FrancophonIA/ELRC3.0 huggingface dataset:
English: One International Unit (IU) of factor IX activity is equivalent to that quantity of factor IX in one mL of normal human plasma.
Danish: En international enhed (IE) af faktor IX-aktivitet er ækvivalent med mængden af faktor IX i én ml normalt humant plasma.
English: Lot Pfizer Europe MA EEIG
Danish: Pfizer Europe MA EEIG
English: It has a primary amino acid sequence that is comparable to the Ala allelic form of plasma-derived factor IX, and some post-translational modifications of the recombinant molecule are different from those of the plasma-derived molecule.
Danish: Det har en primær aminosyresekvens, som er sammenlignelig med Ala allel form af plasmafremstillet faktor IX, og de post-translationelle modifikationer af det rekombinante molekyle ser ud til at være forskellige fra dem med det plasmafremstillede molekyle.
English: In case of severe allergic reactions, alternative therapy should be considered.
Danish: I tilfælde af alvorlige allergiske reaktioner bør alternativ behandling overvejes.
English: Patients known to have major deletion mutations of the factor IX gene should be observed closely for signs and symptoms of acute hypersensitivity reactions, particularly during the early phases of initial exposure to product.
Danish: Patienter, der vides at have omfattende deletionsmutationer i faktor IX-genet, bør observeres tæt for tegn og symptomer på akutte overfølsomhedsreaktioner specielt i de tidlige faser af førstegangseksposition for produktet.
English: However, the half-life of the product (see section 5.2) and the limited pharmacokinetic study data for the once-weekly regimen do not allow recommending this regimen in general for long-term prophylaxis in severe haemophilia B patients.
Danish: 5.2) og de begrænsede data fra farmakokinetiske studier med regimet en gang ugentligt tillader imidlertid ikke, at dette regime anbefales generelt til langtidsprofylakse hos patienter med svær hæmofili B.
English: The following table can be used to guide dosing in bleeding episodes and surgery:
Danish: Følgende doseringsskema kan anvendes som vejledning ved blødningsepisoder og kirurgiske indgreb:
English: It is strongly recommended that every time BeneFIX 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 kraftigt, at præparatets navn og batchnummer registreres, hver gang BeneFIX administreres til en patient, for at opretholde en forbindelse mellem patienten og lægemiddelbatchen.
English: No interactions of human coagulation factor IX (rDNA) products with other medicinal products have been reported.
Danish: Der er ikke rapporteret om interaktioner mellem præparater med human koagulationsfaktor IX (rDNA) og andre lægemidler.
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 erstatningsterapi forøges plasmaniveauerne af faktor IX, som således muliggør midlertidig korrektion af faktormangelen og korrektion af blødningstendenserne.
English: • Dizziness, altered taste
Danish: • Svimmelhed, ændret smagssans
English: If you stop taking BeneFIX
Danish: Hvis du holder op med at bruge BeneFIX
English: In patients with existing cardiovascular risk factors, substitution therapy with FIX may increase the cardiovascular risk.
Danish: Hos patienter med eksisterende kardiovaskulære risikofaktorer kan substitutionsbehandling med BeneFIX øge den kardiovaskulære risiko.
English: In younger patients, shorter dosage intervals or higher doses may be necessary.
Danish: Hos yngre patienter kan kortere doseringsintervaller eller højere doser være nødvendige.
English: BeneFIX, when reconstituted, contains polysorbate-80, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC).
Danish: Rekonstitueret BeneFIX indeholder polysorbat-80, der vides at forøge hastigheden af di-(2ethylhexyl)phtalat (DEHP) ekstraktion fra polyvinylchlorid (PVC).
English: - If you are allergic to hamster proteins.
Danish: hvis du er allergisk over for hamsterproteiner.
English: The frequencies are based on all causality treatment emergent adverse events in pooled clinical trials with 224 subjects.
Danish: Hyppighederne er baseret på alle opståede bivirkninger med kausal sammenhæng med behandlingen i de samlede kliniske forsøg med i alt 224 deltagere.
English: You can use one of the peel-off labels found on the vial to document the batch number in your diary or for reporting any side effects.
Danish: Du kan bruge en af de aftagelige etiketter, der sidder på hætteglasset, til at dokumentere batchnummeret i din dagbog eller i en indberetning af eventuelle bivirkninger.
English: Hypersensitivity/allergic reactions
Danish: Overfølsomhed/allergiske reaktioner
English: Slowly draw back all the solution into the syringe.
Danish: Træk langsomt hele opløsningen tilbage i sprøjten.
English: Side effects with unknown frequency (frequency cannot be estimated from the available data)
Danish: Bivirkninger, hvis hyppighed ikke er kendt (hyppigheden kan ikke beregnes ud fra tilgængelige data):
English: • Vision impairment (including blurred vision, appearance of spots/lights)
Danish: • Synsnedsættelse (inklusive sløret syn og forekomst af prikker/lyspletter)
English: Efficacy analysis in study 3090A1-301-WW was based on 22 evaluable paediatric subjects on prophylaxis regimen including 4 on-demand patients who shortly changed to prophylaxis.
Danish: Effektanalysen i studie 3090A1-301-WW var baseret på 22 evaluerbare pædiatriske patienter i forebyggende behandling, inklusive 4 behovsbehandlede patienter, der en kort overgang også var i forebyggende behandling.
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 der iværksættes klinisk overvågning for tidlige tegn på trombotisk koagulopati og DIC med passende biologisk test, ved indgivelse af dette produkt til patienter med leversygdom, til patienter postoperativt, til nyfødte eller til patienter med risiko for trombotisk fænomen eller DIC.
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 blodkoagulation som følge af mindskede niveauer af faktor IX og resulterer i store blødninger i led, muskler eller indre organer, enten spontant eller som resultat af ulykker eller kirurgisk indgreb.
English: • Chest discomfort (including chest pain)
Danish: • Ubehag i brystet (inklusive brystsmerter)
English: Recombinant coagulation factor IX is a recombinant DNA-based protein therapeutic which has structural and functional characteristics comparable to endogenous factor IX.
Danish: Rekombinant koagulationsfaktor IX er terapeutisk et rekombinant DNA-baseret protein, som har strukturelle og funktionelle karakteristika sammenlignelige med endogen faktor IX.
English: = body weight (in kg) X desired factor IX increase (%) or (IU/dL)
Danish: = legemsvægt (kg) x ønsket faktor IX-forøgelse (%) eller (IE/dl)
English: Known allergic reaction to hamster proteins.
Danish: Kendt allergisk reaktion over for hamsterproteiner.
English: Individual patients may vary in their response to factor IX, demonstrating different half-lives and recoveries.
Danish: Enkelte patienter kan afvige i deres respons over for faktor IX og udvise forskellige halveringstider og bedringsrater.
English: This patient was able to continue treatment with BeneFIX with no anamnestic rise in inhibitor or anaphylaxis (see section 4.4).
Danish: Denne patient var i stand til at fortsætte behandlingen med BeneFIX uden nogen stigning af inhibitor eller anafylaksi i anamnesen (se pkt.
English: The number of units of factor IX administered is expressed in International Units (IU), which is related to the current WHO standard for factor IX products.
Danish: Antallet af indgivne enheder faktor IX er udtrykt i internationale enheder (IE), som har relation til den gældende WHO standard for faktor IX-produkter.
English: BeneFIX should be administered at a slow infusion rate.
Danish: BeneFIX bør indgives med en lav infusionshastighed.
English: Close monitoring of factor IX plasma activity should be performed as clinically indicated, as well as calculation of pharmacokinetic parameters such as recovery and half-life, in order to adjust doses as appropriate.
Danish: Omhyggelig monitorering af faktor IX-plasma-aktivitet bør udføres efter kliniske retningslinjer så vel som beregning af farmakokinetiske parametre som genfinding og halveringstid med henblik på passende dosisjustering.
English: Strength of BeneFIX per ml prepared solution
Danish: BeneFIX's styrke pr. ml færdig opløsning
English: No side effects have been reported in association with this observation.
Danish: Der har ikke været rapporteret bivirkninger i forbindelse med denne iagttagelse.
English: Pharmacokinetic Parameter Estimates for BeneFIX (75 IU/kg) at Baseline and Month 6 in Previously Treated Patients with Haemophilia B
Danish: Estimater for armakokinetiske parametre for BeneFIX (75 IE/kg) ved baseline og 6 måneder hos tidligere behandlede patienter med hæmofili B Parameter
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 er udtrykt enten som en procent (relativt til normal human serum) eller i internationale enheder (relativt til en international standard for faktor IX-plasma).
English: The calculation of the required dose of BeneFIX can be based on the finding that one unit of factor IX activity per kg body weight is expected to increase the circulating level of factor IX, an average of 0.8 IU/dL (range from 0.4 to 1.4 IU/dL) in patients  12 years (further information in section 5.2).
Danish: Beregning af den nødvendige dosis BeneFIX kan baseres på den erfaring, at én enhed af faktor IXaktivitet per kg legemsvægt forventes at forøge det cirkulerende niveau af faktor IX med et gennemsnit på 0,8 IE/dl (interval fra 0,4 til 1,4 IE/dl) hos patienter ≥ 12 år (se pkt.
English: EXP Use immediately or within 3 hours of reconstitution.
Danish: EXP Anvendes straks eller inden for 3 timer efter rekonstitution.
English: Your doctor may decide to change the dose of BeneFIX you receive during your treatment.
Danish: Din læge kan beslutte at ændre dosis af BeneFIX, som du vil få under behandlingen.
English: • Hypersensitivity/allergic reactions
Danish: • Overfølsomhedsreaktioner/allergiske reaktioner
English: Recombinant coagulation factor IX is a single chain glycoprotein with an approximate molecular mass of 55,000 Daltons that is a member of the serine protease family of vitamin K-dependent coagulation factors.
Danish: Rekombinant koagulationsfaktor IX er et enkeltkædet glykoprotein med en molekylemasse på cirka 55.000 Daltons som er en del af serin protease familien af vitamin K afhængige koagulationsfaktorer.
English: The solvent syringe should be removed, leaving the vial adapter in place, and a separate large luer lock (a device that connects the syringe to the vial) syringe may be used to draw back the reconstituted contents of each individual vial.
Danish: Sprøjten med opløsningsmiddel skal fjernes, så adapteren til hætteglasset er på plads, og en separat stor luer-locksprøjte (som forbinder sprøjten med hætteglasset) kan bruges til at trække det færdige indhold fra hvert hætteglas op.
English: The rate of administration should be determined by the patient's comfort level.
Danish: Indgivelseshastigheden bør bestemmes ud fra patientens velbefindende.
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 har disse reaktioner udviklet sig til svær anafylaksi, og de er forekommet i tæt tidsmæssig forbindelse med udvikling af faktor IX-inhibitorer (se også pkt.
English: There are insufficient data to provide information on inhibitor incidence in PUPs (see also section 5.1).
Danish: Der er utilstrækkelige data til at give information om forekomst af inhibitorer hos PUP'er (se også pkt.
English: The final solution should be inspected visually for fine particles before administration.
Danish: Den færdige opløsning undersøges visuelt for små partikler inden indgivelse.
English: Inadequate factor IX recovery p,
Danish: Utilstrækkelig faktor IX-bedringsrate p,
English: - After reconstitution with the supplied solvent (0.234% sodium chloride solution), each vial contains 50, 100, 200, 300, 400 or 600 IU/ml (see Table 1).
Danish: Efter opløsning i det medfølgende opløsningsmiddel (0,234% natriumchlorid) indeholder hvert hætteglas 50, 100, 200, 300, 400 eller 600 IE/ml (se tabel 1).
English: Preliminary information suggests a relationship may exist between the presence of major deletion mutations in a patient's factor IX gene and an increased risk of inhibitor formation and of acute hypersensitivity reactions.
Danish: Præliminære oplysninger tyder på, at der kan være en sammenhæng mellem tilstedeværelsen af omfattende deletionsmutationer i en patients faktor IX-gen og en øget risiko for inhibitordannelse og for akutte overfølsomhedsreaktioner.
English: BeneFIX may be administered for long term prophylaxis against bleeding in patients with severe haemophilia B. In a clinical study for routine secondary prophylaxis the average dose for previously treated patients (PTP) was 40 IU/kg (range 13 to 78 IU/kg) at intervals of 3 to 4 days.
Danish: BeneFIX kan gives som langtidsforebyggelse til patienter med alvorlig hæmofili B. I et klinisk studie for rutinemæssig sekundær forebyggelse var den gennemsnitlige dosis for tidligere behandlede patienter (PTP) 40 IE/kg (interval 13 til 78 IE/kg) med intervaller på 3 til 4 dage.
English: Other sterile disposable syringes may be used for administration.
Danish: Andre sterile engangssprøjter kan anvendes til indsprøjtning.
English: Rash k; urticaria
Danish: Udslæt k; urticaria
English: Haemorrhage Early haemarthrosis, muscle bleeding or oral bleeding
Danish: Tidlige hæmartroser, muskulær blødning eller oral blødning
English: BeneFIX is an injectable clotting (coagulation) factor IX product that is produced by recombinant DNA technology.
Danish: BeneFIX er et koagulationsfaktor IX produkt til indsprøjtning, der er fremstillet ved rekombinant DNA-teknologi.
English: Dizziness; Dysgeusia
Danish: Hovedpine d Svimmelhed; dysgeusi
English: Allergic reactions may occur together with the development of factor IX inhibitor (see also “Warnings and precautions”).
Danish: Allergiske reaktioner kan forekomme sammen med udvikling af faktor IX-inhibitor (se også ”Advarsler og forsigtighedsregler”).
English: Patients who have specific mutations of their factor IX gene such as major deletion may be more likely to develop an inhibitor to factor IX and/or experience allergic reactions.
Danish: Patienter, der har specifikke mutationer i deres faktor IX-gen, f.eks. omfattende deletionsmutationer, kan have større sandsynlighed for at udvikle en hæmmer af faktor IX og/eller få allergiske reaktioner.
English: In case of severe allergic reactions, alternative haemostatic measures should be considered.
Danish: I tilfælde af alvorlige allergiske reaktioner bør alternative hæmostatiske tiltag overvejes.
English: • Infusion-site reaction (including itching and redness at the infusion site), infusion-site pain and discomfort
Danish: • Reaktioner på injektionsstedet (inklusive kløe og rødme på infusionsstedet), smerter og ubehag på infusionsstedet
English: As one PTP treated with BeneFIX developed a clinically relevant low responding inhibitor during clinical studies and experience on antigenicity with recombinant factor IX is still limited, patients treated with BeneFIX should be carefully monitored for the development of factor IX inhibitors that should be titrated in Bethesda Units using appropriate biological testing.
Danish: Eftersom en PTP'er behandlet med BeneFIX, udviklede en klinisk relevant svagt reagerende inhibitor i et klinisk studie og fordi erfaringen med rekombinant faktor IX's antigenicitet er begrænset, skal patienter i BeneFIX-behandling nøje monitoreres for udviklingen af faktor IX-inhibitorer, som bør titreres i Bethesda enheder ved anvendelse af passende biologisk test.
English: Allergic-type hypersensitivity reactions are possible with BeneFIX.
Danish: Allergiske overfølsomhedsreaktioner er mulige med BeneFIX.
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 behandlingen tilrådes det at bestemme niveauet af faktor IX med passende intervaller for at fastlægge dosis, og hvor hyppigt infusionen skal gentages.
English: BeneFIX is used for the treatment and prevention of bleeding in patients with haemophilia B (congenital factor IX deficiency) in all age groups.
Danish: BeneFIX anvendes til behandling og forebyggelse af blødning hos patienter med hæmofili B (medfødt faktor IX mangel) i alle aldersgrupper.
English: The table lists adverse reactions reported in the clinical trials of previously treated patients and identified in postmarketing use.
Danish: Skemaet viser bivirkninger, som blev rapporteret i kliniske studier med tidligere behandlede patienter, og bivirkninger, som blev identificeret efter markedsføring.
English: Sufficient data have not been obtained from clinical studies on the treatment of previously untreated patients (PUPs) with BeneFIX.
Danish: Der er ikke opnået tilstrækkelige resultater fra kliniske studier med behandling af tidligere ubehandlede (PUP'er) med BeneFIX.
English: • Renal infarct (interruption to the blood supply to the kidney)
Danish: • Vævsdød i nyren (på grund af afbrydelse af blodforsyningen til nyren)
English: Use the reconstituted solution immediately or within 3 hours.
Danish: Anvend det opløste produkt straks eller i løbet af 3 timer.
English: BeneFIX can cause harm to an unborn baby when given to pregnant women.
Danish: Det vides ikke, om BeneFIX kan skade fosteret, når det gives til gravide kvinder.
English: People who are born with haemophilia B (Christmas disease) lack sufficient factor IX to control bleeding.
Danish: Personer, der er født med hæmofili B (Christmas sygdom) mangler tilstrækkelig med koagulationsfaktor IX til at kunne stoppe blødning.
English: There is a potential risk of thromboembolic episodes following the administration of factor IX products, see section 4.4.
Danish: Der er en potentiel risiko for tromboemboliske episoder efter administration af faktor IX-præparater, se pkt.
English: Two patients underwent surgical procedures (circumcision and port-a-catheter insertion).
Danish: 2 patienter blev opereret (omskæring og indsættelse af centralt venekateter).
English: In addition, the solution should be withdrawn from the vial using the vial adapter.
Danish: Endvidere skal opløsningen trækkes ud af hætteglasset ved anvendelse af hætteglasadapteren.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid til lægen eller på apoteket, hvis du bruger anden medicin eller har gjort det for nylig.
English: The active ingredient in BeneFIX is nonacog alfa.
Danish: Det aktive stof i BeneFIX er nonacog alfa.
English: Tel. +3705 2514000
Danish: Lietuvoje Tel. +3705 2514000
English: BeneFIX works by replacing factor IX in haemophilia B patients to enable their blood to clot.
Danish: BeneFIX virker ved at tilføre faktor IX hos hæmofili B-patienter for at gøre deres blod i stand til at størkne.
English: Mean dosage ( standard deviation) for prophylaxis was 63.7 ( 19.1) IU/kg at intervals of 3 to 7 days.
Danish: Den gennemsnitlige profylaktiske dosis var 63,7 (± 19,1) IE/kg med intervaller på 3-7 dage.
English: Agglutination of red blood cells in the tube/syringe There have been reports of agglutination of red blood cells in the tube/syringe with the administration of BeneFIX.
Danish: Agglutination af røde blodceller i slanger/sprøjter Der har været rapporter om agglutination af røde blodceller i slangen/sprøjten i forbindelse med indgivelse af BeneFIX.
English: • one sterile infusion set
Danish: • et sterilt infusionssæt
English: Very common side effects (may affect more than 1 in 10 people)
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 patienter):
English: Because the use of BeneFIX by continuous infusion has not been evaluated, BeneFIX should not be mixed with infusion solutions or be given in a drip.
Danish: Da anvendelsen af BeneFIX ved kontinuert infusion ikke har været undersøgt, bør BeneFIX ikke blandes i infusionsopløsninger eller gives i drop.
English: Treatment monitoring
Danish: Monitorering under behandling
English: - Sufficient data have not been obtained from clinical studies on the treatment of previously untreated patients (patients who have never received a previous infusion of factor IX), with BeneFIX.
Danish: Der er ikke tilstrækkelige oplysninger fra kliniske studier om behandling af tidligere ubehandlede patienter (patienter, som aldrig har fået indsprøjtet faktor IX) med BeneFIX.
English: Patients should follow the specific venipuncture procedures provided by their doctor.
Danish: Patienterne bør følge den specifikke vejledning for venepunktur, som er foreskrevet af lægen.
English: Inhibitors are an uncommon event in previously treated patients (PTPs) receiving factor IX-containing products.
Danish: Inhibitorer er en ikke almindelig hændelse hos tidligere behandlede patienter (PTP'er), som får produkter indeholdende faktor IX.
English: Potentially life-threatening anaphylactic reactions (severe allergic reactions) have occurred with factor IX products, including BeneFIX.
Danish: Potentielt livstruende anafylaktiske reaktioner (alvorlige allergiske reaktioner) er set med faktor IX-produkter, inklusive BeneFIX.
English: Recombinant coagulation factor IX is a glycoprotein that is secreted by genetically engineered mammalian cells derived from a Chinese hamster ovary (CHO) cell line.
Danish: Rekombinant koagulationsfaktor IX er et glykoprotein som er udskilt fra genetisk fremstillede pattedyrsceller fra en kinesisk hamsteræggestok (CHO) cellelinje.
English: Since the use of factor IX complex concentrates has historically been associated with the development of thromboembolic complications, the use of factor IX-containing products may be potentially hazardous in patients with signs of fibrinolysis and in patients with disseminated intravascular coagulation (DIC).
Danish: Da anvendelse af faktor IX-komplekskoncentrater har været historisk forbundet med udviklingen af tromboemboliske komplikationer, kan anvendelsen af præparater, der indeholder faktor IX, være potentielt risikabelt hos patienter med tegn på fibrinolyse og hos patienter med DIC.
English: - If you are allergic to nonacog alfa or any of the other ingredients of this medicine (listed in section 6).
Danish: hvis du er allergisk over for nonacog alfa eller et af de øvrige indholdsstoffer i BeneFIX (angivet i pkt.
English: In addition, pharmacokinetic parameters were followed up in 23 of the same patients after repeated administration of BeneFIX for six months and found to be unchanged compared with those obtained at the initial evaluation.
Danish: Desuden blev farmakokinetiske parametre fulgt op hos 23 af de samme patienter efter gentagen administration af BeneFIX i seks måneder.