FrancophonIA/ELRC3.0 huggingface dataset:
English: • Review of the PET reading criteria, including method of image review, criteria for interpretation, and images demonstrating the binary read methodology.
Maltese: • Analiżi tal-kriterji tal-interpretazzjoni ta' PET, inkluż il-metodu tal-analiżi tal-immaġini, kriterji ta' interpretazzjoni, u stampi li juru l-metodoloġija binarja tal-interpretazzjoni.
English: Key: Grey matter - f frontal and ac anterior cingulate, pc posterior cingulate and precuneus, lt lateral temporal, tp temporo-parietal and in insula and and s striatum.
Maltese: Indiċi: Materja l-griża - ċingulat f ta' quddiem u ac anterjuri, pc ċingulat posterjuri u precuneus, lt temporali laterali, tp temporo-parjetali u in insula u s striatum.
English: Based on the majority read, the positive and negative likelihood ratios were 2.04 and 0.52 respectively.
Maltese: Ibbażat fuq il-maġġoranza tal-interpretazzjoni, ilproporzjonijiet ta' probabbilità ta' riżultat pożittiv u negattiv kienu ta' 2.04 u 0.52, rispettivament.
English: Muscle tightness Musculoskeletal pain
Maltese: Uġigħ fid-dahar Riġidità fil-muskoli Uġigħ muskulo-skeletali
English: Megabecquerel (MBq) is the unit used to measure radioactivity.
Maltese: Megabecquerel (MBq) hija l-unità użata biex tkejjel radjuattività.
English: Values were calculated assuming emptying of the urinary bladder at 3.5-hour intervals and human biodistribution data using OLINDA/EXM software.
Maltese: Valuri kienu kkalkolati billi wieħed jassumi tbattil tal-bużżieqa tal-awrina f'intervalli ta' 3.5 sigħat u dejta ta' bijodistribuzzjoni umana permezz tas-softwer OLINDA/EXM.
English: In vivo, flutemetamol (18F)
Maltese: Is-sustanza attiva hi flutemetamol (18F).
English: It might be helpful to estimate the effective dose that was applied.
Maltese: Jista' jkun utli li ssir stima tad-doża effettiva li ġiet applikata.
English: 400 MBq at reference time.
Maltese: MBq fid-data u ħin ta' referenza .
English: VIZAMYL 400 MBq/mL solution for injection flutemetamol (18F)
Maltese: VIZAMYL 400 MBq/mL soluzzjoni għal injezzjoni flutemetamol (18F)
English: This medicinal product contains up to 41 mg (or 1.8 mmol) sodium per dose,equivalent to 2 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Dan il-prodott mediċinali fih sa 41 mg (jew 1.8 mmol) ta' sodju f'kull doża ekwivalenti għal 2% talkonsum massimu ta' kuljum ta' 2 g ta' sodju rakkomandat għal adult mill-WHO.
English: • Information on amyloid pathology in Alzheimer Disease; relevant information on VIZAMYL as an β-amyloid PET tracer, including the approved indication according to the SmPC, limitations of VIZAMYL use, interpretation errors, safety information and the results of clinical trials informing on the diagnostic use of VIZAMYL.
Maltese: • Informazzjoni dwar patoloġija amyloid fil-Marda ta' Alzheimer; informazzjoni rilevanti dwar Vizamyl bħala traċċatur PET ta' β-amyloid, inkluż l-indikazzjoni approvata skont l-SmPC, limitazzjonijiet tal-użu ta' Vizamyl, żbalji ta' interpretazzjoni, informazzjoni dwar is-sigurtà u rriżultati tal-provi kliniċi li jagħtu tagħrif dwar l-użu dijanjostiku ta' Vizamyl.
English: VIZAMYL contains a maximum of 41 mg of sodium (main component of cooking/table salt) in each dose.
Maltese: VIZAMYL fih massimu ta' 41 mg ta' sodium (komponent ewlieni tat-tisjir/melħ tal-mejda) kull doża.
English: If using an intravenous line, follow the injection with an intravenous flush of 5 mL to 15 mL of sterile sodium chloride 9 mg/mL (0.9%) solution for injection to ensure full delivery of the dose.
Maltese: Jekk tuża linja intravenuża, segwi l-injezzjoni bi flaxxjatura ġol-vini ta' 5 mL sa 15 mL ta' sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni biex tkun ċert li qed tagħti doża sħiħa.
English: VIZAMYL contains alcohol (ethanol) and sodium VIZAMYL contains alcohol (ethanol).
Maltese: VIZAMYL fih alkoħol (ethanol) u sodium
English: SHIELD LABEL / 15 mL
Maltese: TIKKETTA TAL-PROTEZZJONI / 15 mL
English: This is about the same as 14 mL of beer or 6 mL of wine.
Maltese: Dan huwa bejn wieħed u ieħor listess bħal 14 mL birra jew 6 mL inbid.
English: Renal/hepatic impairment The pharmacokinetics in patients with renal or hepatic impairment have not been characterised.
Maltese: Indeboliment renali/epatiku Il-farmakokinetika f'pazjenti b'indeboliment renali jew epatiku ma ġietx ikkaratterizzata.
English: The following adverse reactions are listed in the Table 1 below:
Maltese: Ir-reazzjonijiet avversi li ġejjin huma elenkati fit-Tabella 1 hawn taħt:
English: For an administered activity of 185 MBq the typical radiation doses delivered to the critical organs, gallbladder, urinary bladder wall, upper large intestine wall, lower large intestine wall, small intestine and liver are 53.1 mGy, 26.8 mGy, 21.6 mGy, 7.8 mGy, 18.9 mGy and 10.5 mGy, respectively.
Maltese: Għal attività amministrata ta' 185 MBq, dożi tipiċi ta' radjazzjoni mogħtija lill-organi kritiċi, marrara, r-rita tal-bużżieqa tal-awrina, ir-rita tal-parti ta' fuq tal-musrana l-kbira, ir-rita tal-parti t'isfel talmusrana l-kbira, il-musrana ż-żgħira u l-fwied huma 53.1 mGy, 26.8 mGy, 21.6 mGy, 7.8 mGy, 18.9 mGy u 10.
English: Elimination of flutemetamol (18F) is approximately 37% renal and 52% hepatobiliary.
Maltese: Ittneħħija ta' flutemetamol (18F) hija madwar 37% mill-kliewi u 52% epatobiljari.
English: See special handling precautions in section 6.6.
Maltese: Għal prekawzjonijiet fir-rigward ta' periklu ambjentali ara sezzjoni 6.6.
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.
Maltese: Kunjett wieħed li jesa 10ml b'ħafna dożi fih 1 sa 10 mL ta' soluzzjoni, li jikkorrespondi għal 400 sa 4000 MBq fid-data u ħin ta' referenza.
English: PET images should be read using a Sokoloff, Rainbow or Spectrum colour scale.
Maltese: Immaġnijiet PET għandhom jinqraw bl-użu ta' skala ta' kuluri Sokoloff, Rainbow jew Spectrum.
English: The apparent elimination half-life is 4.5 hours whereas the radioactive half-life of flutemetamol (18F) is 110 minutes.
Maltese: Il-half-life ta' eliminazzjoni evidenti hija 4.5 sigħat filwaqt li l-half-life radjuattiva ta' flutemetamol (18F) hija
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%).
Maltese: Fit-68 pazjent, PET blinded b'mod visiv sal-livell tal-pazjent li kien interpretat minn 5 interpretaturi blinded irriżulta f'maġġoranza ta' sensittività tal-interpretazzjoni ta' 86% (CI ta' 95%: 72% sa 95%) u speċifiċità ta' 92% (CI ta' 95%: 74% sa 99%).
English: INFORMATION IN BRAILLE Justification for not including Braille accepted 17.
Maltese: Il-ġustifikazzjoni biex ma jkunx inkluż il-Braille hija aċċettata 17.
English: In a re-reading study that increased the patient population of the pivotal study to include 38 additional autopsied patients (i.e., 106 in total), sensitivity and specificity for detection of moderate-frequent βamyloid neuritic plaque density in the primary analysis were 91% (95% CI: 82% to 96%) and 90% (95% CI: 74% to 98%), respectively, based on the majority read (i.e., the image interpretation reached by at least 3 of the 5 readers after electronic training).
Maltese: Fi studju ta' interpretazzjoni mill-ġdid li żied il-popolazzjoni ta' pazjenti tal-istudju pivitali biex jinkludi 38 pazjent ieħor li saritilhom awtopsja (jiġifieri, total ta' 106), is-sensittività u l-ispeċifiċità biex tiġi osservata densità ta' plakka newritika β-amyloid frekwenti b'mod moderat fl-analiżi primarja kienu ta' 91 % (CI ta' 95%: 82% sa 96%) u 90% (CI ta' 95%: 74% sa 98%), rispettivament ibbażat fuq il-maġġoranza ta' interpretazzjoni (jiġifieri, l-interpretazzjoni tal-immaġni ntlaħqet mill-inqas minn 3 mill-5 interpretaturi wara taħriġ elettroniku).
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%).
Maltese: F'analiżi sekondarja li użat standard ta' verità bbażat fuq ir-reġjun ta' involviment massimu ta' plakka newritika fit-3 reġjuni neokortikali oriġinarjament rakkomandati minn CERAD. is-sensittività kienet ta' 92% (CI ta' 95%: 83% sa 97%), u l-ispeċifiċità kienet ta' 88% (CI ta 95%: 71.0% sa 97%).
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.
Maltese: Sensittività u speċifiċità biex tiġi stmata d-depożizzjoni β-amyloid ta' flutemetamol (18F) ġew investigati aktar fi studju addizzjonali ieħor, li fih sett differenti ta' 5 interpretaturi blinded imħarrġa b'mod elettroniku interpretaw l-immaġini mill-istess 68 pazjent segwiti sal-awtopsja fl-istudju pivitali.
English: GE International Inc. Tel: +371 780 7086
Maltese: Tel: +371 780 7086
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 %).
Maltese: AD f'81 konvertit kienet ta' 64% (CI ta' 95%: 54 sa 75%), l-ispeċifiċità f'143 li ma kkonvertewx kienet ta' 69% (CI ta' 95%: 60% sa 76%).
English: The adult effective dose resulting from the administration of a maximal recommended activity of 185 MBq dose for an adult weighing 70 kg is approximately 5.9 mSv.
Maltese: Id-doża effettiva għall-adulti li tirriżulta mill- amministrazzjoni ta' attività rakkomandata massimali ta' doża ta' 185 MBq għal adult li jiżen 70 kg hija madwar5.
English: VIZAMYL is supplied in 10-mL and 15-mL Type I glass vials with halobutyl rubber stoppers and aluminium seals.
Maltese: VIZAMYL huwa fornut f'kunjetti tal-ħġieġ Tip I ta' 10 mL u 15 mL b'tappijiet tal-lastku halobutyl u siġilli tal-aluminju.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1
English: At the 36-month follow-up, 81 (35%) converted to clinical AD. Of the 97 aMCI patients who had a positive PET scan and at least one committee assessment, 52 (54%) were classified clinically as converted to clinical AD after 36 months compared to 29 (23%) of 127 who had a negative scan and at least one committee assessment.
Maltese: Mis97 pazjent b'aMCI li kellhom skan PET pożittiv u mill-inqas valutazzjoni waħda mill-kumitat, 52 (54%) kienu kklassifikati klinikament bħala konvertiti għal AD klinika wara 36 xahar meta mqabbla ma' 29 (23%) minn 127 li kellhom skan negattiv u mill-inqas valutazzjoni waħda mill-kumitat.
English: Fertility No studies on fertility have been performed.
Maltese: Fertilità Ma sar l-ebda studju fuq il-fertilità.
English: There is no relevant use of VIZAMYL in the paediatric population.
Maltese: Ma hemm l-ebda użu rilevanti ta' VIZAMYL fil-popolazzjoni pedjatrika.
English: Advanced Accelerator Applications S.r.l.
Maltese: Advanced Accelerator Applications S.r.l. Via Ribes 5
English: NO-0485 Oslo Norway
Maltese: Oslo In-Norveġja
English: Elimination and half-Life Flutemetamol (18F) is rapidly cleared from circulation (through the intestinal and urinary tracts).
Maltese: Eliminazzjoni u half-Life Flutemetamol (18F) jitneħħa malajr miċ-ċirkolazzjoni (mill-passaġġi intestinali u urinarji).
English: Fluorine (18F) decays to stable oxygen (18O) with a half-life of approximately 110 minutes by emitting a positron radiation of 634 keV, followed by photonic annihilation radiation of 511 keV.
Maltese: Fluworin (18F) jiddegrada għal ossiġnu stabbli (18O) b'half-life ta' madwar 110 minuti billi jitfa radjazzjoni ta' positron ta' 634 keV, segwit minn radjazzjoni fototonika ta' distruzzjoni ta' 511 keV. Eċċipjenti b'effett magħruf
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
Maltese: Liège, Il-Belġju MAP Medical Technologies, Saukonpaadenranta 2, 00180 Helsinki, Il-Finlandja ITEL Telecomunicazioni, Via Labriola (ZI, Lotto 40), 70037, Ruvo di Puglia, L-Italja Helmholtz-Zentrum Dresden-Rossendorf e.V., Zentrum für Radiopharmazeutische Tumorforschung, Bautzner Landstraβe 400, 01328 Dresden, Il-Ġermanja
English: When in doubt, it is important to consult the nuclear medicine doctor who will supervise the procedure.
Maltese: Meta jkun hemm dubju, huwa importanti li tikkonsulta t-tabib tal-mediċina nukleari li se jissorvelja l-proċedura.
English: Any clinically relevant mutagenic potential is therefore considered highly unlikely.
Maltese: Għalhekk huwa meqjus ferm improbabbli li jkun hemm xi potenzjal mutaġeniku klinikament rilevanti.
English: The pharmacokinetics of flutemetamol (18F) in patients with renal or hepatic impairment has not been characterised.
Maltese: Il-farmakokinetika ta' flutemetamol (18F) f'pazjenti b'indeboliment renali jew epatiku ma ġietx ikkaratterizzata.
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.
Maltese: Kunjett wieħed li jesa 15ml b'ħafna dożi fih 1 sa 15 mL ta' soluzzjoni, li jikkorrespondi għal 400 sa 6000
English: Children and adolescents VIZAMYL is not intended for use in children and adolescents below the age of 18 years old.
Maltese: Tfal u adolexxenti VIZAMYL mhux intenzjonat għall-użu fit-tfal u adolexxenti taħt l-età ta' 18-il sena .
English: Uncommon - may affect up to 1 in 100 people.
Maltese: Mhux komuni - jistgħu jaffettwaw sa 1 minn kull 100 persuna.
English: Date of first authorisation: 22 August 2014 Date of latest renewal: 25 July 2019
Maltese: Data taġ-tiġdid tal-awtorizzazzjoni: 25 Lulju 2019
English: Table 2 Estimated radiation absorbed doses from intravenous injection of VIZAMYL (adults)
Maltese: Tabella 2 Id-dożi tar-radjazzjoni assorbiti stmati minn injezzjoni ġol-vini ta' VIZAMYL (adulti)
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).
Maltese: Ir-reazzjonijiet avversi li ġejjin jistgħu jseħħu bħala sintomi u sinjali ta' reazzjoni ta' sensittività eċċessiva għal VIZAMYL jew xi wieħed mill-eċċipjenti tiegħu (ara sezzjoni 6.1): nefħa fl-għajn/fil wiċċ, sfurija, qtugħ ta' nifs, irritazzjoni fil-griżmejn, remettar, raxx, ħakk, tiġbid fil-ġilda, tagħfis fissider (ara wkoll sezzjoni 4.4).
English: Flutemetamol (18F) binds to β-amyloid neuritic plaques in the brain.
Maltese: Flutemetamol (18F) jeħel ma' plakek newritiċi β-amyloid fil-moħħ.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT xx.x mL YYYY MBq at reference time
Maltese: INDIVIDWALI xx.x mL SSSS MBq fil-ħin ta' referenza
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)
Maltese: Dehra temporo-parietal inkluż Insula (in, analiżi assjali u tp-in, analiżi koronali) Lobi laterali temporali (lt, analiżi assjali) Reġjun strijatali (s, reviżjoni assjali)
English: back pain feeling hot or cold increased breathing rate pain at the injection site heart pounding (palpitations) pain in muscles or bones shaking movements (tremor) puffy and swollen skin fever over breathing (hyperventilation) change in the way you taste things a spinning feeling (vertigo) reduced sense of touch or sensation feeling tired or weak inability to get or maintain an erection indigestion, stomach ache or sore mouth vomiting decreased feeling or sensitivity especially in your skin or your face increase in “blood lactate dehydrogenase” or “neutrophils” in blood tests skin tightness
Maltese: skumdita' fis-sider livell baxx ta' zokkor fid-demm (sintomu: ġuħ, uġigħ ta' ras) uġigħ fid-dahar tħoss is-sħana jew il-kesħa żieda fir-rata tan-nifs uġigħ fis-sit tal-injezzjoni taħbit qawwi tal-qalb (palpitazzjonijiet) uġigħ fil-muskoli jew fl-għadam rogħda ġilda minfuħa deni teħid eċċessiv tan-nifs (iperventilazzjoni) bidla fil-mod kif ittiehem l-affarijiet. sensazzjoni li qed iddur (vertigo) tnaqqis fis-sens tal-mess jew tas-sensazzjoni tħossok għajjien/a jew dgħajjef/dgħajfa ma tkunx tista' tikseb jew iżżomm erezzjoni indiġestjoni, uġigħ fl-istonku jew uġigħ fil-ħalq rimettar tnaqqis ta' sensazzjoni jew sensittività speċjalment fil-ġilda tiegħek jew f'wiċċek żieda ta' “lactate dehydrogenase fid-demm” jew “newtrofili” fit-testijiet tad-demm ġilda miġbuda
English: For the limitations of use in patients with mild cognitive impairment (MCI), see section 5.1.
Maltese: Għal-limitazzjonijiet fl-użu f'pazjenti b'indeboliment konjittiv ħafif (MCI), ara sezzjoni 5.1
English: VIZAMYL is a radiopharmaceutical medicinal product indicated for Positron Emission Tomography (PET) imaging of β-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive impairment.
Maltese: VIZAMYL huwa prodott mediċinali radjufarmaċewtiku indikat għal sken ta' Tomografija ta' Emissjoni ta' Positron (PET) ta' densità tal-plakka newritika β-amyloid fl-imħuħ ta' pazjenti adulti li għandhom indeboliment konjittiv li qed jiġu evalwati għall-marda tal-Alzheimer (AD) u kawżi oħrajn ta' indeboliment konjittiv.
English: After 20 minutes approximately 20 % of the active compound flutemetamol (18F) remains in the circulation,
Maltese: Wara 20 minuta, madwar 20% tal-kompost attiv flutemetamol (18F) jibqa' fiċ-ċirkolazzjoni, u jinżel għal 10% wara
English: Summary of the safety profile The overall safety profile of VIZAMYL is based on data from its administrations to 831 subjects.
Maltese: Il-profil tas-sigurtà ġenerali ta' VIZAMYL huwa bbażat fuq dejta mill-amministrazzjonijiet tagħha lil 831 individwu.
English: Flutemetamol (18F) was positive in in vitro genotoxicity tests in bacteria and mammalian cells but negative in three different in vivo studies with sufficiently high doses.
Maltese: Flutemetamol (18F) kien pożittiv f'testijiet ta' ġenotossiċità in vitro f'batterji u ċelloli mammarjani iżda kien negattiv fi tliet studjiin vivo b'dożi għoljin biżżejjed.
English: Flutemetamol (18F) is distributed throughout the body within several minutes of injection.
Maltese: Flutemetamol (18F) huwa distribwit fil-ġisem kollu ftit minuti wara l-injezzjoni.
English: Injection of VIZAMYL through a short intravenous catheter (approximately 12.5 cm or less) minimises the potential for adsorption of the active substance to the catheter.
Maltese: L-injezzjoni ta' VIZAMYL permezz ta' katiter qasir ġol-vina (twil madwar 12.5 cm jew inqas) tnaqqas il-potenzjal għall-adsorbiment tas-sustanza attiva ġol-katiter.
English: In vitro, flutemetamol (18F) binds to β-amyloid neuritic plaques in the brain, with negligible binding to neurofibrillary tangles.
Maltese: In vivo, flutemetamol (18F) jista' jiskopri plakek β-amyloid diffużi meta jkunu frekwenti.
English: For precautions with respect to environmental hazard see section 6.6.
Maltese: Ara prekawzjonijiet tal-immaniġġar speċjali fis-sezzjoni 6.6.
English: Magyarország Radizone Diagnost-X Kft. Tel: +36 1 787-5720
Maltese: Kft. Tel: +36 1 787 5720
English: It is given to adults with memory problems before they undergo a type of brain scan called a positron-emission tomography (PET) scan.
Maltese: Jingħata lil adulti bi problemi tal-memorja qabel jagħmlu tip ta' skan tal-moħħ, imsejjaħ skan ta' tomografija ta' emissjoni ta' positroni (PET).
English: The design of this study does not allow estimating the risk of MCI progression to clinical AD.
Maltese: Id-disinn ta' dan l-istudju ma jippermettix li jiġi stmat ir-riskju ta' progressjoni ta' MCI għal AD klinika.
English: Each mL of solution contains flutemetamol (18F) 400 MBq at reference date and time.
Maltese: Kull mL tas-soluzzjoni fih flutemetamol (18F) 400 MBq fil-ħin ta' referenza.
English: A brain scan is usually taken 90 minutes after VIZAMYL is given.
Maltese: Normalment jittieħed skan tal-moħħ 90 minuta wara li jingħata VIZAMYL.
English: Nausea
Maltese: Marrara
English: Breasts
Maltese: Rimettar
English: A negative scan indicates none or a sparse density of cortical β-amyloid neuritic plaques.
Maltese: L-immaġini negattivi juru disinn sulkali/ġirali fil materja l-bajda.
English: Dyspnoea Hyperventilation Throat irritation
Maltese: Iperventilazzjoni Irritazzjoni fil-griżmejn
English: The usual amount recommended for an adult is 185 MBq.
Maltese: L-ammont tas-soltu rakkomandat għall-adulti huwa 185 MBq.
English: EXPIRY DATE EXP: reference time + 8h
Maltese: ħin ta' riferenza + 8sigħat
English: Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators.
Maltese: Il-proċeduri għall-għoti għandhom isiru b'mod li jnaqqsu r-riskju ta' kontaminazzjoni tal-prodott mediċinali u irradjazzjoni tal-operaturi.
English: The recommended activity for an adult is 185 MBq of flutemetamol (18F) administered intravenously
Maltese: L-attività rakkomandata għal adult hi 185 MBq ta' flutemetamol (18F) mogħti ġol-vina (bħala bolus f'madwar 40 sekonda).
English: Pharmacotherapeutic group: diagnostic radiopharmaceutical, central nervous system, ATC code: V09AX04
Maltese: Kategorija farmakoterapewtika: radjufarmaċewtiku dijanjostiku, sistema ċentrali nervuża.
English: Ear and labyrinth disorders
Maltese: Il-bqija tal-organi
English: No animal studies have been conducted to investigate the reproductive effects of flutemetamol (18F) (see section 5.3).
Maltese: Ma sar l-ebda studju fuq l-annimali biex jinvestigaw l-effetti riproduttivi ta' flutemetamol (18F) (ara sezzjoni 5.3).
English: The dose is administered by intravenous bolus injection within approximately 40 seconds.
Maltese: Id-doża tingħata b'injezzjoni bolus ġol-vini fuq madwar 40 sekonda.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT xx.x m L YYYY MBq at reference time.
Maltese: INDIVIDWALI xx.x m L SSSS MBq fil-ħin ta' referenza
English: 47014 Meldola (FC) Italy
Maltese: Meldola (FC)
English: This radiopharmaceutical will deliver low amounts of ionising radiation, which is associated with very low risk of cancer and hereditary abnormalities (passing on faulty genes).
Maltese: Dan ir-radjufarmaċewtiku se jwassal ammonti baxxi ta' radjazzjoni jonizzanti, li hija assoċjata ma' riskju żgħir ħafna ta' kanċer u abnormalitajiet ereditarji (il-mogħdija ta' ġeni difettużi).
English: Eight hours from the reference date and time.
Maltese: Tmien sigħat mid-data u ħin ta' referenza .
English: EXPIRY DATE EXP: reference time +8 h
Maltese: ħin ta' riferenza +8 sigħat
English: 185 MBq the typical radiation dose to the target organ (brain) is 2.0 mGy.
Maltese: Għal attività amministrata ta' 185 MBq, id-doża tipika ta' radjazzjoni għall-organu fil-mira (il-moħħ) hija 2.0 mGy.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/941/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/14/941/001