FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, caution should be exercised when rivastigmine is combined with beta-blockers and also other bradycardia agents (e.g.class III antiarrhythmic agents, calcium channel antagonists, digitalis glycoside, pilocarpin).
Maltese: Għalhekk, wieħed għandu joqgħod attent meta rivastigmine jiġi kkombinat mal-imblukkaturi beta kif ukoll ma' aġenti oħrajn li jikkawżaw bradikardija (eż. aġenti antiarritmiċi tal-kategorija III, antagonisti tal-kanali tal-calcium, digitalis glycoside, pilocarpin).
English: Patients with clinically significant renal or hepatic impairment might experience more adverse reactions (see sections 4.2 and 5.2).
Maltese: Pazjenti b'indeboliment renali jew epatiku klinikament sinifikanti jista' jkollhom aktar reazzjonijiet avversi (ara sezzjonijiet 4.2 u 5.2).
English: Nimvastid contains sorbitol E420.
Maltese: Nimvastid fih sorbitol E420.
English: Gastrointestinal disorders Very common Very common Common
Maltese: Disturbi gastrointestinali Komuni ħafna Komuni ħafna Komuni
English: 28 hard capsules 30 hard capsules 56 hard capsules 60 hard capsules 112 hard capsules
Maltese: 28 kapsula iebsa 30 kapsula iebsa 56 kapsula iebsa 60 kapsula iebsa 112-il kapsula iebsa
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 jidher li għandu volum ta' distribuzzjoni b'firxa ta' madwar 1.8 - 2.7 l/kg.
English: Muscle rigidity
Maltese: TAGĦRIF
English: Hallucination, visual Depression
Maltese: Alluċinazzjonijiet, viżivi Dipressjoni
English: Some cases of severe vomiting were associated with oesophageal rupture (see section 4.8).
Maltese: F'każijiet oħra rivastigmine ġie mwaqqaf (ara sezzjoni 4.8).
English: Nimvastid 4.5 mg (on carton label only)
Maltese: Nimvastid 4.5 mg (fuq it-tikketta tal-kartuna biss)
English: Date of first authorisation: 11/5/2009 Date of latest renewal: DD month YYYY
Maltese: Data tal-ewwel awtorizzazzjoni: 11 ta' Mejju 2009 Data tal-aħħar tiġdid: 16 ta' Jannar 2014
English: Bradycardia Atrial Fibrillation Atrioventricular block Sick sinus syndrome
Maltese: Fibrillazzjoni atrijali Imblokk atrijuventrikulari
English: Nimvastid 1.5 mg hard capsules
Maltese: Nimvastid 1.5 mg kapsuli ibsin
English: Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 1.5 mg, 3 mg, 4.5 mg or 6 mg rivastigmine.
Maltese: Kull kapsula iebsa ta' Nimvastid fiha rivastigmine hydrogen tartrate ekwivalenti għal 1.5 mg, 3 mg, 4.5 mg jew 6 mg rivastigmine.
English: Based on evidence from animal studies the major cytochrome P450 isoenzymes are minimally involved in rivastigmine metabolism.
Maltese: Ibbażat fuq l-evidenza ta' studji fuq l-annimali, liżoenzimi tas-cytochrome P 450 importanti huma minimament involuti fil-metaboliżmu ta' rivastigmine.
English: 14 hard capsules 28 hard capsules 30 hard capsules 56 hard capsules 60 hard capsules 112 hard capsules
Maltese: 14-il kapsula iebsa 28 kapsula iebsa 30 kapsula iebsa 56 kapsula iebsa 60 kapsula iebsa 112-il kapsula iebsa
English: There is no relevant use of Nimvastid in the paediatric population in the treatment of Alzheimer's disease.
Maltese: M'hemmx użu relevanti ta' Nimvastid fil-popolazzjoni pedjatrika għat-trattament tal-marda ta' Alzheimer.
English: Less than 1% of the administered dose is excreted in the faeces.
Maltese: Anqas minn 1 % tad-doża mogħtija ġiet eliminata mal-ippurgar.
English: Nimvastid 4.5 mg hard capsules
Maltese: Nimvastid 4.5 mg kapsuli ibsin
English: Cardiac arrhythmia (e.g. bradycardia, atrio-ventricular block, atrial fibrillation and tachycardia) Sick sinus syndrome
Maltese: Problemi fir-ritmu tat-taħbit tal-qalb (eż. bradikardija, imblukkar atrijuventrikulari, fibrillazzjoni tal-atrija u takikardija)
English: Gastrointestinal disorders Very common Very common Very common Common
Maltese: Disturbi gastrointestinali Komuni ħafna Komuni ħafna Komuni ħafna Komuni
English: Nimvastid 1.5 mg (on carton label only)
Maltese: Nimvastid 1.5 mg (fuq it-tikketta tal-kartuna biss)
English: Excipient with known effect: Each orodispersible tablet contains 21 µg sorbitol E420.
Maltese: Kull pillola li tinħall fil-ħalq fiha 21 µg sorbitol E420.
English: Nimvastid 6 mg hard capsules
Maltese: Nimvastid 6 mg kapsuli ibsin
English: Excipient with known effect: Each orodispersible tablet contains 5.25 µg sorbitol E420.
Maltese: Kull pillola li tinħall fil-ħalq fiha 5.25 µg sorbitol E420.
English: Total plasma clearance of rivastigmine was approximately 130 l/h after a 0.2 mg intravenous dose and decreased to 70 l/h after a 2.7 mg intravenous dose.
Maltese: Wara doża minn ġol-vina ta' 0.2 mg, it-tneħħija totali mill-plażma ta' rivastigmine kienet ta' madwar 130 l/h, u din naqset għal 70 l/h wara doża minn ġol-vina ta' 2.7 mg.
English: While bioavailability of rivastigmine is greater in elderly than in young healthy volunteers, studies in Alzheimer patients aged between 50 and 92 years showed no change in bioavailability with age.
Maltese: Filwaqt li l-bijodisponibilità ta' rivastigmine hija ogħla fl-anzjani milli f'żgħażagħ voluntiera b'saħħithom, studji fuq pazjenti li jbatu mill-marda ta' Alzheimer bejn 50 u 92 sena ma wrew l-ebda tibdil fil-bijodisponibilità minħabba età.
English: Pull up the edge of the foil and peel foil off completely, 3.
Maltese: Għolli it-tarf tal-fojl u qaxxar il-fojl kompletament, 3.
English: An initial dose of 0.03 mg/kg intravenous atropine sulphate is recommended, with subsequent doses based on clinical response.
Maltese: Fil-bidu huwa rrakkomandat li tintuża doża ta' 0.03 mg/kg atropine sulphate li tingħata minn ġol-vina, b'dożi oħra ibbażati fuq ir-rispons kliniku.
English: 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1 or 112 x 1 tablet in OPA/Alu/PVC foil film and PET/Alu peel off foil perforated unit dose blister packs in a box.
Maltese: Kaxxa li fiha 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1 or 112 x 1 pilloli f'film ta' folja ipperforata ta' doża waħda tal-OPA/Alu/PVC u folja li titqaxxar tal-PET/Alu.
English: Clinically relevant improvement in these studies was defined a priori as at least 4-point improvement on the ADAS-Cog, improvement on the CIBIC-Plus, or at least a 10% improvement on the PDS.
Maltese: F'dawn listudji, it-titjib klinikament rilevanti kien definit a priori bħala mill-inqas b'4 punti fl-ADAS-Cog, bħala titjib fis-CIBIC-Plus, jew tal-anqas titjib tal 10 % fil-PDS.
English: Tear.
Maltese: Qaxxar.
English: Nimvastid 3 mg hard capsules
Maltese: Nimvastid 3 mg kapsuli ibsin
English: Nimvastid 3mg (on carton label only)
Maltese: Nimvastid 3 mg (fuq it-tikketta tal-kartuna biss)
English: Blister pack (PVC/PVDC/Alu-foil): boxes of 14 (only for 1.5 mg), 28, 30, 56, 60 or 112 hard capsules are available.
Maltese: Pakkett ta' folji (Fojl PVC/PVDC/Alu): jiġu f'kaxxi ta' 14 (għal 1.5 mg biss), 28, 30, 56, 60 jew 112il kapsula iebsa.
English: Patients with body weight below 50 kg may experience more adverse reactions and may be more likely to discontinue due to adverse reactions.
Maltese: Pazjenti li jkollhom piż taħt il-50 kg jista' jkollhom aktar reazzjonijiet avversi u hemm aktar ċans li jwaqqfuh minħabba r-reazzjonijiet avversi.
English: No pharmacokinetic interaction was observed between rivastigmine and digoxin, warfarin, diazepam or fluoxetine in studies in healthy volunteers.
Maltese: Fi studju fuq voluntiera b'saħħithom, ma dehret l-ebda interazzjoni farmakokinetika bejn rivastigmine u digoxin, warfarin, diazepam jew fluoxetine.
English: Cholinergic toxicity has been reported with muscarinic symptoms that are observed with moderate poisonings such as miosis, flushing, digestive disorders including abdominal pain, nausea, vomiting and diarrhoea, bradycardia, bronchospasm and increased bronchial secretions, hyperhidrosis, involuntary urination and/or defecation, lacrimation, hypotension and salivary hypersecretion.
Maltese: Kienet irrappurtata tossiċità kolinerġika b'sintomi muskariniċi li huma osservati b'avvelenament moderat bħal mijosi, fwawar, disturbi diġestivi inklużi uġigħ addominali, dardir, rimettar u dijarea, bradikardija, bronkospażmu u żieda ta' sekrezzjonijiet mill-bronki, għaraq eċċessiv, awrina u/jew purgar involontarji, dmugħ, pressjoni baxxa u sekrezzjoni eċċessiva ta' bżieq.
English: Symptomatic treatment of mild to moderately severe Alzheimer's dementia.
Maltese: Trattament ta' sintomi ta' dimenzja ta' Alzheimer li jkunu ħfief għal severi b'mod moderat.
English: Oral studies in pregnant rats and rabbits gave no indication of teratogenic potential on the part of rivastigmine.
Maltese: Studji orali fuq firien u fniek tqal ma taw ebda indikazzjoni ta' potenzjal teratoġeniku b'rivastigmine.
English: 28 x 1, 30 x 1, 56 x 1, 60 x 1 or 112 x 1 tablet in OPA/Alu/PVC foil film and PET/Alu peel off foil perforated unit dose blister packs in a box.
Maltese: Kaxxa li fiha 28 x 1, 30 x 1, 56 x 1, 60 x 1 or 112 x 1 pilloli f'film ta' folja ipperforata ta' doża waħda tal-OPA/Alu/PVC u folja li titqaxxar tal-PET/Alu.
English: Balance disorder Musculoskeletal stiffness Rigors
Maltese: Riġidità muskolu-skeletrali Ebusija tal-ġisem
English: See leaflet for further information.
Maltese: Tnixxija eċċessiva ta' bżieq Diskajnesja
English: Mean data shown for convenience, categorical analysis performed using van Elteren test ITT: Intent-To-Treat; RDO: Retrieved Drop Outs; LOCF: Last Observation Carried Forward
Maltese: Dawk li waqfu u ġew inklużi; LOCF: L-aħħar osservazzjoni trasferita 'l quddiem
English: 14 x 1 orodispersible tablet 28 x 1 orodispersible tablet 30 x 1 orodispersible tablet 56 x 1 orodispersible tablet 60 x 1 orodispersible tablet 112 x 1 orodispersible tablet
Maltese: 14 x 1 pillola li tinħall fil-ħalq 28 x 1 pillola li tinħall fil-ħalq 30 x 1 pillola li tinħall fil-ħalq 56 x 1 pillola li tinħall fil-ħalq 60 x 1 pillola li tinħall fil-ħalq 112 x 1 pillola li tinħall fil-ħalq
English: Each orodispersible tablet contains rivastigmine hydrogen tartrate equivalent to 1.5 mg, 3 mg, 4.5 mg or 6 mg rivastigmine.
Maltese: Kull pillola li tinħall fil-ħalq fiha rivastigmine hydrogen tartrate ekwivalenti għal 1.5 mg, 3 mg, 4.5 mg jew 6 mg rivastigmine.
English: Caution is advised in patients at higher risk of developing torsade de pointes; for example, those with uncompensated heart failure, recent myocardial infarction, bradyarrhythmias, a predisposition to hypokalaemia or hypomagnesaemia, or concomitant use with medicinal products known to induce QT prolongation and/or torsade de pointes (see sections 4.5 and 4.8).
Maltese: Għandha tingħata attenzjoni f'pazjenti b'riskju ogħla li jiżviluppaw torsade de pointes; pereżempju, dawk b'insuffiċjenza tal-qalb mhux ikkumpensata, infart mijokardiku riċenti, bradiarritmiji, predispożizzjoni għal ipokalemija jew ipomagnesimja, jew l-użu konkomitanti ma' prodotti mediċinali magħrufa li jinduċu titwil tal-QT u/jew torsade de pointes (ara sezzjonijiet 4.5 u 4.8).
English: Patients with severe hepatic impairment have not been studied.
Maltese: Pazjenti b'indeboliment epatiku gravi ma ġewx studjati.
English: Cardiac disorders Rare
Maltese: Disturbi fil-qalb Rari
English: Inhibition of butyrylcholinesterase activity in CSF of 14 Alzheimer patients treated by rivastigmine was similar to that of AChE.
Maltese: L-inibizzjoni tal-attività tat-tip butyrylcholinesterase fis-CSF f'14-il pazjent bil-marda ta' Alzheimer li kienu ttrattati b'rivastigmine kienet simili għal dik ta' AChE.
English: Nimvastid 6 mg (on carton label only)
Maltese: Nimvastid 6 mg (fuq it-tikketta tal-kartuna biss)
English: Rivastigmine is rapidly and extensively metabolised (half-life in plasma approximately 1 hour), primarily via cholinesterase-mediated hydrolysis to the decarbamylated metabolite.
Maltese: Rivastigmine jiġi mmetabolizzat malajr u b'mod estensiv għal metabolit decarbamylated (b'half-life fil-plażma ta' madwar siegħa), prinċipalment permezz ta' idroliżi li ssir b'cholinesterase.
English: No adverse effects of rivastigmine were observed on fertility or reproductive performance in rats (see section 5.3).
Maltese: Ma kenux osservati effetti avversi minħabba rivastigmine fuq il-fertilità jew l-imġiba riproduttiva filfirien (ara sezzjoni 5.3).
English: HDPE container: 200 or 250 hard capsules in a box.
Maltese: Reċipjent HDPE: 200 jew 250 kapsula iebsa f'kaxxa.
English: Rivastigmine may cause bradycardia which constitutes a risk factor in the occurrence of torsade de pointes, predominantly in patients with risk factors.
Maltese: Rivastigmine jista' jikkawża bradikardija li tikkostitwixxi fattur ta' riskju fl-okkorrenza ta' torsade de pointes, b'mod predominanti f'pazjenti b'fatturi ta' riskju.
English: Fatigue and asthenia Gait disturbance Parkinson gait
Maltese: Għeja kbira u astenja Disturbi fil-mixi Parkinson fil-mixi
English: 28 x 1 orodispersible tablet 30 x 1 orodispersible tablet 56 x 1 orodispersible tablet 60 x 1 orodispersible tablet 112 x 1 orodispersible tablet
Maltese: 28 x 1 pillola li tinħall fil-ħalq 30 x 1 pillola li tinħall fil-ħalq 56 x 1 pillola li tinħall fil-ħalq 60 x 1 pillola li tinħall fil-ħalq 112 x 1 pillola li tinħall fil-ħalq
English: difficulty in carrying out movements
Maltese: Disturbi fil-moviment
English: The patients studied had an MMSE (Mini-Mental State Examination) score of 10-24.
Maltese: Żgħir tal-Istat Mentali) ta' 10 - 24.
English: Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 1.5 mg rivastigmine.
Maltese: Kull kapsula rivastigmine hydrogen tartrate ekwivalenti għal 1.5 mg rivastigmine.
English: Common Common Not known
Maltese: Komuni ħafna
English: There is no accumulation of rivastigmine or the decarbamylated metabolite in patients with Alzheimer's disease.
Maltese: M'hemmx akkumulazzjoni ta' rivastigmine jew il-metabolit decarbamylated f'pazjenti li jbatu mill-marda ta' Alzheimer.
English: E.J.
Maltese: U L-UŻU
English: United Kingdom Consilient Health (UK) Ltd. Tel: + 44 (0) 203 751 1888
Maltese: Tel: + 44 (0) 203 751 1888
English: Orodispersible tablet.
Maltese: Mhux applikabbli.
English: Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 4.5 mg rivastigmine.
Maltese: Kull kapsula iebsa fiha rivastigmine hydrogen tartrate ekwivalenti għal 4.5 mg rivastigmine.
English: Unchanged rivastigmine is not found in the urine; renal excretion of the metabolites is the major route of elimination.
Maltese: Ma jinstabx rivastigmine mhux mibdul fl-awrina; l-eliminazzjoni mill-kliewi tal-metaboliti hija l-mezz ewlieni ta' eliminazzjoni.
English: Blister pack (PVC/PVDC/Alu-foil): 14, 28, 30, 56, 60 or 112 hard capsules in a box.
Maltese: Pakkett ta' folji (fojl tal-PVC/PVDC/Alu): 14, 28, 30, 56, 60 jew 112-il kapsula iebsa f'kaxxa.
English: Uncommon (may affect up to 1 in 100 people)
Maltese: Mhux komuni (jista' jaffettwa sa persuna waħda minn kull 100)
English: Extrapyramidal symptoms (including worsening of Parkinson's disease)
Maltese: Sintomi ekstrapiramidali (li jinkludu aggravar tal-marda ta' Parkinson)
English: - The other ingredients for Nimvastid 3 mg, 4.5 mg and 6 mg capsules are microcrystalline cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate in the capsule content,
Maltese: - Is-sustanzi l-oħra għal kapsuli ta' 3 mg, 4.5 mg u 6 mg ta' Nimvastid huma microcrystalline cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate li jinsabu fil-kontenut tal-kapsula, u titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) u ġelatine fil-qoxra tal-kapsula.
English: Dizziness
Maltese: Aġitazzjoni
English: 112 hard capsules: EU/1/09/525/024 200 hard capsules: EU/1/09/525/050 250 hard capsules: EU/1/09/525/025
Maltese: EU/1/09/525/024 200 kapsula iebsa:
English: Metabolism and nutritional disorders Common
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni
English: 112 hard capsules: EU/1/09/525/018 200 hard capsules: EU/1/09/525/049 250 hard capsules: EU/1/09/525/019
Maltese: EU/1/09/525/018 200 kapsula iebsa:
English: In more severe cases nicotinic effects might develop such as muscular weakness, fasciculations, seizures and respiratory arrest with possible fatal outcome.
Maltese: F'każijiet aktar severi jistgħu jiżviluppaw effetti nikotiniċi bħal dgħufija muskolari, faxxikulazzjonijiet, aċċessjonijiet u arrest respiratorju b'possibbiltà ta' riżultat fatali.
English: Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 6 mg rivastigmine.
Maltese: Kull kapsula fiha rivastigmine hydrogen tartrate ekwivalenti għal to rivastigmine 6 mg.
English: Abdominal pain and dyspepsia Gastric and duodenal ulcers Gastrointestinal haemorrhage Pancreatitis
Maltese: Ulċeri fl-istonku u duwodenali Emorraġija gastrointestinali
English: These include the ADAS-Cog (Alzheimer's Disease Assessment Scale - Cognitive subscale, a performance based measure of cognition), the CIBIC-Plus (Clinician's Interview Based Impression of Change-Plus, a comprehensive global assessment of the patient by the physician incorporating caregiver input), and the PDS (Progressive Deterioration Scale, 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 (Skala ta' Evalwazzjoni tal-Marda ta' Alzheimer - Sottoskala konjittiva, sistema ta' kejl tal-konjizzjoni bbażata fuq il-ħila), is-CIBIC-Plus (Intervista mit-Tabib Imsejsa fuq Impressjoni ta' Change-Plus, stima globali komprensiva tal-pazjent mit-tabib, li tinkorpora l-involviment ta' min ikun qed jieħu ħsieb il-kura tas-saħħa), u l-PDS (Skala ta' Deterjorazzjoni Progressiva, stima magħmula minn min ikun qed jieħu ħsieb il-kura tas-saħħa, ta' l-attivitajiet tal-ħajja ta' kuljum li jinkludu l-iġene personali, l-ikel, l-ilbies, il-faċendi tad-dar bħax-xiri, iż-żamma tal-ħila li wieħed jorjenta ruħu fl-ambjent tal-madwar, kif ukoll l-involviment f'attivitajiet relatati ma' finanzi eċċ.).
English: 56 hard capsules: EU/1/09/525/016
Maltese: EU/1/09/525/016
English: Blister pack (PVC/PVDC/Alu-foil): 28, 30, 56, 60 or 112 hard capsules in a box.
Maltese: Pakkett ta' folji (fojl tal-PVC/PVDC/Alu): 28, 30, 56, 60 jew 112-il kapsulai iebsa f'kaxxa.
English: 28 hard capsules: EU/1/09/525/008
Maltese: EU/1/09/525/008
English: 30 hard capsules: EU/1/09/525/009
Maltese: EU/1/09/525/009
English: HDPE container: boxes of 200 or 250 hard capsules are available.
Maltese: Reċipjent HDPE: jiġi f'kaxxi ta' 200 jew 250 kapsula iebsa.
English: The Cmax of rivastigmine was approximately 60% higher and the AUC of rivastigmine was more than twice as high in subjects with mild to moderate hepatic impairment than in healthy subjects.
Maltese: Is-Cmax ta' rivastigmine kien madwar 60% ogħla, u l-AUC ta' rivastigmine kien aktar mid-doppju f'individwi li kellhom indeboliment tal-fwied minn ħafif sa moderat meta mqabbla ma' individwi b'saħħithom.
English: Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 3 mg rivastigmine.
Maltese: Kull kapsula iebsa fiha rivastigmine hydrogen tartrate ekwivalenti għal 3 mg rivastigmine.
English: Patients involved in this study had an MMSE (Mini-Mental State Examination) score of 10-24.
Maltese: Il-pazjenti involuti f'dan l-istudju kellhom punteġġ ta' MMSE (Eżami Qasir tal-Istat Mentali) ta' 10 - 24.
English: 112 hard capsules: EU/1/09/525/012 200 hard capsules: EU/1/09/525/048 250 hard capsules: EU/1/09/525/013
Maltese: EU/1/09/525/012 200 kapsula iebsa:
English: Based on ANCOVA with treatment and country as factors and baseline ADAS-Cog as a covariate.
Maltese: Ibbażat fuq ANCOVA bi trattament u l-pajjiż bħala fatturi u l-linja bażi ADAS-Cog bħala kovarjant.
English: If you have to undergo surgery whilst taking Nimvastid, tell your doctor before you are given any anaesthetics, because Nimvastid may exaggerate the effects of some muscle relaxants during anaesthesia.
Maltese: Jekk ikollok bżonn ta' intervent kirurġiku waqt lit kun qed tieħu Nimvastid, għandek tgħarraf lit-tabib qabel ma tingħata xi loppju, peress li Nimvastid jista' jħarrax l-effetti ta' xi rilassanti tal-muskoli li jingħataw waqt l-anestesija.
English: No untoward effects on cardiac conduction were observed following concomitant administration of digoxin and rivastigmine.
Maltese: Ma ġew osservati l-ebda effetti ħżiena fuq ilkonduttività kardijaka, meta ngħataw digoxin u rivastigmine fl-istess ħin.
English: Cogwheel rigidity Dystonia
Maltese: FULJETT TA' TAGĦRIF
English: Breast-feeding
Maltese: Bradajkinesja
English: 30 hard capsules: EU/1/09/525/021
Maltese: EU/1/09/525/021
English: ITT: Intent-To-Treat; RDO: Retrieved Drop Outs
Maltese: ITT: Intenzjoni li jingħata trattament;
English: The results for clinically relevant responders pooled from two flexible dose studies out of the three pivotal 26-week multicentre studies in patients with mild-to-moderately severe Alzheimer's Dementia, are provided in Table 4 below.
Maltese: It-Tabella 4 hawn taħt turi r-riżultati ta' pazjenti li wrew titjib klinikament rilevanti, li kienu miġbura minn żewġ studji bid-doża flessibbli minn tliet studji ewlenin multiċentrali mifruxa fuq 26 ġimgħa f'pazjenti li jbatu minn dimenzja ta' Alzheimer minnn ħafifa sa moderatament severa.
English: • Trembling or feeling confused
Maltese: Ħolm ikrah Aġitazzjoni Konfużjoni Ansjetà
English: Rivastigmine belongs to a class of substances called cholinesterase inhibitors.
Maltese: Rivastigmine jappartjeni għal klassi ta' sustanzi li jissejħu impedituri ta' cholinesterase.
English: Gait abnormality Muscle rigidity
Maltese: .8 Effetti mhux mixtieqa
English: Initial dose 1.5 mg twice a day.
Maltese: Doża tal-bidu 1.5 mg darbtejn kuljum.
English: 60 hard capsules: EU/1/09/525/017
Maltese: EU/1/09/525/017
English: Common (may affect up to 1 in 10 people)
Maltese: Komuni (jista' jaffettwa sa persuna waħda minn kull 10)
English: BLISTER
Maltese: Sturdament
English: Thus, rivastigmine may have an ameliorative effect on cholinergic-mediated cognitive deficits in dementia associated with Alzheimer's disease and Parkinson's disease.
Maltese: Għalhekk, rivastigmine jista' jkollu effett li jtejjeb id-diffikultajiet ta' konjizzjoni fid-dimenzja, li jsiru b'mod kolinerġiku u li huma assoċjati mal-marda ta' Alzheimer u l-marda ta' Parkinson.
English: 30 hard capsules: EU/1/09/525/015
Maltese: EU/1/09/525/015
English: • Trembling
Maltese: Treddigħ
English: Repeated-dose toxicity studies in rats, mice and dogs revealed only effects associated with an exaggerated pharmacological action.
Maltese: Studji tat-tossiċità bid-doża ripetuta li saru fuq firien, ġrieden u klieb, urew biss effetti assoċjati ma' azzjoni farmakoloġika eżagerata.
English: As a cholinesterase inhibitor, rivastigmine may exaggerate the effects of succinylcholine-type muscle relaxants during anaesthesia.
Maltese: Bħala sustanza li xxekkel il-cholinesterase, rivastigmine jista' jeżaġera l-effetti rilassanti tal-muskoli tat-tip succinylcholine waqt il-loppju.
English: Each orodispersible tablet contains rivastigmine hydrogen tartrate equivalent to 4.5 mg rivastigmine.
Maltese: Kull pillola li tinħall fil-ħalq fiha rivastigmine hydrogen tartrate ekwivalenti għal 4.5 mg rivastigmine.
English: 56 hard capsules: EU/1/09/525/022
Maltese: EU/1/09/525/022
English: Busuttil Ltd. Tel: +356 21 445 885
Maltese: Tel: +356 21 445 885
English: Movement disorder Bradykinesia
Maltese: Anoreksja Tnaqqis fl-aptit Deidrazzjoni
English: Do not use this medicine after the expiry date which is stated on the packaging after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-pakkett ta' barra wara »EXP«.
English: Clinical studies in dementia associated with Parkinson's disease The efficacy of rivastigmine in dementia associated with Parkinson's disease has been demonstrated in a 24-week multicentre, double-blind, placebo-controlled core study and its 24-week open-label extension phase.
Maltese: Studji kliniċi ta' dimenzja assoċjata mal-marda ta' Parkinson L-effikaċja ta' rivastigmine f'dimenzja assoċjata mal-marda tal-Parkinson intweriet fi studju ewlieni ta' 24 ġimgħa, multiċentriku, double-blind bi plaċebo bħala kontroll, u bil-fażi tal-estenzjoni tiegħu ta' 24 ġimgħa bit-tikketta mikxufa.