FrancophonIA/ELRC3.0 huggingface dataset:
English: These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections.
Danish: Forholdsreglerne omfatter omhyggelig udvælgelse af donorer af blod og plasma for at sikre, at de, der har risiko for at være smittebærere, udelukkes, og at hver donation og plasmapool testes for tegn på virus/infektioner.
English: When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
Danish: Når lægemidler fremstilles af humant blod eller plasma, tages der visse forholdsregler for at forhindre overførsel af infektioner til patienter.
English: There are insufficient data to recommend the use of Nonafact in children less than 6 years of age.
Danish: Der er ikke tilstrækkelige data til at anbefale brugen af Nonafact til børn under 6 år.
English: In some cases, these reactions have progressed to severe anaphylaxis, and they have occurred in close temporal association with development of factor IX inhibitors (see also 4.4).
Danish: I nogle tilfælde har disse reaktioner udviklet sig til alvorlig anafylaxi, og de er tidsmæssigt faldet sammen med udviklingen af faktor IX-inhibitorer (se også 4.4).
English: Reconstituted products should be inspected visually for particulate matter and discoloration prior to administration.
Danish: Rekonstituerede produkter skal undersøges visuelt for partikelstoffer og misfarvning inden indgivelsen.
English: In rare cases, Nonafact can give rise to a severe allergic reaction (anaphylactic shock).
Danish: I sjældne tilfælde kan Nonafact medføre et alvorligt allergianfald (anafylaktisk chok).
English: The use of Nonafact may also produce an increase in body temperature in rare cases.
Danish: Brugen af Nonafact kan også i sjældne tilfælde føre til en stigning af kropstemperaturen.
English: Bring the two vials to a temperature between 15°C and 25°C.
Danish: Lad begge hætteglas få en temperatur mellem 15 ºC og 25 °C.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. i realiteten 'natriumfrit'.
English: 1066 CX Amsterdam The Netherlands
Danish: 1066 CX Amsterdam Nederlandene
English: The exact dose will depend on the seriousness of the clinical situation, your body weight and the amount of factor IX in your blood.
Danish: Den nøjagtige dosis afhænger af, hvor alvorlig Deres tilstand er, Deres vægt samt mængden af faktor IX i Deres blod.
English: Activated factor IX, in combination with activated factor VIII, activates factor X. Activated factor X converts prothrombin into thrombin.
Danish: Aktiveret faktor IX i kombination med aktiveret faktor VIII aktiverer faktor X. Aktiveret faktor X omdanner prothrombin til thrombin.
English: Overdose
Danish: Overdosering
English: Nonafact contains 100 IU per ml after reconstitution with water for injection.
Danish: Nonafact indeholder 100 IE pr. ml efter rekonstitution med vand til injektion.
English: Immediately before administration, the solution should be inspected: the solution should be clear or slightly opalescent.
Danish: Umiddelbart inden indgivelsen bør opløsningen kontrolleres: Den skal være klar eller let uigennemsigtig.
English: Paediatric population There are insufficient data to recommend the use of Nonafact in children less than 6 years of age.
Danish: Pædiatrisk population Der findes ikke tilstrækkelige data til at anbefale anvendelsen af Nonafact til børn under 6 år.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Do not use if the solution is not totally clear or if the powder is not totally reconstituted.
Danish: Må ikke bruges, hvis opløsningen ikke er fuldstændig klar, eller hvis pulveret ikke er helt rekonstitueret.
English: The following table can be used to guide dosing in bleeding episodes and surgery:
Danish: Nedenstående tabel kan bruges som vejledning til doseringen ved blødningstilfælde og kirurgiske indgreb.
English: Read the package leaflet before use.
Danish: Læs indlægssedlen før anvendelse.
English: Nonafact has no influence on the ability to drive and use machines.
Danish: Nonafact har ingen indflydelse på evnen til at føre bil og betjene maskiner.
English: Individual patients may vary in their response to factor IX, demonstrating different half-lives and recoveries.
Danish: De enkelte patienter kan reagere forskelligt på faktor IX, med forskellige halveringstider og forskellig bedring.
English: Swirl the vial gently to completely dissolve the powder within 5 minutes.
Danish: Sving indholdet i hætteglasset forsigtigt rundt for at opløse pulveret fuldstændigt inden for 5 min.
English: In the case of a severe allergic reaction (anaphylactic shock), immediately stop the administration of the product and contact your doctor immediately.
Danish: I tilfælde af alvorlige allergiske reaktioner (anafylaktisk chok) skal brugen af produktet straks indstilles, og De skal kontakte Deres læge med det samme.
English: The powder dissolves within 5 minutes to produce a clear, colourless to light-yellow solution.
Danish: Pulveret opløses inden for 5 min. og giver en klar, farveløs til lysegul opløsning.
English: In the case of the following haemorrhagic events, the factor IX activity should not fall below the given plasma activity level (in % of normal or IU/dl) in the corresponding period.
Danish: Hvis nogle af følgende blødningstilfælde opstår, må faktor IX-aktiviteten ikke komme under det indikerede plasma-aktivitetsniveau (i % af det normale eller IE/dl) i den korresponderende periode.
English: Plasma coagulation factor IX is a normal constituent of human plasma.
Danish: Plasmakoaguleringsfaktor IX er en normal bestanddel af humant plasma.
English: In patients with existing cardiovascular risk factors, substitution therapy with FIX may increase the cardiovascular risk.
Danish: Hos patienter med eksisterende kardiovaskulære risikofaktorer kan substitutionsbehandling med FIX øge den kardiovaskulære risiko.
English: Factor IX activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an International Standard for factor IX in plasma).
Danish: Faktor IX-aktiviteten i plasma er udtrykt enten som en procentdel (i forhold til normalt, humant plasma) eller i internationale enheder (i forhold til en international standard for faktor IX i plasma).
English: Therefore, factor IX should be used during pregnancy and lactation only if clearly indicated.
Danish: Derfor bør man kun bruge faktor IX under graviditet og amning, hvis der er klare indikationer herfor.
English: By replacement therapy the plasma level of factor IX is increased, thereby enabling a temporary correction of the factor IX deficiency and correction of the bleeding tendencies.
Danish: Ved erstatningsbehandling øges niveauet af faktor IX i plasmaet, hvorved der sker en midlertidig afhjælpning af faktor IX-manglen og en afhjælpning af blødningstendenserne.
English: It is important that the concentration of factor IX in your blood is checked regularly.
Danish: Det er vigtigt, at koncentrationen af faktor IX i blodet bliver regelmæssigt undersøgt.
English: Required units = body weight (kg) x desired factor IX rise (%) (IU/dl) x 0.9
Danish: Antal enheder = kropsmasse (kg) x den ønskede stigning i faktor IX (%) (IE/dl) x 0,9
English: Factor IX is a normal constituent of human blood.
Danish: Faktor IX er en normal bestanddel af blodet.
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: Standardforholdsregler, som skal forhindre, at infektioner overføres fra lægemidler, der er fremstillet af humant blod eller plasma, omfatter udvælgelse af donorer, screening af de enkelte donationer og plasmapools for specifikke infektionsmarkører, samt at effektive fremstillingstrin for inaktivering/eliminering af vira er en del af fremstillingsprocessen.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Sanquin Plasma Products B.V., Plesmanlaan 125, NL-1066 CX Amsterdam, the Netherlands 12.
Danish: Sanquin Plasma Products B.V., Plesmanlaan 125, NL-1066 CX Amsterdam, Nederlandene 12.
English: Contraindications
Danish: Kontraindikationer
English: Because of the potential risk of thrombotic complications, clinical surveillance for early signs of thrombotic and consumptive coagulopathy should be initiated with appropriate biological testing when administering this product to patients with liver disease, to patients post-operatively, to new-born infants, or to patients at risk of thrombotic phenomena or DIC.
Danish: På grund af den potentielle risiko for trombotiske komplikationer, bør der foretages en klinisk kontrol for tidlige tegn på trombotisk og konsumptiv koagulationsdefekt ved hjælp af passende biologiske undersøgelsesmetoder, når dette produkt indgives til patienter med leversygdomme, til patienter, der har gennemgået en operation, til nyfødte eller til patienter med risiko for trombotiske fænomener eller dissemineret intravaskulær koagulering (DIC).
English: You can also report side effects directly via the national reporting system listed in Appendix V*.
Danish: De eller Deres pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V*.
English: It is recommended that the rate of administration should not exceed 2 ml/min.
Danish: Det anbefales, at man ikke indgiver mere end 2 ml i minuttet.
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).
Danish: Overfølsomhed eller allergiske reaktioner (der kan indbefatte angioødem, brændende og sviende fornemmelse omkring injektionsstedet, kuldegysninger, flushing, generaliseret urticaria, hovedpine, kløende udslet, hypotension, sløvhed, kvalme, rastløshed, takykardi, trykken for brystet, prikkende fornemmelse, opkastning og hiven efter vejret) er kun sjældent blevet observeret og kan i nogle tilfælde udvikle sig til svær anafylakse (herunder chok).
English: Your body may develop antibodies (inhibitors) against factor IX, which will inactivate Nonafact.
Danish: Deres krop kan danne antistoffer (inhibitorer) mod faktor IX, hvilket vil gøre Nonafact inaktivt.
English: If you are administered 1 International Unit (IU) per kilogram of body weight, the concentration of factor IX in your blood will increase by 1.1 % of normal activity.
Danish: Hvis De får 1 international enhed (IE) pr. kg kropsvægt, vil koncentrationen af faktor IX i Deres blod stige med 1,1 % af den normale aktivitet.
English: The use of low purity factor IX products has been associated with instances of myocardial infarction, disseminated intravascular coagulation, venous thrombosis and pulmonary embolism.
Danish: Brugen af faktor IX-produkter af mindre renhedsgrad er blevet associeret med tilfælde af myocardieinfarkt, dissemineret intravaskulær koagulering, venøs thrombose og lungeembolisme.
English: Do not use solutions that are cloudy or have deposits.
Danish: Brug ikke opløsninger, der er uklare eller har bundfald.
English: If you are allergic to mouse protein or have had any reactions to mouse protein.
Danish: • hvis De er allergisk over for museproteiner eller har reageret på museprotein.
English: During the course of treatment, appropriate determination of factor IX levels is advised to guide the dose to be administered and the frequency of repeated infusions.
Danish: Under behandlingen tilrådes det at bestemme de passende niveauer af faktor IX for at fastlægge dosis og hyppighed af gentagne infusioner.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Danish: Hvis det ikke bruges straks, påhviler det brugeren at overholde brugsopbevaringstider og -betingelser.
English: The dose and duration of substitution therapy depend on the severity of the factor IX deficiency, on the location and extent of the bleeding and on the patient's clinical condition.
Danish: Dosis og substitutionsbehandlingens varighed afhænger af, hvor alvorlig faktor IX-manglen er, lokaliseringen og omfanget af blødningen samt patientens sundhedstilstand.
English: Known allergic reaction to mouse protein.
Danish: Tidligere allergisk reaktion over for museprotein.
English: Treatment monitoring
Danish: Overvågning af behandlingen
English: Renewal of authorisation: 03 July 2006
Danish: Dato for første markedsføringstilladelse: 03. juli 2001 Dato for seneste fornyelse: 03. juli 2006
English: Factor IX is activated by factor XIa in the intrinsic coagulation pathway and by the factor VII/tissue factor complex in the extrinsic pathway.
Danish: Faktor IX aktiveres af faktor XIa i det interne koaguleringssystem og af faktor VII/vævsfaktorkompleks i det eksterne koaguleringssystem.
English: In addition, the powder will dissolve more readily if both vials are first allowed to reach room temperature (15°C - 25°C).
Danish: Ydermere opløses pulveret lettere, hvis begge hætteglas har stuetemperatur (15 °C - 25 °C).
English: In theory, therefore, the use of Nonafact could generate antibodies to mouse protein.
Danish: Derfor kan brugen af Nonafact i teorien forårsage dannelse af antistoffer mod museprotein.
English: Conventional animal toxicity studies and mutagenicity studies with plasma coagulation factor IX were not carried out.
Danish: Konventionelle toksikologiske og mutagenicitetsstudier på dyr med plasmakoaguleringsfaktor IX er ikke foretaget.
English: A deficiency of factor IX causes blood coagulation problems, which may lead to bleeding in joints, muscles or internal organs.
Danish: Faktor IX-mangel giver blodkoaguleringsproblemer, der kan føre til blødninger i led, muskler eller indre organer.
English: The potency (IU) is determined using the European Pharmacopoeia one stage clotting test..
Danish: Styrken (IE) er bestemt ved den europæiske farmakopés 1-trins koagulationstest.
English: Contents of pack and other information
Danish: Pakningsstørrelser og yderligere oplysninger
English: Method of administration Intravenous use.
Danish: Administration Intravenøs anvendelse.
English: Contents:
Danish: Indhold:
English: One International Unit (IU) of factor IX activity is equivalent to that quantity of factor IX in one ml of human plasma.
Danish: En international enhed (IE) faktor IX-aktivitet svarer til mængden af faktor IX i en ml humant plasma.
English: 30-60 Every 24 hours, at least 1 day, until healing is achieved.
Danish: 30-60 Hver 24. time i mindst 1 dag, indtil heling er indtruffet.
English: Remove the protective sheath from the other end of the transfer needle.
Danish: Fjern beskyttelseskappen fra den anden ende af kanylen.
English: After repeated treatment with human coagulation factor IX products, patients should be monitored for the development of neutralising antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing.
Danish: Efter gentagne behandlinger med humane koagulationsfaktor IX-produkter skal patienterne undersøges for, om de har dannet neutraliserende antistoffer (inhibitorer), der skal mængdebestemmes i Bethesda-enheder (BU) vha. passende biologiske undersøgelsesmetoder.
English: The number of units of factor IX administered is expressed in International Units (IU), which are related to the current WHO standard for factor IX products.
Danish: Antallet af faktor IX-enheder er udtrykt i internationale enheder (IE), der er i overensstemmelse med den nuværende WHO-standard for faktor IX-produkter.
English: In such cases, it is recommended that a specialised haemophilia centre be contacted.
Danish: I sådanne tilfælde anbefales det, at man kontakter en afdeling/hospital med speciale i hæmofili.
English: Sanquin Plasma Products B.V. Plesmanlaan 125
Danish: Sanquin Plasma Products B.V.
English: There have been reports in the literature showing a correlation between the occurrence of a factor IX inhibitor and allergic reactions.
Danish: Der er rapporter, der viser en sammenhæng mellem tilstedeværelsen af en faktor IX-inhibitor og allergiske reaktioner.
English: If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.
Danish: Hvis et centralt venekateter er nødvendigt, bør risikoen for komplikationer tages i betragtning, herunder lokale infektioner, bakteriæmi og trombose ved kateterstedet.
English: Nephrotic syndrome has been reported following attempted immune tolerance induction on haemophilia B patients with factor IX inhibitors and a history of allergic reaction.
Danish: Nephrotisk syndrom er rapporteret efter forsøg på at inducere immuntolerance hos hæmofili B-patienter med faktor IX-inhibitorer og tidligere tilfælde af allergiske reaktioner.
English: Nonafact contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free'.
Danish: Nonafact indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. i realiteten 'natriumfrit'.
English: If you need therapy for repressing antibodies (inhibitors) this should be taken care of in a haemophilia treating centre.
Danish: Hvis De har brug for en behandling, der hæmmer antistofferne (inhibitorerne), skal denne foretages ved hjælp af et hæmofilibehandlingscenter.
English: It is strongly recommended that every time that Nonafact is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
Danish: Det anbefales kraftigt, at produktnavn og batchnummer registreres, hver gang Nonafact gives til en patient, for at sikre, at forbindelsen mellem patienten og lægemidlets batchnummer kan spores.
English: Pharmacotherapeutic group: antihemorrhagics, blood coagulation factor IX.
Danish: Farmakoterapeutisk klassifikation: antihæmorrhagisk stof, blodkoaguleringsfaktor IX.
English: What Nonafact contains - The active substance is human coagulation factor IX.
Danish: Nonafact indeholder: - Aktivt stof: human koagulationsfaktor IX.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness
Danish: Inden for hver enkelt hyppighedsgruppe skal bivirkningerne opstilles efter, hvor alvorlige de er
English: It should be noted that patients with factor IX inhibitors may be at an increased risk of anaphylaxis with subsequent challenge with factor IX.
Danish: Det skal bemærkes, at patienter med faktor IX-inhibitorer kan have en større risiko for anafylaksi ved efterfølgende behandlinger med faktor IX.
English: The powder should be dissolved in the supplied amount of water for injections.
Danish: Pulveret bør opløses i den medfølgende mængde injektionsvæske.
English: Manufacturing also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Danish: Fremstillingen sørger også for, at der i behandlingen af blod eller plasma indgår foranstaltninger til inaktivering eller eliminering af virus.
English: As with all medicinal products derived from human blood, the use of Nonafact can cause allergic reactions which may include swelling of the larynx, burning and stinging at the infusion site, chills, flushing, hives, itching and rash, headache, tiredness, nausea, restlessness, fast heartbeat, chest tightness, tingling, vomiting, wheezing.
Danish: Som alle medicinske produkter, der er fremstillet af menneskeblod, kan brugen af Nonafact forårsage allergiske reaktioner, der kan indbefatte opsvulmning af strubehovedet, brændende og sviende fornemmelse omkring injektionsstedet, kuldegysninger, flushing, kløende udslet, hovedpine, sløvhed, kvalme, rastløshed, hjertebanken, trykken for brystet, prikkende fornemmelse, opkastning og hiven efter vejret.
English: The calculation of the required dose of factor IX is based on the empirical finding that 1 International Unit (IU) factor IX per kg body weight raises the plasma factor IX activity by 1.1 % of normal activity.
Danish: Beregningen af den nødvendige faktor IX-dosis er baseret på den empirisk baserede opdagelse, at 1 international enhed (IE) faktor IX pr. kg kropsmasse øger aktiviteten af faktor IX i plasmaet med 1,1 % i forhold til den normale aktivitet.
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), and for the non-enveloped hepatitis A and parvovirus B19 viruses.
Danish: De trufne forholdsregler anses for at være effektive over for kappebærende vira, såsom humant immundefektvirus (HIV), hepatitis B-virus (HBV) og hepatitis C-virus (HCV), og for hepatitis A og parvovirus B 19, som ikke er kappebærende.
English: Remove the plastic cap from the vials.
Danish: Fjern plastikkappen fra hætteglassene.
English: The safety and efficacy of Nonafact in children 0 to 6 years of age have not been established.
Danish: Pædiatrisk population Nonafacts sikkerhed og virkning hos børn i alderen 0-6 år er ikke klarlagt.
English: For reconstitution of Nonafact.
Danish: Til rekonstitution af Nonafact.
English: You should tell your doctor if you know that you have a risk of thrombosis or you have had thromboembolic complications in the past, if you suffer from liver disease, cardiovascular disease, or if a surgery is planned.
Danish: Fortæl det til lægen, hvis De ved, at De har en risiko for at få en blodprop (trombose) eller har haft problemer med blodpropper (tromboemboli), hvis De har en leversygdom, hjertekarsygdom, eller hvis De skal opereres.
English: 1 vial of powder for solution for injection 1 vial water for injections 5 ml 1 vial water for injections 10 ml
Danish: 1 hætteglas pulver til injektionsopløsning 1 hætteglas med injektionsvæske 5 ml 1 hætteglas med injektionsvæske 10 ml
English: The in vivo increase in factor IX levels obtained with Nonafact is 1.1 IU/dl per IU administered per kg body weight, which corresponds to an in vivo recovery of 49 %.
Danish: Øgningen af faktor IX in vivo vha. Nonafact er 1,1 IE/dl pr. indgivet IE pr. kg kropsvægt, hvilket svarer til en in vivo bedring på 49 %.
English: NL-1066 CX Amsterdam The Netherlands
Danish: NL-1066 CX Amsterdam Nederlandene
English: • A vial of Nonafact containing 500 IU or 1000 IU of factor IX
Danish: • Et hætteglas Nonafact indeholdende 500 IE eller 1000 IE faktor IX
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/186/001 EU/1/01/186/002 13.
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/01/186/001
English: Adverse reaction (PT)
Danish: Bivirkning (PT)
English: It is strongly recommended that every time you receive a dose of Nonafact the name and batch number of the product are recorded in order to maintain a record of the batches used.
Danish: Det anbefales kraftigt, at produktnavn og batchnummer registreres, hver gang De får en dosis Nonafact, således at der kan føres en optegnelse over, hvilke batch der er anvendt.
English: UNIQUE IDENTIFIER - 2D BARCODE 18.
Danish: INFORMATION I BRAILLESKRIFT 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE 18.
English: These are conditions that increase your risk of developing internal blood clots.
Danish: Det er sygdomme, der giver Dem større risiko for at få blodpropper.
English: BATCH NUMBER Lot: {number}
Danish: FREMSTILLERENS BATCHNUMMER Batch: {nummer}
English: For long-term prevention of bleeding in individuals with severe haemophilia B, the usual doses of 20 to 40 IU of factor IX per kilogram body weight should be given at intervals of 3 to 4 days.
Danish: For langvarig forebyggelse af blødninger hos patienter med svær hæmofili B bør de sædvanlige doser på 20 til 40 IE faktor IX pr. kg kropsvægt gives med intervaller på 3-4 dage.