FrancophonIA/ELRC3.0 huggingface dataset:
English: • Amendment to the section 4.1 to advise that “Treatment should be under the supervision of a specialist in childhood and/or adolescent behavioural disorders.” and that “Dexamfetamine is not indicated in all children with ADHD and the decision to use dexamfetamine must be based on a very thorough assessment of the severity and chronicity of the child's symptoms in relation to the child's age and potential for abuse, misuse or diversion.”
Maltese: • Emenda fis-sezzjoni 4.1 biex jingħata parir li "L-kura għandha tkun taħt is-sorveljanza ta' speċjalist f'disturbi fl-imġiba tat-tfal u l-adolexxenti." u li "Dexamfetamine mhuwiex indikat fittfal kollha b'ADHD u d-deċiżjoni biex jintuża dexamfetamine għandha tkun ibbażata fuq valutazzjoni bir-reqqa ħafna tas-severità u l-kroniċità tas-sintomi tat-tifel/tifla fir-rigward taletà tat-tifel/tifla u l-potenzjal għal abbuż, użu ħażin jew devjazzjoni."
English: During the procedure the MAH conducted further research in the literature, online, in databases from European Health Authorities and WHO and its own safety database.
Maltese: Matul il-proċedura, l-MAH wettaq riċerka ulterjuri fid-dokumentazzjoni, online, fid-databases millAwtoritajiet Ewropej tas-Saħħa u d-WHO u d-database tas-sigurtà tagħha stess.
English: The CHMP took note of the fact that the proposed RMP is in line with existing risk management plans for other stimulants (methylphenidate and lisdexamfetamine), and also that dexamfetamine-containing products have been available in the EU for several decades without a risk management plan.
Maltese: Is-CHMP ħa nota tal-fatt li l-RMP proposta hija f'konformità mal-pjanijiet ta' ġestjoni tar-riskju eżistenti għal stimulanti oħra (methylphenidate u lisdexamfetamine), u wkoll li l-prodotti li fihom dexamfetamine kienu disponibbli fl-UE għal diversi deċennji mingħajr pjan ta' ġestjoni tar-riskju.
English: It is a Central Nervous System stimulant, more potent than the racemic mixture.
Maltese: Huwa stimulant tas-Sistema Nervuża Centrali, aktar qawwi mit-taħlita raċemika.
English: The CHMP was therefore asked to consider:
Maltese: Għalhekk is-CHMP intalab jikkunsidra:
English: In addition, at least seven evidence-based guidelines for the pharmacological treatment of ADHD recommend dexamfetamine as first-line therapy; others give an explicit favourable recommendation for use as a therapeutic option in ADHD (Seixas et al., 2012).
Maltese: Barra minn hekk, tal-anqas seba' linji gwida bbażati fuq l-evidenza għal kura farmakoloġika ta' ADHD jirrakkomandaw dexamfetamine bħala terapija tal-ewwel linja; oħrajn jagħtu rakkomandazzjoni favorevoli espliċita għall-użu bħala għażla terapewtika f'ADHD (Seixas et al., 2012).
English: • Checklists for pre-screening and on-going monitoring of patients' blood pressure, heart rate, growth (weight, height, appetite) and emergence of psychoses.
Maltese: • Listi ta' verifika għall-iskrinjar minn qabel u s-sorveljanza li tkun għaddejja ta' pressjoni taddemm tal-pazjenti, it-taħbit tal-qalb, it-tkabbir (piż, tul, aptit) u emerġenza ta' psikożi.
English: Lisdexamfetamine was recently approved in some Member States as part of a comprehensive treatment programme for ADHD in children aged 6 years of age and over when response to previous methylphenidate treatment is considered clinically inadequate.
Maltese: Lisdexamfetamine dan l-aħħar ġie approvat f'xi Stati Membri bħala parti minn programm ta' kura komprensiv għal ADHD fi tfal li għandhom 6 snin u aktar fejn ir-rispons għal kura preċedenti b'methylphenidate hija meqjusa klinikament inadegwata.
English: The two substances have similar efficacy in ADHD but different mechanisms of action.
Maltese: Iż-żewġ sustanzi għandhom effikaċja simili fl-ADHD iżda mekkaniżmi differenti ta' azzjoni.
English: • A physician's guide to prescribing including direction for diagnosis according to DSM/ICD guidelines and for recognition and exclusion of patients with a history of abuse misuse diversion and dependency;
Maltese: • Gwida ta' tabib għall-preskrizzjoni inkluż struzzjoni għal dijanjożi skont il-linji gwida DSM/ID u għar-rikonoxximent u l-esklużjoni ta' pazjenti bi storja ta' abbuż, użu ħażin, devjazzjoni u dipendenza;
English: While the review has methodological limitations, the conclusions reached are based on relevant evidence.
Maltese: Filwaqt li r-reviżjoni għandha limitazzjonijiet metodoloġiċi, il-konklużjonijiet milħuqa huma bbażati fuq evidenza rilevanti.
English: Therefore as a measure to mitigate this risk, the applicant proposed to downgrade dexamfetamine to second line use in ADHD and for children and adolescents of 6 to 17 years of age, if other medicinal and nonmedical treatment options have not achieved adequate results.
Maltese: Għalhekk bħala miżura biex jitnaqqas dan ir-riskju, l-applikant ippropona li jiddegrada deamfetamine għal użu ta' linja sekondarja f'ADHD u għal tfal u adoloxxenti fl-età ta' 6 sa 17-il sena, jekk għażliet ta' kura mediċinali u mhux mediċinali oħra ma jkunux laħqu riżultati xierqa.
English: It is accepted that dexamfetamine has potential for misuse, diversion and also dependence.
Maltese: Huwa aċċettat li dexamfetamine għandu potenzjal għal użu ħażin, devjazzjoni u anki dipendenza.
English: In other publications, authors seem to have further concluded that ADHD treatment with stimulants during childhood is associated with a reduction in the risk of substance use disorder later in life (Biederman et al. 1999; Wilens et al. 2003).
Maltese: F'pubblikazzjonijiet oħra, l-awturi jidher li kkonkludew ukoll li l-kura b'ADHD b'stimulati matul it-tfulija hija assoċjata ma' tnaqqis firriskju ta' disturb fl-użu ta' sustanzi aktar tard fil-ħajja (Biederman et al. 1999;
English: In addition, ADHD patients are prescribed stimulants after an ADHD diagnosis has been made as opposed to deliberately seeking stimulants.
Maltese: ADHD meta mqabbel ma' tfittxija b'mod intenzjonat għal stimulanti.
English: This meta-analysis identified a number of key issues that may explain the differences in outcome of the studies, and the authors noted that, while building on that of Wilens et al. (2003), is still relatively modest in terms of number of studies included.
Maltese: (2003), għadha relattivament modesta f'termini ta' numru ta' studji inklużi.
English: It is acknowledged that abuse and dependence may occur, however there appears to be a difference between the population that abuses stimulants and the general ADHD population.
Maltese: Huwa rikonoxxut li jista' jkun hemm abbuż u dipendenza, madankollu jidher li hemm differenza bejn il-popolazzjoni li tabbuża minn stimulanti u l-popolazzjoni ADHD ġenerali.
English: With regards to other potential risks associated with long-term use of dexamfetamine such as possible impairment of neuro-cognitive development and risk of cardiomyopathy, there is no clinical evidence to support that long-term treatment has any negative influence on neuro-cognitive development.
Maltese: Fir-rigward ta' riskji potenzjali oħra assoċjati ma' użu fit-tul ta' dexamfetamine bħal indeboliment possibbli ta' żvilupp newrokonjittiv u r-riskju ta' kardjomijopatija, m'hemm ebda prova klinika biex jiġi appoġġjat li kura fit-tul għandha influwenza negattiva fuq l-iżvilupp newro-konjittiv.
English: With regards to the risk of misuse and diversion within the ADHD population, a meta-analytic review by Lee et al. (2011) concluded that ADHD patients are at a considerably higher risk for substance abuse as compared to the (age-matched) general population.
Maltese: Fir-rigward tar-riskju ta' użu ħażin u devjazzjoni fil-popolazzjoni ADHD, reviżjoni meta-analitika minn Lee et al.
English: • The Committee is of the opinion that dexamfetamine has a mechanism of action different from that of methylphenidate, and that the available data is supportive of the efficacy of dexamfetamine in treatment of ADHD.
Maltese: • Il-Kumitat huwa tal-opinjoni li dexamfetamine għandu mekkaniżmu ta' azzjoni differenti minn dak ta' methylphenidate, u li d-dejta disponibbli hija ta' sostenn għall-effikaċja ta' dexamfetamine fil-kura ta' ADHD.
English: The study by Elia et al. (1991) concluded that there is a need to try both stimulants because there is individual variability in response.
Maltese: (1991) ikkonkluda li hemm il-ħtieġa li jiġu ppruvati ż-żewġ stimulanti peress li hemm varjabbiltà individwali fir-rispons.
English: Lisdexamfetamine and dexamfetamine can be regarded as pharmacodynamically identical, therefore to grant a marketing authorisation for dexamfetamine as second line ADHD treatment would be consistent with the recent approval of lisdexamfetamine for use in the same population.
Maltese: ADHD ta' linja sekondarja jkun konsistenti mal-approvazzjoni riċenti ta' lisdexamfetamine għall-użu fl-istess popolazzjoni.
English: In addition, the DUS should be expanded to actively obtain reports of abuse, misuse, diversion and dependence in children with ADHD from poison centres, drug monitoring centres, other databases, publicly available information in the literature and online.
Maltese: Barra minn hekk, id-DUS għandha tiġi estiża biex tikseb b'mod attiv rapport ta' abbuż, użu ħażin, devjazzjoni u dipendenza fi tfal b'ADHD minn ċentri tal-veleni, ċentri ta' sorveljanza tal-mediċina, databases oħrajn, informazzjoni disponibbli pubblikament fid-dokumentazzjoni u online.
English: The CHMP issued a positive opinion recommending the granting of the marketing authorisations for which the summary of product characteristics and package leaflet are as set out in Annex III of the CHMP opinion and conditions to the marketing authorisations in Annex IV of the CHMP Opinion for Dexamed and associated names (see Annex I).
Maltese: Anki jekk ebda studju waħdieni ma jista' jittieħed bħala evidenza pivotali, il-pubblikazzjonijiet sottomessi fl-applikazzjoni, li ma jinkludux biss studji ppubblikati iżda anki linji gwida u kotba terapewtiċi, jappoġġjaw l-effikaċja filkura ta' linja sekondarja ta' ADHD.
English: • Conduct a PASS to evaluate the long-term safety profile of dexamfetamine in children with ADHD, specifically targeting key issues such as cardiovascular events, growth and psychiatric related adverse events.
Maltese: • Jitwettaq PASS biex jiġi vvalutat il-profil ta' sigurtà fit-tul ta' dexamfetamine fi tfal b'ADHD, li jimmira b'mod speċifiku kwistjonijiet ewlenin bħal avvenimenti kardjovaskulari, tkabbir u avvenimenti avversi psikjatriċi.
English: Methylphenidate is more selective for the dopamine transporter, while dexamfetamine also has a number of other actions including direct actions on receptors and modulating other modes of dopamine uptake as well as effect on other catecholamines.
Maltese: Methylphenidate huwa aktar selettiv għat-trasportatur ta' dopamina, filwaqt li dexamfetamine għandu wkoll numru ta' azzjonijiet oħra inkluż azzjonijiet diretti fuq ir-riċetturi u modulazzjoni ta' modi oħra ta' assorbiment ta' dopamina kif ukoll effett fuq katekolamini oħra.
English: The experts consulted expressed the fact that ADHD is less likely to produce euphoria in children when the products are used as intended.
Maltese: L-esperti kkonsultati esprimew il-fatt li ADHD huwa anqas probabbli li jipproduċi ewforija fi tfal meta l-prodotti jintużaw kif maħsuba.
English: In addition, this was an independent study published in 1991 which precludes the assessment of the original data.
Maltese: Barra minn hekk, dan kien studju indipendenti ppubblikat fl-1991 li jipprekludi lvalutazzjoni tad-dejta oriġinali.
English: • Whether sufficient scientific and clinical evidence exists to support the use of the product as second line treatment of ADHD.
Maltese: • Jekk teżistix evidenza xjentifika u klinika suffiċjenti biex tappoġġja l-użu tal-prodott bħala kura ta' linja sekondarja tal-ADHD.
English: There is also evidence that amfetamines increase release and turnover of serotonin.
Maltese: Hemm ukoll evidenza li lamfetamini jżidu r-rilaxx u l-ammont prodott ta' serotonin.
English: Indeed it is agreed that stimulants, including dexamfetamine, have potential for misuse, diversion and dependence.
Maltese: Fil-fatt huwa maqbul li l-istimulati, inkluż dexamfetamine, għandhom potenzjal għal użu ħażin, devjazzjoni u dipendenza.
English: --1 Live recombinant E2 gene deleted bovine viral diarrhoea virus containing classical swine fever E2 (CP7_E2alf) 104.8 to 106.5 TCID50* * Tissue culture infectious dose 50%
Maltese: --1 Virus ħaj tal-Bovine Viral Dirrhoea rikombinat mingħajr il-ġin E2 li fih Classical Swine Fever E2 (CP7_E2alf) 104.8 to 106.
English: Sodium chloride Water for injections Potassium chloride Potassium dihydrogen phosphate Disodium phosphate anhydrous
Maltese: Sodium chloride Ilma għall-injezzjonijiet Potassium chloride Potassium dihydrogen phosphate Disodium phosphate anhydrous
English: Adjuvant: Carbomer 2 mg
Maltese: Carbomer 2 mg
English: Duration of immunity: 6 months
Maltese: Perjodu tal-immunità: 6 xhur
English: 20 ml (10 doses) 100 ml (50 doses) 200 ml (100 doses) 12 x 20 ml (12 x 10 doses) 12 x 100 ml (12 x 50 doses) 12 x 200 ml (12 x 100 doses)
Maltese: 20 ml (10 dożi) 100 ml (50 doża) 200 ml (100 doża) 12 x 20 ml (12 x 10 doża) 12 x 100 ml (12 x 50 doża) 12 x 200 ml (12 x 100 doża)
English: Mixing with ReproCyc PRRS EU:
Maltese: Taħlit ma' ReproCyc PRRS EU:
English: One dose (2 ml): Porcine Parvovirus VP2 subunit antigen Carbomer
Maltese: (2 ml): Antiġen subunità tal-Parvovirus tal-Qżieqeż VP2 Carbomer
English: St. Joseph
Maltese: Joseph
English: EU/2/19/237/001 EU/2/19/237/002 EU/2/19/237/003 EU/2/19/237/004 EU/2/19/237/005 EU/2/19/237/006
Maltese: EU/2/19/237/001 EU/2/19/237/002 EU/2/19/237/003 EU/2/19/237/004
English: Store and transport refrigerated (2 °C - 8 C).
Maltese: Aħżen u ttrasporta ġo friġġ (2 °C - 8 C).
English: Primary vaccination scheme:
Maltese: Skema primarja ta' tilqim:
English: Name and address of the manufacturer of the biological active substance Boehringer Ingelheim Vetmedica Inc.
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva Boehringer Ingelheim Vetmedica Inc.
English: Date of first authorisation: 26/04/2019
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 26/04/2019
English: Store and transport refrigerated (2 C-8 C).
Maltese: Aħżen u ttrasporta fil-friġġ (2 C-8 C).
English: An elevation in the body temperature after vaccination is common which resolves spontaneously within 24 to 48 hours.
Maltese: Elevazzjoni fittemperatura tal-ġisem wara t-tilqim hija komuni u tgħaddi b'mod spontanju fi żmien 24 sa 48 siegħa.
English: 20 ml (10 doses)
Maltese: 20 ml (10 dożi)
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated , including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali ttrattat li juru effetti mhux mixtieqa matul il-perjodu ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ittrattat) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ittrattat ) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ittrattat ) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ittrattat , inklużi rapporti iżolati).
English: 100 doses
Maltese: 100 doża
English: ReproCyc ParvoFLEX suspension for injection
Maltese: ReproCyc ParvoFLEX suspensjoni għall-injezzjoni
English: Onset of immunity:
Maltese: Kemm iddum l-immunità:
English: 100 ml (50 doses) 200 ml (100 doses)
Maltese: 100 ml (50 doża) 200 ml (100 doża)
English: No data available.
Maltese: Dejta mhux disponibbli.
English: 100 doses (200 ml)
Maltese: 100 doża (200 ml)
English: For active immunisation of gilts and sows from the age of 5 months to protect progeny against transplacental infection caused by porcine parvovirus.
Maltese: Għall-immunizzazzjoni attiva ta' majjali nisa u majjali nisa żgħar mill-età ta' 5 xhur biex tipproteġihom kontra infezzjoni transplaċentali kkawżata minn parvovirus tal-qżieqeż.
English: Porcine Parvovirus VP2 subunit antigen: ≥ 1.0 RP* * Relative Potency (ELISA) Carbomer 2 mg.
Maltese: RP* * Potenza Relattiva (Relative Potency) (ELISA) Carbomer 2 mg.
English: Carton of 20 ml, 100 ml, 200 ml bottles
Maltese: Flixkun ta' 100 ml, 200 ml
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi (inkluż l-aġġuvanti) elenkati f‘sezzjoni 6.1 tal-Karatteristiċi tal-Prodott huma jew sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: U.S.A.
Maltese: Stati Uniti tal-Amerika
English: Pigs
Maltese: Qżieqeż
English: Overdose (symptoms, emergency procedures, antidotes): No data available.
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti), jekk ikun hemm bżonn Dejta mhux disponibbli.
English: High density polyethylene bottles containing 20 ml (10 doses), 100 ml (50 doses) and 200 ml (100 doses).
Maltese: Fliexken tal-polyethylene ta' densità għolja li fihom 20 ml (10 dożi), 100 ml (50 doża) u 200 ml (100 doża).
English: Name and address of the manufacturers responsible for batch release Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Maltese: Isem u indirizz tal-manifatturi responsabbli mill-ħruġ tal-lott Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
English: Porcine Parvovirus strain 27a VP2 subunit antigen: ≥ 1.0 RP* * Relative potency (ELISA).
Maltese: Antiġen subunità tal-Parvovirus tal-Qżieqeż razza 27a VP2: ≥ 1.0
English: Marketing authorisation holder and manufacturer responsible for batch release: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
English: Do not mix with any other veterinary medicinal product, except with ReproCyc PRRS EU.
Maltese: Tħallatx ma' ebda prodott mediċinali veterinarju ieħor, ħlief ma' ReproCyc PRRS EU.
English: Colourless to slightly brown, opalescent suspension for injection.
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni għall-injezzjoni.
English: 20 ml bottle
Maltese: Flixkun ta' 20 ml
English: The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009.
Maltese: Is-sustanza attiva li hija prinċipju ta' oriġini bioloġika maħsuba sabiex tipproduċi immunità attiva ma taqax fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009.
English: ReproCyc ParvoFLEX suspension for injection for pigs
Maltese: VETERINARJU ReproCyc ParvoFLEX suspensjoni għall-injezzjoni għall-qżieqeż
English: Pharmacotherapeutic group: Immunologicals for Suidae, inactivated viral vaccines, porcine parvovirus ATCvet code: QI09AA02
Maltese: Id-deċiżjoni sabiex jintuża dan il-vaċċin qabel jew wara xi prodott mediċinali veterinarju ieħor, għaldaqstant għandha tittieħed każ b'każ.
English: 12 bottles of 20 ml (10 doses), 100 ml (50 doses) or 200 ml (100 doses) packed in a cardboard box.
Maltese: 12-il flixkun ta' 20 ml (10 dożi), 100 ml (50 doża) jew 200 ml (100 doża) ppakkjati f'kaxxa tal-kartun.
English: Read the package leaflet before use.
Maltese: Mhux id-daqsijiet kollha tal-pakkett jistgħu jkunu qegħdin fis-suq.
English: Administer a single dose (2 ml) of the mixture intramuscularly.
Maltese: (2 ml) tat-taħlita għal ġol-muskoli.
English: Shelf life of the veterinary medicinal product as packaged for sale:
Maltese: Prekawzjonijiet speċjali li għandhom jittieħdu mill-persuna li tamministra l-prodott mediċinali veterinarju lill-annimali:
English: 1 bottle of 20 ml (10 doses), 100 ml (50 doses) or 200 ml (100 doses) packed in a cardboard box.
Maltese: Flixkun wieħed ta' 20 ml (10 dożi), 100 ml (50 doża) jew 200 ml (100 doża) ppakkjat f'kaxxa talkartun.
English: • Quality
Maltese: • Kwalità
English: An active comparator was included in studies 3000 (Haloperidol), 3004 and 3005 (Risperidone), and 3101 (Ziprasidone).
Maltese: Ġie inkluż komparatur attiv fi studju 3000 (Haloperidol), 3004 u 3005 (Risperidone), u 3101 (Ziprasidone).
English: • Non-clinical
Maltese: • Mhux klinika
English: Iloperidone and the metabolite P88 shows relatively high affinity for hERG channel (IC50 of 12.4 and 24.1 ng/mL).
Maltese: Iloperidone u l-metabolit P88 juri affinità relattivament għolja għall-kanal hERG (IC50 ta' 12.4 u 24.1 ng/mL).
English: Late onset of action is regarded as a considerable drawback.
Maltese: Bidu ta' azzjoni tard huwa kkunsidrat bħala nuqqas konsiderevoli.
English: There were 33 deaths of which 3 patients died during sleep, 6 were sudden deaths, and 6 cases were of cardiac origin.
Maltese: Kien hemm 33 mewta li minnhom 3 pazjenti mietu waqt l-irqad, 6 mietu f'daqqa, u 6 każijiet kienu ta' oriġini kardijaka.
English: Doses as low as 4-8 mg/day appeared effective in one study (3004), and in some studies doses of 12 mg/day (3000), 10-16 mg/day (3004) or 12-16 mg/day (3005) likewise showed superiority to placebo.
Maltese: Dożi baxxi daqs 48 mg/jum dehru li kienu effettivi fi studju wieħed (3004), u f'xi studji, dożi ta' 12 mg/jum (3000), 1016 mg/jum (3004) jew 12-16 mg/jum (3005), bl-istess mod urew superjorità fuq il-plaċebo.
English: In the thorough QTc study (Study CILO522A2328), the mean change in QTcF from baseline to steady state at Tmax was approximately 9 msec in the 8 mg and 12 mg BID groups and was 15.4 msec in the group receiving Iloperidone 24 mg q.d.
Maltese: Fl-istudju fil-fond dwar il-QTc (Studju CILO522A2328), il-bidla medja fil-QTcF mil-linja bażi għal stat fiss b'Tmax kienet madwar 9 msec fil-gruppi ta' 8 mg u 12 mg BID u kienet 15.4 msec fil-grupp li rċieva Iloperidone 24 mg q.d. meta mqabbel ma' 1.3 msec fil-grupp li rċieva quetiapine (kontroll negattiv).
English: Action potential prolongation was observed in ventricular dog Purkinje fibres, confirming the pro-arrhythmogenic potential of Iloperidone.
Maltese: Ġiet osservata azzjoni ta' titwil potenzjali fil-fibri Purkinje tal-klieb ventrikulari, li tikkonferma l-potenzjal proaritmoġeniku ta' Iloperidone.
English: Similarly, at Week 2 it was 4.2 for ziprasidone i.e. almost full efficacy, whereas the difference was still only 2.8 for Fanaptum.
Maltese: B'mod simili, f'Ġimgħa 2 din kienet 4.2 għal ziprasidone, jiġifieri kważi effikaċja sħiħa, waqt li d-differenza kienet għadha biss 2.8 għal Fanaptum.
English: In the clinical trial programme, 4.5% of the patients treated with iloperidone regardless of dose (4-24 mg/day) had an increase more than 60 msec at some time point.
Maltese: Fil-programm ta' prova klinika, 4.5 % tal-pazjenti kkurati b'iloperidone irrispettivament mid-doża (424 mg/jum) kellhom żieda ta' aktar minn 60 msec f'xi punt fiż-żmien.
English: As 4423 patients were exposed to Iloperidone, this accounts for 0.14% of all treated patients.
Maltese: Peress li 4423 pazjent ġew esposti għal Iloperidone, dan jammonta għal 0.14 % tal-pazjenti kkurati.