FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP decided that Pandemrix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Pandemrix opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Pandemrix.
English: Pandemrix must not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace (very low) levels in the vaccine, such as egg or chicken protein, ovalbumin (a protein in egg white), formaldehyde, gentamicin sulphate (an antibiotic) and sodium deoxycholate.
Danish: Pandemrix må ikke gives til patienter, der har haft en anafylaktisk reaktion (en alvorlig allergisk reaktion) over for nogen af vaccinens komponenter eller over for nogen af de sporstoffer, den indeholder, f.eks. æg eller kyllingeprotein, ovalbumin (et protein i æggehvide), formaldehyd, gentamicinsulfat (et antibiotikum) og natriumdeoxycholat.
English: • healthy children (210 aged between three and 17 years, and 50 aged between six and 35 months, in three studies).
Danish: • raske børn (210 forsøgspersoner i alderen tre til 17 år og 50 forsøgspersoner i alderen seks til 35 måneder i tre undersøgelser).
English: • healthy elderly subjects over the age of 60 years (120 subjects in one study);
Danish: • raske ældre over 60 år (120 forsøgspersoner i én undersøgelse),
English: Pandemrix is a vaccine that is given by injection.
Danish: Pandemrix er en vaccine, der gives ved injektion.
English: • healthy adults aged between 18 and 60 years (180 subjects in two studies);
Danish: • raske voksne i alderen 18 til 60 år (180 forsøgspersoner i to undersøgelser),
English: The most common side effects with Pandemrix in adults (seen with more than 1 in 10 doses of the vaccine) are headache, arthralgia (joint pain), myalgia (muscle pain), swelling and pain at the site of the injection, shivering, increased sweating and fatigue (tiredness).
Danish: De hyppigste bivirkninger ved Pandemrix (som ses hos flere end 1 ud af 10 doser af vaccinen) hos voksne er hovedpine, ledsmerter, muskelsmerter, hævelser og smerter på injektionsstedet, kulderystelser, øget svedafsondring og træthed.
English: Pandemrix is given as one dose, injected into the muscle of the shoulder or thigh.
Danish: Pandemrix gives som én dosis via injektion i skulder- eller lårmusklen.
English: Pandemrix contains a flu strain called A/California/7/2009 (H1N1)v-like strain (X-179A).
Danish: Pandemrix indeholder en influenzastamme kaldet A/California/7/2009 (H1N1) v-lignende stamme (X-179A).
English: The studies in children also allowed the effectiveness of Pandemrix as a 0.5 ml dose to be compared with that of a 0.25 ml dose.
Danish: Undersøgelserne af børn gav desuden mulighed for at sammenligne virkningen af Pandemrix i en dosis på henholdsvis 0,5 og 0,25 ml.
English: Pandemrix was originally developed as a pandemic vaccine, and was used during the influenza A (H1N1) pandemic declared in June 2009.
Danish: Pandemrix blev oprindeligt udviklet som en pandemisk vaccine til brug under influenza A (H1N1)pandemien, som blev erklæret i juni 2009.
English: In children aged between six months and nine years, 0.25 ml doses were as effective as 0.5 ml doses.
Danish: Hos børn i alderen seks måneder til ni år var doser på 0,25 ml lige så effektive som doser på 0,5 ml.
English: For the full list of all side effects reported with Pandemrix, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Pandemrix fremgår af indlægssedlen.
English: What is the risk associated with Pandemrix?
Danish: Hvilken risiko er der forbundet med Pandemrix?
English: Pandemrix is a vaccine to protect against flu caused by the A (H1N1)v 2009 virus.
Danish: Pandemrix er en vaccine til beskyttelse mod influenza, som er fremkaldt af A (H1N1)v 2009-virus.
English: Why has Pandemrix been approved?
Danish: Hvorfor blev Pandemrix godkendt?
English: When a person is given the vaccine, the immune system recognises the virus as ‘foreign' and makes antibodies against it.
Danish: Når en person vaccineres, opfatter immunsystemet virusset som ”fremmed” og producerer antistoffer mod det. Immunsystemet kan således danne antistoffer hurtigere, når det eksponeres for samme virus igen.
English: What is Pandemrix?
Danish: Hvad er Pandemrix?
English: From 10 years of age the dose is 0.5 ml; younger children aged from six months to nine years receive 0.25 ml per dose.
Danish: Yngre børn i alderen seks måneder til ni år får 0,25 ml pr. dosis.
English: How has Pandemrix been studied?
Danish: Hvordan blev Pandemrix undersøgt?
English: Pandemrix contains small amounts of haemagglutinins (proteins from the surface) of a virus called A(H1N1)v 2009.
Danish: Pandemrix indeholder små mængder af hæmagglutininer (overfladeproteiner) fra en virus kaldet A(H1N1)v 2009, der først er blevet inaktiveret (dræbt), så den ikke længere forårsager sygdom.
English: What is Pandemrix used for?
Danish: Hvad anvendes Pandemrix til?
English: What benefit has Pandemrix shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Pandemrix?
English: How is Pandemrix used?
Danish: Hvordan anvendes Pandemrix?
English: How does Pandemrix work?
Danish: Hvordan virker Pandemrix?
English: 50 (5 x 10) pre-filled syringes (multipack)
Danish: 50 (5 x 10) fyldte sprøjter (Multipakning)
English: If you are pregnant
Danish: Hvis du er gravid
English: It might be helpful to estimate the effective dose that was applied.
Danish: Det kan være nyttigt at estimere den anvendte effektive dosis.
English: Volume: {Z} mL
Danish: Volumen: {Z} ml
English: It will be the smallest quantity necessary to get the desired information.
Danish: Det vil være den mindste mængde, som er nødvendig for at få de ønskede oplysninger.
English: However, in the case of an overdose, you will receive the appropriate treatment.
Danish: I tilfælde af en overdosis vil du modtage den relevante behandling.
English: Possible structural anomalies that could influence quantitation of the cerebellar region should be considered.
Danish: Mulige strukturelle anomalier, der kan påvirke kvantificering af cerebellarregionen skal overvejes.
English: No studies have been conducted in pregnant women.
Danish: Der er ikke udført studier med gravide kvinder.
English: Training should include a sufficient number of clearly positive and negative cases as well as intermediate level cases.
Danish: Undervisningen skal omfatte et tilstrækkeligt antal klart positive og negative tilfælde, samt tilfælde i mellemstadiet.
English: One injection is usually sufficient to carry out the scan that your doctor needs.
Danish: Én indsprøjtning er som regel tilstrækkeligt til at udføre den scanning, som lægen har brug for.
English: Image interpretation).
Danish: Tolkning af billeder).
English: The following information is intended for the specialist only.
Danish: Følgende oplysninger er udelukkende tiltænkt specialisten.
English: Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation.
Danish: Modtagelse, opbevaring, anvendelse, overførsel og bortskaffelse er underlagt bestemmelser og/eller gældende tilladelser fra den kompetente officielle myndighed.
English: 10010 Colleretto Giacosa (TO) Italy
Danish: 10010 Colleretto Giacosa (TO) Italien
English: Amyvid will only be used in specially controlled areas.
Danish: Amyvid anvendes udelukkende på særligt kontrollerede områder.
English: This dose is approximately 500 times the maximum human dose, and showed no evidence of mutagenicity.
Danish: Denne dosis er ca. 500 gange større end maksimal human dosis og viste ikke tegn på mutagenicitet.
English: Radioactive material
Danish: Radioaktivt materiale
English: There are strict laws on the use, handling and disposal of radiopharmaceutical products.
Danish: Der er strenge love vedrørende brug, håndtering og bortskaffelse af radioaktive produkter.
English: This may be harmful to those suffering from alcoholism.
Danish: Dette kan være skadeligt for alkoholikere.
English: • Expertise and qualification of trainers in both electronic and in-person training should be ensured.
Danish: • Undervisernes ekspertise og kvalifikationer ved såvel den elektroniske som den personlige undervisning skal sikres.
English: Cases should be histopathologically confirmed, if possible.
Danish: Hvis muligt, skal tilfældene være histopatologisk bekræftede.
English: No assumptions were made regarding urinary bladder voiding.
Danish: Der blev ikke foretaget antagelser vedrørende tømning af urinblæren.
English: If the quantitation result is inconsistent with the initial visual interpretation:
Danish: Hvis kvantificeringsresultatet ikke stemmer overens med den indledende visuelle tolkning:
English: The physician training course should contain the following key elements:
Danish: Undervisningsmaterialet til læger bør indeholde følgende nøgleelementer:
English: System organ class
Danish: Systemorgan-klasse
English: Appropriate aseptic precautions should be taken.
Danish: Der bør tages tilfredsstillende aseptiske forholdsregler.
English: 08950 Espluges de Llobregat, Barcelona Spain
Danish: 08950 Espluges de Llobregat, Barcelona Spanien
English: Activity: {Y} MBq in {Z}mL ToC: {DD/MM/YYYY} {hh:mm}{Time Zone} Vial No.
Danish: Aktivitet: {Y} MBq i {Z}ml ToC: {DD/MM/YYYY}{hh:mm}{Tidszone} Hætteglas nr.
English: Contact your nuclear medicine doctor if you have any questions.
Danish: Kontakt den nuklearmedicinske læge, hvis du har spørgsmål.
English: Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Danish: Enhver kvinde, der ikke har fået menstruation, skal anses for at være gravid, indtil det modsatte er bevist.
English: Interpretation of Amyvid images
Danish: Tolkning af Amyvid-billeder
English: Only polypropylene/HDPE syringes should be used.
Danish: Der må kun anvendes polypropylen-/HDPE-sprøjter.
English: The design of this study does not allow estimating the risk of MCI progression to clinical AD.
Danish: Studiedesignet tillod ikke estimering af risikoen for progression fra MCI til klinisk AD.
English: A positive scan indicates moderate to frequent density.
Danish: En positiv scanning viser moderat til hyppig densitet.
English: The cognitive status of the subjects could not be reliably measured.
Danish: Forsøgspersonernes kognitive status kunne ikke måles med pålidelighed.
English: The radioactive half-life of 18F is 110 minutes.
Danish: Den radioaktive halveringstid for 18F er 110 minutter.
English: You will not have to store this medicine.
Danish: Du skal ikke opbevare dette lægemiddel.
English: Reconstruction should include attenuation correction with resulting transaxial pixel sizes between 2.0 and 3.0 mm.
Danish: Rekonstruktion skal omfatte dæmpningskorrektion med deraf resulterende transaksiale pixelstørrelser på mellem 2,0 og 3,0 mm.
English: Frequencies are defined as very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: Hyppigheden defineres som 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); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Less than 5% of the injected 18F radioactivity remains in blood 20 minutes following administration, and less than 2% is present 45 minutes after administration.
Danish: Mindre end 5 % af den injicerede 18F-radioaktivitet resterer i blodet 20 minutter efter administration, og mindre end 2 % resterer 45 minutter efter administration.
English: Only essential investigations should therefore be carried out during pregnancy, when the likely benefit far exceeds the risk incurred by the mother and foetus.
Danish: Derfor bør der under graviditet udelukkende udføres undersøgelser af afgørende betydning, når de sandsynlige fordele langt overstiger risikoen for mor og foster.
English: Limitations of use
Danish: Begrænsninger for anvendelse
English: Date of latest renewal: 21 September 2017
Danish: Dato for første markedsføringstilladelse: 14. januar 2013 Dato for seneste fornyelse: 21. september 2017
English: The basis for making a visual positive or negative determination should be reviewed: a.
Danish: Grundlaget for at foretage en positiv eller negativ visuel bestemmelse skal evalueres:
English: Their results closely paralleled the results obtained in the pivotal trial.
Danish: Deres resultater svarede nøje til resultaterne fra det pivotale studie.
English: Withdrawals should be performed under aseptic conditions.
Danish: Optrækningen skal udføres under aseptiske betingelser.
English: Amyvid must not be used after the expiry date which is stated on the shield label after EXP.
Danish: Amyvid må ikke anvendes efter den udløbsdato, der står på afskærmningsetiketten, efter EXP.
English: As a result of differences in the manufacturing process, it is possible that vials of some product batches are distributed with punctured rubber stoppers.
Danish: På grund af forskelle i fremstillingsprocessen, er det muligt at hætteglas fra visse produktionsbatches distribueres med perforerede gummipropper.
English: You should discuss the results of the test with the doctor that requested the scan.
Danish: Du skal gennemgå resultaterne af undersøgelsen sammen med den læge, som bestilte scanningen.
English: Amyvid should be used in conjunction with a clinical evaluation.
Danish: Amyvid skal anvendes i forbindelse med en klinisk vurdering.
English: A final interpretation of the scan should be made based on the final visual read after conducting resolution steps 1-3 above.
Danish: Udfør en endelig tolkning af scanningen baseret på den endelige visuelle aflæsning efter udførelse af løsningstrin 1-3 ovenfor.
English: The highest level of uptake is in regions mainly composed of white matter (pons and centrum semiovale).
Danish: Den højeste grad af optag ses i de regioner, som hovedsageligt består af hvid substans (pons og centrum semiovale).
English: Elderly No dose adjustment is recommended based on age.
Danish: Ældre Der foreligger ingen anbefalede dosisjusteringer pga. alder.
English: Summary of the safety profile The safety profile of Amyvid is based on its administrations to 2,105 subjects in clinical trials.
Danish: Resumé af sikkerhedsprofil Sikkerhedsprofilen for Amyvid er baseret på administration til 2.105 forsøgspersoner i kliniske forsøg.
English: Megabecquerel (MBq) is the unit used to express radioactivity.
Danish: Megabecquerel (MBq) er den enhed, der anvendes til at angive radioaktivitet.
English: This should be taken into account in patients on a low sodium diet.
Danish: Dette skal tages i betragtning hos patienter på en diæt med lavt natriumindhold.
English: Osteogenic cells
Danish: Osteogene celler
English: Effective Dose [µSv/MBq]a a Assumed quality factor (Q) of 1 for conversion of absorbed dose to effective dose for 18F.
Danish: Effektiv dosis [µSv/MBq]a a Antaget kvalitetsfaktor (Q) på 1 til konvertering af absorberet dosis til effektiv dosis for 18F.
English: This medicine will only be handled and given to you by people who are trained and qualified to use it safely.
Danish: Dette lægemiddel håndteres og indgives udelukkende af personale, som er uddannet i og kvalificeret til at bruge det sikkert.
English: The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine.
Danish: Den nuklearmedicinske læge vil informere dig, hvis du skal tage særlige forholdsregler efter at have fået dette lægemiddel.
English: The nuclear medicine doctor supervising the procedure will decide on the quantity of Amyvid to be used in your case.
Danish: Den nuklearmedicinske læge, der er ansvarlig for undersøgelsen, vil bestemme, hvor meget Amyvid, der skal anvendes i dit tilfælde.
English: Dose absorbed per activity administered (µGy/MBq) Average
Danish: Absorberet dosis pr. administreret aktivitet (µGy/MBq) Gennemsnit
English: It is recommended that review of images include all transaxial slices of the brain using a black-white scale with the maximum intensity of the scale set to the maximum intensity of all brain pixels.
Danish: Det anbefales, at billedgennemgangen omfatter alle transaksiale snit af hjernen med anvendelse af en sort-hvid skala, hvor skalaens maksimale intensitet er indstillet til den maksimale intensitet af alle pixel i hjernebilledet.
English: No in vivo interaction studies have been performed.
Danish: Der er ikke udført specifikke in vivo-interaktionsstudier.
English: Extensive dose-range and adjustment studies with the medicinal product in normal and special populations have not been performed.
Danish: Der er ikke udført omfattende dosis-interval og -justeringsstudier med dette lægemiddel i normalpopulationen eller i særlige populationer.
English: Specificity
Danish: Specificitet
English: Children and adolescents Amyvid is not intended for use in children and adolescents.
Danish: Børn og unge Amyvid er ikke beregnet til børn og teenagere.
English: If a CT scan is simultaneously performed as part of the PET procedure, exposure to ionising radiation will increase in an amount dependent on the settings used in the CT acquisition.
Danish: Hvis en CT-scanning foretages samtidigt som en del af PET-proceduren, øges eksponeringen for ioniserende stråling med en mængde, der afhænger af indstillingerne anvendt under CT-optagelsen.
English: Figure 1: Amyvid PET cases showing examples of negative scans (top two rows) and positive scans (bottom two rows).
Danish: Figur 1: PET-tilfælde med Amyvid, der viser eksempler på negative scanninger (to øverste rækker) og positive scanninger (to nederste rækker).
English: Of the patients who had been clinically diagnosed with MCI at study entry, 9 (19%) converted to clinical AD 36 months later.
Danish: Blandt de patienter, som var klinisk diagnosticeret med MCI ved indgang i studiet, konverteredes 9 (19 %) til klinisk AD 36 måneder senere.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Amyvid in all subsets of the paediatric population as there is no intended use in the paediatric population.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Amyvid i alle undergrupper af den pædiatriske population da der ingen anvendelse er i den pædiatriske population.
English: In the event of administration of a radiation overdose, the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by frequent micturition and defaecation.
Danish: I tilfælde af administration af en stråleoverdosering skal patientens absorberede dosis reduceres, hvor det er muligt, ved at øge elimineringen af radionuklidet fra kroppen ved hjælp af hyppig vandladning og defækation.
English: Inter-rater agreement using Fleiss' kappa values ranged from 0.75 to 0.85.
Danish: Inter-rater-overensstemmelsen angivet med Fleiss kappa-værdier varierede fra 0,75 til 0,85.
English: Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Danish: Eksponering for ioniserende stråling er forbundet med cancerinduktion og risiko for at udvikle arvelige defekter.
English: Of the 17 MCI patients who had a positive PET scan, 6 (35%) were diagnosed with clinical probable AD 36 months later compared to 3 (10%) of 30 who had a negative scan.
Danish: Blandt de 17 MCI-patienter, som havde en positiv PETscanning, blev 6 (35 %) diagnosticeret med klinisk sandsynlig AD 36 måneder senere, sammenlignet med 3 (10 %) af de 30, som havde en negativ scanning.
English: Paediatric population There is no relevant use of Amyvid in the paediatric population.
Danish: Pædiatrisk population Der er ingen relevant anvendelse af Amyvid i den pædiatriske population.
English: These persons will take special care for the safe use of this medicine and will keep you informed of their actions.
Danish: Personalet vil være særlig omhyggelig med at bruge dette lægemiddel på sikker vis og holde dig informeret om, hvad der sker.
English: β-amyloid plaques are deposits present in the brains of people with Alzheimer's disease, but may also be present in the brain of people with other dementias.
Danish: β-amyloidplak er aflejringer i hjernen hos personer med Alzheimers, men kan også være til stede i hjernen hos personer med andre demenssygdomme.
English: The use of Amyvid does involve exposure to small amounts of radioactivity.
Danish: Anvendelse af Amyvid medfører, at du udsættes for små mængder radioaktivitet.
English: b.
Danish: C.
English: Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators.
Danish: Administrationsprocedurer skal gennemføres på en måde, så risikoen for kontaminering af lægemidlet og bestråling af brugerne minimeres.
English: The complete SmPC of Amyvid is provided as a separate document in the medicinal product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Danish: Det komplette produktresumé for Amyvid leveres som et separat dokument i lægemiddelpakningen med det formål at give det sundhedsfaglige personale yderligere videnskabelige og praktiske oplysninger om administration og brug af dette radioaktive lægemiddel.
English: Your nuclear medicine doctor will inform you about the usual duration of the procedure.
Danish: Den nuklearmedicinske læge vil informere dig om den normale varighed af undersøgelsen.
English: The activity administered should, in every case, be as low as reasonably achievable to obtain the required diagnostic information.
Danish: Den administrerede aktivitet skal i hvert tilfælde være så lav som muligt for at opnå den ønskede diagnostiske information.
English: While they may in reality occur at lower frequencies than indicated below, the size of the source database did not allow for the assignment of frequency categories lower than the category “uncommon” (≥1/1,000 to <1/100).
Danish: Bivirkningerne kan i realiteten forekomme mindre hyppigt end indikeret nedenfor, men størrelsen af kildedatabasen gav ikke mulighed for at tildele lavere hyppighedskategorier end kategorien “ikke almindelig” (≥1/1.000 til <1/100).
English: This medicine is stored under the responsibility of the specialist in appropriate premises.
Danish: Specialisten har ansvaret for at opbevare dette lægemiddel i egnede lokaler.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advice before you are given this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge den nuklearmedicinske læge til råds, før du får dette lægemiddel.
English: Sensitivity
Danish: Sensitivitet
English: An acute dose study was conducted in rats, and the NOAEL (no observable adverse effect level) was determined to be at least 100 times maximum human dose.
Danish: Der er udført et studie med akut dosis til rotter, og NOAEL-værdien (dosisniveauet, hvor ingen skadelig virkning har kunnet observeres) blev bestemt til at være mindst 100 gange større end den maksimale humane dosis.
English: Organ/tissue
Danish: Organ/Væv
English: Each vial is enclosed in a shielded container of appropriate thickness to minimise external radiation exposure.
Danish: Hvert enkelt hætteglas ligger i en afskærmet beholder af passende tykkelse for at minimere ekstern strålingseksponering.
English: Agreement with baseline diagnosis of MCI
Danish: Overensstemmelse med baseline diagnosen MCI