FrancophonIA/ELRC3.0 huggingface dataset:
English: While holding the vial upside down, tap the syringe gently to let any air bubbles rise to the top.
Danish: Mens hætteglasset vender på hovedet, bankes der let på sprøjten for at lade eventuelle luftbobler stige til tops.
English: - The active substance is turoctocog alfa (human coagulation factor VIII (rDNA)).
Danish: - Aktivt stof: Turoctocog alfa (human koagulationsfaktor VIII (rDNA)).
English: NovoEight is now ready to be injected into your vein.
Danish: NovoEight er nu klar til at blive injiceret i en vene.
English: Powder: Sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, calcium chloride dihydrate, sodium hydroxide, hydrochloric acid Solvent: Sodium chloride, water for injections
Danish: Pulver: Natriumchlorid, L-histidin, saccharose, polysorbat 80, L-methionin, calciumchlorid dihydrat, natriumhydroxid, saltsyre
English: Do not freeze reconstituted NovoEight solution or store it in syringes.
Danish: Opblandet NovoEight opløsning må ikke fryses eller opbevares i sprøjter.
English: Each vial of
Danish: Hvert hætteglas med
English: Overview Vial with NovoEight powder
Danish: Hætteglas med NovoEight pulver
English: In patients with high levels of inhibitor, factor VIII therapy may not be effective and other therapeutic options should be considered.
Danish: terapi muligvis ikke være effektiv og andre behandlingsmuligheder bør overvejes.
English: NovoEight contains turoctocog alfa, a human coagulation factor VIII (rDNA), with a truncated Bdomain.
Danish: NovoEight indeholder turoctocog alfa, en human koagulationsfaktor VIII (rDNA), med et trunkeret Bdomæne.
English: Fatigue, feeling hot, oedema peripheral, pyrexia
Danish: Træthed, hedeture, perifere ødemer, feber
English: How to store NovoEight
Danish: Sådan gives NovoEight
English: Keep the plunger rod pressed down and swirl the vial gently until all the powder is dissolved.
Danish: Hold stempelstangen nede, mens hætteglasset hvirvles forsigtigt rundt, indtil alt pulveret er opløst.
English: Check the reconstituted solution.
Danish: Tjek den opblandede opløsning.
English: White or slightly yellow powder or friable mass. Clear and colourless solution for injection.
Danish: Hvidt eller lettere gult pulver eller løs masse.
English: Do not store the solution without your doctor's advice.
Danish: Opbevar ikke opløsningen uden samråd med din læge.
English: On-demand treatment
Danish: Behandling ved behov
English: NovoEight 250 IU
Danish: NovoEight 250 IE
English: Overweight N=8
Danish: Overvægtig N=8
English: CL (ml/h/kg)
Danish: CL (ml/t/kg)
English: Powder and solvent for solution for injection Pack contains: 1 powder vial, 4 ml solvent in pre-filled syringe, plunger rod and vial adapter
Danish: Pulver og solvens til injektionsvæske, opløsning Pakningen indeholder: 1 hætteglas med pulver, 4 ml solvens i en fyldt sprøjte, stempelstang og hætteglasadapter
English: Remove the syringe cap from the pre filled syringe by bending it down until the perforation breaks.
Danish: Fjern sprøjtehætten fra den fyldte sprøjte ved at bøje den ned, indtil perforeringen knækker.
English: NovoEight 1500 IU
Danish: NovoEight 1500 IE
English: • bleeding in muscle tissue
Danish: • blødning i muskelvæv
English: Rash, lichenoid keratosis, skin burning sensation
Danish: Udslæt, likenoid keratose, brændende fornemmelse på huden
English: For children not previously treated with Factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients); however patients who have received previous treatment with Factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients).
Danish: Men hos patienter, der tidligere har modtaget behandling med faktor VIII (mere end 150 dages behandling), er risikoen ikke almindelig i hyppighed (under 1 ud af 100 patienter).
English: If you or your child´s bleeding is not being controlled with NovoEight, tell your doctor immediately.
Danish: Fortæl det straks til lægen, hvis din eller dit barns blødning ikke holdes under kontrol med NovoEight.
English: Hypersensitivity
Danish: Overfølsomhedsreaktioner
English: Take the vial, the vial adapter and the pre-filled syringe out of the carton.
Danish: Tag hætteglas, hætteglasadapter og den fyldte sprøjte ud af kartonen.
English: Bring the vial and the pre-filled syringe to room temperature.
Danish: Lad hætteglas og den fyldte sprøjte opnå stuetemperatur.
English: <6 years) PUP
Danish: Små børn (0 - <6 år) PUP
English: NovoEight 2000 IU
Danish: NovoEight 2000 IE
English: NovoEight 500 IU powder and solvent for solution for injection NovoEight 1000 IU powder and solvent for solution for injection NovoEight 1500 IU powder and solvent for solution for injection NovoEight 2000 IU powder and solvent for solution for injection NovoEight 3000 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Danish: NovoEight 500 IE pulver og solvens til injektionsvæske, opløsning NovoEight 1000 IE pulver og solvens til injektionsvæske, opløsning NovoEight 1500 IE pulver og solvens til injektionsvæske, opløsning NovoEight 2000 IE pulver og solvens til injektionsvæske, opløsning NovoEight 3000 IE pulver og solvens til injektionsvæske, opløsning turoctocog alfa (human koagulationsfaktor VIII (rDNA))
English: Adolescents <18 years) PTP
Danish: Unge (12 - <18 år) PTP
English: Incremental recovery (IU/dl)/(IU/kg)
Danish: Trinvis genfinding (IE/dl)/(IE/kg)
English: Hold the pre-filled syringe slightly tilted with the vial pointing downwards.
Danish: Hold den fyldte sprøjte en smule skråt med hætteglasset nedad.
English: 4 hours when stored at room temperature or up to 40°C and within 24 hours when stored at 2°C8°C.
Danish: Hvis du ikke kan bruge den opblandede NovoEight opløsning straks, skal det bruges indenfor 4 timer når det opbevares ved stuetemperatur eller ved op til 40°C, og indenfor 24 timer når det opbevares ved 2°C til 8°C.
English: It must be clear to slightly opalescent
Danish: Den skal være farveløs eller let opaliserende (lidt uklar).
English: Overweight N=9
Danish: Overvægtig N=9
English: The reconstituted solution will be clear to slightly opalescent.
Danish: Den opblandede opløsning er klar eller let opaliserende.
English: • stiffness of muscles
Danish: • muskelstivhed
English: NovoEight is recommended to be used immediately after it has been reconstituted.
Danish: Det anbefales, at NovoEight bruges straks efter opblanding.
English: Turn over the protective cap and snap the vial adapter onto the vial.
Danish: Drej beskyttelseshætten og klik hætteglasadapteren fast på hætteglasset.
English: swelling of lips and tongue, difficulty in breathing, wheezing, tightness of the chest, general feeling of being unwell, and dizziness.
Danish: Tidlige symptomer på en overfølsomhedsreaktion er udslæt, nældefeber, hævelse, generel kløe, hævelse af læber og tunge, åndedrætsbesvær, hiven efter vejret, trykken over brystet, generel følelse af ubehag og svimmelhed.
English: Unopened vial 30 months when stored in a refrigerator (2°C - 8°C).
Danish: 30 måneder ved opbevaring i køleskab (2°C - 8°C).
English: More extensive haemarthrosis, muscle bleeding or haematoma
Danish: Mere udbredt hæmarthrose, muskelblødning eller hæmatom
English: Pull the plunger rod slightly downwards to draw the reconstituted solution into the syringe.
Danish: Træk stempelstangen let nedad for at trække den rekonstituerede opløsning ind i sprøjten.
English: NovoEight 1000 IU
Danish: NovoEight 1000 IE
English: Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor VIII, ATC code: B02BD02.
Danish: Farmakoterapeutisk klassifikation: Antihæmorargi, blodkoagulationsfaktor VIII.
English: NovoEight 500 IU
Danish: NovoEight 500 IE
English: • room temperature (≤ 30°C) for a single period no longer than 9 months or
Danish: • stuetemperatur (≤30°C) i en sammenhængende periode på højst 9 måneder eller
English: NovoEight 3000 IU
Danish: NovoEight 3000 IE
English: The target factor VIII levels will depend on the severity and location of the bleeding.
Danish: Den nødvendige mængde af NovoEight afhænger af, hvor alvorlig blødningen er og hvor den er.
English: Table 5 Single-dose pharmacokinetic parameters of NovoEight (50 IU/kg) by age - chromogenic assay - Mean (SD)
Danish: Tabel 5 Enkeltdosis farmakokinetiske parametre for NovoEight (50 IE/kg) efter alder, chromogen assay - Middel (SD)
English: Remove the protective cap from the vial adapter.
Danish: Fjern beskyttelseshætten fra hætteglasadapteren.
English: Method of administration Intravenous use.
Danish: Intravenøs brug.
English: • if you are allergic to the active substance or to any of the other ingredients of this medicine
Danish: • Hvis du er overfølsom over for det aktive stof eller et af de øvrige indholdsstoffer (angivet i punkt 6) • Hvis du er overfølsom over for hamsterproteiner.
English: If the protective paper is not fully sealed or if it is broken, do not use the vial adapter.
Danish: Brug ikke hætteglasadapteren, hvis beskyttelsespapiret ikke er helt forseglet, eller hvis det er i stykker.
English: • above room temperature (30°C up to 40°C) for a single period no longer than 3 months
Danish: • temperaturer over stuetemperatur (30°C til 40°C) i en sammenhængende periode på højst 3 måneder
English: • rash, hives, weals or generalised itching
Danish: • udslæt, nældefeber, hævelse eller generel kløe
English: Major surgery
Danish: Større kirurgi
English: • above room temperature (30°C up to 40°C) for a single period no longer than 3 months.
Danish: • temperaturer over stuetemperatur (30°C til 40°C) i en sammenhængende periode på højst 3 måneder.
English: Injection site reactionsc
Danish: Reaktion ved injektionstedetc
English: NovoEight is a powder and solvent for solution for injection.
Danish: NovoEight er et pulver og en solvens til injektionsvæske, opløsning.
English: • bruising
Danish: • muskelsmerte
English: Obese class I N=7
Danish: Svær overvægtig klasse I N=7
English: Once attached do not remove the vial adapter from the vial.
Danish: Når hætteglasadapteren er påsat må den ikke fjernes fra hætteglasset.
English: tap the syringe gently to let any air bubbles rise to the top.
Danish: Med hætteglasset vendt på hovedet bankes der let på sprøjten, for at lade eventuelle luftbobler stige til tops.
English: • 4 hours stored up to 40°C, for product which has been kept for a single period no longer than 3 months at above room temperature (30°C up to 40°C).
Danish: • 4 timer opbevaret ved temperaturer op til 40°C, for produkter som er blevet opbevaret over stuetemperatur (30°C til 40°C) i en sammenhængende periode på højst 3 måneder.
English: NovoEight 2000 IU EU/1/13/888/005
Danish: NovoEight 2000 IE EU/1/13/888/005
English: What NovoEight is and what it is used for What you need to know before you use NovoEight How to use NovoEight
Danish: Det skal du vide, før du begynder at bruge NovoEight Sådan skal du bruge NovoEight Bivirkninger
English: • 4 hours stored at ≤ 30°C, for product which has been kept for a single period no longer than 9 months at room temperature (≤30°C)
Danish: • 4 timer opbevaret ved 30°C, for produkter som er blevet opbevaret ved stuetemperatur (≤30°C) i en sammenhængende periode på højst 9 måneder
English: L) Unscrew the vial adapter with the vial.
Danish: L) Skru hætteglasadapteren af hætteglasset.
English: NovoEight 3000 IU EU/1/13/888/006
Danish: NovoEight 3000 IE EU/1/13/888/006
English: How to use NovoEight
Danish: Sådan skal du bruge NovoEight
English: NovoEight 1500 IU EU/1/13/888/004
Danish: NovoEight 1500 IE EU/1/13/888/004
English: Posology
Danish: Oversigt
English: NovoEight 250 IU EU/1/13/888/001
Danish: NovoEight 250 IE EU/1/13/888/001
English: NovoEight 250 IU powder and solvent for solution for injection
Danish: NovoEight 250 IE pulver og solvens til injektionsvæske, opløsning
English: • bleeding into joint spaces
Danish: • blødning ud i ledhulrum
English: Number of patients Dose used for prevention per patient (IU/kg BW) Mean (SD) Min ; Max Dose used for treatment of bleed (IU/kg BW)
Danish: Dosis anvendt til forebyggelse per patient (IE/kg
English: Vomiting
Danish: Blødning
English: NovoEight 2000 IU powder and solvent for solution for injection.
Danish: NovoEight 2000 IE pulver og solvens til injektionsvæske, opløsning.
English: NovoEight 1000 IU EU/1/13/888/003
Danish: NovoEight 1000 IE EU/1/13/888/003
English: Table 7 Single-dose pharmacokinetic parameters of NovoEight (50 IU/kg) by BMI classesaChromogenic assay - Mean (SD)
Danish: Tabel 7 Enkeltdosis farmakokinetiske parametre for NovoEight (50 IE/kg) efter BMI klasseachromogenanalyse- Middel (SD)
English: into the plunger inside the pre-filled syringe until resistance is felt.
Danish: Skru den fyldte sprøjte fast på hætteglasadapteren, indtil der mærkes modstand.
English: NovoEight 500 IU EU/1/13/888/002
Danish: NovoEight 500 IE EU/1/13/888/002
English: Adults (≥18 years) PTP
Danish: Små børn (0 - <6 år) PTP
English: NovoEight 1500 IU powder and solvent for solution for injection.
Danish: NovoEight 1500 IE pulver og solvens til injektionsvæske, opløsning.
English: What NovoEight looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Gastrointestinal disorders
Danish: NovoEight Brugervejledning
English: Turn the syringe with the vial upside down.
Danish: Vend sprøjten med hætteglasset på hovedet.
English: Haemorrhage
Danish: • udslæt
English: • difficulty sleeping (insomnia)
Danish: • søvnløshed
English: NovoEight 3000 IU powder and solvent for solution for injection.
Danish: NovoEight 3000 IE pulver og solvens til injektionsvæske, opløsning.
English: NovoEight 1000 IU powder and solvent for solution for injection.
Danish: NovoEight 1000 IE pulver og solvens til injektionsvæske, opløsning.
English: NovoEight 2000 IU powder for solution for injection turoctocog alfa
Danish: NovoEight 2000 IE pulver og solvens til injektionsvæske, opløsning turoctocog alfa
English: One ml of NovoEight contains approximately 62.5 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution
Danish: Én ml af NovoEight indeholder cirka 62,5 IE human koagulationsfaktor VIII (rDNA), turoctocog alfa efter opblanding
English: Table 6 Single-dose pharmacokinetic parameters of NovoEight (50 IU/kg) by BMI classesaOne-stage clotting assay - Mean (SD)
Danish: Tabel 6 Enkeltdosis farmakokinetiske parametre for NovoEight (50 IE/kg) efter BMI-klassea - et-trins koagulationsanalyse - Middel (SD)
English: NovoEight 250 IU powder for solution for injection turoctocog alfa
Danish: NovoEight 250 IE pulver og solvens til injektionsvæske, opløsning turoctocog alfa
English: • pain in muscles
Danish: • betændelse i blodårer
English: One ml of NovoEight contains approximately 375 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution
Danish: Én ml af NovoEight indeholder cirka 375 IE human koagulationsfaktor VIII (rDNA), turoctocog alfa efter opblanding
English: NovoEight 500 IU powder and solvent for solution for injection.
Danish: NovoEight 500 IE pulver og solvens til injektionsvæske, opløsning.
English: NovoEight 3000 IU powder for solution for injection turoctocog alfa
Danish: NovoEight 3000 IE pulver og solvens til injektionsvæske, opløsning turoctocog alfa
English: Table 4 Single-dose pharmacokinetic parameters of NovoEight (50 IU/kg) by age - one stage clotting assay - Mean (SD)
Danish: Tabel 4 Enkeltdosis farmakokinetiske parametre for NovoEight (50 IE/kg) efter alder, et-trins koagulationsanalyse - Middel (SD)
English: Each powder vial contains nominally 2000 IU human coagulation factor VIII (rDNA), turoctocog alfa.
Danish: Hvert hætteglas med pulver indeholder nominelt 2000 IE human koagulationsfaktor VIII (rDNA), turoctocog alfa.
English: After reconstitution NovoEight contains approximately 375 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Danish: Efter rekonstitution indeholder NovoEight cirka 375 IE/ml human koagulationsfaktor VIII (rDNA), turoctocog alfa.
English: After reconstitution NovoEight contains approximately 62.5 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Danish: Efter rekonstitution indeholder NovoEight cirka 62,5 IE/ml human koagulationsfaktor VIII (rDNA), turoctocog alfa.
English: NovoEight 1500 IU powder for solution for injection turoctocog alfa
Danish: NovoEight 1500 IE pulver og solvens til injektionsvæske, opløsning turoctocog alfa
English: NovoEight 500 IU powder for solution for injection turoctocog alfa
Danish: NovoEight 500 IE pulver og solvens til injektionsvæske, opløsning turoctocog alfa
English: NovoEight 250 IU powder and solvent for solution for injection.
Danish: NovoEight 250 IE pulver og solvens til injektionsvæske, opløsning.
English: Each powder vial contains nominally 3000 IU human coagulation factor VIII (rDNA), turoctocog alfa.
Danish: Hvert hætteglas med pulver indeholder nominelt 3000 IE human koagulationsfaktor VIII (rDNA), turoctocog alfa.
English: Each powder vial contains nominally 250 IU human coagulation factor VIII (rDNA), turoctocog alfa.
Danish: Hvert hætteglas med pulver indeholder nominelt 250 IE human koagulationsfaktor VIII (rDNA), turoctocog alfa.
English: AUC ((IU*h)/dl)
Danish: AUC ((IE*time)/dl) 992 (411)
English: NovoEight 250 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Danish: NovoEight 250 IE pulver og solvens til injektionsvæske, opløsning turoctocog alfa (human koagulationsfaktor VIII (rDNA))
English: Each powder vial contains nominally 500 IU human coagulation factor VIII (rDNA), turoctocog alfa.
Danish: Hvert hætteglas med pulver indeholder nominelt 500 IE human koagulationsfaktor VIII (rDNA), turoctocog alfa.
English: One ml of NovoEight contains approximately 125 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution
Danish: Én ml af NovoEight indeholder cirka 125 IE human koagulationsfaktor VIII (rDNA), turoctocog alfa efter opblanding
English: After reconstitution NovoEight contains approximately 125 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Danish: Efter rekonstitution indeholder NovoEight cirka 125 IE/ml human koagulationsfaktor VIII (rDNA), turoctocog alfa.
English: NovoEight 2000 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Danish: NovoEight 2000 IE pulver og solvens til injektionsvæske, opløsning turoctocog alfa (human koagulationsfaktor VIII (rDNA))
English: NovoEight 1000 IU powder for solution for injection turoctocog alfa
Danish: NovoEight 1000 IE pulver og solvens til injektionsvæske, opløsning turoctocog alfa
English: One ml of NovoEight contains approximately 750 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution
Danish: Én ml af NovoEight indeholder cirka 750 IE human koagulationsfaktor VIII (rDNA), turoctocog alfa efter opblanding
English: NovoEight 3000 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Danish: NovoEight 3000 IE pulver og solvens til injektionsvæske, opløsning turoctocog alfa (human koagulationsfaktor VIII (rDNA))
English: After reconstitution NovoEight contains approximately 500 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Danish: Efter rekonstitution indeholder NovoEight cirka 500 IE/ml human koagulationsfaktor VIII (rDNA), turoctocog alfa.
English: After reconstitution NovoEight contains approximately 750 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Danish: Efter rekonstitution indeholder NovoEight cirka 750 IE/ml human koagulationsfaktor VIII (rDNA), turoctocog alfa.
English: NovoEight 500 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Danish: NovoEight 500 IE pulver og solvens til injektionsvæske, opløsning turoctocog alfa (human koagulationsfaktor VIII (rDNA))
English: NovoEight 1000 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Danish: NovoEight 1000 IE pulver og solvens til injektionsvæske, opløsning turoctocog alfa (human koagulationsfaktor VIII (rDNA))
English: Each powder vial contains nominally 1000 IU human coagulation factor VIII (rDNA), turoctocog alfa.
Danish: Hvert hætteglas med pulver indeholder nominelt 1000 IE human koagulationsfaktor VIII (rDNA), turoctocog alfa.
English: NovoEight 1500 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Danish: NovoEight 1500 IE pulver og solvens til injektionsvæske, opløsning turoctocog alfa (human koagulationsfaktor VIII (rDNA))
English: • fast heartbeat
Danish: • hurtig hjertebanken
English: One ml of NovoEight contains approximately 500 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution
Danish: Én ml af NovoEight indeholder cirka 500 IE human koagulationsfaktor VIII (rDNA), turoctocog alfa efter opblanding
English: After reconstitution NovoEight contains approximately 250 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Danish: Efter rekonstitution indeholder NovoEight cirka 250 IE/ml human koagulationsfaktor VIII (rDNA), turoctocog alfa.
English: Each powder vial contains nominally 1500 IU human coagulation factor VIII (rDNA), turoctocog alfa.
Danish: Hvert hætteglas med pulver indeholder nominelt 1500 IE human koagulationsfaktor VIII (rDNA), turoctocog alfa.
English: One ml of NovoEight contains approximately 250 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution
Danish: Én ml af NovoEight indeholder cirka 250 IE human koagulationsfaktor VIII (rDNA), turoctocog alfa efter opblanding
English: Medicinal product subject to medical prescription
Danish: Receptpligtigt lægemiddel.
English: Psychiatric disorders Uncommon
Danish: Injicér den opblandede opløsning
English: If you notice visible particles or discolouration, do not use it. Use a new package instead.
Danish: Brug den ikke, hvis der er synlige partikler eller misfarvning.
English: • redness around the site where you placed catheter • vomiting.
Danish: • rødme omkring kateterets placering
English: <6 years) PTP
Danish: Større børn (6 - <12 år) PTP
English: Attach the plunger rod and the syringe
Danish: Påsæt stempelstangen og sprøjten
English: Plunger
Danish: Stempelstang
English: PC:
Danish: PTP
English: 3 months at above room temperature (30°C up to 40°C).
Danish: stuetemperatur (op til 30°C) i en sammenhængende periode på højst 9 måneder eller temperaturer over stuetemperatur (30°C til 40°C) i en sammenhængende periode på højst 3 måneder.
English: If you use more NovoEight than you should
Danish: Hvis du har brugt for meget NovoEight
English: Not known: frequency cannot be estimated from the available data
Danish: Ikke kendt: hyppighed kan ikke vurderes ud fra tilgængelige data
English: Date of first authorisation: 26 July 2018
Danish: Dato for første markedsføringstilladelse: 26. juli 2018
English: TTP = time to progression; "ne" indicates that it could not be estimated or it was not yet reached.
Danish: TTP= tid indtil progression; “ne” betyder, at grænsen ikke kunne estimeres, eller at den endnu ikke var nået.
English: Appropriate aseptic technique should be used.
Danish: Der skal anvendes passende aseptisk teknik.
English: Overall Response Rate,%
Danish: Samlet responsrate, %
English: Children and adolescents Trazimera is not recommended for anyone under the age of 18 years.
Danish: Børn og unge Trazimera anbefales ikke til børn og unge under 18 år.
English: * are summarized in Table 7.
Danish: * er sammenfattet i tabel 7.
English: 88397 Biberach an der Riss Germany
Danish: 88397 Biberach an der Riss Tyskland
English: Time to steadystate (week)
Danish: Tid til steadystate*** (uge)
English: Either of which was administered with:
Danish: Begge blev administreret med:
English: For intravenous/I.V.
Danish: Til intravenøs/i.v.
English: A careful risk-benefit assessment should be made before deciding to treat with Trazimera.
Danish: Der skal foretages en grundig riskbenefit vurdering før det besluttes, om der skal behandles med Trazimera.