FrancophonIA/ELRC3.0 huggingface dataset:
English: Uptake by tumours is rapid, with the highest tumour-to-normal tissue contrast between 4 and 10 minutes after injection and continuing for around 30 minutes, with a 61% reduction in mean tumour uptake at 90 minutes after injection.
Maltese: It-teħid mit-tumuri huwa mgħaġġel, bl-ogħla kuntrast ta' tessut tat-tumur għal tessut normali jkun ta' bejn 4 u10 minuti wara l-injezzjoni u li jdum għal madwar 30 minuta, bi tnaqqis ta' 61 % fit-teħid medju mit-tumur wara 90 minuta wara l-injezzjoni.
English: N True positive n (%) False positive n (%) True negative n (%) False negative n (%) Sensitivity [95% CI] Specificity [95% CI] Positive likelihood ratio [95% CI] Negative likelihood ratio [95% CI]
Maltese: Negattiv veru n (%) Negattiv falz n (%) Sensittività [95% CI]
English: Excipients: sodium citrate, concentrated hydrochloric acid, sodium hydroxide, and water for injections.
Maltese: Eċċipjenti: sodium citrate, hydrochloric acid konċentrat, sodium hydroxide, u ilma għall injezzjonijiet.
English: Other medicines and Axumin
Maltese: Mediċini oħra u Axumin
English: For detection of extraprostatic recurrences (regional lymph node and/or distal metastases) sensitivity was 84.2% (32/38) (95%CI: 68.7-94%) and specificity was 89.7% (78/87) (95%CI: 81.3-95.2%), respectively.
Maltese: 2% (32/38) (95% CI: 68.7-94%) u l-ispeċifiċità kienet ta' 89.7% (78/87) (95% CI: 81.
English: Values were calculated from human biodistribution data using OLINDA/EXM (Organ Level Internal Dose Assessment/Exponential Modeling) software.
Maltese: Esponenzjali - Organ Level Internal Dose Assessment/Exponential Modeling).
English: Mean absorbed dose per unit administered activity (µGy/MBq)
Maltese: Doża medja assorbita għal kull unità ta' attività mogħtija (µGy/MBq)
English: Activity: {YYYY} MBq Volume: {xx.x] mL
Maltese: {YYYY} MBq Volum: {xx.x] mL
English: Individual benefit/risk justification
Maltese: Ġustifikazzjoni tal-benefiċċju/riskju tal-individwu
English: Prostate & prostate bed
Maltese: Prostata u l-bed talprostata
English: The adult effective dose resulting from the administration of the recommended activity of 370 MBq of fluciclovine (18F) is 8.2 mSv.
Maltese: Id-doża effettiva tal-adulti li tirriżulta mill-għoti tal-attività rakkomandata ta' 370 MBq ta' fluciclovine (18F) hija ta' 8.2 mSv.
English: Concentrated hydrochloric acid Sodium hydroxide Water for injections
Maltese: Sodium citrate Hydrochloric acid konċentrat Sodium hydroxide Ilma għall-injezzjonijiet
English: The major route of elimination is via the renal pathway.
Maltese: Eliminazzjoni Ir-rotta ewlenija tal-eliminazzjoni hi permezz tal-passaġġ renali.
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 ġewx ikkaratterizzati.
English: For an administered activity of 370 MBq the typical radiation doses to the critical organs, pancreas, the cardiac wall and uterine wall are 37.8 mGy, 19.1 mGy and 16.5 mGy, respectively.
Maltese: Għal attività mogħtija ta' 370 MBq, id-dożi ta' radjazzjoni tipiċi fl organi kritiċi, fil-frixa, fil-ħajt tal-qalb u fil-ħajt tal-utru huma ta' 37.8 mGy, 19.1 mGy u 16.5 mGy, rispettivament.
English: Parosmia
Maltese: Parosmja
English: Mechanism of action Fluciclovine (18F) is a synthetic amino acid which is transported across mammalian cell membranes by amino acid transporters such as LAT-1 and ASCT2.
Maltese: Mekkaniżmu ta' azzjoni Fluciclovine (18F) huwa amino aċidu sintetiku li jiġi ttrasportat madwar il-membrani taċ-ċelluli mammiferi minn trasportaturi tal-amino aċidi bħal LAT-1 u ASCT2.
English: Activity: {YYYY} MBq in {xx.x} mL at {hh:mm}{Time Zone} {DD/MM/YYYY}
Maltese: {YYYY} MBq f' {xx.x} mL fi {hh:mm}{Żona tal-Ħin} {JJ/XX/SSSS}
English: Each mL of solution contains 7.7 mg of sodium.
Maltese: Kull mL ta' soluzzjoni fih 7.7 mg ta' sodju.
English: The following side effects of Axumin are common (may affect up to 1 in 100 people).
Maltese: L-effetti sekondarji li ġejjin ta' Axumin huma komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100).
English: As the effective dose is 8.2 mSv when the maximal recommended activity of 370 MBq is administered these adverse reactions are expected to occur with a low probability.
Maltese: Peress li d-doża effettiva hija ta' 8.2 mSv, meta tingħata l-attività rakkomandata massima ta' 370 MBq, dawn ir-reazzjonijiet avversi mistennija li jseħħu bi probabbiltà baxxa.
English: Axumin 3200 MBq/mL solution for injection fluciclovine (18F)
Maltese: Axumin 3200 MBq/mL soluzzjoni għall-injezzjoni fluciclovine (18F)
English: Advanced Accelerator Applications (Italy) s.r.l.
Maltese: Advanced Accelerator Applications (Italy) s.r.l. Via Piero Maroncelli 40
English: In in vitro studies, fluciclovine (18F) was not taken up by common drug transporters indicating a negligible potential for drug interactions.
Maltese: Fi studji in vitro, fluciclovine (18F) ma ttiħidx minn transportaturi komuni tal-mediċina li jindika potenzjal negliġibbli għal interazzjonijiet tal-mediċina.
English: The effective half-life of fluciclovine (18F) equates to the radioactive half-life of fluorine (18F), which is approximately 110 minutes.
Maltese: Half life Il-half life effettiva ta' fluciclovine (18F) hija daqs il- half life radjuattiva ta' fluorine (18F), li hija ta' madwar 110 minuti.
English: Blue Earth Diagnostics Ireland Ltd 6th Floor, 2 Grand Canal Square Dublin 2
Maltese: 6th Floor, 2 Grand Canal Square Dublin 2
English: Axumin may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection by a factor of 8.
Maltese: Axumin jista' jiġi dilwit b' soluzzjoni għall injezzjoni ta' klorur tas-sodju (sodium chloride) 9 mg/ml (0.9 %) b'fattur ta' 8.
English: Axumin is supplied in a 10 mL or 15 mL type 1 glass vial sealed with a fluoro-coated chlorobutyl, chlorobutyl or bromobutyl rubber closure and aluminium overseal.
Maltese: Axumin huwa fornut f'kunjett tal-ħġieġ ta' tip 1 ta' 10 mL jew 15 mL issiġillat b'għeluq tal-lasktu chlorobutyl miksi bil-fluwor, chlorobutyl jew bromobutyl u b'siġill tal-aluminju fuqu.
English: For the limitations in the interpretation of a positive scan, see section 4.4 and 5.1.
Maltese: Għal-limitazzjonijiet fl-interpretazzjoni ta' sken pożittiv, ara sezzjoni 4.4 u 5
English: The diagnostic performance of fluciclovine (18F) PET-CT for the detection of recurrence overall (at any location), and in 3 different locations (prostate/bed, pelvic lymph nodes, and distant metastases) is shown in Table 1.
Maltese: Il-prestazzjoni dijanjostika ta' PET-CT bi fluciclovine (18F) għall-iskoprerta tar-rikorrenza b'mod globali (fi kwalunkwe post), u fi 3 postijiet differenti (prostata/bed tal-prostata, noduli limfatiċi pelviċi u metastasi ta' kanċer li jkun infirex 'il bogħod) hija murija fit-Tabella 1.
English: Paediatric population For information on use in the paediatric population, see section 4.2.
Maltese: Għal informazzjoni dwar l-użu fil-popolazzjoni pedjatrika, ara sezzjoni 4.2.
English: 88.6% for all three readers while specificity ranged from 17.2-53.6%.
Maltese: bbażata fuq il-pazjent kienet ogħla minn 88.6% għat-tliet qarrejja kollha filwaqt li l-ispeċifiċità kienet tvarja minn 17.2-53.6%.
English: The injection should be followed by an intravenous flush of sterile sodium chloride 9 mg/ml (0.9%) solution for injection to ensure full delivery of the dose.
Maltese: L-injezzjoni għandha tiġi segwita minn tlaħliħ ġol-vini (intravenous flush) ta' klorur tas-sodju 9 mg/ml (0.9 %) soluzzjoni għall-injezzjoni sterili sabiex jiġi żgurat li d-doża tingħata b'mod sħiħ.
English: FRANCE
Maltese: Irlanda
English: o Physiological distribution of fluciclovine o Image interpretation guidelines o Examples of incidental findings on PET-CT with fluciclovine o Examples of positive and negative findings on PET-CT with fluciclovine o Demonstration cases with image interpretation provided by an expert
Maltese: o Id-distribuzzjoni fiżjoloġika ta' fluciclovine o Linji gwida ta' interpretazzjoni tal-immaġni o Eżempji ta' sejbiet inċidentali fuq PET-CT bi fluciclovine o Eżempji ta' sejbiet pożittivi u negattivi fuq PET-CT bi fluciclovine o Każijiet ta' turija b'interpretazzjoni tal-immaġni pprovduta minn espert
English: The scan will usually start approximately 5 minutes after the Axumin injection is given.
Maltese: Normalment, l-isken jibda madwar 5 minuti wara li tingħata l-injezzjoni ta' Axumin.
English: For instructions on dilution of the medicinal product before administration, see section 12.
Maltese: Għal istruzzjonijiet fuq id-dilwizzjoni tal-prodott mediċinali qabel jingħata, ara sezzjoni 12.
English: University.
Maltese: KLINIKU
English: Advanced Accelerator Applications, 13005 Marseille, France Nucleis SA, 4000 Liège, Belgium
Maltese: Advanced Accelerator Applications, 13005 Marseille, Franza.
English: Axumin 3200 MBq/mL solution for injection 10 hours from the time of calibration (ToC)
Maltese: Axumin 3200 MBq/mL soluzzjoni għall-injezzjoni 10 sigħat mill-ħin tal-kalibrazzjoni (ToC)
English: Organ uptake
Maltese: Organu/Tessut
English: Histopathology standard of truth data was available for 99 of the 115 subjects.
Maltese: Data istopatoloġika li tirrifletti l-istandard veritier (standard of truth) kienet disponibbli għal 99 mill115-il individwu.
English: Adrenal glands Brain
Maltese: Glandoli adrenali
English: - The other ingredients are sodium citrate, concentrated hydrochloric acid, sodium hydroxide, water for injections (see section 2 "Axumin contains sodium")
Maltese: - Is-sustanzi mhux attivi l-oħra huma sodium citrate, hydrochloric acid konċentrat, sodium hydroxide, ilma għall-injezzjonijiet (ara sezzjoni 2 “Axumin fih is-sodju”).
English: Axumin is indicated for Positron Emission Tomography (PET) imaging to detect recurrence of prostate cancer in adult men with a suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment.
Maltese: Axumin huwa indikat għat-teħid ta' immaġni permezz ta' Tomografija b'Emissjoni ta' Pożitroni (PET, Positron Emission Tomography) għall-iskoperta tar-rikorrenza tal-kanċer tal-prostata fl-irġiel adulti b'rikorrenza ssuspettata abbażi ta' livelli għoljin tal-antiġen speċifiku tal-prostata (PSA, prostate specific antigen) fid-demm wara l-kura primarja.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in sections 6.6 and 12.
Maltese: Dan il-prodott mediċinali m'għandux jitħallat ma' prodotti mediċinali oħrajn ħlief dawk imsemmija f'sezzjonijiet 6.6 u 12.
English: Axumin 1600 MBq/mL solution for injection One vial contains 1 to 10 mL of solution, corresponding to 1600 to 16000 MBq at calibration time.
Maltese: Kunjett wieħed fih soluzzjoni ta'1 sa 10 mL, li tikkorrispondi għal 1600 sa 16000
English: Extraprostatic (pelvic and distal recurrence)
Maltese: (rikorrenza pelvika u distali)
English: PET scanning should begin from 3-5 minutes (target 4 minutes) after completion of the injection; an acquisition time of 3 minutes per bed position is recommended.
Maltese: L-iskenjar PET għandu jibda minn 3-5 minuti (mira 4 minuti) wara t-tlestija tal-injezzjoni; huwa rrakkomandat ħin ta' akkwiżizzjoni ta' 3 minuti għal kull pożizzjoni fuq is-sodda tal-iskaner.
English: Adequate shielding is mandatory.
Maltese: Protezzjoni adegwata hija mandatorja.
English: The quantity to be administered usually recommended for an adult is 370 MBq (megabecquerel, the unit used to express radioactivity).
Maltese: 370 MBq (megabecquerel, l-unità li tintuża biex tiġi espressa r-radjuattività).
English: Table 3: Estimated radiation absorbed doses for adults receiving Axumin Organ/Tissue
Maltese: Tabella 3: Dożi stmati assorbiti mir-radjazzjoni għal adulti li jkunu qed jirċievu Axumin
English: Urinary excretion is slow, reaching approximately 3% of administered radioactivity within 4 hours and 5% within 24 hours.
Maltese: L-eliminazzjoni bl-awrina hija bil mod u tilħaq madwar 3 % tar-radjuattività mogħtija f'4 sigħat u 5 % f'24 siegħa.
English: Thymus gland Thyroid
Maltese: Seibersdorf L-AWSTRIJA
English: Diagnostic performance of fluciclovine (18F) to detect recurrences has not been investigated in patients with a suspected recurrence based on elevated blood PSA levels after primary radical treatment with a recent positive whole-body bone scintigraphy.
Maltese: Il-prestazzjoni dijanjostika ta' fluciclovine (18F) għall-iskoperta ta' rikorrenzi ma ġietx investigata f'pazjenti b'suspett ta' rikorrenza abbażi ta' livelli elevati tal-PSA fid-demm wara kura primarja radikali b' scintigraphy riċenti pożittiva tal-għadam tal-ġisem kollu.
English: Fluciclovine (18F) accumulates in prostate cancer and other types of cancer but also in normal tissues and some other prostate pathologies (such as benign prostatic hyperplasia, chronic prostatitis, high grade prostatic intraepithelial hyperplasia).
Maltese: It-teħid ta' fluciclovine (18F) mhuwiex speċifiku għall-kanċer tal-prostata u jista' jsir ma' tipi oħrajn tal-kanċer, prostatite u iperplasija beninna tal-prostata (benign prostatic hyperplasia).
English: After administration of Axumin you should:
Maltese: Tużax Axumin:
English: Axumin 1600 MBq/mL solution for injection fluciclovine (18F)
Maltese: MBq/mL soluzzjoni għall-injezzjoni fluciclovine (18F)
English: Pelvic lymph nodes
Maltese: Waqt l-użu
English: PET images with fluciclovine (18F) should be interpreted visually.
Maltese: PET bi fluciclovine (18F).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Axumin in one or more subsets of the paediatric population in diagnosis of amino acid metabolism in solid tumours (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddiferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'Axumin f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika fid-dijanjożi tal-metaboliżmu tal amino aċidi f'tumuri solidi (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Breasts
Maltese: Belġju
English: This medicine contains up to 39 mg sodium per dose.
Maltese: Din il-mediċina fiha sa 39 mg ta' sodju għal kull doża.
English: Red bone marrow Osteogenic cells Skin
Maltese: Kliewi Fwied Pulmun Muskoli Ovarji Frixa
English: Radiation protection precautions in accordance with national regulations must therefore be taken.
Maltese: protezzjoni kontra r-radjazzjoni f'konformità mar-regolamenti nazzjonali.
English: Axumin 1600 MBq/mL solution for injection 8 hours from the time of calibration (ToC)
Maltese: MBq/mL soluzzjoni għall-injezzjoni 8 sigħat mill-ħin tal-kalibrazzjoni (ToC)
English: This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities.
Maltese: Dan il-prodott radjofarmaċewtiku ser jipprovdi ammonti baxxi ta' radjazzjoni ionising assoċjata malinqas riskju ta' kanċer u ta' anormalitajiet ereditarji.
English: Pharmacodynamic effects At the chemical concentrations used for diagnostic examinations, fluciclovine (18F) does not appear to have any pharmacodynamic activity.
Maltese: Fil-konċentrazzjonijiet kimiċi użati għall-eżaminazzjonijiet dijanjostiċi, fluciclovine (18F) ma jidhirx li għandu xi attività farmakodinamika.
English: Fluciclovine (18F) PET-CT was restricted to the abdomino-pelvic region.
Maltese: PET-CT bi fluciclovine (18F) kien ristrett għar-reġjun addominali-pelviku.
English: Prior to launch of Axumin in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme with the National Competent Authority.
Maltese: Qabel it-tnedija ta' Axumin f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fisSuq (MAH) irid jaqbel fuq il-kontenut u l-format tal-programm edukattiv mal-Awtorità Nazzjonali Kompetenti.
English: Dysgeusia
Maltese: Zaragoza
English: The pivotal efficacy data derives from 115 patients recruited into the BED-001 study at Emory
Maltese: Id-dejta pivotali tal-effikaċja hija miksuba minn 115-il pazjent li ġew reklutati fl-istudju BED-001fl
English: The activities of LAT-1 and ASCT2 are known to be upregulated in prostate cancer, providing a mechanism for the enhanced accumulation of fluciclovine (18F) in prostate cancer.
Maltese: ASCT2 huma magħrufa li jiġu regolati 'l fuq (“upregulated”) fil-kanċer tal-prostata, u b'hekk jipprovdu mekkaniżmu għall-akkumulazzjoni mtejba ta' fluciclovine (18F) fil-kanċer tal-prostata.
English: The patient-based sensitivity of fluciclovine (18F) was higher than
Maltese: Is-sensittività ta' fluciclovine (18F)
English: Please refer to the SmPC [SmPC should be included in the box]
Maltese: [L-SmPC għandu jkun inkluż fil-kaxxa]
English: Image interpretation errors can occur with PET with fluciclovine (18F) (see section 5.1).
Maltese: Jistgħu jsiru żbalji fl-interpretazzjoni tal-immaġni b'PET bi fluciclovine (18F) (ara sezzjoni 5.1).
English: Ιreland
Maltese: OĦRAJN
English: Fluciclovine (18F) distributes immediately following administration to the liver (14% of administered activity), pancreas (3%), lung (7%), red bone marrow (12%) and heart wall (4%).
Maltese: fil-frixa (3 %), fil-pulmun (7 %) fil-mudullun aħmar (12 %) u fil-ħajt tal-qalb (4 %). Fluciclovine ma jiġix inkorporat fil-proteini.
English: Toxicity with repeated administration of up to 1000 mcg/kg/day over 14 days in rats and dogs was not observed.
Maltese: Ma kinitx osservata tossiċità b'għoti repetut sa 1000 mcg/kg/jum fuq 14-il ġurnata fil-firien u l-klieb.
English: Each mL of solution contains 3200 MBq of fluciclovine (18F) at the date and time of calibration (ToC).
Maltese: Kull mL ta' soluzzjoni fih 3200 MBq fluciclovine (18F) fid-data u l-ħin tal-kalibrazzjoni (ToC).
English: Patients were adult and elderly men presenting with suspected recurrence, based on elevated blood PSA levels after primary curative treatment of localized prostate cancer and with negative bone scintigraphy.
Maltese: abbażi ta' livelli elevati tal-PSA fid-demm wara trattament kurattiv primarju ta' kanċer tal-prostata lokalizzat u b'xintigrafija tal-għadam negattiva.
English: Effect of blood PSA level on the patient-based diagnostic performance of fluciclovine (18F) PET-CT at BED-001 Emory
Maltese: Tabella 2: L-effett tal-livell tal-PSA fid-demm fuq il-prestazzjoni dijanjostika ta' PET-CT bi fluciclovine (18F) bbażata fuq il-pazjent f'BED-001 Emory
English: A quantitative correlation between fluciclovine uptake and enhanced fluciclovine influx into cells was not assessed in vivo in healthy volunteers or prostate cancer patients.
Maltese: Korrelazzjoni kwantitattiva bejn it-teħid ta' flucicovine u l-influss miżjud ta' fluciclovine fiċ-ċelluli ma ġietx ivvalutata in vivo f'voluntiera b'saħħithom jew f'pazjenti tal-kanċer tal-prostata.
English: For sodium, see leaflet for further information.
Maltese: Għas-sodju, ara l-fuljett għal aktar informazzjoni.
English: Axumin contains sodium
Maltese: Kif jidher Axumin u l-kontenut tal-pakkett
English: Axumin 3200 MBq/mL solution for injection
Maltese: Axumin 3200 MBq/mL soluzzjoni għall-injezzjoni
English: Paediatric population There is no relevant use of fluciclovine (18F) in the paediatric population.
Maltese: M'hemm l-ebda użu rilevanti ta' fluciclovine (18F) fil-popolazzjoni pedjatrika.
English: Interpretation of fluciclovine (18F) images and limitations of use Fluciclovine (18F) images should be interpreted by appropriately trained personnel.
Maltese: Intepretazzjoni tal-immaġnijiet ta' fluciclovine (18F) u limitazzjonijiet tal-użu
English: The impact of quantitative/semiquantitative measurement of fluciclovine (18F) uptake as an aid to image interpretation has not been assessed.
Maltese: L-impatt tal-kejl kwantitattiv/semi-kwantitattiv tat-teħid ta' fluciclovine (18F) bħala għajnuna għallinterpretazzjoni tal-immaġni ma ġiex ivvalutat.
English: Axumin 3200 MBq/mL solution for injection One vial contains 1 to 10 mL of solution, corresponding to 3200 to 32000 MBq at calibration time.
Maltese: Kunjett wieħed fih soluzzjoni ta'1 sa 10 mL, li tikkorrispondi għal 3200 sa 320000
English: The impact of anti-mitotic agents and colony stimulating factors on uptake of fluciclovine in patients with prostate cancer has not been studied.
Maltese: L-impatt ta' aġenti antimitotiċi u l-fatturi li jistimulaw il-kolonji (colony stimulating factors) fuq it teħid ta' fluciclovine f'pazjenti bil-kanċer tal-prostata ma ġiex studjat.
English: Chemical and physical in-use stability has been demonstrated for Axumin 1600 MBq/mL for 8 hours and for Axumin 3200 MBq/mL for 10 hours.
Maltese: L-istabilità kimika u fiżika waqt l-użu ntweriet għal 8 sigħat għal Axumin 1600
English: The recommended maximum volume of injection of undiluted Axumin is 5 mL.
Maltese: Il-volum massimu tal-injezzjoni rakkomandat ta' Axumin mhux dilwit hu ta' 5 mL.
English: The MAH shall ensure that in each Member State where Axumin is marketed, all Healthcare professionals who are expected to use Axumin have access to self-training educational material in order to reduce the risk of PET imaging interpretation errors.
Maltese: Il-MAH għandu jiżgura li f'kull Stat Membru fejn Axumin huwa kkummerċjalizzat, il-Professjonisti tal-kura tas-saħħa kollha li huma mistennija li jużaw Axumin ikollhom aċċess għal materjal edukattiv ta' taħriġ personali sabiex jitnaqqas ir-riskju ta' żbalji fl-interpretazzjoni ta' immaġni PET
English: Each mL of solution for injection contains 3200 MBq of fluciclovine (18F) at date and time of calibration (ToC).
Maltese: Kull mL ta' soluzzjoni għall-injezzjoni fih 3200 MBq ta' fluciclovine (18F) fid-data u l-ħin talkalibrazzjoni (ToC).
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 tal-għoti għandhom jitwettqu b'mod li jiġi mminimizzat ir-riskju ta' kontaminazzjoni tal prodott mediċinali u irradjazzjoni tal-operaturi.
English: Pharmacotherapeutic group: Other diagnostic radiopharmaceuticals for tumour detection, ATC code:
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: Fluorine (18F) decays to stable oxygen (18O) with a half-life of 110 minutes by emitting a positronic radiation of maximum energy of 634 keV, followed by photonic annihilation radiations of 511 keV.
Maltese: Fluorine (18F) jiddekomponi (decays) għal ossiġenu stabbli (18O) b'half-life ta' 110 minuti permezz ta'
English: Each mL of solution contains 3200 MBq fluciclovine (18F) at date and time of calibration (ToC).The activity per vial ranges from 3200 MBq to 32000 MBq at the date and time of calibration.
Maltese: Axumin 3200 MBq/mL soluzzjoni għall-injezzjoni Kull mL ta' soluzzjoni fih 3200 MBq ta' fluciclovine (18F) fid-data u l-ħin tal-kalibrazzjoni (ToC).
English: How Axumin is stored 6.
Maltese: Kif taħżen Axumin 6.
English: Gallbladder wall Lower large intestine wall Small intestine wall Stomach wall Upper large intestine wall Heart wall
Maltese: Il-professjonisti tal-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: Adverse reactions were reported commonly (≥ 1/100 to < 1/10) during clinical trials.
Maltese: Matul il-provi kliniċi, ir-reazzjonijiet avversi ġew rrappurtati b'mod komuni (≥ 1/100 sa < 1/10).
English: From a microbiological point of view, unless the method of opening/ dose withdrawal/dilution precludes the risk of microbiological contamination, the product should be used immediately.
Maltese: Mil-lat mikrobijoloġiku, jekk il-metodu tal-ftuħ/it-twaqqif tad-doża/id-dilwizzjoni ma jipprekludix ir riskju ta' kontaminazzjoni mikrobijoloġika, il-prodott għandu jintuża immedjatament.
English: An additional study BED002 conducted a blinded read of fluciclovine (18F) PET-CT images from the
Maltese: Il-valur tal-PSA jista' jaffettwa l-prestazzjoni dijanjostika ta' PET bi fluciclovine (18F) (ara sezzjoni 5
English: Blinded reads were compared with the histopathological standard of truth.
Maltese: Ir-riżultati tal-qari blinded tqabblu mal-istandard istopatoloġiku veritier.
English: Effective dose
Maltese: Ġisem kollu Doża effettiva