FrancophonIA/ELRC3.0 huggingface dataset:
English: The marketing authorisation application (MAA) for Merisone was submitted under Article 10(1) of Directive 2001/83/EC (i.e. a generic application), vis-à-vis the reference medicinal product Mydeton (Gedeon Richter Plc).
Maltese: L-applikazzjoni għal awtorizzazzjoni għat-tqegħid fis-suq (MAA) għal Merisone ġiet sottomessa skont l-Artikolu 10(1) tadDirettiva 2001/83/KE (jiġifieri applikazzjoni ġenerika), fil-konfront tal-prodott mediċinali ta' referenza Mydeton (Gedeon Richter Plc).
English: • The Committee considered the notification of the referral triggered by Hungary under Article 29(4) of Directive 2001/83/EC where Germany raised objections that were considered to be a potential serious risk to public health;
Maltese: • Il-Kumitat ikkunsidra n-notifika tar-riferiment mibdi mill-Ungerija skont l-Artikolu 29(4) tadDirettiva 2001/83/KE fejn il-Ġermanja qajmet oġġezzjonijiet li kienu kkunsidrati bħala riskju potenzjalment serju għas-saħħa pubblika;
English: The CMDh therefore referred the matter to the CHMP through an Art 29(4) referral procedure.
Maltese: IsCMDh għalhekk irrefera l-kwistjoni lis-CHMP permezz ta' proċedura ta' riferiment tal-Artikolu 29(4).
English: 2 Co-ordination group for mutual recognition and decentralised procedures - human
Maltese: 2 Grupp ta' koordinazzjoni għal rikonoxximent reċiproku u proċeduri deċentralizzati - bniedem
English: Although the results of the bioequivalence studies were considered to be borderline by the objecting CMS, the applicant argued that the second bioequivalence study was a replicate design study where it was shown that tolperisone is a highly variable drug - the within-subject variability of the reference medicinal product Cmax was 46.99%.
Maltese: Għalkemm ir-riżultati tal-istudji tal-bijoekwivalenza kienu kkunsidrati marġinali mis-CMS li kien qed joġġezzjona, l-applikant argumenta li t-tieni studju dwar il-bijoekwivalenza kien studju ta' disinn replika fejn intwera li tolperison huwa mediċina varjabbli ħafna - il-varjabbiltà fi ħdan l-individwi talprodott mediċinali ta' referenza Cmax kienet 46.99%.
English: • The Committee was of the view that results of the submitted bioequivalence studies showed that Merisone 50 and 150 mg tablets was bioequivalent to the reference medicinal product Mydeton 50 and 150-mg tablets under fasting conditions;
Maltese: • Il-Kumitat kien tal-fehma li r-riżultati tal-istudji dwar il-bijoekwivalenza sottomessi wrew li l-pilloli Merisone 50 u 150 mg huma bijoekwivalenti għall-prodott mediċinali ta' referenza Mydeton 50 u 150 mg pilloli f'kundizzjonijiet ta' sawm;
English: The majority of the CHMP members agreed that in vivo dissolution differences between formulations are likely to be less apparent and more difficult to observe in fed conditions since gastric emptying time is longer in the fed state than in the fasting state.
Maltese: Il-maġġoranza tal-membri tas-CHMP qablu li d-differenzi fiddissoluzzjoni in vivo bejn il-formulazzjonijiet x'aktarx ikunu anqas evidenti u aktar diffiċli biex jiġu osservati f'kundizzjonijiet ta' sawm peress li l-ħin ta' tbattil tal-istonku huwa itwal fl-istat mitmugħ milli fl-istat sajjem.
English: Therefore based on the results of the submitted bioequivalence studies, the CHMP members agreed that Merisone 50 and 150 mg tablets are bioequivalent to the reference medicinal product Mydeton 50 and 150-mg tablets (Gedeon Richter Plc) under fasting conditions.
Maltese: Għalhekk, abbażi tar-riżultati tal-istudji dwar il-bijoekwivalenza sottomessi, il-membri tas-CHMP qablu li l-pilloli ta' 50 u 150 mg ta' Merisone huma bijoekwivalenti għall-prodott mediċinali ta' referenza Mydeton 50 u 150 mg pilloli (Gedeon Richter Plc) f'kundizzjonijiet ta' sawm.
English: The CHMP noted that the excipients mannitol and betaine found in the product subject to the referral but not in the reference medicinal product, had no effect on the bioequivalence of these products in fasting state.
Maltese: Is-CHMP innota li l-eċċipjenti mannitol u betaina misjubin fil-prodott suġġett għar-riferiment iżda mhux fil-prodott mediċinali ta' referenza, ma kellhom ebda effett fuq il-bijoekwivalenza ta' dawn il-prodotti fi stat sajjem.
English: Taking into account that the MAH had submitted data which showed that tolperisone is a highly soluble and highly permeable active substance, neither solubility nor dissolution was considered to be a limiting factor in terms of in vivo absorption.
Maltese: Meta wieħed iqis li l-MAH kien issottometta dejta li wriet li tolperison huwa sustanza attiva li jinħall ħafna u permeabbli ħafna, la s-solubbiltà u lanqas id-dissoluzzjoni ma tqiesu bħala fattur ta' limitu f'termini ta' assorbiment in vivo.
English: Since the summary of product characteristics (SmPC) of the reference medicinal product did not make any recommendations regarding food and did not mention a food effect, the MAA that was submitted for Merisone included two bioequivalence studies with 50 and 150 mg tolperisone film-coated tablets conducted under fasting conditions with 52 volunteers each.
Maltese: Peress li s-sommarju tal-karatteristiċi tal-prodott (SmPC) tal-prodott mediċinali ta' referenza ma għamel ebda rakkomandazzjoni fir-rigward tal-ikel u ma għamilx referenza għall-effett tal-ikel, l-MAA li kienet sottomessa għal Merisone inkludiet żewġ studji ta' bijoekwivalenza b'pilloli miksijin b'rita ta' tolperison ta' 50 u 150 mg imwettqa f'kundizzjonijiet ta' sawm bi 52 voluntier kull wieħed.
English: 1 Following the outcome of an Article 31 referral procedure on tolperisone-containing medicinal products, for which a Commission decision was adopted in January 2013.
Maltese: 1 Wara l-eżitu tal-proċedura ta' riferiment tal-Artikolu 31 dwar il-prodotti mediċinali li fihom tolperison, li għalihom ġiet adottata deċiżjoni tal-Kummissjoni f'Jannar 2013.
English: • Therefore, the Committee concluded by majority that the bioequivalence studies conducted in the fasting state give sufficient evidence to conclude on the bioequivalence also in the fed state since Merisone contains a highly soluble and highly permeable active substance, and pharmacokinetic principles and convincing experimental evidence suggest that the food effect of this active substance is formulation independent.
Maltese: • Għalhekk, il-Kumitat ikkonkluda b'maġġoranza li l-istudji ta' bijoekwivalenza li saru fl-istat sajjem jagħtu biżżejjed evidenza biex tinstilet konklużjoni dwar il-bijoekwivalenza anki fl-istat mitmugħ peress li Merisone fih sustanza attiva li tinħall ħafna u hija permeabbli ħafna, u l-prinċipji farmakokinetiċi u l-evidenza sperimentali konvinċenti jissuġġerixxu li l-effett tal-ikel ta' din issustanza attiva ma jiddependix fuq il-formulazzjoni.
English: The information that was introduced in the SmPC of tolperisone was based on two well-designed studies conducted with different formulations of tablets, which showed that compared to the fasting state, fat-rich food increases the bioavailability of tolperisone by about
Maltese: Linformazzjoni li ġiet introdotta fl-SmPC ta' tolperison kienet ibbażata fuq studji mfasslin sew, imwettqa b'formulazzjonijiet differenti ta' pilloli, li meta mqabbla mal-istat sajjem, urew li l-ikel b'ħafna xaħam iżid il-bijodisponibbiltà ta' tolperison b'madwar 100%.
English: The objecting concerned member state (CMS) was of the view that a similar extent of the food effect that was shown for the two different products referred to above, does not have to hold true for this generic formulation since it has not been proven that the food effect is a characteristic of the active substance and not a formulation related factor.
Maltese: L-Istat Membru kkonċernat (CMS) li kien qed joġġezzjona kien tal-fehma li firxa simili tal-effett tal-ikel li ntweriet għaż-żewġ prodotti differenti msemmijin hawn fuq, ma għandhiex tapplika għal din ilformulazzjoni ġenerika peress li ma ngħatatx prova li l-effett tal-ikel huwa karatteristika tas-sustanza attiva u mhux fattur relatat mal-formulazzjoni.
English: The Pharmacokinetics Working Party (PKWP) was also consulted to seek their view on whether there is any scientific reasoning that tolperisone (classified as a highly variable drug as the within-subject variability of the Cmax of the reference medicinal product was 46.99%) may have the option of showing bioequivalence in either the fasted or fed state.
Maltese: Il-Parti ta' Ħidma dwar il-Farmakokinetika (PKWP) ġiet ikkonsultata wkoll biex tagħti l-fehma tagħha dwar jekk hemmx xi raġunament xjentifiku li tolperison (ikklassifikat bħala mediċina varjabbli ħafna peress li l-varjabbiltà fi ħdan l-individwi tas-Cmax tal-prodott mediċinali ta' referenza kienet 46.99%) setax ikollu l-għażla li juri bijoekwivalenza fl-istat sajjem jew mitmugħ.
English: The CHMP has recommended the granting of the marketing authorisation for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group, for Merisone and associated names (see Annex I).
Maltese: Is-CHMP irrakkomanda l-għoti tal-awtorizzazzjoni għat-tqegħid fis-suq li għaliha, is-sommarju talkaratteristiċi tal-prodott, it-tikkettar u l-fuljett ta' tagħrif jibqgħu skont il-verżjonijiet finali miksuba waqt il-proċedura tal-Grupp ta' Koordinazzjoni, għal Merisone u ismijiet assoċjati (ara Anness I).
English: • The Committee reviewed the responses submitted by the applicant to address the issues raised with regard to the bioequivalence of Merisone with respect to the reference medicinal product;
Maltese: • Il-Kumitat irreveda r-risponsi sottomessi mill-applikant biex jindirizza l-kwistjonijiet imqajma firrigward tal-bijoekwivalenza ta' Merisone fir-rigward tal-prodott mediċinali ta' referenza;
English: Because the within-subject coefficient of variation is higher than 30%, the applicant was of the view that according to the current bioequivalence guideline extended limits could have been used to show bioequivalence, which would have been in this case 71.25%
Maltese: Peress li l-koeffiċjent tal-varjazzjoni fi ħdan lindividwi huwa ogħla minn 30%, l-applikant kien tal-fehma li skont il-linja gwida attwali dwar ilbijoekwivalenza, setgħu jintużaw limiti estiżi biex tintwera bijoekwivalenza, li f'dan il-każ kienu jkunu ta' 71.25% - 140.35%.
English: Since the effect of these excipients would be diluted in the presence of food, it was considered unlikely that excipients such as mannitol would be larger in fed conditions compared to fasting conditions, given that the effect of mannitol is based on its osmotic effect.
Maltese: Peress li l-effett ta' dawn l-eċċipjenti jkun dilwit fil-preżenza tal-ikel, ma kienx ikkunsidrat probabbli li eċċipjenti bħal mannitol ikunu akbar f'kundizzjonijiet mitmugħa meta mqabbel ma' kundizzjonijiet ta' sawm, peress li l-effett ta' mannitol huwa bbażat fuq l-effett osmotiku tiegħu.
English: Teva Eesti esindus UAB Sicor Biotech Eesti filiaal
Maltese: Teva Eesti esindus UAB Sicor Biotech Eesti
English: Table 1 *
Maltese: Tabella 1 *
English: At least 4 points improvement on ADAS-Cog with no worsening on CIBIC-Plus and PDS *p<0.05, **p<0.01, ***p<0.001
Maltese: Titjib ta' mill-inqas 4 punti fl-ADAS-Cog u li ma jiħżienux is-CIBIC-Plus u PDS *p<0.05, **p<0.01, ***p<0.001
English: Computerweg 10, 3542 DR Utrecht The Netherlands
Maltese: Computerweg 10, 3542 DR Utrecht L-Olanda
English: Placebo N=444
Maltese: Plaċebo N=444
English: The active substance is rivastigmine
Maltese: Is-sustanza attiva hi rivastigmine
English: Placebo N=472
Maltese: Plaċebo N=472
English: In vitro, this metabolite shows minimal inhibition of acetylcholinesterase (<10 %).
Maltese: In vitro, dan il-metabolit juri inibizzjoni minima għal acetylcholinesterase (<10 %).
English: INFORMATION IN BRAILLE Rivastigmine Teva 1.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Rivastigmine Teva 1.5 mg
English: Cardiac arrhythmia (e.g. bradycardia, atrio-ventricular block, atrial fibrillation and tachycardia)
Maltese: Arritmiji tal-qalb (eż. bradikardja, blokk atrijo-ventrikulari, fibrillazzjoni atrijali u takikardja)
English: Adjusted treatment difference n/a p-value versus placebo ITT - LOCF population (n=287)
Maltese: Valur p kontra il-plaċebo Popolazzjoni ITT - LOCF (n=287)
English: Capsule shell - titanium dioxide (E171), gelatin and ink used for imprinting Black S-1-17822/S-117823 (shellac glaze-45% in ethanol containing iron oxide black, N-butyl alcohol, isopropyl alcohol, propylene alcohol and ammonium hydroxide).
Maltese: Il-qoxra tal-kapsula - titanium dioxide (E171), gelatin u linka użata biex tistampa Black S-1-17822/S-117823 (żmalt tax-xellak-45% tal-etanol li fih iron oxide black, N-butyl alcohol, isopropyl alcohol, propylene alcohol u ammonium hydroxide).
English: ADAS-Cog: improvement of at least 4 points
Maltese: ADAS-Cog: titjib ta' mill-anqas 4 punti
English: Absolute bioavailability after a 3 mg dose is about 36 % ± 13 %.
Maltese: Il-bijodisponibilità assoluta wara doża ta' 3 mg hi ta' madwar 36 % ± 13 %.
English: Parkinsonism
Maltese: Parkinsoniżmu
English: In addition, Rivastigmine Teva 3 mg, 4.5 mg and 6 mg hard capsules contain red iron oxide (E172) and yellow iron oxide (E 172).
Maltese: Barra dan, il-kapsuli iebsin ta' Rivastigmine Teva 3 mg, 4.5 mg u 6 mg fihom red iron oxide (E172) u yellow iron oxide (E 172).
English: 28 hard capsules 50 x 1 hard capsules 56 hard capsules 112 hard capsules
Maltese: 28 kapsula iebsa 50 x 1 kapsula iebsa 56 kapsula iebsa 112-il kapsula iebsa
English: CIBIC-Plus: improvement
Maltese: CIBIC-Plus: titjib
English: Pharmacotherapeutic group: anticholinesterases, ATC code: N06DA03
Maltese: Kategorija farmakoterapewtika: anticholinesterases, Kodiċi ATC:
English: Capsule contents - microcrystalline cellulose, hypromellose, colloidal silicon dioxide, magnesium stearate.
Maltese: Il-kontenut tal-kapsula - microcrystalline cellulose, hypromellose, colloidal silicon dioxide, magnesium stearate.
English: Frequency categories are defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Maltese: Komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000) u mhux magħruf (ma tistax tittieħed stima mit-tagħrif disponibbli).
English: Adverse reactions in Table 1 are listed according to MedDRA system organ class and frequency category.
Maltese: Ir-reazzjonijiet avversi f'Tabella 1 huma elenkati skont is-sistema tal-klassifika tal-organi MeDRA u l-kategorija tal-frekwenzi.
English: 4.9 Overdose Symptoms
Maltese: .9 Doża eċċċessiva Sintomi
English: Rivastigmine was not mutagenic in a standard battery of in vitro and in vivo tests, except in a chromosomal aberration test in human peripheral lymphocytes at a dose 104 times the maximum clinical exposure.
Maltese: Rivastigmine ma kienx mutaġeniku f'batterija ta' testijiet standard in vitro u in vivo, għajr f'test ta' aberazzjoni kromosomali f'limfoċiti umani periferali meta ngħatat doża ta' 104 darbiet mill-esponiment kliniku massimu.
English: Based on evidence from in vitro and animal studies the major cytochrome P450 isoenzymes are minimally involved in rivastigmine metabolism.
Maltese: Skont evidenza ta' studju in vitro u fuq l-annimali, l-iżoenzimi tas-cytochrome P450 importanti huma minimament involuti fil-metaboliżmu ta' rivastigmine.
English: Teva Ελλάς Α.Ε.
Maltese: Sewqan u tħaddim ta' magni
English: Clinical studies in Alzheimer's dementia
Maltese: Studji kliniċi b'dimenzja ta' Alzheimer
English: Or:
Maltese: JIS:
English: Ink used for imprinting - Black S-1-17822/S-1-17823 Shellac glaze-45%
Maltese: Linka użata għall-istampar - Black S-1-17822/S-1-17823 Shellac glaze-45%
English: Rivastigmine Teva 1.5 mg hard capsules Rivastigmine Teva 3 mg hard capsules Rivastigmine Teva 4.5 mg hard capsules Rivastigmine Teva 6 mg hard capsules Rivastigmine
Maltese: Rivastigmine Teva 1.5 mg kapsuli iebsin Rivastigmine Teva 3 mg kapsuli iebsin Rivastigmine Teva 4.5 mg kapsuli iebsin Rivastigmine Teva 6 mg kapsuli iebsin
English: 747 70 Opava-Komarov Czech Republic
Maltese: Teva Czech Industries s.r.o Ostravska 29, c.p. 305 747 70 Opava-Komarov Ir-Repubblika Ceka
English: Ostravska 29, c.p.
Maltese: Teva Czech Industries s.r.o Ostravska 29, c.p. 305
English: Bottles 250 hard capsules
Maltese: Fliexken 250 kapsula iebsa
English: These events led to the discontinuation of rivastigmine in some cases (e.g. discontinuations due to tremor 1.7 % on rivastigmine vs 0 % on placebo).
Maltese: Dawn il-każijiet wasslu għat-twaqqif ta' rivastigmine f'xi pazjenti (eż. twaqqif minħabba t-tregħid 1.7% fuq rivastigmine kontra 0% tal-plaċebo).
English: Administration of rivastigmine with food delays absorption (tmax) by 90 min and lowers Cmax and increases AUC by approximately 30 %.
Maltese: Meta rivastigmine jingħata mal-ikel l-assorbiment (tmax) jittardja b'90 min u Cmax jonqos u l-AUC jiżdied b'madwar 30 %.
English: Capsule contents Microcrystalline cellulose Hypromellose Colloidal silicon dioxide Magnesium stearate
Maltese: Il-kontenut tal-kapsula Microcrystalline cellulose Hypromellose Colloidal silicon dioxide Magnesium stearate
English: Rivastigmine Teva hard capsules are available in blister packs of 28, 56 and 112 capsules, perforated blisters containing 50 x 1 capsules, and bottles containing 250 capsules.
Maltese: Il-kapsuli iebsin ta' Rivastigmine Teva jiġi f'folji ta' 28, 50, 56 u 112-il kapula, folji pperforati li fihom 50 x 1 kapsula, u fliexken li fihom 250 kapsula.
English: Ink used for imprinting - Black S-1-17822/S-1-17823
Maltese: Linka użata għall-istampar - Black S-1-17822/S-1-17823
English: Rivastigmine Teva 4.5 mg
Maltese: Teva 4.5 mg
English: Dose titration:
Maltese: Żieda tad-doża:
English: It readily crosses the blood brain barrier and has an apparent volume of distribution in the range of 1.8 - 2.7 l/kg.
Maltese: Huwa jaqsam malajr il-barriera bejn il-moħħ u d-demm u għandu volum apparenti ta' distribuzzjoni b'firxa ta' madwar 1.8 - 2.7 l/kg.
English: Ink used for imprinting - Black S-1-17822/S-1-17823:
Maltese: Linka użata għall-istampar - Black S-1-17822/S-1-17823:
English: - HDPE tablet container with a polypropylene cap and induction seal: 250 capsules
Maltese: - Reċipjent tal-pilloli tal-HDPE b'għatu tal-polypropylene ssiġġillat b'induzzjoni: 250 kapsula
English: The most commonly reported adverse reactions are gastrointestinal, including nausea (38 %) and vomiting (23 %), especially during titration.
Maltese: L-aktar reazzjonijiet avversi komuni rapportati huma dawk gastrointestinali, li jinkludu tqalligħ (38 %) u remettar (23 %), speċjalment waqt li tkun qed tiġi miżjuda d-doża.
English: Do NOT take Rivastigmine Teva
Maltese: Tieħux Rivastigmine Teva
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoluskeletriċi u tattessut konnettiv
English: Patients with Clinically Significant Response (%) Intent to Treat
Maltese: Pazjenti b'Rispons Klinikament Sinifikanti (%)
English: - HDPE tablet container with a polypropylene cap and induction seal: 250 capsules - 28, 56 or 112 capsules in transparent PVC/Alu push through blisters - 50 x 1 capsules in PVC/Alu push through perforated unit dose blisters
Maltese: - Reċipjent tal-pilloli HDPE b'għatu tal-polypropylene ssiġġillat b'induzzjoni: 250 kapsula - Folji trasparenti tal-PVC/Alu li tista' timbotta minnhom ta' 28, 56 jew 112-il kapsula - Folji tal-PVC/Alu ta' doża waħda perforati li tista' timbotta 'l barra b'50 x 1 kapsula
English: Rivastigmine Teva 1.5 mg hard capsules
Maltese: Rivastigmine Teva 1.5 mg kapsuli iebsin
English: Rivastigmine Teva 3 mg hard capsules contains 3 mg rivastigmine as rivastigmine hydrogen tartrate Rivastigmine Teva 4.5 mg hard capsules contains 4.5 mg rivastigmine as rivastigmine hydrogen tartrate
Maltese: Il-kapsuli iebsin ta' 3 mg Rivastigmine Teva fihom 3 mg rivastigmine bħala rivastigmine hydrogen tartrate Il-kapsuli iebsin ta' 4.5 mg ta' Rivastigmine Teva fihom 4.5 mg rivastigmine bħala rivastigmine hydrogen tartrate
English: Cardiac disorders Rare
Maltese: Disturbi tal-qalb Rari
English: Less than 1 % of the administered dose is excreted in the faeces.
Maltese: Anqas minn 1 % tad-doża mogħtija ġiet eliminata malippurgar.
English: Rivastigmine Teva 6 mg hard capsules contains 6 mg rivastigmine as rivastigmine hydrogen tartrate
Maltese: Il-kapsuli iebsin ta' 6 mg ta' Rivastigmine Teva fihom 6 mg rivastigmine bħala rivastigmine hydrogen tartrate
English: Hard capsule Orange colour cap imprinted with “R” & orange color body imprinted with “4.5”
Maltese: Kapsula iebsa Ras ta' kulur oranġjo li fuqha hemm stampat “R” u korp lewn oranġjo li fuqu hemm stampat “4.5”
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea dwar ilMediċini (EMA) http://www.ema.europa.eu
English: The patients studied had an MMSE (Mini-Mental State Examination) score of 10 - 24.
Maltese: Żgħir tal-Istat Mentali) ta' 10 - 24.
English: Table 2 shows the adverse reactions reported in patients with dementia associated with Parkinson's disease treated with rivastigmine.
Maltese: It-Tabella 2 turi reazzjonijiet avversi rapportati f'pazjenti b'dimenzja assoċjata mal-marda ta' Parkinson ikkurati b'rivastigmine.
English: Rivastigmine Teva 1.5 mg hard capsules contains 1.5 mg rivastigmine as rivastigmine hydrogen tartrate
Maltese: Il-kapsuli iebsin ta' 1.5 mg ta' Rivastigmine Teva fihom 1.5 mg rivastigmine bħala rivastigmine hydrogen tartrate
English: Balance disorder
Maltese: Disturbi fil-bilanċ
English: Vascular Disorders Very rare
Maltese: Mhux magħruf Disturbi vaskulari Rari ħafna
English: Musculoskeletal stiffness Rigors
Maltese: Ebusija muskoluskeletrika Tertir
English: PDS: improvement of at least
Maltese: PDS: titjib ta' mill-inqas 10%
English: Some cases of severe vomiting were associated with oesophageal rupture (see section 4.4).
Maltese: Pazjenti b'indeboliment epatiku sever ma kienux studjati (ara sezzjoni 4.4)
English: These include the ADAS-Cog (a performance based measure of cognition), the CIBIC-Plus (a comprehensive global assessment of the patient by the physician incorporating caregiver input), and the PDS (a caregiver-rated assessment of the activities of daily living including personal hygiene, feeding, dressing, household chores such as shopping, retention of ability to orient oneself to surroundings as well as involvement in activities relating to finances, etc.).
Maltese: Dawn jinkludu l-ADAS-Cog (kejl ta' prestazzjoni dwar il-konjizzjoni), Is-CIBIC-Plus (stima globali komprensiva tal-pazjent mit-tabib li tinkorpora l-involviment ta' min qed jieħu ħsiebu), u l-PDS (stima magħmula minn min ikun qed jieħu ħsieb l-attivitajiet tal-ħajja ta' kuljum li jinkludu l-iġene personali, l-ikel, l-ilbies, il-faċendi tad-dar bħax-xiri, ir-ritensjoni tal-ħiliet sabiex wieħed jorjenta ruħu fl-ambjent tal-madwar kif ukoll fl-involviment f'attivitajiet relatati ma' finanzi, eċċ.).
English: Mean baseline ± SD
Maltese: Bidla medja f'24 ġimgħa ± SD
English: NAME OF THE MARKETING AUTHORISATION HOLDER Teva Pharma B.V.
Maltese: ID-DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Teva Pharma B.V.
English: Table 3 lists the number and percentage of patients from the specific 24-week clinical study conducted with rivastigmine in patients with dementia associated with Parkinson's disease with pre-defined adverse events that may reflect worsening of parkinsonian symptoms.
Maltese: Tabella 3 telenka l-għadd u l-perċentwali ta' pazjenti b'każijiet mill-prova klinika speċifika ta' 24 ġimgħa li saret b'rivastigmine f'pazjenti b'dimenzja assoċjata mal-marda ta' Parkinson b'każijiet avversi li jistgħu jirriflettu aggravar tas-sintomi ta' Parkinson.
English: Initial dose: 1.5 mg twice a day.
Maltese: Doża tal-bidu: 1.5 mg darbtejn kuljum.
English: 1 Based on ANCOVA with treatment and country as factors and baseline ADAS-Cog as a covariate.
Maltese: 1 Ibbażat fuq ANCOVA bi trattament u l-pajjiż bħala fatturi u linja bażi ADAS-Cog bħala ko-varjant.