FrancophonIA/ELRC3.0 huggingface dataset:
English: Because of the risk of allergic reactions with factor IX concentrates, the initial administrations of factor IX should, according to the treating physician's judgement, be performed under medical observation where proper medical care for allergic reactions could be provided.
Danish: På grund af risikoen for allergiske reaktioner med faktor IX-koncentrater bør de første administrationer af faktor IX foretages under lægeligt opsyn ud fra den behandlende læges vurdering, med mulighed for korrekt medicinsk behandling af allergiske reaktioner.
English: The vacuum will draw the solvent into the RIXUBIS vial (Fig. c).
Danish: Vakuummet vil trække solvensen ind i RIXUBIS-hætteglasset (fig. c).
English: A total of 26 bleeding episodes were treated with RIXUBIS, of which 23 bleeds were due to injury, 2 spontaneous and 1 of unknown origin.
Danish: I alt 26 blødningsepisoder blev behandlet med RIXUBIS, hvoraf 23 skyldtes skader, 2 var spontane og 1 af ukendt årsag.
English: The powder is white to off-white.
Danish: Pulveret er hvidt til råhvidt.
English: x reciprocal of observed recovery (dL/kg)
Danish: x den reciprokke værdi af den observerede bedring (dl/kg)
English: One International Unit of factor IX activity is equivalent to that quantity of factor IX in one ml of normal human plasma.
Danish: En international enhed faktor IX-aktivitet svarer til mængden af faktor IX i én ml normalt humant plasma.
English: Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.
Danish: Alle patienter, der oplever allergiske reaktioner, bør derfor undersøges for tilstedeværelse af inhibitorer.
English: RIXUBIS was well tolerated in single dose and repeated dose toxicity studies conducted in mice, rats and cynomolgus monkeys up to doses of 7500 IU/kg (single dose) and 750 IU/kg (repeated application).
Danish: RIXUBIS blev tolereret godt i toksicitetsstudier med enkeltdosis og gentagne doser udført på mus, rotter og cynomolgusaber i doser op til 7.500 IE/kg (enkeltdosis) og 750 IE/kg (gentagen dosering).
English: All 23 male subjects underwent an initial pharmacokinetic evaluation of RIXUBIS in a non-bleeding state as part of the combined phase 2/3 paediatric study.
Danish: Alle 23 drenge fik foretaget en indledende farmakokinetisk vurdering af RIXUBIS i en ikke-blødende tilstand som led i det kombinerede pædiatriske fase 2/3-studie.
English: Repeat infusion every 8 to 24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor IX activity of 30% to 60% (IU/dl).
Danish: Gentag infusionen hver 8.-24. time, indtil tilstrækkelig sårheling er opnået, derefter behandling i mindst yderligere 7 dage for at opretholde en faktor IX-aktivitet på 30-60 % (IE/dl).
English: The same table as for adults can be used to guide dosing in bleeding episodes and surgery (see above).
Danish: Tabellen for voksne kan bruges som vejledning til dosering ved blødningsepisoder og kirurgiske indgreb (se ovenfor).
English: RIXUBIS Repeat Evaluation (N=23)
Danish: RIXUBIS Gentagne studier (N=23)
English: Factor IX is activated by factor XIa in the intrinsic coagulation pathway and by factor VII/tissue factor complex in the extrinsic pathway.
Danish: Faktor IX aktiveres af faktor XIa i intrinsic pathway i koagulationssystemet og af faktor VII/vævsfaktorkompleks i extrinsic pathway.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Danish: Hvis injektionsvæsken ikke anvendes straks, har brugeren ansvaret for opbevaringstid og -forhold under brug.
English: Store below 30°C.
Danish: Opbevares ved temperaturer under 30 °C.
English: Of a total of 249 bleeding episodes, 163 were moderate, 71 were minor, and 15 were major.
Danish: Af de i alt 249 blødningsepisoder var 163 moderate, 71 var ubetydelige, og 15 var alvorlige.
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: Når det er nødvendigt at anvende et centralt venekateter (CVK), skal risikoen for CVK-relaterede komplikationer inklusive lokale infektioner, bakteriæmi og trombose på kateterstedet tages i betragtning.
English: Insert the white plastic spike through the RIXUBIS stopper.
Danish: Stik den hvide plastikspids gennem RIXUBIS-proppen.
English: Do not use this medicine after the expiry date which is stated on the outer box and vial label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på den ydre pakning og hætteglassets etiket efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Individual patients may vary in their response to factor IX, demonstrating different half-lives and recoveries.
Danish: De enkelte patienter kan respondere forskelligt på faktor IX og udvise forskellige halveringstider og bedringsrater.
English: RIXUBIS is to be administered intravenously after reconstitution of the powder with the provided solvent.
Danish: RIXUBIS skal administreres intravenøst efter rekonstitution af pulveret med den medfølgende solvens.
English: Previously treated patients 12 years and older:
Danish: Tidligere behandlede patienter på 12 år og derover:
English: Nine subjects (39.1%) experienced zero bleeds.
Danish: 9 forsøgspersoner (39,1 %) oplevede ingen blødninger.
English: - Do not use if the BAXJECT II device, its sterile barrier system or its packaging is damaged or shows any sign of deterioration.
Danish: - BAXJECT II-devicet må ikke anvendes, hvis det sterile filter eller pakningen er beskadiget eller viser tegn på nedbrydning.
English: In some cases, depending upon the individual patient´s pharmacokinetics, age, bleeding phenotype and physical activity, shorter dosage intervals or higher doses may be necessary.
Danish: I nogle tilfælde kan det - afhængigt af den enkelte patients farmakokinetik, alder, fysiske aktivitet samt resultatet af fænotypeanlaysen - være nødvendigt med kortere doseringsintervaller eller højere doser.
English: RIXUBIS was administered by bolus infusions.
Danish: RIXUBIS blev administreret som bolusinfusioner.
English: Clinical studies with RIXUBIS included 99 subjects with at least one exposure to RIXUBIS reporting in total 5 adverse reactions.
Danish: Kliniske studier med RIXUBIS har omfattet 99 forsøgspersoner med mindst én eksponering for RIXUBIS, og der er rapporteret 5 bivirkninger i alt.
English: Area under the plasma concentration-time curve from time 0-72 hours post-infusion.
Danish: Arealet under plasmakoncentration-tids-kurven fra tiden 0-72 timer efter infusion.
English: Place the vials on a flat clean surface.
Danish: Placer hætteglassene på en plan, ren overflade.
English: Of the 26 bleeding episodes, 15 were minor, 9 moderate, and 2 major.
Danish: Af de 26 blødningsepisoder var 15 ubetydelige, 9 var moderate, og 2 var alvorlige.
English: The solution should be clear or slightly opalescent.
Danish: Opløsningen skal være klar og let opaliserende.
English: Open the package of BAXJECT II device by peeling away the paper lid without touching the inside (Fig. a).
Danish: Åbn pakken med BAXJECT II-devicet ved at trække papirlåget af uden at røre devicet (fig. a).
English: Fifty-six of these PTPs who received RIXUBIS for a minimum of 3 months were included in the efficacy evaluation for prophylaxis.
Danish: 56 af disse fik RIXUBIS i minimum 3 måneder og blev inkluderet i vurderingen af den profylaktiske virkning.
English: Known allergic reaction to hamster protein.
Danish: Allergisk reaktion over for hamsterprotein.
English: No investigations on carcinogenicity, fertility impairment, and fetal development have been conducted.
Danish: Karcinogenicitet, nedsat fertilitet og fosterudvikling er ikke undersøgt.
English: Careful monitoring of replacement therapy is especially important in cases of major surgery or life-threatening haemorrhages.
Danish: Omhyggelig monitorering af substitutionsbehandlingen er særlig vigtig ved større kirurgiske indgreb og livstruende blødninger.
English: Do not use solutions that are cloudy or have deposits.
Danish: Brug ikke opløsninger, som er uklare eller har udfældninger.
English: The risk for developing inhibitors is highest in patients who have not been treated with a factor IX replacement medicine before or in the early phases of treatment, i.e. for small children.
Danish: Risikoen for at udvikle inhibitorer er størst hos patienter, der ikke er blevet behandlet med faktor IX som erstatningsmedicin tidligere, eller som er i behandlingens tidlige fase, dvs. hos mindre børn.
English: Pharmacokinetic parameters for all subjects (full analysis set) are presented in the table below.
Danish: Farmakokinetiske parametre for alle forsøgspersoner (fuldt analysesæt) er vist i nedenstående tabel.
English: The RIXUBIS dose range in the repeat pharmacokinetics study was 64.48 to 79.18 IU/kg (n=23).
Danish: RIXUBIS-dosisintervallet i det gentagne farmakokinetiske studie var 64,48 til 79,18 IE/kg (n=23).
English: Pharmacokinetic parameters for evaluable subjects (per-protocol analysis) are presented in the table below.
Danish: Farmakokinetiske parametre hos evaluerbare forsøgspersoner (per-protokol-analyse) er vist i nedenstående tabel.
English: RIXUBIS did not cause any adverse clinical, respiratory, or cardiovascular effects up to 450 IU/kg in cynomolgus monkeys.
Danish: RIXUBIS forårsagede ingen kliniske, respiratoriske eller kardiovaskulære virkninger ved doser op til 450 IE/kg hos cynomolgusaber.
English: RIXUBIS should be administered using a rate that ensures the comfort of the patient, up to a maximum of 10 ml/min.
Danish: RIXUBIS skal administreres med en hastighed, der er behagelig for patienten, op til maksimalt 10 ml/min.
English: 24 subjects (42.9%) experienced zero bleeds.
Danish: 24 forsøgspersoner (42,9 %) oplevede ingen blødninger.
English: A total of 249 bleeding episodes were treated with RIXUBIS, of which 197 were joint bleeds and 52 non-joint bleeds (soft tissue, muscle, body cavity, intracranial and other).
Danish: I alt 249 blødningsepisoder blev behandlet med RIXUBIS, heraf var 197 ledblødninger og 52 ikke-ledblødninger (bløddele, muskler, kropshulrum, intrakranielt mv.).
English: Nonacog gamma (recombinant coagulation factor IX) is a single-chain purified glycoprotein that has 415 amino acids.
Danish: Nonacog gamma (rekombinant koagulationsfaktor IX) er et enkeltkædet renset glykoprotein med 415 aminosyrer.
English: Perioperative management:
Danish: Perioperativ behandling:
English: RIXUBIS is used in patients with haemophilia B (Christmas disease, an inherited bleeding disorder caused by lack of factor IX).
Danish: RIXUBIS bruges til patienter med hæmofili B (Christmas' sygdom, en arvelig blodsygdom, der skyldes mangel på faktor IX).
English: Draw the reconstituted solution into the syringe by pulling the plunger back slowly (Fig. e).
Danish: Træk den rekonstituerede injektionsvæske ind i sprøjten ved at trække stemplet langsomt tilbage (fig. e).
English: Early haemarthrosis, muscle bleeding or oral bleeding
Danish: Tidlig hæmartrose, muskelblødning eller oral blødning
English: The recommended dose range for paediatric patients less than 12 years is 40 to 80 IU/kg at intervals of 3 to 4 days.
Danish: Det anbefalede dosisområde for pædiatriske patienter under 12 år er 40-80 IE/kg med intervaller på 3 til 4 dage.
English: Each powder vials contains nominally 250, 500, 1000, 2000 or 3000 IU, corresponding to a concentration of 50, 100, 200, 400 or 600 IU/ml after reconstitution with 5 ml solvent.
Danish: Hvert pulverhætteglas indeholder nominelt 250, 500, 1.000, 2.000 eller 3.000 IE, svarende til en koncentration på 50, 100, 200, 400 eller 600 IE/ml efter rekonstitution med 5 ml solvens.
English: RIXUBIS was not thrombogenic at a dose of 750 IU/kg in a rabbit stasis model (Wessler-Test).
Danish: RIXUBIS var ikke trombogent ved en dosis på 750 IE/kg i en hæmostasemodel hos kaniner (Wessler-test).
English: Haemophilia B is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor IX and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Danish: Hæmofili B er en kønsrelateret arvelig forstyrrelse af blodkoagulationen, der skyldes et nedsat niveau af faktor IX, og som resulterer i kraftig blødning i led, muskler eller indre organer, enten spontant eller som følge af uheld eller kirurgisk traume.
English: Treatment with RIXUBIS will be started by a doctor who is experienced in the care of patients with haemophilia B.
Danish: Behandling med RIXUBIS bliver indledt af en læge, der har erfaring med behandling af patienter med hæmofili B.
English: A randomised, blinded, controlled, crossover pharmacokinetic study of RIXUBIS and a comparator was conducted in non-bleeding male subjects (≥15 years of age) as part of the combined phase 1/3 pivotal study.
Danish: Et randomiseret, blindet, kontrolleret, farmakokinetisk crossover-studie af RIXUBIS og en komparator blev udført med ikke-blødende mandlige forsøgspersoner (≥15 år) som led i det kombinerede fase 1/3-pivotalstudie.
English: With BAXJECT II attached to the solvent vial, invert the system so that the solvent vial is on top of the device.
Danish: Når BAXJECT II er monteret på solvenshætteglasset, vendes systemet om, så solvensglasset sidder oven på devicet.
English: Subjects in the on-demand cohort had to have at least 12 documented bleeding episodes requiring treatment within 12 months prior to enrollment.
Danish: Forsøgspersonerne i den kohorte, der fik medicin efter behov, skulle have haft mindst 12 dokumenterede behandlingskrævende blødningsepisoder inden for 12 måneder forud for inklusion i studiet.
English: Hypersensitivity Allergic type reactions have been manifested by dyspnoea, pruritus, generalised urticaria and rash.
Danish: Overfølsomhed Allergiske reaktioner har manifesteret sig som dyspnø, pruritus, generaliseret urticaria og udslæt.
English: • one vial of RIXUBIS 250, 500, 1000, 2000 or 3000 IU powder in a glass vial with a rubber stopper
Danish: • RIXUBIS 250, 500, 1.000, 2.000 eller 3.000 IE pulver i et hætteglas med gummiprop
English: Administration Use Aseptic Technique
Danish: Administration Brug aseptisk teknik.
English: Factor IX level required (%) or (IU/dL)
Danish: Krævet faktor IX-niveau (%) eller (IE/dl)
English: No interactions of RIXUBIS with other medicines are known.
Danish: RIXUBIS har ingen kendte interaktioner med andre lægemidler.
English: The pharmacokinetic evaluation was repeated for RIXUBIS in an open-label, uncontrolled study with RIXUBIS in male subjects who participated in the initial PK crossover study and had received prophylaxis with RIXUBIS for 26±1 weeks (mean ± SD) and accumulated at least 30 exposure days (EDs) to RIXUBIS.
Danish: Den farmakokinetiske vurdering blev gentaget for RIXUBIS i et åbent, ikke-kontrolleret studie af RIXUBIS med mandlige forsøgspersoner, der deltog i det indledende farmakokinetiske crossover-studie og havde fået RIXUBIS profylaktisk i 26±1 uger (gennemsnit ± SD) og akkumuleret mindst 30 dages eksponering for RIXUBIS.
English: RIXUBIS has no influence on the ability to drive and use machines.
Danish: RIXUBIS påvirker ikke evnen til at føre motorkøretøj og betjene maskiner.
English: The risk is highest during the early phases of initial exposure to factor IX concentrates in previously untreated patients (PUPs), in particular in patients with high-risk gene mutations.
Danish: Der er størst risiko i de tidlige faser af den første eksponering for faktor IX-koncentrater hos tidligere ubehandlede patienter, især hos patienter med højrisiko-genmutationer.
English: Patients less than 12 years
Danish: Patienter under 12 år
English: Treatment should be under the supervision of a physician experienced in the treatment of haemophilia.
Danish: Behandlingen bør superviseres af en læge med erfaring i behandling af hæmofili.
English: If you get any side effects, talk to your doctor or, pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge eller apotekspersonalet.
English: Connect the syringe to BAXJECT II (Fig. d).
Danish: Tilslut sprøjten til BAXJECT II (fig. d).
English: RIXUBIS is used for the treatment and prevention of bleeding in patients with haemophilia B of all age groups.
Danish: RIXUBIS bruges til behandling og forebyggelse af blødning hos patienter i alle aldersgrupper med hæmofili B.
English: During the course of treatment, appropriate determination of factor IX levels is advised to guide the dose to be administered and the frequency of repeated infusions.
Danish: Under behandlingsforløbet anbefales relevant bestemmelse af faktor IX-niveauet som vejledning til den dosis, der skal administreres, og til doseringsintervallet ved gentagne infusioner.
English: Grip the package at its edge and pull the package off BAXJECT II (Fig. b).
Danish: Hold fast i kanten af pakken og fjern emballagen fra BAXJECT II (fig. b).
English: Mannitol Sodium chloride Calcium chloride L-Histidine Polysorbate 80
Danish: Saccharose Mannitol Natriumchlorid Calciumchlorid L-histidin Polysorbat 80
English: There have been reports in the literature showing an association between the occurrence of a factor IX inhibitor and allergic reactions, in particular in patients with a high-risk gene mutation.
Danish: I litteraturen er der rapporter, som viser en forbindelse mellem forekomsten af faktor IX-inhibitor og allergiske reaktioner, især hos patienter med en højrisiko-genmutation.
English: On demand treatment:
Danish: Behandling efter behov:
English: Dose and duration of the substitution therapy depends on the severity of the factor IX deficiency, on the location and extent of the bleeding, and on the patient's clinical condition, age and pharmacokinetic parameters of factor IX, such as incremental recovery and half-life.
Danish: Dosis og substitutionsbehandlingens varighed afhænger af, hvor alvorlig faktor IX-manglen er, af blødningsstedet og -omfanget samt af patientens kliniske tilstand, alder og faktor IX's farmakokinetiske parametre, f.eks. trinvis bedring og halveringstid.
English: Inject intravenously.
Danish: Injicer intravenøst.
English: 19 bleeds were non-joint (soft tissue, muscle, body cavity, intracranial and other) and 7 were joint bleeds of which 1 was a bleed into a target joint.
Danish: 19 blødninger var ikke-ledblødninger (bløddele, muskler, kropshulrum, intrakranielt mv.), og 7 var ledblødninger, hvoraf 1 var blødning i et 'target joint' (led med hyppige blødninger).
English: Contents: 1 powder vial, 1 solvent vial, 1 BAXJECT II device
Danish: Indhold: 1 pulverhætteglas, 1 solvenshætteglas, 1 BAXJECT II-device
English: Cleanse stoppers with alcohol swabs.
Danish: Rens propperne med alkoholservietter.
English: In the case of the following haemorrhagic events, the factor IX activity should not fall below the given plasma activity level (in % of normal or IU/dL) in the corresponding period.
Danish: I tilfælde af følgende blødningsepisoder må faktor IX-aktiviteten ikke falde under det givne plasma-aktivitetsniveau (i % af det normale eller IE/dl) i den tilsvarende periode.
English: The following table can be used to guide dosing in bleeding episodes and surgery:
Danish: Følgende tabel kan bruges som vejledning til dosering ved blødningsepisoder og kirurgiske indgreb:
English: 6.5 Nature and contents of container and special equipment for use
Danish: 6.5 Emballagetype og pakningsstørrelser og specielt udstyr til anvendelse
English: However, no data are available on previously untreated patients as only previously treated patients have been enrolled in the clinical studies; no immunogenicity investigation on inhibitor development was therefore made in this at risk population.
Danish: Der findes imidlertid ingen data fra tidligere ubehandlede patienter, da kun tidligere behandlede patienter er inkluderet i de kliniske studier.
English: Incremental recovery 30 min after infusion (IU/dL: IU/kg)a
Danish: Trinvis bedring 30 min. efter infusio n (IE/dl:IE/kg)
English: What you need to know before you use RIXUBIS
Danish: Det skal du vide, før du begynder at bruge RIXUBIS
English: (IU/dL: IU/kg)
Danish: (IE/dl): IE/kg)
English: To ensure that the desired factor IX activity plasma level has been attained, careful monitoring using an appropriate factor IX activity assay is advised and, if necessary, appropriate adjustments to the dose and the frequency of repeated infusions should be performed.
Danish: For at sikre at den ønskede faktor IX-aktivitet nås, anbefales omhyggelig monitorering af plasmakoncentrationen med en relevant faktor IX-aktivitetsanalyse, og om nødvendigt bør der foretages passende justering af dosis og doseringsinterval ved gentagne infusioner.
English: The use of low purity factor IX products has been associated with instances of myocardial infarction, disseminated intravascular coagulation, venous thrombosis and pulmonary embolism.
Danish: Faktor IX-præparater med lav renhed har været forbundet med tilfælde af myokardieinfarkt, dissemineret intravaskulær koagulation, venøs trombose og lungeemboli.
English: For long-term prophylaxis against bleeding in patients with severe haemophilia B, the usual doses are 40 to 60 IU of factor IX per kilogram of body weight at intervals of 3 to 4 days for patients 12 years and older.
Danish: Til langtidsprofylakse mod blødning hos patienter med svær hæmofili B er de sædvanlige doser 40-60 IE faktor IX pr. kg legemsvægt i intervaller på 3 til 4 dage for patienter på 12 år og derover.
English: An additional 14 PTPs received RIXUBIS for the treatment of bleeding episodes only.
Danish: Derudover fik 14 tidligere behandlede patienter RIXUBIS alene til behandling af blødningsepisoder.
English: Haemostatic efficacy at resolution of bleed was rated excellent or good in 96% of all treated bleeding episodes.
Danish: Den hæmostatiske virkning ved behandling af blødningen blev vurderet som fremragende eller god for 96 % af alle behandlede blødningsepisoder.
English: Stop your infusion and contact your doctor immediately or seek emergency medical care if you experience early signs of hypersensitivity/allergic reactions like hives, rash, tightness of the chest, wheezing, low blood pressure or anaphylaxis (severe allergic reaction that can cause difficulty in swallowing and/or breathing, red or swollen face and/or hands).
Danish: Stop infusionen og kontakt straks lægen eller søg akut lægehjælp, hvis du oplever tidlige tegn på overfølsomhed/allergiske reaktioner som f.eks. nældefeber, udslæt, trykken i brystet, hvæsende vejrtrækning, lavt blodtryk eller anafylaksi (alvorlig allergisk reaktion, der gør det vanskeligt at synke og/eller trække vejret og får ansigt og/eller hænder til at blive røde eller hæve).
English: The recommended initial loading dose of RIXUBIS was to ensure that during surgery, factor IX activity levels of 80-100% for major surgeries and 30-60% for minor surgeries were maintained.
Danish: Den anbefalede startdosis af RIXUBIS skulle sikre, at faktor IX-aktivitetsniveau på 80-100 % ved større kirurgiske indgreb og 30-60 % ved mindre kirurgiske indgreb blev opretholdt.
English: The European Medicines Agency has waived the obligation to submit the results of studies with RIXUBIS in previously untreated patients in the treatment and prophylaxis of bleeding in haemophilia B (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med RIXUBIS hos tidligere ubehandlede patienter ved behandling og profylakse af blødning ved hæmofili B (se pkt.
English: Solvent vial: 5 ml sterilised water for injections.
Danish: Solvenshætteglas: 5 ml vand til injektionsvæsker.
English: One pack contains a powder vial (type I glass) with a stopper (butyl rubber) and a flip-off seal, a vial containing 5 ml solvent (type I glass) with a stopper (chlorobutyl rubber) and a flip-off seal and a needle-less reconstitution device (BAXJECT II).
Danish: En pakke indeholder et hætteglas med pulver (type I-glas) med prop (butylgummi) og vippelåg, et hætteglas med 5 ml solvens (type I-glas) med prop (chlorbutylgummi) og vippelåg og et rekonstitutionsdevice (BAXJECT II) uden nål.