FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/01/186/002 (1000 IU)
Danish: EU/1/01/186/002
English: Haemophilia B is a chronic disease, therefore lifelong treatment with a factor IX product may be necessary.
Danish: Hæmofili B er en kronisk sygdom, og derfor kan det være nødvendigt at fortsætte behandlingen resten af livet.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains nominally 500 IU or 1000 IU of human coagulation factor IX.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert hætteglas indeholder 500 IE eller 1000 IE human koagulationsfaktor IX.
English: Haemophilia B is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor IX and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Danish: Hæmofili B er en kønsbundet, arvelig blodkoaguleringssygdom, der skyldes en nedsat mængde faktor IX , og som indebærer kraftige blødninger i led, muskler eller indre organer - enten spontant eller pga. tilfældige skader eller kirurgiske indgreb.
English: If you forget to use Nonafact
Danish: Hvis De har glemt at bruge Nonafact
English: There is a potential risk that higher doses of Nonafact will cause clots to form in blood vessels, resulting in thrombosis.
Danish: Der er en mulig risiko for, at højere doser af Nonafact kan føre til dannelsen af blodkoagler i blodkarrene, hvilket resulterer i blodpropper.
English: 30-60 Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved.
Danish: 30-60 Gentag infusionen hver 24. time i 34 dage eller længere, indtil smerten og det akutte handicap er ophørt.
English: Duration of treatment
Danish: Behandlingens varighed:
English: No interactions of human coagulation factor IX products with other medicinal products have been reported.
Danish: Der er ikke indberettet interaktioner mellem humane koagulationsfaktor IX-produkter og andre lægemidler.
English: Remove the protective sheath from one end of a transfer needle and pierce the stopper of the vial containing water for injections.
Danish: Fjern beskyttelseskappen fra den ene ende af kanylen, og gennembor proppen på hætteglasset med injektionsvæske.
English: Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breastfeeding is not available.
Danish: Pga. den sjældne forekomst af hæmofili B hos kvinder, er der ingen erfaringer med brugen af faktor IX under graviditet og amning.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu og på Lægemiddelstyrelsens hjemmeside http://www.dkma.dk>.
English: 60-100 Repeat infusion every 8 to 24 hours until threat is resolved.
Danish: 60-100 Gentag infusionen hver 8. til 24. time, indtil faren er drevet over.
English: Nonafact contains approximately 500 or 1000 IU (100 IU/ml) of human coagulation factor IX after reconstitution.
Danish: Nonafact indeholder ca. 500 IE eller 1000 IE (100 IE/ml) human koagulationsfaktor IX efter rekonstitution.
English: Special precautions for disposal and other handling
Danish: Regler for bortskaffelse og anden håndtering
English: Individuals with haemophilia B who receive factor IX preparations, should be monitored for the development of neutralising antibodies against factor IX (inhibitors) (see Possible side effects).
Danish: Hæmofili B-patienter, der får faktor IX-præparater, bør overvåges for at holde øje med udviklingen af neutraliserende antistoffer mod faktor IX (inhibitorer) (se Hvilke mulige bivirkninger).
English: Animal reproduction studies have not been conducted with factor IX.
Danish: Med faktor IX er der ikke udført reproduktionsstudier på dyr.
English: 500 IU: one vial (glass type I) of powder + one vial (glass type I) of 5 ml solvent with stoppers (bromobutyl).
Danish: 500 IE: et hætteglas (glastype I) med pulver + et hætteglas (glastype I) med 5 ml solvens med propper (bromobutyl).
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (at 2C - 8C).
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab (ved 2 °C - 8 °C), må ikke nedfryses.
English: - The other ingredients are sodium chloride, sucrose, histidine and water for injections.
Danish: - Øvrige indholdsstoffer: natriumchlorid, sakkarose, histidin og injektionsvæske.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, even those not prescribed.
Danish: Fortæl det altid til lægen, apotekspersonalet eller sygeplejersken, hvis De tager anden medicin eller har gjort det for nylig.
English: For long-term prophylaxis against bleeding in patients with severe haemophilia B, the usual doses are 20 to 40 IU of factor IX per kilogram of body weight at intervals of 3 to 4 days.
Danish: For permanent, forebyggende behandling af blødninger hos patienter med alvorlig hæmofili B er de sædvanlige doser på 20 til 40 IE faktor IX pr. kg kropvægt med intervaller på 3-4 dage.
English: Nonafact is presented as a powder and a solvent for solution for injection (vial of 5 ml or 10 ml)
Danish: Nonafact består af pulver og solvens til injektionsopløsning (hætteglas med 5 eller 10 ml).
English: If, after administration, you develop hypersensitive reactions like hives, itching and rash, chest tightness, wheezing and light headedness contact your physician immediately.
Danish: Hvis De efter at have taget produktet udviser overfølsomhedsreaktioner såsom kløende udslæt, trykken for brystet, hiven efter vejret eller svimmelhed, skal De straks kontakte Deres læge.
English: Special warnings and precautions for use
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen
English: For storage conditions after reconstitution of the medicinal product, see section
Danish: Opbevaringsforhold efter rekonstitution af lægemidlet, se pkt.
English: 1000 IU: one vial (glass type I) of powder + one vial (glass type I) of 10 ml solvent with stoppers (bromobutyl).
Danish: 1000 IE: et hætteglas (glastype I) med pulver + et hætteglas (glastype I) med 10 ml solvens med propper (bromobutyl).
English: No symptoms of overdose with human coagulation factor IX have been reported.
Danish: Der er ingen meddelelser om tilfælde af overdosering med human koaguleringsfaktor IX.
English: Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
Danish: Behandling og forebyggelse af blødninger hos patienter med hæmofili B (medfødt faktor IX-mangel).
English: Remove from the refrigerator and allow the two vials to reach room temperature (15°C - 25°C).
Danish: Tag begge hætteglas ud af køleskabet, og lad dem få stuetemperatur (15 °C - 25 °C).
English: Contains: sodium chloride, histidine and sucrose.
Danish: Indeholder: natriumchlorid, histidin og sakkarose
English: Powder and solvent for solution for injection.
Danish: Pulver og solvens til injektionsopløsning
English: Nonafact contains trace amounts (< 0.1 ng mouse IgG/IU of factor IX) of the murine monoclonal antibody used in its purification.
Danish: Nonafact indeholder meget små mængder (<0,1 ng murint igG/IE faktor IX) af det murine, monoklonale antistof, der bruges til oprensningen af faktor IX.
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Danish: Hos undervægtige eller overvægtige patienter kan det være nødvendigt at justere dosis baseret på kropsvægt.
English: Remove the empty vial and the transfer needle.
Danish: Fjern det tomme hætteglas og kanylen.
English: Thromboembolism
Danish: Tromboembolisme
English: Other medicines and Nonafact
Danish: Brug af anden medicin sammen med Nonafact
English: Patients with haemophilia B may develop neutralising antibodies (inhibitors) to factor IX.
Danish: Patienter med hæmofili B kan udvikle neutraliserende antistoffer (inhibitorer) mod faktor IX.
English: On demand treatment
Danish: Behandling ved behov
English: Therefore, factor IX should be used by pregnant or breast-feeding women only if clearly indicated.
Danish: Derfor bør gravide og ammende kvinder kun bruge faktor IX, hvis der er klare indikationer herfor.
English: There is a very slight risk that Nonafact will cause clots to form in blood vessels, resulting in thrombosis.
Danish: Der er en meget lille risiko for, at Nonafact kan forårsage dannelse af størknet blod i blodårerne, hvilket kan føre til blodpropper.
English: BOX VIAL OF POWDER 500 IU BOX VIAL OF POWDER 1000 IU
Danish: ÆSKE MED HÆTTEGLAS MED PULVER 500 IE ÆSKE MED HÆTTEGLAS MED PULVER 1000 IE
English: Repeat infusion every 8-24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor IX activity of 30 % to 60 % (IU/dl).
Danish: Fortsæt derpå behandlingen i mindst endnu 7 dage for at opretholde en faktor IXaktivitet på 30-60 % (IE/dl).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION Date of first authorisation: 03 July 2001
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: What you need to know before you use Nonafact
Danish: Det skal De vide, før De begynder at tage Nonafact
English: NAME OF THE MEDICINAL PRODUCT Nonafact 100 IU/ml powder and solvent for solution for injection.
Danish: LÆGEMIDLETS NAVN Nonafact 100 IE/ml pulver og solvens til injektionsopløsning.
English: PHARMACEUTICAL FORM Powder and solvent for solution for injection.
Danish: LÆGEMIDDELFORM Hvidt frysetørret pulver og solvens til injektionsopløsning.
English: Nonafact 100 IU/ml powder for solution for injection Human coagulation factor IX for intravenous use
Danish: Nonafact 100 IE/ml pulver til injektionsopløsning Human koaguleringsfaktor IX til intravenøs anvendelse
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER
English: Do not use Nonafact:
Danish: Brug ikke Nonafact
English: If you are allergic to human coagulation factor IX or to any of the ingredients of this medicine (listed in section 6).
Danish: • hvis De er allergisk over for human koagulationsfaktor IX eller et af de øvrige indholdsstoffer i
English: There is a potential risk of thromboembolic episodes following the administration of factor IX products, with a higher risk for low purity preparations.
Danish: Der eksisterer en potentiel risiko for thrombo-emboliske episoder efter indgivelsen af faktor IXprodukter.
English: Nonafact 100 IU/ml powder and solvent for solution for injection Human coagulation factor IX
Danish: Nonafact 100 IE/ml pulver og solvens til injektionsopløsning Human koaguleringsfaktor IX
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11.
Danish: IKKE ANVENDT LÆGEMIDDEL SAMT AFFALD HERAF 11.
English: If you have existing cardiovascular risk factors, substitution therapy with Factor IX may increase the cardiovascular risk.
Danish: Hjertekarsygdomme (kardiovaskulære hændelser) Hvis De har en risiko for hjertekarsygdomme, kan en substitutionsbehandling med Faktor IX øge risikoen.
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Danish: På trods af dette kan overførsel af smitstoffer ved anvendelse af lægemidler fremstillet ud fra humant blod eller plasma ikke helt udelukkes.
English: Solvent: water for injections
Danish: Solvens: injektionsvæske
English: Keep the container in the outer carton, in order to protect from light.
Danish: Opbevar beholderen i den ydre karton for at beskytte mod lys.
English: Instructions for use:
Danish: Brugsanvisning:
English: Nonafact can be administered to prevent and treat bleeding in patients suffering from haemophilia B (a congenital lack of active factor IX).
Danish: Nonafact kan indgives for at forhindre blødninger hos patienter med hæmofili B - en arvelig faktor IXmangel.
English: Haemorrhage
Danish: Hududslæt
English: Solvent: Water for injections.
Danish: Opløsningsmiddel: Vand til injektionsvæske.
English: Swirl the vial gently to completely dissolve the powder.
Danish: Sving indholdet i glasset forsigtigt rundt for at opløse pulveret.
English: Before administration, check that the solution is clear or slightly opalescent.
Danish: Kontrollér, at opløsningen er klar eller let uigennemsigtig, umiddelbart før den indgives.
English: VIAL OF SOLVENT 5 ml VIAL OF SOLVENT 10 ml
Danish: HÆTTEGLAS MED SOLVENS 10 ml
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU (100 IU/ml after reconstitution) 1000 IU (100 IU/ml after reconstitution)
Danish: 500 IE (100 IE/ml efter rekonstitution) 1000 IE (100 IE/ml efter rekonstitution)
English: During the course of treatment it is advised that the concentrations of factor IX in your blood are checked regularly.
Danish: Det tilrådes, at faktor IX-koncentrationen i Deres blod kontrolleres jævnligt i løbet af behandlingen.
English: Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of plasma-derived factor IX products.
Danish: For patienter, der regelmæssigt/gentagne gange får plasma-deriverede faktor IX-produkter, bør en passende vaccination (hepatitis A og B) overvejes.
English: • If you have further questions, ask your doctor or pharmacist or nurse.
Danish: Er De i tvivl, så spørg lægen eller apotekspersonalet.
English: Life threatening bleeding
Danish: Livstruende blødninger
English: More extensive bleeding in joints, muscle bleeding or haematoma
Danish: Mere udtalte blødninger i led, muskelblødninger eller hæmatomer
English: 500 IU human coagulation factor IX (100 IU/ml after reconstitution).
Danish: 500 IE human koaguleringsfaktor IX (100 IE/ml efter rekonstitution) 1000 IE human koaguleringsfaktor IX (100 IE/ml efter rekonstitution)
English: DD month YYYY
Danish: DD måned ÅR
English: At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Danish: Gentag infusionen hver 24. time i mindst 1 dag, indtil blødningen som angivet ved smerte er standset eller heling er indtrådt.
English: VIAL OF POWDER 500 IU VIAL OF POWDER 1000 IU
Danish: HÆTTEGLAS MED PULVER 500 IE HÆTTEGLAS MED PULVER 1000 IE
English: What Nonafact is and what it is used for What you need to know before you use Nonafact How to use Nonafact
Danish: Det skal De vide, før De begynder at bruge Nonafact Sådan skal De bruge Nonafact Bivirkninger
English: Prophylaxis
Danish: Dosering
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription 15.
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING Receptpligtigt lægemiddel
English: Keep the vials in the outer carton, in order to protect from light.
Danish: Opbevar hætteglassene i den ydre karton for at beskytte mod lys.
English: How to use Nonafact
Danish: Sådan skal De bruge Nonafact
English: The product must not be used if any cloudiness, lumps or particulate matter are visible.
Danish: Produktet må ikke anvendes, hvis man kan se nogen former for uklarheder, klumper eller partikler i det. Spørg på apoteket, hvordan De skal bortskaffe medicinrester.
English: Early signs of bleeding in joints, muscle bleeding or oral bleeding
Danish: Tidlige tegn på ledblødninger, muskelblødninger eller blødninger i mundhulen
English: For safety information with respect to transmissible agents, see 4.4.
Danish: Sikkerhedsoplysninger om stoffer, der kan overføres, findes i pkt.
English: Reconstitute with 5 ml of water for injections.
Danish: Rekonstitueres med 5 ml injektionsvæske Rekonstitueres med 10 ml injektionsvæske Indgives straks
English: More extensive haemarthrosis, muscle bleeding or haematoma
Danish: Mere omfattende ledblødning, muskelblødning eller hæmatomer
English: Sodium chloride Sucrose
Danish: Natriumchlorid Saccharose Histidin.
English: Minor surgery including tooth extraction
Danish: Kirurgiske indgreb Mindre kirurgiske indgreb inkl.
English: Early haemarthrosis, muscle bleeding or oral bleeding
Danish: Tidlig ledblødning, muskelblødning eller blødning i mundhulen
English: Flushing
Danish: Flushing sjælden
English: Posology
Danish: BATCHNUMMER
English: Tilt the product vial when transferring the solvent to allow the solvent to flow down the side of the vial.
Danish: Tip hætteglasset med pulveret, mens injektionsvæsken overføres, så væsken flyder ned langs glasset.
English: Check with your doctor or pharmacist if you are not sure.
Danish: • Spørg lægen eller apotekspersonalet, hvis der er mere, De vil vide.
English: Allergic type hypersensitivity reactions are possible with Nonafact The product contains traces of mouse proteins.
Danish: Produktet indeholder spor af museproteiner.
English: Hypersensitivity to the active substance or to any of the excipients: sodium chloride, sucrose, histidine.
Danish: nældefeber, generel urticaria, trykken for brystet, hiven efter vejret, hypotension og anafylaxi.
English: If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the product immediately and contact their physician Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Danish: Hvis der opstår symptomer på overfølsomhed, skal patienterne rådes til straks at indstille brugen af produktet og kontakte deres læge.
English: • A vial water for injections containing 5 ml or 10 ml
Danish: • Et hætteglas injektionsvæske indeholdende 5 ml eller 10 ml Indehaver af markedsføringstilladelsen og fremstiller Sanquin Plasma Products B.V.
English: Invert the solvent vial and pierce the stopper of the vial containing the powder.
Danish: Vend hætteglasset med injektionsvæske på hovedet, og gennembor proppen på hætteglasset med pulveret.
English: Two initial opinions were issued.
Danish: To oprindelige udtalelser blev afgivet.
English: The corresponding decision from the Commission was issued on 13 July 2011.
Danish: Kommissionen traf en afgørelse i den forbindelse den 13. juli 2011.
English: Care should be taken to ensure consistency.
Danish: Man bør være omhyggelig med at sikre konsekvens.
English: The Singaporean manufacturing plant was only used once and no longer considered as an alternative.
Danish: Produktionsanlægget i Singapore blev kun anvendt én gang og blev ikke længere betragtet som et alternativ.
English: A 12 month monitoring should also be undertaken upon qualification.
Danish: Der skal også gennemføres et 12-måneders tilsyn efter kvalifikation.
English: The investigation supports that a combination of factors have contributed to the findings.
Danish: Det fremgår af undersøgelsen, at en kombination af faktorer har bidraget til fundene.
English: In addition to the programme of quality improvement, future assured supply steps were developed.
Danish: Ud over programmet til forbedring af kvaliteten blev der udviklet fremtidige garanterede forsyningstiltag.
English: These dialysis solutions were thus imported from Canada, Singapore, Turkey and USA.
Danish: Disse dialysevæsker blev således importeret fra Canada, Singapore, Tyrkiet og USA.
English: A second opinion was then issued in May 2011 to recommend the inclusion of the site located in USA as an additional manufacturing site.
Danish: En anden udtalelse blev afgivet i maj 2011 for at anbefale medtagelsen af et produktionssted beliggende i USA som supplerende produktionssted.
English: The CHMP agreed with the proposed studies.
Danish: CHMP godkendte de foreslåede undersøgelser.
English: Although protein/biofilm were not found upon dismantling the line, Gram positive and Gram negative microorganisms were identified.
Danish: Selv om der ikke blev fundet protein/biofilm ved demontering af produktionslinjen, blev der påvist Gram-positive og Gram-negative mikroorganismer.
English: On the basis of the proposed measures, the CHMP was reassured that corrective actions are being implemented and will be subject of further monitoring.
Danish: På grundlag af de foreslåede foranstaltninger blev CHMP forsikret om, at korrigerende foranstaltninger er ved at blive gennemført og vil blive underlagt yderligere tilsyn.
English: For completeness, the CHMP considered that a pharmacovigilance inspection should be carried out.
Danish: For fuldstændighedens skyld mente CHMP, at der skulle gennemføres en lægemiddelovervågningsinspektion.
English: This should allow early detection of low levels of endotoxin and trend analysis which should provide an early safety warning.
Danish: Dette burde muliggøre en tidlig påvisning af lave niveauer af endotoksin og analyse af tendenser, hvilket burde resultere i en tidlig sikkerhedsadvarsel.
English: This heightened pharmacovigilance was applied to products from alternative sites supplying Europe.
Danish: Denne øgede lægemiddelovervågning blev anvendt på lægemidler fra alternative produktionssteder, der leverer til Europa.
English: The CHMP requests that the inspection of the Castlebar site be performed by the end of December 2011 and that the outcome of the inspection be provided to national competent authorities.
Danish: CHMP kræver, at inspektionen af produktionsstedet i Castlebar foretages inden udgangen af december 2011, og at resultatet af inspektionen sendes til de nationale kompetente myndigheder.
English: The product information for dialysis solutions includes the risk of peritonitis.
Danish: Produktinformationen for dialysevæsker medtager risikoen for peritonitis.
English: The contingency plan for sufficient/alternative providers/stocks for raw materials was agreed.
Danish: Nødplanen for tilstrækkelige/alternative leverandører/lagre for råvarer blev godkendt.
English: Monosol and 0.9% sodium chloride for haemodialysis solutions were promptly recalled from the market as alternatives were available.
Danish: Monosol og 0,9 % natriumchlorid til hæmodialyseopløsninger blev straks tilbagekaldt fra markedet, da der fandtes alternativer.
English: New re-designed equipment was installed with the intention of minimising areas where pooling of water/solutions could occur.
Danish: Der blev installeret nyt og ændret udstyr med det formål at minimere de områder, hvor samling af vand/opløsninger kunne forekomme.
English: The first on the inclusion of the sites located in Canada, Poland and Turkey as additional manufacturing sites to the marketing authorisations of the respective peritoneal dialysis solutions was issued by the Committee in April 2011, and the corresponding decision from the Commission was issued on 12 May 2011.
Danish: Den første om medtagelse af produktionssteder i Canada, Polen og Tyrkiet som supplerende produktionssteder i forbindelse med markedsføringstilladelserne til de respektive peritonealdialysevæsker udstedt af udvalget i april 2011, og den tilsvarende beslutning fra Kommissionen blev udstedt den 12. maj 2011.
English: To meet supply demands, the unprecedented importation of PD solutions from Canada, Turkey and USA increased.
Danish: For at imødekomme efterspørgslen blev den hidtil usete import af PD-væsker fra Canada, Tyrkiet og USA forøget.
English: Dialysis solutions produced at the affected lines are not being released onto the market pending the outcome of this inspection.
Danish: Dialysevæsker fremstillet på de berørte produktionslinjer frigives ikke til markedet, før resultatet af denne inspektion foreligger.
English: • The Committee considers that the establishment of a 12 month monitoring period, upon qualification of the Castlebar plant by the IMB, is appropriate.
Danish: • Udvalget mener, at en 12-måneders tilsynsperiode efter IMB's kvalifikation af fabrikken i Castlebar er passende.
English: Enhancements of the affected line were proposed in order to prevent the occurrence of future biofilm/microbial contamination problems.
Danish: Forbedringer af den berørte produktionslinje blev foreslået for at forhindre fremkomsten af biofilm/problemer med mikrobiologisk forurening i fremtiden.
English: Grounds for variation of the marketing authorisations
Danish: Begrundelser for ændring af markedsføringstilladelserne