FrancophonIA/ELRC3.0 huggingface dataset:
English: This protects the pigs against the disease.
Danish: Dette beskytter svinene mod sygdommen.
English: The vaccine also contains ‘adjuvants' to stimulate a better response.
Danish: Vaccinen indeholder desuden "adjuvanser" for at forstærke responsen.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Gripovac 3 to Merial on 14.01.2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Gripovac 3 til Merial den 14.01.2010.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) GRIPOVAC 3 EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) GRIPOVAC 3 EPAR - sammendrag for offentligheden
English: In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses.
Danish: Herefter vil immunsystemet hurtigere være i stand til at producere antistoffer, når det igen bliver udsat for viraene.
English: In case of accidental self-injection only a minor injection site reaction is expected.
Danish: I tilfælde af selvinjektion ved hændeligt uheld forventes kun en mindre lokal reaktion på injektionsstedet.
English: The benefit-risk balance may be found in module 6 of this EPAR.
Danish: Benefit/riskforholdet fremgår af afsnit 6 i denne EPAR.
English: Sometimes, a slight increase in the rectal temperature might occur after vaccination.
Danish: Af og til ses en let stigning i legemstemperaturen efter vaccination.
English: When a pig is given the vaccine, the immune system recognises the killed viruses as ‘foreign' and makes antibodies against them.
Danish: Når et svin får vaccinen, opfatter immunsystemet de dræbte vira som "fremmede" og producerer antistoffer imod dem.
English: Gripovac 3 is a vaccine.
Danish: Gripovac 3 er en vaccine.
English: Gripovac 3 is a vaccine that contains 3 different strains of swine influenza A virus which have been inactivated (killed).
Danish: Gripovac 3 er en vaccine, der indeholder 3 forskellige stammer af svineinfluenza (A-virus), som er blevet inaktiveret (dræbt).
English: Gripovac 3 is a suspension for injection.
Danish: Gripovac 3 er en injektionsvæske, suspension.
English: Other information about Gripovac 3:
Danish: Andre oplysninger om Gripovac 3:
English: Gripovac 3 contains small amounts of a modified and then killed form of the pig's influenza virus that causes lesions and illness.
Danish: Gripovac 3 indeholder små mængder af en modificeret og herefter inaktiveret form for svineinfluenzavirus, som medfører læsioner og sygdom.
English: The effectiveness of Gripovac 3 has been studied in animals 56 days of age and older and in sows before and during pregnancy and these studies document that the vaccine protects against swine influenza.
Danish: Virkningen af Gripovac 3 blev undersøgt hos dyr, der var over 56 dage gamle, og hos søer før og under drægtighedsperioden, og disse undersøgelser dokumenterer, at vaccinen beskytter mod svineinfluenza.
English: Gripovac 3 is also used to vaccinate pregnant sows following their first immunisation by giving them one dose 14 days prior to farrowing in order that the sows milk contains enough antibodies to help protect the piglets against swine influenza for at least 33 days after birth.
Danish: Gripovac 3 anvendes ligeledes til at vaccinere drægtige søer efter deres første immunisering ved at give dem en enkelt dosis 14 dage før faring for at opnå et højt indhold af antistoffer i somælken, der giver pattegrisene beskyttelse mod svineinfluenza i mindst 33 dage efter fødslen.
English: Use of the Gripovac 3 in pigs reduces clinical signs and reduces the amount of virus in the lungs after infection caused by swine influenza A virus.
Danish: Brug af Gripovac 3 hos svin reducerer de kliniske symptomer og reducerer virusmængden i lungerne efter en infektion, der skyldes svineinfluenza (A-virus).
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Gripovac 3 exceed the risks for the vaccination of pigs from the age of 56 days onwards inluding pregnant sows against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection and recommended that Gripovac 3 be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Gripovac 3 er større end risiciene, når det anvendes til vaccination af svin, som er over 56 dage gamle, herunder drægtige søer, mod svineinfluenza forårsaget af undertyperne H1N1, H3N2 og H1N2 for at reducere de kliniske symptomer og virusmængden i lungerne efter infektion.
English: What is the risk associated with Gripovac 3?
Danish: Hvilken risiko er der forbundet med Gripovac 3?
English: Why has Gripovac 3 been approved?
Danish: Hvorfor blev Gripovac 3 godkendt?
English: What is Gripovac 3?
Danish: Hvad er Gripovac 3?
English: Gripovac 3 is used to vaccinate pigs including pregnant sows over the age of 56 days against swine influenza in order to help them clinically but also to reduce the amount of virus present in the lungs.
Danish: Gripovac 3 anvendes til at vaccinere svin, som er over 56 dage gamle, herunder drægtige søer, mod svineinfluenza for at give dem klinisk beskyttelse, men også for at reducere virusmængden i lungerne.
English: How has Gripovac 3 been studied?
Danish: Hvordan blev Gripovac 3 undersøgt?
English: A slight swelling may occur after vaccination at the site of injection in a small number of pigs but this goes down within 2 days.
Danish: Der kan hos et mindre antal svin forekomme let hævelse på injektionsstedet efter vaccination.
English: What is Gripovac 3 used for?
Danish: Hvad anvendes Gripovac 3 til?
English: What benefit has Gripovac 3 shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Gripovac 3?
English: Oral use Oral use Oral use Oral use blister (OPA/alu/PVC/alu) blister (OPA/alu/PVC/alu) blister (OPA/alu/PVC/alu) blister (OPA/alu/PVC/alu)
Danish: Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse blister (OPA/alu/PVC/alu) blister (OPA/alu/PVC/alu) blister (OPA/alu/PVC/alu) blister (OPA/alu/PVC/alu)
English: EU/1/18/1291/005 EU/1/18/1291/006
Danish: EU/1/18/1291/003 EU/1/18/1291/004 EU/1/18/1291/005 EU/1/18/1291/006
English: Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Danish: Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet
English: 84 tablets 10 tablets 30 tablets 100 tablets
Danish: 84 tabletter 10 tabletter 30 tabletter 100 tabletter
English: The median time to event was nine days.
Danish: Mediantiden til hændelsen var 9 dage.
English: The study should be based on an agreed protocol.
Danish: Studiet skal baseres på en godkendt protokol.
English: Validation has not been successful, yet.
Danish: Der har endnu ikke været en succesfuld validering.
English: ≥ 8 hours
Danish: ≥ 8 timer
English: Please note this medicine is mainly used in emergency situations, and the doctor will have decided that you needed it.
Danish: Vær venligst opmærksom på, at dette lægemiddel overvejende anvendes i nødsituationer, og lægen vil have besluttet, at du har brug for det.
English: System organ class/ Preferred term
Danish: Systemorganklasse/ foretrukken term
English: The following are needed before starting reconstitution:
Danish: Der er brug for følgende før start på rekonstitution:
English: In an updated interim analysis, data of 352 patients were evaluated.
Danish: I en opdateret interimanalyse blev data fra 352 patienter evalueret.
English: In case of mild or moderate infusion reactions, careful observation may be sufficient.
Danish: I tilfælde af lette eller moderate infusionsreaktioner kan omhyggelig observation være tilstrækkelig.
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, er brugsopbevaringstider og betingelser før brug brugerens ansvar.
English: There were no blood clots in these healthy people.
Danish: Der var ingen blodpropper hos disse raske personer.
English: PK/PD modelling
Danish: PK/PD-modellering
English: Do not breast-feed your child while you are taking this medicine.
Danish: Undlad at amme dit barn, mens du får dette lægemiddel.
English: Read all of this leaflet carefully, because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, da den indeholder vigtige oplysninger.
English: Diphenhydramine may be administered.
Danish: Diphenhydramin kan administreres.
English: Monitoring for signs and symptoms of thrombosis is, therefore, strongly recommended.
Danish: Overvågning for tegn og symptomer på trombose anbefales derfor kraftigt.
English: Duration of this effect in bleeding patients is not known.
Danish: Varigheden af denne virkning hos blødende patienter er ikke kendt.
English: Your doctor or nurse will give you this medicine by injection or infusion into a vein.
Danish: Lægen eller sygeplejersken vil give dig dette lægemiddel ved hjælp af injektion eller infusion i en vene.
English: < 8 hours or unknown
Danish: < 8 timer eller ukendt
English: Approximately half of the patients were male, and the mean age was 77.4 years.
Danish: Ca. halvdelen af patienterne var mænd, og gennemsnitsalderen var 77,4 år.
English: These elevations were maintained between several hours to a few days following administration, but no thrombotic events were reported.
Danish: Disse forhøjelser blev opretholdt i mellem adskillige timer og få dage efter administration, men der blev ikke rapporteret nogen trombotiske hændelser.
English: This medicine will be stored in the hospital, and these instructions are intended for hospital staff only.
Danish: Dette lægemiddel opbevares på hospitalet, og disse anvisninger er udelukkende beregnet for hospitalspersonale.
English: The dissolution time for each vial is approximately three to five minutes.
Danish: Opløsningstiden for hvert hætteglas er ca. 3 til 5 minutter.
English: C/ La Relba s/n
Danish: C/ La Relba s/n Porrino
English: Frequency in bleeding patients
Danish: Hyppighed hos blødende patienter
English: Your doctor or nurse will work out the dose of this medicine that you need.
Danish: Lægen eller sygeplejersken vil beregne hvilken dosis af lægemidlet, du skal have.
English: Each vial is reconstituted according to the following instructions:
Danish: Hvert hætteglas rekonstitueres i henhold til følgende anvisninger:
English: • Calculated number of vials as given in table 1.
Danish: • Beregnet antal hætteglas som anført i tabel 1.
English: The elimination halflife ranges from four to seven hours.
Danish: Eliminationshalveringstiden ligger i intervallet fra 4 til 7 timer.
English: It is unlikely that Ondexxya will influence the effect of other medicines or that other medicines will influence Ondexxya.
Danish: Det er usandsynligt, at Ondexxya vil påvirke virkningen af andre lægemidler, eller at andre lægemidler vil påvirke Ondexxya.
English: • effects on blood clotting markers: some markers which affect blood clotting were increased for a little while and then returned to normal.
Danish: • påvirkning af markører for blodstørkning: niveauet af nogle markører, der indvirker på blodstørkningen, blev forøget i et kort tidsrum og returnerede herefter til normalniveauet.
English: For reconstituted solutions, chemical and physical in-use stability have been demonstrated for at least eight hours at 25°C.
Danish: For rekonstituerede opløsninger er der blevet påvist kemisk og fysisk brugsstabilitet i mindst 8 timer ved 25 °C.
English: There is no information on the use of Ondexxya in children and adolescents.
Danish: Der er ingen oplysninger om brug af Ondexxya til børn og unge.
English: Haemostatic efficacy was good or excellent in 81.9% of 249 patients.
Danish: Den hæmostatiske virkning var god eller meget god hos 81,9 % af 249 patienter.
English: Reconstitute each vial according to the following instructions: 1.
Danish: Hvert hætteglas rekonstitueres i henhold til følgende anvisninger: 1.
English: These antibodies were generally low titre, and no clinical consequences were observed.
Danish: Disse antistoffer var generelt ved en lav titer, og der blev ikke observeret nogen kliniske følger.
English: Frequency in healthy volunteers
Danish: Hyppighed hos raske frivillige
English: Tell your doctor if you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby.
Danish: Fortæl det altid til lægen, hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid.
English: Plasma TFPI activity has been shown to be inhibited for 10 to 20 hours following andexanet alfa administration.
Danish: Plasma-TFPI-aktivitet har vist sig at være inhiberet i 10 til 20 timer efter administration af andexanet alfa.
English: PK comparability with andexanet alfa in Ondexxya (Generation 2) has not yet been proven.
Danish: PKsammenlignelighed med andexanet alfa i Ondexxya (generation 2) er endnu ikke blevet vist.
English: Distribution The Vd for andexanet alfa is 5.3 ± 2.6 L, approximately equivalent to the blood volume.
Danish: Fordeling Vd for andexanet alfa er 5,3 ± 2,6 l, hvilket omtrent svarer til blodvolumenet.
English: All PK studies were conducted using a former drug substance generation.
Danish: Alle PK-studier er udført ved anvendelse af en tidligere generation af lægemiddelstoffet.
English: Chemical and physical in-use stability have been demonstrated for 16 hours at 2°C to 8°C in the primary packaging vial.
Danish: Der er blevet påvist kemisk og fysisk brugsstabilitet i 16 timer ved 2 °C til 8 °C i det primære emballeringshætteglas.
English: mannitol, and polysorbate 80.
Danish: mannitol og polysorbat 80.
English: Data from bleeding patients are limited.
Danish: Data fra blødende patienter er begrænset.
English: The clinical relevance of this interaction in terms of maintenance of thrombin generation and the potential for a prothrombotic effect has not been fully elucidated.
Danish: Den kliniske relevans af denne interaktion i forhold til opretholdelse af trombingenerering og potentialet for en protrombotisk virkning er ikke blevet fuldt belyst.
English: The reconstituted solution should be inspected for particulate matter and/or discolouration prior to administration.
Danish: Den rekonstituerede opløsning skal inspiceres for partikelformet materiale og/eller misfarvning før administration.
English: Based on its mechanism of action and on the characteristics of proteins, no carcinogenic or genotoxic effects are anticipated.
Danish: Baseret på dets virkningsmekanisme og på proteinegenskaberne forventes ingen karcinogen eller genotoksisk virkning.
English: * Andexanet alfa is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells.
Danish: * Andexanet alfa fremstilles ved hjælp af rekombinant-DNA-teknologi i ovarieceller fra kinesisk hamster (CHO-celler).
English: Reconstituted medicinal product
Danish: Rekonstitueret lægemiddel
English: Conclusions presented by the European Medicines Agency on: • Conditional marketing authorisation
Danish: Konklusioner fremlagt af Det Europæiske Lægemiddelagentur vedrørende: • Betinget markedsføringstilladelse
English: Transient elevations of D-dimer and F1+2 fragments very common
Danish: Forbigående forhøjelser af D-dimer og F1+2-fragmenter meget almindelig
English: Although determination of anti-FXa-activity in emergency situations is increasingly recommended, no recommendation for adapted andexanet alfa dosage is available.
Danish: Selvom bestemmelse af anti-FXa-aktivitet i nødsituationer anbefales i stigende grad, findes der ingen anbefaling for tilpasset andexanet alfa-dosering.
English: This medicine is unlikely to affect your ability to drive and use machines.
Danish: Det er usandsynligt, at dette lægemiddel påvirker din evne til at føre motorkøretøj og betjene maskiner.
English: Among the healthy subjects studied, women experienced more adverse reactions (mainly infusion-related reactions) than men.
Danish: Blandt de undersøgte raske forsøgspersoner oplevede kvinder flere bivirkninger (overvejende infusionsrelaterede reaktioner) end mænd.
English: Treatment-emergent, non-neutralizing antibodies to andexanet alfa were detected in approximately 10% (35/345).
Danish: Under-behandling-fremkomne, ikkeneutraliserende antistoffer mod andexanet alfa blev påvist hos ca. 10 % (35/345).
English: The adverse reactions are classified by system organ class (SOC) and frequency, using 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); or not known (cannot be estimated from available data).
Danish: Bivirkningerne er klassificeret efter systemorganklasse (SOC) og hyppighed ved anvendelse af følgende konvention: 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 forhåndenværende data).
English: Continuous intravenous infusion
Danish: Kontinuerlig intravenøs infusion
English: Aseptic technique during the reconstitution procedure should be used.
Danish: Der skal benyttes aseptisk teknik under rekonstitutionsproceduren.
English: The maximal reversal of anti-FXa activity was achieved within two minutes of completing the bolus administration.
Danish: Den maksimale revertering af anti-FXa-aktivitet blev opnået inden for to minutter efter gennemførelse af bolusadministrationen.
English: Biliary and/or faeces elimination of protein therapeutics is not a known route of protein elimination.
Danish: Elimination via galde og/eller fæces af terapeutiske proteiner er ikke en kendt vej for proteinelimination.
English: Administer the reconstituted solution at the appropriate rate.
Danish: Administrér den rekonstituerede opløsning ved den passende hastighed.
English: The updated interim analysis demonstrated that the change in anti-FXa activity (surrogate) was not predictive for achievement of hemostatic efficacy in the overall patient population.
Danish: Den opdaterede interimanalyse viste, at ændring i anti-FXa-aktivitet (surrogat) ikke var prædiktiv for opnåelse af hæmostatisk virkning i den samlede patientpopulation.
English: Submission by 30 September
Danish: Indsendelse: 30. september
English: Elderly patients (aged 65 years and over): No dose adjustment is required in elderly patients (see section 5.2).
Danish: Ældre patienter (i alderen 65 år og derover): En dosisjustering er ikke nødvendig hos ældre patienter (se pkt.
English: The reconstituted solution is a clear, colourless, or slightly yellow solution.
Danish: Den rekonstituerede opløsning er en klar, farveløs eller lysegul opløsning.
English: Dosage recommendation is based upon data-modelling in healthy volunteers.
Danish: Dosisanbefalinger er baseret på datamodellering for raske frivillige.
English: Known allergic reaction to hamster proteins.
Danish: Kendt allergisk reaktion mod hamsterproteiner.
English: Of 352 enrolled patients, 249 (70.7%) were included in the efficacy-analysis.
Danish: Ud af de 352 patienter, der indgik i studiet, blev 249 (70,7 %) inkluderet i effektanalysen.
English: DO NOT SHAKE the vials, as this can lead to foaming.
Danish: UNDLAD AT RYSTE hætteglassene, da det kan føre til skumdannelse.
English: For moderate symptoms, consideration may be given to a brief interruption or slowing of the infusion with resumption of the infusion after symptoms subside.
Danish: Ved moderate symptomer kan det overvejes at foretage en kort afbrydelse eller nedsætte infusionshastigheden med genoptagelse af infusionen, når symptomerne har fortaget sig.
English: Use for edoxabanor enoxaparin-reversal is not recommended due to lack of data.
Danish: Bør ikke anvendes til edoxaban- eller enoxaparin-revertering på grund af manglende data.
English: Clearance (L/hr) for andexanet alfa is 4.4 ± 1.2 L/hr with low renal elimination.
Danish: Clearance (l/time) for andexanet alfa er 4,4 ± 1,2 l/time med lav renal elimination.
English: The time courses of anti-FXa activity before and after andexanet alfa administration are shown in Figure 1.
Danish: Tidsforløbet for anti-FXa-aktivitet før og efter administration af andexanet alfa er vist i figur 1.
English: A total of 33.3% of patients with thromboembolic events (12/36) experienced the thromboembolic event during the first three days.
Danish: I alt 33,3 % af patienterne med tromboemboliske hændelser (12/36) oplevede den tromboemboliske hændelse i løbet af de første 3 dage.
English: Do not use if opaque particles or discolouration are present.
Danish: Må ikke anvendes, hvis der er uigennemsigtige partikler eller misfarvning.
English: These levels of unbound FXa inhibitor provide little or no anticoagulant effect.
Danish: Disse niveauer af ubundet FXa-inhibitor medfører en ringe eller ingen antikoagulativ virkning.
English: Antithrombotic therapy can be re-initiated as soon as medically indicated following treatment if the patient is clinically stable and adequate haemostasis has been achieved.
Danish: Antitrombotisk terapi kan genstartes, så snart det er medicinsk indiceret efter behandling, hvis patienten er klinisk stabil, og der er opnået tilstrækkelig hæmostase.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity studies up to two weeks in rats and monkeys.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi og toksicitet efter gentagne doser i op til to uger hos rotter og aber.
English: Andexanet alfa does not need to be brought to room temperature before reconstitution or administration to the patient.
Danish: Andexanet alfa behøver ikke at blive opvarmet til stuetemperatur før rekonstitution eller administration til patienten.
English: Each pack contains four vials.
Danish: Hver pakning indeholder 4 hætteglas.
English: Table 4: List of adverse reactions in healthy subjects and bleeding patients System organ class/ Preferred term
Danish: Tabel 4: Liste over bivirkninger hos raske forsøgspersoner og blødende patienter Systemorganklasse/ foretrukken term
English: Of the 209 patients who were re-anticoagulated prior to a thrombotic event, 10 (4.8%) patients experienced a thromboembolic event.
Danish: Ud af de 209 patienter, der var re-antikoaguleret før en trombotisk hændelse, oplevede 10 (4,8 %) patienter en tromboembolisk hændelse.
English: Your doctor may give you an antihistamine medicine to help with any side effects (see section 4).
Danish: Lægen kan give dig et antihistamin-lægemiddel til afhjælpning af eventuelle bivirkninger (se punkt 4).
English: Headache, cough, or shortness of breath (common side effects which may affect up to 1 in 10 people) happened within a few minutes to a few hours of the infusion.
Danish: Hovedpine, hoste eller stakåndethed (almindelige bivirkninger, der kan forekomme hos 1 ud af 10 personer) indtrådte inden for få minutter til få timer efter infusionen.
English: No dose-limiting toxicities have been observed during clinical trials.
Danish: Der er ikke observeret nogen dosisbegrænsende toksiciteter under kliniske studier.
English: Repeat steps 1 and 2 as necessary to transfer the complete volume of the bolus and the infusion into an IV bag.
Danish: Gentag om nødvendigt trin 1 og 2 til overførsel af det fulde volumen af bolussen og infusionen til en i.v.-pose.
English: Your doctor may decide to give you Ondexxya to rapidly reverse the effects of the anticoagulant in case of a life-threatening or uncontrolled bleeding situation.
Danish: Din læge kan beslutte at give dig Ondexxya for hurtigt at modvirke virkningen af antikoagulanten i tilfælde af en livstruende eller ukontrolleret blødning.
English: Reversing the effect of a factor Xa inhibitor with Ondexxya may increase the risk of blood clots.
Danish: Den modsatte virkning af virkningen af en faktor Xa-hæmmer med Ondexxya kan øge risikoen for blodpropper.