FrancophonIA/ELRC3.0 huggingface dataset:
English: • Multidose pack containing 7 vials with powder, 7 pre-filled syringes with solvent, 7 vial adapters, 7 hypodermic needles (30 gauge) and 14 alcohol swabs.
Danish: • Flerstyks pakning indeholdende 7 hætteglas med pulver, 7 fyldte injektionssprøjter med solvens, 7 hætteglasadaptere, 7 hypodermiske kanyler (30 gauge) og 14 alkoholservietter.
English: Do not remove the syringe from the vial.
Danish: Fjern ikke injektionssprøjten fra hætteglasset.
English: While no increased risk of bleeding was observed in clinical trials, concomitant treatment with antiplatelet agents and / or LMWH requires a benefit/risk assessment and close clinical monitoring.
Danish: Ved samtidig brug af antitrombotiske lægemidler og/eller lavmolekylært heparin (LMH) Selv om der ikke blev observeret øget risiko for blødning i kliniske studier, kræver samtidig behandling med antitrombotiske lægemidler og/eller LMH en benefit/risk-vurdering og tæt klinisk monitorering.
English: Place the syringe on the clean flat surface.
Danish: Læg injektionssprøjten på den rene, flade overflade.
English: Studies in guinea pigs showed no effect of caplacizumab on the dams or foetuses (see section 5.3).
Danish: Studier hos marsvin viste ingen virkning af caplacizumab på mødrene eller fostrene (se pkt.
English: Do not use the medicine if you see any cloudiness, clumps or anything else that looks abnormal.
Danish: klumper eller andet, der ser unormalt ud.
English: • Put the syringe with the needle in a disposal container.
Danish: • Læg injektionssprøjten med kanyle i affaldsbeholderen.
English: Haematuria*
Danish: Hæmaturi*
English: • Gently lock the syringe onto the vial by turning it clockwise until resistance is felt.
Danish: • Lås forsigtigt injektionssprøjten på hætteglasset ved at dreje den med uret til der føles modstand.
English: Each vial contains 10 mg caplacizumab.
Danish: Hvert hætteglas indeholder 10 mg caplacizumab.
English: Number of days of Plasma Exchange (days)
Danish: Antal dage med plasmaudskiftning
English: • multidose packs each containing 7 vials with caplacizumab powder, 7 pre-filled syringes with solvent, 7 vial adapters, 7 needles and 14 alcohol swabs.
Danish: • flerstyks pakning som hver indeholder 7 hætteglas med caplacizumab-pulver, 7 fyldte injektionssprøjter med solvens, 7 hætteglasadaptere, 7 kanyler og 14 alkoholservietter.
English: Each vial of powder contains 10 mg of caplacizumab*.
Danish: Hvert hætteglas med pulver indeholder 10 mg caplacizumab*.
English: • powder vial The active substance is caplacizumab.
Danish: • hætteglas med pulver - Aktivt stof: caplacizumab.
English: • Turn the whole - vial, adapter and syringe - upside down.
Danish: • Vend det hele - hætteglas, adapter og injektionssprøjte - på hovedet.
English: 1 vial with powder 1 syringe with solvent 1 sterile vial adapter 1 sterile needle 2 alcohol swabs
Danish: 1 hætteglas med pulver 1 sprøjte med solvens 1 steril hætteglasadapter 1 steril kanyle 2 alkoholservietter
English: PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Cablivi 10 mg powder for injection caplacizumab IV and SC
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Cablivi 10 mg pulver til injektionsvæske caplacizumab i.v.+s.c.
English: STATEMENT OF ACTIVE SUBSTANCE Each vial of powder contains 10 mg caplacizumab.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas med pulver indeholder 10 mg caplacizumab.
English: • bleeding hemorrhoids
Danish: • blødende hæmorider
English: MARKETING AUTHORISATION NUMBERS EU/1/18/1305/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/18/1305/002
English: In case of active clinically significant bleeding, consider actions outlined in sections 4.4 and 4.9.
Danish: I tilfælde af aktiv klinisk signifikant blødning skal handlingerne beskrevet i pkt.
English: • excessive bleeding during periods
Danish: • perioder med kraftig blødning
English: Willebrand factor antigen, and consequently factor VIII:C, were noted in cynomolgus monkeys and, to a lesser extent for factor VIII:C, in guinea pigs.
Danish: Desuden blev farmakologi-relaterede fald i von Willebrandfaktorantigen og dermed faktor VIII:C set hos cynomolgusaber og i mindre grad for faktor VIII:C hos marsvin.
English: What Cablivi is and what it is used for What you need to know before you use Cablivi How to use Cablivi
Danish: Det skal du vide, før du begynder at bruge Cablivi Sådan skal du bruge Cablivi Bivirkninger
English: • single packs each containing 1 vial with caplacizumab powder, 1 pre-filled syringe with solvent, 1 vial adapter, 1 needle and 2 alcohol swabs
Danish: • enkeltstyks pakning indeholdeende 1 hætteglas med caplacizumab-pulver, 1 fyldt injektionssprøjte med solvens, 1 hætteglasadapter, 1 kanyle og 2 alkoholservietter.
English: The other ingredients are sucrose, citric acid anhydrous, trisodium citrate dihydrate and polysorbate 80.
Danish: - Øvrige indholdsstoffer: saccharose, citronsyre vandfri, trinatriumcitratdihydrat og polysorbat
English: • Remove the plastic flip-off cap from the vial.
Danish: • Fjern plastikhætten på hætteglasset.
English: Place the tip of the syringe on the connector part of the vial adapter.
Danish: Sæt spidsen af injektionssprøjten på hætteglasadapteren.
English: METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use Intravenous and subcutaneous use For single use only
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug.
English: • Hold the syringe at eye level with the needle pointing upwards.
Danish: • Hold injektionssprøjten i øjenhøjde med kanylen pegende opad.
English: Step 5 - Prepare the syringe
Danish: Trin 5 - Klargøring af injektionssprøjten
English: • stroke
Danish: • træthed
English: How to use Cablivi
Danish: Sådan skal du bruge Cablivi
English: • vomiting blood
Danish: • ophostning af blod
English: • Place the syringe on the clean flat surface.
Danish: • Læg injektionssprøjten på den rene, flade overflade.
English: • blood in the stools
Danish: • blod i afføring
English: PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT SYRINGE LABEL NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Cablivi
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Solvens til Cablivi
English: Step 10 - Attach the needle
Danish: Trin 10 - Fastgør kanylen
English: • multipacks each containing 7 single packs
Danish: Flerstyks pakning: 7 enkeltstyks pakninger
English: If you use more Cablivi than you should
Danish: Hvis du har brugt for meget Cablivi
English: • tiredness
Danish: • kortåndethed
English: Number of days in ICU
Danish: Antal dages hospitalsindlæggelse
English: Read the package leaflet before use Intravenous and subcutaneous use
Danish: Intravenøs og subkutan anvendelse.
English: • Pull out the needle at the same angle you inserted it. Do not rub the injection site.
Danish: • Træk kanylen ud af huden i den samme vinkel, som den blev indført.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Neuraceq on 20 February 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Neuraceq den 20. februar 2014.
English: This is a summary of the European public assessment report (EPAR) for Neuraceq.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Neuraceq.
English: These data were further supported by the results from additional patients analysed after completion of the study.
Danish: Disse data støttedes af resultaterne fra yderligere patienter, som blev analyseret efter at undersøgelsen var afsluttet.
English: Doctors will therefore need to use the scans together with clinical evaluation.
Danish: Lægerne skal derfor bruge scanningerne sammen med en klinisk vurdering.
English: The full EPAR and risk management plan summary for Neuraceq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og en sammenfatning af risikohåndteringsplanen for Neuraceq findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Neuraceq
Danish: Andre oplysninger om Neuraceq
English: There is however a risk of false positive results, and therefore Neuraceq should not be used as the sole diagnostic method for dementia, but in conjunction with clinical evaluation.
Danish: Der er dog risiko for falske positive resultater, hvorfor Neuraceq ikke bør anvendes som eneste metode til diagnosticering af demens, men sammen med en klinisk vurdering.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Neuraceq's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Neuraceq opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: When the results of the autopsies were compared with the PET scans, the scans were shown to have a sensitivity of 77.4% and a specificity of 94.2%.
Danish: Ved sammenligning af obduktionsresultaterne med PET-scanningerne viste scanningerne sig at have en følsomhed på 77,4 % og en specificitet på 94,2 %.
English: A risk management plan has been developed to ensure that Neuraceq is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Neuraceq anvendes så risikofrit som muligt.
English: This means that the PET scans were able to correctly identify as positive 77.4% of the cases where patients had significant amounts of plaques, and that almost all patients without significant plaques were correctly rated as negative.
Danish: Det betyder, at PET-scanningerne korrekt udpegede 77,4 % af patienter med nævneværdige mængder plak som positive, og at næsten alle patienter uden nævneværdig plak korrekt blev bedømt som negative.
English: The most common side effects with Neuraceq (which may affect up to 1 in 10 people) are pain, irritation and reddening of the skin at the site of injection.
Danish: De hyppigste bivirkninger ved Neuraceq (som kan optræde hos op til én ud af 10 personer) er smerte, irritation og rødfarvning af huden på injektionsstedet.
English: What measures are being taken to ensure the safe and effective use of Neuraceq?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Neuraceq?
English: Neuraceq delivers a very low amount of radiation with minimal risk of cancer or any hereditary abnormalities.
Danish: Neuraceq afgiver en meget lille mængde stråling med minimal risiko for kræft eller arvelige defekter.
English: The medicine is given by injection into a vein about 90 minutes before obtaining an image from a PET scan.
Danish: Lægemidlet gives ved injektion i en vene ca. 90 minutter før der optages et billede ved PET-scanning.
English: The type of scan used with Neuraceq is called positronemission tomography (PET).
Danish: Den type scanning, hvor Neuraceq anvendes, er positronemissionstomografi (PET).
English: This is regarded as a significant improvement in the diagnosis of patients with memory problems who are being evaluated for Alzheimer's disease and other types of dementia.
Danish: Dette anses for et betydeligt fremskridt i diagnosticering af patienter med hukommelsesproblemer, der undersøges for Alzheimers sygdom og andre typer demens.
English: Neuraceq can only be obtained with a prescription, and PET scans with Neuraceq should only be requested by doctors experienced in the management of patients with diseases such as Alzheimer's and other dementias.
Danish: Neuraceq fås kun på recept, og PET-scanning med Neuraceq bør kun rekvireres af læger med erfaring i behandling af patienter med sygdomme såsom Alzheimers og andre former for demens.
English: β-amyloid plaques are deposits sometimes present in the brain of people with memory problems caused by dementia (such as Alzheimer's disease, Lewy-body dementia and Parkinson's disease dementia) and also in the brain of some elderly people with no symptoms.
Danish: β-amyloidplak er aflejringer, der undertiden findes i hjernen hos personer med hukommelsessvækkelse forårsaget af demens (såsom Alzheimers sygdom, Lewy body demens og demens ved Parkinsons sygdom).
English: What is Neuraceq and what is it used for?
Danish: Hvad er Neuraceq, og hvad anvendes det til?
English: However, a positive scan on its own is not sufficient to make a diagnosis in patients with memory problems, as plaques may be seen with several types of dementia and also in some elderly people with no symptoms.
Danish: En positiv scanning er dog ikke i sig selv nok til at stille diagnosen hos patienter med hukommelsesproblemer, da plak forekommer både hos patienter med forskellige typer demens og hos nogle ældre uden symptomer.
English: It is not intended to provide practical advice on how to use Neuraceq.
Danish: Det er ikke en praktisk vejledning i, hvordan Neuraceq bør anvendes.
English: In addition, the usefulness of Neuraceq in predicting the development of Alzheimer's disease in patients with memory problems or in monitoring patients' response to treatment has not been established.
Danish: Desuden er det ikke fastslået, i hvor høj grad Neuraceq er egnet til at forudsige forløbet af Alzheimers sygdom hos patienter med hukommelsesproblemer eller til at overvåge patienternes respons på behandlingen.
English: Why is Neuraceq approved?
Danish: Hvorfor er Neuraceq blevet godkendt?
English: With regard to the safety profile of Neuraceq, this was considered reassuring, with the most common adverse events being related to injection site reactions.
Danish: Sikkerhedsprofilen af Neuraceq blev anset for betryggende, idet de hyppigste bivirkninger var reaktioner på injektionsstedet.
English: If few or no β-amyloid plaques are seen in the PET scan (a negative scan), the patient is unlikely to have Alzheimer's disease.
Danish: Hvis scanningen kun viser få eller ingen β-amyloidplak, er det usandsynligt, at patienten har Alzheimers sygdom.
English: For more information about treatment with Neuraceq, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Neuraceq, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What are the risks associated with Neuraceq?
Danish: Hvilke risici er der forbundet med Neuraceq?
English: After the image is obtained, it is read by physicians specially trained in interpreting PET scans with Neuraceq.
Danish: Når billedet er optaget, vurderes det af læger, der er særlig oplært i at vurdere PET-scanninger med Neuraceq.
English: For the full list of all side effects and restrictions with Neuraceq, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger og begrænsninger med Neuraceq fremgår af indlægssedlen.
English: After it attaches to the plaques, the radiation it emits can be detected by the PET scanner, enabling doctors to see whether or not significant amounts of plaques are present.
Danish: Når stoffet bindes til plak, kan dets stråling iagttages på PET-scanningen, så lægerne kan se, om der er nævneværdige mængder plak til stede.
English: The active substance in Neuraceq, florbetaben (18F), is a type of medicine known as a radiopharmaceutical that emits low amounts of radiation and works by targeting and attaching to β-amyloid plaques in the brain.
Danish: Det aktive stof i Neuraceq, florbetaben (18F), er et radioaktivt lægemiddel, der udsender små mængder stråling og virker ved at bindes til β-amyloid plak i hjernen.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Neuraceq, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: I produktresuméet og indlægssedlen for Neuraceq er der indsat sikkerhedsoplysninger baseret på denne plan, herunder passende forholdsregler, der skal følges af sundhedspersonale og patienter.
English: Neuraceq has been investigated in one main study involving 216 volunteers divided into two groups: a group of healthy young people and a group of patients nearing the end of their lives who had consented to autopsies when they died; 41 volunteers (10 healthy young people and 31 patients) completed the study and were included in the results.
Danish: Neuraceq blev undersøgt i én hovedundersøgelse med 216 forsøgspersoner fordelt på to grupper: en gruppe unge raske forsøgspersoner og en gruppe patienter, der var højt oppe i årene og som havde samtykket i at få foretaget obduktion, når de døde.
English: At the planned end of the study, 31 patients had died and had autopsies carried out on them to prove whether or not they had significant amounts of β-amyloid plaques in their brains.
Danish: Ved den planlagte afslutning af undersøgelsen var 31 patienter døde og fik foretaget obduktion for at afgøre, om de havde nævneværdige mængder β-amyloidplak i hjernen.
English: The CHMP did however note that, due to the limited effects of currently available treatments for Alzheimer's disease, there is no strong evidence that early diagnosis following PET scans with Neuraceq and early management of treatment will improve patient outcomes.
Danish: CHMP bemærkede dog, at der ikke er sikkert bevis for et bedre udfald for patienterne gennem tidlig diagnose efter PET-scanning med Neuraceq og tidlig behandling.
English: Neuraceq is used during brain scans in patients with memory problems so that doctors can see whether or not they have significant amounts of β‑amyloid plaques in the brain.
Danish: Neuraceq anvendes ved scanning af hjernen hos patienter med hukommelsesproblemer, for at lægerne kan se, om de har nævneværdige mængder β-amyloidplak i hjernen.
English: Neuraceq is a solution for injection that contains the active substance florbetaben (18F); it is for diagnostic use only.
Danish: Neuraceq er en injektionsvæske, der indeholder det aktive stof florbetaben (18F).
English: For practical information about using Neuraceq, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Neuraceq, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Results from the main study demonstrated that PET scans with Neuraceq have high sensitivity and specificity for detecting β-amyloid plaques in the brain, with results of the scans closely reflecting what was seen at autopsy.
Danish: Resultaterne fra hovedundersøgelsen viste, at PET-scanningerne med Neuraceq havde høj følsomhed og specificitet til påvisning af βamyloidplak i hjernen, og at scanningsresultaterne nøje afspejlede obduktionsresultaterne.
English: The study looked at sensitivity and specificity of the PET scans (how well they identified volunteers with plaques in the brain and how accurate they were in distinguishing them from those who did not).
Danish: Undersøgelsen vedrørte PETscanningernes følsomhed og deres specificitet (dvs. hvor sikkert de var i stand til at skelne forsøgspersoner med betydelig plakdannelse i hjernen fra personer uden plak).
English: What benefits of Neuraceq have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Neuraceq?
English: How is Neuraceq used?
Danish: Hvordan anvendes Neuraceq?
English: PET scans with Neuraceq were shown to have high specificity and sensitivity when used for identifying patients with significant amounts of β-amyloid plaques in the brain.
Danish: Det blev påvist, at PET-scanning med Neuraceq har høj specificitet og følsomhed til udpegelse af patienter med nævneværdige mængder β-amyloidplak i hjernen.
English: How does Neuraceq work?
Danish: Hvordan virker Neuraceq ?
English: Xgeva has been authorised since July 2011.
Danish: Xgeva har været godkendt siden juli 2011.
English: The full European Public Assessment Report for Xgeva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige europæiske offentlige vurderingsrapport for Xgeva findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 January 2017
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27.
English: What is happening with Xgeva for the prevention and treatment of other diseases?
Danish: Hvad sker der med Xgeva til forebyggelse og behandling af andre sygdomme?
English: High calcium levels are a serious complication that can affect cancer patients in the last stages of their disease.
Danish: Højt calciumniveau er en alvorlig komplikation, der kan ramme cancerpatienter i de sidste faser af deres sygdom.
English: The company presented the results of a study involving 33 patients with hypercalcaemia.
Danish: Virksomheden fremlagde resultaterne af en undersøgelse omfattende 33 patienter med hyperkalcæmi.
English: What is Xgeva?
Danish: Hvad er Xgeva?
English: Xgeva was not compared with any other treatment in this study.
Danish: Xgeva blev ikke sammenlignet med nogen anden behandlingsform i denne undersøgelse.
English: It is used in patients who cannot be treated by surgery or in whom surgery would cause severe problems.
Danish: Det anvendes hos patienter, der ikke kan behandles med operation, eller hos hvem operation vil medføre alvorlige problemer.
English: This reduces the loss of bone, making fractures and other serious bone complications less likely to happen, and also lowers calcium levels in the blood.
Danish: Dette reducerer knogletabet og gør knoglebrud og andre alvorlige knoglekomplikationer mindre sandsynlige og reducerer også calciumniveauet i blodet.
English: What was Xgeva expected to be used for?
Danish: Hvad forventedes Xgeva anvendt til?
English: The main measure of effectiveness was based on the number of patients who had a response to treatment, defined as having their blood calcium levels reduced to 2.9 mmol/l or lower within 10 days of the first dose.
Danish: Virkningen blev hovedsageligt bedømt på antallet af patienter, som behandlingen virkede på, defineret som en reduktion af calciumniveauet i blodet til 2,9 mmol/l eller lavere inden for 10 dage efter den første dosis.
English: There are no consequences for the use of Xgeva in its authorised indications.
Danish: Afgørelsen vil ikke få konsekvenser for brugen af Xgeva til de godkendte indikationer.
English: By attaching to and blocking RANKL, denosumab reduces the formation and activity of the osteoclasts.
Danish: Ved at binde sig til og blokere RANKL reducerer denosumab dannelsen og funktionen af osteoklaster.
English: The active substance in Xgeva, denosumab, is a monoclonal antibody, a protein that has been designed to recognise and attach to another protein called RANKL.
Danish: Det aktive stof i Xgeva, denosumab, er et monoklonalt antistof, et protein, der er udformet, så det genkender og bindes til et andet protein kaldet RANKL.
English: These complications include fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), or complications requiring radiotherapy (treatment with radiation) or surgery.
Danish: Disse komplikationer omfatter knoglebrud, sammenfald i ryggen (når rygmarven trykkes sammen af knoglen) eller komplikationer, der kræver strålebehandling eller operation.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the results of the study were not sufficient and concluded that the medicine could not have been approved based on the data presented by the company.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at undersøgelsens resultater ikke var tilstrækkelige, og konkluderede, at lægemidlet ikke kunne være blevet godkendt på baggrund af de oplysninger, som virksomheden havde fremlagt.