FrancophonIA/ELRC3.0 huggingface dataset:
English: No additives of human or animal origin are used in the cell culture, purification, conjugation, or formulation of Refixia.
Danish: Der anvendes ingen tilsætningsstoffer af human eller animalsk oprindelse i cellekulturen eller ved oprensning, konjugering eller formulering af Refixia.
English: Haemostatic effect of Refixia during surgery was confirmed with a success rate of 100% in the 15 major surgeries in the trials.
Danish: Den hæmostatiske effekt af Refixia under kirurgi blev bekræftet med en succesrate på 100% i de 15 større kirurgiske indgreb i studierne.
English: The completed clinical trial programme included one phase 1 trial and four phase 3 multicentre, noncontrolled trials.
Danish: Det afsluttede kliniske forsøgsprogram omfattede et fase 1-studie og fire ikke-kontrollerede fase 3multicenterstudier.
English: • pale and cold skin, fast heartbeat, and/or dizziness (low blood pressure).
Danish: • bleg og kold hud, hurtige hjerteslag (puls) og/eller svimmelhed (for lavt blodtryk).
English: • Do not touch the rubber stopper with your fingers as this can transfer germs.
Danish: • Rør ikke ved gummiproppen med dine fingre, da dette kan overføre bakterier.
English: Tell your doctor, if any of the following apply to you as there is an increased risk of blood clots during treatment with Refixia:
Danish: Fortæl det til din læge, hvis noget af følgende gælder for dig, da der er øget risiko for blodpropper under behandling med Refixia:
English: • if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for det aktive stof eller et af de øvrige indholdsstoffer i Refixia (angivet i punkt 6).
English: The equipment in this package is designed to reconstitute and inject Refixia.
Danish: Udstyret i denne pakning er beregnet til opblanding og injektion af Refixia.
English: Talk to your doctor immediately if your bleeding does not stop as expected or if you have to significantly increase your usage of Refixia in order to stop a bleed.
Danish: Tal straks med din læge, hvis din blødning ikke stopper som forventet, eller hvis du er nødt til at bruge betydeligt mere Refixia for at stoppe en blødning.
English: The specific activity of Refixia is approximately 152 IU/mg protein.
Danish: Den specifikke aktivitet af Refixia er cirka 152 IE/mg protein.
English: If you stop using Refixia you may no longer be protected against bleeding or a current bleed may not stop.
Danish: Hvis du holder op med at tage Refixia, er du måske ikke længere beskyttet mod blødning eller mod, at en aktuel blødning ikke stopper.
English: The success rate for treatment of bleeding episodes was also independent of whether the bleed was traumatic or spontaneous of nature.
Danish: Succesraten for behandling af blødningsepisoderne var ligeledes uafhængig af, om blødningen var af traumatisk eller spontan karakter.
English: No difference in the safety profile of Refixia was observed between previously treated adolescent (12-18 years) and adult patients.
Danish: Der blev ikke observeret nogen forskel i sikkerhedsprofilen for Refixia mellem tidligere behandlede unge (12-18 år) og voksne patienter.
English: Due to the long half-life of Refixia, the frequency of dosing in the post-surgical period may be extended to once weekly after the first week until bleeding stops and healing is achieved.
Danish: Som følge af den lange halveringstid af Refixia kan doseringshyppigheden i perioden efter det kirurgiske indgreb forlænges til en gang om ugen efter den første uge, indtil blødningen er standset, og heling er opnået.
English: The listed warnings and precautions apply both to adults and adolescents (12-18 years).
Danish: De opførte advarsler og forholdsregler gælder for både voksne og unge (12-18 år).
English: A pre-operative dose of 80 IU/kg Refixia was effective and no patients required additional doses on the day of surgery.
Danish: En præoperativ dosis på 80 IE/kg Refixia var effektiv, og ingen patienter havde behov for yderligere doser på operationsdagen.
English: The number of units of factor IX administered is expressed in International Units (IU), which are related to the current WHO standard for factor IX products.
Danish: Antal administrerede enheder af faktor IX udtrykkes i Internationale Enheder (IE), som er relateret til den nuværende gældende WHO-standard for faktor IX-produkter.
English: Overdoses up to 169 IU/kg have been reported in clinical trials.
Danish: Der er rapporteret overdosering på op til 169 IE/kg i kliniske studier.
English: The potency (International Units) is determined using the European Pharmacopeia one-stage clotting test.
Danish: Potensen (Internationale Enheder) er bestemt ved brug af den Europæiske Farmakopés 1-trinskoagulationstest.
English: Reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to administration.
Danish: Rekonstitueret lægemiddel skal inspiceres visuelt for partikler og misfarvning før administration.
English: Read these instructions carefully before using Refixia.
Danish: Læs denne brugervejledning omhyggeligt, inden du bruger Refixia.
English: Therefore a pre-heating step or a wash-out is recommended in order to ensure detection of low-titre inhibitors.
Danish: Derfor anbefales et forvarmningstrin eller en udvaskning for at sikre påvisning af inhibitorer med lav titre.
English: This finding was not associated with tissue damage or abnormal clinical signs.
Danish: Dette fund var ikke associeret med vævsskader eller unormale kliniske tegn.
English: The dose recommendations in adolescents (12-18 years) are the same as for adults: 40 IU/kg body weight.
Danish: Dosisanbefalingerne for unge (12-18 år) er de samme som for voksne: 40 IE/kg legemsvægt.
English: See “Instructions on how to use Refixia” for more information.
Danish: Se 'Brugervejledning til Refixia' for yderligere information.
English: The dose of Refixia is 40 international units (IU) per kg of body weight.
Danish: Dosis af Refixia er 40 IE (Internationale Enheder) per kg legemsvægt.
English: Activated factor IX, in combination with activated factor VIII, activates factor X. Activated factor X converts prothrombin into thrombin.
Danish: Aktiveret faktor IX, i kombination med aktiveret faktor VIII, aktiverer faktor X. Aktiveret faktor X omdanner protrombin til trombin.
English: Factor IX activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an International Standard for factor IX in plasma).
Danish: Faktor IX-aktiviteten i plasma er udtrykt enten som en procentdel (i forhold til normalt humant plasma) eller i Internationale Enheder (i forhold til den internationale standard for faktor IX i plasma).
English: It is strongly recommended that every time that Refixia is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
Danish: Det anbefales stærkt at notere præparatnavn og batchnummer, hver gang, Refixia administreres til en patient, for at opretholde en forbindelse mellem patienten og lægemidlets batchnummer.
English: When you prepare and inject medicine directly into the veins, it is important to use a clean and germ free (aseptic) technique.
Danish: Når du klargør og injicerer et lægemiddel direkte ind i en vene, er det vigtigt at bruge en ren og bakteriefri (aseptisk) metode.
English: In the clinical trial programme, dose adjustment was not performed.
Danish: I det kliniske forsøgsprogram blev der ikke foretaget dosisjustering.
English: The dose in adolescents is also calculated according to body weight and is the same dose as for adults.
Danish: Dosis til unge beregnes også i forhold til legemsvægt og er den samme som til voksne.
English: There are insufficient data to provide information on inhibitor incidence in previously untreated patients.
Danish: De foreliggende data er ikke tilstrækkelige til at give information om incidenser af inhibitorer hos tidligere ubehandlede patienter.
English: Refixia has a prolonged half-life compared to unmodified factor IX.
Danish: Refixia har en forlænget halveringstid sammenlignet med ikke-modificeret faktor IX.
English: In the post-surgery period Day 1 to 6 and Day 7 to 13, the median number of additional 40 IU/kg doses administered was 2.0 and 1.5, respectively.
Danish: I den postoperative periode fra Dag 1 til 6 og Dag 7 til 13 var det mediane antal yderligere administrerede doser på 40 IE/kg henholdsvis 2,0 og 1,5.
English: As expected, body weight adjusted clearance in paediatric and adolescent patients was higher compared to adults.
Danish: Som forventet var den legemsvægtjusterede clearance hos pædiatriske og unge patienter højere end hos voksne.
English: You must contact your doctor or an emergency unit immediately if you have early signs of an allergic reaction such as:
Danish: Du skal omgående søge læge eller tage på skadestuen, hvis du får tidlige tegn på en allergisk reaktion, såsom:
English: The primary amino acid sequence of the rFIX in Refixia is identical to the Ala148 allelic form of human plasma-derived factor IX.
Danish: Den primære aminosyresekvens af rFIX i Refixia er identisk med Ala148 allel-formen af humant plasmaafledt faktor IX.
English: For Refixia some reagents will cause underestimation (30-50%), while most silica containing reagents will cause severe overestimation of the factor IX activity (more than 400%).
Danish: Nogle reagenser vil medføre en underestimering (30-50%) for Refixia, mens de fleste silicaholdige reagenser vil medføre en markant overestimering af faktor IXaktiviteten (over 400%).
English: • if you are allergic to hamster proteins.
Danish: • hvis du er allergisk over for hamsterproteiner.
English: The rate of administration should be determined by the patient's comfort level up to a maximum injection rate of 4 ml/min.
Danish: Administrationshastigheden bør bestemmes ud fra patientkomfort med en maksimal injektionshastighed på 4 ml/min.
English: No interactions of human coagulation factor IX (rDNA) products with other medicinal products have been reported.
Danish: Der er ikke rapporteret interaktioner mellem human koagulationsfaktor IX-produkter (rDNA) og andre lægemidler.
English: If sudden and severe allergic reactions (e.g. anaphylactic reactions) occur, the injection must be stopped immediately.
Danish: Hvis der forekommer pludselige og alvorlige allergiske reaktioner (f.eks. anafylaktiske reaktioner), skal injektionen straks ophøre.
English: Caution: The pre-filled syringe is made of glass and is designed to be compatible with standard luerlock connections.
Danish: Advarsel: Den fyldte sprøjte er lavet af glas og er designet til at passe sammen med standard luer-lock anordninger.
English: Patients on prophylaxis who forget a dose are advised to take their dose upon discovery and thereafter continue with the usual once weekly dosing schedule.
Danish: Patienter, som får profylakse, og som glemmer en dosis, skal informeres om at tage dosis, når de opdager forglemmelsen, og derefter fortsætte deres sædvanlige doseringsplan med dosering en gang om ugen.
English: The overall success rate for treatment of breakthrough bleeds was 97.1% (67 out of 69 evaluated bleeds).
Danish: Den samlede succesrate for behandling af gennembrudsblødninger var 97,1% (67 ud af 69 evaluerede blødninger).
English: Frequencies have been evaluated according to the following convention: very common (≥ 1/10);
Danish: Hyppigheden er angivet efter følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til
English: The use of high purity factor IX products like Refixia is rarely associated with such adverse reactions.
Danish: Anvendelse af faktor IX-produkter med høj renhed såsom Refixia er sjældent forbundet med sådanne bivirkninger.
English: Tremors have not been reported in the clinical trials.
Danish: Der er ikke rapporteret tremor i de kliniske studier.
English: Do not use the equipment if it has expired.
Danish: Anvend ikke udstyret, hvis det er udløbet.
English: If you have a central venous access device (CVAD), you may develop infections or blood clots at the site of the catheter.
Danish: Hvis du har et centralt venekateter (CVAD), kan du udvikle infektioner eller blodpropper på kateterstedet.
English: • The powder is white to off-white and the solvent is clear and colourless.
Danish: • Pulveret er hvidt eller råhvidt, og solvensen er klar og farveløs.
English: Non-clinical data reveal no concern for humans based on conventional safety pharmacology and repeated dose toxicity studies in rats and monkeys.
Danish: Ikke-kliniske data viser ingen risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi og toksicitet efter gentagne doser hos rotter og aber.
English: Long-term studies in animals to evaluate the carcinogenic potential of Refixia, or studies to determine the effects of Refixia on genotoxicity, fertility, development, or reproduction have not been performed.
Danish: Der er ikke udført langvarige dyrestudier for at evaluere det karcinogene potentiale af Refixia eller studier for at bestemme indvirkning af Refixia på genotoksicitet, fertilitet eller reproduktions- og udviklingstoksicitet.
English: Refixia is supplied as a powder.
Danish: Refixia leveres som et pulver.
English: In a dedicated surgery trial, the efficacy analysis included 13 major surgical procedures performed in 13 previously treated adult and adolescent patients.
Danish: I et dedikeret kirurgistudie omfattede virkningsanalysen 13 større kirurgiske indgreb foretaget hos 13 tidligere behandlede voksne og unge patienter.
English: Treatment should be under the supervision of a physician experienced in the treatment of haemophilia.
Danish: Behandlingen skal foregå under supervision af en læge med erfaring i behandling af hæmofili.
English: A total of 115 previously treated male patients with moderate or severe haemophilia B have been exposed to Refixia for a total of 170 patient years in the completed clinical trials.
Danish: I alt 115 tidligere behandlede mandlige patienter med moderat eller svær hæmofili B blev eksponeret for Refixia i 170 patientår i alt i de afsluttede kliniske studier.
English: Adjustments of doses and administration intervals may be considered based on achieved FIX levels and individual bleeding tendency.
Danish: Justering af dosis og doseringsinterval kan overvejes på basis af opnået FIX-niveau og individuel blødningstendens.
English: Clearance = body weight adjusted clearance; Incremental recovery = incremental recovery 30 min post dosing, Volume of distribution = body weight adjusted volume of distribution at steady state.
Danish: Clearance = legemsvægtjusteret clearance; trinvis bedring = trinvis bedring 30 min. efter dosering; fordelingsvolumen = legemsvægtjusteret fordelingsvolumen ved steady state.
English: • Injecting into a CVAD may require using a sterile 10 ml plastic syringe for withdrawal of the reconstituted solution.
Danish: • Injektion ind i et CVAD kræver muligvis en steril 10 ml plastiksprøjte til optrækning af den opblandede injektionsvæske.
English: This is because if left, the medicine may no longer be sterile and could cause infections.
Danish: Hvis det opbevares, er lægemidlet muligvis ikke længere er sterilt, og dette kan forårsage en infektion.
English: Very rarely development of antibodies to hamster protein with related hypersensitivity reactions has been observed.
Danish: Der har meget sjældent været observeret dannelse af antistoffer mod hamsterprotein med relaterede overfølsomhedsreaktioner.
English: In the absence of compatibility studies, this medicine must not be mixed with other medicinal products or reconstituted with infusion solutions other than the provided histidine solvent.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler eller rekonstitueres med andre infusionsvæsker end den medfølgende histidinsolvens.
English: If your dose requires more than one vial, repeat steps A to J with additional vials, vial adapters and pre-filled syringes until you have reached your required dose.
Danish: Hvis din dosis kræver mere end et hætteglas, gentages trinene A til J med yderligere hætteglas, hætteglasadaptere og fyldte sprøjter, indtil du har blandet den nødvendige dosis.
English: The pivotal trial included 74 adolescent (13-17 years) and adult (18-65 years) previously treated patients.
Danish: Det pivotale studie omfattede 74 unge (13-17 år) og voksne (18-65 år) tidligere behandlede patienter.
English: The risk for developing inhibitors is highest if you have not been treated with factor IX medicines before i.e. for small children.
Danish: Risikoen for at danne inhibitorer er størst, hvis du ikke er blevet behandlet med faktor IX-lægemidler før, f.eks. hos små børn.
English: Refixia is indicated for patients 12 years and above.
Danish: Refixia er indiceret til patienter på 12 år og derover.
English: • Use a clean and germ free (aseptic) technique.
Danish: • Anvend en ren og bakteriefri (aseptisk) metode.
English: Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breastfeeding is not available.
Danish: På grund af den sjældne forekomst af hæmofili B hos kvinder er der ingen erfaring med anvendelse af faktor IX under graviditet og amning.
English: In case of residual FIX activity levels, there is a risk of interference when performing the Nijmegen modified Bethesda assay for inhibitor testing.
Danish: I tilfælde af residualt FIX-aktivitetsniveau,er der risiko for interferens, når den Nijmegen-modificerede Bethesda-analyse udføres for at teste for inhibitorer.
English: Non-interventional post-authorisation safety study (PASS): In order to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other tissues/organs, the MAH should conduct and submit the results of a noninterventional post-authorisation safety study deriving from a registry of Haemophilia patients according to an agreed protocol.
Danish: Ikke-interventionssikkerhedsundersøgelser efter tilladelse til markedsføring (PASS): For at undersøge de potentielle virkninger af PEG akkumulation i choroidea plexus i hjernen og andre væv/organer skal indehaveren af markedsføringstilladelsen udføre og forelægge resultaterne af en ikkeinterventionssikkerhedsundersøgelse efter tilladelse til markedsføring, fra et register med hæmofilipatienter i henhold til en aftalt protokol.
English: Half-life (t1/2) (hours)
Danish: Halveringstid (t1/2) (timer)
English: The long-term safety of Refixia in children below 12 years has not yet been established.
Danish: Den langtidsvarende sikkerhed af Refixia hos børn under 12 år er endnu ikke klarlagt.
English: * Factor IX trough levels = factor IX activity measured prior to next weekly dose (5 to 10 days post dosing) at steady state.
Danish: * Dal (trough)-niveauer af faktor IX = faktor IX-aktivitet målt inden næste ugentlige dosis (5-10 dage efter dosering) ved steady state.
English: Early haemarthrosis, muscle bleeding or oral bleeding.
Danish: Tidlig hæmartrose, muskelblødning eller oral blødning.
English: After repeated treatment with human coagulation factor IX (rDNA) products, patients should be monitored for the development of neutralising antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing.
Danish: Efter gentagen behandling med humane koagulationsfaktor IX-produkter (rDNA) skal patienterne monitoreres for udvikling af neutraliserende antistoffer (inhibitorer), som skal kvantificeres i Bethesda-enheder (BE) ved hjælp af passende biologiske test.
English: • If the CVAD line needs to be flushed before or after Refixia injection, use sodium chloride 9 mg/ml solution for injection.
Danish: • Hvis slangen til CVAD skal skylles igennem enten før eller efter injektion af Refixia, skal du bruge 9 mg/ml natriumchlorid-injektionsvæske.
English: (bromobutyl) and a tip cap with a stopper (bromobutyl) - 1 plunger rod (polypropylene).
Danish: (bromobutyl) og en endekapsel med en prop (bromobutyl) - 1 stempelstang (polypropylen).
English: Do not stop using Refixia without talking to your doctor.
Danish: Du må ikke holde op med at tage Refixia uden først at have talt med din læge om det.
English: Based on modelled data using observed terminal half-lives (1549 days) in rat tissue distribution studies, the 40 kDa polyethylene-glycol (PEG) moiety will reach steady state levels in all human tissues within 1-2 years of treatment.
Danish: Baseret på modellerede data ved brug af observerede terminale halveringstider (15-49 dage) i distributionsstudier med rottevæv vil 40 kDa polyethylenglycol (PEG)molekyledelen nå steady state-niveau i alle humane væv inden for 1-2 års behandling.
English: Pharmacokinetics were investigated in 16 adult and adolescent patients of which 6 were normal weight (BMI 18.5-24.9 kg/m2) and 10 were overweight (BMI 25-29.9 kg/m2).
Danish: Farmakokinetikken blev undersøgt hos 16 voksne og unge patienter, hvoraf 6 var normalvægtige (BMI 18,5-24,9 kg/m2), og 10 var overvægtige (BMI 25-29,9 kg/m2).
English: Do not use Refixia after the expiry date which is stated after “EXP” on the carton and on the vial and the pre-filled syringe labels.
Danish: Brug ikke Refixia efter den udløbsdato, der står på pakningen efter ”EXP” på kartonen og etiketten på hætteglasset og den fyldte sprøjte .
English: A total of 69 (98.6%) of the 70 bleeding episodes were treated with one injection.
Danish: I alt 69 (98,6%) af de 70 blødningsepisoder blev behandlet med én injektion.
English: Use the injection immediately after reconstitution.
Danish: Brug injektionsvæsken straks efter opblanding.
English: An overall assessment of haemostatic efficacy was performed by the patient or caretaker (for home treatment) or study site investigator (for treatment under health care professional supervision) using a 4-point scale of excellent, good, moderate, or poor.
Danish: En samlet vurdering af den hæmostatiske virkning blev foretaget af patienten eller omsorgspersonen (ved hjemmebehandling) eller af forsøgsstedets investigator (ved behandling under supervision af sundhedspersonale) ved hjælp af en 4-punktsskala med mulighederne 'meget god', 'god', 'moderat' eller 'dårlig'.
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-produkter, og risikoen er større for præparater med lav renhed.
English: All pharmacokinetic studies with Refixia were conducted in previously treated patients with haemophilia B (factor IX ≤2%).
Danish: Alle farmakokinetiske studier med Refixia blev udført hos tidligere behandlede patienter med hæmofili B (faktor IX ≤2 %).
English: Three trials of which one trial was a dedicated surgery trial included in total 15 major and 26 minor surgery procedures (patients aged 13 to 56 years).
Danish: Tre studier, hvoraf det ene var et dedikeret kirurgistudie, omfattede i alt 15 større og 26 mindre kirurgiske indgreb (patienter i alderen 13 til 56 år).
English: Allergic type hypersensitivity reactions are possible with Refixia.
Danish: Der er mulighed for allergiske overfølsomhedsreaktioner med Refixia.
English: • Do not mix Refixia with any other intravenous infusions or medications.
Danish: • Bland ikke Refixia med andre intravenøse infusionsvæsker eller lægemidler.
English: Table 2 Treatment in surgery with Refixia
Danish: Tabel 2 Behandling med Refixia i forbindelse med kirurgi
English: For modified long-acting factor products it is known that the one-stage clotting assay results are highly dependent on the aPTT reagent and reference standard used.
Danish: For modificerede langtidsvirkende faktorprodukter er det kendt, at resultaterne af 1-trins-koagulationsanalysen er stærkt afhængige af det aPTT-reagens og den referencestandard, der anvendes.
English: The success rate and dose needed for treatment of the bleeding episodes were independent of the localisation of the bleed.
Danish: Succesraten og den nødvendige dosis til behandling af blødningsepisoderne var uafhængige af blødningsstedet.