FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharyngolaryngeal pain Rhinalgia
Danish: Øvre luftvejsobstruktion Faryngolaryngeale smerter
English: You can do this by holding them in your hands until they feel as warm as your hands.
Danish: Det kan du gøre ved at holde dem i hænderne, indtil de føles lige så varme som dine hænder.
English: Allow the alcohol to dry.
Danish: Lad alkoholen tørre.
English: Repeat every 12 to 24 hours.
Danish: Gentag hver 12. til 24. time.
English: Taken out of refrigerator: _____________
Danish: Taget ud af køleskab: _____________
English: This is particularly important if you are having major surgery.
Danish: Dette er især vigtigt, hvis du skal have foretaget et større kirurgisk indgreb.
English: Vihuma can be used for all age groups.
Danish: Vihuma kan bruges til alle aldersgrupper.
English: Of these patients, 34 (85%) were treated twice weekly or less.
Danish: Af disse patienter blev 34 (85 %) behandlet højst to gange om ugen.
English: How often you need an injection will depend on how well Vihuma is working for you.
Danish: Hvor ofte du har brug for en indsprøjtning, vil afhænge af, hvor godt Vihuma fungerer for dig.
English: This is of importance particularly when changing the laboratory and/or reagents used in the assay.
Danish: Dette er navnlig vigtigt ved skift af laboratorium og/eller de reagenser, der anvendes i analysen.
English: Adult and adolescent population 12 - 65 years of age
Danish: Voksne og unge i alderen 12-65 år
English: You must contact your doctor immediately if you notice any of the following symptoms:
Danish: Du skal straks kontakte lægen, hvis du får nogen af følgende symptomer:
English: This will be checked by your doctor.
Danish: Dette skal kontrolleres af lægen.
English: The regimen may be adjusted based on patient response.
Danish: Behandlingsregimet kan justeres ud fra patientens respons.
English: Severe symptoms require prompt emergency treatment.
Danish: Alvorlige symptomer kræver omgående lægebehandling.
English: The result was positive only at dilution factor 1 and the antibody titre was very low.
Danish: Resultatet var kun positivt ved fortyndingsfaktor 1 og antistoftiteren var meget lavt.
English: All (n=20)
Danish: Alle (n = 20)
English: The sample was tested by the central laboratory at eight dilutions.
Danish: Prøven blev testet af centrallaboratoriet ved 8 fortyndinger.
English: Wait until all the powder dissolves completely.
Danish: Vent, indtil al pulveret er helt opløst.
English: These symptoms can be early symptoms of an anaphylactic shock.
Danish: Disse symptomer kan være de første symptomer på et anafylaktisk shock.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, bedes du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: From a microbiological point of view, the product should be used immediately after reconstitution.
Danish: Ud fra et mikrobiologisk synspunkt bør præparatet anvendes straks efter rekonstitution.
English: The solution is now prepared for immediate use.
Danish: Opløsningen er nu klar til brug med det samme.
English: Minor surgery including tooth extraction
Danish: Mindre kirurgisk indgreb, herunder tandudtrækning
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 February 2017
Danish: Dato for første tilladelse: 13. februar 2017
English: Solvent: a clear, colourless liquid.
Danish: Solvens: en klar, farveløs væske.
English: These inhibitors, especially at high levels, stop the treatment working properly and you or your child will be monitored carefully for the development of these inhibitors.
Danish: Disse inhibitorer stopper behandlingen i at virke ordentligt, især ved høje niveauer, og du eller dit barn vil blive overvåget nøje for udvikling af disse inhibitorer.
English: These data were corroborated by a long-term follow-up of 49 of these children who were treated for an additional median period of approximately 30 months (range from 9.5 to 52 months); during this period 45% of children had no spontaneous bleeds
Danish: Disse data blev bekræftet ved en langvarig opfølgning af 49 af disse børn, som blev behandlet i en yderligere gennemsnitligperiode på ca. 30 måneder (interval 9,5-52 måneder); i denne periode havde 45 % af børnene ingen spontane blødninger.
English: 33 (82.5%) patients did not experience any bleeds and 36 (90.0%) patients had no spontaneous bleeds.
Danish: 33 patienter (82,5 %) oplevede ingen blødning, og 36 patienter (90,0 %) havde ingen spontane blødninger.
English: Paediatric population The listed warnings and precautions apply both to adults and children.
Danish: Pædiatrisk population De angivne advarsler gælder både for voksne og børn.
English: The way Vihuma is used in children does not differ from the way it is used in adults.
Danish: Den måde, hvorpå Vihuma anvendes til børn adskiller sig ikke fra den, der anvendes til voksne.
English: Once the product has been taken out of the refrigerator the product must not be returned to the refrigerator.
Danish: Når først præparatet er blevet fjernet fra køleskab, må det ikke sættes tilbage i køleskab.
English: Weight adjusted subgroups
Danish: Vægtjusterede undergrupper
English: In general, minor bleeds required slightly lower, and more severe bleeds required up to three-fold higher median doses.
Danish: Generelt krævede mindre blødninger lidt lavere doser, og mere alvorlige blødninger krævede op til 3 gange højere gennemsnitsdoser.
English: You should be aware of the early signs of allergic reactions.
Danish: Du bør være opmærksom på tidlige tegn på allergiske reaktioner.
English: If severe, sudden allergic reactions (anaphylactic) occur (very rare, up to 1 in 10,000), the injection must be stopped immediately.
Danish: Hvis der opstår en alvorlig, pludselig allergisk (anafylaktisk) reaktion, (meget sjælden, forekommer hos færre end 1 ud af 10.000), skal injektionen stoppes øjeblikkeligt.
English: Toxicology studies showed that local intravenous administration and systemic exposure were well tolerated in laboratory animals (rats and cynomolgus monkeys).
Danish: Toksicitetsstudier viste, at lokal intravenøs administration og systemisk eksponering var veltålt hos laboratoriedyr (rotter og cynomolgusaber).
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Danish: Doser baseret på legemsvægt kan kræve justering hos undervægtige eller overvægtige patienter.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Danish: Hvis præparatet ikke anvendes straks, er andre opbevaringstider og -betingelser på brugerens eget ansvar.
English: The reconstituted medicinal product is a clear, colourless solution, free from foreign particles and has a pH of 6.5 to 7.5.
Danish: Det rekonstituerede lægemiddel er en klar, farveløs opløsning, fri for fremmede partikler og med en pH-værdi på 6,5 - 7,5.
English: After reconstitution, chemical and physical in-use stability has been demonstrated for 24 hours when stored at room temperature.
Danish: Efter rekonstitution er der påvist kemisk og fysisk stabilitet under anvendelse i 24 timer ved stuetemperatur
English: Vihuma is for intravenous use.
Danish: Vihuma er til intravenøs brug.
English: Normal weight (n=14)
Danish: Normalvægt (n=14)
English: No blood must flow into the syringe due to the risk of formation of fibrin clots.
Danish: Der må ikke trænge blod ind i injektionssprøjten på grund af risikoen for dannelsen af fibrinpropper.
English: As known from the literature, recovery and half-life was lower in young children than in adults and clearance higher, which may be due in part to the known higher plasma volume per kilogram body weight in younger patients.
Danish: Som det er kendt fra litteraturen, var bedringen og halveringstiden lavere hos små børn end hos voksne, og clearance var højere, hvilket til dels kan skyldes det kendte højere plasmavolumen pr. kg legemsvægt hos yngre patienter.
English: The specific activity of Vihuma is approximately 9500 IU/mg protein.
Danish: Den specifikke aktivitet for Vihuma er ca. 9.500 IE/mg protein.
English: Data have been obtained in 29 previously treated children between 2 and 5 years of age, 31 children between 6 and 12 years of age and one adolescent of 14 years.
Danish: Der er indhentet data for 29 tidligere behandlede børn i alderen 2 til 5 år, 31 børn i alderen 6 til 12 år og en ung patient på 14 år.
English: There is a rare chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to Vihuma.
Danish: Der er meget lav risiko for, at du kan få en anafylaktisk reaktion (en alvorlig, pludselig allergisk reaktion) over for Vihuma.
English: Every 24 hours, at least 1 day, until healing is achieved.
Danish: Hver 24. time, i mindst 1 døgn, indtil heling er opnået.
English: Your doctor will perform appropriate laboratory tests to make sure that you have adequate factor VIII levels.
Danish: Lægen foretager passende laboratorieundersøgelser for at sikre sig, at du har de ønskede faktor VIII-niveauer.
English: At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Danish: Mindst 1 døgn indtil blødningsepisoden, der viser sig ved smerter, er ophørt eller heling er opnået.
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
Danish: Hyppigheden er vurderet i henhold til 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: You should be aware of the early signs of allergic reactions as they are listed in section 4 “Allergic reactions”.
Danish: Du skal være opmærksom på de første tegn på en allergisk reaktion, som er angivet i afsnit 4 "Allergiske reaktioner.
English: On-demand treatment
Danish: On-demand-behandling
English: Therefore, it is recommended to monitor all patients carefully for inhibitor occurrence following any product switch.
Danish: Det anbefales derfor at overvåge alle patienter nøje for udvikling af inhibitorer efter ethvert præparatskift.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indberette bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden ved dette lægemiddel.
English: A non-neutralizing anti-Factor VIII antibody was detected in one adult patient (see Table 1).
Danish: Der blev konstateret ikke-neutraliserende antifaktor VIII hos 1 voksen patient (se Tabel 1).
English: Vihuma replaces the missing factor VIII and is used for treatment and prevention of bleeding in patients with haemophilia A and can be used for all age groups.
Danish: Vihuma erstatter den manglende faktor VIII og anvendes til behandling og forebyggelse af blødning hos patienter med hæmofili A og kan anvendes til alle aldersgrupper.
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: Især i tilfælde af større kirurgiske indgreb er nøjagtig overvågning af substitutionsbehandlingen ved hjælp af koagulationsanalyse (plasmafaktor VIII-aktivitet) helt nødvendig.
English: No symptoms of overdose have been reported.
Danish: Der er ikke indberettet nogen symptomer på overdosering.
English: Do not increase the total dose of Vihuma to control your bleeding without consulting your doctor.
Danish: Du må ikke øge den samlede dosis Vihuma til kontrol af dine blødninger uden at have rådført dig med lægen.
English: Specific studies with long-term repeated administration such as reproduction toxicity, chronic toxicity, and carcinogenicity were not performed with Vihuma due to the immune response to heterologous proteins in all non-human mammalian species.
Danish: Specifikke studier med gentagne doser over lang tid, såsom reproduktionstoksicitet, kronisk toksicitet og karcinogenicitet, blev ikke udført med Vihuma på grund af immunrespons over for heterologe proteiner hos alle ikke-humane pattedyr.
English: Inject the solution into the vein at a slow speed, not faster than 4 ml per minute.
Danish: Injicér langsomt opløsningen intravenøst, ikke hurtigere end 4 ml pr. minut.
English: Twenty patients used median doses of more than 45 IU/kg.
Danish: Tyve patienter brugte gennemsnitsdoser på over 45 IE/kg.
English: If you use more than one vial of powder for one treatment, you may use the same injection needle again.
Danish: Hvis du bruger mere end et hætteglas med pulver til en behandling, kan du genbruge den samme injektionsnål.
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 overvåges omhyggeligt for udvikling af inhibitorer ved passende kliniske observationer og laboratorietests.
English: Do not use the product in case you notice visible signs of deterioration of the tamper proof of packaging especially of the syringe and/or the vial.
Danish: Brug ikke lægemidlet, hvis du bemærker synlige tegn på nedbrydning af den forseglede pakning, især af injektionssprøjten og/eller hætteglasset.
English: Do not remove the adapter from the package.
Danish: Fjern ikke adapteren fra pakningen.
English: See section 2, “Vihuma contains sodium”.
Danish: Se afsnit 2, "Vihuma indeholder natrium".
English: This should be taken into consideration if you are on a controlled sodium diet.
Danish: Dette skal du huske at tage hensyn til, hvis du er på en kontrolleret natriumdiæt.
English: Vihuma contains traces of human host cell proteins other than factor VIII.
Danish: Vihuma indeholder spor af andre humane stamcelleproteiner end faktor VIII.
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: In preclinical studies, Vihuma was used to safely and effectively restore haemostasis in dogs with haemophilia.
Danish: I prækliniske studier blev Vihuma anvendt til sikker og effektiv genoprettelse af hæmostase hos hunde med hæmofili.
English: If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician.
Danish: Hvis symptomer på overfølsomhed optræder, bør patienterne rådgives om straks at afbryde behandlingen med lægemidlet og tage kontakt til deres læge.
English: Factor VIII is necessary for the blood to form clots and stop bleeding.
Danish: Faktor VIII er nødvendig for, at blodet ikke skal danne blodpropper og for at standse blødning.
English: Only the provided injection sets should be used because treatment failure can occur as a consequence of human coagulation factor VIII adsorption to the internal surfaces of some injection equipment.
Danish: Kun de medfølgende injektionssæt må bruges, fordi behandlingssvigt kan forekomme som en konsekvens af adsorption af human koagulationsfaktor VIII til den indre overflade af visse injektionssæt.
English: As with any intravenous protein product, allergic type hypersensitivity reactions are possible.
Danish: Som for alle proteinpræparater, der indgives intravenøst, kan allergiske overfølsomhedsreaktioner forekomme.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe præsenteres bivirkningerne efter faldende sværhedsgrad.
English: In another clinical study, 22 adult patients were treated on demand.
Danish: I et andet klinisk studie blev 22 patienter behandlet on-demand (efter behov).
English: Paediatric population Frequency, type and severity of adverse reactions in children are assumed to be the same as in adults.
Danish: Hyppighed, type og bivirkningernes sværhedsgrad hos børn antages at være den samme som hos voksne.
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 findes der ingen erfaringer med brugen af faktor VIII under graviditet og amning.
English: Proceed with the next dose immediately and continue as advised by your doctor or pharmacist.
Danish: Fortsæt omgående med den næste dosis, og fortsæt efter lægens eller apotekspersonalets anvisninger.
English: What you need to know before you use Vihuma 3.
Danish: Det skal du vide, før du begynder at bruge Vihuma 3.
English: If you forget to use Vihuma
Danish: Hvis du har glemt at tage Vihuma
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 behandlingen anbefales tilstrækkelig måling af faktor VIII-niveauerne for at styre den dosis, der skal indgives, og hyppigheden af de gentagne infusioner.
English: Inhibitory activity, as measured by the modified Bethesda assay, was not detected in this patient.
Danish: Den hæmmende aktivitet, som målt i den modificerede Bethesda-test, blev ikke konstateret hos denne patient.
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 for aktiveret faktor IX og accelerer derved omdannelsen af faktor X til aktiveret faktor X. Aktiveret faktor X omdanner protrombin til trombin.
English: The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Danish: Den dosis, der skal indgives, samt administrationshyppigheden skal altid tilpasses den kliniske virkning i det enkelte tilfælde.
English: The amino acid sequence is comparable to the 90 + 80 kDa form of human plasma factor VIII (i.e. B-domain deleted).
Danish: Aminosyresekvensen kan sammenlignes med 90 + 80 kDa formen for humant plasma faktor VIII (dvs. slettet B-domæne).
English: None of the patients developed inhibitors.
Danish: Ingen af patienterne udviklede hæmmere.
English: Ex vivo evaluations using a commercial assay kit to quantify T cell response to protein therapeutics indicate a low risk of immunogenicity.
Danish: Ex vivo-vurderinger ved brug af et kommercielt testkit til kvantificering af T-celleresponsen over for proteinbehandling indikerer en lav risiko for immunogenicitet.
English: No studies were performed on the mutagenic potential of Vihuma.
Danish: Der blev ikke udført studier med hensyn til Vihumas mutagene potentiale.
English: The mean ± SD annualised bleeding rate was 1.2 ± 3.9 and the mean ± SD dose were 52.2 ± 12.2 IU/kg per injection and 99.7 ± 25.6 IU/kg per week.
Danish: Den gennemsnitlige ± SD årlige blødningsrate var 1,2 ± 3,9, og den gennemsnitlige ± SD-dosis var 52,2 ± 12,2 IE/kg pr. injektion og 99,7 ± 25,6 IE/kg pr. uge.
English: For intravenous use after reconstitution.
Danish: Til intravenøs anvendelse efter rekonstitution.
English: Common side effects may affect up to 1 in 10 people Hypersensitivity, fever.
Danish: Almindelige bivirkninger kan forekomme hos op til 1 ud af 10 patienter Overfølsomhed, feber.
English: This temperature should be maintained during reconstitution.
Danish: Denne temperatur skal opretholdes under rekonstitutionen (tilberedningen).
English: The powder should only be reconstituted with the supplied solvent (2.5 ml water for injections) using the supplied injection set.
Danish: Pulveret bør kun rekonstitueres med den medfølgende solvens (2,5 ml vand til injektionsvæsker), ved brug af det medfølgende injektionssæt.
English: Uncommon* Uncommon (PTPs) # Very common (PUPs)#
Danish: Ikke almindelig* Ikke almindelig (PTP)# Meget almindelig (PUP)#
English: The reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to administration.
Danish: Det rekonstituerede lægemiddel skal inspiceres nærmere for partikler og misfarvning inden administration.
English: Do not remove the gray stopper or metal ring around the top of the vial.
Danish: Du må ikke fjerne den grå prop eller metalringen rundt om hætteglassets overkant.
English: Do not use solutions that are cloudy or have deposits.
Danish: Anvend ikke opløsninger, der er uklare, eller som indeholder bundfald.
English: In total 986 bleeding episodes were treated with a median dose of 30.9 IU/kg.
Danish: I alt behandledes 986 blødningsforekomster med en gennemsnitsdosis på 30,9 IE/kg.
English: AUC = Area under the curve (FVIII:C), T1/2 = Terminal half-life, IVR = Incremental in vivo recovery, CL = Clearance, SD = Standard deviation
Danish: AUC = Areal under kurven (FVIII:C), T1/2 = Afsluttende halveringstid, IVR = Marginal in vivo-bedring, CL = Clearance, SD = Standardafvigelse
English: Vihuma contains sodium
Danish: Vihuma indeholder natrium
English: No animal or human derived materials are added during the manufacturing process or to the final medicinal product.
Danish: Hverken under fremstillingsprocessen eller til det færdige lægemiddel er der tilsat materialer, der er fremstillet på basis af animalske eller humane materialer.
English: Pharmacotherapeutic group: Antihaemorrhagics: blood coagulation factor VIII, ATC code: B02BD02.
Danish: Farmakoterapeutisk klassifikation: Antihæmorargisk, blodkoagulationsfaktor VIII, ATC kode: B02BD02.
English: Vihuma is produced by recombinant DNA technology in genetically modified human embryonic kidney (HEK) 293F cells.
Danish: Vihuma er fremstillet med rekombinant DNA-teknologi i genmodificerede humane nyreceller (HEK) 293F fra fostre.
English: Do not use this medicine after the expiry date which is stated on the label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Younger children in general required higher median doses (6-12 years: 43.9 IU/kg; 2-5 years: 52.6 IU/kg).
Danish: Yngre børn (6 til 12 år) havde i almindelighed brug for højere gennemsnitsdoser: 43,9 IE/kg; 2 til 5 år: 52.6 IE/kg).
English: Your doctor will calculate your dose of Vihuma (in international units = IU) depending on your condition and body weight, and on whether it is used for prevention or treatment of bleeding.
Danish: Lægen udregner din Vihuma-dosis i internationale enheder (IE) i forhold til din helbredstilstand og din legemsvægt og afhængigt af, om lægemidlet skal bruges til at forebygge eller behandle blødning.
English: Haemophilia A is a sex-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 kønsrelateret arvelig forstyrrelse af blodets koagulation, som skyldes nedsatte niveauer af faktor VIII:C og resulterer i kraftig blødning i led, muskler eller indre organer, enten spontant eller som følge af en ulykke eller et kirurgisk traume.
English: Hold the plunger rod at the end and do not touch the shaft.
Danish: Hold i enden af stemplet, og rør ikke ved stempelstangen.