FrancophonIA/ELRC3.0 huggingface dataset:
English: Four subjects were aged 0 to 5 years and five were aged 6 to 11 years inclusive.
Danish: 4 personer var i alderen fra 0 til 5 år, og 5 personer var i alderen fra 6 til og med 11 år.
English: This also applies to any unknown or emerging viruses or other types of infections.
Danish: Dette gælder også for alle ukendte eller nye vira eller andre typer infektioner.
English: If any of these symptoms occur, they should be advised to discontinue use of the product immediately and contact their physician.
Danish: Hvis nogen af disse symptomer opstår, skal patienten rådes til straks at seponere produktet og at kontakte lægen.
English: It is recommended that your blood factor X level is kept above 50 units/dL.
Danish: Det anbefales, at dit blods faktor X-niveau holdes over 50 enheder/dl.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonale til råds, før du bruger dette lægemiddel.
English: If the solution is cloudy or has any particles, do not use it.
Danish: Hvis opløsningen er grumset eller indeholder partikler må den ikke benyttes.
English: The median dosing interval for all of the nine children was 3 days (range 2 to 8 days).
Danish: Det mediane doseringsinterval for alle de 9 børn var 3 dage (interval fra 2 til 8 dage).
English: Do not use this medicine: - if the solvent is not pulled into the vial (this indicates loss of vacuum in the vial, so the powder must not be used).
Danish: Dette lægemiddel må ikke benyttes, hvis: - opløsningsmidlet ikke trækkes ind i hætteglasset (dette indikerer tab af vakuum i hætteglasset, så pulveret må ikke benyttes).
English: Six children (66.7%) remained free of bleeds during routine prophylaxis.
Danish: 6 børn (66,7 %) fik ingen blødninger med rutinemæssig profylakse.
English: Although the dose can be estimated using the calculations above, whenever possible appropriate laboratory tests, such as serial factor X assays, should be performed to guide dose adjustments.
Danish: Selvom dosis kan estimeres ved hjælp af beregningerne ovenfor, skal der, når det er muligt, udføres relevante laboratorieprøver, såsom serielle faktor X-analyser, til vejledning for dosisjustering.
English: The solution should be colourless, clear or slightly opalescent when administered.
Danish: Opløsningen skal være farveløs, klar eller let opaliserende, når den administreres.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic safety update reports
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: The mean age was 7.3 (range 2.6 to 11.9) years.
Danish: Gennemsnitsalderen var 7,3 (interval 2,6 til 11,9) år.
English: Depending on individual clinical response, longer intervals, e.g. once weekly, might be adequate (see section 5.1).
Danish: Afhængigt af det individuelle kliniske respons kan det være tilstrækkeligt med længere intervaller, f.eks. én gang ugentligt (se pkt.
English: Not more than 60 IU/kg daily should be administered in any age group.
Danish: Der må ikke administreres over 60 IE/kg dagligt hos nogen aldersgruppe.
English: For all surgical procedures, Coagadex was assessed as excellent (no post-operative bleeding, no requirement of blood transfusions, and blood loss was no more than ‘as expected') in controlling blood loss during and after surgery.
Danish: Coagadex blev vurderet som udmærket til alle kirurgiske procedurer (ingen postoperativ blødning, intet behov for blodtransfusioner, og blodtab var ikke mere end 'som forventet) til at kontrollere blodtab under og efter operationen.
English: The following examples assume the patient's baseline factor X level is <1 IU/dL:
Danish: Følgende eksempler antager, at patientens baseline faktor X-niveau er <1 IE/dl:
English: Make up the medicine as follows:
Danish: Bland lægemidlet som følger:
English: If you administer more Coagadex than your doctor prescribed, it is possible you might develop a blood clot.
Danish: Hvis du tager mere Coagadex end din læge har ordineret, er det muligt, at du vil danne en blodprop.
English: There are no data available on routine prophylaxis in paediatric patients aged >12 to <18 years.
Danish: Der foreligger ingen data om rutinemæssig profylakse hos pædiatriske patienter i alderen >12 til <18 år.
English: Follow the normal safety practices for administration.
Danish: Følg de gængse sikkerhedsforanstaltninger for administration.
English: - if the dissolved powder and solvent form a gel or a clot (if this happens please tell your healthcare provider, reporting the batch number printed on the vial).
Danish: - det opløste pulver og opløsningsmidlet danner en gel eller en klump (hvis dette sker, så fortæl det til dit sundhedspersonale og angiv batchnummeret, som er trykt på hætteglasset).
English: Immediate containers
Danish: Umiddelbare beholdere
English: Four bleeding episodes in two subjects were considered treatment failures.
Danish: Fire blødningsepisoder hos to forsøgsdeltagere blev anset som behandlingsfiaskoer.
English: Routine prophylaxis was used by two subjects.
Danish: Rutinemæssig profylakse blev brugt af to forsøgsdeltagere.
English: Factor X is converted from its inactive form to the active form (factor Xa) by the cleavage of a 52-residue peptide from the heavy chain.
Danish: Faktor X omdannes fra dets inaktive form til den aktive form (faktor Xa) ved spaltning af et 52-rest peptid fra den tunge kæde.
English: Three children (33.3%), one in the 0-5 years age group and two in the 6-11 years age group had a total of 10 bleeds due to epistaxes, trauma or menorrhagia.
Danish: 3 børn (33,3 %), et af børnene i aldersgruppen fra 0-5 år, og 2 af dem i aldersgruppen fra 6-11 år, havde i alt 10 blødninger som følge af epistakse, traume eller menoragi.
English: Frequency, type and severity of adverse reactions in children are expected to be the same as in adults (see section 5.1).
Danish: Hyppighed, type og alvorlighed af bivirkninger hos børn forventes at være de samme som hos voksne (se pkt.
English: Note: If you have more than one vial to make up your dose, repeat steps 1 through 6 withdrawing the solution in the vial into the same syringe.
Danish: Bemærk: Hvis du skal bruge mere end ét hætteglas til din dosis, skal du gentage trin 1 til 6 og trække opløsningen op i hætteglasset i den samme sprøjte.
English: • A clear or slightly pearl-like solution should be obtained, usually in about 1 minute (5 minutes maximum).
Danish: • Der skal opnås en klar eller let perlelignende opløsning, som regel på omkring 1 minut (maksimalt 5 minutter).
English: A clear or slightly pearl-like solution should be obtained, usually in less than 1 minute (5 minutes maximum).
Danish: Der skal opnås en klar eller let perle lignende opløsning, som regel på mindre end 1 minut (maksimalt 5 minutter).
English: - careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, - the testing of each donation and pools of plasma for signs of virus/infections, - the inclusion of steps in the processing of the blood or plasma that can inactivate or remove viruses.
Danish: - omhyggelig udvælgelse af blod- og plasmadonorer for at sikre, at de, der risikerer at være inficerede, udelukkes, - testning af hver enkelt donation og puljer af plasma for tegn på virus/infektioner, - inklusion af trin i behandlingen af blod eller plasma, som kan inaktivere eller fjerne vira.
English: Neither subject had any bleeds during these periods.
Danish: Ingen af forsøgsdeltagerne havde blødninger i disse perioder.
English: The dose and duration of the treatment depend on the severity of the factor X deficiency (i.e. the patient's baseline factor X level), on the location and extent of the bleeding and on the patient's clinical condition.
Danish: Dosis og varighed af behandlingen afhænger af sværhedsgraden af faktor X-mangel (dvs. patientens baseline faktor-X-niveau), stedet og omfanget af blødningen samt af patientens kliniske tilstand.
English: It is recommended that post-infusion plasma factor X levels are measured for each patient before and after surgery, to ensure that haemostatic levels are obtained and maintained.
Danish: Det anbefales, at post-infusionsplasma faktor X-niveauer måles for hver enkelt patient før og efter operation, for at sikre, at der opnås og opretholdes hæmostatiske niveauer.
English: Coagadex is indicated in all age groups
Danish: Coagadex er indiceret til alle aldersgrupper.
English: Of the 187 bleeding episodes in the efficacy analysis, 155 bleeds (83%) were treated with one infusion, 28 bleeds (15%) with two infusions, 3 bleeds (2%) with three infusions and 1 bleed (0.5%) with four infusions.
Danish: Af de 187 blødningsepisoder i effektivitetsanalysen blev 155 blødninger (83%) behandlet med én infusion, 28 blødninger (15%) med to infusioner, 3 blødninger (2%) med tre infusioner og 1 blødning (0,5%) med fire infusioner.
English: For safety information with respect to transmissible agents, see section 4.4.
Danish: For sikkerhedsoplysninger om smitsomme stoffer henvises til afsnit 4.4.
English: You can dissolve Coagadex using the needle-free Mix2Vial transfer device included within each pack.
Danish: Du kan opløse Coagadex med den nålefri Mix2Vialoverførselsenhed, som er inkluderet i hver pakke.
English: Pharmacokinetic studies have not been performed in children under the age of 12 years.
Danish: Der er ikke gennemført farmakokinetiske undersøgelser hos børn i alderen under 12 år.
English: The third study evaluated the use of Coagadex in routine prophylaxis of bleeding episodes in nine children aged less than 12 years of age.
Danish: Det tredje studie evaluerede anvendelsen af Coagadex til rutinemæssig profylakse af blødningsepisoder hos 9 børn under 12 år.
English: There are limited data on the use of Coagadex for long periods of prophylaxis in adults.
Danish: Der er begrænsede data om brugen af Coagadex i lange perioder med profylakse hos voksne.
English: When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to recipients.
Danish: Når lægemidler fremstilles af humant blod eller plasma, tages der visse forholdsregler for at forhindre, at infektioner overføres til modtageren.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeat-dose toxicity, thrombogenicity and local tolerability.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter enkelte eller gentagne doser, thrombogenicitet og lokal tolerabilitet.
English: The dose you need will depend on your normal blood level of factor X and will be calculated by your doctor.
Danish: Den dosis, du har brug for, afhænger af dit blods normale factor Xniveau og beregnes af din læge.
English: Adult How much Coagadex is given to treat a bleed or prevent further bleeding?
Danish: Hvor meget Coagadex gives til behandling af en blødning eller for at forhindre yderligere blødning?
English: Both before and after treatment with this medicine, particularly for your first course of treatment, your doctor will probably carry out tests to check the level of factor X in your blood.
Danish: Din læge vil sikkert, både før og efter behandling med dette lægemiddel, - særligt ved dit første behandlingsforløb - udføre tests for at kontrollere koncentrationen af faktor X i dit blod.
English: Factor Xa associates with factor Va on a phospholipid surface to form the prothrombinase complex, which activates prothrombin to thrombin in the presence of calcium ions.
Danish: Faktor Xa associerer med faktor Va på en fosfolipid overflade til dannelse af prothrombinasekomplekset, som aktiverer prothrombin til thrombin i nærvær af calciumioner.
English: 70 kg x 90 IU/dL/{[2 IU/dL]/[IU/kg]} = 3150 IU.
Danish: 70 kg x 90 IE/dl/{[2 IE/dl]/[IE/kg]} = 3150 IE.
English: Your doctor will tell you how much Coagadex to administer to treat a bleed and to prevent further bleeding; the dose required will depend on your normal blood level of factor X
Danish: Lægen vil fortælle dig, hvor meget Coagadex du skal administrere, for at behandle en blødning eller forhindre yderligere blødning; den påkrævede dosis vil afhænge af dit blods normale faktor X-niveau
English: Your treatment centre will provide a special container to dispose of any solution that remains, any used syringes, needles and empty containers.
Danish: Behandlingscentret vil give dig en særlig beholder til bortskaffelse af eventuel resterende opløsning, ubrugte sprøjter, kanyler og tomme beholdere.
English: • Each individual bleed should be judged on its own severity
Danish: • Hver enkelt blødning bør bedømmes efter dens individuelle sværhedsgrad.
English: Patients may vary in their pharmacokinetic (e.g. half-life, in vivo recovery) and clinical responses to Coagadex.
Danish: Patienter kan variere i deres farmakokinetiske (f.eks. halveringstid, in vivo bedring) og kliniske respons over for Coagadex.
English: • pain or redness at site of injection
Danish: • smerter eller rødmen omkring injektionsstedet
English: -if you have a larger or longer bleed than usual and the bleeding does not stop after an injection of Coagadex.
Danish: - Hvis du har større eller længere blødning end normalt og blødningen ikke stopper efter injektion af
English: The careful control of dose and duration of treatment is especially important in cases of major surgery.
Danish: Omhyggelig kontrol af dosis og behandlingens varighed er især vigtig ved større kirurgiske indgreb.
English: Your treatment should be initiated by a doctor who is experienced in the treatment of bleeding disorders.
Danish: Din behandling skal igangsættes af en læge, som har erfaring med behandling af blødningsforstyrrelser.
English: If you get any of these contact your doctor.
Danish: Hvis du oplever nogen af disse, skal du kontakte lægen.
English: Your doctor will usually tell you your dose in terms of the number of full vials that supply the dose most suited to you.
Danish: Lægen vil normalt angive din dosis som det antal hele hætteglas, der giver dig den dosis, der passer bedst til dig.
English: Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly or repeatedly receive human plasma-derived factor X products.
Danish: Din læge vil eventuelt anbefale, at du overvejer at blive vaccineret mod hepatitis A og B, hvis du regelmæssigt eller gentagne gange får human plasma-afledt faktor X-produkter.
English: Follow the normal safety practices to administer the medicine.
Danish: Følg de gængse sikkerhedsforanstaltninger for administration af medicinen.
English: The following side effects have been reported with Coagadex.
Danish: Følgende bivirkninger er blevet indberettet med Coagadex.
English: Bring the containers of Coagadex to room temperature before mixing.
Danish: Bring beholderne med Coagadex til stuetemperatur før blanding.
English: The measures taken are considered effective for the following viruses: human immunodeficiency virus (HIV), hepatitis B virus, hepatitis C virus, hepatitis A virus and parvovirus B19.
Danish: De foranstaltninger, der træffes, anses som effektive over for følgende vira: human immundefekt virus (HIV), hepatitis B-virus, hepatitis C-virus, hepatitis A-virus or parvovirus B19.
English: Ninety eight (53%) were major bleeding episodes, and 88 (47%) were minor bleeds (one bleed was not assessed).
Danish: Otteoghalvfems (53%) var større blødningsepisoder og 88 (47%) var mindre blødninger (én blødning blev ikke vurderet).
English: • The medicine should be injected when the first sign of bleeding occurs
Danish: • Lægemidlet bør injiceres ved første tegn på blødning.
English: Vaccination against hepatitis A and B in patients who regularly or repeatedly receive human plasma-derived Factor X products may be warranted.
Danish: Vaccination mod hepatitis A og B hos patienter, der regelmæssigt eller gentagne gange modtager humane plasma-afledte faktor X-produkter, kan være berettiget.
English: Of the 208 bleeding episodes treated with Coagadex, 187 bleeding episodes in 15 subjects were evaluated for efficacy.
Danish: Af de 208 blødningsepisoder behandlet med Coagadex blev 187 blødningsepisoder hos 15 forsøgsdeltagere vurderet for effektivitet.
English: Thrombin then acts upon soluble fibrinogen and factor XIII to generate a cross-linked fibrin clot.
Danish: Thrombin virker derefter på opløseligt fibrinogen og faktor XIII til dannelse af en tværbundet fibrinkoagel.
English: The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV, and for the non-enveloped viruses HAV and parvovirus B19.
Danish: De forholdsregler, der tages, anses for at være effektive for kappeklædte vira som HIV, HBV og HCV, og for de ikke-kappeklædte vira HAV og parvovirus B19.
English: powder and solvent for solution for injection human coagulation factor X This medicine is subject to additional monitoring.
Danish: pulver og opløsningsmiddel til injektionsvæske human koagulationsfaktor X Dette lægemiddel er underlagt supplerende overvågning.
English: One subject, aged 58 years, used 28 IU/kg once weekly for 8 weeks and, later, 25 IU/kg every 2 weeks for more than 5 months.
Danish: Én forsøgsdeltager på 58 år brugte 28 IE/kg én gang ugentligt i 8 uger og senere 25 IE/kg hver 2. uge i mere end 5 måneder.
English: Inject your normal dose as you remember and then continue dosing as instructed by your doctor.
Danish: Du skal injicere den normale dosis, når du kommer i tanke om det og fortsætte doseringen som anvist af lægen.
English: Therefore, Coagadex should be used during pregnancy only if clearly indicated.
Danish: Coagadex må derfor kun anvendes under graviditet, hvis det er klart indiceret.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Danish: LÆGEMIDLETS NAVN OG/ELLER ADMINISTRATIONSVEJ(E)
English: If your blood factor X concentration is too low (this will be tested by your doctor), or if it decreases faster than expected, an inhibitor to factor X may be present which stops Coagadex from working properly.
Danish: Hvis dit blods faktor X-koncentration er for lav (dette testes af lægen), eller hvis den falder hurtigere end forventet, kan der være en faktor X-hæmmer til stede, som forhindrer Coagadex i at virke rigtigt.
English: Your doctor will advise if this use is suitable for you and, if so, of the appropriate dose.
Danish: Din læge vil fortælle, om dette er passende for dig, og i så fald angive den passende dosis.
English: Coagadex is a white or off-white powder and is packed in quantities of 250 IU and 500 IU.
Danish: Coagadex er en/et hvidt eller råhvidt pulver og er pakket i mængder på 250 IE og 500 IE.
English: Due to inter-and intra-patient variability, it is recommended that trough blood levels of Factor X should be monitored at intervals, especially in the first weeks of therapy or after dosage changes.
Danish: Som følge af inter- og intra-patient variabilitet anbefales det, at minimumsniveauer af faktor X i blodet overvåges periodisk, især i de første ugers behandling og efter doseringsændringer.
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Danish: Standardforanstaltninger til forebyggelse af infektioner som følge af brugen af lægemidler fremstillet af humant blod eller plasma omfatter udvælgelse af donorer, screening af individuelle donationer og plasmapuljer for specifikke markører for infektion og inklusion af effektive fremstillingstrin til inaktivering/fjernelse af vira.
English: There were no adverse drug reactions in this study in children less than 12 years of age.
Danish: Der var ingen bivirkninger i dette studie med børn under 12 år.
English: Coagadex has no or negligible influence on the ability to drive and use machines.
Danish: Coagadex påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Allergic type hypersensitivity reactions, including anaphylaxis, are possible.
Danish: Der kan forekomme allergiske overfølsomhedsreaktioner, herunder anafylaksi.
English: For home therapy, the patient should be given appropriate training and reviewed at intervals.
Danish: Ved hjemmebehandling skal patienten have passende instrukser, og disse skal genopfriskes med jævne mellemrum.
English: The factor X in Coagadex is extracted from human plasma (the liquid part of blood).
Danish: Faktor X i Coagadex udvindes af humant plasma (den flydende del af blodet).
English: The efficacy of Coagadex in treating bleeding episodes was assessed by the subject and/or investigator for each new bleeding episode, using a pre-determined bleed-specific ordinal rating scale of excellent, good, poor and unassessable.
Danish: Effekten af Coagadex ved behandling af blødningsepisoder blev vurderet af forsøgsdeltageren og/eller investigator for hver ny blødningsepisode ved hjælp af en forudbestemt blødningsspecik ordinal bedømmelsesskala bestående af fremragende, god, dårlig og ikke vurderbar.
English: The recommended dose of 25 IU/kg Coagadex to treat a bleed was maintained during the study for 14 of the 16 subjects.
Danish: Den anbefalede dosis på 25 IE/kg Coagadex til behandling af en blødning blev opretholdt under forsøget for 14 af de 16 forsøgsdeltagere.
English: Careful control of replacement therapy is especially important in cases of major surgery or life-threatening bleeding episodes.
Danish: Omhyggelig styring af substitutionsterapi er især vigtig i tilfælde af en større operation eller livstruende blødningsepisoder
English: The vials should be brought to room temperature (not above 30oC) prior to the removal of the snap-off cap closure from the powder vial.
Danish: Hætteglassene skal bringes til stuetemperatur (ikke over 30 °C), inden snapp-off-låget fjernes fra pulverhætteglasset.
English: Treatment should be initiated under the supervision of a physician experienced in the treatment of rare bleeding disorders.
Danish: Behandlingen skal indledes under opsyn af en læge med erfaring i behandling af sjældne blødningslidelser.
English: For routine prophylaxis of bleeding episodes in children aged less than 12 years: 40 IU/kg twice weekly.
Danish: Til rutinemæssig profylakse af blødningsepisoder hos børn under 12 år: 40 IE/kg to gange ugentligt.
English: No investigations on genotoxicity, carcinogenicity and reproductive or developmental toxitcity have been conducted since human plasma coagulation factor X (as contained in Coagadex) is an endogenous protein.
Danish: Der er ikke foretaget undersøgelser om genotoksicitet, carcinogenicitet og reproduktionstokcitet og udviklingstoksicitet, idet human plasma koagulationfaktor X (som er indeholdt i Coagadex) er et endogent protein.
English: Post-surgery: dose as necessary to maintain plasma factor X levels at a minimum of 50 IU/dL until the subject is no longer at risk of bleeding due to surgery.
Danish: Post-operativt: Dosis efter behov for at opretholde plasma faktor X-niveauer på minimum 50 IE/dl, indtil patienten ikke længere risikerer blødning pga. operationen.
English: The desired factor X rise is the difference between the patient's plasma factor X level and the desired level, and based on the observed recovery of 2 IU/dL per IU/kg.
Danish: Den ønskede faktor X-stigning er forskellen mellem patientens plasma faktor X-niveau og det ønskede niveau, og baseret på observeret bedring på 2 IE/dl pr. IE/kg.
English: The other subject, aged 22 years, used 24.6 IU/kg once weekly for 8.5 months.
Danish: Den anden forsøgsdeltager på 22 år brugte 24,6 IE/kg én gang om ugen i 8,5 måneder.
English: When the reconstitution process is complete, the used transfer device should be disposed of it in the ‘sharps box'.
Danish: Når restitueringen er færdig, skal overførselsenheden bortskaffes i “beholderen til skarpe genstande”.