FrancophonIA/ELRC3.0 huggingface dataset:
English: In general, all patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests.
Danish: Generelt bør alle patienter, der er i behandling med koagulationsfaktor VIII-produkter, overvåges nøje for udvikling af inhibitorer ved passende kliniske observationer og laboratorietests.
English: ADYNOVI is usually injected into a vein (intravenously) by your doctor or nurse.
Danish: ADYNOVI injiceres som regel i en vene (intravenøst) af lægen eller sygeplejersken.
English: The safety and efficacy of ADYNOVI in previously untreated patients have not yet been established.
Danish: ADYNOVIs sikkerhed og virkning hos tidligere ubehandlede patienter er endnu ikke klarlagt.
English: Do not draw air into the syringe.
Danish: Undgå at trække luft ind i sprøjten.
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 kendetegnet ved smerter er ophørt, eller heling er opnået.
English: The specific activity of ADYNOVI is approximately 4000-6500 IU/mg protein.
Danish: ADYNOVIs specifikke aktivitet er ca. 4000-6500 IE/mg protein.
English: The European Medicines Agency has deferred the obligation to submit results of studies with ADYNOVI in one or more subsets of the paediatric population in the treatment of congenital factor VIII deficiency.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med ADYNOVI i en eller flere undergrupper af den pædiatriske population ved behandling af medfødt faktor VIII-mangel.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V
English: The dose in adolescents is also calculated to body weight and is the same dose as for adults.
Danish: Doseringen til unge beregnes også efter legemsvægt og er den samme dosering som til voksne.
English: In case of anaphylactic shock, standard medical treatment for shock should be implemented.
Danish: I tilfælde af anafylaktisk shock skal gældende medicinsk standard for shockbehandling iværksættes.
English: If any of these symptoms occur, stop the injection immediately and contact your doctor.
Danish: Hvis nogen af disse symptomer opstår, skal du stoppe injektionen med det samme og kontakte lægen.
English: No studies on genotoxicity, carcinogenicity or reproductive toxicity have been performed with ADYNOVI.
Danish: Der er ikke udført studier af genotoksicitet, karcinogenicitet eller reproduktionstoksicitet med ADYNOVI.
English: Factor VIII level required (% or IU/dl)
Danish: Nødvendigt faktor VIIIniveau (% eller IE/dl)
English: Warnings and precautions Talk to your doctor before using ADYNOVI.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du bruger ADYNOVI.
English: The listed warnings and precautions also apply to adolescents.
Danish: De anførte advarsler og forsigtighedsregler gælder også for unge.
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: i tilfælde af større kirurgiske indgreb i særdeleshed er præcis overvågning af substitutionsbehandlingen med koagulationsanalyse (plasma faktor VIII-aktivitet) ufravigelig.
English: Use within 3 hours of reconstitution.
Danish: Bruges inden for 3 timer efter rekonstitution.
English: Immune tolerance induction (ITI) No clinical data for use of ADYNOVI in ITI are available.
Danish: Immuntoleranceinduktion (ITI) Der foreligger ingen kliniske data for brugen af ADYNOVI ved ITI.
English: • Do not use if the BAXJECT II Hi-Flow device, its sterile barrier system or its packaging is damaged or shows any sign of deterioration.
Danish: • BAXJECT II Hi-Flow-udstyret må ikke anvendes, hvis dets sterile barrieresystem eller dets pakning er beskadiget eller viser tegn på nedbrydning.
English: Prophylactic treatment for patients from 12 to <18 years is the same as for adult patients.
Danish: Profylaktisk behandling til patienter fra 12 til <18 år er den samme som behandlingen til voksne patienter.
English: Solutions that are cloudy or have deposits should not be used.
Danish: Opløsninger, som er uklare eller har udfældninger, må ikke bruges.
English: Nonclinical data are limited to 1 month exposure and no studies in juvenile animals were conducted with ADYNOVI.
Danish: Prækliniske data er begrænset til 1 måneds eksponering, og der blev ikke udført studier med ungdyr med ADYNOVI.
English: If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician.
Danish: Hvis der opstår symptomer på overfølsomhed, skal patienterne rådes til straks at ophøre med brugen af lægemidlet og kontakte lægen.
English: Population PK with sparse sampling b
Danish: Population FK med sparsom prøvetagning b
English: Therefore, factor VIII should be used during pregnancy and lactation only if clearly indicated.
Danish: Faktor VIII bør derfor kun bruges under graviditet og amning på tvingende indikation.
English: If a patient is to receive more than one vial of ADYNOVI, the contents of multiple vials may be drawn into the same syringe.
Danish: Hvis en patient skal have mere end ét hætteglas med ADYNOVI, kan indholdet af flere hætteglas trækkes op i samme sprøjte.
English: A higher dose may be required in children less than 12 years of age, see section 4.2.
Danish: Det kan være nødvendigt at give en højere dosis til børn under 12 år, se pkt.
English: Swirl gently until all material is dissolved (Figure 3).
Danish: Sving forsigtigt rundt, indtil alt stof er opløst (figur 3).
English: Instructions for preparation and administration
Danish: Instruktioner vedrørende klargøring og administration
English: Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII 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 hensyn til anvendelse af faktor VIII under graviditet og amning.
English: If you stop using ADYNOVI Do not stop using ADYNOVI without consulting your doctor.
Danish: Hvis du holder op med at bruge ADYNOVI Du må ikke stoppe med at bruge ADYNOVI uden at have rådført dig med lægen.
English: • Do not use if the lid is not completely sealed on the blister
Danish: • Må ikke bruges, hvis låget ikke er fuldstændigt forseglet på blisteren.
English: In this case, this medicine expires at the end of this 3-month period or the expiration date printed on the product vial, whichever is earlier.
Danish: i så fald udløber lægemidlet efter denne 3-måneders periode eller efter den udløbsdato, som er trykt på hætteglasset, hvad der end kommer først.
English: Intravenous use, after reconstitution.
Danish: Intravenøs anvendelse efter rekonstitution.
English: The solvent vial has a blue stripe.
Danish: Hætteglasset med solvens har en blå stribe.
English: Do not use ADYNOVI: - if you are allergic to rurioctocog alfa pegol, octocog alfa or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to mouse or hamster proteins
Danish: Brug ikke ADYNOVI: - hvis du er allergisk over for rurioctocog alfa pegol, octocog alfa eller et af de øvrige indholdsstoffer i ADYNOVI (angivet i punkt 6) - hvis du er allergisk over for muse- eller hamsterproteiner
English: Known allergic reaction to mouse or hamster protein.
Danish: Kendt allergisk reaktion over for muse- eller hamsterprotein.
English: You should check with your doctor if you are not sure.
Danish: Du bør konsultere din læge, hvis du er i tvivl.
English: The factor VIII/von Willebrand factor complex consists of two molecules (factor VIII and von Willebrand factor) with different physiological functions.
Danish: Faktor VIII/von Willebrand-faktor komplekset består af to molekyler (faktor VIII og von Willebrandfaktor) med forskellige fysiologiske funktioner.
English: Severe symptoms, including difficulty in breathing and (nearly) fainting, require prompt emergency treatment.
Danish: Svære symptomer, herunder vejrtrækningsbesvær og (næsten) besvimelse, kræver akut behandling omgående.
English: Haemophila A occurs only rarely in women.
Danish: Hæmofili A forekommer sjældent hos kvinder.
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 fungerer som en kofaktor for aktiveret faktor IX, hvilket accelererer omdannelsen af faktor X til aktiveret faktor X. Aktiveret faktor X omdanner protrombin til trombin.
English: The mean (SD) age was 3.3 (1.55) and 8.1 (1.92) years respectively.
Danish: Gennemsnitsalderen (SD) var henholdsvis 3,3 (1,55) og 8,1 (1,92) år.
English: Trehalose dihydrate Histidine
Danish: Trehalosedihydrat Histidin
English: Paediatric population The listed warnings and precautions apply both to adults and children.
Danish: Pædiatrisk population De anførte advarsler og forsigtighedsregler gælder for både voksne og børn.
English: The powder is a white to off-white crumbly powder.
Danish: Pulveret er et hvidt til off-white løst pulver.
English: Administer over a period of up to 5 minutes (maximum infusion rate 10 ml per min).
Danish: Opløsningen skal administreres over en periode på op til 5 minutter (maksimal infusionsrate 10 ml i minuttet).
English: Instructions for injection
Danish: Instruktion i injektion
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 VIII lægemidler.
English: Haemorrhage Early haemarthrosis, muscle bleeding or oral bleeding.
Danish: Tidlig hæmartrose, muskelblødning eller oral blødning.
English: Individual PK with full sampling a
Danish: Individuel FK med fuld prøvetagning a
English: Twenty-five of the 137 subjects were adolescents (12 to less than 18 years of age).
Danish: 25 af de 137 forsøgspersoner var unge (12 til <18 år).
English: Adjustments of doses and administration intervals may be considered based on achieved FVIII levels and individual bleeding tendency (see section 5.2).
Danish: Dosisjusteringer og administrationsintervaller kan overvejes på basis af opnåede FVIII-niveauer og blødningstendensen hos den enkelte patient (se pkt.
English: Glutathione
Danish: Glutathion
English: Post-authorisation safety study (PASS): In order to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other tissues/organs, the MAH should conduct and submit the results of a post-authorisation safety study according to an agreed protocol.
Danish: Ikke-interventionssikkerhedsundersøgelser efter tilladelse til markedsføring (PASS): For at undersøge de potentielle virkninger af PEG-akkumulering i plexus chorioideus i hjernen og andre væv/organer skal indehaveren af markedsføringstilladelsen gennemføre og forelægge resultaterne af en sikkerhedsundersøgelse efter tilladelse til markedsføring ifølge en aftalt protokol.
English: In patients with haemophilia A (inborn lack of factor VIII), it is missing or not working properly.
Danish: Hos patienter med hæmofili A (medfødt mangel på faktor VIII) mangler det, eller det fungerer ikke ordentligt.
English: Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or preferably in International Units (relative to an International Standard for factor VIII in plasma).
Danish: Faktor VIII-aktivitet i plasma udtrykkes enten som en procentdel (i forhold til normalt humant plasma) eller fortrinsvis i internationale enheder (i forhold til en international standard for faktor VIII i plasma).
English: Haemophilia A is a X-chromosomal linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as results of accidental or surgical trauma.
Danish: Hæmofili A er en X-kromosomal arvelig forstyrrelse af blodkoagulationen, der skyldes et nedsat niveau af faktor VIII:C, og som resulterer i kraftig blødning i led, muskler eller indre organer, enten spontant eller som følge af utilsigtet eller kirurgisk traume.
English: Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Danish: Hyppighed, type og sværhedsgrad af bivirkninger hos børn forventes at være på samme niveau som hos voksne.
English: If you forget to use ADYNOVI
Danish: Hvis du har glemt at bruge ADYNOVI
English: • Do not use after the expiry date stated on the labels and carton.
Danish: • Brug ikke ADYNOVI efter den udløbsdato, der står på etiketterne og æsken.
English: Perioperative haemostatic efficacy was rated as excellent (blood loss less than or equal to that expected for the same type of procedure performed in a non-haemophilic patient, and required blood components for transfusions less than or similar to that expected in non-haemophilic population) for all 26 (21 major, 5 minor) procedures.
Danish: Den perioperative hæmostatiske virkning blev bedømt som særdeles god (blodtab mindre end eller lig med det forventede for samme type indgreb foretaget hos en ikke-hæmofilipatient, og de nødvendige blodkomponenter til transfusioner var mindre end eller de samme som forventet i en ikkehæmofilipopulation) for alle 26 (21 større, 5 mindre) indgreb.
English: During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated infusions.
Danish: Under behandlingsforløbet tilrådes relevant bestemmelse af plasma faktor VIII-niveauer som vejledning for den dosis, der skal administreres, og hyppigheden af gentagne infusioner.
English: * Human factor VIII produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) cell line.
Danish: *Human faktor VIII produceret ved hjælp af rekombinant DNA-teknologi i en ovariecellelinje fra kinesiske hamstere (CHO).
English: If you think that the effect of ADYNOVI is insufficient, talk to your doctor.
Danish: Hvis du mener, at ADYNOVI har utilstrækkelig virkning, skal du tale med din læge.
English: Swirl gently until the powder is completely dissolved.
Danish: Sving forsigtigt rundt, indtil alt pulveret er helt opløst.
English: In patients with existing cardiovascular risk factors, substitution therapy with factor VIII may increase the cardiovascular risk.
Danish: Hos patienter med kardiovaskulære risikofaktorer kan substitutionsbehandling med faktor VIII øge den kardiovaskulære risiko.
English: In patients with high levels of inhibitor, factor VIII therapy may not be effective and other therapeutic options should be considered.
Danish: Hos patienter med høje niveauer af inhibitor er behandling med faktor VIII måske ikke tilstrækkeligt effektiv, og andre behandlingsmuligheder bør overvejes.
English: Important note:
Danish: Vigtigt:
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: ADYNOVI contains sodium, see section 2.
Danish: ADYNOVI indeholder natrium, se punkt 2.
English: NA, Not applicable, as Incremental Recovery and Cmax in children were determined by individual PK.
Danish: NA, Ikke relevant, da trinvis bedring og Cmax hos børn blev bestemt ved individuel FK.
English: Reconstitution with the BAXJECT III system Do not use if the lid is not completely sealed on the blister
Danish: Rekonstitution med BAXJECT III-systemet Må ikke bruges, hvis låget ikke er fuldstændigt forseglet på blisteren.
English: Table 1 Guide for dosing in bleeding episodes and surgery Degree of haemorrhage/type of surgical procedure
Danish: Tabel 1 Vejledning til dosering ved blødningsepisoder og kirurgiske indgreb Blødningsgrad/type af kirurgisk procedure
English: The dose and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and on the patient's clinical condition.
Danish: Dosis og varighed af substitutionsbehandlingen afhænger af sværhedsgraden af faktor VIII-manglen, blødningens placering og omfang samt af patientens kliniske tilstand.
English: By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
Danish: Ved substitutionsterapi forøges plasmaniveauerne af faktor VIII, hvorved der opnås en midlertidig afhjælpning af faktormanglen og afhjælpning af blødningstendenserne.
English: Thus it was not possible to conclude on the potential risks of PEG accumulation in various tissues/organs relevant for chronic use of ADYNOVI in the paediatric population.
Danish: Det er derfor ikke muligt at drage nogen konklusioner om de potentielle risici for PEG-akkumulering i væv/organer, der er relevante for kronisk anvendelse af ADYNOVI hos den pædiatriske population.
English: The vacuum will draw the solvent into the powder vial.
Danish: Vakuummet vil trække solvensen ind i hætteglasset med pulver.
English: Name and batch number of the medicinal product
Danish: Lægemidlets navn og batchnummer
English: Catheter-related complications
Danish: Kateterrelaterede komplikationer
English: Factor VIII inhibitors (for patients who have received previous treatment with Factor VIII (more than 150 days of treatment))
Danish: Factor VIII-inhibitorer (hos patienter, som tidligere har modtaget behandling med faktor VIII (flere end 150 dages behandling))
English: Use antiseptic technique (clean and low-germ conditions) and a flat work surface during the reconstitution procedure.
Danish: Anvend antiseptisk teknik (rene forhold med lav forekomst af bakterier) og en jævn arbejdsoverflade under rekonstitutionsproceduren.
English: Population PK model with 3 post-infusion samples based on randomized drawing schedule.
Danish: Populations-FK-model med 3 prøver efter infusionen baseret på randomiseret prøvetagningsplan.
English: The reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to administration.
Danish: Det rekonstituerede lægemiddel skal inspiceres visuelt for partikelmateriale og misfarvning før administration.
English: Therefore no experience regarding the use of ADYNOVI during preganancy and breast-feeding is available.
Danish: Derfor foreligger der ingen erfaringer fra brugen af ADYNOVI under graviditet og amning.
English: MedDRA Standard System Organ Class
Danish: Systemorganklasser i henhold til MedDRA-standarden
English: Treatment monitoring:
Danish: Overvågning af behandling:
English: Of the 70 bleeding episodes observed during the paediatric study, 82.9% were controlled with 1 infusion and 91.4% were controlled with 1 or 2 infusions.
Danish: Af de 70 blødningsepisoder, der blev observeret under det pædiatriske studie, blev 82,9 % kontrolleret med 1infusion, og 91,4% blev kontrolleret med 1 eller 2 infusioner.
English: Treatment with ADYNOVI will be started and supervised by a doctor who is experienced in the care of patients with haemophilia A.
Danish: Behandling med ADYNOVI bliver indledt og overvåget af en læge, der har erfaring med behandling af patienter med hæmofili A.
English: From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt bør produktet anvendes omgående, medmindre rekonstitutionsmetoden udelukker mikrobiel kontaminering.
English: The median (IQR) observed intraoperative blood loss (n = 14) was 10.0 (20.0) ml compared to the predicted average blood loss (n = 14) of 150.0 (140.0) ml for major orthopaedic surgeries.
Danish: Medianen (IQR) for observeret intraoperativt blodtab (n=14) var 10,0 (20,0) ml sammenlignet med det forventede, gennemsnitlige blodtab (n=14) på 150,0 (140,0) ml for større kirurgiske ortopædiske indgreb.
English: AUC0-Inf [IU·h/dL] Vss [dL/kg] Cmax [IU/dL]
Danish: AUC0-Inf [IE·t/dl] Vss [dl/kg] Cmax [IE/dl]
English: It is strongly recommended that every time that ADYNOVI is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
Danish: Det anbefales på det kraftigste at registrere navn og batchnummer for produktet, hver gang ADYNOVI administreres til en patient, for derved at bevare en forbindelse mellem patienten og lægemidlets batchnummer.
English: The safety of ADYNOVI was evaluated in 243 previously treated patients with severe haemophilia A (factor VIII less than 1% of normal), who received at least one dose of ADYNOVI in 3 completed multi-center, prospective, open label clinical studies and 2 ongoing clinical studies.
Danish: ADYNOVIs sikkerhed er evalueret hos 243 tidligere behandlede patienter med svær hæmofili A (factor VIII mindre end 1 % af normalen), som fik mindst en dosis ADYNOVI i 3 afsluttede, åbne, prospektive, kliniske multicenterstudier og 2 igangværende kliniske studier.
English: If you inject more ADYNOVI than recommended, tell your doctor as soon as possible.
Danish: Hvis du har injiceret mere end den anbefalede dosis ADYNOVI, skal du fortælle det til lægen hurtigst muligt.
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: En international enhed (IE) af faktor VIII-aktivitet svarer til mængden af faktor VIII i én ml normalt humant plasma.
English: PK parameters
Danish: FK-parametre
English: This should be taken into consideration by patients on a controlled sodium diet.
Danish: Dette skal tages i betragtning hos patienter, der er på en natriumkontrolleret diæt.
English: The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current WHO concentrate standard for factor VIII products.
Danish: Antallet af faktor VIII-enheder, som administreres, udtrykkes i internationale enheder (IE), der er baseret på den aktuelle WHO-koncentratstandard for faktor VIII-produkter.
English: o Do not use if particulate matter or discoloration is observed.
Danish: o Må ikke bruges, hvis der observeres partikelmateriale eller misfarvning.
English: The dose of ADYNOVI is calculated depending on your body weight and the factor VIII levels to be achieved.
Danish: Doseringen af ADYNOVI beregnes efter din legemsvægt og det faktor VIII-niveau, der skal opnås.
English: The median annualised bleed rate (ABR) in the on-demand treatment arm was 41.5 compared to 1.9 while on a twice a week prophylaxis regimen.
Danish: Medianen for den annualiserede blødningsrate (ABR) i armen, der fik behovsbehandling, var 41,5 sammenlignet med 1,9 med et profylakseregime to gange ugentligt.
English: INFORMATION IN BRAILLE
Danish: INFORMATION i BRAILLESKRIFT
English: In the repeat dose toxicity study in Cynomologous monkey, two animals showed vacuolation in the kidney in the mid dose group (350IU/kg).
Danish: I studiet af toksicitet efter gentagne doser hos Cynomolgus-aber udviste to dyr vakuolisering i nyren i mellemdosisgruppen (350 IE/kg).
English: Open the ADYNOVI blister by peeling away the lid.
Danish: Åbn blisteren med ADYNOVI ved at trække låget af.
English: Common side effects (may affect up to 1 in 10 people) Headache, nausea, diarrhoea, rash
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer) Hovedpine, kvalme, diarré, udslæt
English: If you are unsure about this, ask your doctor.
Danish: Er du i tvivl, så spørg lægen.
English: ADYNOVI has no influence on the ability to drive and use machines.
Danish: ADYNOVI påvirker ikke evnen til at føre motorkøretøj og betjene maskiner.