FrancophonIA/ELRC3.0 huggingface dataset:
English: You can also report side effects directly to your national medicines regulator, using the reporting system in your country.
Danish: Du kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale indberetningssystem.
English: Visit your national medicines regulator at: www.mhra.gov.uk (United Kingdom) www.imb.ie (Ireland) www.medicinesauthority.gov.mt (Malta)
Danish: www.laegemiddelstyrelsen.dk
English: All medicines are carefully monitored after they are placed on the EU market.
Danish: ”Dette lægemiddel er underlagt supplerende overvågning.” Alle lægemidler overvåges nøje, efter at de er bragt på markedet i EU.
English: Repeat every 24 hours.
Danish: Gentag hver 24. time.
English: It is not known whether they respond differently from younger subjects.
Danish: Det vides ikke, om de reagerer anderledes end yngre personer.
English: Use immediately.
Danish: Bruges straks.
English: The product dissolves rapidly (within 2 minutes).
Danish: Præparatet opløses hurtigt (inden for 2 minutter).
English: See tables below.
Danish: Se tabellerne nedenfor.
English: If not coinciding with week 26 visit.
Danish: Hvis dette ikke falder sammen med uge 26-besøget.
English: Tel.: +800 66838470
Danish: Tlf.: +800 66838470
English: Volume of distribution at steady state
Danish: Fordelingsvolumen ved steady state.
English: Required units
Danish: Krævede enheder
English: Uferstraße 15
Danish: Uferstrasse 15
English: Proceed with the next injection as scheduled and continue as advised by your doctor.
Danish: Fortsæt med den næste injektion som planlagt og fortsæt derefter som anvist af lægen.
English: At study completion/ termination b
Danish: Ved studiets af- slutning/ studieophør b
English: Your doctor may need to treat you promptly for these reactions (see section 2 ‘Warnings and precautions').
Danish: Lægen kan finde det nødvendigt at behandle dig for disse reaktioner med det samme (se punkt 2 ‘Advarsler og forsigtighedsregler').
English: In each of these situations, the benefit of treatment with RIXUBIS should be weighed against the risk of these complications.
Danish: I hvert enkelt tilfælde skal fordelen ved behandling med RIXUBIS vejes op imod risikoen for disse komplikationer.
English: Pack size of 1.
Danish: Pakningsstørrelse på 1 sæt.
English: In such cases, it is recommended that a specialised haemophilia centre be contacted.
Danish: I sådanne tilfælde anbefales det, at et specialiseret hæmofilicenter kontaktes.
English: You or somebody else might also administer RIXUBIS as an injection but only after receiving adequate training.
Danish: Du eller en anden person kan også indgive RIXUBIS som injektion, men kun efter at have fået tilstrækkelig oplæring.
English: Your doctor may need to treat you promptly for these reactions.
Danish: Lægen kan finde det nødvendigt at behandle dig for disse reaktioner med det samme.
English: Please, contact your doctor immediately if you experience such signs.
Danish: Kontakt straks lægen, hvis du oplever sådanne symptomer.
English: Hypersensitivity a)
Danish: Overfølsomhed a)
English: Common a) ADR explained in the section below.
Danish: Almindelig a) Bivirkningen er forklaret i afsnittet nedenfor.
English: Your doctor will decide the dose of RIXUBIS you will receive.
Danish: Din læge afgør, hvilken dosis RIXUBIS du skal have.
English: A-2304 Orth an der Donau Austria
Danish: A-2304 Orth an der Donau Østrig
English: Haemophilia B very rarely occurs in women.
Danish: Hæmofili B optræder meget sjældent hos kvinder.
English: All patients were dosed based on their most recent individual incremental recovery.
Danish: Alle patienter fik doser, der var baseret på deres seneste individuelle trinvise bedring.
English: Therefore if you are known to have such a mutation, your doctor will monitor you more closely for signs of an allergic reaction.
Danish: Hvis det er kendt, at du har en sådan mutation, vil lægen derfor overvåge dig tættere for tegn på en allergisk reaktion.
English: If such inhibitors occur, the condition will manifest itself as an insufficient clinical response.
Danish: Hvis sådanne inhibitorer forekommer, vil tilstanden vise sig ved utilstrækkeligt klinisk respons.
English: Factor IX should be used during pregnancy and breast-feeding only if clearly indicated.
Danish: Faktor IX bør kun bruges under graviditet og amning, hvis det er klart indiceret.
English: The osmolality is greater than 240 m osmol/kg.
Danish: Osmolaliteten er større end 240 m osmol/kg.
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. hætteglas, dvs. det er stort set ”natriumfrit”.
English: Frequency of doses (hours)/Duration of therapy (days)
Danish: Doseringsfrekvens (timer)/ Behandlingsvarighed (dage)
English: Paediatric population (previously treated patients younger than 12 years)
Danish: Pædiatrisk population (tidligere behandlede patienter under 12 år)
English: Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Danish: Hyppighed, type og sværhedsgrad af bivirkninger hos børn forventes at være det samme som hos voksne.
English: Patients undergoing major surgeries had to perform a pharmacokinetic (PK) evaluation.
Danish: Patienter, der fik foretaget større kirurgiske indgreb, skulle gennemføre en farmakokinetisk (PK) vurdering.
English: As for all patients, dose selection for an elderly patient should be individualised.
Danish: Som for alle andre patienter bør dosis til en ældre patient bestemmes individuelt.
English: If you stop using RIXUBIS Do not stop using RIXUBIS without consulting your doctor.
Danish: Hvis du holder op med at bruge RIXUBIS Du må ikke stoppe med at bruge RIXUBIS uden at have rådført dig med lægen.
English: Frequencies have been evaluated according to the following convention: very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppighed er vurderet i henhold til følgende konvention: meget almindelig (1/10), almindelig (1/100 til < 1/10), ikke almindelig (1/1.000 til <1/100), sjælden (1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: In case of self-administration or administration by a caregiver appropriate training is needed.
Danish: I tilfælde af selvadministration eller administration af en omsorgsperson er relevant oplæring nødvendig.
English: Posology is the same in adults and paediatric population from 12 to 17.
Danish: Dosering er den samme hos voksen og pædiatrisk population fra 12 til 17 år.
English: 17 procedures, including 10 dental extractions, were considered minor.
Danish: 17 procedurer, herunder 10 tandudtrækninger, blev anset for mindre indgreb.
English: Every 24 hours, at least 1 day, until healing is achieved.
Danish: Hver 24. time, mindst 1 dag, indtil heling er opnået.
English: The effects of higher than recommended doses of RIXUBIS have not been characterised.
Danish: Virkningen af doser, der er højere end de anbefalede RIXUBIS-doser, er ikke blevet karakteriseret.
English: This is of importance particularly when changing the laboratory and/or reagents used in the assay.
Danish: Dette er af særlig vigtighed, når der skiftes laboratorium og/eller ændres på de reagenser, der anvendes i analysen.
English: Whenever possible, please record the name of the product and the batch number every time you use RIXUBIS (e.g. in your diary) to keep track of the products and product batches you have used.
Danish: Når det er muligt, skal du registrere præparatets navn og batchnummer, hver gang du bruger RIXUBIS (f.eks. i din dagbog) for at holde styr på de præparater og produktionsbatcher, du har brugt.
English: Swirl gently until all material is dissolved.
Danish: Sving forsigtigt, indtil alt stof er opløst.
English: Date of first authorisation: 19 December 2014 Date of latest renewal: DD month YYYY
Danish: Dato for første markedsføringstilladelse: 19. december 2014 Dato for seneste fornyelse: DD måned ÅÅÅÅ
English: Side effects with unknown frequency (frequency cannot be estimated from the available data) - allergic reactions (hypersensitivity).
Danish: Bivirkninger, hvor hyppigheden ikke er kendt (hyppigheden kan ikke vurderes ud fra tilgængelige data) - allergiske reaktioner (overfølsomhed).
English: Adult population
Danish: Voksen population
English: In case of shock, standard medical treatment for shock should be implemented.
Danish: I tilfælde af shock skal gældende klinisk standard for shockbehandling iværksættes.
English: Talk to your doctor immediately if your bleeding does not stop as expected or if you experience a significant increase in your usage of RIXUBIS in order to control a bleed.
Danish: Kontakt straks lægen, hvis en blødning ikke stopper som forventet, eller hvis du oplever en betydelig stigning i brugen af RIXUBIS for at kontrollere en blødning.
English: Adverse reactions Frequency per Patient
Danish: Hyppighed pr. patient
English: If you suffer from liver or cardiac disease or if you have recently had major surgery, please inform your doctor, as there is an increased risk for blood clotting (coagulation) complications.
Danish: Hvis du lider af en lever- eller hjertesygdom, eller hvis du for nylig har gennemgået en større operation, skal du fortælle det til lægen, da der er en øget risiko for komplikationer med dannelse af blodpropper (koagulation).
English: There are no or limited amount of data from the use of Factor IX in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra brug af faktor IX til gravide kvinder.
English: Thrombin then converts fibrinogen into fibrin and a clot is formed.
Danish: Trombin omdanner derefter fibrinogen til fibrin, og der dannes et koagel.
English: The data demonstrate that the incremental recovery is consistent over time across all paediatric age groups.
Danish: Dataene viser, at den trinvise bedring er konsistent over tid i alle pædiatriske aldersgrupper.
English: The data demonstrate that the incremental recovery is consistent over time (see table below).
Danish: Dataene viser, at den trinvise bedring er konsistent over tid (se tabellen nedenfor).
English: If you injected more RIXUBIS than recommended, tell your doctor as soon as possible.
Danish: Hvis du har injiceret mere end den anbefalede dosis RIXUBIS, skal du fortælle det til lægen hurtigst muligt.
English: The product contains traces of hamster proteins.
Danish: Præparatet indeholder spor af hamsterproteiner.
English: Animal reproduction studies have not been conducted with factor IX.
Danish: Der er ikke udført reproduktionsstudier hos dyr med faktor IX.
English: RIXUBIS is indicated in patients of all age groups.
Danish: RIXUBIS er indiceret til patienter i alle aldersgrupper.
English: Clinical studies of RIXUBIS did not include subjects aged 65 and over.
Danish: Kliniske studier af RIXUBIS har ikke omfattet personer på 65 år og derover.
English: Fertility There is no information on the effects of factor IX on fertility.
Danish: Fertilitet Der findes ingen data om virkningen af faktor IX på fertilitet.
English: Twenty procedures were major including 13 orthopaedic and 3 dental surgeries.
Danish: Der var 20 større procedurer, herunder 13 ortopædiske og 3 dentale indgreb.
English: Reconstituted medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
Danish: Rekonstituerede lægemidler skal inspiceres visuelt for partikler og misfarvning før administration.
English: At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Danish: Mindst 1 dag, indtil blødningsepisoden kendetegnet ved smerter er ophørt, eller heling er opnået.
English: Degree of haemorrhage/Type of surgical procedure
Danish: Blødningsgrad/type af kirurgisk procedure
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Danish: Skemaet nedenfor er klassificeret efter MedDRA-systemorganklasser (systemorganklasse og foretrukken term).
English: Haemostasis was maintained throughout the study duration.
Danish: Hæmostase blev opretholdt under hele studiets varighed.
English: The contents of the pack are:
Danish: Pakken indeholder:
English: It is a vitamin K-dependent coagulation factor and it is synthesised in the liver.
Danish: Det er en K-vitamin-afhængig koagulationsfaktor, der syntetiseres i leveren.
English: Treatment was individualised based on the severity, cause and site of bleed.
Danish: Behandlingen blev tilpasset individuelt på basis af sværhedsgrad, årsag og blødningssted.
English: After reconstitution, the solution is clear, colourless, free from foreign particles and has a pH of 6.8 to 7.2.
Danish: Den rekonstiturede injektionsvæske er klar, farveløs, fri for fremmede partikler og har en pH-værdi på 6,8 til 7,2.
English: This should be taken into consideration if you are on a controlled sodium diet.
Danish: Det skal tages i betragtning, hvis du er på en natriumkontrolleret diæt.
English: Only plastic luer-lock syringes should be used with this product.
Danish: Der bør kun anvendes luer-lock-sprøjter af plastik sammen med dette præparat.
English: For intravenous use, single use only.
Danish: Til intravenøs anvendelse, kun til engangsbrug.
English: These may include heart attack, blood clots in the veins or blood clots in the lung.
Danish: Disse kan omfatte hjerteanfald, blodpropper i venerne eller blodpropper i lungerne.
English: Do not refrigerate the preparation after reconstitution.
Danish: Præparatet må ikke nedkøles efter rekonstitution.
English: The following side effects have been observed with RIXUBIS:
Danish: Følgende bivirkninger er set med RIXUBIS:
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates and published on the European medicines web-portal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene for fremsendelse af PSUR´er for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: The specific activity of RIXUBIS is approximately 200-390 IU/mg protein.
Danish: RIXUBIS' specifikke aktivitet er ca. 200-390 IE/mg protein.
English: Factor IX is a single chain glycoprotein with a molecular mass of about 68,000 Dalton.
Danish: Faktor IX er et enkeltkædet glykoprotein med en molekylemasse på ca. 68.000 Dalton.
English: Continuous infusion Do not administer RIXUBIS by continuous infusion.
Danish: Kontinuerlig infusion RIXUBIS må ikke administreres som kontinuerlig infusion.
English: Factor IX is a normal constituent of human blood necessary for effective blood clotting.
Danish: Faktor IX er en normal bestanddel af menneskers blod og er nødvendig for at blodet kan størkne effektivt.
English: Subjects were randomised to one of two blood sampling sequences to reduce the burden of frequent blood draws on the individual subjects.
Danish: Forsøgspersonerne blev randomiseret til én af to blodprøvetagningssekvenser for at reducere byrden med hyppig blodprøvetagning for de enkelte forsøgspersoner.
English: This should be taken into consideration if the patient is on a controlled sodium diet.
Danish: Dette skal tages i betragtning hvis patienten er på en natriumkontrolleret diæt.
English: Repeat infusion every 8 to 24 hours until threat is resolved.
Danish: Gentag infusionen hver 8.-24. time, indtil faren er ovre.
English: Of the 249 bleeding episodes, the majority (211; 84.7%) were treated with 1-2 infusions.
Danish: Af de 249 blødningsepisoder blev størstedelen (211; 84,7 %) behandlet med 1-2 infusioner.
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Danish: Ved dosering basereret på kropsvægt kan justering være nødvendig hos under- og overvægtige patienter.
English: Incorrect dosing can occur as a consequence of human coagulation factor IX adsorption to the internal surfaces of some infusion equipment.
Danish: Forkert dosering kan forekomme som følge af adsorption af human koagulationsfaktor IX til de indre overflader i noget infusionsudstyr.
English: The use of high purity factor IX is rarely associated with such adverse reactions.
Danish: Faktor IX med høj renhed er sjældent forbundet med sådanne bivirkninger.
English: It works by replacing the missing factor IX to enable the patient's blood to clot.
Danish: Det virker ved at erstatte den manglende faktor IX, så patientens blod kan størkne.
English: Incremental recovery 30 min after infusion
Danish: Trinvis bedring 30 min. efter infusion
English: - For administration the use of a luer-lock syringe is required.
Danish: - Til administration skal der anvendes en luer-lås-sprøjte.
English: • one BAXJECT II (needle-less reconstitution device)
Danish: • et BAXJECT II-device (opblandingsenhed uden nål)
English: Common side effects (may affect up to 1 in 10 patients) - altered taste - pain in limbs.
Danish: Almindelige bivirkninger (kan ses hos op til 1 ud af 10 patienter) - ændret smagssans - smerter i arme og ben.
English: RIXUBIS contains sodium
Danish: RIXUBIS indeholder natrium
English: If you forget to use RIXUBIS
Danish: Hvis du har glemt at bruge RIXUBIS
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 (rDNA)-præparater og andre lægemidler.
English: Do not use RIXUBIS if the solution is not clear and colourless.
Danish: RIXUBIS må ikke anvendes, hvis opløsningen ikke er klar og farveløs.
English: Very rarely development of antibodies to hamster protein with related hypersensitivity reactions has been observed.
Danish: I meget sjældne tilfælde er der observeret udvikling af antistoffer mod hamsterprotein med relaterede overfølsomhedsreaktioner.
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor IX activity) is indispensable.
Danish: Ved større kirurgiske indgreb er præcis monitorering af substitutionsbehandlingen ved hjælp af koagulationsanalyse (faktor IX-aktivitet i plasma) uundværlig.
English: The subjects received either of the products as a single intravenous infusion.
Danish: Forsøgspersonerne fik et af præparaterne som én enkelt intravenøs infusion.
English: Area under the plasma concentration-time curve from time 0 to infinity.
Danish: Arealet under plasmakoncentration-tids-kurven fra tiden 0 til uendelig.
English: Turn the package over and insert the clear plastic spike through the solvent stopper.
Danish: Vend pakken rundt og stik den gennemsigtige plastikspids gennem proppen på solvenshætteglasset.
English: It is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line.
Danish: Det er fremstillet ved rekombinant DNA-teknologi i en cellelinje fra kinesiske hamstres ovarier.
English: RIXUBIS Initial cross-over study (N=25)
Danish: RIXUBIS Indledende crossover-studie (N=25)
English: Breast-feeding It is unknown whether Factor IX/metabolites are excreted in human milk.
Danish: Amning Det vides ikke, om faktor IX/metabolitter udskilles i human brystmælk.
English: From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt bør præparatet anvendes omgående, medmindre rekonstitutionsmetoden udelukker mikrobiel kontaminering.
English: Adverse Drug Reactions, from clinical trials and spontaneous reports MedDRA Standard System Organ Class
Danish: Bivirkninger fra kliniske forsøg og spontane rapporter Systemorganklasser i henhold til MedDRA
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: På grund af den potentielle risiko for trombotiske komplikationer skal klinisk overvågning for tidlige tegn på trombose og konsumptionskoagulopati under anvendelse af relevant biologisk testning initieres, når dette præparat administreres til patienter med leversygdom, til patienter postoperativt, til nyfødte og til patienter med risiko for trombotisk fænomen eller DIC.
English: However, depending on your body weight and your dose of RIXUBIS, you could receive more than one vial.
Danish: Afhængigt af din kropsvægt og din dosis af RIXUBIS kan du imidlertid få mere end ét hætteglas.
English: The production of factor IX in the body is controlled by the factor IX gene.
Danish: Produktionen af faktor IX i kroppen styres af faktor IX-genet.
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: Be sure that RIXUBIS is completely dissolved, otherwise not all reconstituted solution will pass through the device filter.
Danish: Kontrollér, at RIXUBIS er fuldstændigt opløst, ellers vil ikke al den rekonstituerede opløsning passere gennem enhedens filter.
English: Patients aged 12 to 17 years of age:
Danish: Patienter i alderen 12 til 17 år:
English: Repeat infusion every 24 hours for 3 - 4 days or more until pain and acute disability are resolved.
Danish: Gentag infusionen hver 24. time i 3-4 dage eller mere, indtil smerte og akut funktionsindskrænkning er forsvundet.
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: Antallet af faktor IX-enheder, som administreres, udtrykkes i internationale enheder (IE), der er relateret til den aktuelle WHO-standard for faktor IX-produkter.
English: Invert the system (the vial with the reconstituted solution has to be on top).
Danish: Vend systemet om (hætteglasset med den rekonstituerede injektionsvæske skal være øverst).
English: By replacement therapy the plasma levels of factor IX is increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
Danish: Ved substitutionsterapi øges plasmaniveauet af faktor IX, hvorved der opnås en midlertidig korrektion af faktormanglen og afhjælpning af blødningstendenserne.
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 human koagulationsfaktor IX (rDNA)-præparater skal patienterne monitoreres for udvikling af neutraliserende antistoffer (inhibitorer), der bør kvantificeres i Bethesda-enheder (BE) under anvendelse af relevante biologiske test.
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-aktivitet i plasma udtrykkes enten som en procentdel (i forhold til normalt humant plasma) eller i internationale enheder (i forhold til en international standard for faktor IX i plasma).
English: Problems from exaggerated blood clotting (thromboembolic episodes) have not been observed with this product, but may occur with any factor IX products.
Danish: Problemer med overdreven blodstørkning (tromboemboliske episoder) er ikke observeret med dette præparat, men kan forekomme med andre faktor IX-præparater.