FrancophonIA/ELRC3.0 huggingface dataset:
English: Hold the syringe upright and push the plunger until no air is left in the syringe.
Danish: Hold sprøjten opret, og tryk på stemplet, indtil der ikke er mere luft i sprøjten.
English: Patients with inhibitors
Danish: Patienter med inhibitorer
English: If you have any questions about this medicine and compatible separate filters, contact your doctor.
Danish: Hvis du har spørgsmål om lægemidlet og om egnede, separate filtre, skal du kontakte lægen.
English: Do not use this medicine if you notice any particles or the solution is cloudy.
Danish: Brug ikke dette lægemiddel, hvis du bemærker partikler, eller hvis opløsningen er uklar.
English: However, during in vitro studies, the chemical and physical in-use stability has been demonstrated for 24 hours at 30°C in PVC bags for continuous infusion.
Danish: Men i in vitro-studier er kemisk og fysisk stabilitet under brug blevet påvist i 24 timer ved 30 °C i PVC-poser til kontinuerlig infusion.
English: KOGENATE Bayer is not likely to affect the fertility in male or female patients, as the active substance is naturally occurring in the body.
Danish: Det er ikke sandsynligt, at KOGENATE Bayer vil påvirke frugtbarheden hos patienter af hverken haneller hunkøn, da det aktive stof forekommer naturligt i kroppen.
English: This is similar to that of plasmaderived factor VIII which has a mean terminal half-life of approx. 13 hours.
Danish: Dette svarer til halveringstiden for plasmaderiveret faktor VIII, som har en gennemsnitlig terminal halveringstid på omkring 13 timer.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERRESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Additional pharmacokinetic parameters for KOGENATE Bayer for bolus injection are: mean residence time [MRT (0-48)] of about 22 hours and clearance of about 160 mL/h.
Danish: Yderligere farmakokinetiske parametre for KOGENATE Bayer til bolusindgift er: en mean residence time [MRT (0 - 48)] på omkring 22 timer og en clerance på omkring 160 ml/time.
English: Patients should be monitored for the development of factor VIII inhibitors.
Danish: Patienten bør overvåges for udvikling af faktor VIII-inhibitorer.
English: The reconstituted solution must be used within 3 hours.
Danish: Den blandede (rekonstituerede) opløsning skal anvendes inden for 3 timer.
English: Data on Immune Tolerance Induction have been collected in patients with haemophilia A who had developed inhibitors to FVIII.
Danish: Data for immuntolerans-induktion er blevet indsamlet hos patienter med hæmofili A, som havde udviklet inhibitorer over for FVIII.
English: Do not touch the syringe tip with your hand or any surface.
Danish: Rør ikke enden på injektionssprøjten eller andre overflader med hænderne.
English: Treatment of congenital haemophilia is currently based on prophylactic or on-demand replacement therapy with coagulation factor VIII (FVIII).
Danish: Behandling af kongenit hæmofili er på nuværende tidspunkt baseret på profylaktisk eller behovsbestemt erstatningsterapi med koagulationsfaktor VIII (FVIII).
English: Follow the directions given by your doctor closely and use the detailed instructions for reconstitution and administration provided at the end of this leaflet.
Danish: Følg din læges anvisninger nøje og brug den detaljerede vejledning i opløsning og anvendelse af lægemidlet i slutningen af denne indlægsseddel.
English: >), the above frequency for PUPs should not be implemented.
Danish: >), bør ovennævnte hyppighed for tidligere ubehandlede patienter ikke anføres.
English: Medical devices for reconstitution and administration are provided with each package of this medicine.
Danish: Medicinsk udstyr til opløsning og anvendelse findes i hver pakke med lægemidlet.
English: Pharmacotherapeutic group: antihemorrhagics: blood coagulation factor VIII, ATC code B02BD02.
Danish: Farmakoterapeutisk klassifikation: Hæmostatika, blodkoagulationsfaktor VIII, ATC-kode: B02B D02.
English: Determine the point of injection, clean the skin with an alcohol swab, and prepare site of injection antiseptically as advised by your doctor.
Danish: Bestem indstiksstedet, rengør huden en spritserviet, og forbered instiksstedet antiseptisk, som din læge har fortalt dig.
English: Further to the assessment of the totality of the responses submitted by the MAH for susoctocog alfa (Obizur), the PRAC is of the opinion that the outcome of this article 31 referral procedure does not apply to this product in view of the indication of Obizur (acquired haemophilia A due to inhibitory antibodies to endogenous FVIII) and the different target population.
Danish: I tilslutning til vurderingen af samtlige besvarelser fra indehaveren af markedsføringstilladelsen for susoctocog alfa (Obizur) er PRAC af den opfattelse, at resultatet af denne artikel 31indbringelsesprocedure ikke bør finde anvendelse på dette produkt på baggrund af indikationen for Obizur (erhvervet hæmofili A som følge af inhibitor-antistoffer mod endogen FVIII) og forskellen i målpopulation.
English: For long term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of KOGENATE Bayer per kg body weight at intervals of 2 to 3 days.
Danish: Ved landtidsforebyggelse af blødninger hos patienter med svær hæmofili A er den sædvanlige dosis på 20-40 IE KOGENATE Bayer pr. kg legemsvægt med 2-3 dages mellemrum.
English: No interactions of KOGENATE Bayer with other medicinal products have been reported.
Danish: Der er ikke rapporteret interaktioner mellem KOGENATE Bayer og andre lægemidler.
English: The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per mL of plasma using the modified assay.
Danish: Dannelsen af neutraliserende antistoffer (inhibitorer) til faktor VIII er en kendt komplikation i behandlingen af individer med hæmofili A. Disse inhibitorer er sædvanligvis IgG-immunglobuliner rettet mod faktor VIII's prokoagulante aktivitet, som kvantificeres i Bethesda Enheder (BE) pr. ml plasma ved brug af den modificerede test.
English: For children not previously treated with Factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients); however patients who have received previous treatment with Factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients).
Danish: Hos børn, som ikke tidligere har været i behandling med faktor VIII-lægemidler, er det meget almindeligt (flere end 1 ud af 10 patienter), at der udvikles inhibitor-antistoffer (se punkt 2), mens hos patienter, som tidligere har modtaget behandling med faktor VIII (flere end 150 behandlingsdage), er risikoen ikke almindelig (færre end 1 ud af 100 patienter).
English: There was also evidence for an increased risk with Refacto AF (another 3rd generation rFVIII) vs Advate, but only for all inhibitor development.
Danish: Der var desuden evidens for højere risiko med Refacto AF (endnu et 3. generations rFVIII) end med Advate, men kun for al inhibitordannelse.
English: Due to very different study methods and patient populations that have been studied over time, and inconsistent findings across studies, the PRAC found that the totality of evidence does not support a conclusion that recombinant factor VIII medicines, as a class, poses a greater risk of inhibitor development than the class derived from plasma.
Danish: På grund af meget forskellige undersøgelsesmetoder og patientpopulationer, som er undersøgt over tid, og de usammenhængende resultater af undersøgelserne fandt PRAC, at evidensen som helhed ikke underbygger en konklusion om, at rekombinante faktor VIII-lægemidler som klasse medfører større risiko for inhibitordannelse end klassen deriveret af plasma.
English: The aPTT is prolonged in all haemophiliacs.
Danish: aPTT er forlænget hos alle hæmofili-patienter.
English: Expert consultation
Danish: Samråd med eksperter
English: Then, strongly press down the fingerplate near the syringe tip using your thumb and index finger (C) until the finger plate meets the top edge of the reconstitution cap (Bio-Set).
Danish: Pres derefter fingerpladen nær sprøjtens spids ned ved at bruge tommel og pegefinger (C) indtil fingerpladen møder topkanten af Bio-Set.
English: Treatment of patients who have developed inhibitors requires careful individual management and can be resistant to therapy.
Danish: Patienter, der har dannet inhibitorer, behøver omhyggelig individuel behandling og kan være behandlingsresistente.
English: • you experience tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing, you may be experiencing a rare severe sudden allergic reaction (a socalled anaphylactic reaction) to this medicine.
Danish: • du får trykken for brystet, bliver svimmel, føler dig syg eller svag, eller bliver svimmel, når du står op, drejer det sig måske om en sjælden, alvorlig, pludseligt opstået allergisk reaktion (en såkaldt anafylaktisk reaktion) over for dette lægemiddel.
English: PRAC discussion on grounds for re-examination
Danish: PRAC's diskussion om begrundelsen for fornyet overvejelse
English: The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current WHO standard for factor VIII products.
Danish: Antallet af indgivne enheder af faktor VIII er udtrykt i Internationale Enheder (IE) i henhold til den gældende WHO-standard for faktor VIII-produkter.
English: Recombinant coagulation factor VIII (octocog alfa)
Danish: Rekombinant koagulationsfaktor VIII (octocog alfa)
English: Many of these studies were small and not specifically designed to evaluate the inhibitor risk in PUPs with severe haemophilia A. The studies were mostly single arm and do not provide data to perform comparative analysis (either between pdFVIII and rFVIII as a class comparison, or within the rFVIII class).
Danish: Mange af disse undersøgelser var små og ikke udformet specielt med henblik på at evaluere risikoen for inhibitordannelse hos tidligere ubehandlede patienter med svær hæmofili A. Undersøgelserne var for størstedelen enkeltarmede og tilvejebringer ikke data til en komparativ analyse (hverken mellem pdFVIII og rFVIII som klassevurdering, eller inden for rFVIIIklassen).
English: 2 plasters
Danish: 2 plastre
English: The statistical concerns include the fact that no pre-specified primary analysis has been published and the fact that the study was stopped early following the publication of the RODIN study indicating that Kogenate FS might be associated with an increased risk of inhibitor formation.
Danish: Forbeholdene vedrørende statistikken består i, at der ikke er offentliggjort en præspecificeret primæranalyse, og at undersøgelsen blev standset tidligt efter offentliggørelsen af RODIN-undersøgelsen som tegn på, at Kogenate FS kan være forbundet med øget risiko for inhibitordannelse.
English: FVIII replacement therapy can be generally categorised into two broad classes of products; plasma derived (pdFVIII) and recombinant (rFVIII) FVIII.
Danish: Produkter til FVIIIerstatningsterapi kan generelt inddeles i to brede grupper: plasmaderiveret FVIII (pdFVIII) og rekombinant FVIII (rFVIII).
English: If you want to stop using KOGENATE Bayer Do not stop using KOGENATE Bayer without consulting your doctor.
Danish: Hvis du holder op med at bruge KOGENATE Bayer Du må ikke holde op med at bruge KOGENATE Bayer uden at rådføre dig med din læge.
English: The study was not designed and powered to generate sufficient product-specific data and, therefore, to draw any conclusions on the risk of inhibitor development for individual products.
Danish: Undersøgelsens design og styrke var ikke beregnet til at generere tilstrækkelige produktspecifikke data og derved drage konklusioner om risikoen for inhibitordannelse med de enkelte produkter.
English: Therefore, KOGENATE Bayer should be used during pregnancy and breast-feeding only if clearly indicated.
Danish: KOGENATE Bayer bør derfor kun anvendes under graviditet og amning på tvingende indikation.
English: Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries.
Danish: De enkelte patienter kan have forskellig respons på faktor VIII, udvise forskellige halveringstider og bedringer.
English: Based on the rare occurrence of haemophilia A in women, experience regarding the use of KOGENATE Bayer during pregnancy and breast-feeding is not available.
Danish: På grund af den sjældne forekomst af hæmofili A hos kvinder er der ingen erfaring med anvendelse af KOGENATE Bayer under graviditet og amning.
English: Therefore, there is a high degree of uncertainty around extrapolating the SIPPET findings to the entire rFVIII class, particularly for more recentlyauthorised rFVIII products which were not included in the SIPPET trial.
Danish: Der er derfor stor usikkerhed forbundet med at ekstrapolere resultaterne af SIPPET til hele rFVIII-klassen, især til senere godkendte rFVIII-produkter, der ikke er omfattet af SIPPET-undersøgelsen.
English: A major complication of FVIII therapy is the occurrence of IgG alloantibodies (inhibitors) that neutralise FVIII activity, causing loss of bleeding control.
Danish: En vigtig komplikation ved FVIII-behandling er dannelse af IgG-alloantistoffer (inhibitorer), som neutraliserer aktiviteten af FVIII, hvorved blødningskontrollen mistes.
English: The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all Factor VIII medicines.
Danish: Udvikling af inhibitorer (antistoffer) er en kendt komplikation, som kan opstå under behandling med alle faktor
English: The MAHs provided an analysis of low and high titre inhibitor development in PUPs with severe haemophilia A (FVIII < 1%) from all clinical trials and observational studies conducted with their products, along with critical discussion on the limitations of these studies.
Danish: Markedsføringstilladelsesindehaverne forelagde en analyse af dannelsen af lav- og højinhibitortiter hos tidligere ubehandlede patienter med svær hæmofili A (FVIII <1%) i alle kliniske forsøg og observationsstudier, der var udført med deres produkter, sammen med en kritisk diskussion af disse undersøgelsers begrænsninger.
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable.
Danish: Specielt ved større kirurgiske indgreb er en nøje overvågning af substitutionsbehandlingen ved hjælp af koagulationsanalyse (faktor VIII-aktiviteten i plasma) et absolut krav.
English: The PRAC considered that as a prospective randomised trial, the SIPPET study avoided many of the design limitations of the observational and registry-based studies undertaken so far to evaluate the risk of inhibitor development in PUPs.
Danish: PRAC fandt, at SIPPET-undersøgelsen i kraft af, at den er en prospektiv, randomiseret undersøgelse, har undgået mange af de designbetingede begrænsninger ved de observationsundersøgelser og registerbaserede undersøgelser, der hidtil er udført til evaluering af risikoen for inhibitordannelse hos tidligere ubehandlede patienter.
English: Importantly, the EU SmPCs do not include modified prophylaxis (as defined in the SIPPET study) as an authorised posology, and the impact of the apparent imbalance in the unspecified other combinations of treatment modality on the SIPPET findings is unclear.
Danish: Det må anses for vigtigt, at den godkendte dosering i EU-produktresuméerne ikke omfatter modificeret profylakse (som defineret i SIPPET-undersøgelsen), og at det er uklart, i hvilket omfang den tilsyneladende uligevægt i de uspecificerede andre kombinationer af behandlingsformer har påvirket resultaterne af SIPPET.
English: For products for which section 4.2 contains the following statement for PUPs: “<Previously untreated patients.
Danish: 4.2 indeholder følgende udsagn vedrørende tidligere ubehandlede patienter: "<Tidligere ubehandlede patienter.
English: Do not use this medicine after the expiry date which is stated on labels and cartons.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen.
English: 2 alcohol swabs for single use
Danish: 2 spritservietter til engangsbrug
English: In May 2016, an open-label, randomised controlled trial aimed at addressing the incidence of inhibitors between the two classes (pdFVIII vs. rFVIII products) was published in the New England Journal of Medicine1.
Danish: I maj 2016 offentliggjordes en åben, randomiseret, kontrolleret undersøgelse til sammenligning af forekomsten af inhibitorer i de to klasser (pdFVIII- og rFVIII-produkter) i New England Journal of Medicine1.
English: Treatment with both pdFVIII and rFVIII can lead to development of inhibitors (tested with the Nijmegen method of the Bethesda assay and defined as ≥0.6 Bethesda units (BU) for “a low titre” inhibitor and >5 BU for a “high-titre” inhibitor).
Danish: Både med pdFVIII og rFVIII kan behandlingen medføre dannelse af inhibitorer (som, ved testning med Nijmegen-metoden i Bethesda-assayet, er defineret som ≥0,6 Bethesda-enheder (BU) for en "lavtiter"-inhibitor og > 5 BU for en "højtiter"-inhibitor).
English: Some experimental studies have suggested a role for VWF in protecting FVIII epitopes from recognition by the antigen-presenting cells, thereby reducing immunogenicity, although this remains theoretical.
Danish: Visse eksperimentelle undersøgelser har peget på, at VWF spiller en rolle ved at beskytte FVIII-epitoper mod at blive genkendt af de antigenpræsenterende celler, hvorved immunogeniciteten mindskes.
English: Reconstitute the desired amount of product, repeating steps 2 - 9, using a new syringe and connect it to the venipuncture set.
Danish: Opløs den krævede mængde lægemiddel og gentag trin 2-9 med en ny sprøjte, som du forbinder til venepunktursættet.
English: Specific studies with repeated administration such as reproduction toxicity, chronic toxicity, and carcinogenicity were not performed with octocog alfa due to the immune response to heterologous proteins in all non-human mammalian species.
Danish: Der er ikke foretaget specifikke studier med gentagen indgift af octocog alfa, for eksempel med henblik på reproduktionstoksicitet, kronisk toksicitet og karcinogenicitet på grund af det immunrespons over for heterologe proteiner, som findes hos alle ikke humane pattedyr.
English: However, in the presence of an inhibitor the doses required are variable and must be adjusted according to clinical response and monitoring of plasma factor VIII activity.
Danish: Hvis der er en inhibitor til stede, varierer den nødvendige dosis imidlertid, og dosis må justeres i forhold til den kliniske respons og overvågningen af aktiviteten i faktor VIII i plasma.
English: KOGENATE Bayer contains sodium
Danish: KOGENATE Bayer indeholder natrium
English: Table 1: Guide for dosing in bleeding episodes and surgery Degree of haemorrhage/
Danish: Tabel 1: Doseringsvejledning ved blødning og kirurgi Blødningsgrad/
English: It is uncertain whether the findings of SIPPET can be extrapolated to the risk of inhibitors in PUPs in current clinical practice in the EU as treatment modality and intensity have been suggested as risk factors for inhibitor development in previous studies.
Danish: Det er usikkert, om resultaterne af SIPPET kan ekstrapoleres til risikoen for inhibitorer hos tidligere ubehandlede patienter ved den nuværende kliniske praksis i EU, eftersom der i tidligere undersøgelser er udtrykt formodning om, at behandlingsform og -intensitet er risikofaktorer for inhibitordannelse.
English: Repeat infusion every 8 to 24 hours until threat is resolved
Danish: Gentag indgiften hver 8. til 24. time, indtil den kritiske tilstand er ophørt.
English: If you have any questions about KOGENATE Bayer and compatible separate filters contact Bayer AG.
Danish: Hvis du har spørgsmål om KOGENATE Bayer og kompatible, separate filtre, skal du kontakte Bayer AG.
English: Therefore, it remains uncertain whether the same differential risk of inhibitor development observed in the SIPPET study would be apparent in patient populations treated in routine care in other countries where the modality of treatment (i.e. primary prophylaxis) is different from that in the study.
Danish: Det er således usikkert, om den forskel i risikoen for inhibitordannelse, der er iagttaget i SIPPET-undersøgelsen, ville ses hos patientpopulationer, der behandles efter rutinen i andre lande med en anden behandlingsform (dvs. primær profylakse) end den, der er anvendt i undersøgelsen.
English: Table 3: Frequency of adverse drug reactions MedDRA
Danish: Tabel 3: Hyppighed af bivirkninger MedDRA standard
English: In this case, this medicine expires at the end of this 12-month period or the expiration date on the product vial, whichever is earlier.
Danish: I dette tilfælde udløber dette lægemiddel ved slutningen af denne 12-måneders periode eller ved udløbsdatoen på hætteglasset, hvis det er en tidligere dato.
English: Mean baseline clearance for 14 adult patients undergoing major surgeries with continuous infusion are 188 mL/h corresponding to 3.0 mL/h/kg (range 1.6-4.6 mL/h/kg).
Danish: Den gennemsnitlige baseline-clearance for 14 voksne patienter, der gennemgik større kirurgiske indgreb med kontinuerlig indgift, var 188 ml/time, hvilket svarer til 3,0 ml/time/kg (variationsbredde 1,6 -4,6 ml/time/kg).
English: In a clinical study about the use of continuous infusion in surgeries, heparin was used to prevent thrombophlebitis at the infusion site as with any other long term intravenous infusions.
Danish: I et klinisk studie vedrørende brugen af kontinuerlig infusion ved kirurgi blev heparin anvendt til at forebygge tromboflebitis på indgiftsstedet som ved enhver anden langvarig intravenøs indgift.
English: One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in one mL of normal human plasma.
Danish: 1 International Enhed (IE) af faktor VIII-aktivitet svarer til indholdet af faktor VIII i 1 ml normal human plasma.
English: Haemorrhage Early haemarthrosis, muscle bleed or oral bleed
Danish: Hæmorrhagi Tidligt hæmartron, muskelblødning eller oral blødning
English: In this study heparin was used to prevent thrombophlebitis at the infusion site as with any other long term intravenous infusions.
Danish: Heparin blev anvendt i studiet til at forebygge tromboflebitis på administrationsstedet som ved enhver anden langvarig intravenøs infusion.
English: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Danish: Parenterale lægemidler skal inspiceres visuelt for partikler og misfarvning før administration.
English: EXP (End of the 12 month period, if stored at room temperature): ........... Do not use after this date.
Danish: EXP (Slutningen af 12-måneders perioden ved opbevaring ved stuetemperatur):………..
English: Finally, apply a small pressure dressing to the injection site and consider if a plaster is necessary.
Danish: Til slut lægges en lille kompressionsforbinding på indstiksstedet, og hvis nødvendigt et plaster.
English: PRAC conclusions
Danish: PRAC's konklusioner
English: If you forget to use KOGENATE Bayer
Danish: Hvis du har glemt at bruge KOGENATE Bayer
English: No case of overdose with recombinant coagulation factor VIII has been reported.
Danish: Der er ikke rapporteret tilfælde af overdosering med rekombinant koagulationsfaktor VIII.
English: For most rFVIII products, newer and more relevant information from clinical trials in PUPs is available.
Danish: For de fleste rFVIII-produkter foreligger der nyere og mere relevante oplysninger fra kliniske forsøg hos tidligere ubehandlede patienter.
English: Swirl vial gently until all material is dissolved (H).
Danish: Drej hætteglasset forsigtigt rundt til alt materiale er opløst (H).