FrancophonIA/ELRC3.0 huggingface dataset:
English: Please tell your doctor if in the past 2 days you have: - had frequent and/or repeated angina or chest pain, especially if you have history of heart disease, - had recent electrocardiography changes.
Danish: - har haft hyppige og /eller gentagne hjertekramper eller brystsmerter, især hvis du tidligere har lidt af en hjertesygdom.
English: Connect the plunger rod by screwing it clockwise into the syringe.
Danish: Sæt stempelstangen på injektionssprøjten ved at skrue den med uret ind i sprøjten.
English: False negative cases can occur with voiding ultrasonography with SonoVue and have not been clarified (see section 5.1).
Danish: Fortolkning af ultralydscanning af urinvejene med SonoVue efter tømning og begrænsninger heraf Der kan forekomme falske negative resultater ved ultralydscanning af nyrer og urinveje med SonoVue efter tømning, og disse er ikke klarlagt (se pkt.
English: Type I clear glass pre-filled syringe containing 5 mL sodium chloride 9 mg/mL (0.9%) solution for injection.
Danish: En fyldt injektionssprøjte af gennemsigtigt type I glas, indeholdende 5 mL natriumchlorid 9 mg/mL (0,9%) injektionsvæske, opløsning.
English: The glass syringe contains sodium chloride 9 mg/mL (0.9%) solution for injection.
Danish: Den fyldte injektionssprøjte af glas indeholder: natriumchlorid 9 mg/mL (0,9%) injektionsvæske, opløsning.
English: Macrogol 4000, distearoylphosphatidylcholine, dipalmitoylphosphatidylglycerol sodium, palmitic acid, Solvent: sodium chloride 9 mg/mL
Danish: Macrogol 4000, distearoylphosphatidylcholin, dipalmitoylphosphatidylglycerolnatrium, palmitinsyre.
English: Intravesical use
Danish: Intravesikal anvendelse
English: SonoVue will then be administered through the thin tube and will be followed by administration of saline to continue filling the bladder.
Danish: SonoVue indgives så gennem denne tynde slange, efterfulgt af saltvand for at fylde blæren op. Fyldning og tømning af blæren med en saltvandsopløsning kan gentages efter behov.
English: The intensity of the reflected signal is dependent on concentration of the microbubbles and frequency of the ultrasound beam .The interface between the sulphur hexafluoride bubble and the aqueous medium acts as a reflector of the ultrasound beam thus enhancing blood echogenicity and increasing contrast between the blood and the surrounding tissues .
Danish: Grænseoverfladen mellem boblen af sulphurhexafluorid og det vandige medie virker som reflektor for ultralydbølgen.
English: Marketing Authorisation Holder and Manufacturer:
Danish: Indehaveren af markedsføringstilladelsen og fremstiller: Indehaveren af markedsføringstilladelsen
English: Vomiting
Danish: Hududslæt
English: NAME OF THE MEDICINAL PRODUCT SonoVue 8 microlitres/mL powder and solvent for dispersion for injection
Danish: Indlægsseddel: Information til patienten SonoVue 8 mikroliter/mL, pulver og solvens til injektionsvæske, dispersion
English: The vial is for a single use only.
Danish: Hætteglasset er kun beregnet til engangsbrug.
English: Gastrointestinal disorders
Danish: Vaskulære sygdomme Flushing
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Sodium chloride 9 mg/mL solution for injection Solvent for SonoVue
Danish: Natriumchlorid 9 mg/mL (0,9%) injektionsvæske, opløsning Solvens til SonoVue
English: What SonoVue looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Breastfeeding
Danish: Sulphurhexafluorid
English: (Invented) name
Danish: Særnavn Styrke
English: If you are taking any of the following:
Danish: Hvis du tager noget af følgende:
English: Possible side effects (under corresponding frequencies):
Danish: Bivirkninger (under de respektive hyppigheder):
English: Adopted at the 14-17 May 2018 PRAC
Danish: Vedtaget på PRAC's møde 14.-17. maj 2018
English: What you need to know before you use REVLIMID [...]
Danish: Det skal du vide, før du begynder at bruge REVLIMID [...]
English: Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of.
Danish: Patienter bør også rådes til at orientere deres partner eller omsorgspersoner om behandlingen, da disse kan bemærke symptomer, som patienten ikke selv er klar over.
English: If you had these symptoms prior to treatment with lenalidomide, tell your doctor about any change in these symptoms.
Danish: Hvis du havde disse symptomer før behandlingen med lenalidomid, skal du fortælle det til lægen, hvis du oplever en ændring af dem.
English: The following medicines may increase the effects of Eliquis and increase the chance for unwanted bleeding:
Danish: Følgende lægemidler kan øge virkningen af Eliquis og øge risikoen for uønsket blødning:
English: PML was reported several months to several years after starting the treatment with lenalidomide.
Danish: PML blev rapporteret fra adskillige måneder til adskillige år efter påbegyndelse af behandling med lenalidomid.
English: Physicians should monitor patients at regular intervals and should consider PML in the differential diagnosis in patients with new or worsening neurological symptoms, cognitive or behavioural signs or symptoms.
Danish: Læger bør overvåge patienter med regelmæssige intervaller og overveje PML ved differentialdiagnostik hos patienter med nye eller forværrede neurologiske symptomer, kognitive eller adfærdsmæssige tegn eller symptomer.
English: Concomitant use of medicines affecting haemostasis may increase the risk of bleeding.
Danish: Anvendelse sammen med lægemidler, der påvirker hæmostasen, kan øge risikoen for blødninger.
English: Cases have generally been reported in patients taking concomitant dexamethasone or prior treatment with other immunosuppressive chemotherapy.
Danish: Der er generelt rapporteret om tilfælde hos patienter, der er i samtidig behandling med dexamethason, eller som tidligere er blevet behandlet med anden immunsuppressiv kemoterapi.
English: If PML is confirmed, lenalidomide must be permanently discontinued.
Danish: Hvis PML bekræftes, skal lenalidomid seponeres permanent.
English: At any time during or after your treatment, tell your doctor or nurse immediately if you: experience blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk or problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion.
Danish: Hvis du oplever følgende, når som helst under eller efter behandlingenskal du øjeblikkeligt fortælle det til lægen eller sygeplejersken: sløret syn, synstab, dobbeltsyn, talebesvær, svækkelse af en arm eller et ben, ændring af den måde, du går på, eller problemer med at holde balancen, vedvarende følelsesløshed, nedsat føleevne, tab af føleevne, hukommelsestab eller forvirring.
English: What you need to know before you take Eliquis Other medicines and Eliquis
Danish: Det skal du vide, før du begynder at tage Eliquis Brug af anden medicin sammen med Eliquis
English: A significant increase in bleeding risk was reported with the triple combination of apixaban, ASA and clopidogrel in a clinical study in patients with acute coronary syndrome (see section 4.4).
Danish: En signifikant øget blødningsrisiko er blevet rapporteret med trippelkombinationen apixaban, ASA og clopidogrel i et klinisk studie med patienter med akut koronart syndrom (se pkt.
English: If PML is suspected, further dosing must be suspended until PML has been excluded.
Danish: Hvis der er mistanke om PML, skal behandlingen afbrydes, indtil PML er udelukket.
English: Pembrolizumab - Aseptic meningitis (EPITT no 19115)
Danish: Pembrolizumab - aseptisk meningitis (EPITT nr. 19115)
English: Special warnings and precautions for use Interaction with other medicinal products affecting haemostasis
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen Interaktion med andre lægemidler, der påvirker hæmostasen
English: Despite these findings, there may be individuals with a more pronounced pharmacodynamic response when antiplatelet agents are coadministered with apixaban.
Danish: Til trods for disse fund kan nogle individer have et mere udtalt farmakodynamisk respons, når trombocythæmmere gives samtidig med apixaban.
English: Lenalidomide - Progressive multifocal leukoencephalopathy (PML) (EPITT no 19130)
Danish: Lenalidomid - progressiv multifokal leukoencefalopati (PML) (EPITT nr. 19130)
English: The evaluation for PML should be based on neurological examination, magnetic resonance imaging of the brain, and cerebrospinal fluid analysis for JC virus (JCV) DNA by polymerase chain reaction (PCR) or a brain biopsy with testing for JCV.
Danish: Undersøgelsen for PML bør baseres på neurologisk udredning, MR-scanning af hjernen og analyse af rygmarvsvæsken for JC-virus (JCV)-dna ved hjælp af polymerasekædereaktion (PCR) eller en JCV-test på en biopsi af hjernevæv.
English: Eliquis should be used with caution when coadministered with SSRIs/SNRIs or NSAIDs (including acetylsalicylic acid) because these medicinal products typically increase the bleeding risk.
Danish: Eliquis bør anvendes med forsigtighed ved samtidig behandling med SSRI'er/SNRI'er eller NSAID (herunder acetylsalicylsyre), da disse lægemidler typisk øger blødningsrisikoen.
English: Cases of progressive multifocal leukoencephalopathy (PML), including fatal cases, have been reported with lenalidomide.
Danish: Der er rapporteret om tilfælde af progressiv multifokal leukoencefalopati (PML), herunder med fatal udgang, ved behandling med lenalidomid.
English: Lenograstim; lipegfilgrastim; pegfilgrastim - Pulmonary haemorrhage (EPITT no 19181)
Danish: Lenograstim, lipegfilgrastim, pegfilgrastim - pulmonal blødning (EPITT nr. 19181)
English: • anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid (aspirin))
Danish: • Betændelsehæmmende midler og smertestillende lægemidler (f.eks. naproxen eller acetylsalicylsyre (aspirin))
English: Apixaban; edoxaban - Drug interaction between apixaban or edoxaban and selective serotonin reuptake inhibitors (SSRI) and/or serotonin and noradrenaline reuptake inhibitors (SNRI) leading to increased risk of bleeding (EPITT no 19139)
Danish: Apixaban, edoxaban - lægemiddelinteraktion mellem apixaban eller edoxaban og selektive serotoningenoptagelseshæmmere (SSRI) og/eller serotoninog noradrenalingenoptagelseshæmmere (SNRI), der medfører øget risiko for blødning (EPITT nr. 19139)
English: *Note: Stated frequencies are applicable for pegfilgrastim; for lipegfilgrastim and lenograstim the frequency is to be calculated by the MAHs.
Danish: *Bemærk: De oplyste hyppigheder gælder for pegfilgrastim.
English: Inflammation of the membrane around the spinal cord and brain, which may present as neck stiffness, headache, fever, eye sensitivity to light, nausea and vomiting (meningitis)
Danish: Sjælden (kan forekomme hos op til 1 ud af 1.000 patienter) Betændelse i den hinde, der omgiver rygmarven og hjernen, som kan vise sig som nakkestivhed, hovedpine, feber, lysfølsomhed i øjnene, kvalme og opkastning (meningitis)
English: - medicines for high blood pressure or heart problems (e.g., diltiazem) - antidepressant medicines called selective serotonin re-uptake inhibitors or serotonin
Danish: - medicin mod for højt blodtryk eller hjerteproblemer (f.eks. diltiazem) - antidepressiv medicin (såkaldte selektive serotoningenoptagelseshæmmere eller serotonin- og noradrenalingenoptagelseshæmmere)
English: Anticoagulants, antiplatelets, and thrombolytics Interaction with other medicinal products affecting haemostasis
Danish: Antikoagulanter, trombocythæmmende midler og trombolytika Interaktion med andre lægemidler, der påvirker hæmostasen
English: Care is to be taken if patients are treated concomitantly with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), or non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid.
Danish: Der skal udvises forsigtighed, hvis patienten samtidig bliver behandlet med selektive serotoningenoptagelseshæmmere (SSRI'er) eller serotonin- og noradrenalingenoptagelseshæmmere (SNRI'er) eller non-steroide antiinflammatoriske lægemidler (NSAID'er), herunder acetylsalicylsyre.
English: Undesirable effects Nervous system disorders Frequency ‘rare': meningitis (aseptic)
Danish: Hyppighed "sjælden": meningitis (aseptisk)
English: Coughing up blood (haemoptysis) - uncommon* Bleeding from the lung (pulmonary haemorrhage) - rare*
Danish: Ophostning af blod (hæmoptyse) - ikke almindelig* Blødning i lungerne (pulmonal blødning) - sjælden*
English: Undesirable effects Respiratory, thoracic and mediastinal disorders Haemoptysis (uncommon*) Pulmonary haemorrhage (rare*)
Danish: Bivirkninger Luftveje, thorax og mediastinum Hæmoptyse (ikke almindelig*) Pulmonal blødning (sjælden*)
English: Interaction with other medicinal products and other forms of interaction Anticoagulants, antiplatelets, and NSAIDs and SSRIs/SNRIs
Danish: Interaktion med andre lægemidler og andre former for interaktion Antikoagulantia, antitrombotiske midler, og NSAID'er og SSRI'er/SNRI'er
English: Interaction with other medicinal products and other forms of interaction Anticoagulants, platelet aggregation inhibitors, SSRIs/SNRIs and NSAIDs
Danish: Interaktion med andre lægemidler og andre former for interaktion Antikoagulantia, trombocytaggregationshæmmere, SSRI'er/SNRI'er og NSAID
English: • antidepressant medicines called selective serotonin re-uptake inhibitors or serotonin
Danish: • antidepressiv medicin (såkaldte selektive serotoningenoptagelseshæmmere eller serotonin- og noradrenalingenoptagelseshæmmere)
English: What you need to know before you take Lixiana/Roteas Other medicines and Lixiana/Roteas
Danish: Det skal du vide, før du begynder at tage Lixiana/Roteas Brug af anden medicin sammen med Lixiana/Roteas Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: The current fee system consists of around 130 different fees.
Danish: Den nuværende gebyrordning bestod af ca. 130 forskellige gebyrer.
English: The experience was largely welcomed by the committee Chair and members.
Danish: Disse erfaringer blev i det store hele hilst velkomne af udvalgets formand og medlemmer.
English: A separate discussion with the ECDC will be organised.
Danish: Der ville blive arrangeret en særskilt drøftelse med ECDC.
English: The second meeting of the chairs took place on 31 May 2010.
Danish: Det andet møde mellem formændene fandt sted den 31. maj 2010.
English: The first report is expected at the beginning of 2011.
Danish: Den første rapport forventedes i begyndelsen af 2011.
English: The European Commission study estimates that 5-7 full time equivalents will be needed for this task.
Danish: Ifølge Europa-Kommissionens undersøgelse skønnedes der at være behov for 5-7 fuldtidsækvivalenter til denne opgave.
English: Transparency is the key aspects of the new proposals.
Danish: Åbenhed var det centrale aspekt ved de nye forslag.
English: The dates for 2011 are as follows: 16-17 March, 9 June, 6 October and 15 December.
Danish: Datoerne for 2011 er følgende: 16.-17. marts, 9. juni, 6. oktober og 15. december.
English: In total there were 32 votes cast.
Danish: I alt blev der afgivet 32 stemmer.
English: No conflicts of interests were declared.
Danish: Der blev ikke afgivet erklæringer om interessekonflikt.
English: This item was considered at the beginning of the meeting by the Vice-Chair.
Danish: Dette punkt blev behandlet i begyndelsen af mødet af næstformanden.
English: Alternates and other participants
Danish: Suppleanter og andre deltagere
English: European Commission initiative on vigilance system for substances of human origin: cells, tissues, blood
Danish: Europa-Kommissionens initiativ vedrørende et overvågningssystem for stoffer af menneskelig oprindelse: celler, væv, blod
English: The system is complex and therefore requires simplification, while assuring sustainability and providing needed flexibility.
Danish: Ordningen var kompleks og burde derfor forenkles, samtidig med at der blev sikret bæredygtighed og skabt den fornødne fleksibilitet.
English: Otherwise, the national competent authorities may have significant difficulties contributing to activities which are important for public health.
Danish: I modsat fald kunne de nationale kompetente myndigheder have betydelige vanskeligheder ved at bidrage til aktiviteter, som var vigtige for folkesundheden.
English: Amongst other measures to increase transparency, all declarations of interests submitted by the experts will be systematically published on the website.
Danish: Blandt andre foranstaltninger til at skabe større åbenhed ville alle interesseerklæringer fra eksperterne systematisk blive offentliggjort på webstedet.
English: Activities related to referrals increased since the 2004 review of legislation.
Danish: Aktiviteterne vedrørende henvisninger var steget siden revisionen af lovgivningen i 2004.
English: The lease of the Agency's premises expiries in 2014.
Danish: Agenturets lejemål ville udløbe i 2014.
English: Ombudsman and access to EMA documents
Danish: Ombudsmanden og adgang til EMA-dokumenter
English: Following the adoption, the Board's opinion and the final accounts will be sent to the relevant EU institutions.
Danish: Efter vedtagelsen ville bestyrelsens udtalelse og det endelige regnskab blive fremsendt til de relevante EUinstitutioner.
English: Currently, the Agency uses teleconferencing for meetings involving small numbers of participants.
Danish: Agenturet anvendte for øjeblikket telekonference i forbindelse med møder med et lille antal deltagere.
English: Observers from Liechtenstein and Norway were appointed as tellers.
Danish: Observatører fra Liechtenstein og Norge blev udpeget til stemmetællere.
English: Written comments were invited within 2 weeks after the meeting.
Danish: Der kunne indgives skriftlige bemærkninger inden for to uger efter mødet.
English: Contractual arrangements: monitoring of key performance indicators
Danish: Kontraktordninger: overvågning af centrale resultatindikatorer
English: Common systems need to be developed for proactive release of information.
Danish: Der var behov for at udvikle fælles systemer til proaktiv videregivelse af oplysninger.
English: • The political agreement on cross-border healthcare directive.
Danish: • Den politiske enighed om direktivet om grænseoverskridende sundhedsydelser.
English: The reflection paper has been released for public consultation until 30 September 2010.
Danish: Arbejdsdokumentet var blevet sendt til offentlig høring indtil den 30. september 2010.
English: A new legislative proposal may be adopted by Autumn 2011.
Danish: Et nyt lovgivningsforslag ville eventuelt blive vedtaget i efteråret 2011.
English: It is important to have a linkage between the volume of work and the resources made available to carry out the required work.
Danish: Det var vigtigt at have sammenhæng mellem arbejdsmængden og de ressourcer, der blev stillet til rådighed til at udføre det nødvendige arbejde.
English: Key principles of a revised policy and procedure for the handling of conflicts of interest
Danish: Hovedprincipper for en revideret strategi og procedure for håndtering af interessekonflikter
English: The Board also asked the European Commission to assure timely communication with the Board at the highest level.
Danish: Bestyrelsen anmodede også Europa-Kommissionen om at sikre en rettidig kommunikation med bestyrelsen på højeste plan.
English: However, if combined with physical meetings of the scientific committees, the use of other meeting technologies would increase the efficiency of the use of scientific resources.
Danish: Hvis det imidlertid blev kombineret med fysiske møder i de videnskabelige udvalg, ville anvendelsen af andre mødeteknologier øge effektiviteten af anvendelsen af de videnskabelige ressourcer.
English: Declaration of conflict of interests
Danish: Erklæring om interessekonflikt
English: Therefore for all the aforementioned reasons, Prof. Nisticò does not endorse the nomination of the new nominee from Poland as CHMP member".
Danish: Af alle de førnævnte grunde støtter prof. Nisticò derfor ikke udnævnelsen af den nye kandidat fra Polen som CHMP-medlem".
English: Referrals to CVMP of veterinary medicinal products: a report from the Agency
Danish: Henvisninger til CVMP af lægemidler til dyr: en rapport fra agenturet
English: CHMP and CVMP meetings are already broadcast internally and now the technical facilities are available to broadcast to national competent authorities.
Danish: Møder i CHMP og CVMP blev allerede transmitteret internt, og der fandtes nu teknisk udstyr, hvormed der kunne transmitteres til de nationale kompetente myndigheder.
English: The procedure for the appointment of the Executive Director will be discussed in October.
Danish: Proceduren i forbindelse med udnævnelsen af den administrerende direktør ville blive drøftet i oktober.
English: The European Commission will contact the candidates and those applicants who were late to send their applications to explain the procedure.
Danish: Europa-Kommissionen ville kontakte kandidaterne og de ansøgere, som havde indgivet ansøgning for sent, og forklare dem proceduren.
English: The conclusions of the evaluation are positive and highlight the effectiveness and the efficiency of the Agency, as part of the network, as well as recognising its contribution to EU policies.
Danish: Konklusionerne af evalueringen var positive og understregede agenturets effektivitet som en del af netværket og anerkendte dets bidrag til EU-politikker.
English: However, an agreement on what information should be considered confidential is pending.
Danish: Der var imidlertid endnu ikke opnået enighed om, hvilke oplysninger der skulle betragtes som fortrolige.
English: • The ongoing work with a view to reviewing the Clinical Trials Directive.
Danish: • Det igangværende arbejde med henblik på at revidere direktivet om kliniske forsøg.
English: As a consequence, resources needed to respond to a single request are currently disproportionate.
Danish: Som følge heraf krævedes der for øjeblikket uforholdsmæssigt store ressourcer til at besvare en enkelt anmodning.
English: The proposals coming from the discussions will be classified into those requiring legislative changes and those that can be implemented without changing the legislation.
Danish: De forslag, som drøftelserne mundede ud i, ville blive inddelt i forslag, som krævede lovgivningsmæssige ændringer, og forslag, som kunne gennemføres uden at ændre lovgivningen.
English: However, the European Commission representative stated that the Commission will be unable to allocate additional resources and the tasks will have to be accommodated within the existing human and financial resources at either Agency.
Danish: Europa-Kommissionens repræsentant anførte imidlertid, at Kommissionen ikke ville være i stand til at stille yderligere midler til rådighed, og at opgaverne skulle udføres med de eksisterende menneskelige og finansielle ressourcer hos begge agenturer.
English: The re-opening of the vacancy will be announced by 26 June with a four-week deadline for applications.
Danish: Stillingen ville blive genopslået den 26. juni med en frist på fire uger til at indgive ansøgning.
English: Draft agenda for 10 June 2010 meeting
Danish: Forslag til dagsorden for mødet den 10. juni 2010
English: The Board recognised that the arrangements on handing of conflicts of interest differ in different Member States and this needs to be reflected in the memorandum.
Danish: Bestyrelsen anerkendte, at ordningerne for håndtering af interessekonflikter var forskellige i de forskellige medlemsstater, og at dette skulle afspejles i memorandummet.