FrancophonIA/ELRC3.0 huggingface dataset:
English: Prophylaxis against venous thromboembolism should be instituted, according to the current recommendations.
Danish: Profylakse af venøs tromboemboli bør iværksættes i henhold til gældende rekommandationer.
English: Draw air into an empty, sterile syringe.
Danish: Træk luft ind i en tom, steril sprøjte.
English: Experience in the treatment of pregnant or breast-feeding women is not available.
Danish: Der er ingen erfaring med behandling af gravide kvinder eller kvinder, der ammer.
English: Of note, annualized bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies.
Danish: Det noteres at den årlige blødningsrate (ABR) ikke kan sammenlignes i forskellige kliniske studier eller mellem forskellige faktorkoncentrater.
English: This is equivalent to 1.48% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 1,48 % af den anbefalede maximale daglige indtagelse af natrium for en voksen.
English: Preclinical studies with repeated dose applications (chronic toxicity, carcinogenicity and mutagenicity) cannot be reasonably performed in conventional animal models due to the development of antibodies following the application of heterologous human proteins.
Danish: Prækliniske studier med administration af gentagne doser (kronisk toksicitet, karcinogenicitet og mutagenicitet) kan ikke umiddelbart udføres i konventionelle dyremodeller pga. udvikling af antistoffer efter administration af heterologt humant protein.
English: DATE OF FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: The table presented below is according to the MedDRA system organ classification.
Danish: Tabellen nedenfor er opstillet efter MedDRAs systemorganklasser.
English: Based on the rare occurrence of haemophilia A in women, experience regarding the treatment during pregnancy and breastfeeding is not available.
Danish: På grund af sjælden forekomst af hæmofili A hos kvinder foreligger der ingen data fra behandling under graviditet og amning.
English: Your doctor may recommend that you consider being vaccinated against hepatitis A and B if you regularly/repeatedly receive human plasma-derived medicines such as Voncento.
Danish: Din læge vil måske anbefale, at du overvejer vaccination mod hepatitis A og B, hvis du regelmæssigt eller gentagne gange får lægemidler udvundet af humant plasma såsom Voncento.
English: Therefore, patients at risk must be monitored for early signs of thrombosis.
Danish: Patienter i risikogruppen bør derfor monitoreres for tidlige tegn på trombose.
English: • The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all factor VIII medicines.
Danish: • Udvikling af inhibitorer (antistoffer) er en kendt komplikation, som kan opstå under behandling med alle faktor VIII-lægemidler.
English: • Voncento must not be mixed with other medicines, diluents or solvents except those mentioned in section 6.
Danish: • Voncento må ikke blandes med andre lægemidler, fortyndingsmidler eller solvenser end dem, der omtales i punkt 6.
English: * The FVIII potency (IU) is determined using the European Pharmacopoeia chromogenic assay.
Danish: * FVIII-aktiviteten (IE) bestemmes ved hjælp af den Europæiske Farmakopés kromogene assay.
English: The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titre posing less of a risk of insufficient clinical response than high titre inhibitors.
Danish: Den kliniske relevans af inhibitorudviklingen afhænger af inhibitorens titer, hvor lav titer, udgør en mindre risiko for utilstrækkeligt klinisk respons end højtiter-inhibitorer.
English: • the testing of each donation and pools of plasma for signs of virus/infections,
Danish: • testning af hver enkelt donation og alle plasmapools for tegn på virus eller infektioner.
English: This also applies to any unknown or emerging viruses or other types of infections.
Danish: Det gælder også ukendte eller nytilkomne virus og andre infektionstyper.
English: Treatment of bleeding
Danish: Behandling af blødninger
English: Frequency of doses (hours) / Duration of therapy (days)
Danish: Interval mellem doser (timer) / Behandlingsvarighed (dage)
English: If you have been prescribed Voncento to use at home, your doctor will make sure that you are shown how to inject it and how much to use.
Danish: Hvis du har fået Voncento, så du selv kan bruge det derhjemme, vil din læge sørge for, at du får vist, hvordan du skal give injektionen, og hvor meget du skal have.
English: • for individuals with a weakened immune system or with an increased production of red blood cells due to certain types of anaemia (e.g. sickle cell anaemia or haemolytic anaemia).
Danish: • for personer med svækket immunsystem eller med øget produktion af røde blodlegemer på grund af visse former for anæmi (f.eks. seglcelleanæmi eller hæmolytisk anæmi).
English: This also applies to unknown or emerging viruses and other pathogens.
Danish: Dette gælder også ukendte eller nytilkomne vira samt andre patogener.
English: • inclusion of steps in the processing of the blood or plasma that can inactivate or remove viruses.
Danish: • Fremstillingen omfatter også trin i behandlingen af blod eller plasma, som kan inaktivere eller fjerne virus.
English: No interaction of VWF and FVIII with other medicinal products have been studied.
Danish: Der er ikke udført studier af interaktion mellem VWF og FVIII og andre lægemidler.
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 til at forhindre, at infektioner overføres fra lægemidler, tilberedt ud fra humant blod eller plasma, omfatter selektion af donorer, screening af de enkelte donationer og plasmapools for specifikke infektionsmarkører samt indførelse af effektive trin til inaktivering/ eliminering af virus under fremstillingsprocessen.
English: The vials must not be heated above body temperature (37 ºC).
Danish: Hætteglassene må ikke opvarmes til over legemstemperatur (37 ºC).
English: Required units = body weight [kg] x desired factor VIII rise [% or IU/dl] x 0.5.
Danish: Antal enheder = legemsvægt [kg] x ønsket faktor VIII-stigning [% eller IE/dl] x 0,5.
English: These include:
Danish: Det drejer sig bl.a. om følgende:
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within six months following authorisation.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende den første PSUR for dette lægemiddel inden for seks måneder efter godkendelsen.
English: Patients aged 12 to 18 years old: Dosing is based on the same guidelines as for adults.
Danish: Patienter i alderen 12-18 år: Dosering baseres på de samme retningslinjer som hos voksne.
English: Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries.
Danish: Enkelte patienter kan udvise afvigende resultater for faktor VIII, idet de udviser forskellige halveringstider og recoveries.
English: Catheter-related complications
Danish: Kateterrelatede komplikationer
English: Administered intravenously, VWF binds to endogenous FVIII (which is produced normally by the patient), and by stabilising this factor, avoids its rapid degradation.
Danish: Ved intravenøs administration bindes VWF til endogen FVIII (som patienten danner normalt), og ved at stabilisere denne faktor undgås det, at den hurtigt nedbrydes.
English: ask your doctor or pharmacist for advice before taking this medicine.
Danish: skal du spørge din læge eller apotekspersonalet til råds, før du får dette lægemiddel.
English: If you forget to use Voncento
Danish: Hvis du har glemt at bruge Voncento
English: Reconstitution and withdrawal must be carried out under aseptic conditions.
Danish: Rekonstitution af opløsning og fyldning af sprøjte skal ske under aseptiske forhold.
English: If you get any side effects, talk to your doctor, nurse or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: Always take this medicine exactly as your doctor has told you.
Danish: Brug altid dette lægemiddel nøjagtigt efter lægens anvisning.
English: There is a risk of formation of blood clots (thrombosis), particularly in patients with known risk factors (see also section 2).
Danish: Der er en risiko for dannelse af blodpropper (tromboser), især hos patienter med kendte risikofaktorer (se også afsnit 2).
English: No side effects have been associated with these reports.
Danish: Der var ikke tilknyttet bivirkninger til disse indberetninger.
English: General instructions
Danish: Generel vejledning
English: • The powder must be mixed with the solvent (liquid) and withdrawn from the vial under aseptic conditions.
Danish: • Pulveret skal blandes (rekonstitueres) med vandet (solvens), og opløsningen skal overføres fra hætteglasset under aseptiske forhold.
English: • careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded,
Danish: • omhyggelig udvælgelse af blod- og plasmadonorer for at sikre udelukkelse af personer, som kunne være smittebærere af infektioner
English: For prevention of excessive bleeding during or after surgery the application should start 1 - 2 hours before the surgical procedure.
Danish: For at hindre omfattende blødninger under eller efter et kirurgisk indgreb bør administrationen indledes 1-2 timer før indgrebet.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLERE AF DE BIOLOGISKE AKTIVE STOFFER OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: <6 years
Danish: <6 år
English: Prophylaxis and treatment of bleeding in patients with haemophilia A.
Danish: Profylakse og behandling af blødning hos patienter med hæmofili A.
English: The relative content of HMW (high molecular weight) VWF multimers in Voncento is on average 86 % when compared to normal human plasma (NHP).
Danish: Voncentos relative indhold af VWF-multimerer med høj molekylvægt er i gennemsnit 86 % sammenlignet med normalt humant plasma (NHP) .
English: When medicines are made from human blood or plasma, certain measures are put in place by the manufacturer to prevent infections being passed on to patients.
Danish: Når lægemidler fremstilles ud fra humant blod eller plasma, tager fremstilleren visse forholdsregler for at undgå at overføre infektioner til patienterne.
English: In some cases it may progress to a serious allergic reaction (anaphylaxis) that causes severe difficulty in breathing, dizziness or shock.
Danish: I nogle tilfælde kan der udvikles en alvorlig allergisk reaktion (anafylaksi), der kan give alvorlige vejrtrækningsproblemer, svimmelhed eller shock.
English: The product is made from human plasma (the liquid part of the blood) and contains the active substances called human coagulation factor VIII (FVIII) and human von Willebrand factor (VWF).
Danish: Lægemidlet er udvundet af plasma fra mennesker (blodets væskedel) og indeholder de aktive stoffer human koagulationsfaktor VIII (FVIII) og human von Willebrand-faktor (VWF).
English: Check yourself for any side effects that might happen straight away.
Danish: Vær opmærksom på, om der forekommer bivirkninger med det samme.
English: The listed warnings and precautions apply to children and adolescents.
Danish: De anførte advarsler og forsigtighedsregler gælder både for børn og unge.
English: Therefore, Voncento should be used during pregnancy and breast-feeding only if clearly indicated.
Danish: Derfor bør Voncento kun anvendes under graviditet og amning, hvis det er absolut nødvendigt.
English: If your doctor thinks you could administer Voncento yourself, appropriate instructions will be provided to you by your doctor.
Danish: Hvis din læge mener, at du selv vil kunne indgive Voncento, vil du få vejledning i selvbehandling hos lægen.
English: Voncento is used for all age groups to prevent or to halt bleeding caused by the lack of VWF in von Willebrand disease (VWD) and the lack of FVIII in haemophilia A. Voncento is only used when treatment with another medicine, desmopressin, is not effective alone or cannot be given.
Danish: Voncento anvendes i alle aldersgrupper til at stoppe blødninger, der skyldes mangel på VWF ved von Willebrands sygdom (VWD) og mangel på FVIII ved hæmofili A. Voncento anvendes kun, når behandling med et andet lægemiddel, desmopressin, ikke virker alene, eller det ikke kan gives.
English: Factor VIII level required (% or IU/dl)
Danish: Terapeutisk nødvendigt faktor VIII-niveau (% eller IE/dl)
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: It is strongly recommended that every time Voncento is given, you record the date of administration, the batch number and the injected volume in your treatment diary.
Danish: Det må absolut anbefales, at du, hver gang du får Voncento, skriver datoen for behandlingen samt det batchnummer og den mængde, som du har fået, i din behandlingsdagbog.
English: Talk to your doctor, nurse or pharmacist before taking Voncento.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Voncento.
English: • The solution should be clear or slightly opalescent, i.e. it might be sparkling when held up to the light but must not contain any obvious particles.
Danish: • Opløsningen skal være klar eller med let opalglans, dvs. den kan funkle, når den holdes op i lyset, men må ikke indeholde tydelige partikler.
English: Allergic type hypersensitivity reactions are possible.
Danish: Der kan forekomme allergiske overfølsomhedsreaktioner.
English: Contents of the pack and other information What Voncento contains
Danish: Pakningsstørrelser og yderligere oplysninger Voncento indeholder:
English: The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Danish: Den mængde, som skal administreres, og administrationshyppigheden bør tilpasses den kliniske virkning i hvert enkelt tilfælde.
English: In such cases, it is recommended that a specialised haemophilia centre be contacted.
Danish: I disse tilfælde anbefales det at kontakte et specialiseret hæmofilicenter.
English: You may develop an inhibitor (neutralising antibody) to VWF, in which case VWF will not work properly any more.
Danish: Du kan udvikle inhibitorer (neutraliserende antistoffer) af VWF, og i så fald holder VWF op med at virke korrekt.
English: By replacement therapy the plasma level of FVIII is increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendency.
Danish: Ved substitutionsterapi øges plasmakoncentrationen af FVIII, hvilket muliggør en midlertidig afhjælpning af FVIII-manglen og dermed en afhjælpning af blødningstendensen.
English: The pharmacokinetic data in patients with von Willebrand disease are very similar to those observed in the adult population.
Danish: De farmakokinetiske data hos børn og unge med von Willebrands sygdom er meget lig data observeret hos den voksne population.
English: Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia).
Danish: Parvovirus B19-infektioner kan være alvorlige for gravide kvinder (føtal infektion) og for personer med immundefekt eller med forhøjet produktion af røde blodlegemer (f.eks. hæmolytisk anæmi).
English: Your treatment should be monitored by a doctor who is experienced in the treatment of blood clotting disorders.
Danish: Behandlingen skal forestås af en læge med erfaring i behandling af blødersygdomme.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C.
Danish: Hvis det ikke bruges med det samme, er brugeren ansvarlig for opbevaringstiderne efter anbrud og betingelserne før brug, som normalt ikke bør overstige 24 timer ved 2 ºC - 8 ºC.
English: In all such cases, it is recommended that a specialised haemophilia centre be contacted.
Danish: I alle sådanne tilfælde anbefales det at kontakte et specialcenter for hæmofili.
English: Voncento has no influence on the ability to drive and use machines.
Danish: Voncento påvirker ikke evnen til at føre motorkøretøj eller betjene maskiner.
English: The reconstituted preparation should be injected/infused slowly intravenously at a rate comfortable for the patient.
Danish: Den rekonstituerede opløsning skal gives som langsom intravenøs injektion/infusion med en hastighed, som er behagelig for patienten.
English: • During pregnancy and breast-feeding, Voncento should be given only if it is clearly needed.
Danish: • Gravide kvinder og kvinder, der ammer, må kun få Voncento, hvis det er absolut nødvendigt.
English: The ratio between FVIII:C and VWF:RCo in a vial is approximately 1:2.4.
Danish: Forholdet mellem FVIII:C og VWF:RCo i et hætteglas er ca. 1:2,4.
English: Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of human plasma-derived factor VIII/VWF products.
Danish: Passende vaccination (hepatitis A og B) anbefales til patienter, der regelmæssigt/gentagne gange får humane plasmabaserede lægemidler med FVIII/VWF.
English: The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per ml of plasma, using the modified assay.
Danish: Dannelsen af neutraliserende antistoffer (inhibitorer) til faktor VIII er en kendt komplikation i behandlingen af individer med hæmofili A. Disse inhibitorer er sædvanligvis IgG-immunglobuliner rettet mod faktor VIII's prokoagulante aktivitet, som kvantificeres i Bethesda Enheder (BE) pr. ml plasma ved brug af den modificerede test.
English: • Any unused product or waste material should be disposed of in accordance with local requirements and as instructed by your doctor.
Danish: • Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer og efter lægens anvisning.
English: • Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: • Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: - Administration of a FVIII:C containing VWF preparation restores the FVIII:C level to normal immediately after the first infusion.
Danish: - Administration af et VWF-præparat, som indeholder FVIII:C, genopretter FVIII:C til et normalt niveau umiddelbart efter den første infusion.
English: The following table can be used to guide dosing in bleeding episodes and surgery:
Danish: Tabellen nedenfor kan anvendes som vejledning til beregning af dosis ved blødningsepisoder og kirurgiske indgreb:
English: Voncento should be administered to pregnant or breast-feeding VWF deficient women only if clearly indicated, taking into consideration that delivery confers an increased risk of haemorrhagic events in these patients.
Danish: Voncento bør kun administreres til gravide eller ammende kvinder med VWF-mangel, hvis det er absolut nødvendigt, idet der tages højde for, at en fødsel indebærer en øget risiko for blødningsepisoder hos disse patienter.
English: If you have any side effects that might be related to the administration of Voncento, the injection or infusion should be stopped (see also section 2).
Danish: Hvis du får bivirkninger, der kan skyldes indgift af Voncento, skal du stoppe injektionen eller infusionen (se også punkt 2).
English: An appropriate dose should be re-administered every 12 - 24 hours.
Danish: Infusionen gentages med en passende dosis hver 12.-24. time.
English: Patients with VWD, especially type 3 patients, may develop neutralising antibodies (inhibitors) to VWF.
Danish: Patienter med von Willebrands sygdom, specielt type 3, kan udvikle neutraliserende antistoffer (inhibitorer) over for VWF.
English: • you notice any symptoms of an impaired perfusion in your extremities (e.g. cold and pale extremities) or vital organs (e.g. severe chest pain)
Danish: • du bemærker symptomer på nedsat kredsløb i arme og ben (f.eks. hvis de bliver kolde og blege) eller de vitale organer (f.eks. alvorlige brystsmerter).
English: Exogenously administered human plasma-derived VWF behaves in the same way as endogenous VWF.
Danish: Eksogent administreret humant plasmabaseret VWF opfører sig på samme måde som endogen VWF.
English: The active substance is:
Danish: Aktivt stof:
English: One pack contains:
Danish: Pakning indeholder:
English: After filtering/withdrawal (see below) the reconstituted product should be inspected visually for particulate matter and discoloration prior to administration.
Danish: Efter filtrering/fyldning af sprøjten (se nedenfor) skal det rekonstituerede præparat kontrolleres visuelt for partikelindhold og misfarvning, før det indgives.
English: * Adverse events assessed as related to administration of the Voncento **Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients.
Danish: ** Hyppigheden er baseret på studier med alle FVIII-produkter, som omfattede patienter med svær hæmofili A. PTPs = tidligere behandlede patienter, PUPs = tidligere ubehandlede patienter.
English: The replacement of VWF and FVIII by Voncento will temporarily repair the blood clotting mechanisms.
Danish: Ved at erstatte VWF og FVIII med Voncento rettes der midlertidigt op på mekanismen bag blodets koagulation.
English: Because of this, administration of pure VWF (VWF product with a low FVIII level) restores the FVIII:C level to normal as a secondary effect after the first infusion with a slight delay.
Danish: På grund af dette genopretter administration af ren VWF (VWF-præparat med lavt indhold af FVIII) FVIII:C-niveauet til et normalt niveau som en sekundær effekt med nogen forhaling efter den første infusion.
English: If such inhibitors occur, the condition will manifest itself as an inadequate clinical response.
Danish: Såfremt sådanne inhibitorer forekommer, vil tilstanden manifestere sig som et utilstrækkeligt klinisk respons.
English: Other medicines and Voncento
Danish: Brug af anden medicin sammen med Voncento
English: It is strongly recommended that every time that Voncento 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 product.
Danish: Det må absolut anbefales at notere produktnavn og batchnummer, hver gang Voncento administreres til en patient, så koblingen mellem patienten og lægemidlets batch bevares.
English: Degree of haemorrhage / Type of surgical procedure
Danish: Blødningsgrad/Type kirurgisk indgreb
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, diluents or solvents except those mentioned in section 6.1.
Danish: Da der ikke foreligger studier over eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler, fortyndingsmidler eller solvenser end dem, der er anført under pkt.
English: Management of such patients should be directed by physicians with experience in the care of haemophilia and factor VIII inhibitors.
Danish: Behandling af disse patienter bør ledes af en læge med erfaring i behandling af hæmofili og faktor VIII-inhibitorer.