FrancophonIA/ELRC3.0 huggingface dataset:
English: Driving and using machines RIXUBIS has no influence on the ability to drive and use machines.
Danish: Trafik og arbejdssikkerhed RIXUBIS påvirker ikke evnen til at føre motorkøretøj og betjene maskiner.
English: Depending on body weight and Posology of RIXUBIS, patients could receive more than one vial.
Danish: Afhængigt af kropsvægt og dosering af RIXUBIS kan patienter få mere end ét hætteglas.
English: Attach a butterfly needle to the syringe.
Danish: Sæt en sommerfuglekanyle på sprøjten.
English: Haemostatic efficacy at resolution of a bleed was rated excellent or good in 96.2% of all treated bleeding episodes.
Danish: Den hæmostatiske virkning ved behandling af blødningen blev vurderet som fremragende eller god for 96,2 % af alle behandlede blødningsepisoder.
English: Always use RIXUBIS exactly as your doctor has told you.
Danish: Brug altid RIXUBIS nøjagtigt efter lægens anvisning.
English: For an incremental recovery of 0.7 IU/dL per IU/kg, the dose is calculated as follows:
Danish: For at opnå en trinvis bedring på 0,7 IE/dl pr. IE/kg beregnes dosis på følgende måde:
English: Incremental recovery 30 minutes after infusion was determined for all subjects in the combined phase 1/3 study at exposure day 1, at their week 5, 13, and 26 visits, and at the time of study completion or termination, if it did not coincide with the week 26 visit.
Danish: Trinvis bedring 30 minutter efter infusion blev bestemt hos alle forsøgspersoner i det kombinerede fase 1/3-studie på eksponeringsdag 1, ved besøgene i uge 5, 13 og 26 samt på tidspunktet for studiets afslutning eller studieophør, hvis dette ikke faldt sammen med uge 26-besøget.
English: Reconstitution Use Aseptic Technique
Danish: Rekonstitution Brug aseptisk teknik.
English: • one vial of 5 ml sterilised water for injections in a glass vial with a rubber stopper
Danish: • 5 ml vand til injektionsvæsker i et hætteglas med gummiprop
English: All subjects had severe (factor IX level <1%) or moderately severe (factor IX level ≤2%) haemophilia B. All 23 subjects received prophylactic treatment with RIXUBIS for a minimum of 3 months and were included in the efficacy evaluation for prophylaxis.
Danish: Alle forsøgspersoner havde svær (faktor IX-niveau <1 %) eller moderat svær (faktor IX-niveau ≤2 %) hæmofili B. Alle 23 forsøgspersoner fik profylaktisk behandling med RIXUBIS i minimum 3 måneder og blev inkluderet i vurderingen af den profylaktiske virkning.
English: VIAL LABEL FOR THE POWDER
Danish: HÆTTEGLASETIKET TIL PULVERET
English: The median ABR on prophylaxis with RIXUBIS for all bleeds was 2.0, for spontaneous bleeds 0.0, and for joint bleeds 0.0.
Danish: Den mediane ABR ved profylaktisk behandling med RIXUBIS var 2,0 for alle blødninger, 0,0 for spontane blødninger og 0,0 for ledblødninger.
English: AUCinf (IU.hr/dL)
Danish: AUCinf (IE time/dl)
English: For an incremental recovery of 0.9 IU/dL per IU/kg, the dose is calculated as follows:
Danish: For at opnå en trinvis bedring på 0,9 IE/dl pr. IE/kg beregnes dosis på følgende måde:
English: There have been reports in the literature showing a correlation between the occurrence of a factor IX inhibitor and allergic reactions.
Danish: I litteraturen er der rapporter, som viser en forbindelse mellem forekomsten af faktor IX-inhibitor og allergiske reaktioner.
English: Your doctor will do a blood test to check if you have developed activity-neutralising antibodies (inhibitors) against RIXUBIS.
Danish: Lægen kan tage en blodprøve for at undersøge, om du har udviklet neutraliserende antistoffer (inhibitorer), der hæmmer aktiviteten af RIXUBIS.
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 skal informeres om de tidlige tegn på overfølsomhedsreaktioner inklusive nældefeber, generaliseret urticaria, thoraxkonstriktion, hvæsende åndedræt, hypotension og anafylaksi.
English: Allergic type hypersensitivity reactions have been reported with RIXUBIS.
Danish: Der er rapporteret allergilignende overfølsomhedsreaktioner med RIXUBIS.
English: The mean (± SD) and median dose of RIXUBIS in the full analysis set (n=23) was 75.50 ± 3.016 and 75.25 IU/kg, respectively, with a range of 70.0 to 83.6 IU/kg.
Danish: Den gennemsnitlige dosis (± SD) og mediandosen af RIXUBIS i det fulde analysesæt (n=23) var henholdsvis 75,50±3,016 og 75,25 IE/kg med et interval på 70,0-83,6 IE/kg.
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).
Danish: Overfølsomhedsreaktioner eller allergiske reaktioner (som kan omfatte angioødem, brænden og svien på infusionsstedet, kuldegysninger, ansigtsrødme, generaliseret urticaria, hovedpine, nældefeber, hypotension, letargi, kvalme, rastløshed, takykardi, konstriktion af thorax, prikkende fornemmelse, opkastning, hvæsende åndedræt) er observeret i sjældne tilfælde og kan i nogle tilfælde udvikle sig til alvorlig anafylaksi (herunder shock).
English: The potency (IU) is determined using the European Pharmacopoeia one stage clotting assay.
Danish: Potensen (IE) bestemmes ved hjælp af Den Europæiske Farmakopés 1-trins koagulationsanalyse.
English: When using an in vitro thromboplastin time (aPTT)-based one stage clotting assay for determining factor IX activity in patients' blood samples, plasma factor IX activity results can be significantly affected by both the type of aPTT reagent and the reference standard used in the assay.
Danish: Ved anvendelse af en in vitro tromboplastintid (aPTT)-baseret 1-trins-koagulationsanalyse til bestemmelse af faktor IX-aktiviteten i patienternes blodprøver, kan resultaterne af faktor IX-aktiviteten i plasma blive signifikant påvirket både af typen af aPTT-reagens og af den referencestandard, der bruges i analysen.
English: Incremental recovery 30 minutes after infusion was determined for all subjects in the combined phase 2/3 study at the initial pharmacokinetic evaluation (exposure day 1), at week 5, 13, and 26 visits, and at the time of study completion or termination, if it did not coincide with the week 26 visit.
Danish: Trinvis bedring 30 minutter efter infusion blev bestemt for alle forsøgspersoner i det kombinerede fase 2/3-studie ved den indledende farmakokinetiske vurdering (eksponeringsdag 1), ved besøgene i uge 5, 13 og 26 samt på tidspunktet for studiets afslutning eller ophør, hvis dette ikke faldt sammen med uge 26-besøget.
English: AUC0-72h (IU.hr/dL)
Danish: AUC0-72 t (IE∙time/dl)
English: There is a potential risk of thromboembolic episodes following the administration of factor IX products, with a higher risk for low purity preparations.
Danish: Der er en potentiel risiko for tromboemboliske episoder efter administration af faktor IX-præparater.
English: 6 - < 12 years (N=12)
Danish: 6- <12 år (N=12)
English: This dose and duration will depend on the severity of your factor IX deficiency, on the location and extent of the bleeding and on your clinical condition, age and how quickly your body uses up factor IX which will have to be checked regularly.
Danish: Dosis og behandlingsvarighed afhænger af, hvor alvorlig din faktor IX-mangel er, af blødningsstedet og af, hvor meget det bløder, samt af din kliniske tilstand, alder, og hvor hurtigt din krop bruger faktor IX.
English: The pharmacokinetic parameters were calculated from factor IX activitiy measurements in blood samples obtained up to 72 hours following each infusion.
Danish: De farmakokinetiske parametre blev beregnet ud fra målinger af faktor IX-aktiviteten i blodprøver indsamlet op til 72 timer efter hver infusion.
English: Prophylaxis:
Danish: Profylakse:
English: Prophylaxis and control of bleeding in previously treated patients 12 years and older The efficacy of RIXUBIS has been evaluated in the open-label, uncontrolled part of a combined phase 1/3 study, in which a total of 73 male, previously treated patients (PTPs) between 12 and 59 years of age received RIXUBIS either for prophylaxis and/or for the treatment of bleeding episodes on an on-demand basis.
Danish: Profylakse og blødningskontrol hos tidligere behandlede patienter på 12 år og derover RIXUBIS' virkning er blevet vurderet i en åben, ikke-kontrolleret del af et kombineret fase 1/3-studie, hvor i alt 73 tidligere behandlede drenge/mænd mellem 12 og 59 år fik RIXUBIS efter behov, enten profylaktisk og/eller til behandling af blødningsepisoder.
English: In some cases, these reactions have progressed to severe anaphylaxis, and they have occurred in close temporal association with development of factor IX inhibitors (see also 4.4).
Danish: Disse reaktioner er forekommet i tæt tidsmæssig sammenhæng med udvikling af faktor IX-inhibitorer (se også pkt.
English: The pharmacokinetic parameters were calculated from factor IX activity measurements in blood samples obtained up to 72 hours following the infusion.
Danish: De farmakokinetiske parametre blev beregnet ud fra måling af faktor IX-aktiviteten i blodprøver indsamlet op til 72 timer efter infusionen.
English: VIAL LABEL FOR THE SOLVENT
Danish: HÆTTEGLASETIKET TIL SOLVENSEN
English: Allergic-type hypersensitivity reactions are possible with RIXUBIS.
Danish: Der kan være risiko for allergilignende overfølsomhedsreaktioner med RIXUBIS.
English: - The other ingredients in the powder are sucrose, mannitol, sodium chloride, calcium chloride, L-histidine, polysorbate 80.
Danish: - Øvrige indholdsstoffer i pulveret: saccharose, mannitol, natriumchlorid, calciumchlorid, L-histidin og polysorbat 80.
English: Incremental recovery for RIXUBIS 30 minutes after infusion, both paediatric age groups:
Danish: Trinvis bedring for RIXUBIS 30 minutter efter infusion, begge pædiatriske aldersgrupper:
English: In patients with existing cardiovascular risk factors, substitution therapy with FIX may increase the cardiovascular risk.
Danish: Hos patienter med kardiovaskulære risikofaktorer kan substitutionsbehandling med faktor IX øge den kardiovaskulære risiko.
English: The mean (± SD) and median dose of RIXUBIS in the per protocol analysis set (n=25) were 74.69±2.37 and 74.25 IU/kg, respectively, with a range of 71.27 to 79.38 IU/kg.
Danish: Den gennemsnitlige dosis (± SD) og mediandosen af RIXUBIS i per-protokol-analysesættet (n=25) var henholdsvis 74,69±2,37 og 74,25 IE/kg med et interval på 71,27-79,38 IE/kg.
English: Week 26 (N=55)
Danish: Uge 26 (N=55)
English: Remove the blue cap from BAXJECT II.
Danish: Tag det blå låg af BAXJECT II.
English: Week 5 (N=71)
Danish: Uge 5 (N=71)
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: Injektionsvæsken skal administreres langsomt med en hastighed, der er behagelig for patienten, maksimalt 10 ml i minuttet.
English: All subjects had severe (factor IX level <1%) or moderately severe (factor IX level ≤2%) haemophilia B. Fifty-nine PTPs received RIXUBIS for prophylaxis.
Danish: Alle forsøgspersoner havde svær (faktor IX-niveau <1 %) eller moderat svær (faktor IX-niveau ≤2 %) hæmofili B. 59 tidligere behandlede patienter fik RIXUBIS profylaktisk.
English: The median ABR was 2.0, for spontaneous bleeds 0.0 and for joint bleeds 0.0.
Danish: Den mediane ABR var 2,0 for alle blødninger og 0,0 for spontane blødninger og ledblødninger.
English: Incremental recovery for RIXUBIS 30 minutes after infusion, paediatric patients < 6 years:
Danish: Trinvis bedring for RIXUBIS 30 minutter efter infusion, pædiatriske patienter <6 år:
English: The efficacy of RIXUBIS has been evaluated in a combined phase 2/3 study, in which a total of 23 male PTPs between 1.8 and 11.8 years (median age 7.10 years) with 11 patients < 6 years, received RIXUBIS for prophylaxis and control of bleeding episodes.
Danish: Profylakse og blødningskontrol hos tidligere behandlede patienter under 12 år: RIXUBIS' virkning er blevet vurderet i et kombineret fase 2/3-studie, hvor i alt 23 tidligere behandlede drenge mellem 1,8 og 11,8 år (medianalder 7,10 år) med 11 patienter <6 år fik RIXUBIS profylaktisk og til kontrol af blødningsepisoder.
English: RIXUBIS contains recombinant coagulation factor IX (nonacog gamma).
Danish: RIXUBIS indeholder rekombinant koagulationsfaktor IX (nonacog gamma).
English: Incremental recovery for RIXUBIS 30 minutes after infusion, paediatric patients 6 to < 12 years:
Danish: Trinvis bedring for RIXUBIS 30 minutter efter infusion, pædiatriske patienter 6 til <12 år:
English: Patients less than 12 years:
Danish: Patienter under 12 år:
English: Such reactions may include burning sensations and stinging at the infusion site, chills, flushing, lethargy, restlessness, tingling, hives, itching and rash, low blood pressure, fast heart rate, tightness of the chest, wheezing, swelling of the throat, anaphylaxis (severe allergic reaction), headache, nausea and vomiting.
Danish: Sådanne reaktioner kan omfatte brænden og svien på infusionsstedet, kuldegysninger, ansigtsrødme, udtalt træthed, rastløshed, prikkende fornemmelse, nældefeber, kløe og udslæt, lavt blodtryk, hurtig puls, trykken i brystet, hvæsende vejrtræning, hævet hals, anafylaksi (alvorlig allergisk reaktion), hovedpine, kvalme og opkastning.
English: Calculated as (C30min-baseline factor IX) divided by the dose in IU/kg, where C30min is the factor IX measurement 30 minutes after infusion.
Danish: Beregnet som (C30min-baseline-faktor IX) divideret med dosen i IE/kg, hvor C30min er faktor IX-koncentrationen målt 30 minutter efter infusion.
English: Calculated as (Cmax-baseline factor IX) divided by the dose in IU/kg, where Cmax is the maximal post-infusion factor IX measurement.
Danish: Beregnet som (Cmax-baseline-faktor IX) divideret med dosen i IE/kg, hvor Cmax er den maksimale faktor IX-koncentration målt efter infusion.
English: RIXUBIS 250 IU powder and solvent for solution for injection
Danish: RIXUBIS 250 IE pulver og solvens til injektionsvæske, opløsning
English: Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
Danish: Behandling og forebyggelse af blødning hos patienter med hæmofili B (medfødt faktor IX-mangel).
English: RIXUBIS contains the active substance nonacog gamma and is a coagulation factor IX product.
Danish: RIXUBIS indeholder det aktive stof nonacog gamma og er et koagulationsfaktor IX-præparat.
English: Patients with factor IX inhibitors may be at an increased risk of anaphylaxis during future treatment with factor IX.
Danish: Patienter med faktor IX-inhibitorer kan have øget risiko for anafylaksi under fremtidig behandling med faktor IX.
English: If symptoms of hypersensitivity occur, patients or their caregivers should be advised to discontinue use of the medicinal product immediately and contact their physician.
Danish: Patienter eller deres omsorgspersoner skal informeres om straks at seponere lægemidlet og kontakte lægen, hvis der opstår overfølsomhedssymptomer.
English: < 6years (N=11)
Danish: <6 år (N=11)
English: - For reconstitution use only the solvent and the reconstitution device (BAXJECT II) provided in the pack.
Danish: - Solvensen og rekonstitutionsenheden (devicet) (BAXJECT II), der følger med i pakken, er kun til brug ved rekonstitution.
English: Remove caps from powder and solvent vials.
Danish: Tag lågene af hætteglassene med pulver og solvens.
English: Do not use RIXUBIS - if you are allergic to nonacog gamma or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to hamster proteins
Danish: Brug ikke RIXUBIS - hvis du er allergisk over for nonacog gamma eller et af de øvrige indholdsstoffer i RIXUBIS
English: Patients who have specific mutations of their factor IX gene such as major deletion may be more likely to have factor IX inhibitors and an allergic reaction in the early period with any factor IX concentrate.
Danish: Patienter, der har specifikke forandringer (mutationer) i deres faktor IX-gen, for eksempel hvis der mangler et stykke af et kromosom (større deletion), kan have større risiko for at udvikle faktor IX-inhibitorer og få en allergisk reaktion i starten af den periode, hvor de får et faktor IX-koncentrat.
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 injektionsvæskens kemiske og fysiske holdbarhed, mens den er i brug, er 3 timer ved maks.
English: It should be noted that patients with factor IX inhibitors may be at an increased risk of anaphylaxis with subsequent challenge with factor IX.
Danish: Det skal bemærkes, at patienter med faktor IX-inhibitorer kan have øget risiko for anafylaksi ved efterfølgende eksposition for faktor IX.
English: RIXUBIS is provided as a powder and solvent for solution for injection.
Danish: RIXUBIS leveres som pulver og solvens til injektionsvæske, opløsning.
English: = body weight (kg) x desired factor IX rise (%) or (IU/dL)
Danish: x ønsket faktor IX-forøgelse (%) eller (IE/dl)
English: How to use RIXUBIS
Danish: Sådan skal du bruge RIXUBIS
English: All (N=23)
Danish: Alle (N=23)
English: RIXUBIS 250 IU powder and solvent for solution for injection RIXUBIS 500 IU powder and solvent for solution for injection RIXUBIS 1000 IU powder and solvent for solution for injection RIXUBIS 2000 IU powder and solvent for solution for injection RIXUBIS 3000 IU powder and solvent for solution for injection
Danish: RIXUBIS 250 IE pulver og solvens til injektionsvæske, opløsning RIXUBIS 500 IE pulver og solvens til injektionsvæske, opløsning RIXUBIS 1.000 IE pulver og solvens til injektionsvæske, opløsning RIXUBIS 2.000 IE pulver og solvens til injektionsvæske, opløsning RIXUBIS 3.000 IE pulver og solvens til injektionsvæske, opløsning
English: Median (range) Incremental recovery at Cmax (IU/dL:IU/kg)
Danish: Gennemsnit±SD Median (interval) Trinvis bedring ved Cmax (IE/dl:IE/kg)
English: Use the reconstituted solution immediately.
Danish: Brug den opblandede (rekonstituerede) injektionsvæske straks.
English: Mean±SD Median (range)
Danish: Gennemsnit ±SD Median (interval)
English: Week 13 (N=68)
Danish: Uge 13 (N=68)
English: Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor IX.
Danish: Farmakoterapeutisk klassifikation: hæmostatika, koagulationsfaktor IX.
English: What RIXUBIS contains - The active substance is nonacog gamma (recombinant human coagulation Factor IX).
Danish: RIXUBIS indeholder: - Aktivt stof: nonacog gamma (rekombinant human koagulationsfaktor IX).
English: PK (ED 1) All (N=22)
Danish: PK (ED 1) Alle (N=22)
English: Nephrotic syndrome has been reported following attempted immune tolerance induction in haemophilia B patients with factor IX inhibitors.
Danish: Der er rapporteret nefrotisk syndrom efter forsøg på immuntoleranceinduktion hos hæmofili B-patienter med faktor IX-inhibitorer.
English: Solvent: sterilised water for injections
Danish: Solvens: vand til injektionsvæsker
English: Do not remove the device from the package.
Danish: Lad devicet blive i pakken.
English: The mean treatment duration in the on-demand cohort was 3.5±1.00 months (median 3.4, ranging from 1.2 to 5.1 months), the mean total annualised bleeding rate (ABR) was 33.9±17.37 with a median of 27.0, ranging from 12.9 to 73.1.
Danish: Den gennemsnitlige totale årlige blødningsrate (ABR) var 33,9±17,37 med en median på 27,0 (12,9-73,1).
English: Single use injection.
Danish: Til injektion, engangsbrug.
English: PK (ED 1) All (N=12)
Danish: PK (ED 1) Alle (N=12)
English: Nephrotic syndrome has been reported following attempted immune tolerance induction in haemophilia B patients with factor IX inhibitors and a history of allergic reactions.
Danish: Der er rapporteret nefrotisk syndrom efter forsøg på immuntoleranceinduktion hos hæmofili B-patienter med faktor IX-inhibitorer og allergiske reaktioner i anamnesen.
English: If you are not sure check with your doctor.
Danish: Er du i tvivl, så spørg lægen.
English: PK (ED 1) All (N=10)
Danish: PK (ED 1) Alle (N=10)
English: Week 5 All (N=23)
Danish: Uge 5 Alle (N=23)
English: Treatment was individualised based on the severity, cause and site of bleed The majority (23; 88,5%) were treated with 1-2 infusions.
Danish: Størstedelen (23; 88,5 %) blev behandlet med 1-2 infusioner.
English: If the product is stored in a refrigerator, take both the RIXUBIS powder and solvent vials from the refrigerator and let them reach room temperature (between 15°C and 30°C).
Danish: Lad dem antage rumtemperatur (mellem 15 °C og 30 °C).
English: Median (range) Clearance (dL/(kg.hr)) Mean±SD
Danish: Gennemsnit ±SD Median (interval) Clearance (dl/(kg.time)) Gennemsnit ±SD Median (interval)
English: Excipients: sodium chloride, sucrose, calcium chloride, histidine, mannitol, polysorbate 80.
Danish: Hjælpestoffer:, som behandleren skal være opmærksom på: natrium (fra natriumchlorid) Øvrige hjælpestoffer: saccharose, calciumchlorid, histidin, mannitol, polysorbat 80.
English: RIXUBIS 500 IU powder and solvent for solution for injection RIXUBIS 1000 IU powder and solvent for solution for injection RIXUBIS 2000 IU powder and solvent for solution for injection RIXUBIS 3000 IU powder and solvent for solution for injection nonacog gamma (recombinant human coagulation factor IX)
Danish: RIXUBIS 500 IE pulver og solvens til injektionsvæske, opløsning RIXUBIS 1.000 IE pulver og solvens til injektionsvæske, opløsning RIXUBIS 2.000 IE pulver og solvens til injektionsvæske, opløsning RIXUBIS 3.000 IE pulver og solvens til injektionsvæske, opløsning nonacog gamma (rekombinant human koagulationsfaktor IX)
English: If you use more RIXUBIS than you should
Danish: Hvis du har brugt for meget RIXUBIS
English: Week 5 All (N=12)
Danish: Uge 5 Alle (N=12)
English: Tell your doctor if you are using or have recently used or might use any other medicines.
Danish: Brug af anden medicin sammen med RIXUBIS Fortæl det altid til lægen, hvis du bruger anden medicin eller har gjort det for nylig.
English: The calculation of the required dose of factor IX is based on the empirical finding that 1 International Unit (IU) factor IX per kg body weight raises the plasma factor IX activity by 0.7 IU/dL (range from 0.31 to 1.0 IU/dL) or 0.7% of normal activity in patients less than 12 years of age (further information see section 5.2).
Danish: Beregningen af den nødvendige dosis faktor IX er baseret på det empiriske fund, at 1 international enhed (IE) faktor IX pr. kg legemsvægt øger plasma faktor IX's aktivitet med 0,7 IE/dl (interval fra 0,31 til 1,0 IE/dl) eller 0,7 % af den normale aktivitet hos patienter under 12 år (se pkt.
English: The calculation of the required dose of factor IX is based on the empirical finding that 1 International Unit factor IX per kg body weight raises the plasma factor IX activity by 0.7 IU/dL (range from 0.31 to 1.0 IU/dL) or 0.7% of normal activity in patients less than 12 years of age (further information see section 5.2).
Danish: Beregningen af den nødvendige dosis faktor IX er baseret på det empiriske fund, at 1 international enhed faktor IX pr. kg legemsvægt øger plasma faktor IX's aktivitet med 0,7 IE/dl (interval fra 0,31 til 1,0 IE/dl) eller 0,7 % af den normale aktivitet hos patienter under 12 år (se pkt.
English: Reconstitution and administration
Danish: Rekonstitution og indgivelse
English: The calculation of the required dose of factor IX is based on the empirical finding that 1 International Unit factor IX per kg body weight raises the plasma factor IX activity by 0.9 IU/dL (range from 0.5 to 1.4 IU/dL) or 0.9% of normal activity in patients 12 years and older (further information see section 5.2).
Danish: Beregning af den nødvendige dosis faktor IX er baseret på det empiriske fund, at 1 international enhed faktor IX pr. kg legemsvægt øger aktiviteten af faktor IX i plasma med 0,9 IE/dl (interval fra 0,5 til 1,4 IE/dl) eller 0,9 % af den normale aktivitet hos patienter på 12 år og derover (se pkt.
English: One vial contains 19 mg sodium.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Et hætteglas indeholder 19 mg natrium.