FrancophonIA/ELRC3.0 huggingface dataset:
English: Because Posaconazole Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Posaconazole Accord huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, tqies li l-benefiċċji u r-riskji tiegħu huma l-istess bħal dawk tal-mediċina ta' referenza.
English: • coccidioidomycosis (fungal infection of the lungs caused by breathing in spores).
Maltese: • koċċidijojdomikożi (infezzjoni fungali tal-pulmun ikkawżata minn teħid tan-nifs fl-ispori).
English: How has Posaconazole Accord been studied?
Maltese: Kif ġie studjat Posaconazole Accord?
English: The list of fungi Posaconazole Accord is active against can be found in the summary of product characteristics.
Maltese: Il-lista ta' fungi li Posaconazole Accord huwa attiv kontrihom tista' tinstab fis-sommarju tal-karatteristiċi tal-prodott.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Posaconazole Accord has been shown to have comparable quality and to be bioequivalent to Noxafil.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li, b'mod konformi mar-rekwiżiti tal-UE, Posaconazole Accord wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Noxafil.
English: The company also carried out studies that showed that it is ‘bioequivalent' to the reference medicine.
Maltese: Il-kumpanija għamlet ukoll studji li wrew li hija “bijoekwivalenti” għall-mediċina ta' referenza.
English: This means that Posaconazole Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Noxafil.
Maltese: Dan ifisser li Posaconazole Accord fih l-istess sustanza attiva u jaħdem bl-istess mod bħal "mediċina ta' referenza" diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Noxafil.
English: How is Posaconazole Accord used?
Maltese: Kif jintuża Posaconazole Accord?
English: Therefore, the Agency's view was that, as for Noxafil, the benefit of Posaconazole Accord outweighs the identified risk and it can be authorised for use in the EU.
Maltese: Għaldaqstant, lopinjoni tal-Aġenzija kienet li, bħal fil-każ ta' Noxafil, il-benefiċċju ta' Posaconazole Accord huwa akbar mir-riskju identifikat u jista' jiġi awtorizzat għall-użu fl-UE.
English: Side effects reported with Posaconazole Accord are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Posaconazole Accord huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Posaconazole Accord can only be obtained with a prescription and treatment should be started by a doctor who has experience in managing fungal infections or in treating patients at high risk of invasive fungal infections.
Maltese: Posaconazole Accord jista' jinkiseb biss b'riċetta ta' tabib u l-kura għandha tinbeda u tkun taħt issuperviżjoni ta' tabib b'esperjenza fl-immaniġġjar tal-infezzjonijiet fungali jew fil-kura ta' pazjenti b'riskju għoli ta' infezzjonijiet fungali invażivi
English: November 2018
Maltese: Novembru 2018
English: Activity: {XXX} MBq in {XX} mL ToC: {DDMMYYYY} {XX}h{XX} {Time zone} Volume: {XX} mL
Maltese: {JJXXSSSS} f'{XX}h{XX} {Żona tal-Ħin} Volum {XX} mL
English: 20052 Monza Italy
Maltese: 20052 Monza L-Italja
English: Effective dose (mSv/MBq)
Maltese: Doża effettiva (mSv/MBq)
English: 33100 Udine Italy
Maltese: 33100 Udine L-Italja
English: EXP: ToC + 6 h
Maltese: EXP: ToC + 6 sigħat
English: Table 3: List of adverse reactions System Organ Class
Maltese: Tabella 3: Lista ta' reazzjonijiet avversi Sistema tal-Klassifika tal-Organi
English: Germany e-mail: gra@life-mi.com
Maltese: Il-Ġermanja e-mail: gra@life-mi.com
English: ATC code: V09AX06
Maltese: V09AX06
English: Dose absorbed per activity administered [mGy/MBq]
Maltese: Doża assorbita għal kull attività amministrata [mGy/MBq]
English: Curium Pharma Spain, S.A. Thomas Alba Edison, s/n 41092 Seville
Maltese: Spain, S.A. Thomas Alba Edison, s/n 41092 Seville
English: 1081 HV Amsterdam The Netherlands
Maltese: 1081 HV Amsterdam
English: Negative scan
Maltese: Skenn negativ
English: Fluorine (18F) has a physical half-life of 110 minutes.
Maltese: Fluorine(18F)għandu half-life fiżika ta' 110 minuti.
English: Seibersdorf Labor GmbH Grundstueck Nr. 482/2 EZ 98 KG 2444 Seibersdorf Austria
Maltese: Seibersdorf Labor GmbH Grundstueck Nr. 482/2 EZ 98 KG 2444
English: Cis Bio International Hôpital Xavier Arnozan Avenue du Haut Lévèque 33600 Pessac (Bordeaux) France
Maltese: Cis Bio International Hôpital Xavier Arnozan Avenue du Haut Lévèque 33600 Pessac (Bordeaux) Franza
English: Customer ref
Maltese: Ref tal-klijent
English: Neuraceq contains ethanol and sodium ascorbate
Maltese: Neuraceq fih ethanol u sodium ascorbate.
English: EXP {DD/MM/YYYY} {XX}h{XX} {Time zone}
Maltese: EXP {JJ/XX/SSSS}-{XX}h{XX}{Żona tal-ħin}
English: Life Radiopharma Warszawa Sp. z o.o.
Maltese: Life Radiopharma Warszawa Sp. z o.o. ul.
English: METALLIC BOX (with Blue Box)
Maltese: KAXXA METALLIKA (mingħajr Kaxxa Blu)
English: Table 1: Definitions of regional cortical tracer uptake (RCTU) RCTU score
Maltese: Tabella 1: Tifsiriet tat-teħid ta' intraċċar kortikali reġjonal (RCTU - regional cortical tracer uptake)
English: Pol. Ind. Conpisa, C/ Veguillas, 2 Nave 16, Ajalvir 28864 (Madrid) Spain
Maltese: Ind. Conpisa, C/ Veguillas, 2 Nave 16, Ajalvir 28864
English: Unit 19, Quadrum Park, Old Portsmouth Road, Peasmarsh, Guildford, Surrey, GU3 1LU United Kingdom
Maltese: Unit 19, QuadrumPark, Old Portsmouth Road, Peasmarsh, Guildford, Surrey, GU3 1LU Ir-Renju Unit
English: Hepatic function abnormal
Maltese: - Fwied: funzjoni epatika anormali
English: Cis Bio International CHU de Brabois Avenue de Bourgogne 54500 Vandoeuvre les Nancy France
Maltese: Cis Bio International CHU de Brabois Avenue de Bourgogne 54500 Vandoeuvre les Nancy Franza
English: Florbetaben (18F) is highly bound to plasma proteins (>98.5%).
Maltese: Florbetaben (18F) jintrabat b'mod qawwi ma' proteini fil-plażma (>98.5%).
English: The adverse reactions are ranked under heading of frequency using the following convention: 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: Lista tabulata tar-reazzjonijiet avversiIr-reazzjonijiet avversi huma kklassifikati taħt kategoriji ta' frekwenza, bl-użu tal-konvenzjoni li ġejja: 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 jistax jiġi stmat mit-tagħrif disponibbli).
English: Curium Pharma Spain, S.A. Pol. Ind. Conpisa, C/ Veguillas - 2 Nave 16, Ajalvir 28864 (Madrid) Spain
Maltese: Spain, S.A. Pol. Ind. Conpisa, C/ Veguillas - 2 Nave 16, Ajalvir 28864
English: Table 2: Definitions of brain amyloid plaque load (BAPL) Assessment
Maltese: Tabella 2: Definizzjonijiet ta' tagħbija ta' plakka ta' amyloid fil-moħħ (BAPL-brain amyloid plaque load) Stima
English: Pharmacotherapeutic group: diagnostic radiopharmaceuticals, central nervous system;
Maltese: Kategorija farmakoterapewtika: radjofarmaċewtiku dijanjostiku, sistema nervuża ċentrali;
English: BAPL score
Maltese: Punteġġ BAPL
English: At 12 hours post injection 98.93% of the activity is decayed, at 24 hours post injection 99.99 % of the activity is decayed.
Maltese: Wara 12-il siegħa mill-injezzjoni 98.93 % tal-attività tkun iddeterjorat; 24 siegħa wara l-injezzjoni 99.99 % tal-attività tkun deterjorat.
English: Cis Bio International 14, rue de la Grange aux Belles 75010 Paris
Maltese: Cis Bio International 14, rue de la Grange aux Belles 75010
English: Cis Bio International 14 rue de la Grange aux Belles 75010 Paris
Maltese: Cis Bio International 14 rue de la Grange aux Belles 75010
English: The effective dose resulting from the administration of a maximal recommended activity of 360 MBq dose for an adult weighing 70 kg is about 7.0 mSv.
Maltese: Id-doża effettiva li tirriżulta mill-amministrazzjoni ta' attività massima rrakkomandata ta' 360 MBq għal adult li jiżen 70 kg hi madwar 7.0 mSv.
English: Individual benefit/risk justification
Maltese: Ġustifikazzjoni għall-benefiċċju/riskju individwali
English: Inter-rater agreement using Fleiss' kappa values ranged from 0.68 to 0.87.
Maltese: Qbil bejn gradaturi permezz ta' valuri ta' Fleiss kappa kienu fil-firxata' bejn 0.68 sa 0.87.
English: Neuraceq 300 MBq/mL solution for injection florbetaben (18F)
Maltese: Neuraceq 300 MBq/mL soluzzjoni għall-injezzoni florbetaben (18F)
English: Based on in vitro investigations florbetaben (18F) is metabolised predominantly by CYP2J2 and CYP4F2.
Maltese: Abbażi ta' stħarriġ in vitro, florbetaben (18F) jiġi mmetabolizzat prinċipalment b' CYP2J2 u CYP4F2.
English: In vitro studies using human liver microsomes did not indicate any potential to inhibit the cytochrome P450 enzyme system.
Maltese: Studji in vitro permezz ta' mikrosomi tal-fwied uman ma wrewx xi potenzjal għall-impediment tas-sistema ta' enzimi P450.
English: Gallbladder Gastrointestinal tract
Maltese: Passaġġ gastrointestinali
English: Date of first authorisation: 20.
Maltese: Data tiġdid tal-awtorizzazzjoni: 20.
English: Neuraceq 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: Neuraceq huwa prodott radjofarmaċewtiku indikat għal immaġni bi Positron Emission Tomography (PET) ta' densità ta' plakka newritika ta' β-amyloid fil-moħħ ta' adulti b'indeboliment konjittiv li qed jiġu valutati għall-marda ta' Alzheimer (AD - Alzheimer's Disease) u kawżi oħra ta' indeboliment konjittiv.
English: Multidose.
Maltese: Doża multipli
English: Neuraceq contains the active substance florbetaben (18F).
Maltese: Neuraceq fih is-sustanza attiva florbetaben (18F)
English: 2 Scan with moderate beta-amyloid deposition
Maltese: 2 Skenn b'depożizzjoni moderata ta' beta-amyloid
English: Adequate shielding is mandatory.
Maltese: Protezzjoni xierqa hi obbligatorja.
English: At the 24-month follow-up, 19 (42.2%) converted to clinical AD. Of the 29 MCI subjects who had a positive PET scan, 19 (65.5%) were classified clinically as converted to clinical AD after 24 months compared to 0 (0%) of 16 who had a negative scan.
Maltese: Minn 29 individwu b'MCI li kellhom PET skenn pożittiva, 19 (65.5 %) kienu kklassifikati klinikament għal AD wara 4 xhur meta mqabbla ma' 0 (0 %) minn 16 li kellhom skenn negattiva.
English: Each multidose vial contains 1 to 10 mL of solution, corresponding to 300 to 3000 MBq at the date and time of calibration (ToC).
Maltese: Kull kunjett b'ħafna dożi fih 1 mL sa 10 mL ta' soluzzjoni li jikkorispondi għal 300 sa 3000 MBq fiddata u l-ħin ta' kalibrazzjoni (ToC).
English: For an administered activity of 360 MBq the typical radiation dose to the target organ (brain) is 4.5 mGy.
Maltese: Għal attività amministrata ta' 360 MBq id-doża ta' radjazzjoni tipika għall-organu fil-mira (moħħ) hi ta' 4.5 mGy.
English: Act.: ≤ 3000 MBq at ToC (see outer label)
Maltese: ≤ 3000 MBq fit-ToC (ara fuq il-pakkett ta' barra).
English: - This medicine contains 15 vol % ethanol (alcohol), i.e. up to 1.2 g per dose, equivalent to 30 mL beer or 12.5 mL wine per dose.
Maltese: - Dan il-prodott mediċinal fih 15 vol % ethanol (alcohol), jiġifieri sa' 1.2 g f'kull doża, ekwivalenti għal 30 ml birra, 12.5 ml inbid f'kull doża.
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: Fluorine (18F) jiddeġenera f'ossiġnu stabbli (18O) b'half-life ta' madwar 110 minuti billi jemittja radjazzjoni ta' positron ta' 634 keV, segwita minn trasformazzjoni għal radjazzjoni fotonika ta'
English: A 20-minute PET image should be acquired starting at approximately 90 minutes after intravenous injection of florbetaben (18F).
Maltese: Immaġini PET ta' 20 minuta għandha tinkiseb li tibda madwar 90 minuti wara l-injezzjoni ġol-vina bi florbetaben (18F).
English: - The active substance is florbetaben (18F).
Maltese: - Is-sustanza attiva hi florbetaben (18F).
English: Other medicines and Neuraceq
Maltese: Mediċini oħra u Neuraceq
English: A positive scan indicates moderate to frequent density.
Maltese: Skenn pożittiva tindika densità minn moderata għal frekwenti.
English: The dose is administered by intravenous slow bolus injection (6 sec/mL) followed by a flush of approximately 10 mL of sodium chloride 9 mg/mL (0.9%) solution for injection to ensure full delivery of the dose.
Maltese: Id-doża għandha tingħata b'injezzjoni bolus li tingħata bil-mod (6 sek/mL) li tiġi segwita bi tlaħliħa ta' madwar 10 mL ta' 9 mg/mL (0.9 %) sodium chloride għall-injezzjoni sabiex jiġi żgurat li d-doża ngħatat kollha.
English: Alliance Medical Radiopharmacy Ltd. Unit 19, Quadrum Park, Old Portsmouth Road Peasmarsh, Guildford, Surrey, GU3 1LU United Kingdom
Maltese: Unit 19, Quadrum Park, Old Portsmouth Road Peasmarsh, Guildford, Surrey, GU3 1LU Ir-Renju Unit
English: Figure 1: Neuraceq PET cases showing examples of negative florbetaben (18F) PET scan (top row) and positive scan (bottom row).
Maltese: Figura 1: Każijiet b'Neuraceq PET li juru eżempji ta' florbetaben (18F) PET skenn negattiv (ringiela ta' fuq) u skenn pożittiv (ringiela ta' taħt).
English: Residual activity in the midsagittal sinus can be sometimes observed (see section 5.2).
Maltese: L-attività residwa fil-midsagittal sinus xi kultant tista' tkun osservata (ara sezzjoni 5.2).
English: Life Radiopharma Bonn GmbH, Germany IBA Molecular Italy S.R.L., Monza, Italy IBA Molecular Italy S.R.L., Rome, Italy IBA Molecular Italy S.R.L., Udine, Italy Curium Pharma Spain, S.A., Seville, Spain Curium Pharma Spain, S.A., Madrid, Spain Seibersdorf Labor GmbH, Austria BetaPlus Pharma SA, Brussels, Belgium Institut Radiofarmacia Aplicada Barcelona-IRAB, Barcelona, Spain
Maltese: Life Radiopharma Warszawa Sp. z o.o., Il-Polonja Life Radiopharma Bonn GmbH, Il-Ġermanja IBA Molecular Italy S.R.L., Monza, L-Italja IBA Molecular Italy S.R.L., Rome, L-Italja IBA Molecular Italy S.R.L., Udine, L-Italja Curium Pharma Spain, S.A., Seville, Spanja Curium Pharma Spain, S.A., Madrid, Spanja Seibersdorf Labor GmbH, L-Awstrija BetaPlus Pharma
English: RCTU score 1 in each of the 4 brain regions (lateral temporal lobes, frontal lobes, posterior cingulate/precuneus, parietal lobes)
Maltese: Punteġġ RCTU 1 f'kull wieħed mill-4 reġjuni tal-moħħ (lobi temporali posterjuri, lobi frontali, ċingulat posterjuri/perkuneju, lobi parijetali).
English: This medicinal product contains 15 vol % ethanol (alcohol), i.e. up to 1.2 g per dose, equivalent to 30 mL beer or 12.5 mL wine per dose.
Maltese: Dan il-prodott mediċinal fih 15 vol % ethanol (alcohol), jiġifieri sa' 1,2 g f'kull doża, ekwivalenti għal 30 ml birra jew 12.5 ml inbid f'kull doża.
English: Reconstruction should include attenuation correction with resulting transaxial pixel sizes between 2.0 and 3.0 mm.
Maltese: Ir-rikostruzzjoni għandha tinkludi korrezzjoni għall-attenwazzjoni b'riżultati ta' daqsijiet ta' pixel transassjali ta' bejn 2.0 u 3.0 mm.
English: 3 Scan with pronounced beta-amyloid deposition
Maltese: 3 Skenn b'depożizzjoni enfasizzata ta' beta--amyloid
English: Ascorbic acid, ethanol anhydrous, macrogol 400, sodium ascorbate, water for injections.
Maltese: TA' EĊĊIPJENTI Ascorbic acid, ethanol anidru, macrogol 400, sodium ascorbate, ilma għall-injezzjoniijiet
English: This medicinal product contains up to 1.2 g of ethanol and up to 33 mg of sodium per dose (see section 4.4).
Maltese: Eċċipjenti b'effett magħruf Dan il-prodott mediċinali fih sa 1.2 g ta' ethanol u sa 33 mg ta' sodju f'kull doża (ara sezzjoni 4.4).
English: Interpretation of Neuraceq images
Maltese: Interpretazzjoni tal-immaġini b'Neuraceq
English: Ascorbic acid, ethanol anhydrous, macrogol 400, sodium ascorbate (for pH adjustment), water for injections
Maltese: Ascorbic acid, ethanol anidru, macrogol 400, sodium ascorbate (għall-aġġustament tal-pH), ilma għall-injezzjoniijiet
English: Sodium ascorbate (for pH adjustment) Water for injections
Maltese: Sodium ascorbate (għall-aġġustament tal-pH)
English: Feeling hot
Maltese: Skenn pożittiv
English: Quality control
Maltese: Kontroll tal-kwalità.
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: Qabel it-tnedija f'kull Stat Membru d-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jaqbel mal-programm edukattiv finali tal-Awtorità Nazzjonali Kompetenti.
English: Alliance Medical Radiopharmacy Ltd., UK BV Cyclotron VU, the Netherlands Cis Bio International, Nancy, France Cis Bio International, Nîmes, France Cis Bio International, Paris, France Cis Bio International, Rennes, France Cis Bio International, Pessac, France Life Radiopharma Berlin GmbH, Germany Advanced Accelerator Applications Germany GmbH, Germany Life RadiopharmaWarszawa Sp. z o.o., Poland
Maltese: Cis Bio International, Nancy, Franza Cis Bio International, Nîmes, Franza Cis Bio International, Paris, Franza Cis Bio International, Rennes, Franza Cis Bio International, Pessac, Franza Life Radiopharma Berlin GmbH, Il-Ġermanja Advanced Accelerator Applications Germany GmbH, Il-Ġermanja
English: - The other ingredients are ascorbic acid, ethanol anhydrous, macrogol 400, sodium ascorbate, and water for injections (see section 2 “Neuraceq contains ethanol and sodium ascorbate”).
Maltese: - Is-sustanzi l-oħra huma ascorbic acid, ethanol anidru, macrogol 400, sodium ascorbate, u ilma għall-injezzjonijiet (ara wkoll sezzjoni 2 “Neuraceq fih ethanol u sodium ascorbate”).
English: In all 31 subjects, a blinded visual subject-level PET reading by 3 blinded readers resulted in a majority read sensitivity of 100% (95% CI: 80.5-100%) and specificity 85.7% (95% CI: 67.4 - 100%).
Maltese: F'kull wieħed mill-31 individwu, qari fil-għama ta' PET fuq livell individwali minn 3 qarrejja fl-għama rriżultaw f'sensittività maġġoritarja moqrija ta' 100 % (95% CI: 80.5-100%) u speċifiċità ta' 85.7 % (95%CI: 67.4-100%).
English: As the effective dose is about 5.8 mSv when the maximum recommended activity of 300 MBq of florbetaben (18F) is administered, these adverse reactions are expected to occur with a low probability.
Maltese: 5.8 mSv meta l-attività massima rrakkomandata ta' 300 MBq ta' florbetaben (18F) hija mogħtija; dawn ir-reazzjonijiet avversi huma mistennija li jseħħu bi probabilità baxxa.
English: In vitro, florbetaben (18F) shows nanomolar binding affinity to synthetic β-amyloid fibrils and to AD brain homogenate.
Maltese: In vitro, florbetaben (18F) juri affinità għal irbit nanomolari ma' fibrili sintetiċi li jkun fihom β-amyloid u mal omoġenat tal-moħħ tal-AD.
English: The overall safety profile of Neuraceq is based on data from 1,295 administrations of Neuraceq to 1,077 subjects and 12 subjects who received vehicle.
Maltese: Il-profil tas-sigurtà globali ta' Neuraceq hu bbażat fuq tagħrif minn 1,295 għotja ta' Neuraceq lil 1,077 individwu u 12-il individwu li ngħataw trasportatur.
English: For an administered activity of 360 MBq the typical radiation doses delivered to the critical organs, gallbladder, urinary bladder, upper large intestine wall, lower large intestine wall, small intestine and liver are 49.3 mGy, 25.0 mGy, 13.8 mGy, 12.6 mGy, 11.3 mGy and 13.9 mGy, respectively.
Maltese: 0 mGy, 13.8 mGy, 12.6 mGy, 11.3 mGy u 13.9 mGy, rispettivament.
English: via Pergolesi, 33
Maltese: IBA Molecular Italy S.R.L. via Pergolesi, 33
English: After intravenous bolus injection a radioactivity concentration of 2-3% injected dose/L is achieved in arterial plasma 10 minutes after injection.
Maltese: Wara injezzjoni ta' bolus li jingħata ġol-vina, tintlaħaq konċentrazzjoni ta' radjoattività ta' 2-3 % taddoża injettata/L fil-plażma arterjali 10 minuti wara l-injezzjoni.
English: DATE OF REVISION OF THE TEXT 11.
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: A negative scan indicates sparse or no density of cortical β-amyloid plaques.
Maltese: Skenn negattiva tindika plakki rari jew li ma hemm l-ebda densità ta' β-amyloid fil-kortiċi.
English: 3 (Pronounced tracer uptake)
Maltese: 3. (Teħid ta' intraċċatur notevoli)
English: For precautions with respect to environmental hazard, see section 6.6.
Maltese: Għal prekawzjonijiet fir-rigward ta' periklu ambjentali ara sezzjoni 6.6.
English: Pharmacodynamic effects At the low chemical concentrations present in Neuraceq, florbetaben (18F) does not have any detectable pharmacodynamic activity.
Maltese: Fil-konċentrazzjonijiet kimiċi baxxi preżenti f'Neuraceq, florbetaben (18F) m'għandux xi attività farmakodinamika li tista' tiġi osservata.
English: Sensitivity and specificity to estimate beta-amyloid deposition of florbetaben (18F) was further investigated in one additional study, in which a different set of 5 electronically-trained blinded readers interpreted images from 54 subjects followed to autopsy in the pivotal study.
Maltese: Is-sensittività u l-ispeċifiċità sabiex tiġi stmata d-depożizzjoni ta' beta-amyloid ta' florbetaben (18F) ġew mistħarrġa aktar fi studju addizzjonali ieħor, li fih sett differenti ta' 5 qarrejja mħarrġa elettronikament fl-għama interpretaw immaġini minn 54 individwu segwiti sal-awtopsja fl-istudju ewlieni.
English: The potential toxicity of 28 days of repeated intravenous injections of florbetaben (18F) was tested in rats and dogs, and the NOAEL was found to be at least 20 times the maximum human dose.
Maltese: It-tossiċità potenzjali ta' 28 jum ta' injezzjonijiet ġol-vina ripetuti ta' florbetaben (18F) kienu ttestjati fil-firien u l-klieb, u n-NOAEL instabu li huma tal-anqas 20 darba d-doża massima għall-bniedem.
English: The activity per vial ranges from 300 MBq to 3000 MBq at the date and time of calibration.
Maltese: L-attività f'kull kunjett tvarja minn 300 MBq sa 3000 MBq fid-data u l-ħin ta' kalibrazzjoni.
English: The pharmacokinetics of florbetaben (18F) in patients with renal or hepatic impairment has not been characterised.
Maltese: Il-farmakokinetika ta' florbetaben (18F) f'pazjenti b'indeboliment talkliewi u tal-fwied ma ġietx ikkaraterizzata.
English: A recent co-registered computed tomography (CT) scan or magnetic resonance (MR) imaging of the patient to get 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).
Maltese: computerized tomography) jew resonanza manjetika (MR - magnetic resonance) tal-pazjent sabiex tinkiseb immaġini PET-CT jew PET-MR hija rrakkomandata f'każijiet ta' inċertezza dwar l-allokazzjoni ta' materja griża u tal-burdura tal-materja griża/bajda fil-PET skenn (ara sezzjoni 4.4).
English: Vessel puncture site pain Catheter site pain Injection site haematoma Injection site irritation Puncture site reaction Injection site discomfort Injection site warmth
Maltese: Il-professjonisti dwar il-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: Florbetaben (18F) should not be diluted.
Maltese: MBq florbetaben (18F).
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 ta' għoti għandhom isiru b'mod li jnaqqsu kemm jista' jkun ir-riskju ta' kontaminazzjoni tal-prodott mediċinali u l-irradjazzjoni tal-operaturi.
English: Paediatric population There is no relevant use of Neuraceq in the paediatric population.
Maltese: M'hemmx użu rilevanti ta' Neuraceq fil-popolazzjoni pedjatrika.
English: At 12 hours post-injection, up to approximately 30% of the injected radioactivity is excreted with urine.
Maltese: Fi 12-il siegħa wara l-injezzjoni, sa madwar 30 % tar-radjoattività injettata tiġi eliminata mal-awrina.