial stopper by pushing straight down (Figure D).
Danish: Stik hurtigt den lilla plastikspids helt igennem proppen på hætteglasset med pulver ved at trykke lige ned (figur D).
English: Grip the BAXJECT II Hi-Flow package at its edge and pull the package off the device (Figure C).
Danish: Hold fast i kanten af pakningen med BAXJECT II Hi-Flow, og træk pakningen af udstyret (figur C).
English: - ADYNOVI with BAXJECT II Hi-Flow device: Each pack contains a powder vial, a solvent vial and a device for reconstitution (BAXJECT II Hi-Flow).
Danish: - ADYNOVI med BAXJECT II Hi-Flow-udstyr: Hver pakning indeholder et hætteglas med pulver, et hætteglas med solvens og udstyr til rekonstitution (BAXJECT II Hi-Flow).
English: The following table can be used to guide dosing in bleeding episodes and surgery.
Danish: Nedenstående tabel kan bruges som vejledning til dosering ved blødningsepisoder og kirurgiske indgreb:
English: This medicine contains 0.45 mmol sodium (10 mg) per vial.
Danish: Lægemidlet indeholder 0,45 mmol (10 mg) natrium pr. hætteglas.
English: - ADYNOVI in BAXJECT III system: Each pack contains a ready to use BAXJECT III system in a sealed blister, withthe powder vial and the solvent vial preassembled for reconstitution.
Danish: - ADYNOVI i BAXJECT III-system: Hver pakning indeholder et brugsklart BAXJECT IIIsystem i en forseglet blister, med hætteglasset med pulver og hætteglasset med solvens færdigsamlet til rekonstitution.
English: Chemical and physical in-use stability has been demonstrated for 3 hours at a temperature not above 30 °C.
Danish: Det er påvist, at væskens kemiske og fysiske holdbarhed, mens den er i brug, er 3 timer ved maks.
English: If the product is still stored in a refrigerator, take the sealed blister (contains powder and solvent vials preassembled with the system for reconstitution) from the refrigerator and let it reach room temperature (between 15 °C and 25 °C).
Danish: Hvis produktet fortsat opbevares i et køleskab, tages den forseglede blister (indeholdende hætteglas med pulver og solvens, som er færdigsamlet til rekonstitution), ud af køleskabet.
English: The solvent is a clear, colourless solution.
Danish: Solvensen er en klar og farveløs væske.
English: On demand treatment
Danish: Behandling efter behov
English: ADYNOVI contains the active substance rurioctocog alfa pegol, pegylated human coagulation factor VIII.
Danish: ADYNOVI indeholder det aktive stof rurioctocog alfa pegol, pegyleret human koagulationsfaktor VIII.
English: Calcium chloride dihydrate Tris(hydroxymethyl)aminomethane Polysorbate 80
Danish: Calciumchlorid-dihydrat Tris(hydroxymethyl)aminomethan Polysorbat 80
English: More extensive haemarthrosis, muscle bleeding or haematoma
Danish: Mere udbredt hæmartrose, muskelblødning eller hæmatom
English: If you or your child´s bleeding is not being controlled with ADYNOVI, tell your doctor immediately.
Danish: Fortæl det straks til lægen, hvis din eller dit barns blødning ikke holdes under kontrol med ADYNOVI.
English: Preparation and reconstitution using the BAXJECT II Hi-Flow device: For reconstitution use only the solvent vial and the reconstitution device provided in the pack.
Danish: Klargøring og rekonstitution med BAXJECT II Hi-Flow-udstyret: Anvend kun hætteglasset med solvens og rekonstitutionsenheden, der medfølger i pakken, til rekonstitutionsbrug.
English: Use only the solvent and the reconstitution device for preparation of the solution that are provided with each package of ADYNOVI.
Danish: Til klargøring af opløsningen må kun anvendes solvens og det rekonstitutionsudstyr, der er leveret i pakningen med ADYNOVI.
English: Peel-off labels are provided on the powder vial.
Danish: Der er aftagelige etiketter på hætteglasset med pulver.
English: - The other ingredients are mannitol, trehalose dihydrate, histidine, glutathion, sodium chloride, calcium chloride dihydrate, tris(hydroxymethyl)aminomethane, polysorbate 80 and sterilised water for injections.
Danish: - Øvrige indholdsstoffer: mannitol, trehalosedihydrat, histidin, glutathion, natriumchlorid, calciumchloriddihydrat, tris(hydroxymethyl)aminomethan, polysorbat 80 og vand til injektionsvæsker.
English: - The solvent vial contains 5 ml of sterilised water for injections.
Danish: - Hætteglasset med solvens indeholder 5 ml vand til injektionsvæsker.
English: - The solvent vial contains 2 ml of sterilised water for injections.
Danish: - Hætteglasset med solvens indeholder 2 ml vand til injektionsvæsker.
English: OUTER CARTON (BAXJECT II HI-FLOW DEVICE)
Danish: YDERKARTON (BAXJECT II HI-FLOW-UDSTYR)
English: Each pack contains one powder vial, one solvent vial and a device for reconstitution (BAXJECT II Hi-Flow).
Danish: Hver pakning indeholder et hætteglas med pulver, et hætteglas med solvens og udstyr til rekonstitution (BAXJECT II Hi-Flow).
English: The active substance rurioctocog alfa pegol is a covalent conjugate of the protein octocog alfa* with a 20 kDa polyethylene glycol (PEG).
Danish: Det aktive stof rurioctocog alfa pegol er et kovalent konjugat af proteinet octocog alfa* med 20 kDa polyethylenglycol (PEG).
English: Solvent Sterilised water for injections
Danish: Solvens Vand til injektionsvæsker
English: Type I glass vial, closed with a chlorobutyl rubber stopper, containing 250 IU, 500 IU, 1000 IU or 2000 IU of powder.
Danish: Type I-hætteglas (glas) lukket med chlorbutyl-gummiprop, med 250 IE, 500 IE, 1000 IE eller 2000 IE pulver.
English: Sterilised water for injections
Danish: Vand til injektionsvæsker
English: You should be aware of the early signs of allergic reactions such as rash, hives, wheals, generalised itching, swelling of lips and tongue, difficulty in breathing, wheezing, tightness in the chest, general feeling of being unwell, and dizziness.
Danish: Du bør være opmærksom på de tidlige tegn på allergiske reaktioner såsom udslæt, nældefeber, blærer, udbredt kløe, hævelse af læber og tunge, vejrtrækningsbesvær, hvæsende åndedræt, trykken for brystet, generel fornemmelse af utilpashed og svimmelhed.
English: Do not refrigerate after reconstitution.
Danish: Må ikke opbevares i køleskab efter rekonstitution.
English: Type I glass vial, closed with a chlorobutyl rubber stopper, containing 250 IU, 500 IU, or 1000 IU of powder.
Danish: Type I-hætteglas (glas) lukket med chlorbutyl-gummiprop, med 250 IE, 500 IE eller 1000 IE pulver.
English: How to use ADYNOVI
Danish: Sådan skal du bruge ADYNOVI
English: o The appearance of the reconstituted solution is clear and colourless.
Danish: o Efter rekonstitution skal opløsningen fremstå klar og farveløs.
English: Type I glass vial, closed with a chlorobutyl rubber stopper, containing 2 ml of sterilised water for injections.
Danish: Type I-hætteglas (glas) lukket med chlorbutyl-gummiprop, med 2 ml vand til injektionsvæsker.
English: Type I glass vial, closed with a chlorobutyl rubber stopper, containing 5 ml of sterilised water for injections.
Danish: Type I-hætteglas (glas) lukket med chlorbutyl-gummiprop, med 5 ml vand til injektionsvæsker.
English: Treatment of bleeding episodes
Danish: Behandling af blødningsepisoder:
English: After reconstitution the solution should be clear, colourless and free from particles.
Danish: Efter rekonstitution skal opløsningen fremstå klar, farveløs og fri for partikler.
English: Remove the blue cap from the BAXJECT II Hi-Flow device (Figure E).
Danish: Tag det blå låg af BAXJECT II Hi-Flow-udstyret (figur E).
English: OUTER CARTON (BAXJECT III SYSTEM)
Danish: YDERKARTON (BAXJECT III-SYSTEM)
English: - rash, hives, wheals, generalised itching, - swelling of lips and tongue, - difficulty in breathing, wheezing, tightness in the chest, - general feeling of being unwell, - dizziness and loss of consciousness.
Danish: - udslæt, nældefeber, blærer, udbredt kløe, - hævelse af læber og tunge, - vejrtrækningsbesvær, hvæsende åndedræt, trykken for brystet, - en generel fornemmelse af utilpashed, - svimmelhed og bevidstløshed.
English: Excipients: mannitol, trehalose dihydrate, histidine, glutathion, sodium chloride, calcium chloride dihydrate, tris(hydroxymethyl)aminomethane, polysorbate 80
Danish: Hjælpestoffer: mannitol, trehalosedihydrat, histidin, glutathion, natriumchlorid, calciumchloriddihydrat, tris(hydroxymethyl)aminomethan, polysorbat 80
English: ADYNOVI Adults (18 years and older) N = 18 Dose: 45 ± 5 IU/kg
Danish: ADYNOVI Voksne (18 år og derover) N=18 Dosis: 45 ± 5 IE/kg
English: ADYNOVI Adolescents (12-<18 years) N = 8 Dose: 45 ± 5 IU/kg
Danish: ADYNOVI Unge (12-<18 år) N=8 Dosis: 45 ± 5 IE/kg
English: Plasma factor VIII activity was measured by the one stage clotting assay and chromogenic assay.
Danish: Plasma faktor VIII-aktivitet blev målt med et-trins koagulationsanalysen og kromogen analyse.
English: ADYNOVI Paediatric patients (6-<12 years) N = 17 Dose: 50 ± 10 IU/kg
Danish: ADYNOVI Pædiatriske patienter (6-<12 år) N=17 Dosis: 50 ±10 IE/kg
English: Do not remove the device from the package.
Danish: Lad udstyret blive i pakningen.
English: 250 IU
Danish: 250 IE
English: ADYNOVI Paediatric patients (< 6 years) N = 14 Dose: 50 ± 10 IU/kg
Danish: ADYNOVI Pædiatriske patienter (<6 år) N=14 Dosis: 50 ±10 IE/kg
English: Excipient(s) with known effect Each powder vial contains 0.45 mmol (10 mg) sodium, see section 4.4.
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på Hvert hætteglas med pulver indeholder 0,45 mmol (10 mg) natrium.
English: 1 powder vial, 1 vial with 2 ml solvent, 1 BAXJECT II Hi-Flow device.
Danish: 1 hætteglas med pulver, 1 hætteglas med 2 ml solvens, 1 BAXJECT II Hi-Flow-udstyr.
English: 1 powder vial, 1 vial with 5 ml solvent, 1 BAXJECT II Hi-Flow device.
Danish: 1 hætteglas med pulver, 1 hætteglas med 5 ml solvens, 1 BAXJECT II Hi-Flow-udstyr.
English: Connect the syringe to the BAXJECT II Hi-Flow.
Danish: Tilslut sprøjten til BAXJECT II Hi-Flow.
English: If you use more ADYNOVI than you should
Danish: Hvis du har brugt for meget ADYNOVI
English: Remove the blue cap from the BAXJECT III device.
Danish: Tag det blå låg af BAXJECT III-udstyret.
English: • Do not refrigerate the solution after preparation.
Danish: • Opløsningen må ikke opbevares i køleskab efter klargøringen.
English: ADYNOVI 250 IU / 5 ml powder and solvent for solution for injection ADYNOVI 500 IU / 5 ml powder and solvent for solution for injection ADYNOVI 1000 IU / 5 ml powder and solvent for solution for injection ADYNOVI 2000 IU / 5 ml powder and solvent for solution for injection
Danish: ADYNOVI 250 IE/5 ml pulver og solvens til injektionsvæske, opløsning ADYNOVI 500 IE/5 ml pulver og solvens til injektionsvæske, opløsning ADYNOVI 1000 IE/5 ml pulver og solvens til injektionsvæske, opløsning ADYNOVI 2000 IE/5 ml pulver og solvens til injektionsvæske, opløsning
English: 1 powder vial and 1 vial with 5 ml solvent preassembled in BAXJECT III system.
Danish: 1 hætteglas med pulver og 1 hætteglas med 5 ml solvens, samlet i BAXJECT III-system.
English: BLISTER LABEL (BAXJECT III SYSTEM)
Danish: BLISTERMÆRKNING (BAXJECT III-SYSTEM)
English: What ADYNOVI looks like and contents of the pack ADYNOVI is provided as a powder and solvent for solution for injection.
Danish: ADYNOVI leveres som pulver og solvens til injektionsvæske, opløsning.
English: 1 powder vial and 1 vial with 2 ml solvent preassembled in BAXJECT III system.
Danish: 1 hætteglas med pulver og 1 hætteglas med 2 ml solvens, samlet i BAXJECT III-system.
English: VIAL LABEL FOR THE POWDER (BAXJECT II HI-FLOW DEVICE)
Danish: MÆRKNING TIL HÆTTEGLAS MED PULVER (BAXJECT II HI-FLOW-UDSTYR)
English: ADYNOVI 250 IU / 2 ml powder and solvent for solution for injection ADYNOVI 500 IU / 2 ml powder and solvent for solution for injection ADYNOVI 1000 IU / 2 ml powder and solvent for solution for injection
Danish: ADYNOVI 250 IE/2 ml pulver og solvens til injektionsvæske, opløsning ADYNOVI 500 IE/2 ml pulver og solvens til injektionsvæske, opløsning ADYNOVI 1000 IE/2 ml pulver og solvens til injektionsvæske, opløsning
English: Connect the syringe to the BAXJECT II Hi-Flow device.
Danish: Tilslut sprøjten til BAXJECT II Hi-Flow-udstyret.
English: VIAL LABEL FOR THE SOLVENT (BAXJECT II HI-FLOW DEVICE)
Danish: MÆRKNING TIL HÆTTEGLAS MED SOLVENS (BAXJECT II HI-FLOW-UDSTYR)
English: What ADYNOVI is and what it is used for What you need to know before you use ADYNOVI How to use ADYNOVI
Danish: Det skal du vide, før du begynder at bruge ADYNOVI Sådan skal du bruge ADYNOVI Bivirkninger
English: The safety, efficacy, and pharmacokinetics of ADYNOVI were evaluated in a pivotal multicenter, open-label, prospective clinical trial that compared the efficacy of a twice weekly prophylactic treatment regimen to on-demand treatment and determined haemostatic efficacy in the treatment of bleeding episodes.
Danish: Studiet sammenlignede virkningen af et profylaktisk behandlingsregime to gange ugentligt med behandling efter behov og fastlagde hæmostatisk virkning ved behandling af blødningsepisoder.
English: VIAL LABEL FOR THE SOLVENT (BAXJECT III SYSTEM)
Danish: MÆRKNING TIL HÆTTEGLAS MED SOLVENS (BAXJECT III-SYSTEM)
English: Overall, 95.9% of bleeding episodes were controlled with 1 to 2 infusions and 85.5% were controlled with only 1 infusion.
Danish: Mediandosen pr. infusion til behandling af alle blødningsepisoder i per protokolpopulationen var 32,0 (Interkvartilområde (IQR): 21,5) IE pr. kg. i alt blev 95,9 % af blødningsepisoderne kontrolleret med 1-2 infusioner, og 85,5 % blev kontrolleret med kun 1 infusion.
English: Blood and lymphatic system disorders Factor VIII inhibition
Danish: Blod og lymfesystem
English: VIAL LABEL FOR THE POWDER (BAXJECT III SYSTEM)
Danish: MÆRKNING TIL HÆTTEGLAS MED PULVER (BAXJECT III-SYSTEM)
English: Connect the syringe to the BAXJECT III device.
Danish: Tilslut sprøjten til BAXJECT III-udstyret.
English: What ADYNOVI contains - The active substance is rurioctocog alfa pegol (pegylated human coagulation factor VIII
Danish: ADYNOVI indeholder - Aktivt stof: rurioctocog alfa pegol, (pegyleret human koagulationsfaktor VIII) produceret med rekombinant dna-teknologi).
English: 1 vial: 2000 IU rurioctocog alfa pegol, 400 IU/ml after reconstitution.
Danish: 1 hætteglas: 2000 IE rurioctocog alfa pegol, 400 IE/ml efter rekonstitution.
English: Powder and solvent vials preassembled in BAXJECT III system.
Danish: Hætteglas med pulver og hætteglas med solvens, samlet i BAXJECT III-system.
English: 1 vial: 250 IU rurioctocog alfa pegol, 125 IU/ml after reconstitution.
Danish: 1 hætteglas: 250 IE rurioctocog alfa pegol, 125 IE/ml efter rekonstitution.
English: ADYNOVI 2000 IU / 5 ml powder and solvent for solution for injection Each vial contains nominally 2000 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 400 IU/ml after reconstitution with 5 ml solvent.
Danish: ADYNOVI 2000 IE/5 ml pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder nominelt 2000 IE human koagulationsfaktor VIII (rDNA) rurioctocog alfa pegol, svarende til en koncentration på 400 IE/ml efter rekonstitution med 5 ml solvens.
English: 1 vial: 500 IU rurioctocog alfa pegol, 250 IU/ml after reconstitution.
Danish: 1 hætteglas: 500 IE rurioctocog alfa pegol, 250 IE/ml efter rekonstitution.
English: ADYNOVI 2000 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol
Danish: ADYNOVI 2000 IE/5 ml pulver og solvens til injektionsvæske, opløsning rurioctocog alfa pegol
English: 1 vial: 1000 IU rurioctocog alfa pegol, 200 IU/ml after reconstitution.
Danish: 1 hætteglas: 1000 IE rurioctocog alfa pegol, 200 IE/ml efter rekonstitution.
English: 1 vial: 500 IU rurioctocog alfa pegol, 100 IU/ml after reconstitution.
Danish: 1 hætteglas: 500 IE rurioctocog alfa pegol, 100 IE/ml efter rekonstitution.
English: ADYNOVI 2000 IU / 5 ml powder for injection rurioctocog alfa pegol IV
Danish: ADYNOVI 2000 IE/5 ml pulver til injektionsvæske rurioctocog alfa pegol IV
English: ADYNOVI 500 IU / 5 ml powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 100 IU/ml after reconstitution with 5 ml solvent.
Danish: ADYNOVI 500 IE/5 ml pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder nominelt 500 IE human koagulationsfaktor VIII (rDNA) rurioctocog alfa pegol, svarende til en koncentration på 100 IE/ml efter rekonstitution med 5 ml solvens.
English: 1 vial: 250 IU rurioctocog alfa pegol, 50 IU/ml after reconstitution.
Danish: 1 hætteglas: 250 IE rurioctocog alfa pegol, 50 IE/ml efter rekonstitution.
English: 1 vial: 1000 IU rurioctocog alfa pegol, 500 IU/ml after reconstitution.
Danish: 1 hætteglas: 1000 IE rurioctocog alfa pegol, 500 IE/ml efter rekonstitution.
English: ADYNOVI 250 IU / 2 ml powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 125 IU/ml after reconstitution with 2 ml solvent.
Danish: ADYNOVI 250 IE/2 ml pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder nominelt 250 IE human koagulationsfaktor VIII (rDNA) rurioctocog alfa pegol, svarende til en koncentration på 125 IE/ml efter rekonstitution med 2 ml solvens.
English: ADYNOVI 2000 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol (pegylated recombinant human coagulation factor VIII)
Danish: ADYNOVI 2000 IE/5 ml pulver og solvens til injektionsvæske, opløsning rurioctocog alfa pegol (pegyleret rekombinant human koagulationsfaktor VIII)