FrancophonIA/ELRC3.0 huggingface dataset:
English: Erythematous oedema mainly of the lower limbs has been reported with an unknown frequency.
Danish: Der er med ukendt hyppighed rapporteret erytematøst ødem, primært i underekstremiteterne.
English: Common Dyspepsia/heartburn
Danish: Almindelig Dyspepsi/ halsbrand
English: What Pemetrexed Pfizer looks like and contents of the pack Pemetrexed Pfizer is a powder for concentrate for solution for infusion in a glass vial.
Danish: Pemetrexed Pfizer er et pulver til koncentrat til infusionsvæskeopløsning i hætteglas.
English: ATC code: L01BA04.
Danish: Farmakoterapeutisk klassifikation: Folsyreanaloger, ATC-kode L01BA04
English: Pemetrexed as a single agent
Danish: Pemetrexed givet alene
English: METHOD OF ADMINISTRATION Reconstitute and dilute before use See leaflet.
Danish: Rekonstituer og fortynd før brug.
English: Pemetrexed Pfizer 500mg vial:
Danish: Pemetrexed Pfizer 500 mg hætteglas:
English: The table below provides the frequency and severity of undesirable effects considered possibly related to study medicinal product that have been reported in > 5% of 800 patients randomly assigned to receive single-agent pemetrexed and 402 patients randomly assigned to receive placebo in the singleagent pemetrexed maintenance (JMEN: N= 663) and continuation pemetrexed maintenance (PARAMOUNT: N=539) studies.
Danish: Bivirkningerne blev rapporteret hos > 5 % af de 800 patienter, som var randomiseret til enkeltstofbehandling med pemetrexed, og de 402 patienter, som var randomiseret til placebo i studiet med pemetrexed vedligeholdelsesbehandling (JMEN: n=663) og studiet med pemetrexed induktionsbehandling efterfulgt af pemetrexed vedligeholdelsesbehandling (PARAMOUNT: n=539).
English: Median overall survival (months) (95% CI)
Danish: Median overlevelse (OS) (måneder) (95 % - CI)
English: Before the start of any cycle of chemotherapy, patients are required to have the following: absolute neutrophil count (ANC) should be ≥ 1,500 cells/mm3 and platelets should be ≥ 100,000 cells/mm3.
Danish: Det absolutte neutrofiltal (ANC) skal være ≥ 1.500 celler/mm
English: Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion 18 months
Danish: Pemetrexed Pfizer 100 mg pulver til koncentrat til infusionsvæske, opløsning 18 måneder
English: Including the induction phase, the median OS for patients with NSCLC other than predominantly squamous cell histology was 18.6 months for the pemetrexed arm and 13.6 months for the placebo arm, hazard ratio = 0.71 (95% CI = 0.56-0.88, p = 0.002).
Danish: Ved at inkludere induktionsfasen blev den mediane OS for patienter med NSCLC bortset fra cancer hovedsageligt bestående af pladeepitelceller 18,6 måneder for pemetrexed-armen og 13,6 måneder for placeboarmen, hazard ratio=0,71 (95 % CI = 0,56-0,88, p=0,002).
English: From the start of pemetrexed plus cisplatin first-line induction treatment, the median OS of patients was 16.9 months for the pemetrexed arm and 14.0 months for the placebo arm (hazard ratio= 0.78, 95% CI= 0.64-0.96).
Danish: Målt fra starttidspunktet for pemetrexed plus cisplatin førstelinje induktionsbehandling var den mediane overlevelse 16,9 måneder for pemetrexedarmen og 14,0 måneder for placeboarmen (hazard ratio= 0,78, 95 % CI=
English: Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion Store below 30°C.
Danish: Pemetrexed Pfizer 100 mg pulver til koncentrat til infusionsvæske, opløsning Opbevares ved temperaturer under 30 °C.
English: Clinically relevant toxicity that was reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: AST increase, ALT increase, infection, febrile neutropenia, renal failure, pyrexia, dehydration, conjunctivitis, and creatinine clearance decrease.
Danish: Klinisk relevant toksicitet, som blev rapporteret hos ≥ 1 % og ≤ 5 % af de patienter, der var randomiseret til cisplatin og pemetrexed, omfattede: forhøjet ASAT, forhøjet ALAT, infektion, febril neutropeni, nyresvigt, pyreksi, dehydrering, konjunktivitis og nedsat kreatininclearance.
English: Conjunctivitis (inflamed eye) Upset stomach
Danish: Bindehindebetændelse (øjenbetændelse) Mavegener
English: Efficacy of pemetrexed plus cisplatin vs. cisplatin in malignant pleural mesothelioma Randomised and treated patients Fully supplemented patients
Danish: Effekt af pemetrexed sammen med cisplatin versus cisplatin alene til patienter med malignt pleuramesoteliom
English: Dose modification table for pemetrexed (as a single agent or in combination) and cisplatin - neurotoxicity
Danish: Tabel 3 - Dosisjustering for pemetrexed (som et enkeltstof eller i kombination) og cisplatinneurotoksicitet CTC a-grad
English: Squamous cell (N = 473)
Danish: Pladeepitelceller (N = 473)
English: Clinically relevant CTC toxicities that were reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: renal failure, infection, pyrexia, febrile neutropenia, increased AST, ALT, and GGT, urticaria and chest pain.
Danish: De klinisk relevante CTC-toksiciteter, som blev rapporteret hos ≥ 1 % og ≤ 5 % af de patienter, der var randomiseret til cisplatin og pemetrexed, omfattede: nyresvigt, infektion, pyreksi, febril neutropeni, forhøjet ASAT, ALAT og GGT, nældefeber og brystsmerter.
English: Pemetrexed Pfizer 500 mg powder for concentrate for solution for infusion This medicinal product does not require any special storage conditions.
Danish: Pemetrexed Pfizer 500 mg pulver til koncentrat til infusionsvæske, opløsning Dette lægemiddel kræver ingen særlige opbevaringsbetingelser.
English: Uncommon cases of radiation pneumonitis have been reported in patients treated with radiation either prior, during or subsequent to their pemetrexed therapy (see section 4.4).
Danish: 4.4) er rapporteret hos patienter i strålebehandling enten før, under eller efter behandling med pemetrexed.
English: The median OS for patients with NSCLC other than predominantly squamous cell histology (N = 481) was 15.5 months for the pemetrexed arm and 10.3 months for the placebo arm, hazard ratio = 0.70 (95% CI = 0.56-0.88, p = 0.002).
Danish: Den mediane OS for patienter med NSCLC bortset fra cancer hovedsageligt bestående af pladeepitelceller (N = 481) var 15,5 måneder for pemetrexed-armen og 10,3 måneder for placeboarmen (hazard ratio = 0,70, 95 % CI = 0,56-0,88, p = 0,002).
English: Read the package leaflet for the shelf life of the reconstituted product.
Danish: EXP Læs indlægssedlen angående opbevaringsforhold af det rekonstituerede lægemiddel
English: Pemetrexed Pfizer 1,000 mg powder for concentrate for solution for infusion This medicinal product does not require any special storage conditions.
Danish: Pemetrexed Pfizer 1.000 mg pulver til koncentrat til infusionsvæske, opløsning Dette lægemiddel kræver ingen særlige opbevaringsbetingelser.
English: Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion Store the 100 mg vial below 30°C.
Danish: Pemetrexed Pfizer 100 mg pulver til koncentrat til infusionsvæske, opløsning Opbevar hætteglasset med 100 mg ved temperaturer under 30 °C.
English: Maidenhead
Danish: Docetaxel
English: Reconstitute each 100 mg vial with 4.2 ml of sterile water for injections, resulting in a solution containing 25 mg/ml pemetrexed.
Danish: Rekonstituer hvert 100 mg hætteglas med 4,2 ml sterilt vand til injektionsvæsker, til en opløsning indeholdende 25 mg/ml pemetrexed.
English: Pemetrexed Pfizer 1,000mg powder for concentrate for solution for infusion 2 years
Danish: Pemetrexed Pfizer 1.000 mg pulver til koncentrat til infusionsvæske, opløsning 2 år
English: Pemetrexed Pfizer 500 mg powder for concentrate for solution for infusion The 500 mg vial does not require any special storage conditions.
Danish: Pemetrexed Pfizer 500 mg pulver til koncentrat til infusionsvæske, opløsning Hætteglasset med 500 mg kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Reconstitute each 1,000 mg vial with 40 ml of sterile water for injections, resulting in a solution containing 25 mg/ml pemetrexed.
Danish: Rekonstituer hvert 1.000 mg hætteglas med 40 ml sterilt vand til injektionsvæsker, til en opløsning indeholdende 25 mg/ml pemetrexed.
English: Contact your doctor if you get a severe rash, or itching, or blistering (Stevens-Johnson syndrome or toxic epidermal necrolysis).
Danish: FortældettilDereslæge,hvisDe får alvorligtudslæt, kløenellerblæredannelse (Stevens-Johnsonssyndromellertoksisk epidermalnekrolyse).
English: Pemetrexed Pfizer in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Danish: Pemetrexed Pfizer er indiceret til behandling sammen med cisplatin, som 1. linje-behandling til patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungecancer, bortset fra cancer hovedsageligt bestående af pladeepitelceller (se pkt.
English: Pemetrexed Pfizer 500 mg powder for concentrate for solution for infusion 2 years
Danish: Pemetrexed Pfizer 500 mg pulver til koncentrat til infusionsvæske, opløsning 2 år
English: Reconstitute each 500 mg vial with 20 ml of sterile water for injections, resulting in a solution containing 25 mg/ml pemetrexed.
Danish: Rekonstituer hvert 500 mg hætteglas med 20 ml sterilt vand til injektionsvæsker, til en opløsning indeholdende 25 mg/ml pemetrexed.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 1,000 mg
Danish: YDRE KARTON 1.000 mg
English: Pemetrexed Pfizer is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Danish: Pemetrexed Pfizer er indiceret som 2. linjes monoterapi til behandling af patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungecancer, bortset fra cancer hovedsageligt bestående af pladeepitelceller (se pkt.
English: Pemetrexed Pfizer 1,000 mg powder for concentrate for solution for infusion The 1,000 mg vial does not require any special storage conditions.
Danish: Pemetrexed Pfizer 1.000 mg pulver til koncentrat til infusionsvæske, opløsning Hætteglasset med 1.000 mg kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Allergic reaction: skin rash / burning or prickling sensation Infection including sepsis
Danish: Almindelig (kan forekommerhos op til1 ud af10 personer) Allergisk reaktion: udslæt/en brændende eller prikkende fornemmelse Infektion,inklusivesepsis (blodforgiftning) Feber
English: 1050 Bruxelles
Danish: 500 mg
English: Neutrophils/Granulocytes decreased
Danish: Nedsat neutrofil-/ granulocyttal
English: Men are advised not to father a child during and up to 6 months following treatment with pemetrexed and should therefore use effective contraception during treatment with pemetrexed and for up to 6 months afterwards.
Danish: Mænd rådes til ikke at gøre en kvinde gravid hverken under eller i op til 6 måneder efter behandlingen med pemetrexed.
English: Frequency Event*
Danish: Hyppighed Bivirkning*
English: Interstitial pneumonitis (scarring of the air sacs of the lung) Oedema (excess fluid in body tissue, causing swelling).
Danish: Interstitiel lungebetændelse (lungebetændelse med talrige små udbredte infektionsområder mellem alveolerne).
English: Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion Each vial contains 100 milligrams of pemetrexed (as pemetrexed ditromethamine).
Danish: Pemetrexed Pfizer 100 mg pulver til koncentrat til infusionsvæske, opløsning: Hvert hætteglas indeholder 100 milligram pemetrexed (som pemetrexed ditromethamin).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 100 mg
Danish: YDRE KARTON 100 mg
English: Loss of sensation
Danish: Hudirritation og kløe
English: Pemetrexed Pfizer 1,000 mg powder for concentrate for solution for infusion Each vial contains 1,000 milligrams of pemetrexed (as pemetrexed ditromethamine).
Danish: Pemetrexed Pfizer 1.000 mg pulver til koncentrat til infusionsvæske, opløsning: Hvert hætteglas indeholder 1.000 milligram pemetrexed (som pemetrexed ditromethamin).
English: GENERAL CLASSIFICATION FOR SUPPLY 15.
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING
English: Serious renal events, including acute renal failure, have been reported with pemetrexed alone or in association with other chemotherapeutic agents.
Danish: Der er rapporteret om alvorlige nyrepåvirkninger, inklusive akut nyresvigt, med pemetrexed både som eneste lægemiddel, og når det blev brugt i kombinationsbehandling med andre cytostatika.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mg
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: Pemetrexed Pfizer 500 mg powder for concentrate for solution for infusion Each vial contains 500 milligrams of pemetrexed (as pemetrexed ditromethamine).
Danish: Pemetrexed Pfizer 500 mg pulver til koncentrat til infusionsvæske, opløsning: Hvert hætteglas indeholder 500 milligram pemetrexed (som pemetrexed ditromethamin).
English: Common Pain
Danish: Almindelig Smerte Ødemer
English: 9 l/m2.
Danish: 100 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 500 mg
Danish: YDRE KARTON 500 mg
English: PHARMACEUTICAL FORM Powder for concentrate for solution for infusion.
Danish: Pulver til koncentrat til infusionsvæske, opløsning.
English: • If you experience sudden breathlessness, intense chest pain or cough with bloody sputum
Danish: Hvis De pludselig får åndenød, stærke smerter i brystet eller hoste med blodigt spyt (ikke almindeligt) (dette kan betyde, at der er en blodprop i en af lungernes blodårer).
English: Horizon
Danish: cisplatin
English: If you have heart disease or a history of heart disease, please tell your doctor.
Danish: Informér Deres læge, hvis De har en hjertesygdom eller tidligere har haft en hjertesygdom.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL 100 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER
English: Owing to the possibility of pemetrexed treatment causing irreversible infertility (see section 5.3), men are advised to seek counselling on sperm storage before starting treatment.
Danish: 5.3), rådes mandlige patienter til at søge rådgivning om opbevaring af sæd, inden behandlingen påbegyndes.
English: For the purpose of this table a cut off of 5% was used for inclusion of all events where the reporter considered a possible relationship to pemetrexed and cisplatin.
Danish: Til denne tabel blev der anvendt en afskæringsværdi på 5 % til inkludering af alle hændelser, hvor indberetteren anså, at bivirkningen muligvis var forbundet med pemetrexed og cisplatin.
English: Neuropathy-sensory Common Taste disturbance
Danish: Nervesystemet Almindelig Sensorisk neuropati
English: Common Constipation
Danish: Almindelig Forstoppelse
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Pfizer 1,000 mg powder for concentrate for solution for infusion pemetrexed
Danish: Pemetrexed Pfizer 1.000 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion pemetrexed
Danish: Pemetrexed Pfizer 100 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Pfizer 500 mg powder for concentrate for solution for infusion pemetrexed
Danish: Pemetrexed Pfizer 500 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: In the absence of other compatibility studies this medicinal product must not be mixed with other medicinal products.
Danish: Hvis der ses partikler må medicinen ikke indgives.
English: A multi-centre, randomised, double-blind, placebo-controlled Phase-3 study (PARAMOUNT), compared the efficacy and safety of continuation maintenance treatment with pemetrexed plus BSC (N = 359) with that of placebo plus BSC (N = 180) in patients with locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC other than predominantly squamous cell histology who did not progress after 4 cycles of first-line doublet therapy of pemetrexed in combination with cisplatin.
Danish: Et multi-center, randomiseret, dobbeltblindet, placebokontrolleret fase 3-studie (PARAMOUNT) sammenlignede virkningen og sikkerheden af fortsat vedligeholdelsesbehandling med pemetrexed plus bedste understøttende pleje (BSC, Best Supportive Care) (N=359) med placebo plus BSC
English: Haemoglobin decreased 33.0* Neutrophils/Granulocytes decreased
Danish: Nedsat neutrofil-/ granulocyttal Nedsat leukocyttal
English: Common Leucocytes decreased
Danish: Nedsat hæmoglobin Almindelig Nedsat leukocytttal Nedsat neutrofiltal
English: After reconstitution (see section 6.6), each vial contains 25 mg/ml of pemetrexed.
Danish: Efter rekonstitution indeholder hvert hætteglas 25 mg/ml pemetrexed.
English: For the purpose of this table a cut off of 5% was used for inclusion of all events where the reporter considered a possible relationship to pemetrexed.
Danish: Til denne tabel blev der anvendt en afskæringsværdi på 5 % til inkludering af alle hændelser, hvor indberetteren anså, at bivirkningen muligvis var forbundet med pemetrexed.
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Danish: Resumé af bivirkninger i tabelform
English: Lower limb swelling with pain and redness Increased urine output
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværende data) Hævelse i de nedre lemmer med smerter og rødme Øget urinproduktion
English: Inflammation of the lining of the oesophagus (gullet) has been experienced with pemetrexed / radiation therapy.
Danish: Betændelse ispiserørets overfladeerforekommetmedpemetrexed/strålebehandling.
English: Acute renal failure
Danish: Ubrudt hætteglas
English: Breast-feeding
Danish: ANC-nadir
English: CTC a Grade
Danish: Alle grader
English: Fatigue (tiredness)
Danish: Amning (se pkt.
English: cisplatin (N = 222)
Danish: (N = 222)
English: Haemoglobin decreased
Danish: Nedsat hæmoglobin
English: The efficacy analyses using PQ population are consistent with the analyses for the ITT population and support the non-inferiority of AC versus GC.
Danish: EffektanalysermedbrugafPQ-populationen erkonsistente medanalyserforITT-populationenog understøtternon-inferiøriteten afAC versusGC.
English: Taste change
Danish: Smagsforstyrrelser
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution and dilution Read the package leaflet before use.
Danish: Virkning og sikkerhed blev målt fra tidspunktet for randomisering efter gennemført 1. linje-(induktions) behandling.
English: - if you are breast-feeding; you must discontinue breast-feeding during treatment with
Danish: hvis De ammer, skal De afbryde amningen under behandlingen med Pemetrexed Pfizer.
English: MA (EU) number
Danish: EU-nummer
English: (Invented) name Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform Administration Emballage Indhold
English: Pack size
Danish: Pakningsstørrelse vævsklæber
English: This summary was last updated in 01-2013.
Danish: Dette sammendrag blev sidst ajourført i 01-2013.
English: 106 volunteers completed the study and were included in the results.
Danish: 106 forsøgspersoner gennemførte undersøgelsen og indgik i resultaterne.
English: This is a summary of the European public assessment report (EPAR) for Amyvid.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Amyvid.
English: Other information about Amyvid
Danish: Andre oplysninger om Amyvid
English: The European Commission granted a marketing authorisation valid throughout the European Union for Amyvid on 14 January 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Amyvid den 14 januar 2013.
English: Amyvid is for diagnostic use only.
Danish: Amyvid er udelukkende til diagnostisk brug.
English: The most common side effect with Amyvid (seen in between 1 and 10 patients in 100) is headache.
Danish: Den hyppigste bivirkning ved Amyvid (som optræder hos mellem 1 og 10 ud af 100 patienter) er hovedpine.
English: A main study was conducted in 226 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.
Danish: Der blev udført en hovedundersøgelse hos 226 frivillige personer, der var opdelt i to grupper: en gruppe unge raske personer og en gruppe patienter, der var højt oppe i årene og havde givet deres samtykke til at få foretaget obduktion, når de døde.
English: The effects of Amyvid were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Amyvid blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: Doctors will therefore need to use the scans in conjunction with clinical evaluation.
Danish: Lægerne bruger derfor scanningerne i kombination med en klinisk vurdering.
English: When the results of the autopsies were compared with the PET scans, the scans were shown to have a sensitivity of 92% and a specificity of 100%.
Danish: Når resultaterne af obduktionen blev sammenlignet med PETscanningerne, viste scanningerne sig at have en følsomhed på 92 % og en specificitet på 100 %.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Amyvid.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Amyvid.
English: The type of scan used with Amyvid is called positron emission tomography (PET).
Danish: Den type scanning, der anvendes med Amyvid, er positronemissionstomografi (PET).
English: β-amyloid plaques are deposits sometimes present in the brains of people with dementias (such as Alzheimer's disease, Lewy body dementia and Parkinson's disease dementia) and some elderly people with no symptoms.
Danish: β-amyloidplak er aflejringer, der undertiden findes i hjernen hos personer med demens (såsom Alzheimers sygdom, Lewy body demens og demens ved Parkinsons sygdom) og hos visse ældre uden symptomer.
English: Amyvid delivers a very low amount of radiation with minimal risk of cancer or any hereditary abnormalities.
Danish: Amyvid afgiver en meget lille mængde stråling med minimal risiko for kræft eller arvelige defekter.
English: Patients should discuss the results of their PET scan with their doctor.
Danish: Patienterne bør drøfte resultaterne af PET-scanningen med lægen.
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 neurodegenerative diseases.
Danish: Dette anses for at være en væsentlig forbedring i diagnosticeringen af patienter med hukommelsesproblemer, der undersøges for Alzheimers sygdom og andre neurodegenerative sygdomme.
English: The Committee recommended that Amyvid be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Amyvid.
English: The company that markets Amyvid will provide access to a training course for all nuclear medicine physicians expected to use this product in the EU in order to ensure accurate and reliable reading of the PET scan images.
Danish: Den virksomhed, der markedsfører Amyvid, vil tilbyde et kursus til alle nuklearmedicinske læger, der forventes at anvende dette produkt i EU, med henblik på at sikre en nøjagtig og pålidelig vurdering af PET-scanningerne.
English: What measures are being taken to ensure the safe use of Amyvid?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Amyvid?