FrancophonIA/ELRC3.0 huggingface dataset:
English: Frequency of doses (hours)/ Duration of therapy (days)
Danish: Hyppighed af doser(timer)/ behandlingsvarighed (dage)
English: • Do not take a double dose to make up for a forgotten dose.
Danish: • Du må ikke tage en dobbelt dosis som erstatning for den glemte dosis.
English: 20024 Garbagnate Milanese (MI) Italy
Danish: 20024 Garbagnate Milanese (MI) Italien
English: This must be checked by an experienced doctor.
Danish: Dette skal kontrolleres af en erfaren læge.
English: The experts emphasized that collaboration between academia, industry and regulators should be encouraged to collect harmonised data through registries.
Danish: Eksperterne understregede, at der bør tilskyndes til samarbejde mellem den akademiske verden, industrien og tilsynsmyndighederne med henblik på at indsamle harmoniserede data ved hjælp af registre.
English: • whether you have inhibitors and how high the inhibitor titre is
Danish: • om du har inhibitorer, og hvor høje inhibitor-titrene er
English: Use in children and adolescents
Danish: Anvendelse til børn og unge
English: In particular, only 13 patients (10% of the FVIII arm) received a third generation rFVIII product.
Danish: Navnlig fik kun 13 patienter (10 % af FVIII-armen) et tredjegenerations rFVIII-produkt.
English: This association was consistently observed in multivariable analysis.
Danish: Denne sammenhæng iagttoges konsekvent ved flerdimensional analyse.
English: In case of shock, standard medical treatment for shock should be implemented.
Danish: I tilfælde af shock skal standardbehandling af shock udføres.
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Danish: Tabellen nedenfor er i henhold til MedDRA-systemorganklassifikationen (SOC og foretrukket term).
English: Bio-Set System:
Danish: Bio-Set overføringssystem:
English: Desired plasma FVIII level
Danish: Ønsket FVIII-niveau i plasma
English: There are no fertility data available.
Danish: Fertilitetsdata er ikke tilgængelige.
English: Immune Tolerance Induction (ITI)
Danish: Immuntolerans-induktion (ITI)
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Danish: Hvis det ikke anvendes straks, er opbevaringstiderne under anvendelse og betingelserne før anvendelse brugerens ansvar.
English: The PRAC adopted a recommendation on 01 September 2017 which was then considered by the CHMP, in accordance with Article 107k of Directive 2001/83/EC.
Danish: PRAC vedtog en henstillng den 1. september 2017, som derefter blev behandlet af CHMP i overensstemmelse med artikel 107k i direktiv 2001/83/EF.
English: The solution must be prepared on a clean and dry surface.
Danish: Opløsningen skal tilberedes på en ren og tør overflade.
English: Data have been obtained from clinical studies in 61 children under 6 years of age and non-interventional studies in children of all ages.
Danish: Der foreligger data fra kliniske studier med 61 børn i alderen op til 6 år og ikke-interventionelle studier med børn i alle aldre.
English: After reconstitution, from a microbiological point of view, the product should be used immediately.
Danish: Efter rekonstitution bør præparatet fra et mikrobiologisk synspunkt anvendes straks.
English: Please consult your doctor immediately.
Danish: Kontakt din læge omgående.
English: Under certain circumstances larger amounts than those calculated may be required, especially in the case of the initial dose.
Danish: Under visse omstændigheder kan det være nødvendigt at indgive større doser end de beregnede, især hvad angår initialdosis.
English: KOGENATE Bayer should be injected intravenously over 2 to 5 minutes.
Danish: KOGENATE Bayer bør injiceres intravenøst over 2-5 minutter.
English: Frequencies have been evaluated according to the following convention: very common: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppighederne er blevet evalueret i henhold til den følgende konvention: Meget almindelig: (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Do not increase your dose of medicine you use to control your bleeding without consulting your doctor.
Danish: Øg ikke den dosis af dette lægemiddel, du anvender for at kontrollere din blødning, uden at konsultere din læge.
English: For infusion, the product must be prepared under aseptic conditions.
Danish: Til infusion skal præparatet tilberedes under aseptiske forhold.
English: Therefore, if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du derfor spørge din læge til råds, før du bruger dette lægemiddel.
English: Your doctor will tell you, how often and at what intervals this medicine is to be administered.
Danish: Din læge vil fortælle dig, hvor ofte og med hvilke intervaller behandling med dette lægemiddel skal foretages.
English: The data came from a very wide range of heterogenous studies across products and over time.
Danish: Dataene var hentet fra en meget lang række forskelligartede undersøgelser for forskellige produkter og over tid.
English: Consequently, patients should be evaluated and monitored for cardiac risk factors.
Danish: Derfor skal patienterne undersøges og overvåges for kardielle risikofaktorer.
English: The PRAC considered the views expressed by experts during an ad-hoc meeting.
Danish: PRAC gennemgik synspunkter, der var udtrykt af eksperter på et ad hoc-møde.
English: Table 2: Example for calculation of infusion rate for continuous infusion after initial bolus injection
Danish: Tabel 2: Eksempel til udregning af infusionshastighed ved kontinuerlig infusion efter initial bolusinjektion
English: The relevance for clinical practice in the EU (and therefore for the products subject to this procedure) is therefore questioned.
Danish: Dette sætter spørgsmålstegn ved undersøgelsens relevans for klinisk praksis i EU (og dermed for produkterne omfattet af denne procedure).
English: However, in many cases little information was provided on the methods, patient populations and nature of the inhibitors to assess the information in the context of more recent published data.
Danish: I mange tilfælde blev der imidlertid givet for få oplysninger om metoder, patientpopulationer og inhibitorernes art til, at oplysningerne kan vurderes i sammenhæng med nyere offentliggjorte data.
English: This medicine is intended for injection into a vein over 2 to 5 minutes depending on the total volume and your comfort level and should be used within 3 hours after reconstitution.
Danish: Dette lægemiddel er beregnet til indsprøjtning i en blodåre over 2-5 minutter afhængigt af den samlede mængde og dit velbefindende, og det skal anvendes inden for 3 timer efter, at det er opløst.
English: VWF is not present in rFVIII, but there is significant heterogeneity within the rFVIII class for instance due to the different manufacturing processes used, with a wide range of products from different manufacturers produced over the past 20 years.
Danish: VWF findes ikke i rFVIII, men der er betydelig heterogenitet inden for rFVIII-klassen, f.eks. som følge af forskelle i de anvendte fremstillingsprocesser, og der er fremstillet en lang række produkter fra forskellige fremstillere i løbet af de sidste 20 år.
English: The lead authors of the SIPPET study were also invited to respond to a list of questions regarding the study methods and findings and to present their conclusions at the February 2017 PRAC plenary meeting.
Danish: De ledende forfattere til SIPPET-undersøgelsen blev desuden opfordret til at besvare en række spørgsmål om undersøgelsesmetoderne og -resultaterne og fremlægge deres konklusioner på PRAC's plenarmøde i februar 2017.
English: During continuous infusion, infusion bags should be changed every 24 hours.
Danish: Ved kontinuerlig infusion skal infusionsposerne skiftes hver 24. time.
English: The infusion rate should be calculated based on the clearance and the desired FVIII level.
Danish: Infusionshastigheden bør beregnes på basis af clearance og det ønskede FVIII-niveau.
English: Ad hoc expert group meeting
Danish: Ad hoc-ekspertgruppemøde
English: Common (may affect up to 1 in 10 users):
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 brugere):
English: Published observational studies
Danish: Offentliggjorte observationsundersøgelser
English: The safety and efficacy of {(Invented) name} in previously untreated patients have not yet been established.
Danish: Sikkerheden og virkningen af {(sær)navn} hos tidligere ubehandlede patienter er endnu ikke fastlagt.
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Danish: Herefter omdanner trombin fibrinogen til fibrin, og et koagel kan dannes.
English: Berkeley, CA 94710
Danish: CA 94710
English: Rare (may affect up to 1 in 1,000 users):
Danish: Sjælden (kan forekomme hos op til 1 ud af 1.000 brugere):
English: • The SIPPET study has methodological limitations, with particular uncertainty around whether the randomisation process (block size of 2) may have introduced a selection bias in the study.
Danish: • SIPPET-undersøgelsen har metodologiske begrænsninger, navnlig usikkerheden om, hvorvidt randomiseringsprocessen (blokstørrelse på 2) kan have indført selektionsbias i undersøgelsen.
English: This result is similar to the reported values for factor VIII derived from human plasma.
Danish: Dette resultat svarer til de rapporterede værdier for faktor VIII deriveret fra humant plasma.
English: PRAC also considered grounds submitted by LFB Biomedicaments as basis for their request for reexamination of the PRAC recommendation and the views of two experts meetings held on 22 February and 3 August 2017.
Danish: PRAC overvejede desuden begrundelsen fra LFB Biomedicaments for dettes anmodning om fornyet overvejelse af PRAC's henstilling, og synspunkterne på to ekspertmøder afholdt den 22. februar og 3. august 2017,
English: Having reviewed the PRAC recommendation, the CHMP agrees with the PRAC overall conclusions and grounds for recommendation.
Danish: Efter gennemgang af PRAC's henstilling tilslutter CHMP sig henstillingens overordnede konklusioner og begrundelse.
English: KOGENATE Bayer should be reconstituted and administered with the components provided with each package.
Danish: KOGENATE Bayer skal rekonstitueres og administreres ved hjælp af de komponenter, der leveres i hver pakning.
English: The PRAC consulted an ad-hoc expert meeting on some of the aspects that formed part of the detailed grounds submitted by LFB Biomedicaments.
Danish: PRAC rådførte sig ved et ad hoc-ekspertmøde om visse af de aspekter, der indgik i den detaljerede begrundelse fra LFB Biomedicaments.
English: If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor.
Danish: Hvis du mener, at virkningen af dette lægemiddel er for kraftig eller for svag, skal du tale med din læge herom.
English: The material should not be warmer than body temperature (not exceed 37 °C).
Danish: Det må ikke blive varmere end legemstemperatur (højst 37 °C).
English: No conclusions can be drawn on any role of VWF in protecting against inhibitor development.
Danish: Der kan ikke drages konklusioner om VWF's rolle i beskyttelsen mod inhibitordannelse.
English: The listed warnings and precautions apply both to adults and children.
Danish: De angivne advarsler og forsigtighedsregler gælder for både voksne og børn.
English: 4.7 Effects on ability to drive or use machines
Danish: 4.7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
English: May be stored at temperatures up to 25°C for up to 12 months within the expiry date indicated on the label.
Danish: Kan opbevares ved temperaturer på op til 25 °C i op til 12 måneder inden udløbsdatoen, der er anført på etiketten.
English: A wide range of individual pdFVIII and rFVIII products are authorised for use in the European Union.
Danish: Der er godkendt en lang række enkeltprodukter med pdFVIII og rFVIII til anvendelse i EU.
English: • you have been told you have heart disease or are at risk for heart disease.
Danish: • du har fået at vide, at du har en hjertesygdom, eller du har risiko for at få en hjertesygdom.
English: Frequency, type and severity of adverse reactions in children are expected to be the same as in all population groups except for the inhibitor formation.
Danish: Hyppigheden, typen og sværhedsgraden af bivirkninger hos børn forventes at være den samme som i andre populationsgrupper med undtagelse af dannelsen af inhibitorer.
English: Continuous Infusion
Danish: Kontinuerlig infusion
English: Following the adoption of the PRAC recommendation during the May 2017 PRAC meeting, the MAH LFB Biomedicaments expressed their disagreement with the initial PRAC recommendation.
Danish: Efter vedtagelse af PRAC's anbefaling på PRAC's møde i maj 2017 gav markedsføringstilladelsesindehaveren LFB Biomedicaments udtryk for at være uenig i PRAC's indledende anbefaling.
English: The available data showed that in many studies including the EUHASS registry (Iorio A, 20174; Fischer K, 20155) the frequency could be classified as “uncommon”.
Danish: De foreliggende data viste, at hyppigheden i mange undersøgelser, herunder EUHASS-registeret (Iorio A, 20174, Fischer K, 20155), kunne klassificeres som "ikke almindelig".
English: These different manufacturing processes (including the different cell lines used to engineer the rFVIII products) can in theory lead to differential immunogenicity.
Danish: Disse forskelle i fremstillingsproces (herunder de forskellige cellelinjer anvendt til at fremstille rFVIII-produkterne) kan teoretisk føre til forskelle i immunogenicitet.
English: Results of clinical studies not sufficiently robust (e.g. suffering from methodolical limitations) should not be reflected in the product information on FVIIII products.
Danish: Resultater af kliniske undersøgelser, som ikke er tilstrækkeligt substantielle (f.eks. som følge af metodologiske begrænsninger), bør ikke afspejles i produktinformationen for FVIIIIprodukter.
English: patients (<6 years, male, severe haemophilia A, no previous treatment with any FVIII concentrate or only minimal treatment with blood components) were included from 42 sites.
Danish: Egnede patienter (<6 år, hankøn, alvorlig hæmofili A, ingen tidligere behandling med et FVIII-koncentrat eller kun minimal behandling med blodkomponenter) blev inkluderet fra 42 centre.
English: Data show that KOGENATE Bayer has been used to induce immune tolerance.
Danish: Data viser, at KOGENATE Bayer er blevet anvendt til at inducere immuntolerans.
English: The new expiry date must be noted on the outer carton.
Danish: Den nye udløbsdato skal noteres på den ydre karton.
English: However, the general estimates of inhibitor rates from these studies for individual products are broadly in line with the findings from large observational studies.
Danish: Beregningerne af inhibitorandelen for de enkelte produkter i disse undersøgelser er dog stort set i overensstemmelse med resultaterne fra store observationsstudier.
English: Special populations Paediatric population
Danish: Specielle populationer Pædiatrisk population
English: Differences between products in each FVIII class and consequently differential risks between individual products, are biologically plausible.
Danish: Forskelle mellem produkterne i hver FVIII-klasse og deraf betingede forskelle i risiko mellem de enkelte produkter er biologisk sandsynlige.
English: On 6 July 2016 Paul-Ehrlich-Institut Germany initiated a referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, and requested the PRAC to assess the potential impact of the results of the SIPPET study on the marketing authorisations of relevant FVIII products and to issue a recommendation on whether these should be maintained, varied, suspended or revoked and whether any risk minimisation measures should be implemented.
Danish: Den 6. juli 2016 foretog Paul-Ehrlich-instituttet i Tyskland foranlediget af lægemiddelovervågningsdata en indbringelse i henhold til artikel 31 i direktiv 2001/83/EF, og anmodede PRAC om at vurdere den potentielle betydning af resultaterne af SIPPET-undersøgelsen for markedsføringstilladelserne for relevante FVIII-produkter og fremsætte en anbefaling om, hvorvidt disse bør opretholdes, ændres, suspenderes eller inddrages, og hvorvidt der bør indføres risikominimeringsforanstaltninger.
English: Clinical discussion
Danish: Klinisk diskussion
English: No studies were performed on the mutagenic potential of KOGENATE Bayer, since no mutagenic potential could be detected in vitro or in vivo for the predecessor product of KOGENATE Bayer.
Danish: Der er ikke foretaget studier af KOGENATE Bayer's mutagene potentiale, eftersom der ikke kunne detekteres noget mutagent potentiale in vitro eller in vivo for forgængeren til KOGENATE Bayer.
English: Warm both an unopened vial and a syringe in your hands to a comfortable temperature (do not exceed 37 °C).
Danish: Varm både et uåbnet hætteglas og en sprøjte i dine hænder til de har en behagelig temperatur (ikke over 37 °C).
English: This medicine must not be mixed with other infusion solutions.
Danish: Dette lægemiddel må ikke blandes med andre infusionsvæsker.
English: If you have been told by your doctor that you have developed factor VIII inhibitors you may need to use a larger amount of this medicine to control bleeding.
Danish: Hvis din læge har fortalt dig, at du har dannet faktor VIII-inhibitorer, skal du muligvis anvende en større mængde af dette lægemiddel for at kontrollere en blødning.
English: • local reactions where you injected the medication (e.g. burning sensation, temporary redness)
Danish: • lokale reaktioner på det sted, hvor du indsprøjtede medicinen (for eksempel brændende fornemmelse, forbigående rødme)
English: If allergic or anaphylactic reactions occur, the injection/infusion should be stopped immediately.
Danish: Hvis der opstår allergiske eller anafylaktiske reaktioner, skal injektionen/infusionen afbrydes øjeblikkeligt.
English: Although this became non-significant when UK patients (also included in the RODIN/Pednet study were excluded.
Danish: Denne forskel blev dog ikke-signifikant, når man udelukkede patienter i Det Forenede Kongerige (også dem, der indgik i RODIN/Pednetundersøgelsen).
English: In situations where the venipuncture set provided cannot be used (e.g. when infusing into a peripheral or central line), a separate filter compatible with KOGENATE Bayer should be used.
Danish: I situationer, hvor det leverede venepunktursæt ikke kan anvendes (f.eks. når der infunderes i et perifert eller centralt kateter), skal der anvendes et separat filter, der er kompatibelt med KOGENATE Bayer.
English: These studies have yielded different results and suffer from the limitations of observational studies, and in particular from possible selection bias.
Danish: Disse undersøgelser har givet forskellige resultater og er behæftet med begrænsninger som følge af at være observationsundersøgelser, navnlig eventuel selektionsbias.
English: The factor VIII/von Willebrand factor (vWF) complex consists of two molecules (factor VIII and vWF) with different physiological functions.
Danish: Faktor VIII/von Willebrand faktor-kompleks (vWF) består af to molekyler (faktor VIII og vWF) med forskellige fysiologiske funktioner.
English: Not known (frequency cannot be estimated from the available data): • dysgeusia (strange taste)
Danish: Ikke kendt (hyppigheden kan ikke vurderes ud fra tilgængelige data): • smagsforstyrrelser
English: KOGENATE Bayer can be infused by continuous infusion.
Danish: KOGENATE Bayer kan infunderes ved kontinuerlig infusion.
English: As the evidence suggests that all human FVIII products carry a risk of inhibitor development such statements should be removed.
Danish: Da evidensen peger på, at alle produkter indeholdende humant FVIII indebærer risiko for inhibitordannelse, skal sådanne udsagn fjernes.
English: Every 24 hours, at least 1 day, until healing is achieved.
Danish: Hver 24. time i mindst én dag, indtil opheling er nået.
English: In particular the skin related reactions may occur commonly, whereas a progress to severe anaphylaxis (including shock) is considered to be rare.
Danish: Især hudreaktioner kan være almindeligt forekommende, hvorimod udvikling til alvorlig anafylaksi (herunder shock) anses for at være sjælden.
English: Your doctor may carry out tests to ensure that your current dose of this medicine provides adequate factor VIII levels.
Danish: Din læge vil måske forestage undersøgelser for at sikre, at din nuværende dosis af dette lægemiddel er tilstrækkelig til, at der kan opnås et tilstrækkeligt niveau af faktor VIII.
English: The most serious side effects are hypersensitivity reactions or anaphylactic shock (rare side effect).
Danish: De alvorligste bivirkninger er overfølsomhedsreaktioner eller anafylaktisk shock (sjælden bivirkning).
English: KOGENATE Bayer can be used in children of all ages.
Danish: KOGENATE Bayer kan anvendes til børn i alle aldre.
English: If these components cannot be used, please contact your doctor.
Danish: Hvis disse dele ikke kan anvendes, skal du kontakte din læge.
English: Although this could not have been prevented, an early termination of an open label trial raises the possibility of investigator bias and inflation of the probability of detecting an effect that is not present.
Danish: Skønt dette kunne være undgået, øger tidlig afslutning af en åben undersøgelse muligheden for investigator-bias og sandsynligheden for at registrere en virkning, der ikke er til stede.
English: Warm the unopened powder vial and the solvent syringe in your hands until they feel as warm as your hands.
Danish: Varm det uåbnede hætteglas med pulver og sprøjten med opløsningsvæske i dine hænder indtil det føles lige så varmt som dine hænder.
English: In the case of the haemorrhagic events listed, the factor VIII activity should not fall below the given level (in % of normal) in the corresponding period:
Danish: I de nævnte blødningstilfælde bør faktor VIII-aktiviteten ikke komme under det givne niveau (i % af normalniveauet) i den tilsvarende periode:
English: Your doctor will calculate the dose of this medicine and how frequently you should use it to get the necessary level of factor VIII activity in your blood.
Danish: Din læge vil udregne dosis af dette lægemiddel, og hvor ofte du skal have det for at få det nødvendige niveau af faktor VIII-aktivitet i blodet.
English: This product is indicated for adults, adolescents and children of all ages.
Danish: Dette præparat er indiceret til voksne, unge og børn i alle aldre.
English: The experts also suggested studies which could further characterise the immunogenic properties of the factor VIII medicinal products (e.g. mechanistic, observational studies).
Danish: Eksperterne foreslog desuden undersøgelser til yderligere karakterisering af de immunogene egenskaber af faktor VIII-lægemidler (f.eks. mekanistiske undersøgelser og observationsundersøgelser).
English: This will usually be in the range of 20 to 40 IU of octocog alfa per kg of body weight, given every 2 to 3 days.
Danish: Denne vil sædvanligvis være mellem 20 og 40 IE octocog alfa pr. kg legemsvægt indsprøjtet med 2-3 dages mellemrum.
English: Factor VIII level required (%) (IU/dl)
Danish: Krævet faktor VIIIniveau (%)(IE/dl)
English: Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin.
Danish: Aktiveret faktor VIII virker som en co-faktor til aktiveret faktor IX, hvilket accelererer omdannelsen af faktor X til aktiveret faktor X. Aktiveret faktor X omdanner protrombin til trombin.