FrancophonIA/ELRC3.0 huggingface dataset:
English: The subsequent doses should be given every 14 days for a total of five doses.
Danish: Den næste og hver af de følgende doser indgives med intervaller på 14 dage indtil der er givet i alt fem doser.
English: Zenapax should only be prescribed and given by doctors who have experience in the use of immunosuppressive treatment following organ transplant.
Danish: Zenapax må udelukkende ordineres og indgives af læger, som har erfaring med immunosuppressiv behandling efter organtransplantation.
English: In the study of children, five (8%) experienced rejection in the first six months after the transplant.
Danish: I undersøgelsen af børn var der 5 (8 %), som oplevede en afstødning i løbet af de første seks måneder efter transplantationen.
English: Zenapax should not be used in people who may be hypersensitive (allergic) to daclizumab or any of the other ingredients.
Danish: Zenapax må ikke anvendes til personer, som kan være overfølsomme (allergiske) over for daclizumab eller et eller flere af de øvrige indholdsstoffer.
English: The full EPAR for Zenapax can be found here.
Danish: Den fuldstændige EPAR for Zenapax findes her.
English: Daclizumab has been designed to bind to the receptor for interleukin-2 on the surface of white blood cells called T-lymphocytes.
Danish: Daclizumab er udviklet til at binde sig til interleukin-2-receptoren på overfladen af de hvide blodlegemer, der hedder T-lymfocytter.
English: A further study looked at rejection rates in 60 children aged between five and 18 years who were undergoing a kidney transplant.
Danish: I en yderligere undersøgelse så man på afstødningsprocenten for 60 børn mellem 5 og 18 år, der fik en nyretransplantation.
English: By binding to and blocking the receptor, daclizumab prevents interleukin-2 activating the T-lymphocytes, reducing the chance that the transplanted kidney will be rejected.
Danish: Ved at binde sig til og blokere receptoren forhindrer daclizumab interleukin-2 i at aktivere T-lymfocytterne, hvilket mindsker risikoen for, at den transplanterede nyre bliver afstødt.
English: The main measure of effectiveness was the proportion of patients who experienced rejection of the transplanted kidney in the first six months after the transplant.
Danish: Det primære mål for virkningen var andelen af patienter, som afstødte den transplanterede nyre i løbet af de første seks måneder efter transplantationen.
English: Zenapax is used to prevent the body from rejecting a kidney soon after a transplant.
Danish: Zenapax anvendes til at forhindre kroppen i at afstøde en nyre kort tid efter en transplantation.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Zenapax's benefits are greater than its risks for the prophylaxis of acute organ rejection in de novo allogenic renal transplantation, used concomitantly with an immunosuppressive regimen, including ciclosporin and corticosteroids in patients who are not highly immunised.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Zenapax er større end risiciene ved forebyggelse af akut organafstødning ved de novo allogen nyretransplantation, når Zenapax anvendes sammen med en immunosuppressiv behandlingsmetode, herunder ciclosporin og kortikosteroider hos patienter, der ikke er kraftigt immuniserede.
English: Zenapax must not be used in women who are breast feeding.
Danish: Zenapax må ikke anvendes til ammende kvinder.
English: The active substance in Zenapax, daclizumab, is a monoclonal antibody.
Danish: Det aktive stof i Zenapax er daclizumab, som er et monoklonalt antistof.
English: In the first study, the patients were receiving ciclosporin and prednisone (a corticosteroid), and in the second study, they were receiving ciclosporin, prednisone and
Danish: I den første undersøgelse fik patienterne ciclosporin og prednison (et kortikosteroid), og i den anden undersøgelse
English: Zenapax is a concentrate to be made up into a solution for infusion (drip into a vein).
Danish: Zenapax er et koncentrat til fremstilling af en opløsning til infusion (drop i en vene).
English: Both studies compared the effects of adding Zenapax or placebo (a dummy treatment) to other immunosuppressive medicines.
Danish: I begge undersøgelser sammenlignede man virkningerne af at kombinere Zenapax eller placebo (uvirksom behandling) med andre immunosuppressive lægemidler.
English: Zenapax was more effective than placebo in reducing the rate of rejection when added to immunosuppressive therapy.
Danish: Zenapax var mere effektivt end placebo til at reducere afstødningsprocenten, når det blev kombineret med immunosuppressiv behandling.
English: In the first study, 28 (22%) of the 126 adults adding Zenapax to ciclosporin and prednisone experienced rejection, compared with 47 (35%) of the 134 adding placebo.
Danish: I den første undersøgelse oplevede 28 (22 %) af de 126 voksne, der fik Zenapax sammen med ciclosporin og prednison, en afstødning sammenlignet med 47 (35 %) af de 134 voksne, der kombinerede Zenapax med placebo.
English: In the second study, 39 (28%) of the 141 adults adding Zenapax to ciclosporin, prednisone and azathioprine experienced rejection of the kidney, compared with 63 (47%) of the 134 adding placebo.
Danish: I den anden undersøgelse oplevede 39 (28 %) af de 141 voksne, der fik Zenapax sammen med ciclosporin, prednison og azathioprin, en afstødning sammenlignet med 63 (47 %) af de 134 voksne, der fik Zenapax sammen med placebo.
English: What is the risk associated with Zenapax?
Danish: Hvilken risiko er der forbundet med Zenapax?
English: For the full list of side effects reported with Zenapax, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Zenapax fremgår af indlægssedlen.
English: In studies, side effects were seen at similar rates in patients taking Zenapax and those taking placebo, when given in combination with immunosuppressive medicines.
Danish: Undersøgelser viser, at bivirkninger er lige så hyppige hos patienter, der tager Zenapax, som hos patienter, der tager placebo, når det indgives sammen med immunosuppressive lægemidler.
English: Why has Zenapax been approved?
Danish: Hvorfor blev Zenapax godkendt?
English: What is Zenapax?
Danish: Hvad er Zenapax?
English: How has Zenapax been studied?
Danish: Hvordan blev Zenapax undersøgt?
English: What benefit has Zenapax shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Zenapax?
English: azathioprine.
Danish: fik de ciclosporin, prednison og azathioprin.
English: What is Zenapax used for?
Danish: Hvad anvendes Zenapax til?
English: How is Zenapax used?
Danish: Hvordan anvendes Zenapax?
English: How does Zenapax work?
Danish: Hvordan virker Zenapax?
English: Contact your doctor immediately if you suspect that the product is becoming progressively less effective.
Danish: Kontakt omgående Deres læge, hvis De mistænker, at produktet efterhånden bliver mindre og mindre effektivt.
English: Not all pack sizes may be marketed.
Danish: Ikke alle pakningsstørrelser nødvendigvis markedsført.
English: Produced from the plasma of human donors.
Danish: Produceret af plasma fra humane donorer.
English: Previously untreated patients
Danish: Tidligere ubehandlede patienter
English: In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Danish: I henhold til artikel 114 i direktiv 2001/83/EF foretages den officielle batchfrigivelse af et statsligt laboratorium eller et laboratorium udpeget hertil.
English: ATC code: B02BD04.
Danish: ATC-kode: B02BD04.
English: This must be carried out in hospital or under the careful supervision of a doctor.
Danish: Dette skal ske på et hospital eller under nøje overvågning af en læge.
English: The solution should not be too cold when it is administered.
Danish: Opløsningen bør ikke være for kold, når den indgives.
English: The other (serious and non-serious) adverse reactions were received by spontaneous reporting.
Danish: De øvrige (alvorlige og ikke alvorlige) bivirkninger er fremkommet via spontane indberetninger.
English: By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Viral safety
Danish: Viral sikkerhed
English: If you have the impression that the effect of Nonafact is too strong or too weak, talk to your doctor.
Danish: Hvis De har indtrykket af, at effekten af Nonafact er for stærk eller for svag, skal De tale med Deres læge.
English: See your doctor immediately, if bleeding does not stop as expected.
Danish: Kontakt straks egen læge, hvis blødningerne ikke standser som forventet.
English: MedDRA system organ class (SOC)
Danish: MedDRA-systemorganklasse (SOC)
English: DATE OF REVISION OF TEXT
Danish: DATO FOR ÆNDRING AF TEKSTEN
English: In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.
Danish: I visse tilfælde, især blandt yngre patienter, kan det være nødvendigt med kortere dosisintervaller eller højere doser.
English: Once dissolved, the product should be used immediately (at least within 3 hours).
Danish: Når det er opløst, skal produktet bruges straks (inden for 3 timer).
English: In case of shock, standard medical treatment for shock should be implemented.
Danish: I tilfælde af chok skal der foretages medicinsk standardbehandling for chok.
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 (<1/10,000), not known (cannot be estimated from the available data)
Danish: Hyppigheder er vurderet i henhold til følgende: 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) eller ikke kendt (kan ikke estimeres ud fra de forhåndenværende data).
English: (pre- and postoperative)
Danish: (præ- og postoperativt)
English: Do not shake!
Danish: Må ikke rystes!
English: Paediatric population The listed warnings and precautions apply both to adults and children.
Danish: Pædiatrisk population De angivne advarsler og forholdsregler gælder for både voksne og børn.
English: Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.
Danish: Derfor skal patienter med allergiske reaktioner undersøges for tilstedeværelsen af en inhibitor.
English: Your doctor will check your blood regularly for the presence of these antibodies.
Danish: Deres læge vil regelmæssigt undersøge Deres blod for tilstedeværelsen af disse antistoffer.
English: The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Danish: Dosis og administrationens hyppighed skal altid beregnes ud fra den kliniske effektivitet i det enkelte tilfælde.
English: The required dose is determined using the following formula:
Danish: Den nødvendige dosis beregnes ud fra følgende formel:
English: Nonafact has a half-life of approximately 19 (17 - 21) hours.
Danish: Nonafact har en halveringstid på ca. 19 (17-21) timer.
English: In each of these situations, the benefit of treatment with Nonafact should be weighed against the risk of these complications.
Danish: I hver enkelt af disse situationer må fordelen ved en behandling med Nonafact opvejes mod risikoen for disse komplikationer.
English: Factor IX is a single chain glycoprotein with a molecular mass of about 68,000 Dalton.
Danish: Faktor IX er et enkeltkæde-glykoprotein med en molekylmasse på omkring 68.000 Dalton.
English: If such inhibitors occur, the condition will manifest itself as an insufficient clinical response.
Danish: Hvis sådanne inhibitorer forekommer, vil det give sig udslag i en utilstrækkelig klinisk respons.
English: They will then ensure that factor IX is administered to you, should this prove necessary.
Danish: De vil da sikre, at De får faktor IX, hvis dette skulle blive nødvendigt.
English: Dissolving the powder
Danish: Opløsning af pulveret
English: This will show itself as an increased tendency to bleed.
Danish: Dette vil vise sig ved en øget tendens til blødninger.
English: Frequency of doses (hours)/ Duration of therapy (days)
Danish: Dosishyppighed (timer)/terapiens varighed (dage)
English: You will be closely monitored for any possible side effect during this treatment.
Danish: De vil blive nøje overvåget for mulige bivirkninger af dette forløb.
English: This also applies to newborn babies and patients with an increased risk of thrombosis or “DIC” (disseminated intravascular coagulation) a disease in which the blood coagulation system is disturbed.
Danish: Dette gælder også for nyfødte og patienter med en forhøjet risiko for blodpropper eller "DIC" (dissemineret intravaskulær koagulering), der er en sygdom, hvor blodkoaguleringssystemet er forstyrret.
English: Nonafact may be self-administered if it is an approved practice in your country and when you have been trained sufficiently.
Danish: De må dog selv injicere Nonafact, hvis det er en godkendt praksis i Deres land, og hvis De er tilstrækkelig oplært i det.
English: Chemical and physical in-use stability has been demonstrated for 3 hours at a temperature of 21°C.
Danish: Efter rekonstitution: Kemisk og fysisk stabilitet i brug er påvist i 3 timer ved 21 °C.
English: Neutralising antibodies (Inhibitors)
Danish: Neutraliserende antistoffer (inhibitorer)
English: From a microbiological point of view, the product should be used immediately after reconstitution.
Danish: Ud fra et mikrobiologisk synspunkt skal produktet bruges med det samme efter rekonstitution.
English: If you have to undergo surgery or have a tooth extracted, inform your doctor or dentist that you have factor IX deficiency.
Danish: Hvis De skal opereres eller have en tand trukket ud, skal De underrette Deres læge eller tandlæge om, at De lider af faktor IX-mangel.
English: Factor IX level required (%) (IU/dl)
Danish: Nødvendigt faktor IXniveau (%) (IE/dl)
English: For instructions on reconstitution of the medicinal product before administration, see section 6.
Danish: For instruktioner om rekonstitution af lægemidlet før administration, se pkt.
English: Thrombin then converts fibrinogen into fibrin and a clot is formed.
Danish: Thrombin omdanner fibrinogen til fibrin, og derved begynder en størknet masse at dannes.
English: The clinical relevance of antibodies to mouse protein, if these do indeed arise, is not known.
Danish: Den kliniske betydning af antistoffer mod museprotein, hvis sådanne overhovedet dannes, er ikke kendt.
English: You should discuss the possible side effects with your doctor in order to know how to recognise them and what to do if they occur.
Danish: De bør tale med Deres læge om de forskellige bivirkninger, så De kan kende dem og vide, hvad De skal gøre, hvis de opstår.
English: If you have previously experienced hypersensitivity in response to the administration of blood or a blood product, Nonafact should only be administered when absolutely necessary (in life-threatening situations).
Danish: Hvis De tidligere har udvist overfølsomhed over for blod eller blodprodukter, bør Nonafact kun bruges, når det er absolut nødvendigt (livstruende situationer).
English: Powder:
Danish: Pulver:
English: Where necessary, mild allergic reactions, such as hives, can be treated with antihistamines (medicinal products which counteract allergies).
Danish: Om nødvendigt kan milde allergiske reaktioner såsom kløende udslæt behandles med antihistaminer (lægemiddel, der modvirker allergier).
English: Your doctor will determine the dose of Nonafact you need and how frequently you should use it depending on the situation.
Danish: Deres læge vil afgøre, hvilken dosis Nonafact De har behov for, og hvor hyppigt, De bør bruge det, alt afhængigt af omstændighederne.
English: Nonafact should never be mixed with other medicinal products.
Danish: Nonafact må aldrig blandes med andre lægemidler.
English: Your doctor will decide how much Nonafact you require.
Danish: Deres læge vil tage stilling til, hvor meget Nonafact, De har behov for.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke foreligger studier vedrørende eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler.
English: Factor IX in this product therefore behaves like endogenous factor IX.
Danish: Derfor opfører faktor IX i dette produkt sig ligesom endogent faktor IX.
English: Your doctor will check your blood regularly for the presence of these antibodies, especially if you experienced a severe allergic reaction with the previous use of a factor IX product.
Danish: Deres læge vil jævnligt undersøge Deres blod for disse antistoffer - især hvis De har haft en alvorlig allergisk reaktion i forbindelse med tidligere brug af et faktor IX-produkt.
English: If you are unsure, you should discuss this with your doctor.
Danish: Hvis De er i tvivl, så tal med Deres læge om det.
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Danish: Tabellen herunder er angivet ifølge systemorganklassificeringen i henhold til MedDRA (systemorganklasse og foretrukken terminologi).
English: The safety and efficacy of Nonafact in previously untreated patients have not been established.
Danish: Nonafacts sikkerhed og virkning hos tidligere ubehandlede patienter er ikke klarlagt.
English: Disinfect the surface of the stoppers of both vials with a gauze soaked in 70 % alcohol.
Danish: Desinficér overfladen af propperne på begge hætteglas vha. gaze dyppet i 70 % alkohol.
English: Catheter-related complications
Danish: Kateter-relaterede komplikationer
English: If you suffer from a liver or cardiac disease or if you have recently had surgery, there is an increased risk for coagulation complications.
Danish: Hvis De lider af lever- eller hjertesygdomme, eller hvis De er blevet opereret for nylig, er der en forøget risiko for koaguleringskomplikationer.
English: The specific activity of Nonafact is approximately 200 IU/mg protein.
Danish: Nonafacts specifikke aktivitet er ca. 200 IE/mg protein.
English: The use of high purity factor IX is rarely associated with such adverse reactions.
Danish: Brugen af meget rent faktor IX er kun sjældent associeret med sådanne bivirkninger.
English: Do not use this medicine after the expiry date which is stated on the label and carton.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen.
English: Treatment should be under the supervision of a physician experienced in the treatment of haemophilia.
Danish: Behandlingen skal foregå under tilsyn af en læge, der har erfaring med behandling af hæmofili.
English: The adverse reaction flushing is reported in a clinical trial.
Danish: Bivirkningen flushing er indberettet i et klinisk studie.
English: It is a vitamin K-dependent coagulation factor and is synthesised in the liver.
Danish: Det er en vitamin K-afhængig koaguleringsfaktor, der dannes i leveren.
English: The administration of Nonafact can compensate for this deficiency.
Danish: Indgivelse af Nonafact kan afhjælpe denne mangel.
English: In pharmacodynamic studies in rabbits and guinea pigs, the thrombogenicity of Nonafact was shown to be minimal.
Danish: I farmakodynamiske studier på kaniner og marsvin viste det sig, at thrombogeniciteten af Nonafact var minimal.
English: Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/repeatedly receive human plasma-derived coagulation factor IX.
Danish: Deres læge kan anbefale, at De overvejer at blive vaccineret mod hepatitis A og B, hvis De regelmæssigt/gentagne gange får koagulationsfaktor IX, der er deriveret af humant plasma.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Spørg Deres læge eller apotekspersonalet til råds, inden De tager nogen form for medicin.
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor IX activity) is indispensable.
Danish: Især ved større kirurgiske indgreb er præcis overvågning af substitutionsbehandling med koagulationsanalyse (plasma faktor IX-aktivitet) absolut nødvendig.
English: for intravenous use
Danish: til intravenøs anvendelse
English: This also applies to any unknown or emerging viruses or other types of infections.
Danish: Dette gælder også ukendte eller nyopståede vira og andre typer infektioner.
English: Degree of bleeding / Type of surgical procedure
Danish: Grad af blødning/type kirurgisk indgreb
English: Cardiovascular events
Danish: Kardiovaskulære hændelser
English: There are no known interactions between Nonafact and other medicinal products.
Danish: Der er ingen kendte interaktioner mellem Nonafact og andre lægemidler.
English: From a microbiological point of view the product, once dissolved, should be used immediately, but no longer than 3 hours after reconstitution.
Danish: Ud fra et mikrobiologisk synspunkt skal produktet bruges umiddelbart efter, at det er opløst, men ikke mere end 3 timer efter rekonstitution.
English: Nonafact consists of a carton containing:
Danish: Nonafact leveres i emballage, der indeholder:
English: This also applies to unknown or emerging viruses or other pathogens.
Danish: Dette gælder også ukendte eller nyopståede vira og andre patogener.
English: Paediatric population Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Danish: Bivirkningernes hyppighed, type og sværhedsgrad forventes at være de samme hos børn som hos voksne.
English: Particularly with major surgery, it is important that the concentrations of factor IX in your blood are checked carefully before and after the operation.
Danish: Især i forbindelse med større kirurgiske indgreb er det vigtigt, at koncentrationen af faktor IX i Deres blod kontrolleres omhyggeligt før og efter operationen.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V *.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V*.
English: Nonafact is given to you by your doctor or nurse.
Danish: De får Nonafact af lægen eller sygeplejersken.
English: Because of the risk of allergic reactions with factor IX products, the initial administrations of factor IX should, according to the treating physician's judgement, be performed under medical observation where proper medical care for allergic reactions could be provided.
Danish: På grund af risikoen for allergiske reaktioner med faktor IX-produkter skal de første administrationer af faktor IX ske under lægeligt tilsyn i henhold til den behandlende læges vurdering, så der kan ydes passende medicinsk behandling af allergiske reaktioner.
English: This leaflet was last approved
Danish: Denne indlægsseddel blev senest ændret
English: The resulting solution is clear, colourless to light yellow and has a neutral pH.
Danish: Den færdige opløsning er klar, farveløs til lysegul og har en neutral pH-værdi.
English: Nonafact contains sodium chloride
Danish: Nonafact indeholder salt (natriumchlorid)
English: Talk to your doctor or pharmacist or nurse before using Nonafact.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før De bruger Nonafact.
English: Your doctor will consider whether administration of Nonafact imposes a risk for coagulation complications.
Danish: Deres læge vil tage stilling til, om brugen af Nonafact udgør en risiko for koaguleringskomplikationer.
English: Store in a refrigerator (at 2°C - 8°C ).
Danish: Opbevares i køleskab (ved 2 °C - 8 °C).
English: Inhibitors
Danish: Inhibitorer