FrancophonIA/ELRC3.0 huggingface dataset:
English: KOGENATE Bayer is used for treatment and prophylaxis of bleeding in adults, adolescents and children of all ages with haemophilia A (congenital factor VIII deficiency).
Danish: KOGENATE Bayer anvendes til behandling og profylakse af blødning hos voksne, unge og børn i alle aldre med blødersygdommen hæmofili A (medfødt faktor VIII-mangel).
English: The SIPPET study was an open-label, randomized, multi-centre, multi-national trial investigating the incidence of neutralising allo-antibodies in patients with severe congenital haemophilia A (plasma FVIII concentration<1%) with either the use of pdFVIII or rFVIII concentrates.
Danish: SIPPET-undersøgelsen var en åben, randomiseret multinational multicenterundersøgelse af forekomsten af neutraliserende alloantistoffer hos patienter med svær kongenit hæmofili A (FVIIIkoncentration i plasma <1 %) ved anvendelse af enten pdFVIII- eller rFVIII-koncentrat.
English: 60 % (0.6 IU/mL) 1.8 40 % (0.4 IU/mL) 1.2
Danish: 100% (1 IE/ml) 60% (0,6 IE/ml) 40% (0,4 IE/ml)
English: Required IU = body weight (kg) × desired factor VIII rise (% of normal) × 0.5 II.
Danish: Nødvendig IE = legemsvægt (kg) × den ønskede faktor VIII-stigning (% af normal) × 0,5
English: Even doses several fold higher than the recommended clinical dose (related to body weight) failed to demonstrate any acute or subacute toxic effects for KOGENATE Bayer in laboratory animals (mouse, rat, rabbit, and dog).
Danish: Selv doser, der er adskillige gange større end den anbefalede kliniske dosis (relateret til legemsvægt) viste ingen akutte eller subakutte toksiske virkninger for KOGENATE Bayer hos dyr (mus, rotter, kaniner og hunde).
English: How much KOGENATE Bayer you should use and how often you should use it depends on many factors such as:
Danish: Det afhænger af mange faktorer, hvor meget KOGENATE Bayer, du skal anvende, og hvor ofte:
English: Infusion rate (in IU/kg/h) = Clearance (in mL/h/kg) × desired factor VIII level (in IU/mL)
Danish: Indgiftshastigheden (i IE/kg/time) = Clearance (i ml/time/kg) × ønsket faktor VIII-niveau (i IE/ml).
English: The potency (IU) is determined using the one-stage clotting assay against the FDA Mega standard which was calibrated against WHO standard in International Units (IU).
Danish: Potensen (IE) er bestemt ved en 1-trins koagulationganalyse i henhold til FDA Mega-standard, som er kalibreret i henhold til WHO's standard i Internationale Enheder (IE).
English: Example: for a 75 kg patient with a clearance of 3 mL/h/kg, the initial infusion rate would be 3 IU/h/kg to achieve a FVIII level of 100%.
Danish: Eksempel: Ved en patient, der vejer 75 kg og har en clearance på 3 ml/time/kg, vil den initiale infusionstighed være 3 IE/time/kg for at opnå et FVIII-niveau på 100%.
English: The speed of administration should be based on your comfort, but should not be faster than 2 mL per minute.
Danish: Indsprøjtningshastigheden bør afstemmes efter dit velbefindende, men må ikke være hurtigere end 2 ml/min.
English: This should be considered for a continuous infusion administration.
Danish: Dette bør tages i betragtning ved kontinuerlig indgift.
English: The group also agreed that specific data about frequency of inhibitors for each product should not be included in the SmPC as the available studies are not adequately powered to draw precise conclusions on the absolute frequency for each product or on the relative frequency of inhibitors between products.
Danish: Gruppen fandt desuden, at der ikke bør angives specifikke data om hyppigheden af inhibitorer i produktresuméet for hvert produkt, da de foreliggende undersøgelser ikke har tilstrækkelig styrke til, at der kan drages præcise konklusioner om den absolutte hyppighed for hvert produkt eller om den relative hyppighed af inhibitorer for forskellige produkter.
English: Sodium chloride Calcium chloride Histidine Polysorbate 80 Sucrose
Danish: Natriumchlorid Kalciumchlorid Histidin Polysorbat 80 Saccharose
English: When you must withdraw blood before an infusion, use an administration set without a filter, then infuse this medicine through an injection filter.
Danish: Når du skal udtage blod før infusion, skal du anvende et administrationssæt uden filter og dernæst infundere lægemidlet gennem et injektionsfilter.
English: If the inhibitor is present at levels less than 10 Bethesda Units (BU) per mL, administration of additional recombinant coagulation factor VIII may neutralise the inhibitor and permit continued clinically effective therapy with KOGENATE Bayer.
Danish: Hvis inhibitoren er til stede med niveauer på mindre end 10 Bethesda Enheder (BE) pr. ml, kan indgift af yderligere rekombinant koagulationsfaktor VIII muligvis neutralisere inhibitoren og tillade fortsat klinisk effektiv behandling med KOGENATE Bayer.
English: In patients with inhibitor titres above 10 BU or with high anamnestic response, the use of (activated) prothrombin complex concentrate (PCC) or recombinant activated factor VII (rFVIIa) preparations has to be considered.
Danish: Hos patienter med inhibitor-titre på over 10 BE eller med en høj anamnestisk respons må man overveje brugen af (aktiveret) prothrombinkompleks-koncentrat (PCC) eller rekombinant aktiveret faktor VII (rFVIIa)-præparater.
English: FVIII Inhibition (PTPs)*
Danish: Inhibering af faktor VIII (PTPs)*
English: The experts also agreed that the degree of immunogenicity of different products was adequately described overall with the amendments to the SmPC proposed by the PRAC highlighting the clinical relevance of inhibitor development (in particular low compared to high titre inhibitors), as well as the frequency of ‘very common' in PUPs and ‘uncommon' in PTPs.
Danish: Blandt eksperterne var der desuden enighed om, at graden af forskellige produkters immunogenicitet overordnet var tilstrækkeligt beskrevet med de af PRAC foreslåede ændringer af produktresuméet, der fremhæver den kliniske relevans af inhibitordannelse (især lavtiter- vs. højtiter-inhibitorer) samt hyppigheden "meget almindelig" hos tidligere ubehandlede patienter og "ikke almindelig" hos tidligere behandlede patienter.
English: Elevation of FVIII levels following administration, in particular with existing cardiovascular risk factors, might put a patient into the same risk for vessel closure or myocardial infarction as for the non-haemophilic population.
Danish: En stigning i FVIII-niveauerne efter administration kan, især hos patienter, der allerede har kardiovaskulære risikofaktorer, give patienten mindst den samme risiko for karokklusion eller myokardieinfarkt som den del af befolkningen, der ikke har hæmofili.
English: Set the syringe aside for further use.
Danish: Sæt injektionssprøjten til side til senere brug.
English: The additional points of clarification provided by the SIPPET authors do not fully resolve this uncertainty.
Danish: Denne usikkerhed ophæves ikke helt af de supplerende præciseringer, der er givet af SIPPETforfatterne.
English: It has been shown in a clinical study performed with adult haemophilia A patients who undergo a major surgery that KOGENATE Bayer can be used for continuous infusion in surgeries (pre-, during and postoperative).
Danish: Et klinisk studie med voksne hæmofili A-patienter, som gennemgik et større kirurgisk indgreb, har vist, at KOGENATE Bayer kan administreres som kontinuerlig infusion ved kirurgi (præ-, per- og postoperativt).
English: Infusion rate for 75 kg patient mL/h
Danish: Indgiftshastighed i ml/time for patient på 75 kg
English: Human coagulation factor VIII is produced by recombinant DNA technology (rDNA) in baby hamster kidney cells containing the human factor VIII gene.
Danish: Human koagulationsfaktor VIII er fremstillet ved rekombinant DNA-teknologi (rDNA) i nyreceller fra hamsterunger, indeholdende det humane faktor VIII-gen.
English: After reconstitution, the solution is drawn back into the syringe.
Danish: Efter opløsning trækkes opløsningen tilbage i sprøjten.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - FOR BIO-SET SYSTEM
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON - TIL BIO-SET OVERFØRINGSSYSTEM
English: In relation to section 5.1, any reference to inhibitor development studies in PUPs and PTPs should be deleted unless the studies were conducted in compliance with a Paediatric Investigation Plan or the studies provide robust evidence of a frequency of inhibitors in PUP which is less than ‘very common' or for PTPs which is different from ‘uncommon' (as laid down in the attachments of the PRAC AR).
Danish: 5.1 bør enhver henvisning til undersøgelserne af inhibitordannelse hos tidligere ubehandlede patienter og tidligere behandlede patienter slettes, medmindre undersøgelserne er udført i overensstemmelse med en pædiatrisk undersøgelsesplan eller giver substantiel evidens for en hyppighed af inhibitorer, der hos tidligere ubehandlede patienter er mindre end "meget almindelig " eller hos tidligere behandlede patienter forskellig fra "ikke almindelig" (som fastlagt i bilagene til PRAC's vurderingsrapport).
English: Within the expiry date indicated on the label, this medicine when kept in its outer carton may be stored at ambient room temperature (up to 25°C) for a limited period of 12 months.
Danish: Inden udløbsdatoen på etiketten kan dette lægemiddel, hvis det opbevares i den ydre karton, opbevares ved stuetemperatur (op til 25 °C) i en begrænset periode på 12 måneder.
English: Given the detailed grounds provided by the MAH, the PRAC carried out a new assessment of the available data in the context of the re-examination.
Danish: På baggrund af den detaljerede begrundelse fremlagt af markedsføringstilladelsesindehaveren foretog PRAC en fornyet overvejelse af de foreliggende data i forbindelse med den fornyede overvejelse.
English: Filtering is achieved by using the vial adapter.
Danish: Filtreringen finder sted ved at anvende adaptoren til hætteglasset.
English: Nervous System Disorders
Danish: Nervesystemet
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodium free”.
Danish: Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. hætteglas, dvs. den er i det væsentlige natriumfri.
English: The safety and efficacy of KOGENATE Bayer in children of all ages have been established.
Danish: KOGENATE Bayers sikkerhed og virkning hos børn i alle aldre er klarlagt.
English: Type of surgical procedure
Danish: Type af kirurgi
English: Life threatening haemorrhages (such as intracranial bleed, throat bleed, severe abdominal bleed)
Danish: Livstruende hæmoragi (som f.eks. intrakranielle blødninger, blødninger fra svælget og alvorlige abdominale blødninger)
English: Note the new expiry date on the top of the carton.
Danish: Skriv den nye udløbsdato på kartonen.
English: Skin associated hypersensitivity reactions, (pruritus, urticaria and rash)
Danish: Overfølsomhedsreaktioner fra huden (pruritus, urticaria og udslæt)
English: KOGENATE Bayer has no influence on the ability to drive or to use machines.
Danish: KOGENATE Bayer påvirker ikke evnen til at føre motorkøretøj eller betjene maskiner.
English: Within its overall shelf life of 30 months the product when kept in its outer carton, may be stored at ambient room temperature (up to 25°C) for a limited period of 12 months.
Danish: Inden for den samlede opbevaringstid på 30 måneder kan præparatet, hvis det opbevares i den ydre karton, opbevares ved stuetemperatur (op til 25 °C) i en begrænset periode på 12 måneder.
English: Similar to RODIN/Pednet, the UKHCDO study found a significant increased risk of inhibitors (all and high titre) for Kogenate FS/Helixate NexGen (2nd generation rFVIII) compared to Advate (3rd generation rFVIII).
Danish: I lighed med RODIN/Pednet blev der i UKHCDO-undersøgelsen fundet at være signifikant større risiko for inhibitorer (alle og højtiter-) med Kogenate FS/Helixate NexGen (2. generations rFVIII) end med Advate (3. generations rFVIII).
English: • The SIPPET analysis does not allow for product-specific conclusions to be made as it relates only to a small number of certain FVIII products.
Danish: • Analyse af SIPPET giver ikke mulighed for produktspecifikke konklusioner, da undersøgelsen kun omhandler visse få FVIII-produkter.
English: Further to the recent publication on the SIPPET study, the MAHs were requested to assess the potential impact of the results of this study and other relevant safety data on inhibitor development in PUPs on the MA of their FVIII product including consideration on risk minimisation measures.
Danish: I tilslutning til den nylige offentliggørelse af SIPPET-undersøgelsen blev indehaverne af markedsføringstilladelse anmodet om at vurdere, hvilken potentiel betydning resultaterne af denne undersøgelse og andre relevante sikkerhedsdata vedrørende dannelse af inhibitorer hos tidligere ubehandlede patienter kan have for markedsføringstilladelsen for deres FVIII-produkt, herunder at overveje risikominimeringsforanstaltninger.
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, nausea, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Danish: Patienten skal informeres om tidlige tegn på overfølsomhedsreaktioner, herunder udslæt, kvalme, generaliseret urticaria, trykken for brystet, hvæsende vejrtrækning, hypotension og anafylaksi.
English: The reconstituted product must be filtered prior to administration to remove potential particulate matter in the solution.
Danish: Det rekonstituerede præparat skal filtreres før administration for at fjerne eventuelle partikler i opløsningen.
English: Individual studies have identified a wide range of inhibitor frequency in PUPs across products, and the SIPPET study was not designed to differentiate between individual products in each class.
Danish: I de enkelte undersøgelser er der hos tidligere ubehandlede patienter påvist en bred vifte af hyppigheder af inhibitordannelse med forskellige produkter, og SIPPET-undersøgelsens design var ikke beregnet til at skelne mellem de enkelte produkter i hver klasse.
English: Do not remove the adapter from the plastic housing.
Danish: Fjern ikke forbindelsesstykket fra plastikhylstret.
English: Fill the syringe by drawing the plunger out slowly and smoothly.
Danish: Fyld injektionssprøjten ved at trække stemplet langsomt og forsigtigt ud.
English: Each vial contains nominally 250/500/1000/2000/3000 IU human coagulation factor VIII (INN: octocog alfa).
Danish: Hvert hætteglas indeholder nominelt 250/500/1000/2000/3000 IE human koagulationsfaktor VIII (INN: octocog alfa).
English: When blood must be withdrawn prior to an infusion, use an administration set without a filter, then infuse KOGENATE Bayer through an injection filter.
Danish: Hvis der skal udtages blod før infusion, skal der anvendes et administrationssæt uden filter, og KOGENATE Bayer skal så infunderes gennem et injektionsfilter.
English: If a further dose needs to be administered, use a new syringe with product reconstituted as described above.
Danish: Hvis en yderligere dosis er nødvendig, brug da en ny sprøjte med pulver opløst som angivet ovenfor.
English: • The PRAC considered the totality of the data submitted with regards to the risk of inhibitor development for the classes of recombinant and plasma derived FVIII products, in previously untreated patients (PUPs).
Danish: • PRAC vurderede samtlige indsendte data vedrørende risikoen for inhibitordannelse for klasserne rekombinante og plasmaderiverede FVIII-produkter hos tidligere ubehandlede patienter.
English: The doctor should always adjust the dose and the frequency of administration according to your individual needs.
Danish: Lægen vil altid justere dosis, og hvor ofte du skal anvende det, i henhold til dine individulle behov.
English: The primary and secondary outcomes assessed in the study were the incidence of all inhibitors (≥0.4 BU/ml) and the incidence of high-titre inhibitors (≥5 BU/ml), respectively.
Danish: I undersøgelsen vurderedes som primært og sekundært udfald hhv. forekomsten af alle inhibitorer (≥0,4 BU/ml) og forekomsten af højtiter-inhibitorer (≥ 5 BU/ml).
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with KOGENATE Bayer.
Danish: Der kan udvikles neutraliserende antistoffer (inhibitorer) hos patienter med hæmofili A, som behandles med faktor VIII, herunder med KOGENATE Bayer.
English: In 2013, PRAC had concluded that the RODIN/Pednet findings were not sufficiently robust to support a conclusion that Kogenate FS/Helixate NexGen was associated with an increased risk of developing factor VIII inhibitors compared with other products.
Danish: I 2013 havde PRAC konkluderet, at resultaterne af RODIN/Pednet-undersøgelserne ikke var tilstrækkeligt substantielle til at underbygge en konklusion om, at Kogenate FS/Helixate NexGen var forbundet med højere risiko for dannelse af faktor VIIIinhibitorer end andre produkter.
English: • The section 4.4 of the SmPC should be amended to include a warning on the clinical importance of monitoring patients for FVIII inhibitor development (in particular warning on the clinical consequences of low compared to high titre inhibitors).
Danish: 4.4 ændres med tilføjelse af en advarsel om den kliniske vigtighed af at overvåge patienter for dannelse af FVIII-inhibitorer (med særlig advarsel om de kliniske konsekvenser af lavtiter- sammenlignet med højtiter-inhibitorer).
English: The amount to be administered and the frequency of administration should always be adapted according to the clinical effectiveness in the individual case.
Danish: Dosisstørrelsen samt doseringshyppigheden bør altid tilpasses den kliniske effekt i det enkelte tilfælde.
English: After the initial 24 hours of continuous infusion, the clearance should be recalculated every day using the steady state equation with the measured FVIII level and the rate of infusion using the following equation: clearance = infusion rate/actual FVIII level.
Danish: Efter de initiale 24 timers kontinuerlig infusion skal clearance genberegnes hver dag sammen med det målte FVIII-niveau og infusionshastigheden med følgende ligning:
English: Therefore, the PRAC concluded that the benefit-risk balance of the human plasma derived and recombinant coagulation Factor VIII containing medicinal products remains favourable and recommended the variations to the terms of the marketing authorisations.
Danish: konkluderede PRAC,, at benefit/risk-forholdet for humanplasmaderiverede og rekombinante koagulationsfaktor VIII-holdige lægemidler fortsat er gunstigt, og anbefalede ændringer i betingelserne for markedsføringstilladelserne.
English: Inject the solution into a vein over 2 to 5 minutes, keeping an eye on the position of the needle.
Danish: Indsprøjt opløsningen i en vene i løbet af 2-5 minutter, mens du holder øje med kanylens position.
English: The responses of MAHs referred to a range of published observational studies (the CANAL, RODIN, FranceCoag, UKHCDO, amongst others) which have sought to evaluate any differential risks of inhibitor development between the classes of pdFVIII and rFVIII, as well as any differential risk of inhibitor development between products within the rFVIII class.
Danish: Svarene fra indehaverne af markedsføringstilladelse henviste til en række offentliggjorte observationsundersøgelser (bl.a. CANAL, RODIN, FranceCoag og UKHCDO), som skulle vurdere eventuelle forskelle i risiko for inhibitordannelse mellem klasserne pdFVIII og rFVIII samt eventuel forskel i risiko for inhibitordannelse mellem produkterne i rFVIII-klassen.
English: 1 pre-filled syringe with 2.5 mL or 5 mL water for injections with separate plunger rod.
Danish: 1 fyldt injektionssprøjte med 2,5 ml eller 5 ml vand til injektionsvæsker med en separat stempelstang.
English: EU/1/00/143/007 - KOGENATE Bayer 250 IU EU/1/00/143/008 - KOGENATE Bayer 500 IU EU/1/00/143/009 - KOGENATE Bayer 1000 IU EU/1/00/143/011 - KOGENATE Bayer 2000 IU EU/1/00/143/013 - KOGENATE Bayer 3000 IU
Danish: EU/1/00/143/007 - KOGENATE Bayer 250 IE EU/1/00/143/008 - KOGENATE Bayer 500 IE EU/1/00/143/009 - KOGENATE Bayer 1000 IE EU/1/00/143/011 - KOGENATE Bayer 2000 IE EU/1/00/143/013 - KOGENATE Bayer 3000 IE
English: Each vial of KOGENATE Bayer contains nominally 250, 500, 1000, 2000 or 3000 IU octocog alfa.
Danish: Hvert hætteglas med KOGENATE Bayer indeholder nominelt 250, 500, 1000, 2000 eller 3000 IE octocog alfa.
English: * Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously untreated patients
Danish: Dysgeusi * Hyppigheden er baseret på studier med alle FVIII-produkter, som omfattede patienter med svær hæmofili A. PTPs = tidligere behandlede patienter, PUPs = tidligere ubehandlede patienter
English: Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
Danish: Brug altid dette lægemiddel nøjagtigt som beskrevet i denne indlægsseddel eller efter lægens eller apotekspersonalets anvisning.
English: Furthermore, the PRAC examined clinical trials and the scientific literature for de novo inhibitors in PTPs.
Danish: PRAC gennemgik endvidere kliniske undersøgelser og den videnskabelige litteratur for de novoinhibitorer hos tidligere behandlede patienter.
English: In 2016, PRAC had considered the findings of meta-analysis of all three studies (RODIN/Pednet, UKHCDO and FranceCoag studies), and again concluded that the currently available evidence does not confirm that Kogenate Bayer/Helixate NexGen is associated with an increased risk of factor VIII inhibitors, compared with other recombinant factor VIII products in PUPs.
Danish: I 2016 havde PRAC gennemgået resultaterne af en meta-analyse af alle tre undersøgelser (RODIN/Pednet, UKHCDO og FranceCoag) og igen konkluderet, at den aktuelt foreliggende evidens ikke bekræfter, at Kogenate Bayer/Helixate NexGen er forbundet med højere risiko for faktor VIII-inhibitorer hos tidligere ubehandlede patienter end andre rekombinante faktor VIII-produkter.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE WITH 2.5 mL or 5 mL WATER FOR INJECTIONS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER FYLDT INJEKTIONSSPRØJTE MED 2,5 ML ELLER 5 ML VAND TIL INJEKTIONSVÆSKER
English: The active substance is human coagulation factor VIII (octocog alfa) produced by recombinant DNA technology.
Danish: Aktivt stof: Human koagulationsfaktor VIII (octocog alfa), der er fremstillet ved rekombinant DNAteknologi.
English: Expected factor VIII rise (% of normal) = 2 × administered IU
Danish: Forventet faktor VIII-stigning (% af normal) = 2 × indgivet IE legemsvægt (kg)
English: EU/1/00/143/004 - KOGENATE Bayer 250 IU EU/1/00/143/005 - KOGENATE Bayer 500 IU EU/1/00/143/006 - KOGENATE Bayer 1000 IU EU/1/00/143/010 - KOGENATE Bayer 2000 IU EU/1/00/143/012 - KOGENATE Bayer 3000 IU
Danish: EU/1/00/143/004 - KOGENATE Bayer 250 IE EU/1/00/143/005 - KOGENATE Bayer 500 IE EU/1/00/143/006 - KOGENATE Bayer 1000 IE EU/1/00/143/010 - KOGENATE Bayer 2000 IE EU/1/00/143/012 - KOGENATE Bayer 3000 IE
English: The other ingredients are glycine, sodium chloride, calcium chloride, histidine, polysorbate 80, and sucrose (see end of section 2).
Danish: Øvrige indholdsstoffer: Glycin, natriumchlorid, kalciumchlorid, histidin, polysorbat 80 og saccharose (se slutningen på pkt.
English: • The FVIII products are heterogenous, and the plausibility of different rates of inhibitor development between individual products cannot be excluded.
Danish: • at FVIII-produkter er forskelligartede, og at det ikke kan udelukkes, at der er forskelle mellem de enkelte produkter i hyppigheden af inhibitordannelse,
English: If you have used more KOGENATE Bayer than you should, please inform your doctor.
Danish: Hvis du har brugt for meget KOGENATE Bayer, informer da din læge.
English: Remove the stopper attached to the white cap from the syringe (A).
Danish: Fjern proppen fra det hvide låg på sprøjten (A).
English: This preparation does not contain von Willebrand factor and is therefore not to be used in von Willebrand's disease.
Danish: KOGENATE Bayer indeholder ikke von Willebrand-faktor og må derfor ikke anvendes ved von Willebrands sygdom.