FrancophonIA/ELRC3.0 huggingface dataset:
English: The proportion of patients with a recurrence of aTTP (exacerbation or relapse) in the overall study period (including the 28 day follow-up after discontinuation of study drug treatment) was 67% lower in the caplacizumab group (9/72; relapse : 6/72) compared to the placebo group (28/73; relapse 0/73) (p<0.001).
Maltese: Il-proporzjon ta' pazjenti b'rikorrenza ta' aTTP (tmur għall-agħar jew rikaduta) fil-perjodu totali talistudju (inkluż il-perjodu ta' segwitu ta' 28 jum wara t-twaqqif tat-trattament bil-mediċina tal-istudju) kien 67% iktar baxx fil-grupp ta' caplacizumab (9/72; rikaduta: 6/72) meta mqabbel mal-grupp talplaċebo (28/73; rikaduta: 0/73) (p<0.
English: In clinical studies, up to 9% of patients developed treatment-emergent anti-drug antibodies (ADA).
Maltese: Fi studji kliniċi, sa 9% tal-pazjenti żviluppaw antikorpi kontra l-mediċina (ADA, anti-drug antibodies) li jirriżultaw mit-trattament.
English: The pharmacokinetics of caplacizumab were determined using a population pharmacokinetic analysis on pooled pharmacokinetic data.
Maltese: Il-farmakokinetika ta' caplacizumab ġiet stabbilita bl-użu ta' analiżi farmakokinetika tal-popolazzjoni minn dejta ta' farmakokinetika miġbura.
English: For storage conditions of the reconstituted medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet tal-ħażna tal-prodott mediċinali rikostitwit, ara sezzjoni 6.3.
English: Cablivi contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol (23 mg) sodium f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Cablivi is indicated for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression.
Maltese: Cablivi huwa indikat għat-trattament ta' pazjenti adulti li jkollhom episodju ta' purpura tromboċitopenika trombotika akkwiżita (aTTP, acquired thrombotic thrombocytopenic purpura), flimkien ma' skambju tal-plażma u immunosoppressjoni.
English: Allow the vial with connected syringe to stand on a surface for 5 minutes at room temperature.
Maltese: Wieħed għandu jħalli l-kunjett bis-siringa mwaħħla wieqaf fuq xi wiċċ ċatt għal 5 minuti f'temperatura tal-kamra.
English: Treatment with caplacizumab resulted in a statistically significant reduction in time to platelet count response (p<0.01).
Maltese: It-trattament b'caplacizumab wassal għal tnaqqis statistikament sinifikanti fiż-żmien għar-rispons talgħadd tal-plejtlits (p<0.01).
English: In clinical studies, bleeding events occurred in different body systems, independent of treatment duration.
Maltese: Fi studji kliniċi, episodji ta' fsada seħħew f'sistemi differenti tal-ġisem , indipendenti mit-tul tattrattament.
English: In repeat-dose toxicity tests in cynomolgus monkeys, no impact of caplacizumab on fertility parameters in male (testicular size, sperm function, histopathological analysis of testis and epididymis) and female (histopathological analysis of reproductive organs, periodic vaginal cytology) animals was observed.
Maltese: F'testijiet tat-tossiċità minn dożi ripetuti f'xadini cynomolgus, ma kien osservat l-ebda impatt ta' caplacizumab fuq il-parametri tal-fertilità f'annimali rġiel (daqs testikolari, funzjoni talisperma, analiżi istopatoloġika tat-testikoli u tal-epididimi) u f'annimali nisa (analiżi istopatoloġika tal-organi riproduttivi, ċitoloġija vaġinali perjodika).
English: • If the kit was not stored at room temperature, allow the vial and the syringe to reach room temperature (15°C - 25°C) by letting them stand at room temperature for a few minutes.
Maltese: • Jekk is-sett ma kienx maħżun fit-temperatura tal-kamra, ħalli l-kunjett u s-siringa jilħqu t temperatura tal-kamra (15°C - 25°C) billi tħallihom wieqfa f'temperatura tal-kamra għal ftit minuti.
English: * Caplacizumab is a humanised bivalent Nanobody produced in Escherichia coli by recombinant DNA technology.
Maltese: * Caplacizumab huwa Nanobody bivalenti umanizzat prodott f'Escherichia coli minn teknoloġija ta' DNA rikombinanti.
English: Renal And Urinary Disorders
Maltese: Indeboliment renali
English: Upon repeated administration of caplacizumab, a decrease of 30-50% in von Willebrand factor antigen levels was observed in clinical studies, reaching a maximum within 1-2 days of treatment.
Maltese: Fl-istudji kliniċi, wara għoti ripetut ta' caplacizumab, kien osservat tnaqqis ta' 30-50% fil-livelli tal-antiġen tal-fattur von Willebrand, fejn il-massimu ntlaħaq fi żmien ġurnata sa jumejn mittrattament.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Multipack: 7 packs of 1 single dose kit.
Maltese: U KONTENUT Trab u solvent għal soluzzjoni għall-injezzjoni Pakkett multiplu: 7 pakketti ta' doża waħda kull wieħed.
English: • bruise
Maltese: • puplesija
English: 1 vial with powder 1 syringe with solvent 1 sterile vial adapter 1 sterile needle 2 alcohol swabs
Maltese: • Pakkett wieħed waħdu li fih kunjett 1 bit-trab, siringa 1 mimlija għal-lest bis-solvent, adapter 1
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu/
English: Step 6 - Connect syringe with adapter and vial
Maltese: Pass 6 - Qabbad is-siringa mal-adapter u l-kunjett
English: No interaction studies evaluating use of caplacizumab with oral anticoagulants (e.g. vitamin K antagonists, direct oral anticoagulants [DOAC] such as thrombin inhibitors or factor Xa inhibitors) or high dose heparin have been performed (See section 4.4 In the setting of concomitant use of oral anticoagulants or high dose heparin).
Maltese: Ma twettaq l-ebda studju ta' interazzjoni li jevalwa l-użu ta' caplacizumab ma' antikoagulanti orali (eż. antagonisti ta' vitamina K, jew antikoagulanti orali diretti [DOAC] bħal inibituri ta' thrombin jew inibituri ta' fattur Xa) jew eparina b'doża qawwija (Ara sezzjoni 4.4
English: In studied populations; gender, age, blood group and race did not affect the pharmacokinetics of caplacizumab.
Maltese: Fil-popolazzjonijiet studjati; is-sess talpersuna, l-età, il-grupp tad-demm u r-razza, ma affettwawx il-farmakokinetika ta' caplacizumab.
English: Pharmacotherapeutic group: Other antithrombotic agents, ATC code: B01AX07.
Maltese: Sustanzi antitrombotiċi oħra, Kodiċi ATC:
English: Consistent with its mode of action, toxicology studies of caplacizumab have shown an increased bleeding tendency in guinea pigs (haemorrhagic subcutaneous tissue at the injection sites) and cynomolgus monkeys (haemorrhagic subcutaneous tissue at the injection sites, nose bleed, exaggerated menstrual bleeding, haematoma at sites of animal handling or experimental procedures, prolonged bleeding at injection sites).
Maltese: B'mod konsistenti mal-mod ta' azzjoni tiegħu, l-istudji tossikoloġiċi dwar caplacizumab urew żieda fit-tendenza ta' fsada fil-fniek tal-Indi (emorraġija fit-tessut ta' taħt il-ġilda fis-siti tal-injezzjoni) u f'xadini cynomolgus (emorraġija fit-tessut ta' taħt il-ġilda fis-siti tal-injezzjoni, ħruġ ta' demm millimnieħer, ħruġ ta' demm esaġerat tal-menstrwazzjoni, ematoma fis-siti fejn ġew immaniġġjati lannimali jew fis-siti ta' proċeduri sperimentali, ħruġ ta' demm fit-tul fis-siti tal-injezzjoni).
English: • Check the expiry date.
Maltese: • Iċċekkja d-data tal-iskadenza.
English: As a precautionary measure, it is preferable to avoid the use of Cablivi during pregnancy.
Maltese: Bћala miżura ta' prekawzjoni, hu preferribbli li jkun evitat l-użu ta' Cablivi waqt it-tqala.
English: Because von Willebrand factor acts as a carrier for factor VIII, reduced von Willebrand factor antigen levels resulted in a similar reduction in factor VIII:C levels.
Maltese: Minħabba li l-fattur von Willebrand jaġixxi bħala trasportatur tal-fattur VIII, il-livelli mnaqqsa tal-antiġen tal-fattur von Willebrand irriżultaw fi tnaqqis simili fil-livelli tal-fattur VIII:C.
English: Leave the adapter in its opened plastic packaging.
Maltese: Ħalli l-adapter fl-ippakkjar tal plastik miftuħ tiegħu.
English: 7 vials with powder 7 syringes with solvent 7 sterile vial adapters 7 sterile needles 14 alcohol swabs
Maltese: 7 adapters tal-kunjett sterili 7 labar sterili
English: Cablivi may be stored at a temperature not above 25 °C for a single period of up to 2 months, but not beyond the expiry date.
Maltese: Cablivi jista' jinħażen f'temperatura ta' mhux iktar minn 25°C għal perjodu wieħed ta' mhux aktar minn xahrejn, iżda li ma jaqbiżx id-data ta' skadenza.
English: The median treatment duration with caplacizumab in the double blind period was 35 days.
Maltese: It-tul medjan tat-trattament b'caplacizumab fil-perjodu double blind kien ta' 35 jum.
English: The pharmacokinetics of caplacizumab depend on the expression of the target von Willebrand factor.
Maltese: Il-farmakokinetika ta' caplacizumab tiddependi fuq l-espressjoni tal-objettiv, il-fattur von Willebrand.
English: In the clinical development program, caplacizumab has been administered daily for up to 65 days.
Maltese: Fil-programm ta' żvilupp kliniku, caplacizumab ingħata kuljum għal massimu ta' 65 jum.
English: NAME OF THE MEDICINAL PRODUCT Cablivi 10 mg powder and solvent for solution for injection
Maltese: IL-PRODOTT MEDIĊINALI Cablivi 10 mg trab u solvent għal soluzzjoni għall-injezzjoni
English: Children and adolescents Cablivi is not recommended for children under 18 years.
Maltese: Tfal u adolexxenti Cablivi mhuwiex rakkomandat għal tfal u adolexxenti taħt it-18-il sena.
English: The pharmacologic effect of caplacizumab on target disposition was measured using von Willebrand factor antigen and factor VIII clotting activity (factor VIII:C) as biomarkers.
Maltese: L-effett farmakoloġiku ta' caplacizumab fuq id-dispożizzjoni mmirata kien imkejjel bl-użu tal-antiġen tal-fattur von Willebrand u l-attività tal-koagulazzjoni tad-demm tal-fattur VIII (fattur VIII:C) bħala bijomarkaturi.
English: Willebrand factor antigen, and consequently factor VIII:C, were noted in cynomolgus monkeys and, to a lesser extent for factor VIII:C, in guinea pigs.
Maltese: Barra minn hekk, nuqqasijiet relatati mal-farmakoloġija fl-antiġen tal-fattur von Willebrand, u konsegwentement fil-fattur VIII:C, kienu osservati fix-xadini cynomolgus u, sa ċertu punt għall-fattur VIII:C, fil-fniek tal-Indi.
English: • are going to have an operation or dental treatment.
Maltese: • se tagħmel operazzjoni jew trattament tas-snien.
English: In this double-blind, placebo-controlled study, patients with an episode of aTTP were randomised 1:1 to receive either caplacizumab or placebo in addition to daily plasma exchange and immunosuppression.
Maltese: F'dan l-istudju double-blind u kkontrollat bil-plaċebo, pazjenti b'episodju ta' aTTP intgħażlu b'mod każwali fi proporzjon ta' 1:1 biex jirċievu jew caplacizumab jew plaċebo minbarra skambju tal-plażma ta' kuljum u immunosoppressjoni.
English: In healthy volunteers receiving 10 mg caplacizumab subcutaneoulsy once daily, the maximum concentration was observed at 6-7 hours post-dose and steady-state was reached following the first administration, with minimal accumulation.
Maltese: F'voluntiera b'saħħithom li kienu qed jirċievu 10 mg ta' caplacizumab taħt il-ġilda darba kuljum, il-konċentrazzjoni massima kienet osservata 6-7 sigħat wara d-doża, u l-istat fiss intlaħaq wara l-ewwel għoti, b'akkumulazzjoni minima.
English: Marketing Authorisation Holder and Manufacturer Ablynx NV
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Ablynx NV
English: In the clinical studies of patients with TTP, those with renal impairment did not show additional risk of adverse events.
Maltese: Fi studji kliniċi dwar pazjenti b'TTP, dawk b'indeboliment renali ma wrewx riskju addizzjonali ta' episodji avversi.
English: In the setting of concomitant use of anti-platelet agents and / or low molecular weight heparin (LMWH)
Maltese: Fl-ambitu ta' użu fl-istess ħin ta' sustanzi kontra l-plejtlits u/jew eparina b'piż molekulari baxx (LMWH, low molecular weight heparin)
English: Each vial contains 10 mg caplacizumab.
Maltese: - Kull kunjett fih 10 mg ta' caplacizumab.
English: • pre-filled syringe The pre-filled syringe contains 1 mL water for injections.
Maltese: • Iċċekkja l-kontenut tas-siringa.
English: No patients treated with caplacizumab (0/72) were refractory to treatment (defined as absence of platelet count doubling after 4 days of standard treatment and elevated LDH) compared to three patients treated with placebo (3/73).
Maltese: L-ebda pazjent ittrattat b'caplacizumab (0/72) ma kellu ebda rispons għat-trattament (definit bħala nuqqas ta' għadd tal-plejtlits li jirdoppja wara 4 ijiem ta' trattament standard u żieda f'LDH) meta mqabbla mat-tliet pazjenti ttrattati bil-plaċebo (3/73).
English: In animal toxicology studies, no impact of caplacizumab on male and female fertility parameters was observed (see section 5.3).
Maltese: Fi studji tossikoloġiċi fuq lannimali, ma kien osservat l-ebda impatt fuq il-parametri tal-fertilità tal-irġiel u n-nisa (ara sezzjoni 5.3).
English: The reduced von Willebrand factor antigen and FVIII:C levels were transient and returned to baseline upon cessation of treatment.
Maltese: Il livelli mnaqqsa tal-antiġen tal-fattur von Willebrand u tal-FVIII:C kienu temporanji u reġgħu luragħal-livell fil-linja bażi hekk kif waqaf it-trattament.
English: Transfer the entire volume of the reconstituted solution back to the glass syringe and immediately administer the entire volume of the syringe (see section 6.3).
Maltese: Wieħed għandu jittrasferixxi l-volum sħiħ tas-soluzzjoni rikostitwita lura fis-siringa tal-ħġieġ u jagħti minnufih il-volum sħiħ tas-siringa (ara sezzjoni 6.3).
English: Pharmacokinetics of caplacizumab appear as non-dose proportional, as characterized by targetmediated disposition.
Maltese: Il-farmakokinetika ta' caplacizumab tidher bħala li mhijiex proporzjonali għad-doża, kif ikkaratterizzata mid-dispożizzjoni li hija mmirata.
English: hypodermic needle (30 gauge) and 2 alcohol swabs.
Maltese: tal-kunjett, labra 1 ipodermika (gejġ ta' 30) u 2 biċċiet tat-tajjar imxarrbin bl-alkoħol.
English: Do not use Cablivi
Maltese: Mediċini oħra u Cablivi
English: Step 3 - Disinfect the rubber stopper
Maltese: Pass 3 - Iddiżinfetta t-tapp tal-lastku
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1305/001
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1305/001 EU/1/18/1305/003 13.
English: The t1/2 of caplacizumab is, therefore, concentrationand target level-dependent.
Maltese: It-t1/2 ta' caplacizumab tiddependi, għalhekk, fuq il-livell tal- konċentrazzjoni u tal-objettiv.
English: Number of days in ICU
Maltese: U L-UŻU
English: • fever
Maltese: Fsada
English: The following information is intended for healthcare professionals only:
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ:
English: While no increased risk of bleeding was observed in clinical trials, concomitant treatment with antiplatelet agents and / or LMWH requires a benefit/risk assessment and close clinical monitoring.
Maltese: Filwaqt li ma kien osservat l-ebda żieda fir-riskju ta' fsada fil-provi kliniċi, it-trattament fl-istess ħin b'sustanzi kontra l-plejtlits u/jew LMWH jeħtieġ evalwazzjoni ta' benefiċċju/riskju u monitoraġġ kliniku mill-qrib.
English: Each vial of powder contains 10 mg of caplacizumab*.
Maltese: Kull kunjett ta' trab fih 10 mg ta' caplacizumab*.
English: Renal impairment No dose adjustment is necessary for patients with renal impairment (see section 5.2).
Maltese: L-ebda aġġustament fid-doża mhu meħtieġ għal pazjenti b'indeboliment renali (ara sezzjoni 5.2).
English: Pharmacokinetics in patients with aTTP were investigated upon single intravenous and repeated subcutaneous injections.
Maltese: Il-farmakokinetika f'pazjenti b'aTTP kienet investigata wara injezzjonijiet minn ġol-vini ta' darba u injezzjonijiet ripetuti minn taħt il-ġilda .
English: In patients with coagulopathies
Maltese: F'pazjenti b'koagulopatiji
English: Cablivi can be intravenously administered by connecting the prepared syringe to standard Luer locks of IV lines or using a suitable needle.
Maltese: Cablivi jista' jingħata minn ġol-vini billi tgħaqqad is-siringa ppreparata ma' Luer locks standard ta' linji tal-IV jew billi tuża labra xierqa.
English: • subsequent doses: - 1 vial once daily as a subcutaneous injection (under the skin of the belly) - the subcutaneous injection will be given after each daily plasma exchange - after the daily plasma exchange finishes, your treatment with Cablivi will continue for at least 30 days with injection of 1 vial once daily.
Maltese: • dożi sussegwenti: - kunjett 1 darba kuljum bħala injezzjoni taħt il-ġilda (taħt il-ġilda taż-żaqq) - l-injezzjoni taħt il-ġilda se tingħata wara kull skambju tal-plażma ta' kuljum - wara li jkun lest l-iskambju tal-plażma ta' kuljum, it-trattament tiegħek b'Cablivi se jkompli għal mill-inqas 30 jum b'injezzjoni ta' kunjett wieħed darba kuljum.
English: • black, tarry stools
Maltese: • ippurgar iswed, qisu qatran
English: Common, may affect up to 1 in 10 people
Maltese: Komuni, jistgħu jaffettwaw sa 1 minn kull 10 persuni
English: Higher levels of von Willebrand factor antigen, such as in patients with aTTP, increase the fraction of drug-target complex retained in the circulation.
Maltese: Livelli ogħla tal-antiġen tal-fattur von Willebrand, bħal ma jiġri f'pazjenti b'aTTP, iżidu l-frazzjoni tal-kumpless mediċina-objettiv li jkun hemm fiċ-ċirkolazzjoni.
English: • Make sure the kit package is complete.
Maltese: • Kun ċert li l-pakkett tas-sett ikun sħiħ.
English: • powder vial The active substance is caplacizumab.
Maltese: L-ebda dejta dwar it-trattament mill-ġdid b'caplacizumab mhi disponibbli.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON NAME OF THE MEDICINAL PRODUCT Cablivi 10 mg powder and solvent for solution for injection caplacizumab
Maltese: IL-PRODOTT MEDIĊINALI Cablivi 10 mg trab u solvent għal soluzzjoni għall-injezzjoni caplacizumab
English: • single packs each containing 1 vial with caplacizumab powder, 1 pre-filled syringe with solvent, 1 vial adapter, 1 needle and 2 alcohol swabs
Maltese: • f'pakketti waħidhom li kull wieħed fih kunjett 1 bit-trab ta' caplacizumab, siringa 1 mimlija għal-lest bis-solvent,adapter 1 tal-kunjett, labra 1 u 2 biċċiet tat-tajjar imxarrbin bl-alkoħol
English: • first dose - 1 vial injected into a vein by a healthcare professional - the medicine will be given before starting plasma exchange
Maltese: • kunjett 1 injettat ġo vina minn professjonist fil-kura tas-saħħa - il-mediċina se tingħata qabel ma jinbeda l-iskambju tal-plażma
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 mL water for injections
Maltese: INDIVIDWALI 1 ml ta' ilma għall-injezzjonijiet
English: If a recurrence occurred while on study drug treatment, patients were switched to open-label caplacizumab.
Maltese: Jekk tkun seħħet rikorrenza waqt li l-pazjent kien fuq it-trattament bil-mediċina tal-istudju, il-pazjenti ġew maqluba fuq caplacizumab open-label.
English: Daily subcutaneous administration of 10 mg of caplacizumab after completion of each plasma exchange for the duration of daily plasma exchange treatment, followed by daily subcutaneous injection of 10 mg of caplacizumab for 30 days after stopping daily plasma exchange treatment.
Maltese: Waqt it-trattament ta' kuljum tal-iskambju tal-plażma, jingħata 10 mg ta' caplacizumab kuljum minn taħt il-ġilda wara kull għotja ta' skambju tal-plażma, segwit minn injezzjoni minn taħt il-ġilda ta' kuljum ta' 10 mg ta' caplacizumab għal 30 jum wara t-twaqqif tat-trattament ta' kuljum ta' skambju tal-plażma.
English: • if you are allergic to caplacizumab or any of the other ingredients in this medicine (listed in section 6)
Maltese: • jekk inti allerġiku għal caplacizumab jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fissezzjoni 6).
English: As such, caplacizumab prevents the ultralarge von Willebrand factor-mediated platelet adhesion, which is characteristic of aTTP.
Maltese: Tista' wkoll tirrapporta effetti sekondarji direttament permezz tas-sistema ta' rappurtar nazzjonali mniżżla f'Appendiċi V.
English: • vaginal bleeding
Maltese: • demm fl-ippurgar
English: Cablivi may be stored at room temperature (not above 25 °C) for a single period of up to 2 months.
Maltese: Cablivi jista'jinħażen fit-temperatura tal-kamra (mhux iktar minn 25°C) għal perjodu wieħed ta' mhux aktar minn xahrejn.
English: If at the end of this period there is evidence of unresolved immunological disease, it is recommended to optimise the immunosupression regimen and continue daily subcutaneous administration of 10 mg of caplacizumab until the signs of underlying immunological disease are resolved (e.g. sustained normalisation of ADAMTS13 activity level).
Maltese: Jekk lejn it-tmiem ta' dan il-perjodu jkun hemm evidenza ta' marda immunoloġika mhux solvuta, huwa rakkomandat li wieħed jottimizza l-kors ta' immunosoppressjoni u jkompli l-għoti ta' kuljum minn taħt il-ġilda ta' 10 mg ta' caplacizumab sakemm is-sinjali tal-marda immunoloġika li kienet għaddejja fl-istess ħin ma jidhrux aktar (eż. normalizzazzjoni sostnuta tal-livell ta' attività ADAMTS13).
English: Studies in guinea pigs showed no effect of caplacizumab on the dams or foetuses (see section 5.3).
Maltese: L-ebda aġġustament fid-doża mhu meħtieġ għal pazjenti b'indeboliment epatiku (ara sezzjoni 5.2).
English: Neuraceq florbetaben (
Maltese: Sommarju tal-EPAR għall-pubbliku florbetaben (
English: The full EPAR and risk management plan summary for Neuraceq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Neuraceq
Maltese: Informazzjoni oħra dwar Neuraceq
English: This is a summary of the European public assessment report (EPAR) for Neuraceq.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Neuraceq.
English: The type of scan used with Neuraceq is called positronemission tomography (PET).
Maltese: It-tip ta' skan li jintuża b'Neuraceq jissejjaħ tomografija bl-emissjoni tal-positroni (PET).
English: Neuraceq has been investigated in one main study involving 216 volunteers divided into two groups: a group of healthy young people and a group of patients nearing the end of their lives who had consented to autopsies when they died; 41 volunteers (10 healthy young people and 31 patients) completed the study and were included in the results.
Maltese: Neuraceq ġie investigat fi studju ewlieni li fih ħadu sehem 216-il voluntier diviżi f'żewġ gruppi: grupp ta' żgħażagħ b'saħħithom u grupp ta' pazjenti li kienu qorbu lejn tmiem ħajjithom li kienu taw ilkunsens tagħhom għal awtopsji wara mewthom; 41 voluntier (10 żgħażagħ b'saħħithom u 31 pazjent) temmew l-istudju u ġew inklużi fir-riżultati.
English: When the results of the autopsies were compared with the PET scans, the scans were shown to have a sensitivity of 77.4% and a specificity of 94.2%.
Maltese: Meta r-riżultati tal-awtopsji ġew imqabbla mal-PET skans, l-iskans intwerew li kellhom sensittività ta' 77.4% u speċifiċità ta' 94.2%.
English: Why is Neuraceq approved?
Maltese: Għalxiex ġie approvat Neuraceq?
English: The medicine is given by injection into a vein about 90 minutes before obtaining an image from a PET scan.
Maltese: Ilmediċina tingħata permezz ta' injezzjoni ġo vina madwar 90 minuta qabel ma tinkiseb immaġini minn PET skan.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Neuraceq on 20 February 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Neuraceq fl-20 ta' Frar 2014.