FrancophonIA/ELRC3.0 huggingface dataset:
English: In in vitro studies, the activity of lotilaner against some arthropod species was not affected by resistance to organochlorines (cyclodienes, e.g. dieldrin), phenylpyrazoles (e.g. fipronil), neonicotinoids (e.g. imidacloprid), formamidines (e.g. amitraz) and pyrethroids (e.g. cypermethrin).
Maltese: Fi studji in vitro, l-attività ta' lotilaner kontra xi speċi artropodi ma ġietx affettwata minn reżistenza għal organochlorines (cyclodienes, eż. dieldrin), phenylpyrazoles (eż. fipronil), neonicotinoids (eż. imidacloprid), formamidines (eż. amitraz) u pyrethroids (eż. cypermethrin).
English: This veterinary medicinal product provides immediate and persistent killing activity for 1 month for fleas (Ctenocephalides felis and C. canis) and ticks (Rhipicephalus sanguineus, Ixodes ricinus, I. hexagonus, and Dermacentor reticulatus).
Maltese: Dan il-prodott mediċinali veterinarju jipprovdi attività immedjata u persistenti ta' qtil għal xahar, għal briegħed (Ctenocephalides felis u C. canis) u qurdien (Rhipicephalus sanguineus, Ixodes ricinus, I. hexagonus, u Dermacentor reticulatus).
English: This veterinary medicinal product provides immediate and persistent killing activity for 1 month for fleas (Ctenocephalides felis and C. canis) and ticks (Rhipicephalus sanguineus, Ixodes ricinus, I. hexagonus and Dermacentor reticulatus).
Maltese: Dan il-prodott mediċinali veterinarju jipprovdi attività immedjata u persistenti ta' qtil għal xahar, għal briegħed (Ctenocephalides felis u C. canis) u qurdien (Rhipicephalus sanguineus, Ixodes ricinus, I. hexagonus u Dermacentor reticulatus).
English: 10 DATE OF REVISION OF THE TEXT <{DD/MM/YYYY}>
Maltese: <{JJ/XX/SSSS}>
English: for cats (0.5-2.0 kg) for cats (>2.0-8.0 kg)
Maltese: għall-qtates (0.5-2.0 kg) għall-qtates (>2.0-8.0 kg)
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Yeast powder (flavour)
Maltese: 6.1 Lista ta' ingredjenti Cellulose, trab
English: for cats (0.5-2.0 kg) for cats (>2-8.0 kg)
Maltese: għall-qtates (0.5-2.0 kg) għall-qtates (>2-8.0 kg)
English: For cats of more than 8 kg body weight, use an appropriate combination of available strengths to achieve the recommended dose of 6-24 mg/kg.
Maltese: Għal qtates b'piż tal-ġisem ta' aktar minn 8 kg, uża bħala kombinazzjoni adattata ta' qawwiet disponibbli biex tinkiseb id-doża rakkomandata ta' 6-24 mg/kg.
English: No adverse reactions were observed following oral administration to puppies aged 8-9 weeks and weighing 1.3-3.6 kg treated with overdoses of up to 5 times the maximum recommended dose (43 mg, 129 mg and 215 mg lotilaner/kg bodyweight) on eight occasions at monthly intervals.
Maltese: Ma ġew osservati l-ebda reazzjonijiet avversi wara l-għoti orali lil ġriewi li kellhom 8-9 ġimgħat u li jiżnu 1.3-3.6 kg ikkurati b'dożi eċċessivi ta' sa 5 darbiet tad-doża massima rakkomandata (43 mg, 129 mg u 215 mg ta' lotilaner/kg ta' piż tal-ġisem) fi tmien okkażjonijiet f'intervalli ta' kull xahar.
English: 10 DATE OF REVISION OF THE TEXT DD/MM/YYYY
Maltese: JJ/XX/SSSS
English: The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Maltese: Il-prodott mediċinali veterinarju jista' jintuża bħala parti minn strateġija ta' kura għall-kontroll ta' dermatite ta' allerġija għall-briegħed (FAD).
English: Credelio 56 mg, 112 mg, 225 mg, 450 mg chewable tablets for dogs: 3 years
Maltese: Credelio 56 mg, 122 mg, 225 mg, 450 mg pilloli li jintmagħdu għall-klieb: 3 snin Credelio 900 mg pilloli li jintmagħdu għall-klieb:
English: Credelio 56 mg chewable tablets for dogs (1.3-2.5 kg) Credelio 112 mg chewable tablets for dogs (>2.5-5.5 kg) Credelio 225 mg chewable tablets for dogs (>5.5-11 kg) Credelio 450 mg chewable tablets for dogs (>11-22 kg) Credelio 900 mg chewable tablets for dogs (>22-45 kg)
Maltese: Credelio 56 mg pilloli li jintmagħdu għall-klieb (1.3--2.5 kg) Credelio 112 mg pilloli li jintmagħdu għall-klieb (>2.5-5.5 kg) Credelio 225 mg pilloli li jintmagħdu għall-klieb (>5.5-11 kg) Credelio 450 mg pilloli li jintmagħdu għall-klieb (>11-22 kg) Credelio 900 mg pilloli li jintmagħdu għall-klieb (>22-45 kg)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (cats)
Maltese: Kaxxa tal-kartun (qtates)
English: Each strength of Credelio chewable tablets is available in pack sizes of 1, 3 or 6 tablets.
Maltese: Kull qawwa tal-pilloli li jintmagħdu Credelio għall-qtates hi disponibbli fid-daqsijiet tal-pakkett li ġejjin: 1, 3 jew 6 pilloli.
English: Use only accordingly to the benefit/risk assessment of the responsible veterinarian.
Maltese: Uża biss skont l-evalwazzjoni tal benefiċċju/riskju mill-veterinarju responsabbli.
English: Mild and transient gastrointestinal effects such as vomiting and diarrhoea have been reported to occur very rarely based on post-marketing safety experience.
Maltese: Effetti gastrointestinali ħfief u temporanji bħal rimettar u dijarea ġew irrappurtati li jseħħu b'mod rari ħafna abbażi ta' esperjenza mis-sigurtà wara t-tqegħid fis-suq.
English: For the treatment of flea and tick infestations on cats.
Maltese: U METODU TA' AMMINISTRAZZJONI Għal użu orali.
English: Body weight of cat (kg)
Maltese: Piż tal-ġisem tal qattus (kg)
English: for dogs (1.3-2.5 kg) for dogs (>2.5-5.5 kg) for dogs (>5.5-11 kg) for dogs (>11-22 kg) for dogs (>22-45 kg)
Maltese: għall-klieb (1.3-2.5 kg) għall-klieb (>2.5-5.5 kg) għall-klieb (>5.5-11 kg) għall-klieb (>11-22 kg) għall-klieb (>22-45 kg)
English: EU/2/17/206/001 (56 mg lotilaner; 1 chewable tablet) EU/2/17/206/002 (56 mg lotilaner; 3 chewable tablets) EU/2/17/206/003 (56 mg lotilaner; 6 chewable tablets) EU/2/17/206/004 (112 mg lotilaner; 1 chewable tablet) EU/2/17/206/005 (112 mg lotilaner; 3 chewable tablets) EU/2/17/206/006 (112 mg lotilaner; 6 chewable tablets) EU/2/17/206/007 (225 mg lotilaner; 1 chewable tablet) EU/2/17/206/008 (225 mg lotilaner; 3 chewable tablets) EU/2/17/206/009 (225 mg lotilaner; 6 chewable tablets) EU/2/17/206/010 (450 mg lotilaner; 1 chewable tablet) EU/2/17/206/011 (450 mg lotilaner; 3 chewable tablets) EU/2/17/206/012 (450 mg lotilaner; 6 chewable tablets) EU/2/17/206/013 (900 mg lotilaner; 1 chewable tablet)
Maltese: EU/2/17/206/005 (112 mg lotilaner; 3 pilloli li jintmagħdu) EU/2/17/206/006 (112 mg lotilaner; 6 pilloli li jintmagħdu) EU/2/17/206/007 (225 mg lotilaner; pillola 1 li tintmagħad)
English: These signs typically resolve without treatment.
Maltese: Dawn is-sinjali ġeneralment ifiequ mingħajr trattament.
English: The terminal half-life is approximately 4 weeks.
Maltese: Il-half-life terminali hi ta' madwar 4 sigħat.
English: PHARMACEUTICAL FORM Chewable tablet
Maltese: GĦAMLA FARMAĊEWTIKA Pillola li tintmagħad
English: The veterinary medicinal product should be administered in accordance with the following table to ensure a dose of 20 to 43 mg lotilaner/kg bodyweight.
Maltese: Il-prodott mediċinali veterinarju għandu jingħata skont it-tabella li ġejja sabiex tiġi żgurata doża ta' 20 sa 43 mg ta' lotilaner/kg ta' piż tal-ġisem.
English: The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Maltese: Il-prodott mediċinali veterinarju jista' jintuża bħala parti minn strateġija ta' kura għall-kontroll ta' dermatite minn allerġija minħabba l-briegħed (FAD, flea allergy dermatitis).
English: METHOD AND ROUTE(S) OF ADMINISTRATION Administer with food or within 30 minutes after feeding.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Agħti mal-ikel jew fi 30 minuta wara l-għalf.
English: MA (EU) number
Maltese: Numru tal-MA (Numru ta' l-EU)
English: SAFETY
Maltese: SIGURTÀ
English: Angina pectoris
Maltese: EFFIKAĊJA Anġina pectoris
English: • The Committee considered the referral under Article 31 of Directive 2001/83/EC;
Maltese: • Il-Kumitat ikkunsidra r-referenza taħt l-Artikolu 31 tad-Direttiva 2001/83/KE;
English: Ophthalmology
Maltese: Oftalmoloġija
English: The efficacy of trimetazidine was also summarised in a recent network meta-analysis including 358 clinical trials and 27058 patients.
Maltese: L-effikaċja ta' trimetazidine kienet ukoll imqassra f'meta-analiżi reċenti tan-netwerk li tinkludi 358 prova klinika u 27058 pazjent.
English: Otology - Ear, Nose and Throat (ENT)
Maltese: Otoloġija - Widnejn, Imnieħer u Griżmejn (ENT)
English: Less than 50% of patients included in the VASCO study had chronic stable angina despite probable coronary artery disease.
Maltese: Inqas minn 50% tal-pazjenti inklużi fl-istudju VASCO kellhom anġina stabbli kronika minkejja lprobabbiltà ta' mard tal-arterji koronarji.
English: Patients with a cardiovascular profile were significantly older (mean age: 74.8 years) than those with an ophthalmological and ENT profile (70.3 years and 63.5 years, respectively).
Maltese: Il-pazjenti bi profil kardjovaskulari kienu konsiderevolment ixjeħ (età medja: 74.8 snin) minn dawk bi profil oftalmoloġiku jew tal-ENT (70.3 snin u 63.5 snin, rispettivament).
English: However, in the subgroup of symptomatic patients (n= 1574) trimetazidine (140 mg) significantly improved total exercise duration (+23.8 s versus +13.1 s placebo; p=0.001) and time to onset of angina (+46.3 s versus +32.5 s placebo; p=0.005).
Maltese: Madankollu, fissottogrupp tal-pazjenti sintomatiċi (n= 1574), trimetazidine (140 mg) tejjeb b'mod sinifikanti t-tul tal-eżerċizzju (+23.8 s meta mqabbel ma' +13.1 s tal-plaċebo; p=0.001) u l-ħin għall-bidu talanġina (+46.3 s meta mqabbel ma' +32.5 s plaċebo; p=0.005).
English: In patients with moderate renal impairment (creatinine clearance [30-60] ml/min) the recommended dose has been added in the SmPC.
Maltese: F'pazjenti b'indeboliment renali moderat (tneħħija tal-kreatinina [30-60] ml/min), id-doża rakkomandata żdiedet fl-SmPC.
English: A significant difference was also evidenced for the time to onset of angina pectoris (p=0.049).
Maltese: Kien hemm ukoll evidenza ta' differenza konsiderevoli fil-ħin ta' meta bdiet l-anġina pectoris (p=0.049).
English: The CHMP endorsed a communication, Direct Healthcare Professional Communication (DHPC), to communicate the outcome of the present review.
Maltese: Is-CHMP approva komunikazzjoni, Komunikazzjoni Diretta lill-Professjonisti tas-Saħħa (DHPC), biex jikkomunika l-eżitu ta' din ir-reviżjoni.
English: The three studies of short duration (up to 3 months) conducted against reference products of the time (e.g cinnarizine, piridoxilate ), included a small number of patients who presented very heterogeneous or poorly defined pathologies (n=19, n=24 and n=8 respectively for the Cornand (1982), Cordella (1982) and Perdriel (1988) studies).
Maltese: It-tliet studji fuq żmien qasir (sa tliet xhur) li saru f'konfront ma' prodotti ta' referenza ta' dak iżżmien (eż. cinnarizine, piridoxilate), kienu jinkludu numru żgħir ta' pazjenti li ppreżentaw patoloġiji ferm eteroġeni jew mhux definiti sew (n=19, n=24 u n=8 rispettivament għall-istudji Cornand (1982), Cordella (1982) u Perdriel (1988)).
English: The most recent study conducted with trimetazidine 35 mg from 1999 (France, ARMD 2) related to a higher number of patients monitored for 3 to 5 years.
Maltese: L-aktar studju reċenti li sar bi trimetazidine 35 mg mill-1999 (Franza, ARMD 2) kien marbut ma' numru ogħla ta' pazjenti ssorveljati għal 3 sa 5 snin.
English: They were first authorised in France in 1978 and are available in three different pharmaceutical forms in the EU: 20 mg tablet, 20 mg/ml oral solution and 35 mg modified release (MR) tablet.
Maltese: Huma ġew awtorizzati għall-ewwel darba fi Franza fl-1978 u huma disponibbli fi tliet għamliet farmaċewtiċi flUE: pillola ta' 20 mg, soluzzjoni orali ta' 20 mg/ml oral u pillola b'rilaxx modifikat (MR)ta' 35 mg.
English: The main studies conducted versus placebo were Wayoff study (tinnitus, dizziness, hearing loss) and Morgon study (tinnitus).
Maltese: L-istudji ewlenin imwettqa li tqabblu mal-plaċebo kienu l-istudju Wayoff (tinnite, sturdament, te;f ta' smigħ) u l-istudju Morgon (tinnite).
English: Among these nine studies, three were non-comparative studies (Guillaumat, 1982; Millara, 1988; Nowak, 2007); three were comparative studies of short duration (up to 3 months) conducted against products used at the time of these studies e.g. cinnarizine, piridoxilate which are no more considered as therapies of choice to treat or prevent retinal or glaucoma diseases by the ophthalmologists; two studies were conducted against placebo (Couderc, 1984 and Aron-Rosa, 1988).
Maltese: Fost dawn id-disa' studji, tlieta ma kinux studji komparattivi (Guillaumat, 1982; Millara, 1988; Nowak, 2007); tlieta kienu studji komparattivi fuq żmien qasir (sa tliet xhur) magħmula f'konfront ma' prodotti użati fiż-żmien ta' dawn l-istudji eż. cinnarizine, piridoxilate li ma għadhomx ikkunsidrati bħala terapiji ppreferuti mill-oftalmologi għall-kura jew il-prevenzjoni ta' mard tarretina jew glawkoma; żewġ studji saru f'konfront ma' plaċebo (Couderc, 1984 u Aron-Rosa, 1988).
English: In a 1962 patients three-month randomised, double-blinded study (VASCO study, 2011) on top of atenolol 50 mg/d, two dosages of trimetazidine (70 mg/d and 140 mg/d) were tested versus placebo.
Maltese: Fi studju aleatorju u double blind li dam tliet xhur fuq 1962 pazjent (studju VASCO, 2011) minbarra atenolol 50 mg/jum, ġew ittestjati żewġ dożaġġi ta' trimetazidine (70 mg/jum u 140 mg/jum) li tqabblu ma' plaċebo.
English: However, the TRIMPOL-II study (2001), the study by Sellier (2003) and the revised data from the VASCO study (2011) were the studies providing evidence generated in support of the add-on indication of trimetazidine in symptomatic patients with angina pectoris.
Maltese: Madankollu, l-istudju TRIMPOL-II (2001), l-istudju minn Sellier (2003) u d-dejta riveduta mill-istudju VASCO (2011) kienu l-istudji li pprovdew evidenza ġġenerata b'appoġġ għall-indikazzjoni supplementari ta' trimetazidine bħala sustanza f'pazjenti sintomatiċi b'anġina pectoris.
English: The Committee concluded that trimetazidine is associated with the occurrence of Parkinson syndrome and related symptoms.
Maltese: Il-Kumitat ikkonkluda li trimetazidine huwa assoċjat mal-okkorrenza tas-sindromu ta' Parkinson u sintomi relatati.
English: These data support the efficacy of trimetazidine in add-on to beta-blockers.
Maltese: Din id-dejta tappoġġja leffikaċja ta' trimetazidine bħala sustanza supplementari għall-imblokkaturi tal-beta.
English: The TRIMPOL-II showed that trimetazidine significantly improves exercise capacity and exerciseinduced myocardial ischemia when added to metoprolol.
Maltese: TRIMPOL-II wera li trimetazidine itejjeb b'mod sinifikanti l-kapaċità tal-eżerċizzju u l-iskemija mijokardjali kkaġunata mill-eżerċizzju meta jiżdied ma' metoprolol.
English: A prescription study in France showed that trimetazidine was prescribed in patients in cardiovascular indications in 45.3% of cases, in ENT indications in 30% of cases and in ophthalmological indications in 0.4% of cases.
Maltese: Studju tal-preskrizzjoni fi Franza wera li trimetazidine kien preskritt lil pazjenti fl-indikazzjonijiet kardjovaskulari f'45.3% tal-każijiet, fl-indikazzjonijiet tal-ENT fi 30% tal-każijiet u fl-indikazzjonijiet oftalmoloġiċi f'0.4% tal-każijiet.
English: In a 426-patients randomised, double blind, placebo-controlled study (TRIMPOL-II), trimetazidine (60mg/day) added to metoprolol 100mg daily (50 mg b.i.d) for 12 weeks significantly improved statistically exercise tests parameters and clinical symptoms as compared to placebo: total exercise duration +20.1s, p= 0.023, total workload +0.54 METs, p=0.001, time to 1-mm ST-segment depression +33.4s, p=0.003, time to onset of angina +33.9s, p<0.001, angina attacks/week -0.73, p=0.014 and short acting nitrates consumption/week, -0.63, p=0.032, without hemodynamic changes.
Maltese: METs, p=0.001, ħin sad-depressjoni tas-segment ta' 1-mm ST +33.4s, p=0.003, ħin sal-bidu talanġina +33.9s, p<0.001, attakki ta' anġina/ġimgħa -0.73, p=0.014 u konsum ta' nitrati li jaġixxu għal żmien qasir/ġimgħa, -0.63, p=0.032, mingħajr bidliet emodinamiċi.
English: It is acknowledged that extrapyramidal symptoms reported in patients receiving TMZ have a low prevalence (incidence of 0.36/100,000 PY) and are generally reversible after TMZ withdrawal.
Maltese: Huwa rikonoxxut li s-sintomi ekstrapiramidali rraportati f'pazjenti li jkunu qegħdin jieħdu TMZ għandhom prevalenza baxxa (inċidenza ta' 0.36/100,000 PY) u huma ġeneralment riversibbli wara li jitwaqqaf it-TMZ.
English: The analysis performed by the MAH has been repeated independently by the Italian Institutes of Health (ISS).
Maltese: L-analiżi li saret mill-MAH ġiet ripetuta b'mod indipendenti mill-Istituti Taljani tas-Saħħa (ISS).
English: In addition, a pharmacokinetics study was agreed with the MAH to investigate the effects of renal impairment and age on the trimetazidine safety profile.
Maltese: Barra minn hekk, kien hemm qbil mal-MAH rigward studju farmakokinetiku sabiex jinvestiga l-effetti tal-indeboliment renali u l-età fuq il-profil tas-sigurtà ta' trimetazidine.
English: No significant difference between groups could be found for the other secondary endpoints (total exercise duration, total workload and clinical endpoints).
Maltese: Ma nstabet l-ebda differenza sinifikanti bejn il-gruppi għall-punti aħħarin sekondarji l-oħrajn (tul totali tal-eżerċizzju, volum ta' xogħol totali u punti aħħarin kliniċi).
English: Trimetazidine medicinal products have been authorised in 21 European Member states.
Maltese: Il-prodotti mediċinali li fihom trimetazidine ġew awtorizzati f'21 Stat Membru Ewropew.
English: Results from this study did not highlight any clinical benefit of trimetazidine in comparison to the placebo to prevent the bilateralisation of choroidal neovascularisation in patients suffering from age-related macular degeneration, principal criterion of evaluation chosen to demonstrate the clinical benefit of trimetazidine 35 mg to slow the progression of age-related macular degeneration (ARMD).
Maltese: Ir-riżultati minn dan l-istudju ma enfasizzaw lebda benefiċċju kliniku ta' trimetazidine meta mqabbel mal-plaċebo fil-prevenzjoni talbilateralizzazzjoni tan-neovaskularizzazzjoni korojdali f'pazjenti li jbatu minn deġenerazzjoni makulari marbuta mal-età, il-kriterju prinċipali ta' evalwazzjoni magħżul sabiex jintwera lbenefiċċju kliniku ta' trimetazidine 35 mg sabiex irażżen il-progressjoni ta' deġenerazzjoni makulari marbuta mal-età (ARMD).
English: The VASCO study showed a significant difference in the effect on ergometric parameters between trimetazidine at the highest dosage (140 mg) and placebo in the group of symptomatic patients.
Maltese: L-istudju VASCO wera differenza sinifikanti fl-effett fuq il-parametri ergometriċi bejn trimetazidine fl-ogħla dożaġġ (140 mg) u l-plaċebo fil-grupp ta' pazjenti sintomatiċi.
English: Trimetazidine-containing medicinal products are indicated for prophylactic treatment of angina pectoris crisis, ancillary symptomatic treatment of vertigo and tinnitus and ancillary treatment of visual acuity decrease and visual field disturbances due to vascular reasons.
Maltese: Il-prodotti mediċinali li fihom trimetazidine huma indikati għat-trattament profilattiku ta' kriżi ta' anġina pectoris, it-trattament sintomatiku anċillari ta' sturdament u tinnite u t-trattament anċillari ta' tnaqqis fl-akutezza viżiva u disturbi fil-kamp viżiv minħabba raġunijiet vaskulari.
English: Trimetazidine was shown to have an effect very similar to that of non-heart rate−lowering anti-anginal agents: nicorandil, ranolazine, long-acting nitrates and dihydropyridines, with less than a few seconds differences in exercise tolerance test (ETT) ergometric parameters.
Maltese: Intwera li trimetazidine għandu effett simili ħafna għal dak ta' aġenti ta' kontra l-anġina li ma jbaxxux ir-rata ta' taħbit il-qalb: nicorandil, ranolazine, nitrati li jaġixxu fit-tul u dihydropyridines, b'inqas minn ftit sekondi differenzi fil-parametri ergometriċi tattest tal-eżerċizzju tat-toleranza (ETT).
English: Trimetazidine (TMZ) is a metabolic agent whose aim is to protect against ischemia by increasing glucose metabolism relative to that of fatty acids.
Maltese: Trimetazidine (TMZ) huwa aġent metaboliku li l-għan tiegħu huwa li jipproteġi kontra l-iskemija billi jżid il-metaboliżmu tal-glukosju relatat ma' dak tal-aċidi xaħmin.
English: The proposed multicentre, randomised, double-blind, placebo controlled long-term study in postpercutaneous coronary intervention (PCI) patients and the prospective and comparative cohort study to assess the prevalence of EPS in patients receiving trimetazidine may be adequate to solve the concerns on long-term efficacy and safety of trimetazidine.
Maltese: L-istudju multiċentru, aleatorju, double blind u bi plaċebo propost fuq żmien twil f'pazjenti wara intervent koronarju minn ġol-ġilda (PCI) u l-istudju prospettiv u komparattiv li jevalwa l-prevalenza ta' EPS f'pazjenti li jkunu qegħdin jingħataw trimetazidine jistgħu jkunu adattati sabiex isolvu ttħassib dwar l-effikaċja fit-tul u s-sigurtà ta' trimetazidine.
English: Annex II Scientific conclusions and grounds for variation to the terms of the Marketing Authorisations
Maltese: Anness II Konklużjonijiet xjentifiċi u raġunijiet għal varjazzoni fit-termini talAwtorizzazzjonijiet għat-Tqegħid fis-Suq
English: • The Committee also recommended that trimetazidine can cause or worsen parkinsonian symptoms (tremor, akinesia, hypertonia).
Maltese: • Il-Kumitat irrakkomanda wkoll li trimetazidine jista' jikkawża jew jaggrava s-sintomi ta' Parkinson (rogħda, akineżija, ipertonja).
English: The occurrence of movement disorders such as parkinsonian symptoms, restless leg syndrome, tremors, gait instability should lead to definitive withdrawal of trimetazidine.
Maltese: L-okkorrenza ta' disturbi fil-moviment bħas-sintomi ta' Parkinson, is-sindromu tas-saqajn bla kwiet, rogħda, nuqqas ta' stabilità fil-mixi għandha twassal għal waqfien definittiv ta' trimetazidine.
English: In addition, Vitte study (2002) had the same methodological weaknesses as the Wayoff and Morgon studies.
Maltese: Barra minn hekk, l-istudju Vitte (2002) kellu l-istess nuqqasijiet metodoloġiċi bħall-istudji Wayoff u Morgon.
English: In addition the two studies by Manchanda (1997 and 2003) and four other minor studies are considered supportive of the efficacy of trimetazidine in add-on to calcium channel blockers (CCBs).
Maltese: Barra minn hekk, iż-żewġ studji ta' Manchanda (1997 u 2003) u erba' studji żgħar oħra huma kkunsidrati li jsostnu l-effikaċja ta' trimetazidine bħala sustanza supplementari għall-imblokkaturi tal-kanali talkalċju (CCBs).
English: The CHMP considers that the revised indication is in line with the scientific evidence available at present for trimetazidine as add-on therapy and it is supported by trials that became available after the initial authorisation and considered to be of sufficient methodological quality and by meta-analyses that have come to similar conclusions.
Maltese: Is-CHMP jikkunsidra li l-indikazzjoni riveduta hija konformi mal-evidenza xjentifika disponibbli bħalissa għal trimetazidine bħala terapija supplementari u hija appoġġjata minn provi kliniċi li saru disponibbli wara l-awtorizzazzjoni inizjali u li huma meqjusa ta' kwalità metodoloġika suffiċjenti u minn meta-analiżijiet li waslu għal konklużjonijiet simili.
English: In the overall population, including both asymptomatic and symptomatic patients, trimetazidine failed to demonstrate a benefit on both ergometric (total exercise duration, time to onset of 1mm ST and time to onset angina) and clinical endpoints.
Maltese: Fil-popolazzjoni globali, inklużi l-pazjenti asintomatiċi u dawk sintomatiċi, trimetazidine naqas milli juri benefiċċju kemm fuq il-punti aħħarin ergometriċi (tul totali tal-eżerċizzju, il-ħin sal-bidu tal-1mm ST u l-ħin sal-bidu tal-anġina) u kliniċi.
English: They also mixed ENT pathologies and symptomatologies from different etiologies such as tinnitus, different kinds of vertigo or deafness.
Maltese: Ħalltu wkoll patoloġiji tal-ENT ma' sintomatoloġiji minn etjoloġiji differenti bħal tinnite, tipi differenti ta' sturdament jew telf ta' smigħ.