FrancophonIA/ELRC3.0 huggingface dataset:
English: Talk to your nuclear medicine doctor before you are given VIZAMYL if you: have kidney problems have liver problems are pregnant or think you may be pregnant are breast-feeding
Danish: Tal med din nuklearmedicinske læge før VIZAMYL bliver givet til dig, hvis: du har en nyresygdom du har en leversygdom du er gravid eller tror, du er gravid du ammer
English: Resuming breast-feeding should be in agreement with the nuclear medicine doctor who will supervise the procedure.
Danish: Genoptagelsen af amningen skal ske efter aftale med den nuklearmedinske læge, som er ansvarlig for undersøgelsen.
English: Breast-feeding It is not known whether flutemetamol (18F) is excreted in human milk during breast-feeding.
Danish: Amning Det vides ikke, hvorvidt flutemetamol (18F) udskilles i brystmælken under amning.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted 17.
Danish: INFORMATION I BRAILLESKRIFT Fritaget fra krav om brailleskrift 17.
English: MAP Medical Technologies, Saukonpaadenranta 2, 00180 Helsinki, Finland ITEL Telecomunicazioni, Via Labriola (ZI, Lotto 40), 70037, Ruvo di Puglia, Italy Helmholtz-Zentrum Dresden-Rossendorf e.V., Zentrum für Radiopharmazeutische Tumorforschung, 01328 Dresden, Germany
Danish: MAP Medical Technologies, Saukonpaadenranta 2, 00180 Helsinki, Finland ITEL Telecomunicazioni, Via Labriola (ZI, Lotto 40), 70037, Ruvo di Puglia, Italien Helmholtz-Zentrum Dresden-Rossendorf e.V., Zentrum für Radiopharmazeutische Tumorforschung, 01328 Dresden, Tyskland
English: VIZAMYL is supplied in 10-mL and 15-mL Type I glass vials with halobutyl rubber stoppers and aluminium seals.
Danish: VIZAMYL leveres i 10 ml og 15 ml type I hætteglas med flergangs-doser med halobutyl gummiprop og aluminiumsforsegling.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/941/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/14/941/001
English: A region is considered positive (abnormal) if the tracer signal in cortical regions appears high (i.e., approximately at the same or higher signal intensity as adjacent white matter and greater than the grey matter-rich regions of the cerebellum).
Danish: Et område anses som positivt (unormalt), hvis signalet fra markøren i områderne i cortex synes højt (f.eks. tilnærmet eller højere intensitet end i den tilstødende hvide substans og større end i områder i cerebellum rige på grå substans).
English: This is equivalent to approximately 2% of the adult recommended maximum daily dietary intake for sodium These amounts may need to be considered for people on a low sodium diet.
Danish: Dette svarer til ca. 2% af det anbefalede maksimale daglige indtag af natrium for en voksen.
English: The activity per vial may range from 400 MBq to 4000 MBq or from 400 MBq to 6000 MBq at the reference date and time.
Danish: Aktiviteten per hætteglas ligger fra 400 MBq til 4000 MBq eller fra 400 MBq til 6000 MBq på referencedatoen og -tidspunktet.
English: They will provide you with the necessary information on the procedure.
Danish: De vil holde dig informeret om, hvad der sker.
English: The patient's head should be tilted so that the anterior commissure-posterior commissure (ACPC) plane is at right angles to the bore-axis of the PET scanner with the head positioned in a suitable head support.
Danish: Patientens hoved drejes således, at commisura anterior-commisura posterior (AC-PC)-planet er vinkelret på PET-scannerens hovedakse.
English: Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients (see section 4.4).
Danish: Aktivitetsmængden, som indgives, skal overvejes grundigt, eftersom der er risiko for en forøget strålingspåvirkning hos disse patienter (se pkt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/941/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/14/941/002
English: The majority read sensitivity and specificity were 93% (95% CI: 81% to 99%) and 84% (95% CI: 64% to 96%), respectively.
Danish: Følsomhed og specificitet af flertallet af fortolkningerne, var henholdsvis 93% (95% CI: 81% til 99%) og 84% (95% CI: 64% til 96%).
English: The biophysical basis of the white matter retention of flutemetamol (18F) in the living human brain has not been definitively explained.
Danish: Den fysiologiske mekanisme for optagelse af flutemetamol (18F) i den hvide substans i den levende menneskelige hjerne kan ikke definitivt forklares.
English: Excipients: ethanol anhydrous, polysorbate 80, sodium chloride, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate, water for injections.
Danish: Hjælpestoffer: ethanol vandfri, polysorbat 80, natriumklorid, natriumdihydrogenphosphat dihydrat, dinatriumhydrogenphosfat dodecahydrat, vand til injektion.
English: No animal studies have been conducted to investigate the reproductive effects of flutemetamol (18F) (see section 5.3).
Danish: Der er ikke udført dyreforsøg for at undersøge virkningen af flutemetamol (18F) på reproduktionsevnen (se pkt.
English: Activity: 400 MBq/mL at {hh:mm} {Time Zone} on {dd-mm-yyyy} Activity: YYYY MBq at hh:mm {Time Zone} dd-mm-yyyy
Danish: Aktivitet: 400 MBq/ml kl. {tt:mm} {tidszone} {dd-mm-åååå} Aktivitet: ÅÅÅÅ MBq kl. tt:mm {tidsone} dd-mm-åååå
English: In vivo, quantitative correlation was assessed in end-of-life patients between flutemetamol (18F) uptake in cortical grey matter and the total β-amyloid burden in autopsied samples using 4G8 anti-amyloid antibody that stains β-amyloid found in both neuritic and diffuse plaques.
Danish: In vivo hos terminale patienter, som senere gennemgik hjerneobduktion, korrelerte kvantitativt flutemetamol (18F) optag i den kortikale grå substans med β-amyloid niveauer ved brug af 4G8 anti amyloid antistof, som farver β-amyloid i både neuritisk og i diffust plak.
English: Ear and labyrinth disorders
Danish: Øre- og labyrint
English: In a secondary analysis that used a standard of truth based on the region of maximum neuritic plaque involvement in the 3 neocortical regions originally recommended by CERAD, sensitivity was 92% (95% CI: 83% to 97%), and specificity was 88% (95% CI: 71% to 97%).
Danish: I en sekundær analyse, der brugte en kontrolstandard baseret på området med maksimal neuritisk plaktæthedsinfiltrering af de tre neo-kortikale regioner, som oprindeligt anbefalet af CERAD, var følsomheden 92% (95% CI: 83% til 97%) og specificitet var 88% (95% CI: 71,0% til 97%).
English: The pharmacokinetics of flutemetamol (18F) in patients with renal or hepatic impairment has not been characterised.
Danish: Farmakokinetikken for flutemetamol (18F) hos patienter med nedsat nyre- eller leverfunktion er ikke beskrevet.
English: Flutemetamol (18F) binds to β-amyloid neuritic plaques in the brain.
Danish: Flutemetamol (18F) binder sig til neuritisk β-amyloidplak i hjernen.
English: The reader should compare the cortical grey matter signal intensity to the maximum white matter signal intensity.
Danish: Signalintensiteten i den grå substans i cortex sammenlignes med maksimal signalintensitet i den hvide substans.
English: Advanced Accelerator Applications, 47014 Meldola (FC), Italy Advanced Accelerator Applications, Technopole de l'Aube,10430 Rosières près Troyes, France Seibersdorf Labor GmbH, 2444 Seibersdorf, Austria Instituto Tecnológico PET, SA, 28040 Madrid, Spain Advanced Accelerator Applications, 50100 La Almunia de Doña Godina, Zaragoza, Spain Advanced Accelerator Applications, 10010 Colleretto Giacosa (TO) Italy Nucleis SA, 4000 Liège, Belgium
Danish: Advanced Accelerator Applications, 47014 Meldola (FC), Italien Advanced Accelerator Applications, Technopole de l'Aube,10430 Rosières près Troyes, Frankrig Seibersdorf Labor GmbH, 2444 Seibersdorf, Østrig Instituto Tecnológico PET, SA, 28040 Madrid, Spanien Advanced Accelerator Applications, 50100 La Almunia de Doña Godina, Zaragoza, Spanien Advanced Accelerator Applications, 10010 Colleretto Giacosa (TO) Italien Nucleis SA, 4000 Liège, Belgien
English: NAME OF THE MEDICINAL PRODUCT VIZAMYL 400 MBq/mL solution for injection
Danish: LÆGEMIDLETS NAVN VIZAMYL 400 MBq/ml injektionsvæske, opløsning
English: If you have any further questions on the use of this medicine, please ask your nuclear medicine doctor who supervises the procedure.
Danish: Hvis du har flere spørgsmål til brugen af dette lægemiddel, kan du spørge din nuklearmedicinske læge.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL / 15 mL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGEENHEDER HÆTTEGLASETIKET / 15 ml
English: Paediatric population For information on the use in the paediatric population, see sections 4.2 or 5.1.
Danish: 4.2 eller 5.1 for oplysninger vedrørende pædiatrisk brug.
English: In vitro, flutemetamol (18F) binds to β-amyloid neuritic plaques in the brain, with negligible binding to neurofibrillary tangles.
Danish: In vitro binder flutemetamol (18F) sig til neuritisk β-amyloidplak i hjernen med ubetydelig binding til neurofibrillære sammenfiltringer.
English: The other ingredients are sodium chloride and ethanol anhydrous, polysorbate 80, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate and water for injections, see section 2.
Danish: De andre indholdsstoffer er natriumklorid og ethanol anhydrid (se afsnit 2 under 'VIZAMYL' indeholder alkohol (ethanol) og natrium), polysorbat 80, natriumdihydrogenfosfatdihydrat, dinatriumhydrogenfosfatdodecahydrat og vand til injektion, se afsnit 2.
English: Dyspnoea Hyperventilation Throat irritation
Danish: Hyperventilation Halsirritation
English: EXPIRY DATE EXP: reference time +8 h
Danish: Udløbsdato: referencetidspunkt +8 timer
English: Data suggest that flutemetamol (18F) is able to label cored and diffuse amyloid β deposits and neuritic plaques.
Danish: Data tyder på, at flutemetamol (18F) kan binde sig både til koncentrerede og diffuse aflejringer af β-amyloid og neuritisk plak.
English: • The material should include VIZAMYL PET demonstration cases with correct PET scan interpretation by an experienced reader; VIZAMYL-PET scans for self-assessment; and a selfqualification procedure to be offered to each trainee.
Danish: • Materialet skal indeholde demonstrationstilfælde af Vizamyl PET-scanninger med korrekt tolkning af PET-billeder udført af en erfaren radiolog; Vizamyl PET-scanninger mhp.
English: EXPIRY DATE EXP: {hh:mm} {Time Zone} on {dd-mm-yyyy}
Danish: UDLØBSDATO UDLØBSDATO: {tt:mm} {tidszone} {dd-mm-åååå}
English: There is no evidence of flutemetamol (18F) binding to soluble forms of
Danish: Der er ingen tegn på, at flutemetamol (18F) binder sig til opløselige former af A-beta.
English: You must inform the nuclear medicine doctor before you are given VIZAMYL if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding.
Danish: Fortæl det til din nuklearmedicinske læge, før du får injektionen med VIZAMYL, hvis der er mulighed for, at du er gravid, hvis din menstruation er udeblevet, eller hvis du ammer.
English: VIZAMYL 400 MBq/mL solution for injection flutemetamol (18F)
Danish: VIZAMYL 400 MBq/ml opløsning til injektion flutemetamol (18F)
English: Feeling abnormal Feeling cold Infusion site pain Oedema
Danish: Følelse af at være unormal Kuldefornemmelse Smerter ved injektionsstedet, Ødem
English: Advanced Accelerator Applications, 47014 Meldola (FC), Italy Advanced Accelerator Applications, Technopole de l'Aube,10430 Rosières près Troyes, France Seibersdorf Labor GmbH, 2444 Seibersdorf, Austria Instituto Tecnológico PET, SA, 28040 Madrid, Spain Advanced Accelerator Applications, 50100 La Almunia de Doña Godina, Zaragoza, Spain Advanced Accelerator Applications, 10010 Colleretto Giacosa (TO) Italy Nucleis SA, Allée du Six-Août, 8, 4000 Liège, Belgium MAP Medical Technologies, Saukonpaadenranta 2, 00180 Helsinki, Finland ITEL Telecomunicazioni, Via Labriola (ZI, Lotto 40), 70037, Ruvo di Puglia, Italy Helmholtz-Zentrum Dresden-Rossendorf e.V., Zentrum für Radiopharmazeutische Tumorforschung, Bautzner Landstraβe 400, 01328 Dresden, Germany
Danish: Advanced Accelerator Applications, 47014 Meldola (FC), Italien Advanced Accelerator Applications, Technopole de l'Aube,10430 Rosières près Troyes, Frankrig Seibersdorf Labor GmbH, 2444 Seibersdorf, Østrig Instituto Tecnológico PET, SA, 28040 Madrid, Spanien Advanced Accelerator Applications, 50100 La Almunia de Doña Godina, Zaragoza, Spanien Advanced Accelerator Applications, 10010 Colleretto Giacosa (TO) Italien Nucleis SA, Allée du Six-Août, 8, 4000 Liège, Belgien MAP Medical Technologies, Saukonpaadenranta 2, 00180 Helsinki, Finland ITEL Telecomunicazioni, Via Labriola (ZI, Lotto 40), 70037, Ruvo di Puglia, Italien Helmholtz-Zentrum Dresden-Rossendorf e.V., Zentrum für Radiopharmazeutische Tumorforschung, Bautzner Landstraβe 400, 01328 Dresden, Tyskland
English: You should avoid any close contact with young children for 24 hours following the injection.
Danish: Du bør undgå enhver tæt kontakt med små børn 24 timer efter injektionen.
English: Renal/hepatic impairment The pharmacokinetics in patients with renal or hepatic impairment have not been characterised.
Danish: Nyre- og leversygdomme Farmakokinetikken hos patienter med nyre- eller leversygdomme er ikke beskrevet.
English: Elimination of flutemetamol (18F) is approximately 37% renal and 52% hepatobiliary.
Danish: Omkring 37 % af nedbrydningen af flutemetamol (18F) foregår i nyrerne, medens 52 % foregår i leveren og galdevejene.
English: If you get any side effects, talk to your nuclear medicine doctor.
Danish: Hvis du oplever bivirkninger, bør du tale med din nuklearmedicinske læge, sygeplejerske eller apoteket.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL / 10 mL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGEENHEDER HÆTTEGLASETIKET / 10 ml
English: In the 68 patients, a blinded visual patient-level PET read by 5 blinded readers resulted in a majority read sensitivity of 86% (95% CI: 72% to 95%) and specificity 92% (95% CI: 74% to 99%).
Danish: Hos disse 68 patienter resulterede størstedelen af de blindede visuelle fortolkninger af PET scanninger, som blev udført af fem læger, i en følsomhed i billedfortolkningen på 86% (95% CI: 72% til 95%) og en specificitet på 92% (95% CI: 74 % til ca. 99%).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution for injection contains 400 MBq of flutemetamol (18F) at reference date and time.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver ml af opløsningen indeholder 400 MBq flutemetamol (18F) på referencedatoen og -tidspunktet.
English: Axial view (first row), sagittal view (second row) and coronal view (third row) are displayed.
Danish: Aksialt snit (første række), sagittalt snit (anden række) og coronalt snit (tredje række).
English: See special handling precautions in section 6.6.
Danish: Se særlige forholdsregler ved håndtering i pkt.
English: Blood glucose decreased Blood lactate dehydrogenase increased Neutrophil count increased Respiratory rate increased
Danish: Forhøjet blodtryk Lavt blodsukker Forhøjet laktat dehydrogenase i blodet
English: The nuclear medicine doctor supervising the procedure will decide on the amount of VIZAMYL to be used in your case.
Danish: Den nuklearmedicinske læge vil afgøre, hvilken dosis VIZAMYL, der passer bedst til dig.
English: The images should be viewed in a systematic manner (Figure 1) starting at the level of pons (p) and scrolling up through The frontal lobes and anterior cingulate (f, ac, axial review) Posterior cingulate and precuneus (pc, sagittal review) Temporo-parietal aspects including Insula (in, axial review and tp-in, coronal review) Lateral temporal lobes (lt, axial review) Striatal region (s, axial review)
Danish: Se figur 1, start på ponsniveau (p), og rul opad Frontallapperne og forreste cingulum (f, ac, aksialt snit) Posterior cingulum og precuneus (pc, sagittalt snit) Temporo-parietal projektion inklusiv insula (in, aksialt snit og tp-in, koronalt snit) Laterale temporallapper (lt, aksialt snit)
English: Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.
Danish: Opbevaring af radioaktive lægemidler skal være i henhold til nationale bestemmelser vedrørende radioaktive materialer.
English: One multidose vial of 15-mL capacity contains 1 to 15 mL of solution, corresponding to 400 to 6000 MBq at reference date and time.
Danish: Ét flerdosishætteglas på 15 ml indeholder 1 til 15 ml opløsning, svarende til 400 til 6000 MBq på referencedatoen og -tidspunktet.
English: The recommended activity for an adult is 185 MBq of flutemetamol (18F) administered intravenously
Danish: Den anbefalede aktivitet for en voksen er 185 MBq flutemetamol (18F) indgivet intravenøst (som bolus i løbet af ca. 40 sekunder).
English: One multidose vial of 10-mL capacity contains 1 to 10 mL of solution, corresponding to 400 to 4000 MBq at reference date and time.
Danish: Ét flerdosishætteglas på 10 ml indeholder 1 til 10 ml opløsning, svarende til 400 til 4000 MBq på referencedatoen og -tidspunktet.
English: SPECIAL STORAGE CONDITIONS Storage in accordance with national regulation on radiopharmaceuticals.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevaring i overensstemmelse med national lovgivning for radioaktive lægemidler
English: Iterative or filtered back projection reconstruction is recommended with a slice thickness of 2 to 4 mm, and an axial matrix size of 128 x 128 with pixel sizes of approximately 2 mm. Where a postsmoothing filter may be applied with a full width half maximum (FWHM) of not more than 5 mm, the filter FWHM should be chosen to optimize the signal-to-noise ratio while preserving the sharpness of the reconstructed image.
Danish: Der anbefales iterativ eller filtreret tilbageprojektion-rekonstruktion med en snittykkelse på 2 til 4 mm og en aksial matrixstørrelse på 128 x 128 med pixelstørrelser på ca. 2 mm.
English: What is in this leaflet
Danish: Hvad VIZAMYL indeholder
English: If the integrity of the vial is compromised, the medicinal product should not be used.
Danish: Hvis hætteglasset på noget tidspunkt bliver beskadiget, må lægemidlet ikke anvendes.
English: Each mL of solution contains flutemetamol (18F) 400 MBq at reference date and time.
Danish: Hver ml af opløsningen indeholder flutemetamol (18F) 400 MBq på referencedatoen og -tidspunktet.
English: A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD. For the limitations in the interpretation of a positive scan, see sections 4.4 and 5.1.
Danish: Se afsnit 4.4 og 5.1, som omhandler begrænsninger ved tolkningen af et positivt scanningsresultat.
English: can detect β-amyloid diffuse plaques when they are frequent.
Danish: In vivo kan flutemetamol (18F) påvise diffust β-amyloidplak, når disse er hyppigt forekommende.
English: In a longitudinal study, 232 patients clinically diagnosed with amnestic mild cognitive impairment (aMCI), underwent baseline flutemetamol (18F) PET scans, and were followed for 36 months to evaluate the relationship between flutemetamol (18F) imaging and changes in diagnostic status.
Danish: Disse gennemgik flutemetamol (18F) PET-scanning og blev fulgt i 36 måneder for at vurdere forholdet mellem fund med flutemetamol (18F) og ændringer i diagnostisk status.
English: How VIZAMYL will be used
Danish: Sådan skal VIZAMYL bruges
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION VIZAMYL 400 MBq/mL solution for injection flutemetamol (18F)
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) VIZAMYL 400 MBq/ml opløsning til injektion flutemetamol (18F) i.v.
English: Withdrawals should be performed under aseptic conditions.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Udtagning fra pakken skal foregå under aseptiske forhold.
English: Lower large intestine wall Lungs
Danish: Nedre tyktarmsvæg Lunger
English: Read the package leaflet before use.
Danish: Flerdosis hætteglas Læs indlægssedlen inden brug.
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 defecation.
Danish: I tilfælde af en radioaktiv overdosis skal patienten opfordres til hyppig vandladning og defækation med henblik på at minimere strålingsdosis.
English: At 36 months, sensitivity of flutemetamol (18F) scans for predicting conversion from aMCI to AD in 81 converters was 64 % (95% CI: 54% to 75 %), specificity in 143 non-converters was 69% (95% CI: 60% to 76 %).
Danish: billeder til at forudsige udviklingen af AMCI til AD i 81 patienter med klinisk bekræftet AD 64% (95% CI: 54-75%), specificiteten i 143 patienter, som ikke udviklede klinisk AD var 69 % (95% CI: 60% til 76%).
English: However, in the case of an overdose, you would receive the appropriate treatment.
Danish: Hvis det imidlertid skulle ske, vil din nuklearmedicinske læge sørge for, at du får en passende behandling.
English: What VIZAMYL is and what it is used for What you need to know before VIZAMYL is used How VIZAMYL is used
Danish: Det skal du vide, før du bliver undersøgt med VIZAMYL Sådan skal VIZAMYL bruges Bivirkninger
English: Sensitivity and specificity to estimate β-amyloid deposition of flutemetamol (18F) was further investigated in one additional study, in which a different set of 5 electronically-trained blinded readers interpreted images from the same 68 patients followed to autopsy in the pivotal study.
Danish: I denne undersøgelse, fortolket en anden blindet gruppe på fem læger, der havde afsluttet en elektronik uddannelsesprogram for at fortolke billeder, blev PET scanninger af de samme 68 patienter fulgt op af obduktion i det pivotale studie.
English: Close contact with infants and pregnant women should be restricted during the initial 24 hours following the injection.
Danish: Tæt kontakt med spædbørn (eller gravide) skal begrænses indenfor de første 24 timer efter injektionen.
English: Ethanol, anhydrous
Danish: Ethanol uden vand
English: The following adverse reactions may occur as symptoms and signs of a hypersensitivity reaction to VIZAMYL or any of its excipients (see section 6.1): eye/face swelling, pallor, dyspnoea, throat irritation, vomiting, rash, pruritus, skin tightness, chest tightness (see also section 4.4).
Danish: 6.1): Hævede øjenomgivelser/ansigt, bleghed, dyspnø, halsirritation, opkastning, udslæt, pruritus, stram hud, bryststramhed (se også pkt.
English: You should avoid any close contact with young children and pregnant women for 24 hours following the injection.
Danish: Skal du undgå tæt kontakt med små børn og gravide kvinder i de næstfølgende 24 timer efter injektionen.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT xx.x mL YYYY MBq at reference time
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER xx.x ml
English: Multidose vial
Danish: Pakningsstørrelser
English: Muscle tightness Musculoskeletal pain
Danish: Anspændthed i musklerne Muskel- og knoglesmerter
English: Reducing head movement with tape or other flexible head restraints may be employed.
Danish: Hovedet placeres i en passende hovedstøtte, og kan evt. stabiliseres yderligere ved brug af tape eller andet som begrænser hovedets bevægelser.
English: Chest discomfort Feeling hot Asthenia Fatigue
Danish: Ubehag i brystregionen, Varmefornemmelse Asteni
English: What you need to know before VIZAMYL is used
Danish: Det skal du vide, før du bliver undersøgt med VIZAMYL
English: Upper large intestine Bladder
Danish: Skjoldbruskkirtlen Øvre tyktarm
English: A recent co-registered Computed Tomography (CT) scan or Magnetic Resonance (MR) scan of the patient to obtain a fused PET-CT or PET-MR image is recommended in cases of uncertainty about the location of grey matter and of the grey/white matter border in the PET scan (see section 4.4 Interpretation of VIZAMYL images).
Danish: I tilfælde, hvor der på PET-scanningen er usikkerhed om lokaliseringen af den grå substans eller af afgrænsningen mellem den grå og hvide substans, og hvor et nyligt samtidigt computertomografisk (CT)- eller magnetisk resonans (MR)-billede af patienten foreligger, anbefales det at gennemgå disse (se pkt.
English: 400 MBq at reference time.
Danish: ÅÅÅÅ MBq på referencetidspunktet