FrancophonIA/ELRC3.0 huggingface dataset:
English: In distribution and excretion studies in mice and rats, the 40 kDa polyethylene-glycol (PEG) moiety of Refixia was shown to be widely distributed to and eliminated from organs, and excreted via plasma in urine (44-56%) and faeces (28-50%).
Danish: Fordelings- og eliminationsstudier hos mus og rotter viste, 40 kDa polyethylenglycol (PEG)molekyledelen af Refixia er bredt distribueret til og elimineres fra organer og udskilles via plasma i urin (44-56%) og fæces (28-50%).
English: Recommended dose IU/kg body weight
Danish: Anbefalet dosis IE/kg legemsvægt
English: Treatment with Refixia will be started by a doctor who is experienced in the care of patients with haemophilia B. Always use this medicine exactly as your doctor has told you.
Danish: Behandling med Refixia skal påbegyndes af en læge, som har erfaring med at behandle patienter med hæmofili B. Brug altid lægemidlet nøjagtigt efter lægens anvisning.
English: No dose adjustment was required for paediatric or adolescent patients in clinical trials.
Danish: Dosisjustering var ikke nødvendig for pædiatriske eller unge patienter i kliniske studier.
English: • Inject the reconstituted solution as instructed by your doctor or nurse.
Danish: • Injicér injektionsvæsken som instrueret af din læge eller sygeplejerske.
English: • In case you only need part of the entire vial, use the scale on the syringe to see how much reconstituted solution you withdraw, as instructed by your doctor or nurse.
Danish: • I tilfælde af at du ikke har brug for hele dosen i hætteglasset, skal du bruge skalaen på sprøjten for at se, hvor meget injektionsvæske du trækker ind i sprøjten, som din læge eller sygeplejerske har anvist.
English: Single-dose pharmacokinetic parameters of Refixia are listed by age in Table 5.
Danish: De farmakokinetiske parametre efter en enkelt dosis Refixia er angivet efter alder i tabel 5.
English: Fifty-four of the patients across all age-groups were treated with a weekly prophylactic dose of 40 IU/kg where 23 (43%) of these patients had no bleeding episodes.
Danish: 54 af patienterne på tværs af alle aldersgrupper blev behandlet med en ugentlig profylaktisk dosis på 40 IE/kg, og 23 (43%) af disse patienter havde ingen blødningsepisoder.
English: Your doctor will do a blood test to check if you have developed inhibitors (neutralising antibodies) against Refixia.
Danish: Din læge vil tage en blodprøve for at kontrollere, om du har dannet inhibitorer (neutraliserende antistoffer) mod Refixia.
English: The procedures included 9 orthopaedic, 1 gastrointestinal, and 3 surgeries in the oral cavity.
Danish: Indgrebene omfattede 9 ortopædiske indgreb, 1 gastrointestinalt indgreb og 3 indgreb i mundhulen.
English: The mean total consumption of Refixia during and after surgery was 241 IU/kg (range: 81-460 IU/kg).
Danish: Det gennemsnitlige totale forbrug af Refixia under og efter indgrebet var 241 IE/kg (interval: 81-460 IE/kg).
English: If you have such antibodies, you may be at an increased risk of sudden and severe allergic reactions (e.g. anaphylactic reaction) during future treatment with factor IX.
Danish: Hvis du har dannet sådanne antistoffer, kan du have en øget risiko for pludselige og alvorlige allergiske reaktioner (f.eks. en anafylaktisk reaktion) ved fremtidige behandlinger med faktor IX.
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 kønsbunden arvelig koagulationssygdom, der skyldes nedsat niveau af faktor IX, og som indebærer kraftige blødninger i led, muskler eller indre organer, enten spontant eller som følge af et tilfældigt eller kirurgisk traume.
English: If you have to significantly increase your usage of Refixia to stop a bleed, talk to your doctor immediately.
Danish: Hvis du er nødt til at bruge betydeligt mere Refixia for at stoppe en blødning, skal du straks kontakte din læge.
English: Unopened
Danish: Uåbnet
English: Table 1 Treatment of bleeding episodes with Refixia
Danish: Tabel 1 Behandling af blødningsepisoder med Refixia
English: • you have risk factors for heart disease e.g high blood pressure, obesity, or smoking.
Danish: • du har risikofaktorer for hjertesygdom, f.eks. forhøjet blodtryk, svær overvægt eller rygning.
English: • Grasp the plunger rod by the wide top end and take it out of the carton.
Danish: • Tag stempelstangen i den brede ende, og tag den ud af kartonen.
English: Allergic reactions and development of inhibitors There is a rare risk that you may experience a sudden and severe allergic reaction (e.g. anaphylactic reaction) to Refixia.
Danish: Allergiske reaktioner og udvikling af inhibitorer Der er en lille risiko for, at du oplever en pludselig og alvorlig allergisk reaktion (f.eks. en anafylaktisk reaktion) over for Refixia.
English: By replacement therapy the plasma levels of factor IX are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
Danish: Ved substitutionsbehandling øges plasmaniveauet af faktor IX, hvorved faktormanglen midlertidigt udbedres, og blødningstendensen afhjælpes.
English: There have been reports in the literature showing a correlation between the occurrence of a factor IX inhibitor and allergic reactions.
Danish: Der har været rapporter i litteraturen, som viste en forbindelse mellem forekomsten af faktor IXinhibitorer og allergiske reaktioner.
English: When comparing the 10 IU/kg and 40 IU/kg treatments, the annualised bleeding rate for patients in the 40 IU/kg arm was found to be 49% lower than the bleeding rate (95% CI: 5%;73%) for patients in the 10 IU/kg arm (p<0.05).
Danish: Ved sammenligning af behandlingerne med 10 IE/kg og 40 IE/kg blev det konstateret, at den årlige blødningsrate for patienter i 40 IE/kg-armen var 49% lavere end blødningsraten (95% CI: 5%; 73%) for patienterne i 10 IE/kg-armen (p<0,05).
English: Refixia is recommended to be used immediately after it has been reconstituted.
Danish: Det anbefales, at Refixia bruges straks efter opblanding.
English: After storage at room temperature the medicine must not be put back in the refrigerator.
Danish: Efter opbevaring ved stuetemperatur må lægemidlet ikke sættes tilbage i køleskab.
English: Injecting the solution via a central venous access device (CVAD) such as a central venous catheter or a subcutaneous port:
Danish: Injektion af injektionsvæsken gennem et udstyr til central venøs adgang (CVAD), såsom et centralt venekateter eller en subkutan port:
English: Because of the potential risk of thrombotic complications, clinical surveillance for early signs of thrombotic and consumptive coagulopathy should be initiated with appropriate biological testing when administering this product to patients with liver disease, to patients post-operatively, to new-born infants, or to patients at risk of thrombotic phenomena or DIC.
Danish: Da der er en potentiel risiko for trombotiske komplikationer, skal klinisk overvågning med passende biologiske test for tidlige tegn på trombotisk og konsumptiv koagulopati initieres, når præparatet administreres til patienter med leversygdom, til patienter postoperativt, til nyfødte børn eller til patienter med risiko for trombotiske fænomener eller dissemineret intravaskulær koagulation (DIC).
English: When you bleed, Refixia is activated in the blood to form factor IX.
Danish: Når du bløder, aktiveres Refixia i blodet og danner faktor IX.
English: Refixia has no influence on the ability to drive and use machines.
Danish: Refixia påvirker ikke evnen til at føre motorkøretøj og betjene maskiner.
English: Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor IX, ATC code: B02BD04.
Danish: Farmakoterapeutisk klassifikation: hæmostatika, blodkoagulationsfaktor IX, ATC-kode: B02BD04.
English: The patients received 1 pre-operative injection of 80 IU/kg on the day of surgery, and post-operatively, injections of 40 IU/kg.
Danish: Patienterne fik 1 præoperativ injektion af 80 IE/kg på operationsdagen og postoperative injektioner på 40 IE/kg.
English: Of the 597 treated bleeds observed in 79 (75%) of the 105 patients, 521 (87%) of the bleeds were resolved with 1 injection and 60 (10%) of the bleeds were resolved with 2 injections of Refixia.
Danish: Ud af de 597 behandlede blødninger, der blev observeret hos 79 af de 105 patienter (75%), blev 521 (87%) af blødningerne stoppet med 1 injektion, og 60 (10%) af blødningerne blev stoppet med 2 injektioner af Refixia.
English: If you stop using Refixia
Danish: Hvis du holder op med at tage Refixia
English: Stop the injection and contact your doctor or an emergency unit immediately if you have signs of an allergic reaction such as rash, hives, weals, itching on large areas of skin, redness and/or swelling of lips, tongue, face or hands, difficulty in swallowing or breathing, shortness of breath, wheezing, tightness of the chest, pale and cold skin, fast heartbeat, and/or dizziness.
Danish: Stop injektionen, og søg omgående læge eller tag på skadestuen, hvis du får tegn på en allergisk reaktion såsom udslæt, nældefeber, hævelse, kløe på store områder af huden, rødme og/eller hævelse af læber, tunge, ansigt eller hænder, synke- eller åndedrætsbesvær, åndenød, hiven efter vejret, trykken for brystet, bleg og kold hud, hurtige hjerteslag (puls) og/eller svimmelhed.
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: Anvendelse af faktor IX-produkter med lav renhed er blevet forbundet med tilfælde af myokardieinfarkt, dissemineret intravaskulær koagulation, venøs trombose og lungeemboli.
English: Type of surgical procedure
Danish: Type af kirurgisk indgreb
English: • Wipe the rubber stopper with a sterile alcohol swab and allow it to air dry for a few seconds before use to ensure that it is as germ free as possible.
Danish: • Tør gummiproppen på hætteglasset af med en steril alkoholserviet, og lad den lufttørre i nogle sekunder før brug for at sikre, at den er så bakteriefri som muligt.
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 with recombinant factor IX products and may in some cases progress to severe anaphylaxis (including shock).
Danish: Overfølsomhedsreaktioner eller allergiske reaktioner (som kan inkludere angioødem, brændende og stikkende fornemmelse ved infusionsstedet, kuldegysninger, ansigtsrødme, generaliseret urticaria, hovedpine, urticaria, hypotension, sløvhed, kvalme, rastløshed, takykardi, trykken for brystet, prikkende fornemmelse i huden, opkastning, hiven efter vejret) har i sjældne tilfælde været observeret med rekombinante faktor IX-produkter og kan i nogle tilfælde føre til svær anafylaksi (herunder shock).
English: Refixia can be used only in adolescents (12 years and above).
Danish: Refixia må kun bruges af unge (på 12 år og derover).
English: • After injection, safely dispose of all unused Refixia solution, the syringe with the infusion set, the vial with the vial adapter and other waste materials as instructed by your pharmacist.
Danish: • Efter injektion kasseres alt ikke anvendt Refixia injektionsvæske, sprøjten med infusionssættet, hætteglasset med hætteglasadapteren samt andet affald, som instrueret af apotekspersonalet.
English: *Pruritus includes the terms pruritus and ear pruritus **Injection site reactions include injection site pain, infusion site pain, injection site swelling, injection site erythema and injection site rash.
Danish: *Pruritus inkluderer termerne pruritus og ørepruritus **Reaktioner på injektionsstedet inkluderer smerter på injektionsstedet, smerter på infusionsstedet, hævelse på injektionsstedet, erytem på injektionsstedet og udslæt på injektionsstedet.
English: Refixia replaces this faulty or missing factor IX and helps blood to form clots at the site of bleeding.
Danish: Refixia erstatter den defekte eller manglende faktor IX og hjælper blodet til at størkne ved blødningsstedet.
English: Rubber stopper (under plastic cap)
Danish: Gummiprop (under plastikhætten)
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the users and would normally not be recommended for longer than 4 hours stored at room temperature (≤ 30°C) or 24 hours in a refrigerator (2°C - 8°C), unless reconstitution has taken place under controlled and validated aseptic conditions.
Danish: Hvis præparatet ikke anvendes straks, er opbevaringstid og opbevaringsforhold brugerens ansvar og anbefales normalt ikke til mere end 4 timer ved stuetemperatur (≤ 30°C) eller 24 timer i køleskab (2°C - 8°C), medmindre rekonstitutionen har fundet sted under kontrollerede og validerede aseptiske forhold.
English: • difficulty in swallowing or breathing
Danish: • besvær med at synke eller med at trække vejret
English: In children aged 0-12 years, the median (IQR) annualised bleeding rate was 1.0 (0.00; 2.06) and the spontaneous bleeding rate was 0.00 (0.00; 0.00).
Danish: Hos børn i alderen 0-12 år var medianværdien (IQR) for den årlige blødningsrate 1,0 (0,00; 2,06), og den spontane blødningsrate var 0,00 (0,00; 0,00).
English: Syringe tip (under syringe cap) Scale
Danish: Sprøjtespids (under sprøjtehætten) Skala
English: If you forget to use Refixia
Danish: Hvis du har glemt at tage Refixia
English: Common Uncommon Common
Danish: Almindelig Ikke almindelig Almindelig
English: • The active substance is nonacog beta pegol (pegylated human coagulation factor IX (rDNA)).
Danish: • Aktivt stof: Nonacog betapegol (pegyleret human koagulationsfaktor IX (rDNA)).
English: Do not use the equipment if it has been dropped, or if it is damaged.
Danish: Anvend ikke udstyret, hvis det har været tabt, eller det er ødelagt.
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 section 4.4).
Danish: I nogle tilfælde er disse reaktioner progredieret til svær anafylaksi, og de er opstået i tæt tidsmæssig sammenhæng med udvikling af faktor IX-inhibitorer (se også pkt.
English: In patients with haemophilia B, factor IX is missing or does not work properly.
Danish: Patienter med hæmofili B mangler faktor IX, eller faktor IX virker ikke korrekt.
English: The European Medicines Agency has deferred the completion of the study with Refixia in previously untreated patients (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat afslutningen af studiet med Refixia hos tidligere ubehandlede patienter (se pkt.
English: For further information, see section 2 “Allergic reactions and development of inhibitors”.
Danish: Se punkt 2 under 'Allergiske reaktioner og udvikling af inhibitorer' for yderligere information.
English: Due to the interference of polyethylene glycol (PEG) in the one-stage clotting assay with various aPTT reagents, it is recommended to use a chromogenic assay (e.g. Rox Factor IX or Biophen) when monitoring is needed.
Danish: Da polyethylenglycol (PEG) interfererer med forskellige aPTT-reagenser i 1-trinskoagulationsanalysen, anbefales det at anvende en kromogenanalyse (f.eks. Rox Factor IX eller Biophen), når monitorering er nødvendig.
English: • Do not use any other way to warm the vial and pre-filled syringe.
Danish: • Anvend ikke andre metoder til at opvarme hætteglasset og den fyldte sprøjte.
English: During the shelf life Refixia may be stored up to 30°C for a single period not exceeding 6 months.
Danish: Inden for opbevaringstiden må Refixia opbevares ved op til 30°C i en enkelt periode, der ikke overstiger 6 måneder.
English: Refixia is administered by intravenous bolus injection over several minutes after reconstitution of the powder for injection with the histidine solvent.
Danish: Refixia administreres som intravenøs bolusinjektion over flere minutter efter rekonstitution af pulveret med histidinsolvensen.
English: Kidney disorder (nephrotic syndrome)
Danish: Nyresygdom (nefrotisk syndrom)
English: What you need to know before you use Refixia
Danish: Det skal du vide, før du begynder at bruge Refixia
English: Catheter-related problems
Danish: Kateterrelaterede problemer
English: • Refixia is provided as a powder and solvent for solution for injection (500 IU, 1000 IU or
Danish: • Refixia leveres som pulver og solvens til injektionsvæske, opløsning (500 IE, 1000 IE eller
English: Contents of the pack and other information What Refixia contains
Danish: Pakningsstørrelser og yderligere oplysninger Refixia indeholder:
English: Cardiovascular event
Danish: Kardiovaskulære hændelser
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 eksponering for faktor IX.
English: Hypersensitivity Anaphylaxis Inhibitors
Danish: Overfølsomhed Anafylaksi Inhibitorer
English: The overall success rate (defined as excellent or good) for treatment of bleeds was 93% (551 out of 591).
Danish: Den overordnede succesrate (defineret som 'meget god' eller 'god') for behandling af blødningerne var 93% (551 ud af 591).
English: Novo Nordisk A/S Brennum Park 25K DK-3400 Hillerød Denmark
Danish: Novo Nordisk A/S Brennum Park 25K DK-3400 Hillerød Danmark
English: All patients assessed in the steady state pharmacokinetic session had factor IX activity levels above 0.24 IU/ml at 168 hours post dosing with a weekly dose of 40 IU/kg.
Danish: Alle patienter vurderet ved steady state i den farmakokinetiske undersøgelse havde faktor IXaktivitetsniveau over 0,24 IE/ml 168 timer efter dosering med en ugentlig dosis på 40 IE/kg.
English: Because of the risk of allergic reactions with factor IX, your initial treatment with Refixia should be given in a medical clinic or in the presence of health care professionals where proper medical care for allergic reactions can be provided if needed.
Danish: På grund af risikoen for allergiske reaktioner med faktor IX bør din første behandling med Refixia gives på en lægeklinik eller under opsyn af sundhedspersonale, så der kan ydes korrekt behandling af allergiske reaktioner, hvis det er nødvendigt.
English: Your doctor may also do a blood test to check if you have developed factor IX inhibitors (neutralising antibodies) against your medicine, as inhibitors may develop together with allergic reactions.
Danish: Din læge kan også tage en blodprøve for at kontrollere, om du har dannet faktor IX-inhibitorer (neutraliserende antistoffer) mod dit lægemiddel, da der kan dannes inhibitorer i forbindelse med allergiske reaktioner.
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 tidlige tegn på overfølsomhedsreaktioner, herunder nældefeber, generaliseret urticaria, trykken for brystet, hiven efter vejret, hypotension og anafylaksi.
English: Injection site reactions**
Danish: Hedeture Reaktioner på injektionsstedet**
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: Hvis central venøs adgang (CVAD) er nødvendig, skal der tages højde for risikoen for komplikationer ved brug af centralt venekateter, herunder lokale infektioner, bakteriæmi og trombose på kateterstedet.
English: Volume of distribution (Vss) (ml/kg)
Danish: Fordelingsvolumen (Vss) (ml/kg)
English: Please record on the carton the date Refixia is removed from the refrigerator and placed at room temperature.
Danish: Notér den dato på kartonen, hvor Refixia tages ud af køleskabet og opbevares ved stuetemperatur.
English: Other medicines and Refixia Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Refixia Fortæl altid lægen, hvis du bruger anden medicin eller har gjort det for nylig.
English: Previously untreated patients The safety and efficacy of Refixia in previously untreated patients have not yet been established.
Danish: Sikkerhed og virkning af Refixia hos patienter, der ikke tidligere er blevet behandlet, er endnu ikke klarlagt.
English: Clearance CL (ml/hour/kg)
Danish: Clearance CL (ml/time/kg)
English: Refixia is not indicated for use in children (below 12 years).
Danish: Refixia er ikke indiceret til brug hos børn (under 12 år).
English: Because of the risk of allergic reactions with factor IX products, 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-produkter bør de initiale administrationer af faktor IX foretages under lægeligt opsyn i henhold til den behandlende læges vurdering, med mulighed for korrekt behandling af allergiske reaktioner.
English: Refixia is now ready to inject into your vein.
Danish: Refixia er nu klar til at blive injiceret i en vene.
English: Mean residence time (MRT) (hours)
Danish: Gennemsnitlig opholdstid (MRT) (timer)
English: • skin reactions at the site of injection
Danish: • hudreaktioner på injektionsstedet.
English: The mean trough levels at steady state are presented in Table 6; based on all pre-dose measurements taken every 8 weeks at steady state for all patients on once weekly dosing of 40 IU/kg.
Danish: De gennemsnitlige dal-niveauer ved steady state er vist i tabel 6 og er baseret på alle prædoseringsmålinger udført hver 8. uge ved steady state for alle patienter, der fik en dosis på 40 IE/kg en gang om ugen.
English: • Remove the protective paper from the vial adapter.
Danish: • Fjern beskyttelsespapiret fra hætteglasadapteren.
English: Each vial of Refixia contains nominally 500 IU, 1000 IU or 2000 IU nonacog beta pegol corresponding to approximately 125 IU/ml, 250 IU/ml or 500 IU/ml respectively after reconstitution with histidine solvent.
Danish: Hvert hætteglas med Refixia indeholder nominelt 500 IE, 1000 IE eller 2000 IE nonacog betapegol svarende til henholdsvis cirka 125 IE/ml, 250 IE/ml eller 500 IE/ml efter opblanding med histidinsolvens.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. it is essentially “sodium-free”.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. hætteglas, hvilket betyder, at det stort set er 'natriumfrit'.
English: PK Parameter 0-6 years N=12
Danish: PK-parameter 0-6 år N=12
English: The trial included one open-label on-demand arm with treatment for approximately 28 weeks and two prophylaxis treatment arms with single-blind randomisation to either 10 IU/kg or 40 IU/kg once-weekly for approximately 52 weeks.
Danish: Studiet omfattede en åben arm med behandling ved behov i cirka 28 uger og to arme med enkeltblindet randomisering til profylaktisk behandling med enten 10 IE/kg eller 40 IE/kg en gang om ugen i cirka 52 uger.
English: If you are in doubt contact your doctor.
Danish: Er du i tvivl så spørg lægen.
English: Area under the curve (AUC)inf (IU*hours/ml)
Danish: Areal under kurven (AUC)inf (IE·timer/ml)
English: Each pack contains: - 1 glass vial (type I) with powder and chlorobutyl rubber stopper - 1 sterile vial adapter for reconstitution - 1 pre-filled syringe of 4 ml histidine solvent with backstop (polypropylene), a rubber plunger
Danish: Hver pakning indeholder: - 1 hætteglas (type I-glas) med pulver og chlorbutylgummiprop - 1 steril hætteglasadapter til rekonstitution - 1 fyldt sprøjte med 4 ml histidinsolvens med en bagstopper (polypropylen), et gummistempel