FrancophonIA/ELRC3.0 huggingface dataset:
English: You can do this by holding them in your hands until they feel as warm as your hands, see figure A.
Danish: Du kan gøre dette ved at holde dem i dine hænder, indtil de føles ligeså varme som dine hænder, se figur A.
English: This should be done right after step J.
Danish: Dette skal gøres lige efter trin J.
English: b Calculation based on 67 profiles.
Danish: b Beregning på baggrund af 67 profiler.
English: The package contains:
Danish: Pakningen indeholder:
English: Always wash your hands and ensure that the area around you is clean.
Danish: Vask altid dine hænder og sørg for at området omkring dig er rent.
English: From a microbiological point of view, the product should be used immediately.
Danish: Af mikrobiologiske hensyn bør produktet anvendes straks.
English: These may become severe and could be life-threatening, see
Danish: Disse kan blive alvorlige og eventuelt livstruende, se
English: • You will be monitored carefully for development of these inhibitors
Danish: • Du vil blive overvåget nøje for udvikling af disse inhibitorer
English: You will also need:
Danish: Du skal også bruge:
English: Use a new package instead.
Danish: Tag i stedet en ny pakning i brug.
English: • Check the name, strength and colour of the package to make sure it contains the correct product.
Danish: • Kontrollér navnet, styrken og farven på pakningen for at sikre, at den indeholder det rigtige produkt.
English: Within one hour before surgery
Danish: Inden for en time før kirurgi
English: Always use an aseptic technique.
Danish: Anvend altid en aseptisk teknik.
English: Repeat after 24 hours if necessary
Danish: Gentag om nødvendigt efter 24 timer
English: Your doctor may choose another dose or how often the injections should be given, based on your need.
Danish: Din læge kan vælge en anden dosis eller hvor ofte injektionerne skal indgives afhængigt af dine behov.
English: • These inhibitors, especially at high levels, stop the treatment working properly
Danish: • Disse inhibitorer, specielt ved høje koncentrationer, forhindrer, at behandlingen virker korrekt
English: In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarhed af biologiske lægemidler, skal produktnavn og batchnummer på det administrerede produkt tydeligt registreres.
English: This is of importance particularly when changing the laboratory and/or reagents used in the assay.
Danish: Dette er især relevant ved ændring af laboratoriet og/eller reagenser, der anvendes ved analysen.
English: Your doctor will calculate your dose for you.
Danish: Lægen vil beregne din dosis.
English: Do not reuse the equipment.
Danish: Genbrug ikke udstyret.
English: Do not use the powder if the colour has changed.
Danish: Brug ikke pulveret hvis farven er ændret.
English: Osmolality: 590 mOsmol/kg.
Danish: Osmolalitet: 590 mOsmol/kg.
English: • Take out the number of Esperoct packages you need.
Danish: • Tag det antal af pakninger med Esperoct som du har brug for.
English: Do not freeze
Danish: Må ikke fryses
English: Do not use Esperoct if either of the above applies to you.
Danish: Brug ikke Esperoct hvis noget af ovenstående gælder for dig.
English: • Wash your hands and dry them properly using a clean towel or let them air dry.
Danish: • Vask dine hænder og tør dem af i et rent håndklæde eller lad dem lufttørre.
English: In case of shock, standard medical treatment for shock should be implemented.
Danish: I tilfælde af chok skal medicinsk standardbehandling for chok følges.
English: • Place the vial on a flat and solid surface.
Danish: • Anbring hætteglasset på en flad og solid overflade.
English: * PTPs: Previously-treated patients.
Danish: * PTPs: Tidligere behandlede patienter.
English: This corresponds to a higher volume of distribution per kilo body weight in children compared to adults (table 4).
Danish: Dette svarer til en højere distributionsvolumen pr. kg. kropsvægt hos børn sammenlignet med voksne (tabel 4).
English: Proceed with the next injection as scheduled and continue as advised by your doctor.
Danish: Tag den næste injektion som planlagt, og fortsæt derefter som anvist af lægen.
English: How much to use
Danish: Så meget skal du bruge
English: • Check the expiry date.
Danish: • Kontrollér udløbsdatoen.
English: Spike (under protective paper)
Danish: Spids (under beskyttelsespapir)
English: • Inject slowly over approximately 2 minutes.
Danish: • Injicér langsomt over en periode på ca. 2 minutter.
English: The product contains traces of hamster proteins, which in some patients may cause allergic reactions.
Danish: Produktet indeholder spor af hamsterproteiner, som kan medføre allergiske reaktioner hos nogle patienter.
English: The powder is white to off-white.
Danish: Pulveret er hvidt til off-white.
English: The rate of administration should be determined by the patient's comfort level over approximately 2 minutes.
Danish: Administrationshastigheden skal fastsættes ud fra patientens velbefindende over ca. 2 minutter.
English: Once the product has been taken out of the refrigerator, the product must not be returned to the refrigerator.
Danish: Når først produktet er taget ud af køleskabet, må det ikke sættes tilbage i køleskabet.
English: 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 taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge lægen til råds, før du bruger dette lægemiddel.
English: Nine of these patients reverted back to prophylaxis every 4 days during the randomised study phase.
Danish: 9 af disse patienter vendte tilbage til profylaktisk behandling hver 4. dag under den randomiserede studiefase.
English: In general, there was a trend of increasing incremental recovery and decreasing clearance (mL/h/kg) with age.
Danish: Generelt var der tendens til stigende genfinding og faldende clearance (ml/t/kg) med alder.
English: Do not use the equipment without proper training from your doctor or nurse.
Danish: Brug ikke udstyret uden grundig undervisning fra lægen eller sygeplejersken.
English: In such cases, it is recommended that a specialised haemophilia centre is contacted.
Danish: I disse tilfælde anbefales det at kontakte et specialiseret hæmofilicenter.
English: The equipment is for single use only.
Danish: Udstyret er kun til engangsbrug.
English: Until the bleeding is resolved
Danish: Indtil blødningen er ophørt
English: (pre- and post-operative)
Danish: (præ- og postoperativ)
English: Do not use the equipment if you suspect it is contaminated.
Danish: Anvend ikke udstyret, hvis du har mistanke om, at det er forurenet.
English: Prophylaxis in adults/adolescents
Danish: Profylakse hos voksne/unge
English: If such inhibitors occur, the condition will manifest itself as an insufficient clinical response.
Danish: Hvis sådanne inhibitorer forekommer, vil tilstanden komme til udtryk som utilstrækkeligt klinisk respons.
English: Animal reproduction studies have not been conducted with factor VIII.
Danish: Der er ikke udført reproduktionsstudier hos dyr med faktor VIII.
English: • redness and/or swelling of the lips, tongue, face or hands
Danish: • rødme og/eller hævelse af læber, tunge, ansigt eller hænder
English: • gauze pads and plasters.
Danish: • gazestykker og plastre.
English: Do not open the equipment until you are ready to use it. Do not use the equipment if it has been dropped, or if it is damaged.
Danish: Udstyret må ikke åbnes, før du er klar til at bruge det. Anvend ikke udstyret, hvis det har været tabt, eller det er beskadiget.
English: Warnings and precautions Previous use of factor VIII medicine
Danish: Advarsler og forsigtighedsregler Tidligere brug af faktor VIII-medicin
English: As expected incremental recovery appeared to be lower while body weight adjusted clearance appeared to be higher in children compared to adults and adolescents.
Danish: Som forventet viste genfindingen sig at være lavere, mens clearance justeret for legemsvægt viste sig at være højere hos børn sammenlignet med voksne og unge.
English: Tell your doctor if you have used factor VIII medicines before, especially if you developed inhibitors (antibodies) against the medicine, since there might be a risk that it happens again.
Danish: Fortæl lægen, hvis du tidligere har brugt faktor VIII-medicin, især hvis du udviklede inhibitorer (antistoffer) over for medicinen, da der kan være en risiko for, at dette sker igen.
English: • if you are allergic to hamster proteins.
Danish: • Hvis du er allergisk over for hamsterproteiner.
English: Talk to your doctor or pharmacist if you have heart disease or you are at risk of heart disease.
Danish: Tal med din læge eller apotekspersonalet hvis du har en hjertesygdom, eller du har en risiko for at få en hjertesygdom.
English: Single dose or repeat injection every 24 hours for at least 1 day until healing is achieved
Danish: Enkeltdosis eller gentag injektion hver 24. time i mindst én dag, indtil opheling er nået
English: The equipment in this package is designed to reconstitute and inject Esperoct.
Danish: Udstyret i denne pakning er beregnet til opblanding og injektion af Esperoct.
English: Prophylaxis in children (below 12 years)
Danish: Profylakse hos børn (under 12 år)
English: • If you do not need to use all of the reconstituted medicine from the vial,
Danish: • Hvis du ikke skal bruge al den opblandede medicin fra hætteglasset,
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Danish: Trombin omdanner derefter fibrinogen til fibrin, og der kan dannes et koagel.
English: Factor VIII is a protein found in the blood that helps to prevent and stop bleeding.
Danish: Faktor VIII er et protein, som findes i blodet, og som hjælper med at forebygge og stoppe blødning.
English: Protective paper
Danish: Beskyttelsespapir
English: Number of profiles
Danish: Antal profiler
English: 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: Hyppigheder er angivet efter 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 tilgængelig data).
English: The following side effects have been observed with Esperoct
Danish: Følgende bivirkninger er observeret med Esperoct
English: The safety and efficacy of Esperoct in previously untreated patients have not yet been established.
Danish: Sikkerhed og virkning af Esperoct hos patienter der ikke tidligere er blevet behandlet, er endnu ikke klarlagt.
English: The vast majority of bleeds treated with Esperoct were of mild/moderate severity.
Danish: Langt størstedelen af de blødninger, der blev behandlet med Esperoct, var lette/moderate.
English: Consider to continue therapy for another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dL)
Danish: Overvej at fortsætte behandlingen i yderligere 7 dage for at opretholde faktor VIII-aktivitet på 30% til 60% (IE/dl)
English: Follow the instructions for proper use for your connector and CVAD in consultation with your doctor or nurse.
Danish: Følg instruktionen i brug af din forbindelse og CVAD i samråd med lægen eller sygeplejersken.
English: Consideration should be given to maintain a factor VIII activity at or above the target range.
Danish: Det bør tilstræbes at opretholde en faktor VIII-aktivitet på eller over målområdet.
English: • pale and cold skin, fast heartbeat, or dizziness (low blood pressure)
Danish: • bleg og kold hud, hurtig hjerterytme (puls) eller svimmelhed (lavt blodtryk)
English: • Injecting into a CVAD may require using a sterile 10 mL plastic syringe for withdrawal of the reconstituted solution.
Danish: • Injektion ind i et CVAD kræver muligvis en steril 10 ml plastiksprøjte til udtræk af den opblandede opløsning.
English: Of note, annualized bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies.
Danish: Det er værd at tage i betragtning, at den årlige blødningsrate (ABR) ikke er sammenlignelig mellem forskellige faktor-koncentrater og mellem forskellige kliniske studier.
English: Caution: The pre-filled syringe is made of glass and is designed to be compatible with standard luer-lock connections.
Danish: Advarsel: Den fyldte sprøjte er lavet af glas og er designet til at kunne passe sammen med standard luer-lock forbindelser.
English: Treatment monitoring
Danish: Monitorering af behandlingen
English: Factor VIII inhibition Uncommon (PTPs)**
Danish: Inhibering af faktor VIII Ikke almindelig (PTPs)**
English: *Human factor VIII, produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) cells line, and no additives of human or animal origin are used in the cell culture, purification, conjugation or formulation of Esperoct.
Danish: *Human faktor VIII produceret ved hjælp af rekombinant DNA-teknologi i en ovariecellelinje fra kinesiske hamstere (CHO), og der anvendes ikke tilsætningsstoffer af human eller animalsk oprindelse i cellekulturen, oprensningen, konjugeringen eller formuleringen af Esperoct.
English: Including tooth extraction
Danish: Inklusive tandudtrækning
English: The use of Esperoct in children below 12 years is not indicated (see section 4.2 for information on paediatric use).
Danish: Anvendelsen af Esperoct hos børn under 12 år er ikke indiceret (se punkt 4.2 for information om brug hos børn).
English: Pharmacokinetic parameters
Danish: Farmakokinetiske parametre
English: This is equivalent to 1.5% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Det svarer til 1,5% af det anbefalede maksimale daglige indtag af natrium for voksne.
English: If you stop using Esperoct, you may no longer be protected against bleeding or a current bleed may not stop.
Danish: Hvis du holder op med at tage Esperoct, er du måske ikke længere beskyttet mod blødning, eller en aktuel blødning vil måske ikke stoppe.
English: When you prepare and inject medicine directly into a vein, it is important to use a clean and germ- free (aseptic) technique.
Danish: Når du klargør og injicerer lægemidlet direkte ind i en vene, er det vigtigt at bruge en ren og bakteriefri (aseptisk) metode.
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 i behandling med koagulationsfaktor VIII-præparater monitoreres omhyggeligt for udviklingen af inhibitorer ved passende kliniske observationer og laboratorietests.
English: L-Methionine
Danish: L-Methionin
English: The reconstituted medicinal product should be inspected visually for particulate matter and discolouration prior to administration.
Danish: Det rekonstituerede lægemiddel skal inspiceres visuelt for partikler og misfarvning før administration.
English: Esperoct is given as an injection into a vein (intravenously), see “Instructions on how to use Esperoct” for more information.
Danish: Esperoct gives som en injektion i en blodåre (intravenøst), se "Esperoct brugervejledning" for yderligere oplysninger.
English: Anti-PEG antibodies
Danish: Anti-PEG antistoffer
English: Repeat every 8 to 24 hours to maintain factor VIII activity within the target range
Danish: Gentag hver 8. til 24. time for at opretholde faktor VIIIaktivitet inden for målområdet
English: The dose level and dosing intervals for surgery depend on the procedure and local practice.
Danish: Dosisniveau og doseringsinterval i forbindelse med kirurgi afhænger af indgrebet og den lokale praksis.
English: • if you are allergic to the active substance or to any of the other ingredients of this medicine
Danish: • Hvis du er allergisk over for det aktive stof eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6)
English: Do not disassemble the equipment before disposal.
Danish: Skil ikke udstyret fra hinanden før bortskaffelse.
English: If you have previously received more than 150 days of treatment with factor VIII, inhibitors (antibodies) may develop (may affect up to 1 in 100 people).
Danish: Hvis du tidligere har fået behandling med faktor VIII i over 150 dage, kan der udvikles inhibitorer (antistoffer) (kan forekomme hos 1 ud af 100 patienter).
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 Willebrand faktor) med forskellige fysiologiske funktioner.
English: Esperoct is for intravenous use.
Danish: Esperoct er til intravenøs anvendelse.
English: No difference in the safety profile was observed between previously treated adolescents (12-18 years) and adult patients.
Danish: Der blev ikke observeret nogen forskel i sikkerhedsprofilen mellem tidligere behandlede unge (1218 år) og voksne patienter.
English: Stop the injection immediately if you develop severe and sudden allergic reactions (anaphylactic reactions).
Danish: Stop injektionen med det samme, hvis du får alvorlige og pludselige allergiske reaktioner (anafylaktiske reaktioner).
English: It must be clear and colourless and no particles should be visible.
Danish: Den skal være klar og farveløs, og der må ikke være nogen synlige partikler.
English: Of the 68 children below 12 years on prophylaxis, 29 (42.6%) did not have any bleeds.
Danish: Af de 68 børn under 12 år, der fik profylakse, havde 29 (42,6%) ingen blødninger.
English: The listed warnings and precautions apply both to adults and adolescents (12-18 years).
Danish: De anførte advarsler og forsigtighedsregler gælder for både voksne, og unge (12-18 år).
English: Do not touch the rubber stopper with your fingers as this can transfer germs.
Danish: Rør ikke ved gummiproppen med dine fingre, da dette kan overføre bakterier.
English: Before reconstitution (before the powder is mixed with the solvent):
Danish: Før opblanding (før pulveret blandes med solvensen):
English: The single dose pharmacokinetic parameters are comparable between young children (0 to below 6 years) and older children (6 to below 12 years), and between adolescents (12 to17 years) and adults (18 years and above).
Danish: De farmakokinetiske parametre efter en enkeltdosis er sammenlignelige mellem mindre børn (0 til under 6 år) og ældre børn (6 til under 12 år) og mellem unge (12 til 17 år) og voksne (18 år og derover).
English: • headache, nausea or vomiting.
Danish: • hovedpine, kvalme eller opkastning.
English: If your dose requires more than one vial, repeat steps A to J with additional vials, vial adapters and pre-filled syringes until you have reached your required dose.
Danish: Hvis din dosis kræver mere end ét hætteglas, gentages trinene A til J med yderligere hætteglas, hætteglasadapterer og fyldte sprøjter, indtil du opnår den nødvendige dosis.
English: In children below 12 years long-term safety has not been established.
Danish: Hos børn under 12 år er den langsigtede sikkerhed ikke klarlagt.
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 faktor VIII under graviditet og amning.
English: The MAH shall complete, within the stated timeframe, the below measures:
Danish: Indehaveren af markedsføringstilladelsen skal, indenfor den angivne tidsramme, gennemføre følgende foranstaltninger:
English: Esperoct was effective in maintaining haemostasis during major surgery with a success rate of 95.6% in all major surgeries performed (43 out of 45 had the effect rated as ‘excellent‘ or ‘good‘).
Danish: Esperoct var effektivt til at fastholde hæmostase i forbindelse med større kirurgiske indgreb med en succesrate på 95,6% for alle de større kirurgiske indgreb, der blev foretaget (i 43 ud af 45 kirurgiske indgreb blev virkningen vurderet som 'fremragende' eller 'god').
English: • Wipe the rubber stopper with a sterile alcohol swab and allow it to air dry for a few seconds before use to ensure that it is as germ-free as possible.
Danish: • Tør gummiproppen af med en steril alkoholserviet, og lad den lufttørre i nogle sekunder før brug, for at sikre at den er så fri for bakterier som muligt.
English: Therefore, factor VIII should be used during pregnancy and lactation only if clearly indicated.
Danish: Faktor VIII bør derfor kun anvendes under graviditet og amning på tvingende indikation.
English: Overall, including all extensions parts, 31 of 61 patients on every 7 days prophylaxis switched back to every 4 days treatment.
Danish: Samlet set, inklusive alle studieforlængelser, skiftede 31 ud af 61 patienter på profylaktisk behandling hver 7. dag tilbage til behandling hver 4. dag.
English: If you have a catheter where medicines can be injected into your blood (central venous access device), you may develop infections or blood clots at the site of the catheter.
Danish: Hvis du har kateter, hvor medicin kan indsprøjtes i blodet (centralt venekateter), kan du få infektioner eller blodpropper på kateterstedet.
English: If this happens, your medicine may stop working properly and you may experience persistent bleeding.
Danish: Hvis dette sker for dig, kan medicinen holde op med at virke korrekt, og du kan opleve vedvarende blødning.
English: If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for factor VIII inhibitor presence should be performed.
Danish: Hvis de forventede faktor VIII-aktivitetsniveauer i plasma ikke opnås, eller hvis blødning ikke kan kontrolleres med en passende dosis, skal der testes for forekomst af faktor VIII-inhibitor.
English: In patients with existing cardiovascular risk factors, substitution therapy with factor VIII may increase the cardiovascular risk.
Danish: Hos patienter med eksisterende kardiovaskulære risikofaktorer kan substitutionsbehandling med faktor VIII øge den kardiovaskulære risiko.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products or reconstituted with injection solutions other than the provided sodium chloride solvent.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler eller rekonstitueres med injektionsvæske udover den medfølgende natriumchlorid solvens.
English: Esperoct is supplied as a powder.
Danish: Esperoct leveres som pulver.
English: The half-life of Esperoct was 1.6 fold longer compared to unmodified factor VIII products in adults.
Danish: Halveringstiden for Esperoct var 1,6 gange længere sammenlignet med ikke-modificerede faktor VIIIpræparater hos voksne.
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 co-faktor for aktiveret faktor IX, og accelererer omdannelsen af faktor X til aktiveret faktor X. Aktiveret faktor X omdanner protrombin til trombin.
English: The patient had a factor VIII gene intron 22 inversion and was at a high risk of developing factor VIII inhibitors.
Danish: Patienten havde en omlejring af faktor VIII intron 22 genet og var i høj risiko for at udvikle faktor VIII-inhibitorer.
English: Clinical efficacy of Esperoct during major surgery
Danish: Klinisk virkning af Esperoct under større kirurgiske indgreb
English: No interactions of human coagulation factor VIII (rDNA) with other medicinal products have been reported.
Danish: Der er ikke rapporteret interaktioner mellem human koagulationsfaktor VIII (rDNA) og andre lægemidler.