FrancophonIA/ELRC3.0 huggingface dataset:
English: 1, 28700 San Sebastian de los Reyes, Madrid Spain
Danish: 1, 28700 San Sebastian de los Reyes, Madrid Spanien
English: This is of importance particularly when changing the laboratory and/or reagents used in the assay.
Danish: Dette er især af betydning, når laboratoriet og/eller de reagenser, der anvendes i analysen, skiftes.
English: If such inhibitors occur, the condition will manifest itself as an insufficient clinical response.
Danish: Hvis sådanne inhibitorer forekommer, vil tilstanden manifestere sig som et utilstrækkeligt klinisk respons.
English: Inadequate therapeutic response*
Danish: Utilstrækkeligt terapeutisk respons*
English: In each of these situations, the benefit of treatment with BeneFIX should be weighed against the risk of these complications.
Danish: I hver af disse situationer bør fordelen ved behandling med BeneFIX afvejes imod risikoen for komplikationer.
English: The contents of the pack are:
Danish: Pakningen indeholder:
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), not known (cannot be estimated from the available data).
Danish: Hyppigheden 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), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Chemical and physical in-use stability has been demonstrated for 3 hours at temperatures up to 25C.
Danish: Den kemiske og fysiske stabilitet efter anbrud er 3 timer ved temperaturer op til 25C.
English: Lot See front label (Lot, Exp.)
Danish: Se forsiden (Lot, EXP)
English: X 1.3 IU/kg
Danish: x 1,3 IE/kg
English: - Allergic reactions are possible.
Danish: Allergiske reaktioner er mulige.
English: Uncommon ≥ 1/1,000 to
Danish: Ikke almindelig ≥1/1.000 til
English: A population pharmacokinetic model was developed using data collected in 73 patients aged 7 months to 60 years.
Danish: En populationsfarmakokinetisk model blev udviklet ud fra data fra 73 patienter i alderen 7 måneder til 60 år.
English: Baseline n = 24 Mean ± SD
Danish: Baseline n = 24 Middel ± SD
English: BeneFIX should be injected intravenously over several minutes.
Danish: BeneFIX skal indsprøjtes intravenøst over adskillige minutter.
English: After cleaning do not touch the rubber stopper with your hand or allow it to touch any surface.
Danish: Efter rensning må du ikke røre gummiproppen med hænderne eller lade den røre nogen overflade.
English: - See your doctor immediately if your bleeding does not stop as expected.
Danish: Kontakt straks din læge, hvis dine blødninger ikke stopper som forventet.
English: Therefore, factor IX should be used during pregnancy and breast-feeding only if clearly indicated.
Danish: Derfor bør faktor IX udelukkende anvendes under graviditet og amning, hvis det er klart indiceret.
English: This should be considered during the preparation and administration of BeneFIX.
Danish: Dette skal overvejes under tilberedning og indgivelse af BeneFIX.
English: BeneFIX must be stored below 30°C and must be used by the expiry date on the label.
Danish: BeneFIX skal opbevares ved temperaturer under 30C, og det skal anvendes før udløbsdatoen på etiketten.
English: Please contact your doctor immediately if you inject more BeneFIX than your doctor recommends.
Danish: Kontakt straks din læge, hvis du har indsprøjtet mere BeneFIX, end din læge har anbefalet.
English: Month 6 n = 23 Mean ± SD
Danish: Måned 6 n = 23 Middel ± SD
English: Administration (Intravenous Injection):
Danish: Indgivelse (intravenøs indsprøjtning):
English: Do not take BeneFIX:
Danish: Tag ikke BeneFIX:
English: Animal reproduction studies have not been conducted with factor IX.
Danish: Reproduktionsforsøg med dyr har ikke været udført med faktor IX.
English: Frequency of doses (hours)/Duration of Therapy (days)
Danish: Dosisfrekvens (timer)/Behandlingens varighed (dage)
English: In the case of shock, the current medical standards for treatment of shock should be observed.
Danish: I tilfælde af shock skal de almindelige medicinske standarder for behandling af chok følges.
English: The specific activity of BeneFIX is not less than 200 IU/mg protein.
Danish: Den specifikke aktivitet af BeneFIX er mindst 200 IE/mg protein.
English: Repeat infusion every 8 to 24 hours until threat is resolved.
Danish: Gentag infusion hver 8. til 24. time, indtil faren er overstået.
English: Clinical studies of BeneFIX did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Danish: Kliniske studier med BeneFIX inkluderede ikke et tilstrækkeligt antal forsøgspersoner på 65 år og derover til at bestemme, hvorvidt de reagerer forskelligt fra yngre forsøgspersoner.
English: This is done by bending the cap up and down until the perforation is broken.
Danish: Dette gøres ved at bøje den op og ned, indtil perforeringen brækker.
English: Nonacog alfa is a purified protein that has 415 amino acids in a single chain.
Danish: Nonacog alfa er et oprenset protein, som har 415 aminosyrer i en enkelt kæde.
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Danish: Thrombin omdanner derefter fibrinogen til fibrin og et koagel dannes.
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 indikeret ved smerte er faldet til ro, eller heling er opnået.
English: Superior vena cava syndrome i,
Danish: Vena cava superiorsyndrom i,
English: Do not stop taking BeneFIX without consulting your doctor.
Danish: Du må ikke stoppe med at bruge BeneFIX uden du har rådført dig med din læge.
English: Mean  SD Pharmacokinetic Parameters Based on Individual Bayes Estimates from Population Pharmacokinetic Analysis
Danish: Gennemsnitlige farmakokinetiske parametre baseret på individuelle Bayes estimater fra populationsfarmakokinetisk analyse
English: Blood should not enter the syringe.
Danish: Der må ikke komme blod i sprøjten.
English: Your doctor may change your recommended infusion rate to make the infusion more comfortable.
Danish: Din læge kan eventuelt ændre den anbefalede indsprøjtningshastighed for at gøre indsprøjtningen mere behagelig.
English: The product may contain traces of hamster proteins (see Do not take BeneFIX).
Danish: Produktet kan indeholde spor af hamsterproteiner (se afsnittet Tag ikke BeneFIX).
English: Do not use this medicine if you notice the solution is not clear or colourless.
Danish: Brug ikke dette lægemiddel, hvis opløsningen ikke er klar og farveløs.
English: The terminal phase has not been covered unambiguously due to lack of data beyond 24 hours in paediatric subjects < 6 years of age.
Danish: Den terminale fase er ikke entydigt belyst på grund af manglende data ud over 24 timer fra pædiatriske patienter under 6 år.
English: - If you suffer from liver or heart disease or if you have recently had surgery, there is an increased risk for blood clotting (coagulation) complications.
Danish: Hvis du lider af en lever- eller hjertesygdom, eller hvis du fornylig er blevet opereret, er der en øget risiko for problemer med at få blodet til at størkne (koagulationskomplikationer).
English: In some cases, these reactions have progressed to severe anaphylaxis.
Danish: I nogle tilfælde har disse reaktioner udviklet sig til alvorlig anafylaksi.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of genotoxicity.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af genotoksicitet.
English: deep vein thrombosis*; thrombosis*; thrombophlebitis*
Danish: dyb venetrombose*; trombose*; tromboflebit*
English: Only the provided infusion set should be used.
Danish: Kun det medfølgende infusionsudstyr må benyttes.
English: • Fast heart rate, low blood pressure
Danish: • Hurtig hjertefrekvens (puls), lavt blodtryk
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: Især ved større kirurgiske indgreb er præcis monitorering af substitutionsbehandling med koagulationsanalyse (plasma faktor IX-aktivitet) absolut nødvendig.
English: • Lack of response to treatment (failure to stop or prevent bleeding episodes)
Danish: • Manglede virkning (kan ikke standse eller forhindre blødninger)
English: Every 24 hours, at least 1 day, until healing is achieved.
Danish: Hver 24. time mindst 1 døgn, indtil heling er opnået.
English: Aseptic technique (meaning clean and germ free) should be used during the reconstitution procedure.
Danish: Aseptisk teknik (det vil sige rent og kimfrit) skal anvendes under hele opblandingsprocessen.
English: Your doctor may advise you to stop treatment with BeneFIX if you are breast-feeding or become pregnant.
Danish: Din læge kan råde dig til at stoppe behandlingen med BeneFIX, hvis du ammer eller bliver gravid.
English: The solution should appear clear and colourless.
Danish: Opløsningen skal være klar og farveløs.
English: The reconstituted product does not contain a preservative and should be used immediately, but no longer than 3 hours after reconstitution.
Danish: Det rekonstituerede produkt indeholder ikke konserveringsmiddel og skal anvendes straks eller ikke senere end 3 timer efter rekonstitution.
English: Therefore if you are known to have such a mutation your doctor may monitor you more closely for signs of an allergic reaction particularly when you first start to take BeneFIX.
Danish: Derfor, hvis du ved, at du har en sådan mutation, kan din læge overvåge dig nøje for tegn på allergiske reaktioner, især når du begynder at bruge BeneFIX for første gang.
English: Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.
Danish: Derfor skal patienter, der har haft allergiske reaktioner, undersøges for tilstedeværelsen af en inhibitor.
English: - The production of factor IX in the body is controlled by the factor IX gene.
Danish: Dannelsen af faktor IX i kroppen kontrolleres af faktor IX genet.
English: Somnolence; tremor
Danish: Søvnighed; tremor
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, you should only take BeneFIX upon specific instructions from your doctor.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du kun tage BeneFIX hvis din læge har sagt det til dig.
English: No investigations on carcinogenicity, fertility impairment and foetal development have been conducted.
Danish: Ingen studier har været foretaget over karcinogenicitet, påvirkningen af fertilitet og fosterudvikling.
English: There is limited documentation of on-demand treatment and surgery in paediatric patients less than 6 years of age treated with BeneFIX.
Danish: Der er begrænset dokumentation for behovsbehandling og kirurgi hos pædiatriske patienter under 6 år, der er i behandling med BeneFIX.
English: • Development of neutralising antibodies (inhibitors)
Danish: • Udvikling af neutraliserende antistoffer (inhibitorer)
English: A summary of pharmacokinetic data is presented in Table 1.
Danish: En oversigt over farmakokinetiske data er vist i skema 1.
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: Baseret på den sjældne forekomst af hæmofili B hos kvinder er erfaring med hensyn til brug af faktor IX under graviditet og amning ikke tilgængelig.
English: The safety and efficacy of using BeneFIX for immune tolerance induction has not been established.
Danish: Sikkerhed og effekt ved anvendelse af BeneFIX til immuntolerance induktion er ikke fastlagt.
English: Your doctor will decide the dose of BeneFIX you will receive.
Danish: Din læge bestemmer hvilken dosis af BeneFIX du vil få.
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Danish: Dosis baseret på legemsvægt kan kræve justering hos undervægtige og overvægtige personer.
English: The effect of BeneFIX on fertility has not been established.
Danish: Virkning af BeneFIX på fertilitet er ikke klarlagt.
English: The treatment required depends on the nature and severity of side-effects (see also “Warnings and precautions”).
Danish: Den krævede behandling afhænger af arten og alvorligheden af bivirkningerne (se også ”Advarsler og forsigtighedsregler”).
English: The cap may need to be replaced (if not administering reconstituted BeneFIX immediately), so set it aside by placing it on its top.
Danish: Kappen skal måske sættes på igen (hvis ikke den færdige opløsning af BeneFIX skal bruges straks), så sæt den til side ved at placere den på toppen.
English: • one plaster
Danish: • et plaster
English: METHOD OF ADMINISTRATION Use the entire contents.
Danish: Anvend hele indholdet.
English: Repeat infusion every 8-24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor IX activity of 30% to 60% (IU/dL)
Danish: Gentagen infusion hver 8. til 24. time indtil tilstrækkelig sårheling, derefter behandling i mindst yderligere 7 dage for at opretholde en faktor IX-aktivitet på 30% til 60% (IE/dl)
English: Pharmacotherapeutic group: Antihaemorrhagics, blood coagulation factor IX; ATC code: B02BD04
Danish: Farmakoterapeutisk klassifikation: antihæmoragisk koagulationsfaktor IX, ATC kode: B02BD04
English: Treatment should be under the supervision of a physician experienced in the treatment of haemophilia.
Danish: Behandlingen bør gennemføres under supervision af en læge med erfaring i behandling af hæmofili.
English: You may notice a difference in the dose you receive if you are changing from a plasma-derived factor IX product to BeneFIX.
Danish: Du vil eventuelt bemærke en forskel i den dosis, du får, hvis du skifter fra et plasmaderiveret faktor IX produkt til BeneFIX.
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Danish: I nedenstående skema er alle bivirkninger anført i henhold til MedDRA-organklassesystemet (SOC og på niveauet for foretrukne termer).
English: In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.
Danish: I nogle tilfælde, især hos yngre patienter, kan kortere doseringsintervaller eller højere doser være nødvendige.
English: Ask your doctor or pharmacist for advice before taking this medicine.
Danish: Spørg din læge eller apotek til råds, før du tager nogen form for medicin.
English: Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved.
Danish: Gentag infusion hver 24. time i 3-4 dage eller mere, indtil smerte og akut skavank er faldet til ro.
English: Therefore, if you experience allergic reactions such as those described above, you should be tested for the presence of an inhibitor.
Danish: Hvis du derfor fornemmer allergiske reaktioner, som dem beskrevet ovenfor, bør du undersøges for tilstedeværelse af en inhibitor.
English: Chest discomfort o;
Danish: Ubehag i brystet o;
English: • two alcohol swabs
Danish: • to alkoholkompresser
English: This dose and duration will depend upon your individual needs for replacement factor IX therapy and how quickly your body uses up factor IX, which will be checked regularly.
Danish: Denne dosis og hvor længe, du skal have den, vil afhænge af dine individuelle behov for tilførsel af faktor IX og hvor hurtigt, din krop bruger faktor IX, hvilket skal undersøges jævnligt.
English: To minimize the possibility of agglutination, it is important to limit the amount of blood entering the tubing.
Danish: For at mindske risikoen for agglutination er det vigtigt at begrænse mængden af blod i slangen.
English: Very rarely development of antibodies to hamster protein with related hypersensitivity reactions has been observed.
Danish: Der er meget sjældent observeret udvikling af antistoffer mod hamsterprotein med relaterede overfølsomhedsreaktioner.
English: - Even in the absence of factor IX inhibitor, higher doses of BeneFIX may be needed than required for other plasma-derived factor IX products that you may have taken previously.
Danish: Selv når faktor IX inhibitor ikke er til stede, kan det være nødvendigt med højere doser af BeneFIX end krævet for andre plasmabaserede faktor IX-produkter, som du måtte have fået tidligere.
English: As with any patient receiving BeneFIX, dose selection for an elderly patient should be individualised.
Danish: Som for alle andre patienter, som får BeneFIX, skal dosis for ældre patienter individualiseres.
English: Note: If you use more than one vial of BeneFIX per infusion, each vial should be reconstituted as per the previous instructions.
Danish: Bemærk: Hvis du anvender mere end et hætteglas BeneFIX per indsprøjtning, skal hvert hætteglas tilberedes ifølge ovenstående instruktioner.
English: Activated factor IX, in combination with activated factor VIII, activates factor X. This results ultimately in the conversion of prothrombin to thrombin.
Danish: Aktiveret faktor IX i kombination med aktiveret faktor VIII aktiverer faktor X. Dette resulterer til slut i omdannelsen af prothrombin til thrombin.
English: The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Danish: Den dosis, der indgives, og administrationshyppigheden skal altid tilpasses den kliniske effekt i det enkelte tilfælde.
English: Treatment failure can occur as a consequence of human coagulation factor IX adsorption to the internal surfaces of some infusion equipment.
Danish: Der kan forekomme mislykket behandling på grund af adsorption af human koagulationsfaktor IX på de indre overflader af noget infusionsudstyr.
English: Degree of haemorrhage/Type of surgical procedure
Danish: Blødningsgrad/Type kirurgisk procedure
English: X reciprocal of observed recovery
Danish: x reciprokke værdi af fundne genfinding
English: BeneFIX 1000 BeneFIX 1500 BeneFIX 2000 BeneFIX 3000
Danish: BeneFIX 250 BeneFIX 500 BeneFIX 1000 BeneFIX 1500 BeneFIX 2000 BeneFIX 3000
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede lægemiddelovervågningsaktiviteter og foranstaltninger, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Number of factor IX IU required
Danish: Antal krævede Faktor IX IE
English: In the case of the following haemorrhagic events, the factor IX activity should not fall below the given plasma activity levels (in % of normal or in IU/dL) in the corresponding period.
Danish: I tilfælde af følgende blødningsepisoder bør faktor IX-aktiviteten ikke falde under de opgivne plasma aktivitetsniveauer (i % af normal eller IE/dl) i den tilsvarende periode.
English: BeneFIX has no influence on the ability to drive or use machines.
Danish: BeneFIX påvirker ikke evnen til at køre bil eller betjene maskiner.
English: A clinically relevant, low responding inhibitor was detected in 1 out of 65 BeneFIX patients (including 9 patients participating only in the surgery study) who had previously received plasmaderived products.
Danish: En klinisk relevant svagt reagerende inhibitor blev fundet hos 1 ud af 65 BeneFIX patienter (heriblandt 9 patienter, som kun deltog i kirurgisk indgreb-studiet), som tidligere havde modtaget plasmafremstillede præparater.
English: If such inhibitors occur, a sign may be an increase in the amount of BeneFIX typically required to treat a bleed and or continued bleeding after treatment.
Danish: Hvis sådanne inhibitorer forekommer, kan et tegn på denne tilstand være, at der er behov for en øget dosis til at behandle en blødning og/eller fortsat blødning efter behandling.
English: The product contains traces of hamster proteins.
Danish: Præparatet indeholder spor af hamsterprotein.
English: Although BeneFIX contains only factor IX, the risk of thrombosis and disseminated intravascular coagulation (DIC) should be recognised.
Danish: Selvom BeneFIX kun indeholder faktor IX, bør risikoen for tromboser og dissemineret intravaskulær koagulation (DIC) erkendes.
English: Pfizer Biofarmacêutica, Sociedade Unipessoal Lda
Danish: Pfizer Biofarmacêutica, Sociedade Unipessoa Lda
English: FIX consumption for routine prophylaxis in 22 evaluable patients was 4607 ( 1849) IU/kg per year and 378 ( 152) IU/kg per month.
Danish: Faktor IX-forbruget til rutinemæssig profylakse hos 22 evaluerbare patienter var 4607 (± 1849) IE/kg pr. år og 378 (± 152) IE/kg pr. måned.
English: Factor IX activity is absent or greatly reduced in patients with haemophilia B and substitution therapy may be required.
Danish: Faktor IX-aktivitet mangler eller er i høj grad reduceret hos patienter med hæmofili B, og substitutionsterapi kan være nødvendig.
English: Your doctor may want to monitor you for inhibitor development (see “Warnings and precautions”).
Danish: Det kan være, at din læge vil overvåge dig for udvikling af inhibitorer (se ”Advarsler og forsigtighedsregler”).
English: Wipe the top of the vial with an alcohol swab provided, or use another antiseptic solution and allow to dry.
Danish: Aftør toppen på hætteglasset med en de medfølgende alkoholkompresser eller anvend en anden antiseptisk opløsning og lad dem tørre.
English: In two open-label studies BeneFIX was found to be safely administered at 100 IU/kg once-weekly.
Danish: I to åbne studier fandt man, at det var sikkert at administrere BeneFIX 100 IE/kg en gang ugentligt.
English: Note: If the solution is not to be used immediately, the syringe cap should be carefully replaced.
Danish: Bemærk: Hvis opløsningen ikke skal bruges straks, skal sprøjtens kappe sættes forsigtigt på igen.
English: BeneFIX may increase the risk of thrombosis (abnormal blood clots) in your body if you have risk factors for developing blood clots, including an indwelling venous catheter.
Danish: BeneFIX kan øge risikoen for blodpropper (unormal blodstørkning) i kroppen, hvis der er risikofaktorer til stede for at udvikle blodpropper, herunder hvis man har fået lagt venekateter.
English: Factor IX is activated by factor VII/tissue factor complex in the extrinsic pathway as well as factor XIa in the intrinsic coagulation pathway.
Danish: Faktor IX aktiveres af faktor VII/vævsfaktor kompleks i "extrinsic pathway" så vel som faktor XIa i "intrinsic coagulation pathway".
English: Abbreviations: AUC∞ = area under the plasma concentration-time curve from time zero to infinity; Cmax = peak concentration; t1/2 = plasma elimination half-life; CL = clearance; SD = standard deviation.
Danish: Forkortelser: AUC∞ = arealet under plasmakoncentrationstidskurven fra tid nul til uendelig, Cmax = højeste koncentration, t1/2 = halveringstid for udskillelse i plasma, CL = clearance, SD = standardafvigelse.
English: No MedDRA 17.1 PT was retrieved.
Danish: Der kunne ikke hentes nogen MedDRA 17.1 foretrukket term.
English: The procedures below are provided as guidelines for the reconstitution and administration of BeneFIX.
Danish: Fremgangsmåden, som gives nedenfor, er retningslinjer for opblanding og indgivelse af BeneFIX.
English: Dose and duration of the substitution therapy depend on the severity of the factor IX deficiency, on the location and extent of bleeding, and on the patient's clinical condition.
Danish: Dosis og varighed af substitutionssbehandlingen afhænger af sværhedsgraden af faktor IX-manglen, af blødningens lokalisation og udbredelsen samt patientens kliniske tilstand.
English: The only documented serious adverse event related with BeneFIX was reported from the only included PUP, who experienced hypersensitivity and inhibitor development.
Danish: Den eneste dokumenterede alvorlige bivirkning relateret til BeneFIX sås hos den eneste PUP, der var inkluderet i studiet, og var overfølsomhed og udvikling af inhibitorer.