FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetic guided dosing regimen (according to a specific formula) was targeted to maintain factor VIII trough levels ≥ 1% at the inter-dosing interval of 72 hours.
Danish: Målet for det farmakokinetisk styrede dosisregime (i henhold til en specifik formel) var at holde dalniveauet for faktor VIII ≥1 % i intervallet på 72 timer mellem doserne.
English: Prevention of bleeding
Danish: Forebyggelse af blødning
English: Feeling abnormal
Danish: Unormal følelse
English: Allergic type hypersensitivity reactions, including anaphylaxis, have been reported with ADVATE.
Danish: Allergiske overfølsomhedsreaktioner, herunder anafylaksi, er rapporteret med ADVATE.
English: Always take ADVATE exactly as your doctor has told you.
Danish: Brug ADVATE præcis som din læge har sagt.
English: Including tooth extraction.
Danish: Inklusive tandudtræk.
English: However, no correlating adverse histopathological changes could be observed indicating a transient nature of this finding.
Danish: Der blev dog ikke observeret nogen tilknyttede negative histopatologiske ændringer, hvilket indikerer, at de observerede fænomener er forbigående.
English: Cleanse stoppers with alcohol swabs.
Danish: Rens propperne med alkoholkompresser.
English: Invert the system (the vial with the reconstituted solution has to be on top).
Danish: Vend systemet på hovedet (hætteglasset med den rekonstituerede opløsning skal være foroven).
English: The frequency of administration will depend on how well ADVATE is working for you.
Danish: Hvor tit du skal tage ADVATE afhænger af, hvor godt det virker for dig.
English: The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titre inhibitors which are transiently present or remain consistently low titre posing less of a risk of insufficient clinical response than high titre inhibitors.
Danish: Den kliniske relevans af inhibitorudviklingen afhænger af inhibitorens titer, hvor lavtiter-inhibitorer, som er forbigående til stede eller konsekvent forbliver lav titer, udgør en mindre risiko for utilstrækkeligt klinisk respons end højtiter-inhibitorer.
English: These symptoms can constitute an early symptom of an anaphylactic shock, manifestations of which may additionally include extreme dizziness, loss of consciousness, and extreme difficulty in breathing.
Danish: Disse symptomer kan være de første tegn på et anafylaktisk shock, der desuden kan omfatte ekstrem svimmelhed, besvimelse og ekstremt svært ved at trække vejret.
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: Each pack also contains a device for reconstitution (BAXJECT II).
Danish: Hver pakning indeholder også et udstyr til rekonstitution (BAXJECT II).
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 to thrombin.
Danish: Aktiveret faktor VIII virker som en co-faktor til aktiveret faktor IX og accelerer derved omdannelsen af faktor X til aktiveret faktor X. Aktiveret faktor X omdanner protrombin til trombin.
English: Insert the white plastic spike through the ADVATE powder stopper.
Danish: Indsæt den hvide plastik-spike gennem ADVATE-pulverproppen.
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 anvendelsen af ADVATE under graviditet og amning.
English: There is a rare risk that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to ADVATE.
Danish: Der er en sjælden risiko for, at du får en anafylaktisk reaktion (en alvorlig, pludselig allergisk reaktion) mod ADVATE.
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of plasma factor VIII activity assay is indispensable.
Danish: I tilfælde af større kirurgiske indgreb i særdeleshed er præcis overvågning af substitutionsbehandlingen med plasma faktor VIII-aktivitetsanalyse ufravigelig.
English: If you stop using ADVATE Do not stop using ADVATE without consulting your doctor.
Danish: Hvis du holder op med at bruge ADVATE Hold ikke op med at bruge ADVATE uden at kontakte din læge eller sundhedspersonalet.
English: Proceed with the next injection as scheduled and continue as advised by your doctor.
Danish: Tag i stedet næste, planlagte dosis, og fortsæt i henhold til din læges anvisninger.
English: Place the ADVATE on a flat surface with the solvent vial on top (Fig. 1).
Danish: Anbring ADVATE på en jævn overflade med solvens-hætteglasset øverst (Fig. 1).
English: Common side effects (may affect up to 1 in 10 people) headache and fever.
Danish: Almindelige bivirkninger (forekommer hos 1 ud af 10 brugere) Hovedpine og feber.
English: Calcium chloride Trometamol Polysorbate 80
Danish: Calciumchlorid Trometamol Polysorbat 80
English: Boulevard René Branquart 80 B-7860 Lessines Belgium
Danish: Boulevard René Branquart 80 B-7860 Lessines Belgien
English: Related to central venous access devices (CVAD) catheter-related infection, systemic infection and local blood clot at the catheter site.
Danish: Relateret til centralt venekateter (CVAD) kateter-relateret infektion, systemisk infektion og blodprop lokalt ved katetret.
English: - Use within three hours after reconstitution.
Danish: - Skal anvendes inden 3 timer efter rekonstitution.
English: The dose of octocog alfa is calculated depending on your body weight and the factor VIII levels to be achieved.
Danish: Udregning af din dosis af octocog alfa er afhængig af din legemsvægt samt af det faktor VIII-niveau, der skal nås.
English: Open the package of BAXJECT II device by peeling away the paper lid without touching the inside (Fig. a).
Danish: Åben pakningen med BAXJECT II-udstyret ved at trække papirlåget af uden at røre indersiden (Fig. A).
English: Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in IUs (relative to the international standard for factor VIII in plasma).
Danish: Faktor VIII-aktiviteten i plasma er udtrykt enten som en procentdel (i forhold til normal human plasma) eller i IE (i forhold til den internationale standard for faktor VIII i plasma).
English: Treatment of bleeding
Danish: Behandling af blødning
English: Laboratory test abnormal
Danish: Unormal laboratorieprøve
English: Open the ADVATE package by peeling away the lid.
Danish: Åbn pakningen med ADVATE ved at trække låget af.
English: The ADRs that occurred in the highest frequency were development of neutralising antibodies to factor VIII (inhibitors), headache and fever.
Danish: De bivirkninger, som forekom med den højeste hyppighed, var udvikling af neutraliserende antistoffer mod faktor VIII (inhibitorer), hovedpine og feber
English: ADVATE has no influence on the ability to drive and use machines.
Danish: ADVATE påvirker ikke evnen til at føre motorkøretøj og betjene maskiner.
English: The plasma levels of factor VIII are increased by replacement therapy, thereby enabling a temporary correction of the factor VIII deficiency and correction of the bleeding tendency.
Danish: Plasmaniveauer af faktor VIII øges ved substitutionsbehandling, hvorved der opnås en midlertidig korrektion af manglen på faktor VIII og en korrektion af blødningstendenser.
English: Treatment with ADVATE will be started by a doctor who is experienced in the care of patients with haemophilia A.
Danish: Behandling med ADVATE vil blive sat i gang af en læge med erfaring i behandling af patienter med hæmofili A.
English: Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia and with resuscitation support immediately available in case of anaphylaxis.
Danish: Behandlingen skal indledes under supervision af en læge med erfaring i behandling af hæmofil og med genoplivningsudstyr umiddelbart tilgængeligt i tilfælde af anafylaksi.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII activity and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Danish: Hæmofili A er en kønsbunden arvelig forstyrrelse af blodets koagulation, som skyldes nedsatte niveauer af faktor VIII-aktivitet og resulterer i voldsom blødning i led, muskler eller indre organer, enten spontant eller som følge af ulykke eller kirurgisk traume.
English: The administration of ADVATE in children (intravenously) does not differ from the administration in adults.
Danish: Indgivelse af ADVATE til børn (intravenøst) afviger ikke fra indgivelse til voksne.
English: You should tell your doctor if you have been previously treated with Factor VIII products, especially if you developed inhibitors, since there might be a higher risk that it happens again.
Danish: Du skal fortælle det til din læge, hvis du før er blevet behandlet med faktor VIII produkter, især hvis du har udviklet inhibitorer (antistoffer).
English: The vacuum will draw the solvent into the ADVATE powder vial (Fig. c).
Danish: Vakuummet vil trække solvenset ind i ADVATE-pulverhætteglasset (Fig. C).
English: Instructions for injection
Danish: Instruktioner i injektion:
English: The following table 2 provides the frequency of adverse drug reactions in clinical trials and from spontaneous reporting.
Danish: Nedenstående skema 2 viser hyppigheden af bivirkninger i kliniske forsøg og fra spontan rapportering.
English: Parenteral medicinal products should be inspected for particulate matter prior to administration, whenever solution and container permit.
Danish: Parenterale medicinske, præparater bør inspiceres for partikler før indgivelse, når som helst opløsningen og beholderen tillader dette.
English: Paediatric population: The listed warnings and precautions apply to both adults and children.
Danish: Pædiatrisk population De anførte advarsler og forsigtighedsregler gælder for både voksne og børn.
English: Do not use ADVATE if the solution is not fully clear or not completely dissolved.
Danish: Anvend ikke ADVATE, hvis opløsningen er grumset eller ikke fuldstændig opløst.
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 indholdet af faktor VIII i én ml normal human plasma.
English: In study 060201 two long-term prophylaxis treatment schemes have been compared in 53 PTPs: an individualized pharmacokinetic guided dosing regimen (within a range of 20 to 80 IU of factor VIII per kg body weight at intervals of 72 ± 6 hours, n=23) with a standard prophylactic dosing regimen (20 to 40 IU/kg every 48 ±6 hours, n=30).
Danish: I studie 060201 blev to behandlingsplaner med langtidsprofylakse hos 53 tidligere behandlede patienter sammenlignet: et individuelt tilpasset dosisregime, der var styret af farmakokinetikken (mellem 20-80 IE faktor VIII pr. kg legemsvægt med intervaller på 72 ± 6 timer, n = 23) og et standard dosisregime (20-40 IE/kg hver 48 ± 6 timer, n = 30).
English: Other medicines and ADVATE Tell your doctor if you are using, have recently used or might use any other medicines.
Danish: Brug af anden medicin sammen med ADVATE Fortæl det til lægen, hvis du bruger anden medicin eller har gjort det for nylig.
English: Factor VIII is necessary for the blood to form clots and stop bleedings.
Danish: Faktor VIII er nødvendig, for at blodet kan størkne og stoppe blødninger.
English: If any of these symptoms occur, stop the injection immediately and contact your doctor.
Danish: Hvis du får nogle af disse symptomer, skal du straks stoppe injektionen og kontakte din læge eller sundhedspersonalet.
English: Inhibitors are blocking antibodies against factor VIII that reduce the efficacy of ADVATE to prevent or control bleeding.
Danish: Inhibitorer er antistoffer, der blokerer for faktor VIII og dermed nedsætter den ADVATEs evne til at forebygge eller kontrollere blødning.
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: If this happens, you should contact your doctor immediately.
Danish: Kontakt i så fald straks din læge.
English: The reconstituted solution should be inspected visually for any foreign particulate matter and/or discoloration.
Danish: Den rekonstituerede opløsning skal inspiceres visuelt for fremmede partikler og/eller misfarvning.
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 blisterpakningen.
English: Misapplication of ADVATE
Danish: Forkert indgivelse af ADVATE
English: Uncommon (PTPs)d Very common (PUPs)
Danish: Ikke almindelig (PTPs)d Meget almindelig (PUPs)d
English: The safety and haemostatic efficacy of ADVATE in the paediatric population are similar to that of adult patients.
Danish: ADVATES sikkerhed og hæmostatiske virkning hos den pædiatriske population svarer til sikkerheden og virkningen hos voksne patienter.
English: A local tolerance study in rabbits showed that ADVATE reconstituted with 2 ml of sterilised water for injections is well tolerated after intravenous administration.
Danish: En undersøgelse af lokal tolerance hos kaniner viste, at ADVATE rekonstitueret i 2 ml sterilt vand tolereres godt efter intravenøs indgivelse.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ADVATE in all subsets of the paediatric population in haemophilia A (congenital factor VIII deficiency) in "Immune Tolerance Induction (ITI) in patients with haemophilia A (congenital factor VIII deficiency) who have developed inhibitors to factor VIII" and "treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency)".
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med ADVATE i alle undergrupper af den pædiatriske population med hæmofili A (medfødt faktor VIII-mangel) ved "immuntoleranceinduktion hos patienter med hæmofili A (medfødt faktor VIIImangel), som har udviklet inhibitorer mod faktor VIII" og "behandling og forebyggelse af blødninger hos patienter med hæmofili A (medfødt faktor VIII-mangel)" (se pkt.
English: Draw the reconstituted solution into the syringe by pulling the plunger back slowly (Fig. e).
Danish: Træk den rekonstituerede opløsning ind i sprøjten ved at trække stemplet langsomt tilbage (Fig. E).
English: Should a significant increase occur, reducing the rate of administration or temporarily interrupting the injection usually allows the symptoms to disappear promptly (see sections 4.4 and 4.8).
Danish: Skulle en signifikant forøgelse forekomme, vil reduktion af indgivelseshastighed eller midlertidig pause i injektionen normalt omgående få symptomerne til at forsvinde (se pkt.
English: Table 1 Guide for dosing in bleeding episodes and surgery Degree of haemorrhage/type of surgical procedure
Danish: Skema 1 Vejledning til dosering ved blødningsepisoder og kirurgiske indgreb Blødningsgrad/type af kirurgi
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products or solvents.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler.
English: The rate of administration should be determined to ensure the comfort of the patient up to a maximum of 10 ml/min.
Danish: Indgivelseshastigheden bør bestemmes så den sikrer patientens velbefindende, dog maksimalt 10 ml/min.
English: Octocog alfa (recombinant human coagulation factor VIII)
Danish: Octocog alfa (rekombinant humant koagulationsfaktor VIII)
English: Of the 229 treated patients who were assessed for antibodies to murine IgG, 10 showed a statistically significant upward trend, 2 displayed a sustained peak or transient spike and one patient had both.
Danish: Af de 229 behandlede patienter, der blev undersøgt for antistoffer mod murinIgG, viste 10 en statistisk signifikant opadgående tendens, 2 viste en vedvarende top eller kortvarig stigning, og en patient havde begge dele.
English: The analysis of plasma samples was conducted in a central laboratory using a one-stage clotting assay.
Danish: Analyserne af plasmaprøverne blev udført i et centralt laboratorium med et-trins koagulationstest.
English: If central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteremia and catheter site thrombosis should be considered.
Danish: Kateter-relaterede kompliktioner under behandling Hvis der kræves adgang via centralt venekateter (CVAD), skal risikoen for CVAD-relaterede komplikationer, herunder lokale infektioner, bakteriæmi og trombose ved kateterstedet, overvejes.
English: In case of the following haemorrhagic events, the factor VIII activity should not fall below the given plasma activity level (in % of normal or IU/dl) in the corresponding period.
Danish: I tilfælde af følgende hæmorragiske tilstande bør faktor VIII-aktiviteten ikke være mindre end det anførte plasma-aktivitetsniveau (i % af normal eller IE/dl) i den tilsvarende periode.
English: Severe symptoms, including difficulty in breathing and (nearly) fainting, require prompt emergency treatment.
Danish: Alvorlige symptomer som f.eks. åndedrætsbesvær og (næsten) besvimelse kræver omgående lægebehandling.
English: Attach a butterfly needle to the syringe.
Danish: Tilslut en butterfly-nål til sprøjten.
English: Do not tilt the system until the transfer is complete.
Danish: Vend eller vip ikke systemet, før overførslen er helt afsluttet.
English: Use in children and adolescents (from 0 to 18 years of age) For the treatment of bleeding the dosing in children does not differ from adult patients.
Danish: Anvendelse hos børn og voksne (i alderen 0 til 18 år) Til behandling af blødning afviger dosen til børn ikke fra den, der gives til voksne patienter.
English: The solution should be administered slowly, at a rate as determined by the patient's comfort level, not to exceed 10 ml per minute.
Danish: Opløsningen bør indgives langsomt, ved en hastighed bestemt af patientens velbefindende, og må ikke overstige 10 ml per minut.
English: Be sure that the ADVATE powder is completely dissolved, otherwise not all reconstituted solution will pass through the device filter.
Danish: Vær sikker på, at ADVATE-pulveret er fuldstændigt opløst, ellers vil den rekonstituerede opløsning ikke passere gennem udstyrets filter.
English: Slight transient reddening at the administration site was observed after intraarterial application and after paravenous administration.
Danish: Der blev observeret let, forbigående rødmen på indgivelsesstedet efter intraarteriel indgivelse og efter paravenøs indgivelse.
English: Solvent: Clea and colourless solution.
Danish: Solvens: Klar og farveløs opløsning.
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 blisterpakningen.
English: Place the vials on a flat clean surface.
Danish: Anbring hætteglassene på en jævn, ren overflade.
English: Eye inflammation
Danish: Øjenbetændelse
English: For on demand treatment dosing in paediatric patients (0 to 18 years of age) does not differ from adult patients.
Danish: Til behandling ved behov adskiller doseringen hos pædiatriske patienter (i alderen 0 til 18 år) sig ikke fra doseringen hos voksne patienter.
English: No symptoms of overdose with recombinant coagulation factor VIII have been reported.
Danish: Der er ingen rapporter om symptomer på overdosering med rekombinant koagulationsfaktor VIII.
English: Related to surgery catheter-related infection, decreased red cell blood count, swelling of limbs and joints, prolonged bleeding after drain removal, decreased Factor VIII level and post-operative bruise.
Danish: Ved kirurgiske indgreb kateterrelateret infektion, nedsat antal røde blodceller, hævelse af ben og led, forlænget blødning efter fjernelse af dræn, nedsat faktor VIII-niveau og blodansamlinger efter operation.
English: The calculation of the required dose of factor VIII is based on the empirical finding that 1 IU factor VIII per kg body weight raises the plasma factor VIII activity by 2 IU/dl.
Danish: Beregningen af den nødvendige dosis af faktor VIII er baseret på det empiriske fund, at 1 IE faktor VIII pr. kg legemsvægt øger plasma faktor VIII-aktiviteten med 2 IE/dl.
English: Required units (IU) = body weight (kg) x desired factor VIII rise (%) x 0.5
Danish: Nødvendige enheder (IE) = legemsvægt (kg) x ønskede faktor VIII-stigning (%) x 0,5
English: ADVATE is usually injected into a vein (intravenously) by your doctor or nurse.
Danish: ADVATE injiceres normalt i en vene (intravenøst) af din læge eller sygeplejerske eller dig selv, efter du har fået den nødvendige træning.
English: ADVATE contains sodium
Danish: ADVATE indeholder natrium
English: Reconstitution with the BAXJECT II device - For reconstitution use only the sterilised water for injections and the reconstitution device provided in the pack.
Danish: Rekonstitution med BAXJECT II-udstyret - Til rekonstitution må kun anvendes sterilt vand til injektionsvæsker og det rekonstitutionsudstyr, der er leveret i pakningen.
English: Therefore, factor VIII should be used during pregnancy and breastfeeding only if clearly indicated.
Danish: Faktor VIII bør derfor kun anvendes på tvingende indikation til gravide og ammende kvinder.
English: Octocog alfa (human coagulation factor VIII (rDNA)) is a purified protein that has 2332 amino acids.
Danish: Octocog alfa (human koagulationsfaktor VIII (rDNA)) er renset protein, der har 2.332 aminosyrer.
English: - The other ingredients are mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, and glutathione (reduced).
Danish: - Øvrige indholdsstoffer: mannitol, natriumchlorid, histidin, trehalose, calciumchlorid, trometamol, polysorbat 80 og glutathion (reduceret).
English: Haemorrhage Early haemarthrosis, muscle bleeding or oral bleeding.
Danish: Tidlig hæmarthrose, muskelblødning eller oral blødning.
English: Monocyte Count increased
Danish: Forhøjet monocyttal
English: Name and address of the manufacturers responsible for batch release
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse
English: Steady State (dl/kg)
Danish: Distributionsvolumen ved steady state (dl/kg)
English: Other than the development of inhibitors in previously untreated paediatric patients (PUPs), and catheter-related complications, no age-specific differences in side effects were noted in the clinical studies.
Danish: Ud over udvikling af inhibitorer hos tidligere ubehandlede pædiatriske patienter og kateterrelaterede komplikationer blev der ikke bemærket nogle aldersspecifikke bivirkninger i de kliniske studier.
English: Aseptic technique is required during administration.
Danish: Aseptisk teknik er påkrævet under indgivelsen.