FrancophonIA/ELRC3.0 huggingface dataset:
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.
Maltese: Mill-età ta' 10 snin id-doża hija 0.5 ml; tfal iżgħar ta' bejn sitt xhur u disa' snin jirċievu 0.25 ml kull doża.
English: Pandemrix was originally authorised under ‘exceptional circumstances', because, for scientific reasons, limited information was available at the time of approval.
Maltese: Pandemrix oriġinarjament kien awtorizzat taħt "ċirkostanzi ta' eċċezzjoni", għax, għal raġunijiet xjentifiċi, kien hemm disponibbli informazzjoni limitata fi żmien l-approvazzjoni.
English: The CHMP noted that a single dose was able to trigger immunity to a satisfactory level in adults (including the elderly), adolescents and children from 10 years of age.
Maltese: Is-CHMP innota li doża singola kienet kapaċi ttella' l-immunità għal livelli sodisfaċenti fl-adulti (inklużi lanzjani), fl-adoloxxenti u fit-tfal minn 10 snin 'il fuq.
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 12 August 2010.
Maltese: Minħabba li l-kumpanija kienet ipprovdiet l-informazzjoni addizzjonali mitluba, iċ-‘ċirkostanzi ta' eċċezzjoni' intemmew fit-12 ta' Awwissu 2010.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pandemrix on 20 May 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Pandemrix fl-20 ta' Mejju 2008.
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).
Maltese: L-effetti sekondarji l-aktar komuni b'Pandemrix (li dehru f'aktar minn doża 1 minn kull 10 tal-vaċċin) huma wġigħ ta' ras, artralġija (uġigħ fil-ġogi), mijalġija (uġigħ fil-muskoli), nefħa u wġigħ fis-sit talinjezzjoni, tertir, żieda fl-għaraq u għeja (ħedla).
English: What is Pandemrix?
Maltese: X'inhu Pandemrix?
English: • healthy elderly subjects over the age of 60 years (120 subjects in one study);
Maltese: • adulti b'saħħithom imdaħħla fiż-żmien li għandhom 'il fuq minn 60 sena (120 individwu fi studju wieħed);
English: Pandemrix is a vaccine to protect against flu caused by the A (H1N1)v 2009 virus.
Maltese: Pandemrix huwa vaċċin li jipproteġi kontra l-influwenza kkawżata mill-virus A (H1N1)v 2009.
English: Pandemrix was originally developed as a pandemic vaccine, and was used during the influenza A (H1N1) pandemic declared in June 2009.
Maltese: Pandemrix kien oriġinarjament żviluppat bħala vaċċin pandemiku, u kien intużat waqt l-influwenza pandemika A (H1N1) li ġiet iddikjarata f'Ġunju 2009.
English: When a person is given the vaccine, the immune system recognises the virus as ‘foreign' and makes antibodies against it.
Maltese: Meta persuna tingħata l-vaċċin, is-sistema immunitarja tagħraf lill-virus bħala “barrani” u tipproduċi antikorpi kontrih.
English: Pandemrix contains small amounts of haemagglutinins (proteins from the surface) of a virus called A(H1N1)v 2009.
Maltese: Pandemrix fih ammonti żgħar ta' emagglutinini (proteini mis-superfiċje) ta' virus imsejjaħ A(H1N1)v 2009.
English: The resulting ‘emulsion' is then injected.
Maltese: Imbagħad l-‘emulsjoni' li tirriżulta tiġi injettata.
English: What is the risk associated with Pandemrix?
Maltese: X'inhu r-riskju assoċjat ma' Pandemrix?
English: Why has Pandemrix been approved?
Maltese: Għaliex ġie approvat Pandemrix?
English: A risk management plan has been developed to ensure that Pandemrix is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Pandemrix jintuża bl-aktar mod sigur possibbli.
English: • healthy children (210 aged between three and 17 years, and 50 aged between six and 35 months, in three studies).
Maltese: • tfal f'saħħithom (210 tifel u tifla bejn it-tliet snin u s-17-il sena, u 50 tifel u tifla bejn is-sitt xhur u l-35 xahar, fi tliet studji).
English: In children aged between six months and nine years, 0.25 ml doses were as effective as 0.5 ml doses.
Maltese: Fit-tfal ta' bejn is-sitt xhur u d-disa' snin, id-dożi ta' 0.25 ml kienu effettivi daqs dawk ta' 0.5 ml.
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.
Maltese: L-istudji fit-tfal ippermettew ukoll li l-effikaċja tad-doża ta' 0.5 ml ta' Pandemrix titqabbel ma' dik ta' doża ta' 0.25 ml.
English: What measures are being taken to ensure the safe and effective use of Pandemrix?
Maltese: X'miżuri qed jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Pandemrix?
English: For the full list of all side effects reported with Pandemrix, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Pandemrix, ara l-fuljett ta' tagħrif.
English: The CHMP decided that Pandemrix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Pandemrix huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Following rare cases of narcolepsy (a rare sleep disorder that causes a person to fall asleep suddenly and unexpectedly) among people given the vaccine, it was concluded that Pandemrix should only be used if the recommended seasonal influenza vaccine is not available and if immunisation against H1N1 is still needed.
Maltese: Wara każijiet rari ta' narkolessija (disturb rari fl-irqad li minħabba fih persuna torqod f'daqqa waħda u mingħajr mistenni) fost nies li ngħataw il-vaċċin, ġie konkluż li Pandemrix għandu jintuża biss jekk ilvaċċin tal-influwenza staġjonali rakkomandat ma jkunx disponibbli u jekk it-tilqim kontra H1N1 ikun għadu meħtieġ.
English: The solvent contains an ‘adjuvant' (a compound containing oil) to enhance the immune response.
Maltese: Is-solvent fih ‘aġġuvant' (taħlita li fiha ż-żejt) biex itejjeb ir-rispons immunitarju.
English: How has Pandemrix been studied?
Maltese: Kif ġie studjat Pandemrix?
English: It contains parts of influenza (flu) viruses that have been inactivated.
Maltese: Fih partijiet minn virusis tal-influwenza li ġew diżattivati.
English: (Polyribosylribitol Phosphate) conjugated to Tetanus protein
Maltese: (Polyribosylribitol Phosphate) konjugat għal protein tat-Tetnu
English: MA (EU) number (Invented) name
Maltese: Numru ta' l-EU Isem inventat
English: 1 Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al3+) 2 As lower confidence limit (p= 0.95)
Maltese: 1 Assorbit fuq aluminium hydroxide, idrat (0.6 mg Al3+) 2 Bħala l-limitu ta' kunfidenza 'l baxx (p= 0.95) 3 Prodott fuq ċelluli ta' Vero
English: 50 (5 x 10) pre-filled syringes (multipack)
Maltese: 50 (5 x 10) siringi mimlijin għal-lest (multiplu)
English: --1 One dose1 (0.5 ml) contains: Diphtheria Toxoid
Maltese: --1 Doża waħda1 (0.5 ml) fiha: Tossojdi tad-Difterite
English: Bordetella pertussis antigens Pertussis Toxoid
Maltese: Antiġen ta' Bordetalla pertussis
English: Hepatitis B surface antigen5
Maltese: Antiġen superfiċjali ta' Epatite B5
English: 1 pre-filled syringe + 2 needles
Maltese: 1 siringa mimlija għal-lest + 2 labar
English: 4 Or equivalent antigenic quantity determined by a suitable immunochemical method 5 Produced in yeast Hansenula polymorpha cells by recombinant DNA technology
Maltese: Jew kwantità antiġenika ekwivalenti stabbilita b'metodu immunokimiku 5
English: 1 pre-filled syringe + 1 needle
Maltese: 1 siringa mimlija għal-lest + labra
English: Image interpretation).
Maltese: Interpretazzjoni tal-immaġini).
English: 08950 Espluges de Llobregat, Barcelona Spain
Maltese: 08950 Espluges de Llobregat, Barcelona Spanja
English: 10010 Colleretto Giacosa (TO) Italy
Maltese: 10010 Colleretto Giacosa (TO) L-Italja
English: Organ/tissue
Maltese: Organu/tessut
English: The radioactive half-life of 18F is 110 minutes.
Maltese: Il-half-life radjuattiv ta' 18F huwa 110 minuta.
English: Pack size: 1 vial.
Maltese: Daqs tal-pakkett: kunjett 1.
English: Activity: {Y} MBq in {Z}mL ToC: {DD/MM/YYYY} {hh:mm}{Time Zone} Vial No.
Maltese: {Y} MBq f'{Z}mL ToC:
English: Advanced Accelerator Applications, 62660, Beuvry, France Advanced Accelerator Applications, 01630, Saint Genis Pouilly, France
Maltese: Advanced Accelerator Applications, 62660, Beuvry, Franza Advanced Accelerator Applications, 01630, Saint Genis Pouilly, Franza
English: Amyvid contains ethanol and sodium
Maltese: Amyvid fih ethanol u sodium
English: EXPIRY DATE EXP: ToC + 7.5 h
Maltese: DATA TA' SKADENZA EXP: ToC + 7.5 sigħat
English: Adrenal
Maltese: Adrenali
English: Quality control
Maltese: Kontroll ta' kwalità
English: Date of latest renewal: 21 September 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 14 ta' Jannar 2013 Data tal-aħħar tiġdid: 21 ta 'Settembru 2017
English: Sensitivity of Amyvid scan to show the MCI conversion rate to AD in 9 converters was 66.7% (95% CI: 35-88%), specificity in 38 non-converters was 71.0% (95% CI: 55-83%) and positive likelihood ratio was 2.31 (95% CI: 1.2-4.5).
Maltese: Is-sensittività tal-Amyvid skan li turi r-rata ta' konverżjoni minn MCI għal AD f'9 konvertituri kienet ta' 66.7% (95% CI: 35-88%), l-ispeċifiċità f'38 pazjent li ma kinux konvertituri kienet ta' 71.0% (95% CI: 55-83%) u l-proporzjoni ta' probbabiltà ta' riżultat pożittiv kien ta' 2.31 (95% CI: 1.2-4.5).
English: EXPIRY DATE EXP: ToC + 10 h
Maltese: DATA TA' SKADENZA EXP: ToC + 10 sigħat
English: Muscle
Maltese: Muskoli
English: See also section 1.
Maltese: Ara wkoll sezzjoni 1.
English: Inter-rater agreement using Fleiss' kappa values ranged from 0.75 to 0.85.
Maltese: Ftehim inter-rater bl-użu ta' valuri Fleiss kappa jvarjaw minn 0.75 sa 0.85.
English: Sensitivity
Maltese: Sensittività
English: Testes
Maltese: Testikoli
English: System organ class
Maltese: Sistema tal-klassifika tal-organi Komuni
English: PETNET Solutions (Siemens Healthcare Limited), Nottingham, NG5 1PB, United Kingdom PETNET Solutions (Siemens Healthcare Limited), Northwood, HA6 2RN, United Kingdom PETNET Solutions, 91090, Lisses, France
Maltese: PETNET Solutions (Siemens Healthcare Limited), Northwood, HA6 2RN, Ir-Renju Unit PETNET Solutions, 91090, Lisses, Franza
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.
Maltese: Inqas minn 5% tarradjuattività tal-18F injettat tibqa' fid-demm 20 minuta wara l-amministrazzjoni, u inqas minn 2% hija preżenti 45 minuta wara l-amministrazzjoni.
English: Ethanol, sodium ascorbate, sodium chloride, water for injections.
Maltese: Ethanol, sodium ascorbate, sodium chloride, ilma għall-injezzjonijiet.
English: Advanced Accelerator Applications, 53121, Bonn, Germany Advanced Accelerator Applications, 10010, Colleretto Giacosa, Italy Advanced Accelerator Applications, 86077, Pozzilli, Italy Advanced Accelerator Applications, 47014, Meldola, Italy Advanced Accelerator Applications, 50100, Zaragoza, Spain Catalana de Dispensación SAU, 08950, Barcelona, Spain PETNET Solutions (Siemens Healthcare Limited), Nottingham, NG5 1PB, United Kingdom PETNET Solutions (Siemens Healthcare Limited), Northwood, HA6 2RN, United Kingdom PETNET Solutions, 91090, Lisses, France
Maltese: Advanced Accelerator Applications, 53121 Bonn, Il-Ġermanja Advanced Accelerator Applications, 10010, Colleretto Giacosa, L-Italja Advanced Accelerator Applications, 86077, Pozzilli, L-Italja Advanced Accelerator Applications, 47014, Meldola, L-Italja Advanced Accelerator Applications, 50100, Zaragoza, Spanja Catalana de Dispensación SAU, 08950, Barcelona, Spanja PETNET Solutions (Siemens Healthcare Limited), Nottingham, NG51PB, Ir-Renju Unit PETNET Solutions (Siemens Healthcare Limited), Northwood, HA6 2RN, Ir-Renju Unit PETNET Solutions, 91090, Lisses, Franza
English: EXPIRY DATE EXP {DD/MM/YYYY} {hh:mm}{Time Zone}
Maltese: DATA TA' SKADENZA EXP {JJ/XX/SSSS} {ss:mm} {Żona ta' Ħin }
English: Positive likelihood ratio 1.20 (95% CI: 0.76-1.91)
Maltese: 1.20 (95% CI: 0.76-1.91)
English: Adjunctive use of quantitative information for image interpretation:
Maltese: Użu supplimentari ta' informazzjoni kwantitattiva għall-interpretazzjoni tal-immaġini:
English: Advanced Accelerator Applications Ibérica Avda.
Maltese: Ibérica Avda.
English: Effective Dose [µSv/MBq]a a Assumed quality factor (Q) of 1 for conversion of absorbed dose to effective dose for 18F.
Maltese: Doża effettiva [µSv/MBq]a a Għal 18F ġie presuppost fattur ta' kwalità (Q) ta' 1 għall-konverżjoni mid-doża assorbita għad-doża effettiva.
English: • Information on amyloid pathology in Alzheimer Disease; relevant information on Amyvid as an β-amyloid PET tracer, including the approved indication according to the SmPC, limitations of Amyvid use, interpretation errors, safety information and the results of clinical trials informing on the diagnostic use of Amyvid
Maltese: • Informazzjoni dwar il-patoloġija tal-amyloid fil-marda tal-Alzheimer; informazzjoni rilevanti dwar Amyvid bħala PET tracer tal-β-amyloid, inkluż l-indikazzjoni approvata skont l-SmPC, limitazzjonijiet għall-użu tal-Amyvid, żbalji ta' interpretazzjoni, informazzjoni ta' sikurezza u r-riżultati tal-provi kliniċi li juru l-użu dijanjostika ta' Amyvid.
English: See leaflet for further information.
Maltese: Ara l-fuljett għall aktar informazzjoni.
English: Ovaries
Maltese: Ovarji
English: Pruritus Urticaria
Maltese: riżultat pożittiv
English: Amyvid may be diluted aseptically with sodium chloride 9 mg/mL (0.9%) solution for injection to a maximum dilution of 1:5.
Maltese: Amyvid għandu jiġi dilwit b'mod asettiku b'sodium chloride 9 mg/mL (0.9%) soluzzjoni għallinjezzjoni għal dilwizzjoni massima ta' 1:5.
English: • Review of the PET reading criteria, including method of image review, criteria for interpretation, and images demonstrating the binary read methodology
Maltese: • Reviżjoni tal-kriterji tal-qari tal-PET, inkluż il-metodu ta' analiżi tal-immaġni, kriterji talinterpretazzjoni, u immaġni li juru l-metodoloġija binarja tal-qari.
English: Advanced Accelerator Applications, 62660, Beuvry, France Advanced Accelerator Applications, 01630, Saint Genis Pouilly, France Advanced Accelerator Applications, 53121, Bonn, Germany Advanced Accelerator Applications, 10010, Colleretto Giacosa, Italy Advanced Accelerator Applications, 86077, Pozzilli, Italy Advanced Accelerator Applications, 47014, Meldola, Italy Advanced Accelerator Applications, 50100, Zaragoza, Spain Catalana de Dispensación SAU, 08950, Barcelona, Spain
Maltese: Advanced Accelerator Applications, 62660, Beuvry, Franza Advanced Accelerator Applications, 01630, Saint Genis Pouilly, Franza Advanced Accelerator Applications, 53121 Bonn, Il-Ġermanja Advanced Accelerator Applications, 10010, Colleretto Giacosa, L-Italja Advanced Accelerator Applications, 86077, Pozzilli, L-Italja Advanced Accelerator Applications, 47014, Meldola, L-Italja Advanced Accelerator Applications, 50100, Zaragoza, Spanja Catalana de Dispensación SAU, 08950, Barcelona, Spanja PETNET Solutions (Siemens Healthcare Limited), Nottingham, NG5 1PB, Ir-Renju Unit
English: The residual 18F in circulation during the 30-90 minute imaging window is principally in the form of polar 18F species.
Maltese: It-tip ta' 18F residwali fiċ-ċirkolazzjoni fil-perjodu talimmaġini ta' 30-90 minuta huwa prinċipalment fil-forma ta' 18F polari.
English: The usual amount recommended for an adult is 370 MBq.
Maltese: Id-doża normalment irrakkomandata għal adult hija 370 MBq.
English: Pharmacotherapeutic group: diagnostic radiopharmaceutical, central nervous system, ATC code:
Maltese: Kategorija farmakoterapewtika: radjufarmaċewtiku dijanjostiku, sistema ċentrali nervuża.
English: Volume: {Z} mL
Maltese: {Z} mL
English: The recommended activity for an adult weighing 70 kg is 370 MBq florbetapir (18F).
Maltese: Id-doża rrakkomandata ta' attività għal adult li jiżen 70 kg hi ta' 370 MBq florbetapir (18F) .
English: In all 59 subjects, a blinded PET reading by 5 nuclear medicine physicians resulted in a majority read sensitivity of 92% (95% CI: 78-98%) and specificity of 100% (95% CI: 80-100%).
Maltese: Fid- 59 individwu, ġiet imwettqa evalwazzjoni fl-għama fuq imaġini PET minn 5 tobba speċjalizzati fil-mediċina nukleari u din irriżultat f'maġġoranza ta' evalwazzjoni ta' sensittività ta' 92% (95% CI: 78-98%) u speċifiċità ta'
English: Other medicines and Amyvid
Maltese: Mediċini oħra u Amyvid
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.
Maltese: Mis-17 il-pazjent b'MCI li kellhom PET skan pożittiv, 6 (35%) kienu ddijanjostikati b'probabbiltà ta' AD kliniku 36 xahar wara meta mqabbla ma' 3 (10%) minn 30 li kellhom skan negattiv.
English: This medicine contains 10 vol% ethanol (alcohol), i.e. up to 790 mg per dose, equivalent to 20 mL beer or 8 mL wine.
Maltese: Din il-mediċina fiha 10 vol% ethanol (alkoħol), i.e. sa 790 mg kull doża, ekwivalenti għal 20 mL birra jew 8 mL inbid.
English: Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni ieħor
English: Ethanol, anhydrous Sodium ascorbate Sodium chloride Water for injections
Maltese: Ethanol, anidrat Sodium ascorbate Sodium chloride Ilma għall-injezzjonijiet
English: Renal and hepatic impairment
Maltese: Indeboliment renali/epatiku
English: Regional analyses show slightly higher levels of retention in the caudate, putamen and hippocampus.
Maltese: Analiżi reġjonali juru livelli kemmxejn ogħla ta' żamma filcaudate, putamen u hippocampus.
English: The pharmacokinetics of florbetapir (18F) in patients with renal or hepatic impairment have not been characterised.
Maltese: Il-farmakokinetika ta' florbetapir (18F) f'pazjenti b'indeboliment epatiku u renali ma ġietx ikkaratterizzata.
English: Amyvid contains the active substance florbetapir (18F).
Maltese: - Is-sustanza attiva hi florbetapir (18F).
English: In an in vitro bacterial reverse mutation assay (Ames test), increases in the number of revertant colonies were observed in 2 of the 5 strains exposed to florbetapir.
Maltese: F'assay in vitro dwar il-mutazzjoni reversibbli fil-batterj (Ames test), kien hemm żidiet fin-numru ta' kolonji revertanti fi tnejn mill-5 razez esposti għal florbetapir.
English: Megabecquerel (MBq) is the unit used to express radioactivity.
Maltese: Il-Megabecquerel (MBq) hija unità ta' kejl tar-radjuattività.
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).
Maltese: Il-frekwenzi huma mfissra bħala komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mit-tagħrif disponibbli).
English: Marketing Authorisation Holder Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Maltese: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, L-Olanda
English: Reconstruction should include attenuation correction with resulting transaxial pixel sizes between 2.0 and 3.0 mm.
Maltese: Ir rikostruzzjoni għandha tinkludi l-korrezzjoni b'attenwazzjoni li jifformaw pixels transassjali b'daqsijiet ta' 2.0 u 3.0mm.
English: Using non-AD cases (cognitively normal & MCI)
Maltese: (konjittività normali & MCI)
English: Osteogenic cells
Maltese: Ċelluli osteoġeniċi
English: No animal studies have been conducted to investigate the reproductive effects of florbetapir (18F) (see section 5.3).
Maltese: Ma sarux studji fl-annimali biex jiġu investigati l-effetti riproduttivi ta' florbetapir (18F) (ara sezzjoni 5.3).
English: EU/1/12/805/002 (15 mL)
Maltese: EU/1/12/805/001 (10 mL) EU/1/12/805/002 (15 mL)
English: This medicine also contains up to 37 mg sodium per dose (as sodium ascorbate and sodium chloride).
Maltese: Din il-mediċina fiha wkoll sa 37 mg ta' sodium f'kull doża (bħala sodium ascorbate u sodium chloride).
English: EU/1/12/805/004 (15 mL)
Maltese: EU/1/12/805/003 (10 mL) EU/1/12/805/004 (15 mL)
English: Using non-MCI cases (cognitively normal & clinical AD)
Maltese: (konjittività normali & AD kliniku)
English: - The other ingredients are ethanol, sodium ascorbate, sodium chloride, water for injections (see section 2 “Amyvid contains ethanol and sodium”).
Maltese: - Is-sustanzi l-oħra huma ethanol, sodium ascorbate, sodium chloride, ilma għall-injezzjonijiet (Ara sezzjoni 2 Amyvid fih ethanol u sodium).
English: The effective dose resulting from the administration of a 370 MBq dose for an adult weighing 70 kg is about 7 mSv.
Maltese: Id-doża effettiva li tirriżulta mill-għoti ta' doża ta' 370 MBq għal adult li jiżen 70 kg hi ta' madwar 7 mSv.
English: Mechanism of action Florbetapir (18F) binds to β-amyloid neuritic plaques.
Maltese: Florbetapir (18F) jeħel mal-plakki newritiċi ß-amyloid.
English: If the quantitation result is inconsistent with the initial visual interpretation:
Maltese: Jekk ir-riżultat ta' kwantitazzjoni jkun inkonsistenti mal-interpretazzjoni viżwali inizjali:
English: Thyroid
Maltese: Tirojde
English: Left to right panels show sagittal, coronal, and transverse PET image slices.
Maltese: ritratti PET b'mod saġittali, koronali u trasversali.
English: Excipients with known effect Each mL of solution contains 79 mg of ethanol and each dose contains up to 37 mg of sodium.
Maltese: Kull mL ta' soluzzjoni fih 79 mg ta' ethanol u kull doża fiha sa 37 mg ta' sodium.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/
English: Summary of the safety profile The safety profile of Amyvid is based on its administrations to 2,105 subjects in clinical trials.
Maltese: Il-profil ta' sigurtà ta' Amyvid huwa bbażat fuq l-għoti tiegħu lil 2,105 suġġetti fi provi kliniċi.
English: The potential toxicity of 28 days of repeated intravenous injections of florbetapir was tested in rats and dogs, and the NOAEL was found to be at least 25 times the maximum human dose.
Maltese: Ġiet ittestjata t-tossiċità potenzjali ta' 28 jum ta' injezzjonijiet ripetuti ġol-vini ta' florbetapir fil-firien u fil-klieb, u n-NOAEL instab li kien mill-anqas 25 darba aktar mid-doża massima fil-bniedem.
English: Amyvid should be used in conjunction with a clinical evaluation.
Maltese: Amyvid għandu jintuża flimkien ma' evalwazzjoni klinika.
English: Radioactivity in urine is present as polar metabolites of florbetapir (18F).
Maltese: Ir-radjuattività fl-awrina hija preżenti bħala metaboliti polari ta' florbetapir (18F).
English: In vivo, correlation was assessed in end-of-life patients between florbetapir (18F) uptake in cortical grey matter and the total β-amyloid burden using 4G8 anti-amyloid antibody that stains β-amyloid found in both neuritic and diffuse plaques.
Maltese: florbetapir 18F fil-materja griża tal-kortiċi u l-ammont totali ta' β-amyloid permezz ta' antikorp 4G8 anti-amyloid li jlewwen β-amyloid li jinstab kemm fil-plakki newritiċi u kemm fil-plakki mifruxin f'postijiet varji.
English: Radioactive material
Maltese: Materjal radjuattiv
English: Paediatric population For information on the use in the paediatric population, see sections 4.2 or 5.1.
Maltese: Dwar il-limitazzjonijiet fl-interpretazzjoni ta' skan pożittiv, ara sezzjonijiet 4.4 u 5.1.
English: This medicinal product contains 10 vol % ethanol (alcohol), i.e. up to 790 mg per dose, equivalent to 20 mL beer or 8 mL wine per dose.
Maltese: Dan il-prodott mediċinali fih 10 vol % ta' ethanol (alkoħol), jiġifieri sa 790 mg għal kull doża, ekwivalenti għal 20 mL ta' birra jew 8 mL ta' inbid għal kull doża.