FrancophonIA/ELRC3.0 huggingface dataset:
English: Injection of florbetapir (18F) through a short intravenous catheter (approximately 4 cm or less) minimises the potential for adsorption of the active substance to the catheter.
Maltese: L-injezzjoni ta' florbetapir (18F) permezz ta' kateter qasir mgħoddi ġol-vini (ta' madwar 4 cm jew inqas) inaqqas ir-riskju ta' adsorbiment tas-sustanza attiva mal-kateter.
English: Interpretation of Amyvid images
Maltese: X'fih Amyvid
English: The activity per vial ranges from 1900 MBq to 28500 MBq at the ToC.
Maltese: li jikkorrispondi għal 1900 sa 28500
English: In AD subjects, as in controls, there is low retention in cerebellum and hippocampus and high retention in pons and centrum semiovale.
Maltese: F'individwi bl-AD, bħal fil-kontrolli, hemm żamma baxxa fiċ-ċerebellum u hippocampus u żamma għolja fil-pons u fiċ-centrum semiovale.
English: While they may in reality occur at lower frequencies than indicated below, the size of the source database did not allow for the assignment of frequency categories lower than the category “uncommon” (≥1/1,000 to <1/100).
Maltese: Waqt li fir-realtà jistgħu jseħħu fi frekwenzi aktar baxxi milli indikati hawn taħt, id-daqs tas-sors li minnu nġabar it-tagħrif ma kienx biżżejjed biex jiġu assenjati kategoriji ta' frekwenzi aktar baxxi minn “mhux komuni” (≥1/1,000 sa <1/100).
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: Bil-ħruġ ta' pożitronu b'radjazzjoni ta' 634 keV, Fluorine (18F) jinbidel f'ossiġenu stabbli (18O) b'halflife ta' madwar 110 minuti, segwit b'radjazzjoni fotonika ta' qerda totali ta' 511 keV.
English: Lot Vial No.
Maltese: Lot Kunjett Nr.
English: Amyvid is a radiopharmaceutical 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: Amyvid huwa radjofarmaċewtiku indikat biex toħroġ id-densità tal-plakka newritika β-amyloid permezz tat-Tomografija b'Emissjoni ta' Pożitroni (PET) fl-imħuħ ta' pazjenti adulti b'indeboliment konjittiv li qed jiġu evalwati għall-marda tal-Parkinson (AD) u għal kawżi oħra ta' indeboliment konjittiv.
English: Paediatric population There is no relevant use of Amyvid in the paediatric population.
Maltese: M'hemm l-ebda użu rilevanti ta' Amyvid fil-popolazzjoni pedjatrika.
English: Via Piero Maroncelli 40
Maltese: Advanced Accelerator Applications (Italy), S.r.l. Via Piero Maroncelli 40
English: Potential in vivo genotoxicity of florbetapir was evaluated in a rat micronucleus study.
Maltese: Il-potenzjal tal-ġenotossiċità in vivo ta' florbetapir kien evalwat fi studju mikronukleju fil-firien.
English: Amyvid is supplied in 10 mL or 15 mL clear Type I borosilicate glass vials with FluroTec-coated chlorobutyl elastomeric stoppers and aluminium seals.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Amyvid jiġi f'kunjetti ċari tal-ħġieġ tal-borosilicate ta' Tip I ta' 10 mL jew 15 mL b'tappijiet elastomeriċi tal-chlorobutyl miksija bil-FluroTec u b'siġilli tal-aluminju.
English: A 10 minute PET image should be acquired starting approximately 30 to 50 minutes after intravenous injection of Amyvid.
Maltese: Għandu jinkiseb ritratt PET ta' 10 minuti li jibda madwar 30 sa 50 minuta wara injezzjoni ġol-vini ta' Amyvid.
English: The activity per vial ranges from 800 MBq to 12000 MBq at the ToC.
Maltese: li jikkorrispondi għal 800 sa 12000
English: The estimated absorbed radiation doses to organs and tissues of an average adult patient (70 kg) per 370 MBq of florbetapir (18F) using standard methods for dosimetry calculations (ICRP Volume 30) is tabulated below.
Maltese: L-istimi ta' dożi ta' radjazzjoni assorbiti mill-organi u tessuti ta' pazjent adult medju (70 kg) għal kull 370 MBq ta' florbetapir (18F) bl-użu ta' metodi standard għall-kalkulazzjonijiet ta'
English: Figure 1: Amyvid PET cases showing examples of negative scans (top two rows) and positive scans (bottom two rows).
Maltese: Stampa 1: Każijiet PET ta' Amyvid, li juru eżempji ta' skans negattivi (iż-żewġ ringieli ta' fuq) u skans pożittivi ( iż-żewġ ringieli t'isfel).
English: The dose is administered by intravenous bolus injection, followed by a flush of sodium chloride 9 mg/mL (0.9%) solution for injection to ensure full delivery of the dose.
Maltese: 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni biex tiżgura li tkun ingħatat id-doża kollha.
English: In a chromosomal aberration in vitro study with cultured human peripheral lymphocyte cells, florbetapir did not increase the percent of cells with structural aberrations with 3 hour exposure with or without activation; however, 22 hour exposure produced an increase in structural aberrations at all tested concentrations.
Maltese: Fi studju in vitro dwar l-aberrazzjoni kromosomali b'ċelluli umani kkulturati ta' limfoċiti periferali, florbetapir ma żiedx il-persentaġġ ta' ċelluli b'anormalitajiet strutturali wara li ġew esposti għal 3 sigħat, bi jew mingħajr attivazzjoni; madankollu, meta kien hemm espożizzjoni għal 22 siegħa, kien hemm żieda fl-anormalitajiet strutturali fil-konċentrazzjonijiet kollha ttestjati.
English: Organ uptake
Maltese: Assorbiment mill-organi
English: Kidneys
Maltese: Urtikarja
English: Amyvid 800 MBq/mL solution for injection
Maltese: Amyvid 800 MBq/mL:
English: Breasts
Maltese: Beuvry
English: In a study of 47 young (<40 years) healthy volunteers, presumed to be free of β-amyloid, all Amyvid PET scans were negative.
Maltese: F'studju ta' 47 volontiera żgħar (< 40 sena) b'saħħithom, fejn wieħed jista'
English: Each mL of solution for injection contains 800 MBq of florbetapir (18F) at date and time of calibration (ToC).
Maltese: Kull mL ta' soluzzjoni għall-injezzjoni fih 800 MBq ta' florbetapir (18F) fid-data u l-ħin talkalibrazzjoni (time of calibration - ToC).
English: Amyvid 800 MBq/mL: One multidose vial of 10 mL capacity containing 1 to 10 mL of solution, corresponding to 800 to 8000 MBq at date and time of calibration.
Maltese: Kunjett wieħed b'ħafna dożi ta' volum ta' 10 mL li fih minn 1 sa 10mL ta' soluzzjoni, li jikkorrispondu għal 800 sa 8000 MBq fil-waqt u l-ħin tal-kalibrazzjoni.
English: For an administered activity of 370 MBq the typical radiation dose to the target organ (brain) is 3.7 mGy.
Maltese: Meta tingħata attività ta' 370 MBq, id-doża tipika ta' radjazzjoni għall-organu li qiegħed fil mira (il-moħħ) hi ta' 3.7 mGy.
English: One multidose vial of 15 mL capacity contains 1 to 15 mL of solution, corresponding to 800 to 12000 MBq at ToC.
Maltese: Kunjett wieħed b'ħafna dożi ta' volum ta' 15 mL li fih minn 1 sa 15mL ta' soluzzjoni, li jikkorrispondu għal 800 sa 12000
English: Diagnostic performance values of florbetapir (18F) PET are tabulated below:
Maltese: Il-valuri tal-kapaċità dijanjostika ta' florbetapir (18F) PET huma mniżżla f'forma tabulari hawn taħt:
English: One multidose vial of 15 mL capacity contains 1 to 15 mL of solution, corresponding to 1900 to 28500 MBq at ToC.
Maltese: Kunjett wieħed b'ħafna dożi ta' volum ta' 15 mL li fih minn 1 sa 15mL ta' soluzzjoni, li jikkorrispondu għal 1900 sa 28000
English: A negative scan indicates sparse or no density of cortical β-amyloid plaques.
Maltese: Skan negattiv jindika li hemm ftit li xejn jew ebda densità ta' plakki β amyloid fil-kortiċi.
English: In a longitudinal study, 142 subjects (clinically diagnosed as MCI, AD or cognitively normal) underwent baseline florbetapir (18F) PET scans, and were followed for 3 years to evaluate the relationship between Amyvid imaging and changes in diagnostic status.
Maltese: Fi studju lonġitudinali, 142 individwu (li kellhom dijanjosi klinika ta' MCL, AD jew konjittività normali) rċevew linja bażi ta' PET skans b'florbetapir (18F) u kienu mmonitorjati għal 3 snin biex tiġi evalwata r-relazzjoni bejn l-immaġini Amyvid u bidliet fl-istat dijanjostiku.
English: Of the patients who had been clinically diagnosed with MCI at study entry, 9 (19%) converted to clinical AD 36 months later.
Maltese: Mill-pazjenti li b'mod kliniku, fil bidu tal-istudju, kienu ddijanjostikati b'MCI, 9 (19%) ikkonvertu f'AD kliniku 36 xahar wara.
English: Readers should visually interpret the scan, then perform quantitation according to manufacturer's instructions, including quality checks of the quantitative process, and compare quantitation of scan with typical ranges for negative and positive scans.
Maltese: imbagħad jagħmlu kwantitazzjoni skont l-istruzzjonijiet tal-manifattur, inkluż iċċekkjar tal-kwalità tal proċess kwantitattiv, u jqabblu l-kwantitazzjoni tal-iskan ma' firxiet tipiċi għal skans pożittivi u negattivi.
English: For an administered activity of 370 MBq the typical radiation doses delivered to the critical organs, gallbladder, upper large intestine wall, lower large intestine wall, small intestine and liver are 53 mGy, 27.5 mGy, 10.3 mGy, 24.2 mGy and 23.8 mGy, respectively.
Maltese: Meta tingħata attività ta' 370 MBq, id-dożi tipiċi ta' radjazzjoni li jaslu fl-organi kritiċi, il-borża tal marrara, ir-rita tal-parti ta' fuq tal-musrana l-kbira, ir-rita tal-parti t'isfel tal-musrana l-kbira, ilmusrana ż-żgħira u l-fwied huma 53 mGy, 27.5 mGy, 10.
English: The activity of florbetapir (18F) has to be measured with an activimeter (dose calibrator) immediately prior to injection.
Maltese: L-attività ta' florbetapir (18F) għandha tiġi mkejla b'attivimetru (kalibratur tad-doża) eżatt qabel l injezzjoni.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Maltese: Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il portal elettroniku Ewropew tal-mediċini.
English: (precuneus, frontal, anterior cingulate, posterior cingulate, parietal and temporal) was measured quantitatively using standardised uptake values (SUV).
Maltese: Fi provi kliniċi li ġew mitmuma, l-assorbiment ta' florbetapir (18F) f'6 żoni kortikali tal-moħħ li kienu definiti minn qabel (precuneus, frontal, anterior, cingulate, posterior cingulate, parietal u temporal), kien imkejjel b'mod kwantitattiv bl-użu ta' standardised uptake values (SUV).
English: This medicinal product contains up to 37 mg sodium per dose.
Maltese: Dan il-prodott mediċinali fih sa 37 mg ta' sodium għal kull doża.
English: Tabulated list of adverse reactions
Maltese: Lista tar-reazzjonijiet avversi f'forma tabulari
English: Amyvid 800 MBq/mL: 1 mL of solution for injection contains 800 MBq of florbetapir (18F) at the date and time of calibration.
Maltese: Amyvid 800 MBq/mL: 1 mL ta' soluzzjoni għall-injezzjoni fih 800 MBq ta' flobetapir (18F) filwaqt u l-ħin tal-kalibrazzjoni.
English: A positive scan indicates moderate to frequent density.
Maltese: Skan pożittiv jindika ammont moderat għal frekwenti ta' densità.
English: The following side effect of Amyvid is common (may affect up to 1 in 10 people): - headache
Maltese: L-effett sekondarju ta' Amyvid li ġej huwa komuni (jista' jaffettwa minn 1 sa 10 persuni):
English: Sensitivity and specificity to detect the cortical neuritic plaque density of Amyvid was further investigated in two additional studies, in which different sets of readers interpreted images from some subjects followed to autopsy in the pivotal study.
Maltese: Is-sensittività u l-ispeċifiċità biex tiġi skoperta id-densità tal-plakka newritika fil-kortiċi ta' Amyvid ġiet investigata aktar f'żewġ studji oħra, fejn gruppi differenti ta' qarrejja interpretaw l-immaġini minn individwi wara l-awtopsja fl-istudju prinċipali.
English: Image interpretation errors in the estimation of brain β-amyloid neuritic plaque density, including false negatives, have been observed.
Maltese: Ġew osservati żbalji fl-interpretazzjoni tal-immaġini fl-istima tad-densità tal-plakki newritiċi β-amyloid fil-moħħ inklużi riżultati negattivi li rriżultaw foloz.
English: Binding studies using traditional neuropathological staining methods in post-mortem AD brains demonstrated statistically significant (p < 0.0001) correlations between in vitro florbetapir (18F) binding and β-amyloid aggregate deposition.
Maltese: Fil-presenza ta' prodotti mediċinali oħra li b'mod komuni jittieħdu minn pazjenti b'AD, studji ta' rbit in vitro ma wrew ebda interferenza fl-irbit ta' florbetapir (18F) mal-plakki β-amyloid.
English: Participating readers first evaluated a set of 96 PET scans, including 46 scans with autopsy standard of truth, using the visual qualitative read method to establish a baseline and were subsequently asked to re-evaluate the same set of scans with or without access to quantitative software information.
Maltese: Il-qarrejja li pparteċipaw ivvalutaw l-ewwel sett ta' 96 skan PET, inkluż 46 skan bi standard ta' verità tal-awtopsja, bl-użu tal metodu viżwali ta' qari kwalitattiv biex tiġi stabbilita linja bażi u sussegwentement ġew mitluba biex jevalwaw mill-ġdid l-istess sett ta' skans b'aċċess għall-informazzjoni kwantitattiva tal-programm tal kompjuter jew mingħajrha.
English: Lungs
Maltese: Pulmuni
English: In this assay, florbetapir did not increase the number of micronucleated polychromatic erythrocytes at the highest achievable dose level, 372 µg/kg/day, when given twice daily for 3 consecutive days.
Maltese: F'dan l-assay, florbetapir ma żiedx l-għadd ta' eritroċiti polikromatiċi mikronukleati fl-ogħla livell ta' doża li tista' tintlaħaq, 372 µg/kg/kuljum, meta tingħata darbtejn kuljum għal 3 ijiem konsekuttivi.
English: Talk to your nuclear medicine doctor before you are given Amyvid if you: - have kidney problems - have liver problems - are pregnant or think you may be pregnant - are breast-feeding
Maltese: Kellem lit-tabib tiegħek speċjalizzat fil-mediċina nukleari qabel ma jingħatalek Amyvid jekk inti: - għandek problemi fil-kliewi
English: An acute dose study was conducted in rats, and the NOAEL (no observable adverse effect level) was determined to be at least 100 times maximum human dose.
Maltese: Studju ta' doża qawwija sar fil-firien, u n-NOAEL (lebda livell ta' effett negattiv mhu osservabbli) instab li kien mill-inqas 100 darba aktar mid-doża massima fil-bniedem.
English: Amyvid 1900 MBq/mL solution for injection Amyvid 800 MBq/mL solution for injection florbetapir (18F)
Maltese: TAL-PRODOTT MEDIĊINALI Amyvid 800 MBq/mL soluzzjoni għall-injezzjoni florbetapir (18F)
English: For the limitations of use in patients with mild cognitive impairment (MCI), see section 5.1.
Maltese: Dwar il-limitazzjonijiet fl-użu f'pazjenti b'indeboliment konjittiv ħafif (MCI), ara sezzjoni 5
English: This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities (i.e. genetic diseases).
Maltese: Dan ir-radjufarmaċewtiku jipprovdi ammonti baxxi ta' radjazzjoni jonizzanti li hija assoċjata malinqas riskju ta' kanċer u anormalitajiet ereditarji (i.e. mard ġenetiku).
English: The organs of greatest exposure are organs of elimination, mainly the gallbladder, liver, and intestines.
Maltese: L-organi li laktar jiġu esposti huma l-organi tal-eliminazzjoni, prinċipalment il-marrara, il-fwied, u l-imsaren.
English: One multidose vial of 10 mL capacity contains 1 to 10 mL of solution, corresponding to 800 to 8000 MBq at ToC.
Maltese: Kunjett wieħed ta' daqs ta' 10 mL li jagħti aktar minn doża waħda fih minn 1 sa 10 mL ta' soluzzjoni, li jikkorrispondi għal 800 sa 8000 MBq fit-ToC.
English: Amyvid 800 MBq/mL solution for injection florbetapir (18F)
Maltese: MBq/mL soluzzjoni għall-injezzjoni florbetapir (18F)
English: A positive scan does not independently establish a diagnosis of AD or other cognitive disorder since neuritic plaque deposition in grey matter may be present in asymptomatic elderly and some neurodegenerative dementias (Alzheimer's disease, Lewy body dementia, Parkinson's disease dementia).
Maltese: Skan pożittiv ma jistabbilixxix b'mod indipendenti dijanjosi ta' AD jew ta' xi disturbi konjittivi oħra peress li l-preżenza ta' plakki newritiċi fil-materja griża jistgħu jkunu preżenti f'anzjani li m'għandhomx sintomi u f'xi dimenzji newrodeġenerattivi (Marda t'Alzheimer, dimenzja tat-tip Lewy body, dimenzja kkawżata mill-marda tal-Parkinson).
English: Dose absorbed per activity administered (µGy/MBq) Average
Maltese: (µGy/MBq) Medja
English: NAME OF THE MEDICINAL PRODUCT Amyvid 800 MBq/mL solution for injection Amyvid 1900 MBq/mL solution for injection
Maltese: Amyvid 800 MBq/mL soluzzjoni għall-injezzjoni Amyvid 1900
English: Amyvid 1900 MBq/mL solution for injection 10 hours from the ToC.
Maltese: Amyvid 1900MBq/mL:1 mL ta' soluzzjoni għall-injezzjoni fih 1900
English: Possible structural anomalies that could influence quantitation of the cerebellar region should be considered.
Maltese: Għandhom jitqiesu anomaliji strutturali possibbli li jistgħu jinfluwenzaw il-kwantitazzjoni tar-reġjun taċ ċerebellum.
English: The average cortical to cerebellar SUVR values in AD patients show continual substantial increases from time zero through 30 minutes post-administration, with only small changes thereafter up to 90 minutes post-injection.
Maltese: Il-valuri medja SUVR kortikali għall-valuri ċerebellari f'pazjenti blAD juru żidiet sostanzjali kontinwi mil-ħin żero sa 30 minuta wara l-amministrazzjoni, b'bidliet żgħar biss sa 90 minuta wara l-injezzjoni.
English: Resuming breast-feeding should be in agreement with the nuclear medicine doctor who will supervise the procedure.
Maltese: Kellem lit-tabib tiegħek speċjalizzat fil-mediċina nukleari jekk għandek xi mistoqsijiet.
English: Flushing
Maltese: Fwied
English: Elimination occurs primarily by clearance through the liver and excretion into the gallbladder and the intestines.
Maltese: L-eliminazzjoni sseħħ primarjament mill-fwied u fil-marrara u l-intestini.
English: Headache
Maltese: Disgewsja
English: Your doctor and the nuclear medicine doctor have considered that the benefit of this procedure with the radiopharmaceutical outweighs the risk of being exposed to radiation.
Maltese: Waqt it-tqala, it-tabib speċjalizzat fil-mediċina nukleari se jagħtik din il-mediċina biss jekk ilbenefiċċju mistenni huwa akbar mir-riskji.
English: Only polypropylene/HDPE syringes should be used.
Maltese: Għandhom jintużaw biss siringi tal-polypropylene/HDPE.
English: Injection site reactiona Infusion site rash aInjection site reaction includes injection site haemorrhage, injection site irritation, and injection site pain
Maltese: Il-professjonisti tal-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali mniżżla f'Appendiċi V.
English: Specificity
Maltese: Speċifiċità
English: Adjunctive use of quantitative information for image interpretation The feasibility and reliability of using CE-marked quantitative software as an adjunct to clinical qualitative interpretation was investigated in two studies using three different commercially available quantitative software packages.
Maltese: bħala suppliment għall-interpretazzjoni kwalitattiva klinika ġiet investigata f'żewġ studji li użaw tliet programmi tal-kompjuter kwantitattivi disponibbli b'mod kummerċjali.
English: No animal toxicology and safety pharmacology studies have been performed with florbetapir (18F).
Maltese: Ma sarux studji dwar it-tossikoloġija u s-sigurtà farmakoloġika fl-annimali bi florbetapir (18F).
English: Gallbladder wall
Maltese: Ħmura fil-wiċċ
English: Brain
Maltese: Kliewi
English: Lot
Maltese: Milsa
English: Multidose
Maltese: Dożi multipli
English: A brain scan is usually taken about 30 to 50 minutes after the Amyvid injection is given.
Maltese: L-iskan tal-moħħ normalment isir madwar 30 sa 50 minuta wara li tingħata l-injezzjoni ta'
English: The spatial normalisation and fit of the scan to the template should be re-checked to confirm the accuracy of the placement of the regions of interest (ROIs), search for CSF or bone within the ROI, and evaluate the potential impact of atrophy or ventriculomegaly on quantitation.
Maltese: In-normalizzazzjoni spazjali u l-qagħda tal-iskan mal-mudell għadhom jiġu ċċekkjati mill-ġdid biex tiġi kkonfermata l-preċiżjoni tal-mod kif inhuma mpoġġija r-reġjuni ta' interess (ROIs, regions of interest), issir tfittxia għal CSF jew għadam fl-ROI, u jiġi vvalutat l-impatt possibbli ta' atrofija jew ventrikulomegalija fuq il-kwantitazzjoni.
English: average reader accuracy on the scans with autopsy standard of truth improved from 90.1% at baseline to 93.1% (p-value <0.0001), with no observed decrease in either sensitivity or specificity.
Maltese: Il-qarrejja kollha li pparteċipaw li kellhom aċċess għal informazzjoni kwantitattiva, il-preċiżjoni medja tal-qarrej fuq l-iskans bl-istandard ta' verità tal-awtopsja tjiebet minn 90.1% fil-linja bażi għal 93.1% (valur p <0.
English: Healthy controls show relatively low levels of florbetapir (18F) retention in cortex and cerebellum.
Maltese: florbetapir (18F) fil-kortiċi u ċ-ċerebellum.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advice before you are given this medicine.
Maltese: - Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib tiegħek speċjalizzat fil-mediċina nukleari u li se jieħu ħsieb is-sorveljanza tal-proċedura.
English: No in vivo interaction studies have been performed.
Maltese: Ma twettaq l-ebda studju ta' interazzjoni in vivo.
English: Amyvid, along with other brain function tests, may help your doctor find the reason for your memory problems.
Maltese: Amyvid, flimkien ma' testijiet oħra tal-funzjoni tal-moħħ, jista' jgħin lit-tabib tiegħek isib ir-raguni tal-problemi ta' memorja tiegħek.
English: Incorporation of quantitative information generated by CE-marked image quantitation software as an adjunct to the visual interpretation method may improve readers' accuracy.
Maltese: L-inkorporazzjoni ta' informazzjoni kwantitattiva ġġenerata permezz ta' programm tal kompjuter ta' kwantitazzjoni tal-immaġini mmarkat CE bħala suppliment għall-metodu ta'
English: Amyvid images should only be interpreted by readers trained in the interpretation of PET images with florbetapir (18F).
Maltese: Ir-ritratti b'Amyvid għandhom jiġu interpretati biss minn persuni mħarrġa fl-interpretazzjoni tar ritratti PET magħmula b'florbetapir (18F).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING SHIELD LABEL
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: Each mL of solution for injection contains 800 MBq of florbetapir (18F) at the date and time of calibration (ToC).
Maltese: MBq of florbetapir (18F) fil-waqt u l-ħin talkalibrazzjoni (ToC).
English: Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final educational programme with the National Competent Authority.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jippjana programm edukattiv finali mal-Awtorità Kompetenti Nazzjonali qabel l-illanċjar tal-prodott f'kull Stat Membru.
English: Increased uptake has been identified in extracerebral structures such as salivary glands, skin, muscles and bone in some cases (see section 5.2).
Maltese: F'xi każijiet instab li kien hemm żieda fit-teħid minn strutturi ekstraċerebrali bħall-glandoli salivarji, mill-ġilda, mill-muskoli u fl-għadam (ara sezzjoni 5.2).
English: 15 December 2011
Maltese: 11 July 2012
English: Veterinary medicines
Maltese: Mediċini veterinarji
English: EMA/MB/554514/2011 Executive Director
Maltese: EMA/468951/2012 Directorate
English: Highest quality standards
Maltese: Standards tal-ogħla kwalità
English: Another important issue for the Agency is assuring the continuity of its operations during the 2012 London Olympic Games.
Maltese: Kwistjoni oħra importanti għall-Aġenzija hija li tiżgura l-kontinwità tal-operazzjonijiet tagħha waqt ilLogħob Olimpiku tal-2012 f'Londra.
English: Communication and engagement with stakeholders
Maltese: Komunikazzjoni u impenn mal-partijiet interessati
English: MRL extrapolations
Maltese: Governanza tal-Aġenzija